Note: Descriptions are shown in the official language in which they were submitted.
`` 1 327633
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1624W
MEDICAL INSTRUMENT FOR THERAPY
OF HEMORRHOI DAL LES I ONS
The invention relates to an electrical current
therapy de~ice for treatment of hemorrhoids or the like.
Hemorrhoidal disease is one of the most
~- frequent, disabling, and painful conditions of mankind.
The consensus of the Advisory Panel of the United States
Food and Drug Administration defines hemorrhoids as
i 10 "abnormally large or symptomatic conglomerates of blood
vessels, supporting tissues, and overlying mucous
membrane or skin of the anorectal area."
It is estimated that one-third of the U.S.
population has symptomatic internal hemorrhoids, with an
15 incidence of so% at age 50 years. Patients frequently
postpone examination because of concern of pain .
associated with a particular treatment modality,
hospitalization, cost, and time of disability. Such a
- delay in evaluation may lead to progression of the
20 hemorrhoidal disease, or late diagnosis of more serious
colorectal problems.
Medical procedures for hemorrhoidal treatment -
ha~e taken many forms. For example, D.C~ ~direct`
current) management of hemorrhoidal disease was
~25 described in a review pu~lished by Wilbur E. Keesey,
~` ~ M.D~ in 1934~ The~topical suppository approach is
` presently applied to a majority of patients,
particularly those with a specific precipitating ~actor
for hemorr~oidal disease (e~g., acute diarrhea episode)
~30 and in some instances may be àll that is necessary.
Necrosis and slough of hemorrhoidal vessels can also, at
~times, be accomplished by placement of rubber bands over
the vessel base with a specific apparatus. This
treatment is applicable to those vessels well above the
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i pectinate line to avoid severe pain (a complication in 6
to 10% of patients). Mild to moderately diseased
hemorrhoidal vessels are not amenable to this therapy.
Injection sclerotherapy is effective for small (grade 1
5 and 2) bleeding internal hemorrhoids. Submucosal
injection of sclerosant produces chemical thrombosis and
fixation of the mucosa to ~he underlying tissue.
Sclerotherapy of hemorrhoids is limited to mild to --
moderate disease and is associated with complications
including reaction to the injected material, slough of
the overlying mucosa, necrosis, and infection, including
submucosal abcess. Cyrosurgery (i~e., application of a
metal pro'oe cooled by liquid nitrogen or carbon dioxide)
reezes hemorrhoids. Occasionally, local anesthesia is
required because of pain~ Complications may include
imprecise control of the depth of tissue destruction,
post-operative pain, and rectal drainage. Surgical
excision of hemorrhoidal inflammatory disease has the
advantage of removing all associated redundant tissue,
2Q including the external component of a particular
internal hemorrhoid~ However, there are limitations to
the amount of excision possible without major adverse
se~uelae. In a typical patient with many involved :-
vessels, surgery can only approach the most
25 symptomatic-diseased area and is not to be considered
- curative. The disadvantages of these approaches include
- pain, expense associated with hospitalization, time of
disability, and poten~ial complications, e~g~, those -
associated with anesthesia, surgery proper, and
3~ post-operative complications, including anal stenosis.
summarY of the Invention
According to one aspect of the invention, an
instrument for direct current electrical therapy of
hemorrhoidal lesions or the like in a patient, comprises
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a D.C. electric generator means, a grounding pad for the
patient, a monopolar probe having a distal tip for
penetration of the hemorrhoidal lesion to act as a
negative electrode, and an instrument handpiece for -:
~- 5 support of the probe and control of the level of direct
'` current, the probe comprising a base and, extending -.
therefrom, at least one elongated probe electrode
Q terminating in the distal tip adapted for
electricity-conducting engagement with a hemorrhoidal
10 lesion, the instrument handpiece comprising a lower
h~ndle portion sized and constructed to be gripped by a
physician, cooperative means for coupling the probe base
to said handpiece in electricity-conducting engagement,
with the axis of the probe at an obtuse angle to the
! 15 axis of the lower handle portion, the obtuse angle
selected to allow a physician to hold the instrument
i handpiece during treatment of a hemorrhoidal lesion
without ex~ended abnormal flexure of the wrist, : .
therapy-monitoring and control upper handle portion
20 disposed generally above the lower handle portion and ` --
ha~ing a front panel visible to the physician when the
probe distal tip is penetrated into a hemorrhoidal
lesion, the front panel~comprising means for display of .
