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.-34. (canceled)

35. A system for electrical stimulation of a nerve of a living being, including a stimulation media fixation unit configured to be arranged in a formed channel in and out of the skin of the being, and adapted for providing fixation of at least one hydrogel-based electrode member/s configured to be placed in close proximity of a portion of the nerve of the living being, and a pulse generator configured to provide a sequence of electrical pulses, and/or mechanical vibrations, to the at least one hydrogel-based electrode, or vibration generator, for 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 a first end of the formed channel, and the second end of the stimulation media fixation unit is configured to protrude out of a second end of the formed channel, and where a body member of the stimulation media fixation unit forms the structure of the stimulation media fixation unit, the stimulation media fixation unit body member constituting a fixation member onto which the at least one hydrogel-based electrode and/or vibration generator is arranged or included, and where at least one end termination member, configured to be repeatedly non-destructively dismantled from and reassembled to the stimulation media fixation unit body member, 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 when the electrode fixation unit is arranged in the formed channel.

36. The stimulation media fixation unit according to claim 35, wherein the stimulation media fixation unit, now serving as a vibration generator fixation unit, includes a system for mechanical vibration stimulation of the nerve of the living being, through application of at least one built-in vibration generator providing either linear, rotational, shaking, shivering or inhomogeneous random vibrations and thus mechanically activating the surrounding tissue to trigger nervous response, utilizing embodiments with an internally elongated form and the mechanically interlocking and tissue adhesion to effectively transfer the 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.

37. The stimulation media fixation unit according to claim 35, wherein the system is adapted to simultaneously provide electrical stimulation and mechanical stimulation.

38. The stimulation media fixation unit according to claim 35, wherein the at least one end termination member is attached to an end of the stimulation media fixation unit body member but with a gap between the end termination member and the other end of the stimulation media fixation unit body member featuring or not featuring another end termination member.

39. The stimulation media fixation unit according to claim 35, wherein the stimulation media fixation unit is configured to repeatedly be non-destructively dismantled into at least two elements and reassembled, to allow exchange of the at least one hydrogel-based electrode member/s, and repositioned to the stimulation media fixation unit and placed into the initially arranged formed channel, the at least one hydrogel-based electrode member being a monopolar electrode member, bipolar electrode member, or multi-polar electrode member, and where the bipolar or multi-polar electrode member is provided in a single component or in multiple components to be arranged on the stimulation media fixation unit, where the electrical connection to the at least one electrode member is formed internally in the stimulation media fixation unit, thus inside the at least one electrode member.

40. The stimulation media fixation unit according to claim 35, wherein the at least one electrode member has bipolar or multi-polar electrode configurations and constitutes a hydrogel-based electrode member, and a at least second electrode constitutes a non-hydrogel-based electrode member made from biocompatible electrical conductible material being one or more of medical grade titanium, medical grade stainless steel, platinum, platinum/iridium, medical grade metals and other precious metal alloys frequently used for electrical stimulation applications, and/or fully or partially surface treated medical grade metals coated using Titanium-nitride, diamond-like carbon etc. for adjustment of e.g. electrode member impedance.

41. The stimulation media fixation unit according to claim 35, wherein the at least one electrode member is configured with an outer surface partially or totally constituting hydrogel as an interface for the tissue in the formed channel through the skin, the eventual remaining surface area being either metallic, ceramic or polymeric based.

42. The stimulation media fixation unit according to claim 35, wherein a connecting spring member forms the electrode inner part and electrical contact to the stimulation media fixation unit outer surface of the exchangeable hydrogel-based electrode member or integrated hydrogel-based electrode member, and where a scrim member enhances the mechanical integrity of the at least one electrode member, serving as a fixture for the hydrogel element, the hydrogel element itself being assembled and cured into a single unit forming an electrode member.

43. The stimulation media fixation unit according to claim 35, wherein the stimulation media fixation units is configured to the preference and needs of an individual user having cross sections ranging from a diameter of one millimeter to ten millimeters with a typical stimulation media fixation unit body length in the range of ten to forty millimeters.

44. The stimulation media fixation unit according to claim 35, wherein the end termination is formed by configuring the end of the stimulation media fixation unit at least on a part of the first or the second end that is configured to protrude out of the formed channel with a cross-section that is larger than the measured circumscribed cross-section of the formed channel in such a way as to form a stop for movement of the stimulation media fixation unit through the formed channel in one direction.

