The present disclosure generally relates to mechanical and electrical sensor assemblies and antenna designs for implant devices, and more particularly to spinal implant systems which may be used to treat various spinal disorders.
Treatment of spinal disorders, such as degenerative disc disease, disc herniations, scoliosis or other curvature abnormalities, and fractures, often requires surgical treatments. For example, spinal fusion may be used to limit motion between vertebral members. As another example, implants may be used to preserve motion between vertebral members.
Surgical treatment typically involves the use of implants and longitudinal members, such as spinal rods. Implants may be disposed between two vertebral members for supporting and/or repositioning the vertebral members. Implants may also be used to facilitate a fusion process between a superior vertebrae and an inferior vertebrae. Longitudinal members may be attached to the exterior of two or more vertebral members to assist with the treatment of a spinal disorder. Longitudinal members may provide a stable, rigid column that helps bones to fuse, and may redirect stresses over a wider area away from a damaged or defective region. Also, rigid longitudinal members may help in spinal alignment.
Screw assemblies may be used to connect a longitudinal member to a vertebral member. A screw assembly may include a pedicle screw, hook, tulip bulb connector or other type of receiver, and a set screw, among other components. A pedicle screw can be placed in, above and/or below vertebral members that were fused, and a longitudinal member can be used to connect the pedicle screws which inhibits or controls movement. A set screw can be used to secure the connection of a longitudinal member and a pedicle screw, hook, or other connector. However, the connection force and continued integrity of the connection between a longitudinal member and a pedicle screw or other connector can be challenging to monitor during and after implantation. In addition, it is difficult to monitor that an appropriate force is maintained between a set screw and a longitudinal member. Conventional spinal implants, load assemblies, and/or screw assemblies are not capable of sensing and transmitting the connection force between a longitudinal rod and a pedicle screw installed within a patient. Conventional spinal implants are not capable of sensing the stress/strain applied to the spinal implant, by, e.g., the pressure between adjacent vertebrae and/or the pressure applied by an adjacent pedicle screw, longitudinal rod, etc. Furthermore, they cannot continuously monitor and maintain a secure connection on relatively long-time frames.
The techniques of this disclosure generally relate to spinal implants having various sensors for communicating attributes about the spinal implants when installed in patient anatomy to an external reader.
In one aspect, load sensing spinal implants having at least one sensor and an antenna are disclosed. An example implant may include an interbody cage extending in a longitudinal direction from a proximal end to a distal end and in a widthwise direction from a first lateral end to a second lateral end; and an electronics portion including a housing defining a sealed cavity for supporting an electronics assembly and a battery therein. The implant may include at least one antenna in electrical communication with the electronics assembly; and at least one strain gauge configured to detect a localized force experienced by the interbody cage. The at least one antenna may be configured to transmit information received from the at least one strain gauge to an external device. The electronics assembly may be disposed on the side of the cage, a distal end of the cage, or inside a graft window of the cage.
In another aspect, the present disclosure provides a load sensing spinal implant, including an interbody cage extending in a longitudinal direction from a proximal end to a distal end and in a widthwise direction from a first lateral end to a second lateral end. The implant may include an electronics portion including a housing defining a sealed cavity for supporting an electronics assembly and a battery therein. The implant may include at least one antenna in electrical communication with the electronics assembly. The implant may include at least one strain gauge configured to detect a localized force experienced by the interbody cage and being in electrical communication with the electronics assembly. In various embodiments, the at least one antenna may be configured to transmit information received from the at least one strain gauge to an external device.
In another aspect, a load sensing spinal implant including an interbody cage extending in a longitudinal direction from a proximal end to a distal end and in a widthwise direction from a first lateral end to a second lateral end. In various embodiments, the interbody cage may include a graft window and an electronics portion including a housing defining a sealed cavity for supporting an electronics assembly and a battery therein. Disclosed implants may include an overmold portion surrounding the electronics portion thereby forming a hermetic seal. In various embodiments, at least one antenna may be in electrical communication with the electronics assembly and have a size and shape that generally corresponds to a size and shape of at least one sidewall of the graft window. In disclosed embodiments, at least one strain gauge may be configured to detect a localized force experienced by the interbody cage and be in electrical communication with the electronics assembly. In at least some embodiments, the at least one antenna is configured to transmit information received from the at least one strain gauge to an external device.
In another aspect, a load sensing spinal implant including an interbody cage extending in a longitudinal direction from a proximal end to a distal end and in a widthwise direction from a first lateral end to a second lateral end is disclosed. The implant may include an electronics portion including a housing defining a sealed cavity for supporting an electronics assembly and a battery therein. The implant may also include at least one antenna in electrical communication with the electronics assembly, and at least one strain gauge configured to detect a localized force experienced by the interbody cage. The at least one strain gauge may be in electrical communication with the electronics assembly and the at least one antenna may be configured to transmit information received from the at least one strain gauge to an external device. In at least some embodiments, the interbody cage may include an exposed cavity at a distal end thereof having a curved sidewall, and the electronics portion is disposed inside of the exposed cavity. Additionally, the housing may conform to the curved sidewall, and the at least one strain gauge may be disposed inside of the housing and have a geometry corresponding to the curved sidewall.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
Embodiments of the present disclosure relate generally, for example, to spinal implant systems with active sensing, microelectronics, and communication abilities. Embodiments of the devices and methods are described below with reference to the Figures.
