Abstract:
The present invention relates to a double wall prosthetic limb assembly, a vacuum attachment plate component of the outer-wall socket and a method for fabricating double wall prosthetic limb assemblies. The method involves the use of a prefabricated tooling system for fabricating a dual socket for a prosthetic limb. In one embodiment, a double-wall prosthetic limb socket assembly includes: (a) a first inner-wall socket adapted to receive a patient&#39;s residual limb; and (b) a second outer-wall socket seating the first inner-wall socket therein, the second outer-wall socket including, (i) a distal, circular base-plate; and (ii) a molded circumferential wall bonded to and extending proximally from the distal, circular base-plate; where the circular base-plate includes a vacuum port extending radially from a circumferential outer side of the base-plate in fluid communication with a vacuum channel extending through the circular base-plate and out through an outlet hole in a proximal side of the circular base-plate; such that when the vacuum port is coupled to a vacuum pump, the vacuum will help to draw the first inner-wall socket into the second outer-wall socket.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefit from U.S. Provisional App. Ser. No. 60/756,430, filed Jan. 5, 2006, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND  
       [0002]     When attaching a prosthetic limb to an amputee&#39;s residual limb, a thermoplastic socket having a cavity shaped to receive the residual limb is typically fitted over the residual limb, and the prosthetic limb is typically joined to the bottom of the socket using an attachment plate. The socket can be held in place on the residual limb using the Vacuum Assisted Socket System (VASS)™, developed by Otto-Bock HealthCare LP and described in U.S. Pat. Nos. 6,761,742 and 6,926,742, the disclosures of which are incorporated herein by reference.  FIGS. 1 and 2  show two embodiments of a Vacuum Assisted Socket System (VASS) socket and attachment plate joined to a prosthetic limb, according to the prior art. The socket  12  fits over the patient&#39;s residual limb  14  and is held in place by a vacuum seal formed by evacuating air from the space between the socket  12  and the residual limb  14 . The socket features an attachment plate  16  on its bottom end for joining the socket to the hardware of the prosthetic limb  18 . The structure and function of the Vacuum Assisted Socket System (VASS) depicted in  FIGS. 1 and 2  are described in U.S. Pat. No. 6,926,742.  
         [0003]     In a dual socket system (double wall socket system), an inner socket is fitted to the patient&#39;s limb, while the pylon assembly is attached to an outer socket. The outer socket slides over the inner socket. The two sockets are typically held to each other by some mechanical means, such as a latch. The inner socket is fabricated to fit precisely around the patient&#39;s residual limb. It is held to the patients residual limb by some mechanical means, such as a vacuum. The outer socket is formed to accept the inner socket and any additional components associated therewith in proper alignment and then laminating the outer socket over the mold. The outer socket has traditionally been formed by fabricating a temporary mold on the distal end of the inner socket to create the proper spacing and alignment. This process is labor intensive, can be imprecise, and often requires fabrication at a central location in a specialized facility.  
         [0004]     There is a need for a standardized method that saves labor, helps to ensure appropriate alignment, and allows for fabrication at decentralized locations.  
       SUMMARY  
       [0005]     The present invention relates to a double wall prosthetic limb assembly, a vacuum attachment plate component of the outer-wall socket and a method for fabricating double wall prosthetic limb assemblies. The method involves the use of a prefabricated tooling system for fabricating a dual socket for a prosthetic limb.  
