High-profile craniofacial implant with anatomical specificity for hard and soft tissue composite reconstruction using drug delivery embedding technology

Abstract

An anatomically specific implant for neuroplastic surgery includes a soft tissue implant component designed and adapted to replace or restore missing soft tissue in a patient's skull, joint, or spine, and the soft tissue implant component is interconnected with a hard component. The hard component can be a cranial implant adapted to replace a missing skull or vertebra, or a healthy skull or vertebra, either of which can have a downward-extending catheter for medicinal brain or spinal infusion that aids in crossing the blood-brain barrier via multiphase flow. The soft tissue implant can also include functional components with neurotechnology, such as an MRI-lucent pump, a Bluetooth connectivity system, a refillable diaphragm, a remote imaging device, wireless charging capabilities, and / or information-providing biosensors. The soft tissue implant component can be interchangeable with another soft tissue implant component in a plug-and-play manner.

Description

Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Patent Application No. 17 / 400,239, filed on August 12, 2021, and U.S. Provisional Application No. 63 / 065,045, filed on August 13, 2020, entitled "Implant with Multifunctional Anatomical Specificity for Hard - Soft Tissue Composite Reconstruction Using Embedded Technologies to Improve Form and Function", the entire contents of which are incorporated herein by reference.

Technical Field

[0002] This embodiment generally relates to the fields of sustained drug delivery, refillable needle reservoirs, wearable technology, Bluetooth (registered trademark) - enabled devices, wireless charging power platforms, state - of - the - art biotechnology, craniofacial implants, neurosurgery, neuroformative surgery, implantable neural technology, plastic surgery, cranio - maxillofacial surgery, orthopedic surgery, and neuro - oncology, and more particularly to the field of improving the form and function of permanent implants for the anatomical replacement of both hard and soft tissue components.

Background Art

[0003] Modern artificial implants are designed for anatomical replacement of the bone (i.e., hard tissue) defects they replace. For example, the inventor has invented a rope-profile interparietal device described in Patent Document 1 issued on July 13, 2021, which discloses arranging implant technology within the hard tissue (skull space) and is specifically described as an "implant for substantially conforming to the resected portion of the patient's skull". However, as technology has advanced with respect to miniaturization, a less invasive option would be to use an anatomical component that combines soft and hard tissues within the middle cranial fossa as an improved strategy to prevent the surgeon from having to remove large segments of bone to create space for the rope-profile interparietal device. For example, the present invention, unlike more invasive options such as resection of large segments of the skull to create space for implantable neural technology, utilizes a combined soft tissue replacement, thereby enabling the use of a small amount of bone space. Moreover, the use of soft tissue space would likely be safer for the patient.

[0004] Unlike the inventor's prior invention, "Craniofacial Implants with Patient Specificity," described in Patent Document 2 issued on February 16, 2021, the present invention is pre-designed using anatomical compartment sizes that match typical adult men and women. The prior invention discloses using the temporal soft tissue space in combination with the hard tissue (bone) space, but is limited to a "patient-specific" (i.e., custom) design. In contrast, the present invention can use the same amount of temporal reinforcement and implant design, but can be provided in both "anatomy-specific" (i.e., non-customized) and "patient-specific" (i.e., customized) embodiments. The implant according to the present invention may be pre-designed using computer-aided design / manufacturing (CAD / CAM) as an implant with customized patient specificity, or may be pre-designed as an implant with anatomical specificity using anatomical averaging. The present invention can employ anatomical averaging to achieve an "off-the-shelf" one-size-fits implant. Embodiments of the present invention can partially fill some missing bone, but will also partially fill some missing soft tissue, such as the temporalis muscle and / or the temporal fat pad. This type of implant manufacturing process can be equivalent to a safe, biocompatible, pre-fabricated device and / or implant made from a fully plastic material that can maintain a permanent shape and form over time, regardless of subsequent mechanical trauma and / or the internal workings of the biomechanics (i.e., drug delivery by continuous and direct pump support through several connected catheters that extend deep into the adjacent brain white matter as a way to bypass the blood-brain barrier). (That is, the outer shell surrounding the drug delivery component fits snugly inside and is designed to have internal abutments within the hollow space to maintain stability in the event of accidental head trauma.)It should be noted that by utilizing the space of the soft tissue in addition to the space of the skull, an ideal and non-obvious solution for placement at the shortest distance from the brain (i.e., there is no space closer to the temporal lobe of the brain than the temporal bone and the temporal soft tissue) is provided. Therefore, from an engineering perspective, the conduit (i.e., catheter) for drug delivery can be made significantly shorter, and thus, considering that the flow is more predictable, the design and safety of the present invention are greatly improved.

[0005] However, until recently, there has been no "skull facial implant with anatomical specificity" or device that was pre-designed for the temporal region with a drug pump and / or internal biosensor for convective enhanced delivery to the brain in order to improve both the shape and function of the head in the context of intracranial pressure changes (i.e., hydrocephalus, bleeding, tumor growth, altitude changes, seizures, etc.), and at the same time, was strategically designed to simultaneously replace deficiencies in both the temporal hard tissue (i.e., bone) and soft tissue (i.e., temporal muscle, temporal fat pad, subcutaneous tissue) in a way that is non-deformable and completely camouflages the device itself from the naked eye. In fact, the first case scenario using a bone replacement implant with an embedded biosensor design was surgically performed by the inventor (Non-Patent Document 1). Furthermore, the inventor first described a "patient-specific skull facial implant" (Patent Document 3) for replacing both the missing temporal bone and soft tissue in the craniofacial region. However, this prior invention is strictly limited to a customized solution for addressing the problems of the hard and soft tissue scenarios, and is in contrast to the present invention which is non-customized but rather designed based on standard volumes applied to the hard tissue (bone) and soft tissue (muscle / fat) of the temporal region. The patient-specific implant is customized by preoperative CT scans and CAD / CAM modeling based on individual findings, whereas the implant with anatomical specificity of the present invention can be pre-fabricated using standard values and human atlas data to achieve similar results with similar efficacy and similar effects, but with less effort or lead time required for implant procurement. It should be noted that the patented invention of the "patient-specific skull facial implant" takes an average of 3 days to 3 weeks for design, fabrication, and procurement, whereas the "anatomically specific" design of the present example described herein is a more straightforward "right" or "left" temporal implant that is immediately available since it can be pre-fabricated sufficiently in advance, and allows the choice of whether or not to use an internal embedding technique for drug delivery.

[0006] The anatomy of the bones that make up a certain side of the human head maintains a certain form and is thus well-suited to the field of implantable implants and devices in that its shape and form are always constant. For example, one embodiment of the present invention describes a device comprising a curved case with a hard shell that is strategically hollowed out inside to assist internal operations that harmonize with pump-assisted techniques for intracerebral drug delivery. Conversely, soft tissue regions found on the craniofacial bones, such as the temporalis muscle, the temporal fat pad, and the temporal subcutaneous tissue, are constantly changing in shape due to age and / or body movements throughout the day, so the boundaries are not constant and it will face the problem of implant design. Thus, the use of the temporal soft tissue space was not described in the inventor's published patent application (Patent Document 4) entitled "Magnetic Resonance Imaging-Compatible, Convection-Promoting Delivery Cranial Implant Device and Related Methods" because it was initially thought that cranial devices could be used in place of the skull. After further consideration, the inventor determined that the optimal implant design for achieving direct intracerebral drug delivery requires the use of the temporal soft tissue space. Therefore, the present invention may replace the normal soft tissue in the temporal fossa with a rigid plastic device, but in a shape that camouflages the placement and removes visible signs of deformation (i.e., the practice and principles of neurosurgery). According to the disclosure herein, the prefabricated multi-purpose device is designed in a non-customized manner, whereby it can be easily utilized as an "off-the-shelf product" through a novel design algorithm related to standard human data (i.e., anatomical averaging) including several imaging diagnostic methods such as computed tomography (CT) scans or magnetic resonance imaging (MRI). Specifically, the bone landmarks and anatomical boundaries of the craniofacial skeleton are best understood using CT, and the soft tissue landmarks and anatomical boundaries are best understood using MRI.Accordingly, embodiments of the temporal device disclosed herein utilize the aforementioned advancements by the inventor and, at the same time, 1) replace both hard and soft tissues (in both existing and non-existing scenarios), 2) include an internal electroosmotic pump with non-ferrous components, a biosensor for collecting important wireless data such as internal flow rate, a pump assist, multiphase flow, a system capable of convective enhanced delivery, and / or an implantable technology such as an implantable ultrasonic array for remote brain imaging that utilizes the aforementioned advancements by the inventor to assist in determining whether a recurrent brain tumor is regenerating without being affected by local chemotherapy delivery and when it is regenerating, and 3) use implantable technology elements for drug delivery to simultaneously improve the form and function such that it is not visible to an external person that the patient is directly receiving intracranial drug delivery and that there is a refillable diaphragm for needle puncture a few millimeters beneath the skin of the patient's scalp. It should be noted that in the inventor's previous application, "Magnetic Resonance Imaging Compatible, Convective Enhanced Delivery Cranial Implant Device and Related Methods" (Patent Document 4), it was assumed that the cranial device would be placed within the skull beneath the hairy scalp. However, the inventor has realized that such a design is not optimal and causes significant difficulties for healthcare providers when attempting to palpate the scalp to inject drugs. Instead, the inventor has determined that a high-profile temporal implant that replaces both hard and soft tissues places the drug delivery implant in the temporal region, which is an anatomical area without hair, is easily locatable by palpation, and most importantly, the drug injection operation is not cumbersome, there is no possibility of hair or bacteria contamination, and it is more secure. Furthermore, due to the implant having a "high-profile" appearance (i.e., extending through the soft tissue space and being reconstructed), the device can extend immediately beneath the skin, which can be valuable for several reasons such as easier / more secure transdermal needle access for drug refill and providing a shorter distance / less tissue interference for wireless charging and / or Bluetooth wireless communication.

[0007] It should be noted that intercalvarial implants limited to the "intercalvarial" region, such as the intercalvarial device with a rope profile of the inventor's prior invention, do not provide the correct access point for this type of drug delivery invention. For example, the boundaries of this implant move outward, upward, and laterally beyond the cranial space described above (i.e., this implant design is now "extra-cranial" rather than "intercalvarial"), and instead the temporal muscle, temporal fat, and subcutaneous tissue of the temporal scalp are also replaced, so that it can reach just under the skin of the temporal scalp / face. Now, a short non-perforating needle can safely and quickly puncture the skin and enter the refillable valve 1-2 millimeters under the skin in a minimally invasive and rapid manner, bringing significant differences and advantages. In contrast, in the case of the "rope profile intercalvarial device", it is a very invasive method because it is necessary to cross the entire scalp tissue and reach the level of the implant including the bone with a needle. Furthermore, in the case of the "rope profile intercalvarial device", the entry point along the temporal region is dangerously obstructed by the temporal muscle, temporal fat pad, and subcutaneous tissue of the temporal scalp. Therefore, every time a needle is used to refill the drug port, it will cause pain and bleeding to the patient. Thus, the inventor believes that in order to safely achieve drug delivery to the brain through a simple, rapid, and refillable reservoir, a temporal implant with anatomical specificity like the present invention is required. The advantages of the present invention are, as an enhanced strategy for combined replacement of hard and soft tissues, preventing visible deformation by using the location point of the temporal fossa and this new temporal implant design; being able to safely insert a percutaneous needle because there is only a thin temporal scalp covering the implant, different from the full-thickness hairy scalp; and the volume that can be internally adapted by the implant pump support technology that does not use the "intercalvarial device" space limited by human cranial dimensions increases dramatically.

