Abstract:
A manufacturing process and resultant medical devices and components thereof wherein one or more individual laces ( 12 ) is placed within an embroidered structure ( 10 ) using an automated process allowing for the manufacture of embroidered surgical implants containing laces to be mass produced repeatably and cost effectively.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present international patent application claims the benefit of priority from commonly owned and co-pending U.S. Provisional Patent Application Ser. No. 60/847,022, entitled “Embroidery Using Soluble Thread,” filed on Sep. 25, 2006, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein. 
    
    
     BACKGROUND OF THE INVENTION 
     I. Field of the Invention 
     The present invention relates to medical devices and methods generally aimed at surgical implants. In particular, the disclosed system and associated methods are related to a manner of creating surgical implants via embroidery. 
     II. Discussion of the Prior Art 
     Embroidered structures are created on substrates. Some substrates are designed to stay in place with the embroidered structure while other substrates are removed at the end of the embroidery process. If the substrate is designed to be removed, the preferred method of removal is dissolution. The dissolution processes discussed, however, are not intended to preclude the use of other means of substrate removal which those skilled in the art would employ in the manufacture of an embroidered structure, or the omission of substrate removal. 
     As an initial step in the creation of embroidered structures, a plurality of parallel, stationary backing threads are placed and secured on one surface of a substrate, called the “backing surface.” On the opposing surface of the substrate, called the “stitching surface,” is a plurality of stitching threads with one-to-one correspondence to the backing threads. Stitching may be done between one pair of threads at a time or in simultaneous multiplicity, as is described below. 
     The plurality of stitching threads from the stitching surface are passed to the backing surface through openings created in the substrate by the passing of each individual thread. Each stitching thread is then looped over its corresponding backing thread, in essence picking up the backing thread, which creates a lock stitch. Once each stitching thread has picked up its corresponding backing thread, the plurality of stitching threads are returned to the stitching surface by passing through the openings in the substrate created by initially passing the stitching threads to the backing surface. The lock stitches prevent the stitching threads from completely pulling back out of the openings created in the substrate. The plurality of stitching threads are then moved to a new stitching site and the process repeats until all the backing threads are joined by lock stitches to the corresponding stitching threads, creating a plurality of thread pairs of some length. 
     A plurality of thread pairs may be enclosed by one or more pluralities of enclosing thread pairs. To enclose a plurality of thread pairs, a subsequent plurality of backing threads are placed and secured on the backing surface of a substrate already holding at least one plurality of thread pairs, such that the subsequent plurality of backing threads covers the previously stitched plurality of backing threads. A subsequent plurality of backing threads is usually not parallel with the previous plurality of backing and stitching threads. A subsequent plurality of stitching threads, with one-to-one correspondence to the subsequent plurality of backing threads, is then stitched to the subsequent plurality of backing threads by the stitching process described above. 
     When the subsequent plurality of backing threads are all joined to the subsequent plurality of stitching threads by lock stitches over a desired distance, a plurality of enclosing thread pairs has been formed, enclosing all previously stitched pairs. This process may be repeated by stitching even further subsequent pluralities of enclosing thread pairs over the previously stitched thread pairs and enclosing thread pairs, such that, for example, the first plurality is enclosed by a second plurality, which is enclosed by a third plurality, which is enclosed by a fourth plurality, and so forth. This process produces stable embroidered structures which do not unravel into a pile of threads if the substrate is removed. 
     If the substrate is intended to be removed, the removal process is dependent upon the material from which the substrate is composed. If dissolution is the removal method chosen, the substrate materials are chosen such that the process which dissolves the substrate will minimally affect the physical properties of the stitching or backing threads used in the embroidered structure. When the substrate is removed, only the stitching and backing threads remain, in whatever combination of thread pairs and enclosing thread pairs that were utilized. The embroidered structure remains intact despite the removal of the substrate because each stitching thread is stitched to its corresponding backing thread, and vice versa, which is enclosed in one or more pluralities of enclosing thread pairs, all of which provides structural support. 
     In some applications, it may be advantageous to have an independent, unpaired thread, referred to as a “lace,” existing within an embroidered structure. Based upon the methodology of embroidered structure creation above, however, any lace within an embroidered structure would have to be placed after completion of the embroidery process because all threads are stitched, and thus paired, during the embroidery process. On a basic level, one or more laces may be added to an embroidered structure by hand, but this is possible only with the simplest of embroidered structures. The manual placement of laces is also expensive, not easily repeatable, and not conducive to mass production. 
     Repeatability is paramount in medical applications because devices may work reliably in one configuration, but variations of such a configuration may cause the device to perform unreliably, inadequately, or even fail to perform altogether. Repeatable placement of a lace within an embroidered structure used for surgical implantation requires a level of reproducibility exceeding that which may be achieved manually. Repeatability notwithstanding, the expense required to manually add one or more laces to embroidered structures further limits the use of manual insertion techniques, as does the bottleneck such manual insertions would cause in a manufacturing environment. 
     The present invention overcomes, or at least minimizes, the limitations associated with placing one or more laces within an embroidered structure. 
     SUMMARY OF THE INVENTION 
     According to the present invention, there is provided a manufacturing process by which an embroidered structure may be created containing within the structure one or more independent, unpaired threads laces, in a manner which is repeatable, inexpensive, and conducive to mass production. 
     The advantages to placing laces using the process of the present invention are: (1) ease of manufacture of complex devices; (2) the ability to make more complex devices; (3) the ability to improve the repeatability of strength critical items; (4) the ability to pre-load seams; and (5) the ability to create three-dimensional shapes. 
     The process of the present invention may use any of a variety of commercially available, automated embroidery machines and/or any other non-manual technique used to manufacture embroidered structures. A soluble thread composed of acetate (for example) or other soluble material is used as the corresponding partner thread for the lace thread during the embroidery process. The lace thread is stitched with the soluble thread, forming in the embroidered structure a temporary thread pair in the same creation process in which all the other threads in the embroidered structure are stitched. The soluble thread may be either the stitching thread or backing thread, and thus the lace may be placed into the embroidered structure as either the stitching or backing thread. 