         [0006]     It is a first aspect of the present invention to provide a double-wall prosthetic limb socket assembly that includes: (a) a first inner-wall socket adapted to receive a patient&#39;s residual limb; and (b) a second outer-wall socket seating the first inner-wall socket therein, the second outer-wall socket including, (i) a distal, circular base-plate; and (ii) a molded circumferential wall bonded to and extending proximally from the distal, circular base-plate; where the circular base-plate includes a vacuum port extending radially from a circumferential outer side of the base-plate in fluid communication with a vacuum channel extending through the circular base-plate and out through an outlet hole in a proximal side of the circular base-plate; such that when the vacuum port is coupled to a vacuum pump, the vacuum will help to draw the first inner-wall socket into the second outer-wall socket. In a more detailed embodiment, the circular base-plate includes one or more indentations extending into a circumferential outer side of the circular base-plate into which material of the molded circumferential wall is received, thus facilitating a mechanical bond between the circular base-plate and the molded circumferential wall. In a further detailed embodiment, the molded circumferential wall includes layers of fabric-type material impregnated with cured resin. In yet a further detailed embodiment, the circular base-plate is less than 0.75 inches thick.  
         [0007]     In an alternate detailed embodiment of the first aspect of the present invention, the assembly further includes: (c) a first one of a female and a male component of a mechanical lock seated between the first inner-wall socket and the second outer-wall socket over a proximal end of the circular base-plate; and (d) a complimentary component of the first component of the mechanical lock extending from the first inner-wall socket and mating with the first component of the mechanical lock thus providing a mechanical lock between the first inner-wall socket and second outer-wall socket. In a further detailed embodiment, the first component of the mechanical lock is a male, ratchet-type interlock pin and the complimentary component of the mechanical lock is a female, biased-pawl type lock base. In yet a further detailed embodiment, the interlock pin extends from a resilient sleeve covering the first inner-wall socket and includes a vacuum channel extending completely therethrough in fluid communication with the outlet hole of the circular base-plate when locked into the lock base and providing a vacuum the resilient sleeve and the inner-wall socket.  
         [0008]     In another alternate detailed embodiment of the first aspect of the present invention the distal end of the circular base-plate includes a fastener for coupling to a prosthetic limb upright assembly.  
         [0009]     In another alternate detailed embodiment of the first aspect of the present invention the distal end of the circular base is coupled to a prosthetic limb pyramid coupling component.  
         [0010]     It is a second aspect of the present invention to provide a double-wall prosthetic limb socket assembly that includes: (a) a first inner-wall socket adapted to receive a patient&#39;s residual limb; (b) a second outer-wall socket seating the first inner-wall socket therein, the second outer-wall socket including, (i) a distal, circular base-plate, and (ii) a molded circumferential wall bonded to and extending proximally from the distal, circular base-plate; (c) a first one of a female and a male component of a mechanical lock seated between the first inner-wall socket and the second outer-wall socket over a proximal end of the circular base-plate; and (d) a complimentary component of the first component of the mechanical lock extending from the first inner-wall socket and mating with the first component of the mechanical lock thus providing a mechanical lock between the first inner-wall socket and second outer-wall socket; where the circular base-plate including a vacuum port extending an outer surface of the base-plate in fluid communication with a vacuum channel extending through the circular base-plate and out through an outlet hole in a proximal side of the circular base-plate; thereby, when the vacuum port is coupled to a vacuum pump, the vacuum will help to draw the first inner-wall socket into the second outer-wall socket. In a more detailed embodiment, the first component of the mechanical lock is a male, ratchet-type interlock pin and the complimentary component of the mechanical lock is a female, biased-pawl type lock base. In a further detailed embodiment, the interlock pin extends from a resilient sleeve covering the first inner-wall socket and includes a vacuum channel extending completely therethrough in fluid communication with the outlet hole of the circular base-plate when locked into the lock base and providing a vacuum the resilient sleeve and the inner-wall socket.  
         [0011]     In an alternate detailed embodiment of the second aspect of the present invention the distal end of the circular base-plate includes a fastener for coupling to a prosthetic limb upright assembly.  
         [0012]     In another alternate detailed embodiment of the second aspect of the present invention the distal end of the circular base is coupled to a prosthetic limb pyramid coupling component.  