[0008] Systemic delivery of drugs to the brain is inhibited by the highly selective permeability of the blood-brain barrier, allowing only a relatively small percentage (less than 99%) of specific substances to pass from capillary blood into the extracellular fluid of the brain. In fact, recent reports indicate that more than 60% of all pharmaceutical research laboratories specializing in the development of nervous system drugs are annually closed due to complex barriers that prevent the successful delivery of blood-based drugs to the brain. Therefore, many studies have focused on the design of pharmaceutical compounds that are large and hydrophobic enough to diffuse through the endothelial cells that make up the complex blood-brain barrier. However, many pharmaceutically advantageous compounds are either too large or too hydrophilic to be designed for such direct delivery to the brain, resulting in a suboptimal situation. In 1994, Dr. Oldfield of the NIH introduced for the first time in the world a new method called "convection-enhanced delivery" as a way to bypass the blood-brain barrier and convect drugs directly into the white matter of the brain through a single catheter from a pump (i.e., providing a multiphase flow), completely skipping the vascular pathway (Non-Patent Document 2). Oldfield et al. reported that they were the first to successfully convect drugs effectively at a rate of 0.5 - 1.0 microliters per minute using a single catheter system with a pump by opening the scalp and removing the skull of several cats as a method to successfully avoid the blood-brain barrier. However, the technology using a pump could only survive for 24 hours due to invasiveness, the risk of infection, and anatomical design constraints. Thus, in the field of neuroscience over the past 30 years, long-term convection-enhanced delivery has remained promising but unachievable in humans because no appropriate anatomical positions and spaces necessary for the implantation of such devices have been conceived (Non-Patent Document 3). Prior to the present invention, no anatomically specific multi-purpose design for accommodating MRI-lucent pump technology by incorporating the temporal bone, temporal muscle, and temporal fat pad into its design algorithm was envisioned. In other words, no reliable method and device enabling continuous "convection-enhanced delivery" could be found within the inherent size constraints in the human head or skull.For example, the interparietal device with a rope profile, which is a prior invention of the present inventor, was limited to a vertical size of about 4 to 12 millimeters (i.e., thickness) considering the constraints of the interparietal bone space. In contrast, by providing the present invention of a device design adaptable to the composite space of hard and soft tissues, by providing three times the available volume for the internal housing (between about 12 and 40 millimeters in thickness), it is now possible for important high-profile device drug delivery to be carried out in the brain and the body. By replacing the temporalis muscle and the temporal fat, the internal space is enlarged several times, thereby dramatically improving the probability of safe drug delivery to the brain by a pump. Furthermore, space is provided for synergistic technologies such as an ultrasonic probe (to detect recurrence of brain tumors) and a biosensor (to detect excess or deficiency of drug delivery). Therefore, a high profile exceeding the space of the skull is required and is what should be called "outside the skull" in terms of design (i.e., different from being limited only to "interparietal"). By doing so, it extends up to 1 to 2 millimeters under the skin. Furthermore, due to the high profile, palpation by digital examination becomes easier, and due to the circular diaphragm installed for transdermal drug injection, medical staff can be assisted in palpating the skin periphery of the temporal region. The newly designed temporal implant combining hard and soft tissues extends outward from the space of the skull and into the normal temporalis muscle space, the normal temporal fat space, and the normal subcutaneous space. This configuration increases the volume available for use in multi-purpose implant technologies for drug delivery into the brain several times. Furthermore, such an improved anatomical position having a new position of an anatomically specific prehab device in both the space of the skull and the overlying soft tissue regions such as the temporalis muscle and the temporal fat presents a newly discovered strategy for enhanced drug delivery of a rechargeable battery-driven platform capable of local neurological drug delivery and will be a welcome addition to the technology. For example, with more space, it becomes possible to have a larger rechargeable battery platform. And due to this increase in volume, the patient's charging cycle, which originally required charging for 1 hour three times a day (i.e., every 8 hours), can immediately be switched to requiring charging for 1 hour every three days.This is a major difference for neurosurgical patients undergoing local intracranial drug delivery, where the risk of incompatibility changes dramatically (i.e., having a margin internally corresponds to being able to adequately accommodate a large battery size). Also, the advancement here is the utilization of the composite space of hard and soft tissues for the embedding technique within prefabricated implants made by anatomically averaged CAD / CAM designs, eliminating the need to wait days or weeks to customize implant designs when patients present with unexpected brain tumors and new seizures. With the present invention, hospitals can stock skull implants with anatomical specificity for composite reconstruction of soft and hard tissues, and brain tumor patients undergoing tumor resection and craniotomy can have this implant placed in a single operation instead of two. For example, the middle cranial fossa and middle cranial soft tissues are typically on average 22 - 24 cubic centimeters (as published by the inventor in Non-Patent Document 4), and thus the inventor utilized his clinical expertise and knowledge base to design a versatile device with anatomical specificity that fits precisely within this mentioned space, resulting in the implant of the present invention being able to have a capacity of approximately 65 - 70 cubic centimeters, which is nearly two or three times the volume when only using the skull space. Further, the anatomical placement of this technology is above the skull, in contrast to being limited within the skull, which is advantageous for device engineers attempting to mount many different components, and is easily refillable with percutaneous needles (considering that the upper end extends upward to the skin as opposed to remaining at the depth of the bone level), making it less invasive and easier to implant for surgeons. As a result, at least a portion of the functional components extends outward from the bone level towards the skin, and in other words, may be considered "high profile" in that they are above the skull.Similarly, local drug delivery requires that a refillable diaphragm be placed snugly just under the skin to facilitate needle penetration, which means that placing the device within the soft tissue space is advantageous compared to just placing the device within the skull in that it has a thick scalp on top (i.e., a thick scalp with hair containing bacteria will interfere with the important needle penetration system for monthly refillable neurological drugs for chronic brain disease management). In parallel, the present invention can further be applied to tumor regions outside the brain. For example, the device of the present invention can be placed above the chest / ribs and safely maintained in a location where it can utilize the composite tissue space of bone (hard tissue) and pectoralis major muscle (soft tissue) to deliver pump-assisted drugs to the lungs for cases requiring sustained pump-assisted infusion such as lung cancer or for chronic infections such as pneumonia. In parallel, the present invention can further be applied to tumor regions outside the brain. For example, the device of the present invention can be placed above the chest / ribs and safely maintained in a location where it can utilize the composite tissue space of bone (hard tissue) and pectoralis major muscle (soft tissue) to deliver pump-assisted drugs to the lungs for cases requiring long-term pump-assisted infusion such as lung cancer or for chronic infections such as pneumonia. Similarly, the present invention may also be placed along the lower rib cartilage and rectus abdominis muscle (as a composite hard-soft tissue space) to enable placement for sustained infusion of solid organ cancers such as in the case of liver cancer or hepatitis treatment. Yet another composite hard-soft tissue region may include the spine (hard) and paravertebral muscles (soft) as a composite space for device placement enabling direct pump-assisted drug delivery for the spine (i.e., for pain relief, anti-tumor) and / or for injection of chronic pain drugs or for orthopedic joint regions such as the hip, knee, shoulder, and ankle for cancer. Thus, the concept of using bone and soft tissue spaces for local intracerebral drug delivery via a convection-enhanced pump mechanism can be transferred across other anatomical regions requiring composite hard-soft tissue reconstruction and local drug delivery.As has been repeated, (as the inventor has previously explained in Patent Document 1 entitled "Low Profile Intercranial Device" and Patent Document 4 entitled "Magnetic Resonance Image Compatible, Convection Enhanced Delivery Cranial Implant Device and Related Methods"), the strict limits of bone replacement pose the further challenge of the narrow space during design, and thus the amount of internal stored drug, the space for implant wireless charging technology and battery storage, as well as the size dedicated to pump assist technology are all limited. By expanding the implant design and its footprint into the human skull and extending to include the temporal muscle, temporal fat, and temporal subcutaneous tissue adjacent to the outside of the normal bone boundary, the space for intracerebral drug delivery is increased, the need for periodic filling is reduced (space for long-term drug storage and a larger reservoir), and there is room inside for a large energy storage platform for RF charging, safe wireless battery charging (i.e., implants with extensions closer to the skin level have reduced tissue interference with the implant wireless charging mechanism), and also improved patient satisfaction.

[0009] For example, during brain tumor craniotomy for recurrent glioblastoma disease and the need for repeated resections, one would challenge to place a standard MRI-compatible device inside the head. This is because any device within a brain tumor patient should not only have simply MRI safety and / or MRI compatibility (defined as having no iron-containing materials), but more importantly, should be considered MRI radiolucent, unlike simply having MRI safety and MRI compatibility. As used herein, "MRI radiolucent" means that the device can be placed within the temporal fossa, a complex space of hard and soft tissues that is only a few centimeters away from the brain and the location of the previous brain tumor, and is relatively invisible (i.e., radio wave transmissive) to an MRI device that plays a role in identifying brain tumor recurrence in regular scans every 3 - 4 months (i.e., the present invention results in zero radiation artifacts). The inventor assumes that for malignant brain tumor patients who are monitored every 90 - 120 days for brain tumor recurrence, their combined multi-purpose devices must not only be designed to be MRI-compatible, but also be MRI radiolucent. For example, in the PCT application PCT / US2019 / 039519 titled "Magnetic Resonance Image Compatible, Convection-Enhanced Delivery Cranial Implant Device and Related Methods", the inventor has described that the implant has MRI compatibility. However, for the present invention, the design of the device within the complex space of soft and hard tissues is enhanced to have not only MRI compatibility, but rather MRI radiolucency, which is a major advancement for neurosurgical patients with chronic brain diseases such as glioblastoma and malignant brain tumors that require careful MRI monitoring. This may be achieved by avoiding the use of electroactive polymers and instead using an electroosmotic pump filled with simple water (or equivalent). Thus, it is the electroactive polymer (EAP) that can cause artifacts and thereby inhibit the proper monitoring of brain tumor patients who receive chronic drug delivery. Furthermore, in the aforementioned application, the inventor has described placing the device within the cranial space, but currently judges this to be too limited as it would result in constructing a pump-assisted device for intracerebral drug delivery and bypassing the blood-brain barrier.In contrast, the present invention improves upon the deficiencies of the inventor's prior patents and patent applications described herein. First, the device of the present invention is not patient-specific, but rather anatomically specific. Second, the device of the present invention does not need to remain within the cranial space like an L.I.D., but instead is placed within a composite anatomical space that incorporates both the cranial muscles / fat and the skull, thereby allowing the engineer to significantly improve the volume for pump assist technology. This additional space allows the engineering team, unlike before, to use non-ferrous materials when dealing with limited implants that occupy the cranial space. The engineer is freed from design constraints and has successfully constructed device components that do not use any materials that cause iron or artifacts. Third, the device of the present invention includes an MRI-lucent design that completely eliminates radiation artifacts and instead uses electroosmotic pumps (or equivalents) rather than electroactive polymers (i.e., replaces the MRI-opaque gel with MRI-lucent water).

