US20080051835A1 - High strength suture coated with rgd peptide - Google Patents

High strength suture coated with rgd peptide Download PDF

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Publication number
US20080051835A1
US20080051835A1 US11/845,683 US84568307A US2008051835A1 US 20080051835 A1 US20080051835 A1 US 20080051835A1 US 84568307 A US84568307 A US 84568307A US 2008051835 A1 US2008051835 A1 US 2008051835A1
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Prior art keywords
suture
yarns
molecular weight
ultrahigh molecular
weight polyethylene
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Abandoned
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US11/845,683
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Augustus D. Mazzocca
Mary Beth McCarthy
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University of Connecticut
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Mazzocca Augustus D
Mccarthy Mary Beth
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Application filed by Mazzocca Augustus D, Mccarthy Mary Beth filed Critical Mazzocca Augustus D
Priority to US11/845,683 priority Critical patent/US20080051835A1/en
Publication of US20080051835A1 publication Critical patent/US20080051835A1/en
Assigned to CONNECTICUT, UNIVERSITY OF reassignment CONNECTICUT, UNIVERSITY OF ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MAZZOCCA, AUGUSTUS D., MCCARTHY, MARY BETH
Priority to US13/186,054 priority patent/US8383188B2/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/005Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/04Non-resorbable materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/14Post-treatment to improve physical properties
    • A61L17/145Coating
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D06M15/01Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment with natural macromolecular compounds or derivatives thereof
    • D06M15/15Proteins or derivatives thereof
    • DTEXTILES; PAPER
    • D07ROPES; CABLES OTHER THAN ELECTRIC
    • D07BROPES OR CABLES IN GENERAL
    • D07B1/00Constructional features of ropes or cables
    • D07B1/02Ropes built-up from fibrous or filamentary material, e.g. of vegetable origin, of animal origin, regenerated cellulose, plastics
    • D07B1/025Ropes built-up from fibrous or filamentary material, e.g. of vegetable origin, of animal origin, regenerated cellulose, plastics comprising high modulus, or high tenacity, polymer filaments or fibres, e.g. liquid-crystal polymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06028Means for attaching suture to needle by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/25Peptides having up to 20 amino acids in a defined sequence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M2200/00Functionality of the treatment composition and/or properties imparted to the textile material
    • D06M2200/35Abrasion, pilling or fibrillation resistance
    • DTEXTILES; PAPER
    • D07ROPES; CABLES OTHER THAN ELECTRIC
    • D07BROPES OR CABLES IN GENERAL
    • D07B2201/00Ropes or cables
    • D07B2201/10Rope or cable structures
    • D07B2201/1096Rope or cable structures braided
    • DTEXTILES; PAPER
    • D07ROPES; CABLES OTHER THAN ELECTRIC
    • D07BROPES OR CABLES IN GENERAL
    • D07B2201/00Ropes or cables
    • D07B2201/20Rope or cable components
    • D07B2201/2083Jackets or coverings
    • D07B2201/209Jackets or coverings comprising braided structures
    • DTEXTILES; PAPER
    • D07ROPES; CABLES OTHER THAN ELECTRIC
    • D07BROPES OR CABLES IN GENERAL
    • D07B2205/00Rope or cable materials
    • D07B2205/20Organic high polymers
    • D07B2205/201Polyolefins
    • D07B2205/2014High performance polyolefins, e.g. Dyneema or Spectra

Definitions

  • the present invention relates to high strength surgical suture materials, and more particularly to braided suture blends of ultrahigh molecular weight polyethylene coated with RGD peptide.
  • Suture strength is an important consideration in any surgical suture material.
  • One of the strongest materials currently formed into elongated strands is an ultrahigh molecular weight long chain polyethylene, typically used for fishing line and the like, which is sold under the trade names Dyneema or Spectra. This material is much stronger than ordinary surgical suture, however, it does not have acceptable knot tie down characteristics for use in surgical applications.
  • the present invention advantageously provides a high strength surgical suture material with improved tie down characteristics.
  • the suture features a braided jacket made of ultrahigh molecular weight fibers.
  • the suture is coated with arginine-glycine-aspartate (RGD) peptide.
  • the ultrahigh molecular weight polyethylene provides strength.
