High profile anatomically specific craniofacial implants for combined soft and hard tissue reconstruction with embedded technology for dosing

Abstract

An anatomically specific implant for neuroplastic surgery. The implant includes a soft tissue implant component designed to replace or repair missing soft tissue in a patient's skull, joint, or spine, wherein the soft tissue implant component is adapted to be coupled to a rigid component via interdigital connections. The rigid component may be a cranial implant suitable for replacing a missing skull or vertebra, or a healthy skull or vertebra, either of which may have a downwardly extending catheter for drug delivery to the brain or spinal cord to facilitate bypassing the blood-brain barrier via multiphase flow. The soft tissue implant may include functional components incorporating neurotechnology such as an MRI transparent pump, a Bluetooth connectivity system, a refillable septum, a remote imaging device, wireless charging capability, and / or information biosensors. The soft tissue implant component is interchangeable with another soft tissue implant component in a plug-and-play manner.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 17 / 400,239, filed August 12, 2021, and U.S. Provisional Application No. 63 / 065,045, filed August 13, 2020, entitled “Multipurpose Anatomically Dedicated Implant for Combined Soft and Hard Tissue Reconstruction with Embedded Technology for Improved Form and Function,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] Examples of these embodiments generally relate to the following areas: chronic drug delivery, refillable needle reservoirs, wearable technology, Bluetooth-enabled devices, wireless charging power platforms, state-of-the-art biotechnology, craniofacial implants, neurosurgery, neuroplastic surgery, implantable neurotechnology, plastic surgery, craniofacial surgery, orthopedic surgery, and neuro-oncology. Specifically, they relate to the field of improving the form and function of permanent implants for the anatomical replacement of hard and soft tissue components. Background Technology

[0004] Modern artificial implants have been designed for anatomical replacements (relative to defects in the bone (i.e., hard tissue) they replace). For example, the inventors have developed a low-profile intracranial device described in U.S. Patent No. 11,058,541, issued July 13, 2021, which discloses placing the implantation technique within hard tissue (skull space), specifically described as "an implant substantially consistent with a resected portion of the patient's skull." However, with advancements in miniaturization, a less invasive option is to use anatomical components combining soft and hard tissues within the temporal fossa as an improved strategy to prevent surgeons from having to remove large chunks of bone to make room for low-profile intracranial devices. For example, the present invention could utilize combined soft tissue replacement, allowing for minimal bone space utilization, rather than the more invasive option of using large segments of skull resection to make room for embedded neurotechnologies; furthermore, the utilization of soft tissue space may be safer for the patient.

[0005] This invention is pre-designed using anatomical compartment dimensions that match typical adult males and females, in contrast to the inventors' prior invention, a "patient-specific" craniofacial implant, described in U.S. Patent No. 10,918,485, issued February 16, 2021. That prior invention disclosed the combined use of temporal soft tissue space and hard tissue (bone) space, but was limited to "patient-specific" (i.e., custom) designs. In contrast, this invention can use the same temporal lift volume and implant design; however, it can be provided in both "anatomy-specific" (i.e., non-custom) and "patient-specific" (i.e., custom) embodiments. Implants according to the invention can be pre-designed as custom, patient-specific implants using computer-assisted design / manufacturing (CAD / CAM), or pre-designed as anatomy-specific implants using anatomical averaging. This invention can utilize anatomical averaging to achieve "off-the-shelf," universal implants. Embodiments of the invention may partially fill missing bone, but will also partially fill missing soft tissue, such as the temporalis muscle and / or temporal fat pad. The manufacturing process for this type of implant may be equivalent to that of a prefabricated device and / or implant made of a safe, biocompatible allogeneic plastic material, and which, relative to time, can have a permanent shape and form, regardless of bioengineered internal movement (i.e., long-term, direct, pump-assisted drug delivery via several connected catheters extending into the white matter of the adjacent brain as a way to bypass the blood-brain barrier) and / or subsequent mechanical trauma (i.e., the shell surrounding the drug delivery component is designed to fit snugly within the cavity and have internal support within the cavity to remain stable in the event of accidental head trauma). Notably, the utilization of soft tissue space, in addition to the cranial space, provides an ideal, inconspicuous solution for placement at the lowest possible distance from the brain (i.e., there is no space closer to the temporal lobe of the brain than the temporal skull and temporal soft tissue). Therefore, from an engineering perspective, the design and safety of the present invention are greatly improved, given that the channel (i.e., catheter) used for drug delivery can be made shorter, thus making the flow more predictable.

[0006] However, until recently, there has been no “anatomically specific craniofacial implant” or device that is pre-designed for the temporal region, featuring a drug pump for enhanced convection drug delivery to the brain and / or internal biosensors for improving the form and function of the human head in the event of intracranial pressure changes (i.e., hydrocephalus, hemorrhage, tumor growth, elevation changes, seizures, etc.), while being strategically designed—in a way that makes the device itself completely invisible to the naked eye and without deformity—to simultaneously replace temporal hard tissue (i.e., bone) defects and temporal soft tissue (i.e., temporalis muscle, temporal fat pad, and subcutaneous tissue) defects. In fact, the first-ever case scenario using a bone replacement implant with an embedded biosensor design was performed surgically by the inventors (Gordon CR, et al. “First in-human experience with integration of wireless intracranial pressure monitoring device within a customized cranial implant.” Operational Neurosurgery 2020 Jan 28). Furthermore, the inventors have described for the first time a “patient-specific craniofacial implant” (US Patent No. 10,639,158) for replacing missing temporal bone and soft tissue in the craniofacial region. However, this prior art invention is strictly limited to customized solutions for hard and soft tissue scenarios, whereas the present invention is non-customizable and designed based on standard volumes applied to the temporal hard tissue (bone) and soft tissue (muscle / fat). While patient-specific implants are customized based on individualized findings through preoperative CT scans and CAD / CAM modeling, the anatomically specific implant of the present invention can be prefabricated using standard values ​​and anthropometric data to achieve similar results and have similar efficacy and effects, but with less labor or preparation time required for implant availability. Notably, the design, manufacture, and delivery of the patented “patient-specific craniofacial implant” typically takes 3 days to 3 weeks, while the “anatomically specific” design described herein can be well prefabricated in advance, thus providing a much simpler “right” or “left” temporal implant that is ready for immediate use, with or without the use of embedded technology for drug delivery.

[0007] The skeletal anatomy that constitutes certain aspects of the human head maintains a constant form, making them well-suited for the field of implantable devices because their shape and form remain constant. For example, embodiments of the present invention describe a device with a rigid, curved shell that is strategically hollowed out internally to support internal operation consistent with pump-assisted techniques for brain drug delivery. In contrast, soft tissue regions found on the craniofacial bones, such as the temporalis muscle, temporal fat pad, and temporal subcutaneous tissue, constantly change shape depending on a person's age and / or daily body movements, thus exhibiting inconsistent boundaries that pose a challenge to implant design. Therefore, the use of temporal soft tissue space was not described in the inventors' published patent application entitled "Magnetic Resonance Imaging Compatible, Convection-Enhanced Drug Delivery Cranial Implant Device and Related Method" [WO-20200006240-A1] because it was initially thought that cranial devices could be used to replace a person's skull. Upon further consideration, the inventors determined that the optimal implant design for achieving direct brain drug delivery requires the use of temporal soft tissue space. Therefore, this invention can replace normal soft tissue within the temporal fossa with a rigid plastic device, but in a concealed manner that removes visible deformities (i.e., the practice and principles of neuroplastic surgery). According to the disclosure herein, prefabricated multipurpose devices can be designed non-customized using a novel design algorithm (i.e., anatomical averaging) associated with standard human data, thus allowing for "off-the-shelf" ease of use. This algorithm incorporates several imaging modalities, such as computed topography (CT) or magnetic resonance imaging (MRI). Specifically, CT is used to best understand the skeletal landmarks and anatomical extent of the craniofacial skeleton, while MRI is used to best understand the soft tissue landmarks and anatomical extent. Therefore, embodiments of the temporal device disclosed herein can be fabricated to simultaneously: 1) replace hard and soft tissues (in both existing and non-existent scenarios) using the inventors’ aforementioned advancements; 2) include embedded technologies such as: an internal electroosmotic pump with non-ferrous metal components; biosensors for important wireless data collection (e.g., internal flow rates); a system capable of pump-assisted, multiphase flow, convection-enhanced drug delivery; and / or an embedded ultrasound array that uses the inventors’ aforementioned advancements for remote brain imaging to help determine whether and when recurrent brain tumors regrow unaffected by local chemotherapy administration; and 3) use embedded technology elements for drug delivery to simultaneously improve form and function so that external personnel cannot see that the patient is receiving direct brain drug delivery and cannot see the refillable septum for needle puncture just millimeters below the skin of the patient’s scalp.It is worth noting that in the inventors' previous application, "Magnetic Resonance Imaging Compatible, Convection-Enhanced Drug Delivery Cranial Implant Device and Related Method" [WO-20200006240-A1], the cranial device was envisioned to be placed within the skull beneath the hair-bearing scalp. However, the inventors have recognized this as a suboptimal design and would pose a significant challenge to healthcare providers when and / or when attempting to palpate and inject drugs through the scalp. Instead, the inventors have determined that a high-profile temporal implant that replaces both hard and soft tissue allows for better positioning of the drug delivery implant in the temporal region, a hairless anatomical area that is easier to locate by palpation, and, more importantly, the drug injection process would be less cumbersome and safer, free from hair and potential bacterial contamination. Furthermore, the "high-profile" appearance of the implant (i.e., extending through and reconstructing soft tissue space) allows the device to extend beneath the skin, which is valuable for several reasons: for example, easier / safer access for percutaneous needle insertion for drug refilling, and providing shorter distances / less tissue interference for wireless charging and / or Bluetooth wireless communication.

[0008] It is noteworthy that craniofacial implants confined to the “intracranial” region, such as the low-profile intracranial device previously invented by the inventors, fail to provide the proper access point for such drug delivery inventions. For example, the boundaries of this implant extend outward, upward, and laterally beyond the previously described cranial space (i.e., the implant design is now “extracranial” rather than “intracranial”), and instead, the temporalis muscle, temporal fat, and temporal scalp subcutaneous tissue are also replaced, extending all the way to below the temporal scalp / facial skin. This, in turn, provides a major distinction and benefit: it now allows for safe and rapid, minimally invasive access to a refillable valve one or two millimeters below the skin using a short, non-drilling needle puncturing the skin. In contrast, refilling the “low-profile intracranial device” would be highly invasive, given that the needle would need to penetrate the entire scalp tissue down to the level of the bone-containing implant. Furthermore, with the “low-profile intracranial device,” the entry point along the temporal region would be dangerously obstructed by the temporalis muscle, temporal fat pad, and temporal subcutaneous tissue. This causes pain and bleeding to the patient each time the drug port is refilled with a needle. Therefore, the inventors believe that an anatomically specific temporal implant, such as the one of the present invention, is needed to safely deliver drugs to the brain via a simple, rapid, and refillable reservoir. The advantages of the present invention include: the use of a temporal fossa localization point and this novel temporal implant design as an enhancement strategy for combined soft and hard tissue replacement, thereby preventing visible deformities; providing a safe entry point for percutaneous needle insertion given that only a thin layer of temporal skin covers the implant rather than the full thickness of hairy scalp; and 3) providing an exponentially increased internal volume (unlike the space of “intracranial devices” limited by human skull size), allowing for the adaptation of embedded pump-assisted technology.

