JPH0546775Y2 - - Google Patents

Description

[Detailed explanation of the idea]

(Industrial Application Field) The present invention relates to an electric current therapy device for treating hemorrhoids and the like. Problems to be Solved by the Prior Art and Ideas Hemorrhoid disease is one of the most frequent disabling and painful conditions in humans. The US Food and Drug Administration Advisory Panel Opinion defines hemorrhoids as "abnormally large or symptomatic collections of blood vessels, supporting tissues, and overlying mucus membranes or skin in the anorectal region." It is estimated that one-third of the US population has symptomatic internal hemorrhoids by age 50, with an incidence of 50%.
Patients often postpone testing due to concerns about pain associated with special treatment physical therapy, hospitalization, cost, and time to disability. Such delays in evaluation may advance hemorrhoid disease or delay determination of the most serious colorectal problems. Medical procedures for the treatment of hemorrhoids take many forms. For example, DC (direct current) treatment techniques for hemorrhoid disease were described in a review published in 1934 by Wilbur E. Kesey, MD. The topical suppository approach is currently applicable to the majority of patients, especially those with special precipitating factors for hemorrhoidal disease (eg episodes of acute diarrhea), and may be all that is needed in some cases. Also, sometimes necrosis and carrion of rectal vessels is performed by placing a rubber band over the vessel base with a special device.
This procedure can be applied to the vessels above the pectinate line to avoid severe pain (complications in 6-10% of patients).
Mild to moderately diseased rectal vessels do not respond to this treatment. Injection sclerotherapy is effective for small (grade 1 and 2) bleeding internal hemorrhoid disease.
Submucosal injection of sclerotherapy agents results in chemical thrombosis and fixation of the mucosa to the underlying tissue. Sclerotherapy for hemorrhoid disease is limited to mild to moderate disease and is effective against reactions to injections, carrion of the overlying mucous membrane, necrosis,
and associated complications, including infection, including submucosal abscesses. Cryosurgery (ie, the use of a metal probe cooled with liquid nitrogen or carbon dioxide) freezes hemorrhoids. Sometimes local anesthesia is required due to pain.
Complications may include inaccurate control of the depth of tissue destruction, post-operative pain, and rectal drainage. Surgical excision of inflammatory hemorrhoids has the advantage of removing all associated redundant tissue, including the external components of certain internal hemorrhoids. However, there are limits to the amount of resection possible without many malignant sequelae. In a typical patient with many involved vessels, the surgeon has access to only the most symptomatic lesions and are not considered curable. Disadvantages of these approaches include pain, costs associated with hospitalization, time to failure, and potential complications such as anesthesia, surgery-specific complications, and postoperative complications including anal stenosis. Means and Effects for Solving the Problems According to one aspect of the present invention, an apparatus for direct current electrical treatment of hemorrhoid lesions in a patient includes direct current generator means, a ground pad of the patient, and a negative electrode. a monopolar probe with a distal tip for penetrating the hemorrhoidal lesion;
an instrument handpiece for supporting a probe and controlling a direct current level, the probe extending from a base and at least one elongated body terminating in a distal tip adapted for electrically conductive engagement with the hemorrhoidal lesion; a lower handle portion sized and configured such that the instrument handpiece is grasped by a physician; and coupling a probe base to the handpiece in electrically conductive engagement;
cooperating means with the axis of the probe relative to the axis of the lower handle portion at an obtuse angle selected to allow the physician to hold the instrument handpiece during treatment of the hemorrhoid lesion without extending the carpus and causing abnormal flexion; a treatment monitoring and control upper handle portion having a front panel positioned generally above the lower handle portion and visible to the clinician upon penetration of the probe distal tip into the hemorrhoid lesion; means for displaying the condition, the display means and the distal tip of the probe are positioned generally in line with the line of sight of a physician holding the lower handle portion, and the distal probe tip is inserted into the hemorrhoid lesion; a direct current level control means disposed proximate the lower handle portion such that the control means can be operated by fingers of a hand gripping the lower handle portion, thereby allowing the physician to treat the hemorrhoid lesion; It is possible to grasp the instrument and operate the control means with one hand, while leaving the other hand free, while at the same time viewing the treatment site and observing the status of the treatment appearing on the display means. Preferred embodiments of this aspect of the invention may include one or more of the following features. The means for displaying the state of the treatment situation of the instrument include, for example, means for displaying the elapsed treatment time, means for displaying the state of the treatment situation of the direct current