U.S. patent application number 11/279469 was filed with the patent office on 2006-10-19 for systems and methods for rfid-based medical implant identification.
This patent application is currently assigned to SDGI Holdings, Inc.. Invention is credited to Jeffrey H. Nycz, David W. Polly, Steven M. Tethrake.
Application Number | 20060235488 11/279469 |
Document ID | / |
Family ID | 36753897 |
Filed Date | 2006-10-19 |
United States Patent
Application |
20060235488 |
Kind Code |
A1 |
Nycz; Jeffrey H. ; et
al. |
October 19, 2006 |
Systems and methods for RFID-based medical implant
identification
Abstract
Methods and systems for identifying medical implants. Data input
is supplied by an operator including implant identification number,
procedure date, and/or other patient record information. An RF
module writes the data input to an RFID tag associated with and/or
attached to the medical implant. Once the implant is set, but prior
to closure, the RF module reads the data from the tag to insure
readability. A data record including the data input and other
procedure specific information may be automatically transmitted to
a patient record management system in a medical facility.
Inventors: |
Nycz; Jeffrey H.;
(Collierville, TN) ; Tethrake; Steven M.;
(Collierville, TN) ; Polly; David W.; (Edina,
MN) |
Correspondence
Address: |
HUNTON & WILLIAMS LLP;INTELLECTUAL PROPERTY DEPARTMENT
1900 K STREET, N.W.
SUITE 1200
WASHINGTON
DC
20006-1109
US
|
Assignee: |
SDGI Holdings, Inc.
|
Family ID: |
36753897 |
Appl. No.: |
11/279469 |
Filed: |
April 12, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11108130 |
Apr 18, 2005 |
|
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11279469 |
Apr 12, 2006 |
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Current U.S.
Class: |
607/60 ;
607/2 |
Current CPC
Class: |
A61F 2/3859 20130101;
A61F 2002/3067 20130101; A61F 2002/488 20130101; A61F 2/367
20130101; A61F 2002/3611 20130101; A61F 2/3662 20130101; A61F
2002/3071 20130101; A61B 90/90 20160201; A61F 2250/0002 20130101;
G16H 10/65 20180101; A61F 2/32 20130101; A61F 2/3877 20130101; A61B
90/98 20160201; A61F 2/389 20130101; A61F 2/34 20130101; A61F
2250/0085 20130101; A61B 17/8605 20130101; A61F 2/38 20130101; A61F
2002/4632 20130101 |
Class at
Publication: |
607/060 ;
607/002 |
International
Class: |
A61N 1/00 20060101
A61N001/00 |
Claims
1. An RFID-based medical implant identification process comprising:
entering a first data input into a data processing system; writing
the first data input to a memory of an RFID tag associated with a
medical implant; and validating the data input stored in the tag
after the medical implant is set.
2. The process according to claim 1, wherein entering a first data
input comprises manually entering an identification number of a
medical implant into the data processing system.
3. The process according to claim 1, wherein entering a first data
input comprises scanning a bar code label associated with a medical
implant with a bar code reader in communication with the data
processing system.
4. The process according to claim 1, wherein entering a first data
input comprises loading a patient record from a patient record
management system into the data processing system.
5. The process according to claim 1, wherein writing the data to a
memory of an RFID tag comprises transmitting an RF signal
containing the data with an RF writer in communication with the
data processing system, energizing a circuit in the tag with the
signal and storing the information in a memory structure connected
to the circuit.
6. The process according to claim 1, wherein validating the data
input stored in the tag comprises performing an RFID read operation
of the RFID tag associated with the medical implant while the
implant is in the patient's body but prior to closure.
7. The process according to claim 1, wherein the data processing
system comprises an apparatus selected from the group consisting of
a hand held RFID reader/writer, a hand held data processing system,
a desktop data processing system, and combinations thereof.
8. The process according to claim 1, further comprising, after the
step of validating, writing an electronic data record to a
database.
9. The process according to claim 8, wherein writing an electronic
data record to a database comprises writing a record including at
least a procedure date and an implant identification number to a
patient record management system.
10. The process according to claim 9, wherein writing a record
including at least a procedure date and an implant identification
number to a patient record management system comprises transmitting
a signal from the data processing system to the patient record
management system over a wireless network in a medical
facility.
