U.S. patent application number 10/870202 was filed with the patent office on 2005-12-22 for ablation apparatus and system to limit nerve conduction.
Invention is credited to Buske, Jeffrey Michael, Janssen, William Michael, Jones, James Whitney, Newman, James Paul.
Application Number | 20050283148 10/870202 |
Document ID | / |
Family ID | 35481620 |
Filed Date | 2005-12-22 |
United States Patent
Application |
20050283148 |
Kind Code |
A1 |
Janssen, William Michael ;
et al. |
December 22, 2005 |
Ablation apparatus and system to limit nerve conduction
Abstract
A surgical system and the associated methods for use in
Minimally Invasive Surgical procedures for use in the short- and
long-term termination of signals through nerves. Such a procedure
is an improvement over the current state-of-the-art because of the
use of a tightly coupled single-needle bi-polar probe. The
proximity of both electrodes, to the nerve or tissue targeted for
the treatment, is such that it reduces the losses experienced with
external electrodes (e.g. plates or probes). Further, the probe has
features associated with locating the probe and dispensing or
sampling far above the probes currently available. The resulting
improvements provide a quantum leap in technology for the
associated medical industries and a base line for these procedures
in the future.
Inventors: |
Janssen, William Michael;
(Elizabeth, CO) ; Newman, James Paul; (Mountain
View, CA) ; Jones, James Whitney; (Emerald Hills,
CA) ; Buske, Jeffrey Michael; (Boulder, CO) |
Correspondence
Address: |
Richard S Missimer
2218 S Santuary Drive
P O Box 511224
New Berlin
WI
53151
US
|
Family ID: |
35481620 |
Appl. No.: |
10/870202 |
Filed: |
June 17, 2004 |
Current U.S.
Class: |
606/34 ; 606/48;
606/50 |
Current CPC
Class: |
A61B 90/30 20160201;
A61B 34/20 20160201; A61B 2018/00434 20130101; A61B 2018/162
20130101; A61B 2090/0814 20160201; A61B 2018/00702 20130101; A61B
2018/00761 20130101; A61B 2018/00732 20130101; A61B 18/1206
20130101; A61B 2018/0072 20130101; A61B 2017/00482 20130101; A61B
2018/1467 20130101; A61B 18/16 20130101; A61B 18/1477 20130101;
A61B 2090/0803 20160201; A61B 2090/3937 20160201; A61B 2018/00577
20130101; A61B 2018/00988 20130101 |
Class at
Publication: |
606/034 ;
606/048; 606/050 |
International
Class: |
A61B 018/14 |
Claims
We claim:
1) A System for Minimally Invasive Surgery comprising: a. an
electrically isolated RF Energy Generator, that delivers up to 500
watts of RF energy in amplitude or frequency modulated form with a
frequency between 50 Khz and 2.5 Mhz; b. a single-needle bi- or
multi-polar probe that requires but a single puncture entranceway
and has electrodes in close proximity to the extent necessary to
promote precision within the procedure itself; and c. a secondary
means to locate and position said single-needle probe by
illumination, the creation of electrical signal or signals, or by
use of florescent dye.
2) A generator as described in claim #1 that delivers RF energy
regulate-able intelligently by use of dynamic load detection
measuring the effective load-by voltage, current, phase or varying
frequency comprising: a. connection to the probe; b. connection to
the probe's internal microcontroller for memory and sensor reading
and writing if any, and to retrieve procedural, control sequence
and limitations that are in turn used for that probe's specific
procedure; c. display and sound as required for surgical
functionality; d. memory storage for record keeping of procedural
information related to the operating parameters, date, time, sensor
measurements taken, and voice or data recording; and e. connection
to a communication channel such as RS-232, RS485, Ethernet,
Bluetooth, or any other viable communication media.
3) A single needle two electrode probe used in a bi- or multi-polar
configuration for Minimally Invasive Surgery comprising: a. an
inner diameter electrode made of surgical grade metal of a size and
shape dictated by the application requirement; b. a voltage
insulator that covers and creates an electrical isolation between
the two exposed electrodes; and c. an Outer-sleeve return-electrode
made of a surgical grade metal with surface area greater than that
necessary to eliminate burning of the tissue in contact;
4) A single needle multiple electrode probe used in a multi-polar
configuration for Minimally Invasive Surgery comprising: a. an
inner diameter electrode made of surgical grade metal of a size and
shape dictated by the application requirement; b. a voltage
insulator that covers and creates an electrical isolation between
the two exposed electrodes; and c. an Outer-sleeve return-electrode
made of a surgical grade metal with surface area greater than that
necessary to eliminate burning of the tissue in contact;
5) A single needle probe as in claim #3 or #4 with a inner diameter
electrode hollow such that injections of medications, florescent
dyes and the like can be made and samples of the surrounding tissue
can be taken.
6) A single needle probe as in claims #3, #4, or #5 that
communicates, to the generator, information related to the
procedure, measurements of sensors embedded within the probe and
probe specific information.
7) A single needle probe as in claim #3, #4, #5 or #6 with an
electrical isolator that is capable of illuminating the area so
that placement of the probe can be facilitated;
8) A method for ablating tissues or terminating the flow of nerve
impulses utilizing a single puncture probe introduced via a
Minimally Invasive surgical techniques comprising: a. locating
probe tip in close proximity to said nerve or target tissue with a
needle type probe having an exposed active area or areas on or near
the distal tip, said probe and system to generate RF energy so as
to ablate, destroy tissue or render nerve conduction through said
nerves impossible on either semi permanent or permanent basis; b.
placing said probe tip in position so that ablative energy may be
selectively delivered to target tissue thus avoiding destruction or
areas and tissues that must remain intact and not be destroyed or
traumatized; and c. delivering RF energy from a tuned RF source so
as to destroy target tissues in close proximity to electrode(s) at
tip.
9) A method as in claim #7 wherein guidance between auxiliary
probes and ablation probes is provided via current signals,
illumination or other means.
10) A method as in claim #7 wherein positioning involves placing
tip of the probe in desired general area using physiologic and
anatomic landmarks with manual guidance.
11) A method as in claim #7 wherein precise positioning is done
using illumination from tip region of probe so operator can see
exact location of tip through the skin and other intervening
structures.
12) A method as in claim #7 whereby the therapeutic probe is guided
in to general area desired and then directed precisely under
surface marking by observing the location of illumination point
emanating from tip of probe.
13) A method as in claim #7 wherein auxiliary probes are inserted
into vicinity of target tissues, stimulation energy is applied from
the auxiliary probes, location is determined, and the target area
is identified by marking the tissue or other means.
14) A method as in claim #7 wherein nerve, muscle, or physiologic
reaction is observed by applying stimulation currents from ablative
tip(s), thus confirming proper location of tip in relation to
target tissue(s).
Description
FIELD OF INVENTION
[0001] The present invention relates to a method and device used in
the field of Minimally Invasive Surgery (or MIS) for interrupting
the flow of signals through nerves. These nerves may be rendered
incapable of transmitting signals either on a temporarily (hours,
days or weeks) or a permanent (months or years) basis. This new
device itself consists of a single puncture system, which
incorporates both an active and return electrode capable of
creating areas of nerve destruction, inhibition and ablation; a
generator for precisely delivering RF energy, and the method
necessary for properly locating the active tip and generating
energy to ablate target nerves.
BACKGROUND OF THE INVENTION
[0002] The human nervous system is used to send and receive
signals. The pathway taken by the nerve signals convey sensory
information such as pain, heat, cold and touch and command signals
which cause movement (e.g. muscle contractions).
[0003] Often extraneous, undesired, or abnormal signals are
generated (or are transmitted). Examples include (but are not
limited to) the pinching of a minor nerve in the back, which causes
extreme back pain, or the compression (or otherwise activation) of
nerves causing referred pain. Also with certain diseases the lining
of the nerves is compromised, or signals are spontaneously
generated, which can cause a variety of maladies, from seizures to
pain or (in extreme conditions) even death. Abnormal signal
activations can cause many other problems including (but not
limited to) twitching, tics, seizures, distortions, cramps,
disabilities (in addition to pain), other undesirable conditions,
or other painful, abnormal, undesirable, socially or physically
detrimental afflictions. This device can be used to treat various
types of nerve conditions. Such as functional applications to
innervations of the posterior neck muscles that will relieve
headaches, muscle strain, and pain. The device can be used to treat
abnormal muscle activity a result of over stimulation of peripheral
nerves, for relief of pain, spasticity, and dystonias. Further,
conditions such as hyperhidrosis, rhinorrhea, drooling, and facial
flushing, caused by the overactive signals from sympathetic and
parasymapathetic nerve path ways, can be treated.
[0004] In other situations, the normal conduction of nerve signals
can cause undesirable effects. For example in cosmetic applications
the activation of the corrugator supercilli muscle causes frown
lines which may result in permanent distortion of the brow (or
forehead); giving the appearance of premature aging. By
interruption of the corrugator supercilli activation nerves, this
phenomenon may be terminated. Other cosmetic applications include
all neck and facial expression muscles, which are innervated by
cranial nerves (including, but not limited to, the orbicularis
oculi, orbicularis ori, frontalis, procerus, temporalis, masseter,
zygomaticus major, depressor anguli oris, depressor labii
inferioris, mentalis, platysma, and/or corrugator supercili
muscles). Further, Platysma myoides, Procerus muscles, back
muscles, back pain, and other pain/abnormal muscle or nerve
activations would be treatable.