~: ~ status of treatment conditions of the instrument, the
- 25 means for display and the distal tip of the probe
disposed generally in the same line of sight of a
~ physician holding the lower handle portion with the
: distal probe tip penetrated into a hemorrhoidal lesion,
and means for contro} of the level of direct current
~- 30 disposed adjacent the lower handle portion in a manner
to allow a physician~to operate the means for cantrol
: with digits of a hand gripping said lower handle
portion, whereby a physician may simultaneously view a
treatment site and observe conditions of treatment
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- appearing on the means for display, while gripping the
instrument and operating the means for control with one
hand, leaving the other hand free as he conducts therapy
on a hemorrhoidal lesion.
referred embodiments of this aspect of the
invention may include one or more of the following
features~ The means for display of status of treatment
~- conditions of the instrument includes means for display
of, e.g., elapsed time of treatment, means for display
10 of status of treatment conditions of direct current
intensity of treatment, and/or actuation status of
treatment~ The means for control comprises first means
for increasing the level of current, and second means
c for decreasing the le~el of current, and may further
~` 15 comprise third means for ceasing direct current,
~- preferably the third means being actuated ~y
simultaneous actuation of the first and second means.
T~e obtuse angle is of the order of about 120~ The
cooperative means comprises the probe base comprising a
20 key of predetermined size and shape, and a keyway
defined by the instrument handpiece of siæe and shape to ;
receive the key therewithin~ Preferably, the key, taken
in cross sec~ion, has 'he general form of a square with
radiused corners of predetermined dimension
25 corresponding to. but slightly less than, dimensions of
the keyway~ The probe is replaceable and comprises at
least two elongated probe elec~rodes disposed in
parallel array, preferably at least two distal tips of
the elongated probe are longitudinally offset from each `
30 other~ `
According to another aspect of the invention,
;~ a probe adapted for use, e.g~, with a hemorrhoid
treatment instrument as described above comprises a base
and, extending therefrom, at least one elongated
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;monopolar probe electrode terminating in a distal tip
adapted for electricity-conducting engagement with a
hemorrhoidal lesion, and the probe further comprises
cooperative means for coupling the probe base to the
:5 handpiece in electricity-conducting engagement, with the
-axis of the probe at an obtuse angle to the axis of the
handpiece. the obtuse angle ~elected to allow a
physician to hold ~he instrument during treatment of a
hemorrhoidal lesion without extended abnormal flexure of .
10 the wrist, the probe base comprising a key of
pred~termined size and shape, and a keyway defined by
the instrument handpiece being of si2e and shape to
receive the key therewithin, the key, taken, in cross
section having the general form of a square with
lS radiused corners of predetermined dimension
corresponding to, but slightly less than, the dimensions
of the keyway.
The device of the invention offers a number of
advantages over prior art approaches, including that it
20 is effective, relatively safe and painless, and is cost
containing, when compared to other methods of curative
treatment of hemorrhoidal disease~
These and other features and advantages of the
i~vention will be apparent from the following
25 description of a presently preferred embodiment and from
the drawings~ :
Preferred Embodiment
We first briefly describe the drawings~
Drawinqs
30Fig~ 1 is a perspective view of a medical
instrument of the invention;
Fig~ 2 is a plan view of the handpiece of Fig.
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Fig. 3 is a side view of the handpiece of Figs.
1 and 2, and Fig. 3A is a plan view of the probe
receptacle of the handpiece of Fig. 3, taken at 3A-3A of
Fig. 3;
Figs. 4, 4A and 4B are diagrammatic views of
the instrument of the invention during treatment of a
hemorrhoidal lesion, taken from different perspectives;
Fig. 5 is a plan view of the instrument probe,
while Fig. 5A is an end view of the probe base segment
taken at 5A-SA of Fig. 5;
`~ Fig~ 5B is a plan view of an alternate
embodiment of an instrument probe of the invention and
~ig. 5C is a sectional end view of a base segment of the
r probe of Fig~ 5B, taken at 5~-5C;
Fig~ 6 is a table of probe orientations of the
alternative probe base segment:
Fig~ 7 is a plan view of the instrument
grounding pad;
Fig. 8 is a side view of the instrument base
unit;
Fig~ 9 is a face plan view of an alternate
embodiment of the instrument handpiece, and Fig~ 9A is a
sectional side view of the distal end of a handpiece of
the invention having a rotatable tip;
~5 Fig. 10 is a block diagram of instrument
circuitry;
Figs. 11, 12 and 13 are schematic diagrams of a
first embodiment of the electrical circuitry of Fig. 10;
and
3a Figs. 1~ through 16 are schematic diagrams of a ~
second embodiment of the electrical circuitry of Fig~ 10~ -
Referring t~ Fig~ 1, the medical instrument 10
of the invention consists of a base unit 12 and a -
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- medical treatment handpiece 14. The instrument further
consists of a monopolar, detachable probe 16 (Fig. 5)
and a grounding pad 17 (Fig. 7).
