Patent Application
20120126948
The present invention generally relates to identification systems and methods. More particularly, this invention relates to an identification system and method in which a radio frequency identification (RFID) device is placed within the oral cavity of a human to provide rapid and secure access to personal information from a secure database.
Transponders and particularly radio frequency identification (RFID) tags and microchips (hereinafter, RFID transponders) have been employed to identify products, inventory, and various other inanimate objects for purposes of tracking shipment, manufacturing, theft protection, etc. For use in product and inventory identification, RFID transponders are relatively large in size and mounted to an adhesive strip for application to the objects of interest. The RFID transponder is then interrogated with a reader unit, which causes the transponder to transmit a signal containing data stored on the transponder that uniquely identify the object. The use of RFID transponders has also found use in other scenarios, such as reuniting lost dentures with their owners in different medical venues.
More recently, RFID transponders have been used to identify living beings, including pets, livestock, etc., for purposes of determining ownership. For use in animals, RFID transponders are typically encapsulated in a biologically inert casing and placed beneath the skin by injection. Such RFID transponders are typically small, such as about 11 mm in length and about 3 mm in diameter, and can be coded with up to nine digits to uniquely identify the animal. A commercial example of such an RFID transponder is sold under the name Avid® by Avid Marketing, Inc. Because RFID transponders have the undesirable potential to migrate, cause foreign body tissue reactions, and use an invasive placement or surgical removal procedure when implanted subdermally, their use in humans has not been widely accepted or practiced. However, if RFID transponders could be securely placed in a manner that eliminates such issues, their use in human identification might become more widely practiced.
Electronic medical records (EMR) are becoming more prevalent across the world. Any section of information that pertains to a patient's health, including but not limited to a doctor's diagnosis, treatment options, insurance information and radiographs may be recorded and stored for later retrieval through the use of emerging EMR systems. Patients can also choose to keep their own records digitally through the use of a patient health record (PHR), a commercial example of such is sold under the name MedFlash® by Connectyx Inc. The use of a PHR allows individuals to expand their records, for example, by keeping a more extensive family medical history or recording emergency medical information on a portable flash (thumb) drive or internet portal. Access is typically via a USB connection or the Internet by simple password protection or name recognition. However, identification information to a PHR portal has the undesirable potential of password theft, as well as being unaccessible at a time of need, for example, if the individual is unconscious or otherwise unable to communicate.
Notwithstanding the above, it would be desirable to provide a human identification capability that could be linked to an individual's PHR and ultimately used as a unique patient identifier, enabling communication between various PHR and EMR services on the market today. Such a capability could also enable the use of a unique access code for EMR vaults that are currently in their infancy. Such capabilities would be particularly advantageous for use by children, the elderly, and others whose age, mental capacity, and/or other physical and medical status puts them at risk of being lost, abducted or in immediate need of their medical information by first responders in an emergency situation. Members of the armed services and others whose jobs put them at risk of being injured could also benefit from having rapid access to their medical records.
Increased regulation on traceability of dental prostheses, combined with the opportunity to provide an immediate personalized clinical profile to select healthcare providers, provides additional scenarios where a cost-effective, automated and user friendly solutions would be desirable to help identify and trace dentures and provide a personalized identification system to access patient-authorized clinically-relevant health information stored in secure databases and link together different PHR/EMR systems.
The present invention provides an identification system and method by which an electronic identification transponder is placed within the oral cavity of a human to provide a unique personalized identification system for rapid, secure access to clinically-relevant patient-authorized emergency medical and health information records from a secure database.
According to a first aspect of the invention, information regarding or relating to an individual is accessed with an electronic identification transponder adapted to be interrogated by, to be written to, and to communicate with a reader unit. The electronic identification transponder and the reader unit are adapted to communicate over a distance limited to less than ten centimeters. The electronic identification transponder is attached to a dental structure within an oral cavity of the human. The dental structure may be a mammalian tooth, denture, removable partial denture, athletic mouth-guard, crown or bridge.
