System and method for embedding electronic components within an implant

Abstract

To provide a system and a method for an electronic device embedded in a medical implant.SOLUTION: An implant body 100, a circuit surface 110 including at least one electronic component and at least partially embedded along at least one path within a defined cavity of the implant, a covering including a protective structure, wherein at least the partially embedded portion of the circuit surface 110 is encapsulated, an electronic component connected to the circuit surface 110 or disposed directly on the circuit surface 110, the electronic component including a set of electrodes 132 and an antenna 134, and wiring connecting the circuit surface 100 and the electronic component. The system and method can further include a casing that is a sealing structure directly connected to the implant body 100. The casing includes a printed circuit board (PCB) housed within the casing itself.SELECTED DRAWING: Figure 9

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS)

[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 929,681, filed November 1, 2019, U.S. Provisional Application No. 62 / 976,139, filed February 13, 2020, and U.S. Provisional Application No. 63 / 025,831, filed May 15, 2020, all of which are incorporated herein by reference in their entireties.

[0002]

[0002] The present invention relates generally to the field of medical implants, and more particularly to new and useful systems and methods for embedding electronic components within implants. [Background technology]

[0003] Spinal fusion is one of the most commonly performed surgical procedures in the United States and Europe. The goal of spinal fusion surgery is to introduce bone growth between two or more vertebrae, fusing them into a single contiguous body. Spinal fusion surgery is performed in the lumbar, cervical, and thoracic regions, and fusion within each region is associated with a different set of complications. Nevertheless, most complications after spinal fusion can be generalized into two broad categories: nonfusion, in which insufficient bone formation within the fusion space prevents the vertebrae from fusing together, and heterotopic ossification, in which bone growth damages or impacts tissue, causing harm or discomfort to the patient. Examples of heterotopic ossification include anterior osteophyte formation, which can cause a mass effect on the esophagus and lead to swallowing difficulties (cervical fusion), ossification of the posterior longitudinal ligament, and posterior osteophyte formation and / or other excessive posterior bone growth compressing the spinal cord and / or spinal nerves.

[0004]

[0004] Currently, implantable or external electrical stimulation devices can be used to mitigate some of the risk of nonunion. Many existing implantable stimulation devices use a sealed, constant-current DC power supply attached to one or more electrodes. These are large, cumbersome, and prone to infection or complications. Furthermore, the electrodes in these implantable systems are long and thin and fragile. Because implantable systems are designed to be placed along the length of the spine, spanning multiple vertebrae, they frequently move, potentially causing injury.

[0005]

[0005] As the technology and use of spinal fixation hardware, and more generally, long-term implants, improves, greater emphasis must be placed on the placement and maintenance of the implant's electronic components. While electronic components play a larger role in the implant's effectiveness as technology improves, they are often the most susceptible to degradation over time within the body and potentially the most harmful to the body once they begin to fail. Furthermore, many previously available materials and manufacturing techniques are incompatible with electronics. For example, the manufacturing temperatures of some materials destroy adjacent electronics. Thus, there is a need in the medical implant field to create new and useful systems and methods for embedding electronic components within implants. The present invention provides such new and useful systems and methods. [Brief explanation of the drawings]

[0006] [Figure 1]

[0006] FIG. 1 is a schematic diagram of a variation of the system. [Figure 2]

[0007] FIG. 10 is a schematic diagram of another variation of the system. [Figure 3]

[0008] 1 is a schematic diagram of an exemplary spinal cage implant. [Figure 4]

[0008] FIG. 1 is a schematic diagram of an exemplary spinal cage implant. [Figure 5]

[0008] FIG. 1 is a schematic diagram of an exemplary spinal cage implant. [Figure 6]

[0009] FIG. 1 is a schematic diagram of a spine cage showing exemplary dimensions. [Figure 7]

[0010] FIG. 1 is a cross-sectional schematic view of a spine cage. [Figure 8]

[0011] 1 is an illustration of the system, first showing the internal components including the antenna within the implant body (not shown), and then showing the implant body. [Figure 9]

[0012] 1 is an illustration of the system, first showing the internal components including two antennas and eight electrodes within the implant body (not shown), and then showing the system together with the implant body. [Figure 10]

[0013] 1 is a schematic diagram of a printed circuit board (PCB) of a preferred embodiment. [Figure 11]

[0014] 1A-1C are various schematic diagrams of a PCB having a component arrangement configured for a complex folding arrangement shown in a side view in a folded state. [Figure 12A]

[0015] 1 is a schematic diagram of a system variation with a defined PCB cavity having a uniform outline. [Figure 12B]

[0016] 10 is a schematic diagram of a system variation with a defined PCB cavity having a varied geometry. [Figure 13A]

[0017] 1 is a schematic diagram of an exemplary system of a preferred embodiment with a PCB embedded along a single path. [Figure 13B]

[0017] FIG. 1 is a schematic diagram of an exemplary system of a preferred embodiment with a PCB embedded along a single path. [Figure 14A]

[0018] FIG. 1 is a schematic diagram of an exemplary system with a folded PCB. [Figure 14B]

[0018] FIG. 1 is a schematic diagram of an exemplary system with a folded PCB. [Figure 15A]

[0019] FIG. 1 is a schematic diagram of an exemplary system including a PCB in a reverse folded configuration. [Figure 15B]

[0019] FIG. 1 is a schematic diagram of an exemplary system having a PCB in a reverse folded configuration. [Figure 16]

[0020] 1 is a schematic diagram of an exemplary system including a table-like geometry PCB of a preferred embodiment; [Figure 17]

[0021] FIG. 1 is a schematic diagram of an exemplary system using multiple PCB cavities and PCB configurations to achieve antennas in three orthogonal planes within an implant body. [Figure 18]

[0022] FIG. 1 is a schematic diagram of an exemplary system showing the integration of two electrodes with the implant body. [Figure 19]

[0023] FIG. 1 is a diagram of the casing of one variant of the system, first showing an external view of the casing and then showing the internal components within the casing. [Figure 20]

[0024] 1 includes a schematic diagram of a system with integrated electrodes. [Figure 21]

[0025] FIG. 10 is a schematic diagram of one variation of a system in which a circuit system within a casing connects to a circuit surface component within an implant body. [Figure 22]

[0026] FIG. 10 is a schematic diagram of another variation of the system. [Figure 23]

[0027] FIG. 10 is a view of an implant body with an exposed connector that connects to a circuit system within the casing. [Figure 24]

[0028] 1 is a flowchart of a first method of a preferred embodiment. [Figure 25]

[0029] 10 is a flow chart of a variation of the method applied to embedding a circuit surface in an implant body. [Figure 26]

[0030] 10 is a flow chart of a variation of a method applied to a medical implant device comprising a casing connected to a circuit surface embedded in an implant body. [Figure 27]

[0031] 4 is a flowchart of a second method of a preferred embodiment. [Figure 28]

[0032] 1 is a step-by-step illustration of an embodiment of a method. [Figure 29]

[0032] A step-by-step illustration of an embodiment of the method. [Figure 30]

[0033] 1 is a step-by-step illustration of an embodiment of a method. [Figure 31]

[0034] 1 is a schematic illustration of combining an implant body and a casing. DETAILED DESCRIPTION OF THE INVENTION

[0007]

[0035] The following description of embodiments of the invention is intended to enable those skilled in the art to make and use the invention, but not to limit the invention to these embodiments.

[0008] 1. Overview

[0036] Systems and methods for embedding electronic components within implant bodies function to address the manufacturing challenges of efficiently and robustly integrating electronics into medical device implants. Specifically, the systems and methods address embedding electronic components into orthopedic implants, and more particularly, spinal cage implants (also known as intervertebral body fusion devices) used in spinal fusion procedures.

[0009]

[0037] The systems and methods enable medical implant devices (e.g., orthopedic implants such as spinal cages) with integrated electronics and / or enable the creation of such medical implants. More specifically, the systems and methods can provide a spinal implant with an electrode set for stimulating and / or monitoring bone growth and an antenna for controlling and powering these electrodes. The electrode set can be integrated internally such that individual electrode sites are exposed at the implant surface. One or more antennas can be embedded internally and used for energy coupling (e.g., for wireless charging / powering) and / or wireless communication. In some variations, the systems and methods enable medical implants with antennas of different orientations.

[0010]

[0038] As shown in FIG. 1 , the system and method include an implant body and a circuit system including at least one circuit surface integrated with at least one functional electronic component. The circuit surface is integrated within the implant body. Specifically, the implant body is made of a biocompatible implant material, such as polyetheretherketone (PEEK). The at least one functional electronic component of the circuit surface can include one or more electrodes and / or antennas. The circuit surface is preferably at least partially embedded within the implant body in a specific geometric shape to fit within the implant body's shape and potentially properly position and distribute different electronic components, such as electrodes and antennas, to specific locations within the implant. This geometric shape within the implant body is defined as an internal cavity of the implant body that accommodates the circuit surface along at least one path. The path of the circuit surface within the implant body can be a line, a curve, and / or multiple connected path segments. Thus, a circuit surface embedded along a single path can have a linear or curved geometric shape. Additionally, the circuit surface embedded in the implant body along multiple paths may have folded, bent, tabular, and / or more complex geometries. The systems and methods may further include coverings (e.g., coatings and / or structural members) along the circuit surface for protection and / or support.

[0011]

[0039] The systems and methods may anticipate many challenges in integrating electronic components into biocompatible medical implants, as well as the challenge of integrating electronic components into load-bearing medical devices, such as spinal cages, without compromising the mechanical properties of the medical devices.

[0012]

[0040] As a first example, the medical implant of the system and method may integrate electrical stimulation features, wireless charging / communication / power delivery, and / or other electronics-enabled features with minimal impact on the overall size of the implant. The system and method may allow a biocompatible material such as PEEK to be injection molded, 3D printed, or otherwise formed around the circuit surface.

[0013]

[0041] As another example, medical implants of the systems and methods can have integrated electronics embedded within a biocompatible material such as PEEK, which has a relatively high melting temperature that traditionally poses challenges when injection molding in close proximity to active electronic components.

[0014]

[0042] The circuit surface comprises a generally two-dimensional surface, whose shape and composition may vary depending on the embodiment. The circuit surface functions as an embedded circuit element (i.e., a "circuit insert") integrated into the implant body material (e.g., an injection-molded thermoplastic). In many variations, the circuit surface is a structural member having a substantially planar aspect ratio and can be embedded within the implant body to support integration of electrodes and antennas at desired locations. That is, the circuit surface may comprise a relatively thin, planar surface. Examples of circuit surfaces include a printed circuit board (PCB) or another circuit system integrated with some physical scaffold structure or substrate. In some variations, the systems and methods may include multiple circuit surfaces, each at least partially embedded within the implant body in a particular geometric shape. The systems and methods function as systems including an implant body with a circuit system partially embedded in a particular geometric shape, and methods for manufacturing the systems.

