U.S. patent application number 13/184289 was filed with the patent office on 2012-05-10 for database management for a treatment system.
This patent application is currently assigned to IZEX Technologies, Inc.. Invention is credited to Steven Backes, Timothy J.B. Hanson, Gary Manninen, Duane Oyen, John G. Stark, Timothy Tracey.
Application Number | 20120116806 13/184289 |
Document ID | / |
Family ID | 23287417 |
Filed Date | 2012-05-10 |
United States Patent
Application |
20120116806 |
Kind Code |
A1 |
Stark; John G. ; et
al. |
May 10, 2012 |
DATABASE MANAGEMENT FOR A TREATMENT SYSTEM
Abstract
A process for treating orthopedic injuries including the steps
of presenting a set of treatment protocols; approving a treatment
protocol from among the presented set of treatment protocols;
capturing information identifying the approved treatment protocol
from among the set of presented protocols; and generating
information from the captured information into a form compatible
with a handheld computer adapted for connection to an orthopedic
sensor system. The generated information includes parameters of the
identified approved treatment protocol. The process may also
include the steps of basing the presented set of treatment
protocols upon a database of historic patients, orthopedic
injuries, treatment protocols and outcomes, and retaining
information about the current patient, the patients injury,
treatment protocol and outcome.
Inventors: |
Stark; John G.; (Deephaven,
MN) ; Oyen; Duane; (Maple Grove, MN) ; Hanson;
Timothy J.B.; (Plymouth, MN) ; Tracey; Timothy;
(Wayzata, MN) ; Backes; Steven; (Minneapolis,
MN) ; Manninen; Gary; (Maple Grove, MN) |
Assignee: |
IZEX Technologies, Inc.
Golden Valley
MN
|
Family ID: |
23287417 |
Appl. No.: |
13/184289 |
Filed: |
July 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09968595 |
Oct 1, 2001 |
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13184289 |
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09329880 |
Jun 11, 1999 |
6371123 |
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09968595 |
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Current U.S.
Class: |
705/3 |
Current CPC
Class: |
A61B 90/00 20160201;
G16H 50/70 20180101; G16H 20/00 20180101; Y10S 128/92 20130101;
A61B 34/10 20160201; G16H 70/20 20180101; G06F 19/00 20130101 |
Class at
Publication: |
705/3 |
International
Class: |
G06Q 50/24 20120101
G06Q050/24 |
Claims
1.-39. (canceled)
40. A system for monitoring patient compliance with a treatment
protocol, the system comprising: a server configured to: present at
least two orthotic injury treatment protocols; receive information
identifying an approved treatment protocol, wherein the approved
treatment protocol is one of the at least two presented treatment
protocols; generate formatted parameters, using a computer
processor, the formatted parameters corresponding to the approved
treatment protocol and in a form compatible with a monitoring
device; send the formatted parameters to the monitoring device;
receive compliance data generated by the monitoring device; present
the compliance data generated by the monitoring device; wherein the
monitoring device is configured to: receive data from a sensor
included on an orthosis device; generate the compliance data based
on the data from the sensor and the formatted parameters, the
compliance data indicating adherence to the treatment protocol;
send the compliance data to the server.
41. The system of claim 40, wherein the at least two orthotic
injury treatment protocols comprise a set of images.
42. The system of claim 40, wherein the at least two orthotic
injury treatment protocols comprise prior patient records of
patients with similar injuries.
43. The system of claim 42, wherein the at least two orthotic
injury treatment protocols comprise statistical information
including a success rate of the at least two orthotic injury
treatment protocols.
44. The system of claim 40, wherein the information identifying the
approved treatment protocol includes information relaying the
degree of motion to be accomplished by a patient.
45. The system of claim 40 wherein the server is configured to:
compare the formatted parameters against a safeguard to determine
if the formatted parameters are consistent with patient data.
46. The system of claim 40, wherein the received information
identifying the approved treatment protocol is less than
information detailing the approved treatment protocol in its
entirety.
47. A machine readable medium that stores instructions, the
instructions, which when performed by a machine, cause the machine
to perform operations comprising: presenting at least two orthotic
injury treatment protocols; receiving information identifying an
approved treatment protocol, wherein the approved treatment
protocol is one of the at least two presented treatment protocols;
generating formatted parameters corresponding to the approved
treatment protocol, the formatted parameters in a form compatible
with a monitoring device; sending the formatted parameters to the
monitoring device; receiving compliance data, the compliance data
generated by the monitoring device, the compliance data based on
data received from a sensor and the formatted parameters, the
sensor included in an orthosis device; and presenting the
compliance data generated by the monitoring device.
