Cranial prostheses

Abstract

The present invention relates to cranial prostheses and their use in therapy. More specifically, it relates to a cranial prosthesis comprising a plate with holes, the holes including a plurality of holes substantially equidistant from a central location. One such cranial prosthesis comprises a curved plate with holes (1), the holes including four holes (2) substantially equidistant from a central location. The plate further comprises a further hole at the central location (3), removable screw / suture fixation tabs (4) for attaching the cranial prosthesis to the skull via screws / sutures, removable fixation means consisting of a flap (6) for fixing the electrodes when closed, and a recess (7) in the form of a channel suitable for the escape of an extension lead wire, the recess having at least one exit point (15) for connecting the individual electrodes to the main lead wire. A removable protective cap (5) can be placed over the removable fixation means when closed.

Description

Technical Field

[0001] This specification relates to cranial implants. More specifically, this specification relates to cranial implants comprising a perforated plate and a recess suitable for routing lead wires, the holes including a plurality of holes that are substantially equidistant from a central point.

Background Art

[0002] Electrotherapy involves the use of electrical energy in treatment and can be applied to various treatments including the use of electrical devices such as deep brain stimulation devices (DBS) for neurological diseases such as Parkinson's disease. Electrotherapy can be used as physical therapy such as muscle stimulation, pain management, and wound healing, and can also be used for the treatment of mental symptoms such as anxiety, insomnia, depression, hyperarousal, and obsessive-compulsive disorder.

[0003] Electrotherapy has also been proven to be an effective treatment for glioblastoma multiforme (GBM), the most common type of primary brain tumor in adults. In a phase III multi-center clinical trial, it has been shown that when electrotherapy is used in addition to surgery (e.g., surgical resection), chemotherapy, and radiotherapy, the overall survival period of patients can be extended to 21 months (Stupp et al., JAMA, 2017, 318(23):2306 - 16, doi:10.1001 / jama.2017.18718.). This is achieved by supplying an alternating sinusoidal electric field of a predetermined frequency (50 - 300 kHz) to the head. At these frequencies, it has been shown that the electric field inhibits the mitosis of cancer cells, thereby delaying the growth of recurrent tumors and extending the survival period of patients (Kirson et al., PNAS, 2007, 104(24):10152 - 7, doi:10.1073 / pnas.0702916104).

Summary of the Invention

Problems to be Solved by the Invention

[0004] Currently, there is only one electrotherapy device clinically used for cancer treatment. In this device, a therapeutic electric field is delivered to the patient's head by a transducer array attached to the scalp. These transducers are connected to an external battery and stimulator pack, which the patient must carry with them, and the recommended treatment time is 18 hours per day. However, this external stimulation approach has several problems. Firstly, the electric field generated in the brain (where the tumor resection margins are located) is exponentially weaker than the electric field at the skin surface where the electric field is generated, thus limiting the therapeutic effect. Considering this, a large and heavy battery is used to ensure that an electric field of sufficient effective strength is generated at the treatment site, resulting in a very cumbersome device that affects the patient's independence and mobility. Furthermore, the transducers attached to the scalp are very conspicuous, taking about 50 minutes to attach to the head each morning, and the patient's head must be shaved every two days. This has a significant impact on the patient's quality of life, and continuous placement of transducers on the scalp can cause severe skin irritation and associated pain due to the high current flowing through the skin. Due to these impacts on patients' quality of life, only a small percentage of patients utilize the recommended daily administration time (Toms et.al., Journal of Neuro-Oncology, 2019, 141(2):467-473, doi:10.1007 / sll060-018-03057-z). There is a clear correlation between the amount of time GBM patients receive electrotherapy daily and their overall survival. Since the data strongly suggest that continuous (24-hour / day) treatment achieves the highest overall survival rate, patient compliance issues directly limit the effectiveness of the treatment.

[0005] Many of the challenges of existing treatments can be overcome by delivering an electric field from within the tumor or tumor resection cavity. This should result in a higher electric field strength and improved patient outcomes. Furthermore, this approach can eliminate the problem of painful skin irritation experienced with the existing devices mentioned above (for example, there is no sensation when delivered from within brain tissue). This allows for continuous electrotherapy, potentially significantly improving patient outcomes. Delivering an electric field from within the tumor or tumor resection cavity also has advantages for the ancillary devices required to deliver the charge. By applying the electric field intensively, the voltage required to generate the same electric field strength is exponentially lower than with existing devices. Using lower voltages allows for the use of smaller batteries (with longer lifespans), enabling miniaturization and implantation of the device. Complete implantation of the device can overcome several quality of life issues. Nothing is visible from the outside of the body, there is no cumbersome device to carry around, and in the case of brain tumors, there is no need to shave the head.

[0006] Deep brain stimulation (DBS) is a neurosurgical procedure that involves the implantation of a medical device called a nerve stimulator, which delivers electrical impulses to a designated target in the brain through implanted electrodes. Typically, DBS treatment is performed with a single implanted electrode, which may have multiple active sites along its axis. DBS is used to treat movement disorders such as Parkinson's disease, essential tremor, and dystonia. These electrodes can be partially implanted into the patient's brain through a cranial cavity formed in the patient's skull. The cranial cavity is usually formed using a drill fitted with a special drill bit. The electrodes are connected to a charge delivery device via lead wires, which are implanted through the cranial cavity and secured in place via a cranial cavity cover. Various such systems have been disclosed. For example, U.S. Patent Document US2019308025A1 describes a cranial implant for securing a device in a cranial cavity. U.S. Patent Document US2019282802A1 describes a kit and method for securing a cranial cavity plug for a stimulation system. U.S. Patent Document US2014257325A1 describes a recessed cranial cavity cover and its use. U.S. Patent Document US2013304216A1 also describes a cranial cavity cover and its use. However, all of these systems describe devices for a single electrode.

[0007] JingLe Jiang et al. (J. Neurosci. Methods 2017 Feb 1, 277:21-29) described a testbed for optimizing electrodes implanted in the skull or artificial skull prosthesis used after injury. They theorized that chronic brain recording is beneficial for monitoring brain health and seizure progression after injury or surgery, and that directly implanting electrodes in these artificial skull prosthesis is a novel and low-risk method for performing chronic brain monitoring in these patients. The device by JingLe Jiang et al. is not used or suitable for supporting the optimal placement of electrodes implanted in brain tissue.

