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WO1989001320A1 - Prothese de tissu souple - Google Patents

Prothese de tissu souple Download PDF

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Publication number
WO1989001320A1
WO1989001320A1 PCT/US1988/002709 US8802709W WO8901320A1 WO 1989001320 A1 WO1989001320 A1 WO 1989001320A1 US 8802709 W US8802709 W US 8802709W WO 8901320 A1 WO8901320 A1 WO 8901320A1
Authority
WO
WIPO (PCT)
Prior art keywords
soft tissue
stiff
tissue prosthesis
braid
elastomeric
Prior art date
Application number
PCT/US1988/002709
Other languages
English (en)
Inventor
Donald Harvey Brunk
Peter Popper
Dale Richard Peterson
Joseph Daniel Trentacosta
Original Assignee
E.I. Du Pont De Nemours And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by E.I. Du Pont De Nemours And Company filed Critical E.I. Du Pont De Nemours And Company
Publication of WO1989001320A1 publication Critical patent/WO1989001320A1/fr
Priority to DK042190A priority Critical patent/DK42190A/da

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Classifications

    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • D04C1/12—Cords, lines, or tows
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene

Definitions

  • This invention relates to a soft tissue prosthesis, and specifically to a prosthesis for use in place of a natural ligament, such as an anterior cruciate ligament.
  • Soft tissue structures such as ligaments, tendons, and the like are prevalent in vertebrate anatomy. These soft tissue structures are inherently susceptible to damage resulting from excessive force or disease. Ligaments, in particular, have attracted a great deal of medical attention. Ligaments are frequently implicated in knee problems .
  • a particularly problematic ligament is the anterior cruciate ligament (ACL) , one of the ligaments which connects the femur and tibia across the knee.
  • ACL anterior cruciate ligament
  • damaged ligaments may be repaired surgically with minimal after-effects .
  • damaged ligaments must be replaced with a prosthetic ligament.
  • a suitable prosthetic ligament should be compliant at low strains to permit movement of the interconnected bones, stiff at high strains to prevent excessive movement, and suitably strong to withst.and breakage from the forces generated during all such movement.
  • a suitable prosthetic ligament should be capable of long term attachment to the bones and should be resistant to fraying in areas subject to abrasion.
  • a suitable, prosthetic ligament should possess a unique combination of certain over-all (global) properties and certain local (regional) properties.
  • the region of a ligament which replaces the natural ACL in the joint space should be capable of extending to large deformations with low force (low axial stiffness)
  • the region of the ligament which provides bone attachment should be porous and not stretch or move relative to the bones (high axial stiffness)
  • a suitable ligament should have variable properties along its length.
  • the present invention solves these problems by providing an artificial prosthesis made by a special braiding technique which permits elastomeric materials to be inserted in one region, stiff materials to be inserted in another region, and a special binding system which permits the prosthesis to function without premature failure at the interface between the regions.
  • the present invention solves these problems by providing in a first aspect a novel structure comprising a tube formed from a braid of stiff braiding components, said tube enclosing a channel, said tube having along its length:
  • a central region comprising (i) an elastomeric core component within said channel, or (ii) an elastomeric warp component within said braid, or (iii) a combination of (a) (i) and (a) (ii) ;
  • a porous primary attachment region comprising (i) a stiff core component within said channel, or (ii) a stiff warp component within said braid, or a combination of (b) (i) and (b) (ii) ; and (c) binding means defining a transition region extending over a portion of said central region and a portion of said primary attachment region for minimizing the relative motion of said stiff braiding components, elastomeric core components, elastomeric warp components, stiff core components, and stiff warp components, within said portions of said regions over which said binding means extends.
  • the present invention solves these problems by providing a novel structure comprising a plurality of first braided tubes, each of which has along its length at least a first and a second region characterized by braiding angles which may be the same or different, and each of which first regions of said tubes encloses a first channel therein; said prosthesis having along its length:
  • a porous primary attachment region comprising a braid formed from said second regions of said first tubes, thereby forming a single second braided tube enclosing a second channel therein said primary region further comprising (i) a stiff core component within said second channel, or (ii) a stiff warp component within said second braided tube, or (iii) a combination of b(i) and b(ii); and
  • FIG. 1 is a perspective view of a preferred ligament prosthesis of the first aspect of the present invention showing its various regions.
  • FIG. 2 is an exploded view of a portion of a preferred ligament prosthesis of the first aspect of the present invention showing, in section, the central region, the transition region and the primary attachment region.
  • FIG. 3 is a schematic view illustrating a preferred ligament prosthesis of the present invention implanted between adjacent bones of a knee joint in replacement of a natural anterior cruciate ligament.
  • FIG. 4 is a perspective view of a biaxially braided tube.
  • FIG. 5 is an exploded view of a ligament prosthesis of the present invention showing in phantom a portion of an optional over-sleeve.
  • FIG. 6 is a stylized perspective view of a braided tube in accordance with the second aspect of the present invention.
  • FIGS. 7 and 8 are exploded perspective views of portions of first braided tubes in accordance with the second aspect of the present invention, showing braiding angles of said portions.
  • FIG. 9 is a perspective view of the central region, transition and primary attachment regions of a prosthesis in accordance with the second aspect of the present invention.
  • FIG. 10 is an exploded view of a prosthesis in accordance with the second aspect of the present invention.
