U.S. patent application number 11/024888 was filed with the patent office on 2006-06-29 for system and method for determining patient follow-up subsequent to an orthopaedic procedure.
Invention is credited to Terry Dietz, Mark R. DiSilvestro, Robert Hastings.
Application Number | 20060142670 11/024888 |
Document ID | / |
Family ID | 36046844 |
Filed Date | 2006-06-29 |
United States Patent
Application |
20060142670 |
Kind Code |
A1 |
DiSilvestro; Mark R. ; et
al. |
June 29, 2006 |
System and method for determining patient follow-up subsequent to
an orthopaedic procedure
Abstract
A method of determining patient follow-up subsequent to an
orthopaedic procedure includes determining the number of cycles of
use of an orthopaedic joint of the patient. If a predetermined
threshold is exceeded, communication with an orthopaedic care
provider is initiated. A patient monitoring system is also
disclosed.
Inventors: |
DiSilvestro; Mark R.; (Fort
Wayne, IN) ; Dietz; Terry; (Columbia City, IN)
; Hastings; Robert; (Warsaw, IN) |
Correspondence
Address: |
BARNES & THORNBURG
11 SOUTH MERIDIAN
INDIANAPOLIS
IN
46204
US
|
Family ID: |
36046844 |
Appl. No.: |
11/024888 |
Filed: |
December 29, 2004 |
Current U.S.
Class: |
600/587 |
Current CPC
Class: |
G16H 40/67 20180101;
A61B 5/1071 20130101; A61B 5/0002 20130101; G16H 20/40 20180101;
A61F 2002/30953 20130101; A61B 5/4528 20130101; A61F 2002/3067
20130101; A61B 5/076 20130101; A61B 5/1076 20130101; A61F 2/38
20130101; A61F 2002/488 20130101; G16H 20/30 20180101; A61F 2/30
20130101; A61B 5/0031 20130101; A61B 5/1118 20130101; A61F
2250/0002 20130101; A61B 5/4851 20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 5/103 20060101
A61B005/103 |
Claims
1. A method of determining patient follow-up subsequent to an
orthopaedic procedure, the method comprising the steps of:
determining the number of cycles of use of an orthopaedic joint of
a patient, and initiating communication with an orthopaedic care
provider in response to the determining step.
2. The method of claim 1, wherein the determining step comprises
determining the number of cycles of use of the orthopaedic joint
and generating an output signal in response thereto, further
comprising the step of: generating a message to the patient in
response to generation of the output signal.
3. The method of claim 2, wherein the step of generating the
message comprises generating an audible message.
4. The method of claim 2, wherein the step of generating the
message comprises generating a visual message.
5. The method of claim 1, wherein the determining step comprises
determining the number of steps taken by the patient.
6. The method of claim 5, wherein determining the number of steps
taken by the patient comprises monitoring output from a
pedometer.
7. The method of claim 1, wherein the determining step comprises
determining the activity level of the patient.
8. The method of claim 7, wherein determining the activity level of
the patient comprises monitoring output from a sensor external to
the body of the patient.
9. The method of claim 1, wherein the determining step comprises
determining the number of occasions that a predetermined flexion
angle is obtained by the orthopaedic joint of the patient.
10. The method of claim 1, wherein the determining step comprises
determining the number of loading cycles of the orthopaedic joint
of the patient.
11. The method of claim 1, wherein the determining step comprises
monitoring output from a sensor implanted into the body of the
patient.
12. The method of claim 1, wherein the determining step comprises
monitoring output from a sensor external to the body of the
patient.
13. The method of claim 1, wherein: the orthopaedic joint of the
patient comprises a prosthetic orthopaedic joint comprising a
sensor, and the determining step comprises monitoring output from
the sensor.
14. The method of claim 1, wherein the orthopaedic joint of the
patient comprises at least one natural joint component.
15. The method of claim 1, wherein the orthopaedic joint of the
patient comprises at least one prosthetic joint component.
16. The method of claim 1, wherein the initiating step comprises
generating an automated, device-initiated electronic
communication.
17. The method of claim 1, wherein: the determining step comprises
determining the number of cycles of use of the orthopaedic joint
and generating an output signal in response thereto, and the
initiating step comprises generating an automated, device-initiated
electronic communication with an electronic device of the
orthopaedic care provider in response to generation of the output
signal.
18. The method of claim 1, wherein the determining step comprises
determining the distance between a first component and a second
component of the orthopaedic joint of the patient.
