U.S. patent application number 16/262465 was filed with the patent office on 2019-08-08 for soft tissue balancing in robotic knee surgery.
The applicant listed for this patent is ORTHOsoft, Inc.. Invention is credited to Pierre Couture.
Application Number | 20190240045 16/262465 |
Document ID | / |
Family ID | 67475028 |
Filed Date | 2019-08-08 |
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United States Patent
Application |
20190240045 |
Kind Code |
A1 |
Couture; Pierre |
August 8, 2019 |
SOFT TISSUE BALANCING IN ROBOTIC KNEE SURGERY
Abstract
A system and method may be used to evaluate soft tissue. A knee
arthroplasty soft tissue evaluation may use an adjustable spacer,
such as varying sized physical spacers or an inflatable bladder,
along with a sensor to measure force, pressure, gap distance, or
the like during a range of motion test. A method may include
maintaining an equal pressure or gap distance for a medial
component and a lateral component of an adjustable spacer during a
range of motion test. Information, including, for example a maximum
or minimum gap distance or pressure may be determined during the
range of motion test. The determined information may be output for
display or used to update a surgical plan.
Inventors: |
Couture; Pierre; (Montreal,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ORTHOsoft, Inc. |
Montreal |
|
CA |
|
|
Family ID: |
67475028 |
Appl. No.: |
16/262465 |
Filed: |
January 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62625706 |
Feb 2, 2018 |
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62697227 |
Jul 12, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/4657 20130101;
A61F 2002/4633 20130101; A61B 34/30 20160201; A61F 2/4684 20130101;
A61B 2034/252 20160201; A61B 2034/2048 20160201; A61B 2090/061
20160201; A61B 2017/00221 20130101; A61B 2034/105 20160201; A61B
2090/065 20160201; A61F 2/461 20130101; A61F 2002/467 20130101;
A61B 2034/108 20160201; A61B 2034/2055 20160201; A61B 2034/256
20160201 |
International
Class: |
A61F 2/46 20060101
A61F002/46; A61B 34/30 20060101 A61B034/30 |
Claims
1. A surgical device for evaluating soft tissue during a surgical
procedure comprising: a pump to: inflate a first adjustable
component of an adjustable spacer to separate a femur and a tibia
of a knee on a medial side of a patient; inflate a second
adjustable component of the adjustable spacer to separate the femur
and the tibia of the knee on a lateral side of the patient, the
second adjustable component independently adjustable to the first
adjustable component; and during a range of motion test, maintain
an equal pressure in the first adjustable component and the second
adjustable component by allowing a medial gap distance between the
femur and the tibia caused by the first adjustable component or a
lateral gap distance between the femur and the tibia the second
adjustable component to change; and a processor to: determine a
maximum gap distance during the range of motion test; and output
the maximum gap distance for display on a user interface.
2. The surgical device of claim 1, wherein the pump is further to
decrease the equal pressure during a repeated range of motion
test.
3. The surgical device of claim 1, wherein the processor is to use
a preoperative plan to determine the equal pressure.
4. The surgical device of claim 3, wherein the processor is further
to adjust the preoperative plan based on the maximum gap
distance.
5. The surgical device of claim 1, wherein the range of motion test
occurs after a tibial cut during a knee arthroplasty.
6. The surgical device of claim 1, wherein the processor is further
to determine an implant based on a maximum medial gap distance and
a maximum lateral gap distance, the implant having a first height
for the medial side and a second height different from the first
height for the lateral side.
7. The surgical device of claim 1, wherein to determine the maximum
gap distance, the processor is to use optical tracking of the femur
and the tibia.
8. The surgical device of claim 1, wherein the surgical device is a
robotic surgical device, wherein the processor operates a robotic
controller, wherein the pump is controlled by the processor, and
wherein the robotic surgical device includes a display, the display
configured to present the user interface including the maximum gap
distance.
9. A surgical device for evaluating soft tissue during a surgical
procedure comprising: a pump to: inflate a first adjustable
component of an adjustable spacer to separate a femur and a tibia
of a knee on a medial side of a patient; inflate a second
adjustable component of the adjustable spacer to separate the femur
and the tibia of the knee on a lateral side of the patient, the
second adjustable component independently adjustable to the first
adjustable component; during a range of motion test, maintain an
equal gap distance between a medial gap of the knee caused by the
first adjustable component and a lateral gap of the knee caused by
the second adjustable component by increasing or decreasing
pressure in the first adjustable component or the second adjustable
component; a processor to: determine a maximum pressure during the
range of motion test; and output the maximum pressure for display
on a user interface.
10. The surgical device of claim 9, wherein is further to decrease
the equal gap distance and perform the range of motion test
again.
11. The surgical device of claim 9, wherein the processor is to use
a preoperative plan used to determine the equal gap distance and
adjust the preoperative plan based on the maximum pressure.
12. The surgical device of claim 9, wherein the range of motion
test occurs after a tibial cut during a knee arthroplasty.
13. The surgical device of claim 9, wherein the processor is
further to determine an implant based on a maximum medial pressure
and a maximum lateral pressure, the implant having a first height
for the medial side and a second height different from the first
height for the lateral side.
14. The surgical device of claim 9, wherein to determine the
maximum pressure, the processor is to use optical tracking of the
femur and the tibia.
15. The surgical device of claim 9, wherein the surgical device is
a robotic surgical device, wherein the processor operates a robotic
controller, wherein the pump is controlled by the processor, and
wherein the robotic surgical device includes a display, the display
configured to present the user interface including the maximum gap
distance.
16. A method comprising: inserting a trial between a femur and a
tibia of a knee, the trial including a medial spacer of a first
height and a lateral spacer of a second height differing from the
first height; using a pressure sensor device, measuring pressure on
a medial side of the knee and a lateral side of the knee throughout
a range of motion test with the trial in place; determining a
maximum pressure during the range of motion test; and outputting
the maximum pressure for display on a user interface.
17. The method of claim 16, further comprising decreasing the first
height or the second height by replacing the medial spacer or the
lateral spacer and performing the range of motion test again.
18. The method of claim 16, further comprising using a preoperative
plan to determine the first height and the second height, and
adjusting the preoperative plan based on the maximum pressure.
19. The method of claim 16, further comprising performing the range
of motion test after a tibial cut during a knee arthroplasty.
