CA1282205C - Surgical repair device - Google Patents
Surgical repair deviceInfo
- Publication number
- CA1282205C CA1282205C CA000530746A CA530746A CA1282205C CA 1282205 C CA1282205 C CA 1282205C CA 000530746 A CA000530746 A CA 000530746A CA 530746 A CA530746 A CA 530746A CA 1282205 C CA1282205 C CA 1282205C
- Authority
- CA
- Canada
- Prior art keywords
- denier
- yarns
- yarn
- implant
- braid
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/26—Mixtures of macromolecular compounds
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G1/00—Producing crimped or curled fibres, filaments, yarns, or threads, giving them latent characteristics
-
- 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
- D04C1/02—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof made from particular materials
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
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- 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
- D10B2403/00—Details of fabric structure established in the fabric forming process
- D10B2403/03—Shape features
- D10B2403/031—Narrow fabric of constant width
- D10B2403/0311—Small thickness fabric, e.g. ribbons, tapes or straps
-
- 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
Abstract
SURGICAL REPAIR DEVICE
ABSTRACT
A surgical repair device having a length to width ratio of greater than one is disclosed. The device comprises a plurality of fibers. The majority of the fibers are in a direction essentially parallel to the device length.
The device has an absorbable component comprising a glycolic or lactic acid ester linkage. The remainder of the device. if any, has a non-absorbable component. The device can be used as a flat braid in the repair of a lignment or tendon.
ABSTRACT
A surgical repair device having a length to width ratio of greater than one is disclosed. The device comprises a plurality of fibers. The majority of the fibers are in a direction essentially parallel to the device length.
The device has an absorbable component comprising a glycolic or lactic acid ester linkage. The remainder of the device. if any, has a non-absorbable component. The device can be used as a flat braid in the repair of a lignment or tendon.
Description
128;~205 29,819 - 1 -SURGICAL REPAIR DEVIC~
BACKGROUND
Thls invention relates to an implantable devlce composed of one or more bio-absorbable polymer(s) or combinations of bloabsorbable/non-absorbable polymer~s) for the repair or augmentatlon of connectlve tlssue damaged by disease or in~ury. The devices shall serve as scaffolds for ingrowth and orientation of new flbrous connective tlssue, (e.g. llgaments, tendons) ln both intra-artlcular and extra-articular sltes by malntalnlng structural stablllty durlng inltlal heallng and then undergolng at least partlal gradual absorptlon to prevent stress shlelding and allow newly formed tlssue to become correctly orlented and load bearlng.
The lnvention lncludes several aspects of device design that are lntended to provide for simulation of natural tissue function lmmedlately after implantation and to support subsequent fibrous tissue ingrowth as well as orientatlon in the dlrection of natural loadlng. The devlces are bralded or woven into a flat tape geometry having the plurality of flbers allgned ln parallel to form the axlal warp. The physlcal/mechanlcal/chemlcal propertles of all or part of the component fibers may be enhanced by a number of temperature/time/
stress treatments. One or more ad~acent plies of the devlce are used ln surgery to achleve biomechanlcal propertles approximately equlva-lent to the healthy tissue prior to being damaged. A swlvel needle 1'~8~ 05 attachment system may be lncorporated to facllltate handllng and surglcal placement of the devlces. The interfibrillar space, that provides for initial tissue ingrowth, occurs as a result of the braiding~weavinq process or may be enhanced by means of texturlzing the yarns. Gradual b1oabsorption, in whole or in part, provides for additional interfibrillar space to form during the healing period, and for flbrous tlssue orientation to be induced as load is trans-ferred from the weakened implant to the 'neo-ligament' or 'neo-tendon'.
The bioabsorbable materials, biocompatible nonabsorbable materlals, physical and chemical combinations thereof, and the processes involved in Eabricating them into the implantable devices are all included in this invention.
Llgaments and tendons are bands or sheets of fibrous connective tissue which provide support and stability to the musculoskeletal system. Relief of the pain and/or instability caused by damage to a ligament or tendon is currently achieved by techniques ranglng from s~mple suturing to removal and replacement with other tissue or a permanent synthetic prosthesis. Although no single technique is appropriate for all situations, it is generally preferred to return the tissue to it's healthy, pre-damaged state as naturally as possible. Furthermore, it is highly desirable to reduce the need for activity restriction during the healing period. The permanent retention of implanted foreign materials is considered undeslrable and should be minlmized because it may result in stress shielding and subsequent atrophy of natural tissue, or the migration of the materials to other tissues and/or systems ~i.e. lymphatic) may occur.
The surgical repair device of this invention has functional advantages over prior art devices. For example, this invention can utilize absorbable fibers in the axial (lengthwise) direction. The ma~ority of absorbable fibers in the axial direction enhances or ~'~8~0S
essentially guarantees the transfer of the connective tlssue stress from the device to the ingrowing collagen fibers. In summary, with the ma~ority of fibers belng in the axial dlrectlon and wlth these fibers belng at least about 80'~, absorbable flbers, there appears to be more tlssue lngrowth and better orlented collagen flbers.
This invention is useful as a temporary or augmentation device. In this utility. it seems to match as closely as possible the biologlcal properties of a connective tissue until ingrown collagen fibers can replace the ma~ority of fibers (preferably havlng an absorbable component comprising at least about 80 percent) in the axlal dlrectlon. That ls, an advantage of thls invention over the prlor art implant devlces ls that lt appears to provlde a surgical repair devlce (speclflcally for connective tissue, and more specifically for ligament or tendon repair) that will have the correct stress related properties to act as a connective tissue (untll llvlng tlssue can replace the devlce). Thls is accomplished by the ingsown collagen fibers replacing the absorbable fibers in the axial direction. The use of nonabsorbable fibers is as a support or backbone for the absorbable fibers.
This invention -has superior and unexpected structural properties over those disclosed in the prior art. For example, the ma~ority of the fibers in this invention, that is 50 percent or more, are in the axial (lengthwise) direction. Preferably, 80 to 95 percent are in the axial directlon. This approximately twofold increase of flbers ln the axlal (lengthwise) direction is at least one of if not the primary reason for obtaining the functlonal advantages dlscussed above.
The surgical repalr device of this invention has other advantages over the prior art. For example, the thickness of the device is smaller than the known prlor art devices. This is because the ma~ority of the fibers are in the axial dlrection. The smaller thickness allows this devlce to be useful in more constricted connective tissue repair procedures. Also, as a general statement, the smaller the thlckness or width of the repa1r devlce, the greater is its utility as a temporary or augmentation device because tissue ingrowth is facilitated. Conversely, the larger the thickness or width of the device, the more it is used as replacement (that is, as a permanent implant) rather than a temporary device.
It is, therefore, the ob~ect of this invention to provide sterile, surgically implantable devices, means Eor surgical placement/attach-ment, and fabrication processes that are uniquely suited for providing the most advantageous connective tissue (i.e. ligament, tendon, etc.) repair. These implants resolve the apparent disadvantages of the devices described above by: 1.) providing adequate strength and stiffness immediately post-operatively to minimize or eliminate the need for immobilization; 2.) facilitating the ingrowth of vascularized cellular tissue by reason of the open flat tape configuration; 3.) supporting the proper orlentation o$
collagen fibers formed within and around the implant through the predominantly axial alignment of the component yarns and the gradual transfer of applied loads from the biodegradable yarns to the newly formed tissue; 4.) providing a longer lasting bioabsorbable material to permit adequate time for new tissue ingrowth or revascularization of autogenous tissue grafts or allografts; 5.) providing a compliant, elastic, permanent component to protect tissues from over-load, without stress-shielding, for a longer term than provided by the bioabsorbable materials, in those applications (i.e some intraar-ticular ligament reconstructions) where healing occurs more slowly;
and 6.) avoiding the use of materials which fragment and pose risks of migration to ad~acent tissues.
The ob~ect of this lnvention comprises bioabsorbable or combined bioabsorbable/biocompatible polymers fabricated into an elongated textile structure having means for surgical placement/attachment at one or both ends for the purpose of repair, augmentation or replacement of damaged connective tissues, such as ligaments and tendons.
1~8~05 SUMMARY OF THE INVENTION
The invention is a flat braided ligament or tendon lmplant devlce having a length to width ratio of greater than one, comprising a plurality of fibers, the majority of the fibers being in a directlon essentially parallel to the implant length, the braid having about 5 to 25 carrier and up to about 10 warp yarns, wherein the yarn~ are texturized, and said implant having an absorbable component comprising from about 10 to 100 percent of a copolymer, the copolymer having glycolic acid ester and from about 20 to 40 percent by weight of trimethylene carbonate linkages, and the remainder of said implant, if any, having a nonabsorbable component.
Embodiments of the repair device include a knitted, woven, braided and flat braided device. In one embodiment, the longitudinally oriented majority of the fibers comprises about 80 to 95 percent.
In a specific embodiment, the longitudinally oriented majority of the fiberæ comprises about 90 percent.
In another embodiment, the device has an absorbable component comprising at least about 80 percent. In a specific embodiment, the device has a nonabsorbable component selected from the group conslstlng of a poly(C2-C10 alkylene terephthalate), polytC2-C6 alkylene), polyamide, polyurethane and polyether-ester block copolymer. In a more specific embodiment, the devlce conslsts of poly(ethylene terephthalate) or poly(butylene terephthalate) as the poly(C2-C10 alkylene terephthalate), and a polybutester as the polyether-ester block copolymer. In a most specific embodiment, the device consists of Hytrel~ as the polybutester. A polybutester can be defined as a polytetramethylene glycol, polymer with terephthalic acid and 1, 4-butanediol.
Hytrel~ is a trademark of E. I. du Pont de Nemours & Co., Wilm-ington, Del. U.S.A. for a class of polymers having the following generic formula:
~o-cN~ 2~cN2-cl~2~o-~c~o-cu2-c~l2-~ll2-cN2-o-c~c}~
Vol1~ n~-n- ~Irco~ h~n-l"- Vo~ t~l~n- ~ v~
The values for a, x and y are known from the prior art. A specific embodiment of Hytrel which is useful in this invention is a grade of HytrelO having a 72 durometer D. hardness. The polymer in the NOVAFIL (American Cyanamid Company, New Jersey, U.S A.) surgical suture contains HytrelO.
A flat braided ligament or tendon implant device having a length to width ratio of greater than one has been invented. The device comprises a plurality of fibers The ma~ority of the fibers are in a direction essentially parallel to the implant length. The braid has about 5 to 100 carrier and up to about 50 warp yarns.
The implant has an absorbable component comprising from about 10 to 100 percent of a copolymer. The copolymer has glycolic acid ester and from about 20 to 40 percent by welght of trimethylene carbonate linkages The remainder of the implant, if any, has a nonabsorbable component.
~8;~2~S
In one embodlment of the lmplant, the brald has about 13 carrler and about 6 warp yarns. In a speclflc embodiment, the implant conslsts of about 100 percent of the absorbable component. In a more speclflc embodiment, the carrler yarns conslst of about 100 percent of the absorbable component and the warp yarns comprise about 80 percent of the absorbable component. In a most specific embodiment, the nonabsorbable component in the warp yarns is selected from the group conslstlng of a poly(ethylene terephthalate) and polyether-ester block copolymer.
In other embodiments of the implant, the yarns are texturized or heat treated. In a further embodiment of the implant, the brald ls heat treated.
The bloabsorbable filaments may be comprised of man-made polymers includlng glycollde-trimethylene carbonate (GTMC), polyglycollc acid, polydloxanone, poly(L-Lactic) acid, poly(DL-Lactic) acid and copolymers or physlcal comblnations of the components of these polymers. Natural bloabsorbable polymers such as regenerated collagen or surglcal gut may also be used. The biocompatible (nonabsorbable) components include poly~ethylene terephthalate) (PET), poly(butylene terephthalate) (P~T), polyether-ester multi-block copolymers, polypropylene, high strength/modulus polyethylene, polyamide (including polyaramid), or polyether type polyurethanes. Once spun into filaments, the properties oE the above materlals may be improved for this application by various tempera-ture/time/stress treatments.
The device shall be braided, woven or knitted so that the structure has the deslred strength and stiffness ln the primary (axial) loading dlrectlon. It also has adequate interfibrillar space and min~mized thickness to promote the ingrowth of tissue. The end(s) of the device may be ccmpressed inside biocompatible metal sleeve(s) to which swivel end-caps(s) and surgical needle(s) are attached in such a way as to permit rotation of the needle(s) about the longitudinal axis of the device.
'~S
In use, an appropriate number of plies of the device are implanted to match the biomechanical propertles of the tissue being repalred.
This permits an early return to normal function post-operatively. As the ligament or tendon begins to heal, the implant continues to bear any applied loads and tlssue ingrowth commences. The mechanical properties of the bioabsorbable component(s~ of the implant then slowly decay to permit a gradual transfer of loads to the ingrown fibrous tissue, stimulating it to orient along the loading direction. Additional ingrowth continues into the space provided by the absorbed components of the implant. This process continues until the bioabsorbable component(s) are completely absorbed and only the newly formed tissue remains, or the bicompatible (nonabsorbable) component(s) are left in situ to provide long-term augmentation of the newly formed tissue.
DR~WINGS AND DESCRIPTION
Fig. 1 is a diagrammatic view of the device described as the preferred embodiment, except that two different possible ends are shown.
Fig. 2 is an enlarged view of the flat surface of the preferred embodiment showing the braided construction in greater detail.
Fig. 3 is an anterior view of a knee showing the device asposltioned for repair of the excised patellar ligament in animal (canine) studies.
Fig. 4 is an anterior view of a knee showing the device as positioned for augmentation of the medial third of the patellar ligament in an anterior cruciate ligament reconstruction.
~8~20S
g In preEerred embodiments the elongated textile structure 1 of the implant comprises a flat braid having primarily axlal (quoit) yarns 2 of an absorbable polymer such as GTMC. The number and denier of quoit and sleeve yarns are varled to provide devices having a range of properties that are biomechanically compatible with any likely implant site. Swivel end cap(s) 3 and surgical needle(s) 4 may be attached at the end(s) of the device to facilitate placement and attachment.
The procedures described below are followed when preparing flat braids to be used as artificial ligaments/tendons starting from the appropriate yarns. To begin, the proper denier yarns for the specific braid construction are requlred. This example describes a typical construction designed to fit a particular animal model -repair/replacement of the canine patellar ligament (Fig. 3). An application that had a tensile strength/stiffness requirement three times higher than that described in the example would require three times as much yarn. This could be accomplished by simply tripling the final total braid denier, either by increasing the yarn denier or increasing the number of sleeve and quoit (stuffer yarns) or both.
To produce a braid for canine patellar ligament repair ~Fig. 3), a final braid denier between 13,000 and 24,000 is targeted. In the preferred construction, approximately 90% of the fiber is contained in the parallel quoit or warp yarns 2.
The sleeve yarns 5, which consist completely of absorbable material, are generally about 130 denier. On transfer they are given a nominal 1.4 turn ~er inch (TPI) 'Z' or 'S' twist before further processing. This facilitztes handling and mini~nizes fiber breakage.
The quoit ~stuffer or warp) yarns can be 100% absorbable or they may contain a nonabsorbable component. They are much heavier than the sleeve, generally ranging from 2100 to 2700 denier. This 1~8~
necessitates two passes on a six position ply twlster. A 130 denier yarn would normally be 5-plied 2.8 TPI 'S' or 'Z', then 4 ends of the 5-ply yarn would be twisted 1.4 TPI in the reverse direction. This would result in a final quoit yarn denier of 2600, mechanically balanced from the reverse twist operation (no tendency to twist or unravel).
Nonabsorbable components 6, if included, are blended into the quoit yarns during the 1st ply twisting operation. For instance, a MAXON~/NOVAFIL0 (American Cyanamid Co., NJ 07470 U.S.A.) bicomponent yarn consisting of 18-22% nonabsorbable fiber would be made by running 1 yarn of 130 denier NOVAFILO with 4 yarns of 130 denier MAXON~ in the 5-ply operation. The preparation and polymeric composition of MAXONO and NOVAFILO is disclosed in the~riorart.
The exact proportion of NOVAFIL~ i~ deter~ined by the yarn deniers involved and the proportion of quoit yarns in the braid construction.
An important processing step for some absorbable yarns is post treatment (a vacuum annealing step which upgrades the implant tensile values). Generally speaking, for a construction that is to be 100%
absorbable, the yarns are post treated after ply twisting; for an absorbable/nonabsorbable bicomponent construction, the absorbable yarns are post treated prior to ply twisting. There is another option and that is to post treat the final braid, providing it does not have a deleterious effect on a nonabsorbable component.
After ply twisting and post treatment, the yarns are ready for braiding. The best results to date are obtained with a construction that is made on a 13 carrier flat braider, which has 6 quoit yarn feeds. About 90% of the construction is composed of the heavy parallel quoit yarns held loosely together by the sleeve yarns at 12.3 picks (yarn cross-over points) to the inch.
2~5 After bralding, the ligament ls ready for further processlng. It ls cut to length and sleeved on both ends wlth a 1/4~ alumlnum or silver sleeve. A stalnless steel over cap 3 wlth a small metal swivel pln 7 ls then attached.
The end capped ligaments are now ultrasonlcally washed in xylol to remove any residual flnishlng oils (6 min residence in each of 4 baths). After the implants are air dried, appropriate needles 4 are attached to the metal pins to allow the implant to swivel in use.
They are then packaged in preformed plastlc trays with a lld and ln open alumlnum foil laminate envelopes. They are sterllized in an ethylene oxlde (hereafter abbrevlated as ETO) cycle which includes an elevated temperature vacuum drying step. The foil lamlnate envelopes containing the dry ligaments are then heat-sealed in an asceptic glove box hood fed by dry air. Any lnterim storage needed between vacuum drying and heat sealing is carried out in an asceptic sealed box fed, again, by dry alr.
