SYSTEM FOR ELECTRICAL STIMULATION OF NERVES

Abstract

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.

Claims

1.-24. (canceled)

25. A stimulation media fixation unit for electrical and/or mechanical stimulation of a nerve of a living being, configured to be arranged in a formed channel in and out of the skin of the being, where the stimulation media fixation unit includes 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, including connection/s to a pulse generator configured to provide a sequence of electrical pulses, and/or mechanical vibrations, to the at least one electrode, or the at least one vibration generator, in order to achieve stimulation of the nerve, where the stimulation media fixation unit has a first end and a second end, where the first end of the stimulation media fixation unit is configured to protrude out of the first end of the formed channel and the second end of the stimulation media fixation unit is configured to protrude out of the second end of the formed channel and where at least one end termination member, configured to be dismantled from and reassembled to the stimulation media fixation unit body, is configured to provide a stop for movement of the stimulation media fixation unit body in at least one direction within the formed channel, where the at least one end termination is positioned outside the first and/or second end of the formed channel, providing a mechanically interlocking mechanism by means of geometry of the end termination for the stimulation media fixation unit, further including at least one expanding member and/or at least one adjustable deflectable electrode member adapted for providing tissue fixation enhanced through mechanically anchoring in the formed channel by means of expansion.

26. The stimulation media fixation unit according to claim 25, wherein the deflectable member has a degree of deflection/expansion that is at least 20% relative to the initial dimension it expands.

27. The stimulation media fixation unit according to claim 25, 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 formed 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 formed channel formed by two interconnected perforations of the skin of the living being when said electrode fixation unit is inserted into said formed channel, into which the fixation unit is configured to be deformed/deflected and thus adapted to mechanically anchor and interlock into the tissue.

28. The stimulation media fixation unit according to claim 25, 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 formed channel.

29. The stimulation media fixation unit according to claim 25, 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.

30. The stimulation media fixation unit according to claim 25, wherein the stimulation media fixation unit is holding a vibration generator for vibrations stimulation, the stimulation media fixation unit being adapted to form a hollow tube fitting the vibration generator, said vibration generator and tube not necessarily being circular, 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.

31. The stimulation media fixation unit according to claim 25, 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 the predefined bended 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 formed channel.

32. The stimulation media fixation unit according to claim 25, 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 formed 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.

33. The stimulation media fixation unit according to claim 25, 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 formed 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 formed channel.

34. The stimulation media fixation unit according to claim 25, 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.

35. The stimulation media fixation unit according to claim 25, wherein the at least one deflectable member constitutes an electrode, an anode, a cathode, a non-active fixation means or a combination thereof.

36. The stimulation media fixation unit according to claim 25, 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.

37. The stimulation media fixation unit according to claim 25, 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.

38. The stimulation media fixation unit according to claim 25, 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.

39. The stimulation media fixation unit according to claim 25, 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.

40. The stimulation media fixation unit according to claim 25, 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.

41. The stimulation media fixation unit according to claim 25, 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.

42. The stimulation media fixation unit according to claim 25, 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.

43. A system for stimulation of nerves including the stimulation media fixation unit according to claim 25, wherein the system comprises an electrical connection between the electrode arranged on the stimulation media fixation unit and the pulse generator.

44. A system for stimulation of nerves including the stimulation media fixation unit according to claim 25, wherein the pulse generator is arranged in, on or with the stimulation media fixation unit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0086] For the purpose of illustrating the invention, forms are shown in accompanying drawings, which are presently preferred, it being understood that the invention is not intended to be limited to the precise arrangements and instrumentalities shown. The invention includes:

[0087] FIG. 1, illustrates a smoothly bended embodiment of the stimulation media fixation unit body (2) with one end termination (1) attached using threads and one end termination magnetically attached (10). The latter end termination allows for electrical connection (11 and 12) via a connector and lead to a pulse generator, with no deflectable member attached,

[0088] FIG. 2, illustrates a stimulation media fixation unit similar to the one in FIG. 1, with at least one end termination having integrated connection details (11 and 12), and an adjustable end termination (1) controlling the degree of deflection of the deflectable members, and attached deflectable members presented in the non-deflected state, where the stimulating electrode (4) is positioned between one deflectable element (5) at the first end, and another deflectable element (3) in the second end, and where the deflectable elements need not have similar properties,