         [0013]     It is a third aspect of the present invention to provide a double-wall prosthetic limb socket assembly that includes (a) a first inner-wall socket adapted to receive a patient&#39;s residual limb; and (b) a second outer-wall socket seating the first inner-wall socket therein, the second outer-wall socket including, (i) a distal, circular base-plate and (ii) a molded circumferential wall bonded to and extending proximally from the distal, circular base-plate; where the circular base-plate including one or more indentations extending into a circumferential outer side of the circular base-plate into which material of the molded circumferential wall is received, thus facilitating a mechanical bond between the circular base-plate and the molded circumferential wall; and where the circular base-plate also includes a vacuum port extending an outer surface of the base-plate in fluid communication with a vacuum channel extending through the circular base-plate and out through an outlet hole in a proximal side of the circular base-plate; thereby, when the vacuum port is coupled to a vacuum pump, the vacuum will help to draw the first inner-wall socket into the second outer-wall socket. In a more detailed embodiment, the molded circumferential wall includes layers of fabric-type material impregnated with cured resin. In a further detailed embodiment, the circular base-plate is less than 0.75 inches thick.  
         [0014]     It is a fourth aspect of the present invention to provide a method for fabricating a double-wall prosthetic limb socket assembly comprising the steps of: (a) fabricating a first inner-wall socket that is adapted to receive a patient&#39;s residual limb; (b) installing a positive mold end-block over a distal end of the first inner-wall socket, the positive mold end-block having outer dimensions approximating outer dimensions of components to be installed between the distal end of the inner-wall socket and an outer-wall socket; (c) installing a distal-end attachment plate component of the outer-wall socket over a distal end of the positive mold end-block, the distal-end attachment plate component having one or more indentations extending into a circumferential outer side of the distal-end attachment plate into which material of a molded circumferential wall of the second outer-wall socket will be received; and (d) molding the circumferential wall of the second outer-wall socket over the first inner-wall socket, over lateral sides of the positive mold end-block and into the one or more indentations extending into the circumferential outer side of the distal end attachment plate. In a further detailed embodiment, the method further includes the step of (e) after the circumferential wall of the second outer-wall socket has sufficiently solidified, replacing the positive mold end-block with the components to be installed between the distal end of the inner-wall socket and an outer-wall socket.  
         [0015]     In an alternate detailed embodiment of the fourth aspect of the present invention, the distal-end attachment plate includes a vacuum port extending an outer surface of the base-plate in fluid communication with a vacuum channel extending through the distal-end attachment plate and out through an outlet hole in a proximal side of the circular base-plate, and the method includes, prior to the molding step, a step of covering the vacuum port to keep the vacuum port from being contacted by material of the molded circumferential wall of the second outer-wall socket during the molding step. In a further detailed embodiment, the vacuum port extends radially from a lateral outer side of the distal-end attachment plate. In yet a further detailed embodiment, the distal-end attachment plate is substantially disc-shaped and 0.75 inches thick or less.  
         [0016]     In another alternate detailed embodiment of the fourth aspect of the present invention components installed between the distal end of the inner-wall socket and an outer-wall socket include an actuator mechanism extending-radially outward beyond the circumferential wall of the outer-wall socket; the positive mold end-block includes a lateral projection extending therefrom that has outer dimensions approximating outer dimensions of a hole in the circumferential wall of the outer-wall socket needed to facilitate passage of the actuator mechanism extending therethrough; and the molding step molds the circumferential wall of the second outer-wall socket over at least portions of the lateral projection.  
         [0017]     In another alternate detailed embodiment of the fourth aspect of the present invention the first inner-wall socket includes a distal end-component with a threaded hole extending out from a distal end surface o the distal end-component; and the step of installing the positive mold end-block over the distal end of the first inner-wall socket includes a step of threading a threaded fastener extending from the positive mold end-block into the threaded hole of the distal end-component. In a more detailed embodiment, the method further includes the step of, after the circumferential wall of the second outer-wall socket has sufficiently solidified, (e) replacing the positive mold end-block with the components to be installed between the distal end of the inner-wall socket and an outer-wall socket, and replacing the threaded fastener with a coupling component to extend from the distal end-component of the inner-wall socket and to mate with an associated component installed between the distal end of the inner-wall socket. In a further detailed embodiment, the components installed between the distal end of the inner-wall socket include a shuttle lock component; and the coupling component extending from the distal end-component of the inner-wall socket includes an interlock pin for selectively engaging with the shuttle lock component.  