[0015]

[0043] In some variations, the systems and methods can further include a casing. The casing can include one or more circuit systems operably connected to one or more circuit surfaces. This variation can be used to integrate electronic components, such as antennas and / or electrodes, within the implant body while also having other portions of the overall circuit system housed within the casing. The casing can function to mechanically and hermetically seal the housed circuit system components, protecting them from mechanical stresses and bodily fluids. To accomplish this function, the casing can be made of a different material than the rest of the implant body (e.g., a titanium casing with a PEEK implant body, or vice versa). The casing can be fully or partially embedded and / or integrated into the implant body, functioning as an inseparable subcomponent. Alternatively, the casing can be partially embedded and integrated to be removable. In one exemplary variation, the casing is electrically coupled to the circuit surfaces within the implant body via an electrical connector. The casing can then be welded, glued, or otherwise at least semi-permanently attached to the implant body. The casing can provide separation between the main implant body and the PCB components housed therein. Such a casing can be produced in a separate process from the rest of the implant body and joined / attached / bonded after each of these two geometries are produced in a separate process. Alternatively, the casing and the rest of the implant body can be produced in inseparable steps, such as by overmolding the implant body onto the casing or 3D printing the casing onto the rest of the implant body.

[0016]

[0044] The systems and methods may be applied to any implant that houses electronic components. As previously mentioned, the systems and methods may be particularly advantageous for devices that incorporate antennas and / or electronics within the implant body. The systems and methods are described herein primarily as applied to orthopedic implants, and more specifically, spinal cages. In particular, the systems and methods may be used with spinal cage implants that include integrated electronics and may include exposed electrodes utilized to stimulate and / or sense bone growth for damaged vertebrae. However, the systems and methods are not limited to orthopedic implants and may generally be implemented for any polymer / metal implant structure requiring electronic components that may be implemented within a circuit system.

[0017]

[0045] One potential advantage of the systems and methods is improved integration of electronics with biocompatible materials used in the implant body, such as PEEK, other organic thermoplastic polymers of the polyaryletherketone (PAEK) family, and / or other materials, particularly those manufactured using thermal material operations such as injection molding or 3D printing. The systems and methods address the manufacturing feasibility of incorporating temperature-sensitive electronics within a physical casing using high-temperature manufacturing techniques. The manufacturing process and physical design of the system can address such feasibility risks.

[0018]

[0046] Another potential advantage of the systems and methods is a reduction in the minimum size of the implant. Embedding electronic components within the implant body reduces the space occupied by the electronic components, compared to, for example, when the electronic components are located or attached outside the volume / exterior surface of the implant body, thereby allowing for the construction of smaller implants than previously possible. Reducing the minimum size of the implant can simplify implantation. Furthermore, miniaturization of the implant can increase the utilization of implants in areas where such implants were considered too large prior to the present invention. As a related possibility, the number and size of electronic components may be increased beyond what was previously achieved as a result of increased integration efficiency.

[0019]

[0047] Another potential advantage of embedding electronics within the implant body is that the implant body may protect the electronic components from corrosion. A major reason for implant failure is corrosion of implant components within the human body. While non-reactive polymer components tend to be fairly resistant to corrosion, other components, particularly electronic components, are less resistant. Therefore, embedding electronics within the implant body can provide significant protection for the electronic components. This can generally improve the lifespan and effectiveness of the implant.

[0020]

[0048] Another potential advantage of implanting electronic components is that the systems and methods may utilize "sensitive" electronic components that degrade relatively quickly within the human body, potentially reducing concerns about implant failure by allowing the use of electronic components previously considered too sensitive to corrosion.

[0021]

[0049] Similarly, another potential advantage of the systems and methods is that they allow the use of electronic components that may be considered toxic to the human body. The implanted electronic components also isolate the toxic electronic components from the human body, preventing the harm that harmful electronic components can typically cause inside the body. In some cases, the systems and methods can also act to physically limit the exposure of non-biocompatible materials to the human body in the event of implant failure or during implant removal. Some variations of the systems and methods can be used to seal or encase certain elements to prevent the human body from being exposed to various materials in the circuit system. This protection can be crucial during surgery, during the use of the medical implant within the human body, and / or during the extraction of the medical implant.

[0022]

[0050] Another potential advantage of the systems and methods is maximizing the effectiveness of certain electronic components relative to the implant body. By embedding circuit surfaces with specific geometries within the implant body, the positioning of certain electronic components can be optimized for functionality. The specific geometries can allow for component positioning for maximum effectiveness (e.g., sensors on the surface of the implant, control systems deep within, electrodes in specific locations on the surface, antennas wrapped around the circuit surface to provide optimal signal transmission).

[0023]

[0051] A potential advantage of systems and methods that include a mounting casing is the ease with which a circuit system can be incorporated as part of an implant. Some preferred embodiments of the casing provide a simple and durable structure to house a circuit system that includes elements such as a PCB and other electronic components. In some variations, the casing is integrated with the implant body as a single structure, thereby allowing for the incorporation of a PCB without modification to the implant body.

[0024]

[0052] Another potential advantage of systems and methods that include a mounting casing is that the casing can provide a simple and robust enclosure for at least a portion of the electronic components of the circuit system. In preferred versions, the casing can be constructed to withstand high levels of stress and strain within a patient's body (e.g., constructed of titanium) and to withstand high levels of stress and strain experienced during implantation, such as during impact of a spinal cage. By embedding the electronic components within the casing, they can be protected from these mechanical stresses.

[0025]

[0053] Another potential advantage of the systems and methods is the use of embodiments of electronics-enabled medical implant devices to secure potentially non-biocompatible circuit components within a casing. Furthermore, the casing can potentially offer the particular advantage of being more tolerant to stress and strain levels within a patient's body than other portions of the medical implant. The casing can be made of a mechanically robust material, such as titanium, which allows the casing to be highly tolerant to stress and strain, even though there may be an internal chamber defined to house portions of the circuit system. Thus, even in the unlikely event that other portions of the medical implant mechanically fail or the medical implant device breaks during removal and / or implantation, the electronics within the casing can remain sealed. In this manner, the systems and methods enable medical implant devices in which potentially toxic / non-biocompatible circuit components (e.g., integrated circuits, capacitors, resistors, and other circuit components) can be secured within a casing, ideally with minimal exposure to the human body, while electrodes, antennas, and / or other electronics that may be disposed within the implant body can be made from biocompatible materials such as titanium, gold, platinum-iridium, polyamide, and / or medical-grade silicone.

[0026]

[0054] Preferably, the electronic components are sealed within a mounting casing to completely isolate the electronic components from bodily fluids, which may cause damage and / or degradation to the electronic components. Furthermore, some electronic components may be toxic to the patient. Therefore, sealing the electronic components within a casing provides the advantage of protecting the patient from toxic electronic components, and may also protect the electronic components from damage or degradation.

[0027]

[0055] Another potential advantage of systems and methods that include a mounting casing is that the mounting casing allows access and removal of at least a portion of the circuit system without disturbing the main implant body. The mounting casing may be modified for implant use to change the PCB circuitry with minimal impact to the implant body.

[0028]

[0056] Furthermore, for long-term implant use, the mounting casing may provide the added benefit of easily removing potentially toxic PCB components. After the systems and methods have ceased their "active" functions requiring the use of a PCB, the implant may remain in the patient's body for years and even decades. During this time, degradation of the implant may result in PCB exposure, and further exposure to toxic components on the PCB. Removal of the mounting casing may provide the added potential benefit of easily removing these toxic components while leaving the main implant body in place.

[0029] 2. System

[0057] As shown in Figures 1 and 2, a system for electronics implanted within a medical implant includes an implant body 100, a circuit system 105 housing at least one electronic component, an electronic component 130 connected to or located directly on the circuit system and comprising a set of electrodes 132 and an antenna 134, and wiring 150 connecting the circuit system and the electronic component. In some variations, the circuit system includes at least one circuit surface 110 housing the at least one electronic component, the circuit surface being at least partially embedded within a defined cavity in the implant body along at least one path. In some variations, the system can further include a covering 120 comprising a protective structure. At least the partially embedded portion of the circuit system 105 is enclosed within the covering.

[0030]

[0058] Variations in the path of the defined cavity may include straight channels, uniform contour channels, curved channels, angled channels, and / or other variations described herein. The system functions as an implant with functional circuitry, which is further protected by the implant body 100, most of which occupies little additional space beyond the implant body itself. The system may, among other things, have functionality as a structural implant capable of providing electrical stimulation. Examples of possible system implementations include orthopedic cages (e.g., spinal cages), pacemakers, and surgical nails. Depending on the system embodiment, the system may include fewer or additional components as desired.

[0031]

[0059] As shown in FIG. 2 , in some variations, the system may further include a casing 140. The casing is a sealed structure directly connected to the implant body 100. In variations that include the casing 140, the circuit system 105 includes a casing circuit subsystem (e.g., a printed circuit board (PCB)) housed within the casing 140. Depending on the embodiment, the casing circuit subsystem may include exposed electrical connectors or couplers that operably connect with one or more circuit surfaces 110 within the implant body 100. Variations in the system's casing 140 may provide various manufacturability advantages and may also provide alternative approaches to sealing and protecting certain electronic components 130, such as active electronics, integrated circuits, and / or other sensitive components. In some variations, the casing circuit subsystem may include all circuit components with biocompatibility risks that may be sealed or otherwise housed within the casing 140.

[0032]

[0060] The implant body 100 of preferred embodiments may have general features desirable or necessary for a particular implementation. In one preferred version, the implant body 100 may be any non-biological implant that can be implanted in a living body (e.g., a spinal cage, a pacemaker, a nail). Depending on the implementation, the implant body 100 may function as a three-dimensional housing structure including at least one circuit surface 110 as a component of a system. In some versions, the implant body 100 is constructed as a load-bearing structure that is subjected to stresses and forces during implantation in the body, such as an implant body of a spinal cage, a nail, a hip implant, etc. The implant body 100 is preferably geometrically larger than the circuit surface 110 and constructed of a solid, non-reactive, non-toxic, and / or malleable material. Additional or alternative material attributes may be used for the material of the implant body 100.

[0033]

[0061] In preferred variations, the implant body 100 may be an implant component such as those described in U.S. Patent Application No. 15 / 075,152, filed March 19, 2016, which is incorporated herein by reference in its entirety. Alternatively, the implant body 100 may be an orthopedic implant other than that described in U.S. Patent Application No. 15 / 075,152. The implant body 100 may function as a structural element to house or retain implant subcomponents. In some variations, the implant body 100 is flexible, but may alternatively be semi-flexible or rigid.

[0034]

[0062] The implant body 100 is preferably made of a non-conductive material, but may be partially conductive. In some embodiments, the implant body 100 can be a spinal implant, more preferably a spinal cage. The implant body 100 is preferably constructed of a non-conductive polymer, such as polyetheretherketone (PEEK), but may also be made of engineered, natural, or synthetic bone material, titanium, and / or one or more other suitable materials, or combinations thereof. In some embodiments, the implant body 100 can have additional components of different configurations, such as metal ends on a spinal cage (e.g., as shown in FIG. 3).