     After the stitching of the embroidered structure is complete, the soluble thread is dissolved. The dissolution process used must be suitable for dissolving the material of the soluble thread and should preferably not negatively alter the physical properties of the lace and other threads in the embroidered structure. Once the soluble thread is removed, the temporary thread pair formed by the soluble thread being stitched with the lace ceases to exist, and the lace is no longer a part of the support system of the embroidered structure. This leaves the lace as a single, unpaired thread within the embroidered structure of paired threads. 
     Removal of the substrate may be done before, during and/or after the dissolution of the soluble thread, depending upon the properties of the materials used for the substrate and soluble thread and any specific manufacturing concerns compelling the sequence of removal. If dissolution is the method of removal selected, the dissolution processes for the substrate will not only depend upon the substrate material, but also the material of the soluble threads, laces and other threads in the embroidered structure to ensure that the process only affects the materials targeted by the process. 
     Since the lace was a part of the embroidered structure as it was being created and not placed from outside the otherwise finished embroidered structure, and because the creation was performed non-manually, the positional repeatability of the lace within the embroidered structure is high. The replacement of standard threads with soluble threads and the addition of a process to remove the soluble thread, if not removed during a substrate dissolution process, only nominally increases the cost of manufacturing with laces as opposed to without, and the cost increase is significantly less that of the cost of placing laces by hand. Finally, since the method of creation may be automated using commercially available embroidery machines, the embroidered structures containing laces may be mass produced. Thus, the present invention overcomes, or at a minimum improves upon, the limitations associated with repeatability, expense, and mass producibility inherent to the prior art. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein: 
         FIG. 1  is a flow chart depicting one example of a general process of placing laces in embroidered structures using one or more soluble threads, according to one embodiment of the present invention; 
         FIG. 2  is a perspective view one example of an embroidered structure having a plurality of thread pairs, including a temporary thread pair, formed according to the process of  FIG. 1 ; 
         FIG. 3  is a plan view of a soluble thread stitched to a lace thread to form the temporary thread pair of  FIG. 2 ; 
         FIG. 4  is a perspective view of the embroidered structure of  FIG. 2  after enclosing thread pairs are used to enclose the initial thread pairs and temporary thread pair; 
         FIG. 5  is a perspective view of the embroidered structure of  FIG. 4  after dissolution of the soluble thread and removal of the substrate; 
         FIG. 6  is a plan view depicting one example of a generally flat embroidered structure containing multiple laces manufactured according to the process of  FIG. 1 ; 
         FIG. 7  is a perspective view of a three-dimensional curved embroidered structure formed by tensioning the laces of the embroidered structure shown in  FIG. 6 ; 
         FIG. 8  is a plan view depicting a second example of a generally flat embroidered structure containing multiple laces manufactured according to the process of  FIG. 1 ; 
         FIG. 9  is a perspective view of a generally cylindrical embroidered structure formed by tensioning and tying opposite ends of the laces of the embroidered structure shown in  FIG. 8 ; 
         FIG. 10  is a plan view of a third example of a generally flat embroidered structure containing a single lace running through the embroidered structure multiple times manufactured according to the process of  FIG. 1 ; 
         FIG. 11  is a perspective view of a generally cylindrical embroidered structure formed by tensioning the lace of the embroidered structure shown in  FIG. 10 ; 
         FIG. 12  is a plan view of a fourth example of a generally flat embroidered structure containing multiple laces manufactured according to the process of  FIG. 1 ; 
         FIG. 13  is a perspective view of a polygonal-shaped embroidered structure, with one side open, formed by tying opposite ends of the laces of the embroidered structure in  FIG. 12 ; 
         FIG. 14  is a plan view of a fifth example of a generally flat embroidered structure containing multiple laces manufactured according to the process of  FIG. 1 ; 
         FIG. 15  is a perspective view of a closed polygonal-shaped embroidered structure formed by tying opposite ends of the laces of the embroidered structure in  FIG. 14 ; 
         FIG. 16  is a plan view of a system manufactured according to the process of  FIG. 1 , including a series of individual embroidered structures which act as anchors for one or more laces running through the series of embroidered structures according to one embodiment of the present invention; 
         FIG. 17  is a perspective view of an embroidered structure manufactured according to the process of  FIG. 1 , through which one or more laces are guided and thus prevented from crossing each other while being positioned along the curve of an object according to one embodiment of the present invention; 
         FIG. 18  is a plan view of a system manufactured by the process of  FIG. 1 , including a series of embroidered structures with a single, integral lace running through each which, upon tensioning, causes the inwardly facing side surfaces of the embroidered structures to pull into a uniform line according to one embodiment of the present invention; 
         FIG. 19  is a plan view of an embroidered structure, manufactured according to the process of  FIG. 1 , in which laces are interlaced in a honeycomb pattern according to one exemplary aspect of the invention; 
         FIG. 20  is a plan view of an embroidered structure, manufactured according to the process of  FIG. 1 , in which laces are interlaced in a diagonal weave pattern according to another exemplary aspect of the invention; 
         FIG. 21  is a plan view of a pair of embroidered structures, manufactured according to the process of  FIG. 1 , which are connected by a single, preloaded lace according to one embodiment of the present invention; 
         FIG. 22  is a plan view of the pair of embroidered structures of  FIG. 21 , showing in particular that the seam of the embroidered structure in  FIG. 21  may be used to reproducibly unite objects (not shown) connected to the embroidered structures upon tensioning of the lace according to one embodiment of the present invention; 
         FIG. 23  is a plan view of a pair of embroidered structures, manufactured according to the process of  FIG. 1 , which are connected by two or more preloaded laces, according to one embodiment of the present invention; 
         FIG. 24  is a plan view of the pair of embroidered structures of  FIG. 23 , showing in particular that the seam of the embroidered structure in  FIG. 23  may be used to reproducibly unite objects (not shown) connected to the embroidered structures upon tensioning of the laces according to one embodiment of the present invention; and 
         FIG. 25  is a plan view of a load bearing strap manufactured according to the process of  FIG. 1 . 
     