19. A patient monitoring system, comprising: a sensor, a processor
in communication with the sensor, and a memory device electrically
coupled to the processor, the memory device having stored therein a
plurality of instructions which, when executed by the processor,
cause the processor to: monitor output from the sensor to determine
the number of cycles of use of the orthopaedic joint of a patient,
and generate a message to the patient indicative of a need to
initiate communication with an orthopaedic care provider if the
number of cycles of use of the orthopaedic joint exceeds a
predetermined threshold value.
20. The patient monitoring system of claim 19, wherein the sensor
is implantable into the body of the patient.
21. The patient monitoring system of claim 19, wherein the sensor
is configured to be externally worn by the patient.
22. The patient monitoring system of claim 19, wherein the sensor
is secured to a prosthetic joint component.
23. A method of determining patient follow-up subsequent to an
orthopaedic procedure, the method comprising the steps of:
electronically querying a joint use measurement device to determine
the number of cycles of use of an orthopaedic joint of a patient,
and generating an electronic output signal if the number of cycles
of use of the orthopaedic joint of the patient exceeds a
predetermined threshold value.
24. The method of claim 23, wherein the generating step comprises
generating a phone message which is sent to an orthopaedic care
provider.
25. The method of claim 23, wherein the generating step comprises
generating an electronic mail message which is sent to an
orthopaedic care provider.
26. The method of claim 23, wherein: the joint use measurement
device comprises a sensor implanted into the body of the patient,
and the electronically querying step comprises determining output
from the sensor.
27. The method of claim 23, wherein the joint use measurement
device is configured to be externally worn by the patient, the
joint use measurement device comprises a sensor, and the
electronically querying step comprises determining output from the
sensor.
Description
FIELD OF THE DISCLOSURE
[0001] The present disclosure relates generally to systems and
methods for use in conjunction with orthopaedic procedures.
BACKGROUND
[0002] Currently, patient follow-up subsequent to an orthopaedic
procedure is a function of the time that has elapsed since the
procedure. Indeed, follow-up meetings with the orthopaedic care
provider (e.g., the surgeon) are typically scheduled for dates in
the future which reflect the passage of a given amount of time
since the procedure.
SUMMARY
[0003] According to one aspect of the disclosure, a method of
determining patient follow-up subsequent to an orthopaedic
procedure includes determining the number of cycles of use of an
orthopaedic joint of the patient. If a predetermined threshold is
exceeded, communication with an orthopaedic care provider is
initiated.
[0004] The number of cycles of use of the patient's joint may be
determined by (i) determining number of steps taken by the patient,
(ii) determining the activity level of the patient, (iii)
determining the number of times a predetermined joint flexion angle
is achieved, or (iv) determining the number of loading cycles of
the joint.
[0005] The communication with the orthopaedic care provider (e.g.,
a surgeon) is initiated by notifying the patient and/or the
orthopaedic care provider. Such communication may be initiated by a
phone call, electronic mail message, or other web-based
communication. Such a communication may be an automated,
device-initiated communication.
[0006] The orthopaedic joint of the patient may be a prosthetic
joint. The orthopaedic joint of the patient may have at least one
natural orthopaedic component.
[0007] A patient monitoring system includes a joint use measurement
device configured to determine the cycles of use of an orthopaedic
joint of a patient.
[0008] The joint use measurement device is operable to generate a
message if a predetermined threshold is attained.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The detailed description particularly refers to the
accompanying figures in which:
[0010] FIG. 1 is a diagrammatic view showing a joint use
measurement device in the form of a pedometer being utilized to
determine the cycles of use of a knee endoprosthesis system;
[0011] FIG. 2 is a diagrammatic view showing a joint use
measurement device in the form of a electronic body monitor being
utilized to determine the cycles of use of a knee endoprosthesis
system;
[0012] FIG. 3 is a diagrammatic view showing a joint use
measurement device in the form of an implantable joint cycle
counter being utilized to determine the cycles of use of a knee
endoprosthesis system; and
[0013] FIG. 4 is a diagrammatic view showing a joint use
measurement device in communication with a communication
device.
DETAILED DESCRIPTION OF THE DRAWINGS
[0014] The present disclosure relates to a method for determining
patient follow-up after an orthopaedic procedure, such as a joint
replacement procedure, based on the actual use of the patient's
joint. As will be described herein in greater detail, the number of
cycles of use of the patient's joint may be determined, for
example, by (i) determining number of steps taken by the patient,
(ii) determining the activity level of the patient, (iii)
determining the number of times a predetermined joint flexion angle
is achieved, or (iv) determining the number of loading cycles of
the joint. Determination of these parameters may be achieved in a
number of different manners. When it is determined that the patient
has achieved a level of use in which follow-up is desired, a
communication with the orthopaedic care provider (e.g., a surgeon,
hospital, nurse, primary care provider, or other individual
involved in the care of the patient) is initiated by notifying the
patient and/or the orthopaedic care provider. As will be described
herein in greater detail, such communication may be achieved in a
variety of different manners.