[0035]

[0063] In some preferred variations, the implant body 100 is a spine cage. Alternatively, the implant body 100 may be another type of orthopedic implant or other type of implant body (e.g., a pacemaker). In some embodiments, the geometry of the spine cage is an extruded prism of a defined shape having a generally continuous contour. The spine cage may include one or more graft windows, which may be defined as internal implant cavities. That is, the spine cage may include an enclosure in the side wall of the implant body 100 to define one or more implant cavities, with openings on the top and bottom surfaces of the spine cage. As shown in the exemplary diagrams of FIGS. 3-5, the spine cage includes the foregoing description, but may also be combined with many geometries. Examples of particular types / shapes of spine cages that may be implemented include, but are not limited to, anterior lumbar interbody fusion (ALIF) cages, lateral approach posterior lumbar interbody fusion (TLIF) cages, eXtreme lateral interbody fusion (XLIF) cages, posterior lumbar interbody fusion (PLIF) cages, anterior cervical fusion (ACF) cages, lateral cages, oblique lateral interbody fusion (OLIF) cages, and / or other suitable types of spine cages. The spine cage may also include other design features such as surface coatings (e.g., to protect the implant, increase osteointegration, etc.), surgical tool attachment points (e.g., to facilitate tool access), teeth (e.g., to increase the likelihood of the spine cage not moving), side openings in the spine cage (e.g., to allow electrical charges to easily enter and exit the spine cage and / or other elements), etc.

[0036]

[0064] In addition to various geometries, spine cages can have various sizes as desired or required in various embodiments. When a spine cage is implanted within the spinal column to replace damaged disc / bone tissue, the size (and shape) of the implant body 100 can be varied to fit the damaged tissue area and enable and optimize proper function of that tissue area. As shown in FIG. 6, one variation in implant body geometry can be a spine cage with a single implant cavity, with the side of the implant body 100 facing outward becoming the top of the implant body when oriented in a human patient. Typical dimensions of some preferred embodiments, such as those shown in FIG. 6, can range from 9 mm to 50 mm for 3-1, 20 mm to 80 mm for 3-2, 5 mm to 18 mm for 3-3, 5 mm to 30 mm for 3-4, 5 mm to 30 mm for 3-5, 1 mm to 5 mm for 3-6, and 1 mm to 5 mm for 3-7. While these are typical ranges, actual embodiments can vary beyond these ranges if desired.

[0037]

[0065] The system preferably includes a circuit system 105, which may include one or more circuit surfaces 110. The circuit system 105 may include electrical components, connectors, or functional components of the circuit system. In one variation, the circuit system 105 may be implemented entirely by the circuit surfaces 110 embedded within the implant body 100. In another variation, the circuit system 105 may include a casing circuit subsystem. The casing circuit subsystem is a portion of the circuit system embedded within the casing 140. The casing circuit subsystem may be connected to one or more circuit surfaces 110. The casing-embedded circuit system may be connected to the circuit surfaces 110 via wiring 150, i.e., a wired conductive connection. Alternatively, the casing-embedded circuit system may be operably connected using inductive coupling or other wireless coupling systems in some variations.

[0038]

[0066] The circuit surface 110 of preferred embodiments serves as a generally two-dimensional surface (e.g., a flat surface, a curved surface, a hollow tube) for some and / or all of the medical implant's electronic components 130. The circuit surface 110 is at least partially embedded within the implant body 100. In some variations, at least a substantial portion of the circuit surface 110 (e.g., greater than 95% of the surface area of ​​the circuit surface 110) is embedded within the implant body. In one example, the implant body 100 is overmolded or otherwise formed around the circuit surface 110 to cover a substantial portion. In some variations, portions of the circuit surface 110 may be exposed. More specifically, electrodes 132 integrated with or otherwise connected to the circuit surface 110 may be exposed. As a first example, the exposed surfaces of the electrodes 132 may be exposed in designated areas where electrical stimulation or electrical measurements are to be performed. Similarly, electrical connectors conductively coupled to subsystems of the circuit system (e.g., electrodes 132 and / or antenna 134) of the circuit surface 110 may be exposed at certain locations (i.e., not covered by the implant body 100).

[0039]

[0067] As used herein, circuit surface 110 can refer, without loss of generality, to a single or multiple circuit surfaces contained within a system.

[0040]

[0068] Preferably, the circuit surface 110 is used in part as a scaffolding or structure for orienting the electronic component 130 and facilitating integration of the electronic component 130 into the implant body 100. Specifically, the circuit surface 110 is used to facilitate embedding and positioning within the implant body 100 of the electrical component 130, the electrical component 130 having performance / operation characteristics that depend on its orientation and position relative to the implant body 100. Specifically, the position and orientation of one or more electrodes 132 and / or one or more antennas 134 may be formed within the manufactured implant body by attachment to the circuit surface 110.

[0041]

[0069] For example, in the case of a medical implant device that allows for the delivery of electrical stimuli and / or the performance of electrical measurements using different combinations of electrodes, the location and relative orientation of the electrodes 132 may be important. The circuit surface 110 can facilitate the orientation of electrodes along different surfaces of the exterior portion of the implant body 100. In many cases, the circuit surface 110 is used to seamlessly integrate multiple electrodes (e.g., four, eight, or more electrodes) at different locations on the exterior surface, which may be at least two or more different defined surfaces and / or faces of the implant body 100. For example, the electrodes 132 may be positioned by physically coupling to the circuit surface 110 along one or more interior walls defining an internal cavity (e.g., a bone fixation cavity defined in a spinal cage) and / or one or more exterior walls along the exterior surface of the implant body 100.

[0042]

[0070] The location and relative orientation of one or more antennas 134 may similarly be governed in the medical implant device by the structural scaffolding of the circuit surface 110. Antenna positioning may be important for optimizing wireless power transfer and / or communication between the medical implant device and an external system. In some variations, by forming the antenna 134 in or around the circuit surface 110 and depending on how the circuit surface 110 is configured (e.g., folded) within the implant body 100, the antenna 134 may be oriented along various defined planes.

[0043]

[0071] The circuit surface 110 may include any general or specific circuitry that enables the functionality of the system electronic components 130. In one variation, the circuit surface 110 includes a printed circuit board (PCB), and the electronic components 130 may be based on or connected to the PCB. In another variation, the circuit surface 110 includes an integrated chip (IC), and the electronic components 130 may be built on or connected to the IC. For example, the circuit surface 110 may include an application specific integrated chip (ASIC), and the antenna 134 and capacitor components may be embedded in the chip. In a third variation, as shown in FIGS. 2 and 7, the circuit surface 110 may include a cavity tube, and the electronic components 130 may be embedded within or wrapped around the tube (e.g., the antenna 134). In another variation, the circuit surface 110 includes biocompatible electronic components 130, such as one or more electrodes 132 and / or one or more antennas 134, which can be connected to another portion of the circuit system 105, such as a casing circuit subsystem, via wiring 150 or other conductive couplers.

[0044]

[0072] The geometry of the embedded circuit surface 110 within the implant body 100 can be simple, along a line (straight path) or a curve (curved path). Alternatively, the geometry of the embedded circuit surface 110 can be more complex, consisting of multiple straight and / or curved paths. By utilizing multiple straight and / or complex paths, the geometry of the embedded circuit surface 110 can include any combination of folds, bends, and table-like geometries. These simple and / or complex folds and paths can be determined depending on the type of circuit surface 110 (e.g., IC, PCB, orientation surface, etc.) and the potential space available for implementing the defined cavity geometry within the implant body 100.

[0045]

[0073] In some variations, the circuit surface 110 includes an orienting circuit surface that functions as a structural frame upon and around which other electronic components 130 may be mounted. In these variations, the electronic components 130 may be embedded or housed directly in the implant body 100 without a chip or circuit board. The circuit surface 110 may again function to provide a fixed, orientable surface (e.g., for positioning electrodes and for wrapping and positioning antennas). This may be true for components that may be particularly durable during implant construction (e.g., highly resistant to exposure to high temperatures). Both Figures 8 and 9 show renderings of the orienting circuit surface 110, including an antenna 134 (shown in Figure 8) wrapped around the circuit surface 110 and an electrode 132 (shown in Figure 9) oriented and connected via the circuit surface.

[0046]

[0074] In some variations, the circuit surface 110 comprises at least one PCB, as shown in FIG. 10 . FIG. 10 is a schematic diagram of the front (top) and side (bottom) of a single-layer PCB. The PCB can be single-sided, double-sided, and / or multi-layered, and each side / layer can include electronic components 130 embedded within the PCB or on the surface of the PCB. In some embodiments, the PCB is single-sided and single-layered. In other embodiments, the PCB can be multi-sided, as shown in FIG. 11 . FIG. 11 is a schematic diagram of the front, back, side, and folded state of a multi-sided PCB. In a preferred variation, the PCB itself can be flexible, with all or part of the PCB being bendable (although the electronic components 130 on the PCB may not be bendable). In other words, the PCB comprises a flexible substrate. Because the PCB is preferably part of a medical implant, the PCB can be constructed of any suitable non-toxic, non-reactive material. In a preferred version, the PCB is constructed of polyimide, although other non-toxic, non-reactive materials may alternatively be used.

[0047]

[0075] PCBs typically have a flat, sheet-like geometry, with the size of the sheet (or layer of the sheet) depending on the required motion desired from the PCB and the physical space available for placement of the PCB. In one variation, the PCB may be formed on a substrate having a rectangular outline. However, the PCB may alternatively be formed on a substrate having a non-rectangular outline or modified to have a non-rectangular outline. For example, the PCB may have a central rectangular area, but one or more smaller areas may extend away from this central rectangular area. In a preferred variation, the thickness (C) of the PCB sheet is 0.1 mm, as shown in FIG. 10. In spine cage variations, the dimensions of the PCB may vary depending on the particular implementation. Referring to FIG. 10, the dimensions of the PCB may typically be (A) 10 mm to 100 mm in length and (B) 1 mm to 100 mm. In addition to the PCB thickness (C) itself, electronic components 130 housed on the PCB may protrude and / or extend outward from the plane of the PCB by a certain amount, increasing the thickness of the PCB. In spinal cage variations, (D) < 5 mm, while in some preferred embodiments, (D) ≤ 3 mm. For example, some PCB sheets (with components) have an effective thickness of less than 1 mm, e.g., about 0.6 mm. However, if the PCB is a flexible PCB and is folded or layered, and therefore thicker than the effective thickness of a flat PCB, the implant body 100 may accommodate a greater thickness.

[0048]

[0076] The PCB may include bends and / or folds (however, the general dimensions of an unbent / unfolded PCB described above still apply). The PCB may include any number of bends / folds, limited so that the final PCB geometry can be incorporated into the implant body 100 and so that the electronic components 130 on the PCB do not lose functionality (e.g., if the electronic components are placed on a bend in the PCB and bent beyond their functionality). In some variations, the PCB may layout components and leads in coordination with a planned fold pattern. For example, the electronic components 130 may be positioned outside of defined fold seams to facilitate folding. Depending on the topology of the electronic components 130 on the PCB, bends or folds may not be performed on electronic components 130 that cannot be bent or folded. For example, an antenna region may be folded without affecting the functionality of the antenna 134, while folding may impair the functionality of a capacitor, but bending (depending on the angle of the bend) may not affect the functionality of the capacitor. Preferably, the layout of electronic components 130 on the PCB can be configured within a defined area. In particular, the component layout can include bend regions where there are few or no electronic components or components that can accommodate the bend. For example, in a transformation in which the PCB includes a 90-degree bend, there can be areas where electronic components 130 are not located at the bend point and / or do not overlap the bend / flexion region. Furthermore, to mitigate mechanical issues with the leads, conductive traces can be oriented to cross defined fold seams.