    
    
     DESCRIPTION OF PREFERRED EMBODIMENT 
     Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers&#39; specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The process of embroidery with soluble thread disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination. 
       FIG. 1  outlines the one example of the process of manufacturing an embroidered structure using soluble thread according to one embodiment of the present invention. The process begins with a substrate, upon which a plurality of backing threads are placed and secured on one side, called the backing surface. A soluble thread may be substituted for any backing thread within the plurality of backing threads. For each backing thread on the backing surface of the substrate, there is a corresponding stitching thread on the opposing side of the substrate, called the stitching surface. A soluble thread may be substituted for any stitching thread within the plurality of stitching threads. Any soluble thread, used on either the backing surface or the stitching surface, will correspond to a lace on the opposing surface. Laces may be physically identical to the stitching threads or backing threads or may be composed of different materials or possess different physical properties than the stitching threads or backing threads. 
     Stitching may be done between one pair of threads at a time or in simultaneous multiplicity, as is described below. The plurality of stitching threads, lace threads, and/or soluble threads on the stitching surface are passed from the stitching surface to the backing surface, making openings in the substrate for each individual thread, to meet with corresponding backing threads, soluble threads, and/or laces on the backing surface. Each stitching thread, lace, and/or soluble thread from the stitching surface is then looped over its corresponding backing thread, soluble thread, and/or laces on the backing surface. In essence, this looping over engages or “picks up” each thread from the backing surface, creating a “lock stitch.” Once each thread from the stitching surface has picked up its corresponding thread from the backing surface, the plurality of threads originating from the stitching surface are returned from the backing surface to the stitching surface through the same openings made upon initial passage through the substrate from the stitching surface. The lock stitch prevents the threads from completely pulling out of the openings made when returning to the stitching surface through the substrate. 
     The process then repeats at a distance from the last stitch site, and continues to repeat until each thread from the stitching surface and its corresponding thread from the backing surface are joined by lock stitches over a desired length. The end result is a plurality of stitching threads stitched to backing threads in thread pairs held together by lock stitches. Each thread pair is parallel to the rest of the thread pairs on the substrate. Also parallel to the thread pairs are the one or more temporary thread pairs formed by stitching laces to corresponding soluble threads. 
     A plurality of parallel stitched thread pairs and temporary thread pairs may be enclosed by enclosing thread pairs. To enclose a previously stitched plurality of thread pairs and temporary thread pairs, the embroidery process above is repeated over the previous embroidery already on the substrate. This process may be repeated further by embroidering subsequent pluralities of enclosing thread pairs over each other in a manner such that the first plurality of enclosing thread pairs is enclosed by the second plurality of enclosing thread pairs, which is enclosed by a third plurality, which is enclosed by a fourth plurality, and so forth. This process of producing embroidered structures containing multiple pluralities of enclosing thread pairs results in stable embroidered structures which do not unravel into a pile of threads upon removal of the substrate. 
     The process of substrate removal, if not omitted, is dependent upon the material from which the substrate is composed. Removal of the substrate may be done before, after or simultaneously with the dissolution of the soluble thread(s). If dissolution is the chosen method or removal, the selection of materials used to form the substrate and soluble thread will be in part compelled by any manufacturing concerns regarding the sequence of dissolution. Substrate and soluble thread materials are chosen such that the process or processes which dissolve the substrate and soluble thread will not negatively alter the physical properties of the stitching threads, backing threads, and/or laces. 
     If the substrate is removed and the soluble threads are dissolved, only the stitching threads, backing threads, and/or laces will remain. The embroidered structure remains intact despite the removal of the substrate because each stitching thread is stitched to its corresponding backing thread, and vice versa, which is enclosed in one or more pluralities of enclosing thread pairs, all of which provides structural support. Once both the soluble threads and substrate are removed, the laces are no longer a part of the support system of the embroidered structure because the temporary thread pairs cease to exist when the soluble threads are dissolved, leaving the laces as single, unpaired threads within the embroidered structure. 
       FIG. 2  is an example of an embroidered structure  10  during creation by the process of manufacture according to one embodiment of the present invention. Each thread pair  20  is created by stitching together a stitching thread  11  and a backing thread  13  to form lock stitches  15  on a substrate  16 . The temporary thread pair  30  is created by stitching together a lace  12  and a soluble thread  14  to form lock stitches  15 . 
       FIG. 3  is a closer view of the temporary thread pair  30  from the embroidered structure  10  in  FIG. 2 . The lace  12  is substituted for a stitching thread and has passed from the stitching surface  18 , creating an opening  19  through the substrate  16 , to the backing surface  17 . There it engaged the soluble thread  14  forming a lock stitch  15  and returned to the stitching surface  18  through the same opening  19 . This process is repeated at intervals along the path of the soluble thread  14  until the desired length of stitching has been achieved. Although the lace  12  has been substituted for a stitching thread in this embodiment, the inverse is equally applicable, where a soluble thread  14  could be substituted for a stitching thread to form a temporary thread pair  30  with a lace  12  having been substituted for a backing thread. 