[0010] The present invention may also find use in chronic neurological disease states such as neurodegenerative diseases (i.e., Alzheimer's disease, Parkinson's disease), drug-resistant epilepsy, nerve trauma / paralysis, major depression, schizophrenia, bipolar disorder, ADHD in children, brain dysfunction (i.e., paralysis), brain-related age changes (i.e., memory loss), and post-traumatic stress disorder. Also, in the future, options such as stem cell injection with this device to promote recovery of the brain after traumatic brain injury, cancer, stroke, and brain-enhancing drugs and supplements to improve memory, motor ability, balance, hand-eye coordination, brain-computer interface, and performance in high-stress situations (military, police, etc.) are also conceivable.

[0011] For placement, the surgeon may remove any and all diseased or damaged portions of the skull (craniotomy defect), or may selectively remove normal bone to create space with the brain left exposed below without injury. Further, since the normal temporalis muscle and fat contract after previous craniotomy (i.e., temporalis soft tissue cavitation after craniotomy), there is an excess volume in which the device of the present invention can be placed, as opposed to the normal pre-operative volume of the muscle and fat. Thus, a temporalis implant for hard-soft tissue composite reconstruction having a drug delivery function facilitates passage across the blood-brain barrier and, further, due to its design and reconstructive aspects, can return the soft tissue volume to its pre-operative state. This phenomenon of "temporalis soft tissue cavitation" is related to denervation and / or vasculature resection of the temporalis soft tissue during standard pterional craniotomy for brain tumors. Thus, when the surgeon returns for re-operation, the muscle and fat require some kind of implant reconstruction (i.e., augmentation), where the device of the present invention can be used. The device of the present invention not only provides more internal volume but also functions as a reconstructive option for brain surgery patients who desire to correct and / or prevent temporalis bone cavitation deformities. After such craniotomy defect (either "multistage", where bone removal is done prior to implant placement, or "single stage", where the implant is placed simultaneously with resection) of the diseased skull, such craniotomy defects are often reconstructed with custom craniofacial implants (CCIs) as opposed to using off-the-shelf "off-the-shelf" materials that cannot currently provide true anatomical replacement. Historically, however, craniofacial patients who require CCI-based reconstruction for an ideal appearance have been limited to "two-stage" surgery in cases of existing skull defects so that accurate fitting and design can be obtained. However, recent improvements by the present inventor have revolutionized the field of skull replacement surgery, such that clinicians such as neuroform surgeons or neurosurgeons manually shape / size a previously ordered custom implant (oversized) to perfectly fit the skull defect as a true anatomical replacement, as opposed to using off-the-shelf materials that only partially restore the missing bone, which is referred to as "single-stage cranioplasty".In any case, in single-stage methods including skull tumors or two-stage cranioplasties for predefined skull defects, the advent of computer-aided design / manufacturing (CAD / CAM) has provided surgeons with perfectly shaped CCIs designed and manufactured based in part on preoperative precise CT scans and three-dimensional reconstructions (+ / - stereolithography models). However, the current challenge does not stop at skull defects. The new invention now requires the use of CAD / CAM design for implants with anatomical specificity that can replace both hard tissue (bone) and soft tissue (overlying muscle and fat), and the advancement of the inventor's implantation technology has, in order to truly advance this field, a larger footprint (i.e., Bluetooth module, wireless RF charging unit, microprocessor, MRI lucent pump technology, real-time biosensor, imaging array by ultrasonic crystals, etc.) and docking station. Such devices over time may have a wireless charging platform developed to ensure complete MRI safety in certain areas, such as being charged with a wireless frequency (RF) signal instead of a standard magnetic coil that can adversely affect MRI used in common household devices and mobile phones. Such multipurpose devices can also be designed with enhanced security by Bluetooth, wireless connection, and extensive threat modeling to prevent biohacking and abnormal drug delivery rates. Such devices may incorporate a computer chip and internal processor to self-induce the ideal flow of the pump support mechanism. Such devices may also have a small computer chip capable of constantly monitoring the flow rate through each of four to five catheters delivering drugs to the brain, thereby enabling self-detection, overcoming, and immediate response in the event of unexpected scar tissue or increased resistance to flow in any one or more of the catheters.Such a novel constant monitoring mechanism is placed within the temporal implant, and each catheter that delivers drugs to the brain can maintain a stable flow of about 0.5 - 1.0 microliters per minute regardless of the resistance at the catheter-brain interface. Scar tissue, radiation changes, recurrence of brain tumors, etc. can all potentially affect the flow rate exiting each implanted catheter. Thus, the newly created space in this hard-soft tissue implant enables the addition of safety mechanisms such as embedding multiple biosensors along the fluid circuit to "cruise control" the flow rate. Such a device may be equipped with a remote biosensor that, when detecting the accumulation of abnormal body fluids around the brain, may immediately require a doctor's examination or the sending of a mobile phone message. For example, since normal intracranial pressure is about 5 - 15 mmHg, it is necessary to immediately detect any increase in pressure due to fluid leakage or malfunction of the implant. The addition of this space now allows for the embedding of additional technologies. Such a device may also have a small ultrasonic array housed within the bottom of the device and facing the brain, and may use artificial intelligence to self-monitor the brain tumor cavity for any growth changes related to recurrent tumors and / or radiation-induced scar tissue. Such a device may also be equipped with a palpable "high-profile" diaphragm located just 1 - 2 millimeters beneath the skin of the temporal scalp. This serves as a safer injection port that can repeat percutaneous needle punctures (through the scalp) approximately 1000 times using special non-piercing needles and material design, preventing any kind of accidental leakage (especially since chemotherapy filling is very dangerous and irritates the surrounding skin). Such a device may also be equipped with a small computer chip capable of "cruise control" so that it can constantly monitor the flow rate through each of the 4 - 5 catheters delivering drugs to the brain, thereby enabling it to self-detect, overcome, and respond to any unexpected scar tissue or increased resistance to flow in any one or more of the catheters at any time. Such a device may also have a mobile app that can transmit patient protection data, including important information such as drug storage levels and data related to flow rates, in real-time to the patient, the patient's family, and / or the patient's healthcare provider.Such a device may one day have an internal suction function, be able to self-suction liquid from diseased brains along with cells for biopsy or diagnosis, and by simply reversing the flow of an MRI lucent pump, be able to access all the liquid from a small subcutaneous port.

[0012] As discussed herein, the prior invention by the inventor was limited to the bone space only. However, according to the inventor's recent investigations, it has now been found that all components such as MRI lucent batteries, computer chips, catheters, biosensors, pumps, Bluetooth modules, RF charging components, wireless antennas, etc. all require more three-dimensional space prior to the inventor's original concept. Therefore, different from before, in order to incorporate powerful life-changing technologies, it is necessary to pre-fabricate a soft-hard tissue composite temporal implant with a larger footprint to advance this field. Thus, the field of solid bone replacement for neuroplastic surgery, neurosurgery, neuro-oncology, and craniofacial surgery can be significantly improved by changing the design boundaries to include a portion of the surrounding soft tissues (i.e., the temporal muscle, temporal fat pad, and subcutaneous temporal tissue) and providing additional footprints for using embedding technologies such as biosensors, drug delivery, or remote image processing within implants with versatile anatomical specificities.

[0013] Parallel to skull replacement, orthopedic joint replacement surgery since the 1960s has also replaced bones lost due to diseases such as osteoarthritis and cancer in a way that permanently improves the restoration of form and function, achieving overwhelming success. However, orthopedic implants are only for replacing bones such as the hip joint, knee joint, shoulder joint, and ankle joint. In orthopedic surgery as well as in this implant neural technology, the utilization of the space of the surrounding soft tissues has not been considered. Furthermore, these bone-only implants (both off-the-shelf and prefabricated) are solid objects without embedded functions inside. Therefore, the field of solid bone replacement for orthopedic joint surgery can be significantly improved by changing the design boundary to include a part of the surrounding soft tissues and providing additional footprints for using embedded technologies such as biosensors, drug delivery, remote imaging processing, etc.

[0014] Parallel to skull replacement, in spinal surgery for various diseases such as trauma, paralysis, and cancer, many successes have been achieved using hard tissue implants designed for the missing vertebrae (bone elements of the spine). However, spinal implants are only designed to replace structures such as bones like the spine and pelvis. In this regard, the utilization of the space of the surrounding soft tissues such as the paravertebral muscles, which are very similar to the temporalis muscle, has not been considered. Furthermore, these bone-only implants (both off-the-shelf and prefabricated) are solid objects without functions embedded inside. Therefore, the field of solid bone replacement for spinal surgery can be greatly improved by changing the design scope to include a part of the surrounding soft tissues and providing additional footprints for using embedded technologies such as biosensors, drug delivery, Bluetooth connection, wireless charging, remote imaging processing, etc.

[0015] In fact, the use of the dual-purpose CCI (Non-Patent Document 5) designed by the present inventor has been shown in recent journal publications to better maintain the appearance after brain surgery, prevent postoperative deformities and the associated social stigma, reduce the total operation time, prevent scalp-related wound complications, enhance patient satisfaction, and thus function as an ideal medium for the reconstruction of brain surgery patients. This major advancement was achieved using a novel design algorithm provided by the present inventor, taking advantage of the fact that the space of the hard and soft tissues around the brain has not been fully utilized (thereby dispelling the old and outdated generational dogma that cranial implants can only be designed for anatomical bone spaces), and demonstrating how reliably this new advancement can be achieved using preoperative CAD / CAM design. However, at that time, when performing "single-stage bone replacement of the skull", there was no computer-assisted surgical technique to guide the surgeon other than carving by hand during the operation, with simple eye-hand coordination and general deburring. Therefore, the present inventor has been diligently working on designing and inventing a technique that provides computer-guided information to the surgeon in real time and allows for reasonable size modification. Therefore, in Patent Document 5 titled "Computer-Assisted Planning and Execution System" and Patent Document 6 titled "Cutting Machine for Changing the Size of a Living Implant During Surgery", the present inventor provided a novel intraoperative visual guidance for a recently developed surgical workstation to compare the planned position and the actual position of the CCI after placing the CCI within the three-dimensional craniofacial defect (in relation to the virtual plan) and then (on the intraoperative visual monitor), and explained that it has the ability to finally add further accuracy and simplicity to this complex operation. It should be noted that this CCI-related technology (both computer-assisted and robot-assisted) is applicable to both designs for bone replacement only and dual-purpose designs combining hard and soft tissues. However, all CCIs until recently have been used to replace abnormal bones with some disease caused by either a benign or malignant etiology. Thus, customized cranial implants were called "static CCIs" (SCCIs).This is mainly because its main persistent purpose (i.e., a purpose invariant with respect to time) encompasses exactly two advantages, namely "brain protection" and "appearance improvement" after placement. Thus, in the past, the inventor has described a novel solution for "static" or "non-functional" implants for bone replacement, as a way to improve this field, by introducing a low-profile interparietal device (L.I.D.) that precisely describes bone replacement by implantation techniques (mainly for the skull). There, the term "interparietal" was used to describe a technique limited to the space of only bone. However, with the inventor's recent efforts leading to successful sustained intracerebral drug delivery that helps bypass the blood-brain barrier, this has been shown to be an obstacle and a speed limit. Currently, the inventor is further evolving this field by expressing the limitations of "static" or "non-functional" patient-specific and anatomically specific craniofacial implants in terms of a dual-purpose design that replaces complex hard and soft tissue defects and dramatically expands the scope of its design away from "interparietal" and instead to "extra-parietal". Accordingly, the present invention is directed to an implant having multi-purpose anatomical specificity for the composite reconstruction of hard and soft tissues incorporating techniques for improving form and function.

