MED EUROPE EUROPEAN MEDICAL SUPPLIES s.r.l. Special Dental Sutures

Transcription

1 Special Dental Sutures January 2017

2 Suture definition Sutures (lat. Suture, sewing, seam, to sew). The re-unitingof the margins of a traumatic or surgical wound. Sutures are placed in order to re-unite the two edges of a wound, to maintain in contact fragments of fractured bone or the extremities of a tendon or cut nerve, to smoothly re-attach the wall of a hollow organ such as the intestines, to unite between themselves parts of certain organs (stomach, intestines, bladder, blood vessels). With sutures the surgeon does not actually repair tissue, but re-positions the edges, placing them in tight enough and prolonged enough contact that the organism can perform this repair with little difficulty, and obtaining a good and rapid healing. Sutures are performed with threads of various sizes and of different substances: catgut, linen, silk, nylon, polyester, steel, silver, VITALLIO. The suture thread passes through the tissue with the help of a suture needle, on which the threads have been mounted, and are manoeuvred manually or with special needle holder forceps. With regard to the type of stitch methods employed, these can be separated (straight, U-shaped, X-shaped, etc.), continuous, tobacco purse type, over-stitch, fur-maker, loosenable, interflecting, extraflecting, etc. Methods The traditional method in use some decades ago used needles with eyes (Fig. 1) on which suture threads were mounted during the operation upon request by the surgeon. Both the needles with eyes (re-usable) and the suture threads (in skeins or bobbins) required laborious and preventive preparations on the part of the operating room personnel, as for example: cleaning and possibly sharpening of the needles, the arranging of the different types of needles and the winding of the suture threads in specially separated gauzes with sterilisation of both. The above described preparative procedure had to be performed for each single operation and the mounting of the thread on the needle was performed by the instrument nurse each time the surgeon requested it. Fig. 1

3 Besides the laborious preparation the traditional method made the passage of the suture through the tissues quite traumatic. The trauma of passage through the tissues was due to the cross position of the thread (doubled) which was created by the eye of the needle (Fig. 2). Fig. 2 (needle with eyes and mounted thread showing the effect of passage through the tissues) Modern surgical sutures have for the last decades utilised atraumatic needles (without eyes). These needles have a hole (or canal) situated at the needle bottom to allow the insertion and anchorage of the suture thread. Atraumatic needles, with respect to the traditional types of the past, are characterised by a considerable list of advantages and characteristics as follows: calibre continuity between needle and thread to minimise trauma to tissues on-the-spot choice by the surgeon of the needle-thread combination needle always new and sharp to permit safe penetration into tissue always sterile and ready for quick use in double sterile packaging, always identifiable in the sterile field economical in comparison to traditional methods of preparation as described above easy needle recovery (anchored to suture thread) in the event it is inadvertently dropped into the surgical field no loss of time to clean, sharpen and re-sterilise needles as once occurred

4 Characteristics of surgical needles Atraumatic needles act as a guide for the passage of the suture through the tissues and must possess the following characteristics: Guide the suture through the tissues with minimum trauma Be sufficiently sharp to pass through the tissues with minimum effort Be sufficiently rigid to prevent bending Be sufficiently pliable to bend before breaking Be sterile Be resistant to corrosion in order to prevent introduction of micro-organisms and foreign bodies into the wound Needle types and curvatures and their principal field of application STRAIGHT Gastrointestinal tract, tendons, nerves, skin 1/4 CIRCLE Ophthalmic and micro-surgery 3/8 CIRCLE Biliary tracts, nerves, dura, fascia, peritoneum, eye, orthodontics 1/2 CIRCLE Gastrointestinal tract, tendons, pleura, micardium, vessels, uro-genital tract, orthodontics 5/8 CIRCLE Uro-genital tract, orthodontics, pelvis

5 Types of needle tips and bodies and their principal field of application Internal cutting Skin External or back cutting Skin, fascia, ligaments, orthodontics Spatula Ophthalmology Precision point spatula Ophthalmology Long cutting edge only tip cutting Heart, vessels, orthodontics Taper cutting - only tip cutting Heart, vessels, orthodontics Cylindrical Intestinal, vessels, orthodontics Blunt tip Parenchymatous tissue kidney, liver, spleen) Blunt dissection through friable tissue

