SUTURES & LIGATURES SUTURES AND LIGATURES A FOR ELECTIVE SUBJECT SUBMITTED TO THE in PROJECT REPORT bn et .a c. HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATAN fli IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE DEGREE OF gn u. in BACHELOR OF PHARMACY SUBMITTED BY RASHMIN S. THAKOR DEPARTMENT OF PHARMACEUTICS AND PHARMACEUTICAL TECHNOLOGY SHREE S.K.PATEL COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, GANPAT VIDYANAGAR KHERVA-GUJARAT 2004-2005 SUTURES & LIGATURES CERTIFICATE This is to certify that the project work for elective subject entitled “sutures and in ligatures” Represents the bona fide work of Rashmin s. Thakor, carried out under my guidance and supervision at the Department of pharmaceutics & pharmaceutical bn et .a c. Technology, Shree S.K.Patel College of pharmaceutical Education and Research, Ganpat Vidyanagar, during the Academic Year 2004-05. He has collected the literature very sincerely and methodically. This work is up to my satisfaction. GUIDE Shri Rakesh. P.Patel M.pharm PRINCIPAL (I/C) Dr N.J. Patel M.pharm, Ph.D. Lecturer Head of the Department Dept. of Pharmaceutics & Dept. of Pharmacology Pharmaceutical Technology Shree S.K.Patel college of Pharmaceutical fli Shree S.K.Patel college of education & research. Ganpat Ganpat Vidyanagar, Kherva u. in Vidyanagar, Kherva Pharmaceutical education& research Date: gn Place: Ganpat Vidyanagar. 2 SUTURES & LIGATURES ACKNOWLEDGEMENTS This Thesis on “sutures and ligatures” has been prepared for partial fulfillment of the academic requirements leading to the Bachelor‟s degree in pharmacy. in Numerous people have been instrumental in enabling me to give a concrete shape to my thesis. Constraints of time and space preclude the mention of all of them here. bn et .a c. However, I must mention the names of a few people who have made a catalytic impact on the development of this thesis. First, and foremost, I would like to acknowledge the continuous encouragement and help extended to me by Mr. Rakesh P. Patel for preparing this thesis. Right from the day I started working on it till it was completed, he has been my sole guide, philosopher, and friend throughout the period of my work. But for the spontaneous support and expert guidance provided by him, this project would not have seen the light of day in its present form. His extensive knowledge of the subject and the way he imparted the same to me has enabled me to develop the thesis in a cohesive manner and has kindled within me a passion for the subject. I take this opportunity to place on record my indebtedness to Shree P.D. Bharadia, Shree J.K. Patel, and all the other faculty members who have also contributed a lot, at inputs. fli various stages of my academic career in the Institute, in terms of valuable knowledge I also express my profound gratitude to Dr. M.M.Patel, our Ex. Principal, who has in been a constant source of inspiration to steer me forward throughout the four years of my study. I am also thankful to the members of my family not only for their support and u. encouragement in my work. I owe a special thanks to my dad, whose help has been invaluable at various stages, and especially during the finalization of the thesis. Lastly, I gn wish to thank my friends in the college, as well as, the administrative staff for their kindness and support during the course of my studies. RASHMIN.S. THAKOR 3 bn et .a c. in SUTURES & LIGATURES DEDICATED TO gn u. in fli MY PARENTS, KEYUR AND BHAVIKA. 4 SUTURES & LIGATURES CONTENTS CHAPTER PAGE NO. 1 2. Definition 3 3. Classification Non-absorbable 3 3 4. Standards and legal requirements for sutures and ligatures 5 5. Natural Absorbable material 7 Surgical catgut 7 5.1 (i) standards for catgut 10 5.1(ii) Sterilization of catgut 11 5.1(iii) Absorption of catgut in body 15 Kangaroo tendon Ribbon gut Fascia lata fli 6. Synthetic absorbable material 17 18 19 6.2 Chromic surgical gut 19 in 19 6.3 Coated VICRYL (Polyglactin 910) 20 6.4 Monocryl 21 6.5 PDS-II 21 6.6 VICRYL Rapide 7. 17 6.1 Plain surgical gut u. gn 3 bn et .a c. Absorbable in 1. Introduction Non absorbable sutures 22 23 7.1 Silk 23 7.2 Linen 24 7.3 Polyamides 24 7.4 Polyesters 25 7.5 Monofilament polyamide 25 5 SUTURES & LIGATURES 7.6 MERSILENE 25 26 7.8 Monofilament stainless steel suture 27 7.9 PROLENE MONOFILAMENT 28 7.10 PROLENE MONOFILAMENT POLYPROPYLENE 29 7.11 PERMA-HAND 8. Suture used in various body surgery 31 33 33 bn et .a c. 8.1 Cardiovascular surgery in 7.7 Polybutylate coated braided polyester suture 8.2 G.I.Tract surgery suture 34 8.3 General closure surgery suture 34 8.4 OB-GYN Surgery suture 35 8.5 Ophthalmic surgery suture 36 8.6 Orthopedic surgery suture 38 8.7 Plastic surgery suture 40 8.8 Urology 41 9 Miscellaneous product 43 9.1 Stainless steel wire 44 9.2 Suture clips 44 9.3 Wire staples 44 fli 10 Surgical needles 46 Needles type 46 10.2 Needle shape 47 in 10.1 10.3 Types of needles 47 51 12 References 52 gn u. Marketed preparation 2 in SUTURES & LIGATURES gn u. in fli bn et .a c. 1. INTRODUCTION 3 SUTURES & LIGATURES Sutures and Ligatures 1. Introduction: The use of strings made by twisting vegetable and animal materials is in described in the most ancient of surviving records of the history of mankind. Animal skins, intestines and sinews were used for musical instruments, bows and many other bn et .a c. items. Vegetable fibres, Spun and Woven, date back to pre-historic times. Linen as spun strand was well known by 5000 B.C. and probably was first prepared long prior to this date. In surgery Susruta (1500 B.C.) records the use of ligatures for tying umbilical cord and celsus in the first century A.D. describes the ligatures of ancient origin. In the highly developed civilization off ancient Egypt surgeons closed wound with sutures. Galen (c. A.D. 200) used silk and hemp cords as ligatures and also recommended the use of animal gut. The term „catgut‟ is said to be derived from the gut used to string a musical instrument known as a kit, an Arabic word for a dancing master Arabian surgeon Rhazes (c. A.D. 900) used harp strings made from sheep intestine to repair abdominal wounds, but the use in surgery of twisted animal intestines was not generally practiced as the patients nearly always became infected. Ambroise Pare (1517-90) appears to have revived the use of ligature and there are fli numerous references in his works to their use, particularly in amputations where he preferred them to the cautery, His valuable work, however appears not to have been in generally recognized and surgeons continued with the old methods of the hot knife and searing iron. The credit for the reintroduction of catgut is given to P.S.Physick (1816) house u. surgeon to j. Hunter, and later Professor of Surgery in Philadelphia, but his observations, and publications of other workers of the same period, did not persuade surgeons to adopt gn the material. It was not until 1869 that Joseph Lister; as a result of his Observations on the Ligature of Arteries on the Antiseptic system opened the way to the modern surgical suture techniques. The first step had been to show that sepsis was due to the growth of 4 SUTURES & LIGATURES microorganisms from the site of infection. From that time onwards the search to find means of preventing infection has not ceased. The history of this work applied to surgical sutures and ligatures during the past seventy years is too large a subject for this chapter gn u. in fli bn et .a c. procedures has led to the highly efficient methods being employed today. in but the investigations by a host of dedicated workers into hundreds of different 5 bn et .a c. in SUTURES & LIGATURES DEFINITION & gn u. in fli CLASSIFICATION 6 SUTURES & LIGATURES 2.DEFINATION LIGATURE: A ligature is a thread used to constrict and seal off a blood vessel, vein or in artery – hence to ligate. SUTURE: The thread is a suture when it is used to stitch together the edges of various tissues, e.g. skin, fascia, muscle, tendon, peritoneum, etc. Hence a needle is always used bn et .a c. for a suture (sewing) but not for ligature. 3. CLASSIFICATION Sutures and ligatures are classified as absorbable and non-absorbable, depending on the materials on which they are made. 3.1 ABSORBABLE: Absorbable sutures and ligatures are absorbed by the tissues in which they are implanted and the time taken for complete disappearance is dependent on a number of factors, which will be treated more fully later in this chapter. Absorbable materials are catgut (non-boilalable and boilable), reconstituted collagen, synthetic fli absorbable polymers, kangaroo tendon, ribbon gut and fascia lata. 3.2 NON-ABSORBABLE: in Non-absorbable sutures and ligatures are not absorbed by tissue and unless they are on the surface, remain in the body after the wound has healed. Some, notably silk, fragment after a long period of time; other is encapsulated by fibrous tissue, u. while others remain as inert implants. The most commonly used are silk, linen, nylon (polyamides), polyester, polyolefin‟s and stainless steel wire, and to a very small extent: cotton, horse hair, human hair, silk worm gut and wires of other metals, e.g. tantalum, gn silver, phosphor bronze, etc. The polymeric materials are also used in the form of the woven meshes particularly for hernia repair and silk and nylon in floss have specialist uses also. Mention should also be made of the use of clips (Michel. Kifa, etc.) For surface application and the past few years have seen a good deal of development, particularly in 7 SUTURES & LIGATURES Russia and the USA, in the use of small wire staples (usually stainless steel) which are gn u. in fli bn et .a c. in implanted by means of stapling guns. 8 bn et .a c. in SUTURES & LIGATURES gn u. in fli STANDARDS 9 SUTURES & LIGATURES 4. STANDARDS AND LEGAL REQIRMENTS FOR SUTURES AND LIGATURES Although the national Pharmacopoeias of most countries publish monographs on surgical sutures, the European Pharmacopoeia establishes the standards nowadays for in EEC countries, Denmark, Sweden, and Switzerland, i.e. the signatories to the Convention. Volume II of the first edition published in 1971 contained monographs for bn et .a c. Sterile Catgut, Sterile Reconstituted Collagen Strings and Sterile Non absorbable strands including Braided Polyester, braided poly amide 6 and 6/6and linen thread. Some amendments were introduced in volume III published in 1975 to the USP XIX (1975). Both these compendia have adopted a metric numbering systems where by the gauge number applied to the suture represent the actual diameter it the tenths of a millimeter. Previously a so- called conventional system was used and, although in the case of the UK and the USA the sizes represented were comparable, the value for diameter differed between absorbable and non-absorbable materials. The conventional system employed by the other countries themselves differed and there was a lack of flexibility as finer sutures were developed for modern surgical techniques (see table.) Sutures have always been the odd man out as far as legislation is concerned and have fli been classed sometimes as `drugs` and sometimes as `devices`. In the UK the manufacture and sterilization of catgut and other products of animal origin became subject to control by licensing under the Therapeutic Substances Act in 1929 largely as a in result of the reports of T.J. Mackie and of Bulloch, Lampitt and Bushill. This control now extends to various `Surgical materials` of animal origin and to synthetic materials capable of being absorbed. u. The Medicines Act is in process of taking over from the Therapeutic Substance Act. Anomalies still remain however those in meantime non-absorbable materials of vegetable gn or synthetic origin are not subject to such control. 