U.S. patent application number 17/249341 was filed with the patent office on 2021-08-26 for mobile monitoring of fracture healing in external fixators.
The applicant listed for this patent is THE PENN STATE RESEARCH FOUNDATION. Invention is credited to Gregory S. LEWIS, J. Spence REID.
Application Number | 20210259626 17/249341 |
Document ID | / |
Family ID | 1000005568459 |
Filed Date | 2021-08-26 |
United States Patent
Application |
20210259626 |
Kind Code |
A1 |
LEWIS; Gregory S. ; et
al. |
August 26, 2021 |
MOBILE MONITORING OF FRACTURE HEALING IN EXTERNAL FIXATORS
Abstract
A device for and a method of monitoring the healing status of a
fractured bone in a person's limb is disclosed. The external
fixation device may include one or more rods or struts that
incorporate strain gauges designed to measure the mechanical forces
on the strut when force is applied to the fractured bone. The
mechanical force data may be collected by an electronic module and
transmitted to a computer for statistical analysis. The device may
also include a foot insole sensor for measuring the foot plantar
force to normalize the data collected by an external fixation
device attached to a person's leg. The method of measuring the
healing status of a fractured bone includes measuring the changes
in mechanical forces exerted on the one or more struts, and based
on the measurements, estimating the healing status of the bone.
Inventors: |
LEWIS; Gregory S.;
(Hummelstown, PA) ; REID; J. Spence; (Hummelstown,
PA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
THE PENN STATE RESEARCH FOUNDATION |
University Park |
PA |
US |
|
|
Family ID: |
1000005568459 |
Appl. No.: |
17/249341 |
Filed: |
February 26, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15873651 |
Jan 17, 2018 |
10932713 |
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17249341 |
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PCT/US2016/045358 |
Aug 3, 2016 |
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15873651 |
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62200919 |
Aug 4, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/1038 20130101;
A61B 5/4848 20130101; A61B 17/60 20130101; A61B 2562/0261 20130101;
A61B 5/4842 20130101; A61B 5/1075 20130101; A61B 5/4504 20130101;
A61B 17/62 20130101; A61F 5/01 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 17/62 20060101 A61B017/62; A61B 5/103 20060101
A61B005/103; A61F 5/01 20060101 A61F005/01; A61B 17/60 20060101
A61B017/60; A61B 5/107 20060101 A61B005/107 |
Claims
1. A method of measuring the healing status of a fractured bone,
the method comprising: modifying an external fixator apparatus that
is attached to a patients limb to include one or more struts
comprising one or more gauges configured to measure the strains
acting on the strut; exerting varying amount of pressure on the
patient's limb; measuring data covering the changes in strains
acting on the strut as the patient exerts varying amounts of
pressure on the strut; and normalizing the data by including a
measured foot plantar force.
2. The method of claim 1, wherein the patient's limb is a leg;
measuring the foot plantar force as the patient walks on said
leg.
3. The method of claim 2, further comprising normalizing the
measured changes in mechanical forces acting on the strut as the
patient walks based on the foot plantar force that is measured.
4. The method of claim 1, further comprising calculating the
mechanical forces acting on the strut and estimating the healing
status of a bone fracture based on the mechanical forces.
5. The method of claim 1, further comprising transmitting the
measured changes in strains as data to a computer.
6. The method of claim 5, wherein the transmitting step is
wireless.
7. The method of claim 6, wherein the wireless transmission is
Bluetooth.
8. The method of claim 1, wherein the foot plantar force is measure
using portable instrumented shoe insoles.
9. The method of claim 8, further comprising calibrating the
portable instrumented shoe insoles using a patient's body
weight.
10. A system for measuring the healing status of injured limb,
comprising: an external fixator comprising a frame including one or
more ring members, a plurality of strut members interconnecting the
one or more ring members, and wherein at least one of the plurality
of strut members comprises one or more strut gauges configured to
measure the strains acting on the at least one of the plurality of
strut members; and a secondary sensor remote of the external
fixator to acquire secondary data associated with the force applied
by the injured limb; wherein the secondary data is used to
normalize the measured data of the external fixator.
11. The system of claim 10, wherein the secondary sensor comprises
a portable instrumented shoe insole.
12. The system of claim 11, wherein the secondary data comprises
measured foot plantar forces.
13. The system of claim 12, wherein the portable instrumented shoe
insole is calibrated using a weight of a patient having the injured
limb.