The following discussion omits or only briefly describes certain components, features and functionality related to medical implants, installation tools, and associated surgical techniques, which are apparent to those of ordinary skill in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views, where possible. Reference to various embodiments does not limit the scope of the claims appended hereto because the embodiments are examples of the inventive concepts described herein. Additionally, any example(s) set forth in this specification are intended to be non-limiting and set forth some of the many possible embodiments applicable to the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations unless the context or other statements clearly indicate otherwise.
Terms such as “same,” “equal,” “planar,” “coplanar,” “parallel,” “perpendicular,” etc. as used herein are intended to encompass a meaning of exactly the same while also including variations that may occur, for example, due to manufacturing processes. The term “substantially” may be used herein to emphasize this meaning, particularly when the described embodiment has the same or nearly the same functionality or characteristic, unless the context or other statements clearly indicate otherwise. The term “about” may encompass a meaning of being +/−10% of the stated value.
Referring to the disclosed embodiments generally, various vertebral pedicle screw systems are disclosed. The components of the vertebral pedicle screw systems can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyimide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe, polylactic acid or polylactide and their combinations.
Various components of the vertebral implant system may be formed or constructed with material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of the present vertebral pedicle screw system, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of the vertebral implant system may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. The components of the vertebral implant system may be formed using a variety of subtractive and additive manufacturing techniques, including, but not limited to machining, milling, extruding, molding, 3D-printing, sintering, coating, vapor deposition, and laser/beam melting.
Furthermore, various components of the vertebral implant system may be coated or treated with a variety of additives or coatings to improve biocompatibility, bone growth promotion or other features. Various embodiments and components may be coated with a ceramic, titanium, and/or other biocompatible material to provide surface texturing at (a) the macro scale, (b) the micro scale, and/or (c) the nano scale, for example. Similarly, components may undergo a subtractive manufacturing process such as, for example, grit blasting and acid etching, providing for surface texturing configured to facilitate osseointegration and cellular attachment and osteoblast maturation. Example surface texturing of additive and subtractive manufacturing processes may comprise (a) macro-scale structural features having a maximum peak-to-valley height of about 40 microns to about 500 microns, (b) micro-scale structural features having a maximum peak-to-valley height of about 2 microns to about 40 microns, and/or (c) nano-scale structural features having a maximum peak-to-valley height of about 0.05 microns to about 5 microns. In various embodiments, the three types of structural features may be overlapping with one another. Additionally, such surface texturing may be applied to any surface, e.g., both external exposed facing surfaces of components and internal non exposed surfaces of components. Further discussion regarding relevant surface texturing and coatings is described in, for example, U.S. Pat. No. 11,096,796, titled Interbody spinal implant having a roughened surface topography on one or more internal surfaces, and filed on Mar. 4, 2013—the entire disclosure of which is incorporated herein by reference in its entirety. Accordingly, it shall be understood that any of the described coating and texturing processes of U.S. Pat. No. 11,096,796, may be applied to any component of the various embodiments disclosed herein, e.g., the exposed surfaces and internal surfaces. Another example technique for manufacturing an orthopedic implant having surfaces with osteoinducting roughness features including micro-scale structures and nano-scale structures is disclosed in U.S. Pat. No. 10,821,000, the entire contents of which are incorporated herein by reference. Additionally, an example of a commercially available product may be the Adaptix™ Interbody System sold by Medtronic Spine and comprising a titanium cage made with Titan nanoLOCK™.
The disclosed implant systems may be employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to deliver and introduce instrumentation and/or one or more spinal implants at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, the vertebral implant system may be employed with surgical procedures, as described herein, and/or, for example, corpectomy, discectomy, fusion and/or fixation treatments that employ spinal implants to restore the mechanical support function of vertebrae. In some embodiments, the implant system may be employed with surgical approaches, including but not limited to: anterior lumbar interbody fusion (ALIF), direct lateral interbody fusion (DLIF), oblique lateral lumbar interbody fusion (OLLIF), oblique lateral interbody fusion (OLIF), transforaminal lumbar Interbody fusion (TLIF), posterior lumbar Interbody fusion (PLIF), various types of posterior or anterior fusion procedures, and any fusion procedure in any portion of the spinal column (sacral, lumbar, thoracic, and cervical).
