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WO1996004942A1 - Composition de revetement pour fils chirurgicaux et fils chirurgicaux enduits de cette composition - Google Patents

Composition de revetement pour fils chirurgicaux et fils chirurgicaux enduits de cette composition Download PDF

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Publication number
WO1996004942A1
WO1996004942A1 PCT/KR1995/000104 KR9500104W WO9604942A1 WO 1996004942 A1 WO1996004942 A1 WO 1996004942A1 KR 9500104 W KR9500104 W KR 9500104W WO 9604942 A1 WO9604942 A1 WO 9604942A1
Authority
WO
WIPO (PCT)
Prior art keywords
suture
coating composition
composition
surfactant
lubricant
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.)
Ceased
Application number
PCT/KR1995/000104
Other languages
English (en)
Inventor
Seung Goo Lee
Sang Baik Wi
Jin Whan Lee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Samyang Corp
Original Assignee
Samyang Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Samyang Corp filed Critical Samyang Corp
Priority to AU31224/95A priority Critical patent/AU3122495A/en
Publication of WO1996004942A1 publication Critical patent/WO1996004942A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06—At least partially resorbable materials
    • A61L17/10—At least partially resorbable materials containing macromolecular materials
    • A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/14—Post-treatment to improve physical properties
    • A61L17/145—Coating

