U.S. patent application number 15/177692 was filed with the patent office on 2016-12-15 for sensor technologies with alignment to body movements.
The applicant listed for this patent is OrthoDrill Medical Ltd.. Invention is credited to Ehud ARDEL, Shlomo DAVID, Zvi FRIEDMAN.
Application Number | 20160361070 15/177692 |
Document ID | / |
Family ID | 56464258 |
Filed Date | 2016-12-15 |
United States Patent
Application |
20160361070 |
Kind Code |
A1 |
ARDEL; Ehud ; et
al. |
December 15, 2016 |
SENSOR TECHNOLOGIES WITH ALIGNMENT TO BODY MOVEMENTS
Abstract
Disclosed herein is a method for monitoring the interaction of a
surgical tool with a patient's bone, comprising interacting a
surgical tool with a proximal bone region; detecting at least one
signal emanating from the bone following the surgical tool
interaction with the bone region; and identifying based on the
signal an interaction progression of the surgical tool relative to
the bone.
Inventors: |
ARDEL; Ehud; (Givat Ada,
IL) ; DAVID; Shlomo; (Binyamina, IL) ;
FRIEDMAN; Zvi; (Kiryat-Bialik, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OrthoDrill Medical Ltd. |
Binyamina |
|
IL |
|
|
Family ID: |
56464258 |
Appl. No.: |
15/177692 |
Filed: |
June 9, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62173365 |
Jun 10, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00128
20130101; A61B 2017/00123 20130101; A61B 2090/571 20160201; A61B
17/1626 20130101; A61B 2017/00119 20130101; A61B 90/60 20160201;
A61B 2017/00106 20130101; A61B 17/14 20130101; A61B 17/162
20130101; A61B 2034/2048 20160201; A61B 17/1617 20130101; A61B
2017/00039 20130101; A61B 2017/00199 20130101; A61B 17/142
20161101; A61B 17/1628 20130101; A61B 2017/00694 20130101; A61B
17/15 20130101; A61B 90/53 20160201; A61B 17/1622 20130101; A61B
2017/00084 20130101; A61B 2017/00026 20130101 |
International
Class: |
A61B 17/16 20060101
A61B017/16 |
Claims
1. A method for monitoring the interaction of a surgical tool with
a patient's bone, comprising: interacting a surgical tool with a
proximal bone region; detecting at least one signal emanating from
said bone following said surgical tool interaction with said bone
region; and identifying based on said signal an interaction
progression of said surgical tool relative to said bone.
2. The method according to claim 1, wherein said at least one
signal is sound waves having a frequency equal to or below 10
KHz.
3. The method according to claim 2, further comprising filtering
said sound waves to extract sound waves emanating from the bone
only.
4. The method according to claim 1, wherein said identifying
comprises correlating said at least one signal with an orientation
of an operating tip of the tool with respect to the bone.
5. The method according to claim 1, said detecting is provided by
contacting a sensor with a body portion of a patient and not
contacting said sensor with the tool.
6. The method according to claim 1, wherein said at least one
signal is body vibrations.
7. The method according to claim 1, wherein said at least one
signal is air pulses.
8. The method according to claim 1, further comprising conducting a
stopping event based on said identifying of interaction
progression.
9. The method according to claim 8, wherein said stopping event is
conducted when identifying said interaction progression comprises
extrusion of a tip of the surgical tool through the bone.
10. The method according to claim 8, wherein said stopping event is
conducted when identifying said interaction progression comprises a
predetermined pattern.
11. The method according to claim 8, wherein said stopping event
comprises tool operation cessation.
12. The method according to claim 8, wherein said stopping event
comprises activating an alert.
13. The method according to claim 1, wherein said identifying an
interaction progression comprises correcting said signal to at
least one second signal.
14. The method according to claim 13, wherein said second signal
comprises at least one of: a. patient's body vibrations; b.
vibrations of a hand operating said tool; and c. mechanical output
from said tool.
15. The method according to claim 1, wherein said identifying an
interaction progression further comprises correlating said signal
with a database having a plurality of signals resulting from
previously conducted surgical tool interactions with a bone
region.
16. The method according to claim 1, further comprising
transmitting a monitoring signal to a monitoring region of said
bone prior to said detecting at least one signal.
17. The method according to claim 16, wherein said monitoring
region is a distal region of said bone.
18. The method according to claim 16, wherein said monitoring
signal comprises at least one of acoustic sound waves and acoustic
sound pulses.
19. The method according to claim 16, wherein said monitoring
signal comprises at least one of ultrasound waves and ultrasound
pulses.
20. The method according to claim 19, wherein said detecting at
least one signal comprises detecting ultrasound waves.
21. The method according to claim 20, wherein said detecting
ultrasound waves comprises detecting Doppler Effect.
22. The method according to claim 19, wherein said detecting at
least one signal comprises detecting ultrasound pulses.
23. The method according to claim 19, further comprising:
determining a proximal region of a bone for penetrating using said
surgical bone tool, and a distal region of said bone in an opposite
orientation to said proximal region; transmitting ultrasound waves
to said distal region of said bone; positioning an ultrasound
receiver such that a backscatter of said transmitted ultrasound
signal is not detected by said receiver; interacting said surgical
tool with said bone region; and detecting a scatter of said
transmitted ultrasound by said receiver.
24. The method according to claim 1, further comprising calculating
an appropriate screw size based on said determined interaction
progression.
25. An apparatus for monitoring the interaction of a surgical tool
with a bone region of a patient, comprising at least one sensor for
detecting at least one signal emanating from said bone following
said surgical tool interaction with said bone region.
26. The apparatus according to claim 25, wherein said sensor is an
acoustic transducer.
27. The apparatus according to claim 25, further comprising a sonic
emitter.
28. The apparatus according to claim 25, further comprising an
ultrasound transducer and wherein said sensor is an ultrasound
receiver.
29. The apparatus according to claim 28, wherein said ultrasound
transducer and ultrasound receiver are embedded in the tool
tip.
30. The apparatus according to claim 25, further comprising a
housing containing said sensor.
Description
RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. Provisional
Patent Application No. 62/173,365 filed on Jun. 10, 2015.
[0002] This application is also related to co-filed, co-pending and
co-assigned PCT Patent Application entitled "SENSOR TECHNOLOGIES
WITH ALIGNMENT TO BODY MOVEMENTS" (Attorney Docket No. 65771) by
Ehud ARDEL, Shlomo DAVID and Zvi FRIEDMAN, claiming priority of
U.S. Provisional Patent Application No. 62/173,365 filed on Jun.
10, 2015, the contents of which are incorporated herein by
reference in their entirety.
FIELD AND BACKGROUND OF THE INVENTION
[0003] The present invention, in some embodiments thereof, relates
to monitoring surgical bone tools and, more particularly, but not
exclusively, to monitoring an interaction of a surgical bone tool
with a bone and monitoring the interaction effects on a patient's
body.
[0004] Scuola Superiore Di Studi University disclosed in U.S. Pat.
No. 6,033,409 "a surgical drill comprising a rotating head having a
drill bit suitable to bore a body and support means to which the
head is pivotally connected. An actuating unit of the movement of
the drill bit with respect to the body to bore is provided for,
comprising a first support comprising the head and a second
support, suitable for resting directly upon the body and
translating with respect to the first support parallel to the drill
bit. The movement between drill bit and body is caused by the
relative movement between drill bit and second support. Means for
the detection of the force acting on the drill bit and means for
the control of the drill bit displacement in function of the
drilling force are provided for. The drill, manually holdable,
presents both a reference with respect to the patient body and
allows a precise control of the drill bit displacement".
[0005] Hsu et al., disclosed in U.S. Pat. No. 6,336,931 "an
automatic bone drilling apparatus for surgery operation using a
computer to control a hand tool drilling device to drill opening in
skeleton. The computer has a fuzzy logic software to control the
hand tool operation through a control box and a manual-automatic
mode switch box. The hand tool drilling device may be securely
mounted on the patient. Drilling location and size and depth may be
precisely controlled to enhance surgical operation safety".
[0006] U.S. Pat. No. 8,463,421 discloses a method of "drilling a
hole in a workpiece in order to control breakthrough of the
workpiece comprising the steps of: a) initiating contact between a
drill bit of a drill unit and the workpiece; b) operating the drill
unit to rotate the drill bit to drill the workpiece; c) during
drilling of the workpiece measuring the force, F and torque, T,
experienced by the drill bit; d) calculating a variable F', based
on the measured force, F, representing the rate of change of F; e)
calculating a variable, T' based on the measured torque, T,
representing the rate of change of T; calculating a variable F''
representing the rate of change of F'; g) calculating a variable
T'' representing the rate of change of T''; h) detecting the onset
of breakout of the workpiece by use of the variables F', F'', T'
and T''; i) thereby controlling the speed of rotation of the drill
bit during breakthrough of the workpiece to control the degree of
breakout of the drill bit from the workpiece".
[0007] Additional background art includes U.S. Patent Application
Publication No. US2014148808, International Patent Application No.
WO2015014771, U.S. Pat. No. 8,926,614, CN Patent No. CN101530341,
U.S. Patent Application Publication No. US2015066030, U.S. Patent
Application Publication No. US2015088183, U.S. Patent Application
Publication No. US2005131415, U.S. Patent Application Publication
No. US20050116673 and U.S. Pat. No. 8,821,493.
SUMMARY OF THE INVENTION
[0008] Following are some examples of some embodiments of the
invention:
Example 1
[0009] A method for monitoring the interaction of a surgical tool
with a patient's bone, comprising:
[0010] interacting a surgical tool with a proximal bone region;
[0011] detecting at least one signal emanating from the bone
following the surgical tool interaction with the bone region;
and
[0012] identifying based on the signal an interaction progression
of the surgical tool relative to the bone.
Example 2
[0013] The method according to example 1, wherein the at least one
signal is sound waves having a frequency equal to or below 10
KHz.
Example 3
[0014] The method according to example 2, further comprising
filtering the sound waves to extract sound waves emanating from the
bone only.
Example 4
[0015] The method according to any of examples 2-3, further
comprising filtering the sound waves to extract sound waves
emanating from the surgical tool only.
Example 5
[0016] The method according to any of examples 1-4, wherein the
identifying comprises correlating the at least one signal with an
orientation of an operating tip of the tool with respect to the
bone.
Example 6
[0017] The method according to any of examples 1-5, the detecting
is provided by contacting a sensor with a body portion of a patient
and not contacting the sensor with the tool.
Example 7
[0018] The method according to any of examples 1-6, wherein the at
least one signal is body vibrations.
Example 8
[0019] The method according to any of examples 1-7, wherein the at
least one signal is air pulses.
Example 9
[0020] The method according to any of examples 1-8, further
comprising conducting a stopping event based on the identifying of
interaction progression.
Example 10
[0021] The method according to example 9, wherein the stopping
event is conducted when identifying the interaction progression
comprises extrusion of a tip of the surgical tool through the
bone.
Example 11
[0022] The method according to any of examples 9-10, wherein the
stopping event is conducted when identifying the interaction
progression comprises being about 0.1 to about 0.5 seconds from the
tip extrusion.
Example 12
[0023] The method according to any of examples 9-11, wherein the
stopping event is conducted when identifying the interaction
progression comprises being about 0.1 to 0.5 mm distanced from the
tip extruding the bone.