[0008] When treating brain tumors, cancer cells can be located at any point in the three-dimensional space within the tumor or tumor resection margin, and the local tissue area (<1 cm) that is targeted by deep brain stimulation technology. 3 Much larger than (10cm) 3 It can cover a total tissue volume of approximately [amount]. To ensure effective treatment of all cancer cells within the tumor or tumor resection margin, it is necessary to generate an electric field in the relatively large tissue volume such that the minimum electric field intensity at any spatial point within the 3D volume of the tumor resection margin is sufficient to inhibit mitosis of cancer cells. This can be defined as the clinically effective electric field. Since the electric field intensity decreases exponentially with increasing distance from the stimulating electrode, the generation of a large-capacity clinically effective electric field can be better achieved by using multiple electrodes implanted on spatially separated orbits. By implanting these multiple electrodes along the circumference or periphery of the tumor or tumor resection margin, it is possible to reduce the maximum distance between any point in the 3D space within the tumor or tumor resection margin and the nearest implanted electrode. This increases the minimum electric field intensity in the total volume within the tumor or tumor resection margin. This reduces the required input voltage and the energy required to generate the clinically effective electric field, resulting in extended battery life and a reduction in the overall size of the stimulator. This allows for complete implantation of the medical device, and consequently, can improve the patient's quality of life without affecting the therapeutic effect.

[0009] In addition to ensuring that the electric field strength is a clinically effective electric field, it is also advantageous that the electric field is as uniform as possible. Here, a uniform electric field is defined as an electric field where the electric field strength at any point within the electric field does not depend on the position of that point in 3D space. A uniform electric field further reduces the energy required to generate a clinically effective electric field by reducing the region of the electric field that is overstimulated beyond the clinically effective electric field strength. The uniformity of the electric field generated by multiple implanted electrodes can be enhanced by implanting the electrodes substantially equidistant from the center. The uniformity of the electric field generated by multiple implanted electrodes can be further enhanced by implanting an electrode at the center. The uniformity of the electric field can be further enhanced by implanting one or more electrodes substantially equidistant from the center (e.g., a concentric arrangement with an optional electrode at the center).

[0010] International Patent Publication No. 2017 / 039762 describes a thin intracranial device for use in surgical procedures, particularly cranioplasty, craniofacial surgery, and neurosurgery, but does not anticipate multi-electrode electrotherapy or related issues addressed by the cranial prosthesis of this application. U.S. Patent Document No. 2010 / 0280585 describes a method and apparatus for fixing electrodes, particularly in surgical procedures, in particular a method and apparatus for fixing at least one electrode, for example, at least one electrode of a deep brain stimulator (DBS), to an anatomical structure. However, it does not anticipate or address issues related to multi-electrode electrotherapy addressed by the cranial prosthesis of this application.

[0011] While electrotherapy involving the implantation of multiple electrodes in the brain offers many advantages over existing electrotherapy methods, a device is needed to securely fix the electrodes to the skull in order to safely implant and firmly hold them in place during surgery. This device should be economically compatible with the charge delivery device and accommodate, and preferably neatly organize, the individual leads connecting the multiple implanted electrodes to the charge delivery device. This is because loose leads after surgical implantation pose a risk of skin erosion and wound damage. Furthermore, proper placement helps protect the leads from induced currents during MRI scans. The device must be able to secure these leads in place while minimizing irregular protrusions. Since the device is implanted as part of a complex surgical procedure, surgical ease of use is also important. The more difficult the implantation is for the surgeon, the longer the surgery will be. Longer surgery times increase risks for the patient and increase costs for the hospital system. This application describes a novel cranial prosthesis suitable for use in electrotherapy for the treatment of brain tumors and metastases. [Means for solving the problem]

[0012] This specification partially describes a cranial prosthesis comprising a perforated plate and a recess suitable for accommodating lead wires, wherein the perforation includes a plurality of holes substantially equidistant from a central point.

[0013] This specification also describes, in part, the manufacturing process for cranial prostheses, which includes injection molding, machining, and casting or 3D printing.

[0014] This specification also describes, in part, cranial prostheses for use in electrotherapy.

[0015] Many embodiments of the present invention are described in detail throughout the specification and will be apparent to those skilled in the art. The present invention should not be construed as being limited to any of the embodiments described.

[0016] "A" means "at least one". In any embodiment, if "a" is used to indicate a given material or element, "a" may mean one.

[0017] "Comprising" means that a given material or element can contain other materials or elements. In any embodiment in which "comprising" is mentioned, the given material or element may be formed in an amount of at least 10% w / w, at least 20% w / w, at least 30% w / w, or at least 40% w / w of that material or element. In any embodiment in which "comprising" is mentioned, "comprising" may also mean "consisting of" (or "consists of") or "consisting essentially" (or "consists essentially of") the given material or element.

[0018] "Consisting" or "consists of" means that a given material or element is entirely made of that material or element. In any embodiment in which "consisting" or "consists of" is referred to, the given material or element may be made of 100% w / w material or element.

[0019] "Consisting essentially" or "consists essentially of" means that a given material or element is composed almost entirely of that material or element. In any embodiment in which "consisting essentially" or "consists essentially of" is referred to, the given material or element may be formed of at least 50% w / w, at least 60% w / w, at least 70% w / w, at least 80% w / w, at least 90% w / w, at least 95% w / w, or at least 99% w / w of that material or element.

[0020] "Substantially" means more than 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, or at least 99%.

[0021] In any embodiment in which “comprising” is referred to, “comprising” may also mean “consisting” (or “consists of”) or “consisting essentially” (or “consists essentially of”) a given material or element.

[0022] In any embodiment in which “is” or “may be” is used to define a material or element, “is” or “may be” may mean that the material or element “consists of” or “consists essentially of” that material or element.

[0023] The claims are embodiments.

[0024] The embodiments can be combined.

[0025] (Skull implant) Here, the skull implant includes a perforated plate, specifically, a perforated plate and a depression suitable for the escape of lead wires, and the holes include a plurality of holes that are substantially equidistant from the central location. The skull implant usually replaces a part of the patient's original skull bone that is removed during surgery. Ideally, the skull implant includes an outward-facing surface, and the outward-facing surface is designed so that no pressure points are applied to the skin thereon.

[0026] In one embodiment, the skull implant includes one or more materials, such as metals (e.g., titanium and its alloys), stainless steel, and cobalt-chromium-molybdenum alloys, polymers (e.g., polyetheretherketone, polyethylene, polypropylene, acrylonitrile, butadiene styrene, polysiloxane, polyamide, and polysulfone), ceramics (e.g., zirconia, alumina, and silicate glass), and composites of the above materials.

[0027] In one embodiment, the skull implant can include a carbon material, such as a graphene-based material.

[0028] In one embodiment, the skull implant can include a metal skull implant, such as a skull implant made of titanium and its alloys, stainless steel, and cobalt-chromium-molybdenum alloys.

[0029] In one embodiment, the skull implant can include a polymer skull implant, such as a skull implant made of polyetheretherketone, polyethylene, polypropylene, acrylonitrile, butadiene styrene, polysiloxane, polyamide, and polysulfone.

[0030] In one embodiment, the skull implant can include a polymer skull implant.

[0031] In one embodiment, the skull implant can include a polyetheretherketone skull implant.

[0032] In one embodiment, the cranial prosthesis may include a polyethylene cranial prosthesis.

[0033] In one embodiment, the cranial prosthesis may include a polypropylene cranial prosthesis.

[0034] In one embodiment, the cranial prosthesis may include a cranial prosthesis made of acrylonitrile.

