Source: http://www.google.com/patents/US8052753?dq=5920316
Timestamp: 2014-08-28 10:42:55
Document Index: 593367377

Matched Legal Cases: ['art 13', 'art 14', 'art 13', 'arts 15', 'art 17', 'art 17', 'art 7', 'art 7', 'art 13']

Patent US8052753 - Prosthetic anchor and method of making same - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe present invention is directed towards a prosthetic anchor (36) including a central layer (1) through which embedded fibers (2), such as artificial tendons, pass in defined pathways (4), a �deep� surface membrane (7) which interfaces with a hard structure, whether that is a prosthesis, a bone,...http://www.google.com/patents/US8052753?utm_source=gb-gplus-sharePatent US8052753 - Prosthetic anchor and method of making sameAdvanced Patent SearchPublication numberUS8052753 B2Publication typeGrantApplication numberUS 11/813,469PCT numberPCT/US2006/000555Publication dateNov 8, 2011Filing dateJan 9, 2006Priority dateJan 7, 2005Also published asUS20080269894, WO2006074413A2, WO2006074413A3Publication number11813469, 813469, PCT/2006/555, PCT/US/2006/000555, PCT/US/2006/00555, PCT/US/6/000555, PCT/US/6/00555, PCT/US2006/000555, PCT/US2006/00555, PCT/US2006000555, PCT/US200600555, PCT/US6/000555, PCT/US6/00555, PCT/US6000555, PCT/US600555, US 8052753 B2, US 8052753B2, US-B2-8052753, US8052753 B2, US8052753B2InventorsDavid Boyd MelvinOriginal AssigneeUniversity Of CincinnatiExport CitationBiBTeX, EndNote, RefManPatent Citations (64), Non-Patent Citations (10), Referenced by (4), Classifications (9) External Links: USPTO, USPTO Assignment, EspacenetProsthetic anchor and method of making sameUS 8052753 B2Abstract The present invention is directed towards a prosthetic anchor (36) including a central layer (1) through which embedded fibers (2), such as artificial tendons, pass in defined pathways (4), a �deep� surface membrane (7) which interfaces with a hard structure, whether that is a prosthesis, a bone, or other hard tissue, and a �superficial� surface membrane (8) which interfaces adjacent tissue and may be configured to adhere or not to adhere to that tissue. The central layer (1) is positioned intermediate the surface membranes (7, 8) which are mechanically and/or adherently attached thereto. Also, non-limiting examples of methods of fabrication and of affixing the anchor (36) to a relatively rigid structure, natural or prosthetic, in a human or animal body with improved stress distribution in the fixed tension member end are taught.
a surface membrane configured to be coupled to at least one of the first and second opposing surfaces. Description
RELATED APPLICATION This application claims priority from U.S. Provisional Application Ser. No. 60/642,016 filed Jan. 7, 2005.
FIELD OF THE INVENTION The present invention relates generally to fixation of artificial tendons, transmitting force from skeletal muscles, either to energy converters powering cardiac or other devices, or to natural or prosthetic bones, and more particularly, to a prosthetic anchor, to methods of fabrication, and to means of fixing thereof to a relatively rigid structure, natural or prosthetic, in a human or animal body with improved stress distribution in a fixed tension member, e.g. fixed fibers defining a tendon or ligament.
BACKGROUND OF THE INVENTION Fixation of prosthetic flexible tension members, such as tendons or ligaments, to relatively rigid structures is a serious problem. A notable example is the use of artificial ligaments, such as the Leeds-Keio anterior cruciate ligament replacement in the knee. In that example, published experience with the usual means of bone fixation�drilling a hole in the tibia, inserting the ligament, and securing with a suture or pin�has included several instances of fragmentation of the polyester fibers of the prosthesis within a few months to a few years. A compression plate fixation has been used whereby tension members are cut and the end grasped between two plates, generally textured and held together by compression screws to grasp the tension member. While this allows greater control of local stress concentration than does a simple bone-hole, in theory it delivers extremely high shear stresses to the tension member locally, which may cause fatigue failure and breakage over the immense number of stress cycles expected to be required.
