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. All of the embroidered structures discussed below are created on removable substrates, specifically ones removed through processes of dissolution.
On a dissolvable substrate, a plurality of parallel, stationary backing threads are placed and secured on one surface of a dissolvable 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 through openings created in the dissolvable substrate by the passing of each individual thread to the backing surface. Each stitching thread is then looped over its corresponding backing thread, in essence picking up the backing thread, forming a lock stitch. Once each stitching thread has picked up its corresponding backing thread, the plurality of stitching threads are passed from the backing surface to the stitching surface through the openings in the dissolvable substrate created during the passage to the backing surface. The lock stitches prevent the stitching threads from completely pulling back out of the openings created in the dissolvable substrate. The plurality of stitching threads is 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.
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 plurality of enclosing backing threads is placed and secured on the backing surface of a dissolvable substrate already holding at least one plurality of thread pairs, such that the plurality of enclosing backing threads covers the previously stitched plurality of backing threads. A plurality of enclosing backing threads is usually not parallel with the previous plurality of backing and stitching threads. A plurality of enclosing stitching threads, with one-to-one correspondence to the plurality of enclosing backing threads, is then stitched to the plurality of enclosing backing threads by the stitching process described above.
When the enclosing backing threads are all joined to the enclosing stitching threads by lock stitches, a plurality of enclosing thread pairs has been formed. This process may be repeated by stitching even more pluralities of enclosing thread pairs over all the previously stitched thread pairs, such that the first plurality is enclosed by the second plurality, which is enclosed by a third plurality, which is enclosed by a fourth plurality, etc. This process produces stable embroidered structures which do not unstitch into a pile of threads when the dissolvable substrate is removed.
The process of dissolvable substrate removal is dependent upon the material from which the dissolvable substrate is composed. Substrate materials are chosen such that the dissolution process which removes the dissolvable substrate will minimally affect the physical properties of the remaining embroidered structure. The embroidered structure remains intact despite the removal of the dissolvable 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. The result of the stitching is the creation of a generally two dimensional embroidered structure. There are, however, applications where it would be advantageous to have a generally three-dimensional embroidered structure rather than a generally two-dimensional embroidered structure, but the processes by which three-dimensional embroidered structures may be formed have been complicated and not conducive to cost effective and repeatable mass production.
The first type of process for creating three-dimensional embroidered structures has been to build up the structural shape of the embroidered structure with layer upon layer of embroidered thread. The drawbacks to this technique are: it makes the embroidered structure thicker where the building up has been done; the building up only yields block-type structures and does not allow for the embroidering of curvatures; and this layering process must be done three-dimensionally, which excludes the use of a cost effective, repeatable form of mass production such as an automated embroidery machine.
A second process of manufacturing three-dimensional embroidered structures takes two or more generally flat embroidered structures and stitches them together such that they form a three-dimensional structure. While preserving the uniform thickness of the embroidered structures lost by the layering technique above and allowing for the simplicity of embroidering each flat section in two-dimensions, this process requires several stitching steps which must be done three-dimensionally after the embroidering of the sections is completed. This process is costly with repeatability concerns where the final results and dimensions will be subject to the skill and dexterity of the individual who performs the stitching.
A third known process creates a single, generally two-dimensional embroidered structure which may be folded such that the edge or edges of the structure meet and may be stitched together to form a three-dimensional structure. However, this process suffers from the same post-embroidering stitching steps in three-dimensions as the second process, and thus suffers from the same drawbacks.
The present invention is intended to deal with these and other limitations of creating three-dimensional embroidered structures cost effectively and repeatably.
According to the present invention, there is an embroidery process by which a three-dimensional embroidered structure may be embroidered on a two-dimensional, dissolvable substrate and as such may be mass produced in a cost effective and reproducible manner.
According to one embodiment, the present invention may include three-dimensional embroidered structures which may, by way of example only, be generally dome shaped. The three-dimensional embroidered structure may be achieved by stitching thread pairs and enclosing thread pairs, which form the embroidered structure, in paths longer than the shortest distance between the endpoints of each thread pair. This extra thread length may be laid down and stored on the dissolvable substrate upon which the embroidering may be done by stitching the thread pairs in a zigzagging or otherwise meandering path. Once the dissolvable substrate is removed, the extra thread pair length relaxes from the zigzag path into a straight run of thread. This relaxation causes the two-dimensional zigzagging thread pair to become a three-dimensional structure-dependent shape, e.g. straight, curved, arcuate, or any combination thereof, as the length stored in the zigzagging path between its two fixed endpoints is conserved in the length between the same two fixed endpoints.
By way of example only, the summation of all the structure-dependent shaped thread pairs may form a dome-shaped embroidered structure. This dome effect may be enhanced by adding straight embroidered threads around the outside borders of the zigzagged area or, if the zigzagged area is surrounded by a uniform straight mesh, then around those borders. This straight embroidered thread border may be rigid and thus may prevent the zigzagged embroidered threads from expanding radially and thereby force them into a more pronounced dome shape.
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:
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' 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 creating three-dimensional structures by embroidering with zigzagging thread pairs disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
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.
The present application is a nonprovisional patent application claiming benefit under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 60/898,892, filed on Jan. 31, 2007, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein.
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