Method for setting up a myoelectric-controlled prosthesis system and prosthesis system

Description

[0001] The invention relates to a method according to claim 1 for setting up a myoelectrically controlled prosthetic system with a prosthetic socket and several recording electrodes for detecting electrical muscle activity. The invention also relates to a prosthetic system according to claim 15 with a prosthetic socket that can be attached to a limb stump, comprising several recording electrodes for detecting electrical muscle activity, a control unit connected to the recording electrodes, and a powered prosthetic component that is attached to the prosthetic socket and coupled to the control unit.

[0002] Prostheses serve to replace a missing limb. Beyond purely aesthetic aspects, it is desirable that the prosthesis perform as many functions as possible of the missing limb to facilitate the patient's daily activities. In lower extremity prostheses, prosthetic components are often attached to a remaining limb or stump via a prosthetic socket. This can be achieved in various ways, for example, using a strap system, a vacuum system, and / or a liner system with mechanical locking elements at the distal end of the liner. A joint is often located distally on the prosthetic socket to connect another prosthetic component, such as a prosthetic knee joint or a prosthetic ankle joint.In lower extremity prostheses, the joints can be designed as locking joints, joints with a unique damping behavior setting, sensor-controlled passive joints with damping behavior that can be adapted to the respective movement sequence, or as motor-driven joints.

[0003] Even in the case of upper extremities, the designs of prostheses range from purely decorative prostheses to cable-operated gripping devices and motor-driven prosthetic hands that are attached to the patient via an elbow joint on upper arm shafts.

[0004] With powered prostheses, it is essential to precisely control the drives so that each prosthetic component performs the desired or required movement. Control can be achieved remotely via a healthy limb. For this purpose, sensors are attached to a healthy limb and their movement signals are recorded. Each sensor signal is assigned a control command for the respective drive. When a specific movement is performed and a sensor signal is detected, a command is transmitted via the control system, stored in a computer, to the drive to execute a specific displacement or pivot over a defined path within a specific time.

[0005] Alternatively, electrodes can be used to record a patient's biosignals, such as electrical muscle activity resulting from muscle contractions. These signals are recorded as electromyographic signals and can be used to control one or more drives. Through learned contraction patterns, a patient can trigger different actions of the prosthetic component by contracting one or more muscles. Often, two electrodes are sufficient for this, enabling a so-called dual-channel connection. A gripping device can be easily opened and closed using a simple signal sequence.

[0006] Complex prosthetic devices, such as those with a powered prosthetic elbow joint on a prosthetic hand with individually movable prosthetic fingers and / or a flexible and / or rotatable wrist, cannot be reliably controlled by a patient using a two-channel controller. Controlling such a complex device requires eight or more electrode pairs to enable pattern recognition, the assignment of numerous myoelectric signals, and the derivation of a correspondingly complex control signal.

[0007] Patients should receive prosthetic care as quickly as possible after limb loss to optimally utilize the remaining muscles and prevent them from adapting to the limbless state. A potential problem is that, following amputation, the wound must heal and any swelling or bruising must subside, making it impossible to fit a final prosthetic socket immediately. Furthermore, it is difficult to predict which type of prosthesis will be feasible for a patient requiring a new prosthesis.

[0008] US Patent 2014 / 0031952 A1 concerns methods and systems for connecting physiological devices and a prosthetic system. This involves receiving a variety of different types of physiological activity signals from the user and decoding a movement intention based on each signal type. These movement intentions are then combined into a single decision to control movable elements of the prosthetic device.

[0009] DE 10 2009 056 466 A1 relates to a system and method for the adaptive control and regulation of a prosthesis with voluntary control, in which a multitude of muscle activity signals are first measured in a muscle of the prosthesis wearer. Simultaneously, information about the actual movement state of the prosthesis wearer is measured, from which at least one possible, current movement state is determined. Subsequently, muscle activity characteristics are extracted from the muscle activity signals using a method for detecting signal patterns. From the extracted muscle activity characteristics, at least one voluntary signal is determined using the current movement state. The voluntary signal is used for evaluation and / or for the regulation and / or control of an actuator of the prosthesis.

[0010] US Patent 2009 / 0216339 A1 concerns a system for transmitting myoelectric signals through the liner of a prosthetic device. A flexible conductive electrode insert defines a first region that is positioned on an inner surface of the liner and makes contact with the user's skin. A second region extends through the liner, and a third region extends along the outer surface of the liner. At least the second and third regions of the insert are fixed to the liner using an adhesive.

[0011] DE 10 2008 036 714 A1 relates to a method for visualizing multi-channel sensor signals, in particular myoelectric signals, which are derived from a limb or amputation stump via electrodes. Each sensor signal is assigned a display direction and a display amplitude. The display direction represents exactly one sensor signal, and the display amplitude represents the intensity of the respective signal. The display direction and the display amplitude of all sensor signals are simultaneously displayed in real time on a display device as a single graphical object.

[0012] WO 2018 / 026842 A1 concerns a signal processing technology for deriving intended limb movements from intramuscular or surface electromyographic signals. Electromyographic signals are acquired by an electrode array and routed to a processor connected to a memory. The electromyographic data are associated with a training movement performed by a user in response to a training movement prompt. Differential channel pairings are determined from the single-ended channels, and characteristic data features are extracted. These characteristic data features are then mapped to the movement prompt. A set of characteristic data features is selected as a training input in a decoding model configured to correlate the characteristic feature set with the intended movement.The decoding model is configured to use the characteristic data model.

[0013] US Patent 8 591 599 B1 relates to an electrode arrangement for recording muscle signals in a prosthetic liner, in which the signals are transmitted via cables and connectors.

[0014] US patent 8 828 093 B1 concerns a myoelectrically controlled lower extremity prosthesis in which the gait phase is determined and a movement pattern is defined based on it. Dome electrodes are generally mentioned.

[0015] DE 20 2006 007 460 U1 relates to a prosthetic socket system with an inner socket and an outer socket, wherein the inner socket has at least one recess for conducting myoelectric signals from an electrode mounted on the inner socket. The electrode is attached in a holder that seals the recess.

