JPH0661366B2 - Organ coordination and synchronous function controller in anatomical system - Google Patents

Description

FIELD OF THE INVENTION The present invention broadly relates to devices for controlling body function, and in particular to placing one or more electrodes on a selected nerve fascicle and applying a pulse train to this or these electrodes. In addition, the present invention relates to a device for controlling, adjusting or treating the function.

Background Art Various patients exhibit involuntary control of the bladder and / or bowel. Usually, cystectomy or artificial sphincter implanted around the urethra is used to partially control the excretory function of the bladder and control self-control, but these solutions are specialized in medicine and related technology. The house has well-known drawbacks. Other patients who have little control over their bladder function equally need devices to restore their nerve and muscle dysfunction. Similar problems arise with involuntary bowel control.

The physiology of the bladder and intestines is the pelvic floor urethral muscle (levator ani muscle;
evator ani muscle) and related urethra and anal sphincter physiology. When the bladder stores urine and the intestine stores feces, two complementary but complementary behaviors are seen. In particular, the bladder and rectum should normally be relaxed and the urethral and anal sphincter muscles should continue to contract. The opposite is true when excreting urine or feces.
That is, the urethral or anal sphincter relaxes with the pelvic floor, and then the bladder or rectum contracts.

Once urination and defecation are completed, the phenomenon is reversed, that is, the sphincter muscles and the muscles of the pelvic floor return to the contracted state, and the bladder and rectum become accumulated. This behavior has been demonstrated by recording blood pressure (or EMG / pressure) simultaneously for bladder / rectal and urethral / anal movements when the bladder is full and empty. The sequence of such events is well established and generally accepted.

DISCLOSURE OF THE INVENTION Various surgical methods for controlling excretion of the bladder or intestine are disclosed (FIGS. 1 to 11), and symptoms are caused by the loss of coordination between functions of the internal organs which are normally synchronized. Twenty-one methods of altering are also disclosed (Table I) and seven methods of treating incontinence by increasing sphincter tone are also disclosed. (Table II).

The terms "control", "modulation" and "treatment" as used herein basically include not only selective control, modulation or treatment of a specific organ, but also distinction of organs for the purpose of diagnosis or rehabilitation. , Cyclic stimulation, eg, neuromodulating muscle behavior to restore muscle dysfunction in the pelvic bed without stimulating the pelvic nerves that control the detrusor muscle of the bladder. As used herein, the term "organ" includes the bladder, intestine and colon and associated organs such as sphincter, cuff and muscle, which are independent parts of the human body responsible for one or more specific functions. Means widely.

The essence of the present invention is to identify the anatomical location and functional characteristics of selected nerve fascicles that control the individual functions of the human bladder, intestine and / or at least one organ including the associated sphincter. Electrode means are then placed on such nerve bundles to electrically stimulate them and at the same time to separate these nerve bundles from adjacent nerve bundles. The electronic control unit, which will be described later, sequentially applies a pulse train to the electrode means to individually control the functions of one organ or several organs at the same time.

Each of the disclosed methods of treatment can be performed bi-directionally or uni-directionally depending on the needs of a particular patient.

Other advantages and objects of the present invention will become apparent from the description given with reference to the following drawings.

Description (FIGS. 1-11) FIGS. 1 and 18 are schematic illustrations of the pelvic plexus region of the human body including the nervous system that controls the bladder and intestinal excretory functions and related functions. This nervous system includes fibers (or nerve bundles) S of the somatic nervous system and nerve bundle A of the autonomic nervous system. Their direct origin is the sacral segment S of the spinal cord and sacrum
2, S3 and S4, below the lumbar spine, in a triangular bone with five fused sacrum wedged dorsally between the two hip bones. The main nerve leading to the detrusor of the bladder B mainly comes from the sacral segment S3, a smaller number from the sacral segment S2, and a smaller number from the sacral segment S4. Fig. 2 shows the stimulation of these sacral nerves. Bladder response that “responds” to.

The surgical methods and devices described herein provide for control of the bladder or intestine and related functions, modulation of symptoms due to loss of coordination of the normally synchronous bladder and intestine, and their associated sphincter muscles and sphincter muscle. It can be applied to treat incontinence due to increased tension. Permanent surgical implants or temporary percutaneous implants can be applied for the purpose of nerve stimulation.
Further, the electrodes can be embedded unidirectionally or bidirectionally.

As shown in FIG. 1, the main nerve exiting from each sacral segment S2, S3 and S4 comprises two elements, a dorsal root D and a ventral root V. The dorsal root is primarily sensory, sending sensations to the spinal cord. The ventral root, on the other hand, is primarily motile and sends motor impulses (impulsions) from the spinal cord to the bladder B and associated sphincter muscles. Although shown separately, the dorsal and ventral roots of each nerve are actually one in the normal case,
The fibers or bundles mix and proceed as a single trunk.

The nerve bundle is divided into a somatic nerve bundle S reaching the voluntary muscle and an autonomic nerve bundle A reaching an internal organ such as the bladder B. The dorsal root D and the ventral root V can be separated, since only a specific ventral root motor nerve bundle stimulation is expected in many surgical methods. In this way, the motor nerve bundle can be stimulated painlessly and without generating impulses along the sensory passage.

The somatic nerve S and the autonomic nerve A can also be separated from each other. For example, in a special way where you want to drive only the muscles controlled by the somatic nerve, you can stimulate only the somatic nerve. If it turns out that only the muscles of internal organs such as the detrusor of the bladder B are to be controlled, the autonomic nerve bundles can be stimulated. Stimulation of all nerve trunks stimulates dorsal, ventral, somatic and autonomic nerve bundles.

However, such stimulation may be undesirable in some patients. The reason is that the uncoordinated motion may continue and the bladder B and the external sphincter E may contract, respectively, and may not respond effectively to the stimulus. Therefore, by allowing the dorsal and ventral roots to be isolated from each other and the somatic and autonomic nerves to be isolated from each other, the practitioner reduces patient discomfort while at the same time identifying one or more organs. You can control the response.