Definitions

  • the present invention relates to a coating composition for surgical sutures and surgical sutures coated with the coating composition.
  • Surgical sutures have been coated with lubricating agents to improve their knot slipdown property and bioabsorbability.
  • U.S. Patent No. 3,297,030 discloses polyglycolic acid surgical sutures coated with silicones or waxes
  • U.S. Patent No. 4,027,676 describes a coating composition for sutures comprising a bioabsorbable film-forming polymer, a hydrophobic material and a bioabsorbable lubricant polyalkylene glycol
  • U.S. Patent No. 4,047,533 provides a coating composition for sutures comprising polyoxyethylene-polyoxypropylene copolymer as a lubricant.
  • the coating material in accordance with U.S. Patent No. 3,297,030 is not bioabsorbable and remains in tissues after the suture is absorbed into the body; the coating composition of U.S. Patent No. 4,027,676 is difficult to prepare due to its complexity; and the suture prepared in accordance with U.S. Patent No. 4,047,533 loses the knot slipdown property when wetted with water or blood in surgery.
  • U.S. Patent No. 4,624,256 teaches a surgical suture coated with a lubricating agent selected from the group consisting of polycaprolactone; a copoly er of at least 90% of caprolactone and a biodegradable monomer; and a blend of at least 50% of the polycaprolactone or the copolymer and up to 50% of another biodegradable lubricant.
  • U.S. Patent No. 4,788,979 gives, as a coating agent, a copolymer of 50% to 80% of caprolactone and lactide, lactone or carbonate; and U.S. Patent No.
  • 4,994,074 uses a coating composition comprising a copolymer of a larger amount of caprolactone and a smaller amount of glycolide or glycolic acid. Even though various sutures coated with coating compositions comprising a homopolymer or a copolymer of caprolactone as mentioned above may have improved the knot slipdown property under wet conditions, their knot security has shown the tendency to deteriorate.
  • an object of the present invention is to provide a coating composition which imparts both improved knot slipdown property and superior knot security to surgical sutures coated therewith.
  • a coating composition for a surgical suture which comprises at least 50wt% of a surfactant having both hydrophilic and hydrophobic portions and/or a powdery lubricant insoluble in an organic solvent, and at most 50wt% of a polymer component, based on the total weight of the composition, for fixing the surfactant and/or the lubricant onto the surface of the suture.
  • a surgical suture is coated with a coating composition which includes a part of the main components of the suture, thereby improving the compatibility between the coating composition and the suture.
  • the coating composition so prepared is not easily removable from the suture and imparts a good knot slipdown property to the suture, which may, however, reduce the knot security in the surgical area.
  • a hydrophobic coating composition will be compatible with the suture and the coating layer therefrom may not be easily removable from the suture; whereas a hydrophilic coating composition will not be compatible with the suture and may not be easily coated on the surface of the suture.
  • a coating composition comprising both a hydrophilic component and a hydrophobic component may be compatible with the suture and the coating layer formed therefrom may be easily removable from the suture, depending on the ratio of the two components, regardless of the hydrophilicity or hydrophobicity of the suture.
  • the coating composition comprises: (A) a surfactant which has both hydrophilic and hydrophobic portions and a polymer which serves to withhold the surfactant when the composition is applied to the surface of a suture and forms a film thereon; (B) a powdery lubricant which is insoluble in an organic solvent and a polymer which serves to withhold the lubricant onto the surface of the suture when the composition is applied thereon; or (C) a surfactant which has both hydrophilic and hydrophobic portions, a powdery lubricant which is insoluble in an organic solvent, and a polymer which serves to withhold the surfactant and the lubricant onto the surface of the suture.
  • the coating layer of the suture coated with the above coating composition is readily removable from the surface of the suture when the suture is threaded through a surgical area. After the suture loses its coating layer, it hardly slips or moves through the suturing site, that is, its knot security increases .
  • the powdery lubricant which is insoluble in an organic solvent and useful in the present coating composition, may be a salt of a fatty acid having six or more carbons, preferably, magnesium stearate.
  • the preferred polymer which serves to withhold the surfactant and/or the lubricant onto the surface of the suture is polycaprolactone.
  • the polymer in the present coating composition forms a film on the surface of the surgical suture together with the surfactant and/or the lubricant.
  • the surfactant and/or the lubricant in the present coating composition lowers the friction coefficient of the surface of the surgical suture, therefore, the suture coated therewith slips smoothly.
  • Polysorbate 80 is effective in smoothing the surface
  • magnesium stearate is effective in facilitating the removal of the coating layer and enhancing the knot security of the suture.
  • the mixing ratio of the surfactant and/or the lubricant to the polymer plays a critical role.
  • the composition comprises at least 50wt% of the surfactant and/or the powdery lubricant and at most 50wt% of the polymer.
  • the polymer is preferably incorporated in an amount ranging from 20 to 50wt%, more preferably, from 40 to 45wt% of the total composition.
  • the surfactant and/or the lubricant is preferably incorporated in an amount ranging from 50 to 80wt%, more preferably, from 60 to 80wt%.
  • the amount of the surfactant preferably ranges from 17 to 33wt%, based on the total amount of the surfactant and the lubricant.
  • the surgical suture in accordance with the present invention may be prepared by using a method which comprises dispersing the coating composition in an organic solvent to make a suspension, coating the suspension on the surface of a suture by a conventional method such as spraying or immersion, evaporating the solvent in the coated suspension and drying the suture.
  • a method which comprises dispersing the coating composition in an organic solvent to make a suspension, coating the suspension on the surface of a suture by a conventional method such as spraying or immersion, evaporating the solvent in the coated suspension and drying the suture.
  • the coating and drying steps may be repeated. After the drying, the coating composition remains on the suture preferably in an amount ranging from 6 to 18wt%, based on the weight of the uncoated suture.
  • the coating composition of the present invention may be applied to any suture made of a conventional material including a synthetic bioabsorbable material, e.g., polygly- colic acid or a copolymer of lactide and glycolide, and a synthetic non-absorbable material, e.g., polyester or polyamide.
  • a synthetic bioabsorbable material e.g., polygly- colic acid or a copolymer of lactide and glycolide
  • a synthetic non-absorbable material e.g., polyester or polyamide.
  • the suture may be prepared by melt-spinning the synthetic material into strands and braiding more than, e.g., 3 strands.
  • Conventional surgical sutures are 3, 8, 12 or 16-braided, and, if needed, more than 16 braids are stranded.
  • Polyglycolic acid with a number average molecular weight of 50,000 to 100,000.
  • the polyglycolic acid was melt-spun into strands and the strands were braided into sutures.
  • the sutures were immersed in a coating solution containing 12% of a 4:6 mixture of Polycaprolactone P 300(a number average molecular weight: 15,000, Union Carbide Co. (US)) and Polysorbate 80 (I.C.I. Co.) in methylene chloride, and then dried to evaporate the organic solvent.
  • the Polycaprolac- tone P 300 had a viscosity ranging from 500 to 2,500cps, measured with a B type viscometer at 204°C.
  • the surgical sutures coated with the above coating composition in accordance with the present, invention had a smooth surface and contained 13% of the coating composition, based on the weight of the uncoated suture. Both the knot slipdown and knot security were good and the removal of the coating layer was easily done.
  • Knot slipdown property and knot security of the surgical sutures were evaluated under wet conditions measured as follows: Knot slipdown property
  • Example 1 The same procedure as in Example 1 was repeated using the same sutures of polyglycolic acid of Example 1 and the coating composition of which the components were given in Table 1.
  • Polycaprolactone P 767 had a number average molecular weight of 43,000, and Poloxa er 188 was manufactured by BASF. The results are given in Table 1.
  • Example 1 The same procedure as in Example 1 was repeated using sutures made of polyethylene terephthalate having a melt viscosity of 3,000 poise at 290°C and the coating compositions of which the components were given in Table 1.
  • Example 2 The same procedure as in Example 1 was repeated using the same suture of polyglycolic acid of Example 1 and the coating composition of which the components were given in Table 2. The results are given in Table 2.
  • Example 2 The same procedure as in Example 1 was repeated using the same suture of polyethylene terephthalate of Example 18 and the coating compositions of which the components were given in Table 2. The results are given in Table 2.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne une composition de revêtement pour fil chirurgical. Elle contient au moins 50 % en poids d'un agent tensioactif présentant une partie hydrophile et une partie hydrophobe et/ou un lubrifiant pulvérulent insoluble dans un solvant organique, au plus 50 % en poids, par rapport au poids total de la composition, d'un composant polymère servant à fixer l'agent tensioactif et/ou le lubrifiant. Cette composition, lorsqu'elle est appliquée sur le fil chirurgical permet au n÷ud de mieux glisser et d'être serré avec plus de sécurité.
PCT/KR1995/000104 1994-08-11 1995-08-09 Composition de revetement pour fils chirurgicaux et fils chirurgicaux enduits de cette composition Ceased WO1996004942A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU31224/95A AU3122495A (en) 1994-08-11 1995-08-09 Coating composition for surgical sutures and surgical sutures coated therewith