         [0018]     In another alternate detailed embodiment of the fourth aspect of the present invention the molding step includes the step of applying one or more layers of resin-soaked fabric-like material over the first inner-wall socket and over lateral sides of the positive mold end-block and allowing the resin to at least partially cure. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]      FIGS. 1 and 2  show two embodiments of a Vacuum Assisted Socket System (VASS) socket and attachment plate joined to a prosthetic limb, according to the prior art.  
         [0020]      FIG. 3  shows a socket and attachment plate according to an exemplary embodiment of the present invention.  
         [0021]      FIG. 4  shows an interlock pin for securing the inner socket and liner inside the outer socket, according to an exemplary embodiment of the present invention.  
         [0022]      FIG. 5  shows the interlock pin and the plate that joins it to the inner socket, according to an exemplary embodiment of the present invention.  
         [0023]      FIGS. 6 and 7  show the attachment plate according to an exemplary embodiment of the present invention.  
         [0024]      FIG. 8  shows an exemplary inner socket assembly.  
         [0025]      FIG. 9  shows an exploded view of another exemplary inner socket and exemplary prefabricated tooling blocks.  
         [0026]      FIG. 10  shows the exemplary tooling and inner socket assembled and prepared for fabrication of the outer socket.  
         [0027]      FIG. 11  shows an exemplary outer socket that has been formed around the exemplary inner socket and tooling. 
     
    
     DETAILED DESCRIPTION  
       [0028]      FIG. 3  shows a double-wall prosthetic limb socket assembly and associated vacuum-port attachment plate  100  according to an exemplary embodiment of the present invention. The outer socket  20  is generally conical in shape and has a circumferential wall  21  that can be made of a relatively rigid thermoplastic material or other material using techniques known to persons skilled in the art. In the exemplary embodiment, the circumferential wall  21  of the outer socket  20  is made from lamination techniques as known to those of ordinary skill in the art (producing at least one layer of fabric-like material impregnated with cured resin). The circumferential wall  21  of the outer-wall socket  20  is joined (mechanically bonded to) to a relatively thin, disc-shaped attachment plate  100 . At least one circumferential indentation  102  around the edge of the attachment plate  100  facilitates the fabrication of the outer socket  20  such that the narrow (distal) end of the circumferential wall  21  is mechanically joined to the attachment plate  100  during the lamination step as described below (several smaller indentations circumferentially distributed thereover will function adequately as well; likewise, a plurality of projections circumferentially distributed thereabout will also provide a mechanical bonding function).  
         [0029]     As seen in  FIG.3 , an inner-wall socket  26 , which can also be made of a relatively rigid thermoplastic material or other material using techniques known to persons skilled in the art (including lamination techniques of the exemplary embodiment), defines a cavity that receives the residual limb  14 . A resilient roll-on liner  22 , which can be a silicone sleeve or other similar material, can be fitted over the inner socket  26 . At the bottom of the liner  22 , a plate  40  is joined or molded to the liner  22 . The plate  40  is relatively thin (preferably approximating the thickness of the liner  22 ) and generally semi-spherical or conical and includes a threaded cavity at its downward facing apex for seating a correspondingly threaded, ratchet-type interlock pin  30 , otherwise known in the art as a “plunger” pin. It is also within the scope of the invention that the plate  40  be molded into the distal end of the inner socket  26 ′ (see  FIG. 9 , for example), rather than the liner  22  (and that the liner  22 , if used, have a distal hole for allowing at least the plunger pin, and usually some of the inner socket, to extend through).  