Devices, as described above, may be surgically implanted to bridge a defect in a ligament, as a replacement for an excised damaged ligament (Fig. 3) or as an augmentation (Fig. 4) for autogenous tissue graft (or allograft) llgament reconstructlon. In those surgical procedures requlring passage through and/or attachment to soft tlssue 9, implants havlng the end-cap 3 and swivel needle(s) 4 at the end(s) would be used. For those applications ln which the implant only needs to be passed through an open ~olnt space 10 or through pre-drllled tunnels ln bone 11, the swlvel needles would not be required. Implants provlded for such procedures may lnstead have either: a) melt-fused ends to prevent fraying, or b) ends stiffened by surrounding tubes 8 that are melt-fused or heat-shrunk onto the material of the devlce ltself.
The lnventlon can be described by the following examples 1 to 17.
8~Z2~5 ExamPle 1 The implant consists of 100~ MAXON~ yarns ln a 13 carrler flat braid construction. It was made from 100 denler/B fll MAXON~ yarns that were post treated prior to twisting. Both sleeve and quoit yarns were twisted at 10 TPI to retaln yarn integrity. The sleeve yarns consisted of 13 carrlers holding 200 denier yarns made by 2-plylng the 100 denier yarns. The 6 quoit or stuffer yarns were made by a double pass (6 yarns over 6 yarns) on the ply twister to form a 3600 denier yarn. The final braid denier was 24,200 with 89.3~ of the fibers contained in the quoits. Picks/inch were calculated at 12.3.
The braid was then forwarded to an outside vendor to be cut to length and end capped. On return, the implants were washed ultrasonically in xylol, dried, needled and packaged. In this instance, packaging consisted of a 1 mil aluminum foil inner envelope, dry sealed after ETO sterilization and vacuum drying.
Inner envelopes were then overwrapped in a TYVEK~ (8.I. du Pont de Nemours & Co., DE 19898 U.S.A.) package prior to a 2nd ETO
sterilization cycle.
Straight pull tensile strengths averaged at 203 lbs equivalent to 3.8 grams/denier with an extenslon to break of 33.4%. Hydrolytic strength data indicated that the devlce was viable and samples were implanted in 10 month or older beagle dogs replacing the canine patellar ligament. Sacrifices occurred at 2, 4 and 6 months.
Histological examination indicated 50-90~ infiltration of the device by cellular tissue and some collagen fiber at 2 months, and well organized collagen replacing the absorbed MAXON~ at 6 months. Some displacement of the patella was evident at 2 and 4 months, but 6 month X-ray data approximated the non-operated controls.
'Neo-ligament' cross sectional area at the 2 month lnterval was approximately 2 to 3 times that seen on the non-operated controls.
The size of the tissue mass gradually decreased at subsequent post-operative evaluatlon periods. Flnal tensile strengths of excised ligaments ranged from approxima~ely 180 lb. at 2 months, to approximately 250 lb. at 4 and 6 months, with extenslons at break of 7.9 to 9.2 mm which are ln the range of the unoperated controls.
Example 2 Thls implant also consists of 100% MAXON~ in a flat braid construction. However, the source yarns were heat stretched at 32~
prior to braiding and post treated after braiding. The construction itself consisted of 13 - 124d sleeve yarns twlsted to 2.2 TPI 'S' and 6 - 2232d quoit yarns ply twisted as follows: first 3 yarns at 2.2 TPI 'Z' which were then reverse twlsted - 6 yarns at 1.1 TPI 's'.
The total final denier was 15,000 with 89.3~ comprised of quoit yarns. This construction also had 12.3 Picks/inch.
This braid had a 148 lb breaking strength (equivalent to 3.94 grams/denier) with an extension at break of 26.2~. Hydrolytic data indicated the material was viable as an implant. Sterile devices of this type were prepared as in Example 1.
Exam~le 3 This implant was a MAXoN~/DAcRoN9 bicomponent in an approximately 80/20 blend. DACRONO is a trademark of E. I. du Pont de Nemours &
Co., Deleware 19898 U.S.A., for a synthetic poly(ethylene tereph-thalate) fiber. ~oth components had been heat stretched at 18.5-20 prior to ply twisting. To make the quoit yarns, four yarns of 120d MAXON~ were twisted at 1.4 TPI ' Z ' and then combined with 1 yarn of 127d DACRONO (also twisted at 1.4 TPI 'Z') in a ply twisting operatlon at 2.8 TPI 'S'. Four of these bicomponent yarns were then reverse twisted at 1.4 TPI '2' for a total denier of 2428. The sleeve yarn was simply 120d MAXON~ twisted to 9.1 TPI 'Z'.
1~8~
The flat braid was made on a 13 carrier machlne wlth 6 quolt yarns at a 12.3 pick. Total denier was 16,128 with 90.3~ of the total construction comblned ln the quolts. 18.9~ of the total constructlon consisted o~ the nonabsorbable (DACRONO) component.
Thls sample broke at 140 lbs (equivalent to 3.94 grams/denler) wlth a 24.2~ breaklng elongation. Hydrolytic data indicated the sample was viable. Samples were prepared as in Example 1, and implanted in 10 month or older beagle dogs replacing the canine patellar ligament. Histologlcal evaluatlon of the repalred llgament at 2 months lndicated the lngrowth of cellular tissue to be locallzed near the lmplant periphery. At subsequent post-operative intervals, collagen was observed as an orlented fibrous sheath surroundlng the remaining Dacron~ yarns wlth minlmal tissue inflltratlon or vascularlzatlon noted. However, the cross-sectlonal area, as well as the length of the neo-llgaments were substantially equlvalent to those obtalned with the devlce of Example 1. ~verage tensile strengths of the repaired llgaments at the 2, 4, and 6 month post-operative evaluation perlods also ranged from approximately 180 lb. to 250 lb. The extenslons at break for ligaments repalred with these partlcluar devices were between 8 and 16 mm; generally greater than the unoperated controls.
ExamPle_4 Thls construction utillzed heat stretched MAXOU~ comblned with NOVAFILO ln an 80/20 comblnatlon. The sleeve yarn was simply 120d MAXON~ twlsted at 9.1 TPI 'Z'. The quolt yarns consisted of 2 yarns of 68d NOVAFILO that had prevlously been ply twlsted at 1.4 TPI 'Z' combined wlth 4 yarns of MAXOU~ twisted to 1.1 TPI 'Z' prlor to heat stretching at 2Q~. These yarns were ply twlsted at 2.8 TPI 'S'.
Four of these blcomponent yarns (of about 616 denier) were then reverse twisted at 1.4 TPI 'Z' to give a quoit yarn of 2464 denier.
~'~8~20~;
These yarns were braided on a 13 carrler ~lat bralder wlth 6 quolt ends at 12.3 picks/inch. Final brald denler was 16,344, of whlch 90.5~ was contained in the quolts. ~pproxlmately 22.1~ of the total construction was the nonabsorbable component-NOV~FIL .
The resulting ligament broke at 155 lbs ~equ~valent to 4.31 grams/denier). The extension at break was 27.4~. Hydrolytic tests indicated that thls deslgn was a viable one. ~fter further processing, as in Example 1, devices of this type were implanted in month or older beagle dogs replacing the patellar ligament.
Compared to the repairs made with the devices described in Examples 1 and 3, these implants appeared to yield the best histological results. Approximately 70-90~ of each of the implants had been infiltrated with well organized, vascularized, cellular tissue and some collagen fibers within 2 months. Results improved with time, so that at six months the non-absorbable NOVAFIL0 yarns served as a scaffold that was completely inEiltrated with well vascularized, axially oriented collagen fibers. The 'neo-ligament' cross-sectional area and length followed the same trends as in Examples 1 and 3.
Tensile strengths gradually increased from approxlmately 180 lb. at 2 months to about 250 lb. at 6 months; well within the range of unoperated control strengths which averaged 220 lb. The extension-at-break remained fairly constant at 11-12 mm which, while generally greater than the unoperated controls was intermediate to the results noted in Examples 1 and 3.
Examples 5 to 10 were part of an experimental study designed to determine the effect of heat stretching and post treatment on MAXON~.
The net conclusion was that post treatment served to upgrade lmplant properties; heat stretching by itself or in combination with post treatment dld not markedly improve MA-xON~ implant properties after sterilization.
Exam~le 5 Thls construction is also 100% MAXON~ in a flat braid construction. The yarns were not heat stretched before braidlng.
The sleeve yarns consisted of 130d MAXON~ twisted to 1.4 TPI 'S'.
The quoit consisted of 5 yarns of 130d MAXON~ twisted to 2.8 TPI
'Z'. Four yarns of this 5 ply constructlon were then twlsted to 1.4 TPI 'S' for a total denier of 2600.
The above yarns were then braided on a 13 carrier braider with 6 quoit ends set at a 12.3 pick. The final construction came to 17.694 denier, of which 90.2~ were quoit ends.
After sterilization this construction measured 19,134 denier. It had a 138 lb breaking strength (equivalent to 3.27 grams/denier) and an extension at break of 54.2~.
Example 6 The same as Example 5 except that the yarns used were post treated before braiding.
The final denier was 17,550 which changed to lB,288 after steriIization. The sterile devices had a breaking strength of 126 lbs (3.13 grams/denier) with an extension at break of 38.1~.
Example 7 The same as Example 5 except that the braid itself was post treated.
The final denier was 17,811 which changed to 18,414 after sterilization. Strength to break was 145 lbs ~3.57 grams/denier) with an extension at break of 39.3~.
~1~8Z205 Example 8 The same as Example 5 except that the ply twlsted yarn was heat stretched at 26% be~ore braiding. Material was not post treated either as a yarn or braid.
The inal denier was 16,497 which changed to 19,332 after sterilizatlon. Strength to break was 121 lbs (2.84 grams/denier) with an extension at break of 44%.
ExamDl~ 9 Same as Exa~ple 8 except that thls yarn was post treated after heat stretching.
The final denier was 15,786 ater braiding. On sterilizatlon this changed to 18,034. The strength to break of the sterile devices was 135 lbs (3.41 grams/denier) with an extension at break of 34.~.
Example 10 Same as Example 8 except that the braid itself was post treated.
The final denier was 16,362 after post treating; 17,392 after sterilization. The strength to break o the sterile implants was 150 lbs (3.90 grams/denier) with an extension at break o 34.6%.
ExamPle 11 This embodiment consisted of 100% MAXON~ in a flat braid construction. It differs from constructions described in previous examples in that it was alr~et texturized prior to the initial twisting steps. The sleeve yarn consisted of 149d texturized MAXON~. This was made by overfeeding 2 yarns of 66 denier MAXON~
into the air~et chamber-one by 15% and the other by 8%. This material was then twisted to 1.9 TPI 'Z'. The quoit yarn started with 219 denier texturized MAXON~. This was made by overfeeding 1 end of 66d MAXON~ at 15% into the air~et along with 1 end of 130d MAXON~ at 8~. The 219 denier yarns were then 3-plled at 2.8 TPI
'S'. Four yarns of the 3-ply material were then reverse twisted at 1.4 TPI 'Z' to glve a flnal denier of 2523.
This material was braided on a 13 carrier flat machine at 12.3 picks per inch. Its flnal denier measured 17,693 with 88.7% of the construction in the quoits.
The straight pull to break averaged 130 lbs (3.3 gms per denier) with an extension at break of 26.7%. As expected, its surface appearance resembled that made of yarns spun from a natural, staple fiber such as cotton or wool. Optically, the braid could be characterized as having a loose, single fil looped appearance.
Subsequent processing of the braid is as described above under the heading ~Drawings and Description~.
Exam~le 12 This design is identical to Example 11 except that in the initial 3-plying of the quoit yarns one end of a 245 denier MAXON~/NOVAFILO
texturized bicomponent yarn was substituted for one of 219 denier texturized MAXON~ yarns. This MAXON~/NOVAFIL bicomponent was made by overfeeding a 66d MAXON~ yarn at 55% and two 69d NOVAFILO yarns at 11% into the air~et chamber. The denier of the 12 ply quoit yarn was measured to be 2667d.
This material was braided on a 13 carrier flat machine at a 12.3 pick. Its final denier was 18,467 of which 89.2% was quoit yarn and 19.1% was the nonabsorbable NOVAFILO component.
1~:8~5 The final non-sterlle ligament had a breaklng strength of 122 lbs (3.00 grams per denier) and an extension at break of 25.9%.
Hydrolytic data indicates that this will make a viable product with a residual strength of 29.5 lbs.
Subsequent processing of the braid is as descrlbed above under the heading ~Drawings and Description~.
Example 13 This implant design is identical to Example 11 except that in the initial 3 plying of the quolt yarns one end of a 226 denier MAXON~/Heat Stretched Texturized DACRONO bicomponent yarn was substltuted for one of the 219 denier MAXON~ yarns. This MAXON~/Heat Stretched DACRON0 blcomponent was made by overfeeding a 66 denier MAXON~ yarn at 55% and a 127 denier heat stretched DACRONO yarn at 11% into the air~et chamber. The denier of the 12 ply quoit yarn measured 2613.
This material was braided on a 13 carrier flat machine at a 12.3 Pick. Its final non-sterile denier was 18.054. of which 89.0% was quolt yarn and 20.7% was the nonabsorbable heat stretched DACRO~O
component.
The final non-sterile ligament had a breaking strength of 97 lbs (2.43 grams per denier) and an extension at break of 21.7~.
Hydrolytic data indicated it would remain unchanged in strength for 14 days and would have a residual strength of 34.7 lbs.
Subsequent processing of the braid is as described above under the heading ~DRAWINGS AND DESCRIPTION~.
8'~5 ExamPle_14 This construction consists of 100% MAXON~ in a flat brald construction. It differs from previous constructlons in that it ls braided on a 21 carrier machine.
The sleeve yarn consists of 66 denler MAXON~ yarn twlsted to 1.4 TPI 'Z'. The 130 denler quoit yarns are first 2-plled at 2.8 TPI 'S' - then 5 yarns of this 2-ply construction are reverse twisted at 1.4 TPI 'Z'. The final denier of the 10 ply quoit yarn ls 1300.
The above yarns are then braided on a 21 carrier machine with 10 quoit yarns set at a 12 picks/inch. The final construction measures 16,986 denier, of which 91.8~ is quoit yarn.
Samples are expected to have a non-sterile breaking strength of 124 lbs (equivalent to 3.31 grams per denier) with an extension at break of 35.2%.
ExamDle 15 This construction consists of 100% MAXON~ in a flat braid construction. It differs from previous constructions in that it is braided on a 15 carrier machine.
The sleeve yarn consists of 98 denier MAXON~ twisted to 1.4 TPI
'Z'. The 130 denier quoit yarns are 5-plied at the same level of twist to give a total denier of 650. All yarns are post treated after plying.
The above yarns are braided on a 45 carrier machine. Only 15 out of 45 available carriers are used for the sleeve yarns. All of the available 22 quoit positions are used. The braider is set for a 4.1 pick. The final construction measures 15,770 denier, of which 90.7%
is parallel quoit yarn.
~8~
Straight pull tensile strength is expected to average approxlmately 168 lbs (4.83 grams/denier) with a 37.2% elongation at break.
Example 16 This implant design is similar to Example 15 except that 1 yarn of heat stretched DACRON~ is substituted in ply twisting the quoit yarns. ~lso, all MAXON~ yarns are post treated prior to twisting.
The final braid denier is 15,700, of which 90.7% is parallel quoit yarn. Approxlmately 18.1% of the total construction ls the nonabsorbable DACRONO component.
Straight pull tensile strength is expected to be approximately 127 lbs ~3.67 grams/denier) with a breaking elongation o 29.3%.
Hydrolytic data from similar constructlons indicate that this design would make a viable product wlth a residual strength of 29 lbs due to the nonabsorbable component.
Example l?
Thls design conslsts of 100% MAXON~ ln a flat brald construction.
Although bralded on a 45 carrier machine, it differs from Sample 15 ln that it ls 3.3 times heavier.
The sleeve yarns consist of 130 denier MAXON~ twisted to 1.4 TPI
'Z'. The 130 denier quoit yarns were first 4-plied to 2.8 TPI 'Z'.
then four 4-ply yarns are reverse plied to 1.4 TPI 'S' to give a final quoit yarn denier of 2080. All yarns are post treated after twlstlng.
The above yarns are then braided on a 45 carrier machlne uslng all avallable carriers for the sleeve and all of the avallable 22 quolt yarn positions. The bralder ls set for a 12.3 pick. The final construction measures 51,610 denier, of which 88.7% is parallel quoit yarn.
~1~8~ 5 Str~ight pull tensile strength is expected to average 525 lbs ~4.61 grams/denier) with a breaking elongdtion of 31.6%.
The following examples, and varlations thereof, may be suitable for some soft tlssue orthopedic (l.e. tendon) repair/recon- struction appllcatlons. They have been found to be lnappropriate as ligament implants. They are disclosed for their comparatlve and contrast value to Examples l-to-17, and as a contribution to the state of the art.
ComDarative ExamPle A
This construction ls a round bicomponent braid consisting of three bralded elements.
a. A subcore which is a blend of 20/80 PGA/Heat Stretched DACRONO.
This subcore was made on an 8 carrier braider set at 5 picks/inch with each carrier containing a 1060 denier bicomponent yarn. The 1060 denier yarn was made by ply twisting 4 yarns of 210 denier heat stretched DACRONO with 2 yarns of 110 denier DEXONO (American Cyanamid Co., NJ 07470, U.S.A.) at a low nominal level of twist. The preparation and polymeric composition of DEXONO is disclosed in the prior art.
b. A core is also a blend of 20/80 PGA/Heat Stretched DACRONO.
This was made by braiding on a 12 carrier braider set at 5 picks/inch using the 8 carrier braid described above as a core. Each of the 12 carriers contained a 1270 denier bicomponent yarn which was made by ply twisting 5 yarns of 210 denier Heat Stretched DACRONO with 2 yarns of 110 denier DEXONO at a low level of twist.
1~82%~
c. The final sleeve was a blend of 60/40 PGA/Heat Stretched DACRONO. This was made by braiding on a 16 carrier braider set at 15 picks per inch using the 12 carrler brald described above as a core.
Each of the 16 carriers contalned a 1510 denier blcomponent yarn whlch was made by ply twlstlng 3 yarns of 210 denier Heat stretched DACRONO with 8 yarns of 110 denier DEXONO at a low level of twist.
All of the above yarns were post treated after ply twisting. Thls braid broke at 430 lbs straight pull (equivalent to 4.07 grams/denier) with an 18.8% extension at break. Braid denier was calculated to be 47,900.
