Patent Application
20180085186
The present invention relates generally to identifiable implantable rods and screws and, in particular, structurally encoded titanium screw assemblies.
Medical implant devices used in surgical procedures, such as surgical rods and screws, can be associated with particular information to guide medical professionals before and after the surgical procedure. Each implant device carries a wealth of information that is valuable to the patient, the implant manufacturer, medical researchers, healthcare professionals, and medical facilities. However, the information, which may include the implant manufacturer and manufacturer's lot number, the data and location of surgical implantation, the responsible surgeon, any medical notes, photographs, or diagrams relating to the implant, surgery, or condition, may not be adequate, properly recorded, or readily accessible for beneficial use by a healthcare professional, implant manufacturer or medical researcher after implantation. Problems relating to poor implant records can lead to unnecessary delay or even medical error by healthcare professionals. Moreover, there are many different implant identification methods currently in place instead of a common system to allow manufacturers, distributors, and healthcare facilities and professionals to effectively track, identify, and manage implant devices and medical device recalls. The U.S. Food and Drug Administration recently announced a program focusing on requirements for unique device identifiers for every medical implant device to address the need for a more robust implant device identification system, the details of which are hereby incorporated by reference here: www.fda.gov/udi, as of the filing date of this application.
Consequently, there is a long felt need in the art for a robust implant device identification system that enables a provider to quickly and un-invasively retrieve information from an implanted device, such as a surgical screw. There is also a long felt need for a structurally encoded implant device, such as a surgical rod and/or screw that protects patient privacy. Finally, there is a long felt need for a structurally encoded device that accomplishes all of the forgoing objectives, and that is relatively inexpensive to manufacture and safe and easy to use.
The following presents a simplified summary in order to provide a basic understanding of some aspects of the disclosed innovation. This summary is not an extensive overview, and it is not intended to identify key/critical elements or to delineate the scope thereof. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
The subject matter disclosed and claimed herein, in one aspect thereof, comprises a rod or a screw device, such as a titanium screw, that is identifiable after implantation and comprises a main portion and a readable portion. The readable portion may comprise a readable element, such as a radiopaque element, and indicia disposed on at least one surface thereof or disposed within the screw. The indicia may include a plurality of modifications to at least one surface of the readable element or a plurality or readable elements disposed within the readable portion such that the indicia are discernible by any medical imaging modality, such as at least one of x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, and magnetic resonance imaging.
In accordance with further aspects of the invention, the readable portion may be integral with the main portion. The readable portion may also be disposed within the main portion. The plurality of modifications may include an array of holes in the at least one surface of the readable element. The plurality of modifications may include an array of notches or variations of density in the at least one surface of the readable element. The array of notches in the at least one surface of the readable element may form at least one bar code. The at least one bar code may comprise a Hamming code. The plurality of modifications may be less than or equal to two centimeters in length, and can vary in width, depth and shape.
In accordance with further aspects of the invention, a system for identifying a rod or screw device is provided comprising a device comprising a main portion and a readable portion. The readable portion may comprise a readable element and indicia disposed on at least one surface thereof. The indicia may include a plurality of modifications to at least one surface of the readable element or a plurality of readable elements disposed within the readable portion. The indicia may further include a database containing a plurality of records associated with a plurality of implant devices and a user interface comprising means for displaying information associated with the indicia based on the plurality of records. The indicia may be discernible by at least one of x-ray, fluoroscopy, ultra-sound computed tomography, electromagnetic radiation, ultrasound, and magnetic resonance imaging.
In accordance with further aspects of the invention, a method of identifying a micromanufactured rod or screw device is provided comprising discerning indicia by at least one of x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, and magnetic resonance imaging. The indicia may include a plurality of modifications to at least one surface of a readable element or a plurality of readable elements disposed within a readable portion. The method of identifying a micromanufactured rod or screw device may further comprise accessing a plurality of records associated with at least one of a plurality of rod or screw devices and providing information associated with the micromanufactured rod or screw based on the indicia and the plurality of records. As used herein, the term “micromanufactured” encompasses all microfabrication techniques such as additive manufacturing and micromachining, and use of this term is not intended to limit the size or scale constraints or the type of the manufacturing process in any way. The term is used to elucidate the desire for the detectable portion of the rod or screw device of the present invention to be an incorporated portion of said rod or screw.