strength of the treatment and/or the operating state of the treatment. The control means may include first means for increasing the current level, second means for decreasing the current level, and may further include third means for stopping the direct current, preferably the third means is equal to or greater than the first and second means. Activated by simultaneous activation of the second means. Obtuse angles are of the order of about 120°. The cooperating means includes a probe base including a key of predetermined size and shape and a keyway defined by an instrument handpiece sized and configured to receive the key therein. Preferably, the key has a generally square shape in cross-section and has rounded corners of predetermined dimensions slightly smaller and corresponding to the dimensions of the keyway. The probe is replaceable and
and includes at least two elongated probe electrodes arranged in parallel rows, preferably with at least two distal tips of the elongated probe being longitudinally offset from each other. According to another aspect of the invention, a probe adapted for use with a hemorrhoid treatment instrument, such as those described above, includes a proximal portion and a distal portion extending therefrom and adapted for electrically conductive engagement with the hemorrhoid lesion. at least one elongated monopolar probe electrode terminating in the tip, and the probe further includes cooperating means for coupling the probe base to the handpiece in electrically conductive engagement, the axis of the probe being at an obtuse angle with the axis of the handpiece. and the obtuse angle is selected to allow the physician to hold the instrument during the treatment of the hemorrhoid lesion without abnormal extended flexion of the carpus; a keyway defined by an instrument handpiece of a size and shape to be received therein, the key having a generally square shape having rounded corners of corresponding predetermined dimensions slightly smaller than the dimensions of the keyway; It has a cross section of The device of the present invention has many advantages over prior art approaches, including that it is effective, relatively safe, painless, and cost-effective when compared to other methods of therapeutic treatment for hemorrhoid disease. I will provide a. These and other features and advantages of the invention will become apparent from the following description and drawings of the preferred embodiment. (Example) Referring to FIG. 1, the medical device 10 of the present invention
consists of a base unit 12 and a medical procedure handpiece 14. Additionally, the instrument includes a monopolar removable probe 16 (FIG. 5) and a ground pad 17.
(Figure 7). Referring to FIGS. 2 and subsequent figures, the handpiece 14 comprises a lower handle portion 18 from which a connector cord 20 extends to the base unit 12 and a rear recess for receiving the user's index finger in a gripping engagement, as shown in FIG. Contains 22. The flat front face 23 of the handpiece on the upper patient treatment part 24 shows, for example, the elapsed treatment time (light-emitting diode numerical display 2
6), treatment current level (light emitting diode bar graph 28), and circuit status indicator (on/off indicator 3)
0) display elements. Additionally, the upper patient treatment portion increases and decreases the level of direct current passing through the probe in increments, respectively, and when simultaneously actuated by the surgeon, e.g., by pressing down with the thumb, as described below. Includes switches 32, 34 to stop the flow of electricity. Handpiece front 2
3 is sealed to prevent fluid from entering the handpiece during cleaning between procedures. Figures 4, 4A, 4B, 5 and 5
Referring to Figure A, the probe 16 has a hole 40 (fourth
It consists of a pair of elongated conductive electrodes 36, 38 extending from a keying block 41 of, for example, square cross-section, with rounded corners (FIG. 5A) dimensioned to snap into the keying block 41 (FIG. 5A) to a pointed distal tip. A banana 43 plug adjacent to keying block 41 securely attaches probe 16 to handpiece 14. The probe electrodes are covered with a non-conductive sleeve 46 on their distal portions to prevent inadvertent tissue contact while minimizing obstruction to the surgeon's view of the treatment site. The proximal portion of the electrode is housed in a sleeve 48 of, for example, injection molded plastic. The probe base segment is configured to be received into the bore in four orientations (90° rotation) selected by the surgeon depending on the quadrant of the rectum to be treated. Separately, probe 16' (5th B
Figure 5) has an octagonal cross-section base segment 41' (Figure 5C) fitted into the probe base segment. (An alternative probe orientation table is shown in Figure 6C). The tip element of one electrode 36 of the pair extends longitudinally beyond the tip element of the second electrode 38 so that the tip does not simultaneously penetrate tissue during the procedure, reducing patient discomfort. For ease of manufacture, the probe 16' can be made of a simple, smooth sleeve 48' that separately houses the proximal portion of the electrode. During assembly with the handpiece, the axis P of the probe
extends at an angle A, preferably about 120°, to the plane of the front face 23 of the handpiece. In this way, during hemorrhoid treatment, the distal tip element of the probe contacts the hemorrhoid tissue 50, and the important display elements on the patient treatment portion of the handpiece are both visible to the surgeon 50.