48. The machine readable medium of claim 47, wherein the at least
two orthotic injury treatment protocols comprise a set of
images.
49. The machine readable medium of claim 47, wherein the at least
two orthotic injury treatment protocols comprise prior patient
records of patients with similar injuries.
50. The machine readable medium of claim 49, wherein the at least
two orthotic injury treatment protocols comprise statistical
information including success rate of the at least two orthotic
injury treatment protocols.
51. The machine readable medium of claim 47, wherein the approved
treatment protocol includes information relaying the degree of
motion to be accomplished by the patient.
52. The machine readable medium of claim 47, wherein the
instructions include instructions which when performed by the
machine, cause the machine to perform operations comprising:
comparing the formatted parameters against a safeguard to determine
if the formatted parameters are consistent with patient data.
53. The machine readable medium of claim 47, wherein the received
information identifying the approved treatment protocol is less
than information detailing the approved treatment protocol in its
entirety.
54. A method for monitoring patient compliance with a treatment
protocol, the method comprising: presenting, with a server, at
least two orthotic injury treatment protocols; receiving, at the
server, information identifying an approved treatment protocol,
wherein the approved treatment protocol is one of the at least two
presented treatment protocols; using a computer processor,
generating with the server, formatted parameters corresponding to
the approved treatment protocol, the formatted parameters
configured in a form compatible with a monitoring device; sending,
with the server, the formatted parameters to the monitoring device;
receiving, at the monitoring device, data from a sensor included on
an orthosis device; generating, using the monitoring device, the
compliance data based on the data from the sensor and the formatted
parameters, the compliance data indicating adherence to the
treatment protocol; sending, using the monitoring device, the
compliance data to the server; receiving, at the server, compliance
data generated by the monitoring device; and presenting, with the
server, compliance data generated by the monitoring device;
55. The method of claim 54, wherein the at least two orthotic
injury treatment protocols comprise a set of images.
56. The method of claim 54, wherein the at least two orthotic
injury treatment protocols comprise prior patient records of
patients with similar injuries.
57. The method of claim 56, wherein the at least two orthotic
injury treatment protocols comprise statistical information
including success rate of the orthotic injury treatment
protocol.
58. The method of claim 54, comprising: comparing the formatted
parameters against at least one safeguard to determine if the
formatted parameters are consistent with patient data.
59. The method of claim 54, wherein the received information
identifying the approved treatment protocol is less than
information detailing the approved treatment protocol in its
entirety.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims the benefit
of priority under 35 U.S.C. .sctn.120 to U.S. patent application
Ser. No. 09/968,595, entitled "DATABASE MANAGEMENT FOR A TREATMENT
SYSTEM," filed on Oct. 1, 2001, which is a continuation of and
claims the benefit of priority under 35 U.S.C. .sctn.120 to U.S.
application Ser. No. 09/329,880, entitled "SYSTEM FOR ORTHOPEDIC
TREATMENT PROTOCOL", filed on Jun. 11, 1999, now U.S. Pat. No.
6,371,123, issued on Apr. 16, 2002, all of which are hereby
incorporated by reference herein in their entirety.
BACKGROUND OF THE INVENTION
Field of Invention
[0002] The present invention relates to orthopedic treatment
processes and, in particular, the present invention relates to
preparing orthopedic treatment protocols used in conjunction with
computerized or digitalized orthopedic treatment devices.
[0003] Orthopedic treatment historically involved a physician
examining and diagnosing an orthopedic injury in a patient,
prescribing a treatment protocol of activities or exercises for the
patient to follow in order to facilitate healing, and subsequent
re-examination to assess patient progress. Additionally, the
patient was traditionally guided and assisted in following the
prescribed treatment protocol by trained medical professionals,
such as physical therapists, who could inform and advise the
attending physician concerning patient compliance with the protocol
and communicate and assist with the patient to provide desired
activity details and elicit patient response. The traditional
treatment path often included either hospitalization or patient
visits at a physical therapy facility.