  • the present invention involves a prosthesis which is capable of providing a strong, functional replacement for damaged soft tissue, such as, but not limited to, ligaments, tendons, heart valve leaflets, vascular tissue, muscle tissue, fallopian tubes, ureters, and hernial grafts. Most preferably the prosthesis is a replacement for ligaments, particularly the anterior cruciate ligament (ACL) .
  • ACL anterior cruciate ligament
  • the basic framework.of the prosthesis may be provided by a biaxially braided structure, or • "circular braid,-" as illustrated in Figure 4.
  • This circular braid is tubular in form and runs the entire length of the prosthesis.
  • tubular is meant that the basic braid encloses a hollow channel, which may be filled, partially or wholly, with a "core component.”
  • tube 1 is cylindrical, it is to be understood that the tube may be in various other shapes, such as square with rounded corners, ovoid, rectangular, etc.
  • This braid itself is fabricated from braiding components 2 and 3, depicted in Figures 2 and 4.
  • braiding components are oriented in opposite directions but at substantially the same braid angle, with braid angle measured relative to the longitudinal axis 4 of the braided tube.
  • the braid angle may be varied along the length of the tube to vary axial stiffness.
  • the braiding components are shown in Figure 2 in a "two- up”, “two-down” manner with respect to each other, and in Figure 4 in a “one-up”, “one-down” manner, other braiding patterns may also be employed.
  • Components 2 and 3 may both be of the same or different diameter, as desired.
  • the basic framework may also be provided by a so-called 3D braided tube such as described in U.S. Patent No. 4,719,837.
  • the braiding components would not be restricted to running in opposing helices, but would also run through the thickness of the braid.
  • Each braiding component may comprise one or more strong, stiff monofilament and/or multifilament yarns.
  • Suitable yarns can be made from fibers of polyesters, such as polyethylene-terephthalates (PET) , including Dacron®; polyaramids, such as Kevlar® and Nomex®; polyolefins, such as polyethylenes and polypropylenes; polyglycolic acids; polylactic acids; fluoropolymers, such as polytetrafluoroethylene (PTFE; Teflon®) ; and suitable combinations thereof.
  • PET polyethylene-terephthalates
  • polyaramids such as Kevlar® and Nomex®
  • polyolefins such as polyethylenes and polypropylenes
  • polyglycolic acids polylactic acids
  • fluoropolymers such as polytetrafluoroethylene (PTFE; Teflon®) ; and suitable combinations thereof.
  • Other suitable fibers will be readily apparent to those skilled in the art.
  • the fibers are polyolefins, particularly polyethylene; polyaramids, particularly Kevlar®; or polyesters, particularly Dacron®. Dacron®, Kevlar®, Nomex® and Teflon® are all available from E. I. du Pont de Nemours and Company, Wilmington, Delaware, 19898.
  • a braiding component comprises more than one yarn
  • the yarns may themselves be braided, left in parallel array or otherwise arranged.
  • a preferred braiding component is a low angle (less than 5 degrees) biaxial braid of Dacron® polyester multifilament yarns.
  • the number of yarns in the braid is optional, and will depend on the size of the finished prosthesis. Alternatively, the yarns may be randomly interlaced.
  • Each braiding component, as well as the yarn or groups of yarn used therein may, if desired, be wrapped with one or more yarns.
  • Suitable yarns include the strong, stiff yarns and the elastomeric yarns discussed herein.
  • the term "wrap”, as used herein, means a helical overwinding of one or more yarns, in one or more layers. Wraps serve, among other things, to provide abrasion resistance.
  • the braided tube is modified along its length through various types of inclusions, additions, or alterations in braiding angle or pattern or the like, which result in a desirable combination of both regional and global properties.
  • Figures 1 and 2 illustrate regions of differentiation in a preferred ligament prosthesis of the first aspect of the present invention.
  • the central region 5 as shown in Figures 1 and 2, defines one area of modification.
  • central region is, in the case of a ligament prosthesis, the area which, in vivo, substantially spans the space between the joined bones.
  • Figure 3 depicts an implanted anterior cruciate ligament prosthesis.
  • the central region 5 of a ligament prosthesis requires a combination of stiffness at high strains, compliancy at low strains, and overall strength.
  • an elastomeric component is added to the core and/or the warp position of the central region of the basic braid.
  • the term "core,” as used herein, designates a position within the hollow channel of the braided tube shown in Figure 4.
  • the elastomeric core component (which may, itself, be a complex structure) substantially fills the core of the braided tube in its rest position in vivo.
  • warp signifies an inclusion in the wall of the braided tube, the inclusion having an orientation parallel to the longitudinal axis 4 of the braid.
  • Each core and/or warp component in the central region is comprised of one or more elastomeric monofilament and/or multifilament yarns.
  • Suitable elastomeric yarns can be made from fibers of polyurethane polymers; silicone elastomers; polyester/polyether block copolymers, such as
  • Hytrel® spandex-type polyurethane/urea/ether block copolymers;- spandex-type polyurethane/urea/ester block copolymers; polypropylene; fluoroelastomers; elastomeric polyolefins; and suitable combinations thereof.
  • Other suitable fibers will be readily apparent to those skilled in the art.
  • Other suitable fibers include those fibers having a Young's modulus similar to the aforementioned elastomeric fibers.
  • the fibers are polyester/polyether block copolymers, particularly Hytrel®, or spandex-type polyurethane/urea/ether block copolymers. The most preferred fibers are spandex-type polyurethane/urea/ether block copolymer.
  • an elastomeric core component comprises more than one yarn
  • the yarns may themselves be braided, left in parallel array or otherwise arranged.
  • Each of the yarns or groups of yarns used in the core and/or warp component may, if desired, be wrapped with one or more multifilament yarns for added abrasion resistance.
  • the elastomeric component may be omitted from the "central region.”
  • Figure 2 there is shown a preferred core component 11, which comprises elastomeric yarns 12 positioned in "parallel" array.
