Suture Manual

REPAIR AND REGENERATE Suture Manual

List of Contents

Introduction Page 3

Principles Page 6

Surgical needles Page 12

Sutures Page 15

Manufacture and packaging Page 28

Organisational aids Page 33

No claim is made for the completeness of the information given about the suture material: this must be gathered from the relevant literature for healthcare specialists. More detailed information concerning the materials can be obtained from the information leaflets in each package. We shall be pleased to send these on request. Visit our website: www.resorba.com for constantly updated and comprehensive information on our products and developments.

2 Introduction

In nature, damaged or destroyed tissue Absorbable materials, e.g. PGA RESORBA®, Requirements for an layers must be covered over quickly to support the natural healing process until ideal suture: preserve the integrity and functions of form and function are restored. Such • high tensile strength the organism. We humans have copied materials are subsequently metabolised • high knot security this response from nature. by the organism. • good tie down • no capillary function It is the aim of modern wound care, first Non-absorbable suture materials (e.g. • good tissue tolerance and foremost, to preserve intact tissues MOPYLEN®) guarantee lasting support • easy passage through tissue and support the damaged parts. Our su- and best biotolerance, which is especially • sterile presentation ture materials, based on biocompatible essential for long-term implants. raw materials, make possible the targeted application of every kind of wound care, A large number of suture materials are The optimum use of any and guarantees the best possible tissue nowadays used in wound closure. In many particular suture is determined acceptability. respects they are adapted to their specific by its: • absorption characteristics use (indication) and are chosen for the • structure, composition Surgical suture is a typical medical device particular properties of the tissue. and diameter for tissue repair. Most wound closures • elasticity and stability are still done with sutures. The mechanical • tissue acceptance properties of the inserted material are of • tensile strength the greatest importance in temporarily replacing the lost strength.

3 Introduction

A journey into the history of surgical sutures

The development of surgical suture 1100 BC 625 – 690 revisited Oldest surviving suture, placed about 1000 Paulus of Agina was the first physician BC in the abdomen of a mummy (Rodegra to treat a fracture by winding 1982). Linen was already being used as around it. suture material at that time. 1732 500 BC Various suturing techniques, still in com- Susruta, an Indian, was the first to describe mon use today, were drawn on animal in detail wound sutures and the material skin (exhibited at the Germanic National used for it, e.g. bowstring (earliest absorb- Museum in Nuremberg). able suture material?), linen thread, plant 1827 - 1912 fibres, tree bark sutures and thin strips Wound became preventable cut from tanned skin. after the introduction of the first usable Production of around 1930 460 BC – 199 AD disinfection and sterilisation methods The great medical books by (antiseptics) by Lister (1827 – 1912) and 3000 BC (460 – 377 BC), the most famous physician Schimmelbusch (1860 – 1895). First reference to a wound suture in an- of antiquity, the Roman physician Celsus 1868 cient Egyptian texts. (25 – 50 AD), and the physician Galen Lister, a surgeon, discovered absorbable 1900 – 1600 BC (129 – 199 AD) already contain detailed sutures made of sheep gut string. He Oldest surviving description of wound descriptions of many suture techniques. disinfected the sutures with carbolic care in papyri named after F. Smith (1862) Celsus distinguished between single and acid to keep them germ-free. This is the and Ebers (1873), from about 1900 – 1600 continuous sutures. Galen was the first origin of resorbable catgut sutures. BC. to recommend thin strings made of gut for ligating bleeding vessels.

4 Introduction

1900 1939 In principle, different types of suture Beginning of the industrial manufacture Perlon was specially treated to produce packaging have been available since the of suture material (catgut), based on the synthetic thread Supramid to meet beginning of the industrial manufacture technical experience gathered in the the particular requirements in . of sutures. But it was only with the meantime in making strings for musical After World War II, this was joined by instruments. synthetic threads made from 1908 and . In 1908 F. Kuhn (1866-1929), a German Until 1960 surgeon, demanded the exclusive use of Sutures were sterilized by bactericidal surgical sutures made of catgut that had chemical solutions or by heating (steam). been made under especially clean, partly Since 1960 sterile conditions. This catgut (sterilized Introduction of safe modern methods of with potassium iodide) became the most sterilization with ethylene oxide gas or commonly used surgical suture material gamma irradiation. Early packaging of sutures next to twine and . After the introduc- 1968 tion of catgut an intensive search began First synthetic suture threads made from development of packaging techniques for other absorbable suture materials. An polyglycolic acid. with synthetic materials around 1960, unsuccessful attempt was made to obtain The production of ”atraumatic sutures” and of new methods of sterilisation that absorbable thread from animal tissues was also further developed and improved it became possible to make the sterile ( from kangaroo tails; skin, , starting at the beginning of 1970. The and ready-for-use packs available nowa- strips of muscle, tendon and from basic idea of a minimal transition in dia- days. whale, rabbit, dog, deer, camel, turtle and meter from needle to thread for providing others). the most sparing way of passing a suture 1931 through tissues was put forward over First production of synthetic threads from 100 years ago (Gaillard) and has been polyvinyl alcohol. used since about 1920.