[0005] This technology describes an improved method of interrupting
signal flows through nerve fibers with a new single puncture
technique; used in the emerging field of Minimally Invasive Surgery
(or MIS). Interrupting such flows is done using electricity to form
an electrical circuit with the nerve. The circuit created is formed
with a source of energy connected to an active electrode with a
return path again connected to the source.
[0006] Traditional electrosurgical procedures use either a unipolar
or bipolar device connected to that energy source. A unipolar
electrode system includes a small surface area electrode, and a
return electrode. The return electrode is generally larger in size,
and is either resistively or capacitively coupled to the body.
Since the same amount of current must flow through each electrode
to complete the circuit; the heat generated in the return electrode
is dissipated over a larger surface area, and whenever possible,
the return electrode is located in areas of high blood flow (such
as the biceps, buttocks or other muscular or highly vascularized
area) so that heat generated is rapidly carried away, thus
preventing a heat rise and consequent burns of the tissue. The
advantage of these system is the ability to place the unipolar
probe exactly where it is needed and optimally focus the energy
where desired. The disadvantage of the system is that the return
electrode must be properly placed and in contact throughout the
procedure. A resistive return electrode would typically be coated
with a conductive paste or jelly. If the contact with the patient
is reduced or if the jelly dries out, a high-current density area
would result, increasing the probability for burns at the contact
point.
[0007] Bipolar electrode systems use a two surface device (such as
forceps, tweezers, pliers and other grasping type instruments)
where two separate surfaces can be brought together mechanically
under force. Each opposing surface is connected to one of the two
source connections of the electrical generator. Then the desired
object is held and compressed between the two surfaces. Then when
the electrical energy is applied, it is concentrated (and focused)
so that tissue can be cut, desiccated, burned, killed, stunned,
closed, destroyed or sealed between the grasping surfaces. Assuming
the instrument has been designed and used properly, the resulting
current flow will be constrained within the target tissue between
the two surfaces. The disadvantage of the conventional bipolar
system is that the target tissue must be properly located and
isolated between these surfaces. To reduce extraneous current flow
the electrodes can not make contact with other tissue, which often
requires visual guidance (such as direct visualization, use of a
scope, ultrasound or other direct visualization methods) so that
the target tissue is properly contained within the bipolar
electrodes themselves, prior to application of electrical
energy.
[0008] In recent years, considerable efforts have been made in
refining sources of RF or electrical energy, as well as devices for
applying electrical energy to specific targeted tissue. Various
applications such as tachyarrhythmia ablation have been developed,
whereby accessory (extra) pathways within the heart conduct
electrical energy in an abnormal pattern. This abnormal signal flow
results in excessive, and potentially lethal cardiac arrhythmias.
RF ablation (as it is called) delivers electrical energy in either
a bipolar or unipolar configuration utilizing a long catheter,
similar to an EP (electrophysiology) catheter. That catheter
(consisting of a long system of wires and supporting structures
normally introduced via an artery or vein which leads into the
heart) is manipulated using various guidance techniques, such as
measurement of electrical activity, ultrasonic guidance, and/or
X-ray visualization, into the target area. Electrical energy is
then applied and the target tissue is destroyed.
[0009] A wide variety of technology in the development of related
systems, devices and EP products has already been disclosed. For
example, U.S. Pat. No. 5,397,339 (issued Mar. 14, 1995) describes a
multipolar electrode catheter, which can be used to stimulate,
ablate, obtain intercardiac signals, and can expand and enlarge
itself inside the heart. Other applications include the ability to
destroy plaque formations in the interior of lumens within the
body; using RF energy applied near (or at the tip of) catheters
such as described in U.S. Pat. No. 5,454,809 (issued Oct. 3, 1995)
and U.S. Pat. No. 5,749,914 (issued May 12, 1998). In these
applications a more advanced catheter (though similar to the EP
catheters (described above)) contains an array of electrodes that
is able to selectively apply energy in a specific direction. This
device allows ablation and removal of asymmetric
deposits/obstructions within lumens in the body. In that
application, guidance may also be applied in various forms. U.S.
Pat. No. 5,098,431 (issued Mar. 24, 1992), discloses another
catheter based system for removing obstructions from within blood
vessels. Parins in U.S. Pat. No. 5,078,717 (issued Jan. 7, 1992)
discloses yet another catheter to selectively remove stenotic
lesions from the interior walls of blood vessels. Auth in U.S. Pat.
No. 5,364,393 (issued Nov. 15, 1994) describes a modification of
the above technologies whereby a guide wire (a much smaller wire
which goes through an angioplasty device and is typically 110 cm or
longer) has an electrically energized tip, which creates a path to
follow and thus guides itself through the obstructions.
[0010] In applications of a similar nature, catheters which carry
larger busts of energy (for example from a defibrillator) into
chambers of the heart have been disclosed. These catheters are used
to destroy both tissues and structures as described in Cunningham
(see U.S. Pat. No. 4,896,671 issued Jan. 30, 1990) that describes a
catheter for delivery in electroshock ablative therapy.
[0011] One application of this technology would induce the
elimination of glabellar furrowing by interrupting the conduction
of nerve signals to muscles causing frown wrinkles. Traditional
treatments have included surgical forehead lifts, resection of
corrugator supercilli muscle, as described by Guyuron, Michelow and
Thomas in Corrugator supercilli muscle resection through
blepharoplasty incision., Plastic Reconstructive Surgery 95 691-696
(1995). Also, surgical division of the corrugator supercilli motor
nerves is used and was described by Ellis and Bakala in Anatomy of
the motor innervation of the corrugator supercilli muscle: clinical
significance and development of a new surgical technique for
frowning., J Otolaryngology 27; 222-227 (1998). These techniques
described are highly invasive and sometimes temporary as nerves
regenerate over time and repeat or alternative procedures are
required.
[0012] More recently, a less invasive procedure to treat glabellar
furrowing involves injection of botulinum toxin (Botox) directly
into the muscle. This produces a flaccid paralysis and is best
described in The New England Journal of Medicine, 324:1186-1194
(1991). While minimally invasive, this technique is predictably
transient; so, it must be re-done every few months.
[0013] Specific efforts to use RF energy via a less sophisticated
two needle bipolar system has been described in an articleby
Hernandez-Zendejas and Guerrero-Santos called Percutaneous
Selective Radio-Frequency Neuroablation in Plastic Surgery,
Aesthetic Plastic Surgery, 18:41 pp 41-48 (1994) They described a
bipolar system using two needle type electrodes. Utley and Goode
described a similar system in Radio-frequency Ablation of the Nerve
to the Corrugator Muscle for Elimination of Glabellar Furrowing,
Archives of Facial Plastic Surgery, Jan-Mar, 99, VI P 46-48. Later
they were granted U.S. Pat. No. 6,139,545 (issued Oct. 31, 2000),
which fully described the two needle bipolar system. These systems
were unable to produce permanent results (i.e. greater than a few
months) because of limitations in the energy and their polar
configurations and like with Botox, would have required periodic
repeat procedures.
[0014] There are many ways of properly locating an active electrode
near the target tissue and determining if it is in close proximity
to the nerve. Traditional methods have included stimulation by
using either unipolar and bipolar energy by means of a test
pacemaker pulse prior to the implantation of a pacemaker or other
stimulation device. A method of threshold analysis called the
`strength duration curve` has been used for many years. This curve
consists of a vertical axis (or Y-axis) typically voltage, current,
charge or other measure of amplitude, and has a horizontal axis (or
X-axis) of pulse duration (typically in milliseconds). Such a curve
is a rapidly declining line, which decreases exponentially as the
pulse width is increased. This curve is described on pp31 ff in The
Third Decade of Pacing, by Barold and Mugica (1982) and also on pp
245 in The Biomedical Engineering Handbook" CRC Press, IEEE Press,
Ed by J. D. Bronzino, (1995).
[0015] Various stimulation devices have been made and patented. The
process of stimulation/ablation using a two-needle system is
disclosed in U.S. Pat. No. 6,139,545 (Oct. 31, 2000). This process
is described in reverse, where the area not desired for detection
of ancillary tissue is treated with stimulation then ablation. The
process is best described in U.S. Pat. No. 5,782,826 (issued Jul.
21, 1998).
[0016] The new method and device of this preferred embodiment also
uses (among other potential methods of locating the tip of the
electrode in proximity to the target nerve) stimulation, followed
by ablation. In this process the energy is delivered via the single
puncture MIS system (as later described). This unique technology
and resulting device is a single needle that contains both
electrodes. It will access the site via a single puncture and will
be used with MIS surgical techniques. It will also have features
that provide for placement and have substantial added benefits,
which are described later in this document.
SUMMARY OF THE INVENTION
[0017] The primary aspect, of the present invention, is to provide
a single-needle type puncture entry way for bi-polar electrodes for
delivering RF energy near the nerve (to terminate signal flow), in
a minimally invasive procedure. Other aspects of this invention
will be apparent from the appended claims, descriptions and
drawings that follow.
