The object of the present invention is the method to assess the pelvic floor muscle injury, comprising the steps of applying the measuring probe into the anus, generation of electric current signals of constant amplitude, using a current generator, and applying the signals into the pelvic floor muscles by means of application electrodes (EA1) and (EA2), detection of electric voltage signals from the pelvic floor muscles by means of a plurality of measuring electrodes (EP1), EP2 . . . EPn, analysis of electric current and voltage signals for amplitude values and phase dependencies of their waveform, wherein the electric current signals and the electric voltage signals from the pelvic bottom muscles constitute signals variable in time, of the frequencies ranging from 2 kHz to 200 kHz. The object of the invention is also an electrode based measuring probe and apparatus implementing the method of assessment pelvic floor muscles injury.

A system and method for treating anorectal dysfunction includes implanting, in a minimally invasive manner, an electro-medical device for stimulation of two or more separate and distinct anatomical or histological structures of the anorectal region. Electrodes operably connected to the device are positioned proximate the target anatomical or histological structures. The device provides either the same or different stimulation algorithms to each anatomical or histological structure. Smooth muscle, such as the internal anal sphincter, is provided with a continuous stimulation algorithm, while skeletal muscle, such as the external anal sphincter, is provided with an on demand stimulation algorithm. Varying stimulation algorithms applied to multiple structures results in improved anorectal function without developing muscle fatigue and tolerance.

The present invention relates to a non-invasive device and method for treating and improving dysfunction or disorders associated with pelvic floor. In one advantageous form, the non-invasive device comprising a generator configured to generate a current with a predetermined intensity of milliampere at a desirable frequency; at least one electrical stimulation applicator comprising a probe unit configured to transmit the current to a target body surface of vulvar tissues and/or pelvic floor muscle for application of an electrical stimulation; wherein the probe unit comprises a negative electrode and at least one positive electrode and the probe unit is shaped for positioning on the target body surface of the vulvar tissues and/or the pelvic floor muscle.

A medical system includes an implantable lead having a plurality of electrode contacts, a pulse generator coupled to the lead and configured to generate electrical pulses to be delivered to a patient through the plurality of electrode contacts, and an electronic programmer coupled to the pulse generator. The electronic programmer programs the pulse generator to generate the electrical pulses. The pulse generator is programmed to generate an electrical stimulation to be applied to the patient via one of the electrode contacts on the implantable lead. A determination is received as to whether the patient, in response to the electrical stimulation, exhibited a bellows response or a toes response. A stimulation parameter of the electrical stimulation is ramped up in response to a determination that the patient did not exhibit the bellows response or the toes response and that the patient did not feel pain in response to the electrical stimulation.

A system and method for treating anorectal and/or genitourinary dysfunction includes implanting, in a minimally invasive manner, an electro-medical device for stimulation of two or more anatomical or histological structures of the anorectal region and/or genitourinary region. Electrodes operably connected to the device are positioned proximate the target anatomical or histological structures. The device provides either the same or different stimulation algorithms to each anatomical or histological structure, which may be the same or different. The varied stimulation parameters, such as pulse width, pulse amplitude, and pulse frequency, are defined such that after an application of the electrical pulses, an abdominal leak pressure, an abdominal leak volume, or a urine volume increases or a number of incontinent episodes or a mean incontinence volume per episode decreases relative to said parameters prior to the application of the electrical pulses.

In various examples, an apparatus includes a stimulation lead including an elongate body including a distal end and a proximal end. At least one first electrode is disposed proximate the distal end of the elongate body and is configured to stimulate a first target nerve. At least one second electrode is disposed between the at least one first electrode and the proximal end of the elongate body and is configured to stimulate a second target nerve. At least one first fixation structure is disposed between the at least one second electrode and the proximal end of the elongate body. The at least one first fixation structure is configured to anchor the stimulation lead proximate the sacrum, wherein the at least one first fixation structure is located on the elongate body and spaced a first distance proximally along the elongate body from the at least one first electrode.

A perineal probe (10) having a probe body which includes electronic members (110, 111, 112) configured to interact with perineal muscles of the patient. The probe body has a cylindrical portion (12) configured to be positioned at the opening of the body cavity of a patient, and a flared portion (13) which extends from one end (121) of the cylindrical portion (12). The flared portion (13) extends widening from the cylindrical portion (12) as far as a free upper end (130), with the flared portion (13) being elastically deformable between a retracted position and a deployed position. The electronic members (110, 111, 112) are arranged on the flared portion (13) and/or on the cylindrical portion (12).

An implantable stimulation lead has electrode contacts that are configured to deliver an electrical stimulation therapy for a patient. A sheath extends along a longitudinal axis. The sheath defines a lumen into which the stimulation lead can be inserted. A distal end of the sheath includes a plurality of base segments that are separated from one another. A plurality of fixation structures are located on the base segments, respectively. In a first configuration, the fixation structures are each disposed proximate to the sheath. In a second configuration, the fixation structures each extend radially outward from the sheath. In a third configuration, the base segments deflect radially inward toward the longitudinal axis.

A pulse generator is configured to generate electrical pulses of an electrical stimulation therapy. The pulse generator includes an N number of output channels and a microcontroller configured to generate instructions. The pulse generator is configured to generate different stimulation waveforms simultaneously for the output channels. The different waveforms have different waveform characteristics. A mesh electrode array includes an M number of electrodes. Each of the electrodes is configured to deliver the electrical pulses of the electrical stimulation therapy. M is at least several times greater than N. A solid state relay contains a plurality of controllable switches that is each configured to be turned on or off in response to the instructions received from the microcontroller, such that the solid state relay routes the output channels of the pulse generator to different subset of the electrodes of the mesh electrode array at different points in time.

A device to relieve hemorrhoid inflammation using electrotherapy including a capsule insertable into a user's anus a predetermined depth, a control unit having a power indicator and power button, the control unit including modulating means for a user to control the intensity and duration of the therapy session. The device also includes a wire that connects the control unit to the capsule. In an alternate embodiment, the device can implement Bluetooth technology to send instructions from the control unit to the capsule wirelessly to actuate it so that it can deliver electrotherapy to a user's anus. A mobile application on a mobile device can be used to control the electrotherapy being sent to a user through the capsule.