DE8806167U1 - Medical instrument for the treatment of hemorrhoidal lesions or similar. - Google Patents

Description

Medical instrument for the treatment of hemorrhoidal lesions

The invention relates to a device for the treatment of hemorrhoids or the like using electric current.

Hemorrhoids are one of the most common, uncomfortable and painful diseases. The Advisory Board of the U.S. Food and Drug Administration defines hemorrhoids as "abnormally large or symptomatic conglomerations of blood vessels. Supportive 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 attack of 50 % by age 50. Patients often delay evaluation due to fear of pain, wounds requiring special treatment, hospitalization, expense, and inability to work. Such delay in evaluation may result in progressive hemorrhoids or late diagnosis of more serious colorectal problems. f

Medical procedures for hemorrhoid treatment are available in many forms. j

For example, direct current treatment of hemorrhoids was already described in a review published by Dr. Wilbur E. Keesey in 1934. |

Topical suppository use is currently used in a majority of patients, especially those with a special predisposition to hemorrhoids (e.g. acute episode of diarrhea), and in some cases this may be all that is necessary.

Necrosis and rejection of the hemorrhoidal vessels can also, occasionally, be achieved

are positioned by rubber bands over the vessel base with a <

special device. This treatment is recommended for vessels well above the

Hilton line can be used to avoid severe pain (in case of complications for *

6 - 10% of patients). Mildly to moderately diseased hemorrhoidal vessels are I

not accessible to this therapy. &idiagr;

Injection sclerotherapy is effective for small (1st and 2nd degree) bleeding internal j

Hemorrhoids. Submucosal injection of sclerosing agent produces chemical thrombosis '

and fixation of the mucosa to the underlying tissue. Skierotherapy of hemorrhoids is limited to mild to moderate disease and is associated with complications, particularly reaction to the injected material, rejection of the overlying mucosa, necrosis and infection including submucosal abscess.

Cryo-surgery (ie application of a metal probe cooled by liquid nitrogen or carbon dioxide) freezes xiäiüorriioids. Occasionally, anaesthesia is required because of pain. Complications may include inaccurate control of the depth of tissue destruction, post-operative pain and rectal drainage .

Surgical excision of hemorrhoidal inflammation has the advantage of removing all associated redundant tissue, including the external component of a particular internal hemorrhoid. However, there are limitations to the extent of excision that can be performed without causing major adverse sequelae. In a typical patient with many vessels involved, surgery can only affect the most symptomatic area and cannot be considered curative. The disadvantages of this approach are primarily pain, hospital stay, duration of incapacity for work and possible complications, e.g. related to anesthesia, actual surgery and post-operative complications including anal stenosis.

The inventive solution and advantageous embodiments of the invention are specified in the claims.

The instrument according to the invention offers a number of advantages over known procedures, in particular effectiveness, relative safety and painlessness and cost limitation compared to other methods of curative treatment of hemorrhoids.

The invention is explained in more detail using the following example:

Fig. 1 shows in perspective a medical instrument according to the invention;

Fig. 2 shows a top view of the handpiece from Fig. 1;

Fig. 3 shows a side view of the handpiece from Fig. 1 and 2;

Fig. 3A shows a top view of the probe receiver of the handpiece of Fig. 3

along 3A-3A of Fig. 3;

Fig. 4,4A,4B schematically show the instrument according to the invention during the treatment of a hemorrhoidal lesion, from different angles;

Fig. 5: top view of the instrument probe;

Fig. 5A shows an end view of the probe base along 5A-5A of Fig. 5;

Fig. 5B shows a plan view of a modified embodiment of the instrument probe according to the invention,

Fig. 5C in sectional end view a base part of the probe of Fig. 5B along

5C-5C;

Fig. 6 shows a table of probe orientations of the modified probe

basic part;

Fig. 7: top view of the instrument grounding pad;

Fig. 8 in side view the instrument base unit,

Fig. 9 shows a modified embodiment of the instrument in plan view.

handpiece;

Fig. 9A in sectional side view the distal end of a handpiece according to the

Invention with rotating tip;

Hg. 10 a block diagram of the instrument circuit;

Kg. 11 - 13 Circuit diagrams of a first embodiment of the electrical circuit of Fig. 10; and

Kg. 14 -16 Circuit diagrams of a second embodiment of the electrical circuit of Fig. 10.