14. The system of claim 11, further comprising a wireless
transmitter for wirelessly transmitting the secondary data, wherein
the wireless transmitter is attached to a shoe with the portable
instrumented shoe insole.
15. The system of claim 14, wherein the external fixator further
comprises a wireless module to transmit measured strain to a
computer.
16. The system of claim 15, wherein the computer collects and
stores the measured strain data and the secondary data.
17. A method of measuring the healing status of an injured limb,
comprising: measuring strain acting on an external fixator
connected to the injured limb, the external fixator comprising a
frame including one or more ring members, a plurality of strut
members interconnecting the one or more ring members, and wherein
at least one of the plurality of strut members comprises one or
more strut gauges; measuring secondary data remote of the external
fixator with a secondary sensor measuring applied force by the
injured limb; and normalizing the measured strain by the external
fixator using, in part, the secondary data acquired by the
secondary sensor.
18. The method of claim 17, further comprising transmitting
measured strain and the secondary data to a computer, wherein the
computer normalizes the measures strain.
19. The method of claim 18, further comprising comparing, at the
computer, the normalized strain with a previously stored normalized
strain to determine the healing status of the injured limb.
20. The method of claim 18, wherein the step of transmitting the
measured strain and the secondary data is done in a wired or
wireless manner.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Divisional Application of U.S. Ser.
No. 15/873,651, filed Jan. 17, 2018, which is a Continuation
Application of PCT Application No. PCT/US2016/045358, filed on Aug.
3, 2016, which claims priority under 35 U.S.C. .sctn. 119 to
provisional application Ser. No. 62/200,919, filed on Aug. 4, 2015,
all of which are herein incorporated by reference in their entirety
and for all purposes.
FIELD OF THE INVENTION
[0002] The invention relates generally to a medical device. More
specifically, but not exclusively, the invention relates to a
modified external fixation device for stabilizing a bone during
healing.
BACKGROUND OF THE INVENTION
[0003] Bone fractures are commonly seen in orthopedic clinics and
emergency rooms. Bone defects occur mostly from trauma, but can
also result from resections associated with bone infections and
tumors. Nonunion or malunion occurs in about 10% of these cases. In
2005 in the U.S., fractures caused 127 million bed days in 4.4
million people, and 72 million lost work days--numbers larger than
corresponding numbers for heart problems, stroke and hypertension.
Severe fractures in the lower limb (approximately 150,000 each year
in the US) are associated with high energy trauma in both civilian
and military patients, and are sometimes treated with external
fixation devices, such as the Ilizarov fixator, to stabilize the
bone until healing has occurred. The devices are kept on the
patient for up to a year at significant cost, intrusiveness, and
risk of infection. The clinician must decide when to remove the
device such that adequate healing has occurred and the bone will
not re-fracture, but healing rates are variable, and x-rays can be
inconclusive. The clinician must also identify when a patient is
starting to progress poorly and an early revision surgery is needed
to prevent further complications.
[0004] Therefore, there remains a need in the art for a medical
device or apparatus in the art for measuring or determining the
state of bone healing. The methods, system, and/or apparatus may be
used to measure the forces on the external fixator struts to
determine the state of bone healing. When the limb is mechanically
loaded during standing and walking, the load is transmitted down
through the struts of the fixator, offloading the bone defect site.
As healing progresses, the bone assumes a larger and larger share
of the load, and the external fixator should experience less load.
This provides the opportunity to use non-invasive sensors on the
external fixator to develop indicators of fracture healing, which
would be helpful to patients and clinicians.
BRIEF SUMMARY OF THE INVENTION
[0005] Therefore, it is a principle object, feature, and/or
advantage of the invention to improve on and/or overcome the
deficiencies in the art.
[0006] It is another object, feature, and/or advantage of the
invention to provide a system or apparatus for stabilizing and/or
supporting damaged and/or fractured bone.
[0007] It is yet another object, feature, and/or advantage of the
invention to provide an external fixator including a frame
comprising one or more rings interconnected by a plurality of strut
members.
[0008] It is a further object, feature, and/or advantage of the
invention to provide an external fixator with modified struts that
include a smooth center section.
[0009] It is still a further object, feature, and/or advantage of
the invention to provide a modified strut including one or more
gauges attached to a smooth center section of the strut.