[0009] Systemic drug delivery to the brain is hampered by the highly selective permeability of the blood-brain barrier, which allows only specific substances to pass highly specifically from capillary blood into the brain's extracellular fluid, with a relative fraction of less than 99%. In fact, recent reports indicate that over 60% of pharmaceutical labs dedicated to developing drugs for the nervous system close annually due to this complex, impasse-like barrier preventing successful delivery of blood-borne drugs to the brain. Therefore, much work has focused on engineering drug components to be small and hydrophobic enough to diffuse across the endothelial cells that constitute the complex blood-brain barrier. However, this is suboptimal, as many medically advantageous components are either too large or hydrophilic to be designed for direct delivery to the brain. Therefore, in 1994, Dr. Oldfield of the NIH became the first scientist in the world to introduce a new method called "convection-enhanced drug delivery," which bypasses the blood-brain barrier and delivers drugs directly from a pump through a single catheter into the brain's white matter via convection (i.e., providing multiphase flow), thus completely bypassing the vascular pathway (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). Oldfield and colleagues reported their first successful opening of the scalp and removal of the skull in several cats, effectively convectioning drugs at rates of 0.5 μL / min to 1.0 μL / min using a single-catheter system with a pump as a successful way to bypass the blood-brain barrier. Despite its great success, the cat only survived for 24 hours due to the invasiveness, risk of infection, and supra-anatomical design limitations imposed by the pump-assisted technique. Therefore, while long-term convection-enhanced drug delivery has remained promising in the field of neuroscience for the past three decades, it has not been feasible in humans because the appropriate anatomical positioning and space required to make room for the implantation of such devices have not yet been conceived (Bruce et al. Convection enhanced delivery. Neurootherapeutics 2017; 14:358–371). Prior to this invention, anatomically specific multi-purpose designs for adapting MRI-transparent pump technology had not been envisioned by incorporating the temporal bone, temporal muscle, and temporal fat pad into their design algorithms. In other words, given the unique dimensional limitations within the human head or skull, a reliable method and device for long-term “convection-enhanced drug delivery” could not be found. For example, due to the limitations of intracranial bone space, the vertical dimensions of the inventors’ previous inventions, namely low-profile intracranial devices, were limited to approximately 4 mm to 12 mm (i.e., thickness).In contrast, the device design provided by this invention, compatible with both soft and hard tissue spaces, now allows for crucial high-contour device drug delivery within the brain and body, achieved by providing three times the usable volume of the internal housing (between approximately 12 mm and 40 mm thick). The addition of temporalis muscle and temporal fat replacement increases the internal space several times over, significantly improving the likelihood of safe, pump-assisted drug delivery to the brain and providing additional space for synergistic technologies such as ultrasound probes (for detecting brain tumor recurrence) and biosensors (for detecting over- or under-drug administration). Therefore, it requires a high-contour profile that extends beyond the limitations of the cranial space and should thus be referred to in the design as “extracranial” (i.e., not limited to “intracranial” space). By doing so, it extends one or two millimeters below the skin. Furthermore, the high-contour configuration facilitates palpation via digital examination, helping healthcare professionals to feel the surrounding temporal skin to set up a circular septum for percutaneous drug injection. The novel temporal implant design (combining soft and hard tissue) extends outward from the cranial space, encompassing and extending outward to the normal temporalis muscle space, normal temporal fat space, and normal subcutaneous space. This configuration increases the available volume of a versatile embedded technology for brain drug delivery several times over. Furthermore, such improved anatomical locations would be a welcome addition to the field, featuring novel locations for anatomically specific prefabricated devices within the cranial space and covered soft tissue areas (such as the temporalis muscle and temporal fat), suggesting a newly discovered enhanced drug delivery strategy for rechargeable battery-powered platforms capable of localized neurological drug delivery. For example, with more space, it becomes possible to have a larger rechargeable battery platform. Due to this volume increase, the patient's charging cycle can immediately shift from requiring three 1-hour charges per day (i.e., once every 8 hours) to one 1-hour charges every three days—a significant difference for neurosurgical patients receiving localized brain drug delivery and dramatically altering the risk of inconsistencies (i.e., more internal space equates to better accommodation of a larger battery size). Furthermore, the advancement here lies in the embedding technology within a prefabricated implant (designed using anatomical averaging and CAD / CAM) that integrates both hard and soft tissue spaces—thus eliminating the need to wait days or weeks for a customized implant design when a patient experiences an unexpected brain tumor or a new seizure. This invention allows hospitals to stock anatomically specific temporal implants for integrated hard and soft tissue reconstruction on their shelves, enabling brain tumor patients undergoing tumor resection and craniotomy to have these implants placed in a single surgery—rather than two.For example, the temporal fossa and temporal soft tissue typically have an average volume of 22 to 24 cubic centimeters (as described by the inventors in their published paper entitled "Quantitative analysis of dual-purpose, patient-specific craniofacial implants for correction of temporal deformity" Neurosurgery 2015PMID 25710104). Therefore, the inventors, utilizing their clinical expertise and knowledge base, designed a multi-purpose, anatomically specific device to fit snugly within the mentioned space; thus, the implant of the present invention can have a volume of approximately 65 to 70 cubic centimeters, which is almost two or three times the volume when using only the cranial space. Furthermore, the anatomical location above the skull—rather than being confined within the skull—is advantageous for device engineers who wish to include many different components, for easier filling with percutaneous needles (given that the top edge extends upwards to the skin rather than remaining at a deeper bone level), and for less invasiveness and easier implantation by the surgeon. Therefore, the functional components can be considered “high-profile” because at least a portion of them extends outward from the skeletal level toward the skin, or in other words, extends above the skull. Similarly, local drug delivery requires a refillable septum close to the skin to facilitate needle penetration, meaning that placing the device within a soft tissue space is advantageous compared to simply placing the device within the skull with a thick layer of scalp on top (i.e., a thick scalp with bacteria-laden hair would interfere with the needle penetration system, which is crucial for allowing monthly supplementation of neurological medications to manage chronic encephalopathy). Furthermore, the invention can be applied to tumor regions, not just the brain. For example, the device of the invention can be positioned above the chest / ribs and utilize the combined tissue space of bone (hard tissue) and pectoral muscles (soft tissue) to be safely maintained in a position allowing pump-assisted drug delivery to the lungs, for cases requiring chronic pump-assisted infusion (such as lung cancer or chronic infections such as pneumonia). Similarly, the invention can also be positioned along the lower ribs and rectus abdominis muscles (as a combined hard and soft tissue space) to allow placement for chronic infusion of solid organ cancers, such as in the treatment of liver cancer or hepatitis. Another combined hard and soft tissue region might include the spine (hard) and paraspinal muscles (soft) as a combined space for device placement, allowing for direct, pump-assisted drug delivery to the spine (i.e., for pain relief, antitumor purposes) and / or orthopedic joint regions such as the hip, knee, shoulder, and ankle, for chronic pain medication infusion or cancer treatment. Therefore, the concept of using skeletal and soft tissue spaces for localized brain drug delivery via a convection-enhanced pump mechanism can be translated into other anatomical regions requiring combined hard and soft tissue reconstruction and localized drug delivery.Similarly, the limitations of strict bone replacement (as described by the inventors previously in U.S. Patent No. 11,058,541 entitled "Low-profile Intracranial Device" and Publication WO-20200006240 entitled "Magnetic Resonance Imaging-compatible, Convection-enhanced Drug Delivery Cranial Implant Device and Related Method") pose further challenges to the design process due to limited space, thus restricting the amount of internal drug storage, the space for embedded wireless charging technology and battery storage, and the size dedicated to pump-assisted technology. By extending the implant design and its footprint within the human skull and beyond the normal bone boundaries to include adjacent temporalis muscle, temporal fat, and temporal subcutaneous tissue, more space for brain drug delivery can be obtained, which equates to less periodic filling required (larger space for long-term drug storage, larger reservoir), more internal space allows for a larger energy storage platform via RF charging, safer wireless battery charging (i.e., with regard to the embedded wireless charging mechanism, an implant with an extension closer to the skin level means less tissue interference), and better patient satisfaction.

[0010] For example, placing a standard MRI-compatible device inside the head during craniotomy for recurrent glioblastoma requiring repeated resections of brain tumors would be a challenge. This is because any device inside a brain tumor patient must not only be MRI-safe and / or MRI-compatible (defined as the absence of iron-containing materials), but more importantly, the device should be considered MRI-transparent, not merely MRI-safe and MRI-compatible. As used herein, “MRI-transparent” means that the device can be located within the temporal fossa, in a combined space of hard and soft tissue only a few centimeters from the brain and the previous brain tumor site, and is relatively invisible to the MRI machine responsible for periodic scans every 3–4 months to identify brain tumor recurrence (i.e., radio-transparent) (i.e., the present invention provides zero radiation artifacts). The inventors have assumed that for patients with malignant brain tumors undergoing brain tumor recurrence monitoring every 90–120 days, their combined, multi-purpose device must not only be MRI-compatible in design but also MRI-transparent. For example, in PCT application PCT / US2019 / 039519 entitled "Magnetic Resonance Imaging Compatible, Convection-Enhanced Drug Delivery Cranial Implant Device and Related Methods," the inventors describe the implant as MRI-compatible. However, for the present invention, the device within the combined soft and hard tissue space is not only MRI-compatible but also enhanced in design to be MRI-transparent—a significant advancement for neurosurgical patients with chronic brain diseases (e.g., glioblastoma and malignant brain tumors) requiring meticulous MRI monitoring. This is achieved by avoiding the use of electroactive polymers, instead using an electroosmotic pump filled with simple water (or equivalent). It is precisely electroactive polymers (EAPs) that can cause artifacts, thus hindering proper monitoring of brain tumor patients receiving chronic drug delivery. Furthermore, in the aforementioned application, the inventors described placing the device within the cranial space, which they have now determined is far too restrictive when it comes to constructing pump-assisted devices for brain drug delivery and bypassing the blood-brain barrier. In contrast, this invention addresses the shortcomings of the prior patents and patent applications described herein. First, the device of this invention is not patient-specific, but anatomically specific. Second, unlike LIDs, the device of this invention does not reside within the cranial space, but is placed within a combined anatomical space encompassing the cranial muscles / fat and the skull, allowing engineers to significantly reduce the volume of pump-assisted technology within it. With this additional space, engineering teams can utilize non-ferrous metal materials, unlike in previous work with implants occupying limited space within the skull. Engineers are now freed from design constraints and have achieved greater success in constructing device components free from any iron and / or artifact-causing materials.Third, the device of the present invention includes an MRI transparent design, which completely eliminates radiographic artifacts and instead uses an electroosmotic pump (or equivalent) instead of an electroactive polymer (i.e., MRI transparent water instead of MRI opaque gel).

