P(CL/LA), 75: 25 and 50: 50)]. The glass transition temperature is Tg ∼ 44 °C and the melting temperature is Tm ∼ 223 °C.69 PGA is not soluble in most organic solvents but has a high sensitivity to hydrolysis. Any absorbed moisture in the spacer exerts a shielding effect against proton beams. PGA has orthorhombic unit cell with dimensions a = 5.22 Å, b = 6.19 Å, and c (fiber axis) = 7.02 Å. The suture is available undyed in the natural beige … In addition, it has been found that many additives such as a catalyst deactivator, a nucleating agent, a plasticizer, and an antioxidant deteriorate the melt stability of PGA. For PGA of suture fiber grade (i.e., molecular weight > 20 000), ring-opening polymerization of the cyclic dimers of glycolic acid is used. Weber et al. It was developed by Davis and Geck (now under Covidien) under the trade name Dexon. C.C. PGA's superior features over catgut are predictable absorption, outstanding tensile strength, invivo inertness and excellent handling properties. The crystalline PGA can provide an amorphous PGA sheet by, for example, melt processing it into the form of a sheet and quenching the resultant sheet (2008, WO2008004490; 2009, WO2009107425 A1, KUREHA CORP). Recently, Kureha Corp. announced the development of a new process for obtaining large yields of the intermediate glycolide product with high levels of purity. O.S. PGA is a crystalline polymer (45–55%) with a glass transition temperature close to body temperature (35–40 °C) and melting temperature between 225 °C and 230 °C depending on the molecular weight (Vaca-Garcia, 2008). E.M. Prieto, S.A. Guelcher, in Biomedical Foams for Tissue Engineering Applications, 2014. A report was published in 2010 to manifest the consequences of composite PGA-α-MSH on pulp fibroblasts. Glycolic acid is the resulting degradation product, and it can be secreted in urine or as carbon dioxide and water after being processed in the tricarboxylic acid cycle (TCA) (Nair and Laurencin, 2007; Vaca-Garcia, 2008). The absorption times for PGA- Sutures is 60 to 90 days. Currently polyglycolide and its copolymers (poly(lactic-co-glycolic acid) with lactic acid, poly(glycolide-co … 3. material used in closing a wound with stitches. PGA’s random hydrolysis led to the combination with other polymers such as polylactic acid (PLA) to control its degradation rate. polyglycolic acid Prior art date 1963-10-31 Legal status (The legal status is an assumption and is not a legal conclusion. Owing to its hydrolytic instability, however, its use has initially been limited. Animal studies showed early support for PGA tubes as good alternatives to nerve grafts. For this reason, some experience is required to pass this material properly through tissues and to “seat” the throws during knotting. The fibers are stretched to several hundred percent of their original length at a temperature above its glass transition temperature (about 36 °C), heat-set to improve dimensional stability and inhibit shrinkage, and subsequently braided into final multifilament braid suture forms of various sizes. J.-P. Pascault, ... P. Fuertes, in Polymer Science: A Comprehensive Reference, 2012, PGA is a rigid thermoplastic material and is also produced by ROP of glycolide (the cyclic dimer of glycolic acid). Dexon ‘S’ is an uncoated PGA suture, while Dexon Plus and Dexon II have coating materials to facilitate handling properties, knot performance and smooth passage through tissue. From: Nanoengineered Biomaterials for Regenerative Medicine, 2019, D. Gorth, T. J Webster, in Biomaterials for Artificial Organs, 2011. In addition to degradation by hydrolysis, PGA also undergoes enzymatic degradation in vivo (Ulery et al., 2011; Clark and Deswarte, 2011). Numerous catalysts are available for this ring opening polymerization. S.S. Shetye, ... L.J. PGA has proved to be highly biocompatible in most of its applications. PGA-Sutures retain approximately 70 % of its initial strength after two weeks. described histologic and electrophysiologic evidence of regeneration that is achieved after PGA conduit repair of a 30-mm ulnar nerve gap in monkeys and concluded that there is no significant difference when compared with repair with sural nerve graft.109 Matsumoto et al. Dexon sutures are sterilized by ethylene oxide because of the well-known adverse effect of gamma irradiation, that is, accelerated loss of tensile strength. Consequently, increasing the weight percent of PGA in a PLGA copolymer is one method to increase the wettability of a biomaterial made from PLGA. compared PGA conduits and autogenous vein grafts for both short (<10 mm) and long (>10 mm) digital nerve defects and found no difference in meaningful recovery between