Patent Application
20180125416
The present invention relates to an apparatus and method for treating a patient by a magnetic field. The application of the magnetic field is provided by at least one high power magnetic field generating device.
Magnet therapy uses the influence of magnetic flux on biological tissue. Electric current is induced in the tissue due to voltage change which causes a polarization of the cell membrane. A fundamental phenomenon of electric current in biological tissue is a transfer of neural excitation or muscle contraction. The intensity of the effect is dependent on the magnetic flux density, repetition rate of the pulses, impulse time duration or envelope of the stimulation signal. One possible application of magnetic treatment is treatment of urogenital diseases, e.g. incontinence or pain in the pelvic area.
Presently magnet treatment is widely applied for treatment of urinary incontinence. The currently used treatment devices are in the form of chair with an integrated coil beneath the seating portion. The coil is fixed within the treatment device and its position is static. A magnetic field generated by the coil is intensified and/or focused by using of magnetic core elements of various shapes, e.g. U-shaped or J-shape type core elements.
The coil is integrally fixed in the seating portion of the chair. A plurality of the J-shape magnetic core elements are surrounded by the coil generating a pulsed magnetic field. The end portions of the J-shape magnetic core elements are within proximity of patient's anus and urethra and/or genital area, e.g. vagina. The magnetic flux is delivered to the patient by the magnetic core elements. Two or four magnetic core elements are most frequently used. The treatment chair also may consist of at least one U-shape magnetic core element with at least one coil wound around the end portions of the magnetic core element. The magnetic field stimulates muscles of pelvic floor via stimulation of pudendal nerves.
The patient sits on the seating portion ergonomically formed to be comfortable for the patient. The chair also includes armrests and backrest for improving patient's comfort. The patient is relaxed in the chair.
The mutual orientation of rotating plates may also be manually adjustable via thumbscrews to fit the coils to the patient region of urethra opening and clitoris. The orientation of the coils is adjusted prior to treatment to stimulate mainly pudendal nerves.
The present devices lack the possibility of dynamic adjusting of the orientation and/or position of the magnetic field generating device to focus or defocus the peak of magnetic treatment to stimulate small or large target biological structure, and are not designed for automatic operation.
Additionally, more efficient treatment devices are needed. There is also a need for improvements for allowing a patient to be positioned in a correct treatment position and to feel comfortable.
Existing treatment devices also lack feedback devices for adjusting the treatment parameters and/or the orientation of the magnetic field generating device during the treatment dynamically.
A magnetic stimulation device may include at least one adjustable component for positioning the patient into a correct treatment position to provide improved effectiveness of the treatment. The magnetic stimulation device may provide improved results by the combined effects of correct treatment position of the patient and the magnetic treatment.
A movable magnetic field generating device may be used, including apparatus for adjusting a position and/or orientation of the magnetic field generating device.
A feedback system may be used to provide feedback information to the magnetic stimulation device to improve the effectiveness of the treatment. The treatment parameters may be influenced by the feedback to improve the treatment. The feedback also provides for adjusting the position and/or orientation of the magnetic field generating device if the patient is repositioned from the correct treatment position.
Pretreatment sequences improve the magnetic treatment by positioning the patient into the correct treatment position and/or by determining at least one treatment parameter according to the patient's needs. The pretreatment sequences enable self-operated treatment.
Biological structure includes a cell, a neuron, a nerve, a muscle fiber, a muscle, a tissue or a ligament.
Stimulation refers to a magnetic flux density inducing an electric current in the biological structure.
Impulse refers to the only one magnetic stimulus.
Pulse refers to a period of stimulation signal of at least one magnetic stimulus and time duration of no stimulation, i.e. time duration between two impulses from rise/fall edge to next rise/fall edge.
Repetition rate refers to frequency of firing the pulses; it is derived from the time duration of a pulse.
Correct treatment position refers to the patient's position in which the treatment is the most effective compared to any other patient's position using the same treatment parameters.
Treatment parameters refer to magnetic flux density, repetition rate, impulse duration, treatment duration, position and/or orientation of the magnetic field generating device.
Active response refers to any biological reaction influenced by the stimulation by time-varying magnetic field including e.g. a change in a permeability of cell membrane for ions or any other particles, a generation of an action potential or at least partial muscle contraction.