[0004] In modern times, financial pressure upon the medical arts
and the surrounding medical industry has increased the number of
patients each physician must treat and reduced the rate of
hospitalization and tendency to employ physical therapy facilities,
as well as reduced the direct supervision of the patient activities
by the physical therapist. Computerized devices have been developed
that at least partially substitute for the physical therapist
contact, and yet monitor patient activities under a treatment
protocol. One particularly innovative device system, the IZEX
sensor-instrumented orthosis and associated Smart IDEA.TM.
computer/communicator, not only replace much of the physical
therapist's function of (1) advising and instructing the patient
and (2) advising the attending physician of patient compliance, but
also allow an improved measuring and monitoring of patient
rehabilitation activities and exercise parameters, such as effort
exerted in rehabilitation exercises or stress applied to the
orthopedic injury. This improved monitoring enables exploitation of
a long observed and literature documented phenomenon of improved
recovery in response to appropriately applied exercises to
orthopedic injuries. The topic of accelerated and improved recovery
through the use of controlled bio-feedback based rehabilitation has
been reviewed extensively by one of the present inventors in
patents U.S. Pat. No. 5,052,375; U.S. Pat. No. 5,368,546; U.S. Pat.
No. 5,484,389; and U.S. Pat. No. 5,823,975, and the entire
disclosures of these patents are incorporated herein by
reference.
[0005] The ultimate goal of efficiency and optimal and accelerated
recovery outcomes still remains elusive, however, since the
utilization of the IZEX.TM. orthosis brace system and Smart
IDEA.TM. computer/communicator continues to rely upon physician
examination, diagnosis and prescription of a treatment protocol for
the injured patient. The physician may not readily know nor have
available information concerning the optimal treatment protocol for
an accurately diagnosed injury. It would be a significant advance
in orthopedic treatment if a physician or other treatment
professional could be rapidly advised concerning optimal treatment
information based upon up-to-date experiential outcomes of similar
treated injuries. It would also be a significant advance if the
physician or treatment professional could leverage their own
expertise and their colleagues' most recent knowledge to
appropriately modify and adapt previously successful protocols to
fit a new patient. It would also be a significant advance if the
protocol could be installed in a handheld computer (monitoring
device/computer/communicator) device with ease and efficiency.
Additionally, it would be a significant advance to allow
modification, particularly real-time modification, of
rehabilitation exercise protocols by a user or in response to a
user request, with such modification being limited by reasonable
constraints. The following invention provides such advances to the
orthopedic arts.
BRIEF DESCRIPTION OF THE FIGURES AND APPENDICES
[0006] FIG. 1 is a schematic diagram of the relationship between
participants and equipment used in the process according to the
present invention;
[0007] FIG. 2 is a schematic of the steps included in the process
of the present invention;
[0008] FIG. 3 is a schematic of details of the generation step of
FIG. 2; and
[0009] FIG. 4 is a another schematic of the inter-rationships of
the systems of the present invention, especially between external
inputs (left column), the handheld portable computer, for example
an IZEX brand SMART IDEA (center column), and an external
fileserver with a database (right column.)
[0010] Appendix A is a recorded data format for use in the present
invention;
[0011] Appendix B is a protocol structure definition for use in the
present invention;
[0012] Appendix C is another view of various embodiments of an
orthopedic treatment system/process/&method of the present
invention; and
[0013] Appendix D is another schematic view of the data handing,
flow, components and approaches of the present invention.
SUMMARY OF THE INVENTION
[0014] The present invention, in a first embodiment, is a process
for treating an orthopedic injury. The inventive process involves
performing a number of steps to generate information about a
prescribed protocol for treating the orthopedic injury of a
patient. Such generated information may be in the form of a script,
which may be used in a handheld computer and orthosis device
combination to treat an orthopedic injury. The process steps
include: [0015] a.) Presentation of a set of treatment protocols.
The presented set of protocols includes at least one treatment
protocol. The presentation might be on a display screen or a paper
printout or similar hardcopy or both. (as represented for example
in FIG. 2 at "1a") [0016] b.) Approval of a treatment protocol from
among the presented set of treatment protocols. This step is
undertaken by a treatment professional using professional judgment
and, generally, the approval is made in light of further
information about the treatment protocol which is being approved.
(as represented for example in FIG. 2 at "1b") [0017] c.) Capture
information identifying the approved treatment protocol of the set
of presented protocols. (as represented for example in FIG. 2 at
"1c") and. [0018] d.) Generate information from the captured
information into a form compatible with a handheld computer adapted
for connection to an orthopedic sensor system, wherein the
generated information includes parameters of the identified
approved treatment protocol. (as represented for example in FIG. 2
at "1d")
[0019] Additionally the method may include e.) communication from
the portable monitoring and communication device of information
concerning interactions, communication exchange and/or patient
exercise; and f.) modification of the treatment protocol; and g.)
monitoring the new protocol.