  • parallel refers to the sharing of a common mechanical load.
  • Yarns which are in a parallel array can be side-by-side, entwined, interbraided, etc.
  • the elastomeric fibers 12 are shown with wrapping 13. Such wrapping is preferred.
  • a particularly preferred central region core component consists of a parallel array of spandex yarns, wrapped with two layers of Dacron® multifilament yarn.
  • the central region 5 may have an optional over-sleeve 22 (shown in phantom) positioned over the basic" braid.
  • the over ⁇ sleeve is preferably a knitted, woven or braided fabric tube.
  • the fibers of the fabric may be the same as those used to form the biaxial components of the basic braid.
  • Particularly preferred fibers are made of polyethylene, and a preferred fabric construction for the over-sleeve is a tubular raschel knit.
  • the over-sleeve should be sufficiently porous to permit ingrowth of fibrous tissue and must have a certain degree of stretchability. Therefore, an inherently stretchable fabric is preferred.
  • the over-sleeve 22 is held in place by the binding means 17 in the transition region 7, discussed more fully below.
  • the over-sleeve serves to minimize abrasion between the central region 5 and the nearby bone.
  • a collar-like member may be inserted into the bone hole exits 18 ( Figure 3) to provide a surface less abrasive than that provided by natural bone.
  • the primary attachment region 6, as shown in Figures 1 and 2 is the region where the prosthesis is biologically fixed to the bones by tissue ingrowth.
  • Tissue ingrowth requires both porosity and a lack of stretchability in the longitudinal direction, under typical biological loads.
  • a strong, stiff component is added to the core position of the basic braid, included in the warp position of the basic braid, or utilized in both the warp and core positions.
  • Each core and/or warp component in the primary attachment region may be comprised of one or more strong, stiff monofilament and/or multifilament yarns.
  • Suitable strong, stiff yarns can be made from the fibers listed for the braiding components.
  • metals, such as titanium and biocompatible ceramics may be used. Where more than one yarn is utilized, the yarns may, themselves, be braided, left in parallel array or otherwise arranged.
  • the core component may comprise one or more strong, stiff porous plugs.
  • Suitable porous plugs include, but are not limited to, those constructed from polyolefins, such as ultrahigh molecular weight polyethylene; polysulfones; resorbable polymers such as polylactide; polyesters; calcium phosphate ceramics such as hydroxylapatite or -tricalcium phosphate; bioglasses; other ceramics such as alumina, barium titanate, or zirconia; metals such as stainless steel, cobalt-chrome alloys, tantalum, titanium and its alloys; natural bone and other natural materials; and suitable combinations thereof.
  • the plug may be of various shapes, including the tapered shape discussed in U.S. Patent 3,973,277. Other suitable porous plug materials and shapes will be readily apparent to those skilled in the art.
  • Preferred fibers include those made from polyolefins, particularly polyethylene; metals, particularly titanium; or polyesters, particularly polyethylene terephthalates (PET) , including Dacron®. The most preferred fibers are PET.
  • Preferred porous plugs include a composite of tricalcium phosphate and polylactide, ultrahigh molecular weight polyethylene and titanium. Most preferred is ultrahigh molecular weight polyethylene and titanium.
  • large diameter monofilament yarns in the construction of the stiff core and/or warp components is preferred.
  • large is meant a yarn diameter such that when the yarns are incorporated into the stiff core and/or warp components, voids are formed which are of sufficient size to permit ingrowth of trabecula bone and/or other tissue.
  • Preferred large monofilament yarns have diameters in the range of about 100 to about 500 micrometers, 250 being preferred.
  • the core and/or warp components of the primary attachment region may, if desired, be wrapped with one or more yarns.
  • the elastomeric core and/or warp components of the central region may, if desired, extend continuously into the primary attachment, as shown in Figure 2.
  • Figure 2 illustrates a preferred embodiment of primary attachment region 6 which contains both core component 11' and warp components 14.
  • Core component 11' is shown as a parallel array of wrapped elastomeric yarns 12, each having wrapping 13, the whole array being overbraided with triaxially braided monofilament yarns 15.
  • Warp components 14 are biaxially braided monofilament yarns.
  • the purpose of the primary attachment region is to provide an area for long-term biological fixation of the device to a desired body part through tissue ingrowth.
  • tissue ingrowth fixation utilizing the present invention is effected as follows. First, a hole is drilled at surgery in the bone 20 to which fixation is desired, and th'e primary attachment region 6 of the prosthesis is placed into the resulting bone tunnel. For best results, the prosthesis should fit snugly in the tunnel. The prosthesis is held in place temporarily by the secondary attachment region, discussed below. The healing process will then provide an ingrowth of tissue into the pores supplied by the stiff components of the primary attachment region. Because of the stiffness of the primary attachment region, shearing of ingrown tissue during movement will be minimized.
  • a radio-opaque substance such as BaS0 4
  • the primary attachment region should have a surface porosity and an interconnected bulk porosity, each of about 5 to about 95 percent, preferably from about 25 to about 50 percent. Most preferably the porosities are between 30 and 50 percent.
  • surface porosity is defined as the percentage of the surface area of the tissue ingrowth region which consists of pores having a minimum dimension of about 50 micrometers.
  • Interconnected bulk porosity is defined herein as the percentage of the volume of the tissue ingrowth region consisting of open areas having a minimum dimension of about 50 micrometers which are in communication with the surface of the braid in this region. This can be measured by standard mercury porosimetry techniques. For the combined reasons of structural integrity and tissue ingrowth compatibility, high porosity and/or interconnected bulk porosity is preferred. (c) Transition Region