[0018] Important aspects of this invention include:
[0019] A visible probe tip illumination to aide in positioning;
[0020] A hollow lumen for delivery of medication, often, but not
limited to, anesthetic;
[0021] Delivery of ionizing radiation, via laser, to probe tip for
direct energy delivery;
[0022] Coordination of ionizing radiation and RF energy
delivery;
[0023] Unique probe identification;
[0024] Prior usage detection to eliminate potential contamination
or unauthorized re use;
[0025] Procedure power settings matched to probe internal
identification;
[0026] Direct reading of ablation probe temperature and
impedance;
[0027] Pre-stored arbitrary amplitude modulation envelopes with
multi-frequency for controlled energy delivery;
[0028] Controlled metered energy delivery determines
permanence;
[0029] Multi-frequency operation for optimal power delivery;
[0030] Dynamic impedance matching for optimal power delivery;
[0031] Integrated dielectric insulator as fiber optic for
illumination, thus reducing diameter;
[0032] Auxiliary nerve locator probe;
[0033] Depth markings on auxiliary probe;
[0034] Auxiliary probe needle shaft insulation;
[0035] Dual needle tipped auxiliary probe;
[0036] Electronic guidance of ablation probe to auxiliary
probe;
[0037] Electronic guidance measures and displays current
proportional probe distances;
[0038] Electronic guidance variable frequency audio tone
proportional to distance/sense current;
[0039] Electronic guidance variable amplitude audio tone
proportional to distance/sense current;
[0040] Electronic guidance variable frequency/flash rate of
ablation tip illumination proportional to distance/sense
current;
[0041] Illumination of florescent-tagged marker;
[0042] Detection of florescent emission of tagged marker;
[0043] Simultaneous illumination of florescent-tagged marker and
emission detection;
[0044] Simultaneous illumination of florescent-tagged marker by
means of a tunable laser;
[0045] Integrated hollow biopsy electrode for florescent-tagged
tumor sampling;
[0046] Integrated hollow electrode for medication delivery to
tagged tumor;
[0047] Integrated hollow electrode for photo-medication delivery to
tagged tumor with illumination activation source; and
[0048] Another aspect of the invention is a probe usage register to
reduce or eliminate chance of patient cross contamination.
[0049] This invention is an improved device (and method for its
use) that will allow the physician to terminate signal flow through
nerves, in a minimally invasive manner, by requiring only a
single-needle type puncture. Said method and device would allow for
a reduced patient recovery time; the patient would be awake during
the procedure; using only a local (or very little) anesthetic; have
a substantially reduced risk of infection; less of a risk of
intensive care (or hospital stay), and subsequently, a reduced
associated costs. Inasmuch, the patient would more rapidly return
to a normal lifestyle as compared to many procedures requiring open
surgery.
[0050] This single-puncture device (hereafter called `single-pass`)
presents an improvement over conventional uni-polar systems because
it does not require a separate return electrode, which is attached
to the patient at a remote site and subsequently must be maintained
during the surgical procedure. Also, it represents an improvement
over bi-polar electrodes and earlier two needle systems, because it
concentrates the energy specifically at the desired location (by
use of one active electrode) and when ablation areas need to be
precisely focused this device may best accomplish that task.
[0051] The device (and the methods needed to operate it) can be
used to terminate, stop or inhibit (on a temporary, semi-permanent
or even permanent basis) the transmission of nerve signals to the
muscles, organs and receivers of nerve signals, which convey
activation, perception, pain signals or other nervous impulses. In
the preferred embodiment, the active electrode (or the probe/needle
tip) may be positioned by various guidance and/or sensing means.
This includes (but is not limited to) ultrasound, traditional
pace/sense (apply stimulating signals and observe placement of the
electrode in proximity to the target nerve), manual palpitation,
proper anatomical positioning, X-ray, CT, MRI, PET or other
radiation or emission type imaging means, fiber-optic video,
external location (and marking) and subsequent location by
illuminating the probe tip or by other similar means.
[0052] In addition to the `single-pass` needle, the complete system
shall include an intelligent external energy generator, which can
be used either by programmed or manual control. The manual control
may be mitigated (or limited for the protection of the patient) by
means of various sensors including (but not limited to) impedance
(and the change in impedance), temperature (and the change in
temperature), normal voltage (or current) regulation, etc. Said
generator will generate RF energy in the frequency range of 50 Khz
to 2.5 Mhz, in a controlled manner.
[0053] The generator will also be usable under program control.
Said programming will deliver a predetermined "bolus" (or packet)
of electrical energy, whereby the dose is adjustable (within
limits) by the physician proportional to the desired effect. This
bolus will be predetermined in clinical studies and may have preset
parameters such as minimal effect, average effect, maximum effect,
corresponding to a low, normal and high-output level. The output
cycle will be activated by the physician via footswitch, a button
on the probe itself, voice or other similar method of activation
methods. When the bolus output is activated it may be terminated
(at any time) by releasing activation means (i.e. the footswitch,
button or the like). However, it will provide output no greater or
longer than the activation device is held down, and will also be
limited to the length of time and dosage preset. To deliver a
second packet of energy, the activation mechanism must be released
for (an internally set) time period before another packet of energy
may be delivered. Also, because this technology may be used in
various applications (e.g. plastic surgery, spinal nerves causing
back pain, and other applications where terminating signal flows
through nerves is desired) the delivery systems (i.e. single-pass
needle or probe, and the generator required to power same) may be
of differing sizes, surface areas or mechanical configurations.
Some may even require a substantially different amount or type of
energy packet. Program setting and preferences made be controlled
for the different applications by providing a specific hand tool
device that would then contain a coded circuit, connector or other
means of providing identification to the generator so that it may
deliver the required energy packets automatically for the different
applications or methods.
[0054] The methods of ablation may include both a linear or
circular zone. The effective ablation area may be modified by
"laying down" a series of individual ablation zones, thus creating
a line of ablated tissues. This would be possible by withdrawing,
inserting, and/or moving the active tip while ablating in the
successive zones, which would expanding the liner component of any
lesion produced. In the alternative, the effective zone of ablation
could be extended circumferentially by manipulating the tip during
the ablation cycle in small circles, thereby mechanically moving
the tip enlarging the effective zone of ablation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0055] FIG. 1 Bi-Polar Driver System
[0056] FIG. 2 Schematic diagram of the bi-polar needle
[0057] FIG. 2A Schematic diagram of the split bi-polar needle
[0058] FIG. 3A Magnified side view of conical bi-polar probe.
[0059] FIG. 3B Magnified side view of hollow chisel bi-polar
probe.
[0060] FIG. 3C Magnified side view of tapered conical bi-polar
probe.
[0061] FIG. 3D Magnified side view of split conical bi-polar
probe.
[0062] FIG. 4 Schematic diagram of the bi-polar driver system
[0063] FIG. 5A Ablation Procedure without Auxiliary probe
[0064] FIG. 5B Ablation Procedure with Auxiliary probe
[0065] FIG. 6. Side view Hybrid bi-polar needle for nerve
ablation.
[0066] FIG. 6A Side view Hybrid bi-polar needle for tumor
ablation.
[0067] FIG. 7 Side view of auxiliary nerve probe.
[0068] FIG. 7A Side view of auxiliary dual-tipped nerve probe.
[0069] FIG. 8 Side view of guided ablation procedure with auxiliary
nerve probe(s).
[0070] FIG. 9 Sample electro-surgery waveforms.
[0071] FIG. 10 Side view of visually guided ablation procedure.
[0072] FIGS. 11-11A Controller and probe data base structure
[0073] Defined below are the terms used here within:
[0074] Medical Terms
[0075] Corrugator supercili muscles--skeletal muscles of the
forehead that produce brow depression and frowning
[0076] Cepressor anguli oris--skeletal muscle of the corner of the
mouth that produces depression of the corner of the mouth
[0077] Depressor labii inferioris--skeletal muscle of the lower lip
that causes the lip to evert and depress downward
[0078] Dystonias--medical condition describing an aberrant
contraction of a skeletal muscle which is involuntary
[0079] Frontalis--skeletal muscle of the forehead that produces
brow elevation or raising of the eyebrows
[0080] Hyperhidrosis--condition of excessive sweat production
[0081] Masseter--skeletal muscle of the jaw that produces jaw
closure and clenching
[0082] Mentalis--skeletal muscle of the lower lip and chin which
stabilizes lower lip position a
[0083] Orbicularis oculio--skeletal muscle of the eyelid area
responsible for eyelid closure
[0084] Orbicularis ori--skeletal muscle of the mouth area
responsible for closure and competency of the lips and mouth
[0085] Parasymapathetic--refers to one division of the autonomic
nervous system
[0086] Platysma myoides--skeletal muscle of the neck that protects
deeper structures of the neck
[0087] Platysma--same as above
[0088] Procerus muscles--skeletal muscle of the central forehead
responsible for frowning and producing horizontal creasing along
the nasofrontal area
[0089] Procerus--same as above
[0090] Rhinorrhea--excessive nasal mucous secretions
[0091] Supercilli--a portion of the corrugator muscle that sits
above the eyelids
[0092] Temporalis--skeletal muscle of the jaw that stabilized the
temporamandibular joint
[0093] Zygomaticus major--skeletal muscle of the face that produces
smiling or creasing of the midface
[0094] Electrical Terms
[0095] ADC: Analog to digital converter
[0096] ASCII: American standard of computer information
interchange.
[0097] BAUD: Serial communication data rate in bits per second.
[0098] BYTE: Digital data 8-bits in length
[0099] CHARACTER: Symbol from the ASCII set.
[0100] CHECKSUM: Numerical sum of the data in a list.
[0101] CPU: Central processing unit.
[0102] EEPROM: Electronically erasable programmable read only
memory.
[0103] FLASH MEMORY: Electrically alterable read only memory. (See
EEPROM)
[0104] GUI: Graphical user interface.
[0105] HEXADECIMAL: Base 16 representation of integer numbers.