[0020] The present invention includes a number of further
embodiments. One particularly notable embodiment involves a
database of historic information of earlier patients, their
injuries, their actual treatments protocols as performed, and
resulting outcomes and a communications and data method to connect
the two optimizing functions together. Information is accumulated
in such a database during the process of certain embodiments and
information from the database is made available and utilized in
other embodiments.
[0021] The present invention in another embodiment is a system for
treating an orthopedic injury. The system includes a handheld
computer adapted for connection to an orthopedic sensor system, a
central computer including historic database of orthopedic
injuries, patient characteristics, treatment protocols and
outcomes. With the system, the central computer is queried to
present a set of treatment protocols to a treatment professional.
The treatment professional approves a treatment protocol of the set
and the system generates formatted parameters corresponding to the
approved treatment protocol for installation in the handheld
computer. Once installed with such parameters, the handheld
computer can mediate the approved treatment protocol when it is
connected to the orthopedic sensor system. The system further
includes monitoring performance of the treatment protocol and
updating the historic database with the monitored performance
parameters. The system further includes modification of the
formatted treatment protocol parameters in real-time in response to
updates to the historic database. Data which is transmitted to the
central computer can be analysed against other databases and more
channels and sent on for other analysis. When the data is sent
(COMMUNICATED) secure communication may be optionally employed.
DETAILED DISCLOSURE OF PREFERRED EMBODIMENTS
[0022] The present invention, in a first embodiment, is a process
for treating an orthopedic injury of a patient under care of a
treatment professional. The process is illustrated in FIG. 2 at 10
and FIG. 1 is provided to depict relationships between participants
and equipment in carrying out the inventive process 10. The process
10 includes the following steps:
[0023] First, a set of treatment protocols is presented "1a" to the
treatment professional 12. The set of treatment protocols to be
presented includes at least one treatment protocol but optionally
and often includes a plurality of treatment protocols which relate
to the patient's orthopedic injury. The presentation step may
include, preferably, displaying the set as an image, preferably a
set of images on a computer screen 14, such as a CRT screen or LCD
screen, or may include providing a printed copy 14 of the presented
set, or may provide both. The presentation may be graphical,
textual or a mixture of graphical and textual. Additional
information, again graphical, textual or mixed graphic and text may
accompany the presentation, for example, in order to provide
additional information about the protocol set or individual
protocols of the set. Examples of additional information which may
be presented to the treatment professional are historic,
statistical, or predicted outcomes. As with the earlier mentioned
presentation of the set, such additional information may be
presented textually or as a graphic, including a color attribute of
a graphic or text being presented.
[0024] To explain further the step of presentation of the set of
treatments protocols to the treatment profession, consider some
preferred embodiments and a few illustrative examples. One
preferred presentation includes graphical figures or icons on the
screen, wherein the graphical figures are animated such that they
facilitate rapid comprehension of the form of exercise motion being
presented. For example, in the situation of an orthopedic injury
associated with a patient's knee, the treatment professional might
be presented with a screen display having a set of animated
graphical figures representing possible treatment protocols
involving the patient's knee performing bending exercises. This may
be accomplished by including animated movement of either a set of
stick-characters' legs with knees bending or a more realistic
depiction of side views of legs having bendable or bending knees.
In such an animated graphical representation, the degree of bending
of each of the depicted animated knees is presented as an animated
graphic by a series of screens with incremental changes of screen
positions of one or both of the portions of the leg adjacent the
knee. The sequential display of such screens conveys an impression
of motion, in the form of knee bending, to the treatment
professional. An arcuate arrow using the knee as an axis or pivot
point, might show limits of range of motion for one or more of the
bending knees. Textual information might also be simultaneously
presented, for example, the patient's name or similar
identification might show on the screen as well as the degree of
motion being depicted by the arcuate arrow. Additionally, sounds,
such as oral descriptions of the exercise treatments protocols or
associated parameters, including especially patient directed voice
comments, might be presented or made available for presentation
with the set, or individual treatment protocols of the set.