Intramuscular and subcutaneous implants in canines exhibited little, if any, tissue ingrowth. 8raids were encapsulated by unorganized collagen. This lack of vascularized cellular tissue and oriented collagen infiltration into the implant is considered undesirable for ligament repair or reconstruction. It is most probably a combined effect of: 1.) the relatively short strength retention period of the PGA (i.e. 28 days); and 2.) the tight round construction which minimizes implant-tissue interface area.
ComParative Example B
This construction was basically the same as that in Comparative Exampie A except that the final sleeve was a 50/50 PGA/Heat Stretched DACRONO bicomponent yarn in a finer ~more dispersed) blend. This was made on a 16 carrier braider set at 15 picks/inch using the 12 carrier braid described in Example A as a core. Each carrier contained a 1320 denier bicomponent yarn made by first ply twisting 1 yarn of 110 denier Heat Stretched DACRONO with 1 yarn of 110 denier DEXONO. Six of the 2-ply bicomponent yarns were then twisted to make the final 12-ply yarn. Twist levels were of a low order of magnitude.
~B~i -- ~4 --The final brald denier was calculated to be 44.8K. The breaklng strength measured 385 lbs ~equivalent to 3.89 grams/denler) wlth a breaklng elongation of 16.8%. Animal implant data were similar to Example A.
Comparative Example C
This construction was, again, basically the same as in Comparatlve Example A except that the final sleeve had a coarser (less dispersed) configuratlon. It conslsted of alternating a 1650 denier DACRONO
(Heat Stretched) yarn with 1650 denier DEXONO yarn on each of the 16 carriers.
The flnal breaklng strength was 429 lbs (equivalent to 3.88 grams/denier). The elongation at break was 17.8%. The final denier was calculated to be 50,100. Animal implant results were similar to example A.
ComParative ExamPle D
This implant design was 100% DEXON~ PGA in a round braid configuration and it consisted of three braided elements:
a. The subcore was made on an 8 carrier braider set at 5 picks/inch. Only 4 out of the eight sleeve carriers were used. The 440 denier yarn was made by plylng four 110 denier yarns at a low number of twists per inch.
b. The core was made on an eight carrier machlne also set at 5 picks/lnch wlth all eight carriers contalning a 550 denier yarn. The yarn was made by plying five 110 denier yarns at a low level of twist. The 4 carrier braid described above was used as a core.
c. The sleeve was made on a twelve carrler bralder set at 15 plcks/lnch wlth all 12 carriers containing a 660 denier yarn. The yarn was made by plying six 110 denier yarns at a low level of twist. The eight carrier braid described above was used as a core.
The final denier was calculated to be 14,100. Tenslle strength was measured to be 134 lbs (equivalent to 4.32 grams/denier). The elongation at break was 33.4~.
ImPlant results This material was implanted as a replacement for the resected patellar ligament of 10 month or older beagle dogs. At 1 and 2 months there was no hlstological evidence of tissue ingrowth. Braids were encapsulated by unorganized collagen and were structurally weak. This construction was abandoned since there was little hope for lts use ln llgament repair or replacement applications where ingrowth ls desired.
ComDaratiVe ExamPle E
This implant design was 100~ DEXOUO (PGA) in a flat braid config-uration and consisted of heavy denier quoit or warp yarns held together by light denier sleeve yarns:
a. Each quoit yarn contained 2214 denier DEXONO which was made by ply twisting three - 123 denier yarns to give 369 denier yarn and then ply twisting six of these 369 denier yarns at 1.5 TPI 'S'.
b. The sleeve yarn contained 110 denier DEXONO yarns which were twisted to 10 TPI 'S'.
128'~Z05 c. The braid was made on a thlrteen carrler bralder - each carrier contalning 110 denier sleeve yarn whlch was bralded about the 2214 denler warp yarns fed through all slx avallable quolt posltlons. The total plck count was estimated at 10 per lnch.
d. This construction was washed and post treated as a brald.
The total braid denier was approximately 15,100. Tensile strength measured 208 lbs. with a 22.3~ elongation-to-break.
Devices of this deslgn were implanted as replacements for the resected patellar ligament of 10 month or older beagle dogs in a comparative study with devices of Example 1. Histologlcal evaluation at 1 and 2 months post-operatlvely revealed no signlficant tissue ingrowth or organization within the PGA implant. This lack of ligament repair was attributed to the relatively shorter ln-vivo property retention perlod of the PGA materlal.
Comparatlve ExamPle F
This lmplant design was 100~ DEXON- (PGA) in a flat brald configuration and again consisted of heavy denier quoit or warp yarns held together by light denier sleeve yarns. However, all the yarns were post treated; then air ~et texturized prior to twisting and braiding.
a. The quoit (warp) yarn consisted of a 6 ply construction using 357 denler texturized DEXONO yarn to give a total 2142 denier yarn.
This 357 denier yarn was made by entangling 3 ends of 110 denier DEXONO yarn - 2 yarns with a 24~ overfeed and one with a 6~ overfeed.
,~
b. The sleeve yarn was made similarly except it was a 152 denier, texturized DEXON- yarn. This was made by entangling 2 yarns of 62 denier DEXON- - one yarn with a 24~ overfeed and the other with an 11% overfeed.
`
.
.
~8220~;
c. The braid was made on a thirteen carrier braider, each carrier containing the 152 denier yarn descrlbed in section b above. These sleeve yarns were braided about the 2142 denier warp yarns fed through all six available quolt positions. The total plck count was estimated at 12.3 per inch.
The total braid denier was 14,800. Tensile strength measured 152 lbs. wlth a 23.2% elongation-to-break.
Devices of this construction were evaluated in-vivo as described in the prevlous example. Upon sacrlfice at 2 months, these implants were found to have better tissue ingrowth/organization than the non-texturized PGA devices of the previous example. However, the results achieved with implants made using the longer lasting GTMC
yarns were consistently, significantly improved over those obtained with the devices of these comparative examples.
BACKGROUND
Thls invention relates to an implantable devlce composed of one or more bio-absorbable polymer(s) or combinations of bloabsorbable/non-absorbable polymer~s) for the repair or augmentatlon of connectlve tlssue damaged by disease or in~ury. The devices shall serve as scaffolds for ingrowth and orientation of new flbrous connective tlssue, (e.g. llgaments, tendons) ln both intra-artlcular and extra-articular sltes by malntalnlng structural stablllty durlng inltlal heallng and then undergolng at least partlal gradual absorptlon to prevent stress shlelding and allow newly formed tlssue to become correctly orlented and load bearlng.
The lnvention lncludes several aspects of device design that are lntended to provide for simulation of natural tissue function lmmedlately after implantation and to support subsequent fibrous tissue ingrowth as well as orientatlon in the dlrection of natural loadlng. The devlces are bralded or woven into a flat tape geometry having the plurality of flbers allgned ln parallel to form the axlal warp. The physlcal/mechanlcal/chemlcal propertles of all or part of the component fibers may be enhanced by a number of temperature/time/
stress treatments. One or more ad~acent plies of the devlce are used ln surgery to achleve biomechanlcal propertles approximately equlva-lent to the healthy tissue prior to being damaged. A swlvel needle 1'~8~ 05 attachment system may be lncorporated to facllltate handllng and surglcal placement of the devlces. The interfibrillar space, that provides for initial tissue ingrowth, occurs as a result of the braiding~weavinq process or may be enhanced by means of texturlzing the yarns. Gradual b1oabsorption, in whole or in part, provides for additional interfibrillar space to form during the healing period, and for flbrous tlssue orientation to be induced as load is trans-ferred from the weakened implant to the 'neo-ligament' or 'neo-tendon'.
The bioabsorbable materials, biocompatible nonabsorbable materlals, physical and chemical combinations thereof, and the processes involved in Eabricating them into the implantable devices are all included in this invention.
Llgaments and tendons are bands or sheets of fibrous connective tissue which provide support and stability to the musculoskeletal system. Relief of the pain and/or instability caused by damage to a ligament or tendon is currently achieved by techniques ranglng from s~mple suturing to removal and replacement with other tissue or a permanent synthetic prosthesis. Although no single technique is appropriate for all situations, it is generally preferred to return the tissue to it's healthy, pre-damaged state as naturally as possible. Furthermore, it is highly desirable to reduce the need for activity restriction during the healing period. The permanent retention of implanted foreign materials is considered undeslrable and should be minlmized because it may result in stress shielding and subsequent atrophy of natural tissue, or the migration of the materials to other tissues and/or systems ~i.e. lymphatic) may occur.
The surgical repair device of this invention has functional advantages over prior art devices. For example, this invention can utilize absorbable fibers in the axial (lengthwise) direction. The ma~ority of absorbable fibers in the axial direction enhances or ~'~8~0S
essentially guarantees the transfer of the connective tlssue stress from the device to the ingrowing collagen fibers. In summary, with the ma~ority of fibers belng in the axial dlrectlon and wlth these fibers belng at least about 80'~, absorbable flbers, there appears to be more tlssue lngrowth and better orlented collagen flbers.
This invention is useful as a temporary or augmentation device. In this utility. it seems to match as closely as possible the biologlcal properties of a connective tissue until ingrown collagen fibers can replace the ma~ority of fibers (preferably havlng an absorbable component comprising at least about 80 percent) in the axlal dlrectlon. That ls, an advantage of thls invention over the prlor art implant devlces ls that lt appears to provlde a surgical repair devlce (speclflcally for connective tissue, and more specifically for ligament or tendon repair) that will have the correct stress related properties to act as a connective tissue (untll llvlng tlssue can replace the devlce). Thls is accomplished by the ingsown collagen fibers replacing the absorbable fibers in the axial direction. The use of nonabsorbable fibers is as a support or backbone for the absorbable fibers.
This invention -has superior and unexpected structural properties over those disclosed in the prior art. For example, the ma~ority of the fibers in this invention, that is 50 percent or more, are in the axial (lengthwise) direction. Preferably, 80 to 95 percent are in the axial directlon. This approximately twofold increase of flbers ln the axlal (lengthwise) direction is at least one of if not the primary reason for obtaining the functlonal advantages dlscussed above.
The surgical repalr device of this invention has other advantages over the prior art. For example, the thickness of the device is smaller than the known prlor art devices. This is because the ma~ority of the fibers are in the axial dlrection. The smaller thickness allows this devlce to be useful in more constricted connective tissue repair procedures. Also, as a general statement, the smaller the thlckness or width of the repa1r devlce, the greater is its utility as a temporary or augmentation device because tissue ingrowth is facilitated. Conversely, the larger the thickness or width of the device, the more it is used as replacement (that is, as a permanent implant) rather than a temporary device.
It is, therefore, the ob~ect of this invention to provide sterile, surgically implantable devices, means Eor surgical placement/attach-ment, and fabrication processes that are uniquely suited for providing the most advantageous connective tissue (i.e. ligament, tendon, etc.) repair. These implants resolve the apparent disadvantages of the devices described above by: 1.) providing adequate strength and stiffness immediately post-operatively to minimize or eliminate the need for immobilization; 2.) facilitating the ingrowth of vascularized cellular tissue by reason of the open flat tape configuration; 3.) supporting the proper orlentation o$
collagen fibers formed within and around the implant through the predominantly axial alignment of the component yarns and the gradual transfer of applied loads from the biodegradable yarns to the newly formed tissue; 4.) providing a longer lasting bioabsorbable material to permit adequate time for new tissue ingrowth or revascularization of autogenous tissue grafts or allografts; 5.) providing a compliant, elastic, permanent component to protect tissues from over-load, without stress-shielding, for a longer term than provided by the bioabsorbable materials, in those applications (i.e some intraar-ticular ligament reconstructions) where healing occurs more slowly;
and 6.) avoiding the use of materials which fragment and pose risks of migration to ad~acent tissues.
The ob~ect of this lnvention comprises bioabsorbable or combined bioabsorbable/biocompatible polymers fabricated into an elongated textile structure having means for surgical placement/attachment at one or both ends for the purpose of repair, augmentation or replacement of damaged connective tissues, such as ligaments and tendons.
1~8~05 SUMMARY OF THE INVENTION
The invention is a flat braided ligament or tendon lmplant devlce having a length to width ratio of greater than one, comprising a plurality of fibers, the majority of the fibers being in a directlon essentially parallel to the implant length, the braid having about 5 to 25 carrier and up to about 10 warp yarns, wherein the yarn~ are texturized, and said implant having an absorbable component comprising from about 10 to 100 percent of a copolymer, the copolymer having glycolic acid ester and from about 20 to 40 percent by weight of trimethylene carbonate linkages, and the remainder of said implant, if any, having a nonabsorbable component.
Embodiments of the repair device include a knitted, woven, braided and flat braided device. In one embodiment, the longitudinally oriented majority of the fibers comprises about 80 to 95 percent.
In a specific embodiment, the longitudinally oriented majority of the fiberæ comprises about 90 percent.
In another embodiment, the device has an absorbable component comprising at least about 80 percent. In a specific embodiment, the device has a nonabsorbable component selected from the group conslstlng of a poly(C2-C10 alkylene terephthalate), polytC2-C6 alkylene), polyamide, polyurethane and polyether-ester block copolymer. In a more specific embodiment, the devlce conslsts of poly(ethylene terephthalate) or poly(butylene terephthalate) as the poly(C2-C10 alkylene terephthalate), and a polybutester as the polyether-ester block copolymer. In a most specific embodiment, the device consists of Hytrel~ as the polybutester. A polybutester can be defined as a polytetramethylene glycol, polymer with terephthalic acid and 1, 4-butanediol.
Hytrel~ is a trademark of E. I. du Pont de Nemours & Co., Wilm-ington, Del. U.S.A. for a class of polymers having the following generic formula:
~o-cN~ 2~cN2-cl~2~o-~c~o-cu2-c~l2-~ll2-cN2-o-c~c}~
Vol1~ n~-n- ~Irco~ h~n-l"- Vo~ t~l~n- ~ v~
The values for a, x and y are known from the prior art. A specific embodiment of Hytrel which is useful in this invention is a grade of HytrelO having a 72 durometer D. hardness. The polymer in the NOVAFIL (American Cyanamid Company, New Jersey, U.S A.) surgical suture contains HytrelO.
A flat braided ligament or tendon implant device having a length to width ratio of greater than one has been invented. The device comprises a plurality of fibers The ma~ority of the fibers are in a direction essentially parallel to the implant length. The braid has about 5 to 100 carrier and up to about 50 warp yarns.
The implant has an absorbable component comprising from about 10 to 100 percent of a copolymer. The copolymer has glycolic acid ester and from about 20 to 40 percent by welght of trimethylene carbonate linkages The remainder of the implant, if any, has a nonabsorbable component.
~8;~2~S
In one embodlment of the lmplant, the brald has about 13 carrler and about 6 warp yarns. In a speclflc embodiment, the implant conslsts of about 100 percent of the absorbable component. In a more speclflc embodiment, the carrler yarns conslst of about 100 percent of the absorbable component and the warp yarns comprise about 80 percent of the absorbable component. In a most specific embodiment, the nonabsorbable component in the warp yarns is selected from the group conslstlng of a poly(ethylene terephthalate) and polyether-ester block copolymer.
In other embodiments of the implant, the yarns are texturized or heat treated. In a further embodiment of the implant, the brald ls heat treated.
The bloabsorbable filaments may be comprised of man-made polymers includlng glycollde-trimethylene carbonate (GTMC), polyglycollc acid, polydloxanone, poly(L-Lactic) acid, poly(DL-Lactic) acid and copolymers or physlcal comblnations of the components of these polymers. Natural bloabsorbable polymers such as regenerated collagen or surglcal gut may also be used. The biocompatible (nonabsorbable) components include poly~ethylene terephthalate) (PET), poly(butylene terephthalate) (P~T), polyether-ester multi-block copolymers, polypropylene, high strength/modulus polyethylene, polyamide (including polyaramid), or polyether type polyurethanes. Once spun into filaments, the properties oE the above materlals may be improved for this application by various tempera-ture/time/stress treatments.
The device shall be braided, woven or knitted so that the structure has the deslred strength and stiffness ln the primary (axial) loading dlrectlon. It also has adequate interfibrillar space and min~mized thickness to promote the ingrowth of tissue. The end(s) of the device may be ccmpressed inside biocompatible metal sleeve(s) to which swivel end-caps(s) and surgical needle(s) are attached in such a way as to permit rotation of the needle(s) about the longitudinal axis of the device.
'~S
In use, an appropriate number of plies of the device are implanted to match the biomechanical propertles of the tissue being repalred.
This permits an early return to normal function post-operatively. As the ligament or tendon begins to heal, the implant continues to bear any applied loads and tlssue ingrowth commences. The mechanical properties of the bioabsorbable component(s~ of the implant then slowly decay to permit a gradual transfer of loads to the ingrown fibrous tissue, stimulating it to orient along the loading direction. Additional ingrowth continues into the space provided by the absorbed components of the implant. This process continues until the bioabsorbable component(s) are completely absorbed and only the newly formed tissue remains, or the bicompatible (nonabsorbable) component(s) are left in situ to provide long-term augmentation of the newly formed tissue.
DR~WINGS AND DESCRIPTION
Fig. 1 is a diagrammatic view of the device described as the preferred embodiment, except that two different possible ends are shown.
Fig. 2 is an enlarged view of the flat surface of the preferred embodiment showing the braided construction in greater detail.
Fig. 3 is an anterior view of a knee showing the device asposltioned for repair of the excised patellar ligament in animal (canine) studies.
Fig. 4 is an anterior view of a knee showing the device as positioned for augmentation of the medial third of the patellar ligament in an anterior cruciate ligament reconstruction.
~8~20S
g In preEerred embodiments the elongated textile structure 1 of the implant comprises a flat braid having primarily axlal (quoit) yarns 2 of an absorbable polymer such as GTMC. The number and denier of quoit and sleeve yarns are varled to provide devices having a range of properties that are biomechanically compatible with any likely implant site. Swivel end cap(s) 3 and surgical needle(s) 4 may be attached at the end(s) of the device to facilitate placement and attachment.