       FIG. 4  depicts the embroidered structure  10  created by enclosing the thread pairs  20  and temporary thread pair  30  from  FIG. 2  with enclosing thread pairs  22 . The enclosing thread pairs  22  contain enclosing backing threads  23  and enclosing stitching threads  21 . The enclosing backing threads  23  are placed and secured on the backing surface of the substrate  16  over the thread pairs  20  and temporary thread pair  30 . The enclosing stitching threads  21  are stitched from over the thread pairs  20  and temporary thread pair  30  on the stitching surface  18  of the substrate  16  by the process discussed above. The result is an embroidered structure  10  where thread pairs  20  and temporary thread pairs  30  are enclosed within the enclosing thread pairs  22 . 
     The embroidered structure  10  is shown by way of example enclosed by a first plurality of enclosing thread pairs  22 . The same stitching process or a different stitching process may be repeated or performed one or more times using the same or different thread materials to enclose thread pairs  20  and temporary thread pairs  30  by multiple pluralities of enclosing thread pairs  22  such that each subsequent plurality of enclosing thread pairs encloses all thread pairs  20 , temporary thread pairs  30  and previous enclosing thread pairs  22  over which it is embroidered. 
       FIG. 5  shows the embroidered structure  10  from  FIG. 4  after dissolution of the soluble thread  14  and dissolvable substrate  16 . Once the structure  10  from  FIG. 4  is embroidered with the desired number of thread pairs  20  and temporary thread pairs  30 , and enclosed by the desired number of enclosing thread pairs  22 , the soluble thread  14  may be dissolved and the substrate  16  may be removed. The dissolution of the soluble thread  14  and removal of the substrate  16  may be done in the same or different processes, and in any order. If dissolution is the chosen method of substrate removal, the dissolution processes will depend upon the composition of the soluble threads  14  and the stitching threads  11 , laces  12 , backing threads  13 , enclosing stitching threads  21 , and enclosing backing threads  23  as well as the composition of the substrate  16  upon which the embroidered structure  10  was created. These compositions are application dependent and different materials may be used according to not only dissolution processes, but also the function of the completed embroidered structure  10 . After dissolution of the soluble thread  14  and substrate  16  is completed, the lace  12  is no longer a part of a temporary thread pair, and thus is unpaired within the embroidered structure  10 . 
       FIGS. 6-25  illustrate multiple embodiments of embroidered structures created using the manufacturing process described above. For the purposes of simplicity and consistency, features common to those shown and described in relation to embroidered structure  10  of  FIGS. 2-5  are designated with common numbers. 
       FIG. 6  depicts an example of an embroidered structure  40  according to a first embodiment of the present invention. The embroidered structure  40  is shown by way of example as being generally flat, having a generally circular shape, and containing a series of laces  12  placed into the embroidery by the process of manufacture described above. The laces  12  are substituted for some of the stitching threads and soluble threads are substituted for the corresponding backing threads. The lace threads  12  and soluble threads are then stitched together forming temporary thread pairs while the remaining stitching threads and backing threads are stitched together forming a plurality of thread pairs  20 . The thread pairs  20  and temporary thread pairs may then be enclosed by enclosing thread pairs  22  formed from enclosing stitching threads and enclosing backing threads. When the embroidering is completed, the soluble threads may be dissolved and the substrate may be removed. After dissolution of the soluble threads and removal of the substrate, the laces  12  will no longer be paired and will be free to move through the embroidered structure  10 . Surrounding structures may be engineered to form eyelets for the laces  12  to run through. 
       FIG. 7  illustrates the effect of tensioning the multiple laces  12  contained in the embroidered structure  40  from  FIG. 6 . Tensioning the laces  12  decreases the circumference of the generally circular path in which the laces  12  run around the fixed area of embroidered thread pairs  20  and enclosing thread pairs  22 . This decreased circumference causes doming as the fixed area takes the three-dimensional shape due to the constraining of the fixed embroidered area within the decreased lace  12  circumference. 
       FIG. 8  depicts an example of an embroidered structure  50  according to a second embodiment of the present invention. The embroidered structure  50  is shown by way of example as being a generally flat, generally rectangular structure through which more than one lace  12  has been placed by the process of manufacture described above. The rectangular embroidered structure  50  necessarily has four edges; two shorter edges  52  and two longer edges  54 . In this embodiment, the laces  12  run parallel to the two short edges  52  from one long edge  54  to the other long edge  54 . Alternatively, the embroidered structure  50  could be arranged such that the laces  12  could run between short edges  54  parallel to the long edges  52 , in which case the resulting cylindrical shape (see below) would be short and wide. 
       FIG. 9  illustrates the effect of tensioning and tying together the opposing ends of the laces  12  contained within the embroidered structure  50  from  FIG. 8 . The laces  12  as laid out in the embroidered structure  50  in  FIG. 8  are generally flat, straight lines in the same plane as the stitched pairs  20  and enclosing pairs  22 . When opposite ends of the laces  12  are brought together to make knots  24 , the paths of the laces  12  becomes generally circular rather than linear, as in  FIG. 8 . Since the laces  12  are enclosed within the thread pairs  20  within the enclosing thread pairs  22 , putting the laces  12  into circular paths also pulls the short edges  52  of the embroidered structure  50  into a generally circular shape while drawing together the opposing long edges  54  of the embroidered structure  50 . Once the long edges  54  meet, the opposing ends of each lace  12  are tied together in knots  24  to secure the now cylindrical shape of the embroidered structure  50 . In forming the cylindrical structure, the short edges  52  become generally circular and the long edges  54  meet to form a seam  56  which is parallel to the height aspect of the cylindrically shaped embroidered structure  50 . 
