U.S. patent number RE44,049 [Application Number 10/702,056] was granted by the patent office on 2013-03-05 for bipolar handheld nerve locator and evaluator.
The grantee listed for this patent is Garrett D. Herzon. Invention is credited to Garrett D. Herzon.
United States Patent |
RE44,049 |
Herzon |
March 5, 2013 |
Bipolar handheld nerve locator and evaluator
Abstract
A hand-held disposable combination surgical nerve evaluator and
locator is provided. The device includes a housing that serves as a
handpiece and that accommodates a printed circuit board, a DC
voltage source and a compressed gas source. Two pre-programmed
settings are provided by way of a nerve evaluation switch and a
nerve location switch. By choosing a nerve evaluation switch, a
pulsed current is sent down one electrical lead that extends
outward from the housing. A return electrical lead is provided that
also extends outward from the housing in a parallel, but
spaced-apart relationship from the other electrical lead.
Compressed gas is delivered to the distal ends of the first and
second electrical leads by a cannula that is connected to the
compressed gas source. It will also be noted that the return or the
second electrical lead can also serve as a cannula for the delivery
of compressed gas. A fiber optic light guide may also be provided
to illuminate the area around the distal ends of the two electrical
leads. In a nerve evaluation mode, when the nerve evaluation switch
has been activated, a pulsed current is delivered to the first
electrical lead. Similarly, in a nerve location mode, a pulsed
current is also delivered to the first electrical lead. However,
the frequency of the pulsed current in the nerve evaluation mode is
less than the frequency of the current in the nerve location mode,
the pulse duration in the nerve evaluation mode is less than the
pulse duration in the nerve location mode and the amplitude of the
current in the nerve evaluation mode is less than the amplitude of
the current in the nerve location mode.
Inventors: |
Herzon; Garrett D. (Los
Angeles, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Herzon; Garrett D. |
Los Angeles |
CA |
US |
|
|
Family
ID: |
24171943 |
Appl.
No.: |
10/702,056 |
Filed: |
November 6, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
09544384 |
Apr 6, 2000 |
6312392 |
Nov 6, 2001 |
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Current U.S.
Class: |
600/554; 600/587;
607/48 |
Current CPC
Class: |
A61B
5/4893 (20130101); A61B 5/4041 (20130101); A61B
5/05 (20130101) |
Current International
Class: |
A61B
5/05 (20060101) |
Field of
Search: |
;600/544,554,486,546-547,557,587,595 ;607/46,48 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2 586 552 |
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Apr 1985 |
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FR |
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WO 01/12089 |
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Feb 2001 |
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WO |
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Other References
US. Appl. No. 11/512,159, filed Aug. 30, 2006, Herzon. cited by
applicant .
U.S. Appl. No. 12/577,531, filed Oct. 12, 2009, Herzon. cited by
applicant .
U.S. Appl. No. 10/326,387, filed Dec. 23, 2002, Herzon. cited by
applicant.
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Primary Examiner: Towa; Rene
Attorney, Agent or Firm: Oblon, Spivak, McClelland, Maier
& Neustadt, L.L.P.
Claims
What is claimed:
1. A hand-held combination surgical nerve evaluator and locator
comprising: a handpiece comprising a housing that accommodates a
circuit board connected to a DC voltage source, the circuit board
comprising a pulsed current source, the pulsed current source being
connected to a first electrical lead, the housing also being
connected to a second electrical lead, the first and second
electrical leads extending outward from one end of the housing in a
parallel and spaced-apart fashion, the circuit board and pulsed
current source being connected to a nerve evaluation .Iadd.on/off
.Iaddend.switch and a nerve location .Iadd.on/off .Iaddend.switch,
movement of the nerve evaluation switch to an activation position
causing a first pulsed current to be generated by the pulsed
current source and transmitted to the first electrical lead, the
first pulsed current having a nerve evaluation frequency, a nerve
evaluation pulse duration and a nerve evaluation amplitude,
movement of the nerve location switch to an activation position
causing a second pulsed current to be generated by the pulsed
current source and transmitted to the first electrical lead, the
second pulsed current having a nerve location frequency, a nerve
location pulse duration and a nerve location amplitude, the nerve
evaluation frequency being less than the nerve location frequency,
the nerve evaluation pulse duration being less than the nerve
location pulse duration, and the nerve evaluation amplitude being
less than the nerve location amplitude, the second electrical lead
serving as a ground.