Appropriate position refers to the position of the magnetic field generating device where the ideal biological response is induced by stimulation with time-varying magnetic field.
Ideal biological response refers to active response induced by stimulation of e.g. a muscle motor point or the weakest biological response.
Motor point refers to a small region of a muscle in which motor endplates are aggregated i.e. the muscle is most sensitive to stimulation by time-varying magnetic field at this point.
Electric current is induced in the stimulated biological structure during time-varying magnet treatment. A distribution of magnetic field is uniform in the biological structure. Particles (e.g. atoms, ions, molecules etc.) in the biological structures are influenced by the magnetic field and permeability of a cell membrane also increases.
The present methods may be used for treatment of disease of urogenital and/or digestive tract, e.g. improvement of circulation and/or trophic problems, faecal incontinence, urinal incontinence (stress or urge), neuromuscular dysfunction of bladder, mixed incontinence, sexual dysfunction, priapism, erectile dysfunction, orgasmic disorder, fertility issues, chronic pelvic pain syndrome, pain in pelvic area, hyperplasia of prostate, prostatitis, prostatodynia syndrome, dysmenorrhea, vulvodynia, pain and other conditions associated with menstrual cycle, menopausal and/or postmenopausal disorders, cystitis (such as interstitial), inflammatory disease of uterus or cervix uteri, parametris, peritonitis, vaginitis, vulvitis, endometriosis, genital prolapse, hemorrhoids, peripheral paresis or pelvic floor issues in general. The present methods may be used for muscle strengthening, muscle relaxation, regeneration after childbirth (such as pelvic floor prolapse), vaginal tightening or scar treating.
The present invention relates to apparatus and methods of operating said apparatus for stimulation of biological structure by time-varying magnetic field of magnetic flux density sufficient to induce at least partial muscle contraction. Referring to
The present method stimulates the biological structure, preferably at least one pelvic floor muscle, by pulsed magnetic field defined by peak to peak magnetic flux density of at least 0.1 T, more preferably at least 0.5 T, even more preferably at least 1 T, even more preferably at least 1.5 T, most preferably at least 2 T, or up to 7 Tesla on the coil surface and/or repetition rate of at least 100, 120, 140, 180, 200, 250 or up to 700 Hertz with treatment/successive treatments lasting several seconds or longer, e.g. at least 5, 10, 30, 60, 120 or 240 seconds, or longer. The impulse width is in the range of tens to hundreds of μs.
The magnetic stimulation device may include at least one component improving ergonomics and/or patient comfort during the treatment. The component may be e.g. a seating portion, back rest, arm rest, adjustable front resting apparatus or patient supporting apparatus sufficiently maintaining the patient in a sitting position. The effectiveness of the treatment is maximal in the correct treatment position compared to any other position using the same treatment parameters because the target biological structure is within the closest proximity of the magnetic field generating device, e.g. a coil. The correct treatment position of the patient may provide improved treatment effects in combination with magnet treatment. Additionally the muscles of pelvic floor may be activated in the correct treatment position. The activation of the pelvic floor muscles may be caused by the position of the patient's torso with respect to vertical direction. Hence the treatment is improved by positioning the patient in the correct treatment position and maintaining the patient in the correct treatment position with appropriate comfort for the patient.
The seating portion may be movable, e.g. in at least one axis of Cartesian coordinate system (CCS). The seating portion 7 may be moved by at least one seat actuator 9 in rotational and/or translational movement, i.e. the seating portion may be tilted about a pivot axis 10 (corresponding to X-axis of CCS) or shifted, e.g. in a direction corresponding to X, Y and/or Z axes of CCS. The movement may set the patient into a correct treatment position and maintain the patient in the correct treatment position. Alternatively the movement of the seating portion 7 may be used for dynamic positioning of the patient to mechanically induce the muscle contraction in response to mechanical movement of the seating portion 7. The muscle contraction may be induced by e.g. vibrational movement of the seating portion 7. Alternatively the movement of the seating portion may be used for positioning of the patient suffering from any muscle imbalance of patient's torso and/or any incorrect body posture. The seat actuator may include motors or actuators and linkages to provide movement of the seating portion. Alternatively the seat actuator 9 may be manually operated to move the seating portion into a desired position.