[0015] Referring now to FIG. 1, there is shown one implementation
of the concepts of the present disclosure. In this case, a joint
use measurement device 10 is utilized to determine the number of
cycles of use of a prosthetic orthopaedic joint 12. In the
exemplary arrangement of FIG. 1, the orthopaedic joint 12 is
exemplary embodied as a knee endoprosthesis system 14 for use in a
total knee replacement procedure. The knee endoprosthesis system 14
is implanted on the distal end of the femur 16 and the proximal end
of the tibia 18. The endoprosthesis system 10 includes a tibial
bearing 20 that is positioned on the proximal tibial component 22.
The proximal tibial component 22 is affixed to the proximal end of
the tibia 18. The tibial bearing 20 has a contoured proximal
surface 24, against which the condyles 26 of the distal femoral
component 28 bear. The distal femoral component 28 is affixed to
the distal end of the femur 16. Articulation of the joint is at the
interface of the proximal surface 24 of the tibial bearing 20 and
the condyles 26 of the distal femoral component 28.
[0016] The actual use of the knee endoprosthesis system 14 may be
characterized as cycles of use of the system. The cycles of use of
the system 14 may be measured in a variety of methods such as, for
example, (i) by determining number of steps taken by the patient,
(ii) by determining the activity level of the patient, (iii) by
determining the number of times a predetermined joint flexion angle
is achieved by the system 14, or (iv) by determining the number of
loading cycles of the system 14.
[0017] In the exemplary embodiment shown in FIG. 1, the joint use
measurement device 10 is embodied as a pedometer 30. The pedometer
30 is worn by the patient subsequent to the patient's orthopaedic
procedure to determine the number of steps taken by the patient.
When the output from the pedometer 30 indicates that the patient
has taken a predetermined number of steps since the patient's
orthopaedic procedure (or since the patient's previous meeting with
the surgeon), a communication with the orthopaedic surgeon may be
initiated. For example, the patient may make an appointment with
the surgeon's office via telephone, electronic mail or other
web-based communication, conventional mail, etcetera.
[0018] Referring now to FIG. 2, there is shown an arrangement
similar to FIG. 1, but showing the joint use measurement device 10
embodied as an electronic body monitor 32. The electronic body
monitor 32 is configured to be worn externally of the patient's
body such as, for example, on an armband. Like the pedometer 30 of
FIG. 1, the electronic body monitor 32 may be used to determine the
number of steps taken by the patient over a given period of time
(e.g., since the patient's procedure or since the patient's
previous post-surgical meeting with the surgeon). The electronic
body monitor 32 may also execute algorithms for determining and
tracking the activity level of the patient. In this way, follow-up
may be initiated as a function of steps taken by the patient,
activity level of the patient, or both.
[0019] As shown in FIG. 2, the electronic body monitor 32 includes
a sensor 34 that is configured to sense parameters associated with
cycles of use of the knee endoprosthesis system 14. The sensor 34
may be embodied as a single sensor or as an array of sensors. In
one exemplary embodiment, the sensor 34 is embodied as a two-axis
accelerometer the output from which may be used to determine the
number of steps taken by the patient. The electronic body monitor
32 also includes a processor 36 electrically coupled to the sensor
34, a memory device 38, and a data output port 40. The processor 36
is electrically coupled to the data output port 40 and the memory
device 38. The electronic body monitor 32 may also include other
devices useful in a computing device such as drivers, registers,
buffers, digital signal processors, and the like. Illustratively,
the electronic body monitor 32 may be embodied, with or without
modification thereto, as any one of the numerous body monitors
commercially available from BodyMedia, Incorporated of Pittsburgh,
Pa. One such BodyMedia device is commercially sold under the name
SenseWare PRO.
[0020] The processor 36 and memory device 38 cooperate to determine
when follow-up subsequent to an orthopaedic procedure is warranted
based on cycles of use of the knee endoprosthesis system 14. In
particular, the memory device 38 has stored therein a plurality of
instructions in the form of a software routine which performs such
a function. The memory device 38 may be Random Access Memory
(hereinafter sometimes RAM), Read Only Memory (hereinafter
sometimes ROM), flash or erasable memory such as Erasable
Programmable ROM (hereinafter sometimes EPROM) and Electrically
Erasable Programmable ROM (hereinafter sometimes EEPROM), and/or
other memory devices. Due to the adaptable nature of programming
languages, there are many embodiments of a software routine stored
in the memory device 38 for performing such a function.