[0049]

[0077] In variations on the basic defined cavity, the defined cavity can have a uniform profile or a non-uniform profile, as shown in FIGS. 12A and 12B. In a uniform profile, the width and shape of the defined cavity along the defined path are uniform in size. Uniform dimensions serve to simplify manufacturing and, more generally, accommodate a wide variety of circuit surfaces 110. Uniformity can be used with straight paths and more complex paths, as shown in the two exemplary defined cavities in FIG. 12A. Non-uniform profiles preferably have the defined profile's width and shape vary along the path. This can be used to address size considerations for particular components on the PCB. As shown in FIG. 12B, a non-uniform profile can include a protruding defined cavity to accommodate electronic components 130 that protrude further from the surface of the PCB. Both uniform and non-uniform PCB cavities can be utilized as desired with any embodiment of the present invention.

[0050]

[0078] In general, variations on the defined PCB cavity are described as being able to form a defined PCB cavity extending from one side of the body into the structure. Thus, one suitable manufacturing process for forming the defined cavity is subtractive machining, with the defined cavity extending downward into the implant body 100 to form a “slit.” Other geometric features can also be achieved by other techniques (e.g., molding around a removable material by investment casting or other techniques). This defined cavity configuration also makes PCB insertion a simpler process, as the PCB can be slid into the defined PCB cavity. In some variations, the PCB may be folded before or during insertion. The system preferably includes a coating 120, which may act as a cavity seal, such as an epoxy, silicone, mounting cap, or other structure that closes off the exposed portion of the defined PCB cavity.

[0051]

[0079] In some alternative variations, the PCB can be molded into the implant body 100 or encapsulated within a multi-part implant body design, and the PCB can be partially or fully embedded in the implant body after manufacture and assembly. In this variation, the defined PCB cavity can be fully embedded within the implant body such that there are no exposed portions outside of the defined PCB cavity. The defined PCB cavity can again have one or more internal defined cavities that serve to accommodate the PCB.

[0052]

[0080] In a preferred variation, the PCB is embedded within the implant body 100 along a path. The path can be a straight path, as shown in FIG. 13A, or a curved path, as shown in FIG. 13B. The PCB can be fully or partially embedded within the body as desired, with each segment of the PCB embedded within the body being embedded along a path (straight or curved). In some preferred examples, multiple straight and / or curved paths may be implemented. Curved paths may take advantage of the bendable nature of the PCB, thus constraining the system to some extent. In curved path embodiments, the curved path preferably does not have a curvature beyond the extent to which the PCB can be bent. Alternatively, the PCB can be printed with a curvature to fit the curved path.

[0053]

[0081] In another variation that further expands the bend path concept, the defined cavity can include at least two segments connected along individual corners. In such an angled path variation, the PCB is at least partially bent at one or more locations and fully or partially embedded within the path. That is, the PCB and PCB fold region are embedded within the same defined cavity in the implant body 100. Each segment can be straight or curved. Given the low bending capacity of the PCB folded segments, the curvature of the curved path can be further limited relative to the PCB folded segments. As shown in FIGS. 14A and 14B, the angled path variation can implement bend angles around the structure of the implant body 100. As shown in FIG. 14A, the defined PCB cavity can have one or more angles and one or more PCB bends, providing two or more path segments and PCB segments. Each segment can be straight or curved, have a uniform or non-uniform profile, and / or have any suitable features. As shown in Figure 14A, both segments of the PCB can be substantially straight, or as shown in Figure 14B, one segment of the PCB can be straight and another segment can be curved.

[0054]

[0082] In additional or alternative variations, as shown in FIG. 15A , the PCB can be folded in the opposite direction (i.e., folded at least once like an accordion), and the defined PCB cavity can accommodate this folded region of the PCB. As shown in FIG. 15B , the PCB can be folded in the opposite direction any suitable number of times. In some variations, the opposite folds can be tailored to the PCB layout of the antenna component to create two or more coil layers of the antenna 134. Thus, multilayer folded PCBs can be implemented to accommodate electronic components 130 that can utilize them (e.g., amplify the signal of a multilayer antenna). Furthermore, multilayer folded PCBs can fit into geometrically limited spaces (e.g., rectangular cavities). For example, the PCB can be folded into a configuration that allows multiple circuit subsystems to be compactly accommodated within a defined cavity in the shape of a rectangular parallelepiped.

[0055]

[0083] In another variation, the defined cavity can utilize different cavity depths. This can function to allow for a folding axis along the surface of the PCB. When using defined cavities with different depths, the PCB can be folded or bent along the folding axis to orient at least one surface so that the normal to this surface is in the direction of the defined insertion axis. As shown in FIG. 16 , the defined cavity can have a “table-like” geometry. The PCB can be bent at both ends so that the center has a surface perpendicular to the insertion direction, and the ends can be bent to insert deeper into the defined PCB cavity. In a table-like geometry, at least a portion of the PCB lies flat along the top, bottom, or side of the implant body 100. One or both of the regions adjacent to the flat-lying segment can then be bent into the implant body 100. Alternatively, one or both sides can be embedded along a curved path. In some variations, the PCB can include multiple adjacent table-like folds, bending the PCB over the edges of the implant body 100 to cover multiple sides of the body. Custom PCB surface geometries can be used to enable multiple folding strategies, as shown in Figure 17. In this exemplary variation, three antenna 134 structures can be oriented orthogonal to one another.

[0056]

[0084] To summarize PCB placement and folding, preferred embodiments of the system can utilize any combination of bending, folding, reverse folding, and table folding along straight and / or curved paths, taking into account the location of the electronic components 130 on the PCB. In other variations, the implant body 100 can be formed as a multi-part design that is glued, sonic welded, attached, or otherwise connected. An internal cavity can be defined within one or more of the body portions to accommodate the PCB when the body portion is encapsulated. In another variation, the implant body 100 can be overmolded on or around the PCB. In one embodiment, a molding frame (i.e., the covering 120) can be connected around the PCB. The molding frame serves to structurally support and, optionally, shield the PCB during the overmolding process. The PCB placement geometries described herein can be used in both variations.

[0057]

[0085] In some variations, the system can include a coating 120. The coating 120 acts as a physical support and / or enclosure for the medical implant and / or system subcomponent, providing protection and / or support to the system subcomponent. The coating 120 can be incorporated for any component of the circuit system 105. The coating can be particularly useful in embodiments using a circuit surface 110. The coating can provide a protective enclosure (e.g., a high-temperature resistant silicone coating / enclosure) and / or increased tensile strength (e.g., a strong titanium support) for the circuit surface 110.

[0058]

[0086] In variations in which the covering 120 provides a protective enclosure, the portion of the circuit surface 110 that is at least partially embedded within the implant body 100 may be "covered" to encapsulate the circuit surface 110 and attached electronic component 130 within the covering 120, potentially protecting the component from implantation conditions and / or protecting the component during fabrication / molding of the medical implant. As shown in FIG. 18 , in variations in which the covering 120 provides tensile strength to the circuit surface 110, the covering 120 may include a rigid structure along the circuit surface 110. In preferred variations, the protective enclosure covering 120 may also serve to completely fill (e.g., by a molding process) the defined cavity in which the circuit surface 110 is embedded.

[0059]

[0087] In variations in which the coating 120 provides tensile strength, the coating may include support structures. This may be especially true in variations involving PCBs with many folds or bends. The support structures function to help maintain the load and shape of the circuit surface 110 and also facilitate manufacturing. The support structures are preferably localized to the area of ​​the circuit surface 110 where the components are attached, but may be located in any other desired area (e.g., PCB components within the casing 140 of a medical implant). The coating 120 also functions to reduce the likelihood of mechanical failure of the electronic components 130 within or along the circuit surface 110.

[0060]

[0088] The covering support structure may be implemented to provide support to other circuit system 105 components, electronic components 130, and other general medical implant components. Materials may be combined as part of the covering support structure to enhance the mechanical properties of the implant body 100 and / or subsections thereof. In some variations, the circuit surface 110 may include one or more covering 120 layers composed of materials having higher (or lower) mechanical strength / stiffness, etc., than the materials comprising the remainder of the implant body 100. In this manner, the covering support structure may increase the tensile strength of both the circuit surface 110 and the implant body 100. The supporting covering 120 may be an external covering on the surface of the implant body 100, an internal covering within the implant body, or both an internal and external covering. The supporting covering 120 may also fully or partially cover the circuit surface 110, thereby fully or partially enveloping the circuit surface 110 and simultaneously providing additional support to the implant body 100. For example, if the bulk of the implant body 100 is primarily made of PEEK, the covering 120 can be made of titanium or carbon fiber reinforced PEEK. In some variations where the implant body 100 is partially hollowed (i.e., creating a defined cavity) to accommodate the circuit surface 110, using a material that is mechanically stronger than the composition of the implant body 100 can ensure that the hollowed portion is not mechanically weaker than the rest of the implant body 100, and is, in fact, mechanically stronger. A covering 120 made of a mechanically strong material can ensure the mechanical integrity of an implant body 100 manufactured using an appropriate form factor characterized by dimensions suitable for implantation in a human (e.g., ensuring that the thickness does not significantly expand, as shown at 3-4, 3-5, 3-6, and 3-7 in FIG. 6, to compensate for the weakened mechanical properties caused by the hollowed portion).

[0061]

[0089] The covering 120 may additionally or alternatively include a protective structure. The protective structure may function to protect the circuit surface 110 and the electronic components 130 on the circuit surface 110 both during normal operation and during construction of the medical implant (e.g., the protective covering 120 may protect the electronic components 130 from failure during a high-temperature molding process). The system may include a covering 120 that can protect the circuit surface 110 embedded within the implant body 100. Furthermore, the covering 120 may electronically insulate the components, thereby protecting the circuit (e.g., circuit system and electronic components) from conductive components. The system may include a circuit surface 110 that is partially or completely embedded within the implant body 100. The covering 120 may provide a complete enclosure for the area of ​​the circuit surface 110 that is embedded within the implant body 100. Alternatively, the covering 120 may completely encapsulate the circuit surface 110, including the area that is not embedded within the implant body 100. Alternatively, the covering 120 can only partially encapsulate the region of the circuit surface 110 embedded within the implant body 100 (e.g., protecting only an antenna component on a PCB). The implant body 100 can have grooves or slits within its structure as cavities for the defined circuit surface 110. The circuit surface 110 can be contained within the defined cavity. The defined cavity can be formed as part of the molding of the implant body 100. Alternatively, a secondary manufacturing process can cut or remove material to form the defined cavity within the implant body 100. As part of embedding the circuit surface 110 within the defined cavity, the embedded region of the circuit surface can be encapsulated within the protective structure covering 120. The covering 120 preferably comprises a non-reactive, non-toxic material. In some variations, the protective structure covering 120 is constructed of silicone, and the circuit surface 110 is secured within the defined cavity of the implant body 100 by overmolding the circuit surface within the defined cavity with the silicone. Alternatively, the protective coating may be constructed of epoxy, resin, or other usable materials.