2. The hand-held combination surgical nerve evaluator and locator
of claim 1 further comprising the nerve location frequency ranges
from about 5 to about 9 Hz, the nerve location pulse duration
ranges from about 300 to about 700 .mu.sec, the nerve location
amplitude ranges from about 700 to about 1100 .[.ma.].
.Iadd.mA.Iaddend., the nerve evaluation frequency ranges from about
1 to about 3 Hz, the nerve evaluation pulse duration ranges from
about 150 to less than 300 .mu.sec and the nerve evaluation
amplitude ranges from about 150 to about 250 .[.ma.].
.Iadd.mA.Iaddend..
3. The hand-held combination surgical nerve evaluator and locator
of claim 1 further comprising a compressed gas source located
within the housing and connected to the circuit board and a cannula
connected to the compressed gas source, the cannula, the first
electrical lead and the second electrical lead all comprising
distal ends, the cannula extending outward from the one end of the
housing and between the first and second electrical leads, movement
of either the nerve location switch or the nerve evaluation switch
to an activation position causing the compressed gas source to
communicate pressurized gas through the cannula and between the
distal ends of the first and second electrical leads.
4. The hand-held combination surgical nerve evaluator and locator
of claim 3 wherein the compressed gas source is a pump.
5. The hand-held combination surgical nerve evaluator and locator
of claim 4 wherein the pump is of a type selected from the group
consisting of solenoid pump, diaphragm pump, rotary pump and vane
pump.
6. The hand-held combination surgical nerve evaluator and locator
of claim 3 wherein the compressed gas source is a canister of
compressed gas.
7. The hand-held combination surgical nerve evaluator and locator
of claim 6 wherein the compressed gas is selected from the group
consisting of carbon dioxide, air, nitrogen and helium.
8. The hand-held combination surgical nerve evaluator and locator
of claim 1 further comprising a compressed gas source located
within the housing and connected to the circuit board, and wherein
the second electrical lead comprises a cannula connected to the
compressed gas source, the first electrical lead and second
electrical lead each comprising distal ends, the first electrical
lead extending outward from the one end of the housing and through
the second electrical lead, movement of either the nerve location
switch or the nerve evaluation switch to an activation position
causing the compressed gas source to communicate pressurized gas
through the second electrical lead and between the distal ends of
the first and second electrical leads.
9. The hand-held combination surgical nerve evaluator and locator
of claim 8 wherein the compressed gas source is a pump.
10. The hand-held combination surgical nerve evaluator and locator
of claim 9 wherein the pump is of a type selected from the group
consisting of solenoid pump, diaphragm pump, rotary pump and vane
pump.
11. The hand-held combination surgical nerve evaluator and locator
of claim 5 wherein the second electrical lead comprises a distal
end having at least one vent.
12. The hand-held combination surgical nerve evaluator and locator
of claim 1 further comprising a fiber optic light guide connected
to the DC voltage source, the fiber optic light guide extending
outward from the one end of the housing and along the first and
second electrical leads.
13. The hand-held combination surgical nerve evaluator and locator
of claim 1 wherein the DC voltage source is a battery.
14. A method of locating a nerve in a patient comprising the
following steps: providing a hand-held combination surgical nerve
locator comprising a handpiece comprising a housing that
accommodates a circuit board connected to the DC voltage source,
the circuit board comprising a pulsed current source, the pulsed
current source being connected to a first electrical lead, the
housing also being connected to a second electrical lead, the
second electrical lead serving as a ground, the first and second
electrical leads extending outward from one end of the housing in a
parallel and spaced-apart fashion, the circuit board and pulsed
current source being connected to a nerve location switch, the
housing also accommodating a compressed gas source which is
connected to the circuit board and a cannula that is connected to
the compressed gas source, the cannula, first electrical lead and
second electrical lead all comprising distal ends, the cannula
extending outward from the one end of the housing and between the
first and second electrical leads, engaging a patient with distal
ends of the cannula and first and second electrical leads, moving
the nerve location switch to an activation position causing the
compressed gas source to communicate pressurized gas through the
cannula and between the distal ends of the first and second
electrical leads thereby removing excess blood disposed between the
first and second electrical leads and further causing a pulsed
current to be generated by the pulsed current source and
transmitted to the first electrical lead.
15. The method of claim 14 wherein the compressed gas source is a
pump.
16. The method of claim 14 wherein the compressed gas source is a
canister of compressed gas regulated by a switch.