[0021] The electronic body monitor 32 also includes a message
generating device 42. The message generating device 42 is operable
to generate visual and/or audible messages for presentation to the
patient. For example, when the electronic body monitor 32
determines that the patient has exceeded a predetermined threshold
relating to the number of steps taken by the patient (or activity
level) since the patient's procedure (or last meeting with the
surgeon), an audible and/or visual alert may be generated by the
message generating device 42. The message generating device 42 may
be embodied as any type of such device including, for example, an
LCD or LED display and/or a tone/sound generator.
[0022] Referring now to FIG. 3, the joint use measurement device 10
includes an implanted sensor 50. The sensor 50 may be embodied as a
single sensor or as an array of sensors. In the exemplary
embodiment of FIG. 3, the implanted sensor 50 includes a signal
source 52, such as a permanent magnet, that is embedded in the
distal femoral component 28, and a sensor 54, such as a Hall effect
switch, embedded in the proximal tibial component 22. The
associated electronics 56 are also secured to the proximal tibial
component 22. The electronics 56 include, amongst other things, a
processor, memory device, power source, modulator, a transmitter,
and antenna to facilitate the maintenance of a running count of the
number of times the knee endoprosthesis system 14 cycles, along
with the ability to transmit such a count from within the patient's
body. In other words, the joint use measurement device 10
illustrated in FIG. 3 utilizes an implanted sensor to determine the
number of occasions in which the components of the knee
endoprosthesis system 14 are in a predetermined relative position
with one another (e.g., the number of occasions in which a
predetermined flexion angle is attained), thereby determining
cycles of use of the system 14.
[0023] The stored count information can be transmitted to a device
external to the patient's body by use of the transmitter and
antenna of the associated electronics 56. As shown schematically in
FIG. 3, an external receiver 58 and data interpretation device 60
may be used to retrieve information from the implanted electronics
56. The external receiver 58 may be embodied as a radio-frequency
antenna that is operable to receive the signal from the internal
antenna of the implanted electronics 56. The data interpretation
device 60 is electrically coupled to the receiver 58, and may be
embodied as a standard computer (e.g., PC) programmed to demodulate
the radio-frequency signal received from the internal transmitter
and the internal antenna of the implanted electronics 56. The data
interpretation device 60 may also be embodied as a hand-held
personal computer, a personal desk assistant, a laptop computer, or
any custom-designed data acquisition device. The data
interpretation device 60 may be programmed to perform calculations
necessary to convert the received and demodulated signal into the
number of cycles recorded by the counter.
[0024] One such implantable system, along with the associated
external components, is disclosed in U.S. patent application Ser.
No. 10/887,766, entitled "In Vivo Joint Implant Cycle Counter"
which is assigned to the assignee of the present application, and
which is hereby incorporated by reference.
[0025] The data interpretation device 60 may have integrated
therein, or be coupled to, a message generating device 62. The
message generating device 62 is operable to generate visual and/or
audible messages for presentation to the patient. For example, when
it is determined from the output of the implanted electronics 56
that the number of occasions in which the knee endoprosthesis
system 14 has attained a predetermined flexion angle has exceeded a
predetermined threshold, an audible and/or visual alert may be
generated by the message generating device 62. The message
generating device 62 may be embodied as any type of such device
including, for example, a PC display monitor, an LCD or LED
display, and/or a tone/sound generator.
[0026] In lieu of the arrangement of FIG. 3 which includes a magnet
and Hall effect switch, other implanted sensor arrangements are
also contemplated. For example, a load sensor may be implanted into
the knee endoprosthesis system 14. In such a system, the cycles of
use of the system 14 could be determined by counting loading cycles
of the system. Such a count could be stored, transmitted, and
received in a similar manner to as described above in regard to the
arrangement of FIG. 3.