10 SUTURES & LIGATURES Former Convention size Metric number Catgut/Collagen Non-absorbable - 0.2 - 0.3 - 10/0 bn et .a c. 0.1 in Synthetic Absorbable 9/0 9/0 - 8/0 8/0 7/0 7/0 6/0 6/0 5/0 5/0 4/0 4/0 3/0 3/0 2/0 2/0 0 0 1 1 2 6 2 3&4 7 3 5 8 4 6 0.4 0.5 0.7 1 1.5 2 3 3.5 4 gn u. in fli 5 11 bn et .a c. in SUTURES & LIGATURES 5. gn u. in fli ABSORBABLE MATERIAL 12 SUTURES & LIGATURES 5. NATURAL ABSORBABLE MATERIALS 5.1SURGICAL CATGUT in Sterilized surgical catgut consists of a strand prepared from collagen derived from healthy mammals purified and sterilized. The most widely used source is the sheep beef cattle. bn et .a c. submucosa of the small intestine from sheep or lambs and to a lesser extent, the serosa The length of ovine intestine is about 20 m and it is desirable in the preparation of surgical catgut that the diameter of the intestine should not be more than 18 mm. A number of factors are important in the selection of suitable intestinal material. Obviously intestines will vary considerably depending on the age of the animal, the pasture, climate, etc. and it is not uncommon to find that intestines from some animals have been affected by scar tissue and are not suitable for preparing surgical catgut. Generally speaking the younger the animal the smaller it‟s intestine, and less likely to be affected by feed. A number of manufacturers of catgut use only the first 8 m of intestine measured from the duodenum. In the meat trade such intestine are described as ligature casing or runners. In the slaughterhouse the gut is removed from the animal by the gut pullers and is fli first of all cleaned to remove faecal matter after which it is inspected, measured and the preserved either in a frozen state or salted. The largest suppliers of intestines come from in Australia and New Zealand and the slaughterhouses in these countries are well equipped to deal with the vast number of animals involved. The intestine of any cadaver is the most vulnerable to bacterial attack and decomposition of this part of the body always begins u. earlier then any other. It is, therefore, vitally important that the slaughterhouse technique involves rapid cleaning and freezing or preservation by other methods in order to keep gn the bacterial growth as low as possible. The ovine intestine consists of four layers (see figure). The outermost is known as tunica serosa or serous layer, much of which is torn off in removal from the animal; next the tunica musculosa made up of two layers, one longitudinal and the other circular; the third layer is the tunica submucosa from which catgut is prepared and in the innermost layer is the tunica mucosa or mucous coat which is the wall to the lumen of the intestine. 13 SUTURES & LIGATURES The intestine receives its blood supply from the mesenteric artery and being some twenty eight times the length of the sheep itself is twisted into a mass of convolutions until near its end where it ascends to join the colon. microphotographs of the submucosal layer. in The Medical Research council report on the preparation of catgut contains interesting The manufacturer of surgical catgut receives intestines either intact or rough scraped at the abbatoir. Made up as knots or bundles which may be frozen, salted or in brine, and bn et .a c. the first step is to soak these in water to thaw out or to remove salt and 0prepare them for splitting. It may be noted in passing that the intestines destined for sausage skins are not split but are cleaned and scraped in the tubular form and known as sausage casings. This cleaning usually takes place in the abbatoir and the product is marketed in barrels or casts. Splitting Inserting the curved horn of a cutting tool into the end of the intestine and pulling the runner over cutting blades carry out the splitting or cutting operation. The number of ribbons produced can be varied but is usually two or three. The horn follows the curvature of the intestine and therefore can be said to locate down the track of the mesenteric vein, which is often called the rough side as distinct from the upper part known as the smooth side. The two parts of the intestine are kept separate throughout the process as they behave in different ways physically and chemically. fli Cleaning of Submucosa The next step is to remove the mucosa, muscle and any remaining serosa, or, if in the material has been cleaned in the abbatoir, the remnants of these layers, and this are facilitated by treatment with alkaline solution. The general method of scraping is to fix the ribbons in a frame or on suitable flat surfaces so that the submucosa can be cleaned of u. unwanted material. Often this is carried out by hand and is a very skilled operation. In other cases an apparatus known as a sliming machine is employed. gn Spinning The apparatus used by manufacturers for spinning ribbons of catgut is largely dependent on the manufacturer‟s choice. The number of hooks on the machine to which the string loops are attached varies from 2 to 20. In some cases spinning takes place from both ends of the strand and may take place immersed in water or alkaline solution. The spinning of catgut destined for surgical use is a highly skilled operation. Multiples of 14 SUTURES & LIGATURES ribbons, which are over spun, will tend to lack elasticity and will curl when dry. On the other hand, if they are under spun the elasticity will too great and the tensile strength reduced. The angle of ply to the horizontal is to some extent a guide as to whether a string has been properly prepared, but many other factors can affect the ultimate quality in of the catgut. Because catgut is a biological material it must of necessity vary considerably and no one animal intestine is exactly the same as another. The spinning of catgut is, therefore, still largely on art rather than a mechanical operation. After spinning, bn et .a c. the catgut is mounted on drying frames, the conditions of drying time and humidity being carefully controlled. The resulting strand of dried catgut is known at this stage as raw catgut and is usually between 3 and 5 m long. Polishing Strands of catgut can be prepared with such care and attention to manufacturing detail that they will vary only slightly in diameter and need only a light manual polishing, but more usually the manufacturer employs a technique which produces an approximate size and then polishes or grinds the string to a predetermined diameter. This process is achieved by means of machines, either by; rotating the strings while a carriage bearing an abrasive paper moves to and fro along their length, or by using a pair of grinding wheels similar to those employed by engineers and setting the wheels the required distance apart. fli Both methods have to be very; carefully controlled to avoid damage to the plies of the strand with consequent loss in tensile strength. The finish, moreover, must be such that in the gut is neither „whiskery‟ nor so smooth that the surgeon‟s knots will slip and cause the wound to re-open. u. Gauging The methods of gauging carried out by various manufacturers vary with their own particular preferences, but the final control instrument for checking diameter is a gauge of gn the dial reading type, in which the details of pressor food and weight loading are specified. As the diameter of catgut will vary with the relative humidity of the atmosphere, the control test as laid down is the diameter in a relative humidity between 60 and 80 per cent and at a temperature between 16 o and 21o. 15 SUTURES & LIGATURES The normal gauge used in British surgery varies from the finest size 1 in ophthalmic work to the thickest size 7, which is occasionally used for specialist surgery. 