5 Principles

Historical classification according to raw materials Natural starting materials: Silk, linen (twine), animal gut (catgut) Synthetic starting materials: Polyglycolic acid, polylactide, polyamide, polyester, polypropylene, PVDF

Modern classification according to absorption characterstics Non-absorbable SILK, RESOPREN®, MOPYLEN®, POLYESTER, SUPOLENE, WIRE Pseudo-absorbable Monofilament material Multifilament material Properties no capillarity very high tensile strength RESOLON®*, *, SUPRAMID* no sawing action high knot security Slow absorption easily knotted very supple easy passage through tissue simple handling CAPROLON® CAPROLON® PGA TM Medium-term absorption Absorbable resoquick material: GLYCOLON® PGA RESORBA® PGA RESORBA® Non-absorbable MOPYLEN® POLYESTER Fast absorption material: RESOPREN® SUPRAMID PGA resoquick TM, GLYCOLON® NYLON SUPOLENE RESOLON® SILK STAINLESS STEEL *Polyamide is not fully inert, but a pseudo-absorbable material, early hydrolytic degradation having been observed after more than 6 months.

6 Principles

Absorption dation into (smaller) pieces and thus loses rent sutures can be achieved by the choice its strength (e.g. polyamide) of the material and modifying the pro- Absorbable sutures approximate the Dissolution duction process. In addition to the imme- tissues during the healing process. During The period during which the suture com- diate, moderately quick or delayed loss this time the suture’s tensile strength pletely dissolves within the tissue. of tensile strength, there is also the cor- gradually diminish. Absorbable suture responding duration of absorption. Any material is metabolised by endogenous given thread material can only fulfil its proteolytic or by hydrolysis Characteristics of purpose as long as it has the desired (in the case of PGA RESORBA®, absorption tensile strength. PGA resoquickTM, CAPROLON® and GLYCOLON®). Different indications also require different Non-absorbable suture remains almost tensile strength and absorption characte- unchanged when placed within body ristics. These particular features of diffe- tissues, and is encapsulated within the wound by the organism. The sutures 100 used for skin closure are removed once 90 CAPROLON® 80 PGA RESORBA® the scar tissue has become sufficiently 70 PGA resoquickTM firm to hold the wound edges together 60 GLYCOLON® (usually after 7 –14 days). It has to be 50 distinguished: 40 30 Absorption time 20

The period in which the suture loses 50% Knot tensile strength % 10 of its knot tensile strength. 0 0 7 14 21 28 35 42 49 56 63 70 77 84 days Disintegration The period during which essentially non- In-vitro trial of suture degradation by measuring the knot tensile strengths of GLYCOLON®, PGA resoquickTM, PGA RESORBA® and CAPROLON®. absorbable suture breaks down by degra- Suture size: 3-0 USP (2 metric).

7 Principles

Thread structure The structure of a thread affects its passage through tissue and its capillarity. We distinguish between four basic thread structures: Monofilament GLYCOLON® CAPROLON® MOPYLEN® RESOPREN® RESOLON® A monofilament consists of only NYLON one thread filament. STAINLESS STEEL, monofilament Multifilament

A multifilament consists of many thin STAINLESS STEEL, multifilament elementary fibres which are either twisted, POLYESTER entwined or braided into bundles. SILK

Coated or pseudo-monofilament

The thread interior (the so-called thread core), a bundle of parallel filaments, is imbedded in a mantle-like or tube-like coating that provides a smooth cover. SUPRAMID

Multifilament coated

Multifilaments can be treated with various special coating materials to improve their mechanical properties. In this way gaps PGA RESORBA® between the filament bundles are evened PGA resoquickTM out and surface friction is reduced. SUPOLENE

8 Principles

Tissue Tissue acceptance, using acceptance PGA RESORBA® as example

Every insertion of suture triggers some tissue reaction within the body (see table). The causes are: - Traumatisation of tissue on placing the suture - Mechanical irritation by the suture’s surface, which cannot be avoided but Microscopy of section through an Microscopy of section through an reduced when using monofilament intramuscular implant, intramuscular implant, threads. 7 days postoperative 14 days postoperative Expectedly, mild cellular infiltration is The suture is embedded within the block - Natural, immunological reaction visible. of tissue. No evidence of either tissue (nonspecific foreign-body reaction and reaction or encapsulation. defence reaction against chemistry of the thread) Degree of tissue reaction SILK POLYAMID POLYESTER MOPYLEN® PGA resoquickTM PGA RESORBA® GLYCOLON® CAPROLON® RESOPREN® STAINLESS STEEL

9 Principles

Diameter of sutures datory for European manufacturers. The from them. In contrast, the metric EP The harmonised standards, as derived table compares the diameters with the numbers can be converted into a thread from the monographs of the European conventional nomenclature used to date diameter: Pharmacopoeia (Ph. Eur.), have established (United States Pharmacopeia). The latter 1 metric = thread diameter of 0.1 mm. the metric classification and nomencla- have no direct connection to thread dia- ture for suture diameter which are man- meter so that they cannot be derived Thread table

TM ament

® ® ® ® ® monofil

OPYLEN ESOPREN OLYESTER UPOLENE YLON ESOLON UPRAMID TAINLESS STEEL TAINLESS STEEL LYCOLON APROLON Ph.Eur Diameterrange in mm PGA RESORBA® PGA resoquick M R P S N R S SILK S multifilamentS monofilamentSynth. monofilamentDiameter in mm G C