11. A control system for an RF-enabled data processing system for
medical implant identification, the control system comprising: a
data input module for receiving a data input corresponding to a
medical implant; an RF transceiver module adapted to write data
from the data input to an RFID tag associated with the medical
implant and to read the written data from the tag to validate that
the data was written; and an output module adapted to provide a
visual indication to an operator based on the validation.
12. The control system according to claim I 1, wherein the data
input is an identification number of the medical implant.
13. The control system according to claim 11, wherein the data
input is a patient medical record from a patient record management
system.
14. The control system according to claim 11, wherein the data
input module comprises a device selected from the group consisting
of a key hoard, a touch screen display, a bar code scanner, and
mixtures thereof.
15. The control system according to claim 11, wherein the RF
transceiver module is adapted read the written data from the tag
after the medical implant is surgically placed in the patient.
16. The control system according to claim 11, further comprising a
communication module adapted to access a remote patient record
management system to obtain information corresponding to a patient
associated with a medical implant.
17. The control system according to claim 16, wherein the
communication module is adapted to write a record of the medical
implant to the patient record management system after validating
that data was written to the tag.
18. The control system according to claim 15, wherein the RF
transceiver module is further adapted to detect any RFID-tagged
surgical items remaining in a patient's body cavity as a result of
placing the implant but prior to closure.
19. A data processing system containing computer readable
instructions stored therein for operating a medical implant
identification system, the instructions comprising: instructions
for receiving a data input; instructions for writing the data input
to a memory of an RFID tag associated with a medical implant; and
instructions for validating that the data is readable after the
medical implant is set in the patient.
20. The data processing system according to claim 19, wherein the
instructions for receiving a data input comprise instructions for
receiving a keyboard input.
21. The data processing system according to claim 19, wherein the
instructions for receiving a data input comprise instructions for
receiving a data input from a bar code scanner.
22. The data processing system according to claim 19, wherein the
instructions for receiving a data input comprise instructions for
accessing a patient record management system and retrieving
information form the patient record management system, said
information comprising at least part of the data input.
23. The data processing system according to claim 19, wherein the
instructions for writing the data input to a memory of an RFID tag
associated with a medical implant comprise instructions for
transmitting an RF write signal including the data input to the
tag.
24. The data processing system according to claim 19, wherein the
instructions for validating that the data is readable comprise
instructions for transmitting an RF read signal to the tag,
obtaining the stored information from the tag in response to the RF
read signal, and comparing this information to the data input.
25. The data processing system according to claim 24, further
comprising instructions for activating an indication means based on
comparing the read information to the data input.
26. The data processing system according to claim 19, further
comprising instructions for writing a record of the medical implant
and data input to a database.
27. The data processing system according to claim 26, wherein the
instructions for writing a record of the medical implant and data
input to a database comprise instructions for wirelessly
transmitting the record to a patient record management system over
a wireless network in a medical facility.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of commonly
assigned U.S. patent application Ser. No. 11/108,130 filed on Apr.
18, 2005 and entitled ";Method and Apparatus for Implant
Identification," the disclosure of which is hereby incorporated by
reference in its entirety.
FIELD OF THE INVENTION
[0002] Embodiments of the invention generally relate to radio
frequency identification systems, and more particularly to systems
and methods for identification of medical implants using RFID-based
identification techniques.
DESCRIPTION OF RELATED ART
[0003] Hips and knees receive continuous stress from walking,
running, sporting activity, and/or injury. These joints are more
commonly affected by the wearing of cartilage (degenerative
arthritis) than the hand joints. Advances in medical technology
have improved the prognoses of persons who suffer from degenerative
joint-based ailments. Knee, hip, hand, wrist, shoulder and even
spine-based medical implants may be used to provide increased
motion for persons suffering from reduced and/or painful function
of these joints. Joint replacement surgery, also known as
arthroplasty, has become very common in modern medicine. Each year,
orthopedic surgeons perform thousands of joint replacement
surgeries in the U.S.--the majority of these procedures are on the
large, weight bearing joints such as the hips and knees.
[0004] A wide range of metals and their alloys, polymers, ceramics
and composites are used in manufacturing medical implant devices
and prostheses. Most implanted devices are constructed of more than
one kind of material (implants of complex composition). Metal
alloys have been developed for these applications to provide
improved physical and chemical properties, such as strength,
durability and corrosion resistance. Also these materials need to
be inert so as not offend soft body tissue or promote the growth of
lesions, cysts and/or cancer.