5.1 (i) Standards for catgut Length. This is determined immediately after removal of the strand from its container length stated on the label. The test is carried out on a machine of the deadweight type, having a bn et .a c. Tensile Strength. in and is measured without stretching. The length must be not less than 90 per cent of the movable jaw with a constant rate of traverse of 30 cm/min, and a capacity so that when the strand breaks, the angle which the pendulum arm makes with the vertical is not less than 9 and not more than 45.The clamp heads are specially designed and any strands breaking within 12.5 mm of the clamps are disregarded. The strands are tested within 15 min of removal from their container and in a temperature between 16 and 21 and in an atmosphere in which the relative humidity is between 60 and 80. As catgut is inevitably knotted in the patient, the test is always carried out on strands in which a surgeon‟s knot has been formed at a point midway between the two clamps. The knot strength is approximately half of the figure, which would be obtained on an unknotted sample. The label on or in the container must state by indelible marking or perforation fli Labeling. the length of the strand, the gauge number, whether the strand is plain, hardened or in chromicized, and that the container should not be subjected to heat treatment. The label on the box must state the name and percentage of any bactericide in the fluid in which the u. sutures are immersed. Storage. Sterilized surgical catgut should be protected from light and stored in a cool gn place. Packaging. The British Pharmacopoeia states that sterilized surgical catgut is packed either in glass tubes sealed by fusion of the glass, or in other suitable containers, which once opened, cannot be resealed. Al though glass tubes are probably the ideal method of packaging surgical sutures in that they are transparent, inert and impermeable, they are 16 SUTURES & LIGATURES nevertheless regarded as a nuisance in the operating theatre because they have to be broken, and a large variety of flexible packages based on aluminum foil of plastic films which can be torn open, have in the past few years tended to replace glass. The bottle packs, which are still used to some extent in continental Europe, in which a continuous in length in the form of a cocoon of catgut is packed in ingenious dispensing devices, is considered to introduce an element of risk of contamination, and this form of packing is Sterility testing. bn et .a c. no longer used in Great Britain. The Therapeutic Substances Act in Great Britain lays down the fundamental required for bacteriological testing of surgical catgut. Definitions are given of the term batch, the percentage of samples from each batch, which are to be tested, and broad definitions of the media and incubation times to be employed. The technique to be adopted where any bactericides present are liable to inhibit growth in the medium is specified. The medium is so designed that it will detect the presence both of aerobes and anaerobes. If after an incubation period of 14 days no growth or microorganism is found in any tube, the sample may be regarded as having passed the test,. If growth of microorganisms is found in any tube a further sample may be taken from the batch and the test repeated. If no growth occurs the sample shall be regarded as having passed the fli test, but if any microorganism is found the batch is treated as not sterile. in 5.1 (ii) STERILIZATION OF CATGUT Lister‟s work on catgut in 1869 using aqueous phenol and later phenol and olive oil u. was the forerunner of antiseptic technique applied to sutures. His experiments and resulting papers stimulated work in which a very large number of chemical compounds were investigated with varying success to bring about a reduction in the number of gn microorganisms present in surgical catgut. Mammalian intestine in the living animal is normally relatively free of microorganisms but immediately after death growth of microorganism‟s proceeds at a very rapid rate. Conditions in slaughterhouses, however clean, are moreover, not conducive to aseptic techniques and the intestines inevitably carry a large bacterial 17 SUTURES & LIGATURES population. The freezing or salting of the material inhibits further growth but does not kill these organisms. Staphylococci, streptococci, with a large proportion of Str. Faecalis, and Escherichia coli are commonly found in intestinal material but although a number may be pathologically significant they are relatively susceptible to sterilizing techniques. Even in if they survive the manufacturing process, the alcohol in the final container would kill many. Sporing aerobes mostly nonpathogenic, such as Bacillus subtilis and its phage type, which used to be known as B. mesentericus rubber, or the catgut bacillus, are very bn et .a c. numerous, but the potentially dangerous organisms are Bacillus anthracis and the anaerobic spore bearing types, among them Clostridium sporogenes, Cl. Tetani, and Cl. Welchii. The spores of both aerobes and anaerobes are not easily killed, the aerobic types being generally more resistant. The fact that they revert to the spore form if conditions for growth are unsatisfactory further complicates the situation. The difficultly is exacerbated by the structure of the catgut strand where ribbons twisted together will carry any contamination throughout their whole cross-section and at the center of the string any organisms are well insulated. The successful means of attack on these microorganisms is buy their chemicals (liquid or gaseous), heat or radiation. The choice of method must, however, be related to other desiderata. It is useless, for instance, to use a method to sterilize the material, which will ruin its physical characteristics such as tensile strength and absorbability. Ideally, the aim will be to interfere as little as possible with the fli inherent structural advantages of collagen as a strong, flexible and elastic fiber that will in be absorbed by; the body in a surgically acceptable manner. Chemical The three methods will now be discussed in further detail. u. The chemical method must employ a material, which is sopricidal as distinct from bactericidal. Most inorganic or organic compounds in common use as antiseptics, disinfectants or bactericides are active against microorganisms in the vegetative phase. gn Certain products such as the quaternary ammonium compounds are even more limited in that they are specific, i.e. they will kill Gram positive organisms and leave Gram negative types unaffected. Other preparations will be effective against most organisms bit certain genera will not be killed and, most important of all, none of these compounds are sporicidal and are therefore useless in bringing about sterility in catgut. 18 SUTURES & LIGATURES The available sporicidal compounds are, in fact, relatively few. The main substances are formaldehyde, hydrogen peroxide, hypochlorite, glutaraldehyde, ethyl iodide, methyl bromide, iodine, ethylene oxide and B-propiolactone. Of these still fewer are suitable for commercial sterilization of catgut. in Histological techniques employing formalin introduced about 1893 led to its application to catgut sterilization by Cunningham (1895). Although a number of workers demonstrated that formaldehyde solutions of the order of 5 percent for prolonged periods bn et .a c. were necessary to destroy anthrax spores and that this treatment seriously affected catgut, the „formalin period‟ lasted for about 15 years and there is little doubt that a great deal of unsterile material was used. The resulting catgut, moreover, was so hardened that its absorption in the body was considerably delayed and its tensile strength much reduced. Hydrogen peroxide will effectively sterilize catgut but results in a material, which is of poor quality. The compound has, however, sometimes been used to improve the colout of catgut by treating the collagen in the ribbon form, i.e. before spinning. Solutions of sodium or potassium hypochlorites although sporicidal, particularly in acid solution, are not suitable for catgut as their penetrative power is very poor and the catgut is unduly swollen and of poor tensile strength. Glutaraldehyde behaves very much in the same way and is only active iin sodium bicarbonate buffered solutions. The solution only retains its sopricidal activity for about fli two weeks. Iodine remains, as the only suitable chemical for large scale commercial sterilizing of in catgut. Ethyle iodide and methyl bromide in alcohol and mixture of iodine and iodine trichloride have also been used. Basically the process consisted of immersion of standard lengths of catgut wound on u. frames or reels in a carefully standardized aqueous solution of iodine, potassium iodide and potassium iodate, the pH being rigidly controlled. The catgut must absorb about 12 percent of its own weight of iodine and when this has taken place the catgut is transferred gn from the solution and excess iodine removed by sterile solvent often containing a bacteriostatic. The sterile strands are then transferred under aseptic conditions to their final container, sterile fluid is added (usually 95 percent ethanol or 90 percent isopropanol) and the container sealed. Processes involving ethyl iodide or iodine and 19 SUTURES & LIGATURES iodine trichloride are carried out in alcoholic solution but in their respect the process is similar to the aqueous method. Ethylene oxide may be employed as a sterilizing agent in the gaseous for or in solution. The important factors to be controlled are concentration, moisture time and temperature in employed. It is an explosive gas and is usually supplied mixed with carbon dioxide or Freon. The process is usually monitored with spore strips of B.subtilis var. niger (B. globigii). Care must be taken to limit the residual ethylene oxide in the suture material. It container. Heat Sterilization bn et .a c. is usually necessary to carry out an aseptic procedure for filling and sealing the final Raw catgut contains 12 percent to 25 per cent by weight of combined moisture, depending on storage conditions. Heating above 80 degree will result in hydrolysis of the collagen and the resulting gelatine or glue would render it useless for surgical purposes. All heat sterilizing processes, therefore, based on the fundamental necessity of removing this combined moisture before the strings can be raised to sterilizing temperature of 150 degree to 165 degree. The process varies with different manufactures, but basically consists in inserting gauged standard lengths of coiled catgut into lass tubes which are then plugged, placed in ovens and the strings dehydrated by gradually raising the fli temperature. Baskets of tubes are then placed in a sterilizing chamber and the catgut covered with an organic fluid of high boiling point and the temperature raised to about in 160 degree. Alternatively the tubes are subjected to the vapor of the organic fluid usually toluene or xylol under pressure, the temperature again being held at about 160 degree for u. a suitable time. Any condensed fluid is removed by a further heating period. Most variations in the methods have been aimed at reducing the fire and explosion hazards and at the same time producing more acceptable catgut. gn After sterilizing the tubes are allowed to cool and are then drained if necessary. The catgut is at this stage very brittle and could not be used in surgery. Under full aseptic condition a suitably hydrated sterile alcoholic fluid is added in order to put back the necessary moisture and the tubes are sealed. This origin of the term tubing fluid, which is 20 SUTURES & LIGATURES still used by many manufactures even though the tubes has been replaced with other forms of pack. After a few days the catgut is sufficiently re-hydrated to be usable. Boilable catgut: Although catgut in Great Britain is now al of the non-boilable type. Up in to a few years ago a boilable Varity was prepared by some manufactures. The term was used to indicate to operating theater staff that the external surface of the tubes could be sterilized by boiling in water. bn et .a c. Boilable catgut was prepared by the heat sterilizing method outlined above bat instead of adding a hydrated tubing fluid the strands were immersed in a non-aqueous compound such as toluene. The catgut, when removed from the tube, was hydrated by the operation theater staff by soaking it in sterile saline or water some time before it was required for use. Radiation Sterilization Currently by far the most commonly employed method of sterilization for suture is that of irradiation by electron particles or by gamma rays. More than 50 percent of the suture companies in Europe use this process. Whilst the original Commercial method in 1957 made use of electron machines, since 1961 most suture manufactures now employ gamma radiation usually from cobalt 60 source. The recognized sterilizing dose for fli sutures is 2.5 megarad. The method has the advantage that sterilization is effected in final in sealed container, indeed some manufactures apply it to the complete sales package. 