2' directly along the line of sight L', allowing the surgeon to constantly observe the treatment location 54 and treatment parameters without turning away from the patient 56. Referring again to FIGS. 1 and 8, the base unit 12 includes a power cord 58 for connecting the instrument to an AC power source, and a cord for connecting the handpiece cord and to the grounding unit 17 (FIG. 7). It has 64 connecting outlets 60, 62. On the front face 13 of the base unit 12 there is an on-off switch 66 and a light element 68 for indicating operation of the instrument. A pair of brackets 70 extend from the sides of the base for receiving handpieces. Grounding unit 17 (FIG. 7) consists of an absorbent pad 72 within a liquid-impermeable container 74. A power cord 64 connects the ground unit to the base unit at outlet 62. Referring to FIG. 10, the medical instrument has three electrical components: a main unit 12, a handpiece 1;
4 and pad 17. The main unit includes a power supply 80 and a current generator 84. Power supply 80 provides DC voltage to switch controllers 32, 34, time and current displays 26, 28, and the logic circuitry of ground pad 17. A current generator 84 is connected to probe 16 and passes probe 1 from pad 17 through the patient.
used to control the electrical direct current transmitted to 6. In the handpiece 14, switches 32, 34 located on the handle of the probe are coupled to a current generator 84 for incremental adjustment of the current transmitted through the patient. Digital circuitry coupled to the current generator 84 and located in the handle of the probe allows visual indications 26, 28 of the amount of current delivered and the course of the treatment. Referring to FIG. 11, the power supply section 80 includes two 110V to 25.2V step-down transformers T1 and _T1 connected in series.
Consisting of _T2 . The common connection part 93 on the secondary side is grounded, and the two remaining secondary lead wires 92, 94 are
When used together they provide a total potential of 50.4 volts AC, or a total potential of 25.2 volts AC from each lead to ground (same as a simple 110V to 50.4V center tap transformer). The AC voltage is converted to DC through the use of bridge rectifier 96 and filtered by two 1000 μf capacitors C ₁ and C ₂ connected to ground. This circuit has 35.6 volts positive and 35.6 volts negative
providing a 35.6 volt power supply to leads 92 and 94;
Also known as split voltage supply. The voltage increase (from 25.2 volts to 35.6 volts) depends on the shape of the feed and its capacitors. Three voltage regulators (REGs) are used to provide three regulated voltages: +15 volts, -15 volts and +5 volts. Each of these regulators is filtered by a 0.1 μf capacitor _C3 . +5 volts is applied to pad 17 and +5 volts is applied to the electrical circuitry described below. 1 megohm resistor in series with 18μf capacitor _C4
R ₁ takes the AC 25.2 volt supply and outputs a 60Hz signal.
Minute timer portion 98 is supplied. Timing circuit 98 divides 60Hz by 3600, thereby providing a 1 pulse/minute signal to driver chip 122,
It can count from zero to seven.
The driver chip 122 has an LED (light emitting diode) display 124 that digitally indicates the number of treatment minutes.
7 LED segments on and off.
The LED display 124 is connected to the current generator 84 (Figure 10).
It is reset to digitally indicate ``0'' when the timer is reset or a new procedure is initiated. Referring to FIG. 12, current generator 84 includes a pulse generator 100, logic gates 1-6, counting circuits 102 and 104, digital-to-analog voltage converter 116, and current driver 120. Pulse generator 100 produces a constant 2 Hz/second square wave output that feeds two 4-bit binary counters that actually operate as one 8-bit binary counter. Switches 32 and 34 located on the probe handle (see Figure 2) apply positive voltages to logic gates 1-4, which tell the counter to count up in three possibilities: 1. (Gate 1), 2. Tell the counter to count down (Gates 1 and 2), or 3. Reset the counter (Gates 3-4). In other words, the switch 32 is pushed down and +5
Upon electrical contact with the volt supply, the counter is signaled to count up through gate 1. When switch 34 is depressed, the counter is signaled to count down through gates 1 and 2. Pressing down both switches 32 and 34 at the same time causes the counters 102 and 104 to
to reset. Preferably, timer 124
(FIG. 11) is also reset when both switches 32 and 34 are depressed. 1 megohm resistors R ₂ and R ₃ in conjunction with parallel 0.1 μf capacitors C ₅ and C ₆ connecting each switch 32 and 34 to ground connect the counters to resets 106 and 108 through gates 3 and 4 when turning on the unit. Used to send pulses. Counters 106, 108 cooperate to produce a digital count of up to 256 outputs O _1-8
has. The output of the counter is 8 input digital.