According to a preferred aspect of the invention, the system and method involve a technique for the preparation and placement of an electronic identification transponder within the oral cavity of an individual, and the use of an identification code stored on the transponder to enable access to a individual's personal health record (PHR). The identification code can be, for example, a sixteen-digit code unique to a single individual, and the transponder can be placed on or within a tooth, denture crown, bridge, athletic mouth guard or various other removable or fixed dental prostheses or appliances that can be placed within the oral cavity.
According to another preferred aspect of the invention, the identification code is only readable with a reader unit placed in close proximity to the transponder, so that the transponder cannot be surreptitiously accessed under most circumstances, yet individual-authorized emergency medical and health information records can be accessed from a secure database even in medical emergencies in which the individual is unable to assist. As such, when placed within the oral cavity of an individual, the unique identification code of the transponder can serve as a unique patient identifier that remains constant with the individual, can speak for them when they are unable, and can be used to unlock portable and medical record vaults, which is currently a missing link between individuals and their PHR/EMR.
In view of the above, the present invention provides a secure, noninvasive, and confidential method for instantaneously retrieving identification and potentially other information concerning a person into which the transponder is implanted. Such information can be vital to identify persons in a variety of emergency and nonemergency situations. Furthermore, the transponder can be present without visual detection by uninformed parties, such that unauthorized removal of the transponder is not likely to occur. Finally, the transponder can be permanent if so chosen, yet removable by a skilled technician without causing pain or permanently disfiguring the individual. Placement and operation of RFID transponders of this invention have been validated in removable dental prosthetics, fixed dental prosthetics, and human teeth.
Other aspects and advantages of this invention will be better appreciated from the following detailed description.
The present invention makes use of RFID transponders that are sufficiently small and biologically inert to permit their attachment to or implantation in a human dental structure, with preferred implantation locations being intra-coronally on certain human teeth, crowns and bridges and preferred attachment locations being extra-coronally on human teeth and removable and fixed dental prosthetics, including but not limited to dentures, removable partial dentures, orthodontic retainers and athletic mouth guards. Placement on dental structures is particularly selected to facilitate attachment or implantation, be accessible for interrogation and communication with a separate reader unit, and reduce the risk that the transponder will be damaged or interfere with the bearer's normal behavior. For this purpose, the transponder is preferably not larger than about one millimeter in width by about six millimeters in length, and is carried in or on a pliable or rigid substrate, for example, a biologically inert glass or resin. When attached or implanted in the oral cavity, the transponder is preferably encased in a strong biocompatible glass or resin so that the transponder does not contact body tissues and will remain fixed, thus eliminating the possibility of an allergic reaction or rejection by body tissues.
Preferably, once placed the transponder is registered to the particular individual by entering or registering a personalized multi-digit (e.g., sixteen digit) identification code. The identification code is preferably encrypted and cannot be altered or removed once associated with the transponder. The transponder can also be encoded to provide certain information concerning the individual, such as the individual's medical history. As an example, the identification code could be or include the individual's social security number, and may contain data that contains portions of the individual's medical history, such as critical medical information that a first responder would require in a life saving emergency situation, including but is not limited to allergies and current medication information. More preferably, the identification code is associated with a secure database that contains portions or all of the individual's medical history. The transponder can be scanned by the reader unit, which is preferably adapted to interrogate the transponder and, optionally, program the transponder. According to a preferred aspect of the invention, the transponder is readable by only a specific reader so as to reduce the likelihood of an unauthorized interrogation or write attempt. Another preferred aspect of the invention is that communication between the transponder and reader unit is very limited in distance, for example, less than 10 cm and preferably not more than 3 cm, so that the individual (if conscious) will be aware of the presence of the reader unit, thereby reducing the risk of surreptitious attempts to access data through the transponder. The communication process is further secured by the duration over which communication between the transponder and reader unit must take place, for example, about 5 to 15 seconds, which further insures individual awareness of any unauthorized attempt to read the transponder.