[0106] 12C BUS: Inter Integrated Circuit bus. Simple two-wire
bi-directional serial bus developed by Philips for an independent
communications path between embedded ICs on printed circuit boards
and subsystems.
[0107] The I2C bus is used on and between system boards for
internal system management and diagnostic functions.
[0108] INTERRUPT: Signal the computer to perform another task
[0109] PC: Personal computer.
[0110] PWM: Pulse-width modulation
[0111] ROM: Read only memory.
[0112] WORD: Digital data 16-bits in length
DETAILED DESCRIPTION OF OVERALL OPERATION
[0113] This section provides information on the overall operation
of this system. FIG. 1 has two main components and one optional
component, which are the energy generator 400, the probe 371
(alternate probes are described in FIGS. 3A-D) and optionally
probes 771 or 772 that may be used.
[0114] In normal operation, the novel probe 371 would combine a
unique bipolar configuration in a single MIS needle, is inserted
into the patient using MIS techniques. The probe, which may contain
and/or convey various functions described later, is initially
guided anatomically to the region of the anticipated or desired
location. Various means of locating the tip 301 are utilized of
placing the zone of ablation in the proper area to interrupt signal
flows through the nerve 101.
DETAILED DESCRIPTION OF DEVICE OPERATION
[0115] This section refers to the drawings to describe use of the
probe. There are many combinations of electrode diameters and tip
shapes are possible. The `novel` probe performs a variety of
functions, such as stimulation, optical and electronic guidance,
medication delivery, sample extraction, and controlled ablation.
This bi-polar electrode is designed as a small diameter needle
inserted from a single point of entry thus minimizing scaring and
simplifying precise electrode placement. This low cost, compact
design provides a new tool to the art.
[0116] Probes may emit fiber optic illumination for deep
applications using electronic guidance as taught in FIGS. 1 and 8.
The invention offers a simple low cost ablation probe that is
capable of performing precise ablation while minimizing damage to
nearby tissue structures. The metered ablation energy and precise
probe targeting give the practitioner a tool is also not available
in prior art. The practitioner has unprecedented control of
treatment permanence in a minimally invasive procedure. Such a
procedure is typically performed in less than one hour with only
local anesthetic and would require no stitches or chemicals common
to prior medical art.
[0117] Stimulation/Ablation
[0118] First the probe electrode 301 must be in the desired
location relative to the target nerve 101 (FIG. 4), then the user
initiates the treatment via switch(s) 410 and 310 using the
selected power setting 404 (FIG. 4). The controller configures the
generators 411 (FIG. 4) and 412 to the amplitude frequency and
modulation envelope, delivering 50 KHz-2.5 MHz of 5 to 500 watts of
available energy. The summing junction 413 combines the RF outputs
as the application requires and passes them to the pulse-width
modulator 415 for output power control. The output of modulation
generator 420 is applied to the multiplier 415 with radio frequency
RF signals 422 and 423. This permits complex energy profiles to be
delivered to a time variant non-linear biologic load. All of these
settings are based on the information provide to the generator by
the installed probe 371 the selected power 404 settings, and the
modulation envelope 420 (FIG. 4) settings, which are then loaded by
the generator 421.
[0119] For example, both a high amplitude sine wave 910 (FIG. 9),
used for cutting, and a pulse-width modulated (or PWM) sine wave
920, used for coagulation, are well known to electro-surgery art.
Precise power rates and limits of average total power are
controlled via integrator 435 minimizing damage to nearby
structures or burning close to the skin for shallow procedures.
Where nearby structures 111(FIG. 2A) are too close to be avoided by
electrodes such as 371 (FIG. 3), 372 (FIG. 3A), and 372 (FIG. 3B),
additional probe geometries as taught in FIGS. 3D, 6 and 6A offer
novel methods to direct energy and limit ablation to a smaller
region, thereby avoiding other structures. For safety a hardwired
switch 436 disables the power amplifier in the event of a system
fault, the probe is unplugged or over power condition, thus
protecting both the patient and practitioner.
[0120] The output of the modulator 415 is applied to the input of
the power amplifier 416 section. The power amplifier's 416 outputs
are then feed into the impedance matching network 418, which
provides dynamic controlled output to the biologic loads that are
highly variable and non-linear, and require dynamic control of both
power levels and impedance matching. The tuning of the matching
network 418 is performed for optimal power transfer for the probe,
power level, and treatment frequencies settled. The system's peak
power is 500 watts for this disclosed embodiment. Precise control
is established by the proximity of the tip and the control loops
included in the generator itself The final energy envelope 420 is
delivered to probe tip 301 and return electrodes 302.
[0121] This precise control of energy permits extension of the
ablation region(s), 140 and 1203 (FIG. 10), and the duration of
treatment efficiency. Low or medium energy settings 404 permit
temporary nerve-conduction interruption for 3-6 months. Higher
energy settings at 404 may result in a longer nerve conduction
interruption of 1 year to permanent. In the prior art, procedures
had little control over duration of termination of such signal flow
through the nerve. This invention gives the practitioner enhanced
control of such duration. Patients can evaluate controlled
temporary treatment before choosing longer or permanent treatment
options.
[0122] A low energy nerve stimulator 771 has been integrated into
the system to assist in more precise identification of nearby
structures and for highly accurate target location. Lastly,
additional sensors, such as temperature 311, voltage, frequency,
current and the like are read directly from the device and/or
across the communications media 403 to the probe.
[0123] Directed Ablation
[0124] In addition to the substantial radially-symmetric ablation
patterns with probes as taught in 371 (FIG. 3) and 372, switching
or dividing ablation power to multiple electrodes (FIG. 3D) can
generate a asymmetric ablation zone. This high intensity source 608
with probe 610 (FIGS. 6 and 6A) minimizes damage to nearby
structures 111 or the burning of skin 330 in shallow procedures.
Also, FIGS. 2A and 3D identifies probe configurations for selective
or asymmetric ablation.
[0125] Power Feedback
[0126] The power amplifier output430 and buffered the feedback
signals 437 are connected to an Analog to Digital converter (or
ADC) 431 for processor analysis and control. Said signals 437
control power modulation 420 settings and impact the impedance
matching control signals 419. This integrated power signal 437 is
recorded to the operating-condition database (FIG. 11) for later
procedure review. This power level is also compared to reading
taken from the probe 1492 (FIG. 11A) as compared against procedure
maximums, which if exceeded will in turn disable the amplifier
output, thereby protecting the patient from error or equipment
fault. Similarly, limits from the probe and generator sensors such
as temperature 330 are also used to terminate or substantially
reduce the modulated power levels and ultimately the procedure.
[0127] Probe Identification
[0128] At power startup, the controller 401(FIG. 4) reads the probe
status and internal identification kept within the probe itself 331
(and 371) via serial communications 403 (or bus). Serial
communications is used because it is commonly available to most
single-chip microprocessors. This or similar methods (e.g. I2C, or
SPI) may be used, but this disclosed embodiment will use serial for
its simplicity. Serial communications 403 permits the generator to
address and control EEROM memory 331, temperature sensors 330,
processors, ADC and DACs within the single-chip microprocessor
embedded in the probe itself The user selects the desired power
setting 404 and based on probe identification read from the EEROM
or microprocessor 331 makes the appropriate configurations. The
probe 371 is connected via cable 1334 (FIG. 1) to control unit 101
or generator. This probe is not intended for multiple procedural
use. So to prevent such use of the probe, the controller 401 (FIG.
4) reads the stored time register from ID memory module 331. If the
probe's initialized time 1467 (FIG. 14) is zero, the current
real-time clock 482 value is written to probe's 331's initial time
register via serial bus 403. If time read on module 331 is
non-zero, the probe's initial time register is added to two(2)
times the procedural time (based on the probe type) FIG. 14 1420.
If that value when compared to current real-time clock 482, is less
than current time, the controller will alert the practitioner via
display 450, speaker 451 and, flashing probe illumination 608, that
the procedure will be terminated and the probe rendered
invalid.
[0129] The controller 401 also verifies selected procedure 1415
(FIG. 11) for compatibility with installed probe. If incompatible,
the user is also prompted to select a different power setting 404,
procedure, or probe 371. If probe 371 matches power setting 404,
the system enables power amplifier 416, guide light source 408, and
low-voltage nerve simulation 732. Both of these procedures are
enforced by a mandatory "hand shake" protocol and the serialized
information, which must be present and properly verified by the
electronic circuitry for a procedure to be instituted. During a
clinical procedure, information is required to be conveyed by the
embedded electronics contained within the probe, which provides
another way of enforcing this protection and thus again preventing
unauthorized re-use. The ultimate goal is prevent
cross-contamination between patients. The probe will accomplish
this by being unique, serialized, and given the above procedures.
Once plugged in, the probe will enter the serial number into the
data logging system via the serial bus 403 and circuit logic will
thereafter prevent re-use of the probe and cross-contamination that
would occur. Further, this scheme will prevent the use of
unauthorized third party probes, for they will not be activated,
preventing potential inferior or uncertified probes from being used
and presenting potential danger to the patient.
[0130] Nerve Target Location Tools
[0131] Prior to treatment, the practitioner may use auxiliary probe
771(FIG. 4), to locate target 101 and nearby structures 111 as
taught in FIGS. 4, 7, 7A, 8, and 10. When needle 771 is in place,
the practitioner may locate and place a mark or marks on the
surface of the skin 755 (see FIGS. 7 and 8) or leaves auxiliary
probe 771 in place. For shallow sub-cutaneous procedures, probe tip
illumination 448 from source 408 is visible to practitioner aiding
in probe placement to pre-marked location.