[0016] On the one hand, there are numerous "commercially available" technologies approved by the FDA that have life-changing or life-saving functions. Specifically, in neurosurgery, there are technologies that can supply electrical impulses (i.e., epilepsy management), pump neurological drugs (i.e., chronic pain), or aspirate / shunt excess cerebrospinal fluid with a programmable shunt valve (i.e., hydrocephalus management), but these are not customizable and are not designed to protect the brain. However, since all of these neural technology implants interact intermittently or continuously with the central nervous system in some way, they have a large and irregular footprint and are not optimal in shape design, which is incompatible with the principles of neuroform surgery, whose mission is to optimize both form and function. Similarly, innovative technologies in orthopedic and spinal surgery also have the exact same design drawbacks. Many innovative technologies are implanted in patients with chronic pain, debilitating diseases, and / or tumor diseases along the spine, pelvis, and joints, but the design flaws associated with these technologies lead to visual deformities and a high protrusion rate due to not considering the incompatible shapes and the anatomical boundaries of the overlying soft tissues (i.e., muscle / fat). To reiterate, such implanted neural implants do not correspond to the normal anatomical barriers of the scalp and skull, thus causing risks due to impacting adjacent tissues and visual deformities. If the implant is on the skull and has a bad shape, it will lead to early extrusion and early removal. Also, if the implant is bulky and placed under the skull, it is equivalent to causing local symptoms related to collisions with the cerebral cortex and the brain. Therefore, in order to greatly advance both the fields of implantology and implant technology together, the present invention 1) incorporates the boundary between hard and soft tissues into both a pre-customized design and a non-customized anatomically specific design, and 2) by adding additional soft tissue space to the CAD / CAM design of bone implants, it can subsequently provide more space (i.e., several times) for encapsulation and long-term safety in implant technology.Therefore, modern nerve devices (brain, spinal, and orthopedic implants) will no longer face and challenge the high extrusion and infection risks that reach an incidence rate of approximately 50% (i.e., the current deficiencies of modern devices result in a high incidence of pain and extrusion through the overlying skin, thereby requiring early removal). Similarly, battery-driven low-profile devices for intercalvarial placement within a specific anatomical tissue plane along only the bone cavity were later described in the inventor's registered patent for low-profile intercalvarial devices (LIDs). In parallel, the fields of neurosurgery, neuroformative surgery, and orthopedics are hampered and restricted in the supply of improved implants in many important areas, including examples such as battery-powered nerve modulation / cortical stimulation for epilepsy / movement disorders, valve devices for hydrocephalus, pump-assisted local delivery of neurological drugs for brain tumors, revolutionary spinal implants for spinal cord injury monitoring / treatment, and chronic pain related to joint deformity osteoarthritis. One of the reasons is that the bone space and current implant designs may not be large enough to accommodate technology modalities that change lives, improve lives, and save lives, and therefore, due to significantly high extrusion, infection, and pain, successful outcomes are limited, and thus, there is undoubtedly a need for new inventions with a larger footprint and anatomically delicate, taking into account the normal soft tissue boundaries. For example, new pump-assisted designs incorporating electroosmotic content, Bluetooth chips, integrated biosensors, RF charging platforms, and refillable drug reservoirs are all capable of being purely MRI lucent, but at the same time require a large footprint and are incompatible with bone-only designs.

[0017] Furthermore, there has long been a need for an implant with a two-piece, multi-purpose anatomical specificity. The first objective of such a device is to restore rigidity and structural integrity to missing or replaced bone. Conversely, having a weak and soft outer case is dangerous for patients undergoing brain surgery. Next, such a device can replace hard and soft tissue defect volumes to correct and / or prevent visible contour deformations. Further, by extending up to near the skin beyond the bone boundary, such a device enables the Bluetooth module / wireless charging battery to cause less soft tissue interference and / or the refill reservoir to be not too deep from the skin surface, thus making it easier for a doctor or nurse to fill the refill drug chamber with a special non-perforating needle. Finally, a device with such a "high-profile contour" can utilize the expanded adjacent space of hard and soft tissues to provide a novel solution on-site considering that it causes less tissue interference with the outside world, which is crucial for wireless technology. Additionally, the design of such a device can provide an integrated or independent soft tissue implant component that replaces or restores missing soft tissue in a "plug and play" manner to be enhanced incomparably in future iterations, as many patients with chronic diseases may change over time, thus enabling the surgeon to do so. It should be noted that this approach is different from the previous inventions described by the inventor in relation to patient-specific craniofacial implants (Patent Document 3). In contrast to them, the soft tissue implant component is physically adapted and coupled to a hard base component that replaces the resected or missing bone (i.e., skull, spine / vertebrae, and joint bones) in a manner similar to the engagement of a lock and key, thereby preventing micromotion and / or fluid leakage. For example, this would be useful in brain tumor patients who need to switch to different chemotherapy agents as cancer changes its cell composition and aggressiveness towards recurrence.Accordingly, the rigid base component thereby includes a skull, spinal or orthopedic joint implant for replacing missing or healthy bone that requires removal and immediate (i.e., "single-stage reconstruction"). Again, since there is no need to move or modify the hard tissue portion of the skull that houses the catheter extending beneath the brain, surgical safety is enhanced. This novel "plug-and-play" soft tissue implant is designed preoperatively based on standard anatomical averages or CAD / CAM designed with an eye to the anatomical boundary lines of the soft tissue thereon. In either case, unlike conventional ones, a newly discovered volume is provided to include embedding techniques of various functions that can provide means for drug delivery for life enhancement, life improvement and / or life support. Another use of this unique "plug-in" design may be the replacement of a non-functional battery or component. Specifically, the component for the soft tissue implant is interchangeable with another component for the soft tissue implant in a plug-and-play manner, and when previous treatments are no longer needed, the drug reservoir or biosensing or imaging hardware or rechargeable battery may be quickly replaced. For example, a neuromedical container having a standardized shape may be provided, enabling a "plug-and-play" design that facilitates easy replacement of the container and enabling the functional components to be drug-independent.

[0018] However, as the experience popularized by the present inventor has increased and the complication rate of surgery is now very low, CCI is often changed in real time for scenarios where more or less skull is removed and the skull defect dimensions do not exactly match the prefabricated CCI (e.g., relative to the original assumption designed at the planning stage). This includes related CCI manufacturing methods, as described in Patent Document 6 titled "Cutting Machine for Changing the Size of a Living Implant During Surgery" that employs robot-assisted technology, Patent Document 7 titled "Method for Performing Single-Stage Cranial Reconstruction Using a Transparent Custom Cranial Implant" that adopts a translucent color to enhance visibility for desktop operations and tracing on an irregularly shaped cranial defect, and Patent Document 5 titled "Computer-Assisted Planning and Execution System" that employs computer-assisted technology to correct and enhance the placement of cranial implants during intraoperative navigation. It should be noted that the present inventor has recently introduced single-stage cranial implant reconstruction by means of a method of a transparent-colored translucent implant, thereby enabling the ability to fluoroscope the implant in real time as a way to minimize the problems associated with marker pen tracing. However, this transparent cranial implant has only been described as replacing the missing cranial bone. Therefore, in the field of reconstructive surgery, there is a need for a transparent-colored implant for replacing the anatomical structures of both hard tissue (i.e., the skull) and soft tissue (i.e., muscle / fat) for the purpose of embedding technology inside. Similarly, the present inventor has described using a transparent-colored implant to fabricate the device described in Patent Document 1 titled "Low-Profile Intercranial Device". However, again, this device was designed only for the purpose of filling the "intracranial" space and could not include design changes and strategies for successfully incorporating a combined replacement strategy for hard and soft tissues for sustained intracerebral drug delivery.Accordingly, in this field, there is a need for a transparent cranial implant of an "extra-cranial" design and an implant of a "high-profile" design that can be easily and safely penetrated percutaneously with a needle (as opposed to a "low-profile" design that compromises the usability of drug delivery and the user's tactile sense of the access point covered by the skin).

