Electrical device for providing pain relief

Abstract

To provide an apparatus for relieving pain in a region of the body of a user by providing electrical impulses.SOLUTION: An apparatus includes: (a) at least two electrodes adapted to contact a surface of a body of the user; (b) a control unit; and (c) a signal generator associated with the control unit and responsive thereto. In an operative mode, the signal generator includes a plurality of cycles, each of the cycles having a positive voltage pulse and a negative voltage pulse. The frequency of the plurality of cycles is within the range of 60-150 cycles per second. The time-averaged voltage amplitude (Vap) of the positive voltage pulse over the entire duration (Tppositive) thereof is 20-90 volts. At least one of the following structural conditions is fulfilled: (1) the positive voltage pulse attains at least 80% of the time-averaged voltage amplitude, within a time (T80) of 70-150 nanoseconds; and (2) the positive voltage pulse increases by at least 20 volts, within 70 nanoseconds.SELECTED DRAWING: Figure 5B

Description

[Technical field]

[0001] The present invention relates to devices and methods for providing pain relief, and in particular to electrical devices and methods for providing pain relief by providing electrical impulses to the surface of the body in areas where pain is experienced. [Background technology]

[0002] In accordance with some teachings of the present invention, a non-invasive device for providing analgesia to a human user is provided, the device including: (a) at least two electrodes adapted to contact a surface of a body of a user; (b) a control unit; and (c) a signal generator associated with and responsive to the control unit, the signal generator and the control unit adapted to operatively connect to a power supply, the signal generator being adapted, in an operational mode, to provide a series of electrical impulses to the surface of the body via the electrodes, the series including a plurality of cycles, each of the cycles including a positive voltage pulse and a negative voltage pulse, the frequency of the plurality of cycles optionally being within a range of 60-150 cycles per second, and a total duration (Tp positive ) the time-averaged voltage amplitude (Va p ) is 20 to 90 volts, and the rising portion of the positive voltage pulse satisfies at least one of the following structural conditions: (1) the positive voltage pulse achieves at least 80% of the time-averaged voltage amplitude within a time (T80) of 70 to 150 nanoseconds, and (2) the positive voltage pulse increases by at least 20 volts within 70 nanoseconds. Summary of the Invention

[0003] In accordance with further teachings of the present invention, there is provided a non-invasive device for providing analgesia to a human user, the device including: (a) at least two electrodes adapted to contact a surface of a body of the user; (b) a control unit; and (c) a signal generator associated with and responsive to the control unit, the signal generator and the control unit adapted to operatively connect to a power supply, the signal generator being adapted in an operational mode to provide a series of electrical impulses to the surface of the body via the electrodes, the series including a plurality of cycles, each of the cycles including a positive voltage pulse and a negative voltage pulse, the series including a plurality of cycles having a total duration (Tp positive ) the time-averaged voltage amplitude (Va p ) is between 20 and 90 volts, the rising portions of the positive voltage pulses of cycles in a first subset of the plurality of cycles have a first rise time, and the rising portions of the positive voltage pulses of cycles in a second subset of the plurality of cycles following the first subset have a second rise time that is shorter than the first rise time, and the rising portions of the positive voltage pulses of cycles in the second subset satisfy at least one of the following structural conditions: (1) the positive voltage pulse achieves at least 80% of its time-averaged voltage amplitude within a time (T80) between 70 and 150 nanoseconds, and (2) the positive voltage pulse increases by at least 20 volts within 70 nanoseconds.

[0004] In accordance with further teachings of the present invention, there is provided a method of providing analgesia to a user, the method including: (a) providing a device as described herein; (b) attaching at least two electrodes to a surface of the user's body; and (c) activating a signal generator to operate in an operating mode to provide a succession of electrical impulses to the surface of the body via the electrodes.

[0005] According to still further features in the described preferred embodiments the attaching includes attaching at least two electrodes to a surface of the body in an area where pain is felt by the user.

[0006] According to still further features in the described preferred embodiments, the area in which pain is felt by the user is an abdominal area of ​​the user.

[0007] According to still further features in the described preferred embodiments the method is affected to provide relief from menstrual or premenstrual pain.

[0008] According to still further features in the described preferred embodiments the method further comprises a user wearing the device.

[0009] According to still further features in the described preferred embodiments the wearing includes attaching the device to clothing worn by the user.

[0010] According to still further features in the described preferred embodiments the wearing includes wearing the device while the device is in an operational mode.

[0011] According to still further features in the described preferred embodiments the device is portable and the method further comprises the user, in the operational mode, moving a distance of at least 10, at least 5, or at least 3 meters while wearing the device for at least 10, at least 5, or at least 3 minutes.

[0012] According to still further features in the described preferred embodiments, T80 is at least 75 nanoseconds.

[0013] According to still further features in the described preferred embodiments, T80 is at least 80 nanoseconds.

[0014] According to still further features in the described preferred embodiments, T80 is at most 140 nanoseconds.