       FIG. 10  depicts an example of an embroidered structure  60  according to a third embodiment of the present invention. The embroidered structure  60  is shown by way of example as being a generally flat, generally rectangular structure through which a single lace  12  was placed multiple times by the process of manufacture described above. The generally rectangular embroidered structure  60  necessarily has four edges; two short edges  62  and two long edges  64 . In this embodiment, the lace  12  runs generally diagonally from one long edge  64  to the other long edge  64 , then around the outside of the embroidered structure  60  and back to the first long edge  64  where it enters the embroidered structure again. In an alternative embodiment, the lace  12  could be run between the short edges  62  to result in a differently dimensioned structure than the one described below. 
     As shown in  FIG. 11 , a three-dimensional, generally cylindrical embroidered structure  60  may be formed by tensioning the lace  12  of the embroidered structure  60  shown in  FIG. 10 . The lace  12  is laid out in the shape of a flat spiral in  FIG. 10 , but as the lace  12  is tensioned, the radii of the spiral loops of the lace  12  begin to decrease until the two-dimensional lace  12  spiral takes the shape of a three-dimensional helix. Since the lace  12  is enclosed within the thread pairs  20  within the enclosing thread pairs  22 , putting the lace  12  in a helical shape causes the embroidered structure  10  enclosing it to curl around the axis of the spiral path of the lace  12 . The curling causes the long edges  64  of the embroidered structure  10  to come closer together such that the edges will eventually meet. Once the long edges  64  meet, the embroidered structure  60  is in the general shape of a cylinder with the long edges  64  forming a seam  66  parallel to the axis of the helix and the height aspect of the cylinder. 
       FIG. 12  depicts an example of an embroidered structure  70  according to a fourth embodiment of the present invention. The embroidered structure  70  is shown by way of example as being a generally flat, polygonal shaped structure through which several laces  12  are placed by the process of manufacture described above. The polygon may have a central panel  72  which shares each of its sides with one of four outer panels  74 . The laces  12  are run through each of the outer panels  74  without running through the central panel  72 , such that the lace  12  runs through one outer panel  74 , then through open space  76 , then through another outer panel  74 , then through open space  76  and so on until the two ends of each lace  12  occupy the same open space  76 . In the example shown in  FIG. 12 , the central panel  72  and outer panels  74  are all square shaped, and thus are dimensionally identical to one another. However, it is contemplated that any variety of complementary polygonal shapes and configurations may be used, such as for example a generally rectangular central panel  72  in combination with a pair of opposing generally rectangular outer panels  72  and a pair or opposing generally square outer panels  72 . Such a configuration would result in a generally rectangular box shape upon tensioning of the laces  12  (as described below). Further embodiments may include combinations of triangles, quadrilaterals, pentagons, hexagons, etc. 
     As shown in  FIG. 13 , a three-dimensional polyhedron open box-shaped embroidered structure  70  may be formed by tensioning the laces  12  shown in  FIG. 12 . Tensioning the laces  12  pulls the length of each lace  12  from the open space  76  between outer panels  74 , which in turn draws the edges of the outer panels  74  together. When all the length of laces  12  between the outer panels  74  has been pulled through the outer panels  74 , the edges of the polygonal embroidered structure  70  unite such that a polyhedron shaped embroidered structure  70  with one open side is formed. Tying the opposite ends of the laces  12  in knots  24  secures the shape of the embroidered structure  70 . 
       FIG. 14  depicts an example of an embroidered structure  80  according to a fifth embodiment of the present invention. The embroidered structure  80  is shown by way of example as being a generally flat, polygonal-shaped structure enclosing a series of laces  12  placed therein by the process of manufacture described above. The polygonal shape may have a first major panel  82  which shares each of its sides with one side of each of four minor panels  84   a ,  84   b ,  84   c , and  84   d . In the example shown, each of the four minor panels  84   a - d  is the same height, and has a length defined by the side it shares with the first major panel  82 . Minor panel  84   c  is positioned between the first major panel  82  and a second major panel  86 , in that the minor panel  84   c  shares one length-defining side with the first major panel  84  and a second, identical length-defining side with the second major panel  86 . By way of example only, the second major panel  86  is identically dimensioned relative to the first major panel  82 . The laces  12  are distributed in three ways. The laces  12   a  run lengthwise successively through the four minor panels  84   a - d . The laces  12   a  originate in a first open space  88   a , pass through the first minor panel  84   a  in a lengthwise direction and into a second open space  88   b . This path continues in succession through minor panel  84   b , open space  88   c , minor panel  84   c , open space  88   d , and minor panel  84   d  until the laces  12   a  emerge within open space  88   a  at which point both ends of each lace  12   a  are in the same open space. The laces  12   b  pass into the second major panel  86 , straight through the minor panel  84   c  (and generally perpendicular to the laces  12   a  therein), through the first major panel  82  and out the end of the polygon through the minor panel  84   a  (and generally perpendicular to the laces  12   a  therein). Laces  12   c  follow a generally horseshoe-shaped path, for example entering minor panel  84   d  and passing through such that laces  12   c  are generally perpendicular to laces  12   a  within minor panel  84   d . Laces  12   c  continue through major panel  82  (such that laces  12   c  are generally perpendicular to laces  12   b  within major panel  82 ) and through the minor panel  84   b  (also such that laces  12   c  are generally perpendicular to laces  12   a  within minor panel  84   b ). Upon exiting minor panel  84   b , laces  12   c  curve back to the polygon to pass through the major panel  86  in a direction generally parallel to the laces  12   c  within major panel  82  and generally perpendicular to laces  12   b  within major panel  86 . Surrounding structures may be engineered to form eyelets for the laces  12   a - c  to run through. 