  • the transition region 7 is the area between the central region and the primary attachment region. It is here that the various modifications in the central and primary attachment regions may begin and end.
  • the structural and functional characteristics of the central region and the primary attachment region are generally significantly different, and thus this segment of the prosthesis provides a region which accommodates these structural and functional variations.
  • the transition region serves to "tie down" the various elastomeric components of the central region and the stiff components of the primary attachment region which may begin or end, as the case may be, in the transition region. Not tying loose component ends down could result in premature prosthesis failure due to abrasion caused by the relative motion of these components.
  • the transition region is defined by the presence of a binding means for preventing substantial relative motion of the braiding, warp, and/or core components which are present in this region.
  • Suitable binding means include, but are not limited to ' , (1) a tight covering positioned around the exterior of at least a portion of this region of the basic braid, and (2) an impregnation material.
  • a tight covering includes a collar or a wrapping and may be constructed from any of the fibers utilized in the stiff and/or elastomeric yarns discussed herein.
  • the material utilized as the tight covering is elastomeric so as to better accommodate small shifts in region components, while allowing the tight covering to remain snugly positioned.
  • the tight covering of the transition region comprises a wrapping of elastomeric yarns.
  • Suitable impregnation materials include silicones, urethanes and biocompatible glues.
  • Figure 2 depicts a preferred embodiment of transition region 7 wherein the binding means comprises a wrapping 17 of an elastomeric yarn.
  • the wrapping 17 comprises at least two layers (not shown) , an underlayer of bare elastomeric yarn, and an overlayer of elastomeric yarn, which is, itself wrapped with a fine multifilament yarn, (d) Secondary Attachment Region.
  • the prosthesis may further comprise a secondary attachment region 8, as shown in Figure 1, located adjacent to each of the primary attachment regions.
  • the secondary attachment region is defined by the presence of means for immediately fixing the prosthesis to a body part during surgical implantation. Suitable means include, but are not limited to an eyelet 9, as shown in Figure 1, which can be screwed to bone, and a plug or anchor (not shown) which serves to keep the prosthesis secured within the bone tunnel.
  • the basic braid and any warp and/or core components in the secondary attachment region are bifurcated into two bundles to form an eyelet 9 suitable for securement by a button, screw (such as screw 16) or other conventional attachment device.
  • a button, screw such as screw 16
  • Several such eyelets could be formed next to each other in the secondary attachment region. This would make it possible to secure the device at several locations or else select the eyelet which lies at a favorable anatomic location for screw insertion.
  • the ligament prosthesis of the present invention may further comprise a tail region 10 located adjacent to each of the secondary attachment regions.
  • the tail region should be stiff, strong and slender, to facilitate installation. Specifically, the tail region can be pushed through bone tunnels and can be used to pull the prosthesis into place. Following installation of the prosthesis, the tail region can be clipped off, such as at point 19, as shown in Figure 3. In this region, strong, stiff core and/or warp components, as described, above may be added to the basic braid. The following is a description of the second aspect of the present invention.
  • the second aspect is similar in most respects to the previously described first aspect, with the exception that the "central region" is, instead of one braided tube, a parallel array of a plurality of individually braided tubes. Each individually braided tube of the central region becomes a single stiff braiding component used to form the "basic braid" of the primary attachment region.
  • the prosthesis in accordance with the second aspect provides a structure with low torsional rigidity compared to the prosthesis in accordance with the first aspect of the invention. Accordingly, the - prosthesis in accordance with the second aspect develops low torque during use.
  • the use of a parallel array of braids allows the central region to flatten if it rubs against another surface, such as bone or another ligament.
  • each individually braided tube in the central region may be the same as or different from the braiding angle of the tube as it forms a single braiding component of the basic braid in the primary attachment region. As the braiding angle is lowered, the braided tube becomes closer to a parallel array of fibers.
  • the invention contemplates a prosthesis having a central region comprising a parallel array of a plurality of braided tubes, each of which tubes becomes yarn-like in the primary attachment region, where it serves as a single braiding component of the basic braid.
  • FIG. 6 there is seen a parallel array 23 of a plurality of braided tubes 24.
  • the braided tubes are themselves braided together to form one large braided tube 25.
  • Figure 7 shows the braiding angle "a” of individual tube 24 in the region designated "A” in Figure 6
  • Figure 8 shows the braiding angle "b” of individual tube 24 in the region designated "B” in Figure 6.
  • FIG 9 shows a preferred embodiment of a ligament prosthesis in accordance with the second aspect of the invention.
  • the central region 5' comprises a parallel array 23 of a plurality (four are shown in the Figure) of individually braided tubes 24, each of which is braided at a predetermined braiding angle.
  • a biaxial braid is preferred.
  • the braiding components of the braid may be the same stiff braiding components described earlier for the "basic braid" of the first aspect of the invention.
  • Each tube 24 of the parallel array 23 of braided tubes 24 enters the transition region 7', where the tubes 24 are, themselves, braided together to form a basic braid 25, which continues into the primary attachment region 6'.
  • the central region 5 ' is flanked by two primary attachment regions 6 ' and two transition regions 7 ' .
  • Figure 10 shows four individually braided tubes 24 emerging from transition region 7 ' .
  • Each of the tubes 24 becomes a braiding component 2', 3' of_ the basic braid of the primary attachment region 6 ' .