[0035] In one embodiment, the cranial prosthesis may include a cranial prosthesis made of butadiene styrene.

[0036] In one embodiment, the cranial prosthesis may include a polysiloxane-based cranial prosthesis.

[0037] In one embodiment, the cranial prosthesis may be a polyamide cranial prosthesis.

[0038] In one embodiment, the cranial prosthesis may include a polysulfone cranial prosthesis.

[0039] In one embodiment, the cranial prosthesis may include a cranial prosthesis made of ceramics, such as zirconia, alumina, and silicate glass.

[0040] In one embodiment, the cranial prosthesis may include a curved, perforated plate.

[0041] In one embodiment, the cranial prosthesis comprises a curved perforated plate, which is shaped to restore the original contour of the skull.

[0042] In one embodiment, the cranial prosthesis comprises a curved perforated plate having a shape substantially similar to that of the removed skull fragment.

[0043] In one embodiment, the cranial prosthesis may comprise a uniformly curved perforated plate, the curvature of which is uniformly distributed.

[0044] In one embodiment, the cranial prosthesis may comprise a perforated plate that is unevenly curved, with the curvature being unevenly distributed.

[0045] In one embodiment, the cranial prosthesis may comprise a curved perforated plate having asymmetrical curvature, where the radius of curvature in one direction is not equal to the radius of curvature in the direction perpendicular to that direction.

[0046] In one embodiment, the cranial prosthesis may comprise a curved, perforated plate having an asymmetrical curvature similar to that of a portion of the skull. The cranial prosthesis can be manufactured in a variety of asymmetrical shapes, allowing the surgeon to select the shape that best approximates the portion of the skull removed during surgery.

[0047] In one embodiment, cranial prostheses can be custom-made for each patient. Custom manufacturing can be achieved, for example, using the patient's own computed tomography (CT) scan. When cranial prostheses are custom-made, replacement parts can more closely replicate the natural skull and fit more smoothly with the intact skull.

[0048] In one embodiment, the cranial prosthesis has a substantially circular shape.

[0049] In one embodiment, the cranial prosthesis has a substantially circular shape with an average diameter between 1 cm and 15 cm.

[0050] In one embodiment, the cranial prosthesis has a substantially circular shape with an average diameter between 3 cm and 12 cm.

[0051] In one embodiment, the cranial prosthesis has a circular shape.

[0052] In one embodiment, the cranial prosthesis has a circular shape with an average diameter of 1 cm to 15 cm.

[0053] In one embodiment, the cranial prosthesis has a circular shape with an average diameter of 3 cm to 12 cm.

[0054] In one embodiment, the cranial prosthesis has a circular shape with an average diameter of 6 cm to 12 cm.

[0055] In one embodiment, the cranial prosthesis has a circular shape with an average diameter of 8 cm to 10 cm.

[0056] In one embodiment, the cranial prosthesis has a thickness of less than 1 cm.

[0057] In one embodiment, the cranial prosthesis has a thickness of less than 0.9 cm.

[0058] In one embodiment, the cranial prosthesis has a thickness of less than 0.8 cm.

[0059] In one embodiment, the cranial prosthesis has a thickness of less than 0.7 cm.

[0060] In one embodiment, the cranial prosthesis has a thickness of less than 0.6 cm.

[0061] In one embodiment, the cranial prosthesis has a thickness of less than 0.5 cm.

[0062] In one embodiment, the cranial prosthesis has a thickness of 0.5 to 0.8 cm.

[0063] (A recess suitable for accommodating lead wires) The cranial prosthesis includes recesses suitable for accommodating lead wires. In one embodiment, the cranial prosthesis may comprise a perforated plate, the perforated plate comprising a plurality of holes substantially equidistant from a central point, and the perforated plate comprising further recesses. These additional recesses may be within the body of the plate and included on the outward-facing surface of the plate. In one embodiment, the recesses are channels suitable for accommodating extension lead wires connecting individual electrodes to the main lead wires. In one embodiment, the perforated plate comprises further recesses, the further recesses being channels suitable for accommodating extension lead wires connecting individual electrodes to the main lead wires. The extension lead wires may be connected to electrodes, or the extension lead wires may be part of the electrodes themselves. The main lead wires are lead wires that can be connected to a charge delivery device. When the extension lead wires are positioned to accommodate the lead wires, the likelihood of them coming loose during use is reduced.

[0064] In one embodiment, the recess suitable for accommodating lead wires includes a series of interconnecting channels.

[0065] In one embodiment, the recess suitable for accommodating the lead wire is a channel that is recessed around the periphery.

[0066] In one embodiment, the recess suitable for accommodating lead wires includes a series of interconnecting channels and recessed channels around the periphery.

[0067] In one embodiment, the recess suitable for accommodating the lead wire comprises a recessed channel located at least 1 mm away from the outer edge of the cranial prosthesis.

[0068] In one embodiment, the recess suitable for accommodating the lead wire comprises a recessed channel located at least 2 mm away from the outer edge of the cranial prosthesis.

[0069] In one embodiment, the recess suitable for accommodating the lead wire comprises a recessed channel located at least 3 mm away from the outer edge of the cranial prosthesis.

[0070] In one embodiment, the recess suitable for escaping the lead wire comprises a series of interconnected channels having at least one exit point. The exit point may be a further recess on the outer circumference of the cranial prosthesis, which allows an extension lead wire to connect to (or form) the main lead wire.

[0071] In one embodiment, the recess suitable for escaping lead wires comprises a recessed channel around a perimeter having at least one exit point. In one embodiment, the at least one exit point is one to ten exit points. In one embodiment, the at least one exit point is four to ten exit points. In one embodiment, the at least one exit point is two exit points. In one embodiment, the at least one exit point is four exit points. In one embodiment, the at least one exit point is eight exit points.

[0072] In one embodiment, the recess suitable for escaping the lead wire comprises a series of interconnected channels having multiple exit points. The multiple exit points allow for the adaptive positioning of the main lead wire during surgery. In one embodiment, only one of the exit points is used for connection to the main lead wire.

[0073] In one embodiment, a recess suitable for escaping lead wires comprises a recessed channel around a periphery having multiple exit points.

[0074] In one embodiment, a recess suitable for escaping lead wires comprises a recessed channel with a width that varies around its periphery. Varying the width allows for narrower sections of the channel that secure the lead wires in place and function as pinch points. These varying widths can be achieved by gentle undulations or by one or more protrusions within the channel.

[0075] (hole) Here, the cranial prosthesis comprises a perforated plate and a recess suitable for accommodating lead wires, the perforation including multiple holes substantially equidistant from the central point.

[0076] In one embodiment, "multiple holes" refers to at least two holes.

[0077] In one embodiment, "multiple holes" refers to at least three holes.

[0078] In one embodiment, the multiple holes refer to at least four holes.

[0079] In one embodiment, the multiple holes refer to at least five holes.

[0080] In one embodiment, "multiple holes" refers to two holes.