The magnetic stimulation device 6 may include a back rest 11 for maintaining the patient in a correct treatment position and providing comfort for the patient during the treatment. The back rest 11 may be adjustable following the patient's anatomical needs, e.g. the back rest 11 may be adjustable in its length, height (adjustment in Z-axis of CCS) and/or the inclination (rotation around X-axis of CCS). The inclination may be preferably adjusted by movement of the back rest 11 around pivot axis 10. The back rest 11 may be extendable as well. In an alternative embodiment the back rest 11 may include movable parts for massaging the patient's back, e.g. rollers. In another alternative embodiment at least one arm rest may be detachable or integral part of the back rest 11.
The magnetic stimulation device 6 may include at least one arm rest 12 for maintaining the patient in correct treatment position and providing high comfort level for the patient during the treatment. The at least one arm rest 12 may be adjustable following the patient's anatomical needs. Arm rest 12 may be adjustable with reference to seating portion 7 of the magnetic stimulation device 6, e.g. it may be extendable, height adjustable and/or adjustable by rotation around X and/or Z axes of CCS. In the preferred embodiment the adjustment of at least one arm rest 12 is independent. In an alternative embodiment the adjustment of each arm rest may be dependent, e.g. the arm rests may be linked via a mechanism.
The magnetic stimulation device 6 may include a resting apparatus 13 for maintaining the patient in a slightly bent or reclined position. The inclination of patient's torso with respect to vertical direction may be in the range of −90 to 90°, more preferably in the range of −45 to 45°, most preferably in the range of −30 to 30°. The tilting portion of the resting apparatus 13 may be adjustable in angle and/or in height. The resting apparatus 13 may be also side adjustable. A distance of the resting apparatus 13 from the magnetic stimulation device 6 may be adjustable as well. The resting apparatus 13 may be preferably situated in front of the magnetic stimulation device 6. In the preferable embodiment the patient may be in contact with the resting apparatus 13 by hand or forearm. In an alternative embodiment the patient may lean against the resting apparatus 13 by chest or any part of upper extremity such as arm or armpit.
In an alternative embodiment the resting apparatus may be represented as an adjustable belt. The belt may be detachably attached to the back rest.
In an alternative embodiment the position of the resting apparatus, e.g. an inclination or a distance from the magnetic stimulation device 6, may be tracked by a sensor 14 to obtain feedback information to adjust treatment parameters to provide the most efficient treatment to the patient. It is clear to a person skilled in the art which sensor is suitable for such a purpose and how to use the at least one sensor for the purpose. In the preferred embodiment such sensor may be any kind of an inclinometer, an accelerometer, a load cell, a force, a magnetic, a distance or an optic sensor. Alternatively, the feedback information may be used for safety reasons, e.g. notification of a safe position may be provided by the magnetic stimulation device and/or resting apparatus when the resting apparatus is within a predetermined distance limit from the magnetic stimulation device. The distance limit may be adjusted by an operator. Alternatively notification of a less safe position may be provided if the distance between magnetic stimulation device and the resting apparatus exceeds the predetermined distance limit. The notification may be in human perceptible form e.g. by mechanical and/or electromagnetic apparatus, such as audibly perceptible notification (e.g. beep) or visually perceptible notification (flashing light, color change etc.).
The magnetic stimulation device may include a patient supporting apparatus for maintaining the patient in correct treatment position and providing high comfort level for the patient during the treatment in the case that the patient is e.g. spinal patient, paralyzed or plegic patient. The patient supporting apparatus may at least partially bear the weight of the patient. The patient supporting apparatus may be adjustable following the patient's anatomical needs. Patient supporting apparatus may be adjustable with reference to seating portion 7 of the magnetic stimulation device 6, e.g. it may be extendable, height adjustable and/or adjustable by rotation around X and/or Z axes of CCS. The patient supporting apparatus may raise or lower the patient, or the torso and/or limbs of the patient, or otherwise maintain the patient in the correct treatment position.
