WO2011045002A1

WO2011045002A1 - Device for magnetically stimulating body tissue

Info

Publication number: WO2011045002A1
Application number: PCT/EP2010/006147
Authority: WO
Inventors: E. Gerhard Fischer; Eberhard Keck; Bernd Hallinger
Original assignee: Quanten-Medicine Ag
Priority date: 2009-10-12
Filing date: 2010-10-08
Publication date: 2011-04-21
Also published as: DE202009019186U1; DE102009049145A1

Abstract

The invention relates to a device for treating biological tissue using magnetic fields, comprising at least one unit (10) for generating at least one magnetic field, wherein the unit comprises: at least one coil (12) that can be supplied with an electric current, and at least one core (16, 18, 20, 22) made of a magnetisable material, which core cooperates inductively with the coil (12), wherein the core (16, 18, 20, 22) has a first end section (25) and a second end section (24) located opposite thereof, and wherein the first end section (25), as viewed in the axial direction of the coil (12), is located within the coil and the second end section (24) is located outside of the coil (12).

Description

Device for magnetic stimulation of body tissue

Description

The present invention relates to a device for treating biological tissue by means of magnetic fields. It primarily serves to stimulate motoneurons and the reflex arc by afferents of the peripheral nervous system to contract skeletal muscles of the pelvis and to attenuate the detrusor vesicae. The device is designed in particular for the treatment of pelvic floor weakness and related incontinence symptoms, irritation of the bladder and for the treatment of erectile dysfunctions of the blood-flow-related form of the circle. It is also designed for a variety of prophylactic and therapeutic applications in the physiotherapeutic, orthopedic and dermatological field.

In medical rehabilitation and sports medicine, electrostimulation is a common procedure, which is also used in incontinence treatment. With regard to its field of application, however, electrostimulation is largely restricted to the periphery or to the peripheral structures of the organism to be treated. Because of the comparatively high electrical resistance of tissue structures, such as skin and bones, it comes within the body tissue to a significant voltage drop. In order to achieve therapeutic success, therefore, high current levels and electrical voltages must be used in electrostimulation. However, this can lead to a painful irritation of sensory nerve endings, which are absolutely to be avoided for the patient. Therefore, nerve and muscle cells deep under the skin are hardly stimulable in practice by electrostimulation.

However, these deficiencies of electrostimulation can be largely circumvented by means of electromagnetic induction. Time-varying electrical currents generate transient magnetic fields which cause an electric field proportional to the temporal change of the magnetic field within the body tissue to be treated. Such electromagnetic fields generated by means of electromagnetic induction in deeper tissue zones can cause a potential difference on cell membranes of the tissue to be treated, typically on the human or animal organism, which can lead to a depolarization of the nerve cells, for example.

The resulting ion currents typically lower the membrane potential of neighboring neurons, so that an externally applied initial pulse is relayed to the motor end plate, or to the synapse and the corresponding muscle. The consequence of this is a muscle contraction as a function of the temporal change and amplitude or intensity of the applied electromagnetic field.

This nerve stimulation principle is already successfully used in transcranial magnetic stimulation. Derived from this is the treatment in the target region of the pelvis of a patient. There are a variety of staggered and lattice-shaped superimposed muscles that function as a unit of the pelvic floor and sphincter occlusions play an important role in micturition, defecation and erectile function and also relate to the stabilization of the trunk and pelvis and the securing of the pelvic organs. Urological therapy concepts emphasize a training necessity of the pelvic floor that is either active or stimulable.

This leads to a muscular adaptation of the target musculature and improved muscular performance including morphological changes, and may e.g. be detected by ultrasound. Not only does this elevate the levator plate in the long term, but it also increases the muscle fiber cross-section, resulting in an increase in the strength of the active and passive pelvic support apparatus. Due to their identical fiber composition, the pelvic floor muscles can thus be trained identically to the skeletal muscles of the extremities or the trunk.

This results in indications for the treatment of various types of incontinence such as stress and urge incontinence and their mixed forms, faecal incontinence and incontinence after prostatectomy. The Pelvic Pain syndrome, whose multifactorial causation is not fully understood, also counts on the musculoskeletal and myofascial influences.

Stress incontinence is based on insufficiency of the pelvic floor, which may be due, among other things, to an episiotomy, muscle overstretching due to pregnancy or childbirth, or a hormonal deficit. A tonus reduction and an insufficient reflex response can thus not withstand an increase in pressure in the abdominal area, so that even when nibbling, laughing or simply walking the natural urinary obstruction fails. Via nerve stimulation, Transpelvine Magnetic Stimulation (TPM) acts as direct contraction training for all parts of the pelvic floor muscles, also addressing muscle areas that can not be reached with physical training exercises such as active pelvic floor training. Thus, the pelvic floor muscles with an active isolated tension can produce only a small part of their potential strength. Also, in a TPM - according to the experience of electrotherapy - the recruitment order of the muscle fibers is not clearly defined and thus takes place globally.