For example, the response obtained by assessing the response to urodynamically recorded stimuli before treatment (before final attachment of the electrode to a given nerve) indicates that the S2 sacral nerve is the main source of motion for the external sphincter E. Yes, while S3 sacral nerve is bladder B
Has been found to be the main source of movement against. Therefore,
The S3 sacral nerve is used to control only the detrusor muscle, and thus the contractile function of the bladder B, while the S2 sacral nerve is the external sphincter E.
Used to control the muscles that control the self-control function of. As a result of the study, it was confirmed that in some patients, only one nerve of the sacrum is responsible for the main motor control of a specific organ, that is, unidirectional control rather than bidirectional control. Pretreatment of certain patients will help determine which changes would be the best choice for the next surgical procedure. The present invention distinguishes different nerves into different components and allows the patient's response during surgery and recording to be tested to identify specific nerve bundles that act on a particular function or functions required. It was possible to distinguish and to stimulate these selectively.

Figures 1 and 3 to 11 show surgery to perform desired nerve stimulation for a specific case study (male or female) in which stimulation control is performed to coordinate the synchronous functions of the sphincter muscles associated with the bladder or intestine. Various combinations of treatments are shown. For example, a quadriplegic patient with a neck injury and spinal cord injury usually requires a surgical procedure in which control of the bladder B and external sphincter E is paramount. In addition, patients with tetraplegia may suffer from uncontrolled bladder evacuation, for example, while bladder control can be controlled simultaneously when such surgery is performed.
In addition, one may want to coordinate other voiding dysfunctions that may result in one or more of many other neurological reasons.

Thus, the particular surgical methods described herein can be combined with one or more other methods referred to as pretreatment evaluation of response to urodynamically recorded stimuli. For example, if it is stated that a particular method (eg, electrode implantation, nerve isolation, amputation, etc.) is done bi-directionally, clinical trials have shown that in some other patients the unidirectional method (or both methods) is used. (In combination with direction) may be required (and vice versa). Similarly, the particular steps or methods used in a single surgical procedure (FIGS. 1 and 3-11) will be apparent to those skilled in the art from one or more steps used in other surgeries. It can also be used in combination.

Although the surgical procedure described herein is usefully applied primarily to the coordinated control of the bladder and intestine and their associated sphincter muscles, a similar method, detailed below, is used for other organs, including the colon, associated sphincter muscles and cuffs. It is applicable to control and to eliminate or suppress spastic voiding activity, spastic pelvic floor activity and spastic urethral and anal sphincter activity. Also, in all of the surgical procedures described herein, a pre-procedural assessment of the response to the stimulus has been recorded urodynamically to ensure that nerves required for nerve stimulation and / or isolation, such as by amputation, are accurately located. Shall be.

Surgical method for controlling excretion (FIG. 1) The following surgical method shown in FIGS. 1 and 3 to 11 is explained mainly in relation to simultaneous control of the coordinated and synchronous functions of the bladder and its sphincter. However, they are also applicable to the control of the intestine and its sphincter.

FIG. 1 shows a method for precisely controlling self-control and excretion of the bladder B in a specific patient such as tetraplegia. The particular surgical method used depends on the patient's ability to electrically stimulate and respond to a strategic location on his or her nervous system in the plexus region of the pelvis. For example, assume that the surgical procedure of FIG. 1 does not allow the patient to self-control the functioning of his or her bladder, and that such location has already been assessed prior to treatment.

As shown in FIG. 1, after percutaneously inserting an electrode into at least the immediate vicinity of the S3 sacral nerve and electrically energizing it, the anatomical position of the S3 sacral nerve was identified. As shown in FIG. 5, the dorsal (sensory) root D and the ventral (motility) root V are surgically separated bidirectionally on both sides of the sacral segment S3.
At this time, the electrode 2 is externally excited and is attached by suturing or embedding on each ventral root V for the purpose of stimulation. This will be described later on the urination control system shown in FIG.

After implanting the electrodes 2 on both sides of the ventral root V, each superior somatic nerve is bidirectionally cut with 3, and the levator muscles at least partially surrounding the external sphincter E and controlled by the superior somatic nerve S _S. Eliminates the increased resistance normally exerted by the ani muscle. Upper body innervation (S _S) of the common anatomy book for (e.g., Ciba or gray) to be set forth as part of the innervation of the levator Ani muscle, while the lower body innervation
(S _I ) is described as the vulvar nerve of the Alcock tract. Note that the internal sphincter I contracts the bladder,
Therefore it is usually automatically opened when no artificial control is required.

Before the surgical procedure shown in Fig. 1, the S3 sacral nerve was identified,
Perioperative stimulation and urodynamic recordings confirmed that it controlled the bladder and related functions. It was considered that the minimum requirement needed to be able to excrete into the bladder without compromising self-control, ie to store the contents of the bladder until the condition was suitable for urination, was met. Next, when the ventral root V was bidirectionally separated from the dorsal root D and the electrodes 2 were embedded on both sides of the ventral root, it was found that pain and other unwanted reflex response were minimal. The resistance to drainage through the urethra U cuts the upper somatic nerve S _S at 3, thereby separating the various nerves that control the resistance to drainage in the external sphincter E, ie, exercise to the levator ani muscle. It was cured by separating the supply.

Pre-treatment electrical stimulation was performed using a bipolar probe to stimulate various nerve bundles. At this time, a square wave of direct current was applied using a nerve stimulator to fulfill the purpose of stimulation. The neural stimulator may be of the type manufactured by Grasse Medical Instruments of Quincy, Inc., Massachusetts, USA under the name Model No. S-44. The electrodes are of a standard type, for example, each electrode is a bipolar cuff electrode having an inner diameter of 3 to 5 mm and a platinum contact of 1 mm × 2 mm, and the electrodes are separated by 3 mm outwardly around the ventral nerve root V. Can be placed. This type of electrode is model No.
Manufactured under the name of 390.

Suitable for receiving RF (radio frequency) pulses coming from an external transmitter, as detailed later in Figures 12 to 17,
A suitable receiver, in the form of an implantable silastic coated unit containing an antenna coil, is implanted in the patient's subcutaneous tissue and the electrodes are pulsed to control bladder evacuation in a controlled manner.