Referring to Figs. 2 et seq., the handpiece 14
consists of a lower handle portion 18 from which extends
a connector cord 20 to the base unit 12, and, as shown
in Fig. 3, includes a rear indentation 22 for receiving
- the fore finger of the user in gripping engagement. The
planar face sùrface 23 of the handpiece, on the upper
patient treatment portion 24, contains display elements
of, e.g., elapsed time of treatment (LED numeric display
26), level of treatment current (LED bar graph 28), and
circuit status indicator (on/off display 30). The upper
patient treatment portion further contains switches 32,
34 for respectively incrementally increasing and
decreasing the level of D.C~ current through the probe
and, when activated by the surgeon simultaneously, e.g.,
by pressing with his thwmb, as described below, for
ceasing flow of electricity~ The handpiece face surface
23 is sealed against entry of fluid into the handpiece
during cleaning between procedures.
~eferring to Figs~ 4, 4A, 4B, 5 and SA, the
probe 16 consists of a pair of elongated, .
electrically-conductive electrodes 36, 38 extending to
sharpened distal tips from a keying block 41, e~g~. of
square cross-section with radiused corners (Fig. 5A), ~
sized to fit snugly within the aperture 40 (Fig. 4) ~-
provided in the distal end 44 of handpiece 14~ A banana
43 plug adjacent to the keying block 41 firmly mounts
the probe 16 to the handpiece 14~ The probe electrodes
are clad in nonconductive sleeves 46 over their distal
portions to prQvent inadvertent tissue contact, but to `-
minimise obstruction to the surgeon's view of the
treatment site. The proximal portions of the electrodes
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-- 8 --
are encased in sleeve 48, e.g., of injection molded
plastic. The probe base segment is constructed to be
received into the aperture at four orientations (soo
rotations), selected by the surgeon depending upon the
5 rectal quadrant to be treated. Alternately, a probe
16' (Fig. 5B) has a base segment 41' of octagonal
cross-section (Fig~ 5C) fitt~d to the probe base
segment. (A table of the alternate probe orientations
is shown in Fig. 6C.) The tip element of one electrode
lo 36 of the pair extends longitudinally beyond the tip
element of the second electrode 38, whereby during
treatment, the tips do not penetrate the tissue
simultaneously, for reduced patient discomfort. For ease
in manufacturing, the probe 16' may alternately be made
15 with a simple, smooth sleeve 48' encasing the proximal
portion of the electrodes, and the functions of the base --
segment and banana plug connector combined in the
octagonal connector 41'.
The axis, P, of the probe, in assembly with the
20 handpiece, extends at an angle, A, preferably about :
120, to the plane of face surface 23 of the handpiece.
In this manner, during treatment of hemorrhoids, the
distal tip elements of the probe are in contact with the
hemorrhoidal tissue 50. and the important display
elements on the patient treatment portion of the
handpiece are both immediately along the line of sight,
L', of the surgeon 52', allowing him to constantly ~
observe the treatment site 54 and the treatment ~ :
parameters, without turning away from the patient 56.
Referring again to Fig~ 1 and to Fig. 8, the
base unit 12 includes a power cord 58 for connection of
the instrument to a source of A.C. power and has outlets
60, 62 for connection of the handpiece cord and for
connection of the cord 64 to the grounding unit 17 (Fig. ~ ~
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7). On the face surface 13 of the base unit 12, there
is an on-off switch 66, and a light element 68 for
indicating actuation of the instrument. Extending from
the side of the base are a pair of brackets 70 for
receiving the handpiece.
