Surgical threads / Sutures for medical

applications
 Surgical threads/sutures for medical
applications
• Sutures are used for sewing/suturing together
the edges and surfaces of tissue, for stopping
blood flow, to facilitate wound healing, to
reduce the dead space between the tissue
surfaces within a wound, and to give stability.
• Sutures are either interrupted (each stitch tied
separately) or continuous (the thread running in
a series of stitches, only the first and last of
which are tied)
 Surgical threads/sutures for medical
applications
• In USA, suture manufacturing processes come
under the regulatory control of the Food and Drug
Administration (FDA), under the classification of
‘medical devices’.
• Sutures are subject to strict quality control;
guidelines for quality control are laid down by
independent organizations such as
• The United States Pharmacopoeia (USP) or
• British Pharmacopoeia (a compendium officially
recognized by the FDA).
• Manufacturers must comply with specific Good
Manufacturing Practices (GMP), and ensure that
their products are safe and effective.
 Characteristics of Ideal Sutures
• Smoothness – the suture should cause
minimum tissue drag and no damage to the
delicate, newly healing tissue during removal.
• Low capillarity – an ideal suture should not have
a wicking effect.
• Maximum tensile strength.
• Handling of the suture should be as easy as
possible – minimum memory and excellent knot
security of the suture are crucial for optimum
tissue sealing.
 Characteristics of Ideal Sutures
• consistent and predictable performance
• cost effectiveness.
• resist bacterial infection.
• suture should cause minimal tissue injury or
tissue reaction (i.e., be non-electrolytic, non-
capillary, non-allergenic and non-
carcinogenic).
 Sutures classification
• Based on their composition and origin:
✓Based on natural polymers derived from animals
or plants.
✓Based on synthetic polymers similar to the
processes used in synthetic fibre production
(melt, dry, wet spinning).
 Sutures classification
• Based on their configuration
✓Monofilament
✓Multifilament (twisted or braided).
• Based on their absorption ability
✓Absorbable/biodegradable
✓Non-absorbable/non-biodegradable
 Adsorable & Non-adsorable
• Measurement of in vivo degradation of
sutures:
• sutures that undergo rapid degradation in
tissues, losing their tensile strength within 60
days, are ‘absorbable sutures’;
• those that maintain their tensile strength for
longer than 60 days are ‘non-absorbable
sutures.
 Absorbable sutures
• An absorbable suture decomposes in the body
relatively quickly (within days) compared to
non-biodegradable sutures, degrading as the
wound or incision heals.
• These types of sutures are generally used
internally or on parts of the body that heal
quickly.
 Synthetic Absorbable sutures
• Development of synthetic degradable sutures
was a major step forward from catgut, as
evidenced by the enhanced success of clinical
outcomes.
 Non-absorbable sutures
• Non-absorbable sutures do not break down and
must eventually be removed by a surgeon after a
surface incision has healed.
 Nylon Non-absorbable sutures
• Monofilament, multifilament, braided forms.
• More pliable than polypropylene, so easier to
handle, hence, favoured for construction of
interrupted suture closures.
• Main disadvantage of nylon suture is that knot
untying can cause cutting in tissues, so a triple
knot must be tied.
 Polypropylene Non-absorbable
sutures
• Inherently smooth, so easy to tie & remove.
• Encounter lower drag forces in tissue than
nylon sutures, accounting for their frequent use
in continuous dermal and percutaneous (needle
puncturing not open approach like scalp) suture
closure.
• Low coefficient of friction facilitates knot
rundown, and suture passage through the
tissue results in low knot security (knots have a
tendency to slip).
 Polypropylene Non-absorbable
sutures
• Polypropylene sutures are extremely inert in
tissue.
• Polypropylene sutures are widely used in
plastic, cardiovascular, general and orthopaedic
surgery.
 Characteristics of Different type of
sutures
• A monofilament passes smoothly through
tissue and thus causes low tissue drag but may
encounter slippage in knot tying.
• Braided or twisted sutures can have higher
tissue drag (and are usually coated in order to
reduce this) but are easier to knot and have
greater knot strength.
 Size/Gauge System
• Sutures are sized according to a system developed by
the USP and are numbered on two scales depending on
whether the suture is large or small:
✓ A whole number system for larger sutures, from 5
(largest) to 0 (smallest). Size 0 has a diameter around
0.30–0.39 mm. Size 5 has a diameter of 1.00–1.09
mm.