Example 13
[0024] The method according to any of examples 9-12, wherein the
stopping event is conducted when identifying the interaction
progression reaching a predetermined spatial position
threshold.
Example 14
[0025] The method according to any of examples 9-13, wherein the
stopping event is conducted when identifying the interaction
progression comprises a predetermined pattern.
Example 15
[0026] The method according to any of examples 9-14, wherein the
stopping event comprises tool operation cessation.
Example 16
[0027] The method according to any of examples 9-14, wherein the
stopping event comprises tool operation attenuation.
Example 17
[0028] The method according to any of examples 9-14, wherein the
stopping event comprises activating an alert.
Example 18
[0029] The method according to example 17, wherein the alert is
selected from a group consisting of visual notification, audio
notification and vibratory indication.
Example 19
[0030] The method according to any of examples 1-18, wherein the
identifying an interaction progression comprises correcting the
signal to at least one second signal.
Example 20
[0031] The method according to example 19, wherein the second
signal comprises patient's body vibrations.
Example 21
[0032] The method according to example 19, wherein the second
signal comprises vibrations of a hand operating the tool.
Example 22
[0033] The method according to example 19, wherein the second
signal comprises mechanical output from the tool.
Example 23
[0034] The method according to any of examples 1-22, wherein the
identifying an interaction progression further comprises
correlating the signal with a database having a plurality of
signals resulting from previously conducted surgical tool
interactions with a bone region.
Example 24
[0035] The method according to any of examples 1-23, further
comprising transmitting a monitoring signal to a monitoring region
of the bone prior to the detecting at least one signal.
Example 25
[0036] The method according to example 24, wherein the monitoring
region is a distal region of the bone.
Example 26
[0037] The method according to example 24, wherein the monitoring
region is a region of the surgical tool interaction with the bone
region.
Example 27
[0038] The method according to example 24, wherein the monitoring
signal comprises acoustic sound waves.
Example 28
[0039] The method according to any of examples 24-27, wherein the
monitoring signal comprises acoustic sound pulses.
Example 29
[0040] The method according to any of examples 24-27, wherein the
monitoring signal comprises ultrasound waves.
Example 30
[0041] The method according to any of examples 24-29, wherein the
monitoring signal comprises ultrasound pulses.
Example 31
[0042] The method according to any of examples 29-30, wherein the
detecting at least one signal comprises detecting ultrasound
waves.
Example 32
[0043] The method according to example 31, wherein the detecting
ultrasound waves comprises detecting Doppler Effect.
Example 33
[0044] The method according to any of examples 29-30, wherein the
detecting at least one signal comprises detecting ultrasound
pulses.
Example 34
[0045] The method according to example 29, wherein the transmitted
ultrasound signal is in the range of about 2 MHz to about 4
MHz.
Example 35
[0046] The method according to any of examples 29-34, wherein
identifying bone extrusion is based on identifying the tool tip
outside a boundary of the bone.
Example 36
[0047] The method according to example 29, further comprising:
[0048] determining a proximal region of a bone for penetrating
using the surgical bone tool, and a distal region of the bone in an
opposite orientation to the proximal region;
[0049] transmitting ultrasound waves to the distal region of the
bone;
[0050] positioning an ultrasound receiver such that a backscatter
of the transmitted ultrasound signal is not detected by the
receiver;
[0051] interacting the surgical tool with the bone region; and
[0052] detecting a scatter of the transmitted ultrasound by the
receiver;
Example 37
[0053] The method according to example 36, further comprising
correlating the detected scattered ultrasound to a roughness level
of the distal region of the bone.
Example 38
[0054] The method according to example 36, further comprising
associating the roughness level to an interaction progression of
the surgical bone tool.
Example 39
[0055] The method according to any of examples 1-38, further
comprising calculating an appropriate screw size based on the
determined interaction progression.
Example 40
[0056] An apparatus for monitoring the interaction of a surgical
tool with a bone region of a patient, comprising at least one
sensor for detecting at least one signal emanating from the bone
following the surgical tool interaction with the bone region.
Example 41
[0057] The apparatus according to example 40, wherein the apparatus
is positioned externally to the surgical tool.
Example 42
[0058] The apparatus according to example 40, wherein the apparatus
is positioned embedded within the surgical tool.
Example 43
[0059] The apparatus according to any of examples 40-42, wherein
the sensor is an acoustic transducer.
Example 44
[0060] The apparatus according to any of examples 40-42, further
comprising a sonic emitter.
Example 45
[0061] The apparatus according to any of examples 40-44, further
comprising an ultrasound transducer and wherein the sensor is an
ultrasound receiver.
Example 46
[0062] The apparatus according to example 45, wherein the
ultrasound transducer and ultrasound receiver are embedded in the
tool tip.
Example 47
[0063] The apparatus according to any of examples 40-45, further
comprising a housing containing the sensor.
Example 48
[0064] The apparatus according to example 47, wherein the housing
is made of a resilient material, rendering the apparatus to
flexibly fit to a surface of the patient's body.
Example 49
[0065] The apparatus according to example 47, wherein the housing
is made of a semi-rigid material, rendering the apparatus to
specifically fit to a designated body part.
Example 50
[0066] A system for determining a desired interaction progression
state of a surgical tool relative to a bone region of a patient's
body, comprising the apparatus according to any of examples 40 to
49 and a controller.
Example 51
[0067] The system according to example 50, wherein the controller
is robotic.
Example 52
[0068] The system according to any of examples 50-51, further
comprising a display for graphically presenting real time
monitoring of the interaction progression.
Example 53
[0069] The system according to any of examples 50-52, wherein the
surgical bone tool is a driller or a saw.
[0070] Unless otherwise defined, all technical and/or scientific
terms used herein have the same meaning as commonly understood by
one of ordinary skill in the art to which the invention pertains.
Although methods and materials similar or equivalent to those
described herein can be used in the practice or testing of
embodiments of the invention, exemplary methods and/or materials
are described below. In case of conflict, the patent specification,
including definitions, will control. In addition, the materials,
methods, and examples are illustrative only and are not intended to
be necessarily limiting.
[0071] As will be appreciated by one skilled in the art, some
embodiments of the present invention may be embodied as a system,
method or computer program product. Accordingly, some embodiments
of the present invention may take the form of an entirely hardware
embodiment, an entirely software embodiment (including firmware,
resident software, micro-code, etc.) or an embodiment combining
software and hardware aspects that may all generally be referred to
herein as a "circuit," "module" or "system." Furthermore, some
embodiments of the present invention may take the form of a
computer program product embodied in one or more computer readable
medium(s) having computer readable program code embodied thereon.
Implementation of the method and/or system of some embodiments of
the invention can involve performing and/or completing selected
tasks manually, automatically, or a combination thereof. Moreover,
according to actual instrumentation and equipment of some
embodiments of the method and/or system of the invention, several
selected tasks could be implemented by hardware, by software or by
firmware and/or by a combination thereof, e.g., using an operating
system.
[0072] For example, hardware for performing selected tasks
according to some embodiments of the invention could be implemented
as a chip or a circuit. As software, selected tasks according to
some embodiments of the invention could be implemented as a
plurality of software instructions being executed by a computer
using any suitable operating system. In an exemplary embodiment of
the invention, one or more tasks according to some exemplary
embodiments of method and/or system as described herein are
performed by a data processor, such as a computing platform for
executing a plurality of instructions. Optionally, the data
processor includes a volatile memory for storing instructions
and/or data and/or a non-volatile storage, for example, a magnetic
hard-disk and/or removable media, for storing instructions and/or
data. Optionally, a network connection is provided as well. A
display and/or a user input device such as a keyboard or mouse are
optionally provided as well.
[0073] Any combination of one or more computer readable medium(s)
may be utilized for some embodiments of the invention. The computer
readable medium may be a computer readable signal medium or a
computer readable storage medium. A computer readable storage
medium may be, for example, but not limited to, an electronic,
magnetic, optical, electromagnetic, infrared, or semiconductor
system, apparatus, or device, or any suitable combination of the
foregoing. More specific examples (a non-exhaustive list) of the
computer readable storage medium would include the following: an
electrical connection having one or more wires, a portable computer
diskette, a hard disk, a random access memory (RAM), a read-only
memory (ROM), an erasable programmable read-only memory (EPROM or
Flash memory), an optical fiber, a portable compact disc read-only
memory (CD-ROM), an optical storage device, a magnetic storage
device, or any suitable combination of the foregoing. In the
context of this document, a computer readable storage medium may be
any tangible medium that can contain, or store a program for use by
or in connection with an instruction execution system, apparatus,
or device.
[0074] A computer readable signal medium may include a propagated
data signal with computer readable program code embodied therein,
for example, in baseband or as part of a carrier wave. Such a
propagated signal may take any of a variety of forms, including,
but not limited to, electro-magnetic, optical, or any suitable
combination thereof. A computer readable signal medium may be any
computer readable medium that is not a computer readable storage
medium and that can communicate, propagate, or transport a program
for use by or in connection with an instruction execution system,
apparatus, or device.
[0075] Program code embodied on a computer readable medium and/or
data used thereby may be transmitted using any appropriate medium,
including but not limited to wireless, wireline, optical fiber
cable, RF, etc., or any suitable combination of the foregoing.
[0076] Computer program code for carrying out operations for some
embodiments of the present invention may be written in any
combination of one or more programming languages, including an
object oriented programming language such as Java, Smalltalk, C++
or the like and conventional procedural programming languages, such
as the "C" programming language or similar programming languages.
The program code may execute entirely on the user's computer,
partly on the user's computer, as a stand-alone software package,
partly on the user's computer and partly on a remote computer or
entirely on the remote computer or server. In the latter scenario,
the remote computer may be connected to the user's computer through
any type of network, including a local area network (LAN) or a wide
area network (WAN), or the connection may be made to an external
computer (for example, through the Internet using an Internet
Service Provider).
[0077] Some embodiments of the present invention may be described
below with reference to flowchart illustrations and/or block
diagrams of methods, apparatus (systems) and computer program
products according to embodiments of the invention. It will be
understood that each block of the flowchart illustrations and/or
block diagrams, and combinations of blocks in the flowchart
illustrations and/or block diagrams, can be implemented by computer
program instructions. These computer program instructions may be
provided to a processor of a general purpose computer, special
purpose computer, or other programmable data processing apparatus
to produce a machine, such that the instructions, which execute via
the processor of the computer or other programmable data processing
apparatus, create means for implementing the functions/acts
specified in the flowchart and/or block diagram block or
blocks.
[0078] These computer program instructions may also be stored in a
computer readable medium that can direct a computer, other
programmable data processing apparatus, or other devices to
function in a particular manner, such that the instructions stored
in the computer readable medium produce an article of manufacture
including instructions which implement the function/act specified
in the flowchart and/or block diagram block or blocks.
[0079] The computer program instructions may also be loaded onto a
computer, other programmable data processing apparatus, or other
devices to cause a series of operational steps to be performed on
the computer, other programmable apparatus or other devices to
produce a computer implemented process such that the instructions
which execute on the computer or other programmable apparatus
provide processes for implementing the functions/acts specified in
the flowchart and/or block diagram block or blocks.