The grounding unit 17 (Fig. 7~ consists of an
absorbent pad 72 within a liquid impervious container
` 74. Power cord 64 connects the grounding unit to the
!` base unit at outlet 62~
Referring to Fig. 10, the medical instrument
consist of three electrical components; a main unit 12,
a hand piece 14 and a pad 17. The main unit is
comprised of a power supply 80 and a current generator
~ 84. The power supply 80 provides D.C. voltage to
; 15 logic circuitry of the switch controls 32, 34, the time
and current display 26, 28 and the ground pad 17. The
current generator 84 is connected to the probe 16 and is
usied for controlling electrical D.C. current that is to
be transmitted from the pad 17 through`the patient 56 to
t~e probe 16. In handpiece 14, switches 32, 34
¦ positioned on the handle of the probe are connected to
the current generator 84 for incremental adjustment of
the current transmitted through the patient 56. Digital
circuitry components, connected to the current generator
84 and placed on the handle of the probe, enable a
visual display 26, 28 of the quantity of current -
transmitted and elapsed time of treatment.
Referring to Fig. ll, the power supply 80
consists of two 110v to 25.2v step-down transformers
Tl and T2 wired in series. The common connection 93
on the secondary side is connected to ground and the two
remain.ng secondary leads 92, 94 provide a total
potential of 50.4 volts A.C. when used together or 2s.2
volts ~.C. from each lead to ground ~the same as a
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simple llOv to so.4v center tap transformer). The A.C.
voltage is converted to D.C. by the use of a bridge
rectifier 96 and is filtered by two looo uf capacitors
Cl and C2 connected to ground. This circuit
provides a positive 35.6 volts and a negative 35.6 volts
power supply on leads 92 and 94, and is known as a split
voltage supply. The voltage increase (from 25.2 volts
to 35.6 volts) is due to the configuration of the power
supply and its capacitors. Three voltage regulators
(REG) are u~ed to provide three regulated voltage
supplies: ~15 volts; -lS volts; and +5 volts. Each of
these regulators are filtered by a O.luf capacitor
C3. The ~15 volts is applied to the pad 17 and the +5
volts is applied to the electronic circuitry discussed
below.
A one megohm resistor Rl in series with an 18
uf capacitor C4 taps off the 25.2 volt A.C. supply to
provide a 60 hs signal for a one minute timer section
98~ The timing circuit 98 divides the 60 hz by 3600
thus giving a one pulse/minute signal 9g to a driver
chip 122, which is capable of counting from zero to
seven. The driver chip ~122 turns on and off seven LED
segments of an LED display 124, which digitally
indicates the number of minutes o~ treatment~ The LED
display 12~ is reset to digitally show "0" when the
current generator 84 ~Fig. 10) is reset or a new
treatment is initiated (discùssed below)~
; Referring to Fig. 12, the current generator 84 `
contains: a pulse generator 100; logic gates 1-6; a :
counting circuit 102 and 104; a digital-to-analog
voltage convertor 116: and a current driver 120~
The p~lse generator 100 provides a constant two
hs~second square wave output which feeds into the two
4-bit binary counters, 102 and 104, operating in effect
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- as one 8-bit binary counter. Switches 32 and 34,
located on the probe handle (see Fig. 2), apply a
positive voltage to logic gates 1-4 which in turn
determine three possibilities:
`'~ 5 1. Tells the counter to count up (Gate l);
' 2. Tells the counter to count down (Gates 1
and 2); or
. Resets the counters (Gates 3-4).
In other words, when switch 32 is depressed tO make
~; 10 electrical contact with the +5 voltage supply, the
counter is told ~o count up via gate 1. When switch 34
.` is depressed, the counter is told to count down via
~` gates 1 and 2~ Pressing both switches 32 and 34
~` simultaneously causes the counters 102, 104 to be `
15 reset. Preferably, the timer 124 (Fig. 11) is also
reset when both switches 32 and 34 are pressed. A one
megohm resistor, R2, R3, in combination with a
parallel 0.1 uf capacitor, C5, C6, which tie each
switch, 32 and 34 to ground, are used to pulse the
20 resets 106 and 108 on the counters via gates 3 and 4
when the unit is turned on.
T~e counter 10~, 108 has outputs l 8 which
operate cooperatively to pro~ide a digital count of up
to 2S6. The outputs of the counters are applied to an `
25 eight input digital-to-analog converter 116~ As the
counter increments or decrements the count, the digital-
to-analog converter 116 increases or decreases its
output voltage 114 proportionately to the output count
of the counters. The output voltage 114 of the
30 digital-to-analog converter 116 is fed to an operational
amplifier 118 which acts as a buffer and multiplies the
output voltage 114 to ~rive a npn transistor 120.
