Patent Document

RELATED APPLICATION 
   This application is claiming the benefit, under 35 U.S.C. § 119(e), of the provisional application filed Apr. 11, 2003 under 35 U.S.C. § 111(b), which was granted Ser. No. 60/462,283. This provisional application is hereby incorporated by reference. 

   BACKGROUND OF THE INVENTION 
   The invention relates to prosthetic devices and methods of forming the same. In particular, the invention relates to a method of forming both transfemoral and transtibial, test or temporary and final, permanent sockets, and an adapter bracket for use therewith. The invention also relates to a method for transferring the alignment of a lock mechanism and/or socket attachment adapter bracket from a test socket to a final socket. 
   In the known prosthetic devices, the residual limb socket is connected, typically via a lock mechanism, to a prosthetic limb. The prosthetic limb is conventionally secured to an amputee&#39;s residual limb stump by securing the prosthetic limb to a rigid socket assembly. This may be done using suction, harnesses, etc. or combinations thereof. It is commonly done through the use of a locking pin. In this technique, the amputee first dons a sock-like liner formed of an elastomer, and which may include a fabric cover. The lower or distal end of the liner is formed of a rigid material, such as urethane, and the locking pin extends from this rigid bottom. These liners are well known in the art. The locking pin is extended through the wall of the socket and a distal adapter mounted within or outside of the socket, and can be locked onto a prosthetic lock mounted to the prosthetic limb to secure the prosthesis. Typically, the lock pin can be released only by moving a pinion gear in a direction parallel to its rotational axis until it disengages from the lock pin, e.g., via a manual release button. 
   In the conventional fabrication process, an initial design is determined for the prosthesis, perhaps with the aid of computer-aided design and manufacturing (CAD/CAM) systems, and a plaster model of the residual limb is created. Then, a “test socket” is formed on the plaster model. The test socket is placed on the patient and, if the fit of the test socket can be improved, revisions may be made and the process repeated until the desired fit is obtained. At that point, the test socket is filled with molding plaster to create a final plaster model for use in creating the final or permanent socket. Once the molding plaster has cured, the final plaster model is separated from the test socket, typically using a cast saw to cut away the test socket. In any event, the test socket must be cut apart to remove the adapter bracket and lock mechanism, if any, for use in the final socket. A final or permanent socket is then fabricated, either laminated or of the thermoplastic resin type, using the final plaster model. Typically, a vertical alignment transfer jig is relied upon in an attempt to recreate in the final socket the orientation of the adapter bracket relative to the socket found to be desirable in the test socket. 
   SUMMARY OF THE INVENTION 
   The invention relates to a method of forming a prosthetic residual limb test socket and an adapter bracket therefore. The adapter bracket includes an upper mounting face, a lower mounting face and a generally smooth sidewall extending therebetween, the sidewall including a plurality of bores in which a corresponding plurality of removable posts are received. The adapter bracket is secured to a model of the residual limb of a patient. Then, a socket forming material is applied about at least a portion of the model and the adapter bracket. The socket forming material covers the plurality of removable posts but not the lower mounting face of the adapter bracket. The socket forming material may be applied so as not to cover the lower mounting face, or any socket forming material that is initially applied to the lower mounting face may be subsequently removed, such as by cutting. The adapter bracket is thus removable and reusable. 
   In another aspect of the invention, a method is provided for forming a prosthetic residual limb socket based upon a test socket. The method comprises positioning a casting anchor within the test socket, the casting anchor being engaged with an alignment member extending out through a hole in the test socket. A molding material is introduced into the test socket so as to at least partially encase the casting anchor, and the molding material is allowed to set to form a model. The test socket is separated from the model and the casting anchor is disengaged from the alignment member. An adapter bracket having at least one through-hole is placed adjacent the model and the alignment member is introduced through the at least one through-hole in the adapter bracket and into engagement with the casting anchor to position the adapter bracket relative to the model. A prosthetic residual limb socket is then formed about the model and adapter bracket, the alignment member is disengaged from the casting anchor, and the prosthetic residual limb socket is separated from the model. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The advantages of the invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments when considered in the light of the accompanying drawings, in which: 
       FIG. 1  is a perspective view of a first embodiment of an adapter bracket in accordance with invention that is adapted for use in a test socket and with a lock mechanism, and being removable and reusable. 
       FIG. 2  is another perspective view of the adapter bracket of  FIG. 1 . 
       FIG. 3  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 1 . 
       FIG. 4  is a perspective view of a second embodiment of an adapter bracket in accordance with invention that is adapted for use in a test socket and with or without a lock mechanism, and being removable and reusable. 
       FIG. 5  is another perspective view of the adapter bracket of  FIG. 4 . 
       FIG. 6  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 4 . 
       FIG. 7  is a perspective view of a third embodiment of an adapter bracket in accordance with invention that is adapted for use in a laminated final socket, with or without a lock mechanism. 
       FIG. 8  is another perspective view of the adapter bracket of  FIG. 7 . 
       FIG. 9  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 7 . 
       FIG. 10  is a perspective view of a fourth embodiment of an adapter bracket in accordance with invention that is adapted for use in a laminated final socket with a lock mechanism. 
       FIG. 11  is another perspective view of the adapter bracket of  FIG. 10 . 
       FIG. 12  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 10 . 
       FIG. 13  is a perspective view of a fifth embodiment of an adapter bracket in accordance with invention that is adapted for use in a thermoplastic test socket with a lock mechanism. 
       FIG. 14  is another perspective view of the adapter bracket of  FIG. 13 . 
       FIG. 15  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 13 . 
       FIG. 16  is a perspective view of a sixth embodiment of an adapter bracket in accordance with invention that is adapted for use in a thermoplastic test socket, with or without a lock mechanism. 
       FIG. 17  is another perspective view of the adapter bracket of  FIG. 16 . 
       FIG. 18  is a further perspective taken from the bottom of the adapter bracket shown in  FIG. 16 . 
       FIG. 19  is an exploded perspective view of an apparatus for forming a prosthetic device with transfer of proper alignment in accordance with the invention. 
       FIG. 20  is a somewhat schematic, exploded perspective view of the apparatus of  FIG. 19  and prosthetic device. 