[0016] CN 1 582 688 A1 relates to a prosthetic hand and control via myoelectric signal patterns. Excitation of an electrode fixed in a prosthetic socket enables haptic or sensory feedback to prevent accidents.

[0017] RU 2 635 632 C1 relates to a method for controlling an upper extremity prosthesis, in which myoelectric signals are recorded in response to a predefined movement. These signals are processed and assigned attributes based on their amplitude. The desired movement is then controlled based on these attributes. The user receives feedback, and the patient-assisted control is further enhanced by an automatic control system.

[0018] The object of the present invention is to provide a method for setting up a myoelectrically controlled prosthetic system and a prosthetic system as such, with which it can be determined as quickly as possible which treatment is possible for the patient and how the prosthetic system can best be configured.

[0019] According to the invention, this problem is solved by a method with the features of claim 1 and a prosthetic system with the features of claim 15. Advantageous embodiments and further developments of the invention are disclosed in the dependent claims.

[0020] The procedure for setting up a myoelectrically controlled prosthetic system with a prosthetic socket and multiple recording electrodes for detecting electrical muscle activity initially involves attaching a surface electrode array around the circumference of a limb stump. The electrical muscle activity of the muscles in the limb stump is detected via these surface electrodes (myoelectric signals). The myoelectric signals are then evaluated for their signal quality. Based on this evaluation, the control method for the prosthetic system is selected. Finally, the recording electrodes are positioned on the prosthetic socket.The surface electrode array allows for the recording and evaluation of myoelectric signals with regard to signal quality without requiring a prosthetic socket to be permanently fitted with recording electrodes. Signal quality encompasses aspects such as signal separation, particularly the signal's shape or propagation pattern, and the location where the signal is recorded. Signal repeatability is another quality criterion; high signal quality is achieved when the signal always appears the same, meaning a patient can consistently generate the same signal. Signal sustainability is also relevant to signal quality. A signal that can be generated and recorded over a longer period is preferable to a short-lived signal that might be perceived as interference and disregarded.For this purpose, patients with the attached surface electrode array are asked to perform muscle activities, for example, the action that the prosthetic device is intended to perform, such as opening the hand, closing the hand, rotating the wrist, or flexing the hand. Naturally, these actions cannot be performed directly by the patients, as the limb replaced by the prosthesis is missing; however, the remaining muscles can be activated as they were before the limb loss. This generates electrical potentials that are recorded by the surface electrodes and transmitted to an evaluation or control unit. Based on factors such as signal duration, signal intensity, slope, or signal frequency during muscle contractions, it is possible to determine whether complex electronic control of a prosthetic device is even feasible.These signal characteristics are part of the signal quality, which is used for evaluation and decision-making regarding the type of control and the type of prosthetic restoration. For example, if muscles and / or nerves are so severely damaged that patients cannot generate complex, sufficiently unambiguous signals, the patient's restoration will be selected based on the assumption that a dual-channel restoration represents the optimal solution. If a patient is able to generate a sufficient number of myoelectric signals of sufficient quality and distinguishability, a complex prosthetic restoration with a multitude of drives and functions can be voluntarily controlled by the patient via pattern recognition or other evaluation of the myoelectric signals.Such a patient can then be fitted with a suitable prosthesis, including a prosthetic socket, powered prosthetic components, control units, and the like. Based on information about whether a two-channel or multi-channel prosthesis is appropriate and implemented, the recording electrodes, which can also be surface electrodes, are positioned at the corresponding location on the final prosthetic socket. This ensures that the selected control unit for the prosthetic actuators always receives signals from the predetermined muscle regions or from the individual muscles themselves, thereby increasing the control accuracy and thus the quality of the movements performed by the prosthetic component.

[0021] Preferably, the surface electrode arrangement is designed independently of the prosthetic socket and is applied separately to distribute the surface electrodes around the circumference of the limb stump. The surface electrodes are applied to the skin surface of the limb stump where the prosthesis is to be placed, eliminating the need for a more or less complex impression of the limb stump to create a positive model on which the prosthetic socket made of fiber-reinforced plastics would then be modeled. In principle, other manufacturing methods for a prosthetic socket are also possible, as is the use of other materials.The arrangement of the surface electrodes separately from the prosthesis shaft via the surface electrode arrangement increases the flexibility of positioning and also enables a very early examination and determination of whether and which electromyographic signals a patient can generate.

[0022] Preferably, the surface electrode array is positioned on the limb stump in a way that allows it to be moved and / or rotated, enabling its placement at different locations on the stump. By rotating and / or moving the array on the stump, the optimal electrode positions can be determined. The array is rotated and / or moved until the best possible signals resulting from the patient's muscle contractions are generated and recorded. The best possible signals are those whose overall signal quality is most suitable for control. This requires considering all signals, necessitating the analysis and evaluation of numerous parameters.The evaluation may, for example, show that in a first position the amplitude of two signals is not maximal, but the slope of the edges and the spatial separation of the signals are better than in a second position with maximum amplitudes, so that the first position is the best position despite not having maximum values ​​in the criteria.

[0023] Preferably, the surface electrodes are arranged around the limb stump at uniform or substantially uniform intervals. For example, with six electrodes, they are spaced 60° or approximately 60° apart; with eight electrodes, 45° or approximately 45° apart; and with four electrodes, 90° or approximately 90° apart. The myoelectric signals from the surface electrodes are preferably evaluated with regard to their signal quality, in particular their amplitude, duration, frequency, and / or bandwidth. The evaluation is performed to determine their suitability for identifying commands.For example, if it is determined that only two muscles are capable of generating usable myoelectric signals, the use of a prosthetic device based on multi-channel control, such as a control system on the prosthetic hand with multiple drives, can be ruled out.

[0024] Further training of the procedure involves selecting and defining a basic setting for the control method. This could include, for example, a basic setting for dual-channel control, pattern recognition, or a basic setting for an orthotist who then adapts it to the individual patient. The control method can be selected automatically by a controller or computer based on predefined criteria, particularly the evaluability of the myoelectric signals. In this training, pattern recognition is selected as the control method, and a basic setting for the pattern recognition method is configured that can only be modified and deleted by an authorized person.