[0015] According to still further features in the described preferred embodiments, T80 is at most 130 nanoseconds.

[0016] According to still further features in the described preferred embodiments, T80 is at most 120 nanoseconds.

[0017] According to still further features in the described preferred embodiments, T80 is at most 115 nanoseconds.

[0018] According to still further features in the described preferred embodiments, T80 is at most 110 nanoseconds.

[0019] According to still further features in the described preferred embodiments the positive voltage pulse increases by at least 20 volts within 70 nanoseconds.

[0020] According to still further features in the described preferred embodiments the positive voltage pulse increases by at least 30 volts within 70 nanoseconds.

[0021] According to still further features in the described preferred embodiments the positive voltage pulse increases by at least 40 volts within 70 nanoseconds.

[0022] According to still further features in the described preferred embodiments the positive voltage pulse increases by at least 50 volts within 70 nanoseconds.

[0023] According to still further features in the described preferred embodiments an intermediate time (Ti) between the positive and negative voltage pulses is at least 0.1 milliseconds, at least 0.2 milliseconds, at least 0.3 milliseconds, or at least 0.4 milliseconds.

[0024] According to still further features in the described preferred embodiments, the intermediate time (Ti) is at most 1 millisecond, at most 0.9 milliseconds, at most 0.8 milliseconds, or at most 0.7 milliseconds.

[0025] According to still further features in the described preferred embodiments the positive pulse achieves at least 80% of the time-averaged voltage amplitude for a pulse duration in a range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds.

[0026] According to still further features in the described preferred embodiments the positive pulse has a substantially constant voltage amplitude for a pulse duration in the range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds.

[0027] According to still further features in the described preferred embodiments a frequency of the plurality of cycles is within a range of 70 to 140 cycles per second, 80 to 130 cycles per second, or 80 to 120 cycles per second.

[0028] According to still further features in the described preferred embodiments the negative voltage pulse is area-symmetric to the positive voltage pulse within 10 area%, within 5 area%, within 2 area%, or within 1 area%.

[0029] According to still further features in the described preferred embodiments the positive voltage pulse achieves at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the time-averaged voltage amplitude within 70 to 150 nanoseconds.

[0030] According to still further features in the described preferred embodiments the signal generator includes a low voltage signal generator adapted to generate a low voltage AC signal, the low voltage signal generator generating a peak voltage of up to 10.0 volts, up to 5.0 volts.

[0031] According to still further features in the described preferred embodiments the signal generator includes at least one of a voltage preamplifier and a voltage amplifier adapted to amplify a voltage of a signal provided thereto as an input.

[0032] According to still further features in the described preferred embodiments, the voltage preamplifier and / or the voltage amplifier are disposed electrically downstream relative to the low-voltage signal generator and receive as an input the low-voltage AC signal generated by the low-voltage signal generator.

[0033] According to still further features in the described preferred embodiments the signal generator includes a transformer adapted to amplify a voltage of a signal provided thereto as an input.

[0034] According to still further features in the described preferred embodiments the transformer is disposed electrically downstream relative to the voltage preamplifier and the voltage amplifier.

[0035] According to still further features in the described preferred embodiments, the signal generator includes an AC-DC converter disposed electrically downstream with respect to the transformer and adapted to generate a substantially DC signal from an input signal provided thereto.

[0036] According to still further features in the described preferred embodiments the signal generator includes an AC-DC converter adapted to generate the substantially DC signal.

[0037] According to still further features in the described preferred embodiments, the AC-DC converter is disposed electrically downstream relative to the voltage preamplifier and the voltage amplifier.

[0038] According to still further features in the described preferred embodiments the AC-DC converter includes a diode circuit adapted to generate the substantially DC signal.

[0039] According to still further features in the described preferred embodiments the diode circuit includes at least one diode and a capacitor disposed electrically downstream of the at least one diode.

[0040] According to still further features in the described preferred embodiments the signal generator includes a switch mechanism responsive to the control unit and adapted to convert an input signal provided to the switch mechanism into a series of electrical impulses.

[0041] According to still further features in the described preferred embodiments the switch mechanism receives a substantially DC signal as the input signal.

[0042] According to still further features in the described preferred embodiments the switch mechanism includes a first switch adapted to generate, in response to the control unit, a succession of positive voltage pulses from the substantially DC signal, and a second switch adapted to generate, in response to the control unit, a succession of negative voltage pulses from the substantially DC signal.

[0043] According to still further features in the described preferred embodiments, the power supply includes a low voltage power supply adapted to provide a nominal voltage of up to 10 volts, up to 8.0 volts, up to 6.0 volts, up to 5.0 volts, up to 4.0 volts, or up to 3.0 volts.

[0044] According to still further features in the described preferred embodiments the device further comprises a housing enclosing the control unit, the signal generator and the power supply.

[0045] According to still further features in the described preferred embodiments, in an operational mode, the power supply enclosed within the housing is the only power supply for the device.