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR19940019758 1994-08-11
KR1994/19758 1994-08-11
KR1019950015352A KR0153754B1 (ko) 1994-08-11 1995-06-12 수술용 봉합사용 코팅 조성물 및 이를 적용한 봉합사
KR1995/15352 1995-06-12

Publications (1)

Publication Number Publication Date
WO1996004942A1 true WO1996004942A1 (fr) 1996-02-22

Family

ID=26630530

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR1995/000104 Ceased WO1996004942A1 (fr) 1994-08-11 1995-08-09 Composition de revetement pour fils chirurgicaux et fils chirurgicaux enduits de cette composition

Country Status (3)

Country Link
KR (1) KR0153754B1 (fr)
AU (1) AU3122495A (fr)
WO (1) WO1996004942A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100266516B1 (ko) * 1998-05-18 2000-09-15 한영수 힌지장치
KR101698928B1 (ko) * 2014-10-31 2017-02-02 주식회사 글로원 미세기공을 갖는 생체흡수성 의료용 실을 제조하는 방법

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4624256A (en) * 1985-09-11 1986-11-25 Pfizer Hospital Products Group, Inc. Caprolactone polymers for suture coating
EP0376656A2 (fr) * 1988-12-29 1990-07-04 Deknatel Technology Corporation Revêtement et mélange absorbables
US4994074A (en) * 1990-02-01 1991-02-19 Ethicon, Inc. Copolymers of ε-caprolactone, glycolide and glycolic acid for suture coatings
EP0558965A2 (fr) * 1992-03-02 1993-09-08 American Cyanamid Company Revêtements pour la réduction de la friction d'articles en contact avec des tissus humains ou animaux
EP0585476A1 (fr) * 1991-08-05 1994-03-09 United States Surgical Corporation Procédé et composition pour traiter un article chirurgical bioabsorbable

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4624256A (en) * 1985-09-11 1986-11-25 Pfizer Hospital Products Group, Inc. Caprolactone polymers for suture coating
EP0376656A2 (fr) * 1988-12-29 1990-07-04 Deknatel Technology Corporation Revêtement et mélange absorbables
US4994074A (en) * 1990-02-01 1991-02-19 Ethicon, Inc. Copolymers of ε-caprolactone, glycolide and glycolic acid for suture coatings
EP0585476A1 (fr) * 1991-08-05 1994-03-09 United States Surgical Corporation Procédé et composition pour traiter un article chirurgical bioabsorbable
EP0558965A2 (fr) * 1992-03-02 1993-09-08 American Cyanamid Company Revêtements pour la réduction de la friction d'articles en contact avec des tissus humains ou animaux

Also Published As

Publication number Publication date
AU3122495A (en) 1996-03-07
KR0153754B1 (ko) 1998-11-16
KR960006945A (ko) 1996-03-22

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