[0080] Some of the methods described herein are generally designed
only for use by a computer, and may not be feasible or practical
for performing purely manually, by a human expert. A human expert
who wanted to manually perform similar tasks, such as determining
the contact force between a wheel and a surface, might be expected
to use completely different methods, e.g., making use of expert
knowledge and/or the pattern recognition capabilities of the human
brain, which would be vastly more efficient than manually going
through the steps of the methods described herein.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0081] Some embodiments of the invention are herein described, by
way of example only, with reference to the accompanying drawings.
With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of embodiments of the
invention. In this regard, the description taken with the drawings
makes apparent to those skilled in the art how embodiments of the
invention may be practiced.
[0082] In the drawings:
[0083] FIG. 1 is a high level flow chart of an exemplary process
for monitoring the interaction of a surgical tool with a bone, in
accordance with some embodiments of the invention;
[0084] FIG. 2 is a block diagram depicting an exemplary signal
integration process, in accordance with some embodiments of the
invention;
[0085] FIG. 3 is a block diagram depicting an exemplary system for
identifying a surgical tool interaction state with a bone, in
accordance with some embodiments of the invention;
[0086] FIG. 4 is a block diagram depicting exemplary external
sensor apparatus configuration, in accordance with some embodiments
of the invention;
[0087] FIG. 5 is a block diagram depicting an exemplary embedded
sensor apparatus configuration, in accordance with some embodiments
of the invention;
[0088] FIG. 6 is a flow chart depicting an exemplary machine
learning algorithm, in accordance with some embodiments of the
invention;
[0089] FIGS. 7A-B are schematic representations of exemplary sensor
configurations using stationary ultrasound monitoring, wherein FIG.
7A depicts having no detection of tool tip cortical bone
breakthrough, and FIG. 7B depicts having a detection of tool tip
cortical bone breakthrough, in accordance with some embodiments of
the invention;
[0090] FIG. 8 is a schematic representation of an exemplary sensor
configuration using dynamic ultrasound monitoring;
[0091] FIG. 9 is a schematic representation of an exemplary sensor
configuration using acoustic detection, in accordance with some
embodiments of the invention;
[0092] FIGS. 10A-C are schematic representations of an exemplary
sensory apparatus, in accordance with some embodiments of the
invention;
[0093] FIGS. 11A-D are schematic representations of exemplary
alternative positioning of the sensor apparatus, in accordance with
some embodiments of the invention;
[0094] FIG. 12 is a graphical presentation of an exemplary surgical
tool mechanical sensing, in accordance with some embodiments of the
invention;
[0095] FIG. 13 is a graphical presentation of an exemplary
identifiable acoustic frequency before cortical breakthrough, in
accordance with some embodiments of the invention;
[0096] FIG. 14 is a graphical presentation of an identifiable
acoustic frequency at cortical breakthrough, in accordance with
some embodiments of the invention;
[0097] FIG. 15 is a graphical presentation of an exemplary acoustic
reflection pattern, in accordance with some embodiments of the
invention;
[0098] FIG. 16 is a graphical presentation of an exemplary
ultrasonic Doppler received signal, in accordance with some
embodiments of the invention;
[0099] FIG. 17 is a graphical presentation of exemplary ultrasound
doppler frequency before cortex breakthrough, in accordance with
some embodiments of the invention;
[0100] FIG. 18 is a graphical presentation of exemplary ultrasound
Doppler frequency after cortex breakthrough, in accordance with
some embodiments of the invention;
[0101] FIG. 19 is a graphical presentation of exemplary pattern
recognition algorithm, in accordance with some embodiments of the
invention; and
[0102] FIG. 20 is a graphical presentation of dynamic dual notch
filter, in accordance with some embodiments of the invention.
DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0103] The present invention, in some embodiments thereof, relates
to monitoring surgical bone tools and, more particularly, but not
exclusively, to monitoring an interaction of a surgical bone tool
with a bone and monitoring the interaction's effects on a patient's
body.
Overview
[0104] An aspect of some embodiments of the invention relates to
monitoring the effects of an interaction of a surgical bone tool
with a patient's bone. In some embodiments, monitoring includes
using sound as an indicator of interaction progression.
Alternatively or additionally, monitoring includes using mechanical
vibrations as indicating interaction progression. Alternatively or
additionally, monitoring includes body vibrations as indicating
interaction progression. Alternatively or additionally, monitoring
includes air pulses as indicating interaction progression.
[0105] In some embodiments, passive detection is provided.
Alternatively or additionally, active detection is provided. In
some embodiments, passive detection is executed by monitoring
output resulting directly from the process, for example output
directly detected from the bone as a result of the interaction of
the tool with the bone, and/or output directly detected from the
operation of the tool.
[0106] In some embodiments, active detection is provided by
actively providing an element of the process with input and
detecting the resultant output. For example, in some embodiments,
an element of the process is the tip interaction region with the
bone. Alternatively or additionally, the element is a region of the
bone not being directly modified, such as for example the distal
boundary opposite to the tool's penetration region. In some
embodiments, input is provided in the form of acoustic waves and/or
pulses. Alternatively or additionally, input is provided in the
form of ultrasound beams and/or pulses.
[0107] In some embodiments, monitoring is provided by detecting
sound waves and/or pulses emanating from the bone itself,
optionally after filtering out the acoustic output emanating from
the tool's mechanical operation. Alternatively or additionally,
monitoring is provided by detecting sound waves and/or pulses
emanating from the tool's mechanical operation, optionally after
filtering out the acoustic output emanating from the bone itself.
Optionally, filtered data is used for identifying bone
deformation.
[0108] In some embodiments, incipient breakthrough of the tool tip
through bone is detected by identifying predefined output
characteristics discovered by the inventors as potentially
indicating breakthrough, such as for example a specific sound.
[0109] Alternatively or additionally, output from the bone tissue
itself is used for detecting tissue transition. As interaction
progresses the composition of the bone tissue changes, potentially
leading to a different sound emanating from the bone region for
each stage. In some embodiments, a stage is a spatial location of
the surgical tool tip relatively to the bone.
[0110] It is a potential advantage to use both an identification of
predefined patterns of the breakthrough point and a real-time
detection of tissue transitioning, likely leading to more accurate
breakthrough determination.
[0111] An aspect of several embodiments of the invention relates to
using ultrasound feedback to identify incipient breakthrough of a
tool's tip through a bone and/or monitor a surgical tool's
interaction with a bone region. In some embodiments, a tool
interacts with a proximal region of a bone and ultrasound feedback
is used to monitor one or more properties of the distal region of
the bone. In some embodiment, bone properties relate to a bone
surface shape, for example being planar or having a curve, and/or
transitioning from a more planar surface to a more curved surface.
Alternatively or additionally, bone properties relate to a bone
surface roughness level, optionally to the change in roughness
level over time when a tool is interacting with a bone.
[0112] In some embodiments, a single ultrasound probe is used,
optionally having transmitting and receiving properties. In some
embodiments, a plurality of ultrasonic waves is transmitted having
variable angles with respect to the bone. Alternatively or
additionally, a plurality of ultrasonic waves is propagated into
variable depths inside the patient's body. In some embodiments, a
plurality of ultrasound waves having variable frequencies is used,
optionally, having values within a specific frequency range, for
example, ranging between 1 MHz and 2 MHz, or between 2 MHz and 3
MHz, or between 3 MHz and 4 MHz, or any range having smaller,
larger or intermittent frequency values.
[0113] In some embodiments, transmitted ultrasound frequency
changes as the tool tip progresses through its interaction with the
bone. Alternatively or additionally, transmitted ultrasound
amplitude changes as the tool tip progresses through its
interaction with the bone. Alternatively or additionally, the
intensity of transmitted ultrasound changes as the tool tip
progresses through its interaction with the bone. It is a potential
advantage to use increasing frequency, which is likely to increase
scattering effect due to surface roughness, potentially increasing
the detection sureness of roughness resulting from the tool's
interaction proximally to the bone boundary. In some embodiments,
effect of surface roughness on the ultrasound scattered energy can
be used, optionally qualitatively, to identify smooth planar flaws,
rough planar flaws and/or volumetric flaws.
[0114] In some embodiments, at least two ultrasonic probes are
provided. In some embodiments, one ultrasonic probe is used as a
transmitter, and the other ultrasonic probe is used as a receiver.
In some embodiments, both probes are moved over the surface of the
patient's body, optionally being spaced apart at a fixed
distance.
[0115] In some embodiments, the tool bit is used for an ultrasonic
transmitter and/or receiver, optionally providing indication for
bit spatial positioning. Optionally spatial positioning comprises
extent of depth.
[0116] In some embodiments, the ultrasound sensor has a detection
area having a two-dimensional boundary, optionally substantially
rectangular. In some embodiments, the ultrasound sensor has a
detected area having a first dimensionality of 200 mm, 180 mm, 150
mm, 120 mm, 100 mm, or any length being larger, smaller or
intermittent. In some embodiments, the ultrasound sensor has a
detected area having a second dimensionality of 100 mm, 80 mm, 60
mm, 40 mm, 20 mm, or any length being larger, smaller or
intermittent.
[0117] In some embodiments, ultrasound energy is transmitted having
a square wave pattern. In some embodiments, the square wave relates
to alternating transmission and reception. In some embodiment,
transmission is provided in a temporal range of between 100 and 500
microseconds. In some embodiments, reception is provided in a range
of between 500 and 1000 microseconds. In some embodiments, the
temporal range is determined as a function of the bone thickness.
Alternatively or additionally, the temporal range is determined as
a function of the surrounding tissue thickness, whether proximally
to the tool or distally.
[0118] In some embodiments, ultrasound waves and/or pulses are
transmitted and/or received using the bit of the surgical tool.
Optionally, an ultrasound transducer transmits the signal through
the bit. In some embodiments the bit serves as a transducer, both
transmitting and detecting ultrasound. In some embodiments,
ultrasound detected by the bit is used for identifying a spatial
location of the bit, for example its depth in the bone.
Alternatively or additionally, ultrasound detected by the bit is
used for identifying incipient breakthrough of the bit through the
bone.
[0119] An aspect of some embodiments of the invention relates to
using ultrasound Doppler Effect detection to monitor a progress of
a surgical tool tip when interacting with a bone. In some
embodiments, Doppler Effect results when ultrasound is transmitted
to the tool's interaction region with the bone, while the tool
mechanically vibrates the bone. In some embodiments, detection of a
Doppler Effect correlates with an occurrence of bone mechanical
vibrations. In some embodiments, increasing bone vibrations
indicate the progression stage of the tool's interaction.
Optionally, Doppler Effect is detected using high pulse repetition
frequency (HPRF).
[0120] In some embodiments, a Doppler Effect results from real-time
formation of surface irregularities. It is postulated by the
inventors that as the interaction of the surgical tool with the
bone progresses, surface irregularities appear at the bone surface.
Potentially, the formation of surface irregularities causes a
relative movement of the bone surface, potentially deflecting a
transmitted ultrasound wave to create a Doppler Effect.
[0121] It is potentially advantageous to use Doppler Effect
sensing, because it may filter out stationary signals scattering
from relatively stationary locations, such as the patient's skin or
other tissue surrounding the bone, but not affected by its
vibrations. However, in some embodiments, stationary scattered
signal is detected in addition to detecting Doppler Effect,
potentially enabling tool bit breakthrough detection.