Applied to analog converter 116. As the counter increases or decreases its count, digital-to-analog converter 116 increases or decreases its output voltage 114 in proportion to the counter's output count. The output voltage 114 of the digital-to-analog converter 116 is provided to an operational amplifier 118, which acts as a buffer and multiplies the output voltage 114.
Drives npn transistor 120. Transistor 120 provides a current sink from the patient to ground.
In other words, the probe acts as a current returning to system ground (GND) from the pad 17 providing a positive voltage current. The current flow is through the transistor 120
is limited by a 131 ohm resistor R ₄ in series with emitter E of . A 12 volt bulb (not shown) may be provided at the tip of the probe to provide light for patient examination.
This bulb can be powered by a 15 volt negative power supply (Figure 11) to provide high intensity light. To protect the patient from the application of large sudden direct currents, the output of the counter is
Applied to 8-input NOR gate 6 (at gates 5 and 2) used to prevent the counter from continuing to count back when it reaches 000000. Referring again to Figure 11, the output of the NOR gate (Figure 12) is the 1 minute timer and the green LED 3.
The green LED indicates the electrical status of the unit. counter 10
When the counts of 2 and 104 equal 000000, a positive voltage is applied from gate 6 on line 113 to transistor 112 causing it to conduct.
As a result of logic gates 7-9, driver chip 122 is reset and green LED 30 is enabled. Referring to FIG. 13, current indicator 28 is coupled to emitter E of transistor 120 through line 115. Using Ohm's law, the current indicator indicates the amount of current passing through the patient by measuring the voltage across the 131 ohm resistor R ₄ (FIG. 12). The amount of current transmitted through the patient is displayed by a bar graph column. Preferably, the indicator 28 is calibrated to a maximum 20 mA scale by a 10000 ohm variable resistor _R5 . Referring to Figures 14, 15, and 16,
Another schematic diagram is shown. The power supply 80 includes a transformer T ₃ and two bridge networks B ₁ and
_B2 , the bridge network converts 115 VAC or 230 VAC from the electrical output to a 5 volt DC power supply labeled +5V and a 30 VDC power supply labeled +30V. DC 5 volt power supply, +
5V, is regulated by voltage regulator 129 and used to power logic circuits used in medical instruments. A 30 volt DC power supply is regulated by voltage regulator 126 and is used to provide a positive potential to ground pad 17. Typically,
Voltage regulator 126 protects the patient from power surges, but with special caution fuse F ₂
31 in series. Preferably, the fuse limits the current to 1/32 amp. Monitoring circuit 1
31 will blow the fuse when there is a voltage surge on the 30 volt line. At that time, Zener diode D ₂
conducts a current that causes the supervisory circuit to fire a silicon controlled rectifier (SCR), thereby shorting the +30V supply to ground and blowing the fuse. Monitoring circuit 131 is also connected to line 8 from optical coupler OC (FIG. 15) by means of a probe.
detects excessive current transmitted through 2. Referring to FIG. 15, the amount of direct current applied to the patient is controlled by a current generator 84.
Current generator 84 includes an 8-bit digital counter 139 driven in increments by a pulse generator (PG). The pulse generator also drives a display circuit, which will be described later. The digital output count of counter 139 is provided to a digital-to-analog converter 132, which converts counter 139 to
provides an output voltage 133 that is directly proportional to the output count of . Output voltage 133 is then applied to the base (B) of transistor 135 forming a current reservoir from the patient to ground. The amount of current transferred through the probe is the base (B) of transistor 135.
controlled by the amount of voltage applied to the Therefore, as the digital count increases, the DC voltage transmitted through the probe increases. Circuitry is provided to limit the amount of voltage applied to the base B of transistor 135. NAND connected to the two most important bits of the counter
The output of gate 134 is connected to counter 13 through a diode (D ₃ ) to establish a terminal count.