[0011] This invention can also be found to have applications in chronic neurological conditions such as neurodegenerative diseases (i.e., Alzheimer's disease, Parkinson's disease), drug-resistant epilepsy, neurotrauma / paralysis, major depressive disorder, schizophrenia, bipolar disorder, ADHD in children, brain dysfunction (i.e., paralysis), age-related brain changes (i.e., memory loss), and post-traumatic stress disorder. Furthermore, future options may include: injecting stem cells through the device to enhance brain recovery after traumatic brain injury, cancer, or stroke; and brain-enhancing drugs or supplements that can improve memory, motor performance, balance, hand-eye coordination, brain-computer interfaces, and / or performance in high-stress situations (military, police, etc.).

[0012] For placement, the surgeon can remove any and all diseased or damaged portions of the skull (craniectomy defects), or selectively remove normal bone to make room while the brain remains exposed underneath uninjured. Furthermore, due to the contraction of normal temporalis muscle and temporalis fat after the previous craniotomy (i.e., post-craniotomy temporal soft tissue depression), there will be additional volume available to place the device of the present invention, in contrast to the normal, pre-operative volume of muscle and fat. Therefore, a temporal implant with combined soft and hard tissue reconstruction and drug delivery capability can facilitate bypassing the blood-brain barrier, and further, due to its design and reconstruction aspects, can restore the soft tissue volume to its pre-operative state. This phenomenon of “soft tissue temporal depression” is associated with denervation and / or shunting of the temporal soft tissue during standard pterional craniotomy for brain tumors. Therefore, when the surgeon returns for reconstructive surgery, some type of implant reconstruction (i.e., supplementation) of muscle and fat is required, in which the device of the present invention can be used. This device not only provides additional internal volume but also serves as a reconstructive option for neurosurgical patients wishing to correct and / or prevent temporal depression deformity. After the removal of the affected skull (either in a “multi-stage” approach, where a pre-operative procedure to remove bone is performed before implantation, or in a “single-stage” approach, where the implant is placed while the bone is being removed), such craniectomy defects are typically reconstructed with a custom craniofacial implant (CCI), rather than with generic “off-the-shelf” materials that currently cannot provide any true anatomical replacement. Historically, however, patients requesting cranioplasty based on CCI reconstruction for an ideal appearance have been limited to “second-stage” procedures performed in cases where a pre-existing skull defect could be achieved, allowing for precise matching and design. However, the inventors’ recent modification has revolutionized the field of cranioplasty with a technique called “single-stage cranioplasty,” in which clinicians, such as neuroplasticity surgeons or neurosurgeons, reshape / resize a previously ordered custom implant (of an oversized form) to perfectly fit the skull defect as a true anatomical replacement—instead of using “off-the-shelf” materials that can only partially repair missing bone. Regardless of the approach, for single-stage cranioplasty involving skull tumors or two-stage cranioplasty for predefined skull defects, the advent of computer-aided design / fabrication (CAD / CAM) has provided surgeons with perfectly shaped cranial incision bodies (CCIs) designed and fabricated in part based on finely cut preoperative computed tomography (CT) scans and three-dimensional reconstructions (+ / - stereolithography models). However, the challenges today are not limited to missing skull fragments.Given the inventors' advancements in embedded technology, which require larger footprints (i.e., to accommodate Bluetooth modules, wireless RF charging units, microprocessors, MRI transparent pump technology, real-time biosensors, imaging arrays with ultrasound crystals, etc.) and docking stations to truly advance the field, a new invention is needed to design anatomically specific implants using CAD / CAM capable of simultaneously replacing both hard tissue (bone) and soft tissue (covering muscle and fat). In specific areas (e.g., charging using radio frequency (RF) signals instead of the standard, MRI-incompatible magnetic coils used in common household appliances and mobile phones), such temporal devices could potentially feature wireless charging platforms developed for complete MRI safety. These versatile devices could also incorporate Bluetooth, wireless connectivity, and enhanced security designs (with extensive threat modeling to prevent biohacking and aberrant dosing rates). Such devices could also include computer chips and internal processors to assist in the self-guided, ideal flow of the pump-assisted mechanism. Such devices may have small computer chips capable of continuously monitoring the flow rate of drugs pumped into the brain through each of four to five conduits, allowing for self-monitoring of the flow in any one or more conduits, overcoming and adapting to any unexpected scar tissue or increased resistance. This novel continuous monitoring mechanism is positioned within the temporal implant so that each conduit pumping drugs into the brain can maintain a steady flow rate of approximately 0.5 μL / min to 1.0 μL / min, regardless of the resistance at the conduit-brain interface. Scar tissue, radiation changes, and / or recurrent brain tumors can all negatively impact the flow rate exiting each embedded conduit. Therefore, the newly discovered extra space in such soft and hard tissue implants now allows engineers to incorporate additional safety mechanisms, such as “cruise control flow rate,” by embedding multiple biosensors along the fluid loop. Such devices may also feature remote biosensors to detect abnormal fluid accumulation around the brain requiring immediate medical attention and mobile messaging. For example, normal intracranial pressure is approximately 5–15 mmHg, so any pressure increase due to fluid extravasation or implant malfunction requires immediate detection; with the additional space in this article, there is now room for additional technologies to be incorporated. Such devices could also be brain-oriented, featuring a miniature ultrasound array at the bottom that could use artificial intelligence to self-monitor the tumor cavity to detect any growth changes associated with recurrent tumors and / or radiation-induced scar tissue. Such devices could also have a tangible, “high-profile” septum located just one or two millimeters below the temporal scalp skin as a safer entry point, capable of supporting approximately 1000 repeated percutaneous needle punctures (through the scalp) (using special non-drilling needles and material designs to prevent any type of accidental leakage (especially since the filling of chemotherapy drugs is extremely dangerous and corrosive to the surrounding skin)).Such devices may have a small computer chip capable of "cruise control," allowing continuous monitoring of the flow rate of medication pumped into the brain through each of four to five catheters. This would enable the device to self-monitor the flow in any one or more catheters, overcoming and adapting to any unexpected scar tissue or increased resistance. Such devices may also have mobile applications capable of sending real-time, patient-protected data, including critical information such as drug levels and flow rate, to the patient, their family, and / or their healthcare provider. One day, such devices may also have internal aspiration capabilities, as they can automatically extract fluid and cells from the diseased brain for biopsies and diagnostics, all through a small subcutaneous port, simply by reversing the flow of the MRI transparent pump.

[0013] As discussed herein, the inventors' prior inventions were limited to skeletal space; however, the inventors' recent research indicates that, prior to their original concepts, components such as MRI-transparent batteries, computer chips, catheters, biosensors, pumps, Bluetooth modules, RF charging components, and radio antennas all require significantly more three-dimensional space. Therefore, there is a need to advance the field with prefabricated temporal implants that combine soft and hard tissues, accommodating unprecedentedly powerful, life-changing technologies. Thus, by modifying the design to include some surrounding soft tissues (i.e., the temporalis muscle, temporal fat pad, and temporal scalp subcutaneous tissue), the field of rigid bone replacement in neuroplastic surgery, neurosurgery, neuro-oncology, and craniofacial surgery can be greatly improved, providing additional space for the use of embedded technologies (such as biosensors, drug delivery, or remote imaging) in multipurpose, anatomically specific implants.

[0014] Similar to cranioplasty, joint replacement surgery via orthopedic procedures has achieved tremendous success since the 1960s, replacing bone defects caused by conditions such as osteoarthritis and cancer in a way that permanently improves form and function. However, orthopedic implants are designed only for replacing bones in joints such as the hip, knee, shoulder, and ankle. The use of surrounding soft tissue space has not been considered, either in orthopedic surgery or in this implantable neurotechnical space. Furthermore, these purely bone implants (off-the-shelf and prefabricated) are solid internally and lack embedding capabilities. Therefore, the field of solid bone replacement in orthopedic joint surgery could be greatly improved by modifying the design to include some surrounding soft tissue to provide additional space for embedded technologies such as biosensors, drug delivery, and / or remote imaging.

[0015] Similar to cranioplasty, the use of hard tissue implants designed for missing vertebrae (the bony elements of the spine) has been highly successful in spinal surgery for various conditions such as trauma, paralysis, and / or cancer. However, surgically designed spinal implants are only designed to replace bony structures such as vertebrae and / or the pelvis, without considering the use of surrounding soft tissue space—such as the paraspinal muscles, which are very similar to the temporalis muscle in this respect. Furthermore, these purely bone implants (off-the-shelf and prefabricated) are solid internally and lack embedding capabilities. Therefore, the field of solid bone replacement in spinal surgery could be greatly improved by changing the design to include some surrounding soft tissue, providing additional space for the use of embedded technologies such as biosensors, drug delivery, Bluetooth connectivity, wireless charging, and / or remote imaging.

[0016] In fact, recent journal publications demonstrate the use of the dual-purpose CCI designed by the inventors ("Zhong S, Huang GJ, Susarla SM, Swanson EW, Huang J, Gordon CR. Quantitative Analysis of Dual-Purpose, Patient-Specific Craniofacial Implants for Correction of Temporal Deformity. Neurosurgery"). (2015 Jun; 11(1):220-9) This technology better preserves the postoperative appearance of neurosurgical patients, prevents postoperative deformities and associated social stigma, reduces the total number of surgeries, prevents scalp-related wound complications, and improves patient satisfaction, making it an ideal medium for neurosurgical reconstruction. This significant advancement was achieved through the use of a novel design algorithm provided by the inventors that utilizes underutilized hard and soft tissue spaces around the brain (thus eliminating the old, outdated, generational dogma: cranial implants can and should be designed solely for anatomical skeletal space) – and how this new development can be reliably achieved using preoperative CAD / CAM design. However, at that time, there were no computer-aided surgical techniques to guide surgeons in “single-stage cranial bone replacement,” and implants could only be hand-carved intraoperatively using simple hand-eye coordination and routine burr polishing. Therefore, the inventors worked to design and invent a technology to provide surgeons with real-time, computer-guided information to simplify dimensional modifications. Therefore, in U.S. Patent No. 10,448,956, entitled "Computer-Aided Planning and Execution System," and U.S. Patent No. 10,603,175, entitled "Cutter for Adjusting Original Implant Size During Surgical Procedure," the inventors describe a recently developed surgical workstation that, after placing the CCI within a three-dimensional craniofacial defect (as associated with virtual planning), possesses the novel ability to provide intraoperative visual guidance (on an intraoperative visual monitor) relating the planned and actual positions of the CCI – ultimately adding greater precision and simplicity to this complex procedure. It is noteworthy that this CCI-related technology – including both computer-aided and robot-aided approaches – can be used solely for bone replacement design or for dual-purpose designs combining hard and soft tissue. In any case, until recently, all CCIs were used to replace abnormal bones with some form of disease (whether benign or malignant). Therefore, these customized cranial implants are referred to as "static CCIs." CCI (Centralized Cerebral Injection) – primarily because their main constant uses (i.e., uses that are unchanging over time) strictly include two benefits after implantation – “brain protection” and “improved appearance”.Therefore, in the past, as a way to improve this field, the inventors described a novel solution for “static” or “non-functional” implants for bone replacement by introducing low-profile intercranial devices (LIDs), which strictly described bone replacement (primarily of the skull) using embedded technology. The term “intracranial” is used here to indicate that the technology is limited to the skeletal space. However, recent efforts by the inventors have shown that this is destructive and rate-limiting when it comes to achieving successful chronic brain drug delivery to help bypass the blood-brain barrier. Now, the inventors of today are further advancing this field by utilizing a dual-purpose design to replace both hard and soft tissue defects, describing the limitations of “static” or “non-functional” patient-specific and anatomically specific craniofacial implants, and significantly expanding the scope of their design from “intracranial” to “extracranial.” Therefore, this invention targets a multi-purpose, anatomically specific implant with embedded technology for improving form and function, for combined soft and hard tissue reconstruction.