[0010] It is still yet a further object, feature, and/or advantage
of the invention to provide a modified strut wherein the one or
more gauges are attached to the smooth center section by an
epoxy.
[0011] It is still yet a further object, feature, and/or advantage
of the invention to provide a modified strut wherein the one or
more gauges are attached to the smooth center section by an epoxy,
an acrylic coating, and/or a silicone coating.
[0012] It is still yet a further object, feature, and/or advantage
of the invention to provide a modified strut including one or more
strain gauges configured to measure the mechanical strains acting
on the modified strut.
[0013] It is still yet a further object, feature, and/or advantage
of the invention to provide a modified strut that utilizes an
electronic module that is removably attached to one or more gauges
by an electrical connector and is configured to measure and record
the mechanical strains acting on a modified strut.
[0014] It is still yet a further object, feature, and/or advantage
of the invention to provide an electronic module configured to
measure and record data from one or more gauges and transmit the
data to a computer through a wired or wireless connection.
[0015] It is still yet a further object, feature, and/or advantage
of the invention to provide a method of measuring the healing
status of a fractured and/or damaged bone by measuring the strains
acting on one or more struts of an external fixator that is
attached to and/or supporting the fractured and/or damaged bone,
and calculating the mechanical forces on the strut to predict the
healing status of a bone.
[0016] It is still yet a further object, feature, and/or advantage
of the invention to provide a method of measuring the healing
status of a fractured and/or damaged bone by measuring the foot
plantar forces using a foot insole device.
[0017] These and/or other objects, features, and advantages of the
invention will be apparent to those skilled in the art. The
invention is not to be limited to or by these objects, features and
advantages. No single embodiment need provide each and every
object, feature, or advantage.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is an example embodiment of a strut for an external
fixator apparatus.
[0019] FIG. 2 is an enlarged view of the strut for an external
fixator apparatus of FIG. 1, including a strain gauge assembly.
[0020] FIG. 3 is an enlarged view of the smooth central section of
the strut for an external fixator apparatus of FIG. 2, including a
strain gauge assembly.
[0021] FIG. 4 is an example embodiment of a strut for an external
fixator apparatus.
[0022] FIG. 5 is an alternative example embodiment of a strut for
an external fixator apparatus including a flexible sleeve member
covering the strut.
[0023] FIG. 6 is an example embodiment of an external fixator
apparatus.
[0024] FIG. 7 is an example embodiment of an electronic module.
[0025] FIG. 8 shows a graph depicting mean peak and valley force
levels during gait, patient.
[0026] FIG. 9 shows part of original data curves for visit 2 and in
particular repeatability across gait cycles in all force signals;
peaks and valleys were obtained for all cycles (automatically using
software) and averaged to obtain summary.
[0027] Various embodiments of the invention will be described in
detail with reference to the drawings, wherein like reference
numerals represent like parts throughout the several views.
Reference to various embodiments does not limit the scope of the
invention. Figures represented herein are not limitations to the
various embodiments according to the invention and are presented
for exemplary illustration of the invention.
DETAILED DESCRIPTION
[0028] The invention is generally directed towards a medical device
for determining the state of bone healing through the use of
non-invasive sensors on the external fixator struts to develop
indicators of fracture healing, which would be helpful to patients
and clinicians.
[0029] An external fixator device may be modified to include struts
with sensors configured to measure mechanical forces acting on the
strut. For example, the Ilizarov external fixator (Smith &
Nephew), and related Taylor Spatial Frames, may be modified to
include the struts with sensors. The Ilizarov external fixator
(Smith & Nephew) and related Taylor Spatial Frames are
orthopedic devices with a long history of use in treating severe
lower limb bone fractures and bone defects. The Ilizarov forms a
support scaffold and stabilizes the fracture until healing has
occurred. Ilizarov fixators have been used in over a million
patients worldwide, and in the US since about 1981. The device
includes several rings 44 external to the skin, vertical steel rods
42 which connect these rings 44 together, and steel pins 46 that
connect the rings 44 directly to bone (passing through the skin).
The modification involves replacing up to four of the external
vertical steel rods 42 with rods 10 of similar material and size,
except modified to include strain sensors 20 adhered to a smooth
rod surface 14 that enable us to measure force. The modified
components are all outside the patient's body.