[0046] According to still further features in the described preferred embodiments the housing has a size within the range of 4 centimeters by 4 centimeters by 8 millimeters to 6 centimeters by 6 centimeters by 13 millimeters.

[0047] According to still further features in the described preferred embodiments the device has a weight, excluding any power supply enclosed within the housing, in the range of 90 to 150 grams.

[0048] According to still further features in the described preferred embodiments the device is portable while in the operational mode.

[0049] According to still further features in the described preferred embodiments the electrodes are adapted to contact a surface of the user's body in an area of ​​the body where pain is experienced.

[0050] According to still further features in the described preferred embodiments, a rising portion of the positive voltage pulse of a cycle in a third subset of the plurality of cycles following the second subset has a third rise time that is shorter than the second rise time.

[0051] In accordance with still further features in the described preferred embodiments, the total period (Tp negative ) the time-averaged voltage amplitude (Va n ) is 20 to 90 volts.

[0052] In accordance with still further features in the described preferred embodiments, the rising portion of the negative voltage pulse satisfies at least one of the following structural conditions: (1) the negative voltage pulse achieves at least 80% of its time-averaged voltage amplitude within a time (T80) of 70 to 150 nanoseconds; and (2) the negative voltage pulse decreases by at least 20 volts within 70 nanoseconds.

[0053] According to still further features in the described preferred embodiments, a rising portion of the negative voltage pulse decreases by at least 20 volts, at least 30 volts, at least 30 volts, or at least 50 volts within 70 nanoseconds.

[0054] According to still further features in the described preferred embodiments the negative pulse achieves at least 80% of the time-averaged voltage amplitude for a pulse duration in a range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds.

[0055] According to still further features in the described preferred embodiments the negative pulse has a substantially constant voltage amplitude for a pulse duration in the range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds.

[0056] According to still further features in the described preferred embodiments the negative voltage pulse achieves at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the time-averaged voltage amplitude within 70 to 150 nanoseconds.

[0057] The present invention is described herein by way of example only, with reference to the accompanying drawings. Now, with particular reference to the drawings in detail, it is emphasized that what is shown is by way of example, and is for the purpose of an illustrative discussion of preferred embodiments of the present invention, presented in the course of providing what is believed to be the most effective and easily understood explanation of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the invention more than are necessary for a fundamental understanding of the invention, and the description taken in conjunction with the drawings will make clear to those skilled in the art how the invention in several forms may be embodied in practice. Throughout the drawings, like reference numerals are used to designate like functionality, although not necessarily identical elements. [Brief description of the drawings]

[0058] [Figure 1] FIG. 1 is a schematic block diagram of an embodiment of a device of the present invention that utilizes a train of electrical impulses of the present invention to provide pain relief, in accordance with an embodiment of the teachings herein. [Diagram 2] 2 is a schematic block diagram of a signal generator according to an embodiment of the teachings herein, the signal generator forming part of the device of FIG. 1. [Diagram 3] 3 is a simplified electrical diagram of a transformer and AC-DC signal converter in accordance with the teachings herein, the transformer and AC-DC signal converter forming part of the signal generator of FIG. [Figure 4A] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 4B] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 4C] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 4D] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 4E] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 4F] 3 is a schematic diagram of pulses transmitted from different components of the signal generator of FIG. 2 in accordance with an embodiment of the teachings herein. [Figure 5A] FIG. 1 is a schematic diagram of an electrical signal transmitted by a prior art device for pain relief. [Figure 5B] 3 is a schematic diagram of an electrical signal of the present invention in accordance with the teachings herein that may be generated by the signal generator of FIG. 2. [Figure 6] 2 is a schematic diagram of a continuous electrical signal in accordance with an embodiment of the teachings herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] Described herein are systems and methods for applying electrical impulses to the surface of a user's body in areas of the body where pain is experienced, thereby providing pain relief.

[0060] Reference is now made to FIG. 1, which is a schematic block diagram of an embodiment of a device of the present invention that utilizes a train of electrical impulses to provide pain relief, in accordance with an embodiment of the teachings herein.

[0061] As will be appreciated, the device 100 for providing pain relief may include at least two stimulating electrodes 102 operatively associated with a signal generator 104. The electrodes 102 receive electrical signals from the signal generator 104 to be provided to a surface of the user's skin. The stimulating electrodes 102 are adapted to contact the surface of the user's body in an area of ​​the body experiencing pain and, in an operational mode, to deliver electrical impulses to the surface of the body, as described below.

[0062] The signal generator 104 is operatively associated with and receives instructions from a control unit 106 which, in some embodiments, is operatively associated with an input module 108 that provides input to the control unit 106 and an output module 110 via which the control unit 106 provides output to a user. The control unit may be any suitable control unit, such as an 8 / 16-bit AVR® XMEGA® microcontroller commercially available from Atmel® of San Jose, California, USA.