[0025] It should be recognized that the ability to directly utilize
sound files for patient directed voice comments requires inclusion
of a speaker in the hand-held computer, however, patient directed
voice comments alternatively might be provided as separate analog
or digital recordings, for example, as cassette tapes or compact
disk recordings and the patient directed to listen by visual
information provided by the hand-held computer. Moreover,
computerized video files or the availability to call up a
designated computerized video file, may also be included in the
presentation. As with sound files, the efficiency of presentations
including video files is dependent on the availability of
sufficient communications "bandwidth." However, both the treatment
professional and patient benefit from such richer or expandable
presentation of the set by rapidly and efficiently comprehending
and considering choices in available and appropriate treatment
protocol for the patient.
[0026] In a second step, a treatment protocol from amongst the
presented set of treatment protocols is approved by the treatment
professional "1b". In a preferred embodiment, the approval step
includes highlighting a graphical representation of the particular
treatment protocol selected for approval by the treatment
professional. This step may be performed efficiently by employing a
mouse or similar pointing device to move a cursor in a graphical
user interface (GUI) and clicking or double clicking to highlight
and approve the selected treatment protocol. Alternatively, in a
textual or mixed textual and graphical interface, each protocol,
including each of any number of predesigned, pre-entered protocols
has a protocol identifier such as a number or letter or name
associated with the treatment protocol. The protocol identifier for
the protocol which is to be approved is input from a keyboard and
entered. Other alternative approval steps may involve a touch
screen, lightpen, or voice input. In a most preferred embodiment,
the approving step includes causing a visual change to the
presentation upon a screen display and then inputting an "enter"
command, either by keyboard, by a mouse button click, by a voice
command of the treatment professional, or by touching the screen of
a touch sensitive screen display.
[0027] Next, the treatment professional's approval of a particular
treatment protocol of the presented set is captured "1c". That is,
information is captured which identifies the approved treatment
protocol of the set of presented protocols. In a first embodiment,
the captured identification is less than the entire information
detailing the approved treatment protocol, but may be used to
retrieve or regenerate the entire information; in a second
embodiment, the captured information includes the entire
information detailing the treatment protocol. To accomplish the
capture, a computer program is provided. A computer system 16 is
present, and may be one or more computers; optimally if separate
computers, the separate computers are linked, for example on an
intranet or on the Internet 32. Other programs 28 and 30 are
present in the computer system 16 as will be discussed
subsequently. Additionally, a historic database 26, also discussed
subsequently, is present in a memory/storage device and available
to the computer system 16.
[0028] In the next step "1d", information is generated from the
captured information into a form compatible with a handheld
computer adapted for connection to an orthopedic sensor system. The
generated information includes parameters and details of the
identified approved treatment protocol. This step might be
understood in terms of a translation of at least a portion of the
information used in the presentation set or represented by the
presentation set into a script usable by a handheld device such as
a SMART IDEA.TM. device available from IZEX Technologies, Inc,
Golden Valley Minn. The recorded data format and protocol structure
definition employed for data recording, storage, and subsequent
communication with the SMART IDEA device, are provided in
Appendices A and B respectively, and together are examples of a
suitable script for generation by this step. Example of other
handheld computer devices which may be adapted to serve in the role
of the handheld computer are the PALM PILOT brand series and PALM
brand series of handheld personal computers available from the 3COM
division of U.S. Robotics Corporation, the NINO brand handheld
computer of Phillips Electronics, the JORNADA brand of handheld
computers of Hewlett Packard. The SMART IDEA.TM. device 20 is
connectable to a compatible orthosis device 22 on the patient 24 to
be treated, such orthosis devices have been previously disclosed in
U.S. Pat. No. 5,052,375, the entire disclosure of which is hereby
incorporated by reference. An orthosis of this type includes
sensors or a system of sensors. When the sensor system of such a
device is connected to a suitable handheld computer, the step of
monitoring may be accomplished by receiving a signal from a sensor
or a system of sensors. The process may also be employed with
sensors directly attached to the body, (instead of mounted upon and
in conjunction with an orthosis,) which communicate by signaling
through a connection to a handheld computer, such as a SMART
IDEA.TM. device.