0.1 EP 0.010-0.019 11-0 0.2 EP 0.020-0.029 10-0 10-0 10-0 10-0 0.3 EP 0.030-0.039 9-0 9-0 9-0 9-0 0.4 EP 0.040-0.049 8-0 8-0 8-0 8-0 8-0 0.5 EP 0.050-0.069 7-0 7-0 7-0 7-0 7-0 7-0 7-0 0.050-0.094 7-0 0.7 EP 0.070-0.099 6-0 6-0 6-0 6-0 6-0 6-0 6-0 6-0 6-0 6-0 6-0 0.095-0.149 6-0 6-0 1 EP 0.100-0.149 5-0 5-0 5-0 5-0 5-0 5-0 5-0 5-0 5-0 5-0 5-0 0.150-0.199 5-0 5-0 1.5 EP 0.150-0.199 4-0 4-0 4-0 4-0 4-0 4-0 4-0 4-0 4-0 4-0 4-0 0.200-0.249 4-0 4-0 2 EP 0.200-0.249 3-0 3-0 3-0 3-0 3-0 3-0 3-0 3-0 3-0 3-0 3-0 0.250-0.339 3-0 3-0 2.5 EP 0.250-0.299 - 2-0 - - - - - 2-0 ------3 EP 0.300-0.349 2-0 2-0 2-0 2-0 2-0 2-0 2-0 2-0 2-0 2-0 2-0 0.340-0.399 2-0 2-0 3.5 EP 0.350-0.399 0 0 0 0 0 0 0 0 0 0 0 0.400-0.499 0 0 4 EP 0.400-0.499 1 1 1 1 1 1 1 1 1 1 1 0.500-0.570 1 1 5 EP 0.500-0.599 2 2 2 2 2 2 2 2 2 2 0.571-0.610 2 6 EP 0.600-0.699 3+4 3+4 3+4 3+4 3+4 3+4 3+4 7 EP 0.700-0.799 5 5 5 5 5 5 8 EP 0.800-0.899 6 6 6 6 6 9 EP 0.900-0.999 7 7 7 7

10 Principles

Tensile strength of surgical suture

Tensile strength is defined as the force Requirements on the tensile strength according to Ph.Eur.* required in Newtons N, to break a knot (harmonised standards) in a suture. Since the tensile strength of a knot is decisive in surgical practice (it is neces- Diameter metric All other non- Synthetic, multi- Synthetic, mono- absorbable filament, absorbable filament, absorbable sutures in N sutures sutures (CAPROLON®) sarily less than with a linear pull), this is (PGA RESORBA®) 0.2 metric 0.10 - the only measure which is defined in 0.3 metric 0.35 0.45 official requirements. In relevant tests 0.4 metric 0.60 0.70 the thread is knotted once before the 0.5 metric 1.00 1.4 1.40 force is applied. 0.7 metric 1.50 2.5 2.50 1 metric 3.00 6.80 6.80 1.5 metric 5.00 9.50 9.50 2 metric 9.00 17.50 17.50 2.5 metric 13.00 - - 3 metric 15.00 26.80 26.80 3.5 metric 22.00 39.00 39.00 4 metric 27.00 50.80 50.80 5 metric 35.00 63.50 63.50 6 metric 50.00 - - 7 metric 62.00 - - 8 metric 73.00 - -

*Minimum mean value from 5 tests

11 Surgical needles

Needle characteristics special stainless steel with optimal flexi- is tested in accordance with the regulati- The characteristics of a needle (diameter, bility and strength. Special surface treat- ons of harmonised standards for surgical point, length of needle curvature) should ment and precision grinding of the point suturing materials according to the Euro- always be optimally suited to the parti- or edge ensure minimal resistance on pean Pharmacopoeia. cular indication, surgical technique and insertion and easy passage of the needle tissue conditions. The parameters to be through the tissue. The firmness with considered are: which the needle is attached to the suture - Response to penetration (on insertion

and pulling through of the needle) Thread - Resistance to bending Point Shaft, i.e. swaging zone - Resistance to breaking - Secure seating in needle-holder

Needle diameter For suturing and suture encircling of Body of needle wounds, atraumatic (eyeless) needles are usually used as needle-thread combina- tions. Needle-thread combination means, the thread is inserted and firmly anchored inside a drilled shaft at the end of the Length of curvature needle. This provides an essentially step- free transition from thread to needle. Needle shapes Thus any further trauma to tissue is avo- 5/8-circle = F 1/2-circle = H 3/8-circle = D 1/4-circle = V half-curved = K straight = G asymptotic = A ided, as could occur if the thread is dou- bled up after passing it through the eye of a needle. RESORBA’s eyeless needles are made from

12 Surgical needles

Cross-section and point of the needle

1. Spatula needle = P 2. Reverse cutting needle = S 3.Round-bodied cutting needle 1/2-, 3/8- or 1/4-circle or straight = 1/2-, 3/8-half-curved or straight, = RT HSPM, DSPM, VSPM, GSPM 1/2 = HS, DS, KS, GS 1/2-, 3/8-circle, asymptotic or straight For ophthalmic and microsurgery For firm tissue, e.g. skin = HRT, DRT, GRT, ART Flattened needle body Triangular needle cross-section For firm tissue, sclerotic vessels, and PREMIUM-cut Some needles available as prostheses Lateral cutting edge PREMIUM-cut: M, MF, and MFX Needle point with three or four cutting edges, thus producing a narrow puncture canal which penetrates tissue like a cutting needle (some available as PREMIUM-cut)