[0063] In some embodiments, the input module 108 may include or be associated with a user interface 109 that includes an on / off switch for activating the device 100 and / or terminating activation of the device 100 .

[0064] In some embodiments, the user interface 109 includes one or more adjustment buttons or settings for increasing and decreasing the desired peak voltage.

[0065] In some embodiments, the signal generator 104, the control unit 106, the input module 108, and the output module 110 may be electrically associated with and powered by one or more power supplies 112. In some embodiments, the power supplies 112 are low-voltage power supplies providing a nominal voltage of up to 10.0 volts, up to 8.0 volts, up to 6.0 volts, up to 5.0 volts, up to 4.0 volts, or up to 3.0 volts. In some embodiments, the power supplies include at least one rechargeable battery, such as at least one nickel-metal hydride (NiMH) battery, nickel-cadmium (NiCd) battery, lithium-ion (Li-ion) battery, or lithium-polymer (Li-Poly) battery. That is, in some embodiments, the device 100 is powered only by the power provided by the rechargeable battery and does not require connection to an additional power supply for its functionality when the rechargeable battery is fully charged.

[0066] The signal generator 104, control unit 106, and power supply 112 may be enclosed within a housing 120, which may include a port 122 for connection of the electrodes 102 to the signal generator 104, and / or a port 124 for connection of the power supply 112 to an external power source, e.g., a charging cable connected to an electrical socket.

[0067] In some embodiments, the device has dimensions in the range of 4 cm x 4 cm x 8 mm to 6 cm x 6 cm x 13 mm, more typically in the range of 4 cm x 4 cm x 9 mm to 5.3 cm x 5.3 cm x 12 mm. The weight of the device excluding the battery is 90 to 150 grams, more typically 100 to 125 grams.

[0068] In some embodiments, device 100 may be easily worn by a user, for example attached to their clothing, In some embodiments, device 100 may be portable and function in its operational signal providing mode while being transported or moved from one location to another, or while the user is in motion.

[0069] Reference is now further made to FIG. 2, which is a schematic block diagram of the signal generator 104 of the device 100, in accordance with an embodiment of the teachings herein.

[0070] The signal generator 104 optionally includes a signal generator, such as low voltage signal generator 200, which generates an alternating current (AC) signal 400, as shown in Figure 4A. In some embodiments, the signal generated by the low voltage signal generator 200 has a peak voltage in the range of 3.0 to 10.0 volts, more typically in the range of 3.0 to 5.0 volts.

[0071] In some embodiments, the signal 400 generated by the low voltage signal generator 200 may be provided to a voltage preamplifier 202. The voltage preamplifier 202 increases the voltage of the received signal to generate a new AC signal 402 having a higher voltage, as shown in Figure 4B. In some embodiments, the voltage preamplifier 202 may be replaced by a voltage amplifier having similar functionality.

[0072] In some embodiments, power supply 112 (shown in FIG. 1) may deliver voltage directly to any one of components 200 , 202 , 204 , or 206 .

[0073] In some embodiments, the power supply 112 may deliver a high DC voltage (eg, at least 20 volts) directly to the switch mechanism 210 .

[0074] The signal 402 output by the preamplifier 202 is provided to a transformer 204, such as the LPR6235 transformer commercially available from Coilcraft® Inc. of Cary, Illinois, USA. At the expense of a reduced current output, the transformer 204 increases the voltage of the received signal to produce a new AC signal 404 having a higher voltage than the signal 402, as can be seen in FIG.

[0075] The signal 404 output by the transformer 204 is provided to the AC-DC converter 206. In some embodiments, such as the embodiment illustrated in Figure 3, the AC-DC converter 206 includes a diode circuit 300 including at least one diode 302 and a capacitor 304 disposed downstream thereof. The signal 404 output by the transformer 204 is provided as an input to the diode 302, which selects a positive voltage section from the signal 404 resulting in the signal 406 illustrated in Figure 4D. A negative voltage section may be obtained from the signal 404 by reversing the direction of the diode 302, as known in the art.

[0076] The signal 406 generated by the diode 302, and in some embodiments also a corresponding signal generated by the inverted diode 302, is provided as an input to the capacitor 304, which converts the signal to a DC signal 408 having a fixed voltage, as illustrated in FIG. 4E.

[0077] The DC signal 408 output by the capacitor 304 is provided as an input to a switch mechanism 210, such as a BSS123LT1G or BVSS123LT1G, commercially available from ON Semiconductor® of Phoenix, Arizona, USA.

[0078] In some embodiments, the switch mechanism includes a first switch 212a to generate a positive pulse of the generated signal, and a second switch 212b to generate a negative pulse of the generated signal, as described in more detail below. The switch mechanism 210, and in some embodiments each of the switches 212a and 212b, may be controlled by the control unit 106 to generate a signal 410, as illustrated in FIG. 4F. The signal 410 is provided to the electrode 102 and from there to a surface of the user's body. The signal 410 and its characteristics are described in more detail below with respect to FIG. 5B.