17. The method of claim 16 wherein the compressed gas is selected
from the group consisting of carbon dioxide, air, nitrogen and
helium.
18. The method of claim 14 wherein the second electrical lead is
the cannula connected to the compressed gas source.
19. The method of claim 14 wherein the hand-held combination
surgical nerve evaluator and locator further comprises a fiber
optic light guide connected to the DC voltage source, the fiber
optic light guide extending outward from the one end of the housing
and along the first and second electrical leads, the method further
comprising the step of illuminating and area around the distal ends
of the cannula and first and second electrical leads with the fiber
optic light guide.
20. The method of claim 14 wherein the nerve location frequency
ranges from about 5 to about 9 Hz, the nerve location pulse
duration ranges from about 300 to about 700 .mu.sec, the nerve
location amplitude ranges from about 700 to about 1100 .[.ma.].
.Iadd.mA.Iaddend..
21. A method of evaluating a nerve in a patient comprising the
following steps: providing a hand-held combination surgical nerve
evaluator and locator comprising a handpiece comprising a housing
that accommodates a circuit board connected to the DC voltage
source, the circuit board comprising a pulsed current source, the
pulsed current source being connected to a first electrical lead,
the housing also being connected to a second electrical lead, the
second electrical lead serving as a ground, the first and second
electrical leads extending outward from one end of the housing in a
parallel and spaced-apart fashion, the circuit board and pulsed
current source being connected to a nerve evaluation switch, the
housing also accommodating a compressed gas source which is
connected to the circuit board and a cannula that is connected to
the compressed gas source, the cannula, first electrical lead and
second electrical lead all comprising distal ends, the cannula
extending outward from the one end of the housing and between the
first and second electrical leads, engaging a patient with distal
ends of the cannula and first and second electrical leads, moving
the nerve evaluation switch to an activation position causing the
compressed gas source to communicate pressurized gas through the
cannula and between the distal ends of the first and second
electrical leads thereby removing excess blood disposed between the
first and second electrical leads and further causing a pulsed
current to be generated by the pulsed current source and
transmitted to the first electrical lead.
22. The method of claim 21 wherein the compressed gas source is a
pump.
23. The method of claim 21 wherein the second electrical lead is
the cannula connected to the compressed gas source.
24. The method of claim 21 wherein the hand-held combination
surgical nerve evaluator and locator further comprises a fiber
optic light guide connected to the DC voltage source, the fiber
optic light guide extending outward from the one end of the housing
and along the first and second electrical leads, the method further
comprising the step of illuminating and area around the distal ends
of the cannula and first and second electrical leads with the fiber
optic light guide.
25. The method of claim 21 wherein the nerve evaluation frequency
ranges from about 1 to about 3 Hz, the nerve evaluation pulse
duration ranges from about 150 to less than 300 .mu.sec and the
nerve evaluation amplitude ranges from about 150 to about 250
.[.ma.]. .Iadd.mA.Iaddend..
26. A hand-held combination surgical nerve evaluator and locator
comprising: a handpiece comprising a housing that accommodates a
circuit board connected to .[.the.]. .Iadd.a .Iaddend.DC voltage
source, the circuit board comprising a pulsed current source, the
pulsed current source being connected to a first electrical lead,
the housing also being connected to a second electrical lead, the
first and second electrical leads extending outward from one end of
the housing in a parallel and spaced-apart fashion, the housing
also accommodating a compressed gas source connected to the circuit
board and a cannula connected to the compressed gas source, the
cannula, first electrical lead and second electrical lead all
comprising distal ends, the cannula extending outward from the one
end of the housing and between the first and second electrical
leads, the DC voltage source being connected to a fiber optic light
guide that extends outward from the one end of the housing and
along the first and second electrical leads, the circuit board and
pulsed current source being connected to a nerve evaluation switch
and a nerve location switch, movement of the nerve evaluation
switch to an activation position causing a first pulsed current to
be generated by the pulsed current source and transmitted to the
first electrical lead, the first pulsed current having a nerve
evaluation frequency, a nerve evaluation pulse duration and a nerve
evaluation amplitude, movement of the nerve location switch to an
activation position causing a second pulsed current to be generated
by the pulsed current source and transmitted to the first
electrical lead, the second pulsed current having a nerve location
frequency, a nerve location pulse duration and a nerve location
amplitude, movement of either the nerve location switch or the
nerve evaluation switch to an activation position causing the
compressed gas source to communicate pressurized gas through the
cannula and between the distal ends of the first and second
electrical leads and further causing the fiber optic light guide to
illuminate the distal ends of the first and second electrical
leads, the nerve evaluation frequency being less than the nerve
location frequency, the nerve evaluation pulse duration being less
than the nerve location pulse duration, and the nerve evaluation
amplitude being less than the nerve location amplitude, the second
electrical lead serving as a ground.