Thus, if a single pelvic floor muscle is electrically stimulated by TPM, there is a tendency for all the other muscles of the composite unit to contract.

Due to its close proximity to the bladder outlet, the urinary tract occlusion mechanism is severely compromised in case of surgical removal of the prostate. Radical prostatectomy not only shortens the urethra, but can also damage the bladder closure or rhabdosphincter, and also applies to transurethral prostatectomy ( DOOR). Men are thrown back to the untrained continence closure of the pelvic floor. The symptoms are identical to those of stress incontinence, i. TPM nerve stimulation serves to strengthen the muscular base tone of the pelvic floor and to train the reflexive contraction force.

Furthermore, from DE 298 08 990 IM a seat and reclining furniture for magnetic field therapy is already known, which has one or more applicator devices for generating magnetic fields. The applicator device can be embedded in the upholstery of the respective sitting or lying furniture. Further, the applicator device may be provided with coils for generating magnetic fields that enable whole body or partial body therapy with in-line or circularly-arranged solid core metal coils.

The therapeutic and prophylactic effects of electromagnetic fields on body tissue to be treated may be of a variety depend on different factors, in particular the concrete composition of the body tissue, such as its water and fat content, but also on the geometric shape, intensity and the time course of the applied electromagnetic fields. Modern treatment methods also provide for an individually adapted to the particular patient application of electromagnetic, especially magnetic fields.

In addition, since the exact interactions and the interaction of magnetic fields with body tissue, especially with nerve and muscle cells are not fully researched in detail and thus the application parameters for magnetic therapy are often only empirically determined, it is particularly desirable, the geometric extension, the spatial Distribution as well as the intensity of magnetic fields as possible to control and influence.

It is therefore an object of the present invention to provide a device for the treatment of biological tissue by means of magnetic fields, the most universal adaptability to predetermined treatment schemes, in particular an individual adaptation and modification of the spatial extent and distribution and the intensity and the time course of generating magnetic fields. In addition, the device should be characterized by the simplest possible, robust, less susceptible to interference and cost-effectively producible and suitable for the generation of sufficiently sized magnetic fields structure.

This object is achieved in that the device for the treatment of biological tissue has at least one device for generating at least one magnetic field. In this case, the magnetic field generating device has at least one coil, which can be acted upon by an electric current, and at least one core, which interacts inductively with the coil, made of a magnetizable material. Of the Inductively cooperating with the coil core has two provided at opposite ends of the core end portions, namely a first and a second end portion.

The coil and the core are in this case arranged within the magnetic field generating device to each other such that the first end portion within the coil and the second end portion comes to lie outside the coil. As a result, the core extends beyond the typically annular wound coil. For this purpose, the core is at least partially outside the coil plane, that is, the core extends at least partially axially offset from the coil, wherein the geometric center of the typically annular or cylindrical shell-like coil coincides with the axial direction.

The core consists of a magnetizable material and causes a gain and / or a geometric influence of the magnetic field generated by the coil.

First and second end portions of the core are in particular formed as "open" ends of the core, which form a magnetic north and south pole in the presence of a magnetic field generated by the coil depending on the existing polarity. The open at its two spaced apart end portions core thus contributes to the generation of an outside of the core, but between the two spaced from each other to come to lie adjacent end portions extending magnetic field, which is referred to in the context of the invention as a treatment field. This treatment magnetic field should preferably be exposed to the biological tissue intended for electromagnetic treatment.

By a suitable geometric design of the core and its two end portions, the extent, the course and the geometric distribution of the treatment field can be selectively influenced and controlled. The core is preferably made of a highly or highly magnetizable material, such as a ferromagnetic material, in particular iron or sheet steel.

So can be generated by a correspondingly high saturability of the core material even at relatively low currents in the coil for the intended treatment sufficiently strong magnetic fields.

For the purposes of the present invention, the generic term for a magnetic field includes, in particular, the magnetic induction B or its intensity, wherein those physical quantities within the body tissue are linearly connected via the known equation B ₀ = μο μ _Γ H, where H is outside the range Tissue ruling magnetic field strength reflects.

According to a first advantageous embodiment of the invention it is further provided that the first and the second end portion of the core lie in a plane whose surface normal extends substantially parallel to the axis of the coil. That is, the ends of the core lie in a common plane, which may be in the coil plane or parallel offset thereto. It can also be provided here that the end sections of the core each themselves have an end face which lies in the plane formed by the two end sections.