4. Blunt, round-bodied needle = RN 5. Round-bodied needle = R 1/2-, 3/8-circle or half-curved 5/8-, 1/2-, 3/8-circle or straight = = HRN, DRN, KRN FR, HR, DR, GR For parenchymatous tissue, cervix For soft (subcutaneous) tissue, e.g. and muscles of the eye muscle, fascia, mucosa The middle of the needle is flat for Blunt needle point better seating in the needle-holder Cannot pierce vessels or Conical tapering fine needle tips Easy tissue penetration

13 Surgical needles

Needle code Control release 1. letter: defines the needles needle curvature To save time, e.g. when inserting single- F = 5/8 circle H = 1/2 circle knot sutures for anastomoses of the D = 3/8 circle V = 1/4 circle or layered wound K = half-curved closure, the needle-thread combination A = asymptotic G = straight has been constructed with a removable needle. 2. letter: defines the shape of After the suture has been placed, the the needle body and point needle can be removed from the suture R = round-bodied needle S = cutting needle with a slight pull.

3.+4. letters: define special forms of the needle body and point M = PREMIUM-cut (e.g. hand-cut) N = blunt point T = cutting point P = spatula-needle (PREMIUM) S = larger diameter X = extra large diameter F = finely PREMIUM-cut “THIN LINE“ (in some cases hand cut)

Numbers define the length of the needle when straight (length of needle curvature) in mm S (after number) = larger diameter F (after number)= extra small diameter A (after number) = control release needle H R X 30

14 Sutures

Table of materials

Trade name Raw material Structure Thread diameter,metric Thread USPdiameter, Colour Tensile strength,50%

GLYCOLON® Polyglycolic acid- monofilament 0.7 to 4 6-0 to 1 USP violet, 9 days 50% caprolactone metric metric undyed

PGA resoquickTM Polyglycolic acid, multifilament/ 0.7 to 5 6-0 to 2 USP undyed 7 days 50% coated braided metric

PGA RESORBA® Polyglycolic acid, multifilament/ 0.2 to 7 10-0 to 5 USP violet, 14-21 days 50% coated braided metric undyed

CAPROLON® [Poly(L-lactide-co-ε- monofilament 0.5 to 5 7-0 to 2 USP violet, 45 days 50% caprolactone)] metric undyed

MOPYLEN® Polypropylene monofilament 0.2 to 5 10-0 to 2 USP blue metric

RESOPREN® PVDF monofilament 0.4 to 4 8-0 to 1 USP blue metric

POLYESTER Polyester multifilament/ 0.5 to 9 7-0 to 7 USP green, braided metric white

SUPOLENE Polyester, multifilament/ 0.7 to 9 6-0 to 7 USP green, coated braided metric white

NYLON Polyamid monofilament 0.1 to 5 11-0 to 2 USP white, metric black

RESOLON® Polyamid monofilament 0.5 to 4 7-0 to 1 USP blue metric

SUPRAMID Polyamid pseudo- 0.5 to 9 7-0 to 7 USP white, monofilament metric black

SILK Silk fibroin multifilament/ 0.2 to 8 10-0 to 6 USP white, blue braided metric black

STAINLESS STEEL Stainless steel monofilament, multi- 0.7 to 9 6-0 to 7 USP filament/twisted metric

15 Sutures Fast absorbable suture

GLYCOLON®

The two material components polyglycolic GLYCOLON® is supplied undyed for skin acid and ε-caprolactone are copolymerised sutures or violet (dyed with the physiolo- Properties: in a certain ratio to make GLYCOLON®. gically safe dye D+C No. 2). • good flexibility Metabolization of the suture Colour: undyed or violet • very good passage through within the tissue occurs by the uptake of Chemical name: tissue water, thus reversing the synthesis. [poly(glycolic acid-co-ε-caprolactone)] • optimum tissue compatibility GLYCOLON® loses half of its tensile Thread diameter: USP 6-0 -1 • high tensile strength strength after about 9 days after implan- (0.7-4 metric) • reliable knot security tation. Complete absorption by hydrolysis Types of packaging: - needle-suture-combination is completed after about 6 weeks. - precut length Tissue reaction is minimal because of the Sterilization method: ethylene oxide completely safe intermediary products and the monofilament structure of thread. GLYCOLON® with its smooth surface pro- vides excellent handling properties and very good passage through tissue. Tissue traumatization is minimal and there is no undesirable wick effect due to the mono- filament structure of GLYCOLON®.