6 Characteristics of suture thread The following table shows a practical scheme for various types of the most common suture threads: Group Material origin Type of material Colour Simple catgut Yellow, ochre Animal ABSORBABLE S (temporary) Synthetic Chromic catgut polyglactyn 910 polydiassanone polyglecaprone 25 Lactic acid glycolic acyd, etc. (braided or o monofilament) Brown Violet, white, other Animal Silk (braided) Black, white Vegetable Linen, cotton (twisted) Black, white NON- ABSORBABLE S (permanent) Nylon Green, blue, white, black Synthetic Polyester Green, white Polypropilen Green, blue, white Mineral Steel (monofilament or twisted) Silver Tantalum (vitalium) Silver Silver Silver The suture material, independently of its characteristics, is nevertheless a foreign body for the human body in which it is implanted and is always attacked by the defence mechanisms of the organism. With regard to suture material classified as ABSORBABLE, the attack and subsequent removal of the foreign body takes place via an enzymatic procedure (the enzymes present in the tissues break down and digest the foreign body) or a hydrolytic procedure (the foreign body is broken down into base elements which are dissolved in organic liquids and then eliminated through the urinary and respiratory system). With regard to suture material classified as NON-ABSORBABLE, although these are attacked by the organism in the same way, they are immune to the enzymatic or hydrolytic breakdown process and generally remain buried or encapsulated in that part of the tissue where they were implanted. For this reason, absorbable sutures are considered temporary, while non-absorbable kinds are considered permanent.

7 Suture materials differentiate through a series of other particular and fundamental characteristics, which, with regard to the dental sutures manufactured by MED EUROPE that will appear ahead in the catalogue, are shown below: +++ = positive result --- = negative result CHARACTERISTICS SILK POLYESTER NYLON POLYPROPILENE Tensile resistance Ease of use by the surgeon Tolerance in tissues Smoothness during application and during eventual removal Knot resistance Besides physical and biological characteristics, surgical sutures differentiate according to calibre (diameter) and thread length. With regard to calibre, sutures are defined according to the metric decimal E.P. system (European Pharmacopea). For non-absorbable sutures found in the MED EUROPE catalogue and synthetic absorbable sutures (not manufactured by Med-Europe), the following table shows the comparison between the E.P. (European pharmacopea) and U.S.P. (United States Pharmacopea) systems: E.P. CALIBRES 0,5 0,7 1 1, , U.S.P. CALIBRES For every calibre (diameter) the standards indicate tolerances for the thread, as they also indicate breakage values for every type of suture material. With regard to the length of the thread and needle assembly, this is generally 75 or 45 cms. For determined types of sutures the length may also be 30 or 90 cms. The choice by the surgeon regarding the type of suture thread to use each time takes into account a series of factors: experience and habits, knowledge of the characteristics concerning the cure of the various tissues, knowledge of the physical and biological characteristics of the various suture materials. Notwithstanding the technological progress that has determined the evolution of the suture materials in many centuries of history, the diversity of the fields and methods of application, and the limits of this same technology, the development and unconditional use of one unique suture type has not been possible to date, which would be characterised by: minimum tissue reaction, maximum tensile strength, maximum slide, extreme manoeuvrability, knot strength and minimum knot mass, uniformity, repeatability and result forecast continuity, absorption of the implant mass.

8 Knotting Of the 1400 suture knots described in the Encyclopaedia of knots, only some are used in modern medicine. It is however of enormous importance that each knot placed with a suture is perfect and holds the right tension. The knot that a surgeon might prefer to insure the suture varies according to the material used, the positioning and the reason for use. The knots must be closed with a technique appropriate for the tissue to be sutured or tied and must be made tight enough to be closed sufficiently without the knot coming undone. Generally, synthetic sutures are better with regard to slide and can therefore require a different number of turns to obtain knot safety compared to natural fibres. Avoid crushing or bending the thread during application with surgical instruments like needle forceps and scissors, except when the free extremity of the suture is crushed during closure of the instrument when creating the knot with the help of the needle forceps. Some types of knots Some examples of complex or multiple knots Simple knot, known as semi-knot or semi-key Cow knot Square or flat knot Surgical knot also known as inertia or sailor s knot

9 Assembly of needle-thread As noted, atraumatic needles can be assembled using two different techniques defined as CHANNEL and DRILLED. The CHANNEL type is characterised by a longitudinal opening at the base of the needle which forms a type of canal in which the suture thread (previously treated) is placed, and which will subsequently be attached to the needle by the closure of the sides of the canal by a special automatic press. This type of assembly is interesting for manufacturers, as it accelerates by two to three times the production time when compared to the drilled method. The only great defect in this channel system assembly method is the step-like difference in diameter between the point of connection between the needle and the thread, and consequently the increased trauma inflicted with respect to the drilled type. Terminal end of a traditional CHANNEL type needle The DRILLED type is more sophisticated, as it is intended to offer the maximum proportion possible between the needle/thread suture dimensions at their connection point. To be able to take advantage of the maximum space available on the inside of the terminal cylinder of the steel needle, it is drilled from the center out, to the predetermined width and depth each time. This method is more costly both for the producer of the needles for the production equipment required and for the manufacturer of the finished sutures due to the assembly time between needle and thread that is required (two or three times longer than required for channel type needles). Terminal end of a MED EUROPE DRILLED type needle Further precision can be obtained when hollowing out the internal terminal end of the steel needle by using computer guided laser drilling technique. NEEDLE FOR MONOFILAMENT THREADS NEEDLE FOR MULTIFILAMENT THREADS