[0062]

[0090] In variations in which the circuit system 105 includes a PCB, the covering 120 may include a PCB envelope that functions to fully or at least partially envelop the PCB as a protective covering. The PCB envelope preferably functions as an inner cover, with at least a second outer surface facing the implant body 100 surrounding the PCB envelope. The PCB envelope is preferably a silicone material molded or formed around the PCB. The PCB-encapsulated PCB envelope can be inserted into a defined cavity. The silicone molding may function to insulate the electronic component 130 during the manufacturing process and to electrically insulate the electronic component from other conductive components. Additionally or alternatively, the silicone molding may function to house elements of the PCB in the event of failure or while the implant is being removed by a physician. Furthermore, a rigid backing or frame may be included with or connected to the PCB. The rigid frame may function to improve the structural integrity of the PCB and the resulting implant. As shown in the example of FIG. 18, the covering 120 may include both a support structure (i.e., a long section of PCB rigid frame disposed along the PCB) and a protective structure (i.e., PCB silicone cover). In this example, the support structure may be constructed using polyimide or other suitable material.

[0063]

[0091] One variation of the support structure can be seen in the bottom image of Figure 19. The support structure enclosure is implemented to support a PCB within a casing 140 that is external to the implant body 100. In a variation including multiple multi-layer PCBs embedded in the external casing 140, the enclosure 120 can include rectangular support structures between the top, middle, and bottom layers of the PCB. The PCB shown can be produced by mounting components on only one side of the PCB. Alternatively, it is possible to have electronic components 130 on both sides of the PCB, with the enclosure 120 positioned between these components to protect and support the multiple layers of electronic components.

[0064]

[0092] Additionally, the coating 120 for the PCB within the casing 140 may include a protective coating. In one variation, the PCB within the casing is overmolded with silicone, or silicone is poured around the PCB and then inserted into the casing 140. This can provide an additional layer of protection for the PCB. Additionally, the protective coating 120 can separate and insulate the PCB from the casing 140. This can be particularly important if the casing is also utilized as an electrode.

[0065]

[0093] The system of the preferred embodiment includes at least one electronic component 130. In a preferred version, the electronic component 130 includes a set of electrodes 132 and an antenna 134. Additional electronic components 130 may be added to the system as desired and depending on the implementation. Depending on the implementation and the type of electronic component 130, the electronic component may be directly connected to the circuit system 105 or may be connected to the circuit system 105 via wiring 150.

[0066]

[0094] In spine cage variations of the system, electronic components 130 may include any desired electronic components. In preferred spine cage variations, electronic components 130 may include electrodes 132 (to transmit electricity to, sink, or source current from tissue), ground electrodes (to establish ground voltage), capacitors (to store external energy), implant transmitters / receivers, rectifier circuits, control circuits (to manage control of components), monitoring circuits (sensor components), impedance measurement circuits, antennas 134 (to transfer power and / or information to and from the medical implant), batteries (long-term power sources), capacitors (short-term rechargeable power sources), and / or other suitable electronic components 130. Electronic components 130 may be positioned on or around circuit system 105 as desired. In variations including a PCB, electronic components 130 are less flexible than the PCB itself, so certain areas of the PCB may be less flexible depending on the electronic components housed therein.

[0067]

[0095] As part of the PCB-inclusive transformation, electronic components 130, like the PCB layout and geometry, can be spatially arranged according to component height, such that subgroups of components with larger effective heights (relative to other components) are grouped within the same subdivision of the PCB's folded pattern. For example, tall components can be positioned adjacent to one another, allowing only one subdivision to accommodate their height when the PCB is folded. In some cases (e.g., when the board's components include only routing leads), the PCB may have a particularly thin profile, allowing the PCB to be folded multiple times without significantly affecting its thickness.

[0068]

[0096] The electronic component 130 preferably includes a set of electrodes 132. As shown in FIG. 20, the set of individual electrodes 132 is preferably exposed at one or more locations along the surface of the implant body 100. In variations including a PCB, the electrodes 132 are preferably conductively coupled to the PCB and configured to be controlled by the PCB (and / or the electronic component 130 thereon). The PCB is preferably capable of providing power and signals to establish an electrical potential at one or more locations and / or to make electrical measurements (e.g., voltage or current). The electrodes 132 are preferably made of a conductive material. The electrodes 132 are preferably comprised of a conductive element (e.g., titanium or platinum).

[0069]

[0097] In one variation, at least one surface of the electrode 132 is externally exposed at the surface of the implant body 100. As shown in FIG. 18 , the electrode 132 may include an internal shoulder structure connected to the exposed electrode structure. The internal shoulder structure is preferably oriented internally within the implant body 100 and functions to prevent removal of the electrode 132. In one embodiment, the electrode 132 is first connected to the internal structure, and an external portion is overmolded around the electrode. The electrode may constitute a separate volume from the PCB, attached after PCB fabrication. The electrode 132 may also be preferably printed directly onto the PCB substrate, either as part of PCB fabrication or as a separate step of metallizing appropriate areas of the PCB with a suitable metal (e.g., titanium and / or platinum) to form the electrode site. The electrode 132 and / or its connections may also be printed directly onto the implant body 100. For example, titanium and / or platinum can be deposited onto the PEEK implant body 100 and / or casing to form the electrodes 132 and / or leads / connectors (FIG. 28). The printing of conductive components on or within the implant body is preferably conductively coupled to traces or other conductive elements that connect the printed conductive elements to the circuit system 105. When printed on a flexible or semi-flexible substrate, these electrodes 132 can bend / fold across non-normal surfaces of the PCB casing and / or implant body.

[0070]

[0098] As shown in FIG. 20 , in a second variation, the electrodes 132 may be exposed on the exterior of the implant body 100, but portions of the electrodes are embedded within the implant body itself. This can help hold the electrodes 132 in place and prevent electrode migration. Each electrode 132 can also be electrically connected (e.g., via traces 150) to the circuit surface 110 that houses the electricity-generating components. The electrodes 132 and their connections can also be printed directly onto the implant body 100. For example, titanium can be deposited on a PEEK implant body and / or casing to form the electrodes and / or leads / connectors. When printed on a flexible or semi-flexible substrate, these electrodes 132 can bend / fold across non-vertical surfaces of the PCB casing and / or implant body.

[0071]

[0099] The electronic component 130 preferably includes an antenna 134. As shown in FIGS. 2, 7, and 16, the antenna 134 can be positioned and oriented in many different ways depending on the embodiment. The antenna 134 functions to send and receive external communications (e.g., to control the function of the electrodes 132) and / or receive external power (e.g., to inductively charge a capacitor, power the system, etc.). The antenna 134 may include a single antenna, as shown in FIG. 16, or may include multiple bodies, as shown in FIG. 17, which includes three orthogonal antennas on a PCB. The antenna 134 can be built onto the circuit surface 110 (e.g., by printing the antenna on the PCB) or positioned separately on the implant body 100 (e.g., embedded within an implant body cavity).

[0072]

[0100] The antenna 134 may be implemented in any desired configuration. The antenna 134 may generally be implemented as a conductive path tuned to a resonant frequency. The antenna may be a coiled loop, a serpentine conductive path, and / or any other suitable type of antenna. In one variation, as shown in FIGS. 7 and 8 , the antenna includes a wire loop surrounding a circuit surface 110 embedded along two sidewalls of the implant body 100. The antenna 134 may also be electrically connected to other electronic components 130 (e.g., embedded in a connected casing 140) by wiring 150. In a second variation, the antenna 134 may be printed or attached to the circuit surface 110 (e.g., an IC or PCB). If the antenna 134 is highly flexible, the antenna may or may not be positioned on a curved portion of the circuit surface 110. In one example of the second variation, the antenna 134 may include multiple antennas extending in three-dimensional space. In this example, as shown in FIG. 17, the PCB can be folded so that it has at least one vertical surface in all three spatial dimensions. Antenna 134 can be printed on each vertical surface of the PCB so that the antenna extends in all three spatial dimensions. In general, the PCB can have any number of folds, and all folds, at least when combined, extend in all spatial dimensions. Also, antenna 134 can be mounted on a sufficient PCB surface so that the antenna extends in all three spatial dimensions. In a third variation, as shown in FIG. 15B, antenna 134 can include connected or separate structures along the folds of the accordion-folded PCB. That is, antenna 134 can utilize opposing folds of the PCB to create an extended antenna with antenna loops (or other geometric structures) linearly arranged along each segment of the opposing folds. In one example of the third variation, the antenna 134 includes a multi-layer geometry in which adjacent layers of the PCB include portions of the antenna, thereby forming a relatively three-dimensional antenna including stacked planar folds.This type of antenna 134 may serve to improve signal transmission compared to relatively planar antennas.

[0073]

[0101] In some variations of the system, the system includes a casing 140. As shown in FIGS. 8, 9, and 19, the casing 140 functions as a separate body structure that can house electronics or other components adjacent to and outside of the rest of the implant body 100. The casing 140 can be integrated with the rest of the implant body 100 during the manufacturing process. FIGS. 21 and 22 show exemplary schematic diagrams of different implant bodies 100 with a casing 140. These schematic diagrams show the casing 140 before and after it is integrated with the implant body 100. In a preferred variation, the casing 140 is irreversibly integrated with the implant body 100 to form a unitary structure. Alternatively, the casing 140 can be incorporated as a separate body structure that can be connected to or detached from the implant body 100. The casing 140 can be constructed of PEEK, but may also be constructed of alternative materials, such as titanium, which may or may not be platinum-plated.

[0074]

[0102] In some variations, the casing 140 may not significantly increase the size and / or shape of the implant body 100. That is, the casing 140 preferably does not impose limitations on the desired volume and / or shape of the implant. The casing 140 is physically adjacent to and connected to the implant body 100. In some variations, the casing 140 may comprise a portion of the outermost surface of the medical implant. Alternatively, the casing 140 may abut the implant body 100 from an internal cavity (e.g., the casing 140 may be positioned within a spinal cage of the medical implant). The casing 140 may be positioned anywhere along the implant body 100 as desired, limited by functionality and size constraints. As shown in FIG. 21 , the casing 140 may be positioned on the lateral exterior of the implant body 100, along a shorter side of the implant body 100. Alternatively, the casing 140 may be positioned along a longer side of the implant body 100. Alternatively, the casing 140 may be positioned within the implant body 100 along a flat or curved surface of the interior cavity.

[0075]

[0103] In some embodiments, the casing 140 may comprise one or both of the thicker short ends (e.g., 3-4, 3-5 in FIG. 6 ) of the implant body 100 (shown in FIG. 9 , showing the apical / anterior and caudal / posterior portions for a lateral, PLIF, OLIF, or TLIF cage). The apical and caudal portions may be enlarged and hollowed out to accommodate the PCB (which may be folded). Furthermore, if the medical implant needs to be removed or drilled out, a mechanically strong casing 140 increases the likelihood that the casing will remain intact during the procedure, reducing the likelihood of PCB elements being exposed during or after the removal procedure. In this manner, the casing 140 may help protect the patient from potentially toxic PCB components both during normal operation and during implantation or removal of the implant.