[0005] Major classes of metals used in medical devices include
stainless steels, cobalt- chromium alloys and titanium (as alloys
and unalloyed). In addition, metal-on- polyethylene implants are
common in hip and knee replacements, among other replacement parts.
In knee or hip replacement surgery, the artificial joint is
typically made out of a hard, lightweight metal such as titanium
and an inert, non- corrosive material such as plastic. In the case
of joint replacement in the hand, the new joint is most commonly
composed of silicone rubber or the subject's own tissues such as a
portion of tendon
[0006] Despite using hardened, corrosive resistant materials, wear
and tear due to continual usage can affect some of those implants
causing them to degrade over time. These orthopedic replacements,
just like the natural orthopedic parts they replaced, are under
daily and repeated stresses, developing wear and tear, thereby
requiring examination on a timely basis. Therefore, because some
implants have a limited and somewhat unpredictable life, there is a
need to acquire information regarding the type, age, and current
condition of the implant that is minimally invasive and ideally
completely non-invasive to the patient.
[0007] Tracking and managing orthopedic implant replacements is an
important health issue, and its effectiveness is paramount to the
hundreds of thousands of individuals that currently have such
replacements implanted in them, as well as the many who will
receive orthopedic implants in the future. Such orthopedic
replacements normally are implanted in a subject (i.e. a human
being, animal or the like) as a replacement to a natural bone or in
some instances, fusing bones together, thereby enabling subjects
who receive those implants to function normally. The basics of
prosthetic implants can be found in, for example, U.S. Pat. Nos.
5,858,020, 5,910,172, 6,013,104, and 6,749,639, the disclosures of
which are incorporated herein by reference in their entirety.
[0008] Typically, each implant device contains a unique
identification number, such as, for example, a manufacturer
identification and/or serial number. Whenever an implant is placed,
this number is recorded as a permanent record in a database. In the
future this number can be referenced to track age of the implant,
manufacturer for purposes of recall and adjustment, and can even be
used postmortem to identify a person having the implant.
[0009] Currently there are no methods or equipment that exists
today that allow one to safely and quickly ascertain the condition
of orthopedic implants without the use of x-rays, or magnetic
resonance imaging bulky machines that are placed in specialized
rooms in hospitals. In order for orthopedic surgeons to ascertain
whether such parts have undergone severe wear and tear, or are
about to fail, the subject is interviewed in regard to how he/she
feels, then the joint is x-rayed to ascertain the level of wear and
tear. However, due to the correlation between exposure to x-rays
and the development of cancers and due to the relatively high costs
of non-x-ray-based diagnostic imaging systems these are less than
ideal solutions. Therefore, there is a need in the art of
orthopedic, and other medical implants for a more robust, less
expensive, and safer procedure for collecting information about
those implants.
[0010] Data carriers such as memory devices provide an alternative
method for tracking and providing information about items. Memory
devices permit linking large amounts of data with an object or
item. Memory devices typically include a memory and logic in the
form of an integrated circuit ("IC") and a mechanism for
transmitting data to and/or from the device. For example, a radio
frequency identification ("RFID") tag typically includes a memory
for storing data, an antenna, an RF transmitter, and/or an RF
receiver to transmit data, and logic for controlling the various
components of the memory device. The basic structure and operation
of RFID tags can be found in, for example, U.S. Pat. Nos.
4,075,632, 4,360,801, 4,390,880, 4,739,328 and 5,030,807, the
disclosures of which are incorporated herein by reference in their
entirety. RFID tags generally are formed on a substrate and can
include, for example, analog RF circuits and digital logic and
memory circuits. The RFID tags also can include a number of
discrete components, such as capacitors, transistors, and diodes.
The RF transmission of data can be accomplished with modulated back
scatter as well as modulation of an active RF transmitter.