✓ A composite number system for sutures smaller than
0, from 1/0 (largest) to 11/0 (smallest). These are
‘aught’ sizes; e.g., 11/0 is pronounced as 11-aught. Size
8/0 has a diameter of 0.05–0.069 mm.
 Size/Gauge System
• Larger sutures (2 and up) are used for jobs like
abdominal repair, 2/0 to 5/0 are used for stitching on
skin, while smaller sutures (5/0 to 11/0) are used for
repairing fine blood vessels, microsurgery and stitches
on the eyelid and eyebrow.
• The smallest possible sutures should be used to
minimize scarring.
• Another important factor is that the incidence of
inflammatory reactions can depend on the surface
area of the suture in contact with the tissue.
 Size/Gauge System
• The guiding principle is always that the
smallest gauge capable of supporting the
wound should be used.
• A larger sized suture than needed does not
provide any better wound support but can
increase the potential for problems related to
inflammation
 Manufacturing process
• Consists of three stages:
(i)production of sutures
(ii) production of needles
(iii) finishing process that attaches needles to the
sutures, packages, and sterilizes.
• The manufacture of sutures for surgical use is not
very different from the production of typical
synthetic filaments.
• It involves extrusion of the polymer filament, then
drawing/stretching and heat-setting resulting in
either a monofilament or a multifilament, which is
then braided or twisted.
Manufacturing process
 Manufacturing process
• The braided or twisted structures are stretched by up to 20%,
passed over a hot plate to iron out any imperfections present, and
then hot annealed (for a few minutes to several hours) under taut
conditions, depending on the type of suture being made.
 Manufacturing process
Annealing or relaxation dramatically influence the
surface characteristics of suture without altering
its strength.
• Changes in surface characteristics facilitate
better knot construction.
• After annealing, the suture may be coated.
• Coating materials vary depending on what the
suture is made from.
 Manufacturing process : Suture
Quality
• Sutures are tested for their length, strength,
defects and dissolvability in animals or in test
tubes (for absorbable sutures).
• Then passed on to next process ‘swaging’,
consists of
• Cutting the sutures into standard lengths
• Mechanically inserting the cut lengths into the
holes of needles.
 Manufacturing process : Polyester
Sutures
• They have satisfactory tensile strength, minimal
tissue reaction, maximal visibility, and non-
absorbent and non-fraying qualities.
• Had high friction.
• Polyester sutures are coated lubricant-silicone,
polybutylene adipate or Teflon, sutures gained
wide acceptance in surgery.
 Manufacturing process : ePTFE Sutures
• Expanded polytetrafluoroethylene (ePTFE)
suture is porous with 50% porosity.
• Porous suture allows tissue in growth into the
suture.
✓ePTFE is over 100 times more supple than any
other monofilament suture
✓Elongation that occurs when a suture is
subjected to constant load for an extended
period) encountered in an ePTFE suture is
significantly less than that of a polypropylene
suture.
 Manufacturing process : ePTFE
Sutures
• Breaking strength of an unknotted and a
knotted ePTFE suture is significantly less than
that of a polypropylene suture.
• For a polypropylene suture, three throws are
required to form secure square knots; an ePTFE
suture requires seven throws to form the same
knot
 Manufacturing process : Suture &
Needle
• Sutures, already attached to a needle, are packed
into foil packs and sterilized to kill all microbes.
• Traditional methods of sterilization include dry
heat or moist heat sterilization, exposure to
ethylene oxide in a fixed chamber, radiation
(gamma and electron beam), liquid chemical
sterilants for sterilizing single-use devices,
exposure to ultraviolet light, and combined
vapour and gas plasma
 Characterization
• Handling characteristics which determine the
mechanical behaviour of the suture before, during and
after wound closure.
• Biological characteristics which define the biological
response in a patient’s body after implantation.
• Biocompatibility includes issues such as inflammatory
reaction, propensity towards infection, carcinogenicity,
allergy etc.
• A suture is a foreign material to the body; the tissues
surrounding the suture can be affected by it and they
can affect the properties of the suture itself
 Physical characteristics
• Knot-pull strength is measured in kilograms.
• Simple knot is made around a rubber tube of
standard dimension, and tensile stress is
applied to the knot’s end until it breaks.
• Needle attachment force is defined as the force
required to separate a needle from a suture.
Physical characteristics : Knot Security
• One very important physical property, knot
security, is one of the main parameters that
govern final knot performance.
• A secured knot is defined as one that, when
tested to failure, breaks rather than unties by
slippage, and this indicates how well the knot
will stay in position.