[0025] A further development of the invention provides that a personalized or calibrated control setting, based on the patient's measured myoelectric signals, is stored as a default setting that cannot be changed by the patient and is saved in the controller or computer. Another further development of the invention provides that the two best-separated myoelectric signals recorded by the surface electrodes are identified and used as a starting point for deciding which type of control to use. These two best signals are used as the guide signal.

[0026] A further development of the invention provides that the surface arrangement on the limb stump is moved and / or rotated into an end position, in which at least two myoelectric signals are detectable. Detectable signals are present, for example, when there is a sufficiently large distance with respect to the predefined criteria for signal quality. The recording electrodes, which are fixed in the prosthetic socket, are then positioned on the prosthetic socket corresponding to the end position. The arrangement of the electrodes on the prosthetic socket is then such that the recording electrodes occupy the positions that the corresponding surface electrodes on the surface arrangement had previously occupied, as determined by the detection and evaluation of the optimal position of the surface electrode arrangement or the surface electrodes on the limb stump.

[0027] For this purpose, a segmented band can be used to mark the respective positions on the prosthesis shaft so that openings can be made in the shaft.

[0028] A further development of the invention provides that the recording electrodes are attached to the prosthetic socket via a dome screw connection. When fitting a patient, an orthotist must equip a prosthetic socket with a multitude of recording electrodes as devices for acquiring myoelectric signals. A currently quite common solution involves an eight-channel setup, in which at least 16 electrode contacts, and possibly several additional electrode contacts for grounding, must be screwed to the prosthetic socket, for example, an inner socket. It is important that the recording electrodes can be attached to the desired location with minimal assembly effort, low profile, and high quality. So-called suction-shaft electrodes are known from the prior art; these have an active amplifier with a housing and integrated contacts.These suction stem electrodes must be attached to a recess in the inner socket. If the suction stem electrodes are to be repositioned, a correspondingly sized recess must be created in a new inner socket; the position of the amplifier must be defined during the fabrication of the inner socket. In an alternative method, after drilling a hole in the prosthetic socket, a threaded rod of a dome is inserted through the hole. A washer is placed on the threaded rod, and a nut is tightened. A contact lug of an electrode is placed over the threaded rod and secured with another nut. The two nuts are tightened against each other using two wrenches. Finally, any protruding threaded rods are ground down. The large number of components used complicates assembly and results in a comparatively large overall height.Grinding down the threaded rod moves the thread, making it difficult to reposition the electrodes. There is no external electrical insulation towards the outer shaft, which can lead to interference when the prosthetic outer shaft is made of carbon material. The use of a dome screw connection according to the invention significantly simplifies assembly. After drilling a hole in the shaft, a threaded dome electrode is inserted through the hole and screwed in place using a dome nut, which is equipped with a moisture-proof washer and an electrical contact. This is done with a single tool, such as a hex key, a square key, or a simple screwdriver. A cover cap is then clipped onto the dome nut to provide external electrical insulation.This results in a significantly reduced overall height. Only a single tool is required. The threaded dome is advantageously mushroom-shaped and may have projections or features on the underside of the head that prevent or hinder rotation on the surface of the inner or prosthetic socket. This eliminates the need for a second tool to secure the dome. The washer secures the dome nut to the dome, preventing unintentional loosening. Additionally, a sealing ring may be provided on the outside of the dome nut, offering further protection against unintentional loosening and moisture ingress. After assembly, no further shortening of the threaded rod is necessary, and the domes and dome nuts can be easily reused. Preferably, the domes are made of a stainless material, such as titanium.

[0029] A further development of the invention provides that the electrodes are connected to a control unit or controller via cables and mechanically secured against detachment by a locking element. The control unit has connector receptacles into which plugs from the respective electrodes, which are permanently mounted on the prosthetic socket, can be inserted. To prevent the plugs from detaching during operation of the prosthesis, the locking element is attached to the control unit over the connector, for example, by being elastically clipped onto the housing of the control unit, so that the backs of the plugs rest against the locking element and the cables extend through recesses within the locking element. The locking element can secure all plugs simultaneously.

[0030] The prosthetic system comprises a prosthetic socket that can be attached to a limb stump, multiple recording electrodes for detecting electrical muscle activity, a control unit connected to the recording electrodes, and a powered prosthetic component attached to the prosthetic socket and coupled to the control unit. It includes a surface electrode array with multiple surface electrodes that can be attached around the circumference of a limb stump, and the surface electrode array can be slidably and / or rotatably positioned on the limb stump. The control unit is detachably connected to the recording electrode(s) or the surface electrodes via at least one connector. An adapter for converting myoelectric signals, whose quality and distinguishability are suitable for multi-channel control, into two-channel control signals is arranged between the control unit and the connector.

[0031] The movable and / or rotatable design of the surface electrode array makes it possible to determine a patient's suitability for specific prosthetic systems or control devices and configurations of a prosthetic system. Unlike a fixed installation of electrodes on a prosthetic socket, such as an inner socket, the surface electrode array can be positioned independently of the socket, allowing it to be moved and / or rotated on the limb stump. The surface electrodes on the array can then easily record electrical muscle activity and process it as myoelectric signals.Instead of training a patient to tense specific muscles in a particular way, the surface electrode array allows for the simple detection of optimal positioning of the surface electrodes and subsequently the recording electrodes. The surface electrodes on the array are detected in their orientation relative to the limb stump, and the optimal position of the array on the stump, and thus also of the surface electrodes on the stump's surface, is then transferred to the prosthetic socket. The socket positions the recording electrodes in the same locations when the prosthesis is in place. The prosthetic socket is typically custom-made to fit the stump, preventing any rotation or displacement relative to the stump.Once the prosthetic socket is in its final position on the limb stump, the electrodes are positioned as definitive electrodes at those positions identified as the best position by means of the surface electrode arrangement.

[0032] Advantageously, the surface electrode arrangement is designed as a cuff that can be placed around the limb stump. The surface electrode arrangement or cuff can be designed as a closed, annular band or have such a support element, preferably being elastic in the circumferential direction.In addition to a surface electrode arrangement or cuff or support element being made of an elastic fabric, it can also be made of an elastic plastic, for example a corrugated plastic, wherein the corrugation or wave contour in cross-section preferably has the surface electrodes on the inwardly directed projections or the areas with the smallest distance to the center of the cross-section or to the central axis in longitudinal extension, i.e. in proximal-distal extension of the surface electrode arrangement, so that the surface electrodes can always have good contact with the skin surface of the limb stump.