45. The stimulation media fixation unit according to claim 35, wherein the end termination is formed by configuring the end of the stimulation media fixation unit at least on a part of the first or the second end that is configured to protrude out of the formed channel with a thread for receiving a nut, said nut having a cross-section that is sufficiently larger than the measured cross-section of the formed channel in such a way as to form a stop for movement of the stimulation media fixation unit through the formed channel in one direction.

46. The stimulation media fixation unit according to claim 35, wherein the stimulation media fixation unit body is hollow and the electrical connection/s to the electrode/s run inside the stimulation media fixation unit body and is/are terminated in a connector accessible from outside the stimulation media fixation unit.

47. The stimulation media fixation unit according to claim 35, 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.

48. The stimulation media fixation unit according to claim 35, wherein the pulse generator is arranged in, on or with the stimulation media fixation unit.

49. An insertion tool for insertion of the stimulation media fixation unit including at least one hydrogel-based member and with one removeable end termination removed, the insertion tool including a polymer or silicone-based needle with a polymer or silicone-based tubing attached, into which the stimulation media fixation unit is arranged and covered with two layers of said polymer or silicone-based tubing, in such a way, that the polymer or silicone-based tubing is peeled off the stimulation media fixation unit when being positioned in the formed channel through the skin.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0089] For the purpose of illustrating the invention, forms are shown in accompanying drawing, 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:

[0090] FIG. 1, illustrates a smoothly bended embodiment of the stimulation media fixation unit body (2) configured for addition of a hydrogel-based electrode member, with one end termination (1) attached using threads and one end termination magnetically attached (10), the latter end termination allowing for electrical connection (11, 12) via a connector and lead to a pulse generator,

[0091] FIG. 2, illustrates a stimulation media fixation unit with integrated hydrogel-based electrode members (5, 6) and with one end termination having integrated connection details (11, 12), configured for optional changes of an electrode member (5 and 15 and/or 6 and 16),

[0092] FIG. 3, illustrates a stimulation media fixation unit configured for addition of the in FIG. 5 illustrated hydrogel electrode member, or singular hydrogel electrode member/s and isolator member/s if required for e.g. bipolar stimulation media fixation unit configurations,

[0093] FIG. 4, illustrates a stimulation media fixation unit including a vibration generator (18) configured for addition of the in FIG. 5 illustrated hydrogel electrode member, or singular hydrogel electrode member/s and isolator member if required for e.g. bipolar stimulation media fixation unit configurations, FIG. 5, illustrates a hollow hydrogel-based electrode member (5, 6) to be arranged on the described stimulation media fixation unit of FIG. 3 or that of FIG. 4, where a flexible electrode member (5, 6) is positioned in the first end and second end of the isolation member (14),

[0094] FIG. 6, illustrates a complete stimulation media fixation unit including a stimulation media fixation unit as described in FIG. 3 or FIG. 4, with the electrode unit member as described in FIG. 5 positioned onto the stimulation media fixation unit body, forming a ready for use stimulation media fixation unit,

[0095] FIG. 7, illustrates an insertion tool configured for any of the above described stimulation media fixation units,

[0096] FIG. 8, illustrates an insertion tool including any of the previous described embodiments of stimulation media fixation units, arranged inside the insertion tool is such a way that the polymer tubing (27) can be rolled of inside the formed channel through the skin, and

[0097] FIG. 9, illustrates an example of the entire system, where the stimulation media fixation unit (70) may be any of the above described stimulation media fixation units, and where the connector (71) of a lead (72) is positioned on the stimulation media fixation unit connector end termination and connected to a pulse generator (73).

DETAILED DESCRIPTION

[0098] FIG. 1 represents a stimulation media fixation unit body (2), 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 and forms the fixation member for the hydrogel-based electrode element to be arranged on the stimulation media fixation unit. The end terminations and the stimulation media fixation unit body could as well be assembled using clicked-in, magnetically attached, spring loaded or attached using similar concepts. The shape or design of the end terminations 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 as long as they are hygienically acceptable and does not harm the surrounding tissue. The end termination providing connection (12) to a lead or a pulse generator is electrically isolated from the skin (10). A second end termination element (11) provides a magnetically counterpart of the electrical connection (12) and may be conductive or non-conductive.

[0099] The isolating materials of the end termination/s (10 and/or 11), when designed not to be part of the electrode interface, can comprise PEEK, fluorinated materials, ceramics or similar biocompatible materials. When the lower section (10) of the end termination shall be part of the electrode interface, this part is then design utilizing 316L or precious metals suitable for the application. Thus, the stimulation media fixation unit body and/or the at least one end termination constitutes an electrical stimulating electrode.