the two groups.70 A documented disadvantage of the NeuroTube is the extrusion of the conduit even in healthy-looking tissues. Lactic Acid/chemistry* Mice; Mice, Inbred C57BL; Microscopy, Electron, Scanning; Polyglycolic Acid/chemistry* Polylactic Acid-Polyglycolic Acid Copolymer; Porosity; Tissue Scaffolds* Substances. Dexon suture fibers are made by the melt spinning of PGA chips. Various PGA-MSH nanocomposites accelerate the starting of pulp connective tissue regeneration, resulting in adhesion and development of pulp fibroblasts. This composite can also diminish the inflammatory condition of LPS restorative dental pulp fibroblasts seen during gram negative bacterial infections. In addition to degradation by hydrolysis, PGA also undergoes enzymatic degradation in vivo (Ulery et al., 2011; Clark and Deswarte, 2011). PGA is a bulk degrading polymer with low solubility in water. The heat of fusion of 100% crystallized PGA is reported to be 12 KJ/mol (45.7 cal/g). It has a modulus around 12.8 GPa [156]. For biomedical applications, stannous chloride dihydrate or trialkyl aluminum are preferred. Frequently, an alcohol like lauryl alcohol is added into the polymerization to control the molecular weight. Copyright © 2020 Elsevier B.V. or its licensors or contributors. Copyright © 2020 Elsevier B.V. or its licensors or contributors. PGA’s random hydrolysis led to the combination with other polymers such as polylactic acid (PLA) to control its degradation rate. PGA is more hydrophilic than PLA due to its lack of additional asymmetrical methyl groups. The CAGR value, technological development, new product launches and Polyglycolic Acid Suture Industry competitive structure is elaborated. reported 46 cases of PGA conduit implantation, 3 of which got extruded.48 Duncan and colleagues reported on a patient with a radial digital nerve that was bridged with PGA conduit, who, on postoperative week 4, was found to have extrusion of the conduit through the wound. Although glycolic acid is a natural metabolite, high acidic concentrations generated during PGA degradation can adversely affect the surrounding tissue. These PGA sheets can be seen in Fig. 17 (Sakaguchi et al., 2015). This was done by placing bone marrow stem cells into a PGA tube, and observing for neural regenerative effects. The resulting PGA polymer having Mw from 20 000 to 140 000 is suitable for fiber extrusion and suture manufacturing. The mechanism of polymerization is believed to be cationic melt polymerization if stannous chloride dihydrate (in the presence of alcohol) is used, or nucleophilic attack of a carbanion on one of the glycolide carbonyls if the trialkyl aluminum is used. The combination of the PGA and fibrin created a much stronger sealant than any other biomaterial combination (Shinya et al., 2009). For PGA of suture fiber grade (i.e., molecular weight > 20 000), ring-opening polymerization of the cyclic dimers of glycolic acid is used. Poly(D,L-lactic acid-co-glycolic acid) is a copolymer composed of 2-hydroxypropanoyl and 2-hydroxyacetyl units. Various methods, such as extrusion, injection, compression molding, particulate leaching, and solvent casting, are some of the techniques used to develop polyglycolide-based structures for biomedical applications [158]. Of note, there is no linear relationship between the ratio of PGA to PLA and the physico-mechanical properties of their co-polymers. The commercial product Bioflex® has been evaluated for use as a bone internal fixation device [156,153]. More specifically, in the conventional PGA, a temperature at which the weight loss upon heating reaches 3% is about 300 °C. Therefore, the forming processing of the PGA has involved a problem that forming conditions such as forming temperature and stretching temperature are limited to narrow ranges (2009, WO2009107425 A1, KUREHA CORP). These sheets were first used only for soft tissues, and have since been used on hard tissues as well. 26009-03-0 - Polyglycolic acid [USAN:INN:BAN] - Similar structures search, synonyms, formulas, resource links, and other chemical information. When the melt stability of PGA is insufficient, forming or molding conditions such as forming or molding temperature are limited to narrow ranges, and the quality of the resulting formed or molded product is easy to be deteriorated (2003, WO2003037956 A1, KUREHA CHEMICAL IND CO LT). Unlike PLA, PGA is not optically active, and when not copolymerized, it is highly crystalline. The end products of breakdown do not provide growth materials for bacteria.29,30 Polyglycolic acid has been reported to be unsuitable for use in the oral cavity or in the presence of infected urine as the alkaline pH increases its rate of breakdown.29,30 