[0033] Preferably, the surface electrodes are arranged at uniform or substantially uniform intervals around the circumference of the surface electrode assembly, so that the signals can be plotted uniformly in a diagram. Markings or labels identifying the respective positions of the surface electrodes can be arranged on the surface electrode assembly, e.g., on the support element; for example, the positions can be consecutively numbered or labeled with consecutive letters.

[0034] Particularly when the surface arrangement is configured as an annular or band-like cuff, or with an annular or band-like support element having a distal end and a proximal end and at least one proximal insertion opening, it is advantageous if the surface electrode arrangement has at least one stabilizing element extending in the proximal / distal direction to prevent shortening in the proximal / distal direction during circumferential expansion. The stabilizing elements can be rod-shaped and advantageously accommodate the surface electrodes.

[0035] A replaceable cover, preferably made of a stretchable material, such as a stretchable textile, can be arranged on the surface electrode assembly. Markings can be provided on the surface electrode assembly, for example, on the support element and / or on the cover, to ensure correct alignment of both the surface electrode assembly with the electrodes and the cover with the surface electrode assembly and the electrodes. The cover can be secured to the surface electrode assembly by means of positive locking elements, such as hook-and-loop fasteners; alternatively, buttons, hooks, or similar fasteners can be provided on the surface electrode assembly to attach the cover. Advantageously, recesses for the surface electrodes are formed within the cover to allow direct skin contact between the surface electrodes and the skin surface of the limb stump.The recesses simultaneously prevent a relative displacement of the coating to the surface electrode arrangement during use, as the inwardly protruding surface electrodes prevent a twisting or displacement of the coating.

[0036] Since the surface electrode assembly is designed as a system component that can be attached to the limb stump independently of the prosthetic socket and is only preferably used for setting up or configuring the prosthetic system, the surface electrode assembly is no longer needed once the prosthetic socket has been finalized with fixed electrodes. Therefore, the surface electrode assembly can then be returned to the prosthetist, who can dispose of the cover and, after proper cleaning, make the remaining surface electrode assembly available to another patient with a new cover.

[0037] In one variant of the invention, it is provided that the surface arrangement is integrated and fixed in the definitive prosthesis socket and that the surface electrodes form the transducer electrodes, which then supply the myoelectric signals for the control of the driven prosthesis device.

[0038] The surface electrodes and / or conduction electrodes can be designed as domed screws with domed nuts and screwed to the surface electrode assembly or the prosthetic stem. By designing the respective electrodes as domed screws with domed nuts, which pass through an opening in the surface electrode assembly (for example, within the cuff or carrier element) or in the prosthetic stem, a large number of electrodes can be attached in the correct position simply, quickly, and with only one tool. The domed screw design with domed nut ensures a moisture-tight connection of the electrodes. The domed screw can have an undercut that creates high surface pressure in the surrounding area, preventing moisture from penetrating behind the cap-like bearing surface of the domed screw.Furthermore, a sealing ring can be arranged on the outside of the dome nut, sealing it against the through-hole. An additional sealing washer, in conjunction with an electrical contact, can be present on the outside of the surface electrode assembly or the prosthesis stem, thus achieving a moisture-tight attachment of the electrodes to the respective carrier.

[0039] Further training stipulates that at least one cable is detachably attached to the prosthetic socket or surface electrode assembly, making electrical contact with the recording electrode or the surface electrode. The cable is insulated from the surface assembly or the prosthetic socket, and the respective electrode is also insulated from the environment, preventing signal interference. This ensures that the myoelectric signals can be transmitted to the respective control unit solely via the cable that is electrically connected to the electrode.

[0040] A mechanical safeguard against disconnection in the opposite direction of insertion of the plug is provided in the form of a locking element in a further development, in which, for example, a recess for the respective cable is provided in the locking element. The recess is dimensioned such that the back of the plug rests against the locking element, so that when the locking element is securely fastened to the control device, for example by means of an elastic snap-fit ​​device or a positive locking element, the respective cable is mechanically secured.

[0041] The description also discloses a surface electrode arrangement, in particular in the form of a cuff, as described above. The description also discloses an electrode in the form of a surface electrode or a current collector electrode, as described above. The description also discloses a locking element as such, as described above.

[0042] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures.

[0043] They show: Figure 1 – an overall view of a current collector electrode; Figure 2 – a sectional view of a current collector electrode before assembly; Figure 3 – a sectional view of a current collector electrode in the assembled state; Figure 4 – a perspective view of a surface electrode assembly with surface electrodes; Figure 5 – a cross-sectional view of the surface electrode assembly according to Figure 4; Figure 6 – a surface electrode assembly with a replaceable cover; Figure 7 – a positioning aid; Figure 8 – a variant of a positioning aid; Figure 9 – a process for applying a surface electrode assembly; Figure 10 – a control unit with a locking element without a connector; Figure 11 – a process for assembling connectors on a control unit with a locking element; Figure 12 – a schematic representation of a prosthetic system; and Figure 13 – a partial view of a completed prosthesis.

[0044] Figure 1Figure 1 shows a perspective view of a mounted electrode in the form of a recording electrode 10, which is mounted on a base body in the form of a prosthetic socket 20. On the outer side 21 facing away from the patient, the recording electrode 10 is covered with an insulating cover cap 11. This cap prevents signals received from the skin surface or from the patient from being conducted to unintended locations or from being affected by interference. The cover cap 11 is arranged around a contact tab 12, which in turn is positioned between two discs 13. These discs provide electrical insulation from the prosthetic socket 20 and also seal any penetration point through the prosthetic socket 20.The contact tab 12 is clamped between the two discs 13. Both the discs 13 and the contact tab 12 have a through-hole through which a dome nut (not visible) is inserted. On an inner surface 22 facing the patient, the dome nut is screwed to a dome screw 15, which has a shaft with an external thread and a head, the so-called dome 152. The dome comes into direct contact with the patient's skin surface.