Fig.l:

The medical instrument 10 according to the invention consists of a base unit 12 and a handpiece 14 for medical treatment, furthermore a unipolar, detachable probe 16 (Fig. 5) and a grounding pad 17 (Fig. 7).

Fig. 2 ff.:

The handpiece 14 consists of a lower handpiece section 18 from which a connecting cable 20 extends to the base unit 12 and, see Fig. 3, a rear recess 22 for receiving the user's front fingers for gripping. A planar front surface 23 of the handpiece on an upper treatment section 24 contains indicators of, for example, elapsed treatment time (numerical LED display 7.6), intensity of the current (LED strip display 28) and switch on (ON/OFF indicator 30). The upper treatment section 24 also contains switches 32, 34 for gradually increasing or decreasing the intensity of the direct current through the probe and, when operated by the surgeon simultaneously, e.g. by pressing with his thumb as described below, for interrupting the electrical current. The handpiece front surface 23 is sealed to prevent liquid from entering the handpiece during cleaning between uses.

Fig. 4,4A, 4B, 5,5A:

The probe 16 consists of two elongated, electrically conductive electrodes 36, 38, which extend to sharpened distal tips from a wedge block 41, e.g., of square cross-section, with rounded corners (Fig. 5a), for snugly receiving into the opening 40 (Fig. 4) in the distal end 44 of the handpiece 14. A banana plug 43 near the wedge block 41 securely holds the probe 16 to the handpiece 14. The probe electrodes are embedded in non-conductive sleeves 46 over their distal portions to avoid inadvertent tissue contact, yet minimize obstruction of the surgeon's view of the treatment site. The proximal portions of the electrodes are embedded in a sleeve 48, e.g., of injection molded plastic.

The probe base is designed to be received in the opening in four orientations (90° turns) selected by the surgeon depending on the rectal quadrant being treated. Optionally, a probe 16' (Fig. 5B ) has a base 41' of octagonal cross-section (Fig. 5C) fitted into the probe base segment (a table of alternative probe orientations is shown in Fig. 6C). The tip member of electrode 36 of the electrode pair extends longitudinally beyond the tip member of the second electrode 38, whereby during treatment the tips do not simultaneously penetrate the tissue to reduce patient discomfort. For ease of manufacture, the probe 16' may optionally be provided with a simple, smooth sleeve 48' encasing the proximal portion of the electrodes, and the functions of the base and banana plug connector may be combined in an octagonal connector 41'.

&bull; · · ta · I

The axis P of the probe, when installed in the handpiece, extends at an angle A, preferably about 120°, to the plane of the front surface 23 of the handpiece. In this way, during the treatment of hemorrhoids, the distal tip elements of the probe are in contact with the hemorrhoidal tissue 50, and the important display elements of the treatment section 24 of the handpiece are both located directly along the line of sight L of the surgeon 52, so that he can constantly observe the treatment site 54 and the treatment parameters without turning away from the patient 56.

Flg. 1, 8:

The base unit 12 has a power cable 58 for connecting the instrument to an AC power source and has connectors 60, 62 for connecting the handpiece cable and for connecting the cable 64 to the grounding unit 17 (Fig. 7). On the top 13 of the base unit 12 there is an ON/OFF switch 66 and an indicator 68 for indicating the operation of the instrument. Two brackets 70 for holding the handpiece extend from the side of the base unit.

The grounding unit 17 (Fig. 7) consists of an absorbent pad 72 in a liquid-tight container 74. The power cable 64 connects the grounding unit to the base unit at the connector 62.

The medical instrument consists of three electrical units: the main or base unit 12, the handpiece 14 and the cushion 17.

