System for electrical stimulation of nerves
In a system for electrical stimulation of nerves of a living being a pulse generator is configured to provide a sequence of electrical and/or vibration pulses to at least one electrode and/or vibration generator that are maintained in close proximity to the nerve of interest with the use of means for securing the electrode to the skin or tissue of the living being.
1. A stimulation media fixation unit for electrical and/or mechanical stimulation of a nerve of a living being configured to be arranged in a channel formed into and out of the skin of the being, the stimulation media fixation unit including:
at least one electrode and/or at least one vibration generator configured to be placed in close proximity of a portion of the nerve of the living being;
a pulse generator configured to provide a sequence of electrical pulses to the at least one electrode or the at least one vibration generator in order to achieve stimulation of the nerve, the at least one electrode being configured to deliver electrical stimulation to the nerve, the at least one vibration generator being configured to deliver mechanical vibrations to the nerve;
a first end and a second end, wherein the first end of the stimulation media fixation unit is configured to protrude out of a first end of the channel and the second end of the stimulation media fixation unit is configured to protrude out of a second end of the channel;
at least one end termination member configured to be dismantled from and reassembled to the stimulation media fixation unit, the at least one end termination member being configured to provide a stop for movement of the stimulation media fixation unit in at least one direction within the channel, wherein the at least one end termination member is adapted to be positioned outside the first and/or second end of the channel and comprises a mechanically interlocking mechanism comprising a geometry that is configured to maintain the stimulation media fixation unit in the channel; and
at least one expanding member and/or at least one adjustable deflectable electrode member adapted to anchor the unit in the channel.
2. The stimulation media fixation unit according to claim 1 , wherein the deflectable member has a degree of deflection/expansion that is at least 20% relative to the initial dimension it expands.
3. The stimulation media fixation unit according to claim 1 , wherein the electrode fixation unit has an elongated form, the electrode fixation unit having a first end and a second end where the first end of the electrode fixation unit is configured to protrude out of the channel in the tissue through a first perforation of the skin and the second end is configured to protrude out of a second perforation of the skin of the channel formed by two interconnected perforations of the skin of the living being when said electrode fixation unit is inserted into said channel, into which the fixation unit is configured to be deformed/deflected and thus adapted to mechanically anchor and interlock into the tissue.
4. The stimulation media fixation unit according to claim 1 , wherein the stimulation media fixation unit includes an internally elongated form and comprises a mechanical expansion mechanism adapted to maintain effective transfer of vibration energy in the form of sinusoidal, linear, rotational, shaking, shivering, haptic movements or random vibration of various amplitudes and frequencies to the targeted tissue, when the stimulation media fixation unit is arranged in the channel.
5. The stimulation media fixation unit according to claim 1 , wherein the stimulation media fixation unit is solid, hollow or tubular in form, and the cross section has a triangular, square or multiple-angled cross section; is substantially circular or elliptical in form with even or uneven sized sides; and/or with straight or curved sides and having one or multiple cross sectional areas over its length between the first end and second end and where the electrode fixation unit can travel in a straight, bended, curved, spiral, meandering or a combination of such travel forms in the longitudinal direction.
6. The stimulation media fixation unit according to claim 1 , wherein the stimulation media fixation unit is holding the at least one vibration generator for vibrations stimulation, the stimulation media fixation unit being adapted to form a hollow tube fitting the at least one vibration generator, the stimulation media fixation unit further comprising a first end termination having an electrical connection to a pulse generator, a second passive end termination fitted at the second end of the stimulation media fixation unit, and at least one deflectable fixation member comprising a nickel titanium based material having shape-memory effect, such as nitinol.
7. The stimulation media fixation unit according to claim 1 , wherein the deflectable member of the stimulation media fixation unit which comprises a material with shape-memory effect, has a deflection state which is temperature controlled to form itself into a predetermined body shape by means of elevation of the temperature from a level in the range between 0-10 degrees Celsius to a level in the range between 30-40 degrees Celsius, which can be achieved by means of heating by body temperature once positioned into the channel.