27. The hand-held combination surgical nerve evaluator and locator
of claim 26 wherein the second electrical lead is the cannula and
the first electrical lead extends through the second electrical
lead.
.Iadd.28. A cordless handheld nerve locator and evaluator device,
the device comprising: first and second electrodes each having
distal ends adjacent to each other and configured to be in contact
with biological tissue; a current source coupled to the first
electrode and configured to generate an electrical stimulus; and a
control device configured to select operation of the current source
in a first mode based solely on actuation of a first mode switch
and a second mode based solely on actuation of a second mode
switch, wherein the current source is further configured to
generate a first electrical stimulus in the first mode, the first
electrical stimulus including a first frequency range, a first
amplitude range, and a first pulse duration range, the current
source is further configured to generate a second electrical
stimulus in the second mode, the second electrical stimulus
including a second frequency range, a second amplitude range, and a
second pulse duration range, and the second frequency range is
greater than the first frequency range, the second amplitude range
is greater than the first amplitude range, and the second pulse
duration range is greater than the first pulse duration
range..Iaddend.
.Iadd.29. The device of claim 28, wherein the first electrode
extends coaxially through at least a portion of the second
electrode..Iaddend.
.Iadd.30. The device of claim 29, wherein the second electrode
includes a cannula configured to direct gas flow to a region
between the distal ends of the first and second
electrodes..Iaddend.
.Iadd.31. The device of claim 30, wherein the cannula further
comprises at least one vent configured to exhaust compressed gas
flowing through the cannula..Iaddend.
.Iadd.32. The device of claim 30, wherein the cannula is disposed
between the first electrode and the second electrode..Iaddend.
.Iadd.33. The device of claim 30, wherein the cannula is formed as
the second electrode..Iaddend.
.Iadd.34. The device of claim 30, further comprising a gas source
coupled to the cannula and configured to provide compressed gas in
a region between the distal ends of the first and second
electrodes..Iaddend.
.Iadd.35. The device of claim 34, wherein the control device is
further configured to activate the gas source based on a selection
of one of the first and second modes..Iaddend.
.Iadd.36. The device of claim 34, wherein the gas source contains a
gas comprising any one of carbon dioxide, air, nitrogen, and
helium..Iaddend.
.Iadd.37. The device of claim 34, wherein the gas source comprises
a pump coupled to the cannula..Iaddend.
.Iadd.38. The device of claim 37, wherein the pump includes any one
of a solenoid pump, diaphragm pump, rotary pump, and vane
pump..Iaddend.
.Iadd.39. The device of claim 28, wherein the first mode includes a
first current amplitude of 200 mA and the second mode includes a
second current amplitude of 900 mA..Iaddend.
.Iadd.40. The device of claim 28, wherein the first mode includes a
first pulse duration of 250 .mu.s and the second mode includes a
second pulse duration of 500 .mu.s..Iaddend.
.Iadd.41. The device of claim 28, wherein the first mode includes a
first frequency component of 2 Hz and the second mode includes a
second frequency component of 7 Hz..Iaddend.
.Iadd.42. The device of claim 28, further comprising an optical
light configured to provide illumination to at least a region
between the distal ends of the first and second
electrodes..Iaddend.
.Iadd.43. The device of claim 28, wherein the first mode includes a
first frequency range from about 5 Hz to about 9 Hz..Iaddend.
.Iadd.44. The device of claim 28, wherein the first mode includes a
first pulse duration range from about 300 .mu.sec to about 700
.mu.sec..Iaddend.
.Iadd.45. The device of claim 28, wherein the first mode includes a
first amplitude range from about 700 mA to about 1100
mA..Iaddend.
.Iadd.46. The device of claim 28, wherein the second mode includes
a second frequency range from about 1 Hz to about 3
Hz..Iaddend.
.Iadd.47. The device of claim 28, wherein the second mode includes
a second pulse duration range from about 150 .mu.sec to about 300
.mu.sec..Iaddend.