[0081] In one embodiment, "multiple holes" refers to three holes.

[0082] In one embodiment, "multiple holes" refers to four holes.

[0083] In one embodiment, "multiple holes" refers to five holes.

[0084] In one embodiment, the hole refers to a substantially circular hole.

[0085] In one embodiment, the term "hole" refers to a circular hole.

[0086] In one embodiment, the hole refers to a slit.

[0087] In one embodiment, the hole refers to a cross-shaped hole.

[0088] In one embodiment, multiple holes may be present at substantially equal distances from the central point (for example, in a concentric arrangement).

[0089] (center location) Here, the cranial prosthesis comprises a perforated plate and a recess suitable for accommodating lead wires, the perforations comprising multiple holes substantially equidistant from a central point. The central point is relative to the holes and does not necessarily have to be at the center of the perforated plate, but it may be.

[0090] In one embodiment, being substantially equidistant from the center means that the nearest point of each hole and the center are the same distance within a range of ±20%.

[0091] In one embodiment, being substantially equidistant from the center means that the midpoint of each hole and the center are the same distance apart within a ±20% range.

[0092] In one embodiment, being substantially equidistant from the center means that the nearest point of each hole and the center are the same distance apart within a range of ±10%.

[0093] In one embodiment, being substantially equidistant from the center means that the midpoint of each hole and the center are the same distance apart within a ±10% range.

[0094] In one embodiment, being substantially equidistant from the center means that the nearest point of each hole and the center are the same distance apart within a range of ±5%.

[0095] In one embodiment, being substantially equidistant from the center means that the midpoint of each hole and the center are the same distance apart within a ±5% range.

[0096] In one embodiment, there is an additional hole in the center. In a further embodiment, the hole in the center has a different shape from the other holes.

[0097] (Fixing means) In one embodiment, the cranial prosthesis further comprises fixing means for securing electrodes in a predetermined position within the holes. This is particularly useful when the holes in the plate are larger than the electrodes. When open, the fixing means allow for flexible positioning of the electrodes. When closed, the fixing means can be used to clamp the electrodes and fix their position. These fixing means may be integral components of the cranial prosthesis, or they may be separate components that can be attached to the cranial prosthesis.

[0098] In one embodiment, the fastening means may include a locking component insert, which, for example, tightens when locked.

[0099] In one embodiment, the fixing means may include a ball and socket fixing device.

[0100] In one embodiment, the fastening means may include a threaded locking component.

[0101] In one embodiment, the fastening means may include one or more sliding locking components.

[0102] In one embodiment, the fixing means may include a flap that secures the electrode when closed. The flap can be attached to a perforated plate via a hinge.

[0103] In one embodiment, the fixing means may include a clip for holding the electrode.

[0104] In one embodiment, the fixing means may include a plug-in type mounting device.

[0105] In one embodiment, the fastening means includes one or more materials, such as metals (e.g., titanium and its alloys), stainless steel, and cobalt-chromium-molybdenum alloys, polymers (e.g., polyetheretherketone, polyethylene, polypropylene, acrylonitrile, butadienestyrene, polysiloxane, polyamide, and polysulfone), ceramics (e.g., zirconia, alumina, and silicate glass), and composites of the above materials.

[0106] In one embodiment, the fixing means may include a carbon material, such as a graphene-based material.

[0107] In one embodiment, the fastening means may include metals such as titanium and its alloys, stainless steel, and cobalt-chromium-molybdenum alloys.

[0108] In one embodiment, the fixation means may include polymers such as polyether ether ketone, polyethylene, polypropylene, acrylonitrile, butadiene styrene, polysiloxane, polyamide, and polysulfone.

[0109] In one embodiment, the fixing means may include ceramics, such as zirconia, alumina, and silicate glass.

[0110] (Protective cap) In one embodiment, protective caps can be placed over the holes in the plate. These protective caps protect the electrodes and extension leads and help hold the electrodes in place. The protective caps may be placed directly over the holes, or, if additional fastening means are used, these protective caps may be placed on additional fastening means.

[0111] In one embodiment, the protective cap includes a thin protective cap.

[0112] In one embodiment, the protective cap includes a push-fit protective cap.

[0113] In one embodiment, the protective cap includes a plastic protective cap.

[0114] In one embodiment, the protective cap includes a protective cap made of polysiloxane.

[0115] In one embodiment, the protective cap includes a protective cap made of polyetheretherketone.

[0116] In one embodiment, the protective cap includes a friction-fit protective cap.

[0117] In one embodiment, the protective cap includes a snap-on protective cap.

[0118] In one embodiment, the protective cap includes a screw attachment.

[0119] In one embodiment, the protective cap includes a plug-in mounting device.

[0120] In one embodiment, the protective cap includes an electrical connector and integrates an extension lead wire that connects an embedded electrode to the main lead wire.

[0121] (Fixing means) In one embodiment, the cranial prosthesis can be fixed in a predetermined position within the cranial window.

[0122] In one embodiment, an adhesive is used to fix the cranial prosthesis.

[0123] In one embodiment, the cranial prosthesis includes means for attaching the cranial prosthesis via screws, such as screw-fastening tabs. These tabs are either incorporated into the cranial prosthesis or fixed to the cranial prosthesis. Suitable screws include titanium screws.

[0124] In one embodiment, the cranial prosthesis includes means for attaching the cranial prosthesis via fixing tabs. The fixing tabs allow for the appropriate placement of screws or sutures through them.

[0125] Alternatively, a series of fixation holes can be introduced along the periphery of the cranial prosthesis. This allows for the attachment of fixation plates, such as titanium bone plates. Or, this allows for the placement of sutures.

[0126] (process) The described cranial prostheses can be manufactured by a variety of techniques, including injection molding, machining (e.g., computer numerical control machining), casting, or 3D printing (e.g., fusion deposition modeling, stereolithography, selective laser sintering).

[0127] In one embodiment, a process for manufacturing the cranial prosthesis described herein is provided, including injection molding.

[0128] In one embodiment, a process for manufacturing the cranial prosthesis described herein is provided, which includes machining (e.g., computer numerical control machining).

[0129] In one embodiment, a process for manufacturing the cranial prosthesis described herein is provided, including casting.

[0130] In one embodiment, a process for manufacturing the cranial prosthesis described herein is provided, including 3D printing (e.g., fusion deposition modeling, stereolithography, selective laser sintering).

[0131] (Use of cranial prostheses) The cranial prostheses described herein can be used in surgery in electrotherapy, including the following procedure:

[0132] 1. Make an incision in the scalp and fold the skin flap back. 2. Open a cranial window large enough to accommodate the prosthesis, and remove the bone. 3. Attach the prosthesis so as to cover the cranial window and fix it in place. 4. Insert the electrodes. 5. Secure the electrodes in place. 6. Cut the electrodes to the appropriate length. 7. Attach the extension lead wires to the electrodes. 8. Optionally, attach protective caps to the electrodes to secure them. 9. Organize the wiring within the channel so that it is not visible and secure it in place. 10. Put the skin flap back in place and suture it. 11. Connect the main lead wires to the charge supply device.