The patient may be positioned by any part of the magnetic stimulation device to correct treatment position. The correct treatment position may be preferably one position during the treatment. In an alternative embodiment the correct treatment position may vary during the treatment hence the treatment position may be dynamically changed following the stimulated target biological structure. The position of the patient may be adjusted manually and/or automatically via at least one actuator. The actuator may preferably tilt the seating portion, back rest or both. Various types of positioning mechanisms may be used for adjusting the position of the patient, e.g. rotational, translational or complex mechanism such as roll-slide mechanism.
All the resting parts such as back rest, arm rests, adjustable resting apparatus may be separate, integral or detachable to the magnetic stimulation device. The apparatus for attaching the resting parts to the magnetic stimulation device may be represented by various embodiments. All contact surfaces of the magnetic stimulation device may be bolstered by soft material. All contact surfaces may be preferably made of well-cleanable material to provide the patient high hygiene standard, in an alternative embodiment the contact surface may be made of sterilizable material. In an alternative embodiment the soft material may be covered by disposable cover.
The magnetic stimulation device may include a plurality of magnetic field generating devices. The positions of the at least two magnetic field generating devices may focus the magnetic fields to the target area; or the magnetic field generated by one magnetic field generating device may interfere with the magnetic field generated by another magnetic field generating device and the resulting magnetic field may be shaped. The magnetic flux density may be summed from the plurality of magnetic field generating devices.
The plurality of the magnetic field generating devices may extend the active time duration of the stimulation in the case that the switching devices are switched in sequence. Therefore the treatment is more effective and the treatment time may be shortened.
The plurality of magnetic field generating devices may be used for treating at least two cooperating muscle groups. In an exemplary application one muscle may be treated to achieve myostimulation effect and other muscle may be treated to achieve myorelaxation effect, analgesic effect may be alternatively induced. Alternatively at least two different muscles or muscle layers may be stimulated by with the same effect.
Alternatively the magnetic field generating device may be in an external applicator such as hand-held applicator.
Alternatively the external applicator may be guided via guiding mechanisms on both sides of the external applicator and one locking mechanism may be on the front side of the applicator (the front side of the applicator is the side closest to the center of the seating portion). The guiding mechanism may be any kind enabling insertion of the external applicator. The locking mechanism may be a clip type mechanism.
Alternatively the latching member may be circular and the locking movement may be rotatable. The rotatable movement may be biased by a resilient member.
Alternatively the external applicator may be inserted into the seating portion of the magnetic stimulation device. The external applicator may be moveable within the seating portion. The movement of the external applicator within the seating portion of the magnetic stimulation device may be translational and/or rotational according to at least one axis of CCS, more preferably according to at least two axes of CCS, most preferably according to all three axes of CCS. The external applicator may be removably attached to a positioning mechanism described below or the external applicator may be attached a rod enabling movement of the external applicator within the seating portion. The movement of the external applicator within the seating portion of the magnetic stimulation device may be automatic and/or manual.
Alternatively the external applicator may be attached to the seating portion from the below. The locking mechanism may be placed on the lower side of the seating portion to prevent free detaching of the external applicator of the seating portion by gravitational force. The movement of the latching mechanism may be rotational and/or translational.
Alternatively the locking mechanism may be a pin-type mechanism wherein at least one pin moves into a corresponding recess. The movement of the at least one pin may be rotational and/or translational. Preferably a plurality of pins may be used. The pins may be oriented to each other, e.g. at least two pins may be oriented on opposite sides of the external applicator, more preferably at least three pins may be uniformly distributed on a periphery of the external applicator, most preferably at least four pins may be uniformly distributed on a periphery of the external applicator such as at cross positions in the case of an applicator of regular shape.
Alternatively the external applicator may be inserted into the hollow core center recess of the seating portion to be covered by the cover.
Alternatively the external applicator may be inserted into a pocket fixed on the lower side of the seating portion.
All the locking mechanisms may be preferably self-locking and may be unlocked manually by direct operating of the latching member or by any mechanism, e.g. lever, press button actuated or pulling mechanism.
The magnetic stimulation device may include at least one component improving effectiveness and/or shortening the duration of the treatment. The effectiveness of the treatment is maximal in the correct treatment position comparing to any other position using the same treatment parameters because the target biological structure is within the closest proximity of the magnetic field generating device.