  • the braiding angle of each individual tube 24 can become quite low, approaching an essentially unbraided yarn.
  • At least one of the individual tubes 24 of the parallel array 23 contains an elastomeric component 26, either in the channel of the tube or in the warp position of the braid.
  • the primary attachment region 6' may contain a stiff component, either in the channel or in the warp.
  • stiff biaxial braids 14' in the warp and concentric braids 27 in the channel there are shown stiff biaxial braids 14' in the warp and concentric braids 27 in the channel.
  • the basic braid of the primary attachment region 6', formed from the individual tubes 24, is kept from unbraiding by binding means, such as tight wrapping 17' positioned over a portion of the parallel array 23 and a portion of the basic braid of the primary attachment region.
  • the binding means serves to minimize the relative motion of the braids and the elastomeric and stiff components included within the braids or within the channels enclosed by the braids.
  • Suitable elastomeric components include elastomeric yarns or a parallel array of elastomeric yarns.
  • the yarns may be wrapped if desired. Unlike the first aspect of the invention, however, it is desirable that the elastomeric yarns not extend beyond the transition region (defined by the presence of binding means 17') into the primary attachment region 6' .
  • Suitable stiff components for the primary attachment region 6' include those already mentioned in connection with the first aspect of the invention. Both aspects of the present invention may be symmetrical structures, in the sense that the central region is flanked by two primary attachment regions and transition regions. Alternatively, in some applications it may be preferable to have an asymmetrical structure, i.e. , a "central region" and only a single primary attachment region and transition region.
  • Suitable means include an eyelet formed by bifurcating the basic braid, as described earlier for the "secondary attachment region.” If an asymmetrical prosthesis in accordance with the second aspect of the invention is used, the free ends of the individual tubes used to form the parallel array can be bound together to form an attachment site. Suitable means for binding the free ends includes a tight wrapping of elastomeric yarn. Examples illustrating construction techniques for ligament prostheses of the present invention are set forth below. These examples are not to be construed as limiting the invention.
  • Example 1 This Example describes the construction of a prosthesis in accordance with the first aspect of the present invention.
  • PET polyethylene-terephthalate
  • Construct First Primary Attachment Region Insert the core component into the center of the braid immediately following the eyelet. Adjust the machine to give an open braid (e.g., 5.8 picks/inch). (7) Construct the First Transition Region, a
  • Central Region and a Second Transition Region Stop braiding just short of the point where the basic braid would begin to cover the region of the core where the monofilament was removed. Set the braiding machine to produce a dense braid (e.g. 19.2 picks/inch). Braid beyond the central region until the beginning of the second set of warp components are captured in the core region of the basic braid as in the first transition region. (8) Complete the Second Transition Region:
  • Begin Second Primary Attachment Region Set the machine to produce the same open braid used for the first primary attachment region (i.e., 5.8 picks/inch) . (10) Construct Eyelet in Second Secondary
  • Attachment Region Stop braiding at an appropriate point and form a second eyelet in the same manner as the first. Continue braiding until the secondary attachment region is complete.
  • Construct Second Tail Region and Complete the Basic Braid Set the machine to produce a dense braid (12.6 picks/inch) . Braid to within a short distance f om the end of the warp components . Move the warp components into the core region. Braid beyond the ends of these components . (12) Remove the completed device from the machine.
  • the device functions best if preconditioned. To precondition the device, cyclicly load the it through its eyelet for a limited number of cycles to remove initial slack in the structure. Typical values are 5 to 200 lbs., for 10 cycles.
  • the device should be cleaned to remove fiber finishes and other contaminants .
  • the device should then be sterilized by exposure to gamma radiation at a dose level, for example, of approximately 2.5 megaRads.
  • Length Central Region inches
  • Length Primary Attachment Region inches
  • Length Transition Region inches
  • Example 2 This Example describes the construction of a prosthesis in accordance with the second aspect of the present invention.
  • Align Braided Tubes In a parallel array, align the central sections of the braided tubes where the wrapped spandex yarn is included. Put a temporary binding around this central section to maintain the alignment and parallel arrangement during subsequent operations.
  • Prepare to Assemble Device Mount the sixteen braided tubes in the braiding machine such that one end of each is attached to one of the sixteen braiding carriers and the other end is attached to the take-off. Adjust the position of the braiding point to correspond to the ends of the central sections of the braided tubes nearest the braiding carriers. Set the machine to give an open braid (e.g., 5.8 picks/inch) .
  • Attachment Region Lash one side of the eyelet by removing a bobbin from that side of the braider and passing the attached braided tube around the remaining braided tubes and half the warp components on that side of the braider. Lash the other side in a similar fashion. Re-install the lashing bobbins on their carriers.
  • the device may function best if preconditioned. To precondition the device, cyclicly load it through its eyelet for a limited number of cycles -to remove initial slack in the structure. Typical values are 5 to 200 lbs., for 10 cycles.
  • the device should be cleaned to remove the fiber finishes and other contaminants.
  • the device should then be sterilized by exposure to gamma radiation at a dose -level, for example, of approximately 2.5 megarads.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Rehabilitation Therapy (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Rheumatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Textile Engineering (AREA)
  • Prostheses (AREA)