.Iadd.48. The device of claim 28, wherein the second mode includes
a second amplitude range from about 150 mA to about 250
mA..Iaddend.
.Iadd.49. The device of claim 28, further comprising a handheld
housing configured to support at least one of the first and second
electrodes..Iaddend.
.Iadd.50. The device of claim 50, wherein the housing includes a
power source..Iaddend.
.Iadd.51. A method of locating and evaluating a nerve using a
cordless handheld nerve locator and evaluator device, comprising:
positioning the device to be in contact with biological tissue at a
first position; operating the device in a first mode to locate the
nerve while the device is in contact with the biological tissue at
the first position; repositioning the device to be in contact with
the biological tissue at a second position; and operating the
device in a second mode to evaluate the nerve while the device is
in contact with the biological tissue at the second position,
wherein the device includes first and second electrodes each having
distal ends adjacent to each other and configured to be in contact
with the biological tissue, a current source coupled to the first
electrode and configured to generate an electrical stimulus, and a
control device configured to select operation of the current source
in a first mode based solely on actuation of a first mode switch
and a second mode based solely on actuation of a second mode
switch, the current source is further configured to generate a
first electrical stimulus when operating the device in the first
mode, the first electrical stimulus including a first frequency
range, a first amplitude range, and a first pulse duration range,
the current source is further configured to generate a second
electrical stimulus when operating the device in the second mode,
the second electrical stimulus including a second frequency range,
a second amplitude range, and a second pulse duration range, and
the second frequency range is greater than the first frequency
range, the second amplitude range is greater than the first
amplitude range, and the second pulse duration range is greater
than the first pulse duration range..Iaddend.
.Iadd.52. The method of claim 51, further comprising flowing gas
between the first electrode and the second electrode when operating
the device in one of the first and second modes..Iaddend.
.Iadd.53. The method of claim 51, wherein operating the device in
one of the first and second modes further includes illuminating the
biological tissue..Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates generally to nerve locators and
evaluators. More specifically, the present invention relates to a
bipolar nerve locator and evaluator. Still more specifically, the
present invention relates to a bipolar nerve locator and evaluator
that includes a pressurized gas source for removing blood and fluid
from the operative field as well as between the electrical leads
and further which includes a fiber optic light source.
BACKGROUND OF THE INVENTION
U.S. Pat. No. 4,962,766 discloses a nerve locator and evaluator
which is used in surgical procedures. An AC energizing current is
transmitted through an electrical lead to the patient. High and low
settings are available and the device is equipped with an auditory
signal to alert the surgeon when current is flowing through the
patient's body.
However, despite the progress provided by the device disclosed in
U.S. Pat. No. 4,962,766, the device has been found to be
unsatisfactory for a number of reasons. First, the device is
mono-polar and is equipped with a single electrode at the
evaluation tip. As a result, the device requires a secondary ground
wire that exits the back end of the handpiece. The ground wire
attaches the patient's body with a conductive patch or needle
electrode. This arrangement is problematic because the needle can
fall out or the patch can peel off during the procedure. Further,
the ground wire can extend across the surgical area and become
entangled with other instruments during the surgical procedure.
Consequently, the ground wire can become dislodged and the device
temporarily inoperable during surgery. As a result, there is a need
for an improved nerve locator and evaluator which does not require
the employment of a ground wire or lead.
Still further, the tip of the device disclosed in U.S. Pat. No.
4,962,766 is applied directly to the patient. Because it is
employed during a surgical procedure, excessive amounts of blood
and fluid are typically present. The blood and fluid makes it
difficult for the surgeon to see the exact area where the distal
tip of the device is being applied. Consequently, it can be
difficult for the surgeon to make visual contact with the nerve
that is being located or stimulated because of the presence of the
blood and fluid. In addition to enhancing the surgeon's
visualization of the nerve under investigation, removal of blood
and fluid would also be important to electrically isolate the nerve
prior to location or evaluation and further to prevent any
electrical shunting of current applied to the nerve. As a result,
there is a need for an improved nerve locator and evaluator which
has a built-in mechanism for removing excess blood and fluid from
an area under observation or investigation.
Similarly, the device disclosed in U.S. Pat. No. 4,962,766 is not
equipped with any sort of a light source to assist the surgeon in
viewing the distal end of the instrument tip. As a result, there is
a need for an improved nerve locator and evaluator that is equipped
with a built-in illumination means.
