i-limb TM digits Component Assembly Guide

Transcription

1 i-limb TM digits Component Assembly Guide

2 This document provides instruction for prosthetists in the assembly of i-limb digits components necessary in the fabrication of i-limb digits prostheses. The instructions within should be read in full prior to fabrication. It is highly recommended that the use of this manual is made in conjunction with instruction from a clinician experienced in the use of i-limb digits. This symbol signifies important information and is used throughout the manual. Refer to to ensure the latest copy of this document. 2

3 i-limb digits Fabrication of a Five Finger Socket with Remote Electrodes Check Socket - Silicone Socket This stage of fabrication (points 1 to 9) details a method of creating a silicone socket used for the check socket. It is accepted that a number of alternative methods are possible. 1 Make an initial cast of the patient s residual hand and up to approximately mid forearm level. Mark on the cast the position of the zip if planned and the four anchors used to fix the frame to the silicone socket, two on the palmer surface and two on the dorsal surface. N.B. the anchors on the dorsal surface should be spaced around 4cm apart to cater for the Wristband attachment dummy. 2 If a zip is required then prepare by burning a series of holes with a soldering iron in the fabric on each side of the zip. This will provide improved adherence between the zip and the silicone (zip not supplied). A ratchet strap, as well as a creative socket design maybe incorporated to aid socket suspension (contact customer service if a rachet strap is required). 3 Fill the center holes of the four anchors with clay and paint with a silicone primer. Standard and Small Silicone Support Anchors are provided with all kit orders ( Silicone Support Anchor; Silicone Support Anchor, Small), alternatively Mesh Silicone Support Anchors (SA091121) are available separately if required. N.B. The number of anchors required will be dependent on socket design of 26

4 4 Shape four silicone discs, one for each anchor and silicone strip for attachment of the zip. Silicone discs should be sized slightly larger than the anchor to be used. Experience with shore hardness between 35 to 50 has provided good results. A harder shore may provide the option for a smaller frame, and should be considered as apart of the full design process. 5 Position the silicone, anchors, zip and zip protector on the cast. 6 Roll a 2mm silicone sheet and layup on the cast to incorporate the anchors and zip. 4 of 26

5 7 Apply six layers of stockinette with a plastic airtight layer and vacuum for approximately 45 minutes. Remove the plastic layer and check the silicone at the mid-way stage for any irregularities. 8 Remove stockinette and trim the silicone to shape as required. 9 Cure the silicone socket at 75 C for 7 hours, or fast cure at 95 C for 2 hours. 5 of 26

6 Check Socket - Frame This section of the guide (points 10 to 20) details a method of fabricating a frame and joining to the silicone socket to form the check socket. 10 Apply a cutting strip to the zip area and pull over a single denier stockinette. 11 Drape a rigid, clear thermoplastic frame directly on to the cast. Experience with frames of finished thickness of between 2 to 3mm has shown good results. 12 Apply vacuum and ensure a good seal to create good form to the frame shape. 13 If the patient has a small residuum, then it may be necessary to build up the cast to create a more anatomical position for the Knuckle Mounting Plate (9, 10 or 11). This can be done using plasticine to give an estimate position. 6 of 26

7 14 Generously grease the silicone and plasticine. 15 Duplicate using impression material. 16 Remove plasticine from the impression 17 Create a plaster cast. 18 Drape with thermoplastic in the same manner as points 11 and 12 7 of 26

8 19 Cut the frame away from the cast, shape and smooth the edges, prepare drill holes to cater for anchor screws in line with the anchors on the silicone socket. 20 Join the silicone socket and frame together with M4 Socket Button Head Screws (42), engaging with the four anchors. 44 N.B. The position of the electrodes or FSR s can be marked on the transparent frame, directly from markings on the patient s residuum, highlighting the optimal position for controls. The electrode positions are then drilled through the frame and transferred directly to the cast. The cast can then be used to position the controls on the definitive socket. Refer to point 28 for further information on electrode placement. See Appendix for further information on the use of FSR s. 8 of 26