20. The method of claim 16, further comprising determining an
implant based on a maximum medial pressure and a maximum lateral
pressure, the implant having a first height for the medial side and
a second height different from the first height for the lateral
side.
Description
CLAIM OF PRIORITY
[0001] This application claims the benefit of priority to U.S.
Provisional Applications Nos. 62/625,706, filed Feb. 2, 2018,
titled "SOFT TISSUE BALANCING IN ROBOTIC KNEE SURGERY"; and
62/697,227, filed Jul. 12, 2018, titled "SOFT TISSUE BALANCING IN
ROBOTIC KNEE SURGERY"; each of which is hereby incorporated herein
by reference in its entirety.
BACKGROUND
[0002] Computer-assisted surgery has been developed in order to
help a surgeon in altering bones, and in positioning and orienting
implants to a desired location. Computer-assisted surgery may
encompass a wide range of devices, including surgical navigation,
pre-operative planning, and various robotic devices. One area where
computer-assisted surgery has potential is in orthopedic joint
repair or replacement surgeries. For example, soft tissue balancing
is an important factor in articular repair, as an unbalance may
result in joint instability. However, when performing orthopedic
surgery on joints, soft tissue evaluations are conventionally done
by hand, with the surgeon qualitatively assessing the limits of
patient's range of motion. The conventional technique may result in
errors or lack precision.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0004] FIG. 1 illustrates a force sensor device used with a robotic
arm in accordance with some embodiments.
[0005] FIGS. 2-3 illustrate surgical planning user interfaces in
accordance with some embodiments.
[0006] FIG. 4 illustrates an eLibra device with various spacers in
accordance with some embodiments.
[0007] FIGS. 5-6 illustrate calibration user interfaces in
accordance with some embodiments.
[0008] FIG. 7 illustrates a system for using an eLibra device in
accordance with some embodiments.
[0009] FIG. 8 illustrates a force measurement display user
interface in accordance with some embodiments.
[0010] FIG. 9 illustrates an adjustable spacer in accordance with
some embodiments.
[0011] FIG. 10 illustrates a surgical technique in accordance with
some embodiments.
[0012] FIG. 11 illustrates an adjustable spacer with independently
adjustable medial and lateral components in accordance with some
embodiments.
[0013] FIG. 12 illustrates an adjustable spacer and graphs showing
effects of the adjustable spacer in accordance with some
embodiments.
[0014] FIG. 13 illustrates a system for using an adjustable spacer
with a robotic surgical device in accordance with some
embodiments.
[0015] FIG. 14 illustrates a unicondylar adjustable spacer used in
a partial knee arthroplasty in accordance with some
embodiments.
[0016] FIG. 15 illustrates a flowchart showing a technique for
using an adjustable spacer in a surgical knee procedure in
accordance with some embodiments.
[0017] FIG. 16 illustrates a system for performing techniques
described herein, in accordance with some embodiments.
[0018] FIG. 17 illustrates a block diagram of an example of a
machine upon which any one or more of the techniques discussed
herein may perform in accordance with some embodiments.
DETAILED DESCRIPTION
[0019] Systems and methods for soft tissue balancing in robotic
knee arthroplasty are provided herein. Knee arthroplasty techniques
may benefit from the use of a robotic device to assist in the
surgery. One aspect of knee arthroplasty includes checking knee
alignment and kinematics throughout a range of motion of the knee.
As the knee moves, gap distance or tension on ligaments may be
measured to determine kinematics and alignment. In an example, a
spacer may be inserted into the knee during a range of motion test
to maintain a particular tension or gap distance while kinematics
or alignment are checked. The spacer may be an electronic device,
such as described below, to transmit force or tension information.
In another example, the spacer may be adjustable, such that the
adjustable spacer may maintain a fixed pressure or gap distance
during a range of motion test. In an example, a spacer may maintain
different forces or gap distances on a medial versus a lateral side
of the knee.
[0020] FIG. 1 illustrates a force sensor device used with a robotic
arm in accordance with some embodiments. Systems and techniques
described herein include adapting for wireless communication an
eLibra dynamic knee balancing system provided by Synvasive
Technology, Reno, Nev. for use with the Medtech SA ROSA robotic
surgical system for total and partial knee arthroplasty.
[0021] As shown in FIG. 1, an eLibra device 102 wirelessly
transmits force and tension data captured by the eLibra device to a
robotic device 104. The eLibra device 102 may track, via onboard
accelerometers and gyroscopes, the relative orientation of the
eLibra device 102 which, combined with the optical tracking system
of the robotic device 104 (e.g., a Medtech ROSA robot) allows a
graph to be shown as displayed on FIG. 1 of the forces in the
medial and lateral compartments of the knee throughout the range of
motion.
[0022] The method of balancing the knee in total knee arthroplasty
using this combination of eLibra and the ROSA knee application may
works as described below.
[0023] Before performing any of the femoral resections in a knee
arthroplasty, the tension of the knee may be checked using a trial
device. As shown in FIG. 2, a knee planning screen of a robotic
device application is described showing the intended v/v
(varus/valgus) of the femoral component, v/v of the tibial cut, the
thickness of the distal resection on the medial compartment, the
distal resection of the lateral compartment, the proximal
resections of both the medial and lateral compartments, or the
posterior resections of the medial and lateral compartments, in an
example.
[0024] The planning screen may show the posterior slope and an
angle value for flexion that represents the flexion value used in
planning the resection showed in FIG. 2.
[0025] FIG. 3 shows an example of how the information from the
eLibra device is incorporated into the planning screen of the
robotic knee application. On the left hand side of FIG. 3, the
values for the eLibra spacer's recorded force are displayed with 62
Newtons in the medial compartment and 77 Newtons in the lateral
compartment. These force values are what are predicted to occur in
an example where the surgeon performs resections according to the
plans developed herein in FIG. 5 and FIG. 6.
[0026] As shown in FIG. 3, in this example, with the knee in 27
degrees of flexion and 2 degree of varus, using a spacer with the
eLibra device of size 4 in extension resulted in 62 Newtons of
force and using a spacer size of -1 in extension resulted in 77
Newtons of force in this example.
[0027] As shown in FIG. 4, this eLibra spacer values can be
accomplished by using shims of variance sizes from -4 mm to -3, -2,
-1, 0 mm and so on, to positive one, positive 2, positive 3,
positive 4 millimeters.