The procedures described below are followed when preparing flat braids to be used as artificial ligaments/tendons starting from the appropriate yarns. To begin, the proper denier yarns for the specific braid construction are requlred. This example describes a typical construction designed to fit a particular animal model -repair/replacement of the canine patellar ligament (Fig. 3). An application that had a tensile strength/stiffness requirement three times higher than that described in the example would require three times as much yarn. This could be accomplished by simply tripling the final total braid denier, either by increasing the yarn denier or increasing the number of sleeve and quoit (stuffer yarns) or both.
To produce a braid for canine patellar ligament repair ~Fig. 3), a final braid denier between 13,000 and 24,000 is targeted. In the preferred construction, approximately 90% of the fiber is contained in the parallel quoit or warp yarns 2.
The sleeve yarns 5, which consist completely of absorbable material, are generally about 130 denier. On transfer they are given a nominal 1.4 turn ~er inch (TPI) 'Z' or 'S' twist before further processing. This facilitztes handling and mini~nizes fiber breakage.
The quoit ~stuffer or warp) yarns can be 100% absorbable or they may contain a nonabsorbable component. They are much heavier than the sleeve, generally ranging from 2100 to 2700 denier. This 1~8~
necessitates two passes on a six position ply twlster. A 130 denier yarn would normally be 5-plied 2.8 TPI 'S' or 'Z', then 4 ends of the 5-ply yarn would be twisted 1.4 TPI in the reverse direction. This would result in a final quoit yarn denier of 2600, mechanically balanced from the reverse twist operation (no tendency to twist or unravel).
Nonabsorbable components 6, if included, are blended into the quoit yarns during the 1st ply twisting operation. For instance, a MAXON~/NOVAFIL0 (American Cyanamid Co., NJ 07470 U.S.A.) bicomponent yarn consisting of 18-22% nonabsorbable fiber would be made by running 1 yarn of 130 denier NOVAFILO with 4 yarns of 130 denier MAXON~ in the 5-ply operation. The preparation and polymeric composition of MAXONO and NOVAFILO is disclosed in the~riorart.
The exact proportion of NOVAFIL~ i~ deter~ined by the yarn deniers involved and the proportion of quoit yarns in the braid construction.
An important processing step for some absorbable yarns is post treatment (a vacuum annealing step which upgrades the implant tensile values). Generally speaking, for a construction that is to be 100%
absorbable, the yarns are post treated after ply twisting; for an absorbable/nonabsorbable bicomponent construction, the absorbable yarns are post treated prior to ply twisting. There is another option and that is to post treat the final braid, providing it does not have a deleterious effect on a nonabsorbable component.
After ply twisting and post treatment, the yarns are ready for braiding. The best results to date are obtained with a construction that is made on a 13 carrier flat braider, which has 6 quoit yarn feeds. About 90% of the construction is composed of the heavy parallel quoit yarns held loosely together by the sleeve yarns at 12.3 picks (yarn cross-over points) to the inch.
2~5 After bralding, the ligament ls ready for further processlng. It ls cut to length and sleeved on both ends wlth a 1/4~ alumlnum or silver sleeve. A stalnless steel over cap 3 wlth a small metal swivel pln 7 ls then attached.
The end capped ligaments are now ultrasonlcally washed in xylol to remove any residual flnishlng oils (6 min residence in each of 4 baths). After the implants are air dried, appropriate needles 4 are attached to the metal pins to allow the implant to swivel in use.
They are then packaged in preformed plastlc trays with a lld and ln open alumlnum foil laminate envelopes. They are sterllized in an ethylene oxlde (hereafter abbrevlated as ETO) cycle which includes an elevated temperature vacuum drying step. The foil lamlnate envelopes containing the dry ligaments are then heat-sealed in an asceptic glove box hood fed by dry air. Any lnterim storage needed between vacuum drying and heat sealing is carried out in an asceptic sealed box fed, again, by dry alr.
Devices, as described above, may be surgically implanted to bridge a defect in a ligament, as a replacement for an excised damaged ligament (Fig. 3) or as an augmentation (Fig. 4) for autogenous tissue graft (or allograft) llgament reconstructlon. In those surgical procedures requlring passage through and/or attachment to soft tlssue 9, implants havlng the end-cap 3 and swivel needle(s) 4 at the end(s) would be used. For those applications ln which the implant only needs to be passed through an open ~olnt space 10 or through pre-drllled tunnels ln bone 11, the swlvel needles would not be required. Implants provlded for such procedures may lnstead have either: a) melt-fused ends to prevent fraying, or b) ends stiffened by surrounding tubes 8 that are melt-fused or heat-shrunk onto the material of the devlce ltself.
The lnventlon can be described by the following examples 1 to 17.
8~Z2~5 ExamPle 1 The implant consists of 100~ MAXON~ yarns ln a 13 carrler flat braid construction. It was made from 100 denler/B fll MAXON~ yarns that were post treated prior to twisting. Both sleeve and quoit yarns were twisted at 10 TPI to retaln yarn integrity. The sleeve yarns consisted of 13 carrlers holding 200 denier yarns made by 2-plylng the 100 denier yarns. The 6 quoit or stuffer yarns were made by a double pass (6 yarns over 6 yarns) on the ply twister to form a 3600 denier yarn. The final braid denier was 24,200 with 89.3~ of the fibers contained in the quoits. Picks/inch were calculated at 12.3.
The braid was then forwarded to an outside vendor to be cut to length and end capped. On return, the implants were washed ultrasonically in xylol, dried, needled and packaged. In this instance, packaging consisted of a 1 mil aluminum foil inner envelope, dry sealed after ETO sterilization and vacuum drying.
Inner envelopes were then overwrapped in a TYVEK~ (8.I. du Pont de Nemours & Co., DE 19898 U.S.A.) package prior to a 2nd ETO
sterilization cycle.
Straight pull tensile strengths averaged at 203 lbs equivalent to 3.8 grams/denier with an extenslon to break of 33.4%. Hydrolytic strength data indicated that the devlce was viable and samples were implanted in 10 month or older beagle dogs replacing the canine patellar ligament. Sacrifices occurred at 2, 4 and 6 months.
Histological examination indicated 50-90~ infiltration of the device by cellular tissue and some collagen fiber at 2 months, and well organized collagen replacing the absorbed MAXON~ at 6 months. Some displacement of the patella was evident at 2 and 4 months, but 6 month X-ray data approximated the non-operated controls.
'Neo-ligament' cross sectional area at the 2 month lnterval was approximately 2 to 3 times that seen on the non-operated controls.
The size of the tissue mass gradually decreased at subsequent post-operative evaluatlon periods. Flnal tensile strengths of excised ligaments ranged from approxima~ely 180 lb. at 2 months, to approximately 250 lb. at 4 and 6 months, with extenslons at break of 7.9 to 9.2 mm which are ln the range of the unoperated controls.
Example 2 Thls implant also consists of 100% MAXON~ in a flat braid construction. However, the source yarns were heat stretched at 32~
prior to braiding and post treated after braiding. The construction itself consisted of 13 - 124d sleeve yarns twlsted to 2.2 TPI 'S' and 6 - 2232d quoit yarns ply twisted as follows: first 3 yarns at 2.2 TPI 'Z' which were then reverse twlsted - 6 yarns at 1.1 TPI 's'.
The total final denier was 15,000 with 89.3~ comprised of quoit yarns. This construction also had 12.3 Picks/inch.
This braid had a 148 lb breaking strength (equivalent to 3.94 grams/denier) with an extension at break of 26.2~. Hydrolytic data indicated the material was viable as an implant. Sterile devices of this type were prepared as in Example 1.
Exam~le 3 This implant was a MAXoN~/DAcRoN9 bicomponent in an approximately 80/20 blend. DACRONO is a trademark of E. I. du Pont de Nemours &
Co., Deleware 19898 U.S.A., for a synthetic poly(ethylene tereph-thalate) fiber. ~oth components had been heat stretched at 18.5-20 prior to ply twisting. To make the quoit yarns, four yarns of 120d MAXON~ were twisted at 1.4 TPI ' Z ' and then combined with 1 yarn of 127d DACRONO (also twisted at 1.4 TPI 'Z') in a ply twisting operatlon at 2.8 TPI 'S'. Four of these bicomponent yarns were then reverse twisted at 1.4 TPI '2' for a total denier of 2428. The sleeve yarn was simply 120d MAXON~ twisted to 9.1 TPI 'Z'.
1~8~
The flat braid was made on a 13 carrier machlne wlth 6 quolt yarns at a 12.3 pick. Total denier was 16,128 with 90.3~ of the total construction comblned ln the quolts. 18.9~ of the total constructlon consisted o~ the nonabsorbable (DACRONO) component.
Thls sample broke at 140 lbs (equivalent to 3.94 grams/denler) wlth a 24.2~ breaklng elongation. Hydrolytic data indicated the sample was viable. Samples were prepared as in Example 1, and implanted in 10 month or older beagle dogs replacing the canine patellar ligament. Histologlcal evaluatlon of the repalred llgament at 2 months lndicated the lngrowth of cellular tissue to be locallzed near the lmplant periphery. At subsequent post-operative intervals, collagen was observed as an orlented fibrous sheath surroundlng the remaining Dacron~ yarns wlth minlmal tissue inflltratlon or vascularlzatlon noted. However, the cross-sectlonal area, as well as the length of the neo-llgaments were substantially equlvalent to those obtalned with the devlce of Example 1. ~verage tensile strengths of the repaired llgaments at the 2, 4, and 6 month post-operative evaluation perlods also ranged from approximately 180 lb. to 250 lb. The extenslons at break for ligaments repalred with these partlcluar devices were between 8 and 16 mm; generally greater than the unoperated controls.
ExamPle_4 Thls construction utillzed heat stretched MAXOU~ comblned with NOVAFILO ln an 80/20 comblnatlon. The sleeve yarn was simply 120d MAXON~ twlsted at 9.1 TPI 'Z'. The quolt yarns consisted of 2 yarns of 68d NOVAFILO that had prevlously been ply twlsted at 1.4 TPI 'Z' combined wlth 4 yarns of MAXOU~ twisted to 1.1 TPI 'Z' prlor to heat stretching at 2Q~. These yarns were ply twlsted at 2.8 TPI 'S'.
Four of these blcomponent yarns (of about 616 denier) were then reverse twisted at 1.4 TPI 'Z' to give a quoit yarn of 2464 denier.
~'~8~20~;
These yarns were braided on a 13 carrler ~lat bralder wlth 6 quolt ends at 12.3 picks/inch. Final brald denler was 16,344, of whlch 90.5~ was contained in the quolts. ~pproxlmately 22.1~ of the total construction was the nonabsorbable component-NOV~FIL .
The resulting ligament broke at 155 lbs ~equ~valent to 4.31 grams/denier). The extension at break was 27.4~. Hydrolytic tests indicated that thls deslgn was a viable one. ~fter further processing, as in Example 1, devices of this type were implanted in month or older beagle dogs replacing the patellar ligament.
Compared to the repairs made with the devices described in Examples 1 and 3, these implants appeared to yield the best histological results. Approximately 70-90~ of each of the implants had been infiltrated with well organized, vascularized, cellular tissue and some collagen fibers within 2 months. Results improved with time, so that at six months the non-absorbable NOVAFIL0 yarns served as a scaffold that was completely inEiltrated with well vascularized, axially oriented collagen fibers. The 'neo-ligament' cross-sectional area and length followed the same trends as in Examples 1 and 3.
Tensile strengths gradually increased from approxlmately 180 lb. at 2 months to about 250 lb. at 6 months; well within the range of unoperated control strengths which averaged 220 lb. The extension-at-break remained fairly constant at 11-12 mm which, while generally greater than the unoperated controls was intermediate to the results noted in Examples 1 and 3.
Examples 5 to 10 were part of an experimental study designed to determine the effect of heat stretching and post treatment on MAXON~.
The net conclusion was that post treatment served to upgrade lmplant properties; heat stretching by itself or in combination with post treatment dld not markedly improve MA-xON~ implant properties after sterilization.
Exam~le 5 Thls construction is also 100% MAXON~ in a flat braid construction. The yarns were not heat stretched before braidlng.
The sleeve yarns consisted of 130d MAXON~ twisted to 1.4 TPI 'S'.
The quoit consisted of 5 yarns of 130d MAXON~ twisted to 2.8 TPI
'Z'. Four yarns of this 5 ply constructlon were then twlsted to 1.4 TPI 'S' for a total denier of 2600.
The above yarns were then braided on a 13 carrier braider with 6 quoit ends set at a 12.3 pick. The final construction came to 17.694 denier, of which 90.2~ were quoit ends.
After sterilization this construction measured 19,134 denier. It had a 138 lb breaking strength (equivalent to 3.27 grams/denier) and an extension at break of 54.2~.
Example 6 The same as Example 5 except that the yarns used were post treated before braiding.
The final denier was 17,550 which changed to lB,288 after steriIization. The sterile devices had a breaking strength of 126 lbs (3.13 grams/denier) with an extension at break of 38.1~.
Example 7 The same as Example 5 except that the braid itself was post treated.
The final denier was 17,811 which changed to 18,414 after sterilization. Strength to break was 145 lbs ~3.57 grams/denier) with an extension at break of 39.3~.
~1~8Z205 Example 8 The same as Example 5 except that the ply twlsted yarn was heat stretched at 26% be~ore braiding. Material was not post treated either as a yarn or braid.
The inal denier was 16,497 which changed to 19,332 after sterilizatlon. Strength to break was 121 lbs (2.84 grams/denier) with an extension at break of 44%.
ExamDl~ 9 Same as Exa~ple 8 except that thls yarn was post treated after heat stretching.
The final denier was 15,786 ater braiding. On sterilizatlon this changed to 18,034. The strength to break of the sterile devices was 135 lbs (3.41 grams/denier) with an extension at break of 34.~.
Example 10 Same as Example 8 except that the braid itself was post treated.
The final denier was 16,362 after post treating; 17,392 after sterilization. The strength to break o the sterile implants was 150 lbs (3.90 grams/denier) with an extension at break o 34.6%.
ExamPle 11 This embodiment consisted of 100% MAXON~ in a flat braid construction. It differs from constructions described in previous examples in that it was alr~et texturized prior to the initial twisting steps. The sleeve yarn consisted of 149d texturized MAXON~. This was made by overfeeding 2 yarns of 66 denier MAXON~
into the air~et chamber-one by 15% and the other by 8%. This material was then twisted to 1.9 TPI 'Z'. The quoit yarn started with 219 denier texturized MAXON~. This was made by overfeeding 1 end of 66d MAXON~ at 15% into the air~et along with 1 end of 130d MAXON~ at 8~. The 219 denier yarns were then 3-plled at 2.8 TPI
'S'. Four yarns of the 3-ply material were then reverse twisted at 1.4 TPI 'Z' to glve a flnal denier of 2523.
This material was braided on a 13 carrier flat machine at 12.3 picks per inch. Its flnal denier measured 17,693 with 88.7% of the construction in the quoits.
The straight pull to break averaged 130 lbs (3.3 gms per denier) with an extension at break of 26.7%. As expected, its surface appearance resembled that made of yarns spun from a natural, staple fiber such as cotton or wool. Optically, the braid could be characterized as having a loose, single fil looped appearance.
Subsequent processing of the braid is as described above under the heading ~Drawings and Description~.
Exam~le 12 This design is identical to Example 11 except that in the initial 3-plying of the quoit yarns one end of a 245 denier MAXON~/NOVAFILO
texturized bicomponent yarn was substituted for one of 219 denier texturized MAXON~ yarns. This MAXON~/NOVAFIL bicomponent was made by overfeeding a 66d MAXON~ yarn at 55% and two 69d NOVAFILO yarns at 11% into the air~et chamber. The denier of the 12 ply quoit yarn was measured to be 2667d.
This material was braided on a 13 carrier flat machine at a 12.3 pick. Its final denier was 18,467 of which 89.2% was quoit yarn and 19.1% was the nonabsorbable NOVAFILO component.
1~:8~5 The final non-sterlle ligament had a breaklng strength of 122 lbs (3.00 grams per denier) and an extension at break of 25.9%.
Hydrolytic data indicates that this will make a viable product with a residual strength of 29.5 lbs.
Subsequent processing of the braid is as descrlbed above under the heading ~Drawings and Description~.
Example 13 This implant design is identical to Example 11 except that in the initial 3 plying of the quolt yarns one end of a 226 denier MAXON~/Heat Stretched Texturized DACRONO bicomponent yarn was substltuted for one of the 219 denier MAXON~ yarns. This MAXON~/Heat Stretched DACRON0 blcomponent was made by overfeeding a 66 denier MAXON~ yarn at 55% and a 127 denier heat stretched DACRONO yarn at 11% into the air~et chamber. The denier of the 12 ply quoit yarn measured 2613.
This material was braided on a 13 carrier flat machine at a 12.3 Pick. Its final non-sterile denier was 18.054. of which 89.0% was quolt yarn and 20.7% was the nonabsorbable heat stretched DACRO~O
component.
The final non-sterile ligament had a breaking strength of 97 lbs (2.43 grams per denier) and an extension at break of 21.7~.
Hydrolytic data indicated it would remain unchanged in strength for 14 days and would have a residual strength of 34.7 lbs.
Subsequent processing of the braid is as described above under the heading ~DRAWINGS AND DESCRIPTION~.
8'~5 ExamPle_14 This construction consists of 100% MAXON~ in a flat brald construction. It differs from previous constructlons in that it ls braided on a 21 carrier machine.
The sleeve yarn consists of 66 denler MAXON~ yarn twlsted to 1.4 TPI 'Z'. The 130 denler quoit yarns are first 2-plled at 2.8 TPI 'S' - then 5 yarns of this 2-ply construction are reverse twisted at 1.4 TPI 'Z'. The final denier of the 10 ply quoit yarn ls 1300.
The above yarns are then braided on a 21 carrier machine with 10 quoit yarns set at a 12 picks/inch. The final construction measures 16,986 denier, of which 91.8~ is quoit yarn.
Samples are expected to have a non-sterile breaking strength of 124 lbs (equivalent to 3.31 grams per denier) with an extension at break of 35.2%.
ExamDle 15 This construction consists of 100% MAXON~ in a flat braid construction. It differs from previous constructions in that it is braided on a 15 carrier machine.