Optimal surgical method for controlling excretion (Fig. 3) Fig. 3 shows an optimal modified example of the surgical method of Fig. 1, mainly for enhancing the excretory function of the bladder. After the various nerves that control bladder excretion were identified by intraoperative stimulation and urodynamic recording, the S2, S3 and S4 sacral nerves were isolated and their ventral and dorsal roots were isolated. Then, the vulva, that is, the lower somatic nerve S _I is unidirectionally cut at 1a to separate the external sphincter E on one side. Then S3
The dorsal root D of the sacral nerve is cut at 2a to block its sensory function. Although illustrated and described as unidirectional, in some cases it may be desirable to make such disconnection bidirectionally.

Next, the electrode 3a is unidirectionally embedded on the entire S3 sacral nerve. At this time, at other sacral levels, dorsal root incision may or may not be involved. Next, the S3 sacral nerve is cut unidirectionally (or bidirectionally) with 4a to float the downstream of the pelvic nerve P so that the S3 sacral nerve does not act on the lower somatic nerve S _I. Note that the electrode 3a is located on the S3 sacral nerve and stimulates the detrusor muscle of the bladder B via the pelvic nerve P.

After appropriately separating the dorsal and ventral roots of the S2 sacral nerve, the dorsal root is unidirectionally (or bidirectionally) cut with 5a, and the electrode 6a is appropriately embedded on the ventral root V of the S2 sacral nerve. It should be noted that the upper somatic nerve S _s is bidirectionally cut as described above in the surgical method of FIG. 1, and when the bladder contracts for the purpose of excretion, it is resisted by contraction of the levator ani muscle. It is preferable not to increase the degree additionally.

The variations described above eliminate or minimize the response of the sphincter of the pelvic floor. Otherwise, this sphincter will prevent low resistance voiding of the bladder that is synchronized with the stimulus. These optimal variants eliminate the excessive sphincter activity that remains after stimulation after attempting the surgical procedure of FIG. The sphincter response occurs reflexively, implying in FIG. 3 that dorsal root transection at 2a and 5a needs to be performed. Response sphincter sometimes occur directly, which is the lower body nerve S _I
Implications that the cut at 1a may be unidirectional or unidirectional. Of course, the above-mentioned steps should be carefully evaluated before selecting the surgical method so as not to impair the contraction of the nerves controlling the bladder or intestines or the erectile process.

An additional optimal method is to percutaneously implant electrodes 7a 'on the sacral nerves S3 and / or S4. This electrode is implanted upstream of the point where the autonomic nerve roots forming the pelvic nerve P separate from the specific part of each sacral nerve, and assists the contraction of the bladder via the pelvic nerve. Another variation is to implant a cuff electrode 8a 'around the sacral nerve S4 unidirectionally or bidirectionally as shown to help control bladder excretion. What you should understand is that the cutting step described above
Implantation of 2a and 5a and electrodes 3a, 6a and 8a requires laminectomy, an incision in the posterior arch of the vertebra.

Non-laminectomy method for controlling internal organs (4th
(Fig. And Fig. 5) Fig. 4 illustrates a surgical method of implanting the electrode 1b on the S3 sacral nerve via the sacral foramen without cutting the posterior arch of the vertebra. In addition to or instead of this electrode 1b, a second electrode 2b can be similarly implanted on the S4 sacral nerve. These electrode implants can be unidirectional or bidirectional as shown, depending on the results of the pretreatment test. Alternatively, the upper somatic nerve S _s can be cut unidirectionally at 3'or bidirectionally as shown in FIG.

Thus, the surgical approach of FIG. 4 usually eliminates or suppresses spastic urinary activity, spastic urethral and pelvic bed activity, and spastic anus activity. The erection can be suppressed or enhanced in this manner.

FIG. 5 illustrates that the electrode 1b is implanted percutaneously through the sacral foramen of the dorsal and sacral segment S3 for the purpose of selectively stimulating the S3 sacral nerve. After confirming the appropriate depth and position of the S3 nerve by electrical stimulation and recording it urodynamically, the electrode 1b is used as a hollow spiral needle (which is used to give such stimulation via a lead wire). ) At the position shown in the figure and the receiver (not shown) on the other end of the lead wire.
Attach. This will be described in detail later. This transcutaneous method can also be used to temporarily implant electrodes for testing purposes on any one or more sacral nerves. The test involves stimulating one or more nerves with electrodes to record bladder activity and determining which nerve controls bladder function. This method can be unidirectional or bidirectional.

For example, electrode 1b is placed percutaneously on the S3 sacral nerve, the inner ends of the leads are connected to the electrodes, the outer ends are connected to the receiver, and taped together on the skin. This way, the patient can have his or her own lifestyle 24 hours a day and the transmitter corresponding to the receiver can artificially stimulate the nerves. Once the response is positive and complete withdrawal is achieved, the electrodes may be permanently or temporarily used to compensate for any dysfunction by "retraining" the nerves and associated muscles. Can be embedded. If the results show little or no improvement, then exactly ascertain which nerves need to be stimulated in the same way. Therefore, the present invention not only controls the excretion of internal organs and the like by implanting one or more electrodes in the sacral nervous system, but also neuromuscularly modulates muscle behavior by using such electrodes and surgical methods. It can also be used to recover from a disorder. This will be described later in Table II.

ADDITIONAL OPTIONAL OPERATING METHOD (FIGS. 6-11) FIG. 6 shows an optional modification for controlling the excretion of the bladder B. In particular, as shown, the upper somatic nerve S _s is severed at 3 unidirectionally or bidirectionally. In addition, depending on the response obtained by assessing the response to the urodynamically recorded stimuli prior to treatment, unidirectionally or bidirectionally implanting electrode 1c on the lower somatic nerve S _I. Put in.

In FIG. 7, the electrode 1d is transcutaneously applied bidirectionally to the lower somatic nerve.
Embedded on S _I, embedding electrode 2d to bidirectionally S3 on sacral nerve. In FIG. 8, the electrode 1e is bidirectionally connected to the upper somatic nerve S.
_The electrode 2e is bidirectionally embedded on the lower somatic nerve S _I.