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In the example embodiment, the cavity 25 may be sealed off by cover 24. Cover 24 may have a size and shape corresponding to an opening in housing 21 that exposes the cavity 25 therein. Due to the hermetically sealed nature of cavity 25, a pass-through connection 23 having suitable waterproof flanges may extend through an aperture 26 of cover 24 (see
Implant system 300 may include a cage 1 having a fixation aperture 3 in a first sidewall and a slotted aperture 5 (also referred to as a sensing slot 5) in a second sidewall. In various embodiments, the slotted aperture may have a geometry, size, and location configured to transfer localized stress and strain to a strain gauge 32 as will be explained in further detail below. In the example embodiment, the fixation aperture 3 and sensing slot 5 each extend through a corresponding sidewall of cage 1. For example, the fixation aperture and sensing slot 5 each extend through a respective sidewall of cage 1 thereby communicating with graft window 2 and the outside. In various embodiments, the electronics portion 20 may include a threaded post 4 and/or set screw that secures the electronics portion 20 to the fixation aperture 3 in a sidewall of the cage 1. In this embodiment, the electronics portion 20 may include a housing 21 defining a cavity 25 therein for housing various electronics components 30. The electronics components 30 may have great variability in the types of circuitry and hardware due to the relatively large size of the housing 21 and cavity 25. Example electronics components may include a flexible circuit board providing an electrical connection between the battery 31, strain gauge 32, and the various other electronics components. A non-limiting list of example electronics components may include an Application Specific Integrated Controller (ASIC) 34, micro controller 35, a wake-up sensor, a memory storage, an impedance sensor, and a temperature sensor. In the example embodiment,
In various embodiments, the housing 21 may include a sensing protrusion 40 having a size and shape corresponding to a size and shape of the slotted aperture 5. Additionally, a strain gauge 32 may be disposed inside of the cavity 25 in the portion thereof corresponding to the sensing protrusion 40. For example, in this embodiment the strain gauge 32 may have a U-like shape corresponding in size and shape to the sensing protrusion 40 (see
In various embodiments, the electronics portion 20 may be disposed in a cavity 8. In the illustrated example, the electronics portion 20 is disposed in a curved cavity 8 formed in the distal end 100D (see
Once the various electronics components are positioned inside of cavity 25, cover 24 may be welded and/or adhered to housing 21 to seal the cavity 25 and thereby form a hermetic seal. In some embodiments, an overmold may be formed around the housing 21 (not illustrated). In the example embodiment, a first and second lead wire 23A, 23B may extend through apertures 26A, 26B of cover 24. The first and second lead wires 23A, 23B may each contact a corresponding first and second terminal 28A, 28B of antenna 22. In this embodiment, antenna 22 may have a size and shape generally corresponding to a centerline cage 1. In this example, a “centerline” may refer to a top-down view of cage 1 where a centerline traverses the oblong oval shape of cage 3 at equal distances from an interior perimeter defined by graft window 2 and an exterior perimeter defined by the outside sidewalls of cage 1. For example, antenna 22 has a size and shape that corresponds to a size and shape of cage 1 such that antenna 22 can be disposed inside of and/or surrounded by cage 1. In at least one embodiment, antenna 22 may be a metallic material such as copper and cage 1 may be an insulative material such as peek that is cast around antenna 22 by a mold in place process. In other embodiments, the general shape of cage 1 and material selection thereof may be chosen to amplify the transmission abilities of cage 1.
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Referring to the top-down view in
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In this embodiment, the electronics portion 20 may include a housing 21 defining a cavity 25 therein for housing various electronics components 30. In this embodiment, two distinct electronics components are shown as a circuit board that are in electrical communication with battery 31, strain gauge 32, and antenna 22. The electronics components 30 may have great variability in the types of circuitry and hardware due to the relatively large size of the housing 21 and cavity 25. Example electronics components may include a flexible circuit board providing an electrical connection between the battery 31, strain gauge 32, and the various other electronics components. A non-limiting list of example electronics components may include an Application Specific Integrated Controller (ASIC) 34, micro controller 35, a wake-up sensor, a memory storage, an impedance sensor, and a temperature sensor. In at least one embodiment an impedance sensor protrudes into the graft window for assessing the status of a fusion process and a temperature sensor is disposed inside of the cavity 25.
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. For example, features, functionality, and components from one embodiment may be combined with another embodiment and vice versa unless the context clearly indicates otherwise. Similarly, features, functionality, and components may be omitted unless the context clearly indicates otherwise. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).
Unless otherwise specifically defined herein, all terms are to be given their broadest possible interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and/or as defined in dictionaries, treatises, etc. It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified, and that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
This application claims priority to U.S. Provisional Application 63/329,982, titled SMART IMPLANT DESIGNS FOR HOUSING A POWER SOURCE, ANTENNA, GAUGES, AND MICROELECTRONICS, and filed Apr. 12, 2022, the entire contents therein are incorporated herein by reference in entirety. This application incorporates by reference U.S. Non-Provisional application Ser. No. 18/062,867, titled SPINAL ROD CONNECTING COMPONENTS WITH ACTIVE SENSING CAPABILITIES, and filed Dec. 7, 2022.
Number | Date | Country | |
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63329982 | Apr 2022 | US |