Alternatively, it could also be provided that the free ends of the core are oblique to the connecting plane of the first and second end portion. In this case, in particular, a mirror-symmetrical configuration of the end faces of the core with respect to the axial direction is possible. Also, in this case, the two spaced-apart end faces of the core can be aligned with each other or facing away from each other. According to a further embodiment of the invention it is provided that the core, viewed in relation to the coil geometry in the radial direction, has a variable cross-section. For example, it may be provided that the end section which comes to lie within the coil has a smaller or larger cross-sectional area than the end section which comes to lie outside the coil. A continuous or abrupt change in the core cross-section along the course of the core results in a different magnetic field or flux density at the spaced-apart first and second end sections. This in turn leads to a spatially inhomogeneous treatment magnetic field, which may be advantageous for the treatment of selected body parts of the patient.

According to a further embodiment of the invention, it is advantageous to have a substantially C-shaped or U-shaped configuration of the core, which in this case has two legs and an intermediate connecting section. Here comes one of the two legs of the C or U-shaped core within the coil and the other leg outside of the coil to lie. The first leg which comes to lie within the coil can thus pass through the coil in the axial direction, so to speak, while the connecting portion forms a substantially radial connection of inner and outer first and second limbs or end portions of the core. The two lying inside and outside the coil legs are preferably aligned parallel to each other.

Also, the two are preferably arranged parallel to each other facing end surfaces of the legs or end portions facing a treatment surface, which may be formed, for example, as a sitting or lying surface and forms a support for the biological tissue to be treated.

It can also be provided that the core is independent of its basic design in the area of the first and / or the second end portion has at least one axially extending extension or leg. In this way, the core can be formed almost arbitrarily in terms of its geometry, as long as it can be placed with an extension or leg to form a sufficient magnetization within the coil or at least as close to the coil.

To form a defined treatment field, it is also advantageous if the free ends of the two extensions or legs are matched with respect to their mutual alignment and positioning and geometric configuration.

According to a further advantageous aspect, the core is formed from a number of adjoining or stacked plate elements, wherein the plate elements preferably have a substantially identical blank and are electrically insulated from each other. Through this layered structure of the core, the formation of eddy currents within the core can be largely prevented. In a homogeneous design of the core of an electrically conductive material would otherwise be expected a significant thermal heating of the core in the operation of the magnetic field generating device.

In addition, by the plate-like structure of the core almost any core geometry can be generated. If the comparatively flat plate elements have approximately the shape of a U or C, then by stacking a plurality of such U-shaped plate elements, a quasi-three-dimensional U- or C-type core can be formed. Also can be created by successive reduction or enlargement or change in the outer contour of the individual plate elements in all three spatial directions variable core structure. The individual plate elements can be electrically insulated from one another, for example, by means of an electrically insulating coating, such as, for example, by means of a lacquer layer Generation and propagation of eddy currents within the core are reduced, if not completely eliminated.

In addition, it can additionally or alternatively also be provided to manufacture the core from a sintered material, for example from a ferrite or a powder pressed material. In any case, such materials are classified as electrically nonconductive, so that heat generation by eddy currents can essentially be prevented from the outset.

Regardless of the choice of a plate or layer-like structure and / or the choice of a sintered material, the core can be made of a substantially electrically insulating material anyway, as long as the material has sufficient for the intended application here magnetic saturation or sufficient susceptibility ,

According to a further advantageous aspect, a plurality of cores are provided for the magnetic field generating device. These are preferably arranged at regular intervals from each other. It can also be provided here that the cores are matched not only in terms of their position, but also in terms of their alignment. In this case, provision is made in particular for adjacent cores to be aligned at regular or equidistant angles with respect to one another. Thus, for example, in the case of an annular coil, two cores can be provided at an angle of 180 ° to one another or three cores at an angle of 120 ° to one another or even four cores, which are each rotated by 90 ° to one another.

Depending on the application, however, it is also conceivable to arrange the individual cores asymmetrically or irregularly relative to one another, so that accordingly asymmetrical, heterogeneous or inhomogeneous magnetic fields can be generated for the targeted treatment of biological tissue. According to a further preferred embodiment of the invention it is further provided that the at least one core and the coil are mutually adjustable and / or mutually movable. Thus, in particular, it may be provided to displace the at least one core in the coil plane with respect to the coil, or vice versa, the coil relative to the core in that plane. Such a displacement can be done manually, for example, by loosening provided fasteners and by a manual, preferably continuously variable displacement and subsequent locking coil and / or core.

However, it is also conceivable to equip the coil and / or core with a drive unit, in particular with an electromotive drive, which enables, for example, a reciprocal movement of coil and / or core during operation of the device.