9 Check Socket Digit and Wristband Positioning This section (points 21 to 25) details the method of positioning the Wristband and digits and aeration of the socket. 21 Positioning of the Remote Electrode and Socket Terminal Dummy For fabrication, place the Remote Electrode Dummy (14) and the Socket Terminal Dummy (15) on the Dorsal surface of the residual hand (figure 1a).The position should be central to the midline of the wrist and elbow joints. A distance of 30mm should be left between the Socket Terminal Dummy and the center of the wrist joint to enable good range of movement at the wrist (figure 1b). If a dorsal interosseous myo-site is used, the Remote Electrode Dummy (14) may require repositioning. Figure 7a 1a Ultimately, the final position of the Dual Remote Electrodes (16) will match the position of the corresponding dummies (figure1c) and optimal position of the wristband (figure 1d). 18 = = = 1 6 Approx. 30mm 30mm Final position of Dual Wrist Remote Final Electrode position of Assembly Dual Remote Electrode Assembly Midline Figure 7b 1b Final position Figure 1cof Dual Remote Electrode Assembly Figure 7c Optimal Wristband Assembly Figure position 1d Figure 7d 9 of 26

10 22 Select either a Multiple Knuckle Mounting Plate (10 or 11), Flat Multiple Knuckle Mounting Plate (12 or 13), or Single Knuckle Mounting Plate (9) (figure 2). Multiple Knuckle Mounting Plates can be cut to cater for patients with 3 or 2 finger loss Figure 2 23 Removal of the Knuckle Fairing Remove the two M2 x 9mm Torx Screws (1) from the Knuckle Fairing (2) using the T6 Screwdriver (3). Remove Knuckle Fairing (2) by sliding the fairing away from the joint. 3 (Figure 3) 1 2 Figure Removal of the Digit from the Knuckle Use the T8 Screwdriver (4) to remove the M2 Tapered Digit Screw (5) from the Knuckle Assembly (6). 7 The Digit (7) can now be freely disengaged from the Knuckle Assembly (6). (Figure 4) Figure of 26

11 25 Attachment of the Knuckle Mounting Plate Use the T6 Screwdriver (3) to attach the Knuckle Assembly (6) to either a Single Knuckle Mounting Plate (9) or a Multiple Knuckle Mounting Plate (10 or 11) using three M2 x 6mm Torx Screws (8). Lamination tabs can be bent or shortened as appropriate at this stage. The single hole on the Single Knuckle Mounting Plate faces the dorsum of the hand when in the correct position. Consider fabrication before cutting and removing tabs, some tab length will be needed for fixation of the plate to the frame. (Figure 5) Take care not to over tighten screws. 11 Figure Attachment of the Digit to the Knuckle Assembly Firmly place the digit (7) into the Knuckle Assembly (6). Insert the M2 Tapered Digit Screw (5) using the T8 Screwdriver (4). 7 (Figure 6) Figure of 26

12 27 Remote Electrode Wiring Map The Dual Remote Electrode Assembly (16) is arranged with a single Ground position and two electrode contact points for each electrode (figure 7b). Optimal setting for the Adjustment dial is 4. Contact Contact Ground (Figure7a) Adjustment dial Figure 8a 7a Contact Set 1 Connects to Wrist Band Loom Ground Contact (Middle) Ground Contact (Middle) Contact set 2 Figure 8b 7b 28 Position of the Remote Electrode Domes Identify potential electrode sites (figure 8a). Create a clear thermoplastic check socket over the patient s positive cast ensuring coverage of the proposed electrode dome sites (figure 8b). Potential electrode sites Figure 9a 8a 12 of 26