[0079] Reference is now further made to Figure 5A, which is a schematic illustration of an electrical signal transmitted by a prior art device for pain relief, and Figure 5B, which is a schematic illustration of an electrical signal of the present invention in accordance with the teachings herein that may be generated by the signal generator of Figure 2. It will be appreciated that the signals in Figures 5A and 5B are not drawn to scale and are intended only to provide an understanding of the structure and shape of those signals, and are not intended to limit the duration of different portions of the signals.

[0080] 5A, a prior art device for pain relief provides a signal 500 that defines a pulse 502. The pulse 502 has a total pulse time (Tp) that includes (a) a rise time (Tru) indicated by segment 505 of the pulse, (b) a peak voltage time (Tpv) indicated by segment 506 of the pulse, and (c) a fall time (Trd) indicated by segment 508 of the pulse.

[0081] Peak voltage is defined as the voltage within 15%, 10%, 5%, 3%, or 1% of the maximum voltage in the pulse, which is the highest voltage achieved by a positive voltage pulse or the lowest voltage achieved by a negative voltage pulse during the entire duration of the pulse.

[0082] The rise time (Tru) is generally the time for the voltage of the pulse to increase or transition to at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the peak or maximum voltage of the signal. Typically, the rise time includes an increase in voltage from a reference voltage, which is typically zero. Conversely, the fall time (Trd) is generally the time for the voltage of the pulse to decrease or transition from the peak voltage of the maximum voltage for the signal by at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the voltage, or up to 20%, up to 15%, up to 10%, up to 5%, or a voltage substantially equal to the reference voltage, which is typically zero.

[0083] The rise time Tru of prior art devices may be at least 0.5 microseconds, and more typically may be in the range of 0.5 to 1 microsecond (500 to 1000 nanoseconds).

[0084] Turning to Figure 5B, it can be seen that the signal 550 provided by the device 100 of the present invention of Figures 1-3 includes a plurality of cycles, each cycle being biphasic and including a positive voltage pulse 552 having a positive voltage and a negative voltage pulse 554 having a negative voltage. Each of the positive voltage pulse 552 and the negative voltage pulse 554 has a total pulse time (Tp) (Tp for the positive voltage pulse 552) positive and Tp for the negative voltage pulse 554 negative5, where the total pulse time (Tp) includes a rise time (Tru), a peak voltage time (Tpv), and a fall time (Trd). For each of the positive voltage pulse 552 and the negative voltage pulse 554, the rising segment of the pulse is indicated by reference numeral 556, the falling segment of the pulse is indicated by reference numeral 558, and the peak voltage segment of the pulse is indicated by reference numeral 555. It will be appreciated that the rising segment 556 of the positive voltage signal 552 is achieved by the control unit 106 operating the switch 212a. The falling segment 558 may be provided passively by the switch 212a or the switch mechanism 210 ceasing to provide a signal, or alternatively, may be provided actively by the switch 212a actively reducing the voltage provided by the pulse 552.

[0085] Similarly, it will be appreciated that the rising segment 556 of the negative voltage signal 554 is provided by the control unit 106 operating the switch 212b. The falling segment 558 may be provided passively by the switch 212b or switch mechanism 210 ceasing to provide a signal, or alternatively, may be provided actively by the switch 212b actively increasing the voltage provided by the pulse 554.

[0086] In some embodiments, the positive voltage pulse 552 has a total duration (Tp positive ) through the time-average voltage amplitude (Va) in the range of 20 to 90 volts p ), and the negative voltage pulse 554 has a total duration (Tp negative ) through the time-averaged voltage amplitude (Va n ).

[0087] The rise time (Tru) and fall time (Trd) are defined as discussed above with respect to Figure 5A. It will be appreciated that for the positive voltage pulse 552, the peak voltage is a positive voltage, so that during the rise time the voltage increases from a reference voltage, typically zero, to the peak voltage, and during the fall time the voltage decreases from the peak voltage to the reference voltage, and for the negative voltage pulse 554, the peak voltage is a negative voltage, so that during the rise time the voltage decreases from the reference voltage to the peak voltage, and during the fall time the voltage increases again from the peak voltage to the reference voltage.

[0088] In particular, it is assumed that the positive voltage pulse 552 has a time-averaged voltage amplitude (Va p It is a particular feature of the teachings herein that the positive voltage pulse 552 achieves at least 80% of the negative time-averaged voltage amplitude (Va) within a time period (T80) between 70 and 150 nanoseconds, and / or the positive voltage pulse 552 increases by at least 20 volts within 70 nanoseconds. Similarly, the negative voltage pulse 554 achieves at least 80% of the negative time-averaged voltage amplitude (Va) within a time period (T80) between 70 and 150 nanoseconds. n ) and / or decreases by at least 20 volts within 70 nanoseconds.