Such an approximately electrically implemented mutual mobility of the coil and the core can be used, for example, to adjust the strength and intensity of the electromagnetic field to be applied in accordance with the subjective sensation of the patient, but in particular for the individual adjustment of an electromagnetic field that is still perceived as comfortable for the patient , In this case, it is also provided that the spatial distribution of the field profile and thus also the flux density of the field, that is to change the field strength per unit area. In addition to a mutual adjustment and / or mobility of core and coil in the coil plane can also be provided an adjustment and / or mobility perpendicular thereto, namely in the axial direction of the coil. By means of the adjustment or movability of coil and core in radial as well as axial direction, the strength, the extent and the course of the magnetic treatment field can be specifically influenced and controlled. In the embodiment of the magnetic field generating device having a plurality of cores, it is provided according to a further preferred embodiment of the invention that the cores are arranged so as to be adjustable relative to one another and / or movable. The adjustability can hereby be implemented equally manually or by means of a drive. The individual cores can also be arranged to be adjustable relative to one another in the magnetic field generating device both in the radial direction and in the axial direction. It is particularly conceivable that individual cores are arranged displaceably along a path predetermined by guide rails.

In an embodiment with about four individual cores, for example, it can be provided that each of the individual cores is arranged to be adjustable in the radial direction. Alternatively, it would also be conceivable for individual cores to be movable approximately at an angle to the radial direction, but in the plane of the coil or parallel thereto, and other cores to be movable perpendicularly or at an angle thereto.

It is also conceivable for the plurality of individual cores that these are arranged to be parallel and / or perpendicular to the plane of the coil adjustable and / or movable. It can also be provided that the movement of individual cores is coupled to that of other cores. For example, the position of one core in the coil plane may be coupled to the position of another core, such that an approximately radial movement of one core is converted into a diametrically opposite radial movement of the other core. In the end, the cores would indeed be moved to each other, but remain symmetrically and / or regularly arranged relative to the coil.

According to an advantageous embodiment of the invention, it is further provided that the individual cores come to lie adjacent to one another in the region of their respective first end sections with at least one side face. In addition, the individual cores in the area of their first end section Furthermore, a square or rectangular cross-section, it may be provided for a number of four cores, for example, that they even adjoin each other with two side surfaces. By providing a plurality of cores can also be achieved that the lying within the annular coil area is largely filled with magnetizable core material, each of the cores by its approximately U- or C-like shape to a radially outward distribution of the of Coil can be generated magnetic field.

According to a further advantageous aspect, the coil has at least two wires which are electrically insulated from one another and are twisted together and / or stranded with one another.

In a coil-like current-carrying conductor with an asymmetric coil core, it should be noted that the magnetic field of the coil causes a displacement of the charge carriers in the direction of the coil normal, i. effected in the axial direction, so that viewed over the bobbin uneven distribution of the current results. In that regard, only a portion of the coil would be effectively used and an increase in the cross-section of the line would be only partially effective.

By a mutual twisting or stranding of individual current-carrying wires of the coil, a substantially uniform current distribution can be achieved within the cross-section of the individual wires of the coil and the coil as a whole, as seen by the twisting or stranding each wire in the circumferential direction of the coil alternately in a radially outer and a radially inner portion extends.

It can further be provided that the coil is designed as a wire with electrically conductive and mutually electrically insulated strands or individual wires. It is advantageous for the strands or for the single wires copper wire or a wire made of a material with a comparably low electrical resistance in question. The isolation of the individual wires or strands with each other can be done by means of a hole or a coating.

According to a development of the invention may further be provided that the coil itself is designed as a wound around a core wire rope. Again, copper or the like should preferably be provided as the wire material. The coil can lie directly on the outer boundary of the core, or be formed at a radial distance thereto.

The design of the coil as a wire rope also causes a mechanical stabilization of the coil, so that according to an advantageous embodiment of the invention may even be dispensed with a coil support on which the coil is to be wound.

According to a further embodiment of the invention, it is further provided that the magnetic field generating device is arranged within a housing. By embedding the magnetic field generating device in a housing, a modular structure can be provided, which allows a variable configuration of the device according to the invention. Thus, for example, it may be provided to fix the housing at different positions of the device, depending on which part of the body of a patient is to be treated.

Advantageously, the magnetic field generating device and / or the device receiving housing is arranged below a sitting or lying surface of the device. Here, first and / or second end portions of the core or cores of a sitting or lying surface of the device are arranged facing and aligned towards this, so that the outgoing from the free end portions of the core treatment magnetic field passes through the sitting or lying surface and in the on it In the case of treatment located body parts of a patient penetrates. According to a further advantageous embodiment, a control unit is further provided for the device according to the invention, which is coupled to the coil. The control unit is designed to generate a magnetic flux density between 0.3 and 1.2 T, preferably between 0.5 and 1 T. The dimensioning of the control unit is matched to the geometry, the structure and the material properties and the mutual arrangement of coil and core.

In addition, it is further provided that the control unit is designed to generate magnetic fields in a frequency range of 5 to 50 Hz. This frequency range proves to be particularly advantageous for the magnetic field stimulation of body tissue, in particular nerve cells and muscle tissue.