Returned to 9. The terminal count prevents sudden current steps to the patient when the counter reverts from its maximum value to its minimum value during a count-up indication. If a terminal count were not provided, the severe drop in applied current would cause discomfort to the patient. Referring to FIG. 16, the voltage at the output of the digital-to-analog converter is controlled by an "up" switch 32 and a "down" switch 34 on the handle of the probe. Both switches 32 and 3
4 is connected at one end to a 5 volt output power supply with a +5V indication. At the other end, switches 32 and 34 are coupled by lines 88 and 89, respectively, to logic gates 136, 137, and 138 (FIG. 15). The opening and closing of switches 32 and 34 generate output signals that control the output count of counter 139. By depressing switch 32 alone, counter 139 is told to count up to the maximum count established by the predetermined terminal count. By depressing switch 34 alone, the counter is commanded to decrement to a minimum count of 000000, which is a digital zero count. As mentioned above,
This prevents the counter from reverting to a maximum count that causes the maximum amount of current to be transferred through the probe. If both switches are pressed down at the same time, the counter will be reset. An indication of the amount of current applied to the patient is indicated by a bar graph display 28 located on the probe handle. The bar graph display is driven by an analog-to-digital converter 144 which senses the voltage at the emitter E of transistor 135 through line 143. An analog-to-digital converter generates a digital signal proportional to the voltage sensed at emitter E. Analog-
Digital converter 144 provides output to fire eight separate light emitting diodes (LEDs), each of which preferably displays 2 milliamps on the bar graph display. In this way, when all the light emitting diodes are lit, 16 milliamps or full scale will be displayed. A digital display 26 is also provided on the probe handle to indicate the amount of time that has elapsed for applying current to the patient. A digital clock driver 146, which may be a counter, is clocked by a 10 Hz signal on line 143 from a pulse generator PG (FIG. 15). The output count of counter 146 is used to drive three seven segment digital displays displaying minutes and seconds. During the procedure, a seven segment digital display keeps track of the amount of time the patient has received direct current. If the current carried by the probe decreases to zero, a signal 145 indicating a digital zero count applied to the digital-to-analog converter 132 is applied to the counter 14.
6 to latch the displayed time. In other words, the time shown on the clock stops and
It also indicates the elapsed treatment time when the current decreases to zero. When the current is reapplied to the patient, the time shown on the clock continues. The handpiece 14 may also include an indication indicating whether the probe is electrically active for the current it carries. When the output count of counter 139 is other than logic zero (i.e., when the probe has a potential with respect to the transmitted current), line 1
50 is the red light emitting diode 1 through the gate O ₂
51 is enabled. Referring to FIG. 9, in another embodiment of the handpiece 14, a reset switch 76 may be provided to reset the time on the display. Also in this embodiment, "up" and "down" switches 32', 34' are arranged in side-by-side relationship. The instrument is installed on the base segment 4 of the new probe 16.
1 into the hole 40 of the handpiece 14. Handpiece and ground pad connector cords 20, 64 are inserted into their respective outlets 60, 62, and the base unit is connected by cord 58 to an AC power source. The patient is placed in the right lateral lateral position and a ground pad 17 is placed under the patient's right thigh which is moistened with saline for good electrical contact and acts as a positive electrode. The surgeon inserts and positions anoscope 51 so that the hemorrhoid 50 to be treated is exposed for viewing through window 53. The surgeon depresses switch 66 on base unit 12 to activate the instrument as directed by light 68. At this time, the display 30 on the handpiece indicates that the circuit is not closed. The surgeon places the electrode 3 of the probe 16 at the base of the hemorrhoid lesion.
6,38 tips are engaged, which is indicated by indicator 30 as closing the circuit (from the ground pad through the patient to the electrode tip). The surgeon increases the current through the probe in increments by depressing switch 32, the current level is indicated by bar graph 28, and the elapsed time of the procedure is indicated by display 26. Once the current begins to flow, the surgeon pushes the probe tip into the base of the lesion. It has been observed that the degree of treatment required is a function of time and current, ie, the higher the current level, the shorter the time required for each treatment task. The factor that limits the current strength is patient discomfort, so the surgeon
By pressing down 2, the current level is slowly increased as high as possible without patient discomfort (perceived as pain) to reduce procedure time. When the patient feels uncomfortable or when the procedure is complete, the surgeon reduces the current in increments by depressing switch 34. Although the length of each procedure can typically be longer than 5 to 10 minutes, the shape of the handpiece handle portion and probe axis, best shown in FIGS. 4, 4A, and 4B, is determined by the surgeon. Allows the carpus to be comfortably positioned without abnormal flexion. Additionally, as discussed above, the display of the procedure status relative to the surgeon's line of sight and the relative positioning of the probe tip elements allows the surgeon to simultaneously monitor the patient's condition and the procedure status. Results Forty-two patients with symptomatic hemorrhoid disease were treated with the device of the invention. The group consisted of 28 men and 14 women with a mean age of 47 years (range 21-70 years). All subjects underwent medical history investigation, visual and numerical examination,
and underwent anoscopy using a Hinkel-James proctoscope. Subjects with symptomatological origins other than hemorrhoid disease were not included in the study. Eight segments were visualized at anoscopy. With the patient in the right lateral position, segment 1 is on the patient's left and segment 6 is on the patient's right front.