A knob-loop fixation device has been previously disclosed to address the stress-concentration issue, but requires a substantial thickness that may be disadvantageous. Such thickness could be problematic in some cardiac surgical, plastic and reconstructive surgical, or orthopaedic surgical devices, for example, in regions where skin is quite close to a coupled bone (e.g., the frontal bone in the case of a cosmetic surgical �brow lift� prosthesis and the olecrenon in an orthopaedic surgical elbow prosthesis). Further, for either of these applications, for other plastic and orthopaedic surgical applications, or for some potential configurations of mechanical energy converters for cardiac power applications, the surface to which the coupler is attached may vary in its contour. Therefore a much thinner adapting terminus, which maintains sufficient flexibility to allow a finite number of size/shape models to conform to anatomy of reasonable individual variation, would be of benefit. Further, a structure with a soft flexible interface to fibers (reducing stress concentration) and yet a harder external surface (to interface with other tissues, adhering or not as desired) would also be advantageous.
Natural tendon ends, which are living tissue, have been connected to �towel bar� fixtures on artificial bones, over which they are looped and sewn. Because of the shape of tendons�generally flattened in the plane of attachment, the axis of curvature is generally perpendicular to the surface to which they are to be attached. To avoid intolerable protrusion dimensions into surrounding tissue structures, the radius of curvature is very small. Since the compressive stress on a tension member surface, when that tension member is looped about any rod or pulley, is directly proportional to the tension applied and inversely proportional to both the radius of curvature and the projection of contact surface perpendicular to the transmitted tension, compressive forces intolerable by the tension member may be generated. An artificial force transmitting tension member, however, such as an artificial tendon, can be formed in any cross-sectional configuration. This allows the central stabilizing point to be relatively thin, flat, and oriented in the plane of the surface to which the tension member is to be attached.
In contrast to the �towel bar� concept, the radius of curvature of the present invention may be made substantially larger with only minimal protrusion into surrounding tissue structures. In contrast to the �knob loop� or �tangential pulley� concept, the present invention does not require fibers to be organized into a circular cross-section, with imposition of a minimum thickness for a given number of fibers. The number of fibers still dictates the cross-sectional area of the bundle that passes through the matrix, but it can be very wide and quite thin, or any other combination of dimensions dictated by the device (e.g., a mechanical energy converter) or anatomic structure (e.g., a bone) to be joined.
SUMMARY OF THE INVENTION The present invention provides for a prosthetic anchor including an implantable, flexible, force-transmitting fiber-based tissue coupler or central layer with fibers, and to non-limiting examples of methods of fabrication and of fixing the anchor to a relatively rigid structure, natural or prosthetic, in a human or animal body with improved stress distribution in a fixed tension member, such as fibers defining a tendon or ligament. The invention may be useful in addressing cardiac surgical, plastic and reconstructive surgical, or orthopedic surgical problems.
To this end, the prosthetic anchor defines a thin wafer-like device including a central layer that incorporates, or embeds, multiple bundles of fibers of a tension member, e.g. a natural or artificial tendon, to form a matrix. This central layer may include an elastomeric or other polymer material. The fibers are packed closely and concentric to each other, and generally in a horseshoe pattern, but permit permeation and interstitial distribution of the matrix. Opposing ends of each fiber exit generally on the same aspect or edge of the central layer and may be attached, such as to the muscle of a human or animal, by means commonly known in the art. Harder and thinner surface membranes such as carbon-fiber/epoxy or glass-fiber/epoxy or sheets of a biocompatible metal optionally cover both faces of the central layer, forming a �sandwich� of variable flexibility. Flexibility is dependent on thickness of the overall structure and the materials chosen both for the surface membranes and the central matrix layer. Generally, regions near the center of the concentric path of fibers will not contain fibers and comprise either none of the layers (a central �hole� or opening), or one, two, or all three layers.