[0028] Alternatively, as shown in FIG. 9, rather than using shims,
an adjustable spacer tool, similar to those described in U.S. Pat.
No. 9,808,356 to Synvasive Technology may be used to adjust
platform heights of the medial and lateral compartments via
rotation of a screw or screws. Platform adjustment can also occur
via electrometrical means, potentially under control of the robotic
device. For example, the a robot system may wirelessly adjust the
heights of the medial and lateral compartments of the adjustable
spacer as the knee is moved through a range of motion, by detecting
the change in orientation of the leg with optical tracking.
[0029] FIG. 5 shows how the resections of a total knee replacement
can be planned using the eLibra spacer and recorded flexion and
positioning values.
[0030] In this example, on the medial compartment, bone cuts of 15
millimeters total (8.0 distal+7.0 proximal) are planned. With the
planned implant size of 19 millimeters the plan would therefore
result in an overstuff of the medial compartment of 4 millimeters.
Thus, in order to test and measure the tension forces in the medial
compartment with this planned resection, the eLibra device should
be loaded with a spacer size of 4 millimeters in the medial
compartment.
[0031] In the lateral compartment, in order to test the tension
experienced using these planned resections, the combination of the
proximal and distal resections of 10 millimeters each result in
planned bone cuts of 20 millimeters total. With a planned implant
size of 19 millimeters this would therefore result of laxity and
understuff of 1 millimeter in the lateral compartment and a thus -1
millimeter eLibra spacer would be used to measure the forces
experienced with this planned cut (FIG. 5) in extension.
[0032] In Flexion as shown in FIG. 6, here the plan calls for a
posterior resection of 9 millimeters and a proximal resection of 7
millimeters, thus totaling planned bone cuts in the medial
compartment of 16 millimeters. The implant size again being 19
millimeters would result in overstuff of 3 millimeters in the
medial compartment and the eLibra spacer then necessary to measure
the forces experienced in flexion under these planned resections
would be 3 millimeters.
[0033] Similarity on the lateral side, with bone cuts planned of 17
millimeters, 10 on the proximal section and 7 on the posterior
resection, an implant size of 19 millimeters would therefore result
in an overstuff of 2 millimeters in the lateral compartment and
therefore an eLibra spacer size of 2 millimeters would be required
in order to accurately measure tensions experienced under these
planned resections.
[0034] The surgeon may adjust the planned resections, test and
record the forces captured by the eLibra device in flexion and
extension, and then repeat as necessary until the plan results in
the desired expected tension values. The surgeon may then perform
the femoral resections according to the final plan.
[0035] Once the cuts are done, the resections are complete
according to the planned values, and tension may be confirmed over
the entire range of motion with trial implants such as described in
patent applications related to the eLibra device (e.g. U.S.
application Ser. No. 13/709,506, incorporated herein by reference
in its entirety).
[0036] As shown in FIG. 7, the eLibra device may be inserted in
between the femur and tibia and the patient's leg can be moved
throughout the range of motion from flexion to extension and the
eLibra device will record (or the CAS system of the ROSA robot will
record) force values throughout the range of motion. The force (in
Newtons) experienced in the medial compartment is a solid line and
the lateral compartment is a dotted line in FIG. 8. The angular
values for flexion are captured by virtue of the angular tracking
of the eLibra device, which may be performed using an additional
sensor, such as an inertial measurement unit (IMU), an
accelerometer, a gyroscope, or the like, or the tracking of the
robotic device (which may track the degree of flexion/extension of
the patient's leg by optical tracking of the femur and tibia or
using contact with a portion of the knee to track the knee using
the robotic device's internal accelerometer or gyroscope).
[0037] Systems and methods for using an adjustable spacer for a
surgical knee procedure, such as evaluating soft tissue during a
knee arthroplasty are described herein. The systems described
herein may include using an adjustable spacer with independently
adjustable components (e.g., a medial component and a lateral
component) for soft tissue evaluation. In an example, the
independently adjustable components may be controlled using
independent pressure or independent gap distance during a soft
tissue evaluation. The adjustable spacer systems and methods
described herein may be used with a robotic surgical device.
[0038] Robotics offer a useful tool for assisting the surgeon in
the surgical field. A robotic device may assist in the surgical
field performing tasks such as biopsies, electrode implantation for
functional procedures (e.g., stimulation of the cerebral cortex,
deep brain stimulation), open skull surgical procedures, endoscopic
interventions, other "key-hole" procedures, arthroplasty
procedures, such as total or partial knee replacement, hip
replacement, shoulder implant procedures, or the like. In an
example, a surgical procedure may use a surgical robot. The
surgical robot may include a robotic arm for performing operations.
A tracking system may be used to determine a relative location of
the surgical robot or robotic arm within a coordinate system or a
surgical field. The surgical robot may have a different coordinate
system or tracking system (e.g., using known movements of the
surgical robot). The robotic arm may include an end effector of the
robotic arm of the surgical robot, which may use sensors, such as a
gyroscope, magnetoscope, accelerometer, etc. In an example, a
processor may be used to process information, such as tracking
information, operation parameters, applied force, location, or the
like.
[0039] FIG. 10 illustrates a surgical technique 1000 in accordance
with some embodiments. The technique 1000 uses a robotic surgical
device to assist in surgical procedures, such as a resection, a
range of motion test, or a soft tissue balancing test. The
technique 1000 includes initiating a 3D plan, such as using a user
interface of the robotic surgical device (e.g., the Medtech SA ROSA
robotic surgical system). The technique 1000 includes an operation
to perform a tibial cut, for example using the ROSA or other
robotic arm for a total or partial knee arthroplasty. The technique
1000 includes an operation to capture balance during a range of
motion test, for example using an inflatable device or a robotic
arm. The inflatable device is described in more detail below.
[0040] The technique 1000 may include using feedback from the range
of motion test to adjust the plan (e.g., automatically change a
parameter of the preoperative plan based on the range of motion
test, such as balance information, a maximum or minimum distance,
range of motion, or angel). The technique 1000 may include
performing a distal cut, such as using the robotic arm. The
technique 1000 may include evaluating balance in soft tissue, such
as flexion or extension balance using the inflatable device, or the
robotic arm (e.g., the Rosa robotic arm with a tool attached to an
end effector on a distal end of the robotic arm).