[0029] The generation step is shown in more detail in FIG. 3 at
"1d". The input is the captured identification information
resulting from earlier step "1c". The program 18 begins with a
retrieval 40 of the full set of protocol parameters for the
identified protocol from a protocol parameters database. The
protocol parameters database, in a preferred embodiment, is, or is
a subpart of, historic database 26. Next 42, the program 18 looks
for any modifications or other input from the treatment
professional 12. Possible modifications and input are discussed
subsequently but might include a recording of voice instructions to
the patient 24. If any modifications or other input are present, it
is combined with the parameters from the database to form a
modified or augmented treatment protocol. The protocol parameters,
possibly modified, are then checked 44 against a set of standard
checks or safeguards. The source of the safeguard information may
be based upon information stored in the historic database 26 or a
separate database, isolated from the historic database 26. Basis of
safeguarding information against which the parameters may be
checked are statistical norms, desired outcome information,
biomechanical safety data, parameter inter-relationships, and
information generated by querying the database, for example by
program 28, to determine whether a simulated outcome result is
consistent with the predicted outcome previously presented to the
treatment professional 12. Yet another safeguard involved checking
to see whether the protocol parameters are consistent with the
handheld computer 20 which will be used. This safeguard becomes
more significant should more than one model or type of handheld
computer 20 be present in an installed base of handheld computers
and variations exist between the capabilities of the handheld
computers 20. For example, if the protocol were supplying a patient
voice communication file or initiator of such a file to a handheld
computer 20 which is incapable of playing the file, then the check
would generate a prompt to the treatment professional to substitute
a different instruction set, different equipment, or augment the
sound limited handheld computer 20 with a compact disk player which
can be controlled by the handheld computer 20.
[0030] If the safeguard checking fails 46, then the program 18
preferably provides for a prompt 48 of the treatment professional
12 to provide different modifications. The prompt 48 is made by a
presentation to the treatment professional 12 that the modification
is unacceptable. Newly provided modifications, if any, are then
recombined with the original full treatment protocol parameter set
40 to reattempt to create a modified treat protocol parameter set
42. If the check passes, then the parameter set is formatted 50
consistent with the script acceptable to the handheld computer 20.
Appendices A and B represent a recorded data format and protocol
structure definition consistent and compatible with a SMART IDEA
device, and may be used in a process according to a preferred
embodiment of the present invention.
[0031] Having generated or translated the treatment protocol
information into an appropriate form, the process has resulted in
production of a treatment protocol script by an attending treatment
professional in an efficient manner. The treatment protocol script
is available and useful in treating the patient's orthopedic
injury. The most useful basic process of the present invention may
be employed, expanded, and incorporated into several inventive
processes, as summarized below.
[0032] In one preferred embodiment of the present invention, the
process further includes the step of loading 2 the generated
information in the handheld computer 20. Continuing the application
involving the SMART IDEA.TM. device, the information, in the form
of a script would be loaded into the SMART IDEA.TM. device. The
SMART IDEA.TM. device would then be available for connection to an
orthosis which may be attached or pre-attached to the patient. In
some situations, the loading may be by direct connection to the
treatment professional's computer, for example, through an RS-232
or PCI cable connection. In other situations, the two computers may
separated a considerable distance and the script communicated over
telephone lines through modem connections. In a most preferred
embodiment, the communication sending the script to load the SMART
IDEA.TM. device would be via the Internet 32, an intranet, or other
multi-media communication network.
[0033] In another preferred embodiment, the process further
includes the step of monitoring 3 patient activity relative to the
approved treatment protocol and storing data resulting from the
monitoring in the handheld computer. Continuing the explanation
utilizing the SMART IDEA.TM. device, the patient's exercise
activities, most preferably initiated in response to a patient
signal originating from the SMART IDEA.TM. device, are monitored
and stored in the SMART IDEA.TM. device. The SMART IDEA.TM. device
includes memory elements allowing for such storage of data.
[0034] In yet another preferred embodiment, the process continues
by adding the optional step of processing the stored data from the
monitoring, for determination of compliance relative to the
approved treatment protocol. This embodiment, involving what may be
termed "compliance processing" is within the data processing
capabilities of a SMART IDEA.TM. device.
[0035] In still another embodiment, the process further includes
the step of communicating information 5 concerning the stored
monitoring data to a central computer. Alternatively, the present
invention is embodied in a process including the further step of
communicating the processed stored data from the monitoring for
compliance relative to the approved treatment protocol to a central
computer. These embodiments may be understood as communicating raw
data or processed data from the SMART IDEA.TM. device to a central
computer, respectively. In a preferred embodiment of either of
these, the embodiments may communicate their respective data from
the SMART IDEA.TM. device to a central computer via the Internet or
an intranet. The communication might also involve a combination of
raw and processed data. If raw data is communicated, then the
process may further include the step of processing the communicated
information at the central computer. Data processed prior to
communication may also be further processed or reduced at the
central computer.