  • Polyester fibers woven with the high molecular weight polyethylene provide improved tie down properties.
  • RGD peptide promotes cell adhesion to substrates in vivo by interacting with receptors, integrins, on cell surface proteins. Further, RGD peptides also increase the permeability of endothelial monolayers and therefore may aid in surgical applications.
  • the suture includes a multifilament jacket formed of ultrahigh molecular weight polyethylene fibers braided with polyester.
  • the jacket surrounds a fiber core made substantially or entirely of ultrahigh molecular weight polyethylene.
  • the core preferably includes three strands of ultrahigh molecular weight polyethylene, twisted at about three to six twists per inch.
  • the jacket preferably comprises eight strands of ultrahigh molecular weight polyethylene braided with six strands of polyester.
  • the tinted strands can be included in black or some other contrasting color.
  • Ultrahigh molecular weight polyethylene fibers suitable for use in the present invention are marketed under the Dyneema trademark by Toyo Boseki Kabushiki Kaisha, and are produced in the U.S. by Honeywell under the trademark Spectra.
  • the suture of the present invention advantageously has the strength of Ethibond No. 5 suture, yet has the diameter, feel and tie-ability of No. 2 suture.
  • the suture of the present invention is ideal for most orthopedic procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, and replacement for suture used in or with suture anchors.
  • RGD peptide suitable for use in the present invention is marketed under PCI-36xx-PI by Peptides International, and under GRADSP peptide and GRGDSP peptide by Calbiochem.
  • Other products suitable for use in the present invention marketed by Pierce are: (i) Product #28390-BupH MES Buffered Saline Packs to make a 500 ml of 0.1 M 2-[morpholino]ethanesulfonic acid, 0.9% NaCl, pH 4.7 when dissolved in 500 ml deionized water (5 liters total); (ii) Product # 22980-1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC or EDAC), a zero-length crosslinking agent used to couple carboxyl groups to primary amines and a water-soluble carbodiimide for rapid preparation of peptide conjugates; (iii) Product #24510-N-hydroxysul
  • a trace thread or two in the suture jacket aids surgeons in identifying the travel direction of the suture during surgery, particularly during operations viewed arthroscopically or remotely. Providing the trace threads in a regularly repeating pattern is particularly useful, allowing the surgeon to decode different ends of a length of suture, and to determine the direction of travel of a moving length of suture.
  • the trace threads preferably are provided uniquely on each half of a length of suture to allow for tracing and identification of each end of the suture, such as when the suture is threaded through an eyelet of a suture anchor.
  • FIG. 1 is a copy of a scanning electron micrograph of a length of suture according to the present invention.
  • FIG. 2 is a schematic cross section of a length of suture according to the present invention.
  • FIG. 3 is an illustration of the suture of the present invention attached to a suture anchor loaded onto a driver.
  • FIG. 4A and 4B show the suture of the present invention attached to a half round, tapered needle.
  • yarn(s), is to be understood as including fiber(s), filament(s), and the like used to make a suture of the present invention.
  • yams are comprised of fibers and/or filaments.
  • Suture 2 is made up of a jacket 4 and a core 6 surrounded by the jacket 4 . See FIG. 2 .
  • Strands of ultrahigh molecular weight polyethylene (UHMWPE) 8 such as that sold under the tradenames Spectra and Dyneema, strands of polyester 10 , and tinted strands 12 are braided together to form the jacket 4 .
  • Core 6 is formed of twisted strands of UHMWPE.
  • UHMWPE used for strands 8 , is substantially translucent or colorless.
  • the polyester strands 10 are white (undyed). Due to the transparent nature of the UHMWPE, the suture takes on the color of strands 10 and 12 , and thus appears to be white with a trace in the contrasting color.
  • trace strands 12 are preferably provided in black.
  • the black trace assists surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace. Traces also assist the surgeon in identifying whether the suture is moving.
  • the trace can extend the entire length of the suture or only on half of a length of suture, the other half of the suture length remaining plain (white).
  • the traces can form visibly distinct coding patterns on each half of the suture length.
  • the yarns used in the braided jacket are Honeywell Spectra 2000, polyester type 712, and nylon.