[0011] Radio frequency identification (RFID) systems use an RF
field generator (reader) to wirelessly extract identification
information (i.e., UPC, product name, etc.) contained in RFID
transponder tags that are attached to various products and objects
requiring accurate identification. RFID tags are miniature
electronic circuits that typically consist of a coil that acts as
an antenna and a small silicon- based microprocessor with a memory,
all encapsulated in a protective material. RFID tags store
identification information, usually in the form of an
identification number, product name and/or other information that
corresponds to an object or item to which the tag is attached. This
number may be used to index a database containing price, product
name, manufacture and/or other information. When a transponder tag
enters an RF field generated by a reader device, the circuit of the
tag becomes energized causing the processor to perform a data
operation, usually by emitting a signal containing the processor's
stored information.
[0012] One advantage of RFID tags that makes them ideal for
identifying medical implants is that they provide a long term data
storage device that can hold more data than a bar code or other
machine readable label. Another advantage is that because RF waves
penetrate non-metallic materials, they do not require line of sight
and they can read through materials such as plastic, glass and even
human tissue. Also, while the tag circuits themselves are not
impervious to environmental damage, they can be encased, embedded,
or otherwise surrounded by hardened materials without degradation
in performance. Yet another advantage of RFID tags is that their
memory units can be rewritten to, that is updated to include new
information wirelessly. All of these advantages may make RFID tags
a particular useful identification technique for medical
implants.
[0013] Though RFID tags exist, and as discussed in incorporated
application 11/116,379 there use for identifying medical implants
has been proposed, there is a need for identification system that
incorporates RFID read and write technology with a data processing
device that is portable enough to be used in a surgical environment
but robust enough to interface with existing medical facility
patient record management systems to enable accurate and efficient
implant identification and tracking.
[0014] The description herein of various advantages and
disadvantages associated with known apparatus, methods, and
materials is not intended to limit the scope of the invention to
their exclusion. Indeed, various embodiments of the invention may
include one or more of the known apparatus, methods, and materials
without suffering from their disadvantages.
SUMMARY OF THE INVENTION
[0015] Based on the foregoing, there is a need for a data
processing system and a control and/or operating system for a data
processing system for identifying medical implants based on radio
frequency (RF) identification techniques. It would be desirable to
provide systems and methods for of programming RFID tags associated
with medical implants that can be used in an operating room
environment to receive a data entry including information to be
stored in the tag, validate the tag's readability once the implant
is set, and to update a patient record management system with a
data record including information regarding the implant and implant
surgical procedure, that are efficient, accurate and less reliant
on manual data entry.
[0016] Thus, it is a feature of various embodiments of the
invention to provide systems and methods for programming an RFID
transponder tag associated with a medical implant with data input
information relating to the implant, the patient, the procedure
and/or combinations of any of these.
[0017] Another feature of various embodiments of the invention
provides systems and methods for validating data written to an RFID
tag associated with a medical implant once the implant is set in
the patient and at future times to recall information about the
implant, patient, and or procedure to set the implant.
[0018] Yet another feature of various embodiments of the invention
provides systems and method for transferring a data record
regarding an implant surgical procedure to a patient record
management system.
[0019] Still a further feature of various embodiments of the
invention provides systems and methods for identifying medical
implants upon subsequent visits to a medical practitioner that are
rapid, non-invasive and relatively inexpensive to administer.
[0020] To achieve the above-noted features, and in accordance with
the purposes as embodied and broadly described herein, an
RFID-based medical implant identification process is provided. The
medical implant identification process according to this embodiment
comprises entering a first data input into a data processing
system, writing the data input to a memory of an RFID tag
associated with a medical implant, and validating the data in the
tag after the medical implant is set.
[0021] In accordance with another exemplary embodiment, a control
system for an RF- enabled data processing system for medical
implant identification is provided. The control system according to
this embodiment comprises a data input module for receiving a data
input corresponding to a medical implant, an RF transceiver module
adapted to write data from the data input to an RFID tag associated
with the medical implant and to read the written data from the tag
to validate that the data was written, and an output module adapted
to provide a visual indication to an operator based on the
validation.
[0022] In accordance with a further exemplary embodiment, a data
processing system containing computer readable instructions stored
therein for operating a medical implant identification system is
provided. The data processing system according to this embodiment
comprises instructions for receiving a data input, instructions for
writing the data input to a memory of an RFID tag associated with a
medical implant, and instructions for validating that the data is
readable after the medical implant is set in the patient.