The main unit consists of a power supply 80 and a current generator The power supply 80 supplies DC voltage to the logic circuit of the switch controls 32, 34, the time and current display 26,28 and the grounding pad The current generator 84 is connected to the probe 16 and serves to control the DC current sent from the pad 17 through the patient 56 to the probe 16. In the handpiece 14, the switches 32, 34 on the handle of the probe are connected to the current generator 64 for stepwise adjustment of the current sent through the patient 56. Digital circuit components connected to the current generator 84 and located on the handle of the probe control a visual display 26,28 of the strength of the current sent and the elapsed treatment time.

The power supply 80 consists of two 110 V to 25.2 V step-down transformers T1 and T2 in series. The common terminal 93 of the secondary is connected to ground and the two remaining secondary lines 92, 94 provide a total potential of 50.4 V AC if used together or 25.2 V AC from each line to ground (the same as a simple 110 V to 50.4 V center tapped transformer). The AC voltage (110 AC)

is converted to DC by a bridge rectifier 96 and two IGOO /*F capacitors Ci and C2 which are grounded. This circuit provides + 35.6 V and - 35.6 V supply voltage for lines 92 and 94 and is known as a split power supply. The voltage increase (from 25.2 V to 35.6 V) is due to the construction of the power supply and its capacitors. Three voltage regulators REG give three regulated voltage supplies: + 15 V; -15 V and + 5 V. Each of these regulators is filtered by a 0.1 μΠΩ capacitor C3. The + 15 V is applied to pad 17 and the + 5 V to the electronic circuit to be explained later.

A 1 μΩ resistor Ri in series with an 18 μΩ capacitor C4 taps the 25.2 volt AC supply to provide a 60 Hz signal for a 1 minute timer. The timer 98 divides the 60 Hz by 3,600 to provide a 1 pulse/min signal 99 to a driver chip 122 which can count from 0 to 7. The driver chip 122 switches on and off seven LED segments of an LED display 124 which digitally displays the number of minutes of treatment. The LED display 124 is reset to digitally display "0" when the current generator 84 (Fig. 10) is reset or a new treatment is started (see below).

The current generator £4 has a pulse generator 100; logic elements 1-6; a counting circuit Wl, 104; a digital/analog voltage converter 116 and a current driver 120.

The pulse generator 100 supplies a constant 2 Hz/s square wave, which is fed into the two 4-bit binary counters 102 and 104, which in turn work as an 8-bit binary counter. The switches 32 and 34 on the probe handpiece 14 (see Fig. 2) apply positive voltage to the logic elements 1 - 4, which in turn determine three possibilities:

1. Command to the counter to count up (gate 1);

2. Command to the counter to count down (connectors 1,2);

3. Resetting the counters (connection elements 3,4).

That is, when switch 32 is depressed to make electrical connection to the 4-5 volt supply, the counter is commanded to count up via gate 1. When switch 34 is depressed, the counter is commanded to count down via gates 1 and 2. Depressing both switches 32 and 34 simultaneously causes counters 102,104 to be reset. Preferably, timer 124 (Fig. 11) is also reset when both switches 32, 34 are depressed. A 1 μΩ resistor, R2, R3, combining with a parallel 0.1 μΩ resistor, R4, R5, R6, R7, R8, and a parallel 0.1 μΩ resistor, R9, R10, R11, R22, R33, R44, R55, R66, R77, R88, R90, R91, R102, R104, R116, R120, R121, R130, R131, R132, R140, R141, R150, R151, R162, R170, R171, R180, R181, R190, R22, R230, R240, R250, R260, R270, R280, R290, R310, R321, R330, R340, R311, R321, R330, R311, R322, R3 ...30, R311, R321, R330, R311, R330, R311, R -Capacitor, C5, Cg, each connecting one of the switches 32 and 34 to ground, is used to pulse the reset switches 106 and 108 on the counters via the gates 3 and 4 when the unit is on.