       FIG. 21  is a somewhat schematic, exploded perspective view of the apparatus of  FIG. 19  and prosthetic adapter bracket. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The adapter brackets of the invention and methods of use thereof allow connection of a transtibial or transfemoral socket to a socket attachment plate and a suction locking mechanism during the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). The method eliminates the use of bonding and filler materials to bond and reinforce the test socket or laminated socket. The method also eliminates the application of a second or final lamination to a laminated below knee or above knee socket. 
   Also provided is an adapter bracket whereby the socket attachment plate and the suction lock mechanism are removable, reusable and replaceable. The method allows the alignment of the lock mechanism to be adjusted in several planes (4 or more) to increase functionality and comfort to the patient. 
   In certain embodiments, the adapter bracket for connecting a transtibial or transfemoral socket to a socket attachment plate is used with a quarter moon shaped, C shaped or L shaped heat formable foam during the fabrication of the test socket (thermoforming) or permanent thermoformed socket. The heat formable foam is attached to the mold with nails or other fasteners. 
   The adapter bracket preferably has four or more flat weight bearing areas to act as a foundation of the test socket (thermoforming) or permanent thermoformed socket or laminated socket. In certain preferred embodiments, the adapter bracket includes 12 hole round pattern to accept and fasten various shuttle and clutch lock mechanisms that have, for example, six hole patterns for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In addition, a hard fabrication block may be used to lengthen the thermoplastic during vacuum forming to strengthen and add durability to the plastic and allow the socket attachment plate and suction locking mechanism to be removable, reusable and replaceable in a test socket (thermoforming) or permanent thermoformed socket. 
   In certain preferred embodiments, the adapter bracket may include undercuts with a vacuum hole therein to secure the adapter to the test socket (thermoforming) or permanent thermoformed socket, and to prevent the suction from pulling to hard and popping a hole in the thermoplastic during vacuum forming. 
   In certain preferred embodiments, the adapter bracket may include a relatively large undercut tie in ring to tie off the lamination and secure the adapter for a stronger lamination for a laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include a grooved undercut all around the adapter bracket to house an O-ring to enhance an air or suction seal, where applicable, to secure the adapter bracket for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include a raised round underbody that is tapped to house various mini suction valves and air expulsion mechanisms to offer the prosthetist and the amputee more options in the design of the prosthesis for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include a raised round and tapped underbody to house various round lock pin covers with an O-ring that thread into the adapter for a closed suction system or air expulsion mechanisms to offer the prosthetist and the amputee more options in the design of the prosthesis for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include a raised round and tapped underbody to house a round threaded plug with an O-ring that thread into the adapter for a closed suction system or air expulsion mechanisms to offer the prosthetist and the amputee more options in the design of the prosthesis for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include lengthener plates undercut to increase length on the prosthesis or to increase the length needed to house various options such as lock pin cover or a round threaded plug with an O-ring that thread into the adapter for a closed suction system or air expulsion mechanisms to offer the prosthetist and the amputee more options in the design of the prosthesis for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, adapter brackets may be provided having various preset angles in order that the lock mechanism will have a preset amount of flexion, extension, abduction or adduction to offer the prosthetist and the amputee more alignment options in the design of the prosthesis for the fabrication of the test socket (thermoforming) or permanent thermoformed socket or laminated socket (thermosetting resin). 
   In certain preferred embodiments, the adapter bracket may include an integrated lock mechanism. In certain preferred embodiments, the adapter bracket may include an integrated pyramid (male or female), and/or an integrated lock mechanism and an integrated pyramid (male or female). 
   Turning now to  FIG. 1 , there is shown an adapter bracket  20 . In each of the embodiments of the invention, the adapter bracket may be formed of any material that may be suitably formed and have sufficient strength and dimensional stability. Preferably, the adapter brackets are formed of a metal, especially a lightweight metal such as aluminum. 
   The adapter bracket  20  includes a centrally located bore  22  extending from a top surface to a bottom surface of the adapter bracket  20 . The bore  22  is preferably tapped so that various suction adapters and/or cosmetic adapters (not shown) may be threadedly attached thereto. Examples of suitable suction adapters would include a plug to completely seal the central, a plug incorporating a one-way valve, and a lock pin cover. 
   As shown in  FIGS. 1-3 , a circular recess  24  is provided about and co-axial with the bore  22 . A plurality of circumferentially spaced through-holes  26  are further provided within the recess  24  and radially outward from the bore  22 . Preferably, twelve such holes  26  are equally spaced about the bore  22  to provide flexibility in attaching different locks. As shown in  FIG. 3 , a circular recess  28  is provide in the bottom surface of the adapter bracket  20  having a circular step  30 . A cylindrical boss  32  is provided about the bore  22  on the bottom surface of the adapter bracket  20 . 
   As illustrated, the adapter bracket  20  has a generally square shape when viewed in plan from the top. Sidewalls  34  extend upwardly from the top surface and threaded through-holes  36  are shown in each of the four corners within the sidewalls  34 . The bottom surface of the adapter bracket  20  is generally flat other than the through-holes  36  and recess  28 . 
   The sides  38  of the adapter bracket  20  are smooth to allow for eventual removal from a test socket and reuse. The sides are provided with tapped holes  40  adapted to receive threaded fasteners. As illustrated, a pair of holes  40  is shown on each side. 
   An example of the use of the adapter bracket  20  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took a cast over a suspension liner. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. The plaster model will have a center protrusion replicating the distal end of the suspension liner. 
       3) Drilled a ¼″ hole straight down through the center protrusion 1¼″ deep. 
       4) Flattened the distal end of the model by removing plaster until the diameter of the distal end of the model is equal to the outer dimension of the attachment tooling. Do not exceed the outer dimension of the tooling, because the socket would be too short. If too much plaster was removed, add back plaster to correct. 
       5) Checked how the tooling is centered on distal end of the model. Any voids between the model and the tooling should be filled with plaster to create a smooth transition. 
       6) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       7) Tied a knot in the distal end of a non-stick nylon stockinette. Apply the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       8) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trim the nylon in a circular shape slightly smaller than the lock mechanism. 
       9) Fastened the attachment tooling with four long nails.
 