[0089] FIG. 3, illustrates the stimulation media fixation unit of FIG. 2, where the deflectable members are presented in a deflected state,

[0090] FIG. 4, illustrates internal features of an embodiment of the stimulation media fixation unit holding a vibration generator, and including a mechanism for controlling the degree of the deflection of the deflectable members, by means of threaded components (3, 4 and 5),

[0091] FIG. 5, illustrates an embodiment where the deflectable members constitute the stimulation media fixation unit body, and where the deflection is provided by means of shape memory alloy (e.g. nitinol),

[0092] FIG. 6, illustrates an embodiment of a stimulation media fixation unit of complete closed ring design, where the deflectable members partially constitute the stimulation media fixation unit body, and where the deflection is provided by means of shape memory alloy (e.g. nitinol),

[0093] FIG. 7, illustrates a stimulation media fixation unit, with at least one end termination having integrated connection details (11 and 12), and an end termination specially adapted for pressurization of a build in balloon (24) controlling the degree and shape of deflection of the deflectable member/s (23), and an attached deflectable electrode member (23) presented in the non-deflected state, where the electrode members (21 and 26) are positioned on either side of the deflectable electrode member (23),

[0094] FIG. 8, illustrates the stimulation media fixation unit of FIG. 7, where the deflectable member (23) is presented in a deflected state, and

[0095] FIG. 9, illustrates an example of the entire system, where the electrode fixation unit (70) could be either one of the above presented stimulation media fixation units.

DETAILED DESCRIPTION

[0096] FIG. 1 represents an example of a stimulation media fixation unit body (2) constituting the at least one electrode member and with no added deflectable member/s, where the method of end termination (1) attachment is shown using threads. The stimulation media fixation unit body (2) can be solid as well as hollow. Hollow embodiments having a suitable straight internal section can be equipped with a vibration generator constituting an efficient solution for mechanically vibrations stimulation. However, the internal features inside the stimulation media fixation unit may be fit for squarish vibration generator member/s. The vibrating motors should preferable be encapsulated and waterproof, otherwise water proofing details are incorporated into the stimulation media fixation unit at the end terminations. It has to be understood that the mode of vibrations is only exemplified as rotational movements, and thus may be as well be based on linear resonant actuation, and further the mode of vibration is not limited to sinusoidal vibrations, but can be inhomogeneous, including, shaking or shivering and have various amplitudes and acceleration factors, by use of haptic linear resonators.

[0097] The end terminations (1, 10) could as well be clicked-in, magnetically attached, spring loaded or attached using similar concepts. The shape or design of the end terminations (1, 10) is preferably round and ball-shaped to be the least sharp as possible, and to allow easy hygienically maintenance and thus avoid infectious circumstances. Other designs are optional if they are hygienically acceptable and does not constitute a risk of harm for the surrounding tissue.

[0098] The shape of the stimulation media fixation unit body (2) can vary, having the goal to position the electrodes members/s configured on the stimulation media fixation unit or being an integral part/s of or add-on's to the stimulation media fixation unit, close to the targeted nervous tissue for optimal stimulation efficacy. Therefore, the bending radii and bending angles are configured or selected in accordance with the specific stimulation site of interest. The preferred cross sections of the stimulation media fixation unit body (2) are ranging from ø1 mm to ø6 mm, although not necessarily being circular. Sections of the stimulation media fixation unit body having larger diameter, i.e. up to 10 mm, could be optional where a large charge injection is important for the application, or high level of vibrations energy is required. The preferred stimulation media fixation unit body lengths are from 10 mm to 40 mm and should be anatomically feasible for the site at which the electrode fixation unit shall function. The length of the electrode fixation unit body can be up to for up to 100 mm. If longer distances of fixation are necessary, application of additional stimulation media fixation units are preferable. The curvature and length of the stimulation media fixation unit determines the depth of the stimulation media fixation unit into the tissue. The requirement for how profound the stimulation media fixation unit can be positioned vary depending on the local tissue at the site of interest, considering among other things the length of the stimulation media fixation unit body, the cross section etc., and the anatomical location of the stimulation media fixation unit. If the stimulation media fixation unit is too small, the quality of the fixation will drop, with subsequent increased risk of compromised electrode/tissue interface e.g. loss of performance or function.