Preferred transponders do not contain any moving parts, and when read or written to do not emit heat, vibration, or any other potential source of sensation felt by the individual. A preferred transponder is an ultrahigh frequency (UHF) RFID transponder or chip (microchip), such as an RFID tag commercially available from Lutronic International under the name NONATEC®. According to Lutronic International literature, the NONATEC® tag utilizes an electronic chip from Philips Research. In contrast to conventional silicon-chip-based RFID tags, the Philips chip is understood to be a fully functional RFID chip that operates at a frequency approved by the FCC (13.56 MHz) and is compatible with FDA standards. The Philips chip is printed directly onto a plastic substrate along with an antenna. For illustrative purposes,
The transponder 10 is not required to be self-powered, and therefore does not contain any internal power supply that would require periodic replacement. Instead, the transponder 10 is preferably passive, meaning that the transponder 10 is capable of transmitting and receiving data only when interrogated by the reader unit. Intra-oral and extra-oral reader units 20 are schematically represented in
In investigations leading up to this invention, the NONATEC® transponders and reader/writer units noted above were shown to perform well for the intended application, including the capability of interrogation and communication when the reader/writer unit was placed immediately adjacent to the external surface of an individual's cheek, such that the communication distance was within the 0.5 to 3 cm operational range of the units. Nonetheless, it is foreseeable that other transponders and reader/writer units could be used, as long as the aforementioned communication distance limitation is provided. However, as reported in U.S. Pat. No. 6,734,795, communication distances of various commercially-available RFID tags, for example, the Avid® RFID tag sold by Avid Marketing, Inc., far exceed the prescribed distance for the RFID transponder 10 of this invention. Finally, it is foreseeable that various functionalities could be incorporated into the transponder 10, including a global positioning system (GPS) capability and increased storage capacity as technology progresses.
While the NONATEC® RFID tag is adapted to be placed subdermally in animals by injection; the present invention places the transponder 10 in the human oral cavity, such as in or on a mammalian tooth as schematically represented in
According to the site prioritization proposed by this invention, a suitable location for implanting the transponder 10 is the buccal pit in the facial surface of Tooth #30 (right lower first molar), as well as the buccal pit on the facial surface of Tooth #19 (left lower first molar). The buccal pit of Tooth #30 and Tooth #19 are desirable locations because each bears an inherent enamel defect and uncoalesced enamel, which is commonly filled as a preventative measure to ward off the development of a dental cavity. Other prioritized sites of this invention include the lingual groove in the lingual surface of Tooth #3 (right upper first molar) or Tooth #14 (left upper first molar), which also bear an inherent enamel defect and uncoalesced enamel. Still other prioritized sites include the facial surface of Tooth #31 (right lower second molar) or Tooth #18 (left lower second molar), and the lingual surface of Tooth #2 (right upper second molar) or Tooth #15 (left upper second molar). Other possible sites include the lingual and occlusal surfaces of Tooth #30 or #19, the occlusal surface of Tooth #31 or #18, and the facial and occlusal surfaces of Tooth #15 or #2.
Following rinsing and drying to remove debris, a standard acid etch and bond is performed. Any conventional acid etch and bond technique can be used, though a one-component light-cured self-etched/self-priming dental adhesive is preferred. Alternatively, a separate etch and bond could be performed, in which case it is necessary that all etchant is remove by a water rinse. Suitable self-etching/self-bonding dental adhesives are known to contain mono-, di- or trimethacrylate resins, dipenta-crythritol penta acrylate monophosphate, photo-initiators, stabilizers, water acetone, and cetyl amine hydrofluoride. All tooth surfaces are preferably scrubbed with generous amounts of the adhesive for about fifteen to twenty seconds to thoroughly wet all tooth surfaces. This procedure is then repeated, after which excess adhesive is removed and the remainder dried for about five to ten seconds with clean dry air. Cure can then be accomplished by subjecting the adhesive to light for about ten seconds.