In accordance with further aspects of the invention, the method of identifying a micromanufactured rod or screw device may further comprise displaying information associated with the micromanufactured rod or screw based on the indicia and the plurality of records through a user interface. The readable portion may be disposed upon a main portion of the micromanufactured device. The plurality of modifications may include an array of holes in the at least one surface of the readable element. The plurality of modifications may include an array of notches in the at least one surface of the readable element. The array of notches in the at least one surface of the readable element may form at least one bar code. The at least one bar code may comprise a Hamming code or other similar methods for error detection and correction that are known in the coding theory art. Additionally data compression may be used in the coded indicia of the preferred embodiment.
In accordance with further aspects of the invention, a rod or screw device identifiable after implantation is provided that comprises a main portion and a readable portion. The readable portion may comprise a plurality of laminae or laminar planes (a finite planar volume). Each of the laminae, hereafter referred to as “laminar planes,” may comprise separately readable indicia such that the indicia may be discernible in three dimensions by at least one of x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, and magnetic resonance imaging.
The readable portion may be integral with the main portion. Also, the readable portion may be disposed within the main portion. Further, the indicia may include an array of voids on or in a corresponding laminar plane of the readable portion. The indicia may include an array of embedded markers on or in a corresponding laminar plane of the readable portion. The embedded markers may comprise a modulation of material compositions such that a first material composition of at least one first embedded marker is different than a second material composition of at least one second embedded marker. Further, the indicia may include a first array of embedded markers on or in a first laminar plane of the readable portion and a second array of embedded markers on or in a second laminar plane of the readable portion. The first array may comprise a first embedded marker having a first material composition different than a second material composition of a second embedded marker disposed in the second array. The indicia may comprise information in the form of a code. The code may comprise a Hamming code or other similar methods for error detection and correction that are known in the coding theory art. Additionally, data compression may be used in the coded indicia of the preferred embodiment.
In accordance with further aspects of the present invention, a method of manufacturing an identifiable rod or screw device is provided comprising providing a main portion of the device, providing a readable portion of the device, printing a first material onto a first readable portion surface to create a first printed layer, and printing a second material onto the first printed layer to create a second printed layer. The printing of the first material onto the first readable portion surface or the printing of the second material onto the first printed layer may comprise printing encoded indicia. The encoded indicia may comprise voids in the first material or measurable variations in density. The method of manufacturing an identifiable rod or screw device may further comprise printing a second material onto at least one of the first readable portion surface and the first printed layer, such that the encoded indicia comprises the second material.
In accordance with further aspects of the present invention, a rod or screw device identifiable after implantation is provided that comprises a main portion and a readable portion. In this embodiment, the readable portion comprises an internal structure inside the readable portion. The internal structure comprises a plurality of linking structures. Each of the linking structures has a predetermined size or orientation. The linking structures are interconnected to substantially form the internal structure. The linking structures form predetermined indicia such that the indicia are discernible by any medical imaging modality, such as x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, and/or magnetic resonance imaging. The readable portion may be integral with the main portion or disposed upon the main portion. The indicia in the readable portion of the rod or screw device may comprise a Hamming code or other similar methods for error detection and correction that are known in the coding theory art. Additionally, data compression may be used in the coded indicia of the preferred embodiment. The present disclosure further includes unique device identification and information extraction through high data density structural encoding.
To the accomplishment of the foregoing and related ends, certain illustrative aspects of the disclosed innovation are described herein in connection with the following description and the annexed drawings. These aspects are indicative, however, of but a few of the various ways in which the principles disclosed herein can be employed and is intended to include all such aspects and their equivalents. Other advantages and novel features will become apparent from the following detailed description when considered in conjunction with the drawings.