Lock Preparation
 
       10) Removed the lock cartridge from the lock mechanism. Install and tighten the round fabrication sleeve with a standard screwdriver. Filled in the screwdriver slot on the round fabrication sleeve with (Fillauer) fitting gel or clay putty. 
       11) Attached the lock to the adapter bracket with the six screws. 
       12) Installed the center plug with through hole and O ring on the bottom of the adapter bracket  20  and tighten. Attached a ⅜″ four-hole fabrication spacer block to the bottom of the adapter bracket with the four 6 mm socket head cap screws. Tightened the four screws to the spacer block. 
       13) Installed the eight 5 mm hex socket set screws in the sides of the adapter bracket. The set screws protruded 3/16″ for 3/16″ plastic or ¼″ for ¼″ plastic to mark the location for easy removal. 
       14) Filled any undercuts around the lock mechanism with fitting gel or clay. 
       15) Installed a circular foam lock block on the lock mechanism. 
       16) Fastened the with the adapter bracket  20  to the plaster model using a socket head cap screw provided with the lock mechanism. Prosthetist checks and adjusts the adapter bracket position for correct rotation prior to tightening. 
       17) Installed the two-inch cotton stockinette separator over the adapter bracket  20  and cut a small hole over each setscrew and pushed the stockinette around the setscrew until the setscrews protruded from the stockinette. If a copolymer or polypropylene temporary socket is being fabricated for your patient to wear outside of your facility with a removable adapter bracket, four 1/16″ rectangular reinforcement plates are sprayed with an adhesive such as 3M Super Spray adhesive 77 and the plates are installed over the four sets of setscrews for socket attachment reinforcement. 
       18) Vacuum-formed the test socket using the blister or drape methods. For drape molding with an open non-welded seam, left the plastic on one side of the Vivak. Placed the side of the Vivak with the plastic facing up in the horizontal oven during the heat process. The oven temperature will vary 355-360 F for about 20 minutes. The side with the plastic on it will be turned toward the cast for vacuum forming and this will act as a separator. Fastener screws are used to secure the plastic seam if this procedure is used.
 
Trimming
 
       19) Let the test socket cool down. Sanded off the plastic on top of the lock attachment bolt and removed the bolt with a hex key. 
       20) Trimmed out the ⅜″ four-hole spacer block. Removed the four 6 mm socket head cap screws and removed the four-hole spacer block, providing access to the entire bottom of the adapter bracket. 
       21) Trimmed out and removed the test socket from the plaster model. Sanded and buffed the trim lines. 
       22) Sanded off the plastic on top of the eight 5 mm hex socket set screws and removed screws with a 5 mm hex key. 
       23) Sanded off the plastic covering the round fabrication sleeve and removed it with a standard screwdriver.
 
Assembly
 
       24) Removed any fitting gel or stick wax residue from the lock body and threaded attachment holes. Followed the lock manufacturer&#39;s directions to reassemble the lock. 
       25) Installed and tightened the eight 5 mm socket head cap head screws and stainless steel washers to secure the attachment of the adapter bracket to the test socket. Tightened to a torque setting of 12 Nm or 9 foot pounds. 
       26) Install the other endoskeletal components according to manufacturer&#39;s directions.
 
Filling the Test Socket
 
       27) Filled the locking pinhole with fitting gel or clay in order to prevent plaster from leaking into the lock mechanism. Taped over the posterior foam contour on the inside of the socket with masking tape in order to prevent the plaster from leaking into and around the lock mechanism. 
       28) Marked the location of the locking pin on the model for the fabrication of the definitive socket. 
     
  
   Turning now to  FIGS. 4-6 , another embodiment of an adapter bracket is shown and denoted by the numeral  50 . The adapter bracket  50  includes a centrally located bore  51  extending from a top surface to a bottom surface of the adapter bracket  50 . The bore  51  is preferably tapped so that various suction adapters and/or cosmetic adapters (not shown) may be threadedly attached thereto. Examples of suitable suction adapters would include a plug to completely seal the central and a plug incorporating a one-way valve. 
   A circular recess  52  is provided about and co-axial with the bore  51  on the bottom surface of the adapter bracket  50 , as shown in  FIG. 6 . As illustrated, the adapter bracket  50  has a generally square shape when viewed in plan from the top. Sidewalls  53  extend upwardly from the top surface on three of the sides, slanting downwardly to the top surface of the adapter bracket  50  on two of the opposed sidewalls  53 . Threaded through-holes  54  are shown in each of the four corners within the sidewalls  53 . The top and bottom surfaces of the adapter bracket  50  are generally flat other than the through-holes  54  and recess  52 . 
   The sides  55  of the adapter bracket  50  are smooth to allow for eventual removal from a test socket and reuse. The sides are provided with tapped holes  56  adapted to receive threaded fasteners. As illustrated, a pair of holes  56  is shown on each side. 
   An example of the use of the adapter bracket  50  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took the cast over the cushioned liner. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. 
       3) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       4) Tied a knot in the distal end of a non-stick nylon stockinette. Applied the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       5) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trimmed the nylon in a circular shape slightly smaller than the lock mechanism. 
       6) Attached a ⅜″ four-hole fabrication spacer block to the adapter bracket  50  with the four 6 mm socket head cap screws. Tightened the four screws to the spacer block. 
       7) Installed eight 5 mm hex socket set screws in the sides of the adapter bracket. The setscrews protruded 3/16″ for 3/16″ plastic or ¼″ for ¼″ plastic to the mark the location for easy removal. 
       8) Fastened the adapter bracket to the plaster model using double stick tape to secure the posterior foam to the adapter bracket and align or bench align the components. The Prosthetist should check and adjust the adapter bracket position for correct alignment. Nail the foam to secure the adapter bracket to the model. 
       9) Installed the two-inch cotton stockinette separator over the adapter bracket and cut a small hole over each setscrew and pushed the stockinette around the setscrew until the setscrews protruded from the stockinette. If a copolymer or polypropylene temporary socket is being fabricated for your patient to wear outside of your facility with a removable adapter bracket, four 1/16″ rectangular reinforcement plates are sprayed with an adhesive such as 3M Super Spray adhesive 77 and the plates are installed over the four sets of setscrews for socket attachment reinforcement. 
       10) Vacuum-formed the thermoplastic socket using the blister or drape methods. For drape molding with an open non-welded seam, leave the plastic on one side of the Vivak. Place the side of the Vivak with the plastic facing up in the horizontal oven during the heat process. The oven temperature will vary 355-360 F for about 20 minutes. The side with the plastic on it will be turned toward the cast for vacuum forming and this will act as a separator. Fastener screws will be needed to secure the plastic seam if this procedure is used.
 