10 Quality MED EUROPE sutures were developed to offer plastic surgeons a synthesis of essential quality to obtain the best results possible for today's technology. The high quality of these products are the result of a scrupulous selection of components and applied methods that are described briefly in the following sections.

11 Needles Our needles are made in the USA, of a special quality steel that guarantees a perfect mirror-like surface. The points of these needles are produced under the control of a computer that automatically verifies and rejects any needle with imperfections. MED EUROPE needles are characterized by extremely high penetration capabilities and exceptional slide within the tissue. All MED EUROPE needles are the DRILLED type. For this reason, the surgeon will always be certain that trauma will be reduced to the minimum. The connection between the needle and the suture is checked under a microscope and then undergoes a special "anti-detachment" test, which is performed on 100% of all production, rather than by sample as is normal industrial practice. MED EUROPE s production is extremely flexible and available for the production of particular sutures not found in this catalogue, and even for small quantities. MED EUROPE Needles Points LONG CUTTING EDGE REVERSE CUTTING TAPER POINT

12 Sutures specific for odontological use MED EUROPE sutures are the result of years of research performed in the most advanced international markets. The result is a selection of sutures that guarantee the requirements of inertia, slide ability, noncapillarity, elasticity, caliber uniformity and easy knotting properties which, depending on the type of suture chosen for each operative phase, offer solutions for the most demanding orthodontist surgeons during their most delicate operations. A further indication of the high specificity of MED EUROPE dental sutures line is the 60 cm. length of the suture thread, which is ideal for the orthodontic sector. The various types and relative characteristics of MED EUROPE sutures are briefly illustrated as follows. 45 cms. = short 60 cms. = MED EUROPE sutures 70 cms. = long MED SILK Non capillary to avoid diffusion of any eventual infection Well sliding while allowing an easy pull on the suture stitch. The non-capillarity of braided, coated silk is obtained via a special silicone coating which allows both the blockage of any infected serum transfers as well as an absolute easy sliding and softness of the silk suture when it is in contact with blood. As is noted, silicone is hydrorepellant and therefore slides on liquids. For this reason, both easy sliding and softness of both silk and all other multifilament sutures must not be evaluated dry, but exclusively when wet. This because it is impossible that the suture does not become saturated in blood during use. The amount of silicone coating applied on this special silk has been calculated to obtain maximum slide ability and softness of the thread, while maintaining a slight elasticity and consequently an easy knotting capability; a requirement which every demanding orthodontic surgeon cannot do without.

13 Nylon MED LON Standard nylon suture material has always been easy to remove but too difficult to knot and too tough for the patient to bear. The special MED LON used by MED EUROPE has instead been chosen for its particular softness and elasticity; characteristics which are similar to polypropilene for cardiac surgery. The resulting advantages are: Easy to remove Easier to knot Easier for the patient to bear (less tough ) Less sharp on tissue In synthesis, MED LON fulfills the necessities of the most demanding and advanced dentist. MED LON is also very adapt to use as an interdermal suture during maxillo -facial surgery. Braided Polyester MED BOND MED BOND braided polyester (Polyethylene Terephthalate) is a prestabilised thread. The latest technological developments have allowed the manufacture of a thread which is much more regular and consistent, due to an increase in the number and density of filaments per meter. This thread is treated with colorant D&C Green n.6, which conforms to FDA (USA) requirements and Official European Pharmacopea. This suture is treated with silicone.

14 MED EUROPE labelling and packaging Some examples of MED EUROPE suture labels. Each label includes all the necessary information for the identification of both the thread and the needle. MED EUROPE MED-SILK braided black silk seta intrecciata nera 3-0 (2 m.) 60 cm C-9 Via Gramsci, San Pietro in Casale (BO) - Italy REF S-642 LOT B STERILE R MED EUROPE MED-LON NYLON blue monofilament monofilamento blu 4-0 (1.5 m.) cm T-14 Via Gramsci, San Pietro in Casale (BO) - Italy REF N-444 LOT B STERILE R MED EUROPE MED-BOND POLIESTERE green braided intrecciato verde 0476 D-16 Via Gramsci, San Pietro in Casale (BO) - Italy REF P-923 LOT B STERILE R Example of box of 24 sutures