[0089] In some embodiments, T(80) is at least 75 ns or at least 80 ns, hi some embodiments, T(80) is at most 140 ns, at most 130 ns, at most 120 ns, at most 115 ns, or at most 110 ns.

[0090] In some embodiments, the positive voltage pulse 552 increases by at least 30 volts, at least 40 volts, or at least 50 volts within 70 nanoseconds, hi some embodiments, the negative voltage pulse 554 decreases by at least 30 volts, at least 40 volts, or at least 50 volts within 70 nanoseconds.

[0091] In some embodiments, the positive voltage pulse 552 has a time-averaged voltage amplitude (Vap ) at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100%.

[0092] In some embodiments, the negative voltage pulse 554 has a time-averaged voltage amplitude (Va n ) at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100%.

[0093] Thus, in some embodiments, the rise time (Tru) controlled by the switch mechanism 210 is in the range of 50-200 ns, 60-175 ns, 70-150 ns, 75-140 ns, 80-130 ns, 80-120 ns, or 80-110 ns.

[0094] 5A and 5B, the rise time (Tru) during which the prior art pulse 502 rises and reaches a peak voltage is much longer than the rise time during which the positive voltage pulse 552 of the present invention reaches a peak voltage. The inventors have surprisingly discovered that shorter rise times, when present, are associated with improved relief of pain and discomfort, including relief of physiological pain and / or device induced pain.

[0095] More specifically, the inventors have discovered that at rise times shorter than 70 nanoseconds, the pain caused by the device is significantly increased and is not adequately compensated for by the body's pain relief mechanisms. The inventors have further discovered that at rise times greater than 200 nanoseconds, the pain caused by the device may be significantly reduced, but activation of the body's pain relief mechanisms (e.g., production of opiates or morphine-like substances) is also significantly reduced, such that such slow rise times are relatively ineffective in reducing pain for the user.

[0096] Without wishing to be bound by theory, Applicant believes that the rapid onset of the signal provided by the present invention in the area of ​​the body where pain is felt by the user causes the brain to deliver significantly increased amounts of opiate or morphine-like molecules to that area, which, due to the provision of the signal, provides rapid and effective pain relief to the area and also provides immediate and substantially complete relief to any pain experienced by the user, such that the signal itself does not cause the user pain, and the enhanced presence of the opiate or morphine-like molecules in that area of ​​the body relieves the pain felt by the user before the treatment was received.

[0097] Stated differently, applicants believe that the application of an electrical signal to a pain-sensing area occupies pain-sensing nerves in the area, such that the brain effectively eliminates the pain felt by the application of the signal, if any, and provides the area with a sufficient amount of pain-relieving molecules to relieve the pain for which treatment is being considered. The midpoint time (Ti) is defined as the time between the positive voltage pulse 552 and the negative voltage pulse 554, and the rest time (Trest) is defined as the time remaining between cycles, or the time from the end of the negative voltage pulse 554 of one cycle and the beginning of the positive voltage pulse 552 of the next cycle. The total time per cycle (Ttotal) is given by Ttotal=Tp positive +Tp negative It is defined as +Ti+Trest.

[0098] In some embodiments, the frequency of the cycles in signal 550 is in the range of 60-150 cycles per second, 70-140 cycles per second, 80-130 cycles per second, or 80-120 cycles per second. Stated differently, the total time per cycle (Ttotal) is in the range of 6.5-16.7 milliseconds, in the range of 7.1-14.3 milliseconds, in the range of 7.7-12.5 milliseconds, or in the range of 8.3-12.5 milliseconds.

[0099] In some embodiments, the total pulse time (Tp) for each of the positive voltage pulse 552 and the negative voltage pulse 554 is in the range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds. In some embodiments, the positive pulse is Va for a pulse duration in the range of 70 to 130 microseconds, 80 to 120 microseconds, or 90 to 110 microseconds. p and / or the negative pulse achieves at least 80% of Va n In some embodiments, the positive voltage pulse and / or the negative voltage pulse have a substantially constant voltage amplitude for a pulse duration in the range of 70-130 microseconds, 80-120 microseconds, or 90-110 microseconds.

[0100] In some embodiments, the intermediate time per cycle (Ti) is at least 0.1 ms, at least 0.2 ms, at least 0.3 ms, or at least 0.4 ms, hi some embodiments, the intermediate time per cycle (Ti) is at most 1 ms, at most 0.9 ms, at most 0.8 ms, or at most 0.7 ms.

[0101] In some embodiments, the rest time (Trest) between the end of the final voltage impulse of a particular cycle and the beginning of the initial voltage impulse of the following adjacent particular cycle is at least 0.3 ms, at least 0.4 ms, or at least 0.5 ms, hi some embodiments, the Trest per cycle is at most 1 ms, at most 0.9 ms, at most 0.8 ms, or at most 0.7 ms.