Abstract

Une prothèse de tissu souple comprend une tresse tubulaire (6) ayant des régions de raideur et d'élasticité obtenues à l'aide de composants raides et élastomères (12) disposés dans un canal enfermé par le tube et/ou dans la tresse (6), et des moyens définissant une région de transition (7) pour réduire au minimum le mouvement relatif parmi les composants de la tresse, les composants raides et les composants élastomères.
PCT/US1988/002709 1987-08-19 1988-08-15 Prothese de tissu souple WO1989001320A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DK042190A DK42190A (da) 1987-08-19 1990-02-16 Ledbaandsprotese

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US8686687A 1987-08-19 1987-08-19
US086,866 1987-08-19

Publications (1)

Publication Number Publication Date
WO1989001320A1 true WO1989001320A1 (fr) 1989-02-23

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Application Number Title Priority Date Filing Date
PCT/US1988/002709 WO1989001320A1 (fr) 1987-08-19 1988-08-15 Prothese de tissu souple

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Country Link
EP (1) EP0375729A4 (fr)
JP (1) JPH03505823A (fr)
DK (1) DK42190A (fr)
WO (1) WO1989001320A1 (fr)

Cited By (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0397500A2 (fr) * 1989-05-10 1990-11-14 United States Surgical Corporation Fil semi-absorbable, tissu et prothèse tubulaire
WO1991007929A2 (fr) * 1989-11-28 1991-06-13 Baxter International Inc. Conception de ligament prothetique croise anterieur
EP0437174A1 (fr) * 1990-01-08 1991-07-17 SULZER Medizinaltechnik AG Implant pour substitution artificielle des ligaments et/ou tendons
DE4012602A1 (de) * 1990-04-20 1991-10-31 Ethicon Gmbh Resorbierbare implantat-kordel
WO1991017719A1 (fr) * 1990-05-22 1991-11-28 British Technology Group Ltd. Ligaments artificiels
EP0485986A1 (fr) * 1990-11-13 1992-05-20 United States Surgical Corporation Prothèse pour tissu conjonctif
FR2672204A1 (fr) * 1991-02-05 1992-08-07 Surer Patrick Implant pour chirurgie ligamentaire.
US5147400A (en) * 1989-05-10 1992-09-15 United States Surgical Corporation Connective tissue prosthesis
WO1994022395A1 (fr) * 1993-03-31 1994-10-13 Surgicraft Limited Ligament artificiel
US5376118A (en) * 1989-05-10 1994-12-27 United States Surgical Corporation Support material for cell impregnation
WO1995008966A1 (fr) * 1993-09-30 1995-04-06 White Geoffrey H Greffe endoluminale
US5456722A (en) * 1993-01-06 1995-10-10 Smith & Nephew Richards Inc. Load bearing polymeric cable
FR2729559A1 (fr) * 1995-01-25 1996-07-26 Cousin Freres Sa Renfort ligamentaire textile, en particulier destine a l'articulation du genou
US5540703A (en) * 1993-01-06 1996-07-30 Smith & Nephew Richards Inc. Knotted cable attachment apparatus formed of braided polymeric fibers
WO1999055258A1 (fr) * 1998-04-29 1999-11-04 Michel Merle Element d'aide a la restauration d'un tendon flechisseur, notamment d'un doigt d'une main
WO2000004847A1 (fr) * 1998-07-21 2000-02-03 Ethicon Gmbh Implant absorbable tresse
WO2001052773A1 (fr) * 2000-01-17 2001-07-26 Matsuda Medical Co.,Ltd. Matiere de renforcement des ligaments
FR2865380A1 (fr) * 2004-01-23 2005-07-29 L A R S Laboratoire D Applic E Procede pour la fixation de fils de traction aux extremites d'un ligament prothetique
WO2008116127A3 (fr) * 2007-03-20 2009-03-12 Serica Techonologies Inc Dispositif prothétique et procédé de fabrication de celui-ci
WO2009047767A1 (fr) * 2007-10-11 2009-04-16 Tavor [I.T.N] Ltd. Prothèse de ligament et de tendon
WO2011012783A1 (fr) * 2009-07-31 2011-02-03 Laboratoire D'application Et De Recherche Scientifique - Lars Ligament prothetique pour fixation transversale et procede de confection
WO2013143966A3 (fr) * 2012-03-30 2013-12-05 Teufelberger Gesellschaft M.B.H. Corde à âme et gaine
EP2687188A1 (fr) 2012-07-20 2014-01-22 Le Centre National De La Recherche Scientifique Tendon ou ligament artificiel avec rigidité variable de long de la structure
US8956394B1 (en) 2014-08-05 2015-02-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
USD740427S1 (en) 2014-10-17 2015-10-06 Woven Orthopedic Technologies, Llc Orthopedic woven retention device
US9163341B2 (en) 2010-04-29 2015-10-20 Dsm Ip Assets B.V. Multifilament yarn construction
US9585695B2 (en) 2013-03-15 2017-03-07 Woven Orthopedic Technologies, Llc Surgical screw hole liner devices and related methods
US9907593B2 (en) 2014-08-05 2018-03-06 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9943351B2 (en) 2014-09-16 2018-04-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems, packaging, and related methods
WO2019056774A1 (fr) * 2017-09-21 2019-03-28 上海松力生物技术有限公司 Implant régénératif de ligament croisé, son procédé de préparation et son application
US10555758B2 (en) 2015-08-05 2020-02-11 Woven Orthopedic Technologies, Llc Tapping devices, systems and methods for use in bone tissue
IT201900007665A1 (it) * 2019-05-30 2020-11-30 St Ortopedico Rizzoli Dispositivo per intervento di ricostruzione di un legamento crociato
US11395681B2 (en) 2016-12-09 2022-07-26 Woven Orthopedic Technologies, Llc Retention devices, lattices and related systems and methods