[0133] Alternatively, the cranial prostheses described herein may be used in surgery in electrotherapy, including the following procedure:

[0134] 1. The scalp is incised and the skin flap is retracted. 2. Open a cranial window large enough to accommodate the prosthesis, and remove the bone. 3. Attach the prosthesis so as to cover the cranial window and fix it in place. 4. Insert the electrodes. 5. Secure the electrodes in place. 6. Optionally, cut the electrodes to the appropriate length. 7. Optionally, attach extension lead wires to the electrodes if they are not yet integrated into the electrodes or protective caps. 8. Optionally, attach protective caps to the electrodes to secure them, or create electrical contacts. 9. Organize the wiring within the channel so that it is not visible and secure it in place. 10. Put the skin flap back in place and suture it. 11. Connect the main lead wires to the charge supply device.

[0135] (Electrotherapy) In one embodiment, an electrotherapy device is provided that includes a cranial prosthesis comprising a perforated plate and a recess suitable for accommodating lead wires, wherein the perforation includes a plurality of holes substantially equidistant from a central point.

[0136] In one embodiment, a multi-electrode electrotherapy device is provided that includes a perforated plate and a recess suitable for accommodating lead wires, wherein the perforation includes a plurality of holes substantially equidistant from a central point.

[0137] In one embodiment, electrotherapy is provided, including a cranial prosthesis described herein. In one embodiment, electrotherapy refers to multi-electrode electrotherapy. Electrotherapy is the use of electrical energy as a treatment.

[0138] In one embodiment, the use of electrotherapy comprising a cranial prosthesis described herein for the following treatments is provided.

[0139] Brain tumors (including grade I, II, III, or IV glioma), pilocytic astrocytoma, subependymal giant cell astrocytoma, diffuse astrocytoma, oligodendroglioma, oligodendroglioma NOS, anaplastic astrocytoma, undifferentiated astrocytoma differentiated oligodendroglioma, undifferentiated oligodendroglioma NOS, glioblastoma, giant cell glioblastoma, glioblastoma multiforme, subependymal giant cell astrocytoma, follicular astrocytoma, pleomorphic xanthoastrocytoma, glioma, oligoastrocytoma, Meningiomas (including Grade I, II, or III meningiomas and other neoplasms associated with the meninges, such as perivascular cell tumors), pediatric brain tumors (including ependymoma, medulloblastoma, atypical teratoid / rhapsomatic tumor (AT / RT), choroid plexus papilloma, choroid plexus carcinoma, intracranial teratoma, embryonal tumor with multilayer rosettes (ETMR)), pineal gland tumors (such as pineoblastoma), pituitary gland tumors (such as pituitary adenoma, craniopharyngioma, chordoma), Brain metastases (for example, brain metastases from lung cancer, breast cancer, genitourinary cancer, osteosarcoma, melanoma), Stimulation of nerve tissue for the treatment or symptom relief of neurological conditions (e.g., promoting neurological recovery after brain injury due to stroke / trauma), Recording of brain activity for diagnostic purposes or to enable brain-computer interface communication. Deep brain stimulation (e.g., treatment of motor disorders (e.g., Parkinson's disease, essential tremor, dystonia) and psychiatric symptoms (e.g., anxiety, insomnia, depression, hyperarousal, obsessive-compulsive disorder)), Pain management, or, Wound healing.

[0140] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of diffuse median glioma is provided.

[0141] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for stimulating the seizure-initiating region for the treatment or symptom relief of drug-resistant epilepsy is provided.

[0142] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for adjuvant therapy is provided.

[0143] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of a brain tumor is provided.

[0144] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of grade I, II, III, or IV gliomas is provided.

[0145] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade I glioma is provided.

[0146] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of pilocytic astrocytoma is provided.

[0147] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade II glioma is provided.

[0148] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of diffuse astrocytoma or oligodendroglioma is provided.

[0149] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade III glioma is provided.

[0150] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of undifferentiated astrocytoma or undifferentiated oligodendroglioma is provided.

[0151] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade IV glioma is provided.

[0152] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of giant cell glioblastoma or glioblastoma multiforme is provided.

[0153] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of glioblastoma multiforme is provided.

[0154] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of a brain tumor after surgical resection is provided.

[0155] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of grade I, II, III, or IV gliomas after surgical resection is provided.

[0156] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of grade I glioma after surgical resection is provided.

[0157] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of pilocytic astrocytoma after surgical excision is provided.

[0158] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade II glioma after surgical resection is provided.

[0159] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein is provided for the treatment of diffuse astrocytoma or oligodendroglioma after surgical resection.

[0160] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of grade III glioma after surgical resection is provided.

[0161] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of undifferentiated astrocytoma or undifferentiated oligodendroglioma after surgical resection is provided.

[0162] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of grade IV glioma after surgical resection is provided.

[0163] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of diffuse median glioma is provided.

[0164] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of brain metastases is provided.

[0165] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment or symptom relief of drug-resistant epilepsy is provided.

[0166] In one embodiment, the use of electrotherapy including the cranial prosthesis described herein for the treatment of giant cell glioblastoma or glioblastoma multiforme after surgical resection is provided.

[0167] In one embodiment, the use of electrotherapy including a cranial prosthesis described herein for the treatment of glioblastoma multiforme after surgical resection is provided.

[0168] (use) In one embodiment, a cranial prosthesis for use in electrotherapy is provided, the cranial prosthesis comprising a perforated plate, the perforations comprising a plurality of holes substantially equidistant from a central point.

[0169] In one embodiment, a cranial prosthesis for use in multi-electrode electrotherapy is provided, the cranial prosthesis comprising a perforated plate, the perforations comprising a plurality of holes substantially equidistant from a central point.

[0170] In one embodiment, a cranial prosthesis for use in electrotherapy is provided, comprising a perforated plate and a recess suitable for accommodating lead wires, wherein the perforation includes a plurality of holes substantially equidistant from a central point.

[0171] In one embodiment, a cranial prosthesis for use in multi-electrode electrotherapy is provided, the cranial prosthesis comprising a perforated plate and recesses suitable for accommodating lead wires, wherein the perforations include a plurality of holes substantially equidistant from a central point.

[0172] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy. In one embodiment, electrotherapy refers to multi-electrode electrotherapy.

[0173] Electrotherapy is the use of electrical energy as a treatment.

[0174] In one embodiment, a cranial prosthesis described herein is provided for use in the following electrotherapy treatments.