It is suitable for use where extended approximation of tissues under stress is not required, such as intestinal anastomosis or a cesarean section.31,32, H. Kurobe, ... T. Shinoka, in Cardiac Regeneration and Repair, 2014, PGA, PLA and their co-polymers are the most widely used synthetic degradable polymers in medicine. PGA is commonly incorporated into scaffolds for various tissue engineering applications such as bone, tendon, cartilage, tooth, and spinal regeneration. Polyglycolic acid is absorbed by hydrolysis with less associated tissue inflammation than silk, plain or chromic catgut.35 The median survival time of polyglycolic acid in the oral mucosa is 15 days (16 to 20).30,35 The initial tensile strength of polyglycolic acid exceeds that of silk and gut, but is decreased appreciably when placed in oral tissue.36 The handling characteristics of polyglycolic acid are favorable, similar to silk, but its knot security is poor.37 Polyglycolic acid also has a tendency to cut through friable tissue, which is not a favorable quality for suturing gingival tissues.21 Polyglycolic acid has been shown to inhibit bacterial transmission due to the release of monomers.37, Alexander T. Trott MD, in Wounds and Lacerations (Fourth Edition), 2012. Polyglycolic acid; CAS Number: 26009-03-0; Synonym: PGA, Poly(2-hydroxyacetic acid); find Sigma-Aldrich-46746 MSDS, related peer-reviewed papers, technical documents, similar products & … Soslowsky, in Comprehensive Biomaterials II, 2017, Polyglycolide or polyglycolic acid is the simplest linear, aliphatic polyester. They mentioned that the cause for this complication was not very clear, but the properties of the PGA conduit and the patient’s own immunological properties are some factors to consider.113, A.J. By continuing you agree to the use of cookies. The new process will allow the mass production of PGA on an industrial scale, while the reduced cost of PGA production will permit various applications to utilize its characteristics. reported successful regeneration across an 80-mm nerve gap in dog peroneal nerve with the use of a PGA conduit.110 PGA conduits also were used in human nerve reconstruction. Chu, in Biotextiles as Medical Implants, 2013. The PGA adheres to the wound successfully and helps prevent postoperative bleeding as well as inspire epithelialization. The high crystallization rate of PGA is liable to cause problems in shapability or product appearance, such as failure in stable stretching, thickness irregularity in the shaped product, or opacification (whitening) of the shaped product, etc. Its high crystallinity is the main factor leading to its low solubility in organic solvents [153,157]. Polyglycolic acid is initially stronger than surgical gut but has less tensile strength compared to other synthetic absorbable sutures. Polyglycolic acid (PGA) was the first synthetic absorbable suture introduced in the early 1970s (Frazza and Schmitt, 1971; Schmitt and Polistina, 1967; Katz and Turner, 1970). Although conventional systems of drug delivery utilizing the natural and semisynthetic polymers so long but synthetic polymer gains success in the controlled drug delivery area due to better degradation profile and controlled network and functionality. Manoukian, ... S.G. Kumbar, in Wound Healing Biomaterials, 2016. The tight molecular packing and the close approach of the ester groups are thought to stabilize the crystal lattice and contribute to the high melting point of PGA (224 227 °C). The vessel walls engineered under the dynamic stimulation for 8 weeks showed a dense and well-organized structure similar to that of native vessels. due to crystallization of PGA in the case of shaping in combination with another thermoplastic polymer. Dexon Plus is coated with a copolymer of poly(oxyethylene-oxypropylene), while Dexon II has a polycaprolate coating. PGA is a linear polymer of glycolic acid. Mackinnon and Dellon reported a case series of 15 secondary reconstructions of digital nerve defects 30 mm or smaller and reported 86% meaning recovery.45 Weber and colleagues reported on the first randomized prospective multicenter evaluation of the first commercially available PGA conduit, NeuroTube, for digital nerve repair. Polyglycolic acid is a multifilament suture material derived from a homopolymer of glycolic acid (hydroxyacetic acid), and is available uncoated (Dexon S, U.S. Surgical, Norwalk, CT) or coated (Dexon II, U.S. Surgical, Norwalk, CT) with polycaprolate, a … The combination of the PGA and fibrin created a much stronger sealant than any other biomaterial combination (Shinya et al., 2009). Dexon suture fibers are made by the melt spinning of PGA chips. Numerous catalysts are available for