Transistor 120 provides a current sink from the patient
to ground. In other words, the probe acts as a current
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return from the pad 17, which provides the positive
voltage source, to the system ground (GND). The current
- flow is limited by a 131 ohms resistor R4 in series
: with the emitter E of the transistor 120.
A twelve volt bulb (not shown) may be provided
at the tip of the probe for providing light for the
- examination of a patient. This bulb may be driven by
! the 15 volt negative sour~e (Fig. 11) to provide high
intens.ty light.
In order to protect the patient from a large,
sudden application of D.C~ current, the outputs of the
counters are also applied to an eight input NOR gate 6
which is used (with gates 5 and 2) to prohibit the `
counters from continuing a backward count when the
counter reaches 0000 0000.
Referring again to Fig. 11, the output of NOR
; gate (Fig. 12) is used to control the one minute timer
3 and a green LE~, 30, which indicates the electrical
status of the unit~ When the count of the counters 102
and 104 equals 0000 0000, a positive voltage is applied
to transistor 112 from gate 6 over line 113 causing it
to conduct current~ As a result of logic gates 7-9, the
driver chip 122 is reset and the green LED, 30, is `
enabled.
Referring to Fig~ 13, a current indicator 28, :
is connected to the emitter E of the transistor 120 via
line 115~ The current indicator, using Ohm's law,
indicates the amount of current passing through the
patient by measuring the voltage across the 131 ::
ohmresistor R4 SFig~ 12). The amount of current
transmitted throwgh the patient is displayed by a bar : :
graph array. Preferably the i~dicator 28 is calibrated
to a 20mA maximum scale by a 10,Q00 ohm variable
resistor RS.
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:;
Referring to Figs. 14, 15, 16, an alternate
schematic diagram is shown. The power supply 80 is
comprised of a transformer T3 and two bridge networks
Bl and B2, which convert either 115 VAC or 230 VAC
from an electrical outlet into 5 volt D C., labeled +5V,
and 30 volts D.C., labeled +30V, power supplies. The 5
volt DC power s~pply, +sv, is regulated by a voltage
regulator 129 and is used to power the logic circuitry
used in the medical instrumentation. The 30 volt D.C.
power supply is also regulated by a voltage regulator
126 and is used for supplying a positive potential to
the ground pad 17. Generally, the regulator 126 will
protect the patient from power surges, but for extra
caution, a fuse F2 is connected in series with a
supervisory circuit 131. Preferably the fuse limits the
current to 1/32 amperes~ The supervisory circuit 131
causes the fuse to blow if there is a voltage surge on
the 30 volt line. At that point, a zener diode D2
conducts current, which in turn causes the supervisory
circuit to fire a silicon-controlled r~ctifier (SCR)
thereby shorting the +30V power supply to ground and
blowing the fuse. The supervisory circuit 131 similarly
detects an excessive current transmitted by the probe
via line 82 from an optical coupler, OC, (Fig. 15).
Referring to Fig~ 15, the amount of D.C.
current applied to the patient is controlled by the
current generator 84~ The current generator 84 includes ~ --
an 8-bit digital counter 139 which is driven
incrementally by a pulse generator ~P6). The pulse
generator also drives a display circuit described
below. The digital output count of the counter 139 is
fed to a digital-to-analog converter 1~2 which supplies
an output ~oltage 133 that is directly proportional to
the output count F the counter 139. The output voltage
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133 is then applied to the base (B) of a transistor l35
which provides a current sink from the patient to
ground. The amount of current transmitted through the
probe is controlled by the amount of voltage applied to
5 the base (B) of the transistor 135. Thus, as the
digital count increases, the D.C~ current transmitted
through the probe increases
Circuitry is provided which limits the amount
of voltage applied to the base, B, of the transistor
~- 10 135~ The output of a ~AND gate 134, which is connected
~ to the two most significant bits of the counter, is fed
r, through a diode (D3) back to the counter 139 for the
purpose of establishing a terminal count. The terminal
count prevents a sudden step of current to the patient
lS when the counter cycles from its maximum ~alue to its :~
minimum value during a directive to count up~ If a
¦ terminal count were not provided, the severe drop in the
E applied current would cause discomfort to the patient~
Referring to Fig~ 16, the voltage at the output
20 o~ the digital-to-analog converter is controll~d by an
"up" switch 32 and a "down" switch 34 on the handle of
the probe~ Both switches 32 and 34 are connected at one : :
end to the 5 volt output, labeled 15V, power supply~ At
the other end, the switches 32 and 34 are connected to
25 logic gates 136, 137, and l38 (Fig~ 15) by lines 88 and
89 respectively. Opening and closing switches 32 and 34
generate output signals which control the output count
of the counter 139. By depressing only switch 32, the
counter 13g is told to count up to a maximum count
30 established by the predetermined terminal count~ By
depressing only switch 34, the counter is instructed to
decrement the count to a minimum count of 0000 0000 ;
which is a digital zero count. As discussed above, this .