[0122] The inventors have found that ultrasonic monitoring of a
bone penetration process, for example a long drilling process, is
based on the, optionally, abrupt change of the bone surface
reflection properties, for example upon the drilling bit extruding
it and/or on the simultaneous change of the bone bit-induced
vibrations occurring during bit extrusion.
[0123] In some embodiments, ultrasonic energy is used to identify
the instance of the bit extrusion through the bone. In some
embodiment a stationary ultrasonic monitoring is used.
Alternatively or additionally, a dynamic ultrasonic monitoring is
used.
[0124] In some embodiments, stationary ultrasonic monitoring is
based on the intact bone being smooth relative to the scale of
ultrasonic wavelengths, potentially leading to the beam being
reflected at a reflection angle equal to the angle of
incidence.
[0125] In some embodiments, when there is no tool-bone interaction,
the ultrasound transducer is positioned in a specific geometric
location from the detected area, likely to have a small signal
being scattered back to the sensor. Most of the energy is probably
reflected away from the transducer, which is oriented to receive
energy in the direction of the incident wave, depending on
wavelength, and/or bone smoothness and/or the nature of the
crack.
[0126] In some embodiments, as the penetration proceeds close to
bone extrusion, the surface of the bone becomes irregular. Upon
cracks appearing on bone cortex and any bulge created, a scattered
wave is potentially detectable at the ultrasound transducer. This
is potentially due to reflection becoming more diffuse when bone
smoothness decreases.
[0127] In some embodiments, ultrasound energy is used to monitor
vibrations induced on the surface of the bone in the direction of
the tool's interaction. Potentially, the frequencies of these
vibrations are proportional to rotational velocity of the bit
and/or its detailed design, at an amplitude proportional to the
force exerted on the drill.
[0128] It is likely that at the moment of extrusion, the force of
interacting through the bone, optionally for example due to
pressing down on the tip, is reduced due to the tip of the bit not
pressing any longer on the surface on the bone. In some
embodiments, after extrusion, the tip of the bit becomes a
temporally modulated reflector at a frequency proportional to the
rotational frequency of the drill and/or the detailed design of the
tip. These effects are measured, preferably using the Doppler
Effect.
[0129] In some embodiments, the extrusion time will be determined
based on the analysis of the Doppler signals from both
transducers.
[0130] In some embodiments, a change in sound, optionally at
frequencies below 10 KHz, results from a spatial location of the
tip breaking through and/or getting closer to a bone boundary,
optionally cortical bone tissue boundary, optionally leading to
detection of the tool's tip before penetrating into the cortical
bone Alternatively or additionally, a change in sound results from
a spatial location of the tip changing while breaking through the
cortical bone tissue region, optionally leading to detection of
when the tool's tip broke through the cortical bone and therefore
extruded beyond the bone's boundary.
[0131] In some embodiments, acoustic data is filtered to monitor
the sound emanating from the surgical tool itself, optionally
monitoring the change in the sound, potentially indicating tip bone
breakthrough and/or tissue transition. Alternatively or
additionally, acoustic data is filtered to monitor the sound
emanating from the interacted bone. In some embodiments, audio
waves are detected at frequencies in the range of about 20 Hz and
about 5 KHz, optionally at about 10 KHz and/or below.
[0132] An aspect of several embodiments of the invention relates to
an apparatus having a plurality of sensors for monitoring the
interaction of a surgical tool with a bone region. In some
embodiments, the apparatus comprises a housing enabling mounting of
the apparatus on a patient's body, optionally in proximity to the
operated region. Alternatively or additionally, a sensor apparatus
may be mounted on the surgeon's operating hand. Optionally in
addition is provided a housing enabling positioning of the
apparatus in association with the surgical tool, optionally within
the tool's casing, alternatively or additionally, mounted
externally on the tool. In some embodiments, the apparatus housing
enables positioning of the apparatus on a third object, such as for
example, the patient's bed.
[0133] In some embodiments, the housing is mounted on the patient's
body using a standoff, hydrogel or biologic glue, for enabling wave
propagation. In some embodiments, the housing is substantially
flat, having a high surface contact with the patient's body,
potentially promoting better detection of the sensors. Optionally,
the housing is relatively elastic, enabling the deformation of the
apparatus to fit across a body surface of the patient, for example,
to be shaped to fit the skin surface of a patient's limb. In some
embodiments, the housing is relatively rigid, allowing its mounting
on specifically designed body surfaces. In some embodiments, the
apparatus is positioned non-concentrically to the operation region
of the tool to avoid interfering with the tool's operation.
[0134] In some embodiments, the apparatus comprises at least one
ultrasound probe, optionally a transducer. In some embodiments, a
transducer is oriented to receive energy in the direction of the
incident ultrasonic wave. In some embodiments, prior to the
surgery, the transducer is positioned such that only a relatively
small fraction of the wave will be scattered back. Potentially,
once bone penetration starts, tracking is conducted. Optionally,
once reflection is detected in the transducer, it suggests that the
roughness of the distal portion of the bone increased. In some
embodiments, detected level of roughness is correlated with
progressed bone tissue interaction. Optionally, roughness extent,
measured by the change in the detection of received ultrasound
waves, indicates cortical bone penetration.
[0135] In some embodiments, sensory electrodes, optionally mounted
on the patient's body, transmit sensory data to the sensor
apparatus, optionally also mounted on the patient's body.
Alternatively or additionally, sensory electrodes are mounted on
the body while sensor apparatus is positioned remotely to the
body.
[0136] In some embodiments, the apparatus comprises an acoustic
transducer for detecting acoustic sound waves emanating from the
bone as a result of the interaction of the tool with the bone.
Optionally, the acoustic transducer is configured to detect waves
and/or pulses passing through an intermediary material, without
passing through air. In some embodiments, passing through the body,
rather than through the air, is provided by mounting the apparatus
over a patient's body, and not on the tool, or on a position
remotely located from the tool or the body. In some embodiments,
the housing of the apparatus comprises at least one aperture for
allowing sound waves to propagate into the apparatus and reach the
sensors, for example, when housed within the surgical tool, to
enable detection of sound emanating externally from the tool.
[0137] In some embodiments, the sensor apparatus detects tool
related mechanical parameters. For example, in some embodiments the
sensor unit includes a torque sensor to measure the torque produced
by the tool's motor, optionally between the tool's chuck and its
operating tip.
[0138] In some embodiments, the sensor apparatus comprises a
three-dimensional accelerometer sensor, potentially for detecting
body vibrations when mounted on the patient's body, optionally,
configured to detect frequencies of less than 20 Hz. In some
embodiments, a three-dimensional accelerometer is provided in a
sensor apparatus embedded in the surgical tool. It is a potential
advantage to monitor the tilting of the surgical tool by using a
three-dimensional gyroscope, because tilting of the tool may result
in a change in the acoustic sound emanating from the tool's
interaction with the bone. In some embodiments, gyroscope data is
integrated with acoustics data, potentially to correct for tilting.
It is a potential advantage to correct acoustic data with the
orientation of the surgical tool, due to a sound emanating from the
bone likely being different when interacted through a different
spatial orientation of the tool.
[0139] In some embodiments, the sensor apparatus comprises a range
finder, optionally when the apparatus is housed within the tool,
potentially used to determine the distance of the tool, optionally
the tool's tip, from the patient's bone. Alternatively or
additionally, the measured distance pertains to the distance of the
tool tip from a surgical bone plate. Alternatively or additionally,
the measured distance relates to a distance from the bone to at
least one preset element provided between the tool and the bone,
such as for example a spacer. In some embodiments, a range finder
is used to determine the relative distance of the bit from the
preset elements.
[0140] In some embodiments, the sensor apparatus comprises a
magnetometer, optionally when the apparatus is mounted on the
patient's body, and potentially used for detecting the presence of
the tool's tip, such that, for example, as the tool progresses
along the bone, the tool's tip detection in the magnetometer
increases.
[0141] In some embodiments, the sensor apparatus detects
physiologic parameters of the patient. In some embodiments,
physiologic parameters include heart rate measurements.
Alternatively or additionally, physiologic parameters include body
temperature measurements; optionally specific temperature
measurement is conducted in the penetrated bone area, for example,
by an infrared sensor. Alternatively or additionally, physiologic
parameters include blood pressure measurements.
[0142] In some embodiments, the sensor apparatus detects
environmental parameters related to the ambient environment where
the surgery is being conducted. In some embodiments, environmental
parameters include room temperature measurements.
[0143] Alternatively or additionally, environmental parameters
include room humidity measurements. Alternatively or additionally,
environmental parameters include light conditions. In some
embodiments, environmental parameters are used to normalize other
measurements of the sensor unit.
[0144] In some embodiments, the apparatus is mounted on the
patient's body, optionally in proximity to the operation region.
Alternatively or additionally, the apparatus is mounted on the
surgeon's operating hand. In some embodiments, the apparatus is
mounted in proximity to the distal portion of the bone with respect
to the operation region, optionally in a non-concentric position
opposite to the surgical tool's penetration site. In some
embodiments the apparatus is mounted in proximity to the proximal
portion of the bone with respect to the operation region, for
example, mounted on a plane substantially the same as the operation
region, and optionally axially shifted. In some embodiments a
plurality of apparatuses, optionally each having a distinct set of
sensors, are mounted simultaneously at various positions.
[0145] In some embodiments the apparatus is disposable. In some
embodiments, the apparatus is fit for a single use only because of
battery considerations, optionally having a limited life battery.
Alternatively or additionally, the apparatus is fit for a single
use only because it is produced having a material which is unable
to undergo sterilization. Alternatively, the apparatus is
repeatedly used, and optionally manufactured having materials
suitable for sterilization.
[0146] In some embodiments, the apparatus comprises a replaceable
housing. According to this, in some embodiments, the housing is
provided as an outer disposable housing, containing in it at least
one reusable element, having the potential advantage of not having
to sterilize such reusable elements and only provide them with a
new and/or separately sterile housing.
[0147] In some embodiments, the apparatus further comprises a
controller. In some embodiments the controller has instructions for
collecting sensory data in a digital fashion. In some embodiments,
the apparatus comprises a transmitter for transmitting the digital
sensory data, optionally wirelessly.
[0148] An aspect of some embodiments of the invention relates to
predicting a surgical tool's tip bone extrusion and/or its
interaction stage with a bone. In some embodiments, prediction is
based on sensory data emanating from the bone tissue itself as a
result from the tool's interaction with the bone. In some
embodiments, prediction is calculated by a processor. In some
embodiments, once a desired stage is predicted to occur, the tool's
interaction with the bone is modulated.
[0149] In some embodiments, such as in a limb bone surgery, for
example when drilling a thread for accepting a screw, a desired
stage is progression of the tool up to a region proximal to the
cortical bone tissue but without breaking through it to the tissue
surrounding the bone. In some embodiments, such as in brain
surgery, a desired stage is possibly when a tool penetrates through
the tissue leading up to the skull, but without penetrating into
the skull itself. Alternatively or additionally, such as in sawing
procedures, a desired stage may be an invasion into the bone for up
to 30%, 50%, 70% of the bone's diameter, or any percentage smaller,
higher or intermittent.
[0150] In some embodiments, modulation of the tool's interaction
results in stopping the mechanical operation of the tool,
optionally automatically. In some embodiments, automatic operation
is provided by robotic systems. Alternatively or additionally,
modulation results in attenuating the tool's speed or force, for
example, upon predicted estimation of drilling up to the skull
bone, the driller's torque is attenuated, potentially leading to a
more attentive drilling.