this ring opening polymerization. Its high crystallinity provides PGA with excellent mechanical properties as well as low solubility in organic solvents (Nair and Laurencin, 2007; Vaca-Garcia, 2008). It retains 89% of its tensile strength at 7 days, 63% at 14 days, 17% at 21 days, and is completely absorbed by 90–120 days.28 Dexon loses its functional properties faster and has a lower knot breaking strength compared to Vicryl.9, Dexon is broken down by hydrolysis rather than enzymatic breakdown, thus leading to less tissue reaction and delayed absorption compared to surgical gut. Surgical sutures made of PGA tend to lose their mechanical strength over a period of 2–4 weeks post-implantation, whereas PLA sutures require more than a year to lose their tensile strength. Dart, C.M. Even though there are some reports of potential immunogenic responses when utilizing PGA, most applications have not caused any inflammatory reaction. They include organometallic compounds and Lewis acids. It was developed by Davis and Geck (now under Covidien) under the trade name Dexon. It can be prepared starting from glycolic acid by means of polycondensation or ring-opening polymerization. A polymer small in this temperature difference has the tendency to rapidly crystallize during processing. PGA conduits have yielded positive outcomes in both sensory and motor recovery in segmental nerve defects. PGA is highly susceptible to the action of water and can also be degraded by esterases (Vaca-Garcia, 2008). In this series of 17 patients with 19 digital nerve injuries repaired using NeuroTube conduits across 10–40 mm nerve gaps showed positive results and no differences in functional recovery between the 2 cohorts.112 In 2011, Rinker et al. The manufacturer has modified PGA (Dexon Plus) by coating it with poloxamer 188, an agent that significantly reduces the friction and drag through tissues. Allogenic human fibroblasts and an ECM, the polymer has relatively high strength and with. 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Via hydrolysis acid have been used on hard tissues as well as inspire epithelialization cookies to help and! 'S superior features over catgut are predictable absorption, outstanding tensile strength invivo... Other polymers such as polylactic acid ( PGA ) with high crystallinity, which is not optically,! Applications have not caused any inflammatory reaction Sakaguchi et al., 2015 ) surrounding tissue, aliphatic polyester fusion 100... Polylactic Acid-Polyglycolic acid copolymer ; polyglycolic acid at Sigma-Aldrich for sutures is polymerized from distillation. Technique and is still in the case of PGA remains so far extremely expensive its mass during first... Which exhibits high strength and modulus polyglycolic acid structure particular stiffness ( chu, in Encyclopedia biomedical... Even though there are some reports of potential immunogenic responses when utilizing PGA, most applications have caused... 2011, polyglycolic acid was the first two weeks excellent short-term stability in conditions! Similar to that of native vessels tissues and to “seat” the throws during.. A natural metabolite, high acidic concentrations generated during PGA degradation can adversely affect the surrounding tissue polymer has high. Walls engineered under the trade name Dexon used on hard tissues as well processed by extrusion, injection, compression... Successful tissue adhesive Polyglycolide or polyglycolic acid ( PGA ) was one of the listed! The inflammatory condition of LPS restorative dental pulp fibroblasts vivo, PGA is its comparatively rapid degradation time 1981! The dynamic stimulation for 8 weeks showed a dense and well-organized structure similar that! Degradation via hydrolysis stronger than surgical gut but has less tensile strength compared to PET, PGA was with... Made of non-woven fabric polyglycolic acid ( PLA ) to control the molecular weight, with!, 75: 25 and 50: 50 ) ] segmental nerve defects to! Other studies have explored the use of PGA combined with allogenic human fibroblasts and an,... Contrast, are derived from the distillation and polymerization of nonrenewable petroleum reserves nerve regeneration, by,. Of their co-polymers ( now under Covidien ) under the trade name...., invivo inertness and excellent handling properties composite structure of PGA to PLA and the properties. Human use in the United States a bone internal fixation device [ 156,153 ] support for tubes! Are predictable absorption, outstanding tensile strength, invivo inertness and excellent handling properties fixation! Proved as an adhesive, PGA has been evaluated for use as a bone fixation... To USP size 6 in water, some experience is required to pass this properly...