16 Fast absorbable suture Sutures

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PGA resoquick TM is a polymer of glycolic for specific reduction of surface friction. acid. The linear, high-molecular glycolic Absorbable suture approximates the tis- Properties acid is synthesised in the presence of a sue during the healing phase and pro- • very supple catalyser to a cyclic ester via an interme- gressively loses its tensile strength and • high tensile strength diary product, glycolide. breaking load. After only seven days • minimal tissue reaction Metabolisation of the PGA suture within PGA resoquick TM has already lost 50% of • smooth passage through the tissue occurs by the uptake of water, its original breaking load. After 14 – 21 tissue thus reversing the synthesis. The mono- days the breaking load is lost completely. • high knot security meric glycolic acid is split enzymatically into CO2 and H2O by the normal meta- Colour: undyed bolism. Suture material containing 10% Chemical name: polyglycolic acid lactide as copolymerisate differs only Thread diameter: USP 6-0 -2 slightly in its physical and physiological (0.7-5 metric) Types of packaging: properties from pure PGA sutures. The - needle-thread combinations fine, precision-braided filaments guaran- - precut lengths tee a very high tensile strength as well as sterilization method: great suppleness. The special resolactone gamma irradiation coating thinly covers the fibre bundles

17 Sutures Medium-term absorbable suture

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PGA RESORBA® is a polymer of glycolic as great suppleness. The special resolac- Colour: violet or undyed acid. The linear, high-molecular glycolic tone coating thinly covers the fibre bund- Chemical name: polyglycolic acid acid is synthesised in the presence of a les for specific reduction of surface friction. Thread diameter: USP 10-0 -5 (0.2-7 metric) catalyser to a cyclic ester via an interme- Absorbable suture material approximates Types of packaging: diary product, glycolide. the tissue during the healing phase and - needle-suture combinations Metabolisation of the PGA suture material progressively loses its tensile strength and - precut lengths within the tissue occurs by the uptake of breaking load. The precision-braided fila- Sterilization method: water, thus reversing the synthesis. The ments of polyglycolic acid that make up ethylene oxide monomeric glycolic acid is split enzyma- PGA RESORBA® ensure standardised and tically into CO2 and H2O by the normal moderately rapid absorption in tissue. metabolism. Suture material containing About 14 days after implantation, but Properties: 10% lactide as copolymerisate differs only depending on the suture thickness, • high tensile strength slightly in its physical and physiological PGA RESORBA® still has at least 50% of • very supple properties from pure PGA sutures. The its original breaking load (= half-life). • minimal tissue reaction fine, precision-braided filaments guaran- Violet PGA RESORBA® is coloured with a • smooth passage through tee a very high tensile strength as well physiologically harmless dye by spin dying. tissue • high knot security

18 Slow absorbable suture Sutures

CAPROLON®

In the manufacture of CAPROLON® its Colour: undyed or violet two components, lactide and Chemical name: Properties: ε-caprolactone, are co-polymerised in a [poly(L-lactide-co-ε-caprolactone)] • very high tensile strength fixed proportion. This creates poly(L- Thread diameter: USP 7-0 -2 (0.5-5 metric) • minimal tissue reaction lactide-co-ε-caprolactone). Because of Types of packaging: • smooth passage its high lactide proportion, CAPROLON® - needle-suture combinations through tissue is classified among the slowly absorbed Sterilization method: • robust and suture materials. ethylene oxide high knot security After implantation the breaking load of CAPROLON® decreases by about half after 8 weeks (half-life). Complete absorption by hydrolysis is completed after about 25 weeks. Tissue reaction is minimal because of the completely safe intermediary pro- ducts and the monofilament structure of the thread. The monofilament is coated with resolac- tone to improve its handling and its pas- sage through tissue. CAPROLON® is supplied undyed for skin sutures or violet (dyed with the physiolo- gically safe dye D+C No.2).

19 Sutures Nonabsorbable suture

MOPYLEN®

MOPYLEN® is a synthetic suture which is Colour: blue manufactured by polymerisation of pro- Chemical name: Properties: pylene. The suture is made from the dyed isotactic polypropylene • permanent high tensile strength granules by dry spinning. Thread diameter: USP 10-0 -2 (0.2-5 metric) • non-aging The suture is hydrophobic, i.e. it absorbs Types of packaging: • hydrophobic practically no water and is chemically - needle-suture combinations • excellent passage inert. Due to its non-thrombogenic pro- Sterilization method: through tissue perties MOPYLEN® is suitable for cardiac ethylene oxide • high knot security and vascular surgery, and for sutures which, as permanent implants, must remain unchanged in the tissues, even in inflammatory or infected wounds. Fur- thermore, MOPYLEN® is an ideal skin suture, especially in plastic surgery and wherever an especially good cosmetic result of the suture is required. The material is coloured with a physiolo- gically safe dye.