[0019] In recent years, due to the reduced time required for the design, fabrication, and implantation of CCI, more cranioplasties have been performed worldwide than ever before, but there is a limitation in simply replacing the missing bone pre-defined in the preoperative images. Until recently, these skull implants were opaque in color and rendered the visibility of the brain and its underlying surrounding structures zero for the surgeon. Therefore, the inventors have expended great efforts in the development of both computer-assisted technologies (Patent Document 5, "Computer-Assisted Planning and Execution System") and robot-assisted technologies (Patent Document 6, "Cutting Machine for Changing the Size of a Living Implant During Surgery") to assist in avoiding these obstructive limitations and laborious operations associated with intraoperative size changes of opaque-colored bone replacement implants. As a result, these recent developments regarding the sterility, shape design, efficient production, and color of CCI are providing opportunities to expand CCI-based cranioplasty not only to patients who require replacement of existing craniectomy defects but also. Notably, it has been found that, due to recent advancements by the inventors, an opaque-colored case may be more favorable for drug delivery devices than a transparent-colored case. For example, from a sales perspective, companies may prefer that the surgeon's customer base cannot see all the internal components, and thus having an opaque case may have strategic business advantages. Furthermore, certain internal design elements may vary with respect to visible light, and thus a transparent-colored case may have an adverse effect on long-term functionality. Therefore, what is needed in the art is a new prefabricated, anatomically specific, and / or customized implantable device with a high-profile contour that simultaneously replaces both hard and soft tissues (i.e., avoids soft tissue-related complications and a high protrusion risk leading to early explantation, such as in joint surgery, spinal surgery, and neurocranial surgery). Also needed in the art is a corresponding method for manufacturing and implanting such implant devices, including methods using computer-assisted and / or robot-assisted surgical procedures as described by the inventors.For example, the placement of these soft and hard tissue composite reconstruction implants within the human skeleton can be further improved by robotic platforms or computer guidance, as well as for the protruding parts outside, such as the intracerebral implanted catheter for drug delivery. Such improvements utilize the advantages of direct access to the brain, spinal cord, or joint regions and the ideal anatomical position / proximity provided by these novel CCIs, and are placed directly on the central nervous system (brain and spinal cord) and important nerve structures (various joint positions such as shoulders, hips, knees, and ankles), just a few millimeters apart, providing a novel method of local supply. For example, robotic and computer-assisted technologies will enhance the placement of neurological deep brain stimulation devices, neurological drug delivery systems such as those introduced herein, neuromodulation devices, image processing devices, radiation therapy devices, and remote sensing / monitoring devices onto hard and soft tissues. Also, it is highly safe as it follows the anatomical limitations of soft tissues seen in preoperative imaging diagnoses such as CT scans and MR images (especially soft tissue windows). This is a far more improved approach compared to the standard and suboptimal methods currently employed by neurosurgeons and orthopedic surgeons alike, which involve placing similar functional devices either above or below the skull, spinal vertebrae, or joints in non-anatomical positions. Furthermore, the inventor's Patent Document 1 issued on July 13, 2021, titled "Low Profile Intercranial Device" (the disclosure of which is hereby incorporated by reference in its entirety into this specification) made improvements by using only the predefined anatomical boundaries of the skull to design customized implants (hence the use of the adjective "intercranial"). However, embodiments of the present invention use an improved design and shape by incorporating implants that fill the overlying soft tissue (i.e., "extracranial") as dual-purpose anatomical specificity implants that replace bone and soft tissue, or as single implants that only fill soft tissue (for cases where the bone defect is small, does not exist due to disease, or is not secondarily required due to the connecting footprint size).Finally, the central and peripheral nervous systems are enclosed by the skull, spine, and bones along the joint cavities, just as the solid soft tissues are in the scalp, back, and surrounding joint areas. Therefore, it is believed that implants with such versatile anatomical specificities can further optimize their usefulness, safety, design constraints, and ultimate placement by new methods that utilize the new soft tissue spaces adjacent to the bone. Furthermore, a two-piece design (whether fabricated virtually fused as a single implant or created as two pieces for the surgeon to assemble during the operation) allows for a "plug and play" arrangement for neurosurgical / orthopedic patients who require different functional devices housed within the head, spine, or joint cavities. This enables easy replacement of depleted drug reservoirs / batteries / components, or those that require a change in drug / battery type, a complete memory chip that can no longer capture biosensor or image data, etc. Thus, the first part that employs the bone space remains intact, while the second part that utilizes the soft tissue space can be easily exchanged and modified as desired with a minor operation. By having interchangeable soft tissue components, the procedure for replacing the "soft tissue implant" becomes much less invasive and is better tolerated by each patient. Removing the skull in the head requires a craniotomy that is risky for stroke / bleeding / seizures and highly invasive. Considering this, removing bone along the spine or joint space requires complex spine / limb surgery with risks such as paralysis, reduced mobility, and pain. Therefore, leaving the hard tissue part intact and only replacing the soft tissue part when necessary is the best approach for both the patient and the surgeon.

Prior Art Documents

Patent Documents

[0020]

Patent Document 1

Patent Document 2

Patent Document 3

[0021] [Non-Patent Document 1] Gordon CR, et al., “First in-human experience with integration of wireless intracranial pressure monitoring device within a customized cranial implant.”, Operative Neurosurgery, January 28, 2020 [Non-Patent Document 2] Bobo RH, Laske DW, Akbasak AA, Morrison PF, Dedrick RL, Oldfield EH, “Convection-enhanced delivery of macromolecules in the brain”, Proc Natl Acad Sci USA, 91(6):2076 - 80 [Non-Patent Document 3] Bruce et al., “Convection enhanced delivery”, Neurotherapeutics, 2017;14:358 - 371 [Non-Patent Document 4] Zhong et al., “Quantitative analysis of dual-purpose, patient-specific craniofacial implants for correction of temporal deformity”, Neurosurgery, 2015, PMID: 25710104

Non-Patent Document 5

Non-Patent Document 6

Non-Patent Document 7

Non-Patent Document 8

Non-Patent Document 9

Summary of the Invention

[0022] According to at least one exemplary embodiment, a high-profile implant having anatomical specificity for hard and soft tissue composite reconstruction with an embedding technique for drug delivery is disclosed. The implant can be adapted to fill the hard and soft tissue space within the temporal region. Embodiments disclosed herein can include an extended "high-profile" soft tissue component having at least one catheter for drug delivery to the brain disposed internally therein. The implants of the embodiments disclosed herein need not be customized for the patient, but rather may be anatomically specific and may be designed, for example, by CAD / CAM or non-customized anatomical averaging design. The functional component may be disposed within the soft tissue component, thereby utilizing the soft tissue space above it for multi-phase drug delivery by direct and continuous pump assistance bypassing the blood-brain barrier to the brain. Further, the soft tissue implant component for replacing or restoring the missing soft tissue may be replaceable or exchangeable in a "plug and play" manner. Thus, the soft tissue implant component may be coupled to the hard component replacing the resected or missing bone by a lock and key connection. Further, the functional component can have a refillable reservoir having a diaphragm that can be repeatedly pierced with a needle through the upper skin, or a Bluetooth module / battery platform extending to just under the skin. The hard component can be a skull, spine or orthopedic joint implant that replaces missing bone or healthy bone that needs to be removed for immediate "one-stage reconstruction". The soft tissue implant can include various functions of embedded neurotechnology for providing modalities that enhance life, change lives, and / or save lives. The soft tissue implant component may be exchangeable with another soft tissue implant component in a plug and play manner if the previous technology is no longer needed.

Brief Description of the Drawings

[0023] The advantages of the embodiments of the present invention will become apparent from the following detailed description of the exemplary embodiments. The following detailed description should be considered in conjunction with the accompanying drawings.

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Mode for Carrying Out the Invention

[0024] Aspects of the present invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Those skilled in the art will recognize that alternative embodiments may be devised without departing from the spirit or scope of the claims. Further, well-known elements of exemplary embodiments of the present invention may not be described in detail or may be omitted so as not to obscure the relevant details of the present invention. Additionally, for ease of understanding the explanations of some terms used herein, they are described as follows.

[0025] As used herein, the word "exemplary" means "serving as an example, instance, or illustration." The embodiments described herein are not limiting but rather are merely exemplary. It should be understood that the described embodiments are not necessarily to be construed as preferred or advantageous over other embodiments. Further, the terms "embodiments of the present invention," "embodiments," or "the present invention" do not require that all embodiments of the present invention include the discussed features, advantages, or modes of operation.

[0026] Furthermore, this application references the technology disclosed in Patent Document 3, issued on May 5, 2020, titled "Craniofacial Implants with Patient Specificity," developed by the inventor of the present application, Patent Document 1, issued on July 13, 2021, titled "Low Profile Intercranial Device," and "Magnetic Resonance Image Compatible, Convection Enhanced Delivery Skull Implant Device and Related Methods" (published, Patent Document 4), and these disclosures are hereby incorporated by reference in their entirety herein. As used herein, "multi-purpose implant" may refer to an implant that performs one or more of protecting the brain or spine, restoring or preventing deformities, and providing an anatomically specific housing for implantable neural technology, and more importantly, is not limited to the "intercranial" space.

[0027] Embodiments of the skull In neurosurgery, a craniotomy of a fairly large size is often required. Most (about 75%) of all craniotomies are performed within the pterional region. Therefore, the anatomical structures of the temporal region may be distorted for the resection and denervation of important structures such as the temporalis muscle and the temporal fat pad (i.e., the associated soft tissue). As a result, with the destruction of this anatomical structure, facial symmetry may be permanently impaired and distorted. Furthermore, a significant number of neurosurgical patients may lose a bone flap (i.e., a segment of bone removed for access to the brain) due to any of infection, tumor involvement, brain swelling, and / or traumatic fracture. Therefore, a reoperation is required to reconstruct the lost cranial bone, known as cranioplasty. Similarly, in spinal surgery, bone resection is necessary to access the spinal cord (i.e., laminectomy), so bone-related problems may occur and improvement is required. For both the cranium and the spine, the technology and science of artificial plastic implants emerged in the 1990s and focused solely on replacing the missing bone with patient-specific designs. The inventor previously invented the first description of a craniofacial implant with patient specificity for replacing missing soft tissue simultaneously with skull reconstruction by adopting a new computer-aided design algorithm focusing on the upper soft tissue (described in Patent Document 3, the entire disclosure of which is incorporated herein). Recently, the inventor invented an improved design including making the anatomical vector lines clearer to improve consistency (i.e., improve the results), a prefabricated temporal window to prevent soft tissue collision during placement, and placing these craniofacial implants on the damaged temporalis muscle rather than under it. However, surgeons are limited by the fact that these "dual-purpose craniofacial implants" (the first use is to replace the missing bone for brain protection, and the second use is to restore facial symmetry secondary to soft tissue deformation), as disclosed in Non-Patent Document 5 (the entire disclosure of which is incorporated herein), are procured as one large implant.

[0028] First Embodiment As shown in FIG. 1, the first exemplary embodiment 100 provides a two-piece design for a surgeon that includes a standard cranial bone replacement implant 102 along with small, medium, and large sized soft tissue implant components 104, which the surgeon can decide whether to use during cranial formation based on intraoperative assessment and the degree of soft tissue absorption. In the first exemplary embodiment 100, implants with anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by CT scan and CAD / CAM design, including a) a cranial implant 102 designed to replace the missing cranial bone (i.e., existing cranial defect), and b) a soft tissue implant 104 designed to replace the missing temporalis muscle / fat. The manufacturing process provides the two implants to the surgeon, and a lock-and-key (i.e., intermeshing) connection is utilized between the cranial implant 102 and the soft tissue implant 104 during implantation. The intermeshing connection may be designed, for example, as a "male" component (i.e., a catheter system) that penetrates the soft side of a "female" component (i.e., a fluid-filled chamber for neuropharmaceuticals such as chemotherapy). The connection may be a press fit to ensure no fluid spillage and / or electrical loss between the hard and soft tissue reconstruction components. The soft tissue component may be procured in small, medium, or large sized dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with an existing cranial defect who requests neuroformative surgery.