5.1 (iii) ABSORPTION OF CATGUT IN THE BODY Catgut is used in surgery because it is capable of being absorbed by animal and human u. tissue. This concept was propounded by Lister who recognized that the continued presence of a non-absorbable material presented a focus for infection. The term ´absorption` is often wrongly used to described the loss of tensile strength of holding gn power of the suture in the wound and this is more rapid than the disappearance of the material itself. Formerly, terms such as ´10 day` , ´20 day` ,´´30 day`, and even ´40 day` were applied to catgut sutures. The basis for such claims was never stated and indeed in 1940 Holder showed that in the case of iodine sterilized catgut the terms were meaningless since the iodine process was greater than that of any treatment applied to 21 SUTURES & LIGATURES catgut. These descriptions are now obsolete although they occasionally occur in surgical papers. When the term ´20 day` is used the term is taken to refer tom the present day ´medium chromic material`. Medium chromic, now often abbreviated to ´chromic`, or string to a mild basic chrome tanning. in hardened material is catgut which has been subjected either in the ribbon form or as a Lawrie (1955), working mainly with heat sterilized material implanted in the lumbar muscle of the rat, followed the rate of loss of tensile strength and evolved the concept of bn et .a c. Half Strength Time (HST) which was the time required for the strength of the material to be reduced to 50 percent of its original strength in vivo. Plain catgut was shown to possess a HST of 5-7 days and to reach zero strength in 3-4 weeks, while medium chromic catgut had a HST of 19 days and took about 5 weeks to reach zero strength. The process, which takes place in the body when catgut implants are made, has been extensively studied by histological observation from the day complete disappearance in the tissue (Lawrie et ai. 1959, 1960). It is undoubtedly the reaction of the tissues to the foreign body protein that brings about what is the termed the absorption process. Although catgut prepared and sterilized by different method tends to show different behavior in the body, nevertheless the general histological picture is similar. At first, around the site of the implant there is a fairly rapid gathering of polymorph nuclear leucocytes together with varying proportion of fibrinous exudates. fli These cells are evident as early as one day after implantation of plain catgut which tends to excite a grater reaction in the tissue than chromicized material which does not being to in 10 days after implantation. It should be understood that tissue reaction, i.e. inflammation, is the inevitable result of leucocytic concentration (pus). With plain catgut the polymorph phase begins to die down after about 5 days and u. there is an increasing accumulation of macrophages, by which time the catgut is considerably fragmented and any ultimate suture material is absorbed by phagocytosis. With chromic catgut the mechanism is not necessarily exactly the same although with gn certain types of suture material very little difference can be observed. Where a difference is present thee longer absorption usually involves fragmentation by phagocytes histiocytes and foreign body giant cells. These observations do not, of course, explain why the catgut disappears and although a considerable amount of research has taken place the actual proteolytic enzymes responsible have not been isolated. At the present 22 SUTURES & LIGATURES the leucocytes or histiocytes themselves are believed to carry their own protection enzyme system, and at one time this was thought to be very closely related to αchymotrypsin. The cellular reaction varies somewhat in different animals but the process in the rat is very similar to that which occurs in human tissue although absorption periods in are somewhat longer. Very many attempts have been made by manufactures of surgical catgut to try to relate the in vivo absorption of catgut to a standardized in vitro control. These latter methods have generally been based on exposing catgut to standard solution bn et .a c. of proteolytic enzymes such as trypsin, pepsin, papain, etc., and although the results obtained are of some practical use, it has not been possible to incorporate them into a reliable system of evaluation. RECONSTITUTED COLLAGEN The limitation on length imposed by the length of intestinal material combined with natural biological variation in thickness and character have led manufactures to search for many years for a means of overcoming these disadvantage. Collagen is available from a large number of sources. It is the major constituent of skin, tendon, ligament, etc. As a protein built up of 11 amino acids, it is partially soluble in acids. The basic process has been to obtain an acidic solution of collagen prepared from hides or tendons which can be extruded into a coagulation solution and the resulting fibres oriented by stretching. The fli filaments can then either be spun or rolled to make up the necessary sizes of strand required. Reconstituted collagen is produced mainly in the finer sizes 0.5, 1 and 2 for in ophthalmic and cuticular surgery. 5.2KANGAROO TENDON This absorbable material consists of the tail tendons of the wallaby. The tendons, which u. were usually preserved with naphthalene, were prepared and graded into various sizes, e.g. fine, medium, and stout. Lengths were 30-40 cm. They were sterilized as for catgut and their main use was for hernia repair and bone surgery. This material is virtually gn unobtainable today. 5.3 RIBBON GUT Ribbon gut as its name suggest is in the form of ribbon approximately 12 mm wide and usually about 45 cm long. Its use is limited but is preferred by some surgeons for the 23 SUTURES & LIGATURES repair of large ventral hernia and in the closure of the kidney after nephrology. The material is prepared from bovine esophagus and is sterilized in the same way as catgut. 5.4FASCIA LATA in This may be excised from the patient, or prepared from bovine thigh muscle, cleaned and sterilized. It is supplied in lengths of about 30 cm × 6 mm wide and is used surgically gn u. in fli bn et .a c. for hernia repair, urethral slings, etc. 24 SUTURES & LIGATURES 6. SYNTHETIC ABSORBABLE MATERIAL The search for evenness and continuous length has also been pursued among synthetic organic compounds. A number of patient obtained for filaments produced from the polymerization of certain lactides, hydroxy acids, etc. and two such products are gaining in acceptance in surgery. The USP XIX describes Absorbable Surgical Suture as a sterile strand prepared from collagen derived from healthy mammals or from a synthetic bn et .a c. polymer. 6.1 PLAIN SURGICAL GUT Available as a straw coloured suture. Surgical gut is made from the intestinal submucosa tissue of sheep. These casings are split into ribbons, which are cleaned chemically as well as mechanically and matched by computers to meet the most exacting demands for diameter and tensile strength. Then an exclusive electronic spinning process creates a strand that is virtually a monofilament for dependable strength and holding power. Finally the strand is polished to size to an accuracy of five thousand of a millimeter to produce an extremely smooth, highly uniform suture. Surgical Gut draws through delicate tissue without sawing, ties down securely and holds uniformly and predictably, until the wound regains tensile strength. fli 6.2 CHROMIC SURGICAL GUT SUTURE Available as a tan coloured suture. Chromic gut is made from the intestinal submucosal tissue of sheep. These casing are split into ribbons, which are cleaned in chemically as well as mechanically and matched by computers in order to meet the most exacting demands for diameter and tensile strength. Then an exclusive electronic u. spinning process creates a strand that is virtually a monofilament, for dependable strength and holding power. Finally the strand is polished to size to an accuracy of five thousand of a millimeter to produce an extremely smooth, highly uniform suture. Surgical gut gn draws through delicate tissue without sawing, ties down securely and holds uniformly and predictably until the wounds regains tensile strength. Virtually a monofilament For smooth tissue passage. Smooth tie down and knot security. Natural 25 SUTURES & LIGATURES Produced from intestinal submucosal tissue of sheep. Highest level of collagen purity. This enhances strength, minimizes tissue reaction and promotes greatest patient comfort. Wound support Absorption By enzymatic digestion. Complete in 90 days. Co lour bn et .a c. Tan in Chromic Gut retains tensile strength for approximately 20 days. Range Eyeless needled Sutures: Sizes 6-0 to 2 (USP) Standard and short lengths in sterile foil Over wrap Packs: Sizes 5-0 to 4 (USP) 6.3 COATED VICRYL (Polyglactin 910) Braided Synthetic Absorbable Suture u. in fli Available as a braided suture in distinct violet as well as undyed colures. COATED VICRYL (Polyglactin 910) is now the most widely used Coated Braided Synthetic Absorbable Suture. The braided construction ensures that handling and gn knotting are excellent and the unique lubricant coating remains effectively bonded to the material throughout its use, ensuring smooth passage through tissue and easy knot tie down. The unique molecular structure of coated VICRYL allows it to retain strength during the critical wound healing period, yet, be absorbed rapidly after the suture has excellent handling characteristic and its distinctive violet colour is highly visible in the 26 SUTURES & LIGATURES wound. Coated VICRYL is also available in undyed form, especially for cuticular and plastic surgery. 