FIG. 9 shows another surgical procedure for controlling self-control and bladder contraction. In the illustrated surgical method, the electrode 1f is bidirectionally embedded on the lower somatic nerve S _I. Upper somatic nerve S _S
Is bidirectionally cut as shown, and a pair of second electrodes 2f is bidirectionally embedded on the isolated ventral root of the S3 sacral nerve.

FIG. 10 shows a surgical method particularly suitable for assisting self-control when the muscle of the bladder or intestine is weak. As shown,
Electrodes 1g and 2g are bidirectionally implanted on the inferior somatic nerve S _I and S3 sacral nerve, respectively. Optionally, electrodes are unidirectionally implanted on the S3 sacral nerve and electrode 2g 'is implanted on its ventral root. In addition, the electrode 3g is percutaneously implanted on the S3 sacral nerve in one direction. Alternatively, the electrode 3g 'can also be unidirectionally implanted percutaneously on the S4 sacral nerve.

Another modification shown in Fig. 10 is another electrode 2g.
Are unidirectionally or bidirectionally embedded on the upper somatic nerve S _S. The surgical procedure shown in FIG. 10 shows two factors involved in contraction of the sphincter. The number and location of the electrodes to be implanted, the ability to gradually increase the muscle activity of individual patients, and the electrodes to an appropriate nerve bundle. Rely on transdermal technology and / or full binding.

FIG. 11 illustrates a surgical method particularly suitable for controlling autonomic reflexes and bladder accumulation. The upper somatic nerve S _S is bidirectionally cut at 1 h, and the electrode 2h is bidirectionally embedded on the lower somatic nerve. As an alternative to the latter step, the electrode 2h can also be unidirectionally implanted on the opposite side of the lower somatic nerve cut at 2h '.

As indicated above, the surgical methods shown in FIGS. 1 and 3-11 are indicative of a particular method applicable to a particular patient. Accordingly, the various steps described above in connection with a particular orientation may be tailored to the needs of a particular patient with or instead of the steps included in one or more of the other methods. For example, many steps may be bidirectional even though illustrated as unidirectional, and vice versa.

Thus, in the claims, the expression "implanting" or "attaching" or "cutting" an electrode into a particular nerve covers both unidirectional and bidirectional methods. .

The selection of the various variants mentioned above is based on the evaluation of the responses obtained from the pre-treatment stimuli which are recorded urodynamically. The way in which the particular method can be performed percutaneously or surgically or a combination thereof further extends the application of the invention. Medical practitioners in this regard will appreciate that the surgical methods described above can be used to control not only bladder function, but also central function of other organs such as the colon, intestine and sphincter.

Description of the micturition control system (Figs. 12-14) Fig. 12 illustrates a micturition control system suitable for sending current (radio frequency) pulses to electrodes implanted on selected nerves of the nervous system described above. It is a thing. For example, in the embedding shown in FIG. 9, lead wires 26 and 27 are connected to electrode 1f and lead wires 47 and 48 are connected to electrode 2f. The control system comprises an external control transmitter 10 and a receiver 11 attached to the patient's body for sending current pulses to the electrodes. This control system has a dual purpose. (1) Keep the urethra in good condition, and therefore, control urination until the bladder wants to excrete. (2) When the patient or attendant desires to urinate, the bladder is contracted to save the patient who has a bladder or renal pelvis problem or paralysis.

FIG. 12 shows electronically controlled transceiver elements of the micturition control system,
FIG. 14 shows the type of signal and the time relationship of the electronic control elements. The symbol SR here refers to the element of the control system connected to the electrode that is implanted on a particular sacral nerve or root, IS
Shows connections to the lower somatic nerve S _I that controls self-control.

Continued control of self-control (keeping the contents of the bladder B) is provided by stimulation of the nerve selected as described above. This control function is accomplished by the continuous stimulation generated by the stimulation pulse oscillator 12 (OSC) and associated circuitry. As shown in Fig. 14, this stimulation pulse oscillator operates at a rate of generating 5 to 40 pulses per second, emits a square wave output signal, and has an IS stimulation pulse width one-shot (OS) 13 Preferably produces a signal pulse of width 50 to 500 μsec. These pulses are sent to AND gates 14 and 15, where
It produces a separate pulse train as shown in FIG. The gating pulse is generated by the IS pulse train duration oscillator 16.
It should be noted in FIG. 12 that the square wave output of the oscillator 16 is 2
The individual phases are to be obtained by the illustrated inverter circuit.

The frequency of the square wave output of oscillator 16 is preferably chosen in the range 0.1 to 0.5 Hz. This oscillator 16 is controlled by an IS stimulation control flip-flop 17. When this flip-flop is controlled, it activates oscillator 16,
Radio frequency (RF) oscillator with D-gates 14 and 15 enabled
Send a signal pulse (Fig. 14) to turn on and off 18 and 19.
The output amplitudes of the radio frequency amplifiers 20 and 21 are variable resistors 20 'and
Each antenna can be adjusted by 21 'and each pulse is driven separately.
Send to 22 and 23.

These antennas are inductively coupled to the receivers 24,25. These receivers 24,25 detect a set of RF pulses and send the detected pulses to electrodes implanted on specific nerves via leads 26 and 27, respectively. Receiver 24 and 25
Also, receivers 45 and 46, which will be described later, are each implanted under the skin of the patient.

When it is desired to excrete the bladder B (assuming that four electrodes are correctly implanted in a specific patient as described above), the patient or attendant momentarily closes the switch 28. The transmitter and associated antenna are, of course, properly housed, placed in an external unit and placed near the patient. When the switch 28 is closed, the SR stimulus timer 29 runs for a selected time (preferably in the range 10 to 40 seconds).