8. The stimulation media fixation unit according to claim 1 , wherein the stimulation media fixation unit is partly made of an electrical isolating material having electrical conductible sections which serves as electrode member/s suitable for electrical stimulation, having a hollow fixation member with electrical connection/s to the electrode/s running internally in the stimulation media fixation unit and which are terminated in a connector accessible from outside of the stimulation media fixation unit and at least one deflectable/expandable electrode member securing the positioning of the electrode member in the channel, by means of tightening the passive end termination member to expand/deflect the deflectable/expandable electrode member to the degree tolerable by the user.
9. The stimulation media fixation unit according to claim 1 , wherein at least one electrode member/s is arranged on the stimulation media fixation unit, and further comprises a deflectable electrode member comprising a nickel titanium based alloy having temperature controlled shape-memory effect, such as nitinol, where the deflectable member is configured to collapse into a closed form in an environment having a temperature level in the range between 0-10 degrees Celsius and thus being prepared for insertion into the channel in which it reaches the surrounding temperature of between 30-40 degrees Celsius and thereby return itself into the intended predetermined shape in the channel.
10. The stimulation media fixation unit according to claim 1 , wherein the at least one deflectable member of the stimulation media fixation unit is constituting a passive or non-active fixation member, i.e. not part of, or including an electrode member, where the electrode member is arranged on the stimulation media fixation unit body.
11. The stimulation media fixation unit according to claim 1 , wherein the at least one deflectable member constitutes an electrode, an anode, a cathode, a non-active fixation means or a combination thereof.
12. The stimulation media fixation unit according to claim 1 , wherein the deflectable member of the stimulation media fixation unit is configured to be transformed into the intended shape by control of the deflectable member through turning a threaded end termination member positioned on the stimulation media fixation unit, shortening the distance between the first end termination and the second end termination and thus causing the deflectable member to bend from its initial shape.
13. The stimulation media fixation unit according to claim 1 , wherein the at least one deflectable member is arranged on the stimulation media fixation unit and configured to be transformed into predetermined deflected shape through means of shortening the distance between the first end termination and the second end termination by configuring the first end termination to travel along the stimulation media fixation unit body, where dents positioned on the stimulation media fixation unit body define the travel distance/s and a spring loaded mechanism in the first end termination member fixates the end termination in at least two positions.
14. The stimulation media fixation unit according to claim 1 , wherein the deflectable member further comprises a balloon arranged with the deflectable member where the deflectable member is configured to be formed by means of the balloon, pressurized for expanding and shaping a ductile deflectable fixation and/or electrode member.
15. The stimulation media fixation unit according to claim 1 , wherein the deflectable member features balloon expansion and includes a flexible sheet or tube element added onto the outside or into the inside of the deflection member, the flexible sheet being adapted for avoiding tissue integration into the deflection member.
16. The stimulation media fixation unit according to claim 1 , wherein the flexible conductive element is made of or includes conductive materials and is formed by one or more of plate springs, rod springs, coiled springs, or ductile elements which are at least partially maintaining the deflected shape, once the force providing the deflection is released.
17. The stimulation media fixation unit according to claim 1 , wherein the at least one end termination member is attached to an end of the stimulation media fixation unit body, but with a gap between the end termination member and the other end of the stimulation media fixation unit body featuring or not featuring another end termination member.
18. The stimulation media fixation unit according to claim 1 , wherein the stimulation media fixation unit comprises at least one detachable electrical connection providing the stimulation signal from a pulse generator to the at least one applied electrode.
19. A system for stimulation of nerves including the stimulation media fixation unit according to claim 1 , wherein the system comprises an electrical connection between the electrode arranged on the stimulation media fixation unit and the pulse generator.
20. A system for stimulation of nerves including the stimulation media fixation unit according to claim 1 , wherein the pulse generator is arranged in, on or with the stimulation media fixation unit.