13 Drill a 5 x 3 matrix of Ø3.2mm holes at a distance of 8 to 10mm apart in the check socket, over the potential sites (figure 8c). Figure 9b 8b 10 10mm m m 10mm 10mm 10mm 10mm m m m m 10 10mm m m Figure 8c Ø3.2 mm Figure 9c 29 Position of Ground Electrode Dome Both of the Ground Contact wires, the middle wire from the Remote Electrode Assemblies, use the same dome. Drill a Ø3.2mm hole beneath the position of the Socket Terminal, in the midline (figure 9). If this position is unavailable, select an alternative position away from muscle sites over bone and distal to the wrist. Figure 10 9 Dorsum View Ground Dome Position 13 of 26

14 30 Insertion and Connection of Electrode Domes Insert an electrode dome (21) into the Ground Dome Position and connect the middle wire from each Dual Remote Electrode (16) using the washers and locking nut (17, 18, 19, 20, 21) provided (figure 10a) Figure 11a 10a Insert two domes into two of the holes previously drilled, per electrode site. Connect the contact wires from one electrode to each pair of domes (figure 10b), connecting the M3 Nut (17), Electrode Eye (18) and Conical Washer (19) as illustrated in Figure 10a. It is important to have one hole between electrodes and ensure electrodes run in series with the muscle fibers (figure 10b and 10c). CORRECT Electrode domes are in line with the muscle fibers and one hole separates domes Figure 11c 10b INCORRECT In general the above Dome arrangements are not op2mal for EMG signals. Figure 11d 10c 14 of 26

15 31 Fit the patient with the check socket and connect to biosim. Fit the patient with the check socket and connect to biosim. Analyze muscle signals. If required, reposition domes using predrilled holes to obtain optimal outputs.. 32 Testing for Optimal Digit Positioning and Socket Aeration Glue the digit mount to the test socket using fast set urethane adhesive. Glue thumb position to provide the best opposition to the Index and Middle digits. Thumb Setting Bar (25) may be used to aid alignment. N.B. It may take a number of attempts to find the optimal position for digits. Positioning should be based on function rather than anatomical position. Test the prosthesis on the patient, considering compensatory movements at the elbow and shoulder; in addition to movements in all planes as well as rotational movements. Assessment should use a variety of different objects and tasks, checking all grip options. 33 Aerate the socket as required cutting apertures into the silicone socket and frame, ensure that all wiring is adequately protected within the socket and edges are smoothed. Users may find aeration preferable as it will increase sensation while decreasing weight, heat build up and associated sweating. N.B. During the fitting process the position of electrodes and wiring routes are established. 15 of 26

16 Definitive Socket 34 Fabricate the definitive silicone socket as per the process for the check socket with added pigment (stages 1 to 8). Transfer of Alignment 35 Transfer of Digit Alignment with Thumb Rotator Assembly from Check Socket 3 Remove the Digits (7), Knuckle Assemblies (6) and Thumb Setting Bars (22 or 23) from the check socket. Attach the Single Knuckle Dummies (27) to the Knuckle Mounting Plate (9, 10 or 11) using three M2 x 16mm Countersunk Torx Screw (26) and the T6 Screwdriver (3), (figure 11a) Figure 14a 11a Insert the Alignment Bars (28) into the Single Knuckle Dummies (27) and lock each in place using M2 x 5mm Countersunk Torx Screw (29) and the T6 Screwdriver (use one per digit when using Single Knuckle Mounting Plates (9) and a minimum of two per assembly for Multiple Knuckle Mounting Plates), (figure 11b) Figure 14b 11b 16 of 26

17 36 Position the check socket on the original cast and mount in a vertical alignment jig. Capture alignment in lower container with impression material or plaster and allow to cure. 37 Remove the cast from the vertical alignment jig and then remove the check socket from the cast. Replace with the definitive silicone socket and reposition on the vertical alignment jig, whilst protecting the silicone with cling film. The definitive socket and the Knuckle Mounting Plate will now be accurately positioned with a space in between. 38 Fill the space between knuckle and silicone with clay. N.B. Consideration must be given to the position of the electrical connectors for supply of power to each individual digit. If space is available between the silicone socket and the frame then place the connection points for each digit within this space. If space is limited then an additional area must be build up with plasticine to provide additional space within the frame. 17 of 26