[0017] Meanwhile, many FDA-approved “off-the-shelf” technologies have life-altering or life-saving capabilities. Specifically, in neurosurgery, some technologies can deliver electrical impulses (i.e., epilepsy management), pump neuropharmacy (i.e., chronic pain), or use programmable shunt valves to siphon / transfer excess cerebrospinal fluid (i.e., hydrocephalus management), but they are not customizable or designed to protect the brain. However, each of these neurotechnical implants (which to some extent provide intermittent or continuous interaction with the central nervous system) has a large, irregular footprint and suboptimal shape design, incompatible with the principles of neuroplastic surgery, whose mission is to optimize both form and function. Similarly, revolutionary technologies in orthopedic and spinal surgery suffer from similar design setbacks. Many revolutionary technologies have been used for patients with chronic pain, debilitating conditions, and / or tumors along the spine, pelvis, and joints, but design flaws accompanying these technologies have led to visual distortions and high compression rates due to shape incompatibility and failure to consider the anatomical boundaries of the overlying soft tissue (i.e., muscle / fat). Similarly, such embedded neural implants do not settle within the normal anatomical barriers of the scalp or skull, thus posing a risk of impact to adjacent tissues and visual distortion. If the implant is above the skull and poorly shaped, it equates to premature compression and premature removal. If the implant is bulky and placed below the skull, it equates to cortical impingement and focal symptoms associated with brain impingement. Therefore, to achieve significant advancements in both implantology and embedded technology, this invention can 1) incorporate both hard and soft tissue boundaries into the anatomically specific design of both pre-made and non-pre-made implants, and 2) subsequently provide more (i.e., several times) space for encapsulation and long-term safety for embedded technology by adding additional soft tissue space to the CAD / CAM design of bone implants. Consequently, modern neural devices (brain, spinal, and orthopedic implants, etc.) will no longer face the challenge of a high risk of compression and infection with an incidence rate approaching 50% (i.e., the current deficiencies of modern devices lead to a high incidence of pain and compression through the covering skin, thus requiring premature transplantation). Similarly, in the inventors' subsequent patents for low-profile intracranial devices (LIDs), battery-powered, low-profile devices for intracranial placement within an anatomically specific tissue plane along the skeletal space are described. Meanwhile, the fields of neurosurgery, neuroplastic surgery, and orthopedic surgery have been hampered and limited in many key areas requiring improved implant delivery, including, for example, battery-powered neuromodulation / cortical stimulation for epilepsy / movement disorders, valve devices for hydrocephalus, pump-assisted local delivery of neurological drugs for brain tumors, revolutionary spinal implants for monitoring / treating spinal cord injuries, and chronic pain associated with osteoarthritis.One reason is that bone space—and current implant designs—is not always large enough to accommodate life-altering, pleasure-enhancing, or life-saving technological paradigms, resulting in alarmingly high rates of compression, infection, and pain that limit successful outcomes. Therefore, there is a clear need for new inventions that have a larger footprint and are anatomically sensitive by emphasizing the boundaries of the normal soft tissue capsule. For example, novel pump-assisted designs incorporating electroosmotic contents, Bluetooth chips, integrated biosensors, RF charging platforms, and refillable drug reservoirs (all now MRI-clear and requiring considerable space together) are incompatible with bone-only designs.

[0018] Furthermore, there has long been a need for a two-piece, multi-purpose, anatomically specific implant. The primary purpose of such a device is to restore the stiffness and structural integrity of missing or replaced bone. Conversely, having a fragile, soft shell is dangerous for patients undergoing brain surgery. Next, such a device can replace the volume of missing hard and soft tissue to correct and / or prevent visible contour deformities. Additionally, by extending upwards beyond the bone boundaries and closer to the skin, such a device can allow for less soft tissue interference with the Bluetooth module / wireless charging battery and / or allow the refillable reservoir to be shallower than the skin surface, making it easier for doctors or nurses to fill the refillable drug chamber with specialized non-drilling needles. Finally, such devices with “high contour edges” can provide a new solution in this field by utilizing the enlarged adjacent space of hard and soft tissue (crucial when wireless technologies are involved, given the reduced tissue obstruction to the outside). Furthermore, the design of such devices can be uniquely enhanced in future iterations by providing surgeons with integrated or stand-alone soft tissue implant components suitable for replacing or restoring missing soft tissue in a "plug-and-play" manner, as many patients develop chronic conditions with age that can often change over time. It is noteworthy that this approach differs from the inventors' previous descriptions of patient-specific craniofacial implants (US Patent #10,639,158). Compared to those inventions, the soft tissue implant components can now be physically adapted and coupled to a rigid base component that replaces removed or missing bone (i.e., skull, spine / vertebrae, and joint bones) in an interdigital manner, similar to a lock and key, thereby preventing micromovement and / or fluid leakage. This would, for example, benefit patients with brain tumors, as cancer alters its cellular composition and recurrent aggressiveness, necessitating the use of different chemotherapy drugs. Therefore, the rigid base component thus includes skull, spine, or orthopedic joint implants suitable for replacing missing bone or healthy bone requiring removal and immediate (i.e., "single-stage reconstruction"). Similarly, the hard tissue components and skull housing the conduits extending downwards into the brain do not need to be moved or altered, thus improving surgical safety. This novel “insert” soft tissue implant is designed preoperatively according to standard anatomical averaging or using CAD / CAM design focused on the anatomical boundaries of the overlying soft tissue. In both cases, it provides newly discovered volumes to include embedded technologies with a variety of functions, offering unprecedented, enjoyment-enhancing, life-altering, and / or life-saving drug delivery methods. Another application of this unique “insert” design could be the switching out of non-functional batteries or components. Specifically, soft tissue implant components can be interchanged with other soft tissue implant components in a plug-and-play manner, allowing for rapid replacement of drug reservoirs, biosensing or imaging hardware, or rechargeable batteries if and when the previous treatment is no longer needed.For example, neuromedical containers with standardized shapes can be provided, allowing for "plug-and-play" designs that facilitate container replacement and allow functional components to be independent of drugs.

[0019] However, as the inventors gain more experience and surgical complication rates are now extremely low, CCIs are being modified more frequently in real time for situations where more or less skull bone is removed and where skull defect sizes do not perfectly match the pre-made CCI (relative to what was initially envisioned, e.g., designed during the planning phase)—including related methods for manufacturing such CCIs described in the following patents: U.S. Patent No. 10,603,175, entitled "Cutter for Adjusting Original Implant Size During Surgical Procedure," employing robot-assisted technology; U.S. Patent No. 10,835,379, entitled "Method for Single-Stage Cranioplasty Reconstruction Using Transparent Custom-Made Skull Implants," employing translucent color and enhanced visibility for on-table manipulation and tracking of irregularly shaped skull defects; and U.S. Patent No. 10,448,956, entitled "Computer-Aided Planning and Execution System," employing computer-aided technology to modify and enhance the placement of skull implants through intraoperative navigation. It is noteworthy that the inventors recently introduced single-stage cranial implant reconstruction using color-transparent or translucent implants—allowing for real-time visualization of the implant as a way to minimize the challenges associated with marker tracking. However, such color-transparent cranial implants are only described as replacing missing skull bones. Therefore, the field of reconstructive surgery requires a color-transparent implant for replacing both hard tissue (i.e., skull) and soft tissue (i.e., muscle / fat) anatomy for use in embedded technologies. Similarly, the inventors described using a transparent implant to fabricate a device described in U.S. Patent No. 11,058,541 entitled "Low-profile Intracranial Device." However, this device is also contemplated as merely filling "intracranial" space and fails to incorporate design changes and strategies to successfully include combined soft and hard tissue replacement strategies for chronic brain drug delivery. Therefore, the field needs a transparent cranial implant with an “extracranial” design and a cranial implant with a “high profile extension” to allow easy and safe percutaneous needle insertion (as opposed to a “low profile” design, which compromises usability in terms of drug delivery and the user’s tactile awareness of the access point covered by the skin).

