Abstract:
A stimulating coil for use in the magnetic stimulation of neuro-muscular tissue comprises a self-supporting but flexible conductor in a flexible insulating sheath which can be adjusted by hand to conform the coil to the contours of a selected part of the human body. The coil is provided with a cooling system which includes a conduit disposed adjacent or within the coil and a pump for driving coolant through the conduit.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional application of U.S. patent application Ser. No. 10/999,574, filed Nov. 30, 2004, which claims priority to and benefit of U.K. Patent Application No. 0414909.2, filed on Jul. 1, 2004 and U.K. Patent Application No. 0422468.9, filed on Oct. 11, 2004, all of which are incorporated herein by reference, and to which this application claims priority to and benefit of under 35 U.S.C. §§119, 120, 363, 365, and 37 C.F.R. §1.55 and §1.78. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to magnetic stimulators, particularly for the magnetic stimulation of neuro-muscular tissue. Magnetic stimulators of this kind achieve stimulation by the creation of a rapidly changing magnetic field, for example of the order of 20 kiloTesla per second in the vicinity of the tissue. Electric currents thereby induced in the tissue cause stimulation thereof. 
       BACKGROUND TO THE INVENTION 
       [0003]    Known magnetic stimulators comprise generally a charging circuit for a ‘discharge’ capacitor, a discharge control such as a controlled rectifier for allowing discharge of the capacitor through the stimulating coil, and other circuit elements for limiting the effect of undesirable electrical transients. In known practice the coil may assume a variety of forms but typically comprise a rigid holder or a housing for a multi-turn coil which has appropriate connectors for coupling to the discharge circuit. 
         [0004]    The object of the invention is to allow a more versatile application of the stimulating technique and in particular to allow the coil to be formed around a patient&#39;s limb or other part of the human body, particularly to provide a large surface area which allows sub-maximal and super-maximal stimulation of both superficial and deep muscles for the purposes of therapy or rehabilitation. 
       SUMMARY OF THE INVENTION 
       [0005]    According to one aspect of the invention, a magnetic stimulator for the magnetic stimulation of neuro-muscular tissue comprises a stimulating coil, a charging circuit, a capacitor, and a discharge control for allowing discharge of the capacitor through the stimulating coil. The stimulating coil comprises a flexible conductor in a flexible insulating sheath which can be adjusted by hand to conform the coil to the contours of a selected part of the human body. 
         [0006]    Preferably the coil is wound into a multiple turn coil in which the turns are disposed to lie generally in a common plane and are supported by the flexible sheath in that configuration. The sheath may have a generally flat disc shape. 
         [0007]    The sheath may include at least one sensor for sensing the temperature of the coil, and the sensor may be coupled, either directly or by way of a control circuit, to prevent current flow through the coil on the detection of a temperature above a limit. The measurement of temperature is to ensure that the possibly large area of the coil in close proximity to the patient does not produce a thermally hazardous condition. 
         [0008]    The conductor may be provided with a cooling system, preferably a system which drives coolant in proximity to the coil. For example the coil may be disposed in an outer tube, there being a pump for pumping a coolant through the outer tube so as to provide cooling of the conductor constituting the coil. The outer tube may be connected to a heat exchanger and the pump may be connected to recirculated the coolant through the heat exchanger and the outer tube. The coolant may be water but may be a liquid of high thermal conductivity and low electrical conductivity and may be an organic (carbon-based) liquid such as a fluorocarbon. Other forms of cooling system are feasible. For example, the whole coil may be immersed in a jacket containing coolant. The coil may be constituted by a hollow conductor through which coolant may be driven. The coil could be moulded within a flexible sheath which has an interface with a cooling jacket. 
         [0009]    According to another aspect of the invention a magnetic stimulating coil for the magnetic stimulation of neuro-muscular tissue comprises a flexible conductor in a flexible insulating sheath which can be adjusted by hand to conform the coil to the contours of a selected part of the human body. 
         [0010]    The coil may be a multiple turn coil in which the turns are disposed to lie generally in a common plane and are supported by the flexible sheath in that configuration. 
         [0011]    The conductor may be provided with a cooling system as previously described. 
         [0012]    The invention will now be described in detail with reference to a specific example and with recourse to the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is a schematic circuit diagram of a magnetic stimulator. 
           [0014]      FIG. 2  is a schematic illustration of part of a coil cooling system 
           [0015]      FIG. 3  is a schematic diagram of one embodiment of the invention 
           [0016]      FIGS. 4 ,  5  and  6  are view of a coil, shown from the rear, side and front respectively 
           [0017]      FIG. 7  is a schematic diagram showing the construction of a coil 
           [0018]      FIG. 8  is a diagram illustrating the flexure of the coil. 
       
    
    
     DETAILED DESCRIPTION 
       [0019]      FIG. 1  of the drawings illustrates for the sake of completeness the electrical circuit of one form of magnetic stimulator suitable for use in the present invention. The particular example is one of several different stimulators which are the subject of, and are more fully described in, U.S. Pat. No. 5,766,124 to Polson, commonly assigned herewith. 
         [0020]    This particular example has a high-voltage power supply  1  which charges a reservoir capacitor  2 . Charge is transferred from the reservoir capacitor, substantially independently of the charging rate of the reservoir capacitor, via a transfer capacitor  5  to a ‘discharge’ capacitor  9 , which at appropriate intervals is discharged into a stimulating coil  11 . The transfer capacitor  5  is part of a charge pump which includes a unidirectional switch  3 , a series inductor  4 , the transfer capacitor  5 , a reverse diode  6  in parallel with the capacitor  5 , a series inductor  7  and a switching system  8 , which comprises controlled rectifiers  8   a,    8   b,    8   c  and  8   d.  The discharge of the capacitor  9  is. controlled by the switching system  10  comprising controlled rectifiers  10   a ,  10   b ,  10   c  and  10   d . The discharge current may be in either direction through the coil  11 , which has an earth connection. Discharge pulses, of magnitude and frequency which are controllable by the switching systems  8  and  10 , flow through the coil  11 . Typically the instantaneous current may be of the order of 5 kA, i.e. considerably in excess of 1 kA; the rms value of a typical pulse train may be hundreds of amps, such as 400 A. 