[0029] The second embodiment As shown in FIG. 2, a second exemplary embodiment 200 provides a surgeon with a "soft tissue implant with anatomical specificity" for a neurosurgical patient. In examples where neurosurgical techniques are refined and result in a smaller footprint, it is conceivable that these functional devices need not replace both bone and soft tissue for placement and can be pre-designed to fill soft tissue elements around the brain or spinal cord. For example, in the future, a miniaturized implant could replace the temporal muscle and temporal fat pad, have an internal drug delivery chamber by MRI - lucent pump assist technology, and then a small catheter could connect it into the brain through a small skull hole. Thus, such an embodiment can present a less invasive option for all patients who require such things, and in particular for brain tumor patients who require continuous infusion of brain tumor drugs and desire to maintain as much of their native skull as possible. For example, advancements in solid - state batteries, RF charging, and rechargeable wireless batteries can enable these devices to be made smaller, and thus the smaller versions can be placed in areas that fill only the soft tissue as described above, for example, to fill only the atrophied temporal muscle and / or fat pad regions after repeated craniotomies that coincide with post - neurosurgical temporal hollowing.

[0030] Thus, small, medium, and large - sized soft tissue implant components 204 may be procured for the surgeon based on a preoperative CT scan evaluation, and the surgeon may determine to use them during cranioformation based on the degree of soft tissue deformation identified during intraoperative evaluation and diagnostic tests, depending on the type of central nervous system disease being treated and the size constraints imposed by the transplantable neurosurgical technology.

[0031] In a second exemplary embodiment 200, a craniofacial implant having anatomical specificity is a soft tissue implant 204 having anatomical specificity with a "high profile" extension designed to replace the missing temporalis muscle / fat / subcutaneous tissue, and the fabrication process includes a CT scan and CAD / CAM design that provides a lock and key (i.e., interlocking) connection to the healthy skull 201 for the soft tissue implant 204, and can be procured as one implant after virtual fusion / shape creation. The soft tissue component can be procured in small, medium, or large sizes to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient who has an existing soft tissue defect after a neurosurgical craniotomy defect that requires a neuroplasty procedure.

[0032] A third embodiment As shown in FIG. 3, a third exemplary embodiment 300 provides a surgeon with a "soft tissue implant with anatomical specificity" for neurosurgical patients, anticipating future deformations. Thus, small, medium, and large soft tissue implant components 304 may be delivered to the surgeon based on a preoperative CT scan evaluation (which the surgeon may determine based on the intraoperative evaluation and the degree of soft tissue mobilization identified at the time of craniotomy).

[0033] In a third exemplary embodiment 300, a multi-purpose craniofacial implant having anatomical specificity is a soft tissue implant 304 having anatomical specificity designed to replace the missing temporalis muscle / fat / subcutaneous tissue, the fabrication process including a CT scan and CAD / CAM design that provides a lock-and-key (i.e., intermeshing) connection to the healthy skull 301 for the soft tissue implant 304 upon implantation and can be procured as one implant after virtual fusion / shape creation. The soft tissue component can be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. The soft tissue implant can be pre-embedded with life-changing or life-saving neurotechnologies (e.g., drug delivery functions that bypass the blood-brain barrier) that can actively alter the function of the central nervous system and adjacent brain, such as electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain evaluation, fluid diversion for hydrocephalus, therapeutic neuromodulation, enhancement of brain performance, treatment of any type of chronic neurological disorder, and / or improvement of memory retention. The soft tissue component can be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient who has a non-existent soft tissue defect but requires planned neurosurgical craniotomy and neuroplasty for instances such as brain tumor resection.

[0034] Fourth Embodiment As shown in FIG. 4, in a fourth exemplary embodiment 400, another indication for the use of the novel dual-purpose implant as described herein would be in the case of planned craniectomy (i.e., the selective removal of non-diseased or normal skull bone). Many neurosurgical procedures are planned for brain diseases covered by normal and healthy bone (in the case of patients who have not had surgery in the target area and have intact anatomical structures). However, as the field of neurotechnology expands, the use of implantable neurotechnology requires the selective removal of bone and soft tissue to create space for these space-occupying devices that can change lives and save lives. For example, current and future devices can deliver drugs for chronic neurological diseases such as cancer, epilepsy, neurodegenerative diseases, post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), movement tremor diseases, memory deterioration, age-related performance decline, brain enhancement, stress-related environments, etc. Furthermore, these neurotechnology devices can accommodate image processing devices to avoid the need for postoperative CT scans and MRIs. Such devices can also accommodate a hydrocephalus shunt mechanism and / or optoelectronic neuromodulation components, regardless of the presence or absence of a wireless charging platform based on RF technology. Regardless of their inherent function, such devices require space to avoid collisions with the underlying brain and the overlying thin scalp. Therefore, this novel "dual-purpose implant" will have an anatomically specific design that conforms to the exact dimensions of each patient for both the selectively removed bone and soft tissue. Therefore, a two-piece design (one being the skull implant 402 and the other being the soft tissue implant 404) will be fitted together during surgery based on the expected soft tissue absorption of small, medium, or large sizes evaluated by the surgeon. Therefore, such an embodiment provides the surgeon with a two-piece design comprising a standard skull implant 402 and small, medium, and large size soft tissue implant components 404, so that the surgeon can decide whether to use it during craniectomy based on intraoperative evaluation and the degree of soft tissue absorption.

[0035] In a fourth exemplary embodiment 400, an implant having anatomical specificity includes: a) a skull implant 402 designed to reconstruct / replace a defect for a planned craniectomy (i.e., selective removal of the skull or an existing skull defect), and b) a soft tissue implant 404 designed to prophylactically restore the temporal muscle / fat (i.e., a certain degree of atrophy is expected by the surgeon), where the manufacturing process provides the surgeon with two implants and a lock-and-key (i.e., intermeshing) connection between the skull implant 402 and the soft tissue implant 404 is utilized at the time of implantation. The soft tissue implant 404 can be procured in small, medium, or large sizes to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with an existing skull defect who requires a planned craniectomy and neuroplasty.

[0036] Fifth and sixth embodiments As disclosed in Non-Patent Document 6 (the entire disclosure content of which is incorporated herein by reference), the brain is a complex organ without current alternatives, in contrast to the human heart, lungs, liver, or kidneys. Therefore, the only way to manipulate a diseased or aging brain is to place a wireless power supply device having the ability to change brain function by drugs, electricity, neuroimaging, non-invasive neuromodulation, and / or optoelectronics. Such devices are limited in size by the difficult craniofacial anatomy and need to be strategically placed within a biocompatible compartment. However, there is not much extra space inside or within the skull of the human head. Strategically, as disclosed in Patent Document 1, "Low-Profile Intercranial Device" (i.e., "intercranial" refers to the space within the skull), the skull space is an ideal placement location. Therefore, for patients with existing skull defects who require craniofacial reconstruction by means of a cranioplasty method, the embodiments disclosed herein may provide an improved treatment strategy. However, for the purpose of drug delivery into the brain via a temporal implant, based on a pump assist, multiphase flow circuits, a wireless charging platform, implanted biosensors, and many other functional components, the skull space has been shown to be extremely congested and an infeasible option for the inventors. First, the dual-purpose implant may comprise a skull implant designed to replace the missing craniofacial bone (i.e., the existing defect). Second, for example, a soft tissue component may be provided in which functional components having transplantable neurotechnology for functions such as life-changing, life-saving, and brain-altering are embedded. Of particular note is that the skull space of about 4 to 12 millimeters may not provide sufficient space for current drug delivery designs as the technical applications further develop. Therefore, the embodiments disclosed herein accommodate the implanted neurotechnology within the upper soft tissue portion as an anatomically specific design (having a new thickness of about 13 to 40 mm by means of adding soft tissue, "extra-cranial" space).Furthermore, this extra extension towards the skin (i.e., the high-profile extension) may enable better transcutaneous needle access and reduce soft tissue interference in the case of continuous drug delivery and refillable reservoirs, and may also enable the soft tissue portion to be exchanged in a "plug and play" manner by detaching the portion from the cranial implant and attaching a new soft tissue portion as the patient ages and their neurological disease changes over time. Functional components may be embedded within the soft tissue aspect of this implant, and the functional components may not only include life-changing / life-saving neurotechnologies, but may also provide replaceable drug chambers. Such technologies and drugs may positively alter functions near the central nervous system and brain, such as, for example, electronic neuromodulation, chemical modulation by drug delivery, optical imaging for brain evaluation, liquid shunting for hydrocephalus, hands-free connection to wireless communication devices, prevention of chronic symptoms, reversal of age-related decline over time, remote imaging devices for real-time remote evaluation, and / or memory retention and functional improvement. A similar design is applicable to spinal reconstruction as disclosed in Non-Patent Document 7 (the entire disclosure of which is incorporated herein by reference).

[0037] As shown in FIG. 5, in a fifth exemplary embodiment 500, a facial implant having anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by a method including CT scan and CAD / CAM design, and includes: a) a skull implant 502 designed to replace a missing skull (i.e., an existing skull defect); and b) a soft tissue implant 504 designed to replace missing temporalis muscle / fat / subcutaneous tissue. The fabrication process provides the two implants to a surgeon, and a lock-and-key (i.e., intermeshing) connection between the skull implant 502 and the soft tissue implant 504 is utilized during implantation. The soft tissue implant 504 has a functional component 506 embedded therein with neurotechnologies that actively alter the function of the central nervous system and adjacent brain, life-changing or life-saving, such as, for example, electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain evaluation, fluid diversion for hydrocephalus, therapeutic neuromodulation, alleviation of chronic symptoms, functional enhancement, prevention of age-related deterioration, and / or improvement of memory retention. The soft tissue component 504 may be procured in small, medium, or large size dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may require a patient with an existing skull defect to undergo a neuroforming surgery and placement of an embedded functional component 506 strategically housed within the soft tissue component 504 to address underlying neurological disorders.

[0038] As shown in FIG. 6, in a sixth exemplary embodiment 600, a craniofacial implant having anatomical specificity can be procured as two separate implants after anatomical averaging for standard sizes and / or virtual fusion / shape creation by CT scan using CAD / CAM. A patient-specific design includes a) a skull implant 602 designed to replace bone following a planned craniectomy (i.e., an absent skull defect), and b) a soft tissue implant 604 designed to replace the missing temporalis muscle / fat / subcutaneous tissue. The fabrication process provides the two implants to the surgeon, and a lock-and-key (i.e., intermeshing) connection between the skull implant 602 and the soft tissue implant 604 is utilized during implantation. The soft tissue implant 604 has a functional component 606 with neurotechnology that can actively alter the functions of the central nervous system and the nearby brain, such as electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain evaluation, fluid diversion for hydrocephalus, therapeutic neuromodulation, and / or improvement of memory retention, which can change lives or save lives. The soft tissue component 604 can be procured in small, medium, or large size dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with an absent skull defect requiring a planned craniectomy and neuroplasty surgery who requests brain surgery and requires placement of an embedded functional component 606 housed within the soft tissue implant 604 to address the underlying neurological disorder.