[0030] The modified struts, as shown in FIG. 1, are slightly
modified in design compared to the fully threaded, standard
Ilizarov struts 42. The modified struts 10 may be comprised of 303
stainless steel or a similar material. The struts 10 may include
one or more threaded portions 12. For example, the threaded
portions 12 may be sized to M6x1. The length of the strut 10 may
vary based on the length of the bone to be braced and/or the size
of the fixation device. For example, the struts length may be 12
cm, 15 cm, 20 cm, and/or 25 cm. In one example embodiment, the
struts 10 may be constructed from 303 SS rod stock which meets ASTM
A582 and comes with certification, i.e., with a traceable lot
number and material test report. The modified strut 10 includes a
smooth central section 14, as shown in FIGS. 1 and 2. This section
may have an approximate diameter of 6 mm and a length of
approximately 38 mm (1.5 inches). The diameter of this section is
similar to the major diameter of the M6x1 threads. One of the many
reasons for making this smooth central surface on the struts is to
accurately measure the strains (forces) with adhered strain gauges
20 (as it is impossible to achieve good contact between adhered
gauges and struts if adhered to the threaded portion). Thus, the
length of the smooth central section 14 was determined based on the
area required for adhesion of strain gauges 20.
[0031] Struts 10 may be machined using standard documented
machining and quality control protocols by an experienced machinist
with documented qualifications. A final inspection and measurement
of the final machined parts may be completed to ensure the final
parts comply with known standards established within the industry.
Gauges 20 are attached to the smooth central portion 14 of the
strut 10. This region 14 is composed, as shown below in Table 1, of
four strain gauges in full axial bridge, that may be attached by a
thin epoxy 22 strain gauge adhesive, coated with a thin acrylic
coating 24 for a water tight seal, an outer protective silicone
coating 26, and a polyester mesh sleeve 32. In the preferred
embodiment, the strain gauges are configured to measure pure axial
loading and cancel bending effects. However, alternative strain
gauge configurations, such as 1-3 uniaxial gauges, may also be used
for cost considerations and/or to include bending effects. An
electrical connector 28 may be attached to the gauges 20 to allow
for measuring strain and other mechanical forces acting on the
strut 10. The design and attachment of the gauges and wiring to the
strut 10 may be done by other acceptable methods known in the
art.
TABLE-US-00001 TABLE 1 List of materials for gauged Illizarov
struts (not including the modified metal rod)-these struts are
located external to the patient's skin. Part Model Size Makeup
Purpose Strain Gauges J5E-NC-S4225- 0.155'' .times. 0.220''
general-purpose measure strains 350S (Vishay) tee rosette in within
struts platinum-tungsten alloy M-bond 610 P-37920-00 <1.5''
length 2-component, strain gauge (Vishay) solvent-thinned, adhesive
epoxy-phenolic Gagekote #8 P-3784-00 <1.5'' length
single-component, water tight seal (Vishay) transparent, acrylic
coating Sylgard 164 P-5855-00 (Dow <1.5'' length 2-part,
silicone, physical protective Corning) elastomer coating Shrink
Tubing NA (NA) 1.5'' length polyolefin outer protective layer Mesh
Overbraid NA (NA) 3'' length polyester braided protects wire &
mesh sleeve connector Connector HR582-ND 1.25'' length lead free,
gold waterproof female (Hirose Electric) O 0.5'' contacts, PPS
shell plug leadwire connector Connector Cap HR598-ND <0.125''
thick santoprene robber waterproof cap for (Hirose Electric) O
0.5'' connector Leadwire P-5273-00 1'' length #22 AWG, Vinyl
connects strain (Belden) 4-cond, shielded gauge to connector
[0032] As noted above, the gauges 20 may be sealed with coatings
for mechanical and water protection. The electrical connector 28
may include a removable attached cap 34, wherein the electrical
connector 28 may be capped 34 at all times except when measurements
are taken. Measurements may be taken during clinical visits. A
patient may schedule a clinical visit for measurement purpose at a
set interval, for example, occurring approximately once per month.
The strain gauges 20 are small passive wire resistors with an
insulating backing that prevents any bare wire to strut 10 contact
14. The active electronic 30, which excites the gauges 20 with a
very small voltage (3V), will only be wired to the gauges 20 during
the measurement sessions and removed at the end of the
sessions.