Trimming
 
       11) Let the thermoplastic socket cool down. Sanded off the plastic on top of the attachment bolt and removed the bolt with a hex key. 
       12) Trimmed out the ⅜″ four-hole spacer block Removed the four 6 mm socket head cap screws with a 6 mm hex key. Removed the four-hole spacer block. 
       13) Trimmed out and removed the thermoplastic socket from the plaster model. Sanded and buffed the trim lines. 
       14) Sanded off the plastic on top of the eight 5 mm hex socket set screws and removed screws.
 
Assembly
 
       15) Installed and tightened the eight 5 mm socket head cap head screws and stainless steel washers to secure the attachment of the adapter bracket to the test socket. Tightened with a 5 mm hex key to a torque setting of 12 Nm or 9 foot pounds. 
       16) Installed the other endoskeletal components according to manufacturer&#39;s directions.
 
Filling the Thermoplastic Socket
 
       17) Taped over the posterior foam contour on the inside of the socket with masking tape in order to prevent the plaster from leaking into and around the lock mechanism. 
     
  
   Another embodiment of the adapter bracket of the invention, denoted generally by numeral  60 , is illustrated in  FIGS. 7-9 . The adapter bracket  60  includes a centrally located bore  61  extending from a top surface to a bottom surface of the adapter bracket  60 . The bore  61  is preferably tapped so that various suction adapters and/or cosmetic adapters (not shown) may be threadedly attached thereto. Examples of suitable suction adapters would include a plug to completely seal the central and a plug incorporating a one-way valve. 
   A circular recess  62  is provided about and co-axial with the bore  61  on the bottom surface of the adapter bracket  60 , as shown in  FIG. 9 . As illustrated, the adapter bracket  60  has a generally square shape when viewed in plan from the top. Sidewalls  63  extend upwardly from the top surface on three of the sides, slanting downwardly to the top surface of the adapter bracket  60  on two of the opposed sidewalls  63 . Threaded through-holes  64  are shown in each of the four corners within the sidewalls  63 . The top and bottom surfaces of the adapter bracket  60  are generally flat other than the through-holes  64  and recess  62 . 
   The sides  65  of the adapter bracket  60  are provided with one or more undercuts to allow the flow of material therein and increase the eventual strength of attachment. The undercut preferably takes the form of a groove  66  of rectangular cross section that extends about the entire periphery. The sidewalls  63  are also provided with slots  67  extending therethrough to allow reinforcing tape, such as carbon tape, to be fed through the slots  67 . 
   An example of the use of the adapter bracket  60  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took the cast over the suction liner and or cast sock. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. 
       3) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       4) Tied a knot in the distal end of a non-stick nylon stockinette. Applied the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       5) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trimmed the nylon in a circular shape slightly smaller than the lock mechanism. 
       6) Applied the PVA bag and capped the distal end. 
       7) Cut a round piece of stretch tape the same size as the attachment tooling and apply to the PVA over the drilled hole. The tape will help prevent the PVA from tearing. Punctured a hole in the tape over the drilled center hole. Fasten the attachment tooling with four long nails. 
       8) A layer of carbon tape reinforcement is applied through the slots  67  in the adapter bracket  60 . 
       9) Considering the patient&#39;s age, weight, height, activity level and the other components used in the prosthesis, one, two or more additional layers of carbon tape reinforcement may be applied through the slots  67 . 
       10) Lubricated the four size M6×25 mm socket head cap screws for easy removal. Attached the four-hole ⅜″ square spacer block to the adapter bracket with the four socket head cap screws. Lubricated the M6×25 mm socket head cap screw and installed in a side hole in the square spacer block. Tightened all screws. Filled the screw heads with fitting gel or clay putty.
 
Lay-Up and Lamination
 
Careful consideration should be given to choice of materials used in construction of the laminated socket. The Prosthetist should consider the patient&#39;s age, weight, height, activity level and the other components used in the prosthesis. The following is an example of a standard lay-up used for an average patient.
 
Lay-Up Example:
 
       11) Applied one layer of ½ ounce Dacron Felt. Punched a hole in the Dacron the same size as the attachment screw(s), being careful not to cut the PVA bag. 
       12) Cut a round section of ½ ounce Dacron Felt about 9″ in diameter. Trimmed out a circular hole in the Dacron slightly smaller in size as the nailed round attachment tooling. Applied this round Dacron Felt on top of the first layer of felt. Placed the hole over the attachment tooling. This hides the carbon tape on the inside of the socket. 
       13) Applied the adapter bracket with 1″ carbon tape reinforced anchor holes. 
       14) Fastened the adapter bracket to the plaster model using the socket head cap attachment screw. The Prosthetist should check and adjust the adapter bracket position for correct rotation, then tighten with hex key. Filled the screw head with fitting gel or clay putty. 
       15) Applied two layers of Nyglass stockinette. Tied the Nyglass into the tie ring and reflex back over the model. Note: Spectralon™ stockinette or the like may be substituted for Nyglass. 
       16) Applied two additional layers of Nyglass stockinette. Tied the Nyglass into the tie ring and reflex back over the model. 
       17) Applied two additional layers of Nyglass stockinette. Tie the Nyglass into the tie ring and reflex back over the model. Note: Spectralon™ stockinette may be substituted for Nyglass. 
       18) Applied one layer of Perlon stockinette. Note: Other finish stockinette may be substituted for Perlon. 
       19) Applied the outer PVA bag and pour cone. Laminated with acrylic resin such as Epox-Acryl. Tied off the excess resin with a string.
 
Shell Lamination for a Cosmetic Cover
 
       21) Filled any undercuts with clay putty or fitting gel. Applied one cotton or nylon stockinette for a separator. Applied the inner PVA bag and tie off the top. Applied two nylon stockinette twisted and reflected back. Applied the PVA Bag and pour cone. Laminate with 80-20 polyester resin.
 
Trimming
 
       22) Let the lamination cool down. Sanded away the material covering the end of the lamination over the attachment screw. Removed the socket head cap screw with a hex key. 
       23) Sanded away the material covering the end of the lamination over the five socket head cap screws. Removed the four size M6×25 mm socket head cap screws with a 5 mm hex key. 
       24) Trimmed out the four-hole square spacer block. Removed the four-hole square spacer block. Used the side M6×25 mm socket head cap screw to pull out the square spacer block or use channel lock pliers or the like. 
       25) Trimmed out and removed the socket from the plaster model. Sanded and buffed trim lines. 
       26) Clean off any excess plastic on the adapter bracket.
 