[0099] FIG. 1 represents one shape of the stimulation media fixation unit body (2). Further designs could include bended and coiled wires constituting the stimulation media fixation unit body (2), providing additional means of fixation into the tissue. Similarly, sharper bended stimulation media fixation unit body (2), multi-axis curved stimulation media fixation unit designs are optionally solutions for additional fixation.

[0100] FIG. 1 shows a stimulation media fixation unit body design (2) utilizing magnetic end termination support (10) for the electrical connected end termination (11 and 12), consisting of an isolating or conducting lower section (10), and isolating upper section (11), and the connector detail (12) for the lead connection. The isolating materials of the end termination/s (10, 11), when designed not to be part of the electrode member/s, can comprise PEEK, fluorinated materials, ceramics or similar biocompatible materials. The outer surface of the stimulation media fixation unit body (2) becomes the electrode interface to the tissue. When the lower section (10) of the end termination are part of the electrode interface, this part is then designed utilizing 316L or precious metals suitable for the application. Thus, the stimulation media fixation unit body (2) and/or the at least one end termination (1, 10) constitutes an electrical stimulating electrode member.

[0101] FIG. 2 and FIG. 3 represents a stimulation media fixation unit body with an end termination (1) controlling the degree of deflection of the deflectable member/s (3 and/or 4 and/or 5) attached to either side of the stimulation media fixation unit body (2), presented in closed and open state respectively. The deflectable member/s (3 and/or 4 and/or 5) could as well be positioned below and/or above, in fact in any angle around the electrode fixation unit body (2), for applications when a specific position of the deflectable member/s (3 and/or 4 and/or 5) would be beneficial for targeting nervous tissue at the specific site of stimulation.

[0102] The deflectable member/s (3 and/or 4 and/or 5) constitute either an electrode member and/or a fixation member of the stimulation media fixation unit. In embodiments where the at least one deflectable member/s (3 and/or 4 and/or 5) constitute non-conductive fixation member/s, the stimulation media fixation unit body (2) constitutes at least one electrode member as an integrated stimulation electrode member in a monopolar configuration. Miniaturization of the active part of the electrode member/s is limited by the charge storage capacity and impedance of currently applied materials. A monopolar configuration maximizes the optional area available for electrode member/s relative to the stimulation media fixation unit body length and cross section of the stimulation media fixation unit body, as it need not share the available surface area with a second, third or multiple electrode member/s (4). Larger charge input may thus require longer stimulation media fixation unit body designs (2) to obtain larger electrode surfaces.

[0103] In another embodiment, the at least one deflectable member (3 and/or 4 and/or 5) constitute a non-conductive fixation member, and the stimulation media fixation unit body is designed in a bipolar electrode configuration having two electrode member/s, it is required to have an isolation member positioned in-between the at least two electrode members, where the isolating material between the at least two electrode members shall be biocompatible or bio-inert, of which PEEK or ceramics are ideal. Other materials could include fluorinated based materials. Thus, the stimulation media fixation unit body has sections that are intended to be not electrically conductive. Tri-polar, quadrupolar or 5-polar electrode concepts could also prove to be relevant options in some applications, although such configurations are not included in the illustrations. The shapes of the stimulating electrode areas are of limited importance but should be smooth enough to allow insertion and prevent sharp edges that may become irritant or even unsafe in the formed channel in the tissue. The size of the electrode areas is balanced with the load of charge to be injected, the electrode material chosen, and frequency of use of the application applied. A feature for electrical contact is shown as a dual magnetic connection (11, 12), but other designs are also relevant, utilizing, spring loads or click-in etc.

[0104] The degree of deflection of the deflectable members/s (3 and/or 4 and/or 5) of the either conductive or non-conductive member/s of the stimulation media fixation unit is controlled by strain added to the deflectable elements (3 and/or 4 and/or 5). The level of strain is controlled by relative movement of the first end termination (1) to the second end termination (10), forcing the deflectable member/s (3 and/or 4 and/or 5) to bend outwards away from each other. The mechanism can be provided in various ways, by turning a thread, clicking features, or frictionally controlled.