The magnetic stimulation device may adjust the position and/or orientation of the magnetic field generating device with respect to the patient. The position and/or orientation of the magnetic field generating device may be set statically before the treatment to focus the target biological structure to be stimulated the most efficiently. In an alternative embodiment the position and/or orientation of the magnetic field generating device may be adjusted dynamically during the treatment to treat the target biological structure from different direction with the static focus point while stimulating different surface structures. This approach may be useful for selective stimulation of deep muscle structures, i.e. a muscle partially covered by superficial muscle.
The magnetic field may be focused by interference of the magnetic fields generated by a plurality of magnetic field generating devices and/or by adjusting at least one dimension of the magnetic field generating device.
The focusing of the magnetic field may be enabled by a movement of the magnetic field generating device.
Alternatively a person skilled in the art may focus the magnetic field by various approaches.
The magnetic stimulation device may adjust the position and/or orientation of the magnetic field generating device with respect to the patient dynamically during the treatment. Dynamic movement of the magnetic field generating device may move the focus point of the stimulation to stimulate larger areas and/or volumes of the target biological structure, e.g. large muscles or a plurality of muscles.
The movement of the at least one magnetic field generating device may be constant or accelerated. The movement may follow a random or predetermined trajectory, such as a pattern, an array or a matrix. The movement of the at least one magnetic field generating device may be adjusted by an operator following the patient's needs. Exemplary embodiments of mechanisms enabling dynamic movement of the magnetic field generating device are described below.
The magnetic field generating device may be movable. The movement of the magnetic field generating device may be translational and/or rotational to provide various orientations of the magnetic field generation device within the magnetic stimulation device to improve targeting of the target biological structure or defocusing the peak of magnetic flux density. The translational movement may be according to at least one axis, more preferably according to at least two axes for providing movement in e.g. horizontal plane i.e. according to X and/or Y axes of CCS, or in all three axes of CCS for providing movement in a horizontal plane and also elevation adjustable to correspond with anatomical structures of the patient.
The movement of the magnetic field generating device may be also rotational around at least one axis, more preferably around two axes of a Cartesian coordinate system to improve targeting of the target biological structure.
In most designs, two different types of movement may be used for positioning and/or orienting the magnetic field generating device.
The movement may follow a predetermined trajectory in one plane. The movement may follow a grid pattern by scanning movement of the magnetic field generating device. The scanning movement may cover large body area such as entire pelvic floor. In an alternative embodiment the magnetic field generating device may adjust the position and/or the orientation during the treatment to dynamically stimulate different target biological structure and stimulate a greater area and/or volume.
A positioning mechanism for moving and/or orienting the magnetic field generating device may be used. The positioning mechanism may be an open or closed kinematic chain including at least one degree of freedom. In other embodiments the positioning mechanism may include: at least two degrees of freedom, e.g. two translational, two rotational, or one translational and one rotational around axis of translation; at least three degrees of freedom, e.g. three translational, or two translational and one rotational; or at least four degrees of freedom, e.g. three translational and one rotational or two translational and two rotational. In an alternative embodiment the positioning mechanism may include five degrees of freedom, e.g. three translational and two rotational. In all embodiments the degree of freedom providing elevation of the magnetic field generating device may be reduced and the elevation may be replaced by varying the amplitude of the magnetic flux density.
Alternatively at least two linear actuators may be used for constituting a positioning mechanism enabling scanning movement of the magnetic field generating device.
The elevation of the scanning mechanism may be enabled by additional actuator enabling movement in vertical direction, e.g. linear actuator or worm drive.
Alternatively the positioning mechanism enables tilting of a magnetic field generating device via a mechanism as used in a gyroscopic joystick.
In an alternative embodiment the positioning mechanism may correspond with the anatomical shape of pelvic floor. The endpoint trajectory may move on or over a spherical surface.
The magnetic stimulation device may include at least one feedback information system for improving effectiveness and/or shortening duration of the treatment.
The feedback information may be provided by determining an active response for stimulation, e.g. at least partial muscle contraction. The at least partial muscle contraction causes dynamic forces. The dynamic forces caused by the at least partial muscle contraction may be determined by at least one sensor preferably placed beneath the patient, more preferably a plurality of sensors may be used as well. Following the feedback information the magnetic stimulation device may adjust the position and/or orientation of the magnetic field generating device with respect to the patient to improve the effectiveness of the treatment.