[0036] The data received at the central computer is available for
presentation 7 and preferably includes processed patient monitoring
and compliance information. As with the earlier presentation of the
set, the data may be presented, either on screen or in printed form
or both; and the presented data may be graphically, textually or a
combination of both. The data may also be used to update 8 a
historic database 26 with the processed patient compliance
information. Use of the data for presentation in order to allow
review by a treatment professional or in updating a historic
database are not mutually exclusive, and in a most preferred
embodiment, both steps are available and utilized in a treatment
process according to the present invention. It should be
understood, that the reviewing treatment professional and the
treatment professional involved in the earlier approval step are
not necessarily the same individual. Presented data and updated
data may additionally be communicated and employed for other uses,
such as for example, governmental compliance, insurance purposes,
and/or financial reimbursement or employment records. Methods of
limiting access to the data in the central computer for
confidentiality purposes or financial purposes are, of course well
known, and might include passwords or, in the case of intranets and
private access networks, may also include call back modems as
security enhancements.
[0037] In the process of the present invention, the treatment
protocol information resulting from the script generation step may
include parameters such as an exercise identification parameter, an
exercise replication parameter, and an exercise initiation timing
parameter. These parameters serve to define at least part of the
treatment protocol approved from the presented set of treatment
protocols.
[0038] Consistent with capabilities of a handheld computer such as,
by way of example, the SMART IDEA.TM. device, the handheld computer
may also include patient signaling capabilities selected from the
group consisting of audible signaling, visual signaling, and
tactile signaling. Similarly, the handheld computer may include
input capabilities selected from the group consisting of RS-232
input, sensor signal input, USB input, modem input, keyboard input,
audible input, light input, and Ethernet input. Moreover, the
handheld computer may include output capabilities selected from the
group consisting of RS-232 output, USB output, parallel port
output, light output, textual, graphical, audible output, Ethernet
input, and tactile output.
[0039] The present invention's usefulness may be further understood
in view of some particularly preferred embodiments. In one such
embodiment, the presented set of treatment protocols is based upon
information gleaned from a database 26. The database 26 includes a
plurality of historic treatment protocol records, the records
including fields populated by parameter data for patient
characteristics, orthopedic injury, actual treatment protocol
followed by the patient, and historic outcome. By "historic
treatment protocols" herein is meant herein actual, accomplished
and monitored treatment protocols; and by "historic outcomes"
herein is meant the actual, observed recovery or extent of recovery
resulting from such "historic treatment protocols." Additionally,
in a most particularly preferred embodiment, the database 26
further includes parameter data selected from the group of
characteristics consisting of patient physical characteristics,
patient psychological characteristics, and prescribed protocol
provided to the patient. In one variation of this treatment
process, the presented set of treatment protocols is based upon
statistical analysis of data base records. In another variation,
the presented set of treatment protocols includes at least portions
of one record of the database. That is, in the first variation the
treatment professional is presented with statistical information,
such as summaries, means, averages, medians or the like; in the
second variation, the treatment professional is presented with at
least portions of one or more records presented, where the records
are in effect individual case histories. Most preferably, the
presented case history records are of patients with similar
characteristics and similar injuries to the patient about be
treated.
[0040] In one embodiment, the treatment professional 12 has the
initial opportunity to query the database 26 with at least some
parameters characteristic of the current patient 24 and the current
patient's orthopedic injury. A computer program 28 is present in
the computer system 16 to query the database 26. This allows the
database 26 to be searched for similar case histories in the form
of historic records of treatment protocols and outcomes.
Alternatively, the query might be used to return statistical
information relevant to the patient 24. In an extension of these
treatment processes, the treatment professional 12 may modify the
initial query, to increase or decrease the number of returned
records for presentation. Additionally, the historic database 26
may allow queries for predicting the likely outcome of a treatment
protocol for a patient 24 with a particular set of characteristics
and a particular orthopedic injury. Using this approach, a
treatment professional 12 can rapidly investigate the efficacy of a
range of possible treatment protocols which they might envision for
the patient 24 with the orthopedic injury. Additionally, once at
least one treatment protocol is presented, the treatment
professional 12 may either modify the presented protocol or the
patient characteristics and either re-query the database 26 for
likely outcomes or proceed to approve the protocol. In this process
step, it is further provided that the treatment professional may
utilize the query program and historical database as part of the
treatment system of this invention to simulate an evaluation of a
treatment protocol under consideration for a particular patient,
then re-modify the treatment protocol based upon the simulation
outputs.