18 39 Remove from the vertical jig and set upright. Place the the dummies for the Wristband connection and remote electrodes on the back of the hand. Blend in the contours of the connection using clay. 40 Create routes for the wiring using clay or similar material. 41 Remove the Knuckle Mounting Plate(s) (9, 10 or 11). 42 Using silicone impression material duplicate the model to make a plaster mould, as per points 15 to Laminate the plaster with two layers of Nyglass. 18 of 26

19 44 Transfer of Digits Alignment with Thumb Rotator for the Definitive Socket The inner Silicone and primary lamination will have been completed at this stage. Transfer to the Definitive Socket using the chosen method (also refer to the Alignment Section in the Fabrication guide). Assemble the second set of Mounting Plates to the Dummy components and fix to the Definitive Inner Socket accordingly. Ensuring the Alignment bars are held in position during the process (figure 12a). Figure 12a 15a Remove the Dummy components (figure 12b). Figure 12b 15b Re-attach the Thumb Setting Bar (22 or 23) with the with the Thumb Mounting Plate (25) attached (figure 12c) Figure 12c 15c 19 of 26

20 Fix the Thumb Mounting Plate (25) in position using an appropriate adhesive and remove the Thumb Setting Bar (22 or 23). Alignment has been transferred (figure 12d). Figure 15d Figure 12d 45 Fabrication Preparation and Dummy Component Assembly Once final alignment checks have been carried out, remove all digits and re-assemble the Fabrication Dummy components and position the Thumb Mounting Dummy (32). Use clay to fill the screw heads and any other gaps to ensure no resin seepage (figure 13) Figure 16 Figure of 26

21 46 Layup the model with two layers of woven glass, apply a PVA bag and laminate. 47 When the lamination is fully cured grind down to reveal the lamination blocks. 48 Remove the lamination blocks and grind down further to the surface of the Knuckle Mounting Plate (9, 10 or 11). Clean up around the Thumb Mounting Plate (25) to allow the assembly of the thumb. 49 Remove the cast from the frame. Trim the frame as desired and create apertures as per the check socket. Aeration of the socket is desirable to enhance sensitivity and to reduce heat build up and associated sweating. Aeration of the dorsal aspect of the frame is not recommended. Ensure that aeration does not compromise the strength of the frame. 21 of 26

22 50 Drill a hole at the Thumb Mounting Plate (25) in the frame to allow digit wire to pass through, as per image. 51 The hole in the right hand side of each knuckle must be cleared of debris to accept the wire from the Knuckle Assembly (6). Assembly This section details the assembly of the definitive prosthesis (points 51 to 59). 52 Attach Knuckle Assembly (6) using M2 x 6mm Torx Screws (8), three screws are needed per Knuckle Assembly. 22 of 26

23 53 Attach the Thumb Hinge Plate (41) to the Thumb Rotator Assembly (34 or 35). 54 Thumb Rotator Assembly Setting and Assembly The full Thumb Rotator Assembly is illustrated (34 or 35) (Figure 14a). To increase the force required to rotate the thumb, remove the Nut Cap (36) and use the 8mm Spanner (33) to tighten the Self Locking Nut (35) to tighten the M4 Locking Nut (37). Hand tighten with fingers and then turn a further 120 to 150 to give the desired Thumb Friction depending on patient preferences (figure 14b), using the 8mm Spanner (33) Figure 14b 17b Figure 14a Figure 17a Ensure the Clutch Plate (39) is not contaminated, as this will affect performance. 55 Attach each digit using the supplied screws. Screws are recommended to be single use Attach the remote electrode to the silicone socket as per the method used for the check socket. N.B. The black earth wire is positioned on the dorsal surface of the hand, the red wire attached to signal site positions. 23 of 26