[0033] The struts 42 of the Ilizarov and Taylor Spatial Frames 40
are components which are outside the patient's skin. The
traditional vertical steel struts 42 utilized by the Ilizarov
and/or Taylor Spatial Frames 40 were fully threaded. To incorporate
the gauges 20 into the modified strut, a smooth section 14 was
added to provide improved attachment of the gauges 20 to the strut
10. To ensure that the modified strut 10 would not fail, the
diameter of the smooth section may be increased to provide greater
mechanical properties. For example, the diameter of the smooth
section 14 of the modified strut may be increased one to five
millimeters. In one embodiment, the smooth section 14 of the
modified strut was increased from 5-millimeters to 6-millimeters.
Furthermore, if one strut were to mechanically fail, there is
redundancy in the Ilizarov and/or Taylor Spatial Frames 40
structures such that the other struts 42 and 10 would carry the
load.
[0034] For example, two 304 stainless steel struts 10 modified with
smooth 5 mm dia. central sections 14, lengths 12 cm and 20 cm, were
each cyclically tested 1 million cycles in 500 N (112 lbs) axial
compression with no failure detected.
[0035] The modified struts 10 may be tested to confirm that
mechanical properties of the strut 10 will support the particular
application based on the location and type of fracture and/or
damage to the bone to be supported. Test setup for testing the
mechanical properties of a strut may include: using a
servo-hydraulic mechanical testing machine. One end of the strut
may be rigidly fixed to an axial load cell. After aligning the
strut, cyclic loading may applied to each strut with a target peak
based on the particular application of the external fixator. For
example, force of 500 N may be applied to the strut 10 at a
frequency of 8 Hz for 1 million loading cycles.
Summary of Clinical Study Protocol
[0036] The subject(s) or patient(s) will not perform physical tasks
that are unusual for the patient population while wearing the
modified external fixator device. The patient(s) will ambulate
normally for a predetermined distance. For example, the patient(s)
may walk down the hallway in the clinic or on a sidewalk. While the
present protocol only describes the taking of measurements during
routinely scheduled clinical visits, it should be understood that
it is contemplated that the protocol may also include permanently
mounting an electronics module onto the external fixator and log
the patients data in a mobile manner during routine patient
activities outside of a clinical visit.
[0037] Patient population: Patients seen by the Co-PI (Chief Ortho
Trauma) at our institution for severe tibia fractures or defects
that are being treated by Ilizarov external fixation.
[0038] Protocol: [0039] As part of routine standard care the
patient will receive attachment of a standard Ilizarov external
fixator in a standard operation. This fixator will not be
instrumented at the time of the surgery. [0040] After consent,
during a post-operative clinical visit, the gauged struts will be
switched out with the normal struts, one at a time. (Changing of
struts for other purposes is performed sometimes during standard
clinical care.) A temporary additional strut will be added to the
frame during the switching procedure. The gauged struts will be
physically prepared, calibrated, and sterilized prior to the visit.
[0041] Subject will be instructed to not intentionally disturb the
gauged struts, and how the subject can call the research team with
any issues or concerns. The subject will be shown how the black
protective mesh fits over the strut and how it may be repositioned
properly in the event it is malpositioned. [0042] The research team
will schedule measurement sessions with the goal of conducting
force measurements at approximately five different time points
across the external fixator treatment, which can last from months
to as much as a year and a half [0043] Force measurements will be
conducted as an add-on session to the patient's routine clinical
visits. A wireless electronic module will be temporarily fastened
to the patient's external fixator, and wires will be connected to
the struts. Subjects will be asked to walk across a predetermined,
approximately 50 meter, cleared, flat path within the clinic.
Patients will be asked to use the same ambulation pattern and aide
device (crutch, cane, etc.) as they had been using over the past
week. A nurse and/or member of the research team will walk
alongside the patient. The patient will be allowed to take a break
from walking if he/she requests. External fixator forces+foot
forces will be recorded on a computer during walking. After each
measurement session, the wireless electronic module and wiring to
the struts will be removed and the connectors recapped. [0044]
Force data measured from the external fixator will be analyzed
statistically to determine if it can serve as a functional
indicator of bone healing, providing valuable information to
clinicians and patients.
[0045] The apparatus and method of using described herein is
intended to measure forces within external fixator devices 40 used
to stabilize bone fractures (scaffolds which connect directly to
bone through the skin). These forces should provide a functional
indication of fracture healing, or early indication of progression
of the patient toward poor healing. For example, use of llizarov
external fixation may be utilized to stabilize a fractured tibia.