[0100] The shape of the stimulation media fixation unit can vary, having the goal to position the hydrogel-based electrode/s and/or other suitable conductive electrode/s arranged on the stimulation media fixation unit or being an integral part/s of the stimulation media fixation unit, close to the targeted nervous tissue for optimal stimulation effectivity. Further, the level of tissue adhesion enhances the performance of the electrode/tissue interface.

[0101] Therefore, the bending radii and bending angles shall be configured or selected in accordance with the specific site of interest. The preferred cross sections of the stimulation media fixation unit body are ranging from ø1 mm to 06 mm, although not necessarily being circular. Sections of the stimulation media fixation unit body having larger circumference, i.e. up to 10 mm, could be optional where a large charge injection is important for the application. The preferred shaft lengths are from 10 mm to 40 mm and should be anatomically feasible for the site at which the stimulation media fixation unit is intended to function. The length of the stimulation media fixation unit body can be more than 100 mm, but if longer distances of fixation are necessary, application of additional stimulation media fixation units are preferred. The curvature of the stimulation media fixation unit determines the depth of the stimulation media fixation unit into the tissue. The requirement for this depth can vary depending on the local tissue at the site of stimulation, taking into account among other things the length of the stimulation media fixation unit body, the cross section etc., and the anatomical location of stimulation. 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.

[0102] FIG. 2 represents a stimulation media fixation unit with integrated hydrogel electrodes (5, 6) in a bipolar configuration. Tri-polar, quadrupolar or 5-polar electrode concepts could also prove to be relevant options in some applications, although these designs are not included in the illustrations. The shapes of the hydrogel electrode areas (5, 6) 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 electrode areas (5, 6) shall be 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 magnetic connection (11, 12), but other designs are also relevant, utilizing, spring loads or click-in etc.

[0103] The shape of the stimulation media fixation unit body can vary in order to allow the hydrogel-based electrodes (5, 6) to be positioned in close contact with the tissue targeted for the charge injection. The depth of the stimulation media fixation unit into the tissue is ideally between 2 and 5 mm, but further depth, may be required in some cases, where the excitable tissue is found further profound. For this reason, the bending sections (7) should be configured to position the hydrogel-based electrode members (5, 6) at the site of interest. The clinical success of electrical stimulation-based systems depends among other things on the ability of the electrode member/s (5, 6) 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 member (5, 6) degrading and becoming unsafe. To mitigate the problems associated with reduced physical size, advanced biomaterials and precious materials should be used to ensure longevity. The electrode members (5, 6) are the electrochemically active areas of the stimulation media fixation unit where charge transfer occurs during stimulation. The electrode member/s is supposed to be in close proximity of the target nerve to obtain low stimulation thresholds. Ideally, the electrode member/s 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. Electrical connection (11, 12) to the electrode member/s (5, 6), run inside the stimulation media fixation unit body members (7, 8, 9, 16, 10).

[0104] The internal wiring can also be obtained by the structural parts of the electrodes themselves, or by partially coating of for instance a ceramic based stimulation media fixation unit body. In this manner, simplification of assembly of the stimulation media fixation unit is obtained. For the positioning of the stimulation media fixation unit, at least one end termination (1) shall be detachable, or a separable stimulation media fixation unit body should be used, as presented in FIG. 2.

[0105] FIG. 3 illustrates stimulation media fixation unit configured for addition and/or exchange of hydrogel-based electrode member/s, as e.g. presented in FIG. 5, where the stimulation media fixation unit of FIG. 3 includes an end termination (1) having a channel (9) for injection of liquids to support the removal of the stimulation media fixation unit. Thus, the thread element (3) shall also include an open pathway for liquid to flow through it. Holes are prepared in the isolation member (7), leaking the liquid into the channel in the tissue, reaching the hydrogel-based electrode member/s (5, 6) lubricating the hydrogel for ease of removal. In monopolar configurations of the stimulation media fixation unit, the liquid could be a non-plasticized hydrogel, supporting electrical performance of the hydrogel-based electrode.

[0106] The end terminations (1, 10) further have a detail (4), ensuring the correct positioning and fixation of the electrode member to be included and additionally limiting edge biting effects from the edge/s of the electrode member/s.

[0107] The stimulation media fixation unit body members (16, 8, 7, 9, 17 and 13) provide the charge pathway to the electrode member/s (5, 21 and/or 6, 23) illustrated in FIG. 5. The stimulation media fixation unit body member/s (16, 17) includes a contact surface for the hydrogel-based electrode member/s inner structure. This contact surface can include a spring connection to improve the connection from the stimulation media fixation unit body member/s (16, 17) to the electrode member inner structure (21, 23). The physical size of the first stimulation media fixation unit body member (16) should not necessarily be identical to that of the second stimulation media fixation unit body member (17), but the size of the stimulation media fixation unit body member/s shall match that of the hydrogel-based electrode member/s to be attached to the stimulation media fixation unit body.