The control unit is according to a further preferred embodiment of the invention also designed to generate periodically varying magnetic fields with a strike time in the range of 250 to 300 ps, preferably 270 ps. Such comparatively fast spread or rise times require less energy compared to larger spread times. Accordingly, the efficiency of the magnetic field generating device improves by a higher pulse frequency.

The spread time, preferably in the range of 250 to 300 ps, is also tuned to the time constants of peripheral axons. Considering the comparatively high potential of peripheral nerve cells, which lies between -65 and -75 mV, sufficient depolarization can already be achieved by reducing the membrane potential by -10 to -20 mV. The electromagnetic field that can be generated by the device and applied from the outside acts primarily in the direction of the axon of a nerve cell. Although the magnetic field intensity reduces approximately quadratically with the distance of the coil, the therapeutically effective penetration depth is about 10 to 12 cm because of the system-inherent intensity maximum of more than 1 Tesla. A mono- and polysynaptic reflex with consecutive tension of the pelvic floor muscles takes place via afferents of the pudendal nerve. The reflex arc arises according to the principle of the transmission of sensory stimuli to the spinal cord, whereby interneurons can be excited and their protective reaction with an efferent nerve impulse can be passed as a contraction signal to the pelvic floor muscles.

In urge incontinence, there is a hypersensitivity of receptors that control the filling state in the mucosa of the bladder and suggest a strong urinary urgency even in the smallest urinary bladder volumes. The brain then reacts with a non-suppressible contraction of the bladder muscles (M. detrusor vesicae), resulting in an involuntary opening of the bladder sphincter.

The inhibitory effect of TPM is based on findings of electrical stimulation according to animal experimental and clinical studies on an activation of the afferents of the N. pudendus. This is done with low bladder filling by excitement of the hypogastric nerve, otherwise by a direct inhibition of the nuclei of the pelvic nerve in the sacral marrow and also via a supraspinal inhibition of the detrusor reflex. The corresponding stimulation frequency is between 5 and 10 Hz. An intact pelvic floor is also of crucial importance in urge incontinence. If there is an involuntary opening of the rhabdosphincter, the emptying of the urine is inhibited by a reflex contraction of the fast muscle fiber parts of the pelvic floor.

The field of application described relates primarily to sensory urge incontinence. A chair incontinence is a disturbance in the complex interaction between motor skills, sensors and anatomical conditions. If, for example, the main muscle tracts of the pelvic floor, such as the sphincter ani internus and externus, puborectalis muscle and levator, are addressed with insufficient nervousness, this is also reflected in a reduced perception of the rectum and anal sensors. Muscle stimulation using TPM thus not only strengthens the pelvic floor structures necessary for continence, but also improves the perception of a necessary sphincter activity necessary for a reflex contraction.

For the magnetic stimulation of the different types of urinary incontinence exist over a precursor system over 70 studies. After a treatment frequency of 16 - 20 applications between 6 - 8 weeks, remission, symptom relief or significant improvement is expected in 41 - 78% of the treatment cases. The maintenance period is on average 6 to 12 months, whereby in individual cases 35 months have been achieved. The result of an evidence analysis refers to a total sample of 3,028 patients. In 50 studies, Urinary Incontinence, 1 Fecal Incontinence, 1 Intersititial Cystitis, 1 Pelvic-Pain Syndrome, 3 Healthy Subjects, 1 Animal Experiment, 10 Overactive Bladder Syndrome, the EbM-0 levels (Cochran Collaboration classification) are in 1 study , (EbMO = Experimental Work), EbM1a = 1 study, EbM1b = 11 studies, EbM2a = 5 studies, EbM2b = 9, EbM2c = 12, EbM3b = 12, EbM3a = 0, EbM4 = 23, EbM5 = 1.

While many studies have no peer groups, only 1b% (Randomized Controlled Trial) qualification is warranted in just 12% of the studies, but even with the large number of independent researchers from many regions of the world, even the classification studies are justified 4 give an important role. With regard to the quality of treatment, the grade 1 was awarded 11 times, once the grade 1 - 2, 20 times the grade 2, 21 times the grade 2 - 3 or 3, 7 times the grade 3 - 4 or 4, and 2 times the Grade 5. That is, 50% of the Therapy results the rating good / very good, just under 5% the rating poor and just under 45% the rating satisfactory / sufficient. On average, the quality of treatment is thus rated at 2.4.

The etiology of Pelvic Pain Syndrome is not yet fully understood. Visceral-neuronal as well as myofascial-musculo-skeletal structures may be responsible for the pelvic pain. Especially in the myofascial, that of the muscle attachment points and the connective tissue of the muscle pain development, local hardening in the pelvic floor muscles seem to play a crucial role. Similar to the pain syndromes of the musculoskeletal system it comes to nerve squeezes and corresponding pain sensations. A TPM insert leads to an increase in the microcirculation in the pelvic area, which comes about through muscle contractions of the pelvic floor. Since muscle hardening is always based on a restriction of blood flow, they dissolve again as blood refining begins.