[0151] In some embodiments, once a desired stage is predicted to
occur, a notification is provided, optionally in the form of a
visual and/or an audio alert. In some embodiments, visual
notification is provided on a display, such as a screen.
Alternatively or additionally, visual notification is provided in
the form of a light, such as by using LED. In some embodiments,
audio notification is provided by a buzzer. Alternatively or
additionally, a speaker is provided to sound a notification, such
as in a non-limiting example, speech or buzzing sound. In some
embodiments, the screen, LED, buzzer or speaker, and any
combination thereof, is embedded within the surgical tool.
[0152] An aspect of several embodiments of the invention relates to
identifying a stage of interaction of the tool with a bone by
integrating a plurality of detected signals. In some embodiments,
data provided by sound waves and/or pulses, acoustic and/or
ultrasonic, and/or bone vibrations is integrated with mechanical
sensory data resulting from the tool's mechanical operation. For
example, vibrations resulting from the tool enable filtering out
ultrasonic scattering from the underlying tissue.
[0153] In some embodiments, data integration is performed by
normalization. It is a potential advantage to integrate sound data
with mechanical data, because the mechanical operation profile also
affects the sound emanating from the tool's interaction with the
bone. For example, tilting of the surgical tool, or the extent of
axial force applied, can affect the sound, and it is a potential
advantage to correct the sound according to such mechanical
influences.
[0154] In some embodiments, operating the surgical tool prior to
its interaction with the patient's body gives a baseline of
mechanical characteristics, optionally relating to the tool's
sound, and/or the tool's forces, as being exerted without
interference.
[0155] In some embodiments, mechanical sensory data pertains to
sensing axial force exertion. Each surgeon is likely to produce a
different force exertion, whether relatively to other surgeons,
and/or relatively to himself at distinct times. It is a potential
advantage to monitor the axial force exerted by the surgeon, and
correct prediction accordingly. For example, a surgeon who exerts a
relatively low force exertion will take more time to advance the
tool inside the bone, probably extending the time taken for the
tool's tip to progress. Therefore, in some embodiments, axial force
sensory data prolongs or shortens the predicted tool's tip progress
in the bone.
[0156] In some embodiments, additional sensory data is collected,
such as body vibrations, magnetic and/or electric sensing of the
tool's operating tip, motor torque production, axial forces applied
and/or the tool's radial velocity.
[0157] In some embodiments, a machine learning algorithm is
provided, which includes storing sensory data collected during
surgery and using this data when determining bone extrusion and/or
assessing tissue transition. In some embodiments, the algorithm
includes a training/learning phase. In some embodiments, learning
phase includes providing a database having exemplary data,
potentially allowing buildup of patterns to be detected.
[0158] In some embodiments, audio data, whether raw, filtered,
enhanced, sampled or normalized, or any combination thereof, is
subjected to pattern recognition algorithms, optionally, to detect
a change in frequency during the surgical procedure, optionally by
using the pattern buildup database. In some embodiments, audio data
is filtered to reduce noise and/or background sounds.
[0159] In some embodiments, sensory data is compared, and/or
correlated, and/or analyzed in relation to a database having bone
information, optionally in real time. In some embodiments, sensory
data is compared to predefined patterns pre-identified in the
database, optionally by using pattern recognition algorithms. In
some embodiments, the database includes data related to mechanical
aspects of bones, optionally human bones, such as size, and/or
length, and/or width, and/or radius. Alternatively or additionally,
mechanical aspects include bone rigidity values. Alternatively or
additionally, mechanical aspects include gender dependent
characteristics. Alternatively or additionally, mechanical aspects
include age dependent characteristics. Alternatively or
additionally, patient specific information is provided.
Alternatively or additionally, data regarding the surgical tool is
provided, for example, driller manufacturer, and/or drill bit
information, and/or diameter, and/or length, and/or Trocar use.
[0160] Optionally, data received in real time is compared to
predefined patterns in the database and/or feature set information.
In some embodiments, database and/or feature set information
represent a weighted correlated information regarding breakthrough
probability. Optionally, pattern comparison uses pattern
recognition algorithms. In some embodiments, pattern recognition
algorithms perform correlations to provide a most likely matching,
optionally, taking into account typical statistical variations.
[0161] In some embodiments, the algorithm calculates the
probability of bone breakthrough and, optionally, user can set
actions to occur on any defined probability. For example, setting
the threshold to 90% will stop the mechanic operation of the tool
more frequently than when setting the threshold to 99%.
[0162] In some embodiments, a user interface is provided. In some
embodiments, the user interface is provided for enabling a surgeon
to put in input related to the patient undergoing surgery, such as
in a non-limiting example, age, gender, bone type being operated,
height, weight, tool type being used and so forth. In some
embodiments, the user interface is used for displaying output to
the surgeon, such as in a non-limiting example, statistical data
related to the bone type being operated, or data related to typical
bone parameters of the age group and/or gender of the patient. In
some embodiments, the user interface displays operation progress,
such as the measured depth of the surgical tool. In some
embodiments, the user interface alerts the surgeon of an incipient
breakthrough of a specific depth.
[0163] In some embodiments, the user interface provides a suggested
screw size, fit to accommodate the depth of the resultant hole due
to the tool's penetration. Alternatively or additionally, screw
size is suggested according to the bone's diameter. Alternatively
or additionally, screw size is suggested according to the bone's
texture, for example its level of crispness, or elasticity. In some
embodiments, screw suggestion, and/or another appropriately fitting
element, is transmitted to a 3D printer.
[0164] In some embodiments, bone condition after the operation is
provided as an output, optionally on the user interface.
Optionally, bone condition refers to qualitative characterization
of the bone after being modified, such as for example, if the tool
bit penetrated relatively smoothly, or alternatively penetrated
causing bone fractures and/or cracks.
[0165] In some embodiments, user interface display is mounted on
the surgical tool itself.
[0166] An aspect of some embodiments of the invention relates to a
method for providing an appropriate screw size for a drilled bore
in a patient's bone. In some embodiments, screw size is provided by
associating a calculated penetration depth to a most fitted screw
size from a database having a plurality of screw specifications,
such as length and/or diameter. In some embodiments, suggested
screw size is visualized on a display, optionally, a display
mountable on the surgical drill.
[0167] In some embodiments, a database stores a plurality of
driller bore depths. In some embodiments, driller bore depths
history is graphically presented on a display.
[0168] An aspect of some embodiments of the invention relates to a
method for selective processing of tissue, optionally for the
selective processing of hard tissue, such as bone, cartilage,
teeth, scull and the like. In some embodiments, selective
processing is performed by identifying an inter-joint boundary.
[0169] In some embodiments, the sensor apparatus and/or methods
thereof are used in conjunction with an adaptor for mechanically
modifying the operation of the surgical bone tool, such as
disclosed in PCT Patent Application Agent Ref: 65764, incorporated
herein by reference in its entirety. In some embodiments, the bone
drilling system is composed of a driller with drilling bit,
optionally fitted over an add-on adaptor in between and/or embedded
within the driller itself. In some embodiments, is provided a
sensor unit, i.e. a Bio-Medical patch, and/or at least one
designated sensor, optionally mounted upon the organ and/or in any
other location that enables it to sense and/or get the needed
related information. In some embodiments, the adaptor and/or the
sensor is connected to a controller computer in various
configurations.
[0170] In some embodiments, within the add-on adaptor there is a
set of sensors, optionally, for example, composed of any
combination of the following:
[0171] a. Torque sensor optionally to measure the torque produce by
the driller engine between driller original chuck and the tip of
the driller bit
[0172] b. Pushing/pulling force sensor optionally to measure the
axis force (positive or negative) that is produced at the drill bit
tip
[0173] c. Radial velocity sensor (RPM) optionally to measure the
drilling bit rotating speed
[0174] d. Driller battery power consumed sensor optionally
connected in line to the drilled battery and optionally measures
and power (W) that is consumed by the driller engine. Optionally
measuring current (Ampere) and voltage (Volt) will yield the power
(Watts) supplied
[0175] e. 3 Dimensions accelerometer sensor that is optionally used
to measure radial force measured in the add-on adaptor in all 3
dimensions (X, Y, Z). Optionally this is used to track trembling of
the adaptor
[0176] f. 3 Dimensions tilt sensor that is optionally used to
measure the adaptor tilt comparing to the horizon
[0177] g. Microphone (magnetic or piezoelectric) optionally to pick
up audio waves of frequencies from 100 Hz to 5 KHz
[0178] h. Electro mechanical axial clutch, that is optionally used
to cut the drilling power to the drilling tip
[0179] In some embodiments, at least one of the add-on adaptor
sensors is based on Piezo-Electric devices and/or any other sensing
technology that measures the information in small factor and/or
light weight elements optionally allowing designing of the adaptor
add-on in a light, small size and/or short manner that will cause
as little interferences to the surgeon working and driller handing
comparing to his current way of work. In some embodiments, the
connection to the driller battery is also used to run the internal
add-on adaptor electronics.
[0180] In some embodiments, all of the above is part of a
semi-automated/fully automated drilling/cutting device (optionally
embedded within the system and/or part of it).
[0181] In some embodiments, add-on adaptor rotational sensors
deliver their data to the Add-on adaptor controller board
(optionally a non-moving part at the fixed side of the Add-on
Adaptor), optionally by the use of conductive slippery rings and/or
by the use of laser signal transferring between moving and
non-moving parts of the add-on Adaptor.
[0182] In some embodiments, the add-on adaptor measures all signals
from the sensors and/or checks the changes over time (derivatives
of the signals). In some embodiments, using this information the
controller computer can recognize specific signals pattern that are
potentially unique to bone cortical penetration. In some
embodiments, the controller computer is preconfigured with all
types of bones information and/or human bones attributes. In some
embodiments, the surgeon configures the controller prior to the
surgery start, optionally with the specific information of the
patient information and/or surgery type, such that the controller
will know what pattern to track.
[0183] In some embodiments, upon pattern positive identification,
the controller sends a signal to the add-on adaptor to initiate an
LED light and/or Buzzer and/or any other notification and/or
automatic drilling rotating stop, optionally by using the add-on
adaptor internal clutch.
[0184] In some embodiments, the signals of the add-on adaptor
sensors are being sampled, and/or filtered, and optionally sent to
the controller computer. Optionally the information will be
transferred to the controller computer by the use of wired or
wireless communications path, such as Wi-Fi, Bluetooth, ZigBee or
similar.
[0185] In some embodiments, an external sensor unit, i.e.
Bio-Medical patch, comprises the following sensors (any possible
combination):
[0186] a. 3 Dimensional accelerometer sensor optionally to pick up
body vibrations of frequencies less than 100 Hz
[0187] b. Microphone (magnetic or piezoelectric) optionally to pick
up audio waves of frequencies from 100 Hz to 5 KHz
[0188] c. Ultrasound piezoelectric sensor optionally to produce and
detect ultrasound signals at 4 MHz. Optionally ultrasound waves
will be use to locate the driller tip position and/or assess the
distance to the patch and/or to assess cracks and/or fractions with
the bone itself, as potentially signal reflection is much
difference at bone which is untouched or a bone with a hole in
it
[0189] d. Magnetometers (copper coil) sensor that optionally detect
drilling bit metal tip and produce electricity in relations to the
tip distance from the patch
[0190] e. Hall Effect sensor--optionally when the Hall probe is
held so that the magnetic field lines are passing at right angles
through the sensor of the probe, the meter gives a reading of the
value of magnetic flux density (B). Potentially a current is passed
through the crystal which, when placed in a magnetic field has a
"Hall effect" voltage developed across it.