[0102] In some embodiments, the negative voltage pulse 554 is area symmetric to the positive voltage pulse 552 within 10 area%, within 5 area%, within 2 area%, or within 1 area%. Stated differently, the cumulative charge provided to the surface of the user's body by the negative voltage pulse 554 is within 10%, 5%, 2%, or 1% of the cumulative charge provided to the surface of the user's body by the positive voltage pulse 552. Thus, in some embodiments, each cycle in the signal 550 is a balanced biphasic cycle.

[0103] Reference is now made to Figure 6, which is a schematic diagram of a continuous electrical signal in accordance with an embodiment of the teachings herein. As shown, the electrical signal 600 includes a plurality of cycles 602, each of which includes a positive voltage pulse 604 having a structure similar to that of the positive voltage pulse 552 of Figure 5B and a negative voltage pulse 606 having a structure similar to that of the negative voltage pulse 554 of Figure 5B.

[0104] In each cycle 602, the rise time (Tru) of the positive voltage pulse is substantially equal to the rise time of the negative voltage pulse, but the rise times differ between cycles. More specifically, with each cycle 602, the rise time Tru decreases, or gradually decreases, until it reaches a rise time of 70 to 150 nanoseconds, which is described in detail with respect to FIG. 5B.

[0105] Thus, in the first cycle 602a, or the first sequence of such cycles, the positive and negative voltage pulses have relatively long rise times, which in some embodiments may be greater than 100 nanoseconds, or may be in the range of 100-200 nanoseconds. In subsequent cycles or sequences of cycles, the positive and negative voltage pulses have progressively shorter rise times. For example, the second cycle 602b, or the second sequence of cycles, may have a rise time of 100 nanoseconds, the third cycle 602c, or the third sequence of cycles, may have a rise time of 95 or 90 nanoseconds, etc., until the rise time reaches a desired rise time, e.g., 80 nanoseconds as shown in the two final illustrated cycles 602e and 602f. In accordance with the teachings herein, any additional cycles following cycle 602f continue to have rise times in the range of 70-150 nanoseconds, as described above.

[0106] Without wishing to be bound by theory, the inventors believe that the signal shown in Figure 6 eliminates any residual pain caused by the application of the signal due to the relatively long rise time of the first cycle 602a, and that the body delivers sufficient pain relieving molecules, such as sedative or morphine-like molecules, to the area where the electrodes are placed to alleviate any pain felt due to the somewhat shorter rise time of the pulse in signal 602b, due to the pulse provided in cycle 602a. The inventors believe that this behavior continues, with sufficient pain relieving molecules being present at the beginning of each cycle other than cycle 602a, such that no pain is felt by the user due to the application of the signal in cycle 602a because the rise time is long enough not to cause pain as known in the art, and in subsequent cycles because sufficient pain relieving molecules have been delivered in the vicinity of the electrodes to alleviate any pain potentially caused by the application of the signal.

[0107] A device such as that described in connection with any of Figures 1-3 may be provided to a user. In typical use, the user or clinician attaches electrodes 102 to the surface of the body in the general area where pain is experienced. In some embodiments, the pain is menstrual or premenstrual pain, and the user attaches the electrodes to the surface of the skin in or near the abdominal area of ​​the body where the pain is experienced.

[0108] Once the electrodes are attached to the user's skin, the user uses the user interface 109 to activate the device 100, such that the processor 106 activates the signal generator 104 to provide the signal described in Figure 5B to the surface of the skin of the user's body, thereby relieving pain. In some embodiments, the user then provides input to the processor 106 via the input module 108 and / or its user interface 109, such as indicating whether the treatment is helping, increasing or decreasing the frequency or intensity of the signal, or terminating operation of the device 100.

[0109] In some embodiments, the user may wear the device before, after, and during the operation, e.g., attached to clothing worn by the user. In such embodiments, device 100 is portable and may thus be used in an operational mode using only an on-board power supply while worn by the user and / or while the user moves about without being tied to a particular location for a period of at least 5 minutes, at least 10 minutes, at least 15 minutes, or at least 30 minutes.

[0110] As used in the specification and the claims section that follow, the term "or" is considered to be inclusive, so that "A or B" means either of the groups "A," "B," and "A and B."

[0111] As used in the specification and the claims section that follow, the terms "pulse," "signal," and "impulse" all relate to electrical signals applied, for example, via electrodes.

[0112] As used in the specification and the claims section that follows, the term "cycle" refers to a repetitive or quasi-repetitive biphasic section of an electrical voltage signal, as generally recognized and understood in the art. Expressed in terms of a voltage versus time plot, a "cycle" typically consists of a positive voltage pulse, a negative voltage pulse, any intermediate time therebetween (Ti), and the remaining time (Trest) between the end of the final voltage impulse of a particular cycle and the beginning of the initial voltage impulse of the following adjacent particular cycle. By convention, Trest ≧ Ti.