[0039] Spinal embodiments Seventh and eighth embodiments In spinal surgery for cancer or trauma, in order to create a space to access the spinal cord, planned bone removal and decompression are often required in some form. Recently, new techniques have been designed to modify impaired spinal cord functions such as recovery from paralysis, tremors, chronic pain, acute trauma, and / or weakness. Therefore, the paravertebral anatomy (i.e., the overlying muscles / fat) can inevitably be distorted during the planned surgery by dissection and denervation of important structures such as the paravertebral muscle groups. As a result, if this important anatomical structure is damaged, the irregularity of the back contour and visual deformity may be permanently impaired. Unfortunately, the technology and science of artificial alloplastic implants for craniofacial and spinal reconstruction emerged in the 1990s and focused only on replacing the missing bone with patient-specific designs. The inventor previously invented, for the first time, a patient-specific craniofacial implant for replacing missing soft tissue simultaneously with skull reconstruction by adopting a new computer-aided design algorithm. The inventor has invented an improved design with a more clearly defined anatomical vector line, a prefabricated temporal window to prevent soft tissue collision during placement, and the placement of these craniofacial implants above rather than under the scarred temporal muscles, in order to improve consistency (i.e., improve the results). This was first described in his seminal paper "Temporal augmentation with methyl methacrylate" in September 2011 as a method using a hand-shaped artificial material implant to simultaneously correct soft tissue and / or hard tissue deformation using an original approach and hand-eye correction (Non-Patent Document 8). However, surgeons are also limited in these inventions by the fact that these "dual-purpose craniofacial implants" (the first use is replacement of the missing bone for brain protection, and the second use is restoration of secondary facial symmetry associated with soft tissue deformation) are procured as one large implant, as disclosed in Non-Patent Document 4, the disclosure of which is hereby incorporated by reference in its entirety.Accordingly, the embodiments disclosed herein provide a two-piece design to a spinal surgeon that includes standard vertebral bone replacement implants, such as laminoplasty, along with small, medium, and large size soft tissue implant components that a surgeon can determine to use during spinal surgery based on intraoperative evaluation and the degree of soft tissue absorption.

[0040] As shown in FIG. 7, in a seventh exemplary embodiment 700, an implant having anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by CT scan and CAD / CAM design, including a) a vertebral implant 702 designed to replace a missing vertebra (i.e., an existing spinal cord deficit following a previous spinal cord decompression surgery such as laminectomy / laminoplasty and / or traumatic injury), and b) a soft tissue implant 704 designed to replace missing paravertebral muscle / fat, and the fabrication process provides the two implants to the surgeon, and a lock-and-key (i.e., intermeshing) connection is utilized between the vertebral implant 702 and the soft tissue implant 704 during implantation. The soft tissue component 704 may be procured in small, medium, or large size dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with an existing, postoperative spinal cord deficit who requests a neuroplasty procedure.

[0041] As shown in FIG. 8, in an eighth exemplary embodiment, a spinal implant having anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by CT scan and CAD / CAM design, including: a) a vertebral implant 802 designed to replace a planned resection of a vertebra (i.e., an absent bone defect; planned spinal cord decompression such as laminectomy / laminoplasty and / or traumatic injury), and b) a soft tissue implant 804 designed to replace the missing paraspinal muscle / fat, where the fabrication process provides the two implants to the surgeon and a lock and key (i.e., intermeshing) connection between the vertebral implant 802 and the soft tissue implant 804 is utilized during implantation. The soft tissue component 804 may be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with an absent defect who requires planned bone removal, placement of implanted neurotechnology, and neuromorphic surgery.

[0042] Further spinal embodiments The spinal cord, as a component of the central nervous system, is a complex organ without current alternatives, in contrast to the human heart, lungs, liver, or kidneys, as disclosed in Non-Patent Document 9 (the entire disclosure of which is incorporated herein by reference). Thus, the only way to manipulate diseased, traumatized, and / or aged spinal cords is to place devices with the ability to alter spinal cord function by drugs, electricity, real-time, wireless connection-based remote nerve imaging, non-invasive neuromodulation, and / or optoelectronics. Such devices have size constraints and need to be strategically placed within a biocompatible compartment. However, there is not much extra space in the human spine or back. Thus, strategically, the bone space above the brain and spinal cord is the ideal placement location, as disclosed in Patent Document 1, "Low Profile Inter-Device," but the inventor has realized that drug delivery technology requires more than just the "bone-only" volume. However, with several iterations, as multi-purpose devices become more miniaturized over time, the space in soft tissue allows for the placement of a two-piece design implant, potentially removing the severity of surgery and minimizing the need to completely remove bone when a "plug and play" switch is required.

[0043] Embodiments 9 and 10 Thus, for patients having an existing spinal defect due to a previous surgery and requiring a planned reconstruction by means of a neurogenic surgery method, such embodiments may provide an improved treatment strategy. First, the dual-use implant may comprise a spinal implant designed to replace the missing vertebrae (i.e., the existing defect), and second, a soft tissue implant may be provided that includes a functional component having an implantable neurotechnology for a life-changing / life-saving, spinal cord-altering function. Of particular note is that the space of the vertebrae is only a few millimeters and there is often not enough space in current designs. Thus, the embodiments disclosed herein can accommodate implantable neurotechnology within the space of the soft tissue implant. Further, as a person ages and their neurological disease changes over time, the soft tissue implant can be exchanged in a "plug and play" manner, for example, by detaching it from the spinal implant and using a new soft tissue implant. Within the soft tissue surface of the implant, for example, a functional component having a life-changing / life-saving neurotechnology is implanted and can actively alter the function of the central nervous system and the surrounding spinal cord. For example, electrical neuromodulation, chemical modulation by drug delivery, real-time remote optical imaging for blood flow assessment by wireless connection, fluid conversion for trauma or disease, improvement of paralysis, fluid conversion for hydrocephalus, hands-free connection to a wireless communication device for patient-physician translation, recovery of paralysis, and / or improvement of physical strength / balance. Of note is that in examples where implantable neurotechnology devices become more refined with a smaller footprint over time, it is conceivable that these functional devices can be pre-designed to fill the soft tissue elements around the brain or spinal cord instead of needing to replace both bone and soft tissue for placement. For example, with solid-state batteries or a rechargeable wireless platform (RF technology) by wireless signals, these devices can be miniaturized, and as a result, the miniaturized devices may be able to be installed at sites that fill only the above soft tissue. In this case, if the exterior is changed to another disease-specific technology, the bone space is not invaded during reoperation, so the invasiveness may be reduced.

[0044] As shown in FIG. 9, in a ninth exemplary embodiment 900, an implant having anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by means of CT scanning and CAD / CAM design methods, including a) a vertebral implant 902 designed to replace a vertebra after a planned decompression (i.e., an absent spinal defect), and b) a soft tissue implant 904 designed to replace the missing paraspinal muscle / fat / subcutaneous tissue. The fabrication process provides the surgeon with the two implants, and a lock-and-key (i.e., intermeshing) connection between the vertebral implant 902 and the soft tissue implant 904 is utilized at the time of implantation. The soft tissue implant 904 includes a functional component 906, which may include life-changing or life-saving neurotechnologies that can actively alter the function of the central nervous system and the nearby spinal cord, such as, for example, electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid diversion for hydrocephalus, therapeutic neuromodulation, prevention of age-related decline, performance improvement for sports, and / or improvement of memory retention. The soft tissue component 904 may be procured in small, medium, or large sizes to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may require a patient with an existing spinal defect to undergo a neurogenic surgery and placement of an implanted neurotechnology device 906 strategically housed within the soft tissue implant 904 to address underlying spinal cord disorders. Since there is no need to drill holes in the bone, future surgical invasiveness associated with the replacement of exterior components, such as refill of drug chambers, battery replacement, hardware updates, changes in neurological disorders, and updates of related applications, can be significantly reduced.

[0045] As shown in FIG. 10, in a tenth exemplary embodiment 1000, a spinal implant having anatomical specificity may be procured as a single implant after virtual fusion / shape creation by CT scan and CAD / CAM design, and includes a soft tissue implant 1004 having anatomical specificity designed to replace missing paravertebral muscle / fat, and the fabrication process provides for locking and keying (i.e., intermeshing) the soft tissue implant 1004 to a healthy vertebra 1001 at the time of implantation. The soft tissue component 1004 may be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may require a patient with an existing soft tissue defect following a previous spinal surgery to undergo a neuroplasty procedure and placement of an implantable neurotechnology device strategically housed within the soft tissue implant 1004 to address underlying spinal cord disorders.

[0046] The eleventh embodiment As shown in FIG. 11, in the eleventh exemplary embodiment 1100, for patients requiring certain planned decompression and / or implanted neurotechnology devices, such embodiments may provide an improved treatment regimen. First, the dual-use implant 1100 may comprise a bone implant 1102 designed to replace a missing vertebra (i.e., an existing defect), and then, for example, a soft tissue implant 1104 may be provided that includes an embedded functional component 1106 having neurotechnology for the ability to change lives / save lives and change the spinal cord. Of particular note is that the vertebral space is only a few millimeters and is often not sufficient space for current designs, so the embodiments disclosed herein are capable of accommodating the embedded neurotechnology within the soft tissue implant space. Further, as a person ages and their neurological disease changes over time, the soft tissue implant 1104 can be exchanged in a "plug and play" manner, for example, by detaching it from the spinal implant 1102 and using a new soft tissue implant 1104. A functional component 1106 may be embedded within the soft tissue surface of the implant 1104, which actively changes the function of the central nervous system and the nearby spinal cord, for example, electronic neuromodulation, chemical modulation with drug delivery, optical imaging for blood flow assessment, fluid conversion for trauma, prevention of degradation associated with aging, performance improvement, resolution of chronic diseases, recovery of lower / upper limb paralysis, fluid conversion for hydrocephalus, hands-free connection to a wireless communication device, recovery of paralysis, and / or improvement of strength / balance are contemplated.

[0047] In the 11th exemplary embodiment 1100, a spinal implant having anatomical specificity may be procured as two separate implants after virtual fusion / shape creation by CT scan and CAD / CAM design, including: a) a vertebral implant 1102 designed to replace a vertebra after a planned decompression (i.e., non-existent spinal defect); and b) a soft tissue implant 1104 designed to replace the missing paraspinal muscle / fat / subcutaneous tissue. The fabrication process provides the two implants to the surgeon, and a lock-and-key (i.e., intermeshing) connection between the vertebral implant 1102 and the soft tissue implant 1104 is utilized at the time of implantation. The soft tissue implant 1104 may have a functional component 1106 embedded therein with neurotechnologies that actively alter, transform, or save lives by changing the function of the central nervous system and the nearby spinal cord, such as, for example, electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain evaluation, fluid diversion for hydrocephalus, therapeutic neuromodulation, prosthetic control, and / or improvement of memory retention. The soft tissue component 1104 may be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may be a patient with a non-existent spinal defect (i.e., planned surgery) who requires a neurogenic surgery and the placement of an embedded functional component 1106 strategically housed within the soft tissue implant 1104 to address underlying spinal cord disorders.