6.4 MONOCRYL (Poliglecaprone 25) bn et .a c. Available as a golden colour monofilament in Monofilament Synthetic Absorbable Suture MONOCRYL (Poliglecaprone 25) is a monofilament, synthetic absorbable suture. A copolymer of 75% glycoside and 25% caprolactone, MONOCRYL is undyed, presenting as a natural golden coloured monofilament. MONOCRYL is the most pliable synthetic absorbable monofilament suture ever, has virtually no memory when dispensed and its exceptionally smooth surface ensure TISSUE GLIDDE when passed through tissue. This added to the fact that it elicts only minimal tissue reaction makes this suture an ideal choice for plastic and cosmetic surgery fli and for Gastrointestinal surgery. 6.5 PDS II in Monofilament Synthetic Absorbable Suture gn u. Available as a distinct violet Suture. 27 SUTURES & LIGATURES PDS II suture is a Monofilament Synthetic absorbable suture made of Polydioxanone. PDS II has the characteristic of extremely high initial tensile strength, coupled with extended wound support. Also, being a monofilament, handling is extremely easy and in knotting is secure. Passage through tissue is smooth, eliminating tissue drag. It is indicated for use in areas such as closure of fascia and sheath, in Pediatric Cardiovascular surgery, in the Gastro intestinal tract, in Obstretrics/Gynaecology, in orthopedic surgery 6.6 VICRYL rapid bn et .a c. and for subcuticular closure. Braided Synthetic Absorbable suture fli Available as an undyed suture VICRYL rapide is a braided suture made of the same material as that of Coated in VICRYL. i.e. Polyglactin 910. It is the specific manufacturing process which gives VICRYL rapide its low molecular weight and hence its unique absorption characteristic. VICRYL rapide is available in undyed form. u. VICRYL rapide is indicated for the closure of skin and mucosa. Its rapid absorption ensures that patient does not have to come back for removal of skin sutures. Absorption gn of VICRYL rapide is predictable and with minimal tissue reaction. 28 bn et .a c. in SUTURES & LIGATURES 7. NON- fli ABSORBABLE gn u. in MATERIAL 29 SUTURES & LIGATURES 7 NON- ABSORBABLE SUTURES 7.1 SILK Silk consists of strands prepared from filaments of the cocoon spun by the silk worm in of the Bombyx family before it enters the chrysalis stage. Three forms are used in surgery- twisted (sometimes known as Chinese twist). Floss and plaited or braided silk. ĎSilk in its natural state contains up to 25 percent of natural gum and strands prepared bn et .a c. from unbleached, undischarged. Twisted silk suture material is prepared from unbleached, undischarged filaments spun in multiples to the British Pharmaceutical Codex range of diameters and may be dyed with non-toxic dyestuffs. The surgical use of twisted silk has very much declined in favour of the braided type. Floss silk is prepared from the coarser filaments on the outer surface of the silkworm cocoon and is used in its spun glossy white form mainly in the repair of hernia. Its use is diminishing fast as the plastic polymer meshes gain in popularity. Plaited or braided silk is the material in large-scale use in modern surgery. It is prepared from discharged silk and the range of sizes is dependent on the number of strands braded together. As the gum has been removed it is not serum proof or noncapillary and for most surgical purposes it therefore treated with proofing waxes or silicones. fli Silk is identified chemically by warming with mercuric nitrate solution when a brickred colour is produced and it is stained yellow by trinitro-phenol solution. Silk, because in of its strength softness and general ease of handling is used in many sites of surgical operation, the fine strand being particularly suited to ophthalmic and neurosurgery. Silk sutures are classified as non-absorbable in the body and are normally encapsulated by u. fibrous tissue. However, many cases have been reported where after a considerable length of time the silk has fragmented or even migrated from the original site of implantation. Silk is sterilized either by autoclaving, which causes a certain loss in its tensile gn strength, or by radiation or ethylene oxide sterilization. It is normally supplied by suture manufactures to comply with the monographs published in the British Pharmaceutical Codex. 30 SUTURES & LIGATURES 7.2 LINEN Linen sutures consist of selected fibers made into a twisted strand from flax (Linum usitatissinum). The strand is normally prepared by spinning three cords together, the size of the cords being chosen to produce the ultimate desired gauge of thread. For surgical microscopic examination. in use it must be firmly and evenly spun and free from fuzziness. Identification is by Linen may be dyed with any non-toxic dyestuff but although a certain amount of black bn et .a c. thread is used the majority of surgeons prefer off-white or ivory colour. It is extensively used in many surgical techniques and frequently needs to be noncapillary and serum proof by treatment with suitable proofing agents similarly to braided silk. It can be sterilized by autoclaving or ethylene oxide. Radiation sterilization does however cause a considerable loss of strength. It is the subject of a monograph in the British Pharmaceutical Codex to which all British manufactures conform. 7.3 POLYAMIDES fli In the U.K. these polymers are better known by the word Nylon but as this is a registered trademark in certain European countries, it is likely that the word polyamide will be used in the future. These compounds are formed from the polymerization of the reaction in product of an acids and an amine. Hitherto, they have been known by suffixing the word Nylon with a number, e.g. Nylon 6, Nylon 66, Nylon 10, 11, 12 etc. Polyamide 66 is formed by the combination of hexamethylenediamine and adipic acid. Polyamide 6 is u. formed by the polymerization of caprolactam. All the polyamides and suture materials are produced by an extrusion process, the gn size of the orifice on the extruder head determining the size of the filament. The bulk of the material used in surgery is produced in the form of monofilament. Its main use is in skin suturing although it is sometimes used internally. Polyamide mesh finds a use in hernia repair. 31 SUTURES & LIGATURES Finer filament of polyamide is braided together to form braided nylon on nonabsorbable surgical sutures. Monofilament polyamide is normally colored with distinctive non-toxic dyestuffs or pigments in order to improve its visibility. It may be sterilized by autoclaving, by ethylene oxide or by radiation treatment, but is incompatible with phenol in and its homologues and other phenolic substances. The knotting of polyamide requires a 7.4 POLYESTER bn et .a c. special knot. This suture material is usually prepared in the plainted or braided form and consists of filaments prepared by polymerizing the ester formed by a combination of ethylene glycol and terephthalic acid. In its commercial form it is known under the trademarks Terylene (I.C.I.) and Dacron (Dupont). The number of filaments in the braid determines the size of the completed strand. The polymer has a softening temperature of not less than 255 degree and may be sterilized by autoclaving, ethylene oxide or radiation treatments, in order to improve its visibility in tissue it is often dyed or pigmented with non-toxic materials. 7.5 Monofilament Polyamide Available as black monofilament. The suture use in this product is an extremely fli strong, very pliable surgical nylon produced by a special, closely controlled extrusion and polishing process that assures uniformity through out its length. It has high in-vivo tensile in strength, does not support bacterial growth and has the further advantages of being minimally irritating to tissue and remarkably smooth and easy to handle. The smoothness of suture makes it suitable for closing skin and subcuticular layers. Its high degree of u. elasticity contributes to its great strength in the fine sizes, enabling the plastic surgeon; the micro surgeon and the ophthalmologist to tie secure knots. gn 7.6 MERSILENE Braided and Monofilament Polyester Available as a highly visible black or white braided suture alternatively, available as a green monofilament. 32 bn et .a c. in SUTURES & LIGATURES MERSILENE suture is made from fine filaments of pure polyester, an extremely strong synthetic material. It is specially processed to render it noncapillary. A special process to produce a tight, smooth, uniform strand braids it. The tensile strength of MERSILINE suture is considerably higher than that of natural non-absorbable sutures. It is not weakened by wetting. It has excellent handling characteristics, draws easily through tissue and knots hold securely with standard synthetic knotting technique. As a synthetic, MERSILENE suture retains its strength in tissue and well tolerated in the body. MERSILINE suture is also available as a Monofilament Green suture specifically meant for ophthalmic surgery. 