Assembly
 
       27) Installed the other endoskeletal components according to manufacturer&#39;s directions. 
     
  
   Turning now to  FIGS. 10-12 , there is shown an adapter bracket  70 . The adapter bracket  70  includes a centrally located bore  71  extending from a top surface to a bottom surface of the adapter bracket  70 . The bore  71  is preferably tapped so that various suction adapters and/or cosmetic adapters (not shown) may be threadedly attached thereto. Examples of suitable suction adapters would include a plug to completely seal the central and a plug incorporating a one-way valve. 
   As illustrated, a circular recess  72  is provided about and co-axial with the bore  71  on the top surface. A plurality of circumferentially spaced through-holes  73  are further provided within the recess  72  and radially outward from the bore  71 . Preferably, twelve such holes  73  are equally spaced about the bore  71  to provide flexibility in attaching different locks. As shown in  FIG. 12 , a circular recess  74  is provided in the bottom surface of the adapter bracket  70  having a circular step  75 . A cylindrical boss  76  is also provided about the bore  71  on the bottom surface of the adapter bracket  70 . 
   The adapter bracket  70  is shown having a generally square shape when viewed in plan from the top. Sidewalls  77  extend upwardly from the top surface and threaded through-holes  78  are shown in each of the four corners within the sidewalls  77 . The bottom surface of the adapter bracket  70  is generally flat other than the through-holes  78  and recess  74 . 
   The sides  79  of the adapter bracket  70  are provided with one or more undercuts to allow the flow of material therein and increase the eventual strength of attachment. The undercut preferably takes the form of a groove  80  of generally rectangular cross section that extends about the entire periphery. The sidewalls  77  are also provided with slots  81  extending therethrough to allow reinforcing tape, such as carbon tape, to be fed through the slots  81 . 
   An example of the use of the adapter bracket  70  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took the cast over the suspension liner. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. The plaster model will have a center protrusion replicating the distal end of the suspension liner. 
       3) Drilled a ¼″ hole straight down through the center protrusion 1¼″ deep. 
       4) Flattened the distal end of the model by removing plaster until the diameter of the distal end of the model is equal to the outer dimension of the attachment tooling. Do not exceed the outer dimension of the tooling, because the socket would be too short. If too much plaster was removed, added back plaster to correct. 
       5) Checked how the tooling is centered on distal end of the model. Any voids between the model and the tooling are filled with plaster to create a smooth transition. 
       6) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       7) Tied a knot in the distal end of a non-stick nylon stockinette. Applied the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       8) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trimmed the nylon in a circular shape slightly smaller than the lock mechanism. 
       9) Applied the PVA bag and cap the distal end. 
       10) Cut a round piece of stretch tape the same size as the attachment tooling and applied to the PVA over the drilled hole. The tape will help prevent the PVA from tearing. Punctured a hole in the tape over the drilled center hole. Fastened the attachment tooling with the four long nails. 
       11) A layer of carbon tape reinforcement is applied through the slots  81  in the adapter bracket  70 . 
       12) Considering the patient&#39;s age, weight, height, activity level and the other components used in the prosthesis, one, two or more additional layers of carbon tape reinforcement may be applied through the slots  81 .
 
Lock Preparation
 
       13) Followed the lock manufacturer&#39;s directions for preparing the lock for attachment to the plaster model. Removed the lock cartridge from the lock mechanism. Filled the interior of the lock body with fitting gel or stick wax to prevent plastic from leaking into the lock. Installed and tightened the round fabrication sleeve with a standard screwdriver. 
       14) Attached the lock to the adapter bracket  70  with the six screws. Moved the Carbon tape to the sides to make room for the lock mechanism in the middle of the adapter. Tightened the sheet metal screws. 
       15) Lubricated the four size M6×25 mm socket head cap screws for easy removal. Attached the four-hole ⅜″ square spacer block to the adapter bracket with the four socket head cap screws. Lubricated the M6×25 mm socket head cap screw and installed in the side hole in the square spacer block. Tightened all screws. Filled the screw heads, set screw for lock cartridge and slot in the round fabrication sleeve with fitting gel or clay putty.
 
Lay-Up and Lamination
 
Careful consideration should be given to choice of materials used in construction of the laminated socket. The Prosthetist should consider the patient&#39;s age, weight, height, activity level and the other components used in the prosthesis. The following is an example of a lay-up used for an average patient.
 
Lay-Up Example:
 
       16) Applied one layer of ½ ounce Dacron Felt. Trimmed out a circular hole in the Dacron the same size as the nailed round holding spacer, being careful not to cut the PVA bag. 
       17) Cut a round section of ½ ounce Dacron Felt about 12″ in diameter. Trimmed out a circular hole in the Dacron slightly smaller in size as the nailed round attachment tooling. Applied this round Dacron Felt on top of the first layer of felt. Placed the hole over the attachment tooling. This hides the carbon tape on the inside of the socket. 
       18) Applied the adapter bracket and lock with 1″ carbon tape reinforced anchor slots to the plaster model. 
       19) Fastened the lock mechanism with the adapter bracket to the plaster model using the socket head cap screw provided with the lock mechanism. The Prosthetist should check and adjust the adapter bracket position for correct rotation, then tighten with hex key. Filled the screw head with fitting gel or clay putty. 
       20) Applied two layers of Nyglass stockinette. Tied the Nyglass into the tie ring and reflex back over the model. Note: Spectralon™ stockinette may be substituted for Nyglass. 
       21) Applied two additional layers of Nyglass stockinette. Tied the Nyglass into the tie ring and reflex back over the model. 
       22) Applied two additional layers of Nyglass stockinette. Tied the Nyglass into the tie ring and reflex back over the model. 
       23) Applied one layer of Perlon stockinette. Note: other finish stockinette may be substituted for Perlon. 
       24) Applied the outer PVA bag and pour cone. Laminated with acrylic resin such as Epox-Acryl.
 
Shell Lamination for a Cosmetic Cover
 
       25) Filled any undercuts with clay putty or fitting gel. Applied one cotton or nylon stockinette for a separator. Applied the inner PVA bag and tie off the top. Applied two nylon stockinette twisted and reflected back. Applied the PVA Bag and pour cone. Laminated with 80-20 polyester resin.
 