[0076]

[0104] In some variations including a casing 140, the circuit system 105 can further include a casing circuit subsystem. In one embodiment, the casing circuit subsystem includes a PCB component. The PCB is enclosed within the casing 140 and electronically connected to one or more circuit surfaces 110 within the implant body 100. That is, the casing 140 includes an enclosure that can hold the casing circuit subsystem (e.g., ICs, PCBs, ASICs, etc.) and / or other electronic components 130, which may be on the casing circuit subsystem or separate from the casing circuit subsystem. In variations including a casing 140 with one or more PCB components, the PCB(s) can have any of the characteristics described above. That is, the PCB can be rigid, flexible, or semi-flexible (e.g., having foldable and rigid regions). The PCB can also be folded and / or shaped to a desired geometry or configuration, as described above. In one example, the casing PCB comprises a semi-flexible PCB folded into an accordion-like configuration, as shown in Figure 21. In another example, the casing PCB comprises a semi-flexible PCB folded into a table-like configuration, as shown in Figure 22.

[0077]

[0105] The enclosure may include a latching opening that can be opened or closed. Preferably, the enclosure is sealed using, for example, a laser welder. Alternatively, the casing 140 may include two or more sections that are assembled to form the outer housing. The electronic component 130 may be placed within the enclosure before the sections are assembled. Preferably, the two or more sections are then sealed to enclose the electronic component within the enclosure.

[0078]

[0106] In some other suitable variations, the casing 140 does not include an enclosure for adding or removing components. In these variations, the casing circuit subsystems (e.g., PCBs) and / or electronic components 130 may be embedded within the casing(s) 140 during construction of the casing(s) 140 (e.g., by an overmolding process).

[0079]

[0107] In connection with the embedded electronic components 130, the one or more casings 140 preferably include at least one connector that allows electrical connection with the implant body 100. The connector functions to connect the PCB and electronic components 130 within the casing 140 with electronic components on or within the implant body 100 (e.g., electrodes 132 and antenna 134). FIG. 19 shows an image of a casing 140 with connectors that connect to other portions of the implant body 100 via a set of complementary connectors, such as those shown in FIG. 23. In a preferred variation, once the casing 140 is integrated with the implant body 100, the connectors and complementary connectors are sealed to form a single structure. In some variations in which all circuit system 105 components are embedded within the casing 140, the casing has a sufficient number of connectors to connect to all of the system's electronic components 130 (e.g., all electrodes 132, antenna 134).

[0080]

[0108] The casing 140 may be manufactured in a separate process from the rest of the implant body 100. In this case, the two parts can be joined / attached / glued together after being manufactured in separate processes. Alternatively, the casing 140 and the rest of the implant body 100 may be manufactured in inseparable steps, such as by overmolding the implant body 100 onto the casing 140 or 3D printing the casing onto the rest of the implant body 100. The casing 140 may also include anchors to aid in attachment to the rest of the implant body 100. The anchors may be attached directly to a body manufactured in a separate step. The anchors may also help secure the casing 140 to the rest of the implant body 100 after the rest of the implant body 100 has been overmolded onto the casing 140 or otherwise joined.

[0081]

[0109] The casing 140 is preferably permanently integrated or fixed in place to the implant body 100. The casing 140 may be sealed, locked, or connected using any desired mechanism, such as, for example, by first welding the casing to the implant body 100 and then overmolding both structures together. Depending on the embodiment, the casing 140 may be a temporary or permanent fixture to the implant body 100. In one example, the casing 140 is a permanent fixture and is sealed by welding the casing to the implant body 100. In one example, the casing 140 may be welded or otherwise connected to the implant body 100 away from the surface of the implant body 100 where the source of forces or stresses are primarily directed when implanted in the body, as shown in FIG. 8 , where the casing is welded to the tip of the implant body 100. For example, the casing 140 may be welded an inset offset from the top and bottom surfaces of the spine cage implant body 100 where forces from adjacent vertebrae are applied ( FIG. 31 ). As such, this reduces forces that may weaken the connection between the casing 140 and the implant body 100 .

[0082]

[0110] In one variation, the casing may not be permanently attached. For example, in a spine cage embodiment, the casing 140 may be utilized during a spinal augmentation procedure. Once the procedure is complete and the spine cage is sufficiently connected to the patient's vertebrae, the casing 140 may be detached and removed from the patient without disturbing the remainder of the implant body 100. Thus, the potentially temporary nature of the casing 140 may be utilized to utilize potentially toxic electronic components 130 (e.g., batteries) that may be beneficial to the treatment. In an alternative preferred embodiment, the potentially temporary nature of the casing may be utilized to utilize components with limited life spans (e.g., sensors). Replacing the casing 140 allows for periodic replacement and / or upgrade of non-functioning components during the procedure.

[0083]

[0111] In variations in which the casing 140 is temporary, the casing may further be removable from the implant body 100. A removable casing 140 allows for the addition or removal of individual casing components. Such variations allow for a PCB or other electronic portions of the system to be contained, embedded, encapsulated, or otherwise housed within modular subsections of the casing 140. If any portion of the medical implant needs to be removed and / or drilled after implantation, the casing 140 or multiple casings can be removed individually to reduce the likelihood of exposing elements of the circuit system (e.g., a PCB) during or after the removal procedure. Additionally or alternatively, new casing 140 components can be added to the implant to add or replace functionality to the implant.

[0084]

[0112] The casing 140 can provide additional functionality to the implant. In some variations, the casing 140 can include additional features. For example, in the case of a mechanically strong casing 140 made of a metal such as titanium and / or platinum and having a surface that is at least partially exposed to the body after implantation, the casing 140, or a small portion of the casing, can further be used as one or more electrodes 132 for sinking and / or sourcing electrical current. For example, in some variations, the casing 140, or one or more small portions of the casing 140, can be used as electrodes 132, with the electrode portions of the casing made of a conductive material and conductively coupled to a control system. The electrodes 132 can be configured as anodes or cathodes, or as switchable electrodes, where a digital or analog switching system can be used to change the polarity of the electrode (e.g., change state between source and sink).

[0085]

[0113] As a separate body or subcomponent of the implant, the casing 140 can provide positional utility as an electrode 132. In spine cage embodiments, the casing 140 can provide an area distal to the area of ​​desired bone growth. One or more electrodes 132 can be positioned on or within the casing 140. The function of the electrodes can be complementary to the electrodes 132 in the bone growth area. For example, the electrodes 132 in the spine cage implant body 100 can function as an electrical source, and the electrodes 132 in the casing 140 can be activated to function as an electrical sink. In some embodiments where the casing 140 is made using titanium (which may be platinum plated), part or all of the metal casing can function as the electrode 132.

[0086]

[0114] In variations in which the casing functions as an electrode source / sink and / or the casing includes other electrodes, the casing circuit subsystem may include a protective coating. In one example, the PCB within the casing 140 includes a protective coating (e.g., overmolded with silicone), which can insulate the PCB from unwanted electrical currents. Additionally, the coating 120 may provide an additional barrier in environments where the casing 140 may be damaged. The casing circuit subsystem may be conductively isolated from the conductive casing element 140 in other ways. In some variations, the casing 140 may be conductively connected to the electronic components 130 (e.g., electrodes) of the circuit system 105.

[0087]

[0115] The system of preferred embodiments includes wiring 150. The wiring 150 functions to connect circuitry and electronic components 130 that are not physically connected. In some variations, as shown in Figure 7, the implant body 100 includes multiple pathways through which the wiring 150 can be routed to connect components. Alternatively, the wiring 150 can be held in place and the implant body 100 can be constructed around the wiring.

[0088]

[0116] The system can be implemented for a wide variety of electrically implanted medical implants. An example of a spine cage, as shown in FIG. 9 , is presented herein. In this embodiment, the system includes a relatively rectangular spine cage implant body 100, a circuit surface 110 including two planes embedded in the two longer sides of the rectangular spine cage, each plane including four electrodes 132 and an antenna 134, a casing 140 physically connected to the shorter sides of the rectangular spine cage and enclosing a multilayer PCB, and wiring 150 connecting the multilayer PCB to the antenna and electrode components. In this example, each circuit plane includes four electrodes 132 and antennas 134, with two electrodes 132 from each plane exposed on the outer side of the implant body 100 and extending perpendicularly outward from the plane. Each plane also includes two electrodes 132 exposed on the inner side of the implant body 100 and extending perpendicularly inward from the plane. Additionally, each plane includes an antenna 134 wrapped around the perimeter of the circuit plane, along the same dimension of the plane. Each antenna 134 is wrapped around the side in the same plane as the circuit side, extending the majority of the length of the implant body 100. Because the electrodes 132 and antennas 134 are the only electronic components 130 embedded within the implant body 100, this example does not require a protective coating 120. Depending on the particular embodiment, this example may also include a support coating 120 to provide greater tensile strength to the implant and / or a protective coating to further help secure the circuit surface 110 in place. Additionally, the PCB within the casing 140 may have a coating 120 (e.g., silicone) to further protect and / or insulate the PCB. This coating 120 for the casing 140 components may help protect or provide additional protection against components that may be harmful to the patient. In some embodiments, the antenna 134 may be embedded in a silicone coating 120 to secure it in place. The silicone coating allows for the use of antenna materials that may be harmful to the patient. Additionally or alternatively, the antenna 134 may be constructed from a bio-friendly material such as gold or platinum iridium.Because the electrodes 132 are directly exposed to human tissue, they are preferably constructed of non-toxic materials (eg, titanium, gold, platinum iridium).

[0089]

[0117] In variations including a casing 140 element, the system preferably includes a circuit system 105, which allows for the division of electronic components 130 between a casing circuit subsystem contained and housed within a structurally strong and sealed casing 140 and biocompatible electronic components 130 integrated into one or more circuit surfaces 110. Electronic components 130 that include materials or properties that are not biocompatible (e.g., toxic if exposed or leaked to the human body) can be securely housed within the casing 140. The electronic components 130 of the electrodes 132 and / or antenna 134 can be made of biocompatible conductive materials without the use of toxic materials.

[0090] 3. Method

[0118] A method for manufacturing a medical implant device with embedded electronic components functions to incorporate at least one circuit component within the body of the implant that protects the electronics during manufacturing and operation. Specifically, the method for manufacturing a medical implant device enables a process for embedding circuit surfaces along a pathway in the implant body created around at least one circuit surface. The method may also include a multi-step process for embedding and then integrating circuit subsystems within various implant body components of the medical implant device.

[0091]

[0119] The method may be used in the production of medical implant devices that tightly integrate electronic components, such as electrodes and / or antennas, with one or more structural components. Specifically, the method may be used in the manufacture of load-bearing medical implant devices (e.g., devices comprising at least one load-bearing medical implant body) with integrated electronics. The method is preferably practiced in the manufacture, assembly, and / or other production of medical implant devices, such as the systems described above. However, the method may be used in the production of any suitable type of medical device. Specifically, the method may be used in the production of load-bearing medical devices, the purpose of which may not only house electronics but also serve as a scaffold and / or mechanical stabilizer for tissue growth and / or serve as a container for implant material. In addition to the method process variations outlined herein, the method may also include the formation and / or implementation of any of the system configurations and variations described herein.