24 57 Attach the Wristband and secure using M4 Socket Button Head (42) Connect the digit wires to each two-way connector from the Wristband. N.B. The order of attachment is un-important as this is later mapped using the biosim software (see the biosim section in the i-limb digits Clinician Manual for full details). 59 Connect the four-way connector to the remote electrode. N.B. The connection plugs between each digit and the Wristband, along with any excess wiring, should be positioned between the silicone socket and the frame, beneath the base of the Knuckle Mounting Plate. 60 Insert the silicone socket into the frame and attach using M4 Socket Button Head Screws (42). 61 i-limb digits Skin Active covers Slide the i-limb digits Skin Active and i-limb digits Thumb Skin Active coverings (30 and 31) in place over the digits (figure 15a), aligning the contours of the covers with the digit (figure 15b) Figure 18b Figure 15b Figure 18a Figure 15a 24 of 26

25 Appendix 62 Removal of Transport Bracket (for replacement of digits only) Remove the O-Ring (12) from the rear of the M2 Digit Screw (5). Withdraw the M2 Tapered Digit Screw (5) from Digit (7) and the Transport Bracket (13). Retain parts for future return to service center. (Figure 16) Figure 6 Figure FSR Control When using FSR control, the head of the FSR must not be distorted as failure of the device is likely to occur. The FSR is sited between the silicone socket and the frame (a second light weight inner frame may be created to support the FSR and protect the wiring). The silicone socket should be a maximum of 1mm thick, 20 shore silicone in the region of the head of the FSR for ease of activation. Routing of wires and fixing points are then established and incorporated within the silicone socket. A flat area must be created within the frame to cater for the head of each FSR. This can be done by taking a cast of the silicone socket mounted on the cast. The cast is then poured to create a positive model. A flat area is then made at the site of the FSR using a plastic disc which is blended into the cast. This ensures a flat surface for the FSR. 25 of 26

26 64 List of i-limb digits Components Item Part Number Description M2 x 9mm Torx Screw Knuckle Fairing T6 Screwdriver T8 Screwdriver M2 Tapered Digit Screw 6 SA Knuckle Assembly 7 Various* Digit M2 x 6mm Torx Screw 9 SA Single Knuckle Mounting Plate 10 SA Multiple Knuckle Mounting Plate, LHS 11 SA Multiple Knuckle Mounting Plate, RHS 12 SA SA O-Ring Flat Multiple Knuckle Mounting Plate, s RHS Flat Multiple Knuckle Mounting Plate, s LHS Transport Bracket Remote Electrode Dummy Socket Terminal Dummy 18 SA Dual Remote Electrode M3 Nut 20 NA** Electrode Eyelet Conical Washer Electrode Dome Spacer Electrode Dome Item Part Number Description Thumb Setting Bar, LHS Thumb Setting Bar, RHS 26 Various* Thumb Thumb Mounting Plate M2 x 16mm Countersunk Torx Screw Single Knuckle Dummy Digit Alignment bar M2 x 5mm Countersunk Torx Screw 32 Various* i-limb digit Thumb Skin Active 33 Various* i-limb digit Thumb Skin Active Thumb Mounting Dummy mm Spanner 36 PL Thumb Rotator Assembly, RHS 37 PL Thumb Rotator Assembly, LHS Nut Cap M4 Locking Nut Thumb Spring Clutch Plate Thumb Spigot Thumb Hinge Plate M4 Socket Button Head Screw Silicone Support Anchor Silicone Support Anchor, Small *Depending on digit size **Comes as part of a set, does not have an individual product code 26 of 26

27 North American Customers (Canada, Mexico & US) Touch Bionics 35 Hampden Road Mansfield MA USA Tel: MY ilimb ( ) International Customers Touch Bionics Unit 3, Ashwood Court Oakbank Park Way Livingston EH53 0TH Scotland Tel: For address details and further information please visit Third party products and brand names may be trademarks or registered trademarks of their respective owners Copyright 2013 Touch Bionics Inc. and Touch EMAS Ltd. All rights reserved. Issue No. 3, June 2013 Part number: MA01073