[0041] In an example, the technique 1000 may include using an
optical tracker to track components of a surgery. For example,
tracked components may include a femur, a tibia, a robotic arm
(e.g., an end effector attached to a distal end of the robotic
arm), a tool, or the like. The technique 1000 may include
performing a range of motion test to evaluate soft tissue tension,
pressure, or gap distance in a knee joint in the range between
extension and flexion. Optical trackers may be used to determine
various attributes of bones or soft tissue during the range of
motion test. For example, distance traveled by the tibia (or femur)
throughout the range of motion test, angle of bone during the range
of motion test (e.g., maximum flexion angle or maximum extension
angle), gap distance at various points or throughout the range of
motion test (which may include separate medial and lateral gap
distances or a combined or maximum gap distance throughout), or the
like.
[0042] In an example, the gap distance may be shown on a user
interface during the range of motion test. The gap distance may be
shown based on a planned resection (or resections, such as a tibial
cut or a femoral cut). The planned resection may be shown on the
user interface, along with gap distances throughout the range of
motion test to display differences or issues that may arise based
on the planned resection and the evaluated gap distances. In an
example, potential errors arise when using the gap distance with
un-resected bone (e.g., the surface of the bone) because the
ultimate gap distances for the resected knee do not include the
surface errors. For example, osteophytes may cause issues with gap
measurement, a varus deformity may impact laxity, an error state
may impact gap measurement, or the lateral and medial laxity from a
spacer tool may cause measurement issues (e.g., because the
ligaments are on the side, the measured laxity may differ from the
actual laxity because of the rotation).
[0043] The technique 1000 may include establishing the preoperative
plan and showing the knee with the planned resections on the user
interface. Then as gap distances are determined throughout the
range of motion test, the gap distances are displayed on the user
interface with the planned resections. This combination of
preplanned resection visualization with actual measured gap
distance information allows for evaluation of the planned
resections with real gap distance feedback. This combination also
allows for evaluating the ultimate gap distances with the planned
resection rather than gap distances pre-resection, which may not
ultimately be accurate. The combination further allows for accurate
planning of what the soft tissue balancing (e.g., rotation of the
femur relative to the tibia) will be after the planned resection
without needing to actually perform the resection. This allows for
accurate planning, and modification to the resection may be
made.
[0044] In an example the technique 1000 may include displaying the
measured and actual gap distances with the planned resection by
reference to a plane (e.g., the tibial resection plane or a femur
horizontal plane). In an example, the femur horizontal plane may be
used along with a determined tibial plane a few degrees offset from
the femur horizontal plane. In another example, the tibial cut may
be performed before the range of motion test. The cut tibial plane
may be used, or may be offset by a few mm for the femur plane. In
an example, the femur horizontal plane may be used because it is
agnostic to movement of the bone, throughout the range of motion
(e.g., laxity independent or laxity based on resection, not where
bone sits or the femur horizontal plane).
[0045] In an example, when expanding the knee, ligaments may be on
a side which causes issues with measurement of the gap distance or
soft tissue balance. Using the preplanned resection with measured
gap distance, and taking into account the plane used for reference,
the measurement may be made in a more consistent manner.
[0046] In an example, the range of motion test may include
registering the tibia with reference to a bone model (e.g., a
preoperative plan), and registering a tracker for the tibia (the
femur may be registered and tracked as well. The range of motion
test is then performed. The tibia is tracked throughout the range
of motion test (e.g., by tracking the gap from the planned
resection of the femur or tibia to the femur or tibia throughout
the range of motion). The gap distance at a point or throughout a
range (e.g., a maximum gap distance, an animation of gap distance
throughout the range of motion, or a gap distance at a selectable
angle of range of motion) may be displayed on the user interface.
The user interface may show the gap distance from the preplanned
resection to the femur (e.g., instead of from the unresected tibia
to the unresected femur).
[0047] The gap distance may be measured using the optical trackers,
may use an adjustable spacer as described throughout this
disclosure, such as an independently adjustable medial and lateral
spacer, or a position sensor (e.g., iAssist). Because a natural
rotation may occur during the range of motion test, using an
independently adjustable medial and lateral spacer may allow for
different gap distances to be measured throughout the range of
motion.
[0048] FIG. 11 illustrates an adjustable spacer 1102 with
independently adjustable medial and lateral components (1104 and
1106, respectively) in accordance with some embodiments. The
adjustable spacer 1102 may be used within a knee, such as for a
total or partial knee arthroplasty (e.g., as described above with
respect to FIG. 10). The adjustable spacer 1102 may be used to
measure, determine, or change a gap distance or pressure difference
between a femur and a tibia of a patient. For example, the
adjustable spacer 1102 may be placed between the tibia and the
femur (e.g., after a tibial resection as described above during
technique 1000) and inflated to measure gap distance or pressure,
for example throughout a range of motion test.
[0049] The adjustable spacer 1102 may be inflated by one or more
pumps (e.g., medial pump 1105 or lateral pump 1107, or a single
pump with a valve configured to control whether the medial
component 1104 or the lateral component 1106 is inflated). The
medial component 1104 and the lateral component 1106 of the
adjustable spacer 1102 may be independently inflated, adjusted
(e.g., undergo an increase in inflation or be deflated), or
controlled (e.g., pressure maintenance).
[0050] The medial component 1104 and the lateral component 1106 of
the adjustable spacer 1102 may be inflated independently to a
particular gap distance. For example, as shown in the example in
FIG. 11, on the left side the medial component 1104 is inflated to
18 millimeters (mm), and the lateral component 1106 is inflated to
12 millimeters. These gap distances may correspond to internal
forces, as shown on the right side of FIG. 11. The example in FIG.
11 shows a pressure of 35 Newtons (N) in the medial component 1104
and 52 Newtons in the lateral component 1106. The gap distances and
forces may further correspond to pressure applied by one or more
pumps. For the example of FIG. 11, the medial pump 1105 is applying
7 pounds per square inch (psi) of pressure, corresponding to the 35
N, which may also correspond to 18 mm of gap distance. The lateral
pump 1107 applies 12 psi, corresponding to 52 N and 12 mm gap
distance. In an example, a surgeon may spread the knee to a desired
force with the adjustable spacer 1102 and the femoral rotation
required to achieve balance between the medial and lateral sides
may be output on a user interface.