The feedback may be determined by at least one force sensor, e.g. load cell, placed below the magnetic stimulation device. More preferably a plurality of force sensors may be used, e.g. at least two, three or four force sensors.
The at least one force sensor 59 may determine whether the patient is present on the magnetic stimulation device. Following this feedback the treatment may be automatically started. Such an application may be illustrated by the following exemplary embodiment described in
As soon as the patient sits on the magnetic stimulation device a limit range of difference between actually measured value (FA) and previously measured value (FP) may be set in step 65. The limit range may be used for preventing incorrect ceasing of the treatment. The limit range (FL) may be set automatically or manually. Automatically set limit range may be e.g. a preset value, or a percentage of the weight of the patient. In an exemplary embodiment the limit range may be at least 1 or more percent, e.g. 5, 10 or 15 percent. In an alternative embodiment the limit range may be preset by and adjusted by the operator.
In next step 66, at least one pretreatment section may be started. In an exemplary embodiment the pretreatment section may include positioning of the patient to correct treatment position, targeting the target biological structure, or determining optimal value of magnetic flux density for treatment which may be adjusted following the patient's needs. All the pretreatment sections may be processed automatically by the magnetic stimulation device and may be adjusted by the operator, or they may be processed manually by the operator. Afterwards the treatment may be started (step 67).
Afterwards actual treatment time (tactual) may be compared to total treatment time (ttotal) in step 68. If the actual treatment time is at least equal to total treatment time then the treatment is stopped (step 69). If the actual treatment time (tactual) is smaller than total treatment time (ttotal) the treatment may continue.
Then in step 70 is examined whether the difference of the actual value (FA) and previously measured value (FP) is within the limit range (FL). If the difference between actual value (FA) and previously measured value (FP) is within limit range (FL) then the magnetic stimulation device may determine that the patient remains in the magnetic stimulation device and the treatment continues by step 71.
If the difference between actual value (FA) and previously measured value (FP) is out of the limit range (FL) then the treatment may be ceased in step 72 and error notification for the operator may be generated by the magnetic stimulation device in a human perceptible form, e.g. by mechanical and/or electromagnetic apparatus, such as audibly perceptible notification (e.g. beep) or visually perceptible notification (flashing light, color change etc.).
The routine may run continuously or in discrete time. Alternatively, the routine may run in predetermined time during the treatment, e.g. repeated in cycles lasting 2, 5 or 10 seconds.
In the case of application of the plurality of force sensors 59 an approximate position of patient's center of gravity may be determined.
Following the center of gravity position the magnetic field generating device may be automatically positioned and/or oriented to provide most effective treatment for the patient. Patient position may be approximated via virtual model of standardized patient using position of the patient's center of gravity position, alternatively various additionally patient parameters may be used, e.g. weight, height or BMI. Alternatively, the treatment may be automatically started and/or stopped following the position of the center of gravity.
If the position of center of gravity is within predetermined distance from the edge of the seating portion then the incorrect patient position may be determined and the patient may be repositioned. The notification concerning this fact may be generated for the operator by the magnetic stimulation device in a human perceptible form, e.g. by mechanical and/or electromagnetic apparatus, such as audibly perceptible notification (e.g. beep) or visually perceptible notification (flashing light, color change etc.). The repositioning may be done automatically and/or manually influenced by the distance and/or the patient's state.
The feedback may be determined by at least one image sensor, preferably video, photographic or IR sensor. Referring to
Alternatively the image sensor may be replaced by a distance sensor, e.g. light based sensors such as laser sensor, or mechanical wave based sensor such as ultrasound sensor.
Alternatively the patient position may be determined by a position determining system. The position determining system may include at least one reference marker, but more preferably a plurality of reference markers which may be attached to a patient to obtain the precise position of the patient following the position of the reference markers.