[0105] The deflectable member/s (3 and/or 4 and/or 5) will determine the deflection shape of the deflectable member/s when activated. The materials and designs applied shall be flexible enough to be controlled by the mechanism means applied but should be rigid enough to maintain a stable position once deflected.

[0106] It is important that the stimulation media fixation unit body (2) is stiff or rigid enough to withstand the resultant force required to deflect the one or more deflectable member/s (3 and/or 4 and/or 5). The stimulation media fixation unit body (2) could be made entirely from conductive or non-conductive materials, or both. The electrode fixation unit body (2) can be solid as well as hollow and when having a suitable straight internal section, the electrode fixation unit body can be equipped with a vibration generator (16) constituting an efficient solution for mechanically vibrations stimulation.

[0107] The clinical success of electrical stimulation-based systems depends among other things on the ability of the electrode contact to consistently provide safe levels of stimulation to the target component of the nervous system. Exceeding the limit for safe charge injection may cause electrode degradation and/or irreversible tissue damage resulting in loss of clinical efficacy and the electrode becoming unsafe. To mitigate the problems associated with reduced physical size, advanced biomaterials and precious materials can be used to ensure longevity. The electrode member/s (3 and/or 4 and/or 5) are the electrochemically active areas of the electrodes where charge transfer occurs during stimulation. The electrode member/s (3 and/or 4 and/or 5) is supposed to be in close proximity of the target nerve to obtain low stimulation thresholds. Ideally, the electrode member/s (3 and/or 4 and/or 5) should have good chemical stability, high charge injection capacity, low electrical impedance, and should remain inserted in the tissue as a compliant material causing low degree of inflammation.

[0108] FIG. 4 represents a stimulation media fixation unit including a vibrations generator (16) and showing further details of an end termination positioned in the first end (13) controlling the degree of deflection of the deflectable member/s attached to either side of the stimulation media fixation unit, by means of threads.

[0109] The first end termination (13) is moved closer to the static connector end termination positioned in the second end, thus adding strain to the at least one deflectable member (3 and/or 4 and/or 5) when turned, pushing an anchor-member (14), which is guided in a tongue groove hindering the at least one deflectable member (3 and/or 4 and/or 5) to twist around the stimulation media fixation unit body (2), to deflect the at least one deflectable member/s (3 and/or 4 and/or 5). At the second connector end termination, a static anchor-member (15) provides rotational fixation of the deflectable member/s (3 and/or and/or 5). The pitch of the thread in the first end termination (1) determines relative movement of the moving end termination (1) per turn, relative to the static connector end termination in the second end. The static connector end termination includes connection details for the electrical pulse generator and/or the vibration generator (16) for vibrations stimulation.

[0110] The compression distance i.e. the distance of linear travel of the moving end termination (1) relative to the static connector end termination shall be planned during the implantation procedure performed in the clinical facility.

[0111] FIG. 5, represents a stimulation media fixation unit, where the deflectable members (3 and/or 4 and/or 5) constitutes the stimulation media fixation unit body, and are self-deflective controlled by means of relative temperature change of shape memory alloy such as nitinol. The end termination (1) can be repeatably dismantled and assembled to the electrode fixation unit by means of e.g. threaded details.

[0112] The degree of deflection is predetermined by the design of the shape memory alloy member. During the clinical procedure, the stimulation media fixation unit is cooled to collapse into the most elongated shape as illustrated in FIG. 2, thus prepared for the insertion into the formed channel through the skin. As the stimulation media fixation unit reaches the body temperature, the at least one deflectable member/s (3 and/or 4 and/or 5) of the stimulation media fixation unit returns to the predetermined shape as designed into the shape memory alloy.

[0113] In order to design bipolar versions of the embodiment presented in FIG. 5, the parts (3 and 5) of the deflectable member/s (3 and/or 4 and/or 5) are isolated from the middle section (4). This can be achieved in various way, the simplest by addition of conductive coating of a suitable length of the elements (3 and 5), and resultantly providing enough electrode area (4) for the therapy planned. In other designs, either of the two deflectable member/s (3 and/or 4 and/or 5), constitute an anode or cathode respectively, where the middle section (4) becomes the electrode member/s, arranged between isolation member/s (3 and 5).