The counters 106, 108 have outputs Oj.g, which together form a digital counter

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gang-Digitiil/Analog-Converter 116. When the counter reaches the counter reading

- 10 -

the digital-to-analog converter 116 increases or decreases its output voltage 114 in proportion to the output count of the counters. The output voltage 114 of the digital-to-analog converter 116 is fed into an operational amplifier 118, which acts as a buffer and multiplies the output voltage 114 to drive an NPN transistor 120. The transistor 120 is a current sink from the patient to ground. That is, the probe acts as a current return from the pad 17, which is the positive voltage source, to the system ground GND. The current flow is limited by a 131 Ω resistor R4 in series with the emitter E of the transistor 120.

A 12 V bulb (not shown) may be provided at the tip of the probe to provide light for examination of the patient. The bulb may be driven by the -15 V source (Fig. 11) to provide very intense light.

To protect the patient from sudden application of high direct current, the output signals of the counters are also fed into an 8-input NOR gate 6, which is used (with gates S and 2) to prevent the counters from counting down further when the counter reaches 0000 0000.

The output of the NOR gate (Fig. 12) is used to control the 1 minute timer and a green LED 30 which indicates the electrical state of the unit. When the count of the counters 102,104 is 0000 0000, a positive voltage is applied to transistor 112 by gate 6 via line 113 to cause it to conduct current. Due to the gates 7-9, the driver chip 122 is reset and the green LED 30 is energized.

A current indicator 28 is connected to the emitter E of transistor 120 by a lead 115. The current indicator indicates the amount of current flowing through the patient based on Ohm's law by measuring the voltage across the 131Ω resistor R4 (Fig. 12). The amount of current flowing through the patient is indicated by a tape indicator. Preferably, the indicator 28 is calibrated to a scale of 20 mA max. by a 10.000Ω variable resistor R5.

Fig. 14,15,16:

show a modified circuit diagram. The power supply 80 consists of a transformer T3 and two bridge networks Bj and B2, which convert either 115 V AC or 230 V AC from a socket into 5 V DC, in short + 5 V, and 30 V DC, in short + 30 V, as supply voltages. The 5 V DC supply + 5 V is regulated by a voltage regulator 129 and is used to supply power to the linkages in the Biedizinijc;hSu instrument. The 30 V voltage regulator ¹²⁶ is also regulated ^by the voltage regulator 126 and is used to apply a positive potential to the

Grounding pad 17. Basically, the controller 126 protects the patient from voltage spikes, however, as an additional safety measure, a fuse F2 is connected in series with a guard circuit 131. Preferably, the fuse limits the current to 1/32 amp. The guard circuit 131 trips the fuse when a voltage spike occurs on the 30 V line. At this time, a Zener diode D2 conducts current which in turn causes the guard circuit to fire a thyristor SCR, thereby shorting the 4-30 V power supply to ground and tripping the fuse. The guard circuit 131 similarly senses an overcurrent sent through the probe over line 82 from an opto-coupler OC (Fig. 15).

The magnitude of the current sent to the patient is controlled by the current generator 84. The current generator 84 has an 8-bit digital counter 139 which is incrementally driven by a pulse generator PO. 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 132 which provides an output voltage 133 which is directly proportional to the output count of the counter 139. The output voltage 133 is then fed to the base B of a transistor 135 which provides a current sink from the patient to ground. The magnitude of the current sent through the probe is controlled by the magnitude of the voltage applied to the base B of the transistor 135. Therefore, as the digital count increases, the direct current sent through the probe increases.

A circuit limits the magnitude of the voltage applied to the base B of transistor 135. The output of a NAND gate 134, connected to the two most significant bits of the counter, is fed back to counter 139 through a diode D3 to form a final count. The final count prevents a sudden jump in current to the patient as the counter swings from its maximum to its minimum during a count-up command. If a final count were not present, the sharp drop in current applied would irritate the patient.