Hemorrhoidal inflammatory disease was graded from 0 to 4 according to Banoff et al. Grade 1 indicates the presence of tufts or internal hemorrhoidal tissue but no prolapse from the anal canal. These have painless bleeding. Grade 2 indicates tense prolapse and tissue retraction after bowel movement. Patients may be unaware of the onset of prolapse. Like grade 1, grade 2 hemorrhoids can bleed. Grade 3 indicates shedding of hemorrhoidal tissue due to intestinal motility and the hemorrhoid remaining outside. The patient has to put them back in by hand. Clade 3 hemorrhoids may bleed and have associated pain.
Grade 4 indicates irreducible hemorrhoid prolapse, often with associated mucoid discharge and bleeding. Each patient underwent treatment for all internal hemorrhoids with inflammatory changes. Most hemorrhoids required a single treatment recorded as milliamperes (ma) multiplied by a multiple of minutes of application (maxmin). Generally, a single treatment was given as directed, but one or more vessels were treated at one time on an ad hoc basis. If reexamination did not result in total detachment of the hemorrhoidal disease from the previous treatment, the vessel was given additional treatment. This was recorded as an additional milliampere of treatment. The typical treatment was visual inspection of the hemorrhoids treated using a Hinkel-James proctoscope. The procedure was performed in the uppermost part of the hemorrhoid in the longitudinal axis of the blood vessel and at a very slight angle to the anal canal. If desired, the area was typically anesthetized with 4% xylocaine using a cotton swab. The probe was firmly inserted into the lumen. Then the current was turned on gradually and it took 2-3 minutes to bring the current to 10-15ma.
Using a two-tip probe, 60-100 milliamps of treatment was required for each vessel involved.
A visual change from bright red to dark red, and in some cases almost black, indicated a satisfactory course of treatment. The current was slowly turned off and the probe and mirror were removed. Forty-two patients with a mean age of 47 years (range 21-70 years) underwent evaluation for symptomatic hemorrhoid disease and treatment. Mean duration of symptoms before treatment was 9.7 years (range 0.01-26 years)
It was hot. The symptoms at presentation and the number of treatments required for complete relief of these symptoms are shown in Table I. The most common symptom was rectal bleeding in 81% of patients, followed by itching (62%) and internal hemorrhoid protrusion from the anal canal (60%).
%) and pain (42%). The mean number of treatments for complete relief of these symptoms with one involved tract treated per visit was 2.0 and 2.9, respectively.
They were 2.9 and 2.8.

[Table] The average number of diseased hemorrhoidal vessels is 6.33 per patient.
It was hot. The hemorrhoidal vascular relationships are shown in Table II, with the mean grade of inflammatory changes being greatest on the left side and least on the right anterior segment. A total of 17 grade 1, 103 grade 2, 99 grade 3, and 46 grade 4 in 42 patients.
treated his hemorrhoids. The amount of milliampere, time, and milliampere-time product required for complete ablation of inflamed hemorrhoidal tissue is directly related to the extent of the inflammatory changes.

Table: All patients were symptom-free at the end of the treatment course. Patient tracing was obtained for all patients by direct contact. The mean duration of follow-up was 18.2 months (range 8-34 months). No symptomatic recurrence was reported at follow-up evaluation. Mechanism of Treatment The exact mechanism of action of direct current that produces relief of hemorrhoid inflammation without the formation of scab tissue is unknown. However, vascular thrombosis with possible carrion is the end result. When applied to hemorrhoids, the negative pole of the direct current causes hydrolysis accompanied by contraction of the tissue. Hydrolysis causes vascular thrombosis, and that of the vascular vessels is probably the best. Two possible explanations for vascular thrombosis with the use of direct current are the release of free hydrogen, i.e. free hydrogen is generated when the probe is placed in a saline solution (such as blood) and a current is passed through it. , and the generation of heat at the location of the probe with hydrogen evolution. Both explanations result in the release of adenosine diphosphorescence (AIP) and/or thromboplastin. Dried hemorrhoidal tissue gradually decomposes over a period of 3 to 7 days and is eliminated through defecation. Hemorrhoids associated with tissue carrion were not experienced. Follow-up evaluation showed no evidence of scab tissue formation. The durability of the therapeutic effect depends on completing the occlusion of the entire vessel from its origin to its most dependent parts. Because the upper (internal) and lower (external) hemorrhoidal plexuses freely anastomose, many patients have a union of hemorrhoids (mixed hemorrhoids), and external hemorrhoid inflammatory disease is similar to the direct current of internal hemorrhoid disease. Resolved with treatment. The presence of pain in this manner is related to the relative lack of truncal innervation at the origin of the internal hemorrhoid. If the patient has innervation on the dentate line, the typical application of 4% cyrocaine does not cause intolerable discomfort during the treatment period. These and other embodiments are within the scope of the utility model claims. For example, base unit 12 can have a bracket adapted to receive an assembled handpiece and probe, and can be wall mounted. The probe can have a number of electrode elements, e.g. 1, 3, 4 or more, and e.g. polygonal or curved or straight or other shapes, chosen based on the shape and dimensions of the hemorrhoidal lesion to be treated. . The electrode elements can be curved or bent to improve visualization or access of the lesion. Also, referring to FIG. 9A, the probe can be rotated into a predetermined number of positions, for example by selection of corresponding shapes (eg, square or other shapes) of the keyblock and handpiece holes 42', or It can be rotated into an infinite number of positions by rotating the handpiece tip 44' around the shoulder of the thread along with it. For example, chip 4
Spring 47 against notch 49 formed in 4'
Ball 45 biased by can be used for locking the position of the probe. The instrument may be used for radiofrequency treatment of lesions or treatment of other conditions, such as fissures. Also, with reference to FIG. 9 and as described above, the increase/decrease element control switches 32', 34' may be arranged side by side and a third switch 76 for resetting the elapsed time of the treatment counter 26, for example.