Trimming
 
       26) Let the lamination cool down. Sanded away the material covering the end of the lamination over the lock screw. Removed the lock socket head cap screw with a hex key. 
       27) Sanded away the material covering the end of the lamination over the five socket head cap screws. Removed the four size M6×25 mm socket head cap screws with a 5 mm hex key. 
       28) Trimmed out the four-hole square spacer block. Removed the four-hole square spacer block. Used the side M6×25 mm socket head cap screw to pull out the square spacer block or use channel lock pliers or the like. 
       29) Trimmed out and removed the socket from the plaster model. Sanded and buffed trim lines. 
       30) Sanded off the plastic covering the round fabrication sleeve and remove it with a standard screwdriver. 
       31) Cleaned off any excess plastic on the adapter bracket.
 
Assembly
 
       32) Removed any fitting gel or stick wax residue from the lock body and threaded attachment holes. Followed the lock manufacturer&#39;s directions to reassemble the lock. 
       33) Installed the other endoskeletal components according to manufacturer&#39;s directions. 
     
  
   The embodiment shown in  FIGS. 13-15 , denoted generally by numeral  85 , is similar in structure to the embodiment of  FIGS. 10-12 . The adapter bracket  80  includes a centrally located bore  86 , a circular recess  87  provided about and co-axial with the bore  86  on the top surface, and a plurality of circumferentially spaced through-holes  88  provided within the recess  87  and radially outward from the bore  86 . As shown in  FIG. 15 , a circular recess  89  is provided in the bottom surface of the adapter bracket  85  having a circular step  90 . A cylindrical boss  91  is also provided about the bore  86  on the bottom surface of the adapter bracket  85 . 
   The adapter bracket  85  is shown having a generally square shape when viewed in plan from the top, with sidewalls  92  extending upwardly from the top surface and threaded through-holes  93  in each of the four corners. The bottom surface of the adapter bracket  85  is generally flat other than the through-holes  93  and recess  89 . 
   The sides  94  of the adapter bracket  85  are provided with one or more undercuts, such as the groove  95  of generally rectangular cross section that extends about the entire periphery. Tapped holes  96  adapted to receive threaded fasteners are provided within the groove  95 . As illustrated, a pair of holes  96  is shown on each side. The sides  94  are also provided with groove  97 , preferably of generally circular cross section, that extends about the entire periphery proximate the bottom surface of the adapter bracket  85 . The groove  97  is adapted to receive an O-ring. An opposed pair of the sidewalls  92  of the adapter bracket  85  are provided with undercut slots  98 , each of which includes an approximately centered through-hole  99 . 
   An example of the use of the adapter bracket  85  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took the cast over the suspension liner. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. The plaster model will have a center protrusion replicating the distal end of the suspension liner. 
       3) Drilled a ¼″ hole straight down through the center protrusion 1¼″ deep. 
       4) Flattened the distal end of the model by removing plaster until the diameter of the distal end of the model is equal to the outer dimension of the attachment tooling. Do not exceed the outer dimension of the tooling, because the socket would be too short. If too much plaster was removed, added back plaster to correct. 
       5) Checked how the tooling is centered on distal end of the model. Any voids between the model and the tooling are filled with plaster to create a smooth transition. 
       6) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       7) Tied a knot in the distal end of a non-stick nylon stockinette. Applied the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       8) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trimmed the nylon in a circular shape slightly smaller than the lock mechanism. 
       9) Fastened the attachment tooling with the four long nails provided with the adapter bracket.
 
Lock Preparation
 
       10) Read the lock manufacturer&#39;s directions for preparing the lock for attachment to the plaster model. Removed the lock cartridge from the lock mechanism. Installed and tightened the round fabrication sleeve with a standard screwdriver. Filled in the screwdriver slot on the round fabrication sleeve with (Fillauer) fitting gel or clay putty. 
       11) Attached the lock to the adapter bracket with the six screws. Tightened the sheet medal screws. 
       12) Installed the center plug with through hole and O-ring on the bottom of the adapter bracket and tightened. Attached the ⅜″ four-hole fabrication spacer block to the bottom of the adapter bracket with the four 6 mm socket head cap screws. Tightened the four screws to the spacer block with a 6 mm hex key. 
       13) Installed the eight 5 mm hex socket set screws in the sides of the adapter bracket. The setscrews protruded 3/16″ for 3/16″ plastic or ¼″ for ¼″ plastic to the mark the location for easy removal. Tightened with a 5 mm hex key. 
       14) Fastened the lock mechanism with the adapter bracket to the plaster model using the socket head cap screw provided with the lock mechanism. The Prosthetist should check and adjust the adapter bracket position for correct rotation, then tighten with hex key. 
       15) Vacuum-formed the test socket using the blister or drape methods. For drape molding with an open non-welded seam, leave the plastic on one side of the Vivak. Place the side of the Vivak with the plastic facing up in the horizontal oven during the heat process. The oven temperature will vary 355-360 F for about 20 minutes. The side with the plastic on it will be turned toward the cast for vacuum forming and this will act as a separator. Fastener screws will be used to secure the plastic seam if this procedure is used.
 
Trimming
 
       16) Let the test socket cool down. Sanded off the plastic on top of the lock attachment bolt and remove the bolt with a hex key. 
       17) Trimmed out the ⅜″ four-hole spacer block. Removed the four 6 mm socket head cap screws with a 6 mm hex key. Removed the four-hole spacer block. 
       18) Trimmed out and removed the test socket from the plaster model. Sanded and buffed the trim lines. 
       19) Sanded off the plastic on top of the eight 5 mm hex socket set screws and removed screws with a 5 mm hex key. 
       20) Sanded off the plastic covering the round fabrication sleeve and removed it with a standard screwdriver.
 
Assembly
 
       21) Removed any fitting gel or stick wax residue from the lock body and threaded attachment holes. Followed the lock manufacturer&#39;s directions to reassemble the lock. 
       22) Installed and tightened the eight 5 mm socket head cap head screws and stainless steel washers to secure the attachment of the adapter bracket to the test socket. Tightened with a 5 mm hex key to a torque setting of 12 Nm or 9 foot pounds. 
       23) Installed the other endoskeletal components according to manufacturer&#39;s directions. 
     