[0132] Location Via Florescence Marker Dye
[0133] In other procedures, whereby somewhat larger targets are
sought, such as more diffuse nerve structures or small areas of
abnormal growth (e.g. such as cancer) the injection of specially
designed dyes that attach to target structures are used, as taught
in FIG. 6A. The probe 610 (FIG. 6) is moved into the proximity of
the target 671. The light source 608 illuminates quantum-dot/dye
tagged antibody 670. The dye fluoresces 675 at a
frequency/wavelength of a particular material and will typically
emit light in the visible to infrared (or IR) or potentially other
wavelength regions. The return fiber(s) 680 deliver emissions 675
to the detector 478 for measurement and are the result is then
displayed on bar graph 554 (FIG. 1) and/or an audio tone sounded
via speaker 451 based on proximity. Visible and IR light emissions
propagate over limited distances permitting additional external
detectors 678 to be used for shallow targets just under the skin
330. Location via this method is similar to the electronically
guided probe method taught in FIG. 8 where probe 610 movement
maximizes the signal output when in close proximity. IR emissions
propagate and can permit deeper (typically several centimeters)
detection with optional additional external sensors 678.
Unfortunately, many dyes fluoresce in the visible region making
external detection imposable for deep targets or when obscured by
bone. However, probe 610 (FIG. 6A) solves this problem by
integrating target illumination 674, emission 675 detector,
ablation, biopsy, and medication delivery in single compact probe.
Electronic probe guidance (FIG. 8) if required is used in
combination with florescence detection to rapidly locate target.
The instant invention offers a minimally invasive system for
locating and treating small/deep tumors and other tissue that are
to be ablated, destroyed or removed.
[0134] Electronic Probe Guidance
[0135] Low energy nerve stimulation current 810 (FIG. 8) assist in
locating desired treatment region and avoiding nearby structures.
Probe 771 is selectable between nerve stimulator and current
measurement to/from auxiliary probe tip 702(FIG. 8). Return
electrode 736 provides a return path for local ground 735. Ablation
probe switch 367 selects low-energy stimulator/receiver and
high-energy ablation to/from probe 372. Amplitude of measured
guidance current 811 and light 478 are transmitted to display 554,
and audio feedback 452 through the speaker 451.
[0136] Optical Probe Guidance
[0137] Disclosed invention provides optical sources 408 that aid in
probe placement (FIG. 10) by supplementing stimulation source 732
and acting as preliminary guide. Probe 771 is selectable between
nerve stimulator or current 811 measurement and to or from the
auxiliary probe tip 702. The ablation probe switch 367 selects
low-energy stimulator/receiver or high-energy ablation to or from
probe 371, 372, 373, and 374. In this mode, the physician operator
will have previously placed marks 755 on the surface of the skin by
various means described. The physician operator 775 will then see
the tip when the 448 if the optical illumination is turned on. It
448 will provide a bright spot under the skin indicating the
location of the tip in relation to the marks 755. The physician 775
will then guide the probe tip 301 into precise alignment under
these marks 755 so as to enable ablation of that target tissue
101.
[0138] Data and Voice
[0139] Real-time engineering parameters are measured such as
average power 437, luminous intensity 478, probe current 811,
energy 438 and, temperature 330 to be recoded into USB memory 438.
Simultaneously, the internal parameters disclosed such as frequency
423, modulation 420 and such are recoded into USB memory 438 as
well. Additionally probe, patient, and procedure parameters (FIG.
11) are written to local storage 438. The practitioner dictates
text and voice notes via microphone 455, which are saved to memory
438 (FIG. 1). All data and records are time stamped using the
real-time clock 482. This permits detailed post procedure graphing
and analysis.
[0140] Data Transfer
[0141] At procedure conclusion, the system transfers the data 438
recorded to the USB removable memory 1338 and to a file server(s)
1309 and 1307. In the disclosed embodiment, data transfer is
performed over Ethernet connection 480. Probe usage records
1460(FIG. 11) that are stored in local memory 438 are then written
to removable memory module 1338. Parallel records are mirrored to
local storage 1309 and remote server 1306 storage 1307 via Ethernet
connection 480 or similar means. Sensitive records are encrypted
and transferred via secure network connection and also written to
removable module 1320. The database contained on the remote server
tracks the following information: equipment by manufacture, probe
accessory inventory, usage, billing, repair/warranty exchange
information, and program recorders. As a system 400 is certified
for new procedures 1410 (FIG. 11), the relational databases are
automatically updated to reflect new billing/procedure codes 1416,
potential power settings 1417 and the like. This insures that the
equipment is current and alerts the practitioner to new
probes/procedures as they are developed and certified.
DETAILED DESCRIPTION OF THE DRAWINGS
[0142] Before explaining the disclosed embodiment of the present
invention in detail, it is to be understood that the invention is
not limited in its application or to the details of the particular
arrangement shown. The invention is capable of other embodiments.
Further, the terminology used herein is for the purpose of
describing the probe and its operation. Each apparatus embodiment
described herein has numerous equivalents.
[0143] FIG. 1 Bi-Polar Driver System
[0144] FIG. 1 identifies the two required components of the system,
various modules and optional items. The two components always
utilized during a procedure will be the energy
generator/controller/data storage device 400 and probe 371. 400
contains advanced electronic systems capable of recognizing a
properly authorized probe, preventing re use of a previously used
probe, generating appropriate energy as described, performing
safety checks, storing data, and other functions as described. Main
functions of 400 may include, but not be limited to, generation of
light, generation of location-stimulation currents, generation of
ablation energies, data logging, storage, communication and
retrieval, and other functions critical to a MIS procedure. Probe
371 and its various forms are single puncture bipolar surgical
tools that may be used in identifying proper location of its tip
301, in relation to target tissue 101 which is desired to be
ablated, modified or destroyed. Probe 771 and its various
derivatives may optionally be used to assist in locating and
properly positioning tip 301 of probe 371.
[0145] FIG. 2 Isometric View of the Bi-Polar Probe
[0146] Bi-polar probe 310 represents probes 371, 372, 373 shown in
FIGS. 3A-C with exception to type of needlepoint on the probe. FIG.
3D varies from the other because it has a split return probe.
Bi-polar probe 310 (not drawn to scale) consists of insulating
dielectric body 309 made from a suitable biology inert material,
such as Teflon, PTFE or other insulative material, covering
electrode 302 except for where 302 is exposed as a return
electrode. Conductive return electrode 302 tube is fabricated from
medical grade stainless steel, titanium or other conductive
material. Hollow or solid conductive tip electrode 301 protrudes
from surrounding dielectric insulator 305. Sizes of 309, 302, 305,
and 301 and its inner lumen (diameter, length, thickness, etc.) may
be adjusted so as to allow for different surface areas resulting in
specific current densities as required for specific therapeutic
applications.
[0147] Hollow Electrode 301 often used as a syringe to deliver
medication such as local anesthetic. Tip electrode 301 is connected
to power amplifier 416 via impedance matching network 418 (FIG. 4).
Return electrode(s) 302 delivers return current to power amplifier
416 via impedance matching network 418. Dielectric insulator in the
disclosed embodiment is a transparent medical grade polycarbonate
acting as a light pipe or fiber optic cable. Light source LED or
laser 408 (FIG. 4) provides illumination at the far end of the
probe via fiber optic cable/transparent dielectric 305 for guiding
the probe under the skin i.e. shallow procedures. In an alternate
embodiment dielectric insulator is replaced with a plurality of
optical fibers for viewing and illumination as taught in FIG.
6.
[0148] Ablation regions 306 and 140 extend radially about electrode
301 generally following electric field lines. For procedures very
close to skin 330 a chance of burning exists in region 306. To
minimize the chance of burning, a split return electrode probe 374
in FIG. 3D is offered. Thereby concentrating the current away from
region 306 to 140 or vice versa. In FIG. 2A, insulator 307 splits
the return electrode into two sections 302 and 303, dividing return
current ratio from 0-50%, which may also be selectively activated.
Active electrodes are also split into two sections 301 and 311 so
energy may be directed in a desired direction. This electrode
configuration is identified on the proximal portion of the probe so
the operator may position the needle and electrodes accordingly.
FIG. 6 teaches a laser directed ablation for more precise energy
delivery.
[0149] FIG. 2A Isometric View of Split Bi-Polar Probe.
[0150] The bi-polar probe 380 (not drawn to scale) consists of an
insulating dielectric body 309 made from a suitable biologically
inert material, such as Teflon PTFE or other electrical insulation,
that covers split return electrodes 302 and 303. The disclosed
conductive return electrodes 302 and 303 are fabricated from
medical grade stainless steel, titanium or other electrically
conductive material. Hollow or solid split conductive tip
electrodes 301 and 311 protrude from the surrounding dielectric
insulator 305. The operation of the hollow/split conductive tip is
very similar to probe tip 310 as taught in FIG. 3D. Ablation
regions 1203 (FIG. 10) and 140-144 extend radially about electrode
301 generally following electric field lines. For procedures very
close to skin 330 a chance of burning exists in region 306. To
minimize chance of burning a split return electrode probe 311 is
used, thereby concentrating the current away from region 306 to
140. For procedures where there is a risk to nearby structures 111,
the ablation region 1203 must be a non-radial ablation zone. The
disclosed split electrode 380 permits dividing or splitting energy
delivered to electrode pairs 301/302 and 311/303. The disclosed
division or ratio between pairs is 0-100%. Dual amplifiers or time
multiplexing/switching main amplifier, 416 located between
electrode pairs, directs energy to target 101 avoiding 111. This
simple switch network reliably ratios electrical energy while
minimizing damage to nearby structures.