[0051] The adjustable spacer 1102 may include one or more sensors,
such as a Hall effect sensor, to accurately measure the gap
distance in the medial component 1104 or the lateral component
1106. For example, the medial component 1104 and the lateral
component 1106 may each have a Hall effect sensor to independently
measure gap distance in the respective components. In an example, a
Hall effect sensor may output a voltage corresponding to a change
in magnetic field based on the gap distance. For example, a magnet
may be placed on a free end of the medial 1104 or lateral 1106
component, and a Hall effect sensor may be used to determine the
change in distance of the component 1104 or 1106 based on the
change in magnetic field from the free end being displaced from a
base of the adjustable spacer 1102. In this example, the Hall
effect sensor may be located on the base of the adjustable spacer
1102 (e.g., on an end opposite the free end of one of the
components 1104 or 1106).
[0052] The medial pump 1105 or the lateral pump 1107 may be
controlled by a pump controller. The pump controller may be coupled
to, operated by, or located within a robotic surgical device (e.g.,
ROSA). For example, the pump controller may be executed using a
processor of the robotic surgical device. A user interface of a
display of the robotic surgical device (or an external display) may
be used to display information (e.g., gap distance, force,
pressure, etc.) related to the adjustable spacer 1102, the pump
controller, or the medial/lateral pumps 1105/1107.
[0053] The gap distance in the medial or lateral component of the
adjustable spacer may be determined using a distance sensor, such
as a Hall effect sensor. In an example, one distance sensor may be
used, such as in a central location of the medial or lateral
component. In another example, two distance sensors may be used,
such as at either end of the medial or lateral component. In
another example, three sensors may be used (e.g., with a sensor
shown at 1108), such as one in a central location and two at either
end of the medial or lateral component. Other configurations of
sensors (e.g., at corners of a component, in the middle of a
component) may be used to increase accuracy of gap distance
measurements. Other measurement techniques may be used, including
using optical tracking of the gap distance, a time-of-flight
sensor, a tension sensor, or the like. The sensor measurements for
gap distance may be used on the adjustable spacer of FIG. 9
similarly.
[0054] FIG. 12 illustrates an adjustable spacer (1202 and 1204) and
graphs 1200 and 1201 showing effects of the adjustable spacer (1202
and 1204) in accordance with some embodiments. The adjustable
spacer (1202 and 1204) may be used within a knee, such as for a
total or partial knee arthroplasty. The adjustable spacer (1202 and
1204) may be used to measure, determine, or change a gap distance
or pressure difference between a femur and a tibia of a patient.
For example, the adjustable spacer (1202 and 1204) may be placed
between the tibia and the femur (e.g., after a tibial resection)
and inflated to measure gap distance or pressure, for example
throughout a range of motion test.
[0055] The adjustable spacer is shown in a first controlled
configuration 1202 corresponding to graph 1200 and a second
controlled configuration 1204 corresponding to graph 1201. The
first configuration 1202 includes controlling the adjustable spacer
such that the pressure in a medial component and a lateral
component of the adjustable spacer are fixed. A fixed pressure
means that the pressure output from a pump or pumps is equal (e.g.,
7 psi) to each component, medial and lateral of the adjustable
spacer. Said another way, the medial and lateral components of the
adjustable spacer are free to change gap distance (e.g., have
unequal gap distance), but have the same pressure applied (air or
other fluid applied within a bladder of each component). The fixed
pressure may also result in equal force (e.g., 35 N) within each
component (e.g., as applied to a free end from a fixed end, shown
in FIG. 12 with an upward arrow).
[0056] Graph 1200 illustrates changes in gap distance for the fixed
pressure adjustable spacer 1202 throughout a range of motion test.
Graph 1200 has an x-axis illustrating degrees of the range of
motion test (e.g., starting at zero degrees for a fully extended
knee, and moving up in degrees towards flexion). The y-axis of
graph 1200 illustrates a gap distance (e.g., in the example shown
in FIG. 12, fluctuating between 15 and 25 mm). The gap distance is
shown on graph 1200 in the medial component (M) and the in the
lateral component (L) of the adjustable spacer 1202 separately. The
graph 1200 may be output to a user interface on a display (e.g., a
display of a robotic surgical system) for evaluation by a surgeon.
In an example, a maximum or minimum gap distance for each component
may be determined from the range of motion test. The maximum or
minimum gap distance (in either component or a maximum or minimum
in both components) may be used to adjust a surgical plan (e.g., a
preoperative plan), such as by changing a parameter for a planned
resection of the femur, changing an implant size, or adjusting soft
tissue (e.g., releases). The changes to the preoperative plan may
be made automatically, for example changing a parameter of a
planned resection by a robotic arm.
[0057] The second configuration 1204 includes controlling the
adjustable spacer such that the gap distances in the medial
component and the lateral component of the adjustable spacer are
fixed. A fixed gap distance means that the pressure output from a
pump or pumps varies (e.g., 7 psi and 12 psi as shown in FIG. 12)
to each component, medial and lateral of the adjustable spacer. The
medial and lateral components of the adjustable spacer are thus
fixed to a certain gap distance, which may be determined as part of
a preoperative plan or interoperative change to a preoperative
plan. The change in pressure may be adjusted during a range of
motion test to retain the equal gap distance between the two
components. The change in pressure may correspond to a change in
force (e.g., 35 N for 7 psi and 52 N for 12 psi), as applied to a
free end from a fixed end, shown in FIG. 12 with an upward
arrow.
[0058] Graph 1201 illustrates changes in pressure for the fixed
equal gap distance in components of the adjustable spacer 1202
throughout a range of motion test. Graph 1201 has an x-axis
illustrating degrees of the range of motion test (e.g., starting at
zero degrees for a fully extended knee, and moving up in degrees
towards flexion). The y-axis of graph 1201 may illustrate a
pressure (e.g., applied from a pump) or a force applied by the or
within each component (e.g., in the example shown in FIG. 12, a
force is illustrated). The pressure change is shown on graph 1201
in the medial component (M) and the in the lateral component (L) of
the adjustable spacer 1202 separately. The graph 1201 may be output
to a user interface on a display (e.g., a display of a robotic
surgical system) for evaluation by a surgeon. In an example, a
maximum or minimum pressure for each component may be determined
from the range of motion test. The maximum or minimum pressure (in
either component or a maximum or minimum in both components) may be
used to adjust a surgical plan (e.g., a preoperative plan), such as
by changing a parameter for a planned resection of the femur,
changing an implant size, or adjusting soft tissue (e.g.,
releases). The changes to the preoperative plan may be made
automatically, for example changing a parameter of a planned
resection by a robotic arm.