The sleeve yarn consists of 98 denier MAXON~ twisted to 1.4 TPI
'Z'. The 130 denier quoit yarns are 5-plied at the same level of twist to give a total denier of 650. All yarns are post treated after plying.
The above yarns are braided on a 45 carrier machine. Only 15 out of 45 available carriers are used for the sleeve yarns. All of the available 22 quoit positions are used. The braider is set for a 4.1 pick. The final construction measures 15,770 denier, of which 90.7%
is parallel quoit yarn.
~8~
Straight pull tensile strength is expected to average approxlmately 168 lbs (4.83 grams/denier) with a 37.2% elongation at break.
Example 16 This implant design is similar to Example 15 except that 1 yarn of heat stretched DACRON~ is substituted in ply twisting the quoit yarns. ~lso, all MAXON~ yarns are post treated prior to twisting.
The final braid denier is 15,700, of which 90.7% is parallel quoit yarn. Approxlmately 18.1% of the total construction ls the nonabsorbable DACRONO component.
Straight pull tensile strength is expected to be approximately 127 lbs ~3.67 grams/denier) with a breaking elongation o 29.3%.
Hydrolytic data from similar constructlons indicate that this design would make a viable product wlth a residual strength of 29 lbs due to the nonabsorbable component.
Example l?
Thls design conslsts of 100% MAXON~ ln a flat brald construction.
Although bralded on a 45 carrier machine, it differs from Sample 15 ln that it ls 3.3 times heavier.
The sleeve yarns consist of 130 denier MAXON~ twisted to 1.4 TPI
'Z'. The 130 denier quoit yarns were first 4-plied to 2.8 TPI 'Z'.
then four 4-ply yarns are reverse plied to 1.4 TPI 'S' to give a final quoit yarn denier of 2080. All yarns are post treated after twlstlng.
The above yarns are then braided on a 45 carrier machlne uslng all avallable carriers for the sleeve and all of the avallable 22 quolt yarn positions. The bralder ls set for a 12.3 pick. The final construction measures 51,610 denier, of which 88.7% is parallel quoit yarn.
~1~8~ 5 Str~ight pull tensile strength is expected to average 525 lbs ~4.61 grams/denier) with a breaking elongdtion of 31.6%.
The following examples, and varlations thereof, may be suitable for some soft tlssue orthopedic (l.e. tendon) repair/recon- struction appllcatlons. They have been found to be lnappropriate as ligament implants. They are disclosed for their comparatlve and contrast value to Examples l-to-17, and as a contribution to the state of the art.
ComDarative ExamPle A
This construction ls a round bicomponent braid consisting of three bralded elements.
a. A subcore which is a blend of 20/80 PGA/Heat Stretched DACRONO.
This subcore was made on an 8 carrier braider set at 5 picks/inch with each carrier containing a 1060 denier bicomponent yarn. The 1060 denier yarn was made by ply twisting 4 yarns of 210 denier heat stretched DACRONO with 2 yarns of 110 denier DEXONO (American Cyanamid Co., NJ 07470, U.S.A.) at a low nominal level of twist. The preparation and polymeric composition of DEXONO is disclosed in the prior art.
b. A core is also a blend of 20/80 PGA/Heat Stretched DACRONO.
This was made by braiding on a 12 carrier braider set at 5 picks/inch using the 8 carrier braid described above as a core. Each of the 12 carriers contained a 1270 denier bicomponent yarn which was made by ply twisting 5 yarns of 210 denier Heat Stretched DACRONO with 2 yarns of 110 denier DEXONO at a low level of twist.
1~82%~
c. The final sleeve was a blend of 60/40 PGA/Heat Stretched DACRONO. This was made by braiding on a 16 carrier braider set at 15 picks per inch using the 12 carrler brald described above as a core.
Each of the 16 carriers contalned a 1510 denier blcomponent yarn whlch was made by ply twlstlng 3 yarns of 210 denier Heat stretched DACRONO with 8 yarns of 110 denier DEXONO at a low level of twist.
All of the above yarns were post treated after ply twisting. Thls braid broke at 430 lbs straight pull (equivalent to 4.07 grams/denier) with an 18.8% extension at break. Braid denier was calculated to be 47,900.
Intramuscular and subcutaneous implants in canines exhibited little, if any, tissue ingrowth. 8raids were encapsulated by unorganized collagen. This lack of vascularized cellular tissue and oriented collagen infiltration into the implant is considered undesirable for ligament repair or reconstruction. It is most probably a combined effect of: 1.) the relatively short strength retention period of the PGA (i.e. 28 days); and 2.) the tight round construction which minimizes implant-tissue interface area.
ComParative Example B
This construction was basically the same as that in Comparative Exampie A except that the final sleeve was a 50/50 PGA/Heat Stretched DACRONO bicomponent yarn in a finer ~more dispersed) blend. This was made on a 16 carrier braider set at 15 picks/inch using the 12 carrier braid described in Example A as a core. Each carrier contained a 1320 denier bicomponent yarn made by first ply twisting 1 yarn of 110 denier Heat Stretched DACRONO with 1 yarn of 110 denier DEXONO. Six of the 2-ply bicomponent yarns were then twisted to make the final 12-ply yarn. Twist levels were of a low order of magnitude.
~B~i -- ~4 --The final brald denier was calculated to be 44.8K. The breaklng strength measured 385 lbs ~equivalent to 3.89 grams/denler) wlth a breaklng elongation of 16.8%. Animal implant data were similar to Example A.
Comparative Example C
This construction was, again, basically the same as in Comparatlve Example A except that the final sleeve had a coarser (less dispersed) configuratlon. It conslsted of alternating a 1650 denier DACRONO
(Heat Stretched) yarn with 1650 denier DEXONO yarn on each of the 16 carriers.
The flnal breaklng strength was 429 lbs (equivalent to 3.88 grams/denier). The elongation at break was 17.8%. The final denier was calculated to be 50,100. Animal implant results were similar to example A.
ComParative ExamPle D
This implant design was 100% DEXON~ PGA in a round braid configuration and it consisted of three braided elements:
a. The subcore was made on an 8 carrier braider set at 5 picks/inch. Only 4 out of the eight sleeve carriers were used. The 440 denier yarn was made by plylng four 110 denier yarns at a low number of twists per inch.
b. The core was made on an eight carrier machlne also set at 5 picks/lnch wlth all eight carriers contalning a 550 denier yarn. The yarn was made by plying five 110 denier yarns at a low level of twist. The 4 carrier braid described above was used as a core.
c. The sleeve was made on a twelve carrler bralder set at 15 plcks/lnch wlth all 12 carriers containing a 660 denier yarn. The yarn was made by plying six 110 denier yarns at a low level of twist. The eight carrier braid described above was used as a core.
The final denier was calculated to be 14,100. Tenslle strength was measured to be 134 lbs (equivalent to 4.32 grams/denier). The elongation at break was 33.4~.
ImPlant results This material was implanted as a replacement for the resected patellar ligament of 10 month or older beagle dogs. At 1 and 2 months there was no hlstological evidence of tissue ingrowth. Braids were encapsulated by unorganized collagen and were structurally weak. This construction was abandoned since there was little hope for lts use ln llgament repair or replacement applications where ingrowth ls desired.
ComDaratiVe ExamPle E
This implant design was 100~ DEXOUO (PGA) in a flat braid config-uration and consisted of heavy denier quoit or warp yarns held together by light denier sleeve yarns:
a. Each quoit yarn contained 2214 denier DEXONO which was made by ply twisting three - 123 denier yarns to give 369 denier yarn and then ply twisting six of these 369 denier yarns at 1.5 TPI 'S'.
b. The sleeve yarn contained 110 denier DEXONO yarns which were twisted to 10 TPI 'S'.
128'~Z05 c. The braid was made on a thlrteen carrler bralder - each carrier contalning 110 denier sleeve yarn whlch was bralded about the 2214 denler warp yarns fed through all slx avallable quolt posltlons. The total plck count was estimated at 10 per lnch.
d. This construction was washed and post treated as a brald.
The total braid denier was approximately 15,100. Tensile strength measured 208 lbs. with a 22.3~ elongation-to-break.
Devices of this deslgn were implanted as replacements for the resected patellar ligament of 10 month or older beagle dogs in a comparative study with devices of Example 1. Histologlcal evaluation at 1 and 2 months post-operatlvely revealed no signlficant tissue ingrowth or organization within the PGA implant. This lack of ligament repair was attributed to the relatively shorter ln-vivo property retention perlod of the PGA materlal.
Comparatlve ExamPle F
This lmplant design was 100~ DEXON- (PGA) in a flat brald configuration and again consisted of heavy denier quoit or warp yarns held together by light denier sleeve yarns. However, all the yarns were post treated; then air ~et texturized prior to twisting and braiding.
a. The quoit (warp) yarn consisted of a 6 ply construction using 357 denler texturized DEXONO yarn to give a total 2142 denier yarn.
This 357 denier yarn was made by entangling 3 ends of 110 denier DEXONO yarn - 2 yarns with a 24~ overfeed and one with a 6~ overfeed.
,~
b. The sleeve yarn was made similarly except it was a 152 denier, texturized DEXON- yarn. This was made by entangling 2 yarns of 62 denier DEXON- - one yarn with a 24~ overfeed and the other with an 11% overfeed.
`
.
.
~8220~;
c. The braid was made on a thirteen carrier braider, each carrier containing the 152 denier yarn descrlbed in section b above. These sleeve yarns were braided about the 2142 denier warp yarns fed through all six available quolt positions. The total plck count was estimated at 12.3 per inch.
The total braid denier was 14,800. Tensile strength measured 152 lbs. wlth a 23.2% elongation-to-break.
Devices of this construction were evaluated in-vivo as described in the prevlous example. Upon sacrlfice at 2 months, these implants were found to have better tissue ingrowth/organization than the non-texturized PGA devices of the previous example. However, the results achieved with implants made using the longer lasting GTMC
yarns were consistently, significantly improved over those obtained with the devices of these comparative examples.
Claims
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A flat braided ligament or tendon implant device having a length to width ratio of greater than one, comprising a plurality of fibers, the majority of the fibers being in a direction essentially parallel to the implant length, the braid having about 5 to 25 carrier and up to about 10 warp yarns, wherein the yarns are texturized, and said implant having an absorbable component comprising from about 10 to 100 percent of a copolymer, the copolymer having glycolic acid ester and from about 20 to 40 percent by weight of trimethylene carbonate linkages, and the remainder of said implant, if any, having a nonabsorbable component.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/835,493 US4792336A (en) | 1986-03-03 | 1986-03-03 | Flat braided ligament or tendon implant device having texturized yarns |
US06/835,493 | 1986-03-03 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1282205C true CA1282205C (en) | 1991-04-02 |
Family
ID=25269640
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000530746A Expired - Fee Related CA1282205C (en) | 1986-03-03 | 1987-02-27 | Surgical repair device |
Country Status (10)
Country | Link |
---|---|
US (2) | US4792336A (en) |
EP (1) | EP0239775A3 (en) |
JP (1) | JPS62270152A (en) |
KR (1) | KR950001375B1 (en) |
AU (1) | AU594435B2 (en) |
CA (1) | CA1282205C (en) |
DK (1) | DK106687A (en) |
FI (1) | FI88259C (en) |
NO (1) | NO166614C (en) |
ZA (1) | ZA871489B (en) |
Families Citing this family (383)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4923470A (en) * | 1985-04-25 | 1990-05-08 | American Cyanamid Company | Prosthetic tubular article made with four chemically distinct fibers |
GB8622563D0 (en) * | 1986-09-19 | 1986-10-22 | Amis A A | Artificial ligaments |
FI81498C (en) * | 1987-01-13 | 1990-11-12 | Biocon Oy | SURGICAL MATERIAL OCH INSTRUMENT. |
SE457692B (en) * | 1987-03-09 | 1989-01-23 | Astra Meditec Ab | IMPLANT PROTECTION PROVIDES WHOLE OR PARTIAL REPLACEMENT OF A SENA, A LIQUOR OR A CROSS BAND |
US5425766A (en) * | 1987-03-09 | 1995-06-20 | Astra Tech Aktiebolag | Resorbable prosthesis |
US5306289A (en) * | 1987-08-26 | 1994-04-26 | United States Surgical Corporation | Braided suture of improved characteristics |
US5222978A (en) | 1987-08-26 | 1993-06-29 | United States Surgical Corporation | Packaged synthetic absorbable surgical elements |
US5019093A (en) * | 1989-04-28 | 1991-05-28 | United States Surgical Corporation | Braided suture |
US5366081A (en) | 1987-08-26 | 1994-11-22 | United States Surgical Corporation | Packaged synthetic absorbable surgical elements |
US5261886A (en) * | 1987-08-26 | 1993-11-16 | United States Surgical Corporation | Cabled core and braided suture made therefrom |
US5226912A (en) | 1987-08-26 | 1993-07-13 | United States Surgical Corporation | Combined surgical needle-braided suture device |
FR2624724B1 (en) * | 1987-12-22 | 1992-08-14 | Rhenter Jean Luc | SYNTHETIC LIGAMENT FOR KNEE |
DE68917501T2 (en) * | 1988-03-22 | 1995-03-02 | American Cyanamid Co | Prosthetic article. |
US5092884A (en) * | 1988-03-24 | 1992-03-03 | American Cyanamid Company | Surgical composite structure having absorbable and nonabsorbable components |
US6171338B1 (en) | 1988-11-10 | 2001-01-09 | Biocon, Oy | Biodegradable surgical implants and devices |
FI85223C (en) * | 1988-11-10 | 1992-03-25 | Biocon Oy | BIODEGRADERANDE SURGICAL IMPLANT OCH MEDEL. |
DE3838568A1 (en) * | 1988-11-14 | 1990-05-17 | Inst Textil & Faserforschung | Joint prosthesis |
US5441508A (en) * | 1989-04-27 | 1995-08-15 | Gazielly; Dominique | Reinforcement and supporting device for the rotator cuff of a shoulder joint of a person |
FR2646343B1 (en) * | 1989-04-27 | 1991-12-20 | Gazielly Dominique | DEVICE FOR REINFORCING AND SUPPORTING THE HAIR OF THE ROTATORS OF AN INDIVIDUAL SHOULDER JOINT |
FR2646590B1 (en) * | 1989-05-03 | 1992-04-17 | Jonnard Pierre | PROCESS FOR THE PREPARATION OF NATURAL DELICATESSEN HOSES AND THE DEVICE FOR ITS IMPLEMENTATION |
US5147400A (en) * | 1989-05-10 | 1992-09-15 | United States Surgical Corporation | Connective tissue prosthesis |
US5217495A (en) * | 1989-05-10 | 1993-06-08 | United States Surgical Corporation | Synthetic semiabsorbable composite yarn |
US5376118A (en) * | 1989-05-10 | 1994-12-27 | United States Surgical Corporation | Support material for cell impregnation |
US4990158A (en) * | 1989-05-10 | 1991-02-05 | United States Surgical Corporation | Synthetic semiabsorbable tubular prosthesis |
US5359831A (en) | 1989-08-01 | 1994-11-01 | United States Surgical Corporation | Molded suture retainer |
US5246104A (en) * | 1989-08-01 | 1993-09-21 | United States Surgical Corporation | Molded suture retainer |
US5156615A (en) * | 1989-09-27 | 1992-10-20 | United States Surgical Corporation | Surgical needle-suture attachment for controlled suture release |
US5139514A (en) * | 1989-09-27 | 1992-08-18 | United States Surgical Corporation | Combined needle-suture device |
US5041128A (en) * | 1989-09-27 | 1991-08-20 | United States Sirgical Corporation | Combined surgical needle-suture device possessing an integrated suture cut-off feature |
US5102418A (en) * | 1989-09-27 | 1992-04-07 | United States Surgical Corporation | Method for attaching a surgical needle to a suture |
US5259845A (en) * | 1989-09-27 | 1993-11-09 | United States Surgical Corporation | Surgical needle-suture attachment with a lubricated suture tip for controlled suture release |