During this time interval, the output Q of the timer 29 is high, actuating the SR delay oscillator 30 and resetting the IS stimulus control flip-flop 17. Therefore, this flip-flop 17 turns off the IS pulse train duration oscillator 16. As a result, the stimulus that closed the urethral sphincter is removed. At the same time, the Q output of the timer 29 is low, causing the flip-flop 31 to be set when the signal from the SR delay oscillator 30 arrives. After a predetermined time delay of 2 to 20 seconds (Fig. 14), the output signal of the SR delay oscillator 30 sets the flip-flop 31, which causes the SR stimulus pulse oscillator 32.
And start the SR pulse train duration oscillator 33.

Oscillator 32 may be 15 to 50, as shown schematically in FIG.
Choosing from the range of Hz produces a suitable square wave signal. The output from this oscillator 32 drives an SR stimulus pulse width oscillator 34, which produces a signal pulse of a selected width of 50 to 500 μs. These pulses are ANDed with the output of oscillator 33 by AND gates 35 and 36 to produce a pulse train as shown in FIG. It should be noted in FIG. 12 that the inverse-phase rectangular wave output of the oscillator 33 can also be obtained by using the illustrated inverter circuit. Gate control is 0.1 to
With oscillator 33 having a selected frequency in the range of 0.5 Hz.

The pulse trains from AND gates 35 and 36 control high frequency oscillators 37 and 38, respectively. These are turned on when the pulse is high. The high frequency signal is amplified by the high frequency amplifiers 39 and 40. Here, the output amplitudes are variable resistors 39 'and
Controlled by 40 '. The outputs of these amplifiers 39 and 40 drive antennas 43 and 44. These antennas are inductively coupled to receivers 45 and 46 that are implanted through the patient's skin. These receivers detect RF pulses and deliver stimulation pulses via leads 47 and 48 to the implanted electrodes.

After a selected time of timer 29, eg 10 to 40 seconds, the output is inverted. The Q output goes low, flip-flop 17 is turned on, and the IS delay oscillator 49 “sets” it.
Allows oscillator 16 to be activated when a signal is sent. The output of timer 29 goes high, activating the IS delay oscillator 49. At the end of the preselected time delay of 2 to 20 seconds, the output (FIG. 14) sets the IS stimulation circuit until bladder evacuation is again required. The output of timer 29 also resets the flip-flop,
Disables 33 and finishes excretion stimulation to the bladder.

The above-mentioned various oscillators (OSC) are M
It may be an astable multivibrator manufactured under the name odel No. ICM7556. one-shot
The (OS) monostable multivibrator can also be of the common type manufactured by Intersil. Flip-flops (FF) are of the type manufactured by RCA of the United States, and the gate is Mo by the same company.
It can be of the type manufactured under the name del No. DC 4081B.

The receivers 24, 25, 45 and 46 have respective receiver antennas 22, 23, 23,
It can be a standard implantable silastic-coated unit containing an antenna suitable for receiving "RF" pulses sent from 43 and 44. For example, each receiver is a Model N
o. It may be of a similar type manufactured under the name of I-110 (bipolar). FIG. 13 shows a typical circuit 55 of the receiver.

In particular, the coil 56 functions as an antenna for receiving inductive signals transmitted by respective transmit antennas located outside the patient and near the implanted receiver. Capacitor 57, together with coil 56, form a tuning circuit that tunes to one of the four different frequencies of the transmitter. If the control system uses four separate radio frequencies, tune the other three receivers to their respective transmit frequencies. Alternatively, the frequencies in these four figures could be the same for all four transmitters and the four receivers could be tuned to the same transmit frequency. In this case, the four transmitting antennas are separated from the four embedded receivers so that the signal of any one transmitting antenna does not become a signal due to the other three receivers.

With further reference to FIG. 13, diode 58 detects pulsed stimulation currents from the RF burst by half-wave rectification. The resistors 59 and 60 and the capacitors 61 and 62 function as a filter, and send only the stimulation signal excluding RF to the nerve electrode through the lead wire as described above. The nerve is maximally stimulated when the negative electrode is attached to a distant electrode contact on the nerve and the corresponding positive electrode is attached to the near contact of the nerve electrode assembly.

Those skilled in the art can appropriately modify the control system shown in FIG. 12 to control the biasing of the electrodes used in the above-described method and its modification. For example, only part of the system that controls the pulse input to antennas 24 and 25 can be used to energize electrode 2 of FIG.

Figures 15 and 16 show a typical way of implanting electrodes for the purpose of stimulation. FIG. 17 is a schematic diagram showing the timing of the stimulation pulse train to the electrode pair.
100 / n% activated. Where n is the number of active (cathode) contacts.

One of the major problems encountered when applying electrical signals to the nervous and muscular system for long periods of time, causing the muscles to contract during that time is nerve and related muscle fatigue. One way to prevent fatigue (muscles are more likely to fatigue than nerves) is to stimulate the system discontinuously over time. Another method is to alternately stimulate different nerve fascicle groups within the nervous system with short bursts of stimulation pulses. According to this stimulation method, the muscles and nerves can be recovered between the stimulation trains while other nerves and muscles are activated, and a desired physiological effect can be obtained.

There are at least two ways to stimulate nerves by changing them over time to cause muscles to contract. Figure 15 is the first
Is shown here, where a large number of electrode pairs 6
3,64,65 and 66 are attached to separate nerve bundles. Each electrode pair is activated so that each electrode is "on" for part of a particular stimulation cycle. For example, if there are 4 pairs of electrodes, each pair of electrodes will have its own nerve bundle for about 1/4 hour (generally speaking, if there are n pairs of electrodes, 100 / n% of the time).
stimulate. It should be noted in FIG. 17 that the overlaps and immobility times between the stimulation trains can be varied, although they are shown as coincident.

FIG. 16 shows a second approach for achieving time modulation of neural stimulation, where multiple active electrode contacts are provided on a single electrode. However, in this case, in order to alternately stimulate a single nerve bundle, the intensity of the stimulation pulse must be low enough so that the entire nerve bundle is not stimulated by a single active electrode contact. I won't. Nevertheless, the amplitude of the stimulation pulse must be high enough to obtain the desired physiological function.