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JP5425797B2 (ja) * 2007-11-02 2014-02-26 バイオメット ユーケイ リミテッド 置換術用人工関節
GB2464952A (en) * 2008-10-30 2010-05-05 Xiros Plc Surgical cord

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US4187558A (en) * 1977-10-25 1980-02-12 Cutter Laboratories, Inc. Prosthetic ligament
US4301551A (en) * 1979-05-24 1981-11-24 Ecole Polythechnique Deformable high energy storage tension spring
US4483023A (en) * 1981-08-21 1984-11-20 Meadox Medicals, Inc. High-strength ligament prosthesis
US4584722A (en) * 1982-05-24 1986-04-29 Yeda Research And Development Co., Ltd. Prosthetic tendon
US4610688A (en) * 1983-04-04 1986-09-09 Pfizer Hospital Products Group, Inc. Triaxially-braided fabric prosthesis
US4642119A (en) * 1984-07-16 1987-02-10 Johnson & Johnson Connective tissue prosthesis

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CH644748A5 (de) * 1980-06-03 1984-08-31 Sulzer Ag Sehnen- und/oder baenderersatzmaterial.

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US3805300A (en) * 1972-07-28 1974-04-23 Cutter Lab Tendon prosthesis
US4187558A (en) * 1977-10-25 1980-02-12 Cutter Laboratories, Inc. Prosthetic ligament
US4301551A (en) * 1979-05-24 1981-11-24 Ecole Polythechnique Deformable high energy storage tension spring
US4483023A (en) * 1981-08-21 1984-11-20 Meadox Medicals, Inc. High-strength ligament prosthesis
US4584722A (en) * 1982-05-24 1986-04-29 Yeda Research And Development Co., Ltd. Prosthetic tendon
US4610688A (en) * 1983-04-04 1986-09-09 Pfizer Hospital Products Group, Inc. Triaxially-braided fabric prosthesis
US4642119A (en) * 1984-07-16 1987-02-10 Johnson & Johnson Connective tissue prosthesis