In treating a fractured tibia, the fixators 40 may be kept on the
patient for months or even more than a year, at significant
inconvenience and risk of infection to the patient. The modified
fixator 40 described above may be used to measure the forces in
external fixator devices 40 that are used to stabilize bone
fractures and inform the surgeon when to remove the fixator 40 base
on the healing status of the bone. This technology could be a
foundation for mobile monitoring of more ubiquitous fracture
fixation implants and braces. The strut 10 designs may be modified
based on principles of load cell design with the aim of
amplifying/conditioning strains for more sensitive monitoring.
[0046] For example, the circular Ilizarov external fixator 40 may
be used to treat a tibial fracture or defect. To measure the
progress of healing at the fracture site, small strain gauges 20
may be adhered to vertical steel struts 10 which span the fracture
site. The force measurements from these gauges 20 can provide an
indication of functional bone healing.
[0047] A similar approach may be utilized with other medical braces
and devices wherein similar instruments may be added to the braces
and/or device to collect mechanical data from. As methodologies for
interpreting this large volume of data continue to evolve, the data
may be utilized to optimize the personalized treatment of
individual patients. While an external fixator 40 is described in
detail, it should be understood that the same principals,
technologies, methodologies, and instruments may be applied to
other braces and orthopedic devices.
[0048] An Ilizarov-type frame 40 modified with two instrumented
struts 10 was installed by the Co-PI onto a tubular bone
substitute, and a 2 cm segmental defect was created in the bone.
Controlled forces up to 125 lbs. were applied along the axis of the
`bone`, and forces were measured in the two struts 10 using the
wireless transmitter 30 as described herein. The measured forces
were very linear with applied load, and reproducible upon
reloading. This testing also indicated that certain struts 10 will
carry more load than others depending on the configuration of the
frame 40. Additionally running computer simulations with finite
element models to better understand the load transfer through the
various struts 10 may improve the accuracy of predicting the bone
healing status.
[0049] When the limb is mechanically loaded during standing and
walking, the load is transmitted down through the struts 10 of the
fixator 40, offloading the bone defect site. As healing progresses,
the bone assumes a larger and larger share of the load, and the
external fixator 40 should experience less load. This provides the
potential opportunity to use sensors 20 on the external fixator 40
to develop potential indicators of functional fracture healing,
which would be helpful to patients and clinicians. As part of
routine standard care the patient will initially have placement of
a standard circular external fixator 40 in a standard operation.
This fixator 40 will not be instrumented at the time of the
surgery. Statistical methods will be used to relate forces measured
from circular external fixators 40 to bone healing, and develop
potentially predictive methods (that could be formally validated in
a larger study).
[0050] The standard fixator 40 includes vertical struts 42 which
are fully-threaded 6 mm diameter (M6) 303 stainless steel rods or
rods with similar mechanical characteristics. At a post-operative
clinical visit, up to four of these struts 42 will be replaced by
instrumented struts 10, as shown in FIG. 6. The instrumented struts
10 may be physically prepared and calibrated prior to being
attached to the patient's fixator 40. The strut modification is
designed to not impact normal clinical care and result in long
term, accurate reliable force measurement. Furthermore, the strain
gauges may be modified to fit a particular application and allow
for improved installation and protection of the gauges on the strut
10. For example, the gauge 20 may be modified to fit a different
support member of a different frame, brace, or orthopedic device.
The gauge may also be modified to be attached to be attached to
different textured surfaces and different profiled surfaces. For
example, modified to be attached to a square or rectangular shaped
strut or bar that has a rough or course surface.
[0051] Gauged struts 10 are similar to the normal 6 mm dia.
threaded struts but include a central smooth region 14 of 6 mm
diameter, as shown in FIGS. 1 and 2. Strain gauges 20 are adhered
to the central smooth region 14 and protected from water and impact
by a special coating(s) 22 and 24; a small waterproof connector 28
is wired (with coated wiring) to the gauge and fastened to the
strut 10, and capped 34 while not in use. The gauges 20 and
connector 28 are protected by a removable mesh 32.
[0052] The circular external fixator 40 to be used will be a
modification of a normal fixator. The modification includes a small
change in the vertical steel struts 42 and 10 to accommodate
measurement of force. Struts 10 may be machined using documented
machining and quality control protocols, and by experienced
machinist with documented qualifications. Review of the protocol
will be conducted, and inspection and measurements of the final
parts completed by a research engineer. Other modifications may
include adding protective coatings and wiring to the strut(s) 10.