7.7 Polybutylate coated braided polyester suture Available as a highly visible green or white coated braided suture fli Suture is made of fine filaments of polyester fiber, braided by a special process to produce a firm suture that remains soft and pliable. For added lubricity and smoothness, the suture is coated with a highly adherent, biologically inert Polybutylate. The unique in process gives suture a number of advantages. Flaking is virtually eliminated and the suture is smooth to plave and tie down making it an excellent choice for cardiovascular u. and ophthalmic work. Knots hold securely when standard synthetic technique is used. Suture is virtually non reactive and will retain its strength in tissue. Braided and coated gn Suture, a braided polyester, is coated with a highly adherent, biologically inert, Polybutylate which acts as a lubricant. Since both the suture as well as the coating are both made of polyester materials, there is a natural affinity between the two and hence, an excellent bond between the suture and coating. With the uniform coating of Polybutylate, 33 SUTURES & LIGATURES suture has a soft pliable hand, ensures smooth passage through tissue, and knotting is secure. Available in highly visible green or white colours. Range in Colour combinations. Minimal reaction bn et .a c. Eyeless needled sutures: sizes 6-0 to 5 (USP) on a variety of needled suture The thin and uniform surgical grade Polybutylate coating virtually eliminates flaking, shredding or bending common to sutures coated with commercial lubricants. Tissue reaction is minimal. Strong and secure Suture is strong and secure and is ideal for use where extended approximation of tissue under stress is required. fli Smooth handling Polybutylate coating imparts superior lubrication to polyester braided materials. Hence in handling is extremely easy and passage through tissue is smooth. Knot tying technique u. As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws as indicated by surgical circumstances and the experience of the operator. gn 7.8 Monofilament stainless steel suture Available as sterile monofilament eyeless needled sutures 34 SUTURES & LIGATURES Surgical stainless steel is made from premium grade steel, formulated specifically for surgical use. This grade of surgical stainless steel must undergo many more quality control steps than ordinary commercial steel. Surgical steel is the strongest suture virtually no tissue reaction. Monofilament Synthetic bn et .a c. Inert, will have virtually no tissue reaction. Knot security is exceptional. in material that makes. It offers the ultimate in knot security. As a inert material it will elicit Made of surgical grade stainless steel. Provides supple “hand” while retaining high tensile strength. Colour Silver. Range Available in a range of eyeless needled sutures: gauges 5-0 to 6(USP) Also specially imported are multistrand straight packs. The straight packs are available in sizes 1,4,5,6,(USP). They are multistrand packs with 4 strands per foil pack. This specially designed packaging minimizes kinks and aids easy handling of the suture in the operating theatre. fli Superior strength Suture is the strongest suture material made. Its applications are in orthopedic surgery in (tendon repair), as well as in cardiovascular surgery (as a sternal closure suture). Inert Suture when implanted in vivo elicits virtually no tissue reaction. u. Knot security Knotting with suture offers excellent security gn 7.9 PROLENE MONO FILAMENT POLYPROPYLENE Available as a bright blue monofilament suture. 35 bn et .a c. in SUTURES & LIGATURES PROLENE Polypropylene suture is made from a polymer of propylene, which is extruded by the special ETHICON a very strong, smooth, uniform suture. The unique combination of qualities in the suture material itself makes PROLENE suture one of the most versatile non- remarkable smoothness remarkable smoothness absorbable sutures available. Its makes it desirable as a cosmetic suture. The same quality is valuable in cardiovascular work. It real, which is important in vascular surgery. The long term holding power of is the least thrombogenic suture matePROLENE suture – it will retain its in vivo tensile strength for years makes it the choice when extended approximation is a must. As a monofilament, it has no interstices to harbour microorganisms. It is unwetted by blood, unweakened by tissue enzymes, offers prolonged tensile strength even in infected areas. PROLENE suture is pliable, ties securely and handles well fli because of its controlled elongation. 7.10 PROLENE Monofilament Polypropylene Non Absorbable Suture Monofilament in High degree of smoothness requires much less force to draw through tissue; easy to place, easy to pull out. PROLENE suture being a monofilament has no interstices to harbour microorganisms. It handles exceptionally well. It is as steel, resists break down u. by infection. It is unaffected by tissue fluids and can be used even in presence of gn infection. Non-absorbable Provides prolonged tensile strength retention in tissue, even in presence of infection. Synthetic 36 SUTURES & LIGATURES PROLENE suture are made from a specially formulated surgical grade of polypropylene. It is made of isotactic form of propylene polymer called isotactic polypropylene resin. Colour Suture is available in a bright blue Colour. It makes PROLENE suture the easiest to seen in in the wound. bn et .a c. Extensibility PROLENE suture has the characteristic of controlled linear elongation as a result of which it is ploiable, ties securely and handles well. Range Eyeless needled sutures: gauges 8-0 to 1 (USP). Available in a variety of needled suture combinations. Knot security Plastic deformity enables knot to flatten out and lock against itself. fli Knot tying technique As with other synthetic sutures, knot security requires the standard surgical technique of in flat and square ties with additional throws as indicated by surgical circumstances and the experience of the operator. CAUTION: care should be taken to avoid damaging the surface of the material with gn u. surgical instruments in use, as this could lead to fracture of the material. 37 SUTURES & LIGATURES 7.11 PERMA-HAND bn et .a c. Available as a black braided suture in Surgical silk PERMA – HAND surgical silk begins as a filament of natural silk. Natural silk is composed of approximately 70 % protein fibers and 30% extraneous material or gum. A specially developed degumming process removes extraneous material amounting to 30% of the original volume of raw silk. This process is essential for a compact braid whilst ensuring that the filaments retain their natural body and elasticity. These filaments are then tightly braided at a sloe controlled rate and electronically Inspented during the fli processing. Finally, proofed to give “hand” to the suture, it will neither soak up fluids nor become limp or brittle. Knots tie down smoothly and securely whilst its natural elasticity in signals when optimum knot placement has been achieved. The enduring popularity of PERMA-HAND braided silk in all surgical specialties is reflected in the wide range of u. needles to which the material is attached. PERMA-HAND gn Braided silk suture Braided For easy handling and knot tying. Uniform tension during braiding makes each knot hold fast, so suture does not slip back between throws. 38 SUTURES & LIGATURES Natural PERMA-HAND surgical silk begins as a filament of natural silk. This silk goes through in degumming process; it is then braided under slow control. It is then TRUPERMANIZED for non-capillarity. This results in a suture material with exceptional hand, uniform Colour bn et .a c. strength and diameter, which is smooth, ties down easily, and knots securely. Black. Twisted virgin silk however is available in blue. Range Eyeless needled sutures braided : Sizes 7-0 to 1 (USP) Eyeless needled sutures (twisted virgin silk) : Size 9-0 to 8-0 (USP) Sutupak pre cut sutures : Size 6-0 to 3 (USP) Reels (non sterile) : Size 6-0 to 4 (USP) ASSURED NONCAPILLARITY fli PERMA-HAND surgical silk does not transfer pathogens from one place to another. UNIFORMITY OF STRENGTH AND DIAMETER in Controlled uniformity of diameter results in high uniform tensile strength. EXTENSIBILITY gn u. PERMA-HAND surgical silk signals to the surgeon that “optimum” knot. 39 SUTURES & LIGATURES SURGERY bn et .a c. 8.1 CARDIOVASCULAR in 8 Suture used in various body surgery Cardiovascular Surgery requires highly specialized needles and selected suture materials. The suture used in this purpose its own suture combination and this allows for reliable quality control. Eyeless needles made of a unique stainless steel alloy, which permits a reduced wire diameter – closely, approximately the diameter of the suture material- fli without sacrificing ductility and strength. It is in the process of introducing a patented needle alloy specially for cardiovascular surgery in many product added strength and improved penetration- time after time. in In ETHICON`s company collection of suture material for cardiovascular work, like PROLENE which offers strength, inertness, unsurpassed tissue passage properties and secure knotting make it the leading suture material as far as cardiovascular work is u. concerned. Newer suture materials such as PDS II, which offer prolonged wound support, make it the suture of choice for vascular anastomosis in small vessels in pediatric gn vascular surgery. The product has a range of needles for cardiovascular work namely CC needles, BV Series needles which requires significantly less penetration force, pass easily through tissue thereby reducing tissue trauma. Other material such as ETHIBOND and 40 SUTURES & LIGATURES ETHISTELL offer the cardiovascular surgeon the complete range of precision product to make exacting tasks go more smoothly. For the specialist, by the specialists SURGERY bn et .a c. 8.2 GASTRO-INTESTINAL in In short the cardiovascular surgery used sutures are: Anastomosis is the most common procedure in Gastro-intestinal Surgery. Therefore the use of Eyeless Needled Suture is essential to minimize tissue trauma, prevent leakage and fli contamination and therefore achieve optimum results. Some company marketed product offers a wide range of Super Smooth Needles that penetrate easily time after time through in tissues with minimum pressure, thus eliminating tissue drag. Stainless Steel Needles are rendered Super Smooth by the exclusive Micro graining process developed by many companies. u. Many companies have introduced the new range of JB needles for anastomosis in the Gastro-intestinal tract. These needles, which have a slim round-bodied tip, have an oval cross section to facilitate separation of the tissue layer. They are blackened for improved gn visibility in the operating field. These needled are available on MONOCRYL suture material. ETHICON like company offer a range of newer suture materials like MONOCRYL, Coated VICRYL, in addition to the conventional suture materials like surgical Gut, 41 SUTURES & LIGATURES PERMA HAND Surgical Silk for exceptional performance during surgery in the Gastro- bn et .a c. 8.3 GENERAL CLOSURE in intestinal tract. All surgical procedure ends with the closure of a wound. The wound may be on the Abdominal wall or an extremity: Different procedures need different techniques of closure and various tissue layers demand varying suture materials and needles for their approximation. Eyeless needled sutures for general closure provide a full range to face any situation. Use of eyeless needled sutures prevents unthreading during surgery, ensures easy passage