will be provided. The handpiece or base unit may also include means for an audible signal of, for example, treatment time or current flow, or may include means for recording treatment time or other conditions.

[Brief explanation of the drawing]

FIG. 1 is a perspective view of the medical instrument of the present invention, FIG. 2 is a plan view of the handpiece of FIG. 1, and FIG. 3 is a side view of the handpiece of FIGS. 1 and 2. , FIG. 3A is a plan view of the probe receiver of the handpiece of FIG. 3 along line 3A-3A of FIG. 3, and FIGS. 4, 4A, and 4B are views of the hemorrhoid lesion taken from different perspective views. 5 is a top view of the instrument probe, FIG. 5A is an end view of the probe base segment along 5A-5A of FIG. 5, and FIG. 5B is a plan view of another embodiment of the instrument probe of the present invention, and FIG. 5C is a cross-sectional end view of the proximal segment of the probe of FIG. 5B along 5C-5C;
FIG. 6 is a table of probe orientations for different probe base segments, FIG. 7 is a plan view of the instrument ground pad, FIG. 8 is a side view of the instrument base unit, and FIG. FIG. 9A is a front view of another embodiment of the piece; FIG. 9A is a cross-sectional side view of the distal end of the handpiece of the present invention having a rotatable tip; FIG. 10 is a block diagram of the instrument circuit; , Figures 11, 12, and 13 are 10
FIG. 14, FIG. 15, and FIG. 16 are schematic diagrams of a second embodiment of the electric circuit of FIG. 10; FIG. 10...Medical instrument, 12...Base unit, 1
4...Medical treatment handpiece, 16...Probe, 17...Ground pad, 18...Lower handle portion, 24...Upper patient treatment portion, 26...Numeric display, 28...Bar graph, 30...On/ Off display, 32, 34... switch, 36, 38... electrode, 80... power supply section, 84... current generator.

Claims (1)

[Scope of Claim for Utility Model Registration] (1) An apparatus for direct current electrical treatment of hemorrhoid lesions or the like of a patient, comprising a direct current generator means, a grounding pad of the patient, and a hemorrhoid lesion penetration penetrating the hemorrhoid lesion acting as a negative electrode. a monopolar probe having a distal tip for;
an instrument handpiece supporting a probe and controlling a direct current level, the probe terminating in a base and said distal tip extending therefrom and adapted to be in electrically conductive engagement with a hemorrhoid lesion. an instrument handpiece including at least one elongated probe; a lower handle portion dimensioned and configured to be grasped by a physician; and coupling the probe base to the handpiece in electrically conductive engagement. , the axis of the probe is at an obtuse angle with respect to the axis of the lower handle portion, selected to allow the physician to extend the carpus and hold the instrument handpiece during treatment of the hemorrhoid lesion without abnormal flexion; and a treatment monitoring and control upper handle portion having a front panel positioned generally above the lower handle portion and visible to the physician upon penetration of the probe distal tip into the hemorrhoid lesion, the front panel comprising: means for displaying the status of a treatment situation of the instrument, the display means and the distal tip of the probe being disposed generally in line with the line of sight of a physician holding the lower handle portion, the distal probe tip an indicating means for penetrating into the hemorrhoid lesion; and direct current level control means disposed proximate to the lower handle portion so that the control means can be operated by the physician with the fingers of a hand grasping the lower handle portion. a display means, which allows the doctor to simultaneously view the treatment area while keeping the other hand free while gripping the instrument and operating the control means when treating a hemorrhoid lesion; An instrument that allows you to observe the status of treatment as it appears. (2) The device according to claim 1, wherein the means for displaying the treatment status of the device includes means for displaying the elapsed time of the treatment. (3) The device according to claim 1, wherein the means for displaying the treatment status of the device includes means for displaying the direct current intensity of the treatment. (4) The device according to claim 1, wherein the means for displaying the state of the treatment status of the device includes means for displaying the operating state of the treatment. (5) The apparatus according to claim 1, wherein said control means includes first means for increasing the current level and second means for decreasing the current level. (6) The device according to claim 5, wherein the control means includes third means for stopping the direct current. (7) The device according to claim 