The patient position may be determined via a pressure sensitive layer 74 placed beneath the patient, preferably on the seating portion of the magnetic stimulation device. Alternatively the pressure sensitive layer may be a part of the seating portion. The pressure sensitive layer may be e.g. stripe-shaped, pad or the mattress. It may be made of a material enabling sensing the pressure changes or distributions, preferably using a biocompatible resilient material. The pressure sensitive layer may include at least one, more preferably a plurality of sensors which are able to determine the patient's position or location, and/or a change in the patient's position or location. The sensor may be represented by a force or weight sensor such as piezo-sensor, strain gauge or load cell, pressure sensor, temperature or optical sensor, capacitive sensor or sensor detecting changes, e.g. distance or velocity sensor, accelerometer or vibration sensor. A plurality of sensors may be preferably used in predefined locations, e.g. a grid or stripes.
A pressure sensitive layer may be placed on the seating portion of the magnetic stimulation device in the area of correct treatment position, e.g. in central area. The pressure sensitive layer may be a fluid filled and connected via a conduit with the pressure sensor external to magnetic field.
Alternatively, the pressure sensitive layer may include a plurality of cells in a predetermined pattern, e.g. an array or preferably a matrix. At least one sensor may be used to determine the pressure inside the pressure sensitive layer, a plurality of sensors may be preferably used. The pattern of cells may accurately determine the position of the patient by determining contact points.
The pressure sensitive layer may be e.g. tube, film or sheet. It may be made of elastically deformable optic material which is at least partially reflective at the end. It may be oriented preferably transversally on the seating portion. The light may enter at one end of the optic material and propagate through the entire length of the optic material to the second end where it may be at least partially reflected. The intensity/energy of the at least partially reflected light may be determined. When patient sits on such pressure sensitive layer the optic path is shorter due to patient's weight. The attenuation is smaller and the intensity/energy of the at least partially reflected light is greater compared to the pressure sensitive layer when there is no patient on the seating portion. Alternatively, the time-of-flight may be used to determine the patient's position.
Alternatively the magnetic stimulation device may include at least one optic band for determining the presence of the patient. Preferably a plurality of optic band may be used for determining the position of the patient.
The pressure sensitive layer may include at least one tube with constant fluid flow, preferably a plurality of fluid tubes may be used. Patient presence may be determined upon change of fluid flow. In preferred embodiment the fluid tube may be in a grid to determine contact points. Alternatively, the pressure sensitive layer may include a plurality of independent cells preferably in a predetermined pattern, e.g. a matrix. The contact cell may be determined by various manners using various approaches. For example the contact cell may be the cell which is loaded so the upper wall contacts the lower wall of the cell, it may be so called bottoming out. In this particular approach the contact cell may be determined by e.g. determining pressure change of cells in surroundings while the pressure in the contact cell remains constant. The pressure sensors may be preferably placed next to the seating portion to be unimpeded by the generated magnetic field.
The pressure sensitive layer may include at least one elastically deformable member which may be preferably oriented in the X-axis of CCS, in more preferred embodiment a plurality of elastically deformable members may be used. The at least one elastically deformable member may include a strain gauge on at least one end enabling determining the deformation of the at least one elastically deformable member in at least one direction, preferably in the Z-axis of CCS. In a preferred embodiment the deformation may be determined in a plurality of directions, most preferred in at least two orthogonal directions, e.g. in the Z-axis of CCS and at least one of X and Y axes of CCS. In an alternative embodiment inclinometers may be used instead of strain gauges.
The pressure sensitive layer may be rigid and it may include at least one accelerometer in at least one location unimpeded by magnetic field. One-axis, more at least two-axis, most preferably three-axis accelerometer may be used. The accelerometer may be preferably oriented in vertical direction. The accelerometer may be preferably placed in at least one edge of the seating portion, more preferably in at least two opposite edges of the seating portion or more accelerometers may be used.
All the above recited feedback methods may be used for determining the active response. The feedback information and/or signal may be processed by a processing unit of the magnetic stimulation device. Using the feedback, the position and/or orientation of the magnetic field generating device may be adjusted automatically and/or manually.
A patient may be stimulated by at least one pretreatment sequence prior to the treatment. The pretreatment sequence is not intended to treat the patient. The pretreatment sequence may be used for improving the effectiveness of the treatment by e.g. setting the magnetic field generating device to an appropriate position and/or determining the appropriate magnetic flux density for the patient. Both pretreatment sequences may be controlled by processing unit of the magnetic stimulation device and may be influenced by the feedback information.