US5089011A (en) * | 1989-09-27 | 1992-02-18 | United States Surgical Corporation | Combined surgical needle-suture device possessing an integrated suture cut-off feature |
US5051107A (en) * | 1989-09-27 | 1991-09-24 | United States Surgical Corporation | Surgical needle-suture attachment for controlled suture release |
US5123911A (en) * | 1989-09-27 | 1992-06-23 | United States Surgical Corporation | Method for attaching a surgical needle to a suture |
US5133738A (en) * | 1989-09-27 | 1992-07-28 | United States Surgical Corporation | Combined surgical needle-spiroid braided suture device |
US5059212A (en) * | 1989-09-27 | 1991-10-22 | United States Surgical Corporation | Surgical needle-suture attachment for controlled separation of the needle from the suture |
US5084063A (en) * | 1989-09-27 | 1992-01-28 | United States Surgical Corporation | Surgical needle-suture attachment |
US5067959A (en) * | 1989-09-27 | 1991-11-26 | United States Surgical Corporation | Surgical needle-suture attachement for controlled suture release |
US5280674A (en) * | 1989-09-27 | 1994-01-25 | United States Surgical Corporation | Apparatus for attaching a surgical needle to a suture |
US5089010A (en) * | 1989-09-27 | 1992-02-18 | United States Surgical Corporation | Surgical needle-suture attachment possessing weakened suture segment for controlled suture release |
US4946377A (en) * | 1989-11-06 | 1990-08-07 | W. L. Gore & Associates, Inc. | Tissue repair device |
US5037950A (en) * | 1990-02-09 | 1991-08-06 | Ethicon, Inc. | Bioabsorbable copolymers of polyalkylene carbonate/RHO-dioxanone for sutures and coatings |
US5290494A (en) * | 1990-03-05 | 1994-03-01 | Board Of Regents, The University Of Texas System | Process of making a resorbable implantation device |
DE4012602C2 (en) | 1990-04-20 | 1994-06-09 | Ethicon Gmbh | Implant cord |
US5593425A (en) * | 1990-06-28 | 1997-01-14 | Peter M. Bonutti | Surgical devices assembled using heat bonable materials |
US6464713B2 (en) | 1990-06-28 | 2002-10-15 | Peter M. Bonutti | Body tissue fastening |
US6203565B1 (en) | 1990-06-28 | 2001-03-20 | Peter M. Bonutti | Surgical devices assembled using heat bondable materials |
US7208013B1 (en) | 1990-06-28 | 2007-04-24 | Bonutti Ip, Llc | Composite surgical devices |
US5116358A (en) * | 1990-07-23 | 1992-05-26 | United States Surgical Corporation | Combined surgical needle-suture device possessing a controlled suture separation feature |
US5306288A (en) * | 1990-09-05 | 1994-04-26 | United States Surgical Corporation | Combined surgical needle-suture device |
US5368595A (en) * | 1990-09-06 | 1994-11-29 | United States Surgical Corporation | Implant assist apparatus |
CA2060635A1 (en) * | 1991-02-12 | 1992-08-13 | Keith D'alessio | Bioabsorbable medical implants |
JP3165166B2 (en) * | 1991-02-27 | 2001-05-14 | セーレン株式会社 | Artificial blood vessel and method for producing the same |
WO1993006790A2 (en) * | 1991-10-04 | 1993-04-15 | Minnesota Mining And Manufacturing Company | Tissue augmentation device and method |
US5464450A (en) * | 1991-10-04 | 1995-11-07 | Scimed Lifesystems Inc. | Biodegradable drug delivery vascular stent |
US5275618A (en) * | 1991-11-13 | 1994-01-04 | United States Surgical Corporation | Jet entangled suture yarn and method for making same |
JPH05161708A (en) * | 1991-12-18 | 1993-06-29 | Terumo Corp | Artificial blood vessel |
US5318575A (en) * | 1992-02-03 | 1994-06-07 | United States Surgical Corporation | Method of using a surgical repair suture product |
US5312437A (en) * | 1992-06-12 | 1994-05-17 | United States Surgical Corporation | Absorbable coating composition and suture coated therewith |
US5356417A (en) * | 1992-10-09 | 1994-10-18 | United States Surgical Corporation | Absorbable sternum closure buckle |
US5417698A (en) * | 1992-10-09 | 1995-05-23 | United States Surgical Corporation | Apparatus for tightening elongated wound closure elements |
US5330489A (en) * | 1992-10-09 | 1994-07-19 | United States Surgical Corporation | Sternum closure buckle |
US5339870A (en) * | 1992-10-09 | 1994-08-23 | United States Surgical Corporation | Sternum buckle and applier |
US5355913A (en) * | 1992-10-09 | 1994-10-18 | United States Surgical Corporation | Surgical repair device |
US5356412A (en) * | 1992-10-09 | 1994-10-18 | United States Surgical Corporation | Sternum buckle with rotational engagement and method of closure |
CA2108603A1 (en) * | 1992-10-23 | 1994-04-24 | Michael P. Chesterfield | Surgical repair product |
US5322925A (en) * | 1992-10-30 | 1994-06-21 | United States Surgical Corporation | Absorbable block copolymers and surgical articles made therefrom |
US5507812A (en) * | 1992-12-28 | 1996-04-16 | Moore; David E. | Modular prosthetic ligament |
US5456722A (en) * | 1993-01-06 | 1995-10-10 | Smith & Nephew Richards Inc. | Load bearing polymeric cable |
US5540703A (en) * | 1993-01-06 | 1996-07-30 | Smith & Nephew Richards Inc. | Knotted cable attachment apparatus formed of braided polymeric fibers |
CA2132011C (en) * | 1993-01-14 | 1999-08-10 | Peter J. Schmitt | Radially expandable tubular prosthesis |
US5468253A (en) † | 1993-01-21 | 1995-11-21 | Ethicon, Inc. | Elastomeric medical device |
CA2114290C (en) * | 1993-01-27 | 2006-01-10 | Nagabushanam Totakura | Post-surgical anti-adhesion device |
GB9306737D0 (en) * | 1993-03-31 | 1993-05-26 | Surgicarft Ltd | Ligament augmentation device |
US5370682A (en) * | 1993-04-26 | 1994-12-06 | Meadox Medicals, Inc. | Solid woven tubular prosthesis |
US6383199B2 (en) | 1993-08-25 | 2002-05-07 | Inlet Medical, Inc. | Devices for investing within ligaments for retracting and reinforcing the same |
US5450860A (en) * | 1993-08-31 | 1995-09-19 | W. L. Gore & Associates, Inc. | Device for tissue repair and method for employing same |
EP0642773B1 (en) * | 1993-09-14 | 2003-05-28 | Lanny L. Johnson | Biological replacement ligament |
GB2282328B (en) * | 1993-09-29 | 1997-10-08 | Johnson & Johnson Medical | Absorbable structures for ligament and tendon repair |
US5653746A (en) * | 1994-03-08 | 1997-08-05 | Meadox Medicals, Inc. | Radially expandable tubular prosthesis |
US5968058A (en) * | 1996-03-27 | 1999-10-19 | Optonol Ltd. | Device for and method of implanting an intraocular implant |
US5780372A (en) * | 1996-02-21 | 1998-07-14 | Libbey-Owens-Ford Co. | Colored glass compositions |
WO1997035533A1 (en) | 1996-03-25 | 1997-10-02 | Enrico Nicolo | Surgical mesh prosthetic material and methods of use |
US5718159A (en) * | 1996-04-30 | 1998-02-17 | Schneider (Usa) Inc. | Process for manufacturing three-dimensional braided covered stent |
US6592617B2 (en) * | 1996-04-30 | 2003-07-15 | Boston Scientific Scimed, Inc. | Three-dimensional braided covered stent |
US5718717A (en) | 1996-08-19 | 1998-02-17 | Bonutti; Peter M. | Suture anchor |
US6162537A (en) * | 1996-11-12 | 2000-12-19 | Solutia Inc. | Implantable fibers and medical articles |
US5948002A (en) * | 1996-11-15 | 1999-09-07 | Bonutti; Peter M. | Apparatus and method for use in positioning a suture anchor |
FR2755846B1 (en) * | 1996-11-20 | 1998-12-31 | Jacques Philippe Laboureau | PRE-ORIENT PROSTHETIC LIGAMENT AND METHOD OF MAKING |
US7789841B2 (en) | 1997-02-06 | 2010-09-07 | Exogen, Inc. | Method and apparatus for connective tissue treatment |
US7108663B2 (en) | 1997-02-06 | 2006-09-19 | Exogen, Inc. | Method and apparatus for cartilage growth stimulation |
CA2280812A1 (en) * | 1997-02-13 | 1998-08-20 | Rodney Brenneman | Percutaneous and hiatal devices and methods for use in minimally invasive pelvic surgery |
AUPO530997A0 (en) | 1997-02-25 | 1997-03-20 | Esnouf, Philip Stuart | Surgical aid for connective tissue grafting and method for employing same |
US20020019670A1 (en) * | 1997-02-28 | 2002-02-14 | Jerald M. Crawley | Implantable tissue augmentation device |
JP2001520559A (en) | 1997-04-18 | 2001-10-30 | エキソゲン,インコーポレイティド | Ultrasound application device to promote sternum healing |
US20050216059A1 (en) * | 2002-09-05 | 2005-09-29 | Bonutti Peter M | Method and apparatus for securing a suture |
US8313454B2 (en) * | 1997-11-20 | 2012-11-20 | Optonol Ltd. | Fluid drainage device, delivery device, and associated methods of use and manufacture |
US6203513B1 (en) * | 1997-11-20 | 2001-03-20 | Optonol Ltd. | Flow regulating implant, method of manufacture, and delivery device |
US5921986A (en) * | 1998-02-06 | 1999-07-13 | Bonutti; Peter M. | Bone suture |
US6045551A (en) * | 1998-02-06 | 2000-04-04 | Bonutti; Peter M. | Bone suture |
US20050049702A1 (en) * | 1998-03-10 | 2005-03-03 | The University Of Cincinnati | Article and method for coupling muscle |
US6177094B1 (en) | 1998-04-30 | 2001-01-23 | United States Surgical Corporation | Bioabsorbable blends and coating composition containing same |
ATE342102T1 (en) | 1998-05-06 | 2006-11-15 | Exogen Inc | ULTRASONIC BANDAGES |
JP2002521082A (en) | 1998-07-21 | 2002-07-16 | アコースティック・サイエンシズ・アソシエイツ | Synthetic structural imaging and volume estimation of biological tissue organs |
DE19833796B4 (en) * | 1998-07-21 | 2015-10-01 | Johnson & Johnson Medical Gmbh | Braided resorbable implant |
US6264674B1 (en) | 1998-11-09 | 2001-07-24 | Robert L. Washington | Process for hot stretching braided ligatures |
US6497726B1 (en) | 2000-01-11 | 2002-12-24 | Regeneration Technologies, Inc. | Materials and methods for improved bone tendon bone transplantation |
SE513491C2 (en) * | 1998-12-15 | 2000-09-18 | Artimplant Dev Artdev Ab | Implants for insertion into humans or animals including flexible filamentous elements |
US6126688A (en) * | 1998-12-21 | 2000-10-03 | Surgical Dynamics Inc. | Apparatus for fusion of adjacent bone structures |
DE19912360A1 (en) * | 1999-03-19 | 2000-09-21 | Aesculap Ag & Co Kg | Strand-shaped implant made of resorbable polymer material, process for its production and use in surgery |
DE60036863T2 (en) * | 1999-03-25 | 2008-07-31 | Metabolix, Inc., Cambridge | Medical devices and uses of polyhydroxyalkanoate polymers |
US6045571A (en) * | 1999-04-14 | 2000-04-04 | Ethicon, Inc. | Multifilament surgical cord |
US6183512B1 (en) | 1999-04-16 | 2001-02-06 | Edwards Lifesciences Corporation | Flexible annuloplasty system |
US6258124B1 (en) | 1999-05-10 | 2001-07-10 | C. R. Bard, Inc. | Prosthetic repair fabric |
US6558342B1 (en) * | 1999-06-02 | 2003-05-06 | Optonol Ltd. | Flow control device, introducer and method of implanting |
DE60018571T8 (en) | 1999-07-28 | 2006-04-27 | Davol Inc. | HERNIENPROTHESE |
US6368343B1 (en) | 2000-03-13 | 2002-04-09 | Peter M. Bonutti | Method of using ultrasonic vibration to secure body tissue |
US6447516B1 (en) | 1999-08-09 | 2002-09-10 | Peter M. Bonutti | Method of securing tissue |
GB9926231D0 (en) * | 1999-11-04 | 2000-01-12 | Smith & Nephew | Medical implants |
US6635073B2 (en) * | 2000-05-03 | 2003-10-21 | Peter M. Bonutti | Method of securing body tissue |
US6296659B1 (en) * | 2000-02-29 | 2001-10-02 | Opus Medical, Inc. | Single-tailed suturing method and apparatus |
US9138222B2 (en) * | 2000-03-13 | 2015-09-22 | P Tech, Llc | Method and device for securing body tissue |
US8932330B2 (en) | 2000-03-13 | 2015-01-13 | P Tech, Llc | Method and device for securing body tissue |
US7094251B2 (en) * | 2002-08-27 | 2006-08-22 | Marctec, Llc. | Apparatus and method for securing a suture |
EP1272127B1 (en) * | 2000-03-24 | 2007-12-26 | Drexel University | Methods for production of ligament replacement constructs |
US20020133229A1 (en) * | 2000-03-24 | 2002-09-19 | Laurencin Cato T. | Ligament and tendon replacement constructs and methods for production and use thereof |
US7404819B1 (en) | 2000-09-14 | 2008-07-29 | C.R. Bard, Inc. | Implantable prosthesis |
DE10046119A1 (en) | 2000-09-15 | 2002-03-28 | Inst Textil & Faserforschung | Medical bioresorbable implant, method of manufacture and use |
JP4126228B2 (en) | 2000-10-25 | 2008-07-30 | エクソジェン インコーポレイテッド | Transmitter mounting assembly |
US6770076B2 (en) | 2001-02-12 | 2004-08-03 | Opus Medical, Inc. | Method and apparatus for attaching connective tissues to bone using a knotless suture anchoring device |
DE10107521A1 (en) * | 2001-02-17 | 2002-09-05 | Inst Textil & Faserforschung | Tensile elastic band |
US7195642B2 (en) | 2001-03-13 | 2007-03-27 | Mckernan Daniel J | Method and apparatus for fixing a graft in a bone tunnel |
US7594917B2 (en) | 2001-03-13 | 2009-09-29 | Ethicon, Inc. | Method and apparatus for fixing a graft in a bone tunnel |
US6517546B2 (en) | 2001-03-13 | 2003-02-11 | Gregory R. Whittaker | Method and apparatus for fixing a graft in a bone tunnel |
GB0107708D0 (en) * | 2001-03-28 | 2001-05-16 | Imp College Innovations Ltd | Bone fixated,articulated joint load control device |
US7344539B2 (en) | 2001-03-30 | 2008-03-18 | Depuy Acromed, Inc. | Intervertebral connection system |
US7429248B1 (en) | 2001-08-09 | 2008-09-30 | Exogen, Inc. | Method and apparatus for controlling acoustic modes in tissue healing applications |
US8512376B2 (en) | 2002-08-30 | 2013-08-20 | Arthrex, Inc. | Method and apparatus for internal fixation of an acromioclavicular joint dislocation of the shoulder |
US6605047B2 (en) * | 2001-09-10 | 2003-08-12 | Vivant Medical, Inc. | Biopsy marker delivery system |
US7029490B2 (en) * | 2001-09-13 | 2006-04-18 | Arthrex, Inc. | High strength suture with coating and colored trace |
US20050033362A1 (en) * | 2001-09-13 | 2005-02-10 | Grafton R. Donald | High strength suture with collagen fibers |
GB0124742D0 (en) * | 2001-10-16 | 2001-12-05 | Biocomposites Ltd | Biodegradable materials |
US6589392B1 (en) * | 2001-10-18 | 2003-07-08 | Shakespeare Company Llc | Multicomponent monofilament for papermaking forming fabric |
US7081298B2 (en) * | 2001-10-29 | 2006-07-25 | Yoz-Ami Corporation | Specific gravity-adjustable yarns with low elongation rate and excellent abrasion resistance |
US6764513B1 (en) | 2001-11-07 | 2004-07-20 | Brian T. Dowling | Tibia tether |
US20110009960A1 (en) * | 2001-11-16 | 2011-01-13 | Allergan, Inc. | Prosthetic fabric structure |
US6902932B2 (en) | 2001-11-16 | 2005-06-07 | Tissue Regeneration, Inc. | Helically organized silk fibroin fiber bundles for matrices in tissue engineering |
FR2832307B1 (en) * | 2001-11-19 | 2004-08-27 | Sofradim Production | DEVICE FOR OCCLUSIONING A BODILY CONDUIT, IN PARTICULAR A VARIOUS VEIN |
US6719765B2 (en) * | 2001-12-03 | 2004-04-13 | Bonutti 2003 Trust-A | Magnetic suturing system and method |
US6780198B1 (en) | 2001-12-06 | 2004-08-24 | Opus Medical, Inc. | Bone anchor insertion device |
US6790213B2 (en) | 2002-01-07 | 2004-09-14 | C.R. Bard, Inc. | Implantable prosthesis |
US7017582B2 (en) | 2002-02-04 | 2006-03-28 | Restore Medical Inc. | Stiffening pharyngeal wall treatment |
US7146981B2 (en) * | 2002-02-04 | 2006-12-12 | Restore Medical, Inc. | Pharyngeal wall treatment |
EP1491665B1 (en) * | 2002-02-28 | 2009-12-02 | Riken | Polyhydroxyalkanoic acid fibers with high strength, fibers with high strength and high modulus of elasticity and processes for producing the same |
US9155544B2 (en) | 2002-03-20 | 2015-10-13 | P Tech, Llc | Robotic systems and methods |
US7101381B2 (en) * | 2002-08-02 | 2006-09-05 | C.R. Bard, Inc. | Implantable prosthesis |
US7682392B2 (en) | 2002-10-30 | 2010-03-23 | Depuy Spine, Inc. | Regenerative implants for stabilizing the spine and devices for attachment of said implants |
WO2004082724A2 (en) * | 2003-03-18 | 2004-09-30 | Opus Medical Inc. | Optimized suture braid |
US7497864B2 (en) | 2003-04-30 | 2009-03-03 | Marctec, Llc. | Tissue fastener and methods for using same |
CA2525132C (en) | 2003-05-08 | 2011-06-28 | Tepha, Inc. | Polyhydroxyalkanoate medical textiles and fibers |
US7905924B2 (en) * | 2003-09-03 | 2011-03-15 | Ralph Richard White | Extracapsular surgical procedure |