Finally, while the device disclosed in U.S. Pat. No. 4,962,766 has
high and low current settings, the device does not incorporate
preset evaluation parameters which allow for locating and
evaluation. As a result, there is a need for an improved nerve
locator and evaluator with predetermined settings for frequency,
evaluation pulse duration and amplitude for the separate operations
of nerve evaluation and nerve location.
SUMMARY OF THE INVENTION
The present invention satisfies the aforenoted needs by providing a
hand-held combination surgical nerve evaluator and locator that
does not require a separate ground lead or connector. The device of
the present invention is a bipolar device and utilizes two
electrical leads in the probe, one of which serves as a return or a
ground lead. In an embodiment, the hand-held combination surgical
nerve evaluator and locator of the present invention also includes
a pressurized gas source for clearing blood and fluids away from
the area between the distal tips of the two electrical leads as
well as the operative field. In an embodiment, the surgical nerve
evaluator and locator of the present invention also includes a
built-in light source in the form of a fiber optic light guide.
Still further, in an embodiment, the surgical nerve evaluator and
locator of the present invention also includes two predetermined
settings, one for nerve location and one for nerve evaluation.
In an embodiment, the present invention provides a hand-held
combination surgical nerve evaluator and locator that comprises a
handpiece that comprises a housing that accommodates a circuit
board connected to a DC voltage source. The circuit board also
comprises a pulsed current source. The pulsed current source is
connected to a first electrical lead. The housing is also connected
to a second electrical lead. The first and second electrical leads
extend outward from one end of the housing in a parallel and
spaced-apart fashion.
The circuit board and pulsed current source are connected to a
nerve evaluation switch and a nerve location switch. Movement of
the nerve evaluation switch to an activation position causes a
first pulsed current to be generated by the pulsed current source
and transmitted to the first electrical lead. The first pulsed
current has a nerve evaluation frequency, a nerve evaluation pulse
duration and a nerve evaluation amplitude.
In contrast, movement of the nerve location switch to an activation
position causes a second pulsed current to be generated by the
pulsed current source and transmitted to the first electrical lead.
The second pulsed current has a nerve location frequency, a nerve
location pulse duration and a nerve location amplitude.
The nerve evaluation frequency is less than the nerve location
frequency. The nerve evaluation pulse duration is less than the
nerve location pulse duration. The nerve evaluation amplitude is
less than the nerve location amplitude.
In accordance with the present invention, the second electrical
lead serves as a return electrical lead or a ground.
In an embodiment, the nerve location frequency ranges from about 5
to about 9 Hz.
In an embodiment, the nerve pulse duration ranges from about 300 to
about 700 .mu.sec.
In an embodiment, the nerve location amplitude ranges from about
700 to about 1100 ma.
In an embodiment, the nerve evaluation frequency ranges from about
1 to about 3 Hz.
In an embodiment, the nerve evaluation pulse duration ranges from
about 150 to less than 300 .mu.sec.
In an embodiment, the nerve evaluation amplitude ranges from about
150 to about 250 ma.
In an embodiment, the nerve location frequency is about 7 Hz; the
nerve location pulse duration is about 500 .mu.sec; the nerve
location amplitude is about 900 ma; the nerve evaluation frequency
is about 2 Hz; the nerve evaluation pulse duration is about 250
.mu.sec; and the nerve evaluation amplitude is about 200 ma.
In an embodiment, the device of the present invention further
comprises a compressed gas source located within the housing and
that is connected to the circuit board. The device further
comprises a cannula connected to the compressed gas source. The
cannula, the first electrical lead and the second electrical lead
all comprise distal ends. The cannula extends outward from the end
of the housing and between the first and second electrical leads.
Movement of either the nerve location switch or the nerve
evaluation switch to an activated position causes the compressed
gas source to communicate pressurized gas through the cannula and
between the distal ends of the first and second electrical
leads.
In an embodiment, the compressed gas source is a pump.
In an embodiment, the pump is selected from the group consisting of
a solenoid pump, a diaphragm pump, a rotary pump and a vane
pump.
In an embodiment, the compressed gas source is a canister of
compressed or liquid carbon dioxide.
In an embodiment, the compressed gas source is a canister of
compressed or liquid air.
In an embodiment, the compressed gas source is a canister of
compressed or liquid nitrogen.
In an embodiment, the compressed gas source is a canister of
compressed or liquid helium.