[0023] These and other embodiments and advantages of the present
invention will become apparent from the following detailed
description, taken in conjunction with the accompanying drawings,
illustrating by way of example the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Purposes and advantages of the embodiments will be apparent
to those of ordinary skill in the art from the following detailed
description in conjunction with the appended drawings in which like
reference characters are used to indicate like elements, and in
which:
[0025] FIG. 1 is a perspective view of system for identifying
medical implants in a surgical environment in accordance with at
least one embodiment of the invention;
[0026] FIG. 2 is a flow chart detailing the steps of a method for
operating a control system for a medical implant identification
apparatus and system in accordance with at least one embodiment of
the invention; and
[0027] FIG. 3 is a block diagram illustrating modules of a control
system for a medical implant identification apparatus and system in
accordance with at least one embodiment of the invention.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0028] The following description is intended to convey a thorough
understanding of the embodiments described by providing a number of
specific embodiments and details involving systems and methods of
programming and tracking medical implants using radio frequency
identification techniques. It is understood, however, that the
present invention is not limited to these specific embodiments and
details, which are exemplary only. It is further understood that
one possessing ordinary skill in the art, in light of known systems
and methods, would appreciate the use of the invention for its
intended purposes and benefits in any number of alternative
embodiments, depending upon specific design and other needs.
[0029] As used herein, the expressions "RFID tag" and "RFID
transponder tag" will refer to any active or passive type of
electronic data storage device, read-only or read and write, that
is wirelessly activated in the presence of a radio frequency (RF)
field, including any currently available inductively coupled RFID
tags, capacitively coupled RFID tags and even future RF-type tags
not yet available. This includes tags operating in the 125 kHz,
13.56 MHz, 868-927 MHz, 2.45 GHz and 5.8 GHz frequency bands as
well as other suitable frequency bands. Also, the tag may be a
silicon-type IC tag, a printed tag printed with a conductive
ink-based printing process or a tag formed by other suitable
means.
[0030] As used herein, the terms "write" and "program" in the
context of storing data to a memory structure contained in an RFID
transponder tag circuit will be used synonymously to refer to the
process of transmitting a radio frequency signal that has been
modulated to contain identification information to be stored in the
memory structure. The tag circuit includes an antenna, processor
and memory structure. The tag circuit is able to receive the
signal, recover the encoded information and store that information
in the non-volatile memory structure so that it can be wirelessly
accessed by RFID reader devices.
[0031] Through out this description, the terms "verify" or
"validate" in the context of confirming that data has been
successfully written to an RFID transponder tag will refer to using
a RF module to create an RF field to "read" information from the
tag and to compare the read information to a data input that was
written to the tag. "Reading" in the context of reading data from
an RFID tag will simply refer to creating an RF field to read
information from a tag. This information may or may not be used to
index a database containing more detailed information associated
with the read information.
[0032] As used herein, the phrase "medical implant" will be given
broad scope including implants such as artificial joints (i.e.,
hips, knees, hand portions), spinal implants, active medical device
implants such as cardiac defibrillators, cardiac pacemakers,
gastrointestinal pace makers, arterial stints, as well as other
passive or active implantable medical devices.
[0033] As used herein, the expression "patient record management
system" will be given broad interpretation to refer to any
conventional or future computer-based record management system
utilized in medical facilities to keep track of current and past
patient information including personal information, health
information, insurance information, procedure information and other
necessary information.
[0034] Referring now to FIG. 1, a system for identifying medical
implants in a surgical environment in accordance with at least one
embodiment of the invention is depicted. In the example of FIG. 1,
the system comprises a hand held data processing apparatus 100
adapted for use in a surgical environment such as an operating
room. The apparatus 100 itself may comprise an interface including
a display 105 and a keyboard 110. The apparatus 100 may also
comprise various other interface components instead of or in
addition to those depicted in FIG. 1 including, but not limited to,
a biometric input device, voice input device, mouse, stylus, bar
code scanner, printer, etc. In various embodiments, the apparatus
100 will also comprise an RF module adapted to generate both read
and write RF signals. An operating room scene is depicted in the
Figure including a patient 50 and corresponding implant surgery
site 55. A sheet or other suitable cover 40 is used to highlight
the surgery site 55.