       FIG. 15  shows the three-dimensional embroidered hexahedron structure  80  created by tensioning and tying the opposite ends of each laces  12   a - c  from  FIG. 14 . Upon tensioning the laces  12   a , the length of lace  12   a  in the open spaces  88   a - d  shorten, which in turn pulls the edges of the minor panels  84   a - d  together. When all the length of lace  12   a  between the minor panels  84   a - d  has been pulled through the minor panels  84   a - d , the edges of the polygonal embroidered structure  80  unite to form a polyhedron-shaped embroidered structure  80  with one open side, and with the major panel  86  attached to an edge of the open side of the polyhedron (minor panel  84   c ). Tying the opposite ends of the laces  12   a  in knots  24   a  secures the shape of the embroidered structure  80 . Tensioning and tying laces  12   b  into knots  24   b  draws the major panel  86  on top of the open side, thus closing the open box structure by adding the sixth side necessary to have a closed hexahedron. Tensioning and tying laces  12   c  into knots  24   c  secures the last remaining unfixed edge of the closed hexahedron. 
       FIG. 16  depicts a set of generally flat embroidered structures  90  according to a sixth embodiment of the present invention, used to anchor and guide a lace  12  which runs through each of the embroidered structures  90 . The process for manufacturing the embroidered structure  90  is described above. The completed embroidered structures  90  may be affixed to a surface or surfaces using the fastener holes  25  to facilitate mechanical attachment between each embroidered structure  90  and the surface to which it is joined. Once in place, the embroidered structures  90  act as anchors and guide the lace  12  as it is pulled through the embroidered structures  90 . The predictability of the path of the lace  12  allows for the lace  12  to be protected from fouling on surrounding objects and protects surrounding objects from being damaged or disturbed through contact with the lace  12 . 
       FIG. 17  shows a generally flat embroidered structure  100  according to a seventh embodiment of the present invention. The embroidered structure  100  has a generally rectangular shape and is used to guide laces  12  in a predictable path around an object. The process for manufacturing the embroidered structure  100  is described above. The completed embroidered structure  100  may be affixed to a surface using the fastener holes  25  to facilitate mechanical attachment between the embroidered structure  100  and the surface to which it is joined. The embroidered structure  100  allows the laces  12  to be guided in a predictable path when positioned partially around an object, such as a generally cylindrical, generally polyhedral or object of some other shape. This guided running prevents the laces  12  from crossing, which would inhibit their freedom of movement. Surrounding structures may be engineered to form eyelets for the laces  12  to run through. 
       FIG. 18  shows a set of generally flat embroidered structures  110  according to an eighth embodiment of the present invention, used to reproducibly position objects in a line. The process for manufacturing the embroidered structure  110  is described above. The embroidered structures  110  are generally rectangular, and may have one or more fastener holes  25 . A single, integral lace  12  runs through all of the embroidered structures  10 , and may run through the embroidered structures  12  either close to the facing sides, over the fastener holes  25  along the periphery opposite the facing sides or at any position there between. The completed embroidered structures  110  may each be affixed to an object using the fastener holes  25  to facilitate mechanical attachment between each embroidered structure  110  and the object to which it is joined. Once the embroidered structures are attached to objects, tensioning the lace  12  by pulling its ends in opposite directions will cause the lace  12  to straighten. As the lace  12  straightens, it will pull the embroidered structures  110 , and the objects to which they are attached, into a line defined by the directions in which the two ends of the lace  12  are pulled. 
       FIG. 19  depicts a woven structure  26  according to one aspect of the present invention, created from laces  12  using the embroidery techniques of the present invention. Each of the woven laces  12 , individually numbered L1-L40, is laid down by stitching to a corresponding soluble thread on a substrate, forming temporary thread pairs. When all of the laces  12  are stitched to corresponding soluble threads, there is an embroidered structure of temporary thread pairs on the substrate. The soluble threads may then be dissolved and substrate may be removed. After dissolution of the soluble thread and substrate, the pairing of the soluble thread with the lace thread  12  is destroyed. As there are no longer any paired threads, but instead only interwoven laces  12  holding each other in the woven structure  26 . The dissolution of the soluble thread and substrate turn what is created as an embroidered structure into a woven structure  26 . 
     The woven structure  26  is exemplary of the use of the embroidering techniques of the present invention to create non-embroidered finished products. The extent of these non-embroidered products is not limited to those which are woven, but includes all other methods of creating structures from filamentary materials. The finished products may be completely non-embroidered or a hybrid of embroidery and one or more other techniques including, but not limited to, weaving. 
     Woven structures may also take many shapes. For example, the woven structure  26  from  FIG. 19  is created by embroidering in the following order and positions: 
     