US7648504B2 (en) * | 2003-09-09 | 2010-01-19 | Bioretec Ltd | Bioabsorbable band system |
US20050070930A1 (en) * | 2003-09-30 | 2005-03-31 | Gene W. Kammerer | Implantable surgical mesh |
US20090216252A1 (en) * | 2004-02-13 | 2009-08-27 | The University Of Cincinnati | A coupling device enabled by mechanical continuity of cellular scaffolding across tissue boundaries |
US20050192600A1 (en) * | 2004-02-24 | 2005-09-01 | Enrico Nicolo | Inguinal hernia repair prosthetic |
US20050192581A1 (en) * | 2004-02-27 | 2005-09-01 | Molz Fred J. | Radiopaque, coaxial orthopedic tether design and method |
US8088146B2 (en) | 2004-06-14 | 2012-01-03 | Teleflex Medical Incorporated | High-strength suture |
US7862531B2 (en) * | 2004-06-25 | 2011-01-04 | Optonol Ltd. | Flow regulating implants |
WO2006015276A2 (en) | 2004-08-03 | 2006-02-09 | Tepha, Inc. | Non-curling polyhydroxyalkanoate sutures |
WO2006026397A2 (en) * | 2004-08-26 | 2006-03-09 | Stout Medical Group, L.P. | Sutures and methods of making the same |
FI119097B (en) * | 2004-08-31 | 2008-07-31 | Bioretec Oy | Surgical thread and surgical instrument |
US20060089672A1 (en) * | 2004-10-25 | 2006-04-27 | Jonathan Martinek | Yarns containing filaments made from shape memory alloys |
US9173647B2 (en) | 2004-10-26 | 2015-11-03 | P Tech, Llc | Tissue fixation system |
US9271766B2 (en) | 2004-10-26 | 2016-03-01 | P Tech, Llc | Devices and methods for stabilizing tissue and implants |
US20060089646A1 (en) | 2004-10-26 | 2006-04-27 | Bonutti Peter M | Devices and methods for stabilizing tissue and implants |
US9463012B2 (en) | 2004-10-26 | 2016-10-11 | P Tech, Llc | Apparatus for guiding and positioning an implant |
US8753392B2 (en) | 2005-01-07 | 2014-06-17 | University Of Cincinnati | Elements for versatility of a prosthetic anchor |
US8052753B2 (en) | 2005-01-07 | 2011-11-08 | University Of Cincinnati | Prosthetic anchor and method of making same |
US9017350B2 (en) | 2005-01-25 | 2015-04-28 | Covidien Lp | Expandable occlusive structure |
BRPI0608186A2 (en) * | 2005-02-18 | 2011-01-04 | Synthasome Inc | synthetic structure for soft tissue repair |
US9089323B2 (en) | 2005-02-22 | 2015-07-28 | P Tech, Llc | Device and method for securing body tissue |
GB2441266B (en) | 2005-06-01 | 2011-03-02 | Arthrocare Corp | Knotless suture anchoring device having deforming section to accommodate sutures of various diameters |
US9271817B2 (en) * | 2005-07-05 | 2016-03-01 | Cook Biotech Incorporated | Tissue augmentation devices and methods |
US7850985B2 (en) | 2005-07-05 | 2010-12-14 | Cook Biotech Incorporated | Tissue augmentation devices and methods |
FI122342B (en) * | 2005-07-18 | 2011-12-15 | Bioretec Oy | Bioabsorbable tape system, bioabsorbable tape and method of forming a bioabsorbable tape. |
US20070038290A1 (en) * | 2005-08-15 | 2007-02-15 | Bin Huang | Fiber reinforced composite stents |
WO2007025241A2 (en) * | 2005-08-26 | 2007-03-01 | Tyco Healthcare Group Lp | Absorbable surgical materials |
US7878970B2 (en) * | 2005-09-28 | 2011-02-01 | Boston Scientific Scimed, Inc. | Apparatus and method for suspending a uterus |
US7899533B2 (en) * | 2005-10-25 | 2011-03-01 | Medtronic, Inc. | System and method of AV interval selection in an implantable medical device |
US9144483B2 (en) * | 2006-01-13 | 2015-09-29 | Boston Scientific Scimed, Inc. | Placing fixation devices |
US8496657B2 (en) | 2006-02-07 | 2013-07-30 | P Tech, Llc. | Methods for utilizing vibratory energy to weld, stake and/or remove implants |
US7967820B2 (en) * | 2006-02-07 | 2011-06-28 | P Tech, Llc. | Methods and devices for trauma welding |
US11253296B2 (en) | 2006-02-07 | 2022-02-22 | P Tech, Llc | Methods and devices for intracorporeal bonding of implants with thermal energy |
US11278331B2 (en) | 2006-02-07 | 2022-03-22 | P Tech Llc | Method and devices for intracorporeal bonding of implants with thermal energy |
US7615061B2 (en) | 2006-02-28 | 2009-11-10 | Arthrocare Corporation | Bone anchor suture-loading system, method and apparatus |
EP1998711B1 (en) * | 2006-03-16 | 2013-12-11 | Boston Scientific Limited | Apparatus for treatment of pelvic conditions |
US20090035572A1 (en) | 2006-04-06 | 2009-02-05 | Tyco Healthcare Group Lp | Yarns containing thermoplastic elastomer copolymer and polyolefin filaments |
AU2007201213A1 (en) | 2006-04-06 | 2007-10-25 | Tyco Healthcare Group Lp | Yarns containing thermoplastic elastomer copolymer and polyolefin filaments |
US9017361B2 (en) | 2006-04-20 | 2015-04-28 | Covidien Lp | Occlusive implant and methods for hollow anatomical structure |
US20070250114A1 (en) * | 2006-04-20 | 2007-10-25 | Sdgi Holdings, Inc. | Flexible tissue sheath for fibrous connective tissue repair |
US11246638B2 (en) | 2006-05-03 | 2022-02-15 | P Tech, Llc | Methods and devices for utilizing bondable materials |
US8133258B2 (en) | 2006-08-03 | 2012-03-13 | Arthrocare Corporation | Method and apparatus for attaching connective tissues to bone using a knotless suture anchoring device |
US7943683B2 (en) | 2006-12-01 | 2011-05-17 | Tepha, Inc. | Medical devices containing oriented films of poly-4-hydroxybutyrate and copolymers |
EP2111240B1 (en) * | 2006-12-27 | 2012-08-08 | Shriners Hospitals for Children | Methods of making high-strength ndga polymerized collagen fibers and related medical devices and constructs |
US7875057B2 (en) | 2007-01-19 | 2011-01-25 | Arthrex, Inc. | Method and suture-button construct for stabilization of cranial cruciate ligament deficient stifle |
US8617185B2 (en) | 2007-02-13 | 2013-12-31 | P Tech, Llc. | Fixation device |
US8858633B2 (en) | 2007-02-20 | 2014-10-14 | Shriners Hospital For Children | In vivo hydraulic fixation including bio-rivets using biocompatible expandable fibers |
US8177834B2 (en) * | 2007-03-12 | 2012-05-15 | Cook Medical Technologies Llc | Woven fabric with shape memory element strands |
EP3549551A1 (en) * | 2007-03-20 | 2019-10-09 | Serica Technologies, Inc. | Tendon prosthesis and method of manufacturing the same |
US9907645B2 (en) * | 2007-05-01 | 2018-03-06 | Moximed, Inc. | Adjustable absorber designs for implantable device |
US8709090B2 (en) | 2007-05-01 | 2014-04-29 | Moximed, Inc. | Adjustable absorber designs for implantable device |
US20100137996A1 (en) | 2007-05-01 | 2010-06-03 | Moximed, Inc. | Femoral and tibial base components |
US7678147B2 (en) * | 2007-05-01 | 2010-03-16 | Moximed, Inc. | Extra-articular implantable mechanical energy absorbing systems and implantation method |
US8123805B2 (en) | 2007-05-01 | 2012-02-28 | Moximed, Inc. | Adjustable absorber designs for implantable device |
US8894714B2 (en) | 2007-05-01 | 2014-11-25 | Moximed, Inc. | Unlinked implantable knee unloading device |
US8100967B2 (en) * | 2007-05-01 | 2012-01-24 | Moximed, Inc. | Adjustable absorber designs for implantable device |
US20080275567A1 (en) * | 2007-05-01 | 2008-11-06 | Exploramed Nc4, Inc. | Extra-Articular Implantable Mechanical Energy Absorbing Systems |
US10022154B2 (en) * | 2007-05-01 | 2018-07-17 | Moximed, Inc. | Femoral and tibial base components |
US20110245928A1 (en) | 2010-04-06 | 2011-10-06 | Moximed, Inc. | Femoral and Tibial Bases |
US8133268B2 (en) * | 2007-05-30 | 2012-03-13 | Cordis Corporation | Stent/fiber structural combinations |
US20090036996A1 (en) * | 2007-08-03 | 2009-02-05 | Roeber Peter J | Knit PTFE Articles and Mesh |
US20090187197A1 (en) * | 2007-08-03 | 2009-07-23 | Roeber Peter J | Knit PTFE Articles and Mesh |
US7905918B2 (en) * | 2007-08-23 | 2011-03-15 | William Wayne Cimino | Elastic metallic replacement ligament |
US7963972B2 (en) | 2007-09-12 | 2011-06-21 | Arthrocare Corporation | Implant and delivery system for soft tissue repair |
WO2009036286A1 (en) * | 2007-09-12 | 2009-03-19 | Surgical Energetics, Inc. | Medical device and tension member for use in a subject |
US8211182B2 (en) | 2007-09-17 | 2012-07-03 | Linares Medical Devices, Llc | Hip socket with assembleable male ball shape having integrally formed ligament and female receiver and installation kit |
WO2009039164A1 (en) * | 2007-09-17 | 2009-03-26 | Linares Medical Devices, Llc | Artificial ligaments for joint applications |
US8328875B2 (en) | 2009-12-30 | 2012-12-11 | Linares Medical Devices, Llc | Combination male/female hip joint and installation kit |
WO2009047767A1 (en) * | 2007-10-11 | 2009-04-16 | Tavor [I.T.N] Ltd. | Ligament and tendon prosthesis |
US9308068B2 (en) | 2007-12-03 | 2016-04-12 | Sofradim Production | Implant for parastomal hernia |
US8834552B2 (en) * | 2007-12-27 | 2014-09-16 | Cook Medical Technologies Llc | Stent graft having floating yarns |
US9282958B2 (en) | 2007-12-28 | 2016-03-15 | Boston Scientific Scimed, Inc. | Devices and method for treating pelvic dysfunctions |
US9078728B2 (en) * | 2007-12-28 | 2015-07-14 | Boston Scientific Scimed, Inc. | Devices and methods for delivering female pelvic floor implants |
US8430807B2 (en) | 2007-12-28 | 2013-04-30 | Boston Scientific Scimed, Inc. | Devices and methods for treating pelvic floor dysfunctions |
US8109896B2 (en) | 2008-02-11 | 2012-02-07 | Optonol Ltd. | Devices and methods for opening fluid passageways |
US9681869B2 (en) * | 2008-02-22 | 2017-06-20 | Mimedx Group, Inc. | Biostaples suitable for wrist, hand and other ligament replacements or repairs |
AU2009222976A1 (en) * | 2008-03-13 | 2009-09-17 | Tavor [I.T.N] Ltd. | Ligament and tendon prosthesis |
US20090264925A1 (en) | 2008-04-17 | 2009-10-22 | Joseph Hotter | Poly(Trimethylene)Terephthalate Filaments And Articles Made Therefrom |
US20090275963A1 (en) * | 2008-05-01 | 2009-11-05 | May Thomas C | High-Strength Suture With Absorbable Components |
US20090278484A1 (en) * | 2008-05-09 | 2009-11-12 | Degree Controls, Inc. | Fan conducted noise reduction |
EP2291143B1 (en) * | 2008-05-16 | 2020-07-08 | Mimedx, Inc. | Medical constructs of twisted lengths of collagen fibers and methods of making same |
US9242026B2 (en) | 2008-06-27 | 2016-01-26 | Sofradim Production | Biosynthetic implant for soft tissue repair |
US8834495B2 (en) | 2008-06-30 | 2014-09-16 | Arthrocare Corporation | Independent suture tensioning and snaring apparatus |
US8414584B2 (en) | 2008-07-09 | 2013-04-09 | Icon Orthopaedic Concepts, Llc | Ankle arthrodesis nail and outrigger assembly |
US8328807B2 (en) * | 2008-07-09 | 2012-12-11 | Icon Orthopaedic Concepts, Llc | Ankle arthrodesis nail and outrigger assembly |
EP2344049B1 (en) | 2008-10-03 | 2021-01-27 | C.R.Bard, Inc. | Implantable prosthesis |
CA2976265C (en) | 2008-10-09 | 2019-03-19 | Mimedx Group, Inc. | Methods of making collagen fiber medical constructs and related medical constructs, including nerve guides and patches |
US20100094423A1 (en) * | 2008-10-15 | 2010-04-15 | Warsaw Orthopedic, Inc. | Systems and methods for assessment of tension in an implant |
EP2349089A4 (en) * | 2008-11-21 | 2014-01-15 | Lifecell Corp | Reinforced biologic material |
US9326840B2 (en) | 2008-12-15 | 2016-05-03 | Allergan, Inc. | Prosthetic device and method of manufacturing the same |
CN105063875A (en) | 2008-12-15 | 2015-11-18 | 阿勒根公司 | Manufacturing method for knitted mesh of prosthetic device |
US9204953B2 (en) | 2008-12-15 | 2015-12-08 | Allergan, Inc. | Biocompatible surgical scaffold with varying stretch |
US9308070B2 (en) * | 2008-12-15 | 2016-04-12 | Allergan, Inc. | Pliable silk medical device |
US9204954B2 (en) * | 2008-12-15 | 2015-12-08 | Allergan, Inc. | Knitted scaffold with diagonal yarn |
US20100151114A1 (en) * | 2008-12-17 | 2010-06-17 | Zimmer, Inc. | In-line treatment of yarn prior to creating a fabric |
WO2010099222A1 (en) * | 2009-02-24 | 2010-09-02 | P Tech, Llc | Methods and devices for utilizing bondable materials |
EP2238944B1 (en) | 2009-03-31 | 2015-10-21 | Arthrex Inc | Adjustable suture button construct for tissue reconstruction |
US8439976B2 (en) * | 2009-03-31 | 2013-05-14 | Arthrex, Inc. | Integrated adjustable button-suture-graft construct with two fixation devices |
CN102481187B (en) * | 2009-03-31 | 2016-06-08 | 医学嵌入公司暨Imds共同创新公司 | Double bundle acl is repaired |
US9125716B2 (en) | 2009-04-17 | 2015-09-08 | Boston Scientific Scimed, Inc. | Delivery sleeve for pelvic floor implants |
DE102009051367B4 (en) * | 2009-04-28 | 2016-07-28 | Mathys Ag Bettlach | Implantable system with continuous dissolution mechanism during healing |
CA2762903C (en) | 2009-05-22 | 2013-07-30 | Soft Tissue Regeneration, Inc. | Mechanically competent scaffold for ligament and tendon regeneration |
US9668868B2 (en) | 2009-08-27 | 2017-06-06 | Cotera, Inc. | Apparatus and methods for treatment of patellofemoral conditions |
US10349980B2 (en) | 2009-08-27 | 2019-07-16 | The Foundry, Llc | Method and apparatus for altering biomechanics of the shoulder |
US9278004B2 (en) | 2009-08-27 | 2016-03-08 | Cotera, Inc. | Method and apparatus for altering biomechanics of the articular joints |
ES2477581T3 (en) | 2009-08-27 | 2014-07-17 | Cotera, Inc. | Apparatus for redistribution of forces in joint joints |
US9861408B2 (en) | 2009-08-27 | 2018-01-09 | The Foundry, Llc | Method and apparatus for treating canine cruciate ligament disease |
FR2949688B1 (en) | 2009-09-04 | 2012-08-24 | Sofradim Production | FABRIC WITH PICOTS COATED WITH A BIORESORBABLE MICROPOROUS LAYER |
NZ598691A (en) * | 2009-09-11 | 2014-05-30 | Allergan Inc | Prosthetic device and method of manufacturing the same |
US20110190886A1 (en) * | 2010-01-29 | 2011-08-04 | Wisconsin Alumni Research Foundation | Braided tertiary nanofibrous structure for ligament, tendon, and muscle tissue implant |
US9757132B2 (en) * | 2010-03-24 | 2017-09-12 | Biorez, Inc. | Mechanically competent scaffold for rotator cuff and tendon augmentation |
WO2011119885A1 (en) | 2010-03-25 | 2011-09-29 | Tyco Healthcare Group Lp | Enhanced suture braid strength through click chemistry |
US20110238094A1 (en) * | 2010-03-25 | 2011-09-29 | Thomas Jonathan D | Hernia Patch |
US8460322B2 (en) | 2010-03-31 | 2013-06-11 | Siesta Medical, Inc. | Suture passer systems and methods for tongue or other tissue suspension and compression |
US8858577B2 (en) | 2010-05-19 | 2014-10-14 | University Of Utah Research Foundation | Tissue stabilization system |
US8911348B2 (en) | 2010-09-02 | 2014-12-16 | Boston Scientific Scimed, Inc. | Pelvic implants and methods of implanting the same |
EP2455001B1 (en) | 2010-11-17 | 2020-07-22 | Arthrex, Inc. | Adjustable suture-button constructs for ligament reconstruction |
EP2455040B1 (en) | 2010-11-17 | 2015-03-04 | Arthrex, Inc. | Adjustable suture-button construct for knotless stabilization of cranial cruciate deficient ligament stifle |
EP2455002B1 (en) | 2010-11-17 | 2019-04-03 | Arthrex, Inc. | Adjustable suture-button construct for ankle syndesmosis repair |
US8814905B2 (en) | 2010-11-23 | 2014-08-26 | Depuy Mitek, Llc | Surgical filament snare assemblies |
US8821543B2 (en) | 2010-12-23 | 2014-09-02 | Depuy Mitek, Llc | Adjustable anchor systems and methods |
US9345468B2 (en) | 2010-11-23 | 2016-05-24 | Medos International Sárl | Surgical filament snare assemblies |
US8808326B2 (en) | 2010-11-24 | 2014-08-19 | Arthrocare Corporation | Suture |
US9095331B2 (en) | 2010-12-23 | 2015-08-04 | Medos International Sàrl | Adjustable anchor systems and methods |
US8852214B2 (en) | 2011-02-04 | 2014-10-07 | University Of Utah Research Foundation | System for tissue fixation to bone |
CA2829339C (en) | 2011-03-08 | 2018-10-16 | Mimedx, Inc. | Collagen fiber ribbons with integrated fixation sutures and methods of making the same |
FR2972626B1 (en) | 2011-03-16 | 2014-04-11 | Sofradim Production | PROSTHETIC COMPRISING A THREE-DIMENSIONAL KNIT AND ADJUSTED |
US9044270B2 (en) | 2011-03-29 | 2015-06-02 | Moximed, Inc. | Apparatus for controlling a load on a hip joint |