[0045] Figure 2Figure 1 shows the construction of the current collector electrode 10 in a partially assembled state. The contact tab 12 is positioned between the two discs 13, and the dome nut 14 is guided through a through-opening 23 in the prosthesis stem 20. The cover cap 11 is already clipped onto the head of the dome nut 14. The dome nut 14 has an internal thread 141, which is located in a shaft 140 of the dome nut 14. The shaft 140 extends from the head of the dome nut 14 towards the inner surface 22 of the prosthesis stem 20. Furthermore, the shaft 140 has a circumferential groove 142 on its outer surface, in which a sealing element, for example a closed sealing ring, can be arranged. The outer diameter of the shaft 140 corresponds essentially to the inner diameter of the through-opening 23.In the illustrated embodiment, the length of the shaft 140 is dimensioned such that it is essentially flush with the surface on the inside 22 of the prosthetic shaft 20. In principle, shorter or longer shafts 140 can also be provided.

[0046] On the inner surface 22, the dome screw 15 is arranged with a bolt 150. The bolt 150 has an external thread 151 that corresponds to the internal thread 141 of the dome nut 14. The external thread 151 is only partially screwed into the internal thread 141. The bolt 150 terminates in a dome cap or the so-called dome 152, which is slightly convex, domed, or mushroom-shaped. From the outer edge of the dome 152, the rear side, which faces the inner surface 22 of the prosthetic stem 20, extends slightly inwards, so that preferably only a bearing ring or bearing ring surface is present. The dome 152, the bolt 150, and the dome nut 14 are all electrically conductive. Excitation potentials from muscle activity are conducted via the dome 152 and the dome mother 14 via the contact tab 12, which is electrically coupled to the dome mother 14, to a cable (not shown), which is then connected to a plug.The detected electrical potentials of muscle activity are transmitted via the cable and connector, for example for evaluation or for controlling a prosthetic component.

[0047] Figure 3 The figure shows the assembled state in a sectional view. The dome screw 15 is fully screwed to the dome nut 14. The dome 152 rests with its underside edge on the inside 22 of the prosthesis stem 20 and is pressed against the prosthesis stem 20 in a moisture-tight manner by the compression. The passage opening 23 is further sealed by the sealing ring in the outer groove 142 and the two washers 13, which clamp the contact tab 12.

[0048] The electrode 10 is mounted after the through-hole 23 has been drilled or otherwise created in the prosthesis stem 20. Advantageously, the bolt 150 with the external thread 151 of the dome screw 15 is first inserted through the through-hole 23 and held in position. The dome nut 14 is pre-assembled with the attached washers 13, the contact tab 12 arranged between them, and, if applicable, a sealing ring. The cover cap 11 is not yet positioned over the dome nut 14. The dome nut 14 may, for example, have an internal hexagon socket or a slot to allow for a moisture-tight, electrically conductive fastening of the electrode 10 to the wall of the prosthesis stem 20 using only one tool. Finally, the cover cap 14 is clipped on and positively locked in place by an undercut formed in the dome nut 14.The cable is inserted through the sheath of the cable receptacle of the contact tab 12, thus achieving simple and quick electrical insulation to the outside. With such an electrode, a reduced overall height above the shaft, particularly on the outer surface 21, is possible. Rapid assembly of the electrode with the dome 152 is possible. Reversible assembly is possible via a screw connection; the dome nut 14 is secured against unintentional loosening of the connection by the sealing ring and the two washers 13. The washers 13 can be designed as compression washers. The dome nut 14 can be pre-assembled with the electrical contact and the sealing ring; the washers 13 and the contact tab 12 are secured against unintentional slippage by the sealing ring. The screw connection allows for adjustment to different wall thicknesses of the prosthetic shaft 20.

[0049] The above statements apply both to electrodes 10 that are attached to a prosthetic stem 20 and to surface electrodes 100 that are mounted on a surface electrode arrangement 200, for example a cuff or the like, which will be explained below.

[0050] In the Figure 4 A surface electrode arrangement 200 is shown, in which the surface electrodes 100 are analogous to the current collector electrodes 10 of the Figures 1 to 3The surface electrode arrangement 200 is designed as a cuff and has a corrugated support element. The surface electrodes 100 are arranged on the inwardly directed corrugated projections of the support element 30 to ensure reliable skin contact. The linearly arranged surface electrodes 100, which are tripolar in design, are distributed uniformly or at least approximately uniformly around the circumference of the support element 30, which is designed as a closed ring. Slight variations in the spacing of the electrodes or electrode lines around the circumference are also permissible. On the outside of the support element 30, each surface electrode 100 is associated with an amplifier 40, in which the received myoelectric signals are amplified and, if necessary, preprocessed and transmitted.Each amplifier unit 40 is arranged in an elongated housing 35 and may have its own energy storage device. A power supply connection 50 is located in an unused recess on the outside of the support element 30, through which energy can be supplied to the individual amplifier units 40. Furthermore, signals from the surface electrodes can be transmitted to a control device via the power supply connection 50. A clamping device 42 is also provided, by means of which the circumference of the sleeve or the support element 30 can be adjusted.

[0051] Due to the corrugated design of the carrier element 30, it is possible to achieve an elastic and radially expandable structure, allowing the surface electrode assembly 200 to be applied to limbs with different diameters and circumferences. This makes it possible to use the surface electrode assembly 200 in the initial treatment and evaluation of patients without the need for a custom-made prosthetic socket.

[0052] In the illustrated embodiment, eight three-pole surface electrode triplets are arranged on the support element 30. As already described, the support element 30, and thus also the surface electrode arrangement 200, is elastic in the circumferential direction and fixed in length or rigidly in the axial direction, i.e., in the proximal-distal direction or along the longitudinal axis of the surface electrodes 100 of an electrode triplet arranged in a line. This makes it possible to define a fixed distance between the surface electrodes 100 of an electrode triplet or between two electrodes of an electrode pair. The surface electrode arrangement 200 is rotatably and slidably mounted on a limb stump in order to determine the optimal position of the surface electrodes 100 for recording unambiguous myoelectric signals.