[0048] The 12th embodiment As shown in FIG. 12, in a twelfth exemplary embodiment 1200, for patients who require planned spinal surgery and reconstruction by neurogenic surgery, such an embodiment may provide an improved treatment strategy by neurogenic surgery. As implantable neurotechnology devices become more refined with a smaller footprint for the purpose of being embedded within an "implant with anatomical specificity," it is conceivable that these functional devices may not need to replace both bone and soft tissue for placement and may be pre-designed to fill the soft tissue elements around the spinal cord. For example, with a drug-based pump-assisted delivery system, a solid-state battery, a wireless rechargeable wireless platform by wireless signals (i.e., RF technology), these devices may be capable of being miniaturized, and thus, the miniaturized version may be installable at sites that fill only the soft tissue on the spine, such as within the paraspinal muscle layer. That is, by changing the exterior to another disease-specific technology, the bone space is not invaded during reoperation, and thus, the invasiveness may be reduced. Further, as a person ages and their neurological disease changes over time, the soft tissue implant 1204 may be exchanged in a "plug and play" manner, for example, by detaching from a healthy vertebra 1201 and using a new soft tissue implant 1204. Within the soft tissue surface of the implant 1204, for example, a functional component 1206 having life-changing / life-saving neurotechnology may be embedded, which can actively change the function of the central nervous system and the nearby spinal cord, for example, electronic neuromodulation, chemical modulation by drug delivery, optical imaging for blood flow assessment, fluid conversion for trauma or disease, improvement of paralysis, fluid conversion for hydrocephalus, hands-free connection to a wireless communication device, recovery of paralysis, and / or improvement of strength / balance.

[0049] In the 12th embodiment 1200, a spinal implant having anatomical specificity may be procured as a single implant after virtual fusion / shape creation by CT scan and CAD / CAM design, and includes a soft tissue implant 1202 having anatomical specificity designed to replace the missing paravertebral muscle / fat / subcutaneous tissue, and the fabrication process provides for a lock-and-key (i.e., intermeshing) connection of the soft tissue implant 1202 to a healthy vertebra 1201 at the time of implantation. The soft tissue component 1202 may be procured in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. The soft tissue implant 1202 may be embedded with a functional component 1206 having life-changing or life-saving neurotechnology that can actively alter the function of the central nervous system and the nearby spinal cord, such as, for example, electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid diversion for hydrocephalus, therapeutic neuromodulation, and / or improvement of memory retention. The soft tissue functional component 1206 may be delivered in small, medium, or large dimensions to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment may require a patient with an absent soft tissue defect that requires a planned spinal surgery to undergo a neurogenic surgery and placement of an implanted neurotechnology device strategically housed within the soft tissue implant 1204 to address underlying spinal cord disorders.

[0050] It should be understood that the embodiments disclosed in this specification may be further modified without departing from the spirit of the present invention. In some embodiments, instead of a lock-and-key fit, the bone implant and the soft tissue implant may be fused during the manufacturing process, or "clicked in" using a plug or adapter, may be designed for intraoperative manipulation, or may include a switch for postoperative manipulation. Implantable neural technologies can further include, for example, any technology capable of or adapted for modulating the brain or spinal cord for drug delivery, disease control, removal or treatment of dysfunctions, recovery of the traumatized brain or spinal cord, or improvement or superficial enhancement of the aging central nervous system by external wireless connection, but are not limited thereto. Some of such neural technologies are shown in FIG. 14. Further, in some embodiments, the soft tissue-only dual-use implant may include a small catheter, filament, or wire that passes through the bone to the brain or spinal cord to enable external wireless connection and / or to perform pump-assisted enhanced delivery to bypass the blood-brain barrier.

[0051] Furthermore, in some embodiments, the implant may be constructed of any material that enables it to function as described herein, such as various artificial biomaterials and / or 3D printed tissues. The biomaterial may further have radiopacity for unobstructed wireless connection such as Bluetooth, acoustic transparency for unobstructed ultrasound examination (both diagnostic and therapeutic), and visual transparency to improve surgical placement accuracy including blood loss examination and to reduce the possibility of collision under the brain or spinal cord during fixation by hardware. Multiple spinal or cranial implants may be used, for example, they can be coupled to multiple vertebrae or used as bilateral cranial implants.

[0052] Embodiments of Functional Components FIG. 13 shows an exemplary functional component 1300 that can be used with an embodiment of the implant described herein. The functional component can be sized and shaped to fit within the middle cranial fossa and further within an embodiment of the soft tissue implant described herein. The functional component 1300 may include a housing 1302 and one or more electronic components 1304 that may include a central processing unit 1306 and a rechargeable battery 1308. The functional component 1300 may further include a refillable reservoir 1310 having a cover or diaphragm 1312 that may be penetrable by a percutaneous needle or similar needle. The functional component 1300 may further include a plurality of conduits or catheters 1314, for example, five catheters having a length such that they can penetrate subcutaneously to a depth of about 2 to 5 centimeters within the brain. Additional electronic components disposed within the functional component 1300 may include, but are not limited to, a Bluetooth module 1316 and at least one electroosmotic pump 1318. Further, the rechargeable battery 1308 may utilize wireless charging so that it can be charged from a distance, for example, up to 18 inches away from the functional component 1300 (i.e., the charging portion may be placed within a patient's bedside table or pillowcase that requires overnight device charging, or within a headgear having internal components so that it can be charged during the day).

[0053] Furthermore, the cover or diaphragm 1312 may protrude beyond the surrounding surface of the housing 1302 such that the diaphragm and “high profile” design are easily palpable under the skin to improve the safety and efficacy of needle refill. This is in contrast to a “low profile” interparietal design where the functional component has a smooth contour with normal bone all around and thus is not palpable by a person's finger rubbing along the skin surface, presenting an obstacle to percutaneous refill of the reservoir. However, the functional component 1300 of the present invention extends into the soft tissue implant and thus, by having a palpable ring structure surrounding the self-sealing diaphragm, digital palpation is possible, for example, prior to refill by a percutaneous needle. Furthermore, the cover or Bluetooth module / wireless RF charging platform 1312 may protrude beyond the surrounding surface of the housing 1302 such that the diaphragm and “high profile” design are easily palpable under the skin to improve the safety and efficacy of the wireless connection. This is in contrast to a “low profile” interparietal design where the functional component has a smooth contour with normal bone all around and has a completely thick scalp and soft tissue element covering it, presenting an obstacle to wireless charging and / or Bluetooth connection. However, the functional component 1300 of the present invention extends into the soft tissue implant and thus enables, for example, more effective and safe wireless communication and / or charging.

[0054] According to the embodiments disclosed herein, FIG. 14 shows a hard tissue implant 1402 and a soft tissue implant 1404 coupled to the skull 14. A functional component 1406 is disposed within the soft tissue implant 1404. Shown as part of the functional component 1406 are a diaphragm 1412, two MRI - lucent electroosmotic pumps 1418, and a plurality of catheters 1414 that extend from the functional component 1406 into the brain tissue 16 to enable delivery of a desired substance into the brain tissue. Although not shown in FIG. 14, the functional component 1406 may include all of the components described above with respect to the functional component 1300.

[0055] Furthermore, the rechargeable battery of the functional component 1406 may be charged by a wireless charging device 1430 that can be disposed within or under the patient's pillow 18. The Bluetooth or other wireless communication component of the functional component 1406 may further communicate with software 1440 running on a mobile computing device or a personal computing device 20. The software 1440 may be adapted to display real - time data from the functional component 1406. Real - time data such as flow rate information, remaining battery life, drug reservoir fill level, and potential flow malfunctions can all be transferred in real - time. Furthermore, the current design algorithm of this drug delivery device includes an alternating rhythm of pump - on for 16 - 20 hours and subsequent alternating brain relaxation time of off for 4 - 8 hours.

[0056] Furthermore, in some exemplary embodiments, both the bone implant and the soft tissue implant may internally include a cavity for an embedded functional device, similar to the embodiments described above.

[0057] The foregoing description and the accompanying drawings illustrate the principles, preferred embodiments, and modes of operation of the present invention. However, the present invention should not be construed as being limited to the specific embodiments described above. Additional variations of the above-described embodiments will be understood by those skilled in the art.

[0058] Accordingly, the above-described embodiments should be considered illustrative rather than restrictive. Thus, it should be understood that variations to those embodiments can be made by those skilled in the art without departing from the scope of the present invention as defined by the following claims.

Claims

1. A craniofacial implant having functional and anatomical specificity, A soft tissue implant that replaces missing soft tissue and occupies a soft tissue space adjacent to the winged region of the skull, the soft tissue implant being coupled to a rigid component, A high-profile functional component disposed within the soft tissue implant and having at least one catheter for delivering a drug to the brain, Comprising, The rigid component is one of a hard tissue implant and the skull, The soft tissue implant has no patient specificity, The soft tissue implant is an implant having anatomical specificity.

2. Comprising a hard tissue implant that replaces missing bone and occupies the hard tissue space of the winged region of the skull, The hard tissue implant has no patient specificity, The implant according to claim 1, wherein the hard tissue implant has anatomical specificity.

3. The implant according to claim 1, wherein the soft tissue space is one or more of the temporalis muscle, the temporal fat pad, and the temporal subcutaneous tissue.

4. The implant according to claim 1, wherein the functional implant comprises a housing, a refillable reservoir, and at least one electroosmotic pump.

5. The implant according to claim 4, wherein the diaphragm of the reservoir protrudes above the surface of the housing.

6. The implant according to claim 4, wherein the functional implant comprises a processor, a wirelessly rechargeable battery, and a wireless communication device.

7. The implant according to claim 1, wherein the soft tissue implant is coupled to one of the hard tissue implant and the skull by an intermeshing connection.

8. The implant according to claim 1, wherein the soft tissue implant is interchangeable with another soft tissue implant.

9. A craniofacial implant having functional and anatomical specificity, A hard tissue implant that replaces missing bone and occupies the hard tissue space of the winged region of the skull, A soft tissue implant that replaces missing soft tissue and occupies a soft tissue space adjacent to the winged region of the skull, the soft tissue implant being coupled to the hard tissue implant, A high-profile functional component disposed within the soft tissue implant, the functional component having at least one catheter for delivering a drug to the brain, comprising, wherein the hard tissue implant and the soft tissue implant do not have patient specificity, the hard tissue implant and the soft tissue implant are implants having anatomical specificity.

10. The implant according to claim 8, wherein the soft tissue space is one or more of the temporal muscle, the temporal fat pad, and the temporal subcutaneous tissue.

11. The implant according to claim 8, wherein the functional implant comprises a housing, a refillable reservoir, and at least one electroosmotic pump.

12. The implant according to claim 11, wherein the diaphragm of the reservoir protrudes above the surface of the housing.

13. The implant according to claim 11, wherein the functional implant comprises a processor, a wireless rechargeable battery, and a wireless communication device.

14. The implant according to claim 8, wherein the soft tissue implant is coupled to the hard tissue implant by an intermeshing connection.

15. The implant according to claim 8, wherein the soft tissue implant is replaceable with another soft tissue implant.

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