- prevents the counter from cycling back to a maximum
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count, which would cause a maximum amount of current to
be transmitted through the probe. When both switches
are depressed simultaneously, the counter 139 is reset.
A display of the amount of current applied to the
S patient is indicated by a bar graph display 28, which is
located on the probe handle~ The bar graph display is
driven by an analog-to-digi~al converter 144, which
: detects the voltage at the emitter E of the transistor
135 via line 143. The analog-to-digital converter
10 produces a digital signal which is proportional to the
voltage detected at the emitter E~ It is preferred that
the analog-to-digital converter 144 supply outputs for
firing eight separate light-emitting diodes (LED), each
of which represent two milliamps on the bargraph
15 display~ Thus, when all the LEDs are lit, sixteen
milliamps or full scale will be represented.
A digital display 26 for indicating the amount
of time elapsed for applying current to the patient is
also provided on the probe handle~ A digital clock ~-
20 driver 146 which may be a counter is clocked by a lo
herts signal over line 143 from the pulse generator PG
(Fig~ 15~. The output count of the counter 146 is used
to drive three 7-segment digital displays, which
represent minutes and seconds~ During treatment, the
7 segment digital displays keep track of the amou~t o~
time that a patient has received D.C. current~ If the
current transmitted by the probe is reduced to zero, a
signal 145 indicative of a digital zero count as applied
to the digital-to-analog convertor 132 is applied to the
30 counter 146 for latching the time displayed. In other -
words, time shown on the clock will stop and indicate
the el.psed treatment time when the current is reduced
down to zero. When current is again applied to the
patient, the time shown on the clock will continue~
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Handpiece 14 may also include a display which
indicates whether the probe is electrically active for
transmitting current. When the output count of the
counter 139 is other than a logic zero (i.e. the probe
has the potential to transmit current), line 150 enables
a red LE~ 151 via gate Q2
Referring to Fig. 9, in an alternate embodiment
of the handpiece 14', in order to reset the time on the
display, a reset switch 76 may be provided. AlSo, in
lo this embodiment, the "up" and "down" switches 32', 34'
are disposed in side-by-side relationship~
he instrument is assembled by inserting the
base segment 41 of a new probe 16 into the aperture 40
of the handpiece 14. The handpiece and grounding pad
connector cords 20, 64 are inserted into their
respective outlets 60, 62, and the base unit is ;
connected to a source of A.C. power via cord 58.
The patient 56 is positioned in a right lateral
fetal position, with the grounding pad 17, moistened
20 with ~aline for good electrical contact, acting as the `~
positive electrode, positioned under the patient's right
thigh~ The surgeon inserts and positions an anoscope 51
to expose to view ~hrough a window 53 a hemorrhoid S0 to
be treated. The surgeon depresses switch 66 on the base
unit 12 to actuate the instrument, as indicated by light
68~ At this point, display 30 on the handpiece
indicates that the circuit is not closed. The surgeon
engages the base of the hemorrhoidal lesion with the
tips of the electrodes 36, 38 of the probe 16, indicated
as a closing of the circuit (from the grounding pad
through the patient to the electrode tips) by display
30~ The surgeon incrementally increases current through
the probe by depressing switch 32, with the level of
current indicated by the bar graph 28, and the elapsed
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time of treatment indicated by display 26. As current
is initiated, the surgeon urges the probe tips into the
base of the lesion. It has been observed that the
degree of treatment required is a function of time and
` 5 current, i.e., the higher the level of current, the
shorter the time required for each treatment procedure.
The factor limiting current intensity is patient
discomfort; the surgeon, therefore, by depressing switch
32, slowly increases the level of current as high as
10 possible without patient discomfort (experienced as an
aching feeling) in order to shorten the time of
- treatment~ Should the patient feel discomfort, or when
the treatment is completed, the surgeon reduces the
current incrementally by depressing switch 34.