The voltage at the output of the digital-to-analog converter is controlled by a "high" switch 321 and a "low" switch 34 on the probe handpiece. Both switches 32, 34 are connected at one end to the 5 V output voltage (+5 V) power supply. At the other end, switches 32, 34 are connected to logic gates 136, 137, 138 (Fig. 15) by lines 88 and 89, respectively. The opening and closing of switches 32, 34 produces output signals which control the output count of counter 139. Pressing switch 32 alone commands counter 139 to count up to a maximum count determined by the predetermined final count. Pressing only the switch commands the counter to count down to a minimum count of 0000 0000, which is a digital zero count. As already discussed, this prevents the counter from swinging back to a maximum count,

which would send a maximum current through the probe. When both switches are pressed simultaneously, counter 139 is reset. An indication of the amount of current being delivered to the patient is provided by a tape indicator 28 provided on the probe handpiece. The tape indicator is driven by an analog-to-digital converter 144 which senses the voltage at the emitter E of transistor 135 via a line 143. The analog-to-digital converter produces a digital signal proportional to the voltage sensed at the emitter E. Preferably, analog-to-digital converter 144 provides output signals to fire eight separate light emitting diodes (LEDs) each representing 2 mA on the tape indicator. Therefore, when all LEDs are illuminated, a current of 16 mA or full scale is present.

The digital display 26 for the duration of the elapsed time of power to the patient is also provided on the probe handpiece. A digital clock driver 146, which may be a counter, is clocked by a 10 Hz signal over a line 143 from the pulse generator PG (Fig. IS). The output count of the counter 146 is used to drive three 7-segment digital displays representing minutes and seconds. During treatment, the 7-segment digital displays record the length of time a patient has received direct current. When the current delivered by the probe is reduced to zero, a signal 145 corresponding to a digital zero count as fed to the digital-to-analog converter 132 is applied to the counter 146 to lock the displayed time. This means that the time shown by the clock stops and shows the elapsed treatment time when the current is reduced to zero. When current is supplied to the patient again, the time shown by the clock continues.

The handpiece 14 may also have an indicator that indicates whether the probe is electrically active to deliver current. If the output count of the counter 139 is different from a logical zero (i.e. the probe has a potential to deliver current), the line 150 energizes a red LED 151 via a logic gate

shows a modified embodiment of the handpiece 14', in which a reset switch 76 can be present for resetting the time on the display. In this embodiment too, the "cook" and "animal" switches 32' and 34' are present next to each other.

The instrument is assembled by inserting the base 41 (Fig. 5, 5A, 5B, 5C) of a new probe 16 into the opening 40 of the handpiece 14. The handpiece and ground pad connection cables 20 and 64, respectively, are inserted into their respective connectors 60, 62, and the base unit is connected to an AC voltage source via a cable 58.

The patient 56 is placed in a right lateral fetal position with the grounding pad 17, moistened with saline for good electrical contact, acting as a positive electrode placed under the patient's right thigh. An anoscope 51 is inserted and positioned by the surgeon to

to view a hemorrhoid to be treated through a window 53. The surgeon then depresses switch 66 on base unit 12 to operate the instrument, which is indicated by light 68. At this time, indicator 30 on the handpiece indicates that the circuit is not closed. The surgeon touches the base of the hemorrhoidal lesion with the tips of electrodes 36, 38 of probe 16, which is indicated by indicator 30 as the circuit being completed (from the grounding pad through the patient to the electrode tips). The surgeon gradually increases the current through the probe by depressing switch 32, the strength of the current being indicated by band indicator 28 and the elapsed treatment time by indicator 26. When the current begins to flow, the surgeon depresses >t«A Cs-fcnstArv&mdash;CrvitoAit in /-ti α &Tgr;3&ogr;&ogr;*&agr; s4a*· T fioirvm T* &bgr; Hat &ogr; ir* Ji herouoCTAotAilt «loft /fAt* &Ggr;»&ggr;&ogr;&EEgr; VAW UVUUVU t/^lUUVU *U UAV WtMIlIf WW* «^«W»VU· *-&Lgr;* MM* UAWAA UWaMWVQWWUWy +*%**+ W* W*«K· The amount of treatment required is a function of time and current, that is, the higher the current, the shorter the time required for each treatment. The factor which limits the current is patient discomfort; therefore, by pressing switch 32, the surgeon slowly increases the current as far as possible without discomfort to the patient (perceived as pain) in order to shorten the treatment time. If the patient experiences discomfort, or at the end of the treatment, the surgeon gradually reduces the current by pressing switch 34.