[0027] In another example, the cycles of use of the patient's joint
may be determined by measuring the wear of certain components of
the knee endoprosthesis system 14. For instance, a sensor
arrangement may be utilized in which the joint space between the
femoral component 28 and the tibial component 22 is
measured/monitored. It should be appreciated that such a distance
may shorten (i.e., reduce) over cycles of the knee endoprosthesis
system as a result of wear of the tibial bearing 20. As such, the
cycles of use of the system 14 could be determined by measuring and
tracking the joint space between the femoral component 28 and the
tibial component 22. Such data could be stored, transmitted, and
received in a similar manner to as described above in regard to the
arrangement of FIG. 3. One such implantable system, along with the
associated external components, is disclosed in U.S. patent
application Ser. No. 10/888,243, entitled "System and Method for
Determining Patient Follow-Up Subsequent to an Orthopaedic
Procedure" which is assigned to the assignee of the present
application, and which is hereby incorporated by reference.
[0028] Referring now to FIG. 4, there is shown the joint use
measurement device 10 being used in conjunction with a
communications device 70. The communications device 70 may be
embodied as hardware and software that is integrated into a
personal computer, wireless (e.g., cellular) telephone, PDA, or
home automation system. Alternatively, the communications device 70
may be a discreet hardware/software assembly electrically coupled
to a personal computer, wireless (e.g., cellular) telephone, PDA,
or home automation system. In either case, the communications
device 70 includes devices useful in a computing device such as
microprocessor(s), memory devices, drivers, registers, buffers,
digital signal processors, and the like
[0029] The communications device 70 may be operated to query the
joint use measurement device 10 and then commence an automated,
device-initiated communication with the orthopaedic care provider
(e.g., the surgeon's office) if a follow-up visit is warranted
based on the number of cycles of use of the knee endoprosthesis
system 14. For example, the communications device 70 may initiate a
telephone call, electronic mail communication, or other web-based
communication with an electronic device or system 72 operated by
the surgeon's office.
[0030] It should be appreciated that the communications device 70
may be configured to accommodate any one or more of the different
exemplary embodiments of the joint use measurement device 10. For
example, in the case of the electronic body monitor 32 of FIG. 2,
the communications device 70 may be configured to communicate with
the body monitor 32 via its data output port 40. Such a
communication may be wired or wireless depending on the
configuration of the port 40. It is contemplated to integrate the
communications device 70 into the electronic body monitor 32.
[0031] Similarly, the communications device 70 may be configured to
communicate with data interpretation device 60 of the arrangement
of FIG. 3 via either a wired or wireless communication link. It
should be appreciated that the communications device 70 may be
integrated into the data interpretation device 60 (i.e., a single
device, such as a PC, may be equipped with the necessary hardware
and software to perform both the functions of the data
interpretation device 60 and the functions of the communications
device 70).
[0032] In the case of when the joint use measurement device 10 is
embodied as a mechanical device (i.e., non-electrical) such as, for
example, certain types of pedometers, data from the mechanical
device may be input into the communications device 70. In such a
case, the communications device 70 may be configured to process
such manually entered data, and then, if appropriate, initiate
communication with the surgeon in any one or more of the manners
described above.
[0033] Although the concepts of the present disclosure have herein
been described in regard to a knee prosthesis, it should be
appreciated that the concepts described herein could also be
applied to other joint endoprosthesis such as endoprosthesis
systems for use in the hip, shoulder, wrist, elbow, ankle, along
with endoprosthesis systems for use with the digits of the
extremities. It should be understood that other configurations of a
joint use measurement device (including its sensors) may be
utilized to accommodate a given application in a desired joint
location.
[0034] Moreover, although the concepts of the present disclosure
have herein been exemplary described in regard to an endoprosthesis
for use in a total joint replacement, it should be appreciated that
the concepts described herein could also be applied to other
arrangements. For example, the concepts of the present disclosure
could be applied subsequent to a procedure in which the resultant
joint includes one or more natural components. Moreover, the
concepts of the present disclosure could be applied subsequent to
an orthopaedic procedure at anatomical locations other than a
joint.
[0035] While the disclosure is susceptible to various modifications
and alternative forms, specific exemplary embodiments thereof have
been shown by way of example in the drawings and has herein be
described in detail. It should be understood, however, that there
is no intent to limit the disclosure to the particular forms
disclosed, but on the contrary, the intention is to cover all
modifications, equivalents, and alternatives falling within the
spirit and scope of the disclosure.
[0036] There are a plurality of advantages of the present
disclosure arising from the various features of the apparatus and
methods described herein. It will be noted that alternative
embodiments of the apparatus and methods of the present disclosure
may not include all of the features described yet still benefit
from at least some of the advantages of such features. Those of
ordinary skill in the art may readily devise their own
implementations of an apparatus and method that incorporate one or
more of the features of the present disclosure and fall within the
spirit and scope of the present disclosure.
* * * * *