         [0030]     The interlock pin  30  is shown more clearly in  FIGS. 4 and 5  and includes a central bore  32  extending axially along the entire length of the pin and also includes a plurality of annular barbs  34  axially distributed therealong for ratcheted engagement with a biased pawl  49  of a standard shuttle-lock mechanism  50  (for more detailed information on shuttle locks, plunger pins, and roll-on sleeves, see U.S. Pat. No. 6,361,569, the disclosure of which is incorporated by reference), see  FIG. 3 . It will be appreciated by those of ordinary skill that other mechanical locks can be utilized instead of the standard shuttle-lock mechanism  50  and associated interlock pin  30  described above—all of which may fall within the scope of the invention as claimed. The plate  40 , which is shown more clearly in  FIG. 5 , includes an attachment hub  42  having a threaded interior into which the threaded portion  36  of the pin  30  may be attached.  FIG. 5  also shows a circumferential groove  46  on the plate  40  to facilitate its mechanical attachment to the liner  22  during fabrication of the liner  22  (or mechanical attachment to the inner socket  26 ′ of  FIG. 9 ). The interior of the plate&#39;s attachment hub  42  provides an open path to a hole  44  on the upper surface of the plate. This hole  44  and the central bore  32  of the pin allow the vacuum to be applied to the space or region  24  between the liner  22  and the inner socket  26 . The vacuum can be applied to the pin&#39;s central bore  32  by a pump mechanism coupled to the attachment plate  100 , which is shown more clearly in  FIG. 6 . In the alternate embodiment of the inner socket  26 ′ (see  FIG. 9 , for example) the applied vacuum could be used to hold the patient&#39;s residual limb within the inner socket  26 ′.  
         [0031]     As seen in  FIGS. 6 and 7 , the circular attachment plate  100  has a generally annular shape, with washer-shaped upper and lower surfaces  103  being joined by an inner annular side-wall  104  and an outer annular side-wall  105  forming a circumferential indentation  102  around the perimeter of the attachment plate  100  to permit the attachment plate  100  to be fastened to the outer socket  20 , as noted above. The upper and lower surfaces  103  of the attachment plate  100  are substantially parallel and are separated by a distance of approximately 0.645 inches in the exemplary embodiment. The upper and lower surfaces  103  include holes  106  into which bolts or screws can be inserted, allowing the attachment plate  100  to be joined to the shuttle lock mechanism  50  above and the prosthetic limb attachment point  60  below. The prosthetic limb attachment point  60  can be an adjustable pyramid plate, such as that described in U.S. Pat. No. 6,033,440, the disclosure of which is incorporated herein by reference, or it can be other coupling components (pyramids, pyramid-receivers, tube-clamps and the like, for example and without limitation) known to persons skilled in the art. The attachment plate  100  of the present invention has a slimmer profile than prior art attachment plates used with vacuum sockets (less than 0.75 inches in an exemplary embodiment). In an exemplary embodiment, the attachment plate  100  and shuttle lock mechanism  50 , stacked together as shown in  FIG. 3 , have a height of 1.2 inches, which could be reduced to 0.98 inches with the current design. The holes  106  by which the attachment plate  100  of the present invention is joined to the prosthetic limb attachment point  60  are through holes rather than tapered holes, as seen on prior art attachment plates. The through holes are less susceptible to stripping than tapered holes, which is advantageous where the attachment plate is laminated to the socket,  
         [0032]     Referring again to  FIGS. 6 and 7 , At the center of the attachment plate  100 , a hub  109  provides a receptacle  110  for receiving the interlock pin  30 . This central hub  109  is fixed to the attachment plate&#39;s inner wall  104  by one or more radial bridges  112 . One radial bridge contains a central bore (a vacuum channel)  114  that connects an outlet hole  115  in the hub&#39;s receptacle  110  to the vacuum port  116  for coupling to a vacuum source of a vacuum pump (not shown). An annular recess  118  at the rim of the receptacle  110  provides an annular seat for an O-ring seal  120  that can form an airtight seal with the interlock pin  30 . The vacuum port  116  advantageously extends radially from the side of the attachment plate, which allows more freedom to couple various coupling components  60  and other mechanisms to the distal (bottom) surface of the attachment plate, as compared to the prior art plate shown in  FIGS. 1 and 2 , because the vacuum port  116  and associated vacuum pump components will not interfere with such distal coupling components. In an exemplary embodiment (as shown in  FIG. 3 ), the vacuum port  116  is located on the same side of the attachment plate  100  as the push button  51  for the shuttle lock  50 , so that the push button  51  provides additional protection for the vacuum port to decrease the chance that a patient fall or other rough handling will break the vacuum seal.  