[0191] f. Pickup coils (at numerous variations of installations
around the drilled area) optionally to pickup electricity induced
from the drilling tip, which is charged with voltage
[0192] g. Resistance sensor to optionally measure conductivity
between driller tip to the patch, through measuring the current run
inside the human tissues
[0193] h. Thermal sensor (based on Infra-Red waves read and/or
piezoelectric sensor) to optionally read the body temperature in
the area of drilling
[0194] In some embodiments, the signals of the Bio-Medical patch
sensors are being sampled, and/or filtered and optionally sent to
the controller computer.
[0195] In some embodiments the Bio-Medical patch is attached to the
body with the aid of either biological glue and/or hydro gel
compound potentially ensuring good transfer of signals from the
body.
[0196] In some embodiments, the Bio-Medical patch is produced in
different forms, other than patches, such as for example: Mattress
cover to be placed under the patient bed or head throne that will
cover patient head during neurological surgery or belly belt to be
used in spinal surgery.
[0197] In some embodiment the Bio-Medical patch is connected to
Controller computer, optionally connected to an automated drilling
robot to optionally send acquired signals and/or enhance drilling
robot information regarding the progress of the drilling and/or
enhance decision making of when to stop the drilling.
[0198] In some embodiments the Add-on adaptor and/or the
Bio-Medical patch can be produced for single use only and/or for a
multiple uses, optionally in surgeries with the ability to be
sterilized before use.
[0199] In some embodiments, the controller computer comprises a
user interface optionally to control all drilling parameters before
the surgery start, and/or display the progress of the drilling
during the surgery and/or review option to track all surgeon
performance to allow later review.
[0200] Potential advantages of the invention may include the
following:
[0201] a. The invention may prevent harming tissues other than the
bone by stopping the driller on time (drilling only the bone
itself)
[0202] b. The bone drilling controlling device of the invention
might be quicker to use by surgeons and as overall performance,
shortening the Orthopedics/Neurologic surgery time. Further, the
device of the invention might be safer to the patients and/or
reduce risks of being harmed by driller tip penetration after
reaching bone cortical layer.
[0203] c. The bone drilling controlling device of the invention may
reduce patients recovery time after surgery
[0204] d. The approach of having an add-on adaptor that is attached
to currently available drillers and drilling bit potentially allows
easy adoption of the tool without the need to reeducate the
surgeons and way of working
[0205] This invention is referring to all and any bone (such as
scull, spine bones, teeth and/or any other bones) drilling and/or
cutting/sawing procedures being done on humans and/or animals
perfumed manually or semi-automated/full-automated system.
[0206] Before explaining at least one embodiment of the invention
in detail, it is to be understood that the invention is not
necessarily limited in its application to the details of
construction and the arrangement of the components and/or methods
set forth in the following description and/or illustrated in the
drawings and/or the Examples. The invention is capable of other
embodiments or of being practiced or carried out in various
ways.
Exemplary Process for Monitoring the Interaction of a Surgical Tool
with a Bone
[0207] Reference is now made to FIG. 1, presenting a high-level
overview of several embodiments of the invention, pertaining to
process 100. According to some embodiments, process 100 is provided
for monitoring and identifying the interaction of a surgical tool
with a patient bone. As herein used, the term surgical tool
includes a drill, a saw, knife and any surgical tool having
interaction with a bone. As used herein the term interaction
includes penetrating, machining, etching, scraping, sawing, cutting
and any active deformation. As used herein, the term bone includes
skull, spine, skeleton, teeth, cartilage and any tissue having
relatively a rigid structure.
[0208] In some embodiments, process 100 begins by interacting the
surgical tool with the bone 102. In some embodiments, interacting
is by penetrating or extruding. Alternatively or additionally,
interacting relates to sawing and/or cutting. Alternatively or
additionally, interacting relates to scraping and/or polishing.
Alternatively or additionally, interaction relates to machining
and/or etching.
[0209] In some embodiments, once interaction starts, monitoring, or
sensing, the effects of this interaction is followed 104. In some
embodiments, sensing is made to monitor the influence of the
interaction between the surgical tool and the bone. In some
embodiments, sensing relates to detecting sound waves emanating
from the interaction. In some embodiments, sensing relates to using
ultrasound feedback to detect patterns apparent in the bone and
resulting from the interaction. In some embodiments, sensing is
provided to detect mechanical aspects of the surgical tool
operation.
[0210] In some embodiments, the detected interaction is used for
identifying the interaction state of the tool with the bone 106. In
some embodiments, sensory data in 104 is collected at real time to
provide the interaction state 106 in real time. In some
embodiments, interaction state pertains to the tool's tip spatial
positioning with respect to the bone, optionally, with respect to
the cortical bone tissue, optionally, with respect to the cortical
bone tissue being distal to the position of the tool.
[0211] In some embodiments, it is desired to identify an
interaction state of the tool with the bone 106 a few seconds,
milliseconds, or microseconds prior to its penetration into a bone
tissue optionally for example, identify the bit is going to extrude
in 0.1-0.5 ms. Alternatively or additionally, it is desirable to
identify when the bit is distanced a few millimeters before
breaking through, optionally for example, identify the bit being
0.1-0.5 mm away from extrusion. In some embodiments, it is desired
to identify an interaction state of the tool with the bone 106 a
few millimeters prior to its penetration into a bone tissue.
[0212] In some embodiments the bone tissue is specific and
predetermined prior to the surgery. In some embodiments the bone
tissue is a cortical bone tissue, optionally the distal portion
with relation to the tool. Alternatively or additionally, the bone
tissue is the cortical tissue proximal to the tool penetration
site. Alternatively or additionally, the bone tissue is the inner
boundary of the cortical bone tissue. Alternatively or
additionally, the bone tissue is the outer boundary of the cortical
bone tissue
Exemplary Signal Integration Process
[0213] Reference is now made to FIG. 2, presenting a block diagram
depicting an exemplary signal integration process. According to an
exemplary embodiment of the invention, sensory data deriving from a
plurality of sensors, at least some of which pertaining to the
interaction of the surgical tool with the bone, is integrated 202.
In some embodiments, integrated sensory data is used for detecting
an interacting state of the tool with the bone 280. In some
embodiments, data integration comprises correcting, and/or
normalizing, at least one sensory data according to at least one
other sensory data deriving from a different sensor. It is a
potential advantage to integrate sensory data, which is likely to
provide a more accurate identification of a bone breakthrough event
and/or the tool-bone interaction state, and/or the bone
characteristics after being extruded.
[0214] In some embodiments, data integration 202 utilizes sensory
data emanating from the bone itself as a result of the tool-bone
interaction 222. For example, some embodiments include sensing
sound waves and/or pulses, and or vibrations emanating from the
interaction site, and/or using ultrasound transmission and feedback
to characterize the interaction site.
[0215] In some embodiments, data integration 202 utilizes sensory
data relating to the tool's mechanical operation 224. It is a
potential advantage to integrate data pertaining to the mechanical
specifications of the tool's operation, because the characteristics
of the mechanical operation are likely to have an influence on
other sensory detections. In some embodiments, mechanical sensing
relates to vibration of the tool. Alternatively or additionally, it
relates to tilting of the tool. Alternatively or additionally, it
relates to pushing/pulling axial forces directed through the tool.
Alternatively or additionally, it relates to spinning speed of a
tool's main shaft. Alternatively or additionally, it relates to a
distance of the tool's tip from the bone.
[0216] In some embodiments, data integration 202 utilizes sensory
data relating to the patient's physiologic parameters 226. For
example, in some embodiments, the temperature of the bone is
measured, potentially contributing to the determination of the
interaction state, because, for example, heated bone tissue is
likely to indicate a proximal action of the tool. In some
embodiments, physiologic parameters pertain to vibrations of the
patient's organ being operated. It is a potential advantage to
integrate sensory data with the patient's movements or vibrations,
likely to correct for spatial shifting which is not related to the
tool-bone interaction.
[0217] In some embodiments, data integration 202 utilizes general
bone information 240. In some embodiments, general bone information
comprises a variety of bone types and their characteristic profile,
optionally pertaining to size, composition, strength, surrounded
tissue, typical surgical operations, age related differences,
gender related differences and so forth. In some embodiments,
general bone information includes tracking of previously conducted
surgeries and its interaction profile of the surgical tool with the
bone. It is a potential advantage to integrate general bone
information with sensory data, likely to contribute to a more
accurate analysis of the sensory data. For example, an acoustic
sound having the same profile could result in completely different
interaction state detection, such as when the sound derives from an
initial penetration into the bone boundary in a healthy young male,
or deriving from an extensive penetration into an elderly woman
suffering from osteoporosis.
[0218] In some embodiments, data integration 202 utilizes patient
specific information 260. In some embodiments, patient information
includes age, gender, weight, medical condition, medical history
and so forth. Optionally, patient information is inputted by the
surgeon. In some embodiments, data integration 202 utilizes patient
information to extract relevant information and profiles from the
general bone information.
Exemplary System for Identifying a Surgical Tool Interaction State
with a Bone
[0219] Reference is now made to FIG. 3, presenting a block diagram
depicting an exemplary system as used herein for identifying and/or
determining the interaction state of a surgical tool with a
patient's bone, and/or bone characteristics after breakthrough.
[0220] According to an exemplary embodiment of the invention,
sensors are used to detect parameters pertaining to the effect of
the surgical tool's interaction with the bone. In an exemplary
embodiment, sensor unit 322 is provided embedded in the surgical
tool 320. Alternatively or additionally, it is added in line to it.
Alternatively or additionally, sensor unit 310 is provided
externally to the surgical tool 320.
[0221] In some embodiments, sensors are configured to detect
parameters resulting from the tool-bone interaction and affecting
the patient's body, for example the patient's bone. Alternatively
or additionally, sensors are configured to detect parameters
resulting from the tool-bone interaction and affecting the surgical
tool, for example the sound emanating from the surgical tool
itself, and its potential distortion as the tool progresses within
the patient's body.
[0222] In some embodiments, sensor unit 310 and/or sensor unit 322
comprise communication means 312, 324, respectively, optionally for
wireless communication. In some embodiments, communication means
312 and/or 324 are transceivers, transmitting sensory data to a
controller 330. In some embodiments, controller 330 is located
externally to the surgical tool, optionally in a server or a
computer. Alternatively or additionally, controller 330 is embedded
within the surgical tool 320. Alternatively or additionally,
controller 330 is embedded within the external sensor apparatus
310. In some embodiments, upon sensing feedback from active signal
sensing, optionally acoustic and/or ultrasound and/or air pulses,
the feedback data is sent in real-time to controller 330.
[0223] In some embodiments, controller 330 comprises communication
means 334 for communicating with sensor units 310 and/or 322. In
some embodiments, sensory data received in the communication means
334 is directed to a processing circuit 332 and/or directly to a
memory circuit 336. In some embodiments, processing circuit 332
analyzes sensory data to identify the interaction state of surgical
tool 320 with the bone.