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Cited By (54)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5147400A (en) * 1989-05-10 1992-09-15 United States Surgical Corporation Connective tissue prosthesis
US4990158A (en) * 1989-05-10 1991-02-05 United States Surgical Corporation Synthetic semiabsorbable tubular prosthesis
US5376118A (en) * 1989-05-10 1994-12-27 United States Surgical Corporation Support material for cell impregnation
EP0397500A3 (fr) * 1989-05-10 1991-09-11 United States Surgical Corporation Fil semi-absorbable, tissu et prothèse tubulaire
US5217495A (en) * 1989-05-10 1993-06-08 United States Surgical Corporation Synthetic semiabsorbable composite yarn
EP0397500A2 (fr) * 1989-05-10 1990-11-14 United States Surgical Corporation Fil semi-absorbable, tissu et prothèse tubulaire
WO1991007929A2 (fr) * 1989-11-28 1991-06-13 Baxter International Inc. Conception de ligament prothetique croise anterieur
WO1991007929A3 (fr) * 1989-11-28 1991-10-31 Baxter Int Conception de ligament prothetique croise anterieur
US5192322A (en) * 1990-01-08 1993-03-09 Sulzer Brothers Limited Implant for a prosthetic ligament and/or tendon replacement
EP0437174A1 (fr) * 1990-01-08 1991-07-17 SULZER Medizinaltechnik AG Implant pour substitution artificielle des ligaments et/ou tendons
DE4012602A1 (de) * 1990-04-20 1991-10-31 Ethicon Gmbh Resorbierbare implantat-kordel
WO1991017719A1 (fr) * 1990-05-22 1991-11-28 British Technology Group Ltd. Ligaments artificiels
US5356434A (en) * 1990-05-22 1994-10-18 British Technology Group Limited Artificial ligaments
EP0485986A1 (fr) * 1990-11-13 1992-05-20 United States Surgical Corporation Prothèse pour tissu conjonctif
EP0498690A1 (fr) * 1991-02-05 1992-08-12 Patrick Surer Implant pour chirurgie ligamentaire
FR2672204A1 (fr) * 1991-02-05 1992-08-07 Surer Patrick Implant pour chirurgie ligamentaire.
US5540703A (en) * 1993-01-06 1996-07-30 Smith & Nephew Richards Inc. Knotted cable attachment apparatus formed of braided polymeric fibers
US5456722A (en) * 1993-01-06 1995-10-10 Smith & Nephew Richards Inc. Load bearing polymeric cable
WO1994022395A1 (fr) * 1993-03-31 1994-10-13 Surgicraft Limited Ligament artificiel
WO1995008966A1 (fr) * 1993-09-30 1995-04-06 White Geoffrey H Greffe endoluminale
FR2729559A1 (fr) * 1995-01-25 1996-07-26 Cousin Freres Sa Renfort ligamentaire textile, en particulier destine a l'articulation du genou
WO1999055258A1 (fr) * 1998-04-29 1999-11-04 Michel Merle Element d'aide a la restauration d'un tendon flechisseur, notamment d'un doigt d'une main
FR2778092A1 (fr) * 1998-04-29 1999-11-05 Michel Merle Element d'aide a la restauration d'un tendon flechisseur, notamment d'un doigt d'une main
WO2000004847A1 (fr) * 1998-07-21 2000-02-03 Ethicon Gmbh Implant absorbable tresse
DE19833796B4 (de) * 1998-07-21 2015-10-01 Johnson & Johnson Medical Gmbh Geflochtenes resorbierbares Implantat
WO2001052773A1 (fr) * 2000-01-17 2001-07-26 Matsuda Medical Co.,Ltd. Matiere de renforcement des ligaments
WO2005079707A1 (fr) * 2004-01-23 2005-09-01 Lars - Laboratoire D'application Et De Recherche Scientifique Procede pour la fixation de fils de traction aux extremites d’un ligament prothetique
FR2865380A1 (fr) * 2004-01-23 2005-07-29 L A R S Laboratoire D Applic E Procede pour la fixation de fils de traction aux extremites d'un ligament prothetique
WO2008116127A3 (fr) * 2007-03-20 2009-03-12 Serica Techonologies Inc Dispositif prothétique et procédé de fabrication de celui-ci
US9060854B2 (en) 2007-03-20 2015-06-23 Allergan, Inc. Prosthetic device and method of manufacturing the same
WO2009047767A1 (fr) * 2007-10-11 2009-04-16 Tavor [I.T.N] Ltd. Prothèse de ligament et de tendon
US20100286775A1 (en) * 2007-10-11 2010-11-11 Tavor [I.T.N] Ltd., Ligament and Tendon Prosthesis
WO2011012783A1 (fr) * 2009-07-31 2011-02-03 Laboratoire D'application Et De Recherche Scientifique - Lars Ligament prothetique pour fixation transversale et procede de confection
FR2948556A1 (fr) * 2009-07-31 2011-02-04 Lars Ligament prothetique pour fixation transversale et procede de confection
CN102625680A (zh) * 2009-07-31 2012-08-01 拉思公司-科学研究与应用实验室 用于横向固定的人工韧带及其制备方法
US9834873B2 (en) 2010-04-29 2017-12-05 Dsm Ip Assets B.V. Multifilament yarn construction
US9163341B2 (en) 2010-04-29 2015-10-20 Dsm Ip Assets B.V. Multifilament yarn construction
WO2013143966A3 (fr) * 2012-03-30 2013-12-05 Teufelberger Gesellschaft M.B.H. Corde à âme et gaine
EP2687188A1 (fr) 2012-07-20 2014-01-22 Le Centre National De La Recherche Scientifique Tendon ou ligament artificiel avec rigidité variable de long de la structure
US9585695B2 (en) 2013-03-15 2017-03-07 Woven Orthopedic Technologies, Llc Surgical screw hole liner devices and related methods
US9907593B2 (en) 2014-08-05 2018-03-06 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US11376051B2 (en) 2014-08-05 2022-07-05 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9808291B2 (en) 2014-08-05 2017-11-07 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US8992537B1 (en) 2014-08-05 2015-03-31 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US8956394B1 (en) 2014-08-05 2015-02-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9532806B2 (en) 2014-08-05 2017-01-03 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US10588677B2 (en) 2014-08-05 2020-03-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9943351B2 (en) 2014-09-16 2018-04-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems, packaging, and related methods
USD740427S1 (en) 2014-10-17 2015-10-06 Woven Orthopedic Technologies, Llc Orthopedic woven retention device
US10555758B2 (en) 2015-08-05 2020-02-11 Woven Orthopedic Technologies, Llc Tapping devices, systems and methods for use in bone tissue
US11395681B2 (en) 2016-12-09 2022-07-26 Woven Orthopedic Technologies, Llc Retention devices, lattices and related systems and methods
WO2019056774A1 (fr) * 2017-09-21 2019-03-28 上海松力生物技术有限公司 Implant régénératif de ligament croisé, son procédé de préparation et son application
WO2020240303A1 (fr) * 2019-05-30 2020-12-03 Istituto Ortopedico Rizzoli Dispositif de reconstruction chirurgicale d'un ligament croisé
IT201900007665A1 (it) * 2019-05-30 2020-11-30 St Ortopedico Rizzoli Dispositivo per intervento di ricostruzione di un legamento crociato

Also Published As

Publication number Publication date
EP0375729A1 (fr) 1990-07-04
JPH03505823A (ja) 1991-12-19
DK42190D0 (da) 1990-02-16
EP0375729A4 (en) 1990-09-26
DK42190A (da) 1990-04-18

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