While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed that the present invention will be better understood from the following description in conjunction with the accompanying Figures, in which like reference numerals identify like elements, and wherein:
In the following detailed description of the preferred embodiment, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration, and not by way of limitation, a specific preferred embodiment in which the invention may be practiced. It is to be understood that other embodiments may be utilized and that changes may be made without departing from the spirit and scope of the present invention.
The present disclosure relates to U.S. patent application Ser. No. 14/302,133, U.S. Pat. No. 9,101,321, U.S. patent application Ser. No. 14/302,197 and U.S. patent application Ser. No. 14/456,665, all of which are hereby incorporated by reference in their entirety.
In this particular embodiment of the present invention, readable portion 16 has a series of notches 12 in one longitudinal side 14 of the readable portion 16. Each of the notches 12 is a modification to the surface of the readable portion 16, and has a predetermined width 22, though it may also have a predetermined, length, depth and/or shape each of which is capable of conveying additional encoded data. Further, each of notches 12 is located at a predetermined axial position 24 so as to create indicia 26 representing one-dimensional data, although it is contemplated that two and three-dimensional data can also be represented. In a preferred embodiment, rod structure 10 is a radiopaque structure, such as a tantalum rod. As will be further described below, rod structure 10 may also have a variable density such that rod structure 10 contains indicia in the form of a variable density internal structure or a particular mesh structure created by additive manufacturing, thereby increasing the density of the data coding. After implantation, rod structure 10 and indicia 26 are detectable and readable via any of a variety of imaging or measurement methods, such as x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, and magnetic resonance imaging. The indicia 26 may also be detected and received by conventional medical imaging devices. Imaging software, preferably high resolution imaging software, then reads and processes the data from the indicia 26 to decode and store and/or display the information from the implant device 20.
In a first embodiment of the present invention, the data represented by the indicia 26 on the surface of the rod structure 10 references unique information located in an external database. One example of such information includes data from the indicia 26 representing a unique numerical identifier corresponding to a wealth of manufacturer, patient, surgeon, or surgical procedure information located in an external healthcare facility database.
In further embodiments of the present information, the size of the indicia may be decreased, and the density of the data thereby increased, such that additional information beyond mere reference data may be recorded onto the surgical implant. Such embodiments are further discussed below. In the preferred embodiment of the present invention, error correction is used to increase the resolution of the imaging technology, thereby allowing an increase in data density. Error correction is discussed in more detail below.
Referring now to
Although the indicia 26, 56 shown in
In a preferred embodiment of the present invention, the data represented by indicia 56 on the surface 50 of rod structure 40 references unique information located in an external database. One example of such information includes the data from the indicia 56 representing a unique implant number corresponding to a wealth of manufacturer, patient, surgeon, or surgical procedure information located in an external healthcare facility database.
Error correction is used in a preferred embodiment of the present invention to increase the resolution of the imaging technology, thereby allowing an increase in data density for a given measurement technology. By encoding, for example, a number into the implant through micro-machined holes and/or notches, sufficient permutations of the code can be recorded. In a preferred embodiment of an implantable device according to the present invention, a tantalum marker used in polymer spine implants contains, for one example, 400 micron discrete notches. The full code width and the bit count could, in this example, be dictated by machining precision and accuracy, number of variable machining widths (e.g., 100 microns, 200 microns, and 300 microns), total bar length, and image resolution. To ensure robustness in the encoding scheme, error correction in the form of a Hamming code is implemented in the preferred embodiment but any error correction method known in the coding theory art could be employed. In the preferred embodiments shown in
Referring now to
Any of the embodiments of the present disclosure may include data relating to the unique image, properties, or manufacturing characteristics of the implant or component itself, such as particular programming language directed to identification or replication of the structure. Further, any of the embodiments, including each particular structure, disclosed in the present application may include encoded implant devices having the forms of, or being incorporated into, screws, rods, or other medical devices such as shoulder implants, hip implants, knee implants, or cardiovascular devices, stents, etc.