  • the jacket is formed using eight strands of 144 decitex Spectra per carrier, braided with six strands of 100 decitex polyester, and two strands of tinted nylon.
  • the core is formed of three carriers of 144 decitex Spectra braided at three to six twists per inch. A No. 5 suture is produced.
  • the suture may range from 5% to 90% ultrahigh molecular weight polymer (preferably at least 40% of the fibers are ultrahigh molecular weight polymer), with the balance formed of polyester and/or nylon.
  • the core preferably comprises 18% or greater of the total amount of filament.
  • the suture is coated with RGD peptide (PCI-36xx-PI).
  • the RGD peptide-coating increases permeability of endothelial monolayers, thereby resulting in a decrease in abrasion resistance to the suture.
  • RGD peptides promote cell adhesion to substrates in vivo by interacting with receptors, integrins, on cell surface proteins and thus, RGD peptide-coated sutures perform better than other sutures in surgical applications.
  • Peptides may be coupled to or adsorbed to the suture.
  • a coupling buffer e.g., about 0.1M MES buffer
  • a base for example NaOH
  • peptides are coupled to a suture.
  • the suture is cut into 6 inch strips and soaked into an MES buffer for at least 30 minutes. Later, acid hydrolysis is performed, i.e., the suture is taken from the MES buffer and quickly dipped into an acid medium, for example, about 15 ml of 6N HCl and about 200 ul of H 2 O 2 . Thereafter, the suture is immediately put back into the MES buffer and washed several times.
  • EDC and sulfo-NHS buffers are added to the MES buffer, for example, about 36 mg of EDC and about 99 mg of sulfo-NHS is added to about 90 ml of MES buffer.
  • the suture is removed from the MES buffer and placed into the EDC buffer for about 15 minutes. The suture is then washed three times with the MES buffer. About 2 ml of peptide solution is immediately prepared and the suture immersed in the peptide solution. The peptide is allowed to react on the suture at 4° C. The suture is then washed about five times with MES buffer and then allowed to air dry under a hood.
  • peptides are adsorbed to a suture.
  • the suture is cut into 6 inch strips and soaked in a MES buffer for at least 30 minutes. Later, the suture is taken out and immediately placed back into the MES buffer and washed about three times. About 2 ml of peptide solution is immediately prepared and the suture immersed in the peptide solution. The peptide is allowed to react on the suture at 4° C. The suture is then washed about five times with MES buffer and then allowed to air dry under the hood.
  • a partially bioabsorbable suture is provided by blending a high strength material, such as UHMWPE fibers, with a bioabsorbable material, such as PLLA or collagen, for example.
  • a suture made with about 10% Spectra or Dyneema blended with absorbable fibers would provide greater strength and with less stretch. Over time, 90% or more of the suture would absorb, leaving only a very small remnant of the knot.
  • the absorbable suture can include coatings, for example collagen.
  • the ultra high molecular weight (UHMW) polymer component of the present invention provides strength, and the polyester component is provided to improve tie ability and tie down characteristics.
  • the UHMW polymer provides an unexpected advantage of acting as a cushion for the polyester fibers, which are relatively hard and tend to damage each other.
  • the UHMW polymer prevents breakage by reducing damage to the polyester when the suture is subjected to stress.
  • the suture 2 is attached to a suture anchor 14 as shown in FIG. 3 (prepackaged sterile with an inserter 16 ), or is attached at one or both ends to a half round, tapered needle 18 as shown in FIGS. 4A and 4B .
  • FIG. 4A also illustrates a length of suture having regularly repeating pattern of trace threads according to the present invention. Sections of the length of suture 2 have tinted tracing threads woven in. The alternating patterned and plain sections aid the surgeon in determining the direction of suture travel when pulling the suture, for example.

Abstract

A high strength surgical material with improved tie down characteristics and tissue compliance formed of ultrahigh molecular weight polyethylene (UHMWPE) yarns, the suture being coated with arginine-glycine-aspartate (RGD) peptide. The suture has exceptional strength, is ideally suited for most orthopedic procedures, and can be attached to a suture anchor or a curved needle.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • This application claims priority to U.S. Provisional Application No. 60/840,467, filed on Aug. 28, 2006, the entire disclosure of which is hereby incorporated by reference.