[0035] In various embodiments, an operator inputs information
relating to a medical implant into the apparatus 100 using the
interface 105, 110. As will be discussed in greater detail herein,
the apparatus 100 may include a bar code scanner for scanning a bar
code label as an input or the device may receive manual input via
the keyboard 110 or display. Alternatively, a wireless connection
120 to an external database may be used to gather additional
information relating to the medical implant. In various
embodiments, an RF module in the apparatus 100 will transmit an RF
signal 115 to an RFID transponder tag associated with the medical
implant. The RFID transponder tag may be contained in the implant,
attached to the implant or otherwise physically associated with the
implant In various embodiments, the RF module of the apparatus 100
will also perform a read operation by reading the information
written to the tag. In various embodiments, this may be performed
prior to setting the implant in the patient's body to insure that
the tag is not defective. However, in various embodiments, because
RF waves can penetrate soft tissue, this may also be performed
after the implant is set but prior to surgical site closure to
insure that the tag remains readable from inside the patient's
body.
[0036] In various embodiments, as will be discussed in greater
detail herein, the apparatus may create a data record following
validation of the data stored in the tag after setting the implant
and transmit the data record wirelessly over a wireless network 120
in a medical facility so that a database or other patient record
management system can retain the data record.
[0037] It should be appreciated that although the apparatus 100
shown in FIG. 1 is a unitary, hand-held apparatus, the apparatus
100 may, in various embodiments, he part of a distributed system or
non-unitary system such as a desktop terminal with a wired or
wireless bar code reader and a wired or wireless RFID
reader/writer, both of which are in communication with the desktop
terminal. The various embodiments of the invention are not
dependent upon a particular configuration, but rather use an
integrated control system for identifying medical implants. In
various embodiments, the apparatus 100 may write the information
input to the apparatus directly to the RFID transponder tag
associated with the medical implant. In various embodiments, the
apparatus 100 may use the input information to index a table and/or
database containing more detailed information associated with input
information and, write this detailed information as well as the
input information to the RFID tag associated with the medical
implant. The detailed information may reside in the apparatus 100
or in an external database that is queried by the apparatus 100
using wireless signals 120 broadcast over a wireless network as
will he discussed in greater detail herein. It should be
appreciated that a wired network connection may also be used if the
possibility of interference to medical equipment precludes use of
wireless networks. If the apparatus 100 is stationary device such
as stationary bench or work station, the user may move a
transponder tag and/or the implant transponder tag assembly into an
RF field area of the apparatus to write the information to the
tag.
[0038] The apparatus may also have an LED panel 115 comprising one
or more LEDs 115 for providing a visual indication to an operator
of the success or failure of RF- based read and write operations
performed with the apparatus 115. In addition, information relating
to the success or failure may be output to the display 105 and/or
to an integral speaker.
[0039] Referring now to FIG. 2, a flow chart detailing the steps of
a method for operating a control system for a medical implant
identification apparatus and system in accordance with at least one
embodiment of the invention is illustrated. The method begins in
step 200 and proceeds to step 205 where a data input is received by
the system. In various embodiments, this may comprise receiving a
data input supplied by an operator keying in an identification
number or other unique indicia associated with a medical implant.
In various embodiments, this may comprise scanning a bar code label
attached to a medical implant or a storage/shipping container for
the medical implant. In various embodiments, this may comprise
entering a patient name, ID or other code that can be used to index
a database containing information corresponding to the medical
implant. In various embodiments, the data input may include a
combination of information obtained through direct operator input
and through querying a database such as, for example, a patient
record management system. In various information all the
information comprising the data input is temporarily stored.
[0040] Next, in step 210, the data input is written to an RFID
transponder tag associated with or attached to the medical implant.
In various embodiments, the medical implant may be manufactured
with an integral RFID tag. In various other embodiments, a tag may
be attached to an implant after the implant's manufacturing
process. In various embodiments, after writing the data input to
the RFID tag, a read operation is automatically performed to
confirm that the data was successfully written and that the tag is
not defective.