20 Nonabsorbable suture Sutures

RESOPREN®

RESOPREN® is a blue monofilament syn- Colour: blue Properties: thetic suture made of polyvinylidene Chemical name: • particularly supple difluoride (PVDF). The suture is made from polyvinylidene difluoride • chemically inert the dyed granules by dry spinning. Thread diameter: USP 8-0 -1 (0.4-4 metric) • extremely non-aging RESOPREN® is chemically inert, hydropho- Type of packaging: • very good passage through bic, and extremely non-aging. - needle-suture combinations tissue Because of its high non-aging quality and Sterilization method: • hydrophobic high knot security, RESOPREN® is parti- ethylene oxide cularly suitable for long-term implantation Information that is applicable to all the Absorbable PGA RESORBA® has proved to in vascular surgery. The material is colou- synthetic sutures described: be especially good for internal sutures, as red with a physiologically safe dye. Due to their elasticity coupled with a relatively for anastomoses, fascia sutures, subcutane- high tensile strength, no synthetic sutures ous tissues and ligatures. Monofilament should be too tightly knotted to ensure low polyamides such as NYLON and RESOLON®, tension within the tissue. Excessively high as well as hydrophobic suture material such tension within the tissue may lead to wound as MOPYLEN® and RESOPREN® are widely healing disturbances, or even necrotic reac- preferred for skin sutures. MOPYLEN® and tions. In view of the elastic stretch and RESOPREN® are especially favoured in vas- smooth surface (especially of monofilament cular surgery because of their antithrombo- sutures), it is recommended that an additional genicity. knot be made to ensure that the knot sits 1 1 Die chirurgische Naht, by Paul Ferdinand very firmly. According to Nockemann it is Nockemann; Thieme Verlag best ”first to place a Surgeon‘s or Friction Knot and then a Square Knot over it for safety”. In principle, synthetic sutures can be used universally for nearly all wounds.

21 Sutures Nonabsorbable suture

POLYESTER

POLYESTER is manufactured by poly- Colour: green, white (no dye) Properties: condensation of ethylene glycol and Chemical name: • high tissue acceptability terephthalic acid. polyethylene terephthalate polyester fibre • high tensile strength The fibres are produced by the dry spin- Thread diameter: USP 7-0 -7 • excellent passage ning method. The stretched, slightly twi- (0.5-9 metric) through tissue sted fibre bundles are then formed into Types of packaging: • high knot security a suture by precision-braiding and tem- - needle-suture combinations pering. The fibre is hydrophobic, i.e. it - in precut lengths does not absorb water. The material is Sterilization method: ethylene oxide or gamma irradiation coloured with a physiologically safe dye.

22 Nonabsorbable suture Sutures

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SUPOLENE, like polyester, is manufactured Colour: green, white (no dye) by polycondensation of ethylene glycol Chemical name: Properties: and terephthalic acid. polyethylene • excellent passage through terephthalate polyester fibre The fibres are produced by the dry spin- tissue, no sawing action Thread diameter: USP 6-0 -7 • very slight tissue reaction ning method. The suture is then precision- (0.7-9 metric) • resistant to endogenous braided, dyed, tempered and the surface Types of packaging: enzymes specially refined by coating the suture. - needle-suture combinations • very even and smooth This surface treatment reduces to a mini- - in precut lengths surface characteristics mum capillarity and the sawing action Sterilization method: ethylene oxide or gamma irradiation • low capillarity during passage through the tissue and the knot rundown. Since SUPOLENE is hydrophobic, i.e. it does not absorb water, is non-ageing and therefore suitable for cardiovascular surgery for securing im- plants and grafts. The material is coloured with a physiologically safe dye.

23 Sutures Nonabsorbable suture

NYLON RESOLON®

NYLON is a monofilament extruded thread Colour: white (no dye), black RESOLON® is initially like NYLON, a mono- (pressed and drawn through dies in a Chemical name: polyamide 6-6.6 filament polyamide thread. However, it malleable condition) made from polyami- Thread diameter: USP 11-0 -2 undergoes special treatment during pro- (0.1-5 metric) de 6-6.6. duction. RESOLON® is exceptionally soft Types of packaging: Because of its high tensile strength, even and supple, even when sterile and dry. - needle-suture combinations when the fibre diameter is very fine, - in precut lengths This gives the monofilament thread ex- NYLON is particularly suitable for very Sterilization method: cellent handling and knotting properties fine suturing in microsurgery. Polyamides ethylene oxide or gamma irradiation with optimum knot security. can bind up to 10% water. The material is coloured with a physiologically safe Colour: blue dye. Chemical name: polyamide 6-6.6 Thread diameter: USP 7-0 -1 (0.5-4 metric) Properties: Types of packaging: • above-average softness - needle-thread combinations and suppleness - in precut lengths • very easy handling and Sterilization method: knotting properties ethylene oxide or gamma irradiation

• no capillarity • excellent passage through tissues • only slight tissue reaction

24 Nonabsorbable suture Sutures

SUPRAMID

SUPRAMID is available as a monofilament, Special feature nonabsorbable, surgical suture material Despite its synthetic origin, due to its Properties: made from a copolymer of polyamide 6 peptide structure SUPRAMID is gradually • very supple and polyamide 6.6. In larger diameters, it degraded after lying in tissue for a while. • good knotting properties is supplied as pseudomonofilament, non- Therefore, with a few exceptions, it is only • minimal tissue reaction absorbable, surgical suture material made suitable for skin sutures. The material is • no capillarity from polyamide 6.6, a polymer of hexa- coloured with a physiologically safe dye. methylenediamine and adipic acid with a coating of polyamide 6, a ε-caprolactam Colour: white (no dye) or black polymer. Chemical name: monofilament: polyamide 6-6.6 pseudomonofilament: polyamide 6.6 and polyamide 6 Thread diameter: USP 7-0 -7 (0.5-9 metric) Types of packaging: - needle-thread combinations - in precut lengths Sterilization method: ethylene oxide or gamma irradiation

25 Sutures Nonabsorbable suture

SILK

The raw material in the production of this Colour: white (without dye), suture is the cocoon of the silkworm. black or blue Properties: These very fine silk threads are degummed Chemical name: • very supple silk fibroin (sericin, a viscous protein, is boiled off), • excellent knotting properties Thread diameter: USP 10-0 -6 spun and precision-braided. The silk thread • low sawing action (0.2-8 metric) • high knot security is impregnated by treating its surface. Types of packaging: This process results in silk made without - thread-needle combinations any undesirable wick effect, i.e. a non- - in precut lengths capillary, hydrophobic thread with a Sterilization method: ethylene oxide or gamma irradiation smooth surface. Black or blue (virgin) silk is coloured with physiologically safe dyes.