[0114] FIG. 6, illustrates a stimulation media fixation unit having a closed-loop stimulation media fixation unit body shape, here presented as a circular unit. The end termination (13) is formed by use of a single end termination member, utilizing spring loaded end termination fixation arranged into carved features in the stimulation media fixation unit body. The stimulation media fixation unit body need not be circular and the end termination (13) need not have a shape identical to the stimulation media fixation unit body onto which it is arranged but can have an identical or similar design becoming a circular endless ring. The end termination (13) and the stimulation media fixation unit body have a smooth surface and overall structure for at least the part positioned or arranged inside the formed channel in the tissue. The stimulation media fixation unit body includes at least one deflectable member (3 and/or 4 and/or 5) constituting a structural element hindering the stimulation media fixation unit to rotate within the formed channel and providing means for tissue integration within the formed channel through the skin.

[0115] The degree of deflection is predetermined by the design of the shape memory alloy. During the clinical procedure, the stimulation media fixation unit is cooled to collapse into the shape as illustrated in FIG. 2, thus prepared for the insertion into the formed channel in the skin. As the stimulation media fixation unit reaches the body temperature, the at least one deflectable member of the stimulation media fixation unit returns to the predetermined shape as designed into the shape memory alloy, leaving no compression distance to be considered during the planning of the clinical procedure.

[0116] FIG. 7 and FIG. 8 illustrates an embodiment of a stimulation media fixation unit utilizing a pressurized balloon type mechanism for activating at least one deflectable member (23), presented in the non-deflected and a deflected state respectively. The shape of the deflectable member/s (23) once inflated, or expanded using a liquid, is controlled by the shape of the balloon (24) and the pressure/volume inflated/filled into the balloon (24), and the fixture-element member (25) provided in both the first and second end of the deflectable member/s. In embodiments including two moveable or non-moveable fixture-elements (25), the deflectable member/s (23) forms a ball-like volume, being rounded triangular, squarish or multiple angled cross sectional until substantially being wholly round ball-shaped or various ellipsoidal shapes. In embodiments utilizing a single fixture-element member (25), the shape of the deflectable member/s (23) becomes rounded triangular, squarish or multiple angled cross-sectional representations of umbrella-shapes. Further in embodiments utilizing sets of at least two singular fixture-elements (25), the at least two deflectable members (23) each forms an umbrella shape.

[0117] The balloon member (24) is pressurized or inflated through an inlet in the first passive end termination member (20) and controlled by means of the volume filled into a syringe, or by use of available laboratory equipment, having a suitable tip fitting to the inlet details in the first end termination member (20).

[0118] There are provided access from the inlet in the first end termination member (20) through any attached external electrode member (21) and to the balloon member (24), which inflates and deflects the at least one deflectable member (23). The at least one fixture-element member (25) fixates the at least one deflectable member (23) radially, and in some embodiments additionally longitudinally on the stimulation media fixation unit. An isolation member (22) is added for embodiments where the deflectable member (23) is configured as an active stimulating electrode.

[0119] In embodiments including sufficient length of internal straight section, a vibration generator is positioned within the electrode member (26), which need not be pathway for operating the balloon member (24). The deflectable member/s (23) can be made from various types of metallic or at least conductive meshes and/or wire-based hoses and be loosely attached to the electrode fixation unit once deflected, to form a deflectable electrode member promoting fibrotic tissue entanglement for optimal electrode and vibration performance.

[0120] Further, the mesh, wire or hoses as described could as well be manufactured from various types of non-conductive fabrics or polymers, functioning exclusively as non-active fixation member/s.

[0121] FIG. 9 shows an example of an entire electrical stimulation system, represented by the electrode fixation unit (70) of any of the above described embodiments. The lead (72) is detachable and is designed to release connection (71) at a predetermined force, the preferred method of connection being magnetically support. A similar connection can be arranged on the pulse generator (73). The lead holds at least the corresponding number of wires as the stimulation media fixation unit holds electrodes, and if also equipped with a vibration generator additional wires for powering said vibration generator, and hence any of the previous systems illustrated in FIG. 1 to FIG. 8 could constitute the stimulation media fixation unit (70) as shown in FIG. 9.