[0108] FIG. 4, illustrates a stimulation fixation unit body, which includes a vibrations generator micromotor (18), positioned inside an electrode member (16). Due to the presence of the micromotor for vibration stimulation, a pathway as included in FIG. 3 is not optional. Apart from this detail, the designs of FIG. 3 and FIG. 4 are identical.

[0109] FIG. 5, illustrates a hollow hydrogel-based electrode unit to be arranged on the above described stimulation media fixation unit body of FIG. 3 or FIG. 4, where a flexible electrode member (5, 6) is positioned in the first end and second end of the isolation member (7). It should have a smooth surface and overall structure also at the transition/s between the hydrogel-based electrode member/s and the isolation member (7), to prevent risk of harm inside the formed channel in the tissue, even though the hydrogel (5, 6) is considered a soft and flexible material. The isolating material of the isolation member (7), if any applied in the given design, should be biocompatible or bio-inert, of which PEEK or ceramics are ideal. Other materials could include fluorinated based materials.

[0110] The internal structure (21, 23) of the electrode unit of FIG. 5, is an electrically conductive spring member, providing contact pressure forces to the stimulation media fixation unit body it shall be attached to. This can be achieved in various ways, by e.g. making the internal structure (21, 23) slightly nonconforming to the stimulation media fixation unit body it should be attached to, exemplified as a slightly triangularly internal structure (21, 23) fitted for a circular stimulation media fixation unit body.

[0111] Other way to create the required contact pressure is by use of an internal structure (21, 23), having a radially spring force such as the commercially available Bal-Seal engineering canted coil springs, or slightly undersized precision coil springs fitted to a matched size of stimulation media fixation unit body.

[0112] The inner structure can also include a scrim or mesh to improve the attachment of the hydrogel member (5, 6) to the inner structure member (21, 23) of the electrode.

[0113] FIG. 6, illustrates a complete stimulation media fixation unit body as described in FIG. 3 and FIG. 4, with the electrode member as described in FIG. 5 positioned onto the stimulation media fixation unit body, forming a ready for use stimulation media fixation unit. For designs where the stimulation media fixation unit body is heavily bended, i.e. the angles between the first end and the second end of the isolation member (7) constitutes a circular section of more than 15°, the isolation member (7) shall be able to flexibly adopt this bending degree. Likewise, the hydrogel electrode member (5 and 21 or 5 and 23) shall allow bending similarly.

[0114] FIG. 7, illustrates an insertion tool configured for any of the above described stimulation media fixation units. The tip (30) is in some embodiments blunt, used for insertion of stimulation media fixation units into established and healed channels through the skin. The tip (30) is in some embodiments sharp, for initial creation or re-creation of the channel through the skin and is established from polymers, metal and/or ceramics. Both embodiments include variants where these are coated with a low friction silicone primer.

[0115] The insertion tool presented in FIG. 7 includes a polymer or silicone-based needle-shaft (31) for guiding the stimulation media fixation unit through the formed channel through the skin and a polymer or silicone-based tubing (27) into which the stimulation media fixation unit shall be arranged. The diameter, length and shape shall be matched to the stimulation media fixation unit to be positioned in the formed channel.

[0116] FIG. 8 illustrates an insertion tool (30, 31, 32, 27 and 28) including any of the previous described embodiments of stimulation media fixation units (70), arranged inside the insertion tool is such a way that a polymer tubing (27) can be peeled and rolled off the stimulation media fixation unit (70) inside the formed channel through the skin, in such a way, that the polymer tubing (27) is peeled off the stimulation media fixation unit (70). The stimulation media fixation unit (70) have the first end termination removed, then positioned at the polymer tubing end (32) and rolled onto the stimulation media fixation unit, forming a neck (28) at the second end termination on the stimulation media fixation unit (70). This procedure covers the stimulation media fixation unit (70) in two layers of polymer tube (27). This provides additionally a means of protection of the hydrogel electrode member/s (5, 6) for increase of shelf life.

[0117] The polymer tube (27) is the preferred embodiment made from elastic materials, of which silicone is preferred. Similar tubing could be made from polyurethane with low wall thickness, or other materials with at least similarly low durometers.

[0118] FIG. 9 shows an example of an entire electrical stimulation system, represented by a stimulation media fixation unit (70), where 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 shall hold 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. 6 could constitute the stimulation media fixation unit (70) as shown in FIG. 9.