  
     FIGS. 16-18  illustrate another embodiment of an adapter bracket, denoted by the numeral  100 . The adapter bracket  100  includes a centrally located bore  101 , preferably tapped, extending from a top surface to a bottom surface of the adapter bracket  100 . A circular recess  102  is provided about and co-axial with the bore  101  on the bottom surface of the adapter bracket  100 , as shown in  FIG. 18 . As illustrated, the adapter bracket  100  has a generally square shape when viewed in plan from the top. Sidewalls  103  extend upwardly from the top surface on three of the sides, slanting downwardly to the top surface of the adapter bracket  100  on two of the opposed sidewalls  103 . Threaded through-holes  104  are shown in each of the four corners within the sidewalls  103 . The top and bottom surfaces of the adapter bracket  50  are generally flat other than the through-holes  104  and recess  102 . 
   The sides  105  and sidewalls  103  of the adapter bracket  100  are provided with a plurality of undercut slots  106  and  107 , respectively. Through-holes  108  are provided in the undercut slots  107 . As illustrated, each through-hole  108  is located approximately centrally within the associated undercut slot  107 . The sides  105  are provided with tapped holes  109  adapted to receive threaded fasteners. As illustrated, a pair of holes  109  is shown on each side. 
   An example of the use of the adapter bracket  50  follows. The specific details and dimensions are for illustration only. 
   Plaster Model Preparation 
   
       
       1) Took the cast over the cushioned liner or cast sock. 
       2) Filled the cast with plaster keeping the pipe 2″ from the bottom of the cast. 
       3) Sealed the plaster model using an appropriate mold sealer such as cellulose crystals dissolved in acetone. 
       4) Tied a knot in the distal end of a non-stick nylon stockinette. Applied the non-stick nylon stockinette to the plaster model for a vacuum air wick. The knot should be centered on the distal end of the plaster model. 
       5) Painted the distal end of the cast around the knot in the nylon with a mold sealer such as cellulose crystals dissolved in acetone. This will glue down the nylon for trimming. Let dry and trimmed the nylon. 
       6) Attached the ⅜″ four-hole fabrication spacer block to the adapter bracket  100  with the four 6 mm socket head cap screws. Tightened the four screws to the spacer block with a 6 mm hex key. 
       7) Installed the eight 5 mm hex socket set screws in the sides of the adapter bracket. The set screws protruded 3/16″ for 3/16″ plastic or ¼″ for ¼″ plastic to the mark the location for easy removal. Tightened with a 5 mm hex key. 
       8) Fastened the adapter bracket to the plaster model using double stick tape to secure the posterior foam to the adapter bracket and aligned or bench aligned the components. The Prosthetist should check and adjust the adapter bracket position for correct alignment. Nailed the foam to secure the adapter bracket to the model. Vacuum-formed the test socket using the blister or drape methods. For drape molding with an open non-welded seam, leave the plastic on one side of the Vivak. Place the side of the Vivak with the plastic facing up in the horizontal oven during the heat process. The oven temperature will vary 355-360 F for about 20 minutes. The side with the plastic on it will be turned toward the cast for vacuum forming and this will act as a separator. Fastener screws will be used to secure the plastic seam if this procedure is used.
 
Trimming
 
       10) Let the thermoplastic socket cool down. Sanded off the plastic on top of the lock attachment bolt and remove the bolt with a hex key. 
       11) Trimmed out the ⅜″ four-hole spacer block. Removed the four 6 mm socket head cap screws with a 6 mm hex key. Removed the four-hole spacer block. 
       12) Trimmed out and removed the thermoplastic socket from the plaster model. Sanded and buffed the trim lines. 
       13) Sanded off the plastic on top of the eight 5 mm hex socket set screws and remove screws with a 5 mm hex key.
 
Assembly
 
       14) Installed and tightened the eight 5 mm socket head cap head screws and stainless steel washers to secure the attachment of the adapter bracket to the test socket. Tightened with a 5 mm hex key to a torque setting of 12 Nm or 9 foot pounds. 
       15) Installed the other endoskeletal components according to manufacturer&#39;s directions.
 
Filling the Thermoplastic Socket
 
       16) Filled the locking pin hole with fitting gel or clay in order to prevent plaster from leaking into the lock mechanism. Taped over the foam contour on the inside of the socket with masking tape in order to prevent the plaster from leaking. 
     