The length of eac~ treatment period may
typically be in excess of 5 or 10 minutes, but the
configuration of the handle portion of the handpiece and
the axis of the probe, best seen in Figs. 4, 4A and 4B,
allows the surgeon to position his wrist comfortably,
1 20 without abnormal flexure. Furthermore, as described
above, the relative arrangement of the displays of -
conditions of treatment and the probe ~ip elements
r~lative to the surgeon`s line of sight allows him to
simultaneously monitor the status of the patient and the
25 canditions of treatment~
Results:
Forty-two patients with symptomatic
hemorrhoidal disease were treated with a device of the
invention~ The group consisted of 28 males and 14
females wit~ a mean age of 47 (range 21-70 years~.
All subjects underwent historical review,
visual and digital e~amination, and anoscopy utilizing
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the Hinkle-James Rectal Speculum. Subjects with source
other than hemorrhoidal disease accounting for their
symptomatology were not included in the study.
At anoscopy, eight segments were visualized.
5 With the patient in the right lateral position, segment
is on the patient's left and segment 6 is on the
patient~s right anterior~ Hemorrhoidal inflammatory
disease was graded from 0-4 according to Banov et al.
~rade o represents no abnormality. Grade 1 represents
tuft or internal hemorrhoidal tissue present but no
prolapse from the anal canal. These produce painless `:
bleeding. Grade ~ represents prolapse with straining, .
and tissue retracts after the bowel movement. The
patient may be unaware of the prolapse episode. Like -
15 Grade 1, ~rade ~ hemorrhoids may bleed. Grade 3 ~
represen~s prolapse of the hemorrhoidal tissue with a . -
bowel movement, and the hemorrhoids remain out. The --
patient has to replace them manually~ Grade 3
hemorrhoids may bleed or have associated pain. Grade 4
represents hemorrhoid prolapse that is unable to be
reduced, often with associated mucoid discharge and
bleeding.
Each patient underwent treatment of all
internal hemorrhoids with inflammatory change~ Most
25 hemorrhoids required a single treatment which was
recorded as milliamperes (ma) applied times minutes of :`
application (ma x min). In general, one treatment would
be given per appointment; however, more than one small ;
vessel would occasionally be treated at a single "
30 sitting. If on re-examination, total ablation of :::
hemorrhoidal disease from a prior treatment was not
obtained, additional ereatment to that vessel would be `
given. This would be recorded as additional
milliamperes and time of treatment.
'''
. ,
1 327 633 604l2-l749
A typical treatment consisted of visualization of the
hemorrhoia to be treated utilizing the Hinkle-James Rectal Specu-
lum. Treatment was directed at the uppermost portion of the
hemorroid, in the longitudinal axis of the vessel ana at a very
slight angle to the rectal canal. If desired, this area was
topically anesthetized with 4X Xylocaine utilizing a cotton tip
swab. The probe was firmly inserted into the vessel lumen. The
current was then turned on gradually, with two to three minutes
being required to bring the current to 10 to 15 ma. Utilizing
the dual tipped probe, 60 to 100 milliampere minutes of treatment
was required per involved vessel. Visual changes of bright to
dark red, and, in some instancès,a nearly black color, indicated
a satisfactory treatment course. The current was slowly turned
off and the probe and speculum removed.
The same forty-two patients, mean age 47 (range 21 to
70), underwent evaluation for symptomatic hemarrhoidal disease
and treatment. The mean duration of symptoms prior to treatment
was 9.7 years trange 0.01 to 26 years). Symptoms at presentation ```
and number of treatments required for complete resolution of these
sympto~s are presented in Table I. The most common symptoms were
rectal bleeding in 81% of patients, followed by pruritus (62%),
internal hemorrhoid protrusion through the anal canal (60~)and pain ~ -
(42%)~ The mean number of treatments for complete resolution of
these symptoms, with one involved vessel treated per visit, was
2.0, 2.9, 2.9, and 2.B, respectively.
-: .-
' ' ..,: -
.''.~
-20- 1 3 2 7 6 3 3 60412-1749
~ABLE I
Symptoms and number of D.C. current treatments -
required for symptoms resolution in the 42 patients
` with hemorrhoidal disease.
PRURITUS PAIN BLEEDING PROTRUSION
.
Symptom %
of Patients 62 42 81 60
_ _
# Treatments (x) 2.9 2.8 2.0 2.9
for Symptom
Resolution --
The mean number of diseased hemorrhoidal vessels was
6.33 per patient. Hemorrhoidal vessel involvement is shown in
Table II, the mean grade of inflammatory change being the greatest
on the left and the least in the right anterior segment.