DETAILED DESCRIPTION OF THE INVENTION Part Numbers
1. central layer; 1 a. opposing first surface; 1 b. opposing second surface 2. embedded fibers 3. entering and exiting fiber bundles 4. concentric pathways of fibers in central layer 5. thickened edge of central layer into which fiber bundles enter 6. optional central opening in central layer 7. deep (semi-rigid) membrane 8. superficial (semi-rigid) membrane 9. face of deep membrane configured for adherence to central layer 10. face of superficial membrane configured for adherence to central layer 11. face of deep membrane configured for adherence to a bone or to a prosthesis 12. face of superficial membrane configured for non-adherence to contiguous living tissue 13. surface, or surface replica 14. mold made to mate part 13, of a soft elastomeric material such as a polyurethane or silicone rubber. Part 14 is termed �fabrication part A� in the continuing description. 15. replica of the applicable surface of part 13, termed �fabrication part B� in description 16. clay, or clay-like moldable material, wafer configured to geometry of the device termed �fabrication part C� in description 17. hard outer cast formed to mate with the parts 15 and 16 (fabrication parts B/C assembly); that outer cast is �fabrication part D� in description 18. inner section of part 17, termed �fabrication part E� in description 19. outer section of part 17, termed �fabrication part F� in description 20. removable pin 21. smooth surface of a composite membrane 22. metal mesh insert in the deep surface of part 7, the deep membrane 23. textured metal plate insert, incorporated into the deep surface (11) of part 7, the deep membrane 24. short needle-like projections 25. peg-like central plateau 26. roughening and texturing of superficial surface (9) of the deep composite membrane (7) 27. generally parabolic disc of fabric or other porous biocompatible material 28. tows or bundles of coupler fibers 29. individual coupler fibers 30. central regions of fiber tows saturated with uncured elastomer 31. hole in disc to accommodate stabilizing pegs 32. stabilizing peg extending from either deep (shown) or superficial membrane 33. ends of tows 34. strip of uncured elastomer 35. fiber-matrix composite layup 36. prosthetic anchor 37. geometric molded or machined master replicating geometry of central layer 38. flanges to guide fiber tows 39. radial carbon or glass fibers in composite layup 40. diagonal �a� fibers in composite layup 41. diagonal �b� fibers in composite layup 42. fiber composite envelope 43. clasp for holding envelope during fiber insertion 44. rim joining outer and inner laminae of envelope 45. flange to hold envelope laminae apart during fiber insertion 46. bone 47. fixation screws 48. stress-distributing metal plate 49. mechanical energy converter surface to be anchored to coupled fibers by the anchor of this invention 50. frontal bone 51. olecranon of an ulna The prosthetic anchor (36) of the present invention is configured for anchoring to a hard structure such as a prosthetic device or a bone, for the goals of minimizing material stress concentration inherent to such anchoring and minimizing height of the profile of the structure beyond the surface of that hard structure.
(a) a central layer (1) of wafer-like structure through which embedded fibers (2), defining a matrix, pass in defined pathways (4). Examples of materials of the central layer (1) include polymers such as elastomeric material, e.g. silicone rubber and polyurethane. The fibers may include natural material (e.g. human and/or animal tendons or ligaments) and/or synthetic materials such as polyester defining a tendon or ligament. (b) a �deep� surface membrane (7) which interfaces with a hard structure, such as by being anchored to, for example, a prosthesis, a bone, or other hard tissue. Examples of materials of surface (7) are titanium alloy or other metal, fiber (e.g., carbon, glass)/epoxy composites, and combinations of metals and fiber composites. (c) a �superficial� surface membrane (8) which interfaces with adjacent tissue and may be configured to adhere or not to adhere to that tissue. Examples of materials of surface (8) are titanium alloy or other metal, fiber (e.g., carbon, glass)/epoxy composites, and combinations of metals and fiber composites. The deep and/or the superficial surface membranes (7, 8) may have one or more projections such as posts or needles, as further described below, that extend through openings in the elastomeric central layer (1) to provide counter force to fibers as fibers are tensed. In addition, it should be understood that the surface membranes (7, 8) are optional insofar as the central layer (1) may be adapted to function alone, or with one surface membrane (7 or 8), thereby defining the prosthetic anchor (36).
FIG. 6 shows step (b) wherein the surface, or surface replica (13), is used to form a mold (14) of a soft elastomeric material such as a polyurethane or silicone rubber. Mold or part (14) is termed �fabrication part A� in the continuing description. FIG. 7 shows step (c) wherein a hard mating surface (15), such as a glass-filled epoxy polyester resin or other material, is cast. This mating surface (15) is a replica of the applicable surface of part 13. Hard mating surface (15) is termed �fabrication part B� in the continuing description.
FIG. 8 shows step (d) wherein a clay wafer (16), or a wafer of curable clay-like modeling polymer, whose geometry mimics the desired geometry of the anchor (36) is formed on the surface of fabrication part B (15). The wafer (16) is cured or hardened to produce �fabrication part C.� FIG. 9 shows step (e) wherein, after applying liberal mold-release agent(s), a hard outer cast (17) is formed to mate with the fabrication parts B (15) and C (16) assembly. The outer cast (17) is termed �Fabrication part D� in which two parts, i.e. an inner and outer section, are made.