The target biological structure may be stimulated by a pretreatment sequence for placing the magnetic field generating device in appropriate position to treat the target biological structure providing the greatest effect for the patient.
The appropriate position may be found by using stimulation of constant treatment parameters, e.g. repetition rate, magnetic flux density or impulse duration, while the magnetic field generating device scans the target biological structure. The time duration may be up to several minutes, more preferably in the range of 1 to 60 seconds, most preferably up to 30 seconds. The appropriate position may be found by firing at least two pulses, preferably at least 10 pulses, more preferably at least 50 pulses, most preferably at least 100 pulses or up to 500 pulses.
The appropriate position may be determined via registering the induced biological response, e.g. visually observed, perceived by the patient or detected by the feedback sensing device. The greatest effect for the patient may be achieved e.g. by stimulation of motor point, or by stimulation in such a position of the magnetic field generating device where the biological response is the weakest. The weakest biological response may correspond with the stimulation of weakened muscle which needs to be strengthened.
The appropriate position of the magnetic field generating device may be manually determined by the operator of the magnetic stimulation device while the operator observes the biological response of the target biological structure.
Alternatively, the patient may determine the appropriate position of the magnetic field generating device by using control apparatus following the perception of the stimulation. The control apparatus may include e.g. a lever mechanism, a joystick or control buttons linked to a seat actuator. Alternatively the control apparatus may adjust the position and/or orientation of the magnetic field generating device.
In an alternative embodiment the appropriate position of the magnetic field generating device may be set automatically by positioning mechanism following the feedback information.
The target biological structure may be stimulated by another pretreatment sequence including a plurality of pulses of different repetition rates. Following the pretreatment sequence an appropriate magnetic flux density may be determined for the treatment. The pretreatment sequence includes at least one repetition rate, more preferably at least two different repetition rates. The complete pretreatment sequence may last up to 120 seconds, more preferably in the range of 1 to 60 seconds, most preferably around 30 seconds.
The pretreatment sequence may include one repetition rate including at least one pulse, more preferably a plurality of pulses, e.g. at least two pulses, more preferably at least 5 pulses, even more preferably at least 10 or more pulses. The plurality of pulses is called a train. The magnetic flux density may be adjusted by an operator during the pretreatment sequence to provide the patient the appropriate treatment.
Alternatively, the pretreatment sequence may include a plurality of trains of different repetition rates. The repetition rate of first train may be the lowest repetition rate of the treatment. The repetition rate of second train may be the highest repetition rate of the treatment.
The magnetic flux density may be adjusted by an operator during the pretreatment sequence. The magnetic flux density of the trains may be the same for at least two trains.
In exemplary embodiment appropriate treatment parameters may be determined by the operator and/or the patient following the patient's needs.
Alternatively, the appropriate treatment parameters may be determined automatically by the magnetic stimulation device influenced the feedback information.
All the above recited methods and embodiments may be used for optimizing the treatment. The term optimizing treatment includes adjusting the position and/or orientation of the magnetic field generating device and/or treatment parameters. In preferred embodiment the treatment optimizing may be influenced feedback.
Novel systems and methods have been described. The invention should be interpreted in the broadest sense. Various changes and substitutions may be made of course without departing from the spirit and scope of the invention. The invention, therefore, should not be limited, except by the following claims and their equivalents.
It is to be understood that the method is not limited to the particular applications and that the method may be practiced or carried out in various ways.
The following applications are incorporated herein by reference:
No. 62/357,679 filed Jul. 1, 2016 and now pending; Ser. No. 15/178,455 filed Jun. 9, 2016 and now pending; Ser. No. 15/151,012 filed May 10, 2016 and now pending; Ser. No. 15/099,274 filed Apr. 14, 2016 and now pending; Ser. No. 15/073,318 filed Mar. 24, 2015 and now pending; Ser. No. 14/951,093 filed Nov. 24, 2015 and now pending; Ser. No. 14/926,365 filed Oct. 29, 2015 and now pending; and Ser. No. 14/789,658 filed Jul. 1, 2015 and now pending; Ser. No. 14/873,110 filed Oct. 1, 2015 and now pending; No. U.S. patent application Ser. No. 14/789,156 filed Jul. 1, 2015 and pending.