         [0021]      FIG. 2  illustrates some of the physical components of the system. They are the coil  11 , which will be more fully described later, a flexible insulating conduit  12 , a heat exchanger connection box  14  and a conduit  15 . The ends of the coil inside their cooling tubes (to be described) pass through the conduit  12  to the box  14  and the coil ends pass through the conduit  15  to the rest of the stimulator as described with reference to  FIG. 1 . As will be described later, in this example the coil is disposed inside a flexible tube which conveys a fluid coolant. 
         [0022]      FIG. 3  illustrates the connections between the coil, the heat exchanger and the stimulator. The stimulator  16  is for example as described with reference to FIG.  1 . The conductor  11   a  constituting the electrical element of the coil  11  is connected as shown in  FIG. 1  to the remainder of the stimulator. The conductor is preferably self-supporting but flexible. It may (for example) be copper wire having a diameter in the range 2.5 to 3 mm. The conductor  11   a , which has an insulating cover, forms the turns  18  of the coil of the coil  11 . Over most of its length the conductor  11   a , which has an insulating cover (not shown) is enclosed in a flexible tube  17  which is connected to allow a pump  19  to pump fluid coolant through the tube  17  and a heat exchanger  20 . In this embodiment there are two segments and to the tube, the conductor at its middle part  11   b  coming out of one end of one tube segment and entering the other tube segment. Respective ends of the tube segments are connected to the pump and the heat exchanger. Thus in this example there are two parallel paths for coolant to flow adjacent the coil, one flow cooling the inner turns of the coil and the other flow cooling the outer turns of the coil. Coolant from the heat exchanger  20  flows to a reservoir  21  connected to the pump  19  and is recirculated through the tube  17  during the operation of the stimulator. 
         [0023]      FIGS. 4-6  are different views of the flexible cooled coil&#39;s general construction. The conductor  11   a  in its tube extends along and within the flexible elongate conduit  15  which comprises two end connectors  12   a  and  12   b  and an intermediate part comprising a ribbed plastics tube  12   c.  The end connector  12   a  is adapted in any convenient manner for connection to the connection box. The other end  12   b  is connected to a generally disc-shaped sheath  22  within which the turns of the coil are located in the same plane.  FIG. 4  illustrates the ‘rear’ of the coil, i.e. that which faces away from the patient in use.  FIG. 5  illustrates a side view, showing the flat character of the sheath  22  in its original unflexed state.  FIG. 6  illustrates the coil head form the front, i.e. that which is adjacent the patient in use. 
         [0024]    Embedded in the sheath  22  and close to its front surface are temperature sensors  23  with electrical connections  24  that extend back along the conduit to the stimulator. Shown schematically is a safety switch  25  ( FIG. 3 ) which in any convenient manner can disable the stimulator, to prevent current flow through the coil, if the sensed temperature is too high. 
         [0025]    There may be flow detectors within the coolant circuit comprising the pump, heat exchanger, reservoir and the connecting conduits. Accordingly if the coolant flow reduces to below some pre-set value the application of current to the stimulating coil would be prevented. This is another safety feature to ensure that a thermally hazardous condition is avoided. By way of example a flow detector  26  within the coolant circuit is shown diagrammatically at  26  and is coupled to the safety switch  25 . 
         [0026]      FIG. 7  illustrates the coil in section, the section being taken on the line X-X in  FIG. 4 . 
         [0027]    The coil, comprising the conductor  11   a  and its surrounding tube  17  is encapsulated in the flexible, silicone rubber moulded disc-shaped sheath  22 . The tube  17  may be a silicone plastic material. The sheath  22  has on its rear side a bulge  26  which accommodates the lead-in and lead-out parts of the conductor in its tube  17 . The coolant can flow along the space  27  between the insulated conductor  11   a  and the surrounding tube  17 . 
         [0028]    Other forms of cooling system may be employed. In the particular example, the outer tube is a conduit through which coolant is driven to cool the coil. However, the coil may be disposed adjacent or within a jacket through which coolant may be driven. The coil could be hollow and itself define a conduit through which coolant may be driven. 
         [0029]      FIG. 8  illustrates the flexing of the sheath  22  and thereby the coil  11  from a flat condition  11 - 1  thorough a moderately flexed condition to a fully flexed condition  11 - 3 . The flexing of the head may be plastic, in that it will remain in the particular flexed state and not elastically revert to the flat un-flexed state. The amount of flexure may be chosen by an administrator to suit the contour or shape of the body part against which the coil is located. It may be necessary to employ straps, or other holding means to locate the coil securely on the patient. 
         [0030]    Alternatively the flexure may be elastic; in this event the use of straps or other holding means is desirable to ensure that the coil is maintained in its flexed configuration and in position on the patient. 
         [0031]    A variety of materials would be suitable for the sheath  22 . A silicone rubber compound may be used. The degree of hardness of the rubber may be chosen according to the desired elasticity of the flexure; a hard silicone rubber would be appropriate for an elastic sheath and a softer silicone rubber if the sheath is intended to flex plastically, the shape being maintained by the flexible copper wire inside the sheath.