In an embodiment, the compressed gas source is a canister of
compressed gas regulated by a switch.
In an embodiment, the second electrical lead is a cannula and the
first electrical lead extends outward from the housing and through
the second electrical lead.
In an embodiment, a distal end of the cannula includes at least one
vent.
In an embodiment, the device of the present invention further
comprises a fiber optic light guide that is connected to the DC
voltage source. The fiber optic light guide extends outward from
the housing and along the first and second electrical leads to
illuminate the area surrounding the distal ends of the first and
second electrical leads.
In an embodiment, the DC voltage source is a battery.
In an embodiment, the present invention includes a method of
locating-a-nerve in a patient that comprises the steps of providing
a hand-held combination surgical nerve evaluator and locator as set
forth above, engaging a patient with the distal ends of the cannula
and the first and second electrical leads, moving the nerve
location switch to an activation position causing the compressed
gas source to communicate pressurized gas through the cannula and
between the distal ends of the first and second electrical leads
thereby removing excess blood disposed between the first and second
electrical leads and further causing a pulsed current to be
generated by the pulsed current source and transmitted to the first
electrical lead, through the patient's body to the second
electrical lead.
In an embodiment, the present invention provides a method of
evaluating a nerve in a patient that comprises the steps of
providing a hand-held combination surgical nerve evaluator and
locator as described above, engaging a patient with the distal ends
of the cannula and the first and second electrical leads, moving
the nerve evaluation switch to an activation position causing the
compressed gas to communicate pressurized gas through the cannula
and between the distal ends of the first and second electrical
leads to thereby remove excess blood disposed between the first and
second electrical leads and further causing a pulsed current to be
generated by the pulsed current source and transmitted to the first
electrical lead, through the patient and to the second electrical
lead.
Other objects and advantages of the present invention will become
apparent upon reading the following detailed description and
appended claims, and upon reference to the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
For a more complete understanding of the present invention,
reference should now be made to the embodiments illustrated in
greater detail in the accompanying drawings and described below by
way of examples of the present invention.
In the drawings:
FIG. 1 is a side plan view of a hand-held combination surgical
nerve evaluator and locator made in accordance with the present
invention;
FIG. 2 is a sectional view of the nerve evaluator and locator shown
in FIG. 1;
FIG. 3 is an end view of the probe section of the nerve evaluator
and locator shown in FIG. 1;
FIG. 4 is a bottom view of the probe section shown in FIG. 3;
FIG. 5 is an end view of a probe section of an alternative
embodiment made in accordance with the present invention;
FIG. 6 is a sectional view of the probe section shown in FIG.
5;
FIG. 7 is a side plan view of a probe section of an alternative
embodiment made in accordance with the present invention
illustrating the use of a fiber optic light guide;
FIG. 8 is an end view of the probe section shown in FIG. 7; and
FIG. 9 is a bottom view of the probe section shown in FIG. 8.
It should be understood that the drawings are not necessarily to
scale and that the embodiments are sometimes illustrated by graphic
symbols, phantom lines, diagrammatic representations and
fragmentary views. In certain instances, details which are not
necessary for an understanding of the invention or which render
other details difficult to perceive may have been omitted. It
should be understood, of course, that the invention is not
necessarily limited to the particular embodiments illustrated
herein.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
Turning first to FIG. 1, a combination surgical nerve evaluator and
locator 10 is illustrated which include a handpiece 11 that
comprises a housing 12. As shown in FIG. 2, the housing 12
accommodates a printed circuit board 13, a DC voltage power supply
14 and a compressed gas source 15. The printed circuit board 13 is
electrically connected to the DC power supply 14, the compressed
gas supply 15, the locating switch 16, the evaluator or stimulating
switch 17 and the light indicator 18.
The printed circuit board 13 includes a pulsed current source which
is connected to the electrical lead 21. The other electrical lead
22 (shown in FIG. 3) serves as a return lead or a ground.
When the locator switch 16 is depressed, the pulsed current source
of the printed circuit board 13 delivers a continuous train of
pulses with a evaluation pattern to the electrical lead 21 at a
frequency, pulse duration and amplitude that is optimized to aid
the surgeon in finding and locating a nerve. In an preferred
embodiment, the nerve location frequency is about 7 hertz but can
range from 5 to 9 hertz. The nerve location pulse duration is
preferably about 500 .mu.sec, but can range from 300 to 700
.mu.sec. Further, the nerve location amplitude is preferably about
900 ma, but can range from 700 to 1100 ma.