[0151] FIG. 3A Conical Bi-Polar Needle
[0152] Bi-polar probe 371 discloses conical shaped electrode 301
and tip 351 for minimally invasive single point entry. Probe
diameter 358 is similar to a 20-gage or other small gauge syringe
needle, but may be larger or smaller depending on the application,
surface area required and depth of penetration necessary. In
disclosed embodiment, electrode shaft 302 is 30 mm long with
approximately 5 mm not insulated. Lengths and surface areas of both
may be modified to meet various applications such as in cosmetic
surgery or in elimination of back pain. The conductive return
electrode 302 is fabricated from medical grade stainless steel,
titanium or other conductive material. The dielectric insulator 305
in the disclosed embodiment is a transparent medical grade material
such as polycarbonate, which may double as a light pipe or fiber
optic cable. The high intensity light source 408 LED/laser (FIG. 4)
provides guidance Illumination 448 at working end of probe. The
illumination source modulation/flash rate is proportional to the
received stimulation current 810 as taught in FIG. 8. A small
diameter electrode permits a minimally invasive procedure that is
typically performed with local anesthetic. This configuration may
contain lumens for delivery of agents as described elsewhere.
[0153] FIG. 3B Hollow Chisel
[0154] The hollow chisel electrode 352 is often used as a syringe
to deliver medication such as local anesthetic, medications,/tracer
dye. The hollow electrode may also extract a sample. Dielectric
insulator 305 in the disclosed embodiment is a transparent medical
grade polycarbonate and performs as a light pipe or fiber optic
cable. The novel dual-purpose dielectric reduces probe diameter and
manufacturing costs. Light source 408, typically a LED or laser
(FIG. 4 not shown), provides Illumination 448 at the working end of
probe. It provides an illumination source for guiding the probe
under the skin. A second embodiment, as taught in FIG. 6,
dielectric insulator is replaced/combined with plurality of optical
fibers for viewing/illumination.
[0155] FIG. 3C Tapered Conical
[0156] The bi-polar probe 373 discloses a tapered conical shaped
probe for minimally invasive single point entry. It is constructed
similarly to probe 371 as taught in FIG. 3A. Probe tip is not drawn
to scale to teach the tip geometry. In disclosed embodiment,
electrode 301 is approximately 5 mm long and fabricated from
medical grade stainless steel but may be of various lengths to
accommodate specific application and surface area requirements. The
solid tapered conductive tip electrode 353 protrudes from tapered
dielectric insulator 305. Transparent dielectric insulator 305 also
performs as light pipe or fiber optic cable terminated to high
intensity light source 408 (FIG. 4) providing illumination 448. The
electrode assembly is mounted in an ergonomic handle 388 (which has
not been drawn to scale). Handle 388 holds ablation on/off switch
310, ablation/stimulation mode switch 367, identification module
331 and terminations for cable 1334 (FIG. 13). Temperature sensor
330 (located close to tip) monitors tissue temperature.
[0157] FIG. 3D Split Conical Bi-Polar Probe
[0158] Description of this probe is described in both drawings 2A
and 3D. Bi-polar probe 374 (not drawn to scale) consists of
insulating dielectric body 309 made from a suitable biologically
inert material, such as Teflon, that covers split return electrodes
302 and 303. Conductive return electrodes 302 are fabricated from
medical grade stainless steel, titanium or other suitable
conductive material. Hollow or solid split conductive tip
electrodes 301 and 311 protrude from surrounding dielectric
insulator 305. Their operation is very similar to probe tip 380 as
taught in FIG. 2A. Solid tapered conductive tip electrodes 311 and
301 protrude from transparent dielectric insulator 305. Dielectric
insulator 305 also performs as a light pipe or fiber optic cable
terminated to high intensity light source 408 providing
illumination 448.
[0159] Probe handle (not drawn to scale) encloses memory module
331, on/off switch 310 and mode switch 367. Temperature sensor 330
(located close to tip) monitors tissue temperature. Split electrode
380 (FIG. 2A) permits dividing or splitting energy delivered to
electrode pairs 301/302 and 311/303. Dual amplifiers or time
multiplexing/switching main amplifier 416 are located between
electrode pairs directing energy to target 101 avoiding 111
creating asymmetric ablation volume. A small diameter electrode
needle is injected from a single point of entry minimizing scaring
and simplifying precise electrode placement.
[0160] Connections consist of a tapered dielectric sleeve 309
covering the ridged stainless electrode tube 302. Insulating sleeve
309 is made from a suitable biologically inert material, which
covers electrode 302. Dielectric 305 insulates conical tipped
electrodes 351 and 301.
[0161] FIG. 4A Schematic Diagram of the Bi-Polar Driver System.
[0162] See section Detailed Description of Device Operation.
[0163] FIG. 5A Ablation Procedure (Without Auxiliary Probes)
[0164] Ablation probe 371 is inserted and directed anatomically
into the area where the target nerve to be ablated (Box 531) is
located. Test current 811 is applied (Box 532). If probe is located
in the immediate proximity of the target nerve a physiological
reaction will be detected/observed (Example: During elimination of
glabellar furrowing, muscle stimulation of the forehead will be
observed). If reaction is observed, then a mark may optionally be
applied on the surface of the skin to locate the area of the nerve.
Power is applied (Box 535) in an attempt to ablate the nerve. If
physiological reaction is not observed, (Box 534) the probe will be
relocated closer to the target nerve and the stimulation test will
be repeated (Box 536 & 537). If no physiological reaction is
observed, the procedure may be terminated (Box 544). Also, the
probe may be moved in any direction, up, down, near, far, circular,
in a pattern, etc. to create a larger area of ablation for a more
permanent result.
[0165] In Box 537, if stimulation is observed again, then the
ablation power may be set higher (Box 538), alternatively, as
mentioned, the needle may be moved in various directions, or a
larger dosage of energy may be reapplied, to form a larger area of
ablation for more effective or permanent termination of signal
conduction through the nerve. After delivery of power (Box 540),
stimulation energy may be applied again (Box 541). If there is no
stimulation, the procedure is completed (Box 544). If there is
still signal flow through the nerve (stimulation or physiological
reaction) then the probe may be relocated (Box 542) and the
procedure is started over again (Box 533).
[0166] FIG. 5B Flow Chart of Visually Guided Ablation Procedure
Using Auxiliary Probes Such As 771 and 772.
[0167] Auxiliary probes 771 and 772 (FIGS. 7 and 7A) provide a
method to quickly and accurately locate target structure 101 and
subsequently mark target location 755. Auxiliary probes may be much
smaller (like acupuncture needles) than ablation probes. Structures
are marked typically with an ink or similar pen allowing the
illuminated ablation probe 371 or other ablation probe to be
quickly guided to mark 755. Optionally, non-illuminated probes may
be used allowing the practitioner to simply feel for the probe tip.
For deep structures, probe 771(FIG. 8) us employed as an electronic
beacon. Small current 811, which is similar to the stimulation
current but smaller, from probe tip 702 is used to guide ablation
probe 372 (FIG. 8)
[0168] Operation 530 (FIG.5B) inserts auxiliary probe 771 or 772
(FIGS. 7 and 7A) thru skin 330 and muscle layer(s) 710 near nerve
101. Target 101 depth 766 is measured (FIGS. 7 and 7A) using
auxiliary probe markings 765. Decision 533 checks if the probe is
in position if not adjustments are performed in 534. Operation 532
enables nerve simulation current 811. When muscle stimulation is
obtained or physiological reaction is obtained, Auxiliary probe tip
is in place. Depth may be noted by reading marks 765 and location
marks 755 may be made in operation 535. With the probe in position
under mark in operations 536 and 537, operation 538 sets power
level 404 and closes ablation switch 410. Alternatively,
stimulation may be applied directly from the ablation probe as
taught elsewhere. Operation 540 and controller 401 set generator
411 (FIG. 4) frequencies, modulation 420 envelope and enables power
amplifier 416 to deliver preset ablation energy. Region 1203 (FIG.
10) shows the general shape of the ablation region for conical tip
301 for example.
[0169] Between each ablation, procedure 540 (FIG. 5C) (nerve
conduction) is tested in 541. Probe amplifier 416 delivers small
nerve stimulation current 811 from electrode 301 or Auxiliary probe
771 or both. Based on the nerve conduction test 541 if the desired
level of conduction is achieved the procedure is compete. Operation
542 moves the probe to the next position and repeats conduction
test 541. If compete, the probe(s) is removed in operation 544.
Number and ablation intensity/energy are set by the particular
procedure and the desired permanence. The practitioner selects the
procedure/power level 404 (FIG. 4) and controller 401 compares the
installed probe via identification 331 (FIG. 4) for compatibility
with selected procedure. The practitioner is alerted if the
installed probe is incompatible with selected power range 404.
[0170] As an example and not a limitation, five ablation regions
(140, 141, 142, 143, and 144) are shown in FIG. 10. Ablation starts
with area 144, then the probe is moved to 143 and so on to 140.