In the 42 patient~, a total of 17 Grade 1, 103 Grade
2, 99 Grade 3, and 46 Grade 4 hemorrhoids were treated. The
amount of milliamperes, time and milliampere-time product required
for complete ablation of inflammed hemorrhoidal tissue is direct-
ly related to the degree of inflammatory change.
TAB~E II
; Hemorrhoidal Quandrants corresponding to mean
inflammatory grade of hemorrhoidal involvement ` :~
in the 42 patients.
Area 1 2 3 4 5 6 7 8
Grade 2.8 1.8 2.5 1.9 2.3 1.2 2.2 2.0
All patients were asymptomatic at completion of the
- treatment course.
. .
,....
~ , . . .
.~ .
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- 21 -
Patient follow-up was obtained in all patients
by direct contact. Mean duration of follow-up was 18.2
months (range 8-34 months). No recurrence of
symptomatology was reported at follow-up evaluation.
-- 5 Mechanism of Treatmen~
The precise mechanism of action of D.C. Current
to bring about resolution of hemorrhoidal inflammation
without resulting scar tissue formation is not known.
However, vessel thrombosis with eventual slough is the
end result. When applied to hemorrhoids, the negative
pole of D.C. Current produces a hydrolytic decomposition
followed by a contraction of the tissues. Hydrolytic
decomposition results in vessel thrombosis, with that of
the vasa vasorum most probably paramount. -
1~ Two possible explanations for vessel thrombosis
by the use of D.C. current are: the release of free
hydrogen, i.e., when the probe is placed in a saline
solution (such as blood) and current is passed, free
hydrogen is produced; and production of heat at the site
o the probe with the formation of hydrogen. Both
explanations will cause the release of adenosine
diphosphage (AIP) and~or thromboplastin.
The dried hemorrhoidal tissue sloughs gradually
over a 3 to 7 day period, being eliminated with
25 defecation. Hemorrhage associated with tissue slough
has not been experienced. Follow-up evaluation reveals
no evidence of scar tissue formation. The permanency of
therapeutic effect is due to complete obliteration of ;
the entire vessel from its point of origin to its most
30 dependent portion. `
~ecause the superior (internal) and inferior ;
(external) hemorrhoidal vascular plexuses anastomose ~
freely, many patients have a combination of hemorrhoids `
. '' ' .. '
`-`: ' 1 327633
- 22 -
(mixed hemorrhoids) and likewise external hemorrhoidal
inflammatory disease is resolved with D.C. current
treatment of internal hemorrhoidal disease~
The absence of pain with this procedure relates
c~` 5 to the relative lack of somatic innervation of the area
of origin of internal hemorrhoids. Should a patient
have innervation above the Dentate Line, topical
application of 4% Xylocaine allows for no greater than a
tolerable discomfort during the treatment period~
~- lo These and other embodiments are within the
following claims~ For example, the base unit 12 may
have brackets adapted to receive the assembled handpiece
and probes, and may be wall mounted. The probe may have -:
a multiplicity of electrode elements, the number, e.g., :
15 1 or 3 or ~ or more, and pateern, e.g., in a palygon or
curve or line or other pattern, selected on the basis of
the shape and size of the base region of the ~-
hemorrhoidal lesion to be treated. The electrode
elemenès may also be curved or bent to improve
20 visibility or access to the lesion.
Also, referring to Fig~ 9A, the probe may be
rotatable to a predetermined number of positions, e.g.,
by selection of corrèsp~nding shapes of keying block and
andpiece aperture 42' te~g., square or other shape), or
2~ to an infinite number of positions by rotation of
handpiece tip 44' about a shoulder of a screw along the
` probe axis~ For example, a ball 45 biased by a spring - :
47 against notches 49 formed in the tip 44' may be used
for locking the position of the probe.
-~ 30 The instrument may be adapted for RF treatment
of lesions, or may be used for treatment of other
conditions, e.g., fissures~
Also, referring to Fig. 9 and a6 mentioned
~` above, the increasing/decreasing element control
~ .
'- . -
. : . .
: ~ ~ : " :.
1 327633
- 23 -
switches 32', 34' may be disposed side by side, and a
third switch 76 provided, e.g., for resetting the
elapsed time of treatment counter 26. The handpiece or
base unit may also include means for audio signals,
e.g., of treatment time or current flow. or may include
means for recording time or other conditions of
treatment.