[0053] Figure 5 shows the surface electrode arrangement 200 according to Figure 4 in cross-sectional view. The individual surface electrodes 100 are analogous to the Figures 1 to 3 The electrodes are constructed as dome bolts 15 with dome nuts 14. The eight electrode rows are arranged in pairs opposite each other around the circumference. The sectional view shows that energy storage devices 41 are only partially arranged in the amplifier units 40. An elastic rope or band 60, or even a tensile-resistant, flexible rope with the tensioning device 42, can be arranged between the individual electrodes 100 to increase the compression effect and to facilitate and enable recovery after expansion.

[0054] Figure 6Figure 1 shows a perspective view of a surface electrode arrangement 200 with a covering 70 arranged around and pulled over it, which can consist of a highly flexible fabric. The covering 70 is arranged on both the inside and outside of the surface electrode arrangement 200 and almost completely surrounds it. Only the domes 152 of the surface electrodes 100 on the inside of the ring-shaped or sleeve-shaped support element 30 are left uncovered to allow direct skin contact.

[0055] Furthermore, the supply connection 50 is left open on the outside of the surface electrode assembly 200 to conduct power and data from the amplifier units 40 and the surface electrodes 100, respectively. The cover 70 is detachably attached to the carrier element 30. An undercut 153 is formed on the domes 152 by the slightly rounded shape of the mushroom-shaped heads, allowing the fabric with the corresponding hole or recess 71 to fit into the space or undercut. The cover 70 can be fastened on the outside using hook-and-loop fasteners, buttons, or snap fasteners, making it easy to put on and take off.

[0056] On one end face of the surface electrode arrangement 200, markings in the form of numbers are applied to enable unambiguous identification of the electrodes or electrode pairs around the circumference. This facilitates signal evaluation and allows the respective signal to be assigned to a series of surface electrodes 100 or a surface electrode pair.

[0057] A variant of the invention in the Figure 7Figure 1 shows how a position of the surface electrodes 100 of a surface electrode arrangement 200, once determined on a limb stump 1, can be transferred to a prosthetic socket 20. In this embodiment, this is achieved using a positioning aid 31, which consists of an elastic textile cuff with uniformly spaced markings around its circumference on its outer surface, e.g., in the form of consecutive numbers from 1 to 8. The markings preferably change their distance from each other uniformly as the textile stretches to adapt to the respective circumference of the limb. In one embodiment, the textile exhibits uniform stretching behavior in the circumferential direction.The width of the cuff or band determines the optimal axial spacing of the electrodes, i.e., in the proximal-distal direction or along the longitudinal axis of the limb stump; the markings indicate the circumferential spacing of the electrodes. In the... Figure 7 The positioning aid is attached to a prosthetic socket 20. The markings allow the respective positions of the electrodes, and thus the locations for a through-hole, to be indicated on the prosthetic socket 20. Instead of markings, the positioning aid can also have appropriately spaced holes, which serve as a template for the optimal positions of the through-holes and thus the electrodes. Such a variant is shown in the Figure 8 shown.

[0058] The surface electrodes 100 attached to the support element and the conducting electrodes 10 to be positioned on the prosthetic socket 20 are distributed approximately equidistantly around the circumference and spaced apart from each other along the longitudinal extent of the limb stump. To reduce the intended electrode spacing, stabilizing elements can be arranged longitudinally in the positioning aid 31, so that the positioning aid 31 is expanded radially but not shortened axially. The support element of a surface electrode arrangement 200 can also be made of or comprise an elastic textile and be equipped with stabilizing elements.

[0059] Figure 8Figure 1 shows a variant of a positioning aid 31 with markings and / or holes, or a surface arrangement 200 with surface electrodes 100. The surface electrode arrangement 200 or positioning aid 31 is band-shaped and not a closed ring. The surface electrode arrangement 200 or positioning aid 31 can be placed around a limb and attached there. The diameter or circumference is variable, for example, by having a hook-and-loop fastener on the outside, so that a surface electrode arrangement 200 can be attached to limb stumps and positioning aids 31 to prosthetic sockets 20 with different circumferences or diameters.

[0060] Figure 9Figure 1 shows the procedure for applying a surface electrode assembly 200 to a patient. The surface assembly is shown in a perspective view in the upper left of the illustration. The amplifier units 40 are arranged in the elongated housings 35, which simultaneously form stabilizing elements. Within the housings 35, the surface electrodes 100 are spaced apart from each other along the longitudinal extent of the housings 35. The individual amplifier units 40 in the respective housings 35 are connected to each other via cables. A cable 60 can be tensioned or released via a tensioning device 42 to adjust the ring-shaped surface electrodes 100 and housings 35 of the surface electrode assembly 200 to their maximum circumference.

[0061] In the second image, top right, the cover 70 is inserted into the circular arrangement of the surface electrode assembly. The cover 70 is designed as a tube or sleeve and has corresponding recesses 71 through which the domes 152 are passed. Sections of the cover 70 protrude from the proximal and distal end faces, i.e., along the longitudinal axis at the ends of the cuff 30. Once all the domes 152 have been passed through the recesses 71, the longitudinally protruding portions of the cover 70 are folded over so that they come into contact with the outside of the housings 35. This step is shown in the middle, left-hand illustration. Figure 9The cover 70 is shown with fastening elements 72, which in the illustrated embodiment are designed as snap fasteners. Alternative fastening elements 72 can be provided, for example, hook-and-loop fasteners or buttons. The fastening elements 72 are engaged with each other so that the outside of the surface electrode assembly 200 is completely surrounded by the cover 70. The fully assembled state of the cover 70 on the surface electrode assembly 200 is shown in the lower right illustration. The fastening elements 72 are located on the outside of the surface electrode assembly, and the domes 152 are formed on the inside of the sleeve-like support element 30.

[0062] The lower left representation of the Figure 9Figure 1 shows the surface electrode arrangement 200 with coating 70 in the applied state. The coating 70 can provide elastic restoring forces; it is also possible for the circumference to be adjusted via the clamping device 42 on one of the housings 35 of the surface electrode arrangement.