[0113] As used hereinafter in the specification and in the claims section that follows, the term "positive voltage pulse" refers to an electrical pulse that provides an electrical signal having a positive voltage, whether that voltage is an absolute positive voltage or a positive voltage relative to a reference voltage, which is typically zero.

[0114] As used hereinafter in the specification and in the claims section that follows, the term "negative voltage pulse" refers to an electrical pulse that provides an electrical signal having a negative voltage, whether that be an absolute negative voltage or a negative voltage relative to a reference voltage, which typically is zero.

[0115] As used hereinafter in the specification and claims section below, the term "peak voltage" refers to a voltage within 15%, 10%, 5%, 3%, or 1% of the maximum voltage in a pulse. The peak voltage of a positive voltage pulse is a positive voltage and the peak voltage of a negative voltage pulse is a negative voltage.

[0116] As used hereinafter in the specification and claims section that follow, the term "peak voltage time" refers to the period during which a pulse achieves the peak voltage.

[0117] As used hereinafter in the specification and in the claims section below, the term "maximum voltage" refers to the highest voltage achieved by a positive voltage pulse or the lowest voltage achieved by a negative voltage pulse during the entire duration of the pulse. As used hereinafter in the specification and in the claims section below, the term "rise time" refers to the time at which the voltage of the pulse, or the absolute value or magnitude of the voltage of the pulse, increases to at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the peak voltage.

[0118] As used hereinafter in the specification and claims section below, the term "fall time" refers to the time over which the voltage of a pulse, or the absolute value or magnitude of the voltage of a pulse, decreases by at least 80%, at least 85%, at least 90%, at least 95%, or substantially 100% of the peak voltage, or to within 20%, within 15%, within 10%, within 5%, or substantially equal to the reference voltage.

[0119] As used hereinafter in the specification and in the claims section below, the term "time-averaged voltage amplitude" refers to the average voltage amplitude over a predetermined period of time, e.g., the average voltage amplitude for a positive or negative voltage pulse over its entire period, or the average voltage amplitude over a section of a positive or negative voltage pulse where a peak voltage amplitude is achieved. Due to the extremely rapid rise times utilized in the present invention, the "time-averaged voltage amplitude" of such a pulse's "plateau" is approximated by the "time-averaged voltage amplitude" of the pulse, or the "time-averaged voltage amplitude" of the portion of the pulse over which voltage is applied, e.g., taken over the rise time (Tru) and peak voltage time (Tpv).

[0120] As used hereinafter in the specification and claims section below, the term "substantially constant voltage amplitude" in relation to a voltage pulse, or a portion thereof, relates to a voltage amplitude that is constant within a deviation of 15%, 10%, 5%, 3%, or 1%.

[0121] As used hereinafter in the specification and claims section below, the term "area symmetric" refers to two voltage pulses, such as a positive voltage pulse and a negative voltage pulse, where the amplitudes of the two voltage pulses are plotted against time and a reference voltage or zero voltage, the areas captured between the plot of the amplitudes of the two pulses and the plot of the reference voltage are equal or are within 10%, 5%, 2%, 1% of each other.

[0122] As used hereinafter in the specification and claims section that follow, the term "balanced cycle" refers to a cycle that includes a positive voltage pulse and a negative voltage pulse such that the charge provided by the positive and negative voltage signals is equal or within 15%, 10%, 5%, 3%, or 1% of each other.

[0123] As used hereinafter in the specification and in the claims section that follows, the term "A is electrically downstream of B" refers to an electrical component A that receives as an input an electrical signal provided by electrical component B, either directly or via an additional component that is electrically located between electrical components B and A.

[0124] As used hereinafter in the specification and in the claims section below, the term "portable" relates to a device that can be implanted or moved around for distances greater than 10 meters and / or for at least 5 minutes, at least 10 minutes, at least 15 minutes, or at least 30 minutes while in its operational mode using an on-board power supply without requiring a wired or wireless connection to a power source or a communication module such as a Wi-Fi transceiver.

[0125] As used hereinafter in the specification and in the claims section below, the term "instrument induced pain" relates to any pain or discomfort caused by the manipulation of a device or instrument on or within a user's body to provide treatment thereto.

[0126] As used hereinafter in the specification and claims section below, the terms "physiological pain" and "physiologically caused pain" relate to pain caused by the physiology of the user, regardless of the presence or operation of a device or appliance on or within the user's body.

[0127] It will be appreciated that certain features of the present embodiments that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the present embodiments that are, for clarity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. Similarly, the content of any claim that is dependent on one or more particular claims may be dependent on or combined with the content of any other unspecified claim(s) in its entirety, without any particular explicit inconsistency therebetween.

[0128] As used herein, unless otherwise stated, the terms "substantially" and "about," when modifying a condition or relationship characteristic of a feature or feature(s) of an embodiment of the present technology, will be understood to mean that the condition or characteristic is defined within acceptable tolerances applicable to the operation of the embodiment for the application for which it is intended.

[0129] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims

[Claim 1] The invention as described in the description and / or drawings.

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