[0059] In an example, only one side of the adjustable spacer 1202
(e.g., medial or lateral) may be inflated. The singly inflated side
may be used to perform a stress test for the knee joint. During a
stress test (which may be performed before or after a tibial cut),
the lateral or the medial side may be inflated to assess ligament
tension and find a gap distance for that side. The stress test for
one or both sides (medial and lateral) inflated, one at a time, may
be conducted instead of or in addition to a range of motion test
with both sides (medial and lateral) inflated.
[0060] FIG. 13 illustrates a system 1300 for using an adjustable
spacer with a robotic surgical device in accordance with some
embodiments. The system 1300 may include a robotic surgical system
or device (e.g., a ROSA robotic surgical system), which may include
a user interface and a robotic arm. The robotic surgical system or
device may include a pump, be configured to hold or support a pump,
interface with a pump, or the like. In another example, the system
1300 may include a pump separate from the robotic surgical system
or device. The pump (which may include more than one pump) may be
used to control an adjustable spacer. In the example where the pump
is controlled by the robotic system or device, a processor of the
robotic system or device may control pressure output to one or more
components of the adjustable spacer. The robotic surgical system or
device may be used to control the pump during a range of motion
test, such as to evaluate gap distance or pressure in a medial or
lateral component of the adjustable spacer.
[0061] FIG. 14 illustrates a unicondylar adjustable spacer used in
a partial knee arthroplasty in accordance with some embodiments.
The diagram 1400 illustrated in FIG. 14 shows a unicondylar
adjustable spacer, which may be inflated or adjusted using a pump
(e.g., controlled by a robotic surgical system). In another
example, an adjustable spacer with both medial and lateral
components may be used, such as by only inflating one side when
used with a partial knee arthroplasty or when doing a unicondylar
surgery on both the medial and the lateral sides of a single knee.
The singularly inflated component may be used during a range of
motion test, holding gap distance to a specific gap distance or
holding pressure to a specific pressure (e.g., a specific gap
distance or specific pressure from a surgical plan). A minimum
tension may be determined during the range of motion test. The
minimum tension may be output, such as for display on a user
interface or for use in automatically adjusting a parameter of a
surgical plan.
[0062] FIG. 15 illustrates a flowchart showing a technique 1500 for
using an adjustable spacer in a surgical knee procedure in
accordance with some embodiments. In an example, the technique 1500
may be performed after an initial tibial cut. In another example,
the technique 1500 is performed before any cuts during a knee
arthroplasty. The technique 1500 may be performed using a robotic
surgical device. The inflation operations described below may be
performed using a pump, which may be automatically controlled by a
pump controller of the robotic surgical device. The robotic
surgical device may include a display to present a user interface
for presenting results of the technique 1500.
[0063] The technique 1500 includes an operation 502 to inflate a
first adjustable component of an adjustable spacer to separate a
femur and a tibia of a knee, for example on a medial side of a
patient. The technique 1500 includes an operation 504 inflate a
second adjustable component of the adjustable spacer to separate
the femur and the tibia of the knee, for example on a lateral side
of the patient. In an example, the second adjustable component is
independently adjustable to the first adjustable component.
[0064] The technique 1500 includes an operation 506 to select
whether to use an equal pressure or an equal gap distance in the
adjustable components. The equal pressure or equal gap distance may
be determined using a preoperative plan. The technique 1500
includes an operation 508 when the equal pressure is selected.
Operation 508 includes, during a range of motion test, maintaining
an equal pressure in the first adjustable component and the second
adjustable component by allowing a medial gap distance between the
femur and the tibia caused by the first adjustable component or a
lateral gap distance between the femur and the tibia the second
adjustable component to change.
[0065] The technique 1500 includes an operation 510 to, when the
equal pressure is selected, determine a maximum gap distance during
the range of motion test. The maximum gap distance may be
determined using a sensor (e.g., a Hall effect sensor) or using
optical tracking of the femur and the tibia. The technique 1500
includes an operation 512 when the equal gap distance is selected.
Operation 512 includes, during a range of motion test, maintaining
an equal gap distance between a medial gap of the knee caused by
the first adjustable component and a lateral gap of the knee caused
by the second adjustable component by increasing or decreasing
pressure in the first adjustable component or the second adjustable
component.
[0066] The technique 1500 includes an operation 514 to, when the
equal gap distance is selected, determine a maximum pressure during
the range of motion test. The maximum pressure may be determined
using a sensor (e.g., a pressure sensor such as an eLibra device)
or using feedback at a pump used to inflate the components. The
technique 1500 includes an operation 516 to output results for
display on a user interface, such as the maximum gap distance or
the maximum pressure. In another example, results may be used to
adjust a preoperative plan. For example, the results may be used to
determine an implant based on a maximum gap distance (e.g., lateral
or medial or both). The technique 1500 may include repeating a
range of motion test, for example after increasing or decreasing
the equal pressure or the equal gap distance. In an example, an
implant with different heights for each side may be used, for
example based on the pressure changes throughout the range of
motion.
[0067] In an example, the pressure and the gap distance may be
allowed to change during the range of motion test. In this example,
a 3D plan (e.g., a preoperative plan) may be used to set limits or
targets for gap distance or pressure. For example, a maximum
pressure may be set for different angles (e.g., from extension to
flexion) or a maximum gap may be set. In an example, operation 506
may include a determination to use the 3D plan. The technique 1500
may then proceed to operation 511 to, during a range of motion
test, maintain a gap distance or pressure based on the 3D plan. At
some portions of the range of motion test, the gap distance may be
held constant while at other portions of the range of motion test,
the pressure may be held constant, according to the 3D plan. The
technique 1500 may include an operation 515 to determine a maximum
pressure or maximum gap distance during the range of motion test
(e.g., at different portions of the test, based on when the gap
distance or the pressure is held constant, respectively).