[0092]

[0120] In a first method, the method details the manufacture of a medical implant device with embedded circuitry, including the manufacture of an implant body. In a second method, the method details the manufacture of a medical implant device with embedded circuitry after the manufacture of an implant body. Either method, or a combination of these methods, can be used to manufacture the system of the preferred embodiments described above.

[0093]

[0121] When used in this manner, the term "implant body" is used to generally refer to the entire implant body as described in the system, the casing as described in the system, and / or a small portion of any component. For example, implant body can refer to the entire implant body, but can also refer to one side segment of the implant body as shown in step 1 of FIG. 28. The distinction between the two implant body components is made simply because the components are integrated together or to specify specific fabrication requirements for the implant body subcomponent. For example, in the manufacture of a medical implant device having a casing, the distinction is made because the casing is integrated with the implant body as described in the system.

[0094]

[0122] When used in this manner, the term "circuit" is used generally to refer to any circuit (e.g., integrated circuit), circuit board (e.g., printed circuit board), and / or part of a circuit system or subsystem used in a medical implant device.

[0095]

[0123] The method may be performed as a single process, in which case implant body constituent components are produced simultaneously or by repetition of multiple steps of the method. The method may also be performed to create separate implant bodies that are subsequently integrated, and / or to manufacture a single implant body with multiple separate circuit systems or multiple connected circuit subsystems. The method may be performed by a system in which a medical implant device includes an implant body and / or one or more casings. As noted above, in embodiments in which the medical implant device includes a casing and / or in embodiments in which the implant body subcomponents are manufactured separately, the method may further include integrating the medical implant device components. For example, in a casing embodiment, the method further includes integrating the implant body with the casing.

[0096]

[0124] 24, a first method for manufacturing a medical implant device with an at least partially embedded circuit includes constructing the circuit (S110) and fabricating an implant body around the circuit (S120). The first method functions to produce the medical implant device by fabricating the implant body to embed the circuit within the implant body.

[0097]

[0125] In a first variant, the first method can be applied to embedding a circuit surface within an implant body. The method can thus include constructing a circuit surface and fabricating an implant body around the circuit surface. As shown in FIG. 25 , this can be applied more specifically to manufacturing medical implant devices with integrated electrodes and / or antennas. This is done by constructing the circuit surface with a set of electronic components including at least one conductively connected antenna and a set of conductively connected electrodes (S1110), configuring the circuit surface along a path (S1112), and molding the implant body around the circuit surface (S1120). This method can be applied to embedding a PCB-compatible circuit system within a PEEK implant body. In this variant, the method can include assembling the circuit system on the circuit surface, which can be used when using PCB elements as the circuit surface. This method can also be applied to embedding only biocompatible electronic components, such as conductive elements forming antenna and / or electrode components, in the circuit surface. In this case, the electronic components on the circuit surface can be conductively connected to some other part of the circuit system.

[0098]

[0126] In variations including a casing, the method further includes integrating the casing with the implant body. As shown in FIG. 26 , variations of the method may thus include constructing a circuit surface with a set of electronic components including at least one conductively connected antenna and a conductively connected electrode set (S2110), configuring the circuit surface (S2112), fabricating an implant body around the circuit surface (S2120), constructing a casing (S2130), enclosing and securely sealing the casing circuit subsystem within the casing (S2132), and connecting the casing to the implant body and conductively connecting the set of electronic components of the circuit system to the casing circuit subsystem (S2140). In some variations, the casing circuit subsystem may include all (or at least a substantial portion, such as greater than 95%) of the non-biocompatible electronic components of the circuit system of the medical implant device. Similarly, the electronic components attached to the circuit surface may be made of a biocompatible material.

[0099]

[0127] In some variations, the method may be performed separately for each implant component before combining the implant bodies. In these variations, the method may include constructing (or otherwise obtaining) a circuit for each implant body subcomponent, fabricating the implant body subcomponent around the circuit for each implant body subcomponent, and integrating all of the implant body subcomponents.

[0100]

[0128] Block S110 includes constructing circuit functionality upon obtaining one or more electronic functional components of the medical implant device. Constructing the circuit (S110) preferably includes obtaining and / or assembling a circuit (e.g., a printed circuit board) with all necessary / required electronic components desired for the implant body structure. Constructing the circuit (S110) may include obtaining multiple circuits to be embedded in a single implant body.

[0101]

[0129] Constructing a circuit preferably includes printing, creating, or obtaining a circuit (e.g., a circuit board of a desired shape and components). That is, in the PCB variant, other than typical sheet PCBs, printing or obtaining a circuit board of a desired shape includes obtaining a PCB with layouts and features that include bent, folded, and table-like geometries as described above.

[0102]

[0130] Constructing a circuit more specifically includes constructing a circuit surface as discussed in the system above. The circuit surface may include a set of electronic components, preferably including an electrode set and / or one or more antennas. The electrode set and / or antenna may be conductively connected via one or more conductive connections (e.g., wires or conductive bonds). The electrode set and optionally the antenna may also be structurally held in place by the circuit surface or by attachment to the circuit surface. The electronic components may be conductively connected to a circuit system that is part of the circuit surface. For example, the circuit surface may be implemented as a foldable PCB with conductive connections to the antenna and electrode set. Alternatively, the electronic components may be connected to an electrical connector that can be connected to another circuit subsystem, such as a casing circuit subsystem.

[0103]

[0131] In addition to constructing the circuit surface, the method may include configuring the circuit surface along a path, which serves to fold and / or orient the circuit surface for proper alignment prior to fabricating the implant body around the circuit surface. Thus, the method may further include folding and positioning the PCB into the intended configuration. Various folding patterns, such as those discussed in the systems above, may be used.

[0104]

[0132] Block S120 includes fabricating an implant body around the circuit, which serves to embed the circuit within the implant body. Fabricating the implant body around the circuit can be performed by a variety of manufacturing techniques.

[0105]

[0133] In one variation, fabricating the implant body around the circuitry includes molding the implant body around the circuitry. More specifically, this includes overmolding the implant body around the circuit surface and its electronic components. Overmolding the circuit serves to form an implant body or substructure with embedded circuitry. Overmolding the circuit board may include 3D printing, injection molding, casting, or otherwise additively forming the implant body around the circuitry. Once completed, overmolding the implant body produces an implant body with embedded circuitry with substantially little impact on the shape of the implant body. In some embodiments, the implant body may be a substantially unibody material structure. In some embodiments, this material may be PEEK or other biocompatible polymer.

[0106]

[0134] In some preferred variations involving overmolding around a circuit surface, the method may include protecting the circuit (e.g., circuit surface) with a temperature shielding material and then overmolding over the protected circuit surface. The protected circuit surface may function to limit the temperature exposure of the circuit and its electronic components to reduce the risk of component damage caused by high temperatures.

[0107]

[0135] In some variations, protecting the circuitry involves placing the circuitry (e.g., the circuit surface) in a protective envelope / enclosure. In one variation, this involves molding the circuitry with a flexible, non-toxic, and non-reactive material (e.g., silicone or another biocompatible material). The silicone or other biocompatible material serves to protect the circuitry during the overmolding process.

[0108]

[0136] In some variations, protecting the circuitry includes attaching at least a portion of the circuitry (e.g., a circuit surface) to a rigid circuit frame and overmolding around the circuitry connected to the rigid circuit frame. This variation is particularly useful for circuits that include a PCB. In one example, the rigid circuit frame can be made of PEEK, although any suitable material may be used. Alternatively, the rigid circuit frame may be made of a stronger material (e.g., titanium) to add additional durability to the body. Similar to a seashell, a small frame can be 3D printed in two halves and annealed around the circuitry. Alternatively, the frame may be a rigid structure to which the circuitry is otherwise attached (e.g., fastened). In one variation, a protective casing is molded around the rigid frame. In either variation, the method can include integrating protruding electrodes from the rigid frame and / or protective casing. Preferably, after fabricating the implant body around the circuitry (e.g., after overmolding a PEEK implant body or closing a multi-part structure around a PCB), the protruding electrodes are secured to at least one exposed electrode surface. In a preferred variation, the protruding portion of the electrode is positioned so that the electrode is fixed in place after the overmolding process.

[0109]

[0137] In a second variation, fabricating the implant body around the circuit (S120) includes generating an implant body with at least two complementary portions with a defined cavity, inserting the circuit into the defined cavity, and attaching the at least two portions of the implant body together. Fabricating the implant body around the circuit in the second variation serves to generate an implant body with embedded circuitry while providing the added benefits of allowing for shaping of the circuitry (e.g., folding and / or bending a PCB, looping an antenna coil) and not exposing the circuitry to the high temperatures of the overmolding.

[0110]

[0138] Producing the implant body in at least two sections includes manufacturing at least two components of the implant body. Producing the implant body in multiple sections functions to allow for insertion of a circuit into the implant body from the inside. Producing the implant body may include injection molding, machining, 3D printing, and / or production using any suitable technique. Producing the implant body in multiple sub-sections includes producing each sub-section of the implant body with a predetermined cavity of an appropriate size and shape to accommodate the circuit. Once all the sub-sections are assembled, the cavity fits the circuit to be embedded within the implant body. The predetermined cavity may be the exact shape of the circuit or may include a curved path to accommodate the circuit within the cavity.

[0111]

[0139] In simpler embodiments (e.g., less complex PCB geometries), generating the implant body in at least two sub-sections preferably includes generating the implant body in exactly two sub-sections. For complex PCB geometries where the PCB cannot simply be inserted between two sub-sections, multiple implant body sub-sections may be generated to accommodate the PCB. Inserting the PCB serves to embed the PCB within a defined PCB cavity, thereby combining the sub-sections to form the implant body. Inserting the PCB may include bending a segment of the PCB sufficiently to fit within the cavity.

[0112]

[0140] Once the circuit is properly inserted into the cavity, it is preferable to attach the body implant sections together. Attachment may include annealing, fixturing (e.g., fastening with screws or clamps), or other methods of securing. Attachment of the implant body sections functions to form a complete implant body construct with the embedded circuitry. Attachment of the implant body sections may be achieved by epoxy adhesive, sonic welding, or any other process that is non-toxic and does not persist over a significant period of time.

[0113]

[0141] The third variation of Block S120 combines the first and second variations to create an implant body around the circuit. The second variation can be performed to create a small frame for the circuit. Once implanted, the small frame and circuit can be overmolded.

[0114]

[0142] As shown in FIG. 27 , a second method variation for manufacturing a medical implant device with at least partially embedded circuitry includes obtaining a circuit (S210), obtaining an implant body (S220), fabricating a defined circuit cavity in the implant body (S230), and embedding the circuit within the implant body (S240). The second method functions to generate a medical implant device after fabrication of the implant body. In variations including a casing, the method further includes integrating the casing with the implant body. In some variations, the method may be performed separately for each implant subcomponent before combining the implant subcomponents to form the implant body. In these variations, the method may include obtaining a circuit for each implant body subcomponent, obtaining the implant body subcomponent, fabricating a defined circuit cavity in the implant body subcomponent, embedding the circuit within the implant body subcomponent, and integrating all of the implant body subcomponents.