[0175] Brain tumors (including grade I, II, III, or IV glioma), pilocytic astrocytoma, subependymal giant cell astrocytoma, diffuse astrocytoma, oligodendroglioma, oligodendroglioma NOS, anaplastic astrocytoma, undifferentiated astrocytoma differentiated oligodendroglioma, undifferentiated oligodendroglioma NOS, glioblastoma, giant cell glioblastoma, glioblastoma multiforme, subependymal giant cell astrocytoma, follicular astrocytoma, pleomorphic xanthoastrocytoma, glioma, oligoastrocytoma, Meningiomas (including Grade I, II, or III meningiomas and other neoplasms associated with the meninges, such as perivascular cell tumors), pediatric brain tumors (including ependymoma, medulloblastoma, atypical teratoid / rhapsomatic tumor (AT / RT), choroid plexus papilloma, choroid plexus carcinoma, intracranial teratoma, embryonal tumor with multilayer rosettes (ETMR)), pineal gland tumors (such as pineoblastoma), pituitary gland tumors (such as pituitary adenoma, craniopharyngioma, chordoma), Brain metastases (for example, brain metastases from lung cancer, breast cancer, genitourinary cancer, osteosarcoma, melanoma), Stimulation of nerve tissue for the treatment or symptom relief of neurological conditions (e.g., promoting neurological recovery after brain injury due to stroke / trauma), Recording of brain activity for diagnostic purposes or to enable brain-computer interface communication. Deep brain stimulation (e.g., treatment of motor disorders (e.g., Parkinson's disease, essential tremor, dystonia) and psychiatric symptoms (e.g., anxiety, insomnia, depression, hyperarousal, obsessive-compulsive disorder)), Pain management, or, Wound healing.

[0176] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of diffuse median glioma.

[0177] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of drug-resistant epilepsy or in the relief of symptoms of drug-resistant epilepsy.

[0178] In one embodiment, a cranial prosthesis described herein is provided for use in adjuvant therapy.

[0179] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of brain tumors.

[0180] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade I, II, III, or IV gliomas.

[0181] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of grade I glioma.

[0182] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of pilocytic astrocytoma.

[0183] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of grade II glioma.

[0184] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of diffuse astrocytoma or oligodendroglioma.

[0185] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of grade III glioma.

[0186] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of undifferentiated astrocytoma or undifferentiated oligodendroglioma.

[0187] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade IV glioma.

[0188] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of diffuse median glioma.

[0189] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of brain metastases.

[0190] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of drug-resistant epilepsy or in the relief of symptoms from drug-resistant epilepsy.

[0191] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of giant cell glioblastoma or glioblastoma multiforme.

[0192] In one embodiment, a cranial prosthesis described herein is provided for use in the electrotherapy treatment of glioblastoma multiforme.

[0193] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of a brain tumor after surgical resection.

[0194] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade I, II, III, or IV gliomas after surgical resection.

[0195] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade I glioma after surgical resection.

[0196] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of pilocytic astrocytoma after surgical excision.

[0197] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade II glioma after surgical resection.

[0198] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of diffuse astrocytoma or oligodendroglioma after surgical resection.

[0199] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade III glioma after surgical resection.

[0200] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of undifferentiated astrocytoma or undifferentiated oligodendroglioma after surgical resection.

[0201] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of grade IV glioma after surgical resection.

[0202] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of giant cell glioblastoma or glioblastoma multiforme after surgical resection.

[0203] In one embodiment, a cranial prosthesis described herein is provided for use in electrotherapy treatment of glioblastoma multiforme after surgical resection.

[0204] (Treatment method) According to further embodiments, a cranial prosthesis as defined herein is provided for use in a method of treating the body of a human or animal by therapy.

[0205] According to further embodiments, a cranial prosthesis as defined herein is provided for use in a method of electrotherapy of the human or animal body.

[0206] A further feature of this embodiment provides a method of electrotherapy for warm-blooded animals such as humans, the method comprising a cranial prosthesis as defined herein, and including performing electrotherapy on the animal.

[0207] A further feature of this embodiment provides a method for treating the following:

[0208] Brain tumors (including grade I, II, III, or IV glioma), pilocytic astrocytoma, subependymal giant cell astrocytoma, diffuse astrocytoma, oligodendroglioma, oligodendroglioma NOS, anaplastic astrocytoma, undifferentiated astrocytoma differentiated oligodendroglioma, undifferentiated oligodendroglioma NOS, glioblastoma, giant cell glioblastoma, glioblastoma multiforme, subependymal giant cell astrocytoma, follicular astrocytoma, pleomorphic xanthoastrocytoma, glioma, oligoastrocytoma, Meningiomas (including Grade I, II, or III meningiomas and other neoplasms associated with the meninges, such as perivascular cell tumors), pediatric brain tumors (including ependymoma, medulloblastoma, atypical teratoid / rhapsomatic tumor (AT / RT), choroid plexus papilloma, choroid plexus carcinoma, intracranial teratoma, embryonal tumor with multilayer rosettes (ETMR)), pineal gland tumors (such as pineoblastoma), pituitary gland tumors (such as pituitary adenoma, craniopharyngioma, chordoma), Brain metastases (for example, brain metastases from lung cancer, breast cancer, genitourinary cancer, osteosarcoma, melanoma), Stimulation of nerve tissue for the treatment or symptom relief of neurological conditions (e.g., promoting neurological recovery after brain injury due to stroke / trauma), Recording of brain activity for diagnostic purposes or to enable brain-computer interface communication. Deep brain stimulation (e.g., treatment of motor disorders (e.g., Parkinson's disease, essential tremor, dystonia) and psychiatric symptoms (e.g., anxiety, insomnia, depression, hyperarousal, obsessive-compulsive disorder)), Pain management, or, Wound healing.

[0209] This includes administering electrotherapy to warm-blooded animals such as humans, including a cranial prosthesis as defined herein.