[0224] In some embodiments, a database 340 is provided, optionally
communicating with controller 330. In some embodiments, database
340 comprises general bone information.
[0225] In some embodiments, a user interface 350 is provided,
optionally communicating with controller 330. In some embodiments,
user interface 350 is used for the surgeon to input information,
potentially relevant for the specific operation taking place.
Alternatively or additionally, user interface 350 is used for
outputting sensor detection and analysis, optionally conducted by
controller 330.
[0226] In some embodiments, a notification unit 360 is provided,
optionally communicating with controller 330. In some embodiments,
upon an identification of a desired state of tool-bone interaction,
the notification unit provides an alert in the form of a visual
and/or audible notification. In some embodiments, upon an
identification of a desired state of tool-bone interaction, the
notification unit signals the surgical tool 320 to cutoff its
mechanical operation, optionally automatically.
[0227] In some embodiments, notification unit 360 is positioned
onto surgical tool 320. Alternatively or additionally, notification
unit is provided as a feature of user interface 350.
Exemplary External Sensor Apparatus Configuration
[0228] Reference is now made to FIG. 4, presenting a block diagram
depicting an exemplary sensor apparatus as used herein for
identifying and/or determining the interaction state of a surgical
tool with a patient's bone, externally to the surgical tool.
[0229] According to an exemplary embodiment of the invention, an
apparatus 310 comprising a plurality of sensor is provided. In some
embodiments, the apparatus comprises sensors suitable for
externally detecting effects of the interaction between the
surgical tool and the bone.
[0230] In some embodiments, in order to utilize ultrasound feedback
to characterize these effects, an ultrasound transducer 4161 and an
ultrasound pickup 4162 are provided.
[0231] In some embodiments, an acoustic transducer 4163 for
passively detecting acoustic waves emanating from the tool and/or
the tool's interaction with the bone is provided. Alternatively or
additionally, a sonic emitter 4164 is provided for actively
transmitting acoustic waves and/or pulses, optionally directed to
the distal portion of the bone where bit breakthrough is expected.
Alternatively or additionally, sonic emitter 4164 may be directed
to transmit to the proximal portion of the bone where the tool
interacts with the bone. Alternatively or additionally, sonic
emitter is directed to any intermediate portion of the bone between
the proximal boundary and the distal boundary. Potentially,
analysis of the return acoustic waves and/or pulses scatter enables
detection of bone characteristics, such as for example bone surface
geometry change over time.
[0232] In some embodiments, vibration sensor 4165, potentially for
detecting patient's movements and vibrations is provided.
Optionally, vibration sensor 4165 is used to pick up body
vibrations resulting from the tool's operation.
[0233] In some embodiments, a magnetometer 4166, such as for
example a magnetic coil, is provided to potentially detect the
presence or nearing of the tool's operating tip within the
patient's body.
[0234] In some embodiments, apparatus 310 further comprises a
controller 414. In some embodiments, the controller has an analog
front end circuitry configured to transform signals from the
sensors into digital signals. Optionally, controller 414 further
comprises circuitry having instructions to analyze sensory
data.
[0235] In some embodiments, apparatus 310 further comprises
communication means 312, optionally a transceiver. The
communication means 312 are configured to transmit the sensory data
provided by the sensors, optionally in a wireless manner.
[0236] In some embodiments, apparatus 310 further comprises power
source 418. In some embodiments, the power source has a limited
lifetime, such as for example being a zinc air battery, rendering
the apparatus disposable at the end of its use.
Exemplary Embedded Sensor Apparatus Configuration
[0237] Reference is now made to FIG. 5, presenting a block diagram
depicting an exemplary sensor apparatus as used herein for
identifying and/or determining the interaction state of a surgical
tool with a patient's bone, optionally being embedded within the
surgical tool.
[0238] According to an exemplary embodiment of the invention,
apparatus 320 is provided having a plurality of sensors suitable
for detecting mechanical parameters of the surgical tool,
optionally parameters which are affected by the tool's interaction
with the bone.
[0239] In some embodiments, axial force sensor 5261 is provided,
potentially detecting axial forces being exerted upon the surgical
tool, such as by a surgeon. In some embodiments, spinning sensor
5262 is provided, potentially detecting the spinning speed of the
tool's main shaft. In some embodiments, torque sensor 5263 is
provided, potentially detecting the torque force provided by the
tool. In some embodiments, vibration sensor 5264 is provided,
potentially detecting vibrations of the tool, optionally of the
tool's tip. In some embodiments, an accelerometer 5265 is provided,
potentially detecting trembling of the tool. Alternatively or
additionally, a gyroscope 5266 is provided, potentially detecting
tilting of the tool relative to the horizon.
[0240] In some embodiments, a distance tracker 5267 is provided,
for example an ultrasound range finder and/or an infrared range
finder, and/or a laser range finder. Optionally, distance tracker
5267 is comprised within the tool's bit. In some embodiments, data
output from range finder may lead to termination of the tool's
operation, for example, after detection of a predetermined depth,
for example, identifying 20 mm penetration, optionally without bone
breakthrough.
[0241] In some embodiments, a temperature sensor 5268 is provided,
optionally a non-contact thermometer. In some embodiments,
temperature sensor 5268 comprises a photodiode, optionally
configured to detect infrared range. Alternatively or additionally,
temperature sensor 5268 comprises a photodiode configured to detect
illumination in any wavelength.
[0242] In some embodiments, sensing of a bone temperature greater
than a predetermined threshold, i.e. detecting overheating of the
interacted region, leads to a stopping event. Alternatively or
additionally, sensing of overheating of the operating tip leads to
a stopping event.
[0243] In some embodiments, sensory data provided by the above
mentioned sensors is transmitted to controller 524, optionally
functioning as an analog front end. In some embodiments, controller
524 receives other sensory data and/or information through
communication means 322, optionally being a transceiver. In some
embodiments, controller 524 transmits data through communication
means 322.
[0244] In some embodiments, controller 524 analyzes sensory data.
In some embodiment, controller 524 integrates sensory data, as will
be further described below.
[0245] In some embodiments, controller 524 comprises instructions
for detecting predetermined patterns in the sensory data. In some
embodiments, upon detection of a specific pattern controller 524
sends a signal to cutoff the power transmission of the tool to the
operating tip. Alternatively or additionally, controller 524
signals to apply a notification, optionally being visual and/or
audible.
[0246] In some embodiments, apparatus 320 further comprises a power
source 528. In some embodiments, power source 528 has a
predetermined limited lifetime, such as for example being a zinc
air battery, rendering the apparatus disposable at the end of its
use. Alternatively or additionally, apparatus 320 receives power
from the power source of the surgical tool. Alternatively or
additionally, power source 528 comprises a capacitor for storing
energy generated by the tool, e.g. the apparatus harvests kinetic
energy and stores it in the capacitor for its own use.
Exemplary Machine Learning Algorithm
[0247] Reference is now made to FIG. 6, presenting a flow chart
depicting an exemplary algorithm as used herein for identifying
and/or determining the interaction state of a surgical tool with a
patient's bone.
[0248] According to an exemplary embodiment of the invention,
sensory data is collected 601 from at least one sensory apparatus
having sensors for detecting the effects of a surgical tool's
interaction with the bone.
[0249] In some embodiments, data is classified 602. In some
embodiments, data is classified by comparing the data to a database
having a plurality of interaction behaviors optionally identifying
predetermined patterns.
[0250] In some embodiments, learning patterns 603 is conducted on
the classified data. In some embodiments, learning patterns is
conducted by identifying statistically recurring patterns
associated with a specific interaction state.
[0251] In some embodiments, learnt patterns 603 are used to predict
pattern 604. In some embodiments, pattern is predicted based on the
classified data. In some embodiments, pattern prediction is done by
comparing the classified data to a known pattern behavior
characteristic of the classification of the data.
[0252] In some embodiments, pattern prediction 604 leads to
identification of the interaction state 605 of the surgical tool
with the bone.
Exemplary Sensor Configuration Using Stationary Ultrasound
Monitoring
[0253] Reference is now made to FIG. 7A, schematically presenting
an exemplary sensor configuration using ultrasound energy to
monitor cortical bone extrusion, in accordance with some
embodiments of the invention.
[0254] According to several embodiments of the invention, surgical
tool 700 is, for example, a bone driller, used for penetrating a
bore into bone 710 through plate 720. In some embodiments, tool 700
comprises an embedded sensor apparatus 320, optionally detecting
parameters resulting from the tool's mechanical operation. In some
embodiments, embedded apparatus 320, and/or tool 700, further
comprises communication means 702 for transmitting sensory data,
for example to an external controller. In some embodiments, tool
700 further comprises a mechanical cutoff mechanism 704 for cutting
the power transmission to the tool's operating tip, optionally
resulting in cessation of the tool's operation. Alternatively or
additionally, distance tracker 742 is provided, optionally for
measuring the penetration depth of bit 706.
[0255] In some embodiments, an external sensory apparatus 310 is
provided, optionally fitted for mounting on the patient's skin,
optionally in opposite orientation to the tool's interaction site,
i.e. distally positioned. In some embodiments, sensory apparatus
310 comprises an ultrasound transducer 701, and ultrasound energy
is used, optionally for detecting bone characteristics of the
distal bone surface, being closest to the sensory apparatus
310.
[0256] In some embodiments, ultrasound beam 744 is transmitted to a
region of the bone expected to change properties as the tool-bone
interaction progresses. In some embodiments, changed properties
pertain to the appearance of a bulge, or curved surface.
Alternatively or additionally, changed properties pertain to
increasing surface roughness. In some embodiments, ultrasound
feedback is analyzed in view of acoustic sound 748 detection.
[0257] Potentially, as long as the tool tip 706 is spatially
positioned away from the cortical bone tissue, ultrasound waves are
reflected away by the smooth, relatively planar surface of the
observed bone region, optionally being reflected at a reflection
angle equal to the angle of incidence, for example as illustrated
in beam 746. Optionally, the apparatus 310 is positioned such that
reflections of smooth surfaces will not be detected as
feedback.
[0258] Reference is now made to FIG. 7B, schematically presenting
the sensor configuration and set up of FIG. 7A, but illustrating
tool tip 706 breaking through the bone, optionally, breaking
through the cortical bone tissue.
[0259] In some embodiments, upon bit breakthrough of the cortical
bone, a stationary scattered signal also becomes detectable,
potentially due to reflection from the operating bit itself.
[0260] In some embodiments, once the tool tip 706 penetrates enough
into the cortical bone tissue, optionally breaking through it, the
bone surface changes such that transmitted ultrasound beams are
reflected back (746) to the apparatus 310, potentially being
detected by ultrasound transducer 701. Alternatively or
additionally, ultrasound beams are detectable at transducer 701 due
to reflection from the operating bit itself.
Exemplary Sensor Configuration Using Dynamic Ultrasound
Monitoring
[0261] Reference is now made to FIG. 8, exemplifying dynamic
ultrasound monitoring.
[0262] In some embodiments, at least two transducers 802 and 804
are provided, optionally positioned at distinct locations over a
patient's body, optionally mounted on skin 808. Alternatively or
additionally, only one transducer is provided. In some embodiments,
one of the transducers or both are positioned near a region of the
bone being distal to the interaction with bit 706, optionally
positioned asymmetrically with respect to the interaction site.