The duration of each treatment time may typically be more than 5 or 10 minutes, however, the design of the handle portion of the handpiece and the axis of the probe, as best seen in Fig. 4, 4A, 4B, allows the surgeon to position his wrist comfortably without abnormal bending. Furthermore, as described above, the relative positioning of the treatment condition indicators and the probe tip elements relative to the surgeon's line of sight allows the surgeon to simultaneously monitor the patient's condition and the treatment conditions.

Results :

42 patients with symptomatic hemorrhoids were treated with an instrument according to the invention. The group consisted of 28 men and 14 women with an average age of 47 (range 21-70 years).

All patients underwent a medical history, visual and palpatory examination and anoscopy using the Hinkle-James rectal speculum. Patients with diseases other than hemorrhoids as the cause of their symptomatology were not included in the study.

During anoscopy, 8 segments were observed. In the patient in the right lateral position, segment 1 is on the left and segment 6 on the right front of the patient. Hemorrhoidal inflammation was rated from 0 to 4 according to Banov et al.

Crad O beueuiei lack of abnormality.

Grade 1 means vascular tangles or internal hemorrhoids, but no prolapse from the anal canal, which produces painless bleeding.

Grade 2 means prolapse with a state of distension, where tissue retracts after bowel movement. The patient may not be aware of the prolapse episode. As with grade 1, grade 2 hemorrhoids may bleed.

Grade 3 means prolapse of the limorrhoidal tissue during bowel movement, and the

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Hemorrhoids can bleed or cause pain.

Grade 4 means hemorrhoid prolapse that cannot be reduced, often associated with mucoid discharge and blood.

Each patient underwent treatment of all internal hemorrhoids with inflammatory change. Most hemorrhoids required a single treatment, which was recorded as milliamperes delivered (oiA) multiplied by minutes of current delivered (mA x min). Generally, one treatment was given per treatment session, but more than one small vessel was occasionally treated in a single session. If at follow-up total ablation of the hemorrhoid was not achieved from a previous treatment, an additional treatment was given to that vessel. This was recorded as additional milliamperes and treatment time.

A typical treatment consisted of observation of the hemorrhoid to be treated using the Hinkle-James rectal speculum. Treatment was directed to the top of the hemorrhoid, on the long axis of the vessel and at a very small angle to the rectal canal. If desired, this area was topically anesthetized with 4% xylocaine using a pointed cotton swab. The probe was inserted firmly into the vessel lumen. The current was then gradually increased, requiring 2-3 min to bring the current to 10'5 mA. When the double-tip probe was used, 60-100 mA x min of treatment per affected hemorrhoid was required. Visual changes from bright 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 speculum were removed.

Forty-two patients with a mean age of 47 (range 21-70) underwent evaluation for symptomatic hemorrhoids and treatment (mean duration of symptoms before treatment was 9.7 years (T Ji 0.01-26 years). Symptoms at presentation and number of treatments required for complete resolution of these symptoms are given in Table I. The most common symptoms were rectal bleeding in 81 % of patients, followed by pruritus (62%), protrusion of internal hemorrhoids through the anal canal (60%), and pain (42%). The mean number of treatments for complete resolution of these symptoms, with one affected vessel treated per visit, was 2.0, 2.9, 2.9, and 2.8, respectively.

TABLE I

Symptoms and number of direct current treatments required to eliminate symptoms in 42 patients with hemorrhoids

Pruritus Pain Bleeding Protrusion Symptoms of &ldquor;&ldquor;

% Patients 62 42 81 60

Treatments 2.9 2.8 2.0 2.9

ffli* Symptom~

The average number of affected hemorrhoidal vessels was 6.33 per patient. The hemorrhoidal involvement is shown in Table 1, the average degree of inflammatory change was greatest in the left and smallest in the right anterior segment.

Of the 42 patients, a total of 17 grade 1, 103 grade 2, 99 grade 3 and 46 grade 4 hemorrhoids were treated. The magnitude of mA, time and mA-time product required to completely ablate the inflamed hemorrhoidal tissue is directly related to the degree of inflammatory change.

TABLE &Pgr;

Hemorrhoidal quadrants corresponding to the average degree of inflammation of hemorrhoidal involvement in 42 patients

Area 12 3 4 5 6 7

Grade 2.8 1.8 2.5 1.9 2.3 1.2 2.2 2.0

All patients were asymptomatic at the end of the treatment course.

Patient follow-up was performed on all patients by direct contact. The mean duration of follow-up was 18.2 months (range 8-34 months). No recurrence of symptomatology was reported at the follow-up evaluation.

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The exact mechanism of action of direct current in eliminating hemorrhoidal inflammation without corresponding fibrous tissue formation is not known. However, vascular thrombosis with eventual rejection is the end result. When applied to hemorrhoids, the negative pole of the direct current produces hydrolytic decomposition followed by tissue contraction. Hydrolytic decomposition leads to vascular thrombosis, of which the vasa vasorum is the most likely.

Two possible explanations for vascular thrombosis when using direct current are:

Release of free hydrogen, i.e. when the probe is placed in a saline solution (such as blood) and current is passed through it, free hydrogen is generated; and

the generation of heat at the location of the probe with the formation of hydrogen.

Both mechanisms lead to the release of adenosine diphosphate (ADP) and/or thromboplastin.

The dried hemorrhoidal tissue is gradually shed within 3-7 days, being removed by defalcation. Hemorrhage associated with tissue shed has not been observed. Follow-up showed no signs of scar tissue formation. The durability of the therapeutic effect is based on the complete obliteration of the entire vessel from its starting point to its most drooping part.

Since the upper (internal) and lower (external) hemorrhoidal vascular plexuses anastomose, many patients have a combination of hemorrhoids (mixed/intermediate hemorrhoids), and similar external hemorrhoidal inflammation is eliminated with direct current treatment of the internal hemorrhoids.

The lack of pain with this procedure is due to the relative absence of somatic innervation of the area of origin of the internal hemorrhoids. Should a patient have innervation above the dentate line, topical application of 4% xylocaine allows no more than tolerable discomfort to occur during the treatment period.

These and other embodiments are within the scope of the following discussion. For example, the base unit 12 may have holders to accommodate the assembled arrangement of handpiece and probes and may also be wall mounted. The probe may have multiple electrode elements, the number being e.g. 1 or 3 or 4 or more, and the pattern being e.g. a polygon or a curve or a line or other pattern depending on the shape and size of the base area of the hemorrhoidal lesion to be treated. The electrode elements may also be curved or bent to improve visibility or access to the lesion.

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The probe may also be rotatable to a predetermined number of positions, e.g. by selecting corresponding shapes of wedge block and handpiece opening 42' (e.g. square or other shape), or to an unlimited number of positions by rotating the handpiece tip 44' about a shoulder of a screw along the probe axis. For example, a ball 45 biased by a spring 47 against grooves 49 in the tip 44' may be used to lock the probe position.

The instrument can be designed for the HF treatment of lesions or used to treat other conditions, e.g. fissures.

fig. 9 (as explained above):

The increase/decrease element control switches 32', 34' may be arranged side by side, and a third switch 76 may be provided, for example, for resetting the counter 26 for elapsed treatment time. The handstack or base unit may also have an audio signal generator, e.g. for treatment time or current, or a device for recording time and other treatment conditions.

Claims (13)

1. Instrument (10) for electrical direct current therapy of hemorrhoidal lesions (50) or similar in patients (56) (Fig. 4), with - DC generator (84), - Grounding cushion (17) for patients and - unipolar probe (16) with - distal tip for penetrating the lesion (SO) as a negative electrode, - Base part (41,4I ¹ ) and - starting therefrom at least one elongated probe electrode (36,38), - which ends in the distal tip for electrically conductive contact of the lesion (50), marked by - an instrument handpiece (14) - for holding the probe (16) and controlling the direct current intensity, with - a lower Haoi piece section (18) - for gripping by the operator (52), - a connection device - ZL'j electrically conductive connection of the probe base part (41,41') with the handpiece (14), - the axis (P) of the probe is arranged at an obtuse angle to the axis of the lower hand stack section (18) (A) (Fig. 4), such that - that the operator (52) holds the instrument handpiece (14) during treatment of the lesion (50) without excessive abnormal flexion of the wrist, - an upper hand stack section (24) - for therapy monitoring and control, - which is arranged substantially above the lower hand stack section (18) and - has a front surface (23) which - is visible to the operator when the distal probe tip penetrates the lesion (50), and has: - a display device - to display the status of the instrument's treatment conditions, - which, with the distal tip of the probe, lies essentially on the same line of sight (L) of the operator holding the lower hand stack section (18) with the distal probe tip penetrated into the lesion (50), and - a control device - to control the direct current strength, - the hub of the lower handpiece section (18) is arranged in such a way that the operator can operate the control device with the fingers of the hand gripping the lower handpiece section, - so that the operator can simultaneously observe the treatment site (54) and conditions displayed by the display device while gripping the instrument and operating the control device with one hand, so that the other hand is free when treating the lesion (50). 2. Instrument according to claim 1, characterized in that - the display device - has a device for displaying the elapsed treatment time. 3. Instrument according to claim 1 or 2, characterized in that - the display device - has a device for displaying the strength of the treatment DC current. 4. Instrument according to one of the preceding claims, characterized in that - the display device - has a device for displaying the actuation state of the treatment. 5. Instrument according to one of the preceding claims, characterized in that - the control device - has a first and a second device (32, 34) for increasing or decreasing the current intensity. 6. Instrument according to claim 5, characterized in that - the control device - has a third device for switching off the direct current. 7. Instrument according to claim 6, characterized in that - the third device - can be actuated by simultaneous actuation of the first and the second device. 8. Instrument according to one of the preceding claims, characterized in that - the obtuse angle (A) is approximately 120 °. 9, Instrument according to one of the preceding claims, characterized in that - the connecting device has: - the probe base - with a wedge (41,4t ¹ ) of predetermined size and shape and - a wedge guide (40), - which is sized and shaped by the instrument handpiece to accommodate the wedge (41) (Fig. 5, 5A, 5B, 5C). 10. Instrument according to claim 9, characterized in that - the wedge (41) (Fig. 5A) - has a substantially square cross-section with rounded corners of a predetermined size, corresponding to, but slightly smaller than, the dimensions of the wedge guide (40). 11. Instrument according to one of the preceding claims, characterized in that - is exchangeable and - has at least two elongated, parallel probe electrodes (36, 38). 12. Instrument according to claim 11, characterized in that - at least two distal tips of the extended fingers (16) - are offset from one another in the longitudinal direction. 13. Probe (16) for instrument (10) for electrical direct current therapy of hemorrhoidal lesions (50) or similar in patients (56) (Fig. 4), with - DC generator (84), - Grounding cushion (17) for patients (56) and - Instrument handpiece (14) - for holding the probe (16) and controlling the direct current intensity, marked by - a basic part and - starting therefrom at least one elongated probe electrode (36, 38), - which ends in a distal tip for electrically conductive contact of the lesion (50), - a connection device - for electrically connecting the probe base (41, 41') to the handpiece (14), - wherein the axis (P) of the probe is arranged at an obtuse angle (A) to the axis of the lower handpiece section (18), such that - that the operator (52) holds the instrument handpiece (14) during treatment of the lesion (50) without excessive abnormal flexion of the wrist, - the probe base - with a wedge (41) of predetermined size and shape, - a wedge guide (40), - which is determined in size and shape by the instrument handpiece (14) to accommodate the wedge (41), - G*Ji wedge (41) (Pig. 5A) - with a substantially square cross-section with rounded corners of a predetermined size corresponding to, but slightly smaller than, the dimensions of the wedge guide (40).