[0063] Figure 10Figure 1 shows a perspective view of a control unit 80 with a housing on the outside of which plug receptacles 81 are formed. Plugs (not shown), connected via cables to the surface electrodes 100 or the electrodes 10, can be inserted into these receptacles. In the illustrated embodiment, the plug receptacles 81 or sockets are arranged on opposite longitudinal sides of a flat, slightly curved housing. A total of eight plug receptacles 81 are provided in the illustrated embodiment, four on each longitudinal side. The slight curvature is provided to facilitate the attachment of the control unit 80 to a prosthetic socket 20 or to a patient.The control unit 80 has a cable output 82, via which the control unit 80 is coupled to a powered prosthetic component 2 (not shown) to transmit control signals to the respective drive based on a selected control method. Based on the myoelectric signals received from the surface electrodes 100 or the conducting electrodes 10, the respective drives are controlled and activated or deactivated. Activation is performed with regard to adjustment speed, adjustment range, adjustment duration, and / or force.

[0064] A locking element 90 is associated with the control unit 80 and is clamped to the outwardly curved outer surface of the control unit 80's housing. The locking element 90 has clips or tabs 91 in the area of ​​the connector receptacles 81, which partially cover the opening of the connector receptacle 81. Each clip or tab 91 has a recess 92 for the cable. To establish the connector connection from the surface electrodes 100 or current collector electrodes 10 to the control unit 80, the connectors 19 on the cables 18 from electrodes 10 and 100 are inserted into the connector receptacles 81. Once all connectors are inserted into the connector receptacles 81, the locking element 90 is placed over the housing of the control unit 80 and clamped in place.The tabs or clips 91 prevent the plugs from being pulled out against the insertion direction; however, the recesses 92 in the tabs or clips 91 allow the cables to be routed out essentially straight in the insertion direction, so that no kinks are formed. The locking element 90 provides a releasable, mechanical lock against unintentional disconnection of the plugs.

[0065] Figure 11 shows a variant of the invention with the control unit 80 and a housing corresponding to the Figure 10 The housing has a total of ten connector receptacles 81 on its narrow longitudinal sides, five on each side. In the upper left image of the Figure 11 Several plugs 19 have already been inserted into the plug receptacles 81. The plugs 19 are designed as three-pin plugs, to which the cables 18 from the individual electrodes 10, 100 are attached. In the upper left illustration of the Figure 11Seven plugs 19 have already been inserted into the plug receptacles 81 of the control unit 80. In the upper right illustration, all plug connections of the surface electrodes 100 of the cuff are inserted according to Figure 4. The lower left illustration shows the secured representation with eight inserted plugs 19, including essentially straight cables 18 and the locking element 90 with the clips 91 and the recesses 92. Unlike in the Figure 10 is in the embodiment according to Figure 11 The locking element 90 is located on the inside of the housing of the control unit 80. The cable outlet 82 connects the control unit 80 to the prosthetic component to be controlled.

[0066] Figure 12Figure 1 shows a schematic representation of the prosthetic system with a prosthetic component 2, which is designed in the form of an existing product. The prosthetic component 2 can be fixed to a carrier 3. In the illustrated embodiment, two different prosthetic components 2 are available: a simple gripping device that can be controlled via a two-channel controller. The gripping device can grasp and release, requiring a single drive to be activated, reversed, and stopped to perform the desired action. The lower prosthetic component 2 is a prosthetic hand with a plurality of driven prosthetic fingers, each with a different drive. This necessitates a significantly more complex control system to operate using signals derived from the patient, particularly electrical signals. The carrier 3 is connected to the control unit 80 via the cable output 82.The control unit 80 is connected to the electrodes 10 via connector 19 and cable 18. The electrode pairs are shown, as well as an electrode triplet with additional electrodes serving as ground.

[0067] An adapter 17 can be arranged between the transducer electrodes 10 and the control unit 80. This adapter converts signals from the transducer electrodes 10, which are actually suitable and intended for pattern recognition-based control, into two-channel control signals that can be used to control the gripping device. The control unit 80 can be wirelessly paired, for example via Bluetooth, with an operating device 16, such as a computer, tablet, or smartphone, to configure the control. The operating device 16 can contain authentication software that specifies that only an authorized person can modify the control underlying the actuation of the respective prosthetic component 2.

[0068] Furthermore, the surface electrode assembly 200 is shown as another component of the prosthetic system. It is designed as described above and can be positioned, in particular, in a sliding and rotatable manner around a limb stump 1. The surface electrodes 100 on the inside of the surface electrode assembly 200 on the carrier element 30 can be connected to a control unit 80 via cable 18 and connector 19. This allows for the rapid acquisition of information, even without a finished prosthetic socket 2, about which electrical signals a patient can generate and which cannot. Based on these electrical signals received by the surface electrode assembly 200, a decision is made, either in the control unit 80 or in another evaluation device or controller, as to whether control via pattern recognition software or a two-channel control system is advantageous and suitable.The surface electrode assembly 200 can be positioned in an optimized location that is most favorable for recording the myoelectric signals. This position and the assignment of the respective electrodes 100 or electrode pairs, for example in the respective housing 35, are stored. The markings on the front face or circumference of the carrier element 30 or the surface electrode assembly 200 determine which electrode 10 is to be located or positioned where. This positioning of the respective electrodes 10 or electrode pairs is then transferred to a final prosthetic socket 20.The transfer can be carried out either via projection, the production of a template, a positioning aid 31 or by superimposing the selected position onto an image, so that the orthopaedic technician knows where each through-hole 23 for attaching and positioning the electrode 10 should be arranged when manufacturing the prosthesis socket 20.