Alternatively, movement may be during insertion, moved laterally,
in a circular manner or other manner to enlarge the area of
targeted nerve destruction. Nerve responses may be tested after
each ablation allowing the practitioner to immediately check the
level of nerve conduction. Probe position and power adjustments are
made before applying additional ablations if required. Accurate
probe location tools and methods taught herein permit use of
minimal ablation energy thereby minimizing damage to non-target
structures. This translates to reduced healing time and minimal
patient discomfort. The instant invention gives the practitioner a
new tool to perform a minimally invasive nerve conduction limiting
procedure with the ability to select, temporary or permanent nerve
conduction interruption with a new level of confidence. This new
tool offers a low cost procedure performed typically in office or
outpatient setting often taking less than one hour with local
anesthetic. In contrast to prior art where surgical procedures
require stitches and longer healing intervals with limited control
of permanence (nerve re-growth).
[0171] FIG. 6 Side View of the Bi-Polar Probe 610 With Enhanced
Laser Targeting.
[0172] Probe insertion and placement is same as taught in FIG. 3.
Probe construction is the same as FIG. 3 with the dielectric 305
having embedded optical fibers 690 and 680 providing
imaging/illumination. Additional fiber(s) 690-691 are illuminated
by a high intensity laser source.
[0173] In special cases were target nerve 101 or ablation region
640 is in close proximity to second nerve 111 or skin 330 bi-polar
probes 371 or 372 (FIG. 3) create an annular ablation region
between electrodes 301 and/or 302, potentially damaging nearby
structures such as other nerves 111. With probe 610 in the desired
position, laser 608 (FIG. 4) is turned on target 670 (FIG. 6A) with
illuminating fiber(s) 690. Fiber(s) transmitting high intensity
laser light to ionized region 640 is illuminated by fiber(s) 690.
Simultaneous with laser illumination, RF energy 470 is delivered to
electrodes 301 and 302. A relatively low impedance path is created
by the high intensity laser illumination wherein RF energy will
follow this newly created path. Thus very specific regions may be
selected for ablation. By permitting operation at a lower power,
energy is concentrated where it is needed and eliminates or reduces
damage to nearby structures such as skin 330 or nerves 111. Probe
610 improves on the already very precise ablation taught in FIG. 3
with the addition of a low power laser (or other type light source)
and fiber delivery system. In the disclosed embodiment a diode
pumped Nd:YAG (Neodymium Doped Yttrium Aluminum Garnet) laser is
offered as an example and not a limitation.
[0174] FIG. 6A Side View is the Florescence Emission Guided Hybrid
Bi-Polar Tumor Probe.
[0175] Probe construction is similar to FIGS. 3A and 6 with
dielectric 305 embedded with a plurality of optical fibers 380,
690, and 680 for illumination detection/imaging. These enhanced
systems and processed augments the selective nature of previously
disclosed probes. Fiber(s) 690-691 are illuminated by a high
intensity light source(s) 608 which is typically a tunable laser or
UV LED. Source(s) 608 (FIG. 4) provides illumination for tagged
marker(s) 670 in the disclose embodiment where a tunable laser is
employed. Excitation/illumination wavelength(s) are specific to the
dye/nano-particle used with marker 670 that is very specific for
the desired target 671. The marker/tag is typically a protein
specific antigen combined with a florescent marker. The novel probe
illumination permits delivery of intense illumination to the target
for maximum system sensitivity. Many dyes excited by short
(Blue/UV) wavelength light are transmitted poorly in tissue but are
easily delivered by fiber 690. A second application offered for
hybrid bi-polar ablation probe 610 is for locating/destroying small
cancer lesions. The probe addresses cases where surgery is not
practical or it dangerous due to location or sub-operable size.
Quantum-dot or dye tagged antibody materials 670 are injected into
the patients where it attaches to target structure 671. Once
tagged, cancer node(s) may be located, tested, and treated.
[0176] FIG. 7 Side View of Auxiliary Single Tipped Nerve Probe
[0177] This probe may be used in conjunction with any of the
therapeutic probes 371 and their derivatives. The needle itself
will be very fine in nature, such as an acupuncture type needle. By
its small size, numerous needle insertions may be accomplished with
no scarring and minimal pain. The probe 771 will be inserted in the
vicinity of the target tissue through skin 330. The exposed tip of
771, 702 will be exposed and electrically connected to generator
732 via wire 734. The surface of probe 771 is covered with
dielectric 704 so the only exposed electrical contact is surface
702 and return electrode 736. Exposed tip 702 will be advanced to
the vicinity of target 101 and test stimulation current will be
applied. Appropriate physiological reaction will be observed and
when the tip 702 is properly located, depth will be noted via
observing marks 765. External mark 755 may be applied for
reference. Ablation probe 371 may then be advanced to the proximity
of the target tissue under the X mark 755 and ablation/nerve
destruction as described elsewhere may be performed.
[0178] FIG. 7A Side View of Auxiliary Dual-Tipped Nerve Probe.
[0179] Dual tipped probe 772 offers an additional embodiment that
eliminates return electrode pad 736. Probe frame/handle 739 holds
two fine needles, 702 and 701, in the disclosed embodiment that are
spaced a short distance (a few mm)-mm apart (730). The shaft of
conductive needle 701 is covered with dielectric insulator 706,
similar to the construction of probe 771 (FIG. 7). The shaft of the
second conductive needle 702 is covered with dielectric insulator
sleeve 703. Electric generator 732 provides current to the probes
via conductors 734 and 735. Current originates from 701 and returns
via electrode 702. Large probe handle 739 is drawn out to teach the
dual probes. To aide in probe depth measurement, markers 765 are
printed on needle shafts. Dielectric insulating sleeves 703 and 706
isolate the needle shaft current from muscle layer 710. Current
applied via generator 732 stimulates the nerve directly while
avoiding muscle 710. Smaller probe tips with smaller current
permits accurately locating small structures.
[0180] Probes 702 and 701 are very small gage needles similar in
size to common acupuncture needles, thus permitting repeated
probing with minimal discomfort, bleeding, and insertion force.
Sharp probes are inserted thru skin 330 and muscle layer(s) 710
near nerve 101. The practitioner locates target nerve 101, then the
skin surface may be marked 755 as location aide for ablation step
as shown in flow chart (FIG. 5B). Once the desired site of ablation
is located, ablation probe(s) 610(FIG. 6), 371 and related probes
(FIG. 3), may be inserted under skin 330, illuminated 448 by tip
305. They are visible through skin (via illumination 448 from tip
305) and are guided to mark 755 (FIG. 8). The observed intensity
765 from illumination source 305 is used as an estimator of
measured depth 765. This simple probe system permits rapid,
accurate locating of target structures with minimal pain and
injury. Accurate target location permits use of lower ablation
energy thereby minimizing damage to nearby structures.
[0181] FIG. 8 Side View of Guided Ablation Procedure With Auxiliary
Nerve Probe(s).
[0182] Auxiliary probes 771 and 772 (FIGS. 7 and 7A) are used to
accurately locate target structure 101. Probe 771 holds a fine
conductive needle 702 that has a shaft covered with dielectric
insulator 704. Electric generator 732 provides a small current to
the auxiliary probe via conductor 734 and return conductor 735 via
return electrode 736. The sharp auxiliary probe is inserted thru
skin 330 and muscle layer(s) 710 near target nerve 101. Dielectric
insulating sleeve 704 isolates needle shaft from muscle layer 710.
Current is applied via generator 732 thereby stimulating the nerve
directly while avoiding muscles 710. Prior art probes without
insulating sleeve 704 stimulate both the nerve and muscle
simultaneously, masking nerve 101 and subsequently making nerve
location difficult.
[0183] Auxiliary probe 771 and 772 provide a method to quickly
locate shallow or deep target structures. Shallow structures are
typically marked with ink pen allowing illuminated ablation probe
371 or its equivalents to be quickly guided to mark 755.
Optionally, non-illuminated probes may be used by the practitioner
who simply feels for the probe tip. For deep structures, probe 771
may also be employed as an electronic beacon; small current 811
(which will be lower intensity and different from the stimulating
current) from probe tip 702 is used to guide ablation probe 372.
Amplifier 430 (FIG. 4) detects current from tip electrode 301 for
reading and displays it by controller 401. Alternately probe 701 is
used as a receiver detecting current 811 from electrode 301 Moving
probe tip 301 horizontally 1202 and in depth 766 relative to
auxiliary probe 702 changes current 810 inversely proportional to
distance. Detected signal current 811 isolated and buffered by
amplifier 430, is measured and the current is displayed to simple
bar graph 554 for rapid reading. In addition, audio feedback, in
which the tone is modulated by proximity of probe tip 351, 352 or
equivalent in relation to auxiliary probe tip 702 is provided to
minimize or eliminate the practitioner having to look away from the
needle, thus assisting in accurate probe placement. Variable
frequency/pitch and volume audio signal are proportional to sensed
current 811 that is generated by 452. The tone signal emitted by
speaker 451 (FIGS. 4 and 1) provides a pleasant and accurate method
to aide in probe placement. Simultaneously, illumination source 408
is modulated by amplifier 456 to blink at a rate proportional to
the sensed current. This permits the practitioner to quickly and
accuracy guide ablation probe 372 into position using a combination
of audio and visual guides. The audio and visual aides also reduce
the practitioner's training/learning time. The novel real-time
probe placement feedback gives the practitioner confidence that the
system is working correctly so he/she can concentrate on the
delicate procedure. Accurate probe location permits use of minimal
energy during ablation, minimizing damage to non-target structures
and reducing healing time and patient discomfort.