Reference is now made to
The notches 404 of the preferred embodiment may be created using known lathe (machining) techniques or through additive manufacturing processes, as further discussed below. As will be recognized by one having ordinary skill in the art, any embodiment of the exemplary rod structures 402 shown in
Referring now to
Furthermore, in a preferred embodiment of the present invention. The implantable rod structure 402 is cannulated for use with minimally invasive surgeries (MIS) and other procedures as needed. When the implantable rod structures 402 are cannulated, the rod structures 402 should have a diameter bigger than 1 mm. Specifically, the MIS surgeries require a guide wire that needs to be threaded through the cannulated body of the rod structure 402 for placement of the screw device 400.
Referring now to
The variation in material, as used in the embodiment of
Referring again to the preferred embodiment of
The implantable device 78 of
ASTM International formed Committee F42 on Additive Manufacturing Technologies in 2009 with the mission of setting the standards for design, process, and materials with regards to AM. The committee defined a taxonomy of seven sub-technologies that together constitute the full suite of AM techniques.
Material extrusion is an additive manufacturing process where material is selectively dispensed through an extrusion nozzle. The most common implementation of this method involves the extrusion of thermoplastic material through a heated orifice. The material available for the most common implementation tends to be functional plastics that are sufficiently robust to withstand harsh environments such as chemical, mechanical, or temperature exposure.
Vat photo polymerization features a vat of liquid photo curable polymer that is selectively cured with an energy source such as a laser beam or other optical energy. The part is typically attached to a platform that descends one cure depth after a layer is completed and the process is repeated. This class of additive manufacturing benefits from feature sizes dictated by either the laser beam width or optical resolution in the X and Y axis and minimum cure depth in Z.
Powder bed fusion processes include selectively melting or sintering a layer of powder using an energy source such as a laser or electron beam, lowering the layer by a fabrication layer thickness, and adding a new powder layer by delivery with a rake or roller and material storage mechanism. The process continues with the next layer. Un-melted powder in the bed acts inherently as support material for subsequently built layers.
Material jetting uses ink-jetting technology to selectively deposit the build material with a cure prior to the application of subsequent layers. An exemplary version of this technology may be ink-jetting multiple photo-curable polymers and following the inkjet head with a UV lamp for immediate and full volume curing. With multiple materials, fabricated items can be multi-colored or materials can be chosen with varying stiffness properties. Ink-jetting is also naturally well suited for parallelism and thus can be easily scaled to larger and faster production.
Binder jetting includes selectively ink-jetting a binder into a layer of powder feedstock. Additional powder material is then dispensed from a material storage location by a rake or roller mechanism to create the next layer. Some binder jetting technologies may require a post-anneal furnace cycle depending on the materials being used (e.g., metals, ceramics). One exemplary system may inkjet color (much like a commercial inkjet color printer) in addition to the binder into a powder, and may therefore provide structures with colors throughout the structure for conceptual models. Another binder jetting system may utilize a post anneal process to drive out the binder to produce metal or ceramic structures.
Sheet lamination is another additive manufacturing process in which individual sheets of material are bonded together to form three-dimensional objects. In one exemplary embodiment, sheets of metal are bonded together using ultrasonic energy. The process has been shown to produce metallurgical bonds for aluminum, copper stainless steel, and titanium. A subsequent subtractive process between layers adds internal structures and other complex geometries impossible with conventional subtractive manufacturing processes that start from a billet of material.
Directed energy deposition is another additive manufacturing process that directs both the material deposition and the energy source (typically a laser or electron beam) at the surface being built. Directed energy deposition processes typically use powder or wire-fed metals and exemplary applications of the process may include repair of high value components used in aircraft engines.
The implant device of the present invention may also be manufactured by conventional methods such as a machining operation using any milling, lathe, or drilling operation to include standard machining and fabrication methods known in the art of manufacturing medical implants.