[0041] It is also part of the present invention that the treatment
professional may, in modifying the treatment protocol, select from
various pre-recorded sound files, one or more patient directed
voice comments, or record one or more individualized i.e.
customized voice comments to the patient. As mentioned previously,
the sound files may be played later for the patient as part of the
treatment protocol or conditionally played as part of the treatment
protocol. If the hand-held computer 20 includes the capability to
play sound files, then the files are played via the hand-held
computer 20. Alternatively, the handheld computer 20 may signal the
patient to play the recorded file, for example, by displaying a
message on an LCD screen for the patient to do an added
motivational or instructional task such as "Listen side #2 cassette
recording!" to cause the patient to play an analog cassette
recording of reproduced sound selected by or custom recorded by the
treatment professional. In another variation of this aspect of the
process, the sound files may be provided to the patient as a set of
sound files on a device in communication with the hand-held
computer 20 such that the device is instructed to play a particular
sound file. By way of example, this variation may involve a compact
disc recording of one or more sound track files of patient directed
comments and a communication link between the hand-held computer 20
and a compact disc player device, with the ability to be controlled
by the hand-held computer. Such control might be by a direct wire
communication connection or by an infrared signal originated by the
handheld computer 20. The compact disc may be recorded with generic
patient directed voice comments or customized comments, such as the
treatment professional's voice recording of custom instructions and
or encouragement for the particular patient. In the case of custom
instructions, treatment protocol modification step, further
includes the treatment professional recording the customized
patient instructions, and the generation step, described earlier,
further includes the substep of recording the track onto a
recordable or rewritable compact disc.
[0042] Once approved, the overall process may be continued to
capture "1c" and then generate "1d" information for a handheld
computer 20. The steps of modifying one or more treatment protocols
of a presented set and re-presenting the modified set for
availability to the approval step facilitates the treatment
professional's ability to rapidly and efficiently prescribe a
treatment protocol with a high degree of confidence.
[0043] Another preferred embodiment of the present invention
includes the additional steps of programming review of the data
received from the handheld computer 20 by the program 30 for
compliance with the prescribed treatment protocol as well as for
reconsideration of the effectiveness of the prescribed protocol
relative to updates in the database since the treatment protocol
was initially prescribed and loaded into the handheld computer.
That is, it is entirely feasible that the updating of the historic
database 26 with information from other patients, rather than the
patient 24 being treated in this process, will suggest a
modification of the treatment protocol. The newly suggested
modification may be presented to the treatment professional or,
alternatively, a new script automatically generated, communicated
to and loaded into the handheld computer 20.
[0044] In another embodiment, failure of the patient 24 to comply
with the treatment protocol may suggest a centrally generated
modification, either with or without presentation and review by the
treatment professional 12. Failure to comply may include under or
over exercise which deviates from the treatment protocol.
[0045] In yet another embodiment, the script corresponding to the
treatment protocol may further include conditional logic. In such
an embodiment, the conditional logic may be used to provide the
criterion for recognition by the remotely located handheld computer
20 of a failure of compliance by the patient 24 and the ability to
alter the treatment protocol. Alternatively, the conditional logic
may be used to provide criteria for recognition by the remotely
located handheld computer 20 of meeting or satisfying the treatment
goal set by the treatment professional as represented by the
approved treatment protocol. The alteration need not be immediately
communicated back to the central computer but might be saved for
later communication.
[0046] In still another embodiment, the treatment protocol may
include information to generate patient communication signals to
alter the patient's perception of either the protocol's
instructions or the urgency of the patient's compliance with the
instructions. Such additional aspects of the information carried
within the scripting being loaded into the handheld computer 20 can
relieve the treatment professional of many time consuming and
inefficient contacts with the patient 24 yet facilitate the
patient's compliance.
[0047] For example, patient oral communication files, or parameters
to cause patient oral communication files which are pre-installed
on the hand-held computer, which might be played to a patient could
be included with a treatment protocol or a modified treatment
protocol. In particular, sounds, such as oral encouragement or
descriptions of the patient exercise to be performed, most
especially patient directed voice comments, such as "Keep going
Bob; You are almost there!" might be available for inclusion in
treatment protocols. The ability to modify the oral comments sound
file is particularly useful with real-time modification for
increasing patient compliance with an individual treatment
protocols of the set.
[0048] Although the present invention has been described with
reference to preferred embodiments, workers skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
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