       
         
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Lace Number 
                   
                   
               
               
                   
                 and Stitching Order 
                 Orientation 
                 Location 
               
               
                   
                   
               
             
             
               
                   
                 L1 
                 Vertical 
                 Centered 
               
               
                   
                 L2 
                 Horizontal 
                 Centered 
               
               
                   
                 L3 
                 Vertical 
                 Right of L1 
               
               
                   
                 L4 
                 Horizontal 
                 Below L2 
               
               
                   
                 L5 
                 Vertical 
                 Left of L1 
               
               
                   
                 L6 
                 Horizontal 
                 Above L2 
               
               
                   
                 L7 
                 Vertical 
                 Right of L3 
               
               
                   
                 L8 
                 Horizontal 
                 Below L4 
               
               
                   
                 L9 
                 Vertical 
                 Left of L5 
               
               
                   
                 L10 
                 Horizontal 
                 Above L6 
               
               
                   
                 L11 
                 Vertical 
                 Right of L7 
               
               
                   
                 L12 
                 Horizontal 
                 Below L8 
               
               
                   
                 L13 
                 Vertical 
                 Left of L9 
               
               
                   
                 L14 
                 Horizontal 
                 Above L10 
               
               
                   
                 L15 
                 Vertical 
                 Right of L11 
               
               
                   
                 L16 
                 Horizontal 
                 Below L12 
               
               
                   
                 L17 
                 Vertical 
                 Left of L13 
               
               
                   
                 L18 
                 Horizontal 
                 Above L14 
               
               
                   
                 L19 
                 Vertical 
                 Right of L15 
               
               
                   
                 L20 
                 Horizontal 
                 Below L16 
               
               
                   
                 L21 
                 Vertical 
                 Left of L17 
               
               
                   
                 L22 
                 Horizontal 
                 Above L18 
               
               
                   
                 L23 
                 Vertical 
                 Right of L20 
               
               
                   
                 L24 
                 Horizontal 
                 Below L30 
               
               
                   
                 L25 
                 Vertical 
                 Left of L21 
               
               
                   
                 L26 
                 Horizontal 
                 Above L22 
               
               
                   
                 L27 
                 Vertical 
                 Right of L23 
               
               
                   
                 L28 
                 Horizontal 
                 Below L24 
               
               
                   
                 L29 
                 Vertical 
                 Left of L25 
               
               
                   
                 L30 
                 Horizontal 
                 Above L26 
               
               
                   
                 L31 
                 Vertical 
                 Right of L27 
               
               
                   
                 L32 
                 Horizontal 
                 Below L28 
               
               
                   
                 L33 
                 Vertical 
                 Left of L29 
               
               
                   
                 L34 
                 Horizontal 
                 Above L30 
               
               
                   
                 L35 
                 Vertical 
                 Right of L31 
               
               
                   
                 L36 
                 Horizontal 
                 Below L32 
               
               
                   
                 L37 
                 Vertical 
                 Left of L33 
               
               
                   
                 L38 
                 Horizontal 
                 Above L34 
               
               
                   
                 L39 
                 Vertical 
                 Right of L35 
               
               
                   
                 L40 
                 Horizontal 
                 Below L36 
               
               
                   
                   
               
             
          
         
       
     
     This order and position creates a honeycomb-shaped woven structure  26 . However, different weaving effects give structures different properties, including but not limited to flexibility and feel. 
       FIG. 20  depicts a woven structure  26  created by the same process as the woven structure in  FIG. 19 , differing only in the number, order, and position of the laces  12  (individually numbered L1-L36). The woven structure  26  in  FIG. 20  is woven in the following order and positions: 
     
       
         
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Lace Number 
                   
                   
               
               
                   
                 and Stitching Order 
                 Orientation 
                 Location 
               
               
                   
                   
               
             
             
               
                   
                 L1 
                 Vertical 
                 Left Edge 
               
               
                   
                 L2 
                 Horizontal 
                 Top Edge 
               
               
                   
                 L3 
                 Vertical 
                 Right of L1 
               
               
                   
                 L4 
                 Horizontal 
                 Below L2 
               
               
                   
                 L5 
                 Vertical 
                 Btw L1 &amp; L3 
               
               
                   
                 L6 
                 Horizontal 
                 Btw L2 &amp; L4 
               
               
                   
                 L7 
                 Vertical 
                 Right of L3 
               
               
                   
                 L8 
                 Horizontal 
                 Below L4 
               
               
                   
                 L9 
                 Vertical 
                 Between L3 &amp; L7 
               
               
                   
                 L10 
                 Horizontal 
                 Between L4 &amp; L8 
               
               
                   
                 L11 
                 Vertical 
                 Right of L7 
               
               
                   
                 L12 
                 Horizontal 
                 Below L8 
               
               
                   
                 L13 
                 Vertical 
                 Between L7 &amp; L11 
               
               
                   
                 L14 
                 Horizontal 
                 Between L8 &amp; L12 
               
               
                   
                 L15 
                 Vertical 
                 Right of L11 
               
               
                   
                 L16 
                 Horizontal 
                 Below L12 
               
               
                   
                 L17 
                 Vertical 
                 Between L11 &amp; L13 
               
               
                   