15 Double sterile packaging which is singularly heat sealed to guarantee better antiseptic quality Sterilisation by gamma rays Uniform thread caliber for complete non-traumatic effect Figure 8 packaging which allows maximum maneuverability

16 Sutures Catalog

17 MED SILK MED SILK black braided sutures undergo a special treatment to render them compact and easy-sliding. Their uniform caliber and non-capillarity are continously verified by MED EUROPE to satisfy requirements of qualitative standards. Traction and knot resistances conform to all international standards. Easy maneuverability and knotting ability are the major characteristics of this traditional and highly used type of suture. 24 S BOX REVERSE LENGTH OF U.S.P. CUTTING COLOR Metric C-22 3/8 O 16.2 mm. 60 cm. black S-650 S-651 C-6 3/8 O 18.7 mm. 60 cm. black S-683 S-684 C-7 3/8 O 24.3 mm. 60 cm. black S-694 C-8 3/8 O 26 mm. 60 cm. black S-674 S-675 C mm. 60 cm. black S-631 S-632 C-9 23 mm. 60 cm. black S-642 S-643

18 TAPER POINT LENGTH OF COLOR U.S.P Metric T-12 3/8 O 12.3 mm. 60 cm. black S-891 T-13 3/8 O 18 mm. 60 cm. black S-881 S-882 T mm. 60 cm. black S-870 S-871 S-872 T mm. 60 cm. black S-861 S-862 T 26 mm. 60 cm. black S-832 S-833 T-56 5/8 O 22.2 mm. 60 cm. black S-563 T-29 5/8 O 26.5 mm. 60 cm. black S-294 S-293

19 LONG CUTTING LENGTH OF U.S.P. EDGE COLOR Metric DE-13 3/8 O 12.3 mm. 60 cm. black S-970 S-971 DE-10 3/8 O 18.7 mm. 60 cm. black S-941 S-942 D mm. 60 cm. black S-951 S-952 S-953 D mm. 60 cm. black S-981 S-982 D mm. 60 cm. black S-963 S-964

20 Nylon MED LON MED LON blue nylon monofilament sutures are particularly resistant, well-sliding, soft and uniform. MED LON is therefore particularly indicated for orthodontic surgery. 24 S BOX REVERSE LENGTH OF U.S.P. CUTTING COLOR Metric C-6 3/8 O 18.7 mm. 60 cm. blue N-661 N-662 N-663 LONG CUTTING LENGTH OF U.S.P. EDGE COLOR Metric D-13 3/8 O 12.3 mm. 60 cm. blue N-930 N-931 D mm. 60 cm. blue N-990 N-991 N-992

21 TAPER POINT LENGTH OF COLOR U.S.P Metric T mm. 60 cm. blue N-214 N-215 T mm. 60 cm. blue N-444 N-445 T-56 5/8 O 22.2 mm. 60 cm. blue N-563 T-29 5/8 O 26.5 mm. 60 cm. blue N-294 N-293

22 Poliestere MED BOND intrecciato Braided MED Polyester BOND The latest technological developments have allowed the La sutura di Poliestere intrecciato MED manufacture BOND of a thread which is much more regular and è un filo pre-stabilizzato. consistent, due to an increase in the number and density Gli of filaments ultimi sviluppi per meter. tecnologici hanno consentito la realizzazione di un filo molto più regolare e consistente, in quanto This thread is treated with colorant D&C Green n.6, which è stato aumentato il numero e la densità dei filamenti per conforms to FDA (USA) requirements and Official metro. European Pharmacopea. Il filo è trattato con il colorante D&C Green (verde) n.6, che This suture is treated with silicone. lo rende conforme a quanto richisto da FDA (USA) e dalla Farmacopea Ufficiale Europea. La sutura è trattata al silicone. 24 S BOX REVERSE CUTTING LENGTH OF COLOR U.S.P Metric C-22 3/8 O 16.2 mm. C-6 3/8 O 18.7 mm. C mm. 60 cm. green P-670 P cm. green P-662 P cm. green P-631 LONG CUTTING EDGE LENGTH OF COLOR U.S.P Metric D mm. D mm. 60 cm. green P-951 P cm. green P-922 P-923

23 TAPER POINT LENGTH OF COLOR U.S.P Metric T mm. 60 cm. green P-870 P-871 P-872 T mm. 60 cm. green P-891 P-892 T-56 5/8 O 22.2 mm. 60 cm. green P-563 T 26 mm. 60 cm. green P-833 T-29 5/8 O 26.5 mm. 60 cm. green P-293

24 Via Gramsci, San Pietro in Casale (BO) ITALY Tel.: (0039) Fax: (0039) info@medeurope.eu