Similarly, depression of the nerve evaluation switch 17 triggers
the pulsed current source of the controller board 13 to deliver a
pulse train to the electrical lead 21 that is optimized to aid the
surgeon in evaluating a located nerve. Preferably, the location
frequency is about 2 hertz, but can range from about 1 to about 3
hertz. The nerve evaluation pulse duration is preferably about 250
.mu.sec, but can range from about 150 to about 300 .mu.sec. The
nerve evaluation amplitude is preferably about 200 ma, but can
range from about 150 to about 250 ma.
By providing location and evaluation pulse trains within the
parameters discussed above, the present invention minimizes the
possibility of any neuropraxia due to overevaluation of the nerve.
The voltage applied to the electrical lead 21 is varied to provide
a constant current source.
Once one of the switches 16, 17 is activated, the compressed gas
source 15 is also activated. Preferably, the compressed gas source
15 is a pump, such as a solenoid, diaphragm, rotary or vane pump.
Such miniature pumps are known, one of which is sold by Sensidyne,
of Clearwater, Fla. The compressed gas source 15 delivers
compressed gas to the cannula shown at 23. In the embodiment
illustrated in FIGS. 1-3, the gas cannula 23 is disposed between
the electrical leads 21 and 22. The purpose of the gas cannula 23
and the compressed gas is to blow or dislodge any blood or fluid
disposed between the distal ends or electrodes 24, 25 connected to
the electrical leads 21, 22 respectively and further to remove
blood and fluid from the operative field. The use of the compressed
gas or air and the cannula 23 is important in terms of the function
of finding or locating nerves.
The compressed gas source 15 may also be a canister of compressed
or liquefied gas, such as carbon dioxide, air, nitrogen or helium.
In such an embodiment, the canister may be regulated by a switch.
Use of a canister of compressed or liquefied gas such as carbon
dioxide, air, nitrogen or helium, is in lieu of a pump as discussed
above.
An alternative embodiment is illustrated in FIGS. 5 and 6.
Specifically, the second or the return electrode 22a is in the form
of a cannula. The first or primary electrode 21a that is connected
to the pulsed current source of the printed circuit board 13
extends through the cannula or return electrode 22a in a coaxial
fashion. Thus, as opposed to the three-part configuration
illustrated in FIGS. 3 and 4, the embodiment illustrated in FIGS. 5
and 6 only requires two primary components due to the use of the
cannula 22a as a ground or return lead. In the embodiment
illustrated in FIGS. 5 and 6, vents 26 are disposed towards the
distal end of the cannula or return lead 22a. The vents 26 permit
the flow of gas through the vents in the event the distal end 27 of
the cannula or return lead 22a becomes clogged with blood, fluid or
other debris.
In a further embodiment illustrated in FIGS. 7-9, a fiber optic
light guide 31 is mounted on top of the cannula 23a and between the
electrical leads 21a and 22a. The fiber optic light guide 31
provides illumination to the area disposed between the distal ends
or electrodes 24a, 25a. In a preferred embodiment, the fiber optic
light guide 31 is connected to the DC power source 14.
Referring back to FIG. 2, it will be noted that the light indicator
18 is connected to both the electrical leads 21, 22 and will be
illuminated when there is a current flow between the leads 21, 22.
In other words, the light indicator 18 will be illuminated when the
device is working or when current is being transmitted from the
electrical lead 21, through the patient's body to the electrical
lead 22.
The electrical circuitry utilized to enable the device 10 to
deliver a pulsed current for purposes of nerve location and another
pulsed current for purposes of nerve evaluation, both of which fall
within the parameters described above, will be apparent to those
skilled in the art. Hence, a detailed schematic of the printed
circuit board 13 is not provided. However, construction of the
printed circuit board 13 in view of the objects described above is
well within the knowledge of those skilled in the art.
Accordingly, an improved hand-held and disposable combination nerve
evaluator and locator is provided which requires no additional
ground connections to the patient or adjacent equipment. The device
can be manufactured easily and inexpensively and therefore can be
disposable. The DC current source 14 can be a suitable battery
intended for one time use.
From the above description it is apparent that the objects of the
present invention have been achieved. While only certain
embodiments have been set forth, alternative embodiments and
various modifications will be apparent from the above description
to those skilled in the art. These and other alternatives are
considered equivalents and within the spirit and scope of the
present invention.
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