                 L18 
                 Horizontal 
                 Between L12 &amp; L16 
               
               
                   
                 L19 
                 Vertical 
                 Right of L15 
               
               
                   
                 L20 
                 Horizontal 
                 Below L16 
               
               
                   
                 L21 
                 Vertical 
                 Between L15 &amp; L20 
               
               
                   
                 L22 
                 Horizontal 
                 Between L16 &amp; L30 
               
               
                   
                 L23 
                 Vertical 
                 Right of L20 
               
               
                   
                 L24 
                 Horizontal 
                 Below L30 
               
               
                   
                 L25 
                 Vertical 
                 Between L20 &amp; L23 
               
               
                   
                 L26 
                 Horizontal 
                 Between L30 &amp; L24 
               
               
                   
                 L27 
                 Vertical 
                 Right of L23 
               
               
                   
                 L28 
                 Horizontal 
                 Below L24 
               
               
                   
                 L29 
                 Vertical 
                 Between L23 &amp; L27 
               
               
                   
                 L30 
                 Horizontal 
                 Between L24 &amp; L28 
               
               
                   
                 L31 
                 Vertical 
                 Right of L27 
               
               
                   
                 L32 
                 Horizontal 
                 Below L28 
               
               
                   
                 L33 
                 Vertical 
                 Between L27 &amp; L31 
               
               
                   
                 L34 
                 Horizontal 
                 Between L28 &amp; L32 
               
               
                   
                 L35 
                 Vertical 
                 Right of L31 
               
               
                   
                 L36 
                 Horizontal 
                 Below L32 
               
               
                   
                   
               
             
          
         
       
     
     After dissolution of the soluble thread and substrate, this order and position creates a diagonal weave throughout the woven structure  26 . This weave will have different characteristics, including but not limited to flexibility and feel, than that of the woven structure  26  in  FIG. 19 . The patterns from  FIG. 19  and  FIG. 20  are merely examples of the numerous patterns possible from interlacing by the process of the present invention. 
       FIG. 21  shows a pair of embroidered structures  10  separated by a seam preloaded with one lace  12  according one example of a ninth embodiment of the present invention. The process for manufacturing the embroidered structure  10  is described above. During the embroidery process of the present invention, a lace  12  is stitched to a soluble thread such that the temporary thread pair zigzags between the pair of embroidered structures  10 . Eyelet threads  28  are then sewn around the lace  12  and soluble thread on each of the embroidered structures  10 . The soluble thread and substrate are then dissolved. The two embroidered structures  10  are now independent of each other, and the lace  12 , no longer a part of a temporary thread pair after dissolution of the soluble thread, is free to run through the eyelet threads  28  between the two embroidered structures  10 . 
       FIG. 22  illustrates the result of tensioning the lace  12  between the embroidered structures  10  in  FIG. 21 . When tensioned, the lace  12  will pull into as straight a line as possible. This straightening imparts a force from the lace  12  onto the embroidered structures  10 , drawing the embroidered structures  10  closer together along the seam  27  separating them. When the embroidered structures  10  are attached to two or more objects, this embodiment provides a manner in which the attached objects may be united in a highly consistent, repeatable manner. 
       FIG. 23  shows a pair of embroidered structures  10  separated by a seam preloaded with more than one lace  12  by the process of the present invention. After the embroidered structures are created according to the process described in the explanation of  FIG. 21  above, two or more laces  12  are stitched to soluble threads such that the temporary thread pairs zigzag between the pair of embroidered structures  10 , one mirroring the path of the other. Eyelet threads  28  are then sewn around the laces  12  and soluble threads on each of the embroidered structures  10 . The soluble threads and substrate are then dissolved. The two embroidered structures  10  are now independent of each other and the laces  12 , no longer a part of temporary thread pairs after dissolution of the soluble threads, are free to run through the eyelet threads  28  between the two embroidered structures  10 . 
       FIG. 24  illustrates the result of tensioning the laces  12  between the embroidered structures  10  in  FIG. 23 . As in the single lace version in  FIG. 22  above, the tensioned laces  12  will pull into as straight a line as possible. This imparts a force from the laces onto the embroidered structures  10 , drawing them closer together along the seam  27  separating them. When the embroidered structures  10  are attached to two or more objects, this embodiment provides a manner in which the attached objects may be united in a highly consistent, repeatable manner. 
       FIG. 25  shows an embroidered structure  10  manufactured according to one embodiment of the present invention in the form of a load bearing structure. During the embroidery process of the present invention, the lace  12  is stitched to a soluble thread on a substrate. The whipping thread  31  is then stitched around the lace  12  and soluble thread such that the whipping thread  31  will hold the stem of the embroidered structure  10  together. The dissolution of the soluble threads and dissolvable substrate may be performed once the stitching of the embroidered structure  10  has been completed. After dissolution, the embroidered structure  10  may be used as a load bearing device such as by coupling the resulting loops  29  between two structures or two regions within a single structure. The use of the embroidery techniques in the production of the embroidered structure  10  ensures the uniformity of the free loops  29  and the equalized length of the lace  12 , thus improving the consistency of performance of embroidered structures  10  through the repeatability of its manufacture. 
     As evidenced above, the present invention overcomes, or at least minimizes, the drawbacks of the prior art. The devices described herein may be repeatably mass produced based on the automated nature of the embroidery process of the present invention. Embroidery with one soluble thread allows for a single, unpaired lace to be laid down reliably, cost effectively, and in a manner conducive to mass production. 
     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined herein.