[0020] Due to recent reductions in the time required for the design, manufacture, and implantation of CCIs, cranioplasty using allogeneic implants is being performed more frequently worldwide than ever before. However, a limiting factor is that these implants strictly replace missing bone that can be predefined on preoperative imaging. Until recently, these cranioplasty implants were opaque, providing surgeons with zero visibility of the brain and surrounding structures. Therefore, the inventors have devoted considerable effort to developing computer-aided technologies (US Patent No. 10,448,956, “Computer-Aided Planning and Execution System”) and robot-aided technologies (US Patent No. 10,603,175, “Cutter for Adjusting Original Implant Size During Surgical Procedure”) to help circumvent the cumbersome limitations and labor-intensive efforts associated with intraoperative sizing modifications of these opaque bone replacement implants. Thus, these recent advancements in CCI asepticity, shape design, streamlined production, and color collectively offer the opportunity to expand CCI-based cranioplasty beyond patients requiring replacement of pre-existing craniectomy defects. It is noteworthy that recent advances by the inventors now suggest that opaque casings may be more suitable for drug delivery devices than those with transparent casings. For example, from a sales perspective, companies may prefer that their surgical clientele cannot see all the internal components, thus opaque casings may have a strategic business advantage. Furthermore, certain internal design elements may vary relative to visible light, so transparent casings may be detrimental to long-term functionality. Therefore, what is needed in the art are novel, prefabricated, anatomically specific, and / or custom-designed implantable devices with high-profile edges that simultaneously replace both hard and soft tissue (i.e., avoiding soft tissue-related complications and the high risk of premature interpretation in procedures such as joint surgery, spinal surgery, and craniotomy). The art also needs corresponding methods for manufacturing and implanting such implantable devices, including methods using computer-assisted and / or robot-assisted surgery as described by the inventors. For example, the placement of these combined hard and soft tissue reconstruction implants within the human skeleton can be better enhanced by robotic platforms and / or computer guidance, as well as outwardly extending portions (e.g., brain implantation catheters for drug delivery). These improvements will leverage the benefits of direct access to brain, spinal cord, or joint regions, and ideal anatomical locations / proximities offered by these novel CCIs, which are placed directly on top and only millimeters away from the central nervous system (brain and spinal cord) and key neural structures (such as various joint locations in the shoulder, hip, knee, and ankle), to deliver life-changing interventions, providing an unprecedented method of local drug delivery. For example, robotic-assisted and computer-assisted technologies will enhance the soft and hard tissue placement of devices such as deep brain stimulators, neuro-drug delivery systems as described here, neuromodulation devices, imaging devices, radiotherapy devices, and remote sensing / monitoring devices.Similarly, by adding soft tissue extensions to each bone implant design, the field is now experiencing a long-awaited supply of additional volume, and this additional volume is safe because it follows the soft tissue anatomical limitations (specifically, the soft tissue window) found on preoperative imaging (such as CT scans or MR imaging). This is a significantly improved approach compared to placing similar functional devices in non-anatomical locations above or below the skull, spine, or joints (the standard, suboptimal approach currently used by neurosurgeons and orthopedic surgeons). Furthermore, the inventors’ U.S. Patent No. 11,058,541, entitled “Low-profile Intracranial Device,” issued July 13, 2021 (the disclosure of which is incorporated herein by reference in its entirety), provides an improvement in designing custom implants using only predefined anatomical boundaries of the skull (hence the use of the adjective “intracranial”). However, embodiments of the invention utilize a further improved design and shape by incorporating the implant into the overlying soft tissue in the same way (i.e., "extracranial"—either as a dual-purpose, anatomically specific implant replacing bone and soft tissue, or as an isolated implant simply filling the soft tissue (for isolated cases with minor bone defects, absent or unnecessary due to disease (secondary to the space occupied by integration)). Finally, both the central and peripheral nervous systems are enveloped by abundant soft tissue along the skull, spine, and joint spaces, as well as the scalp, back, and surrounding joint regions. Therefore, by utilizing the newly discovered soft tissue space adjacent to bone in a novel way, this multi-purpose, anatomically specific implant further optimizes its practicality, safety, design constraints, and final placement. Furthermore, the two-piece design (whether virtually fused and manufactured as a single implant, or created as a two-piece and installed together by the surgeon during surgery) allows for a "plug-and-play" arrangement of external components for use where needed. Neurosurgical / orthopedic patients who require different functional devices encapsulated within their head, spine, or joint spaces—those who can easily replace depleted drug reservoirs / batteries / components or require changes to drug / battery types, or whose full-memory chips can no longer capture biosensor or imaging data—can benefit from this system. The first component utilizing the skeletal space can remain unchanged, while the second component utilizing the soft tissue space can be exchanged and altered as needed via a minor surgical procedure. Having interchangeable soft tissue components makes replacing “soft tissue implants” less invasive and better tolerated by each patient—given that removing the skull requires craniotomy (with risks of stroke / hemorrhagic / seizures and high-invasive surgery), and removing bone along the spine or joint space requires complex spinal / limb surgery (with risks of paralysis, decreased mobility, pain, etc.). Therefore, keeping the hard tissue component undisturbed and replacing the soft tissue component only when indicated is in the best interests of both the patient and the surgeon. Summary of the Invention

[0021] According to at least one exemplary embodiment, a high-profile, anatomically specific craniofacial implant with embedded technology for drug delivery and for combined soft and hard tissue reconstruction is disclosed. The implant is adapted to fill both hard and soft tissue spaces within the temporal region. The disclosed embodiments may include an extended, high-profile soft tissue component with a functional component having at least one conduit for delivering drugs to the brain. The implants of the disclosed embodiments may be non-patient-customized but anatomically specific and may be designed, for example, by CAD / CAM or non-customized anatomically averaged design. The functional component may be disposed within the soft tissue component to utilize the overlying soft tissue space for direct, long-term, pump-assisted, multiphase drug delivery to the brain by bypassing the blood-brain barrier. Furthermore, soft tissue implant components adapted to replace or repair missing soft tissue can be replaceable or interchangeable in a "plug-and-play" manner. Thus, the soft tissue implant component may be adapted to be coupled to a rigid component via a lock-and-key connection that replaces resected or missing bone. The functional component may also have a refillable reservoir with a diaphragm capable of being repeatedly pierced through the skin above by a needle, or the functional component may also have a Bluetooth module / battery platform extending just beneath the skin. Rigid components may be skull, spinal, or orthopedic joint implants suitable for replacing missing bone or healthy bone requiring removal and immediate “single-stage reconstruction.” Soft tissue implants may include embedded neurotechnology with various functions, providing ways to enhance enjoyment of life, transform lives, and / or save lives. Soft tissue implant components may be interchangeable with other soft tissue implant components in a plug-and-play manner if and when the previous technology is no longer needed. Attached Figure Description

[0022] The advantages of embodiments of the present invention will become apparent from the following detailed description of exemplary embodiments. The following detailed description should be considered in conjunction with the accompanying drawings, in which:

[0023] Figure 1 A first exemplary embodiment of a multipurpose implant suitable for the skull is shown;

[0024] Figure 2 A second exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0025] Figure 3 A third exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0026] Figure 4 A fourth exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0027] Figure 5A fifth exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0028] Figure 6 A sixth exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0029] Figure 7 A seventh exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0030] Figure 8 An eighth exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0031] Figure 9 A ninth exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0032] Figure 10 A tenth exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0033] Figure 11 An eleventh exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0034] Figure 12 A twelfth exemplary embodiment of a multipurpose implant suitable for the spine is shown.

[0035] Figure 13 A thirteenth exemplary embodiment of a multipurpose implant suitable for the skull is shown.

[0036] Figure 14 A fourteenth exemplary embodiment of a multipurpose implant suitable for the skull is shown. Detailed Implementation

[0037] Various aspects of the invention have been disclosed in the following description and accompanying drawings with reference to specific embodiments thereof. Those skilled in the art will recognize that alternative embodiments can be devised without departing from the spirit or scope of the claims. Furthermore, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted to avoid obscuring the relevant details of the invention. In addition, several terms used herein are discussed for ease of understanding.

[0038] As used herein, the term "exemplary" means "serving as an example, instance, or illustration." The embodiments described herein are not limiting but merely exemplary. It should be understood that the described embodiments are not necessarily to be construed as preferred or advantageous over other embodiments. Furthermore, the terms "embodiments of the invention," "embodiments," or "invention" do not require that all embodiments of the invention include the features, advantages, or modes of operation discussed.

[0039] Furthermore, this application relates to technology developed by the inventors and disclosed in the following patents: U.S. Patent No. 10,639,158, entitled "Patient-Specific Craniofacial Implant," issued May 5, 2020, and U.S. Patent No. 11,058,541, entitled "Magnetic Resonance Imaging Compatible, Convection-Enhanced Drug Delivery Cranial Implant Device and Related Methods," issued July 13, 2021 [Published, WO-20200006240-A1], the disclosures of which are incorporated herein by reference. As used herein, "multipurpose implant" can mean an implant suitable for performing one or more of the following actions: protecting the brain or spine; restoring or preventing deformities; providing an anatomically specific shell for embedded neurotechnology, and, more importantly, not limited to the "intracranial" space.

[0040] Skull Example

[0041] Neurosurgical procedures often require extensive craniotomies. Most (approximately 75%) of these craniotomies are performed within the pterional region. Consequently, temporal anatomy can be distorted due to the rupture and denervation of key structures such as the temporalis muscle and temporal fat pad (i.e., related soft tissues). Facial symmetry can thus be permanently damaged and distorted along with this anatomical disruption. Furthermore, a significant number of neurosurgical patients may lose bone flaps (i.e., bone segments removed to access the brain) due to infection, tumor involvement, brain swelling, and / or traumatic fractures. Therefore, a second surgery, cranioplasty, is required to reconstruct the missing skull. Similarly, spinal surgery, which involves removing bone to access the spinal cord (i.e., laminectomy), can also present bone-related problems and require modification. For both the skull and spine, the technology and science of artificial allografts emerged in the 1990s, but focused primarily on replacing missing bone with patient-specific designs. The inventors previously invented a first description of a patient-specific craniofacial implant (described in U.S. Patent No. 10,639,158, the entire contents of which are incorporated herein by reference), which, by employing a novel computer-aided design algorithm focused on the aforementioned soft tissue, was used to replace missing soft tissue while simultaneously reconstructing the skull. More recently, the inventors invented an improved design that includes prefabricated temporal windows for better defining anatomical vector lines to improve consistency (i.e., enhance outcomes), preventing soft tissue impact during placement, and, for the first time, placing these craniofacial implants above rather than below the scarred temporalis muscle. However, surgeons are limited in these inventions because these “dual-purpose craniofacial implants” (where the first purpose is to replace missing bone to protect the brain, and the second purpose is to restore facial symmetry secondary to soft tissue deformities) are provided as a single, larger implant (as disclosed by Zhong et al. in “Quantitative Analysis of Dual-Purpose, Patient-Specific Craniofacial Implants for Correction of Temporal Deformities,” the entire disclosure of which is incorporated herein by reference).

[0042] First Embodiment

[0043] like Figure 1As shown, the first exemplary embodiment 100 provides a surgeon with a two-piece design featuring a standard cranioplasty implant 102 and small, medium, and large soft tissue implant components 104—the soft tissue implant component 104 to be used during cranioplasty can be determined by the surgeon based on intraoperative assessment and the degree of soft tissue absorption. In the first exemplary embodiment 100, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific craniofacial implant can be delivered as two separate implants, including: a) a cranioplasty implant 102, designed to replace missing skull (i.e., pre-existing cranioplasty defects), and b) a soft tissue implant 104, designed to replace missing temporalis muscle / fat; wherein the manufacturing process provides the surgeon with two implants and utilizes a lock-and-key (i.e., interdigital) connection between the cranioplasty implant 102 and the soft tissue implant 104 at implantation. This interdigital connection can be designed, for example, for a “convex” component (i.e., a catheter system) penetrating to the soft side of a “concave” component (i.e., a fluid-filled chamber in neuromedicine such as chemotherapy). The connection can have a tight fit to ensure no fluid extravasation and / or electrical loss between the hard tissue reconstruction component and the soft tissue reconstruction component. The soft tissue component can be delivered in small, medium, or large sizes to accommodate different degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient with a pre-existing skull defect requiring neuroplastic surgery.

[0044] Second Embodiment

[0045] like Figure 2 As shown, the second exemplary embodiment 200 provides a surgeon with an "anatomically specific soft tissue implant" for neurosurgical patients. As neurotechnology becomes more sophisticated and space-saving, it is conceivable that these functional devices could be pre-designed to fill soft tissue elements surrounding the brain or spinal cord, rather than requiring the replacement of both bone and soft tissue for placement. For example, one day, a miniaturized implant could replace the temporalis muscle and temporal fat pad, containing a drug delivery chamber employing MRI-assisted transparent pump technology, and then a miniaturized catheter connecting it to the brain through a small opening in the skull. Therefore, such embodiments could provide a less invasive option for all patients with this need, as well as brain tumor patients requiring long-term infusion of brain tumor drugs and wishing to preserve as much of their original skull as possible. For example, advances in solid-state batteries, RF charging, and rechargeable wireless batteries could enable further miniaturization of these devices, allowing smaller versions to be placed in areas that only fill the overlying soft tissue, for example, to fill only the atrophied temporalis muscle and / or fat pad area after repeated craniotomies following neurosurgical temporal fossa resection.

[0046] Therefore, small, medium, and large soft tissue implants 204 can be delivered to surgeons based on preoperative CT scan assessments—surgeons can decide on the soft tissue implant 204 to use during cranioplasty based on intraoperative assessments and the degree of soft tissue deformity determined during exploration—depending on the type of central nervous system disease being treated and the size limitations offered by implantable neurotechnology.

[0047] In a second exemplary embodiment 200, following virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific craniofacial implant can be delivered as an implant, comprising: a) an anatomically specific soft tissue implant 204 having a “high-profile” extension designed to replace missing temporalis muscle / fat / subcutaneous tissue, wherein the manufacturing process provides the soft tissue implant 204 with a lock-and-key (i.e., interdigital) connection to the healthy skull 201 at implantation. This soft tissue component can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such an embodiment could be a patient with a pre-existing soft tissue defect following a neurosurgical craniotomy requiring neuroplasticity surgery.

[0048] Third Embodiment

[0049] like Figure 3 As shown, the third exemplary embodiment 300 provides surgeons with "anatomically specific soft tissue implants" for neurosurgical patients expected to have future deformities. Therefore, small, medium, and large soft tissue implant components 304 can be delivered to surgeons based on preoperative CT scan assessments, and surgeons can determine the type of soft tissue implant component 304 based on intraoperative assessments and the degree of soft tissue movement determined during craniotomy.

[0050] In a third exemplary embodiment 300, following virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific multipurpose craniofacial implant can be delivered as an implant, comprising: a) an anatomically specific soft tissue implant 304 designed to replace missing temporalis muscle / fat / subcutaneous tissue, wherein the manufacturing process provides the soft tissue implant 304 with a lock-and-key (i.e., interdigital) connection to the healthy skull 301 upon implantation. The soft tissue component can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue reabsorption. The soft tissue implant can be pre-embedded with life-altering or life-saving neurotechnologies (e.g., the ability to administer drugs around the blood-brain barrier) that can actively alter the function of the central nervous system and adjacent brain, such as electronic neuromodulation, chemical modulation using drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, enhancement of brain performance, treatment of any type of chronic neurological disorder, and / or improvement of memory storage. Soft tissue components can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient without soft tissue defects who requires planned neurosurgical craniotomy or neuroplastic surgery, such as brain tumor resection.

[0051] Fourth embodiment

[0052] like Figure 4As shown, in the fourth exemplary embodiment 400, another indication for using the novel dual-purpose implant described above is in the case of planned craniectomy (i.e., selective removal of unaffected or normal skull bone). Many neurosurgical procedures are planned for brain diseases covered by normal, healthy bone (for patients who have never undergone surgery in the target area and whose anatomy is not disrupted). However, with the continuous expansion of the neurotechnology field, the use of implantable neurotechnologies will require the selective removal of bone and soft tissue to make room for these space-consuming devices that can be life-altering or life-saving. For example, current and future devices can deliver medication for chronic neurological diseases such as cancer, epilepsy, neurodegenerative diseases, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disease (ADHD), motor tremor, memory decline, age-related poor performance, brain enhancement, stress-related environments, etc. Furthermore, these neurotechnology devices can accommodate imaging equipment to avoid the need for necessary postoperative CT scans or MRIs. Such devices may also accommodate hydrocephalus shunt mechanisms and / or optoelectronic neuromodulation components, with or without an RF-based wireless charging platform. Regardless of their inherent function, such devices require space to avoid impacting the brain below and the delicate scalp above. Therefore, this novel “dual-purpose implant” will have an anatomically specific design to accommodate the precise dimensions of the selectively removed bone and soft tissue for each patient. Thus, the two-piece design—one as a cranial implant 402 and the other as a soft tissue implant 404—will be assembled intraoperatively based on the surgeon’s assessment of small, medium, or large expected soft tissue reabsorption. Thus, such embodiments provide surgeons with a two-piece design featuring a standard cranial replacement implant 402 and small, medium, and large soft tissue implant components 404—allowing the surgeon to determine the soft tissue implant component 404 to use during craniectomy based on intraoperative assessment and the degree of soft tissue reabsorption.

[0053] In the fourth exemplary embodiment 400, after virtual fusion / shape creation via CT scans and CAD / CAM design, an anatomically specific craniofacial implant can be delivered as two separate implants, including: a) a cranial implant 402, designed to reconstruct / replace defects for planned craniectomy (i.e., selective removal of the skull; or in the absence of a cranial defect); and b) a soft tissue implant 404, designed to prophylactically restore (i.e., the surgeon anticipates some degree of atrophy) the temporalis muscle / fat; wherein the manufacturing process provides the surgeon with two implants and utilizes a lock-and-key (i.e., interdigital) connection between the cranial implant 402 and the soft tissue implant 404 at implantation. The soft tissue component can be delivered in small, medium, or large sizes to accommodate different degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient without a cranial defect requiring planned craniectomy and neuroplasticity surgery.

[0054] Fifth and Sixth Embodiments

[0055] As Gordon has described in “The Special Field of Neuroplastic Surgery” published in the Journal of Craniofacial Surgery [January-February 1, 2021; 32(1): 3-7] (www.hopkinsmedicine.org / Neuroplastic-Surgery / about.html) (the entire contents of which are incorporated herein by reference), the brain is a complex organ, unlike the human heart, lungs, liver, or kidneys, for which there is currently no substitute. Therefore, the only way to manipulate a diseased or aging brain is by placing a wirelessly powered device capable of altering brain function through drugs, electricity, neuroimaging, non-invasive neuromodulation, and / or photographic optics. Such devices are size-limited due to the challenging craniofacial anatomy and require strategic placement within a biocompatible compartment. However, there is not much additional space within the human head and cranial cavity. Strategically, as disclosed in U.S. Patent No. 11,058,541, "Low-profile Intracranial Device" (where "intracranial" refers to the space within the skull), the cranial space is an ideal placement location. Therefore, the embodiments disclosed herein can provide improved treatment strategies for patients with pre-existing cranial defects who require planned cranioplasty reconstruction via neuroplastic surgery. However, the cranial space becomes very congested for brain drug delivery via temporal implants (based on pump-assisted, multiphase flow paths, wireless charging platforms, embedded biosensors, and many other functional components), proving impractical for the inventors. Firstly, the dual-purpose implant can have a cranial implant designed to replace missing cranioplasty bone (i.e., a pre-existing defect), and secondly, it can provide a soft tissue component with embedded functional elements, such as neurotechnologies for life-altering, life-saving, and brain-altering purposes. Of particular note is that the approximately 4-12 mm skull space may not provide sufficient space for current drug delivery designs, especially with further advancements in technological applications; therefore, the embodiments disclosed herein are suited for housing embedded neural technologies within an overlying soft tissue assembly as an anatomically specific design (by adding soft tissue, “extracranial” space, with a new thickness of approximately 13 mm-40 mm). Furthermore, this additional upward extension toward the skin (i.e., a high-profile extension) allows for better percutaneous needle access (e.g., in the case of long-term drug delivery and refillable reservoirs) and allows for less soft tissue interference when associated with Bluetooth module / wireless RF charging connections.Furthermore, as patients age and their neurological conditions change over time, such soft tissue components can be interchanged in a "plug-and-play" manner by separating them from the cranial implant and installing new soft tissue components. On the soft tissue side of such implants, functional components can be embedded, which may include life-altering / life-saving neurotechnologies and provide replaceable drug compartments; such technologies and drugs can actively alter the function of the central nervous system and adjacent brain, for example: electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, hands-free connectivity with wireless communication devices, prevention of chronic symptoms, reversal of aging, real-time remote imaging devices, remote assessment, and / or improvement of memory storage and function. Similar designs, as disclosed by Gordon et al. in "First-in-human Experience with Integration of a Hydrocephalus Shunt Device Within a Customized Cranial Implant" (published in the December 2019 issue of Surgical Neurosurgery, featured on its cover image, all disclosures of which are incorporated herein by reference), are also applicable to spinal reconstruction.

[0056] like Figure 5As shown, in the fifth exemplary embodiment 500, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific craniofacial implant can be delivered as two separate implants, including: a) a skull implant 502 designed to replace missing skull (i.e., a pre-existing skull defect), and b) a soft tissue implant 504 designed to replace missing temporalis muscle / fat / subcutaneous tissue; wherein the manufacturing process provides the surgeon with two implants and uses a key-key (i.e., interdigital) connection between the skull implant 502 and the soft tissue implant 504 during implantation; and wherein the soft tissue implant 504 is embedded with a functional component 506 having, for example, life-altering or life-saving neurotechnology that actively alters the function of the central nervous system and adjacent brain, such as electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, chronic symptom reversal, functional enhancement, prevention of age-related deterioration, and / or improvement of memory storage. The soft tissue component 504 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such an embodiment could be a patient with a pre-existing skull defect requiring neuroplastic surgery and the placement of an embedded functional component 506 strategically housed within the soft tissue component 504 to address an underlying neurological condition.

[0057] like Figure 6As shown, in the sixth exemplary embodiment 600, after virtual fusion / shape creation via anatomical averaging (for standard sizes) and / or CT scans (using CAD / CAM patient-specific designs), an anatomically specific craniofacial implant can be delivered as two separate implants, including: a) a skull implant 602, designed to replace bone after planned craniectomy (i.e., in the absence of skull defects), and b) a soft tissue implant 604, designed to replace missing temporalis muscle / fat / subcutaneous tissue; wherein the manufacturing process provides the surgeon with two implants and uses a lock-key (i.e., interdigital) connection between the skull implant 602 and the soft tissue implant 604 at implantation; and wherein the soft tissue implant 604 is embedded with a functional component 606 having, for example, life-altering or life-saving neurotechnology 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 assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, and / or improved memory storage. The soft tissue component 604 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue resorption. An exemplary clinical scenario for such an embodiment could be a patient without skull defects who requires planned craniectomy and neuroplastic surgery and needs brain surgery and requires placement of an embedded functional component 606 housed within the soft tissue implant 604 to address an underlying neurological condition.

[0058] Spine Example

[0059] Seventh and Eighth Embodiments

[0060] Spinal surgery procedures for cancer and / or trauma often require some form of planned bone removal or decompression to make room for access to the spinal cord. Recently, new techniques have been designed to alter damaged spinal cord function, such as paralysis reversal, tremor, chronic pain, acute trauma, and / or weakness. Consequently, paraspinal anatomy (i.e., the overlying muscles / fat) can inevitably be distorted during planned surgery due to the rupture and denervation of critical structures such as the paraspinal muscles. Therefore, once this critical anatomy is disrupted, irregularities in the back's contour and visual deformities can be permanently impaired. Unfortunately, the technology and science for artificial allograft implants for craniofacial and spinal reconstruction emerged in the 1990s but focused only on replacing missing bone with patient-specific designs. The inventors have previously described the first patient-specific craniofacial implant that replaces missing soft tissue during skull reconstruction using a novel computer-aided design algorithm. The inventors have invented an improved design that includes better defined anatomical vector lines for improved consistency (i.e., enhanced results), a prefabricated temporal window to prevent soft tissue impact during placement, and, for the first time, placement of these craniofacial implants above rather than below the scarred temporalis muscle. This was first described by the inventors in their preliminary article entitled “Temporal augmentation with methyl methacrylate” in September 2011, as a way to use hand-shaped allograft implants to simultaneously correct soft tissue deformities and / or hard tissue deformities by using original methods and hand-eye modifications (Gordon, et al. Aesthetic Surgery Journal; 31(7):827-33.). However, surgeons are also limited in these inventions because these “dual-purpose craniofacial implants” (where the first purpose is to replace missing bone to protect the brain, and the second purpose is to restore facial symmetry secondary to soft tissue deformities) are provided as a single, larger implant (as disclosed by Zhong et al. in “Quantitative Analysis of Dual-Purpose, Patient-Specific Craniofacial Implants for Correction of Temporal Deformities,” the disclosure of which is incorporated herein in its entirety). Therefore, the embodiments disclosed herein provide spinal surgeons with a two-piece design featuring a standard vertebral replacement implant (e.g., laminectomy) and small, medium, and large soft tissue implant components—which surgeons can determine to use during spinal surgery based on intraoperative assessment and the degree of soft tissue resorption.

[0061] like Figure 7As shown, in the seventh exemplary embodiment 700, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific spinal implant can be delivered as two separate implants, including: a) a spinal bone implant 702, designed to replace missing vertebrae (i.e., pre-existing spinal defects following prior spinal decompression surgery (e.g., laminectomy / laminoplasty and / or trauma), and b) a soft tissue implant 704, designed to replace missing paraspinal muscles / fat; wherein the manufacturing process provides the surgeon with two implants and utilizes a lock-and-key (i.e., interdigital) connection between the spinal bone implant 702 and the soft tissue implant 704 at implantation. The soft tissue component 704 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient with a pre-existing postoperative spinal defect requiring neuroplasticity surgery.

[0062] like Figure 8 As shown, in the eighth exemplary embodiment, after virtual fusion / shape creation via CT scans and CAD / CAM design, an anatomically specific spinal implant can be delivered as two separate implants, including: a) a spinal bone implant 802, designed to replace a planned portion of vertebral resection (i.e., a non-existent bone defect; a planned spinal cord decompression, such as laminectomy / laminoplasty and / or trauma), and b) a soft tissue implant 804, designed to replace missing paraspinal muscles / fat; wherein the manufacturing process provides the surgeon with two implants and utilizes a lock-and-key (i.e., interdigital) connection between the spinal bone implant 802 and the soft tissue implant 804 at implantation. The soft tissue component 804 can be delivered in small, medium, or large sizes to accommodate different degrees of anticipated soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient without defects requiring planned bone removal, placement of embedded neurotechnology, and neuroplasticity surgery.

[0063] Other spinal embodiments

[0064] As Gordon has described in “The Special Field of Neuroplastic Surgery” published in the Journal of Craniofacial Surgery [January-February 1, 2021; 32(1): 3-7] (www.hopkinsmedicine.org / Neuroplastic-Surgery / about.html) (the entire contents of which are incorporated herein by reference), the spinal cord, as a component of the central nervous system, is a complex organ, unlike the human heart, lungs, liver, or kidneys, for which there is currently no substitute. Therefore, the only way to manipulate diseased, traumatized, and / or aging spinal cords is by placing a device capable of altering spinal cord function through drugs, electricity, real-time remote neuroimaging using wireless connections, non-invasive neuromodulation, and / or photographic optics. Such devices are size-limited and require strategic placement within a biocompatible compartment. However, the human spine and back do not offer much additional space. Therefore, strategically, as disclosed in U.S. Patent No. 11,058,541, "Low-profile Intracranial Device" (where "intracranial" refers to the space within the skull), the skeletal space above the brain and spinal cord is an ideal placement location. However, the inventors have realized that drug delivery technology requires more than just a "bone-only" volume. Nevertheless, as temporal multipurpose devices have become increasingly miniaturized through multiple iterations, soft tissue space may allow for the placement of two-piece design implants, thereby eliminating the severity of surgery when a "plug-and-play" switch is required and minimizing the need for complete bone removal.

[0065] Ninth and Tenth Embodiments

[0066] Therefore, such embodiments can provide improved treatment strategies for patients with pre-existing spinal defects due to previous surgery and who require planned reconstruction via neuroplastic surgery. First, the dual-purpose implant can include a spinal implant designed to replace a missing vertebra (i.e., a pre-existing defect), and second, a soft tissue implant that can include functional components with embedded neurotechnology capable of altering the spinal cord and changing life / life-saving properties. Of particular note is the fact that vertebral space is only a few millimeters, often insufficient for current designs; therefore, the embodiments disclosed herein can accommodate embedded neurotechnology within the soft tissue implant space. Furthermore, as a person ages and their neurological condition changes over time, the soft tissue implant can be interchanged in a "plug-and-play" manner, for example, by separating it from the spinal implant and using a new soft tissue implant. Regarding the soft tissue aspect of the implant, functional components can be embedded, which may possess, for example, life-changing / life-saving neurotechnologies that can actively alter the function of the central nervous system and adjacent spinal cord, such as: electronic neuromodulation, chemical modulation using drug delivery, real-time remote optical imaging using wireless connectivity for blood flow assessment, fluid transfer for trauma or disease, improvement of paralysis, fluid transfer for hydrocephalus, hands-free connectivity for patient-provider interpretation of wireless communication devices, reversal of paralysis, and / or improvement of strength / balance. It is noteworthy that, over time, as implantable neurotechnical devices become more refined and smaller in size, it is conceivable that these functional devices could be pre-designed to fill soft tissue elements surrounding the brain or spinal cord, rather than requiring the replacement of both bone and soft tissue for placement. For example, solid-state batteries and rechargeable wireless platforms with wireless signals (i.e., RF technology) could allow for miniaturization of these devices—thus allowing smaller versions to be placed in areas that are only filled with soft tissue. This means that replacing external components for different, disease-specific technologies could be less invasive, as it does not intrude into bone space during repeated surgeries.

[0067] like Figure 9As shown, in the ninth exemplary embodiment 900, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific spinal implant can be delivered as two separate implants, including: a) a spinal bone implant 902, designed to replace vertebrae (i.e., non-existent spinal defects) after planned decompression, and b) a soft tissue implant 904, designed to replace missing paraspinal muscles / fat / subcutaneous tissue; wherein the manufacturing process provides the surgeon with two implants and uses a lock-key (i.e., interdigital) connection between the spinal bone implant 902 and the soft tissue implant 904 at implantation; and wherein the soft tissue implant 904 includes a functional component 906, which may include, for example, life-altering or life-saving neurotechnologies that actively alter the function of the central nervous system and adjacent spinal cord, such as electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, anti-aging, enhanced motor performance, and / or improved memory storage. The soft tissue component 904 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue resorption. An exemplary clinical scenario for such embodiments could be a patient with a pre-existing spinal defect requiring neuroplastic surgery and placement of an embedded neurotechnology device 906, strategically housed within the soft tissue implant 904 to address an underlying spinal cord condition. Because external components are replaced—e.g., for medication compartment replenishment, battery replacement, hardware updates, or changes in the neurological condition and updates to the corresponding applications—the invasiveness of future surgeries is significantly reduced, eliminating the need to enter the skeletal space.

[0068] like Figure 10 As shown, in the tenth exemplary embodiment 1000, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific spinal implant can be delivered as an implant, including: a) an anatomically specific soft tissue implant 1004 designed to replace missing paravertebral muscle / fat; wherein the manufacturing process provides a lock-and-key (i.e., interdigital) connection for the soft tissue implant 1004 to the healthy vertebra 1001 at implantation. The soft tissue component 1004 can be delivered in small, medium, or large sizes to accommodate different degrees of expected soft tissue reabsorption. An exemplary clinical scenario for such embodiments could be a patient with pre-existing soft tissue defects following prior spinal surgery who requires neuroplastic surgery and placement of an embedded neurotechnology device strategically housed within the soft tissue implant 1004 to address underlying spinal cord disease.

[0069] Eleventh Embodiment

[0070] like Figure 11As shown, in the eleventh exemplary embodiment 1100, such embodiments can provide improved treatment strategies for patients requiring some form of planned decompression and / or implantation of neurotechnology devices. First, the dual-purpose implant 1100 may have a bone implant 1102 designed to replace a missing vertebra (i.e., a pre-existing defect). Second, a soft tissue implant 1104 may be provided, which may include an embedded functional component 1106 having neurotechnology, for example, for life-altering / life-saving purposes, or for altering spinal cord capabilities. It is particularly noteworthy that vertebral space is only a few millimeters, which is typically insufficient for current designs; therefore, the embodiments disclosed herein can accommodate embedded neurotechnology within the soft tissue implant space. Furthermore, as a person ages and their neurological condition changes over time, the soft tissue implant 1104 can be interchanged in a "plug-and-play" manner, for example, by separating it from the spinal bone implant 1102 and using a new soft tissue implant 1104. In the soft tissue aspect of implant 1104, a functional component 1106 may be embedded that can actively alter the function of the central nervous system and adjacent spinal cord, for example: electronic neuromodulation, chemical modulation with drug delivery, optical imaging for blood flow assessment, fluid shunting for trauma, prevention of age-related deterioration, performance enhancement, resolution of chronic diseases, reversal of lower / upper limb paralysis, fluid shunting for hydrocephalus, hands-free connection to wireless communication devices, reversal of paralysis, and / or improvement of strength / balance.

[0071] In the eleventh exemplary embodiment 1100, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific spinal implant can be delivered as two separate implants, including: a) a spinal bone implant 1102, designed to replace vertebrae after planned decompression (i.e., non-existent spinal defects), and b) a soft tissue implant 1104, designed to replace missing paraspinal muscles / fat / subcutaneous tissue; wherein the manufacturing process provides the surgeon with two implants and uses a lock-key (i.e., interdigital) connection between the spinal bone implant 1102 and the soft tissue implant 1104 at implantation; and wherein the soft tissue implant 1104 is embedded with a functional component 1106 having, for example, life-altering or life-saving neurotechnology that actively alters the function of the central nervous system and adjacent spinal cord, such as electronic neuromodulation, chemical modulation with drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, prosthetic control, and / or improved memory storage. The soft tissue component 1104 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue resorption. An exemplary clinical scenario for such an embodiment could be a patient without spinal defects (i.e., planned surgery) requiring neuroplastic surgery and placement of an embedded functional component 1106, which is strategically housed within the soft tissue implant 1104 to address an underlying spinal cord condition.

