Patent Application
20070006887
1. Field of the Invention
The present invention relates to prosthetic and other types of implantable devices and more particularly to a method and apparatus for tracking such devices.
2. Description of Prior Art Including Information Disclosed Under 37 CFR 1.97 and 1.98
Prosthetics are commonly used in medicine to replace parts of the body lost as a result of injury, wear, disease, or trauma, or parts missing from birth. Pacemakers and defibrillators are commonly implanted and recalled. These devices are extremely expensive and tracking the use and supply levels of these devices is beneficial. An RFID tracking system for such devices would be very beneficial.
Recalls in the prosthesis industry are common, and as such, the availability of a prosthesis tracking system is necessary to identify and then replace recalled prostheses. For example, Exactech, Inc., of Gainesville, Fla., had to recall its Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/meta V polymer semi-constrained cemented prosthesis because the implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. Thus, a Cemented Trapezoid Tibial Tray labeled as 4F/4T appeared to dimensionally be a 3F/3T.
Nobel Biocare USA, Inc., Yorba Linda, Calif. recalled a Replace 4.3 mm Conical Abutment, 4.3 mm diameter×4.5 mm height, Catalog #43503. Such an abutment is used either for single or multiple units, screw-retained prosthetic restorations. It was recalled because the conical abutment was not the size as labeled. Nobel Biocare USA, Inc. also had to recall its IMC (Intramobile Connector) Conversion Screw, 3.5 mm diameter, Catalog #8198CA, because the screw in the package was incorrect. An IMC cylinder is used for single or multiple units, screw-retained prosthetic restorations.
Advanced technology has brought significant improvements to many types of prosthetic devices. Lower extremity trauma amputees, on average, use a new prosthesis every two years. See: Use and Satisfaction with Prosthetic Devices Among Persons with Trauma-Related Amputations: A Long-Term Outcome Study. American Journal of Physical Medicine & Rehabilitation. 80(8):563-571, August 2001. Dillingham, Timothy R. MD, MS; Pezzin, Liliana E. PhD; MacKenzie, Ellen J PhD; Burgess, Andrew R. MD
A tracking system with device history records would ease the process of replacing outdated devices. Prosthetics suppliers could be aware of the sale of a given prosthesis immediately. This would allow the supplier to bill the customer sooner and then restock them with another device. A scan of the prosthetic device could also identify a person who is unconscious or deceased, and it could reveal other aspects of a patient's medical history which would be needed for various types of treatments. This has both medical and forensic benefits. A tracking system could also reduce occurrences of infection in prostheses by providing superior control of device expiration/shelf-life.
Hospital inventory control could be greatly enhanced by a tracking system. Such a system could provide for easy verification that correct components are being used. Further, long term data on implant age could easily be obtained.
However, to the best of my knowledge, no such tracking system is currently available which is capable of performing these functions.
It is, therefore a prime object of the present invention to provide a tracking system for prosthetic and other types of implantable devices.
It is another object of the present invention to provide a tracking system for prosthetic and other types of implantable devices capable of tracking lot numbers on such devices.
It is another object of the present invention to provide a tracking system for prosthetic and other types of implantable devices that uses an RFID transducer operating in the frequency range of 50 kHz to 1 MHz.
It is another object of the present invention to provide a tracking system for prosthetic and other types of implantable devices wherein the RFID transducer is situated internally in a non-metallic part of the device.
It is another object of the present invention to provide a tracking system for prosthetic and other types of implantable devices wherein the RFID transducer is situated just below the surface in a metallic part of the device.
It is another object of the present invention to provide a tracking system for prosthetic and other types of implantable devices wherein the transducer is bonded on the device using medical grade epoxy.
In accordance with the present invention, apparatus is provided for tracking prosthetic and implantable devices. The apparatus includes, in combination, a prosthetic or implantable device and an RFID transducer fixed to the device and having lot identification information stored therein. A wand is provided which capable of scanning the transducer and reading the recorded information. Means are provided for storing the read information.
The transducer preferably operates at a frequency range of 50 KHZ to 1 MHZ.
The device may include a non-metallic part. In that case, the transducer is situated internally in the non-metallic part.
The device may include a metallic part. In that case, the transducer is situated proximate the surface of the metallic part.
The apparatus further includes means for fixing the transducer on the device. The fixing means preferably takes the form of medical grade epoxy.
The device may consist of multiple components. In that case, an RFID transducer is fixed to each of the components. Each of the transducers is preferably located in a specific quadrant of the component.
The apparatus may be used in a warehouse. In that case, the device is scanned with the wand prior to being shipped for medical use.
The apparatus may be used in a medical facility. In that case, the device is scanned with the wand as it is implanted into the patient or when the patient returns for further treatment.
The storing means may include information relating to the device history or comprises information relating to the patient's medical history.
The apparatus may also include means for transmitting the read information to the device vendor.
If multiple components are involved, means may be provided for verifying that the correct components of the device have been selected for use.
The apparatus may further include means for recording the medical history of the patent in the transducer.
To these and to such other objects that may hereinafter appears, the present invention relates to a system for tracking prosthetic and implantable devices as described in detail in the following specification and recited in the annexed claims, taken together with the accompanying drawings, in which like numerals refer to like parts and in which:
The apparatus of the present invention is provided for tracking prosthetic and implantable devices, for example the single-part artificial knee tibia, generally designated A, as seen in
A wand, generally designated C, is provided, as illustrated in
Transducer 10 preferably operates at a frequency range of 50 KHZ to 1 MHZ.
The device A may include a non-metallic part. In that case, the transducer is situated internally in the non-metallic part.
The device B may include a metallic part. In that case, the transducer is situated proximate the surface of the metallic part.
Means are provided for fixing the transducer on the device. The fixing means preferably takes the form of medical grade epoxy.
The device B may consist of multiple components, B1 and B2, as shown in
The apparatus may be used in a warehouse. In that case, the device is scanned with the wand prior to being shipped for medical use to obtain and store the identification information. The apparatus may be used in a medical facility. In that case, the device is scanned with the wand as it is implanted into the patient or when the patient returns for further treatment.
The memory means 16 may store information relating to the device history or information relating to the patient's medical history, as well as the identification information. In the latter case, the RFID enabled device allows the patient to have electronically available vital medical data.
The apparatus may also include means for transmitting the read information to the device vendor. That can simply be an Internet connection between computer 14 and the vendor's computer using a modem 18.
If multiple components are involved, computer 16 may contain software for verifying that the correct components of the device have been selected for use.
The apparatus may further include means for recording the medical history of the patent in the transducer.
During a replacement procedure the physician can determine which tools will be required to replace the implant by being able to identify what was previously implanted. The physician will be able to use the information obtained from the transducer to choose the proper replacement component.
In the operating room the physician can have the computer verify that the implants are the ones that were ordered for the patient.
In the physician's office, the apparatus can be used to verify the type and size of implant in the patient. Thus, in the event of a recall, the physician can verify non-invasively whether the implant in a specific patient needs to be replaced.
It will now be appreciated that the present invention relates to a system for tracking prosthetic and implantable devices. The system includes, in combination, a prosthetic or implantable device and an RFID transducer fixed to the device and having lot identification information stored therein. A wand is provided which is capable of scanning the transducer and reading the recorded information. Means are also provided for storing the read information.
While only a limited number of preferred embodiments of the present invention have been disclosed for purposes of illustration, it is obvious that many modifications and variations could be made thereto. It is intended to cover all of those modifications and variations which fall within the scope of the present invention, as defined by the following claims.
| Number | Date | Country | |
|---|---|---|---|
| 60697874 | Jul 2005 | US |