FIG. 10 shows step (f) that includes using a scroll saw, a wire cutter, a laser beam, or other tool, so that Fabrication part D (17) is cut a short distance, generally 2-3 mm inside, and concentric to the margin of Fabrication part C (16) to form an inner section (18), �fabrication part E� and an outer section (19), �fabrication part F.� FIG. 11 shows step (g) wherein Fabrication part F (19) is positioned offset from its original position on Fabrication part E (18) by a short distance, approximately the thickness of a diameter of a fiber tow (28), to facilitate step (m) (See FIG. 17) described below, generally 1 to 3 mm, and held in place by a removable pin (20) or other means.
Specifically, FIG. 12 a shows the process of forming the composite layer under pressure, while FIGS. 12 b, 12 c, and 12 d show a non-limiting set of possible variations in the outer or deep surface of the deep layer surface membrane (7): smooth (21) in FIG. 12 b, incorporating metal mesh (22) in FIG. 12 c, and/or textured metal plate (23) in FIG. 12 d. FIGS. 12 e, 12 f and 12 g show further variations in the superficial surface of the deep layer (7). FIG. 12 e shows a composite layer with short needle-like projections (24) in the superficial surface of the deep surface membrane (7), formed either by drilling appropriate holes in the mating surface of Fabrication Part B (15) or by adding metallic or other projections or �tacks� to Fabrication Part A (14) prior to the layup. These are shown in an array chosen to support the fiber placement procedure described below in FIG. 17, step (m). FIG. 12 f illustrates a deep composite surface membrane (7) with a peg-like central plateau (25) that serves the same purposes of the needle-like projections (24) of FIG. 12 e. Finally, FIG. 12 g shows a roughened, textured (26) portion of superficial surface of the deep composite membrane such as may be effected, for example, by preliminary mechanical pitting of Fabrication part B (15). Features 22 through 26 may be used in any combination or used alone.
FIG. 18 shows step (n) wherein the varying thickness of the space between fabrication parts E (18) and B (15), as determined by the varying thickness of Fabrication part C (the clay wafer 16�See FIG. 9) used to mold part E (18), determines in turn the varying thickness of the fiber layer as it progresses radially away from the central disc (27). The fiber layer may progress differently in terms of distance covered per number of fibers (29), at different points around the central disc (27), dependent on this varying thickness profile. For the non-limiting example shown, the center of the irregular approximately 180� wrap is thinner and wider than are the sides.
Specifically, in step (q), FIG. 21 illustrates each elastomer-saturated bundle, or group of one or more bundles (28), placed around one concentric row of hook-like extensions (24), one at a time, progressing outwardly, and placed under tension until all bundles are in place. Accordingly, it should be understood that the extensions (24) may be provided on one or both of the surface membranes (7, 8). Next, in step (r), FIG. 22 illustrates the uncut part (17) or �Fabrication part D� that is positioned on the surface of projections (24) and bundles (28), pressure is applied, and the central layer (1) cured similar to step (p) of FIG. 20. FIG. 23 shows step (s), another variation of step (q) in which, rather than curved rows of hook-like projections extending from membrane (7) or membrane (8), one or more flanges (35) can support successive concentric bundles of fibers.
More specifically, FIG. 24 shows step (aa) wherein a machined or molded bloc replica, or master (37), of envelope or wafer (42) is provided. FIG. 25 shows step (bb) including providing a two-part silicone mold (38) of the master (37). FIG. 26 illustrates optional step (cc) wherein similar layers or surface membranes could be �laid up� (not shown) on the deep side of the master (37) as well. In particular, FIG. 26 shows radial fibers (39), such as carbon, glass, or other, with two diagonal layers (40, 41) in space.
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BarteeReinforced PTFE medical barriersUS20100161054 *Nov 19, 2009Jun 24, 2010Jason ParkReinforced Biologic MaterialUS20100217392 *Feb 23, 2010Aug 26, 2010Bartee Barry KReinforced ptfe medical barriers* Cited by examinerClassifications U.S. Classification623/13.14, 623/13.2, 623/13.11International ClassificationA61F2/08Cooperative ClassificationA61F2002/087, A61F2002/0858, A61F2002/0888, A61F2/0811European ClassificationA61F2/08FRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google