  • FIELD OF THE INVENTION
  • The present invention relates to high strength surgical suture materials, and more particularly to braided suture blends of ultrahigh molecular weight polyethylene coated with RGD peptide.
  • DESCRIPTION OF THE RELATED ART
  • Suture strength is an important consideration in any surgical suture material. One of the strongest materials currently formed into elongated strands is an ultrahigh molecular weight long chain polyethylene, typically used for fishing line and the like, which is sold under the trade names Dyneema or Spectra. This material is much stronger than ordinary surgical suture, however, it does not have acceptable knot tie down characteristics for use in surgical applications.
  • BRIEF SUMMARY OF THE INVENTION
  • The present invention advantageously provides a high strength surgical suture material with improved tie down characteristics. The suture features a braided jacket made of ultrahigh molecular weight fibers. The suture is coated with arginine-glycine-aspartate (RGD) peptide. The ultrahigh molecular weight polyethylene provides strength. Polyester fibers woven with the high molecular weight polyethylene provide improved tie down properties. RGD peptide promotes cell adhesion to substrates in vivo by interacting with receptors, integrins, on cell surface proteins. Further, RGD peptides also increase the permeability of endothelial monolayers and therefore may aid in surgical applications.
  • In a preferred embodiment, the suture includes a multifilament jacket formed of ultrahigh molecular weight polyethylene fibers braided with polyester. The jacket surrounds a fiber core made substantially or entirely of ultrahigh molecular weight polyethylene. The core preferably includes three strands of ultrahigh molecular weight polyethylene, twisted at about three to six twists per inch.
  • The jacket preferably comprises eight strands of ultrahigh molecular weight polyethylene braided with six strands of polyester. The tinted strands can be included in black or some other contrasting color.
  • Ultrahigh molecular weight polyethylene fibers suitable for use in the present invention are marketed under the Dyneema trademark by Toyo Boseki Kabushiki Kaisha, and are produced in the U.S. by Honeywell under the trademark Spectra.
  • The suture of the present invention advantageously has the strength of Ethibond No. 5 suture, yet has the diameter, feel and tie-ability of No. 2 suture. As a result, the suture of the present invention is ideal for most orthopedic procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, and replacement for suture used in or with suture anchors.
  • The suture is coated with RGD peptide. RGD peptide suitable for use in the present invention is marketed under PCI-36xx-PI by Peptides International, and under GRADSP peptide and GRGDSP peptide by Calbiochem. Other products suitable for use in the present invention marketed by Pierce are: (i) Product #28390-BupH MES Buffered Saline Packs to make a 500 ml of 0.1 M 2-[morpholino]ethanesulfonic acid, 0.9% NaCl, pH 4.7 when dissolved in 500 ml deionized water (5 liters total); (ii) Product # 22980-1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC or EDAC), a zero-length crosslinking agent used to couple carboxyl groups to primary amines and a water-soluble carbodiimide for rapid preparation of peptide conjugates; (iii) Product #24510-N-hydroxysulfosuccinimide (Sulfo-NHS), a product useful in improving the efficiency of EDC coupling.
  • A trace thread or two in the suture jacket aids surgeons in identifying the travel direction of the suture during surgery, particularly during operations viewed arthroscopically or remotely. Providing the trace threads in a regularly repeating pattern is particularly useful, allowing the surgeon to decode different ends of a length of suture, and to determine the direction of travel of a moving length of suture. The trace threads preferably are provided uniquely on each half of a length of suture to allow for tracing and identification of each end of the suture, such as when the suture is threaded through an eyelet of a suture anchor.
  • Other features and advantages of the present invention will become apparent from the following description of the invention which refers to the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a copy of a scanning electron micrograph of a length of suture according to the present invention.
  • FIG. 2 is a schematic cross section of a length of suture according to the present invention.
  • FIG. 3 is an illustration of the suture of the present invention attached to a suture anchor loaded onto a driver.
  • FIG. 4A and 4B show the suture of the present invention attached to a half round, tapered needle.
  • DETAILED DESCRIPTION OF THE INVENTION
  • The term “yarn(s),” as used herein, is to be understood as including fiber(s), filament(s), and the like used to make a suture of the present invention. Typically, though, yams are comprised of fibers and/or filaments.