The pelvic floor muscles play an important role in the formation and maintenance of an erection and also in the orgasm quality. The ischiocavernosus muscle, for example, exerts a pumping function on the deep artery and prevents the venous drainage of the blood through a compression of the corpus cavernosum penis (v. Profunda penis). The M. bulbospongiosis, in turn, surrounds the urethral corpus cavernosum and enters into a rhythmic contraction during orgasm. It also triggers a pulsating pressure wave on the urethral erectile tissue and thus supports ejaculation. The constrictor vulvae in the female, which is comparable to the bulbous spongiosus, is the sphincter of the vulva and is usually injured or severed during birth as part of an episiotomy. The consequence is that the rhythmic convulsions necessary for an orgasm are no longer sufficiently possible. Pelvic floor training in patients with erectile dysfunction (ED) with a proven venous leak enabled 42-47% of men to achieve a satisfactory erection or an additional 24% improved their symptoms of impotence. In another study on the effects of special pelvic floor exercises in ED with a mild or moderate leak, erectile function was improved at 80% compared to the sildenafil group ("Viagra") with 74% and placebo with 18% is more than an active pelvic floor training (18 therapy sessions with TPM correspond to about 4 months or 4 x 30 days x 10 exercises per day = 1 200 active exercises), a transfer of the results is fully possible.

TPM-mediated pelvic floor muscle stimulation is based on general strength and endurance training. Dysfunctions of the diaphragm pelvis (pelvic floor) are basically based on a reduction of strength and coordination. An exercise-induced increase in strength usually results from improved coordination, i. the increase in the number of muscle fibers addressed. However, it may also consist of the coordination of larger structural units in the sense of a synergistic interaction of intrinsic and extrinsic muscles. It is generally believed that synergistic co-contractions provide a natural reaction pattern to effectively counteract sudden abdominal pressure increases.

A coordination advantage arises over the repetition of motor impulses, which encompass here by means of magnetic stimulation the entire pelvic floor musculature. It makes no difference whether the training refers to a concentric or isometric contraction. Active contractions do not per se lead to a synergistic contraction. Thus, while voluntary innervation causes individual muscle components to contract independently, electrical stimulation of a single pelvic floor muscle causes mass contraction. According to the general distribution of skeletal muscle quality, 70% of the paraurethral pelvic floor muscles are type I slow-twitch fibers, ie so-called red muscles rich in myoglobin and well supplied with blood 30% in Fast-Twitch-Fibers type II so-called white muscles, which react very quickly to high levels of glycogen and poor blood circulation. This predominance of type I proves its primary supportive function role for organs and neurovascular structures as well as the resting pressure of the urethra. With a contraction frequency of about 10 Hz, these muscles can sustain the resting tone over a longer period of time. Instead, fast-twitch fibers with a natural contraction frequency of 50 Hz develop a significantly higher force, but tire very quickly. They are responsible for maintaining continence during acute stress situations.

With regard to the treatment of stress incontinence, the stimulus configuration of the TPM system preferably depends on the fast muscle components and is carried out specifically via frequency control in a range above 30-50 Hz. 30 Hz also correspond to the physiological tremor of the musculature. This is done according to the so-called function mimetic principle, i. the number of impulses depends on the number of natural action potentials.

The actual stimulation-induced growth stimuli are caused by exercise-related microtrauma, ie tiny muscle tears. These activate the peptide IGF-1, which acts as an effector hormone in the cascade of human growth hormone HGH and has strong anabolic properties. The necessary increase in protein synthesis stimulates satellite cells, which as muscular stem cells are able to fuse with the muscle cell. To slow the onset of ubiquitous support proteins that are supposed to protect the muscle cell from overloading To circumvent muscle hypertrophy, the recommendations for use provide for slightly progressive exercise by moderately increasing the flux density.

Investigations at the Karolinska Institute Stockholm also prove that slow type I fibers can be transformed into medium-fast type II a fibers for training and stimulus configuration, and vice versa. Consequently, this transformation can be histologically demonstrated by comparable electrical stimulation of the pelvic floor.

A TPM not only improves muscle fiber coordination, reflex response and muscle hypertrophy, but also increases blood circulation by several times the baseline value. Also a new formation of blood vessels is documented.

With a view to the maximum possible improvement of muscle tone and reflexes within a therapeutically acceptable time, sole coordination and contraction training of the pelvic floor muscles is only of limited suitability. Recent findings in the field of adjuvant sports physiology suggest that further stimulation methods that apply to the general care and performance parameters of a test person can sustainably support the microcirculation and the increase in strength and energy via oxygen, light and second messenger activation.