If a separate etch and bond technique is used, the etchant may contain a phosphoric acid concentration of 35 to 50% in solution or gel. A treatment of about thirty to sixty seconds is appropriate, followed by rinsing and drying without dessication for about fifteen seconds. The bonding agent preferably contains a sulfur-based amine activator within an ethyl alcohol solvent. The use of a hydrochloric or hydrofluoric acid etch is not recommended due to the risk that the transponder 10 might be attacked by these acids at high concentrations.
The composite resin undergoes curing until a full set is confirmed, after which the restoration 34 is polished. Armamentarium for finishing the final restoration 34 includes fine grit diamond, 12 to 20 bladed carbide burs, tapered or round stones, finishing strips and disks, rubber cups and a resin glaze.
The transponder 10 can also be bonded directly to the external tooth enamel of the tooth, instead of being implanted beneath the tooth surface. Acceptable locations for this technique are represented in
Prior to attachment directly to the external tooth enamel, the selected tooth location can be conditioned by a pumice slurry or air abrasion to remove plaque and/or pellical layer, and scaling can be performed to remove calculus if needed. Rubber dam isolation is highly recommended. After testing the transponder 10 by interrogation with the reader unit, a 0.5 mm-deep retention groove may be formed in the external tooth enamel of the tooth to eliminate over-contouring and resist rotational forces. Enamelplasty is then preferably performed using air abrasion or rotary burs. The selected site is then washed with copious amounts of water and dried without desiccation. Once the attachment surface has been treated, it should remain uncontaminated, and if contamination occurs (for example, salivary contamination), the cleaning procedure should be repeated.
Attachment of the transponder 10 to the tooth is preferably performed with a one-component light-cured self-etching dental adhesive, for example, a commercial product such as Xeno IV. The adhesive is applied and the surface to which the transponder 10 is to be bonded is scrubbed for about fifteen seconds to thoroughly wet the surface. Adhesive application and scrubbing is then repeated, after which any excess solvent is removed by gently drying with clean, dry air from a dental syringe, preferably for at least five seconds. The surface should have a uniform glossy appearance with no excessive adhesive thickness or pooling and, if not, the application and air drying steps should be repeated.
The adhesive should then undergo curing by treating the tooth surface to a curing light for about ten seconds, after which a drop of flowable resin is applied immediately prior to placement of the transponder 10. If attached to a canine tooth (Tooth #22 or #27), placement of the transponder 10 is preferably vertical or perpendicular to the incisal plane and within the cingulum. The transponder 10 should not be placed on the prominent cingulum ledge, as this would promote over contouring of the restoration. Placement is the same if attaching the transponder 10 to the mandibular central or lateral incisors. If attached to a maxillary or mandibular molar site, the transponder 10 is preferably placed in horizontal or parallel to the incisal plane, whether the site is facial or lingual.
Following placement, the adhesive undergoes further curing with light, for example, with an exposure of about ten seconds. A posterior composite resin, for example, a commercial product known as HELIOMOLAR®, is then applied to completely encapsulate the transponder 10 without over-contouring the final restoration. A light cure for about ten seconds is then performed, followed by a second application and curing of the posterior composite resin. The transponder 10 is preferably covered to a thickness of about 2 mm of the resin. The restoration may be finished using a resin finishing bur and polished if the restoration is substantially over-contoured.
The transponder 10 can also be placed in complete or partial dentures, as represented in
In addition to surface regions of the acrylic prosthetic material of a denture, the transponder 10 can also be directly placed within a porcelain or metallic portion of a denture, such as a tooth or retainer of a complete or partial denture. Examples of suitable locations include facial surface regions interproximal of Teeth #6-7, Teeth #10-11, Teeth #21-22, and Teeth #27-28. If a removable partial denture that replaces only posterior teeth, preferred locations are apical to the mesial root of Tooth #30, mesial root Tooth #19, apical to the mesial-buccal root Tooth #14, and mesial-buccal root Tooth #3.