through tissues and provides comfort and convenience during fli surgery. gn u. in 8.4 OB-GYN SURGERY In Obstetric and Gynecological Surgery, concern for the healing process and for patient comfort has traditionally idea surgeons to select a suture with non- capillarity (For 42 SUTURES & LIGATURES placement in or near contaminated areas), monofilament construction (For smooth pliable action to minimize tissue tearing and promote patient comfort during healing) and knot in security (to hold ligaments and vessels to ensure ligation is secure). ETHICON`s has introduced, in addition to coated VICRYL, the range of synthetic absorbable sutures viz. VICRYL rapid and PDS II for the OB-GYN surgeons. These bn et .a c. suture materials are available with special needles of choice meant to approximate different tissues during various OB-GYN procedures. These special needles of allow smooth and easy penetration through tissues with minimal tissue trauma and the different suture materials provide the necessary wound support required to carry out different procedures with ease and comfort. An example of this is the special Episiotomy code on VICRYL rapid, offering the surgeon the benefit of rapid and predictable absorption, also improving patient comfort. The new synthetic absorbable suture, PDS II, offers long term wound support which is ideal for the closure if fascia. ETHICON Company continued commitment to the safety of the surgeon has resulted in the introduction of the revolutionary ETHIGUARD needle. This needle with its unique Dolphin Nose profile passes through the tissue yet does not penetrate the gloves hence fli preventing the transmission of blood borne infections through needle stick injuries. gn u. in 8.5 OPTHALMIC SURGERY Perhaps no other surgical discipline requires as many specialized needles and specially designed suture material as Ophthalmic Surgery. To meet this need, some company offers the Ophthalmic Surgeon, a comprehensive array of precisely manufactured fine MICRO- 43 SUTURES & LIGATURES POINT and Spatula needles and suture material such as Surgical gut, coated VICRYL, Black Braided Silk, Monofilament Polyamide, PROLENE, MERSILENE and in ETHIBOND. The introduction of the CS-ULTIMA family of Ophthalmic needles with its innovative Concave Spatula design and its breakthrough needle geometry offers the bn et .a c. Ophthalmic surgeon the “Shape of Sharpness” The cutting edge for a superior performance time after time. ETHICON company has also introduced a CATARACT KIT, a combination of 10-0 ETHICON on an Advanced MICRO-POINT, 6 mm cured needle, with a 4-0 Braided Silk Suture on a TAPERCUT, 17 mm, half circle needle offering the benefit of improved operation theatre management, less time wastage and less material wastage. Specialized Needles and Sutures For Ophthalmic Surgery Corneal and Scleral tissue is very tough in order to fulfill its role in protecting the optimal unction of the eye. Needles must, therefore, be both strong and sharp. The ideal needle for suturing of the eye allows easy initial penetration and exact control of the fli depth of penetration. ETHICON`s range of Ophthalmic surgery Needles includes: gn u. in CS ULTIMA Features Dramatically reduced edge angles Innovative concave spatula geometry 44 SUTURES & LIGATURES Superior strength Less force to penetrate Burial of knot made easier Resist bending, maintains curvature bn et .a c. in BENEFITS Specialized Suture Materials VIRGIN SILK Virgin Silk is widely and extensively used in cataract surgery it has excellent handling qualities. It is smooth, soft, has no tissue drag and is very easy to tie. It has god visibility in tissue and provides secure knots. It gives to optimum tissue reaction and being soft, has no tissue drag and is very easy to tie. It has good visibility in tissue and provides secure knots. It gives rise to optimum tissue reaction and being soft in nature, does not cause any irritation in the eye. It gradually fragmented and disappears and results in satisfactory ETHILON fli wound healing. in Polyamide Monofilament ETHILON suture is strong, smooth, inert and in fine sizes, enables the surgeon to produce a small, tight, non-slipping knot-a knot so fine, it can be buried in the needle u. tract. There is no tissue drag and it does not fray. It needs a specific synthetic knot-tying technique and results in good wound healing. It is gn an ideal suture for keratoplasty. VICRYL (Polyglactin 910) Synthetic Absorbable Suture Tissue-timed for predictable performance. A copolymer of lactide and glycolide, VICRYL suture has a unique molecular structure, which causes the suture to retain its 45 SUTURES & LIGATURES strength over the critical wound healing period, and then allows rapid absorption after the suture has served its purpose. Minimal tissue reaction for a “quiet” eye- makes VICRYL Colour for high visibility. SURGERY bn et .a c. 8.6 ORTHOPADIC in suture an excellent choice for cataract and strabismus surgery. Has distinctive violet Orthopedic Surgical procedures are carried out from head to foot. These include surgery of the spine, joints, bones and soft tissues. Various tissue layers, from bone to skin require to be approximated during these procedures. Some tissue need absorbable suture while some need non-absorbable sutures. ETHICON provides a full range of suture on appropriate needles. ETHICON`s Family of Synthetic Absorbable with materials such as PDS II, recommended for extended wound support would be ideal for these procedure like surgery of the spine and other joints. PDS II, recommended for extended wound support would be ideal for these procedures. It also has the advantage of being an absorbable suture. All suture materials are available on Round Bodies needles, Cutting needles, special Mayo needles, Trocar needles, and TAPERCUT needles as per the surgeon‟s preference. fli ETHICON has also introduced a new absorbable suture material, VICRYL rapid, for suturing of skin. The advantage offers by this unique suture material is, that it offers short term wound support and the sutures begin to fall off after the critical wound healing in period, hence there is need of suture removal. u. ETICON Suture Materials for usage in Orthopedic Surgery Procedures. gn Coated VICRYL (Polyglactin 910) synthetic Absorbable Suture Coated VICRYL provides medium term wound support for up to 30 days. Absorption is predictable, 63 days on an average and with minimal tissue reaction. This suture knots well and handles well. It is available on a variety of Needle suture combination for orthopedic surgery procedures. 46 bn et .a c. in SUTURES & LIGATURES VICRYL rapid (Polyglactin 910) synthetic absorbable suture VICRYL rapide is recommended for those areas where short term wound support is required like suturing of skin. It provides just the right strength at the start and loses tensile strength rapidly. Sutures begin to fall of between 10-12 days as the skin wound heals. It is recommended for use under POP casts. Since sutures fall off between 10-12 fli days, there is no need for patient to come back for suture removal. u. in PDS II (Polydioxanone) Synthetic Absorbable Suture PDS II offers extended wound support for up o 56 day. Also being a monofilament, gn handling is exceptionally easy. It is recommended for closure of fasica and also for elderly; dehabitated patients where the slow healing requires extended wound support. 47 SUTURES & LIGATURES in ETHISTEEL Monofilament Stainless Steel bn et .a c. Surgical Stainless Steel is the strongest suture material made by ETHICON. It offers excellent knot security. It is inert and elicits virtually no tissue reaction. It is available in finer sizes for tendon repair. 8.7 PLASTIC fli SURGERY THE surgeon who wishes to achieve the finest cosmetic results must have a complete in range of “tools” in his armoury. ETHICON has taken a quantum leap in the field of plastic surgery needle technology by introducing the Top of the line ETHIPRIME plastic surgery needle. This superior needle a result of numerous years of research has given the gn u. plastic surgeon today the 4 S‟s formula:Sharp Stays Sharp Strong Secure 48 SUTURES & LIGATURES The ETHICON needles backed by the Family of Synthetic Absorbable and non Absorbable Suture ensure that each layer of tissue has that appropriate support to ensure a in beautiful scar. Suture such as MONOCRYL- which allow a phenomenon called “Tissue Glide”, PROLENE, ETHILON, and Coated VICRYL (now available in its undyed version in bn et .a c. those fine gauges) ensure superlative cosmetic results. Suture materials such as VICRYL rapide- a rapidly absorbing skin closure suture that obviates the need for removal of suture materials offer numerous benefits to the plastic surgeon. Finally ETHICON`s PROXI-STRIP range of skin closure designed specially for the plastic surgeon are an asset to any skin closure technique. 8.8 UROLOGY Urology procedure involves the usage of Absorbable suture: both Natural as well as Synthetic Absorbable Suture. ETHICON offers suture materials such as Plain and Chromic Catgut, and coated VICRYL. The range of sutures is available on a variety of needles specially designed for surgery in the urinary tract. fli Since the bladder wound regains 100 percent of its strength by 21 days, VICRYL suture would be ideally suited for closure of the urinary bladder. Special needled suture have been made available for surgery on Prostrate, Ureter, Pelvis of the kidney, Urethra in etc. Very fine-needled sutures have been made available for procedures like VasoVasostomy, A-V Fistula for Renal Dialysis, Uretroplasty and Hypospadius. Use of these u. specially designed eyeless needled sutures ensures minimal tissue trauma and provides immense comfort, convenience and safety during surgery. It helps the surgeon perform gn fast and efficient surgery. 