[0041] Operation of the method then proceeds to step 215 where the
implant is inserted into the patient. This step may involve a
variety of different sub-steps not relevant to the particular
inventive methods of the systems and method of the present
invention depending upon what type of medical implant is being
implanted into the patient. After the implant has been set, in step
220, the tag is validated. In various embodiments, this will
comprise holding a portable reader device over the portion of the
patient's body where the implant is set and generating a read
signal with the device. The read signal will energize the tag's
circuit and cause it to transmit a signal including the information
stored in the tag to the reader device. In various embodiments,
validation will include comparing the information read from the tag
to the data input that was written to the tag in step 210. If the
read data and data input are the same, the tag will be presumed
validated. Otherwise, an error message may be output to alert the
operator that the tag was not validated. As discussed above, in
various embodiments, if in the validation step 220, the tag is
validated, a signal may be sent to a database such as a patient
record management system including a record of the implant
procedure, the record comprising at least part of the data input
written to the tag. The record may also comprise information
relating to the procedure such as, the surgeon, the surgical team,
the date, the time, etc. Operation of the method ceases in step
225.
[0042] After performing the steps of the method of FIG. 2, when a
patient returns to a medical facility for subsequent visits,
information regarding his/her medical implant as well as the
procedure that implanted it may be instantly obtained by scanning
over a portion of the patient's body containing the implant to read
data from the RFID tag associated with the implant. In this manner,
a physician may be able to obtain information about the patient,
about the age of the implant, and even historical information such
as number and date of checkups on the implants since it was
surgically implanted without having to expose the patient to x-rays
or other diagnostic imaging and without having to manually retrieve
database information. In various embodiments, a complete medical
record may be retrieved from the tag. In various other embodiments,
only an identification number or one or more other data fields may
be retrieved from the tag. The identification number and/or the one
or more other data fields may then be used to index a database
containing detailed information regarding the patient and the
transactional history of the implant. This system may also be
useful for alerting the patient for ongoing information regarding
his/her implant. For example, if after an implant is set in a
patient, the manufacturer discovers that the implant or a component
thereof may not be functioning properly, the manufacturer may issue
a warning or even a recall. If the warning and/or recall
information is input into the implant identification system, when
the patient returns to his/her physician for a checkup on the
implant, wirelessly scanning the implant will automatically alert
the physician that the implant of this patient has a warning or
recall associated with it so that the doctor can respond
appropriately. Another advantage is that in some cases, such as
emergency or trauma case, a patient may be incapable of alerting
medical professionals of the presence of a particular medical
implant. Therefore, by using the systems and methods of the present
invention, a medical professional may be able to run a handheld
scanner over patient's body prior to performing any treatment on
that patient. If any RF-enabled medical implants are present, the
professional will be alerted by the device and will he/she will be
able to design a course of treatment that is not incompatible with
the presence of the medical implant.
[0043] Referring now to FIG. 3, a block diagram illustrating
modules of a control system for a medical implant identification
apparatus and system in accordance with at least one embodiment of
the invention is depicted. The system 300 comprises a plurality of
modules including a control module 305, a memory module 310, a
storage module 315, a communication module 320, an interface module
325 and an RF module 330. In accordance with the various
embodiments of the invention, each module may comprise a separate
circuit, routine or application, may be based in hardware, in
software, or both, may be firmware, may be discrete components of a
modular system or merely subroutines/subcomponents of the same
system, such as a single computer program stored in a memory
structure of a device, such as a portable RF-based medical implant
identification apparatus. The control module 305 may in various
embodiments be a microprocessor, a digital signal processor (DSP),
control system, virtual instrument, program kernel or other
suitable command issuing structure. The memory module 310 may
comprise a volatile memory structure such as random access memory.
The storage module 315 may comprise a non-volatile memory such as
flash memory, hard disk, CDRW, DVRW, holographic storage or other
storage media. The communication module may comprise an
Ethernet-based local area network (LAN) card, a wireless Ethernet
card, a modem, Bluetooth transmitter, IR transmitter or other
suitable two-communication device.
[0044] In various embodiments, an operator will interact with the
system 300 through the user interface module 325. As discussed
herein, this module 325 may include a keyboard, mouse, stylus,
biometric sensor, bar code scanner, display screen or other
interface that allows a user to interact with the system such as to
input information, issue commands, power the device on and off,
perform file management, upgrade software and database information,
monitor output, receive feedback and perform other administrative
and non-administrative tasks.
[0045] In various embodiments when a user issues a command to
commence a medical implant identification operation through the
user interface module 325, the control module 305 will cause the
interface module 325 to prompt the user for a data input. As
discussed herein the data input may be an identification number of
the implant. Either automatically or based on an operator
indication through the interface module 325, the control module may
activate a bar code scanner connected to the interface module 325
so that the operator can use the scanner to provide the data input.