The transponder can also be placed in athletic mouth guards, in which case preferred locations are facial surface regions interproximal of Teeth #6-7 for a maxillary guard and interproximal of Teeth #27-28 for a mandibular guard.
The transponder 10 can be programmed before or after placement. As previously noted, programming generally entails storing on the transponder 10 a unique identification code, and preferably coding associated with other pertinent information, such as any critical emergency medical information. Once programmed and placed in accordance with one of the forgoing implantation procedures, the functionality of the transponder 10 should be confirmed with a reader unit. The identification code associated with the transponder 10 and other pertinent information can then be downloaded for storage in a secure database, for example, in a computer with software with which the reader unit communicates, such as through a USB port or BLUETOOTH® technology that allows errorless transfer to a laptop or smart phone, which preferably accesses the Internet utilizing the identification code to enable individual-approved access to the individual's critical medical history.
Depending on the circumstances, the individual may be provided with a printout of their medical records (PHR) for informational purposes, such as updating medical histories recorded in a secure database (PHR/EMR) and/or a flash drive. The individual may also be provided with a printout of the contents of their PHR after the reader unit has recognized the identification code of the RFID transponder 10 and has sent (for example, via BLUETOOTH® technology) the code to a medical/dental office computer or smart phone to allow access the individual's PHR via the Internet. The PHR may be supplied to the medical/dental office as a printout or entered into an EMR database. The individual's PHR may also be accessed by a first responder or hospital emergency department, depending on the purpose of the implantation. The individual's PHR may be included in a database accessible by only certain individuals, such as law enforcement, healthcare providers, and particularly dentistry professionals who in the normal course of a dental examination can verify the identity of an individual, including whether a child/adult individual is listed in a missing child database or attached to the AMBER Alert or Silver Alert systems for dementia/Alzheimer. Other capabilities and uses include but are not limited to identifying military personnel, confirming an individual's identity at military facilities, accessing military PHR on the battlefield, airport security checks and customs, etc.
Increased regulation on the traceability of dental devices and prosthetics can also utilize the RFID transponder 10 to securely hold information such as the manufacturing process of a crown or bridge, including but not limited to site fabrication, country of origin, materials used, dentist, etc. The individual or dentist may then receive a smartcard with the information downloaded to it or simply utilize the implanted/embedded RFID transponder 10 and reader unit for secure access.
Once correctly placed by a dental professional, the transponder 10 will not migrate and cannot be altered or lost, nor can the transponder 10 be readily detected without appropriate equipment capable of communicating with or otherwise sensing the transponder 10. For example, an individual can be equipped with the transponder 10 without the telltale bump associated with a subdermally implanted RFID chip. An additional feature of the invention is the ability to remove the transponder 10 without injuring or scarring the individual. For example, if the individual is a child, he or she may choose to remove the transponder 10 once he or she reaches adulthood. Likewise, if the individual is a military personnel, the transponder 10 may be removed once he or she is discharged from military service. The transponder 10 can generally be removed with a round bur or any other suitable dental tool, and the resulting cavitation repaired by restoration procedures commonly used in dentistry practices.
While the invention has been described in terms of specific embodiments, it is apparent that other forms could be adopted by one skilled in the art. For example, the physical configuration of the transponder 10 could differ from that described, and a wide variety of dentistry materials and procedures are known by dentistry professionals and could be used in place of for those materials and procedures noted. Therefore, the scope of the invention is to be limited only by the following claims.
This application claims the benefit of U.S. Provisional Application No. 61/346,671, filed May 20, 2010, the contents of which are incorporated herein by reference. In addition, this is continuation-in-part patent application of co-pending U.S. patent application Ser. No. 11/943,033, filed Nov. 20, 2007, which claims the benefit of U.S. Provisional Application No. 60/866,531, filed Nov. 20, 2006. The contents of these prior applications are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61346671 | May 2010 | US | |
| 60866531 | Nov 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11943033 | Nov 2007 | US |
| Child | 13111335 | US |