An important concomitant effect of the TPM is the activation of the fat metabolism with a reduction of depot fats. This has a special effect on cellulite. Although this is mainly due to vertical connective tissue features, the only effective therapy is to increase blood flow while muscle building. This does not fundamentally correct cellulite. However, the reduction of fat deposits of the subcutaneous fatty tissue regularly contributes to a visually improved silhouette of the hip, thigh and buttocks contours. An improved microcirculation in the pelvic cavity also indirectly serves the prophylaxis of femoral head necrosis and hip joint arthrosis, since the depth effect of a TPM not only covers the pelvic floor, but the joint structures in this area. According to new findings, non-traumatic arthroses are not due to an increased stress, but due to a reduced perfusion of the joint capsules. This regularly leads to a decrease in cartilage nutrition and a disturbance between the degradative and anabolic forces of the cartilage. A TPM not only improves circulation and cartilage nutrition but also stimulates cartilage stimulation through muscle contraction in the hip area.

Other objects, advantages, features and advantageous applications of the present invention will become apparent from the following description of an embodiment. In this case, all the features described in the figures and also described in the text, both alone and in any meaningful combination with each other form the subject of the present invention. Show it:

1 is a perspective view of a magnetic field generating device with a coil and a total of four U-shaped cores and

2 shows a schematic view of an asymmetrical core of the magnetic field generating device formed from a plurality of layers.

FIG. 1 shows a schematic perspective view of a device 10 for generating a magnetic field to be directed onto a body part. The device 10 has a substantially rectangular or cubic housing 14, in which an annular coil 12 and a total of four individual cores 16, 18, 20, 22 are arranged. The coil 12 ring-like Geometry is connected to an electrical power supply device, preferably to a suitable control unit, by means of which the coil 12 can be acted upon by a suitable current signal for generating transient magnetic fields.

The control unit and the associated electrical connection means to the coil 12 are not explicitly shown in the figures. The coil 12 itself has a toroidal shape in the embodiment shown in FIG. The individual windings of the coil 12 run along the outer circumference of the tome. The coil 12 is preferably formed as a wound wire rope. Their individual electrically insulated conductive wires are twisted together or even stranded into a wire rope to get over the cross section of the individual wires or the wire rope in AC operation as homogeneous and uniform power distribution.

The magnetic field generating device 10 shown in FIG. 1 has four cores of U-shaped configuration which are offset in the circumferential direction by 90 ° or 90 ° twisted to one another. Each of these cores 16, 18, 20, 22 has a square or rectangular cross-section. All of the cores 16, 18, 20, 22 have on their upwardly projecting legs a substantially planar end face 24, 25, as indicated by way of example for the core 18 in FIG. 1.

The planar end surfaces 24, 25 of the individual cores 16, 18, 20, 22 are in the illustrated embodiment all in a plane that can coincide with the plane of the coil 12. Characterized in that each one of the upwardly projecting extensions or end portions of the cores 16, 18, 20, 22 are within the coil 12, each core 16, 18, 20, 22 forms at its planar end faces 24, 25 depending on the direction of current within the coil 12 a magnetic north pole and south pole. Accordingly, run between the planar end portions 24, 25 circular arc-like field lines. The magnetic field generating device 10 shown in FIG. 1, for example, can be arranged below a sitting or lying surface of a treatment device for magnetic stimulation, the magnetic fields emanating from the free end portions 24, 25 of the cores 16, 18, 20 22 relatively deep in the invade a patient's biological tissues to be treated.

In the illustrated embodiment of FIG. 1, the respective first end portions 25 of each core 16, 18, 20, 22 protrude from below through the interior of the coil 12 upwards. Depending on the field strength to be set, field distribution and spatial extent of the magnetic field, the axial position of coil 12 and cores 16, 18, 20, 22 relative to each other can be arbitrarily changed. It is also provided for the invention that the individual cores 16, 18, 20, 22 are arranged both relative to the coil 12 and relative to each other adjustable and / or movable on or in the housing 14 of the magnetic field generating device 10.

By a vertical, i. axially and / or horizontally, i. in the plane of the coil 12 and the lower housing base aligned adjustment or mobility of individual cores 16, 18, 20, 22, both the spatial extent, the homogeneity, the internal field distribution and the intensity and strength of the magnetic field to be generated targeted, if necessary be individually adapted, changed and adapted to each patient to be treated.

As further shown in FIG. 2, the individual cores 16, 18, 20, 22 can be manufactured by means of plate-like elements 28, 30, 32 stacked on one another. The individual plate elements 28, 30, 32 in this case have a substantially identical blank. In the illustrated embodiment of Fig. 2, each plate member 28, 30, 32 has a substantially rectangular Basic geometry with at their side edges in each case upwardly projecting extensions 26, 27.