6, wherein the third means is activated by simultaneous operation of the first means and the second means. (8) The device according to claim 1, wherein the obtuse angle is on the order of about 120°. (9) said cooperating means includes said probe base including a key of predetermined size and shape and a keyway defined by said instrument handpiece sized and configured to receive said key therein; The device according to claim 1 of the utility model registration claim. (10) The device according to claim 9, wherein the key has a generally square shape in cross section with rounded corners of corresponding predetermined dimensions slightly smaller than the dimensions of the keyway. . (11) The device of claim 1 or 9, wherein the probe is replaceable and includes at least two elongated probe electrodes arranged in parallel rows. (12) The device according to claim 11, wherein at least two distal tips of the elongated probe are longitudinally offset from each other. (13) An apparatus for the direct current electrical treatment of hemorrhoid lesions or the like in a patient, the unit having a direct current generator means, a grounding pad for the patient, and a distal tip for penetrating the hemorrhoid lesion serving as a negative electrode. a polar probe;
an instrument employing an instrument handpiece supporting a probe and controlling a direct current level, the probe terminating in a proximal portion and said distal tip extending therefrom and adapted to be in electrically conductive engagement with a hemorrhoidal lesion; an instrument handpiece including at least one elongated probe; a lower handle portion dimensioned and configured to be grasped by a physician; and coupling the probe base to the handpiece in electrically conductive engagement. , the axis of the probe is at an obtuse angle with respect to the axis of the lower handle portion, selected to allow the physician to hold the instrument handpiece during treatment of a hemorrhoid lesion without extending the carpus and causing abnormal flexion; the probe base includes a key of predetermined size and shape and a keyway defined by the instrument handpiece sized and shaped to receive the key therein; cooperating means having a generally square shape with rounded corners of corresponding dimensions slightly smaller than the dimensions of the groove; and cooperating means disposed generally above said lower handle portion and for penetrating the distal tip of the probe into the hemorrhoidal lesion. a treatment monitoring and control upper handle portion having a front panel that is visible to the physician when performing the procedure; , means for displaying the direct current strength of the procedure, and means for displaying the operating status of the procedure, the display means and the distal tip of the probe being generally in line with the line of sight of the physician holding the lower handle portion. indicator means arranged in line to allow the distal probe tip to penetrate into the hemorrhoidal lesion; and proximate to the lower handle portion so that the physician can operate the control means with the fingers of the hand grasping the lower handle portion. direct current level control means arranged as a direct current level control means, the control means including at least a first means for increasing the current level and a second means for decreasing the current level, whereby the physician When performing treatment on a hemorrhoid lesion, one can grasp the instrument with one hand while keeping the other hand free, operate the control means, and at the same time view the treatment area and observe the status of the treatment appearing on the display means. Instruments that can. (14) For use with an apparatus for direct current electrical treatment of hemorrhoid lesions or the like in a patient employing direct current electrical generator means, a patient grounding pad, and an instrument handpiece that supports the probe and controls the direct current level. a probe comprising: a base and at least one elongated monopolar probe electrode extending therefrom and terminating in a distal tip adapted for electrically conductive engagement with the hemorrhoidal lesion; and the probe further includes cooperating means for coupling the probe base to a handpiece in electrically conductive engagement, the axis of the probe being at an obtuse angle with the axis of the handpiece, and the obtuse angle the instrument hand selected to be capable of holding the instrument during treatment of a hemorrhoid lesion without abnormal flexing, the probe base having a key of a predetermined size and shape and a size and shape to receive the key therein; a keyway defined by a piece, said key having a generally square shape having rounded corners of a corresponding predetermined dimension slightly smaller in cross section than the dimension of said keyway.