[0068] FIG. 16 illustrates a system 600 for performing techniques
described herein, in accordance with some embodiments. The system
600 includes a robotic surgical device 602 coupled to a pump 604,
which may be used to control a spacer device 606. The spacer device
606 includes a medial adjustable component 608 and a lateral
adjustable component 612. The system 600 may include a display
device 614, which may be used to display a user interface 616. The
system 600 may include a control system 618 (e.g., a robotic
controller), including a processor 620 and memory 622. In an
example, the display device 614 may be coupled to one or more of
the robotic surgical device 602, the spacer device 606, or the
control system 618.
[0069] In an example, the display device 614 may be used to display
results of a soft tissue procedure on the user interface 616. The
results may include gap distance or pressure information, such as
over different angles during a range of motion test. The gap
distance or pressure information may be derived from a sensor, such
as a sensor 610, which may be on the medial adjustable component
608 or the lateral adjustable component 612 or elsewhere on or
within the spacer device 606. The sensor 610 may be a Hall effect
sensor. The gap distance or pressure information may be related to
a knee joint, and the range of motion test may be performed from
extension to flexion (or vice versa).
[0070] FIG. 17 illustrates a block diagram of an example machine
1700 upon which any one or more of the techniques discussed herein
may perform in accordance with some embodiments. In alternative
embodiments, the machine 1700 may operate as a standalone device or
may be connected (e.g., networked) to other machines. In a
networked deployment, the machine 1700 may operate in the capacity
of a server machine, a client machine, or both in server-client
network environments. In an example, the machine 1700 may act as a
peer machine in peer-to-peer (P2P) (or other distributed) network
environment. The machine 1700 may be a personal computer (PC), a
tablet PC, a set-top box (STB), a personal digital assistant (PDA),
a mobile telephone, a web appliance, a network router, switch or
bridge, or any machine capable of executing instructions
(sequential or otherwise) that specify actions to be taken by that
machine. Further, while only a single machine is illustrated, the
term "machine" shall also be taken to include any collection of
machines that individually or jointly execute a set (or multiple
sets) of instructions to perform any one or more of the
methodologies discussed herein, such as cloud computing, software
as a service (SaaS), other computer cluster configurations.
[0071] Machine (e.g., computer system) 1700 may include a hardware
processor 1702 (e.g., a central processing unit (CPU), a graphics
processing unit (GPU), a hardware processor core, or any
combination thereof), a main memory 1704 and a static memory 1706,
some or all of which may communicate with each other via an
interlink (e.g., bus) 1708. The machine 1700 may further include a
display unit 1710, an alphanumeric input device 1712 (e.g., a
keyboard), and a user interface (UI) navigation device 1714 (e.g.,
a mouse). In an example, the display unit 1710, input device 1712
and UI navigation device 1714 may be a touch screen display. The
machine 1700 may additionally include a storage device (e.g., drive
unit) 1716, a signal generation device 1718 (e.g., a speaker), a
network interface device 1720, and one or more sensors 1721, such
as a global positioning system (GPS) sensor, compass,
accelerometer, or other sensor. The machine 1700 may include an
output controller 1728, such as a serial (e.g., Universal Serial
Bus (USB), parallel, or other wired or wireless (e.g., infrared
(IR), near field communication (NFC), etc.) connection to
communicate or control one or more peripheral devices (e.g., a
printer, card reader, etc.).
[0072] The storage device 1716 may include a machine readable
medium 1722 on which is stored one or more sets of data structures
or instructions 1724 (e.g., software) embodying or utilized by any
one or more of the techniques or functions described herein. The
instructions 1724 may also reside, completely or at least
partially, within the main memory 1704, within static memory 1706,
or within the hardware processor 1702 during execution thereof by
the machine 1700. In an example, one or any combination of the
hardware processor 1702, the main memory 1704, the static memory
1706, or the storage device 1716 may constitute machine readable
media.
[0073] While the machine readable medium 1722 is illustrated as a
single medium, the term "machine readable medium" may include a
single medium or multiple media (e.g., a centralized or distributed
database, and/or associated caches and servers) configured to store
the one or more instructions 1724. The term "machine readable
medium" may include any medium that is capable of storing,
encoding, or carrying instructions for execution by the machine
1700 and that cause the machine 1700 to perform any one or more of
the techniques of the present disclosure, or that is capable of
storing, encoding or carrying data structures used by or associated
with such instructions. Non-limiting machine readable medium
examples may include solid-state memories, and optical and magnetic
media.
[0074] The instructions 1724 may further be transmitted or received
over a communications network 1726 using a transmission medium via
the network interface device 1720 utilizing any one of a number of
transfer protocols (e.g., frame relay, internet protocol (IP),
transmission control protocol (TCP), user datagram protocol (UDP),
hypertext transfer protocol (HTTP), etc.). Example communication
networks may include a local area network (LAN), a wide area
network (WAN), a packet data network (e.g., the Internet), mobile
telephone networks (e.g., cellular networks), Plain Old Telephone
(POTS) networks, and wireless data networks (e.g., Institute of
Electrical and Electronics Engineers (IEEE) 802.11 family of
standards known as Wi-Fi.RTM., IEEE 802.16 family of standards
known as WiMax.RTM.), IEEE 802.15.4 family of standards,
peer-to-peer (P2P) networks, among others. In an example, the
network interface device 1720 may include one or more physical
jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more
antennas to connect to the communications network 1726. In an
example, the network interface device 1720 may include a plurality
of antennas to wirelessly communicate using at least one of
single-input multiple-output (SIMO), multiple-input multiple-output
(MIMO), or multiple-input single-output (MISO) techniques. The term
"transmission medium" shall be taken to include any intangible
medium that is capable of storing, encoding or carrying
instructions for execution by the machine 1700, and includes
digital or analog communications signals or other intangible medium
to facilitate communication of such software.
[0075] Each of these non-limiting examples may stand on its own, or
may be combined in various permutations or combinations with one or
more of the other examples.