[0263] In some embodiments, a single parallel beam is transmitted
to the bone. Alternatively, two parallel beams are transmitted
towards the bone, optionally beam 820 is provided roughly
perpendicular to the surface of the bone, and second beam 840 is
provided at an inclination (for example of about 45.degree.) to the
surface. In some embodiments, the two transducers 802 and/or 804
operate at the constant wave (CW) mode, optionally operating at
distinct frequencies.
[0264] In some embodiments, beam 820 is positioned to intersect the
bone at a position axially shifted to the expected site of
extrusion of bit 706. Alternatively or additionally, beam 840,
optionally also being a parallel wide beam, is directed toward the
expected site of extrusion of bit 706.
[0265] In some embodiments, both transducers 802 and 804 operate in
the Doppler mode, optionally in constant wave (CW) Doppler.
According to some embodiments, transducer 802 receives Doppler
signals reflected from the surface of the bone at roughly right
angles, so that the velocities measured can be potentially
attributed to the vibrating bone 801 surface. The signal of
transducer 802 potentially changes upon extrusion due to the change
of the mechanical coupling between the tip of bit 706 at times
close to and/or immediately post extrusion. Alternatively or
additionally, the signal of transducer 804 changes upon
extrusion.
Exemplary Sensor Configuration Using Acoustic Detection
[0266] Reference is now made to FIG. 9, schematically illustrating
an exemplary sensor configuration using acoustic detection to
identify the interaction state of a surgical tool with a bone, in
accordance with an embodiment of the invention.
[0267] According to an exemplary embodiment of the invention, a
driller 870 is used to thread a bore in a bone 871 through a plate
872, penetrating into the patient through proximal skin region as
illustrated in line 881.
[0268] In some embodiments, acoustic waves emanating from the
interaction of the tool with the bone are detected. In some
embodiments, a sensory apparatus 831 external to the surgical tool
is used, optionally mounted on the patient's body, as illustrated
for example in apparatus 831 being mounted on the distal skin
region as illustrated by line 882. It is noted that mounted
apparatus 831 is illustrated herein for exemplary illustration
only, and it may be mounted over the patient's body in many other
configurations, illustrated for example in FIG. 9.
[0269] Alternatively or additionally, apparatus 831 is mounted on
the surgeon's body, optionally on the surgeon's hand operating the
tool. It is a potential advantage to mount the apparatus on the
tool operating hand, directly receiving mechanical parameters
affecting the tool, but not emanating from the tool's mechanical
operation itself.
[0270] In some embodiments, the external apparatus 831 comprises an
acoustic sensor for detecting acoustic waves and/or pulses.
Optionally, the acoustic sensor is configured to detect sound only
through body and not through the air. Optionally, the acoustic
sensor is piezoelectric. In some embodiments, acoustic waves 862
are emanating from the interaction region. In some embodiments,
acoustic waves 864 are emanating from the surgical tool itself.
Exemplary Sensory Apparatus
[0271] Reference is now made to FIGS. 10A-C, schematically
illustrating an external sensory apparatus having a housing 9310,
in accordance with several embodiments of the invention, wherein
FIG. 10A schematically presents a three dimensional perspective
view of the apparatus according to some embodiments, FIG. 10B
schematically presents a top view of the apparatus according to
some embodiments, and FIG. 10C schematically presents a
cross-section of the apparatus according to some embodiments, taken
at lines A shown in FIG. 10B.
[0272] It should be noted that the shape, size and configuration of
the sensory apparatus and the apparatus housing as provided herein
is for illustration purposes only, and any other form, shape,
material, external configuration, internal configuration,
personalization, and/or body part specific adjustment is within the
scope of this invention.
[0273] According to an exemplary embodiment of the invention, a
sensory apparatus is designed to detect sensory data resulting from
an interaction of a surgical tool with a bone, while being external
to the surgical tool. Reference is now made to FIGS. 10A-B,
illustrating in a schematic manner, according to some embodiments,
the apparatus comprises a housing 9310. In some embodiments, the
housing is shaped to have a relatively large surface area,
potentially fitted for mounting over a patient's skin.
[0274] Reference is now made to FIG. 10C, schematically
illustrating a cross section of the apparatus in accordance with
several embodiments of the invention, and exhibiting a possible
internal configuration. Within housing 9310, according to some
embodiments, are located an ultrasound transducer 9162, ultrasound
pick up sensor 9162, and controller circuit 9164. In some
embodiments, apparatus 9310 further comprises power source
9418.
[0275] In some embodiments, the apparatus is designed to be fitted
over a patient's skin 920, optionally using an intermediary
material 910 for transferring signals efficiently, such as for
example an ultrasound standoff, and/or hydrogel, and/or biologic
glue. In some embodiments, the apparatus housing is made of a
resilient material, enabling twisting or deforming the apparatus,
potentially enabling a better fit with a patient's body part.
Alternatively, the housing is made of a relatively rigid material,
potentially limiting the apparatus for a specific structural use,
for example, to a specific body part, such as the leg, hand, spine,
head and so forth.
[0276] In some embodiments, apparatus 9310 is provided, for a
non-limiting example, in a substantially rectangular shape, In some
embodiments, the rectangular shape having a short dimension of
between 10-40 mm, alternatively between 25-35 mm, or any size
smaller, larger or intermediate to this. In some embodiments, the
rectangular shape having a long dimension of between 80-120 mm,
alternatively between 95-105 mm, or any size smaller, larger or
intermediate to this.
[0277] In some embodiments, apparatus 9310 is provided, for a
non-limiting example, as having a thickness of 10-30 mm,
alternatively between 15-25 mm, or any size smaller, larger or
intermediate to this.
Exemplary Alternative Positions of the Sensor Apparatus
[0278] Reference is now made to FIGS. 11A-D, schematically
illustrating exemplary alternative sensor apparatus positioning, in
accordance with an embodiment of the invention, exemplifying
potential positions with respect to the patient's body and the
tool's interaction region.
[0279] It is noted that alternatively or additionally to the
illustrated, in some embodiments the apparatus is mounted on the
operating hand of the surgeon. Alternatively or additionally, the
apparatus is positioned in a remote location, such as for example,
under the patient's bed mattress.
Exemplary Surgical Tool Mechanical Sensing
[0280] Reference is now made to FIG. 12, graphically presenting an
example of sensory output relating to mechanical aspects of the
surgical tool as the operating tip passes through the bone 1171, in
and out of the cortical bone tissue 1172. For exemplary purpose
only, a drill bit 1170 is provided. The graph presents an example
for signal integration comprising normalized mechanical
measurements versus acoustic data.
Exemplary Acoustic Frequency Pattern
[0281] Reference is now made to FIG. 13, graphically presenting an
example of an identifiable acoustic frequency pattern, indicating
pre-breakthrough of the cortical bone.
[0282] Reference is now made to FIG. 14, graphically presenting an
example of an identifiable acoustic frequency pattern, indicating
at the breakthrough of the cortical bone.
Exemplary Acoustic Reflection
[0283] Reference is now made to FIG. 15, graphically presenting an
example of an identifiable acoustic frequency pattern, indicating
an audio frequency changes before breakthrough of the cortical
bone.
Exemplary Ultrasonic Doppler Received Signal (Audio
Frequencies)
[0284] Reference is now made to FIG. 16, graphically presenting an
example of this figure shows the ultrasound Doppler signal (time
domain) as received by an ultrasound receiver, which the signal
correlates bone vibration and found to be at audio frequencies. It
can show that during the drilling, from start to first cortex
breakthrough (the inner one), the signal is with same properties.
Once first cortex breakthrough, the pattern of the signal
significantly changes in frequency and amplitude and changes again
with the second cortex breakthrough (outside of the bone) to have
different frequencies and amplitude. The reason is different bone
vibrations, as the drilling approaches external cortex.
Exemplary Ultrasound Doppler Frequency Before Cortex
Breakthrough
[0285] Reference is now made to FIG. 17, graphically presenting an
example in conjunction with FIG. 15, presenting an acoustic
spectrum of Doppler received ultrasound waves, that is received
from start of drilling to first cortex breakthrough (same for all
the process).
Exemplary Ultrasound Doppler Frequency after Cortex
Breakthrough
[0286] Reference is now made to FIG. 18, graphically presenting an
example in conjunction with FIG. 15, presenting an acoustic
spectrum of Doppler received ultrasound waves, which is received
after second cortex breakthrough (and is significantly different
than the pattern presented in FIG. 16).
Exemplary Pattern Recognition Algorithm
[0287] Reference is now made to FIG. 19, schematically illustrating
the algorithm in graphical way. It shows the process steps, from
labeling the important and relevant data, training the classifier
which contains the patterns to look for and to the decision made
for unlabeled real time information, as received by the system
during actual drilling process.
[0288] For example, during training session many tests are analyzed
to correlate sensors data (Driller axial force, driller speed,
acoustic audio, ultrasound information and more) in a sliding
window of 300 milisoecind and each sample is labeled with the exact
timing of the breakthrough. Each sensor data is stored in time
domain and also in frequency domain.
[0289] Once training session is ended, the data base contain many
samples it its general pattern. In real time operation, the
classifier can match, its internal labeled sensor data, with the
real time sensors data received, and match patterns in 300 mS
windows to the ones stored inside the databased, thus producing a
probability grade in real time of breakthrough occurrence. The
system will decide of breakthrough timing, based on selected
probability (normally 80% and above).
Exemplary Dynamic Dual Notch Filter
[0290] Reference is now made to FIG. 20, schematically illustrating
a dynamic dual notch filter, that is defined to avoid interference
of internal driller acoustic noise, that is created by the driller
(and relates to its temporal rotation) to distract the acoustic
data analysis. It is done by filtering out audio frequencies with
values correlating to driller speed (RPM) and its second harmony
(2.times.RPM). This filter is dynamically set, according to
temporal speed.
[0291] The terms "comprises", "comprising", "includes",
"including", "has", "having" and their conjugates mean "including
but not limited to".
[0292] The term "consisting of" means "including and limited
to".
[0293] The term "consisting essentially of" means that the
composition, method or structure may include additional
ingredients, steps and/or parts, but only if the additional
ingredients, steps and/or parts do not materially alter the basic
and novel characteristics of the claimed composition, method or
structure.
[0294] As used herein, the singular forms "a", "an" and "the"
include plural references unless the context clearly dictates
otherwise.
[0295] Unless otherwise indicated, numbers used herein and any
number ranges based thereon are approximations within the accuracy
of reasonable measurement and rounding errors as understood by
persons skilled in the art.
[0296] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention, which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable subcombination
or as suitable in any other described embodiment of the invention.
Certain features described in the context of various embodiments
are not to be considered essential features of those embodiments,
unless the embodiment is inoperative without those elements.
[0297] Although the invention has been described in conjunction
with specific embodiments thereof, it is evident that many
alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the spirit and broad scope of the appended claims.
[0298] All publications, patents and patent applications mentioned
in this specification are herein incorporated in their entirety by
reference into the specification, to the same extent as if each
individual publication, patent or patent application was
specifically and individually indicated to be incorporated herein
by reference. In addition, citation or identification of any
reference in this application shall not be construed as an
admission that such reference is available as prior art to the
present invention. To the extent that section headings are used,
they should not be construed as necessarily limiting.
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