  • Referring to FIG. 1, a scanning electron micrograph of a length of suture 2 according to the present invention is shown. Suture 2 is made up of a jacket 4 and a core 6 surrounded by the jacket 4. See FIG. 2. Strands of ultrahigh molecular weight polyethylene (UHMWPE) 8, such as that sold under the tradenames Spectra and Dyneema, strands of polyester 10, and tinted strands 12 are braided together to form the jacket 4. Core 6 is formed of twisted strands of UHMWPE.
  • UHMWPE, used for strands 8, is substantially translucent or colorless. The polyester strands 10 are white (undyed). Due to the transparent nature of the UHMWPE, the suture takes on the color of strands 10 and 12, and thus appears to be white with a trace in the contrasting color.
  • In accordance with the present invention, trace strands 12 are preferably provided in black. The black trace assists surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace. Traces also assist the surgeon in identifying whether the suture is moving. The trace can extend the entire length of the suture or only on half of a length of suture, the other half of the suture length remaining plain (white). Alternatively, the traces can form visibly distinct coding patterns on each half of the suture length. As a result, when the suture is threaded through the eyelet of a suture anchor, for example, the two legs (halves) of the length of suture are easily distinguished, and their direction of travel will be readily evident when the suture is pulled during surgery.
  • Details of the present invention will be described further below in connection with the following examples:
  • Example: USP Size 5 (EP size 7)
  • Made on a 16 carrier Hobourns machine, the yarns used in the braided jacket are Honeywell Spectra 2000, polyester type 712, and nylon. The jacket is formed using eight strands of 144 decitex Spectra per carrier, braided with six strands of 100 decitex polyester, and two strands of tinted nylon. The core is formed of three carriers of 144 decitex Spectra braided at three to six twists per inch. A No. 5 suture is produced.
  • To make various sizes of the inventive suture, different decitex values and different PPI settings can be used to achieve the required size and strength needed. In addition, smaller sizes may require manufacture on 12 carrier machines, for example. The very smallest sizes can be made without a core. Overall, the suture may range from 5% to 90% ultrahigh molecular weight polymer (preferably at least 40% of the fibers are ultrahigh molecular weight polymer), with the balance formed of polyester and/or nylon. The core preferably comprises 18% or greater of the total amount of filament.
  • The suture is coated with RGD peptide (PCI-36xx-PI). The RGD peptide-coating increases permeability of endothelial monolayers, thereby resulting in a decrease in abrasion resistance to the suture. RGD peptides promote cell adhesion to substrates in vivo by interacting with receptors, integrins, on cell surface proteins and thus, RGD peptide-coated sutures perform better than other sutures in surgical applications.
  • Peptides may be coupled to or adsorbed to the suture. Typically, about 500 ml of coupling buffer, e.g., about 0.1M MES buffer, is prepared and a base, for example NaOH, is used to lower the acidity of the coupling buffer to a pH value of about 6.0.
  • In one embodiment of the present invention, peptides are coupled to a suture. For coupling peptides to a suture, the suture is cut into 6 inch strips and soaked into an MES buffer for at least 30 minutes. Later, acid hydrolysis is performed, i.e., the suture is taken from the MES buffer and quickly dipped into an acid medium, for example, about 15 ml of 6N HCl and about 200 ul of H2O2. Thereafter, the suture is immediately put back into the MES buffer and washed several times. EDC and sulfo-NHS buffers are added to the MES buffer, for example, about 36 mg of EDC and about 99 mg of sulfo-NHS is added to about 90 ml of MES buffer.
  • The suture is removed from the MES buffer and placed into the EDC buffer for about 15 minutes. The suture is then washed three times with the MES buffer. About 2 ml of peptide solution is immediately prepared and the suture immersed in the peptide solution. The peptide is allowed to react on the suture at 4° C. The suture is then washed about five times with MES buffer and then allowed to air dry under a hood.
  • In another embodiment of the present invention, peptides are adsorbed to a suture. For adsorbing peptides to a suture, the suture is cut into 6 inch strips and soaked in a MES buffer for at least 30 minutes. Later, the suture is taken out and immediately placed back into the MES buffer and washed about three times. About 2 ml of peptide solution is immediately prepared and the suture immersed in the peptide solution. The peptide is allowed to react on the suture at 4° C. The suture is then washed about five times with MES buffer and then allowed to air dry under the hood.