The embodiments of
Reference is now made to
One or more of the embodiments of the present invention are structurally encoded devices, which refers to the 3D encoding of digital information in a structure as variations in geometric or physical features—widths, densities, color, feature angles, etc. Bar codes are an example of a 2D encoding of digital information with modulations of color (dark versus light) with varying widths of printed bars on a surface. A typical embodiment of the structurally encoded devices of the present invention may contain data that is not readily apparent to a viewer of the device structure to preserve patient privacy. Further, encoding of the typical embodiments of the present invention is handled by physical means other than those accomplished through circuitry, electromagnetic or other, within the implant device itself or through a type of internal storage means such as magnetic storage means or the like. Such structurally encoded devices, as disclosed herein and described in relation to the typical and/or preferred embodiments of the present invention allow simplified production, maintenance, and/or operation costs for identification, storage, and/or retrieval of unique implant data while retaining a substantial amount of information with reduced probability for error.
The preferred embodiments of the present invention, as shown individually in
The identifiable implant device of the present invention enables more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly. Additionally, the identifiable implant device of the present invention reduces medical error by enabling health care professionals and others to rapidly and precisely identify a device and obtain important information concerning the characteristics of the device. The present invention enhances analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources, and registries. Through the identifiable implant device of the present invention, a more robust post-market surveillance system may also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices. The present invention further provides a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls. Moreover, the present invention provides a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies. The identifiable implant device of the present invention enables development of a medical device identification system that is recognized around the world.
Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, a certain illustrated embodiment thereof is shown in the drawings and has been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments of this invention are described herein. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventor intends for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
This application incorporates by reference all of the following in their entirety: (i) U.S. Provisional Application No. 61/938,475, filed Feb. 11, 2014; (ii) U.S. patent application Ser. Nos. 14/302,133, 14/302,171 (now U.S. Pat. No. 9,101,321) and 14/302,197, all filed Jun. 11, 2014; (iii) U.S. patent application Ser. No. 14/456,665, filed Aug. 11, 2014; (iv) U.S. Provisional Application No. 62/035,875, filed Aug. 11, 2014; (v) U.S. patent application Ser. No. 14/823,234, filed Aug. 11, 2015 (now U.S. Pat. No. 9,424,503); (vi) U.S. patent application Ser. No. 14/822,613, filed Aug. 10, 2015 (now U.S. Pat. No. 9,414,891); (vii) U.S. Provisional Application No. 62/204,233, filed Aug. 12, 2015; U.S. patent application Ser. No. 15/235,914, filed Aug. 12, 2016; (viii) U.S. Provisional Application No. 62/419,373, filed Nov. 8, 2016 and entitled Method of Producing Elongate Implant Containing A Structurally Encoded Pin Through Electrical Discharge Machining; (ix) U.S. Provisional Application No. 62/419,341, filed Nov. 8, 2016 entitled Elongate Implant Containing A Structurally Encoded Pin, Carrier And Reading System Therefor; (x) U.S. Provisional Application No. 62/419,353, filed Nov. 8, 2016; and (xi) U.S. Provisional Application No. 62/419,364, filed Nov. 8, 2016 entitled Optical Image Vertebral Implant Cage and Reading System Therefor. All of the forgoing are hereby incorporated by reference in their entirety. This application claims priority from Provisional Patent Application Ser. Nos. 62/419,364, 62/419,341, 62/419,353 and 62/419,373, all of which were filed on Nov. 8, 2016. This application is also a continuation in part of U.S. patent application Ser. Nos. 14/302,133 (filed on Jun. 11, 2014) and 14/456,665 (filed on Aug. 11, 2014), both of which claim priority to Provisional Patent Application Ser. No. 61/938,475 filed on Feb. 11, 2014.
| Number | Date | Country | |
|---|---|---|---|
| 62419364 | Nov 2016 | US | |
| 62419341 | Nov 2016 | US | |
| 62419353 | Nov 2016 | US | |
| 62419373 | Nov 2016 | US | |
| 61938475 | Feb 2014 | US | |
| 61938475 | Feb 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14302133 | Jun 2014 | US |
| Child | 15805317 | US | |
| Parent | 14456665 | Aug 2014 | US |
| Child | 14302133 | US |