[0210] A further feature of this embodiment provides a method for treating diffuse median glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0211] A further feature of this embodiment provides a method for treating drug-resistant epilepsy in warm-blooded animals such as humans, or for reducing symptoms from drug-resistant epilepsy, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0212] A further feature of this embodiment provides a method for treating brain tumors in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0213] A further feature of this embodiment is a method for treating a grade I, II, III, or IV glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0214] A further feature of this embodiment provides a method for treating grade I gliomas in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0215] A further feature of this embodiment provides a method for treating pilocytic astrocytoma in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0216] A further feature of this embodiment provides a method for treating grade II glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0217] A further feature of this embodiment provides a method for treating astrocytoma or oligodendrocyte in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0218] A further feature of this embodiment provides a method for treating grade III glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0219] A further feature of this embodiment provides a method for treating undifferentiated astrocytoma or undifferentiated oligodendroglioma in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0220] A further feature of this embodiment provides a method for treating grade IV glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0221] A further feature of this embodiment provides a method for treating diffuse median glioma in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0222] A further feature of this embodiment provides a method for treating brain metastases in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0223] A further feature of this embodiment provides a method for treating or alleviating drug-resistant epilepsy in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0224] A further feature of this embodiment provides a method for treating giant cell glioblastoma or glioblastoma pleomorphon in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0225] A further feature of this embodiment provides a method for treating glioblastoma polymorphism in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0226] A further feature of this embodiment provides a method for treating brain tumors in warm-blooded animals such as humans after surgical resection, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0227] A further feature of this embodiment provides a method for treating grade I, II, III, or IV gliomas after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0228] A further feature of this embodiment provides a method for treating grade I gliomas after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0229] A further feature of this embodiment provides a method for treating a pilocytic astrocytoma after surgical excision in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0230] A further feature of this embodiment provides a method for treating a grade II glioma after surgical resection in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0231] A further feature of this embodiment provides a method for treating diffuse astrocytoma or oligodendroglioma after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0232] A further feature of this embodiment provides a method for treating a grade III glioma after surgical resection in a warm-blooded animal such as a human, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0233] A further feature of this embodiment provides a method for treating undifferentiated astrocytoma or undifferentiated oligodendroglioma in warm-blooded animals such as humans after surgical resection, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0234] A further feature of this embodiment provides a method for treating grade IV gliomas after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0235] A further feature of this embodiment provides a method for treating diffuse median glioma after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0236] A further feature of this embodiment provides a method for treating brain metastases after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0237] A further feature of this embodiment provides a method for treating or alleviating drug-resistant epilepsy in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0238] A further feature of this embodiment provides a method for treating giant cell glioblastoma or glioblastoma pleomorphoni in warm-blooded animals such as humans after surgical resection, the method comprising administering electrotherapy to the animal, including a cranial prosthesis as defined herein.

[0239] A further feature of this embodiment provides a method for treating glioblastoma multiforme after surgical resection in warm-blooded animals such as humans, the method comprising administering electrotherapy to the animals, including a cranial prosthesis as defined herein.

[0240] (kit) In one embodiment, 1. The cranial prosthesis described herein, 2. One or more electrodes, 3. Charge delivery device and, A kit including this will be provided.

[0241] In one embodiment, 1. The cranial prosthesis described herein, 2. One or more electrodes, A kit including this will be provided.

[0242] In one embodiment, 1. The cranial prosthesis described herein, 2. Charge delivery device and, A kit including this will be provided. [Brief explanation of the drawing]

[0243] [Figure 1A] This figure shows a plan view of a cranial prosthesis comprising a perforated plate (1), wherein the perforations include four holes (2) substantially equidistant from the center. [Figure 1B] The figure shows a plan view of a cranial prosthesis comprising a perforated plate (1), wherein the perforation includes four holes (2) substantially equidistant from a central point, and further comprises at least one exit point (15), a recess suitable for the escape of a lead wire (7), and a projection into a channel (14). [Figure 2A] The diagram shows a plan view of a cranial prosthesis comprising a perforated plate (1), the perforations including four holes (2) substantially equidistant from a central point. The plate also has a further hole at a central point (3) and incorporates screw-fastening tabs (4) for attaching the cranial prosthesis to the skull via screws. [Figure 2B] The diagram shows a plan view of a cranial prosthesis comprising a perforated plate (1), the perforations including four holes (2) substantially equidistant from a central location. The plate also comprises a further hole at a central location (3), at least one exit point (15), a recess suitable for the escape of a lead wire (7), a projection into a channel (14), and an integrated screw hole (13). [Figure 3A]A side view of a cranial prosthesis comprising a curved perforated plate (1), the perforations including four holes (2) substantially equidistant from a central portion. The plate also comprises a further hole at a central portion (3), a removable fastening means comprising a removable screw fastening tab (4) for attaching the cranial prosthesis to the skull via screws, a flap (6) for securing electrodes when closed, and a channel-shaped recess (7) suitable for the clearance of lead wires (7), having at least one exit point (15) for connecting individual electrodes to the main lead wires. A removable protective cap (5) can be placed over the removable fastening means when closed, the cranial prosthesis. [Figure 3B] A side exploded view of a cranial prosthesis comprising a curved perforated plate (1), the perforations including four holes (2) substantially equidistant from a central portion. The plate also comprises a further hole at a central portion (3), a removable screw-fastening tab (4) and screw holes (13) for attaching the cranial prosthesis to the skull via screws or sutures, a removable fastening means comprising a flap (6) for securing electrodes when closed, and a channel-shaped recess (7) suitable for the escape of lead wires (7), having at least one exit point (15) for connecting individual electrodes to a main lead wire and projections into a channel (14) that help to secure the lead wires in place. A removable protective cap (5) can be placed over the removable fastening means when closed, the cranial prosthesis. [Figure 4A] A diagram showing the in situ position of a cranial prosthesis, the cranial prosthesis comprising a curved perforated plate (1), a removable screw-fastening tab (4) for attaching the cranial prosthesis to a skull (9) via screws (10), a removable fastening means comprising a flap (6) for securing electrodes (8) when closed, and a channel-shaped recess (7) suitable for escaping extension lead wires, having at least one exit point (15) for connecting individual electrodes to main lead wires. [Figure 4B]A diagram showing the biological position of a cranial prosthesis, the cranial prosthesis comprising a curved perforated plate (1), a removable screw-fastening tab (4) and screw holes (13) for attaching the cranial prosthesis to a skull (9) via screws (10), a removable fastening means comprising a flap (6) for securing electrodes (8) when closed, and a channel-shaped recess (7) suitable for escaping extension lead wires, having at least one exit point (15), and connecting individual electrodes to main lead wires and projections into channels (14) that help to secure lead wires in place. [Figure 5A] A diagram showing the biological position of a cranial prosthesis, the cranial prosthesis comprising a curved perforated plate (1), a removable screw-fastening tab (4) for attaching the cranial prosthesis to the skull (9) via screws (10), and a removable fastening means comprising a flap (6) for securing electrodes (8) when closed. The electrodes are connected to extension lead wires (11), which connect individual electrodes to main lead wires (12) via one of exit points (15). A removable protective cap (5) can be placed on the removable fastening means when closed. [Figure 5B] A diagram showing the biological position of a cranial prosthesis, the cranial prosthesis comprising a curved perforated plate (1), and removable screw-fastening tabs (4) and screw holes (13) for attaching the cranial prosthesis to the skull (9) via screws (10) or sutures. Electrodes are connected to extension lead wires (11) positioned in channel-shaped recesses (7), and individual electrodes are connected to main lead wires (12) via one of exit points (15). Projections into the channel (14) help to secure the lead wires in place, and removable protective caps (5) are positioned over the electrodes. [Figure 6]A diagram showing the bioprosthetic position of a cranial prosthesis without a protective cap, the cranial prosthesis comprising a curved perforated plate (1), a removable screw-fastening tab (4) and screw holes (13) for attaching the cranial prosthesis to a skull (9) via screws (10), and a removable fastening means comprising a flap (6) for securing electrodes (16) when closed. The electrodes are connected to extension lead wires (11) located in channel-shaped recesses (7) that connect individual electrodes to main lead wires (12) via one of exit points (15). Projections into the channel (14) help to secure the lead wires in place. [Figure 7] Figure 5B is a side view and a top view of a cranial prosthesis, which includes a curved perforated plate. The curved perforated plate has asymmetric curvature, where the radius of curvature in one direction is not equal to the radius of curvature in the direction perpendicular to said one direction. For example, it has asymmetric curvature similar to the cross-section of the skull. Cranial prostheses can be manufactured in a variety of asymmetrical shapes so that the surgeon can select a shape that best resembles the portion of the skull removed during surgery. The cranial prosthesis comprises a curved perforated plate (1), a removable protective cap (5), channel-shaped recesses (7) suitable for escaping extension lead wires that connect individual electrodes to main lead wires (12) via one of exit points (15), screw holes (13) for attaching the cranial prosthesis to the skull, and projections into channels (14) that help to secure the lead wires in place. [Modes for carrying out the invention]

[0244] According to a first aspect of the present disclosure, a cranial prosthesis is provided comprising a perforated plate, wherein the perforations include a plurality of perforations substantially equidistant from a central location.