The vertical struts 10 are components that are entirely outside the
patient's skin and thus any risk is expected to be minimal.
[0053] Prior to installation, the gauged struts 10 may be
sterilized externally with ethanol and UV light and sealed in a
sterile bag until installation on the fixator 40.
[0054] Strain gauges 20 are basically small passive wire resistors
with an insulating backing. Active electronics 30 which excite the
gauges with small voltages (<5V) may be removably wired to the
gauges 20 when measurement are recorded, and removed when not
needed. The electric connector 28 that is attached to the gauges 20
may be capped 34 when the active electronic 30 is not connected, as
shown in FIG. 4.
[0055] Measurements made for this study will occur in conjunction
with routine post-op clinical visits. Measurements for each patient
may be taken at an established time interval. For example,
measurement may be taken at approximately five different time
points, each being approximately two weeks apart. The measurements
taken at each interval may then be compared in order to adequately
characterize the course of healing. Alternatively, measurements may
be taken in monthly time intervals during fracture healing. However
there may be variations in the timing of measurements for several
reasons: (1) The length of time the patient is treated with the
external fixator 40 varies from months to more than a year; (2)
some patients visit the clinic more frequently (e.g. every 2 weeks)
for a period of time such as during bone transport for severe
defects; and (3) Some patients are initially not weight-bearing on
their limb, thus any force measurements would not have clear
meaning.
[0056] During a measurement session, the gauged struts 10 described
above will be switched out with the normal struts 42, one at a
time. A temporary additional strut may be added to the frame 40
during the switching procedure to prevent any transient instability
of the frame 40. Black protective mesh 32 fits over the strut 10
and may be repositioned properly in the event it is
malpositioned.
[0057] A wireless electronic module 30 (74 mm.times.79 mm.times.20
mm plus small antenna 48, weight.about.150 grams, see figure below)
(V-Link LXRS, Lord Microstrain) will be temporarily fastened to the
patient's external fixator, and wires will be connected to the
struts 10. This electronic module 30 will collect and transmit
signals from the strain-gauged struts 10 on the fixator 40. A
wireless router connected to a computer will collect the data.
[0058] In addition to the gauged struts 10, foot plantar force may
be measured using portable instrumented shoe insoles. Because
patients generally have varying amounts of weight-bearing on their
injured limb, the data from the external fixators 40 may be
normalized based on the measured foot plantar force. The insoles
are available in different sizes. The appropriate sized insole may
be inserted into the patient's own shoe(s). Insoles will be
calibrated in a process that may use the patient's body weight.
Data transmission is by wireless Bluetooth, from a small component
also attached to the shoe.
[0059] Subjects wearing the external fixator 40, including the
modified strut(s) 10, and/or the shoe insole will be asked to walk
across a predetermined, approximately 50 meters, along a cleared
and flat path. The length of the walking course may be shortened as
needed if the patient expresses concern over the proscribed 50
meter distance. Patients may be asked to use the same ambulation
pattern and aide device (crutch, cane, etc.) as they had been using
over the past week. External fixator forces and foot forces will be
sampled during walking. Following measurements, the wireless
electronic module 30 and associated wiring to the struts 10 will be
removed from the patient's fixator 40 and the connector(s) 28
recapped 34. Also the foot insole devices will be removed from the
patient's shoe(s). FIGS. 8 and 9 are two graphs showing sample of
the data and measurements collected from a sample patient wearing
the device(s) described above.
[0060] The disclosure is not to be limited to the particular
embodiments described herein. The foregoing description has been
presented for purposes of illustration and description. It is not
intended to be an exhaustive list or limit any of the disclosure to
the precise forms disclosed. It is contemplated that other
alternatives or exemplary aspects of the present invention are
understood to be considered included in the disclosure. The
description(s) provided above are merely examples of embodiments,
processes or methods of the disclosure. It is understood that any
other modifications, substitutions, and/or additions can be made,
which are within the intended spirit and scope of the disclosure.
For the foregoing, it can be seen that the disclosure accomplishes
at least all that is intended.
[0061] The previous detailed description is of a small number of
embodiments for implementing the disclosure and is not intended to
be limiting in scope. The following claims set forth a number of
the embodiments of the disclosure with greater particularity.
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