[0069] In the Figure 13 The final arrangement of the electrodes 10 with the cover caps 11 on the prosthetic stem 2 is shown. The electrodes 10 are coupled via the cables 18 and an adapter 17 to the control unit 80 (not shown), which in turn supplies the prosthetic component 2 (not shown), which is attached to the distal end of the prosthetic stem 20, with the corresponding commands for the respective drive. Reference symbol list

[0070] 1 Limb stump 2 Prosthetic component 3 Carrier 10 Conductor electrode 11 Cover cap 12 Contact tab 13 Washer 14 Dome nut 15 Dome screw 16 Operating device 17 Adapter 18 Cable 19 Connector 20 Prosthetic shaft 21 Outer side 22 Inner side 23 Through-hole 30 Carrier element 31 Positioning aid 35 Housing 40 Amplifier unit 41 Energy storage 42 Tensioning device 50 Supply connection 60 Cable 70 Cover 71 Recess 72 Locking element 80 Control unit 81 Connector receptacle 82 Cable outlet 90 Locking element 91 Clamp 92 Recess 100 Surface electrode 140 Shaft 141 Internal thread 142 Groove 143 Undercut 150 Bolt 151 External thread 152 Dome 153 Undercut 200 Surface electrode arrangement

Claims

1. Method for configuring a myoelectrically controlled prosthetic system with a prosthesis socket (20) and several lead electrodes (10) for detecting electrical muscle activity, comprising the steps: - Placing a surface electrode arrangement (200) with a plurality of surface electrodes (100) around the circumference of a residual limb (1) - Detecting electrical muscle activity in muscles of the residual limb (1) as myoelectric signals by the surface electrodes (100) - Evaluating the myoelectric signals with regard to their signal quality - Selecting the control method used to control the prosthetic system based on the evaluation of the signal quality, and - Fixing the lead electrodes (10) to the prosthesis socket (20).

2. Method according to claim 1, wherein the surface electrode arrangement (200) is designed to be independent from the prosthesis socket (20) and is placed separately from the prosthesis socket (20).

3. Method according to claim 1 or 2, wherein the surface electrode arrangement (200) is placed on the residual limb (1) in a manner that allows it to be shifted and / or twisted.

4. Method according to one of the preceding claims, wherein the surface electrodes (100) are arranged at an equal distance or at least in the main at an equal distance from one another around the residual limb (1).

5. Method according to one of the preceding claims, wherein the signal quality of the myoelectric signals of the surface electrodes (100) is evaluated on the basis of their amplitude, duration, frequency and / or bandwidth.

6. Method according to one of the preceding claims, wherein a selection and definition of a basic setting of the control method is made.

7. Method according to claim 6, wherein the selection of the control method is automatically executed in a control unit (80) on the basis of specific criteria.

8. Method according to claim 6 or 7, wherein pattern recognition is selected as the control method and a basic setting of the pattern recognition method is made which can only be modified and deleted by an authorized person.

9. Method according to claim 6 or 7, wherein a dual-channel control is selected as the control method and the two most distinguishable myoelectric signals are identified and the position of the corresponding electrodes (10, 100) on the stump (1) is indicated in an indicator device.

10. Method according to one of the preceding claims, wherein the position of the surface electrodes (100) is transmitted from the residual limb (1) to the prosthesis socket (20) by means of a positioning aid (31).

11. Method according to one of the preceding claims, wherein the surface electrode arrangement (200) is shifted and / or twisted on the residual limb (1) into an end position in which at least two signals can be detected, and the lead electrodes (10) are fixed on the prosthesis socket (20) correspondingly to the end position.

12. Method according to claim 10, wherein the position of the lead electrodes (10) is displayed on the prosthesis socket (20), projected onto the prosthesis socket (20) or transferred to the prosthesis socket (20) by way of a positioning jig.

13. Method according to one of the preceding claims, wherein the lead electrodes (10) are fixed to the prosthesis socket (20) via a dome bolt connection.

14. Method according to one of the preceding claims, wherein the lead electrodes (10) are connected to a control unit (80) via cables (18) and are mechanically secured from becoming detached by means of a securing element (90).

15. Prosthesis system with a prosthesis socket (20), which can be arranged on a residual limb (1), and several lead electrodes (10) for detecting electrical muscle activities, a control unit that is connected to the lead electrodes (10) and a driven prosthesis component (2), which is fixed to the prosthesis socket (20) and coupled to the control unit (80), with a surface electrode arrangement (200) with several surface electrodes (100) which can be arranged around the circumference of a residual limb (1), wherein the surface electrode arrangement (200) can be arranged on the residual limb (1) in a manner that allows it to be shifted and / or twisted, characterized in that the control unit (80) is connected to the lead electrodes (10) or surface electrodes (100) via plugs(19) such that it can be detached and that an adapter (17) is arranged between the control unit (80) and the plug (19) for converting myoelectric signals, the quality and distinguishability of which are suitable for multichannel control, into two-channel control signals.

16. Prosthesis system according to claim 15, wherein the surface electrode arrangement (200) is designed as a closed, circular strap.

17. Prosthetic system according to claim 15 or 16, wherein the surface electrode arrangement (200) is designed to be elastic in the circumferential direction.

18. Prosthesis system according to one of claims 15 to 17, wherein the surface electrodes (100) are arranged on the surface electrode arrangement (200) at an equal distance or at least in the main at an equal distance from one another in the circumferential direction.

19. Prosthesis system according to one of claims 15 to 18, wherein the surface electrode arrangement (200) has a positioning aid (31) and / or at least one stabilizing element (35) extending in the proximal-distal direction.

20. Prosthesis system according to one of claims 15 to 19, wherein a replaceable cover (70) is arranged on the surface electrode arrangement (200).

21. Prosthesis system according to claim 20, wherein markings are arranged on a positioning aid (31) and / or the cover (70).

22. Prosthesis system according to claim 20 or 21, wherein recesses (71) for surface electrodes (100) are designed to be be provided in the cover (70).

23. Prosthesis system according to one of claims 15 to 22, wherein the surface electrodes (100) and / or lead electrodes (10) are designed as dome bolt (15) with dome nut (14) and are bolted to the surface electrode arrangement (200) or the prosthesis socket (20).

24. Prosthesis system according to claim 23, wherein the dome screw (15) comprises an undercut (153) and the passage spot (23) is sealed against moisture penetration.

25. Prosthesis system according to one of claims 15 to 24, wherein at least one cable (18) is fixed to the prosthesis socket (20) or the surface electrode arrangement (200) such that it can be detached and is in electrical contact with the lead electrode (10) or the surface electrode (100).

26. Prosthesis system according to claim 15, wherein the connectors (19) are mechanically secured against becoming detached by a securing element (90).