The right and left lying in Fig. 2 coming upstanding projections 26, 27 in this case have a different extent in the horizontal, that is in the coil plane, which ultimately leads to the core 18 thus formed by a variable in the radial direction Cross section has. Also, in this case, the end surface 24 formed by the extension 26 is slightly smaller than the end surface 25, which is formed by the extension 27. Consequently, the magnetic flux density at the respective end surfaces 24, 25 is different in the application, resulting in a correspondingly inhomogeneous treatment magnetic field. Due to the two extensions 26, 27, the core ultimately contains a U-shaped form.

The individual plates 28, 30, 32 have a highly saturable material. They are also electrically isolated from each other, such as by applying an electrically insulating layer, such as a suitable paint.

By the plate-like and schematically shown in Fig. 2 structure of the individual cores 16, 18, 20, 22 almost any core geometries can be generated. In addition, the plate-wise and electrically isolated construction of individual plates 28, 30, 32 for the suppression of otherwise resulting eddy currents of advantage, which would lead in the case of a homogeneously formed electrically conductive material to a considerable heating of the core material during operation of the device.

In addition to the construction of a core 18 shown in FIG. 2 with a multiplicity of essentially identical plates 28, 30, 32, it can also be provided that adjacent plates 28, 30, 32 successively have a respectively slightly changed outer contour, so that Overall, cores can be created with almost any three-dimensional contour and geometry. LIST OF REFERENCE NUMBERS

10 magnetic field generating device

12 coil

14 housing

16 core

18 core

20 core

22 core

24 end surface

25 end surface

26 extension

27 extension

28 plate

30 plate

32 plate

Claims

P a n t a n s p r e c h e

Apparatus for treating biological tissue by means of

Magnetic fields, with at least one device (10) for generating at least one magnetic field, the device comprising: at least one coil (12) which can be acted upon by an electric current, and at least one with the coil (12)

cooperating core (16, 18, 20, 22) of a magnetizable material, wherein the core (16, 18, 20, 22) has a first end portion (25) and a second end portion (24) opposite thereto, and wherein in the axial direction Spool (12) seen, the first end portion (25) within the coil and the second end portion (24) outside of the coil (12) comes to rest.

The device of claim 1, wherein the first and second

End portion (24, 25) of the core (16, 18, 20, 22) lie in a plane whose surface normal extends substantially parallel to the axis of the coil (12).

Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) has a variable cross-section with respect to the coil geometry as viewed in the radial direction.

Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) has a substantially C- or U-shaped configuration having.

5. Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) in the region of the first and / or the second

End portion (24, 25) at least one in the axial direction

extending extension or legs (26, 27).

6. Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) a number of adjacent to each other

Plate elements (28, 30, 32) of substantially identical ones

Blank has, which are electrically isolated from each other.

7. Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) is made of a sintered material.

8. Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) is made of a substantially electrically insulating material.

9. Device according to one of the preceding claims, wherein a plurality of cores (16, 18, 20, 22) spaced from each other at regular intervals and / or aligned at regular angular intervals to each other.

10. Device according to one of the preceding claims, wherein the core (16, 18, 20, 22) and the coil (12) are mutually adjustable and / or mutually movable.

11. The device according to claim 9 or 10, wherein the cores (16, 18, 20, 22) are arranged mutually adjustable and / or movable.

12. Device according to one of the preceding claims 9 to 11, wherein the one or more cores (16, 18, 20, 22) are arranged parallel and / or perpendicular to the plane of the coil (12) adjustable and / or movable.

13. Device according to one of the preceding claims 9 to 12, wherein the cores (16, 18, 20, 22) in the region of their respective first end portions (25) come to lie adjacent to each other with at least one side surface.

14. Device according to one of the preceding claims, wherein the

Coil (12) has at least two electrically insulated wires from each other, which are twisted together and / or stranded.

15. Device according to one of the preceding claims, wherein the

Coil (12) is designed as a wire with electrically conductive and mutually electrically insulated strands or individual wires.

16. Device according to one of the preceding claims 14 or 15, wherein the coil is formed as a around a core (16, 18, 20, 22) wound wire rope.

17. Device according to one of the preceding claims, wherein

Magnetic field generating device within a housing (14) is arranged.

18. The apparatus of claim 17, wherein the

Magnetic field generating device (10) below a seat or

Lying surface is arranged.

19. The apparatus of claim 18, wherein the first and / or the second

End portion (24, 25) of the core or cores (16, 18, 20, 22) of the sitting or lying surface facing arranged or aligned.

20. Device according to one of the preceding claims, which further comprises a with the coil (12) electrically coupled control unit, which for generating a magnetic flux density between 0.3 T and 1, 2 T, preferably between 0.5 T and 1, 1 T is formed.

21. The apparatus of claim 20, wherein the control unit is adapted to generate magnetic fields in a frequency range of 5 to 50 Hz.

22. Device according to one of the preceding claims 20 or 21, wherein the control unit for generating periodically varying

Magnetic fields with a strike time in the range of 250 ps to 300 s, preferably formed by about 270 ps.