The active electrodes (cathodes) must be positioned on the nerve bundles so that they stimulate different nerve bundles. Therefore,
As shown in Figures 16 and 17, a single electrode must not activate all nerve bundles in the associated muscle. Ideally, each electrode contact would function to activate a proportional number of nerve fibers. For example, if there are two contacts, each contact stimulates 1/2 nerve bundle, if there are four contacts it stimulates 1/4 nerve bundle, and so on. However, the desired physiological function must be achieved even with a single contact on a particular nerve bundle. The exception is when other nerve bundles are similarly connected to similar time-modulated systems. In this case, partial neural stimulation from the combined group of stimulated nerve bundles achieves the desired physiological effect.

Electrical control for visceral, visceral and somatic neuromuscular dysfunction Bladder and intestinal physiology are closely linked to the urethral physiology of the pelvic floor and associated urethral and anal sphincter muscles. The series of accumulation (self-control) and excretion imply that somatic muscles of the pelvic floor can respond primarily to self-control and excretion. Upon accumulation, visceral organs, such as the bladder / bowel, are released from antireflex and / or contracted directly, or both. It has been found that neural control of the pelvic muscles largely determines the activity status of the pelvic glands (bladder, intestine and possibly erection). A simple example is the "hold" reflex, which is used to suppress the strong desire to urinate or defecate when it is inconvenient.

If the neural regulation of bladder and bowel activity is normal and tied directly to that of the pelvic muscle, it will be tied to it even during abnormal times. Just as the hold reflex suppresses the inconvenient need to empty the bladder or intestine,
Electrically contracting the pelvic sphincter can suppress bladder or bowel activity.

Patients experience a variety of symptoms resulting from dysfunction of the bladder, bowel, urethra, anus and pelvic floor muscle system. Normally, muscle abnormalities are not recognized as any illness. But,
Muscle abnormalities may resemble abnormalities found in other neurological disorders (eg, Meningo, Maierosul, hydrocephalus, spinal cord injury, cirrhosis, seizures, etc.). Built-in dysfunction
Particularly in the case of the bladder associated with pelvic muscle abnormalities, bladder behavior or excessive triggering of bladder contraction that is a direct result of excessive self-control (eg, inability to completely urinate due to inability to fully relax the urethral sphincter). It is substantiated when there is behavior of the ring (ie, the tedious desire to empty the bladder). This is because the effectiveness of reflex coordination between the bladder and pelvic muscles is disrupted. Similar analogies are made for problems that adversely affect the bladder (and erection). Thus, correction of pelvic muscle abnormalities is useful for correction of visceral muscle dysfunction. Other effects complained by the patient are severe neck stiffness, back stiffness and leg cramps.

Visceral muscle dysfunction, which may be the result of overactivity, can lead to spastic colonic, intermittent cystitis, cardiovascular problems such as micturition instability, migraine or papalization, and bladder residual disease. Including. Somatic muscle abnormalities due to weak nerve control and overactivity are pelvic pain, periodic symptoms (instability of pelvic floor and / or urethra), weak relaxation or sphincter instability. Including restraint by (bladder or bowel) and prostatectomy before restraint.

Each of the above showed a response when stimulating the somatic muscles of the pelvic floor (mainly the levator ani muscle of Figure 18). Nervous stimulation of the pelvic muscles stabilizes their neural regulatory mechanisms. At this time, the behavior stabilization of the pelvic muscle adversely affects the internal nerve stimulation.

Because of the similarities in neural control between the bladder and the intestine, bowel problems also involve implanting electrodes in the sacrum or vulva.
It can be treated by "spastic colon" and feces restraint due to spasms or failure of the anal sphincter and irregular or frequent bowel movements.

The Spinoff advantage that has been gaining attention is the handling of footdrops. Plantar flexion of the foot and the distal half of the toe appear to increase gait stability. It has long been believed that footdrops are due to the weakness of muscles controlled by the perineal nerve. I was stimulating this nerve and using a foot dolcis lexer to raise my foot. But it wasn't very successful. Stimulation of the sacral S3 nerve root N3 improved the foot drop. This is because the foot is pushed properly as a result of plantar flexion.

FIG. 18 is labeled with letters indicating the various elements of the human pelvic plexus region that are common to the symbols of FIGS. 1-11. In addition to this common character, the table below shows the meaning of the new character adopted in Figure 18.

A: Autonomic nervous system B: Bladder C1 to C6: Electrode (Although shown as a cuff electrode, other types can be used.) D: Dorsal root of nerve (sensory) E: External sphincter of bladder B F: Pore electrode I: Internal sphincter of ani muscle of levator muscle (pelvic floor, that is, a complex muscle structure mainly composed of ani muscle of levator muscle and constituting outlet of pelvis) J: Dorsal nerve of penis L: Anal branch of vulvar nerve T2 , N3: Sacral nerves derived from sacral segment S2 and S3, respectively P: Pelvic nerve connecting sacral nerve and dorsal muscle of bladder B R: Anal sphincter muscle (sphincter ani) S _I : Lower somatic nerve S _S : Upper body Sexual nerve T: Vulva nerve U: Urethra V: Ventral root of nerve (motor) The method discussed here is the bladder B, which is normally synchronized,
Rectal R and related bladder sphincter E and I and rectal R
It can be used to alter symptoms due to loss of coordination between functions of organs including the anal sphincter (Table I) or to increase sphincter tone and manage self-control (Table II).
The sacral nerves N2 and N3 are derived from the sacral nerves S2 and S3, respectively, and form the pelvic nerve that controls the contraction of the dorsal root that surrounds the bladder B. The sacral nerve also serves as a somatic element and is classified as follows. (1) Upper somatic nerve S _S and (2) Vulva nerve T
_{o The} latter is (1) the lower somatic nerve S ₁ that connects to the muscle that controls the external sphincter E of the bladder B, (2) the anal branch L that connects to the anal sphincter for the rectum R, and (3) the dorsal nerve that connects to the penis. Classified as J. The nerve bundles that connect to the various sphincter muscles
It can be controlled with lower levels of electrical stimulation than are needed to control the muscles of the bladder and rectum itself.