Physical characteristics : Knot Security
• Knot security is dependent on two parameters:
• knot tie-down, which defines how easily a
surgeon can slide the knot down to the wound
edge, and tissue drag, which describes how
easy it is to pull a suture both during wound
closure and its removal after the wound is
healed.
• A suture with low knot security may easily
untie, causing wound reopening (dehiscence).
 Factors Affecting Knot Security
• Knot security depends upon the chemical
composition of the suture, knotting
techniques, the friction coefficient,
compressibility, stiffness, etc.
• Generally, uncoated sutures have higher knot
security than coated ones.
 Physical characteristics : Memory
• Memory depends on the elastic–plastic properties
of the suture material; this is crucially important in
governing a suture’s tendency or ability to return to
its previous shape.
• Sutures with high memory (e.g. nylon) tend to
untie, hence their knot security is quite low; sutures
with low memory (e.g. silk) have fewer tendencies
to untie.
• High memory sutures can even have packaging
memory, which is the tendency of a suture to regain
the spiral form it had inside its packaging.
 Physical characteristics : Capillarity
• Another important physical property,
capillarity, is affected by the configuration of
the suture (i.e. whether it is a monofilament
or multifilament).
• Capillarity is the action by which pores in a
solid transport liquid on contact, so that tissue
fluids transfer from the wet end of the suture
to the dry end.
 Physical characteristics : Capillarity
• Smooth monofilaments exhibit very little
capillarity on their surface pores.
• Braided and twisted sutures have many
interstices and, if they are made of natural
fibres, provide high fluid absorption, i.e. they
can transport fluids or microorganisms found
in tissue.
• Thus, the possibility of the growth of bacteria
is enhanced with a higher capillary suture.
 Handling characteristics
• Handling characteristics define the behaviour of a suture before
and after the knot has been tied.
• Handling properties include pliability, flexibility, smoothness,
packaging memory, knot tie-down, knot slippage/security and
tissue drag.
• The knottability of a suture is defined as the ability of the suture
to be tied with relative ease by surgeons, and the diffi culty of
unknoting it.
Handling characteristics : Knottability
• Knottability of a suture cannot be evaluated by any
single parameter as it encompasses a constellation
of handling characteristics, such as pliability or
flexibility (the ease with which a suture can be
bent), smoothness, the coefficient of friction,
memory and knot security.
• In a continuous suturing technique with small
loops, a stiff suture would act like a spring due to
its tendency to relax from small loops and, as a
result, would eventually pull the wound edges
apart rather than closing them.
• Flexible sutures are thus generally preferred
Improper Selection of Suture
 Handling characteristics : Memory
• Sutures are packed after inserting them into a needle.
• They develop kinks due to prolonged stay in the pack.
• The ability of the sutures to retain these kinks (‘memory’)
hinders the surgeon’s ability during wound closure,
particularly when tying the knot, as the knot tends to untie.
• Sutures should have low memory.
• Thermoplastic fibre sutures such as nylon ,polyester and
polypropylene have very high memory (except for ePTFE
sutures).
• Monofilaments have higher memory than braided ones,
since the frictional forces between the constituents of the
braid bind them upon straightening the suture after
unpacking .
Low Knot security of Nylon
 Handling characteristics
• Braided sutures generally have higher
flexibility and lower memory and handle more
easily than monofilaments of the same size.
Biological characteristics : Neutral
• Should not cause toxicity in the body.
• Should not be carcinogenic, should not have
adverse local or systemic effects.
 Biological characteristics
• Inflammation can occur, depending on the
chemical ingredients of the suture material and
its physical configuration.
• To approve a new absorbable suture, the FDA
needs the documentation of the biodegradation
or resorption profile of the final sterilized suture
in vivo or in vitro, as a function of the residual
tensile strength of the suture for a clinically
significant period of time
 Biological characteristics : Infection
• Propensity of infection due to configuration of
the suture.
• Act act of piercing skin during suturing opens
up avenues for opportunistic bacteria
infiltrating the incision site.
• Presence of a suture further increases the
tissue’s susceptibility to contamination.
 Biological characteristics : Adhesion
• During the wound healing process, cells can
grow inside the interstices of braided
structures. Such tissue in growth can cause a
major problem during removal of the suture,
and can inflict new damage to the delicate
healing tissue.
• The composition and configuration of the
suture, as well as the length of the suture cut
end, can affect adhesion
 Biological characteristics : Allergy
• Allergies to nylon suture have been reported
during vitrectomy (surgery of the eye), or
cataract surgery, and the symptoms of allergy
were resolved after removal of the suture.