26 Nonabsorbable suture Sutures

STAINLESS STEEL

A mineral product, manufactured from Chemical name: stainless steel stainless, non-corroding steel alloy. Very Properties: Thread diameter: USP 6-0 -7 thin steel fibres are drawn from liquid • very low tissue reaction (0.7-9 metric) steel through a suitable die and twisted • high, unchanging Types of packaging: into a multifilament thread to the required tensile strength - needle-thread combinations thicknesses. Stainless steel is also available - in precut lengths • no wick effect as a pure monofilament. Sterilization method: • no stretch ethylene oxide or gamma irradiation

27 Manufacture and packaging

Manufacture of surgical suture Using PGA RESORBA® as an example (multifilament, braided suture made from 100% polyglycolic acid) Raw material must Testing of material comply with All surgical sutures are manufactured standard values All supplied or self-produced raw mate- governing diameter rials and excipients are tested and selected and tested according to the stipulated and knot tensile according to international criteria before legal regulations, which are: strength a. European Pharmacopoeia (Ph. Eur.) use. and the harmonised norms derived Assembly/packing from its monographs. We offer a wide range of product variants b. DIN-ISO standards Multiple suture for different surgical indications. In ad- c. MDD 93/42 EEC packs are made up, dition to special needle-thread combina- The German rules and regulations in part semi- automatically, tions, a multiplicity of customers’ requests governing pharmaceutical companies according to the for specific applications are also met. are based on the basic guidelines (Euro- client’s demands pean or international) of the World He- Sterilization alth Organization (WHO) for the correct The products are sterilized with ethylene production of medicinal products and oxide. quality assurance according to GMP Packing in Drying (Good Manufacturing Practice). The con- moisture-proof tents of these GMP guidelines largely alublisters PGA RESORBA®, made of polyglycolic agree with the European (Ph.Eur.) and acid fibres, reacts with H2O. Drying of the suture after sterilization is an essential the American Pharmacopoeia (USP). step in the manufacturing process to Since 14.6.1998, surgical suture mate- rial is defined solely in terms of the achieve high product safety. quality standards described in the DIN- Final testing ISO or EN standard series, CE marking, Each blister pack is The special characteristic of PGA threads for sale in the entire European market tested for its (breakdown by H2O take-up) requires (European harmonisation), and analo- closeness great care in packaging and packaging gously regulated in Germany by the materials. This is achieved by the almost Medical Devices Act (Medizinprodukte- completely automatic production of bli- gesetz: MPG). ster packs. During the production process the metal foils and their seals are tested to ensure they are intact and tight.

28 Manufacture and packaging

Sterile hand-over in the shortest Peel-eco-pack time Quick and easy handling with approved Sterile conditions and the use of conta- suture primary packet. mination-free sutures are vital prerequi- Less packing material sites for surgical work. This is guaranteed Reduction to two multifunctional wrapping units. for our products by sterilizing them with Environmentally friendly ethylene oxide (EO) gas or gamma irra- Primary packet made of recyclable diation (R), and the safe combination of paper. peelable outer and multifunctional inner Easy handling wrappings. The layered arrangement of the atraumatic needles in the primary packet Multifunctional primary packet makes controlled and safe access This further protects the suture and allows possible. for problem-free and safe removal. Memory effect The enlarged suture primary packet markedly reduces the memory effect when using monofilament suture material. Separate withdrawal The primary packet in pre-cut suture Peelable outer wrapping packs and multipacks makes it possible Can be opened by a non-sterile person to withdraw single sutures. (e.g. a floater in the operating room) by The eco-pack fulfils the provisions of DIN peeling it off so that the inner sterile 58953, part 8 / Sterile supplies. contents can be safely passed on, assuring contamination-free transfer.

29 Manufacture and packaging

Peel-eco-pack A combination of peelable outer wrapping and multifunctional primary packet 2. The floater grasps the two opening flaps at the upper end of the pack and opens it by evenly peeling the flaps apart.

1. The peel-pack is removed from the 3. The sterile contents are handed over storage box. without contamination.

Single pack/needle-thread combination Multipack Pre-cut sutures Precut single sterile sutures with an atta- Several combinations in each sterile pri- One or more threads in each sterile pri- ched surgical needle. The needle is exposed mary packet. This type of packaging sim- mary packet. The suture is meant for by turning over the perforated flap. It is plifies the organisation of handing over ligatures or for use with eyed needles. then removed with a needle-holder. the same thread combinations during After the upper flap has been opened, the standardised procedures. The needles are individual threads can be withdrawn in exposed by opening the side of the paper any desired order. cover, after which the individual needles (one after the other) are taken out with the needle-holder.