49 SUTURES & LIGATURES 9 Miscellaneous Products Mesh Products in Non- Absorbable Tissue Support Products Where permanent, or extended tissue support is a surgical requirement, ETHICON bn et .a c. offers PROLENE Mesh Products PROLENE Polypropylene Mesh Monofilament Polypropylene knitted PROLENE Mesh is constructed from the same material as that of PROLENE suture. It is well recognized for its biological inertness and strength. In the mesh form, it provides a lasting and permanent solution for a “Tension Free” Hernia Repair. PROLENE Mesh may be resterilised once by conventional steam autoclaving process at a temperature of 121º for 20 minutes Code PM-S PM-M Packaging 6 cm x 11 cm 3 sheets per box 15 cm x 15 cm 3 sheets per box 30 cm x 30 cm 1 sheet per box fli PM-L Presentation in Absorbable Tissue Support Products VICRYL (Polyglactin 910) Synthetic u. Absorbable Mesh The proven benefits of the VICRYL Copolymer are now available in the form of an absorbable mesh product designed to provides temporary support during the wound gn healing phase. VICRYL mesh is indicated for traumatized spleen, kidney, and treatment of abdominal eviscerations. The VICRYL mesh retains approximately 80 % of the initial tensile strength at 14 days and 17 % at 28 days. Impressive Mechanical Properties Excellent Handling 50 Essential Permeability Predictable Absorption in SUTURES & LIGATURES Presentation Packaging VKM-M 15 cm x 15 cm 3 sheets per box VKM-L 30 cm x 30 cm 3 sheets per box bn et .a c. Code 9.1 STAINLESS STEEL WIRE Stainless steel wire has largely replaced the various wires which have been used in surgery in past years, such as silver, tantalum, phosphor bronze, etc. it is supplied for surgical purpose in three forms, namely, monofilaments, twisted and plaited or braided. The British Pharmaceutical Codex includes monographs on all three types and lays down standards for diameter and tensile strength. In all three cases the wire is prepared from austenitic chromium-nickel stainless steel and is fully annealed. The austenitic steels are nonmagnetic and only capable of being 1967. fli hardened by cold working. The wire is made to British Standards Specification 4106: in It may be sterilized by dry heat, autoclaving, ethylene oxide or radiation but it is important that the wire should be fully degreased when heat treatment is used. Its main use is in orthopedic work, but very fine wire is also used in plastic surgery u. and for repair of tendons. 9.2 SUTURE CLIPS Michel and Kifa clips are used to some extent for long skin wound approximation and gn find a considerable use in research work on animals where they are less irritating in the skin surface than suture. 9.3 WIRE STAPLES A considerable amount of experimental and clinical work is now being carried out, particularly in the U.S.S.R. and the U.S.A., on the use of very small wire staples, 51 SUTURES & LIGATURES usually of stainless steel. The field of investigation is very wide and papers have been published on their use in orthopedic, cardiovascular and arterial work and in the U.S.S.R. gn u. in fli bn et .a c. in the results of many thousands of cases of gastric resection have been reported. 52 bn et .a c. in SUTURES & LIGATURES gn u. in fli SURGICAL NEEDLES 53 SUTURES & LIGATURES 10 SURGICAL NEEDLES Whenever a suture is required to close a wound, needles to arm the suture material are in necessary. The number of sizes and the variety of different shapes of needles run into many thousand. The range supplied by manufactures is usually classified into types for specific surgery, as for example, arterial, general purpose, intestinal, obstetric, ½ circle,5/8 bn et .a c. ophthalmic, plastic, retention. Shapes are designated as: straight, curved, circle, etc. and the section as round bodied, triangular cutting edge, triangular reverse cutting, cutting point, trocar point. In addition the length of the needle from point to hilt is specified in millimeters and the hilts are designed to take the various diameters of suture material employed. Needles are chosen by the surgeon to suit his operating technique and it is largely because of the surgeon‟s interest in improving suture efficiency that the development of surgical needles has taken place. In very many cases the surgeon himself has caused needles to be made to his own design and a large number of commonly used needles are referred to by the name of the inventing surgeon. Surgical needles are of two types; those which have an eye through which have an eye through which the suture is threaded, and eyeless needles where the suture is inserted into the hollow hilt and held in position by swaging the metal around it. The late Sir fli Henery Souttar obtained the first patent on an eyeless needle in 1921, but in the U.K. their use has only increased appreciably in the past few years. In the U.S.A. 70 percent of the suture needles are of the eyeless type. in The needles themselves are made either of stainless steel or of carbon steel, the latter usually being plated to resist corrosion. At one time the carbon steel needle had a better u. resistance to bending than its counterpart in stainless steel, but recent technological advances have the added advantage that they will not corroded and do not present the surgeon with the dreaded emergency of having to locate and extract the broken point of a gn needle embedded somewhere in the tissue of an unfortunate patient. 10.1 NEEDLE TYPE The basic classification for needle is normally by needle type such as round bodied, conventional cutting, reverse cutting, Trocar Point or Tape cut cutting round-bodied needles. All the type of needles available is discussed in under. 54 fli bn et .a c. in SUTURES & LIGATURES in 10.2 NEEDLE SHAPE The choice of needle shape is frequently governed by the accessibility of the tissue to be sutured, and normally the more confined the operative site the greater the curvature u. required. The basic shapes involved are: straight, ¼ circle, 3/8circle or curved, ½ circle and circle. gn 5/8 10.3 TYPES OF NEEDLES Super smooth 55 SUTURES & LIGATURES Virtually all needles have a micro-thin Super- Smooth finish that permits the needle to penetrate and pass through the toughest tissue with an almost fluid-like flow, with bn et .a c. in minimal resistance and virtually no drag, giving the surgeon a feeling of control. Strong, sharp Micro grain Stainless Steel This needle is made from premium grade stainless steel formulated specifically for surgical use. An exclusive process controls the orientation of the micro grains so that ductility and strength are closely sharp, and stay sharp, thus assuring easy passage through tissue. Needle Swaging Needles are permantely attached to the suture materials, eliminating the need for fli threading and providing a new, sharp needle each time. A good needle give perfect swaging gives the surgeon a needle with an unbroken surface from end to end; without double strands, it draws through tissue easier and with less tissue trauma. in Ribbed for Security and Control Longitudinal ribbing on the inside and outside curvatures of most needles has a cross- u. locking action in the needle holder, minimizing turning, rocking or twisting, and thus providing unsurpassed needle control. Round Bodied gn For soft, easily penetrated tissues. 56 SUTURES & LIGATURES Conventional Cutting Two opposing cutting edges, with a third on inside curve. Change in cross-section from a TAPERCUT Needle bn et .a c. in triangular cutting tip to a flattened body. Cutting tip, taper body. For tough tissue, like two needles in one. Dolphin nosed needle fli For greater surgeon safety while operating in potentially infected areas. Reverse Cutting u. in Cutting edge on outer curve. For tough, difficult to penetrate tissues. Blunt point Needle gn Taper Body. For suturing friable tissue e.g. Liver, Kidney. 57 SUTURES & LIGATURES MICRO-POINT Spatula needle bn et .a c. CS ULTIMA Spatula needle in Thin, flat profile. Specially designed for ophthalmic anterior segment surgery. Reduced edge-angles provide better penetration. Readily facilitates knot rotation in ophthalmic surgery. ETHIPRIME fli Hollow form design enhances penetration for delicate plastic and cosmetic surgery. VISI-BLACK Needle gn u. in Slim taper point needles with a black finish for improved visibility and penetration. 58 SUTURES & LIGATURES 11. MARKETED PREPARATION with trade name MONOCRYL (Poliglecaprone 25) suture PDS II (Polydioxone) suture ETHIGUARD surgical needles bn et .a c. ETHIBOND polyester suture in VICRYL (Polyglactin 910) suture MERSILINE polyester suture PDS II (Polydioxanone) suture CS ULTIMA ophthalmic needles ETHICON surgical steel suture VISI-BLACK surgical needles VICRYL (Polyglactin 910) suture ETHALLOY needle alloy ETHIPRIME surgical needles PROXI-STRIP skin closure VICRYL RAPIDE suture TAPERCUT surgical needles fli MONOCRYL (Poliglecaprone 25) suture VICRYL (Polyglactin 910) suture PDS II (Polydioxanone) suture in ETHIGUARD surgical needles ETHALLOY needle alloy PERMA-HAND silk suture u. ETHIBOND polyester suture MERSILENE polyester suture gn PDS II (Polydioxanone) suture ETHICON surgical steel suture 59 bn et .a c. in SUTURES & LIGATURES gn u. in fli REFERENCE 60 SUTURES & LIGATURES 12.REFERENCES for surgical Use. Medical Research Council Special Report No 138. 2. CUNNINGHAM, R.H. (1895) New York med. J. 61, 494. in 1. BULLOCH .W, LAMPITI, L.H. & BUSHILL, J.H. (1929) The Preparation of Catgut Suppl., 121 T. bn et .a c. 3. DAWSON, J.O., ROYLANCE, T.W. & SMITH, T. (1964) j. Pharm. Pharmacol. 16 4. FANDRE.A. (1944) Le Catgut. Paris: Masson et Cie. 5. HOLDER, E.J.(1955) Studies in the Absorption of Surgical Catgut. Edinburgh: William Blackwood & Sons Ltd. 6. LAWRIE.P. (1955) Studies in the Absorption of Surgical Catgut. Einburgh: William Blackwood & Sons Ltd. 7. LAWRIE, P., ANGUS, E.A.& REESE, A.J.M. (1959) Br.j.Surg. 46, 638. 8. LAWRIE, P., ANGUS, E.A..& REESE, A.J.M. (1960) Br.j.Surg. 47,551. 9. LISTER, J. (1869) Lancet 1869,I.451. 10. MACKIE, T.J. (1928) An inquiry into Post-Operative Tetanus-A Report to the Scottish Board of Health. fli 11. ETHICON PRODUCT CATLOGUE gohnson&gohnson professional Product 12. GROSS, M.2. The Ethic on book of sutures. Ethic on Suture Laboratories, Ebinburgh. HOLDER, E.J. (1939) surgical sutures and ligatures. Livingston, Ebinburgh. 14. HOLDER, E.J. (1946) Desirable Factor in surgical sutures. Blackwood. in 13. Edinburgh. DAWSONE, J.O. (1962) Ligatures and sutures chemist drug., 160, 177-179. u. 15. 16. LAWRIE, P. (1959) A Survey of the absorbality of surgical catgut. Br.J. surg 46,634-637 gn 17. OS, D.VAN. (1946) A new surgical suture. Pharm .j., 103, 164 18. Bentley‟s Textbook of pharmaceutics Edited by E.A. RAWLINS 36, 626-641 19. A textbook of tutorial pharmacy by cooper & gun‟s. 20. Indian journal of clinical practice volume 15 number 2: the matters sutures: vertical, horizontal and corner stitch. 61 SUTURES & LIGATURES 21. Lawrie p Angus g. e. and Reese a.j.m. (1959) The absorption of surgical catgut gn u. in fli bn et .a c. in B.R.J surg. 46, 638-642. 62 gn u. in fli bn et .a c. in SUTURES & LIGATURES 63
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