  • In an alternative embodiment of the present invention, a partially bioabsorbable suture is provided by blending a high strength material, such as UHMWPE fibers, with a bioabsorbable material, such as PLLA or collagen, for example. Accordingly, a suture made with about 10% Spectra or Dyneema blended with absorbable fibers would provide greater strength and with less stretch. Over time, 90% or more of the suture would absorb, leaving only a very small remnant of the knot. The absorbable suture can include coatings, for example collagen.
  • The ultra high molecular weight (UHMW) polymer component of the present invention provides strength, and the polyester component is provided to improve tie ability and tie down characteristics. However, it has been found that the UHMW polymer provides an unexpected advantage of acting as a cushion for the polyester fibers, which are relatively hard and tend to damage each other. The UHMW polymer prevents breakage by reducing damage to the polyester when the suture is subjected to stress.
  • In one method of using the suture of the present invention, the suture 2 is attached to a suture anchor 14 as shown in FIG. 3 (prepackaged sterile with an inserter 16), or is attached at one or both ends to a half round, tapered needle 18 as shown in FIGS. 4A and 4B. FIG. 4A also illustrates a length of suture having regularly repeating pattern of trace threads according to the present invention. Sections of the length of suture 2 have tinted tracing threads woven in. The alternating patterned and plain sections aid the surgeon in determining the direction of suture travel when pulling the suture, for example.
  • Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art.

Claims (11)

1. A suture comprising a jacket comprising a plurality of braided yarns formed of ultrahigh molecular weight polyethylene, the suture being coated with RGD peptide.
2. The suture of claim 1, further comprising a core comprising yarns of a ultrahigh molecular weight polyethylene surrounded by the jacket.
3. The suture of claim 2, wherein the yams of ultrahigh molecular weight polyethylene coated with RGD peptide comprise at least 40% of the yarns in the suture.
4. The suture of claim 2, wherein the core comprises about 18% or greater of the total amount of yarns in the suture.
5. The suture of claim 2, wherein the jacket is formed of yarns of the ultrahigh molecular weight polyethylene braided with yarns of polyester.
6. The suture of claim 2, wherein the jacket is braided with trace yarns for suture identification.
7. The suture of claim 2, wherein the core is formed of at least three yarns of the ultrahigh molecular weight polyethylene twisted at three to six twists per inch.
8. The suture of claim 2, wherein the jacket is formed of yarns of ultrahigh molecular weight polyethylene braided with yarns of a bioabsorbable material comprising PLLA and collagen.
9. The suture of claim 2, wherein the jacket comprises at least eight yarns of the ultrahigh molecular weight polyethylene braided with six yarns of polyester and two yarns of nylon.
10. A suture assembly comprising:
a suture, the suture having a longitudinal length and a multifilament jacket comprising a plurality of braided yarns of ultrahigh molecular weight polyethylene; and
a suture anchor, wherein the suture is threaded through an eyelet of the suture anchor.
11. A suture assembly comprising:
a suture, the suture having a longitudinal length and a multifilament jacket comprising a plurality of braided yarns of ultrahigh molecular weight polyethylene; and
a needle, wherein the suture is attached to the needle.
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US10258401B2 (en) 2015-07-17 2019-04-16 Kator, Llc Transosseous guide
US9962174B2 (en) 2015-07-17 2018-05-08 Kator, Llc Transosseous method
US10820918B2 (en) 2015-07-17 2020-11-03 Crossroads Extremity Systems, Llc Transosseous guide and method
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US9080263B2 (en) * 2012-02-10 2015-07-14 Novus Scientific Ab Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
US10258320B2 (en) * 2012-10-26 2019-04-16 Arthrex, Inc. Systems for locking a cinch loop in tissue repair
US10898179B2 (en) 2012-10-26 2021-01-26 Arthrex, Inc. Systems for locking a cinch loop in tissue repair
US20140121700A1 (en) * 2012-10-26 2014-05-01 Arthrex, Inc. Systems and methods for locking a cinch loop and methods of tissue repair

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