30 Manufacture and packaging

Micro-pack Primary packet with foam for micro- and ophthalmic surgery

1. Peel open the non-sterile outer 2. Peel open the inner sachet. 3. Carefully remove the sterile primary sachet and, without contamination, packet from the blister sachet. pass over the sterile inner sachet.

4. Before taking the needle out first 5. With double swaged sutures first ease 6. Grasp the needle with the needle- remove the fixed thread from the out or cut off the loop, then separate holder and remove from the primary primary packet with forceps. the thread from the primary packet packet by turning it slightly. with forceps. 7. During the operation the needle can be ”parked” in the sterile primary packet. After the operation the primary packet is used for depositing and che- cking the used needles.

31 Manufacture and packaging

Types of packaging

Multi-L-Pack Dispenser packaging Ligature pack Special combinations in the Multi-L-Pack Suture material can be removed asepti- Suture material of up to 4 m in length are available to avoid the memory effect. cally from the dispenser. Suture material can be taken from a hand reel during an This ensures problem-free and quick rem- in so-called suture dispensers is predomi- operation. oval. nantly used in veterinary . The packaging is safe and economical.

32 Organisational aids

Special combinations Should you require a combination which you cannot find in our product range we will provide it without extra charge ac- cording to your individual needs, if tech- nically possible. Please note the longer delivery period and a minimum order of Set pack Suture-Box 15 dozen suture material blisters (non- Individualised sets can be made up with Stacked boxes for storing standard suture returnable). different suture materials for specific material packages, for clearly organised indications according to the client’s spe- arrangement in the operating room (can cifications for materials, quantity and be stacked vertically and/or horizontally). order of use: Minimum number: 72 sets Printed with all relevant information (indication, contents etc.) Only one LOT number for the whole set

33 Organisational aids

New symbols used on the packaging absorbable suture material dyed / braided / coated / absorbable PGA RESORBA® dyed / monofilament/ coated / absorbable CAPROLON®

dyed / monofilament / absorbable GLYCOLON®

undyed / braided / coated / absorbable PGA RESORBA®, PGA resoquick TM undyed / monofilament/ coated / absorbable CAPROLON®

undyed / monofilament / absorbable GLYCOLON®

nonabsorbable suture material dyed / braided / coated / nonabsorbable SUPOLENE

dyed / braided / nonabsorbable POLYESTER, SILK

dyed / twisted / coated / nonabsorbable SUPRAMID

dyed / twisted / nonabsorbable SILK

dyed / monofilament / nonabsorbable MOPYLEN®, RESOPREN®, NYLON, RESOLON®

undyed / braided / coated / nonabsorbable SUPOLENE

undyed / braided / nonabsorbable POLYESTER, SILK

undyed / twisted / coated / nonabsorbable SUPRAMID, STAINLESS STEEL

undyed / twisted / nonabsorbable STAINLESS STEEL

undyed / monofilament / nonabsorbable NYLON, STAINLESS STEEL 34 Organisational aids

Explanation of symbols used for the chemical composition of synthetic sutures

PGA-PCL GLYCOLON® Poly(glycolide-co-caprolactone)

PGA PGA resoquick TM Polyglycolic acid

PGA PGA RESORBA® Polyglycolic acid

P(LA/CL) CAPROLON® Poly(lactide-caprolactone)

PP MOPYLEN® Polypropylene

PVDF RESOPREN® Polyvinylidene difluoride

PET POLYESTER Polyester

PET SUPOLENE Polyester

PA NYLON Polyamid

PA RESOLON® Polyamid

PA SUPRAMID Polyamid Explanation of symbols

control release needle loop suture

Resoclip ligature pack

loop pledgets

35 Organisational aids

Did you know? How to hold the A short lesson in symbols used for medical products needle = Reference number

LOT = Batch number = Use by year / month = Consult instructions for use = Do not reuse The needle must be held in the needle- = Do not resterilize holder at approx. 3/4 of the length of the = Do not use if package is damaged needle from its point. Do not hold it in STERILE EO = Sterilized using ethylene oxide the swaging zone to avoid damage to the STERILE R = Sterilized using irradiation suture or the needle. = Upper Limit of Temperature = CE mark and identification Number of the Notified Body. Product conforms to the essential requirements of the Medical Device Directive 93/42 ECC. = HIBC-Code

Stretching the thread

The thread must be stretched gently after it has been removed from the primary packet. Do not pull or rub it abruptly. Do not grasp the needle and stretch the thread!

36

The RESORBA company was founded in September 1931 as a ”Fabrik medizinischer Präparate” (a manufacturer of medical devices) . Since then both the company and its products have undergone continual development. Our company’s main office on the outskirts of Nuremberg has provided the basis and capacity for us to continue to fulfil future demands in medicine competently and with a high level of quality.

RESORBA Wundversorgung GmbH & Co. KG Am Flachmoor 16 90475 Nürnberg Germany

Tel. +49 9128 / 91 15 0 Fax +49 9128 / 91 15 91 [email protected] www.resorba.com 2011-02 · P1011 REPAIR AND REGENERATE