US8574296B2 (en) * | 2011-03-31 | 2013-11-05 | Biomet Manufacturing Corporation | Dual tendon bundle |
US9694106B2 (en) | 2011-07-11 | 2017-07-04 | Mimedx Group, Inc. | Synthetic collagen threads for cosmetic uses including skin wrinkle treatments and associated methods |
FR2977790B1 (en) | 2011-07-13 | 2013-07-19 | Sofradim Production | PROSTHETIC FOR UMBILIC HERNIA |
FR2977789B1 (en) | 2011-07-13 | 2013-07-19 | Sofradim Production | PROSTHETIC FOR UMBILIC HERNIA |
US9301745B2 (en) | 2011-07-21 | 2016-04-05 | Arthrex, Inc. | Knotless suture constructs |
US9332979B2 (en) | 2011-07-22 | 2016-05-10 | Arthrex, Inc. | Tensionable knotless acromioclavicular repairs and constructs |
US20150335440A1 (en) | 2011-08-23 | 2015-11-26 | Linares Medical Devices, Llc | Multi-component implant assembly with dual articulating and/or rotating surfaces |
US8702800B2 (en) | 2011-08-23 | 2014-04-22 | Linares Medical Devices, Llc | Multi-component shoulder implant assembly with dual articulating surfaces |
US8617176B2 (en) | 2011-08-24 | 2013-12-31 | Depuy Mitek, Llc | Cross pinning guide devices and methods |
US8864835B2 (en) | 2011-08-24 | 2014-10-21 | Linares Medical Devices, Llc | Multi-component knee implant assembly with multiple articulating and traveling surfaces |
US8702802B2 (en) | 2011-08-29 | 2014-04-22 | Linares Medical Devices, Llc | Knee implant assembly with rotary bearing supported and traveling surfaces |
US8753403B2 (en) | 2011-08-30 | 2014-06-17 | Linares Medical Devices, Llc | Multi-component knee implant assembly with combined articulating and belt support and traveling surfaces |
US9168120B2 (en) | 2011-09-09 | 2015-10-27 | Boston Scientific Scimed, Inc. | Medical device and methods of delivering the medical device |
US9107653B2 (en) | 2011-09-22 | 2015-08-18 | Arthrex, Inc. | Tensionable knotless anchors with splice and methods of tissue repair |
USD695970S1 (en) * | 2011-09-23 | 2013-12-17 | Jennifer Beinke | Leash |
WO2013046058A2 (en) | 2011-09-30 | 2013-04-04 | Sofradim Production | Reversible stiffening of light weight mesh |
US10245016B2 (en) | 2011-10-12 | 2019-04-02 | Arthrex, Inc. | Adjustable self-locking loop constructs for tissue repairs and reconstructions |
US8968402B2 (en) | 2011-10-18 | 2015-03-03 | Arthrocare Corporation | ACL implants, instruments, and methods |
WO2013067294A1 (en) | 2011-11-02 | 2013-05-10 | Mimedx Group, Inc. | Implantable collagen devices and related methods and systems of making same |
EP2601894B1 (en) | 2011-12-09 | 2018-08-29 | Arthrex, Inc. | Tensionable knotless anchor systems |
FR2985271B1 (en) | 2011-12-29 | 2014-01-24 | Sofradim Production | KNITTED PICOTS |
FR2985170B1 (en) | 2011-12-29 | 2014-01-24 | Sofradim Production | PROSTHESIS FOR INGUINAL HERNIA |
PL2827914T3 (en) | 2012-03-22 | 2019-09-30 | Trb Chemedica International S.A. | Method for repair of ligament or tendon |
US8790370B2 (en) | 2012-03-30 | 2014-07-29 | Depuy Mitek, Llc | Surgical filament assemblies |
US9060763B2 (en) | 2012-05-07 | 2015-06-23 | Medos International Sàrl | Systems, devices, and methods for securing tissue |
US9345567B2 (en) | 2012-05-07 | 2016-05-24 | Medos International Sàrl | Systems, devices, and methods for securing tissue using snare assemblies and soft anchors |
US9060764B2 (en) | 2012-05-07 | 2015-06-23 | Medos International Sàrl | Systems, devices, and methods for securing tissue |
US8894684B2 (en) | 2012-05-07 | 2014-11-25 | Medos International Sàrl | Systems, devices, and methods for securing tissue using a suture having one or more protrusions |
US9737292B2 (en) | 2012-06-22 | 2017-08-22 | Arthrex, Inc. | Knotless suture anchors and methods of tissue repair |
US9427309B2 (en) | 2012-07-30 | 2016-08-30 | Conextions, Inc. | Soft tissue repair devices, systems, and methods |
US9629632B2 (en) | 2012-07-30 | 2017-04-25 | Conextions, Inc. | Soft tissue repair devices, systems, and methods |
US11253252B2 (en) | 2012-07-30 | 2022-02-22 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
US11944531B2 (en) | 2012-07-30 | 2024-04-02 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
US10219804B2 (en) | 2012-07-30 | 2019-03-05 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
US10390935B2 (en) | 2012-07-30 | 2019-08-27 | Conextions, Inc. | Soft tissue to bone repair devices, systems, and methods |
US10835241B2 (en) | 2012-07-30 | 2020-11-17 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
FR2994185B1 (en) | 2012-08-02 | 2015-07-31 | Sofradim Production | PROCESS FOR THE PREPARATION OF A POROUS CHITOSAN LAYER |
US9468466B1 (en) | 2012-08-24 | 2016-10-18 | Cotera, Inc. | Method and apparatus for altering biomechanics of the spine |
WO2014039848A1 (en) | 2012-09-07 | 2014-03-13 | Siesta Medical, Inc. | Tether line systems and methods for tongue or other tissue suspension or compression |
US9237888B2 (en) * | 2012-09-20 | 2016-01-19 | Medos International Sarl | Methods and devices for threading sutures |
US9763655B2 (en) | 2012-09-20 | 2017-09-19 | Medos International Sarl | Systems, devices, and methods for securing tissue using hard anchors |
FR2995788B1 (en) | 2012-09-25 | 2014-09-26 | Sofradim Production | HEMOSTATIC PATCH AND PREPARATION METHOD |
FR2995778B1 (en) | 2012-09-25 | 2015-06-26 | Sofradim Production | ABDOMINAL WALL REINFORCING PROSTHESIS AND METHOD FOR MANUFACTURING THE SAME |
FR2995779B1 (en) | 2012-09-25 | 2015-09-25 | Sofradim Production | PROSTHETIC COMPRISING A TREILLIS AND A MEANS OF CONSOLIDATION |
EP2900174B1 (en) | 2012-09-28 | 2017-04-12 | Sofradim Production | Packaging for a hernia repair device |
US9271716B2 (en) | 2012-12-27 | 2016-03-01 | Medos International Sàrl | Surgical constructs and methods for securing tissue |
US10076377B2 (en) | 2013-01-05 | 2018-09-18 | P Tech, Llc | Fixation systems and methods |
US9814555B2 (en) | 2013-03-12 | 2017-11-14 | Boston Scientific Scimed, Inc. | Medical device for pelvic floor repair and method of delivering the medical device |
US9284668B2 (en) * | 2013-03-14 | 2016-03-15 | Medos International Sárl | Continuous braided closed loop implant |
US10123862B2 (en) * | 2013-03-14 | 2018-11-13 | Ethicon, Inc. | Randomly uniform three dimensional tissue scaffold of absorbable and non-absorbable materials |
US9352071B2 (en) * | 2013-03-14 | 2016-05-31 | Ethicon, Inc. | Method of forming an implantable device |
US9737293B2 (en) | 2013-03-15 | 2017-08-22 | Medos International Sàrl | Surgical constructs with collapsing suture loop and methods for securing tissue |
FR3006581B1 (en) | 2013-06-07 | 2016-07-22 | Sofradim Production | PROSTHESIS BASED ON TEXTILE FOR LAPAROSCOPIC PATHWAY |
FR3006578B1 (en) | 2013-06-07 | 2015-05-29 | Sofradim Production | PROSTHESIS BASED ON TEXTILE FOR LAPAROSCOPIC PATHWAY |
US9962251B2 (en) | 2013-10-17 | 2018-05-08 | Boston Scientific Scimed, Inc. | Devices and methods for delivering implants |
US11000285B2 (en) * | 2013-12-17 | 2021-05-11 | 3Dt Holdings, Llc | Luminal grafts and methods of making and using the same |
WO2015095380A1 (en) * | 2013-12-17 | 2015-06-25 | Kassab Ghassan S | Devices, systems and methods for tissue engineering of luminal grafts |
US20150250476A1 (en) | 2014-03-05 | 2015-09-10 | Siesta Medical, Inc. | Systems and methods for tissue suspension and compression |
US11583384B2 (en) | 2014-03-12 | 2023-02-21 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
WO2015171962A1 (en) | 2014-05-07 | 2015-11-12 | Bart Bracy | Multipart suture |
US10500303B2 (en) | 2014-08-15 | 2019-12-10 | Tepha, Inc. | Self-retaining sutures of poly-4-hydroxybutyrate and copolymers thereof |
EP3000432B1 (en) | 2014-09-29 | 2022-05-04 | Sofradim Production | Textile-based prosthesis for treatment of inguinal hernia |
EP3000433B1 (en) | 2014-09-29 | 2022-09-21 | Sofradim Production | Device for introducing a prosthesis for hernia treatment into an incision and flexible textile based prosthesis |
RU2708221C2 (en) | 2014-11-04 | 2019-12-04 | Сёрджикал Спешиэлтиз Корпорейшн | Coated woven suture |
US9517062B2 (en) | 2014-12-03 | 2016-12-13 | Smith & Nephew, Inc. | Closed loop suture for anchoring tissue grafts |
EP3029189B1 (en) | 2014-12-05 | 2021-08-11 | Sofradim Production | Prosthetic porous knit, method of making same and hernia prosthesis |
WO2016094669A1 (en) | 2014-12-11 | 2016-06-16 | Tepha, Inc. | Methods of orienting multifilament yarn and monofilaments of poly-4-hydroxybutyrate and copolymers thereof |
US10626521B2 (en) | 2014-12-11 | 2020-04-21 | Tepha, Inc. | Methods of manufacturing mesh sutures from poly-4-hydroxybutyrate and copolymers thereof |
US10385488B1 (en) | 2015-02-03 | 2019-08-20 | Stryker Corporation | Suture of varying cross-section and methods of manufacture and use |
EP3059255B1 (en) | 2015-02-17 | 2020-05-13 | Sofradim Production | Method for preparing a chitosan-based matrix comprising a fiber reinforcement member |
US10925716B2 (en) | 2015-02-25 | 2021-02-23 | Smith & Nephew, Inc. | Closed loop suture for anchoring tissue grafts |
US10323342B1 (en) | 2015-03-16 | 2019-06-18 | Stryker Corporation | Braided filament having flat morphology and methods of manufacture and use |
EP3085337B1 (en) | 2015-04-24 | 2022-09-14 | Sofradim Production | Prosthesis for supporting a breast structure |
ITUB20151239A1 (en) * | 2015-05-29 | 2016-11-29 | Antonio Sambusseti | LIGAMENT PROSTHESES |
ES2676072T3 (en) | 2015-06-19 | 2018-07-16 | Sofradim Production | Synthetic prosthesis comprising a knitted fabric and a non-porous film and method of forming it |
US10265060B2 (en) | 2015-08-20 | 2019-04-23 | Arthrex, Inc. | Tensionable constructs with multi-limb locking mechanism through single splice and methods of tissue repair |
US10335136B2 (en) | 2015-08-20 | 2019-07-02 | Arthrex, Inc. | Tensionable constructs with multi-limb locking mechanism through single splice and methods of tissue repair |
US10058393B2 (en) | 2015-10-21 | 2018-08-28 | P Tech, Llc | Systems and methods for navigation and visualization |
EP3367920A4 (en) * | 2015-10-27 | 2019-09-25 | Teleflex Medical Incorporated | Low friction flat braid |
EP3195830B1 (en) | 2016-01-25 | 2020-11-18 | Sofradim Production | Prosthesis for hernia repair |
EP3432940A2 (en) | 2016-03-25 | 2019-01-30 | Biorez, Inc. | Complex braided scaffolds for improved tissue regeneration |
US11696822B2 (en) | 2016-09-28 | 2023-07-11 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
EP3312325B1 (en) | 2016-10-21 | 2021-09-22 | Sofradim Production | Method for forming a mesh having a barbed suture attached thereto and the mesh thus obtained |
US10575842B2 (en) | 2017-02-09 | 2020-03-03 | Arthrex, Inc. | Knotless self-locking anchor constructs and methods of tissue fixation |
US10646327B2 (en) | 2017-02-09 | 2020-05-12 | Arthrex, Inc. | Self-locking suture constructs and methods of tissue fixation |
GB2560503B (en) | 2017-03-07 | 2019-12-11 | Gc Aesthetics Mfg Ltd | Packaging |
GB201705707D0 (en) | 2017-04-10 | 2017-05-24 | Gc Aesthetics (Manufacturing) Ltd | Implant |
EP3398554A1 (en) | 2017-05-02 | 2018-11-07 | Sofradim Production | Prosthesis for inguinal hernia repair |
FR3073391B1 (en) * | 2017-11-10 | 2021-08-27 | Cousin Biotech | FLAT SOFT TEXTILE LONG LINE ELEMENT INCLUDING A DEVICE FOR IDENTIFYING ITS FACES A AND B OPPOSITE |
KR102233499B1 (en) * | 2017-12-05 | 2021-03-29 | 한국생산기술연구원 | 3-Dimensional fibrous scaffold |
US11547397B2 (en) | 2017-12-20 | 2023-01-10 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
AU2019223962A1 (en) | 2018-02-20 | 2020-09-10 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
CN108744039B (en) * | 2018-05-08 | 2021-06-11 | 佛山市第五人民医院(佛山市干部疗养院、佛山市工伤康复中心) | Composite scaffold for tissue engineering anterior cruciate ligament and preparation method thereof |
EP3653171A1 (en) | 2018-11-16 | 2020-05-20 | Sofradim Production | Implants suitable for soft tissue repair |
US11883243B2 (en) | 2019-10-31 | 2024-01-30 | Orthopediatrics Corp. | Assessment of tension between bone anchors |
Family Cites Families (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CH73454A (en) * | 1916-07-01 | 1916-10-02 | Herm Mahr | Novel belts |
CH325658A (en) * | 1953-07-15 | 1957-11-15 | Graf & Co Sueddeutsche Catgutf | Process for the production of threads and strings from animal raw materials |
US3176316A (en) * | 1963-01-07 | 1965-04-06 | Bruce R Bodell | Plastic prosthetic tendon |
US3463158A (en) * | 1963-10-31 | 1969-08-26 | American Cyanamid Co | Polyglycolic acid prosthetic devices |
US3745590A (en) * | 1971-06-25 | 1973-07-17 | Cutter Lab | Articulating prosthesis with ligamentous attachment |
US3736646A (en) * | 1971-10-18 | 1973-06-05 | American Cyanamid Co | Method of attaching surgical needles to multifilament polyglycolic acid absorbable sutures |
US3982543A (en) * | 1973-04-24 | 1976-09-28 | American Cyanamid Company | Reducing capillarity of polyglycolic acid sutures |
US4340091A (en) * | 1975-05-07 | 1982-07-20 | Albany International Corp. | Elastomeric sheet materials for heart valve and other prosthetic implants |
US4300565A (en) * | 1977-05-23 | 1981-11-17 | American Cyanamid Company | Synthetic polyester surgical articles |
US4137921A (en) * | 1977-06-24 | 1979-02-06 | Ethicon, Inc. | Addition copolymers of lactide and glycolide and method of preparation |
US4329743A (en) * | 1979-04-27 | 1982-05-18 | College Of Medicine And Dentistry Of New Jersey | Bio-absorbable composite tissue scaffold |
SE424401B (en) * | 1979-06-06 | 1982-07-19 | Bowald S | BLODKERLSPROTES |
CH644748A5 (en) * | 1980-06-03 | 1984-08-31 | Sulzer Ag | STRING AND / OR TAPE REPLACEMENT MATERIAL. |
IL65855A (en) * | 1982-05-24 | 1986-09-30 | Yeda Res & Dev | Prosthetic tendon |
CA1205601A (en) * | 1982-09-10 | 1986-06-10 | Carl W. Bolton | Prosthesis for tensile load-carrying tissue and method of manufacture |
US4523591A (en) * | 1982-10-22 | 1985-06-18 | Kaplan Donald S | Polymers for injection molding of absorbable surgical devices |
US4610688A (en) * | 1983-04-04 | 1986-09-09 | Pfizer Hospital Products Group, Inc. | Triaxially-braided fabric prosthesis |
US4834755A (en) * | 1983-04-04 | 1989-05-30 | Pfizer Hospital Products Group, Inc. | Triaxially-braided fabric prosthesis |
EP0145492A3 (en) * | 1983-12-15 | 1987-01-21 | A.W.Showell (Surgicraft) Limited | Replacements for ligaments and tendons |
US4633873A (en) * | 1984-04-26 | 1987-01-06 | American Cyanamid Company | Surgical repair mesh |
GB2159846B (en) * | 1984-06-05 | 1987-02-11 | Showell A W | Surgical element |
GB8418018D0 (en) * | 1984-07-16 | 1984-08-22 | Johnson & Johnson | Connective tissue prosthesis |
US4652264A (en) * | 1985-04-25 | 1987-03-24 | American Cyanamid Company | Prosthetic tubular article |
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1986
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1987
- 1987-02-20 EP EP87102449A patent/EP0239775A3/en not_active Withdrawn
- 1987-02-27 CA CA000530746A patent/CA1282205C/en not_active Expired - Fee Related
- 1987-03-02 KR KR1019870001819A patent/KR950001375B1/en not_active Application Discontinuation
- 1987-03-02 FI FI870898A patent/FI88259C/en not_active IP Right Cessation
- 1987-03-02 AU AU69598/87A patent/AU594435B2/en not_active Ceased
- 1987-03-02 NO NO870858A patent/NO166614C/en unknown
- 1987-03-02 ZA ZA871489A patent/ZA871489B/en unknown
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1988
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NO870858D0 (en) | 1987-03-02 |
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DK106687A (en) | 1987-09-04 |
KR870008569A (en) | 1987-10-19 |
AU594435B2 (en) | 1990-03-08 |
FI870898A0 (en) | 1987-03-02 |
EP0239775A3 (en) | 1989-07-26 |
US4792336A (en) | 1988-12-20 |
NO166614C (en) | 1991-08-21 |
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NO166614B (en) | 1991-05-13 |
ZA871489B (en) | 1987-08-21 |
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