FIG. 18 shows six cuff electrodes C1 to C6, which are placed individually or in combination with at least one other electrode on a nerve bundle selected for the purpose of stimulation (simultaneously adjoining nerves). Separate the bundle). Such a positioning step is performed after identifying the anatomical location and the functional characteristics of the selected nerve bundle. A pulse train is then sequentially applied to the electrodes to control organ function.

Individually, electrodes C1-C6 control the function of the following organs:

C1: bladder B, sphincter E, anal sphincter R and dorsal muscle of bladder B C2: dorsal muscle of bladder B and intestinal sphincter E and anal sphincter R C3: bladder sphincter E and anal sphincter R C4: internal sphincter I ( Pelvic floor) C5: Bladder sphincter E C6: Anal sphincter R The term "reflex control mechanism" means the nerve bundle that controls the correlated activity between the bladder B and the pelvic floor muscles (mainly the levator ani muscle I). This is because the nerve bundles can reflexively influence each other in inhibition and promotion.

It should be noted in the table that different electrode combinations can affect the same organ, but to different degrees of strength. For example, in Table I, electrode combinations (1) and (8) affect bladder B, bladder sphincter E and anal sphincter R, respectively, but in combination (8) the bladder is relatively more responsive. Lid and main pelvic nerve P
Is mainly from the sacral segment S3 and the sacral nerve S2.

The site chosen for implanting the electrodes is determined by careful evaluation of the patient's problem. Such assessments consist of symptom analysis, physical deficits or altered muscle behavior or loss of excitability of the lower extremities of the pelvic muscles, results of urodynamic tests and results of test stimulation of various sacral nerves. Transient electrodes are usually inserted percutaneously into one or more sacral foramina to test-stimulate specific nerve roots and see the response. When the desired response is obtained, a temporary electrode can be "floated" near the nerve (eg, hole electrode F in Figure 18). According to this method, a patient can evaluate the therapeutic outcome of stimulation by simply undergoing a stimulation test for 3 to 5 days.

Based on the response obtained with the test stimulus, the patient can be further evaluated for the response to be obtained by percutaneously implanting electrodes on one or more selected nerve bundles. Also, the electrode can be permanently implanted by sacral laminectomy by placing the electrode directly on a particular sacral nerve or by placing the electrode on the sacral foramen without laminectomy. Thus, by stimulating a specific pelvic muscle, a therapeutic result is obtained.

The electronic control system and electrode arrangements shown in FIGS. 12-17 are also applicable to the methods described in Tables I and II, with appropriate modifications.

[Brief description of drawings]

FIG. 1 is a schematic explanatory view showing a human pelvic plexus region including a nervous system controlling bladder excretion and related functions, and a first surgical method for controlling such a function, and FIG. 2 is S2. , S3 and S4 Stimulation-response curve schematics of bladder contraction in response to stimulation of the sacral nerve, FIGS. 3 and 4 are illustrations showing additional surgical methods for controlling bladder excretion and related functions, FIG. 5 is an explanatory view showing a case where electrodes are percutaneously implanted near the S3 sacral nerve, FIGS. 6 to 11 are explanatory views showing an additional operation method, and FIG. 12 is a block diagram of the micturition control system. FIG. 13 is a circuit diagram of an embedded receiver of the micturition control system of FIG. 12, FIG. 14 is a time diagram showing the time relationship of electric signals of the micturition control system of FIG. 12, and FIG. Fig. 16 is an explanatory diagram of the electrode arrangement for attaching electrode pairs to separate nerve bundles, which is adapted to be used in the control system of Fig. 16, FIG. 17 is an explanatory view in the case of providing a large number of electrode contacts on one electrode, FIG. 17 is an explanatory view showing the time relationship of electric impulses of the electrode arrangement shown in FIGS. 15 and 16, and FIG. 18 is various nerve bundles. It is explanatory drawing which positions an electrode on it and obtains a desired result. 10 …… Transmitter 11 …… Receiver 12 …… Stimulation pulse oscillator 13 …… IS stimulation pulse width one-shot 14,15… AND gate 16 …… IS pulse train duration oscillator 17 …… IS stimulation control slip-flop 18, 19 …… Radio frequency oscillator 20,21 …… Radio frequency amplifier 20 ′, 21 ′ …… Variable resistance 22,23 …… Drive antenna 24,25 …… Receiver 26,27 …… Lead wire 28 …… Switch 29… … SR stimulus timer 30 …… SR delay oscillator 31 …… SR stimulus control flip-flop 32 …… SR stimulus pulse oscillator 33 …… SR pulse train duration oscillator 34 …… SR stimulus pulse width oscillator 35, 36 …… AND gate 37, 38 ...... Radio frequency (RF) oscillator 39,40 ...... Radio frequency amplifier 39 ', 40' ...... Variable resistance 43,44 ...... Antenna 45,46 ...... Receiver 49 ...... IS delay oscillator 55 ...... Receiver Circuit 56 …… Coil 57 …… Capacitor 58 …… Diode 59,60 …… Resistor 61,62 …… Capacitor 63, 64, 65 , 66 …… Electrode pair

 ─────────────────────────────────────────────────── ─── Continued Front Page (72) Inventor Curtis A. Gleason 94303 Palo Alto Charleston Court, California, USA 721 (72) Inventor Tom F. Liu, USA 94030 Millbre Yunita Avenue 407

Claims (19)