[0115]

[0143] Block S210, which includes building the circuit, functions substantially the same as building the circuit (S110) described above. Depending on the transformation, the circuit may include an integrated circuit (IC), an application specific integrated circuit (ASIC), a printed circuit board (PCB), and / or any type of circuit or related electronic component. For transformations / steps that include bending and / or changing shape, the circuit preferably includes a planar / plate-like structure (e.g., a PCB).

[0116]

[0144] Block S220, including obtaining an implant body, functions to obtain a desired implant body. Obtaining an implant body (S220) may include obtaining an implant body of any size or shape desired for the implementation. In a preferred embodiment method, obtaining an implant body (S220) includes obtaining a particular type of spinal cage for the desired implementation. Obtaining an implant body (S220) may include fabricating the implant body or otherwise utilizing or configuring a pre-created implant body. Fabricating the implant body may include forming the implant body by various manufacturing processes, such as injection molding, 3D printing, machining, etc. Preferably, at least an outer portion of the implant body is constructed of a biocompatible material, such as PEEK.

[0117]

[0145] Block S230, which includes manufacturing a defined cavity in an implant body, functions to create a cavity within the implant body for placement of the circuit. In one variation, manufacturing the defined circuit cavity (S230) includes performing subtractive machining, thereby cutting a slit, groove, or opening that accommodates the circuit. The shape, path, geometry, and other features of the defined circuit cavity are discussed above and can be manufactured within the implant body. Milling, drilling, using a water jet or laser cutter, or any suitable technique for subtractive manufacturing may be used. Alternatively, the implant body of block S230 can incorporate the manufacturing of the defined circuit cavity. For example, the implant body may be molded to include the defined circuit cavity. In another variation, the implant body can be a multi-part design, with each part manufactured separately and, when attached together, creating the defined circuit cavity.

[0118]

[0146] Block S240, which includes embedding the circuit within the implant body, functions in creating an implant body construct with embedded circuitry. Embedding the circuit within the implant body (S240) includes positioning and shaping the circuit to fit within the cavity. In PCB variations, this may include bending / folding the PCB and placing it within the implant body. Embedding the circuit may further include covering the surface of the PCB with a protective material. The protective material may be a non-toxic, non-reactive material (e.g., silicone, resin) that protects the circuit from the external environment while it is implemented in vivo. Alternatively, other techniques for sealing or encapsulating the circuit may be used. In some variations, embedding the circuit within the implant body (S240) may include printing the circuit and / or circuit components on the exterior or interior of the implant body.

[0119]

[0147] In embodiments of the method that include a system with a casing and / or that include initially creating an implant body subcomponent, the method may further include integrating the implant body subcomponent (e.g., integrating the casing with the implant body), as shown in Figures 28-31. Integrating the implant body subcomponent serves to create a single "implant body" from the casing and the implant body subcomponent, thereby creating a single medical implant device.

[0120]

[0148] With respect to the casing, integrating the casing with the implant body may include fastening, adhering, attaching, incorporating, and / or otherwise integrating the casing with the implant body as desired. In a preferred variation, integrating the casing with the implant body includes irreversibly joining the implant body and the casing. Preferably, the implant body and the casing are sealed together. As shown in FIG. 31 , integrating the casing with the implant body may include laser welding the casing to the connector of the implant body. Laser welding the casing can seal the case and irreversibly join it to the implant body.

[0121]

[0149] Depending on the embodiment, the implant body and casing may be constructed simultaneously or separately. Also, if the two components are constructed separately, one may be produced prior to the other. In some of these variations, integrating the casing with the implant body may be performed simultaneously with the production of the second component. For example, the first component may be produced first, and the second component may be produced and integrated with the first component simultaneously.

[0122]

[0150] In a first variant, the casing may be produced in a separate process from the implant body, and integrating the casing with the implant body may involve joining / attaching / bonding these two geometries together after each has been produced in a separate process.

[0123]

[0151] In a second variation, the casing or the implant body is produced first. In the first example where the casing is produced first, integrating the casing with the implant body can include overmolding the implant body onto the casing. In the second example where the implant body is produced first, integrating the casing with the implant body can include 3D printing the casing onto the implant body.

[0124]

[0152] Both methods may also include further steps necessary for the medical implant device to function. In a preferred version of the spine cage implant, additional steps may include inserting external electrode components, inserting wiring through the electrodes, connecting to external devices, and any other steps necessary or desirable for the spine cage to function as desired. Electrodes may also be printed directly onto the PCB substrate and / or implant body, for example, by depositing titanium or platinum or any other suitable electrode material onto the PCB substrate to form electrodes 132 of appropriate size and / or shape. If electrodes are printed onto the PCB, this is preferably performed during PCB fabrication, but may also be performed as a separate step, for example, by depositing metal on appropriate portions of an already fabricated PCB that contains other system components but not electrodes. Alternatively, electrode sites may be formed by depositing a suitable electrode metal, such as platinum and / or titanium, onto exposed metal features formed as part of PCB fabrication. The PCB does not contain any exposed platinum or titanium areas prior to this step.

[0125]

[0153] Both methods can be practiced in multiple ways, and portions of the implant body construct can be manufactured separately or together. In one example, the first method can be practiced to produce an implant body in multiple portions, as shown in Figure 28, which are then assembled to form the implant body, as shown in Figure 29. The casing can be manufactured separately and then attached (e.g., by welding) to the implant body, as shown in Figure 30.

[0126]

[0154] One embodiment of a method for constructing a TILF cage with a casing is shown in Figures 28-30. As shown in Figures 28 and 30, the circuitry for the implant body (e.g., circuit surfaces for the antenna and electrodes) and the casing (e.g., a flexible PCB that is later folded into the appropriate configuration) is obtained. As shown in Figure 28, the sides of the implant body (e.g., side segments and connector blocks) are then constructed by an injection molding process (e.g., using PEEK), electrodes are attached or patterned in the side segments, an antenna is wrapped around the sides, and wiring is used to connect the segments. In this embodiment, the antenna is further embedded in silicone.

[0127]

[0155] The side segments are then physically and electrically connected to the connector block and then welded in place, as shown in Figure 29. Screws or other fastening mechanisms may be used to further attach the side segments to the connector block. The "finished" body is then inserted into an injection mold and overmolded to form a unitary implant body with the connector connected to the casing.

[0128]

[0156] The casing body can be prefabricated or molded to the desired specifications to match the dimensions of the implant body and accommodate the PCB. As shown in FIG. 30 , the folded PCB component can be connected to the casing connector plate and then encapsulated in silicone to protect the PCB. The encapsulated PCB component can then be inserted into the casing so that the PCB is positioned within the casing and the connected connector plate is positioned in the exposed opening of the casing. The PCB can then be sealed within the casing (e.g., by laser welding the connector plate to the casing). The casing connector component can then be mated with the implant body, thereby integrating the casing with the implant body. In some embodiments, the casing and implant body can be sealed together (e.g., by laser welding). In some variations, the implant body and casing are welded at an angle inward from the outer periphery of the implant body, thereby preventing pressure and forces on the surface of the implant body 100 from being directly applied to the casing and its connection to the implant body ( FIG. 30 ).

[0129]

[0157] Those skilled in the art will appreciate from the foregoing detailed description, drawings, and claims that changes and variations can be made to the embodiments of the invention without departing from the scope of the invention, which is defined in the following claims.

Claims

1. 1. A system for embedded electronics within a medical implant, comprising: The implant itself, a circuit system including a circuit surface at least partially embedded along a path within a defined internal cavity of the implant body, the circuit surface housing at least one electronic component, the implant body being formed around the circuit surface; an electronic component integrated with said circuit surface, A set of electrodes, -An antenna, an electronic component including: - wiring connecting said circuit surface and electronic components; A system comprising:

2. The system of claim 1 , further comprising a casing or sealing structure directly connected to the implant body, the circuit system further comprising a casing circuit subsystem.

3. 3. The system of claim 2, wherein the casing circuit subsystem includes a printed circuit board (PCB) housed within the casing, and the wiring electrically connects the PCB and electrical components embedded within the implant body.

4. The system of claim 1 , wherein the circuit surface comprises a printed circuit board (PCB).

5. The system of claim 4 further comprising a covering having a protective structure, the at least partially embedded portion of the circuit surface being encapsulated within the covering.

6. 6. The system of claim 5, wherein the coating is constructed of silicone such that the PCB embedded in the defined cavity is encapsulated and covered by the silicone coating.

7. 5. The system of claim 4, wherein the at least one path comprises a single straight or curved path, and the PCB is embedded within the implant body along the single straight or curved path.

8. 5. The system of claim 4, wherein the at least one path comprises a plurality of straight or curved paths, and the embedded PCB along the plurality of paths comprises a folded PCB that generally conforms to the shape of the plurality of paths.

9. 9. The system of claim 8, wherein the folded PCB has a table-like geometric shape, with a central portion of the PCB having a surface perpendicular to a direction of insertion into the implant body and both ends of the PCB bent to be inserted deeper into the defined PCB cavity.

10. 10. The system of claim 8, wherein the folded PCB is foldable to have at least one perpendicular surface in all three spatial dimensions.

11. The system of claim 10 , wherein each vertical surface of the PCB includes an antenna component such that the antenna extends in all spatial dimensions.

12. The system of claim 8 , wherein the folded PCB is folded in an accordion-like manner so as to fold over itself multiple times.

13. 13. The system of claim 12, wherein the antenna comprises a multi-layer geometry, with adjacent layers of the PCB comprising portions of the antenna, thereby forming a relatively three-dimensional antenna comprising stacked planar folds.

14. 5. The system of claim 4, further comprising a casing containing a circuit system enclosed therein, the casing being physically coupled to the implant body with the circuit system operably coupled to the circuit surface.

15. 15. The system of claim 14, wherein the casing is hermetically sealed and the circuit system enclosed within the casing includes a PCB electrically connected to electronic components within the implant body.

16. 15. The system of claim 14, wherein the implant body includes a relatively rectangular spinal cage and a casing physically connected to a shorter side of the spinal cage.

17. 17. The system of claim 16, wherein the circuit surface includes two planes embedded in the two longer sides of the rectangular spine cage, each plane including two electrodes exposed on an outer surface of the implant body and extending perpendicularly outward from the plane, and each plane including two electrodes exposed on an inner surface of the implant body and extending perpendicularly inward from the plane, and each plane having an antenna wrapped around its periphery along the same dimension of the plane.

18. 1. A method for constructing a medical implant device, comprising: - constructing a circuit surface with a set of electronic components including at least one conductively connected antenna and a set of conductively connected electrodes; - configuring the circuit surface along a path; - molding an implant body around said circuit surface; A method comprising:

19. 20. The method of claim 18, wherein constructing the circuit surface comprises assembling a circuit system on the circuit surface.

20. 20. The method of claim 18, further comprising constructing a casing, enclosing and securely sealing a casing circuit subsystem within the casing, connecting the casing to the implant body, and conductively connecting the set of electronic components on the circuit surface to the casing circuit subsystem, wherein the casing circuit subsystem contains all of the non-biocompatible electronic components of a circuit system of the medical implant device.

Images