Also, the control module 305 may, in various embodiments, use the
data input to interrogate a database in the storage module 315 to
index a database of patient information. Alternatively, the control
module 305 may activate the communications module 320 to access and
interrogate a remote database, such as by issuing a command signal
through a wireless transceiver, the command signal containing the
data input. The data input, as well as any additional information
received from either the storage module 315 and/or a remote
database may be at least temporarily stored by the control module
305 in the memory module 310.
[0046] Once the data input has been received and stored in the
memory module 310, the control module may prompt the user through
the interface module 325 to perform an RF write operation to
program the data input to an RFID transponder tag attached to or
otherwise associated with the medical implant that corresponds to
the data input. When the user responds to this prompt by selecting
a write operation through the interface module 325, the control
module 305 may activate the RF module 330 to transmit a signal
including the data input by way of an RF- based signal that is
transmitted in an area containing the implant and/or the RFID tag.
In various embodiments, after the signal has been transmitted, the
control module 305 may activate the RF module 330 to perform a read
operation by transmitting an RF-based signal to the tag, causing it
to become energized and to transmit its stored information. The
control module 305 may compare the information read from the RF
module 330 during the read operation with the data input stored in
the memory module 310. If these two pieces of information match,
the control module 305 may activate the interface module 325 to
provide a positive indication to the user. Otherwise, the control
module 305 may activate the interface module 325 to provide a
negative indication to the user. In various embodiments, the
control module 305, after verifying a successful read operation may
cause the communication module to transmit a data record to a
remote database such as a patient record management system
including a record of the data input and optionally, information
relating to the procedure including a surgeon, surgical team, time,
date, location, patient information, and other procedure specific
information. Alternatively, the control module may store the record
information in the storage module 315 until the operator issues a
command through the interface module to upload the information to a
remote database.
[0047] Subsequent access to the information stored in the implant's
transponder tag may be facilitated by the operator selecting a scan
patient option from a menu displayed by the interface module 325.
Upon selecting such an option, the control module 305 will activate
the RF module 330 to generate an RF read signal and may also
activate the interface module 325 to output an instruction to the
operator to pass the device over the patient's body. Information
obtained by the RF module 330 may be stored in the memory module
310. Depending upon the extent of this information, the control
module 305 may retrieve additional information from the storage
module 315 or an external database using the communication module
320 using the read information as an index to obtain additional
information. Or if, sufficient information is contained in the tag
itself, the control module may automatically activate the interface
module 325 to display the stored information and/or any additional
information. The control module may also cause the interface module
325 to prompt the operator to print a paper record on an attached
output device that is part of the interface module 325 or may
automatically activate such an output device. The control module
may store any additional information provided in the subsequent
record in the storage module 315, such as, for example, doctor's
notes. Alternatively, or in addition, the control module 305 may
prompt the user through the interface module 325 to place the
device back over the implant area so that the control module can
activate the RF module 330 to transmit a write signal to the
implant's transponder tag to write the additional information. As
with the process of FIG. 2, the control module 305 may
automatically perform a validation operation after updating the
implant with the additional information. Alternatively, the control
module 305 may prompt the user through the interface module 325 to
perform such an operation to validate that the additional
information was successfully written to the tag. The control module
305 may activate the interface module 325 to output a message
regarding the success of this operation.
[0048] The embodiments of the present inventions are not to be
limited in scope by the specific embodiments described herein. For
example, although many of the embodiments disclosed herein have
been described with reference to control and/or operating systems
for systems and apparatuses for identifying medical implants using
RF identification techniques, the principles herein are equally
applicable to other aspects radio frequency-based identification
indeed, various modifications of the embodiments of the present
inventions, in addition to those described herein, will be apparent
to those of ordinary skill in the art from the foregoing
description and accompanying drawings. Thus, such modifications are
intended to fall within the scope of the following appended claims.
Further, although some of the embodiments of the present invention
have been described herein in the context of a particular
implementation in a particular environment for a particular
purpose, those of ordinary skill in the art will recognize that its
usefulness is not limited thereto and that the embodiments of the
present inventions can be beneficially implemented in any number of
environments for any number of purposes. Accordingly, the claims
set forth below should be construed in view of the full breath and
spirit of the embodiments of the present inventions as disclosed
herein.
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