         [0033]     Returning to  FIGS. 4 and 5 , the interlock pin  30  features one or more circumferential barbs  34  around its lateral surface. These barbs allow the interlock pin  30  to be mechanically locked in place by the shuttle lock mechanism  50 . The biased pawl  49  mounted within the shuttle lock mechanism  50 , which can be seen in FIGS.  3  with the interlock pin  30  inserted, can engage one of the barbs  34  on the interlock pin  30 , preventing the interlock pin  30  from being withdrawn from the shuttle lock mechanism  50  until the user manually releases the shuttle lock by activating the push-button  51 . This shuttle lock and plunger pin engagement provides a secondary locking mechanism to hold the inner socket  26  and residual limb  14 , which are contained within the liner  22 , in place within the outer socket  20 .  
         [0034]     In operation, the patient&#39;s residual limb, which is dressed with the inner socket  26  and liner  22  with its interlocking pin  30 , is inserted into the outer socket  20 . The interlocking pin  30  first passes through the shuttle lock mechanism  50 , after which it enters the receptacle  110  on the attachment plate  100 . As the pin  30  enters the receptacle  110 , the O-ring seal  120  forms an airtight seal between the pin  30  and the receptacle  110 . A vacuum is applied, as described in U.S. Pat. No. 6,926,742, by a vacuum pump (not shown) connected to the vacuum port  116  on the attachment plate  100 . The vacuum, which is applied via the vacuum port  116 , the central bore  114  in the attachment plate&#39;s radial bridge  112 , the central bore  32  in the pin  30 , and the hole  44  in the plate  40 , lowers the pressure in the region in the cavity  24  within the liner  22 , within which the inner socket  22  and the patient&#39;s residual limb reside. This negative pressure applied to the residual limb greatly reduces fluid volume loss in the residual limb, as is understood by persons skilled in the art and explained in U.S. Pat. No. 6,926,742. The barb  34  on the interlocking pin  30  is engaged by the shuttle lock mechanism  50 , holding the inner socket  22  containing the residual limb in place within the outer socket  20 .  
         [0035]     We now describe a method for fabricating a dual socket for a prosthetic limb using a prefabricated tooling system to create the appropriate voids and proper alignment of the outer socket relative to the inner socket and other components associated therewith. The system allows for more consistency in fabrication; eliminates the labor required to fabricate the molding traditionally used to create voids and properly align the components.  
         [0036]     As seen in  FIG. 11 , a dual socket  12  comprises an inner socket assembly  26 , an outer socket assembly  20 , and, as required by the nature of the specific dual socket system, apparatus to secure the inner socket to the residual limb, apparatus to secure the sockets to each other, and apparatus to secure the prosthetic limb to the outer socket. Such apparatus can be implemented in the manner described above.  
         [0037]     Referencing  FIG. 8 , an exemplary methodology of the present invention starts by providing an inner socket assembly  26 ′ comprising the inner socket and any requisite mounting apparatus, such as plate  40 , incorporated therein. In the present exemplary embodiment, the mounting apparatus will vary depending on the particular dual socket system used. Referencing  FIGS. 9 and 10 , exemplary tooling components  152 ,  154 ,  156 ,  158 , and  160  are provided. These tooling blocks are prefabricated and standardized for a given mounting system. Therefore, the tooling blocks can be mass-produced. Potentially, they could be sold as a kit along with the mounting system. In addition to a tooling apparatus standardized for a given mounting system, it is also possible to create universal tooling for use with multiple mounting systems.  