[Claims] 1. A device for simultaneously controlling the coordinated and synchronized functions of at least one or more organs within an anatomical system such as the bladder and / or intestine and associated sphincter muscles, said device comprising: a. Identification means for identifying the anatomical location and functional characteristics of a selected predetermined nerve bundle controlling individual functions of said one or more organs; b. Separating means responsive to the identifying means for selectively separating adjacent nerve bundles from the predetermined nerve bundle that control different organ functions and / or anatomical organ characteristics; c. One or more electrodes selectively positioned proximate to the predetermined isolated nerve bundle or selectively attached directly to the predetermined nerve bundle; d. An organ in an anatomical system, comprising: stimulating means for supplying a stimulating pulse to the electrode for individually and selectively controlling the function of the one or more organs. Coordination and synchronization function control device. 2. The stimulation means includes a nerve stimulator transcutaneously inserted at least close to the selected nerve bundle and recording the response of the selected nerve bundle to the stimulation pulse. The device according to claim 1. 3. The anatomical system also includes S2, S3 and S4 sacral segments of the spinal cord and sacral nerves originating from each of these sacral segments S2, S3 and S4; said sacral segments S2, S3 and S4. Includes a dorsal and sacral foramen; the neural stimulator is inserted through the dorsal and sacral foramen of at least one sacral segment of the sacral segment S2, S3, and S4. The apparatus according to claim 2. 4. Each of the sacral nerves includes a dorsal root D and a ventral root V in the sacral canal, and when the sacral nerve exits the sacral canal, forms a pelvic nerve, which pelvic nerve contracts the dorsal muscle of the bladder. Connecting to the bladder for control; the identifying means identifying at least one of the sacral nerves; the selective separating means separating the dorsal root V and ventral root V of the at least one identified sacral nerve; 4. A device according to claim 3, characterized in that said one or more electrodes are positioned close to or attached to the corresponding ventral root V. 5. The nerve bundle is divided into a somatic nerve bundle S and an autonomic nerve bundle; each somatic nerve bundle is divided into (1) an upper somatic nerve and (2) a vulvar nerve, and this body The sexual nerve bundle includes (a) a lower somatic nerve connected to the muscles controlling the external sphincter of the bladder, (b) a vaginal bifurcation connected to the rectal anal sphincter, and (c) a dorsal nerve. To allow the connecting nerve bundles to be controlled by electrical stimulation at a level lower than that required to control intestinal and rectal function; cutting the upper somatic nerve to at least partially cut the external sphincter Device according to claim 4, characterized in that the surrounding ani muscle is separated. 6. At least two electrodes are positioned proximate to, or directly attached to, individual nerve bundles; said stimulating means providing coordinated and synchronized pulse trains to said electrodes sequentially or simultaneously to provide said at least two electrodes. 6. Device according to claim 5, characterized in that the function of one organ is controlled simultaneously and / or individually. 7. An electrode is positioned close to or directly attached to at least two individual nerve bundles selected from the sacral nerve derived from the sacral segment and the upper and lower somatic nerves, 7. Device according to claim 6, characterized in that the coordinated and synchronized functions of the intestine and its associated external sphincter are controlled simultaneously. 8. An electrode is positioned proximate to or directly attached to at least two individual nerve bundles selected from the sacral nerve derived from the sacral segment and the upper and lower somatic nerves. Device according to claim 6, characterized in that the intestine and its associated rectum and sphincter are controlled simultaneously. 9. At least two individual electrodes each having an electrode selected from the sacral nerve derived from the sacral segment, the vulva nerve, the upper somatic nerve and the lower somatic nerve, and the anal bifurcation. Claimed to be located close to or directly attached to the nerve bundle to modulate the symptoms caused by the loss of coordination between the normally synchronizing functions of the organ. Apparatus according to claim 6. 10. An electrode having the electrode arrangement described in Table I of the specification.
10. Device according to claim 9, characterized in that it is adapted to be attached close to or directly to the nerve bundle according to one selected from 21 combinations. 11. At least one individual electrode is positioned proximate to at least one nerve bundle selected from the vulva nerve, the upper somatic nerve, the lower somatic nerve, and the anal bifurcation. Or attached directly to it; said stimulators are used to stimulate the sphincter muscles directly so that the sphincter tone is more effective, or to modulate the reflex control mechanism, to reduce incontinence due to increased sphincter tone. Device according to claim 5, characterized in that it is adapted to be treated. 12. The electrode is characterized in that it is positioned close to or directly attached to the nerve bundle according to one selected from the seven electrode arrangements described in Table II of the specification. The device according to claim 11, wherein 13. At least a small number of the electrodes are unidirectionally positioned close to the selected nerve bundle or are unidirectionally directly attached. 13. A device according to any one of claims 1-12. 14. A patent characterized in that at least a few of the electrodes are bidirectionally positioned close to or in direct attachment to the selected nerve bundle. Device according to any one of claims 1 to 13. 15. A method according to claim 1, characterized in that said electrodes comprise at least two separate electrodes, said stimulating means supplying to these electrodes a coordinated and synchronous pulse train, either sequentially or simultaneously. The device according to any one of claims 1 to 14. 16. A pair of first and second receivers for the stimulation means to receive separate electrical pulses in a predetermined time relationship, a first means for generating a first signal pulse, a first signal. Receiving pulses and converting them into separate first and second sets of pulse trains, the first and second sets of pulse trains as separate radio frequency pulses, said first and second sets, respectively.
Device according to any one of claims 1 to 15, characterized in that it also comprises a second means for sending to the receiver. 17. A stimulating pulse oscillating means for emitting a rectangular wave output signal, a pulse width one-shot means for receiving the rectangular wave output signal and generating a signal pulse, and a rectangular wave for the first means. AND gate means for combining the pulse train duration oscillating means for generating, the output of the one-shot means and the output of the pulse train duration oscillating means to generate separate pulse trains, and the pulse train duration oscillating means And a pair of radio frequency generating means for receiving a separate pulse train, i.e. a radio frequency pulse from the AND gate means, and a separate radio frequency pulse from the radio frequency generating means. A pair of amplification means for receiving separate radio frequency pulses from these amplification means,
17. A pair of antenna means for inductively coupling with said first and second receivers for sending said radio frequency pulse train to these receivers. apparatus. 18. The stimulating means selectively interrupts sending the pulse to a pair of third and fourth receivers and the first and second receivers to provide separate radio frequency pulses. Device according to claim 16, characterized in that it also comprises third means for sending to said third and fourth receivers, respectively. 19. The stimulation means comprises: a. First transmitting means for sending a first electrical pulse to at least a first receiver; b. Interrupting means for interrupting the delivery of the first electrical pulse to the first receiver; c. Second transmitting means for transmitting at least a second electric pulse having a predetermined relation to the first electric pulse to at least a second receiver in response to the interrupting means; The device according to claim 1.