  
   In a further aspect of the invention, a method is provided for transferring the alignment of a lock mechanism and/or socket attachment adapter bracket on a transtibial (below knee) or transfemoral (above knee) socket for a prosthesis with or without a suction locking liner with a locking pin and lock mechanism. In this regard,  FIG. 19  shows an alignment retaining device, denoted generally by reference numeral  110 . The alignment retaining device  110  includes an alignment screw  112  formed of a threaded shaft  114  that terminates in a head portion  116 . The shaft  114  may be of different lengths to accommodate various lengths of lock mechanisms, pads and socket inserts. 
   Also provided is a head cap  118  having a body portion  120  and a threaded bore  122  adapted to threadedly engage the threaded shaft  116  of the screw  112 . The cross-section of the body portion  120  of the head cap  118  is preferably formed with one or more corners and may be, for example, triangular, square, rectangular, pentagonal, hexagonal, etc. This configuration helps to prevent the head cap  118  from turning or coming out of the plaster during use. 
   An example of the use of the alignment retaining device  110  to form a test socket is as follows. 
   1. A suction locking liner is applied to the residual limb of the patient. 
   2. The lock pin is unscrewed from the liner and a hollow, internally threaded casting cylinder is attached to the end of the suction locking liner using an adapter have male threads on both ends. 
   3. A cast is made of the patient&#39;s residual limb and is reinforced around the casting cylinder with plaster bandage. The distal end of the casting cylinder is not covered with plaster bandage so that a wrench or screwdriver may subsequently be used to unscrew it from the suction locking liner. 
   4. After the cast has set, the casting cylinder is unscrewed and disengaged from the suction locking liner, and the adapter is removed from the end of the casting cylinder. 
   5. After the casting cylinder has been disengaged, the cast is removed from the patient&#39;s residual limb. 
   6. The alignment screw  112  is introduced into the end of the casting cylinder from the bottom, with the end of the threaded shaft  114  extending into the interior of the cast. 
   7. An O ring is applied over the shaft  114  of the alignment screw  112  in the interior of the cast and is pushed down until the O ring seals against the casting cylinder. Any void is filled with fitting gel or putty to prevent the plaster from leaking out when the cast is filled with plaster. 
   8. Reinforcing tape is applied over the bottom of the alignment screw  112  to ensure that the plaster does not leak. 
   9. The head cap or anchor  118  is then threaded onto the end of the alignment screw  112  until the head cap  118  is positioned about a ½ inch from the bottom of the cast. 
   10. A fill pipe is set to be in the cast about 1 inch from the top of the head cap  118 . 
   11. The molding plaster is mixed with water and the cast is filled. The fill pipe is returned to the same position inside the cast and the plaster is allowed set. 
   12. The casting material is stripped off once the molding plaster has set, and the alignment screw  112  is unscrewed from the head cap  118  and removed. 
   13. The cast of the residual limb is then modified for proper weight bearing in the conventional manner. 
   Referring to  FIG. 20 , the alignment screw  112  is shown as introduced into the end of the plaster model  123  from the bottom, with the end of the threaded shaft  114  extending into the interior of the plaster model  123 . The shaft  114  extends through the central aperture of a four-hole fabrication spacer block  124 , which covers the bottom surface of an adapter bracket  126 . A wedge member  128  may be positioned between the adapter bracket  126  and a lock  130 . The wedge member  128  may be selected from an assortment of wedge members of varying degrees (such as 3, 5 or 7 degrees, as examples) to permit varying of the angle between the adapter bracket  126  and the lock  130  depending upon the needs of the patient. Alternative shapes to the wedge shown can be employed depending upon the structure of the lock utilized. An annular foam piece  132  is positioned on the end of the lock  130  opposite the adapter bracket  126 . The head cap or anchor  118  is threaded onto the end of the alignment screw  112 . 
   As another example of the invention, the alignment retaining device is used to fabricate a thermoplastic socket using an adapter bracket without a lock mechanism. 
   1. Nylon is applied to the plaster mold. The alignment screw  112  is threaded through a tapped hole in an adapter bracket with the center plug through hole. Examples of suitable adapter brackets are those shown in  FIGS. 4-6  and  7 - 9 . 
   2. The alignment screw  112  is screwed through the distal end of a foam piece and threaded onto the head cap or anchor  118  inside the plaster mold. The alignment screw  112  is tightened against the distal end foam until properly secured. The alignment of the adapter bracket is adjusted so that the hole pattern is properly oriented. 
   3. The thermoplastic socket is then fabricated in the conventional manner with the adapter bracket. 
   4. The alignment screw  112  is removed and the socket is trimmed out. 
   This is illustrated in  FIG. 21 , which shows the alignment screw  112  introduced through the hole in the distal end of the mold and threaded onto the head cap or anchor  118  inside the plaster mold. The shaft  114  extends through a four-hole fabrication spacer block  134 , which covers the bottom surface of an adapter bracket  136 . The alignment screw  112  is tightened against the fabrication spacer block  134  on the adapter bracket  136  until secured. 
   As a further example, the alignment retaining device is used to fabricate a thermoplastic socket using an adapter bracket and a lock mechanism. 
   1. Nylon is applied to the plaster mold. The adapter bracket with the center plug through-hole is installed and the alignment screw  112  is pushed through a fabrication block, the adapter bracket and a lock mechanism. 
   2. The alignment screw  112  is introduced through the hole in the distal end of the mold and threaded onto the head cap  118  inside the plaster mold. The alignment screw  112  is tightened against the fabrication block on the adapter bracket until secured. 
   3. The alignment of the adapter bracket and lock mechanism are adjusted as needed so that the attachment hole pattern is properly oriented. 
   4. The thermoplastic socket is then fabricated in the conventional manner with the adapter bracket and lock mechanism. 
   5. The alignment screw  112  is removed and the socket is trimmed out. 
   A still further example of the invention is the use of the alignment retaining device to fabricate a laminated socket using an adapter bracket without a lock mechanism. 
   1. Nylon is applied to the plaster mold and a PVA separator bag is installed. A piece of tape is applied over the hole for the bolt on the distal end of the plaster mold. A hole is punched in the tape and PVA bag for the bolt. The adapter bracket with the center plug through hole is installed by screwing the alignment screw  112  through the adapter bracket with threaded plug. 
   2. The alignment screw  112  is introduced through the hole in the distal end of the mold and threaded onto the head cap  118  inside the plaster mold. The alignment screw  112  is tightened until the adapter bracket is at the desired height above the mold, allowing sufficient room for the thickness of the lamination. 
   3. The lay-up is applied under the adapter bracket. The alignment of the adapter bracket is adjusted so that the attachment hole pattern is in the line of progression. The rest of the lay-up is applied over the adapter bracket. The PVA bag is applied and the socket is laminated. 
   4. The alignment screw  112  is removed and the socket is trimmed out. 
   Another example of the invention is the use of the alignment retaining device to fabricate a laminated socket using an adapter bracket and a lock mechanism. 
   1. Nylon is applied to the plaster mold and a PVA separator bag is installed. A piece of tape is applied over the hole for the bolt on the distal end of the plaster mold, and a hole punched in the tape and PVA bag for the bolt. The adapter bracket with the center plug through hole is attached. The alignment screw  112  is pushed through the fabrication block, adapter bracket and lock mechanism. 
   2. The alignment screw  112  is introduced through the hole in the distal end of the mold and screwed into the head cap  118  inside the plaster mold. The alignment screw  112  is tightened down against the fabrication block on the adapter bracket until properly secured. Enough room is allowed for the thickness of the lamination. 
   3. The lay-up is applied under the adapter bracket, and the alignment of the adapter bracket and lock mechanism is adjusted so that the hole pattern is in the line of progression. The rest of the lay-up is applied over the adapter bracket. The PVA bag is applied and the socket is laminated. 
   4. Then, the alignment screw  112  is removed and the socket is trimmed out. 
   The invention provides a method for transferring the alignment of a lock mechanism and/or socket attachment adapter bracket on a transtibial (below knee) or transfemoral (above knee) socket for a prosthesis with or without a suction locking liner with a locking pin and lock mechanism. The apparatus and method allow the transfer of socket alignment without the use of a vertical alignment transfer jig. 
   In accordance with the provisions of the patent statutes, the invention has been described in what is considered to represent its preferred embodiments. However, it should be noted that the invention can be practiced otherwise than as specifically illustrated and described without departing from its spirit or scope.

Technology Category: 4