[0072] Twelfth Embodiment

[0073] like Figure 12As shown in the twelfth exemplary embodiment 1200, for patients requiring planned spinal surgery and reconstruction via neuroplastic surgery, such embodiments can provide improved treatment strategies through neuroplastic surgery. As implantable neurotechnology devices become more refined and smaller in size—in order to be embedded within an "anatomically specific implant" shell—it is conceivable that these functional devices could be pre-designed to fill soft tissue elements around the spinal cord, rather than requiring the replacement of both bone and soft tissue for placement. For example, pump-assisted drug delivery systems, solid-state batteries, and rechargeable wireless platforms with wireless signals (i.e., RF technology) could enable the miniaturization of these devices—thus allowing smaller versions to be placed in areas that only fill the soft tissue above the spine (such as within the paraspinal muscle tissue). This means that replacing external components for different, disease-specific techniques can be less invasive, as it does not intrude into the bone space during repeated surgeries. Furthermore, as a person ages and their neurological condition changes over time, the soft tissue implant 1204 can be interchanged in a "plug-and-play" manner, for example, by separating it from the healthy vertebra 1201 and using a new soft tissue implant 1204. In the soft tissue aspect of the implant 1204, a functional component 1206 may be embedded, which has, for example, life-altering / life-saving neurotechnology that can actively alter the function of the central nervous system and nearby spinal cord, such as: electronic neuromodulation, chemical modulation with drug delivery, optical imaging for blood flow assessment, fluid transfer for trauma or disease, improvement of paralysis, fluid transfer for hydrocephalus, hands-free connection to wireless communication devices, reversal of paralysis, and / or improvement of strength / balance.

[0074] In the twelfth embodiment 1200, after virtual fusion / shape creation via CT scanning and CAD / CAM design, an anatomically specific spinal implant can be delivered as an implant, comprising: a) an anatomically specific soft tissue implant 1202 designed to replace missing paraspinal muscles / fat / subcutaneous tissue; wherein the manufacturing process provides a lock-and-key (i.e., interdigital) connection for the soft tissue implant 1202 to the healthy vertebra 1201 at implantation. The soft tissue component 1202 can be delivered in small, medium, or large sizes to accommodate different degrees of expected soft tissue reabsorption. The soft tissue implant 1202 may embed a functional component 1206 having, for example, life-altering or life-saving neurotechnologies that can actively alter the function of the central nervous system and adjacent spinal cord, such as electronic neuromodulation, chemical modulation using drug delivery, optical imaging for brain assessment, fluid transfer for hydrocephalus, therapeutic neuromodulation, and / or improved memory storage. The soft tissue functional component 1206 can be delivered in small, medium, or large sizes to accommodate varying degrees of anticipated soft tissue resorption. An exemplary clinical scenario for such an embodiment could be a patient without soft tissue defects who requires planned spinal surgery and necessitates neuroplastic surgery and the placement of an embedded neurotechnology device strategically housed within the soft tissue implant 1204 to address underlying spinal cord disease.

[0075] It should be understood that the embodiments disclosed herein can be further modified without departing from the spirit of the invention. In some embodiments, instead of a lock-and-key fit, the bone implant and soft tissue implant may be fused during manufacturing, or "click-in" using a plug or adapter designed for intraoperative manipulation, or may include a switch for postoperative manipulation. Embedded neurotechnology may also include, but is not limited to, any technology capable of or applicable to modulating the brain or spine, such as drug delivery, disease control, elimination or cure of dysfunction, restoration of an injured brain or spinal cord, or improvement or superficial enhancement of an aging central nervous system via an external wireless connection. Figure 14 Some of these neurotechnologies are illustrated in the figure. Furthermore, in some embodiments, dual-purpose implants for soft tissue only may include small catheters, filaments, or cables that pass through bone into the brain or spinal cord to allow wireless connectivity to the outside world and / or provide pump-assisted, connectivity-enhanced drug delivery to bypass the blood-brain barrier.

[0076] Furthermore, in some embodiments, the implant can be made of any material that enables it to function as described herein (e.g., various artificial biomaterials and / or 3D-printed tissue). Additionally, the biomaterial can be: radiopaque for unobstructed wireless connectivity (e.g., Bluetooth); acoustically transparent for unobstructed ultrasound examination (diagnosis and treatment); and visually clear for improving the accuracy of surgical placement, including bleeding checks and reducing the likelihood of impact to the underlying brain or spine when secured with hardware. More than one spinal implant or cranial implant can be used, for example, coupled to several vertebrae or as a bilateral cranial implant.

[0077] Functional component embodiments

[0078] Figure 13 An exemplary functional component 1300 is shown that can be used with embodiments of the implant described above. The size and shape of the functional component can be designed to fit within the temporal fossa and further within embodiments of the soft tissue implant described herein. The functional component 1300 may include a housing 1302, one or more electronic components 1304, which 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 cap or septum 1312 that can be punctured percutaneously or with a similar needle. The functional component 1300 may further include a plurality of channels or conduits 1314, such as five conduits, whose length allows them to penetrate the subdural space to a depth of approximately 2-5 cm into 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. In addition, the rechargeable battery 1308 can utilize wireless charging to enable charging from a distance of up to 18 inches from the functional component 1300 (i.e., the charging portion can be placed under the pillow or inside the pillowcase of a patient who needs the device to be charged overnight, or placed inside a headdress with internal components to allow charging during the day).

[0079] Furthermore, the cap or septum 1312 may protrude above the surrounding surface of the housing 1302, allowing the septum and the "high-profile" design to be easily accessible under the skin to improve the safety and efficacy of needle filling. This contrasts with a "low-profile" intracranial design, in which the functional component has smooth edges surrounded by normal bone, thus preventing it from being touched by fingers rubbing along the skin surface and obstructing percutaneous refill of the reservoir. However, this functional component 1300 extends within the soft tissue implant, thus allowing for digital palpation, for example, prior to percutaneous needle refill, by having an accessible ring structure around the self-sealing septum.

[0080] Furthermore, the cover or Bluetooth module / wireless RF charging platform 1312 may protrude above the surrounding surface of the housing 1302, allowing the diaphragm and the "high-profile" design to be easily accessible under the skin to improve the security and effectiveness of wireless connectivity. This should be understood as contrasting with a "low-profile" intracranial design, in which functional components have smooth edges surrounded by normal bone and are completely covered by thick scalp and soft tissue elements, thus hindering wireless charging and / or Bluetooth connectivity. However, this functional component 1300 extends within a soft tissue implant, thus allowing for, for example, more efficient and secure wireless communication and / or charging.

[0081] According to the embodiments disclosed herein, Figure 14 A hard tissue implant 1402 and a soft tissue implant 1404 coupled to the skull 14 are shown. A functional component 1406 is disposed within the soft tissue implant 1404. Shown as part of the functional component 1406 are a septum 1412, two MRI transparent electroosmotic pumps 1418, and multiple catheters 1414 extending from the functional component 1406 into the brain tissue 16 to enable the delivery of desired substances to the brain tissue. Although not shown in the diagram... Figure 14 As shown, however, functional component 1406 may include all the components described above with respect to functional component 1300.

[0082] Furthermore, the rechargeable battery of functional component 1406 can be charged by a wireless charging device 1430, which can be located inside or under the patient's pillow 18. Bluetooth or other wireless communication components of functional component 1406 can also communicate with software 1440 executing on a mobile computing device or personal computing device 20. Software 1440 can be adapted to display real-time data from functional component 1406. Real-time data, such as flow rate information, remaining battery life, drug reservoir fill level, and potential flow failures, can be transmitted in real time. Additionally, the current design algorithm of this drug delivery device includes an alternating rhythm of 16-20 hours of pumping followed by 4-8 hours of off-peak brain relaxation time.

[0083] Furthermore, in some exemplary embodiments, both bone implants and soft tissue implants can be housed within cavities that include a cavity for embedding a functional device, similar to the embodiments described above.

[0084] The foregoing description and accompanying drawings illustrate the principles, preferred embodiments, and modes of operation of the invention. However, the invention should not be construed as limited to the specific embodiments discussed above. Other variations of the embodiments discussed above will be understood by those skilled in the art.

[0085] Therefore, the above embodiments should be considered illustrative rather than restrictive. It should be understood that modifications can be made to those embodiments by those skilled in the art without departing from the scope of the invention as defined by the appended claims.

Claims

1. A functional, anatomically specific craniofacial implant, comprising: A soft tissue implant suitable for replacing missing soft tissue and occupying soft tissue space near the pterion region of the skull, the soft tissue implant being coupled to a rigid component; and A high-profile functional component, embedded within the internal space of the body of the soft tissue implant, the functional component having at least one conduit for delivering drugs to the brain; The rigid component is either a hard tissue implant or the skull. The soft tissue implant is not for patient use only; The soft tissue implant is anatomically specific.

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

3. The implant of claim 1, wherein the functional component comprises a housing, a refillable reservoir, and at least one electroosmotic pump.

4. The implant of claim 3, wherein the diaphragm of the refillable reservoir protrudes above the surface of the housing.

5. The implant of claim 3, wherein the functional component further comprises a processor, a wireless charging battery, and a wireless communication device.

6. The implant of claim 1, wherein the soft tissue implant is coupled to one of the hard tissue implant and the skull via interdigital connections.

7. The implant of claim 1, wherein the soft tissue implant is interchangeable with another soft tissue implant in a plug-and-play manner.

8. A functional, anatomically specific craniofacial implant, comprising: Hard tissue implants are suitable for replacing missing bone and occupying hard tissue space in the pterional region of the skull; A soft tissue implant suitable for replacing missing soft tissue and occupying soft tissue space near the pterion region of the skull, the soft tissue implant being coupled to the hard tissue implant; and A high-profile functional component, embedded within the internal space of the body of the soft tissue implant, the functional component having at least one conduit for delivering drugs to the brain; in The hard tissue implant and the soft tissue implant are not for patient use only; The hard tissue implant and the soft tissue implant are anatomically specific.

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

10. The implant of claim 8, wherein the functional component comprises a housing, a refillable reservoir, and at least one electroosmotic pump.

11. The implant of claim 10, wherein the diaphragm of the refillable reservoir protrudes above the surface of the housing.

12. The implant of claim 10, wherein the functional component further comprises a processor, a wireless charging battery, and a wireless communication device.

13. The implant of claim 8, wherein the soft tissue implant is coupled to the hard tissue implant via interdigital connections.

14. The implant of claim 8, wherein the soft tissue implant is interchangeable with another soft tissue implant in a plug-and-play manner.

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