[0076] Example 1 is a surgical device for evaluating soft tissue
during a surgical procedure comprising: a pump to: inflate a first
adjustable component of an adjustable spacer to separate a femur
and a tibia of a knee on a medial side of a patient; inflate a
second adjustable component of the adjustable spacer to separate
the femur and the tibia of the knee on a lateral side of the
patient, the second adjustable component independently adjustable
to the first adjustable component; and during a range of motion
test, maintain an equal pressure in the first adjustable component
and the second adjustable component by allowing a medial gap
distance between the femur and the tibia caused by the first
adjustable component or a lateral gap distance between the femur
and the tibia the second adjustable component to change; and a
processor to: determine a maximum gap distance during the range of
motion test; and output the maximum gap distance for display on a
user interface.
[0077] In Example 2, the subject matter of Example 1 includes,
wherein the pump is further to decrease the equal pressure during a
repeated range of motion test.
[0078] In Example 3, the subject matter of Examples 1-2 includes,
wherein the processor is to use a preoperative plan to determine
the equal pressure.
[0079] In Example 4, the subject matter of Example 3 includes,
wherein the processor is further to adjust the preoperative plan
based on the maximum gap distance.
[0080] In Example 5, the subject matter of Examples 1-4 includes,
wherein the range of motion test occurs after a tibial cut during a
knee arthroplasty.
[0081] In Example 6, the subject matter of Examples 1-5 includes,
wherein the processor is further to determine an implant based on a
maximum medial gap distance and a maximum lateral gap distance, the
implant having a first height for the medial side and a second
height different from the first height for the lateral side.
[0082] In Example 7, the subject matter of Examples 1-6 includes,
wherein to determine the maximum gap distance, the processor is to
use optical tracking of the femur and the tibia.
[0083] In Example 8, the subject matter of Examples 1-7 includes,
wherein the surgical device is a robotic surgical device, wherein
the processor operates a robotic controller, wherein the pump is
controlled by the processor, and wherein the robotic surgical
device includes a display, the display configured to present the
user interface including the maximum gap distance.
[0084] Example 9 is a surgical device for evaluating soft tissue
during a surgical procedure comprising: a pump to: inflate a first
adjustable component of an adjustable spacer to separate a femur
and a tibia of a knee on a medial side of a patient; inflate a
second adjustable component of the adjustable spacer to separate
the femur and the tibia of the knee on a lateral side of the
patient, the second adjustable component independently adjustable
to the first adjustable component; during a range of motion test,
maintain an equal gap distance between a medial gap of the knee
caused by the first adjustable component and a lateral gap of the
knee caused by the second adjustable component by increasing or
decreasing pressure in the first adjustable component or the second
adjustable component; a processor to: determine a maximum pressure
during the range of motion test; and output the maximum pressure
for display on a user interface.
[0085] In Example 10, the subject matter of Example 9 includes,
wherein is further to decrease the equal gap distance and perform
the range of motion test again.
[0086] In Example 11, the subject matter of Examples 9-10 includes,
wherein the processor is to use a preoperative plan used to
determine the equal gap distance.
[0087] In Example 12, the subject matter of Example 11 includes,
wherein the processor is further to adjust the preoperative plan
based on the maximum pressure.
[0088] In Example 13, the subject matter of Examples 9-12 includes,
wherein the range of motion test occurs after a tibial cut during a
knee arthroplasty.
[0089] In Example 14, the subject matter of Examples 9-13 includes,
wherein the processor is further to determine an implant based on a
maximum medial pressure and a maximum lateral pressure, the implant
having a first height for the medial side and a second height
different from the first height for the lateral side.
[0090] In Example 15, the subject matter of Examples 9-14 includes,
wherein to determine the maximum pressure, the processor is to use
optical tracking of the femur and the tibia.
[0091] In Example 16, the subject matter of Examples 9-15 includes,
wherein the surgical device is a robotic surgical device, wherein
the processor operates a robotic controller, wherein the pump is
controlled by the processor, and wherein the robotic surgical
device includes a display, the display configured to present the
user interface including the maximum gap distance.
[0092] Example 17 is a method comprising: inserting a trial between
a femur and a tibia of a knee, the trial including a medial spacer
of a first height and a lateral spacer of a second height differing
from the first height; using a pressure sensor device, measuring
pressure on a medial side of the knee and a lateral side of the
knee throughout a range of motion test with the trial in place;
determining a maximum pressure during the range of motion test; and
outputting the maximum pressure for display on a user
interface.
[0093] In Example 18, the subject matter of Example 17 includes,
decreasing the first height or the second height by replacing the
medial spacer or the lateral spacer and performing the range of
motion test again.
[0094] In Example 19, the subject matter of Examples 17-18
includes, using a preoperative plan to determine the first height
and the second height.
[0095] In Example 20, the subject matter of Example 19 includes,
adjusting the preoperative plan based on the maximum pressure.
[0096] In Example 21, the subject matter of Examples 17-20
includes, performing the range of motion test after a tibial cut
during a knee arthroplasty.
[0097] In Example 22, the subject matter of Examples 17-21
includes, determining an implant based on a maximum medial pressure
and a maximum lateral pressure, the implant having a first height
for the medial side and a second height different from the first
height for the lateral side.
[0098] In Example 23, the subject matter of Examples 17-22
includes, determining the maximum pressure using an iAssist
device.
[0099] Example 24 is at least one machine-readable medium including
instructions that, when executed by processing circuitry, cause the
processing circuitry to perform operations to implement of any of
Examples 1-23.
[0100] Example 25 is an apparatus comprising means to implement of
any of Examples 1-23.
[0101] Example 26 is a system to implement of any of Examples
1-23.
[0102] Example 27 is a method to implement of any of Examples
1-23.
[0103] Method examples described herein may be machine or
computer-implemented at least in part. Some examples may include a
computer-readable medium or machine-readable medium encoded with
instructions operable to configure an electronic device to perform
methods as described in the above examples. An implementation of
such methods may include code, such as microcode, assembly language
code, a higher-level language code, or the like. Such code may
include computer readable instructions for performing various
methods. The code may form portions of computer program products.
Further, in an example, the code may be tangibly stored on one or
more volatile, non-transitory, or non-volatile tangible
computer-readable media, such as during execution or at other
times. Examples of these tangible computer-readable media may
include, but are not limited to, hard disks, removable magnetic
disks, removable optical disks (e.g., compact disks and digital
video disks), magnetic cassettes, memory cards or sticks, random
access memories (RAMs), read only memories (ROMs), and the
like.
* * * * *