[0184] FIG. 9 A High-Energy Electro-Surgery Sinusoid Cutting
Waveform 910.
[0185] Lower energy pulse width modulated (or PWM) sinusoid 920 for
coagulation is also well known to electro-surgery art. Variations
of cut followed by coagulation are also well known.
[0186] FIG. 10 Side View of Visually Guided Ablation Procedure.
[0187] Auxiliary probes 771 and 772 (FIGS. 7 and 7A) have
accurately located target structure 101 and subsequently marked
target locations 140 to 144. Shallow structures are marked
typically with ink pen (755) allowing illuminated ablation probe
371, 372 or equivalent to be quickly guided to that point. For deep
structures, probe 771 is employed as electronic beacon, small
current 811 from probe tip 702 is used to guide ablation probe 372
as taught in FIG. 8.
[0188] Ablation probe 372 is inserted thru skin 330 and muscle
layer(s) 710 near nerve 101. Illumination source 408 permits
practitioner to quickly and accuracy guide illuminated 448 ablation
probe 372 into position. Illumination 448 from ablation probe as
seen by practitioner 775 is used as an additional aide in depth
estimation. Selectable nerve simulation current 811 aids nerve 101
location within region 1204. This novel probe placement system
gives practitioner confidence system is working correctly so s/he
can concentrate on the delicate procedure. Accurate probe location
permits use of minimal energy during ablation, minimizing damage to
non-target structures and reducing healing time and patient
discomfort.
[0189] Region 1203 shows the general shape of the ablation region
for conical tip 301. Tip 301 is positioned in close proximity to
target nerve 101. Ablation generally requires one or a series of
localized ablations. Number and ablation intensity/energy are set
by the particular procedure and the desired permanence.
[0190] Five ablation regions are illustrated 140, 141, 142, 143,
and 144; however, there could be more or less regions. Ablation
starts with area 144, then the probe is moved to 143 and so on to
140, conversely, ablations could start at 140 and progress to 144.
Also, the practitioner could perform rotating motions, thus further
increasing the areas of ablation and permanence of the procedure.
Between each ablation procedure 540 (FIG. 5C), a small nerve
stimulation test current 811 is emitted from electrode 301. The
approximate effective range of the nerve stimulation current 811 is
shown by 1204. Testing nerve response after each ablation allows
the practitioner to immediately check level of nerve conduction.
Without probe 372 removal, the practitioner receives immediate
feedback as to the quality of the ablation. Then minor probe
position adjustments are made before conducting additional
ablations (if required).
[0191] FIG. 11-11A Controller and Probe Data Base Structure
[0192] Controller 101 maintains local probe 1460, patient 1430, and
procedure 1410 databases. All work together to insure correct
probes and settings are used for the desired procedure.
Automatically verifying that the attached probe matches selected
procedure and verifying probe authentication and usage to avoid
patient cross contamination or use of unauthorized probes.
Automatic probe inventory control quickly and accurately transfers
procedure results to the billing system.
[0193] FIG. 11--Procedure Parameters Code(s) Database 1410
[0194] From a touch screen, the practitioner selects the desired
procedure from list 1410. For example "TEMPORARY NERVE CONDUCTION"
1411, "SMALL TUMOR 1CC" 1412, and "SMALL NERVE ABLATE" 1413 are a
few of the choices. Each procedure has a unique procedure code 1416
to be used in the billing system. Power range parameter 1417 is a
recommended power setting via power level control 404. The
recommended probe(s) Associated with procedure 1415 and power range
parameter 1417 are listed in parameters 1419. With the probe
connected, the part number is read from memory 331 (FIGS. 1, 3 and
4) and compared to list 1419. The total power parameter 1418 is the
maximum energy that the system may deliver for this procedure and
is determined by the procedure code, probe being used and software
parameters. These parameters may be modified, updated and changed
as required by addition of new probes and procedures
allowed/approved. Power is delivered, measured and totaled with
integrator 435 (FIG. 4). The power integration circuit is designed
as a hardwired redundant safety circuit that turns off the power
amplifier if maximum energy is exceeded. This novel feature
protects patients from system fault or practitioner error. Standard
procedure time 1420 is doubled and added to current RTC 482 then
written to probe memory 331 (in FIG. 1).
[0195] FIG. 11 & 11A--Probe Usage Authorization Database
1460
[0196] From touch screen 450 (FIGS. 1 and 4) practitioner selects
desired procedure from list 1410. Probe 371 and equivalents (FIGS.
3A-D) type is selected from recommended list 1419 and is connected
via cable 1334 (FIG. 1) to control unit 101. Once connected,
controller 401 (FIG. 4) reads the stored time register from ID
memory module 331 (FIG. 1). If start time 1487 read is zero
(factory default), current real time clock 482 (FIG. 4) is written
to database 1460 in the start time field 1467, 1430 and 1435.
Simultaneously, twice the standard procedure time 1420 parameter is
added to RTC 482 and written to time register 1487 via serial bus
403. If probe start time 1487 reads (331) non-zero, the value
compared to real time clock 482. If greater than current time plus
twice the standard selected procedure duration 1420, the controller
alerts the practitioner via display 450, speaker 451 and flashing
probe illumination 608 of previously probe used condition. To
correct the situation, the practitioner simply connects a new
sterile probe and repeats the above process. FIG. 13 teaches
additional detail regarding probe verification usage and related
database operations. Periodically controller 401 performs the above
verification to alert practitioner that he/she has forgotten to
change probe(s).
[0197] During the procedure (FIG. 10), various parameters such as
peak temperature 1473, power 1472, impedance, etc. . . . are read,
scaled, stored and displayed. Parameters such as procedure start
1467; end time 1468, serial number 1469, and part number 1468 are
recorded as well. Critical parameters are written to local
high-speed memory 438 for display and analysis. On a time
permitting or end of procedure, data is mirrored to removable USB
1320 memory stick 1338. Probe specific parameters 1463 are copied
and written to probe memory 1338 for use at probe refurbishment
facility. Database checksum/CRC(s) 1449, 1479, and 1499 are check
and updated as required. Faults such as shorts (dielectric 305
(FIG. 3) breakdown) that are detected are saved to error field 1494
and 1474. If network connection 1305 is available, email request
for replacement probe are automatically sent to repair/customer
service center 1308. Defective probe 374 with saved failure
information 1494 is returned for credit and repair.
[0198] Use of a USB memory stick permits continued operation in the
event of a network 1326 failure Data is loaded to memory 1338 for
simple transfer to office computer 1306 (FIG. 1) for backup.
Commonly available USB memory sticks 1320 have large data
capacities in the tens to hundreds of megabytes at a low cost with
long retention times. USB memory sticks also can support data
encryption for secure transfer of patient data. Sealed versions are
available as well compatible with chemical sterilization
procedures.
[0199] If computer network 1326 such as Ethernet 802.11 or wireless
802.11x is available, files are mirrored to local storage 1309,
remote server 1307. The remote server (typically maintained by
equipment manufacture) can be remotely update procedure(s). To
insure data integrity and system reliability a high availability
database engine made by Birdstep of Americas Birdstep technology,
Inc 2101 Fourth Ave. Suite 2000, Seattle Wash. is offered as an
example. The Birdstep database supports distributed backups,
extensive fault and error recovery while requiring minimal system
resources.
[0200] FIG. 11--Patient/Procedure Database 1430
[0201] From a touch screen, the practitioner selects or enters
patient name from previous procedure 1430 and creates a new record
1433. Similarly, a procedure is selected from 1410 (for example
"TEMPORARY NERVE CONDUCTION" 1411, "SMALL TUMOR 1CC" 1412, and
"SMALL NERVE ABLATE" 1413). Each procedure has a unique procedure
code 1416 that is used for the billing system. Other information
such as practitioners name 1440, date 1435 is entered to record
1433. As taught above probe appropriate for the procedure is
connected and verified, part 1470 and serial number 1469
recorded.
[0202] FIG. 11--Voice and Notes
[0203] The practitioner enters additional text notes to file 1442
or records them with microphone 455 (FIG. 5) to wave file 1445 for
later playback or transcription. The instant invention permits
temporary/permanent nerve conduction interruption. Thus, procedures
are performed at intervals from months to years apart. A hands free
integrated voice recorder is extremely useful. Detailed text and
voice notes made while probing/ablating are also recording specific
settings, and patient response. A feature that is very helpful when
reviewing treatment progress and saves valuable time instead of
writing notes. Practitioners play back voice/wave files 1445 with
standard audio tools a his/or hers desk. Audio files 1445 can be
sent via email or file transfer for transcription, updating note
field 1442.
[0204] At the end of procedure, records are updated and stored to
memory 438. Backup copies are written to USB 1320 memory stick 1338
(FIG. 1). If computer network 1326 such as Ethernet 802.11 or
wireless 802.11x is available, files are mirrored to local storage
1309, remote server 1307. Patient name 1436, procedure date 1435,
and procedure codes 1416 are automatically transferred via network
or USB device 1320 to billing system 1306. USB memory stick permits
continued operation in the event of a network 1326 failure. Data is
loaded to USB memory 1338 for simple transfer to office computer
1306 (FIG. 1) for backup. USB memory sticks 1320 have large data
capacities in the tens to hundreds of megabytes at a low cost with
long retention times. USB memory stick also support data encryption
for secure transfer of patient data. Insuring patient is accurately
billed with minimal office paper work. Probe inventory is automatic
maintained with replacement probes automatic shipped as needed.
* * * * *