[0245] A second aspect of the present disclosure provides a cranial prosthesis according to the first aspect, wherein the holes include a plurality of at least four holes substantially equidistant from a central location.

[0246] A third aspect of this disclosure provides a cranial prosthesis according to the first or second aspect, which includes a further hole in the central portion.

[0247] A fourth aspect of this disclosure provides a cranial prosthesis according to any one of the first to third aspects, comprising a curved perforated plate.

[0248] A fifth aspect of this disclosure provides a cranial prosthesis according to any one of the first to fourth aspects, which includes a recess suitable for accommodating lead wires.

[0249] According to a sixth aspect of this disclosure, a cranial prosthesis according to any one of the first to fifth aspects is provided, having a substantially circular shape.

[0250] According to a seventh aspect of this disclosure, a cranial prosthesis according to any one of the first to sixth aspects is provided, comprising fixing means for fixing electrodes in a predetermined position within a hole.

[0251] According to the eighth aspect of this disclosure, a cranial prosthesis according to any one of the first to seventh aspects is provided, comprising a protective cap positioned over a hole and useful for holding an electrode in place.

[0252] According to the ninth aspect of this disclosure, a cranial prosthesis according to any one of the first to eighth aspects is provided, comprising means for attaching the cranial prosthesis to the skull via screws.

[0253] According to a tenth aspect of this disclosure, a cranial prosthesis is provided, which is a cranial prosthesis made of metal, polymer, and / or ceramics, as described in any one of the first to ninth aspects.

[0254] According to the eleventh aspect of this disclosure, a method for manufacturing a cranial prosthesis according to any one of the first to tenth aspects is provided, including injection molding, machining, casting, or 3D printing.

[0255] According to a twelfth aspect of this disclosure, a cranial prosthesis according to any one of the first to tenth aspects is provided for use in electrotherapy.

[0256] According to the 13th aspect of this disclosure, Brain tumors (including grade I, II, III, or IV glioma), pilocytic astrocytoma, subependymal giant cell astrocytoma, diffuse astrocytoma, oligodendroglioma, oligodendroglioma NOS, anaplastic astrocytoma, undifferentiated astrocytoma differentiated oligodendroglioma, undifferentiated oligodendroglioma NOS, glioblastoma, giant cell glioblastoma, glioblastoma multiforme, subependymal giant cell astrocytoma, follicular astrocytoma, pleomorphic xanthoastrocytoma, glioma, oligoastrocytoma, Meningiomas (including Grade I, II, or III meningiomas and other neoplasms associated with the meninges, such as perivascular cell tumors), pediatric brain tumors (including ependymoma, medulloblastoma, atypical teratoid / rhapsomatic tumor (AT / RT), choroid plexus papilloma, choroid plexus carcinoma, intracranial teratoma, embryonal tumor with multilayer rosettes (ETMR)), pineal gland tumors (such as pineoblastoma), pituitary gland tumors (such as pituitary adenoma, craniopharyngioma, chordoma), Brain metastases (for example, brain metastases from lung cancer, breast cancer, genitourinary cancer, osteosarcoma, melanoma), Stimulation of nerve tissue for the treatment or symptom relief of neurological conditions (e.g., promoting neurological recovery after brain injury due to stroke / trauma), Recording of brain activity for diagnostic purposes or to enable brain-computer interface communication. Deep brain stimulation (e.g., treatment of motor disorders (e.g., Parkinson's disease, essential tremor, dystonia) and psychiatric symptoms (e.g., anxiety, insomnia, depression, hyperarousal, obsessive-compulsive disorder)), Pain management, or, wound healing, The present invention provides a cranial prosthesis according to any one of the first to tenth embodiments for use in electrotherapy treatment.

[0257] According to a fourteenth aspect of this disclosure, a cranial prosthesis according to any one of the first to tenth aspects is provided for use in electrotherapy treatment of brain tumors.

[0258] According to a 15th aspect of this disclosure, a method for treating glioblastoma polymorphism in a warm-blooded animal such as a human is provided, the method comprising administering electrotherapy to the animal, which includes a cranial prosthesis described in any one of the 1st to 10th aspects.

[0259] According to the 16th aspect of this disclosure, 1. A cranial prosthesis described in any one of the first to tenth embodiments, 2. One or more electrodes, 3. Charge delivery device and, We provide a kit that includes this.

Claims

1. A plate with holes, and a recess suitable for accommodating multiple lead wires, The aforementioned hole includes a plurality of holes that are substantially equidistant from the central point. Cranial prostheses.

2. The aforementioned hole includes four holes that are substantially equidistant from the central point. The cranial prosthesis according to claim 1.

3. Including a further hole in the central area, The cranial prosthesis according to claim 1 or 2.

4. Equipped with a curved perforated plate, A cranial prosthesis according to any one of claims 1 to 3.

5. The recess, suitable for accommodating lead wires, is composed of a series of interconnected channels and recessed channels around the periphery. A cranial prosthesis according to any one of claims 1 to 4.

6. The recess suitable for escaping lead wires includes a recessed channel around the periphery having multiple exit points. A cranial prosthesis according to any one of claims 1 to 5.

7. Having a substantially circular shape, A cranial prosthesis according to any one of claims 1 to 6.

8. It includes fixing means for securing the electrode in a predetermined position within the hole. A cranial prosthesis according to any one of claims 1 to 7.

9. It is equipped with a protective cap positioned over the hole to help hold the electrode in place, A cranial prosthesis according to any one of claims 1 to 8.

10. It comprises means for attaching a cranial prosthesis to the skull via screws or sutures, A cranial prosthesis according to any one of claims 1 to 9.

11. Cranial prostheses made of metal, polymer, and / or ceramics, A cranial prosthesis according to any one of claims 1 to 10.

12. A method for manufacturing the cranial prosthesis according to any one of claims 1 to 11, Including injection molding, machining, casting, or 3D printing, method.

13. The cranial prosthesis according to any one of claims 1 to 11, One or more electrodes, Charge delivery devices and A kit that includes this.

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