         [0038]     Referencing  FIG. 9 , the prefabricated tooling components  152 ,  154 ,  156 ,  158 , and  160  are mounted on the distal end of the inner socket assembly  26 ′, which includes the inner socket plate  40 , but without the plunger pin  30  threaded thereto. First, a primary forming block (a positive mold end-block)  152  is secured to the distal end of the inner socket plate  40 , using threaded fastener  154  (such as a bolt) threaded into the threaded interior of the attachment hub  42 . The primary forming block  152  will create the primary void space between the two sockets for the shuttle lock  50  (or other associated components to be positioned between the distal ends of the two finished inner and outer sockets) during fabrication and ensures proper alignment of the inner and outer sockets. Next, a suspension sleeve (sacrificial, preferably) (not shown) is rolled over the inner socket  26 ′ to provide a void for the roll-on sleeve used in the final product between the inner and outer sockets. Next, a PVA bag (not shown) or some other thin separating material is placed over the inner socket  26 ′ and forming block  152  to keep the resin of the outer socket from such components during molding of the outer socket. A side porthole spacer  156  is then attached to the side of the primary forming block  152 , using a threaded fastener  158 . The side porthole spacer  156  allows for an opening to be created in the side of the outer socket  20 , shown in  FIG. 11 , for the push button  51  of the shuttle lock  50 . If needed, side porthole spacers of a different shape or size as well as a plurality of side porthole spacers could be used. Next, a circular base-plate, which is the attachment plate  100  in the present embodiment, is mounted on top of the primary forming block. In this embodiment, the attachment plate  100  will become a part of the outer socket in the completed assembly. Then, an outer spacer  160  is mounted on top of the outer socket plate  162 . In the exemplary embodiment, the outer spacer  160  serves to cover the attachment plate  100  and protect it from accidental damage or clogging during formation of the outer socket. Finally, as shown in  FIG. 11 , the outer socket  20  is laminated around the tooling components and the inner socket assembly  26  using standard layer(s) of fabric like material and resin, or the outer socket is formed using any other means of socket fabrication presently known in the art or subsequently discovered. The attachment plate  100  is molded to the outer socket  20  during fabrication by filling lamination material within the circumferential indentation  102  during the lamination process, creating a mechanical coupling. Further the outer spacer  160  includes a proximally extending projection  161 , that is inserted into a cutout  163  (See  FIG. 6 ) in the distal end of the plate  100  adjacent to the vacuum port  116 , so as to cover the vacuum port and prevent the vacuum port  116  and an adjacent area from being covered by outer socket material. This leaves an opening  165  (See  FIG. 3 ) in the outer socket material being formed thereover so that the vacuum port  116  is accessible. Finally, after the outer socket material is sufficiently solidified/cured, the tooling ( 152 ,  154 ,  156 ,  158  and  160 ) is removed and the sockets are prepared for use as described above.  
         [0039]     The methods enabled above are not intended to be limiting. Other methods are also possible. The specific tooling system(s) described above are not requisite for the invention. A method using as few as one tooling block or as many tooling blocks as are needed to form a complex geometry are within the scope of the invention.  
         [0040]     Following from the above description and invention summaries, it should be apparent to persons of ordinary skill in the art that, while the methods and apparatuses herein described constitute exemplary embodiments of the present invention, it is to be understood that the inventions contained herein are not limited to the above precise embodiments and that changes may be made without departing from the scope of the invention as defined by the claims. Likewise, it is to be understood that the invention is defined by the claims and it is not necessary to meet any or all of the identified advantages or objects of the invention disclosed herein in order to fall within the scope of the claims, since inherent and/or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein.