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What are

Catheter ? Tube? Scope?


- in surgical practice
Catheters as a diagnostic tool or a therapeutic tool
Tubes as a therapeutic tool
Scopes as a diagnostic and therapeutic tool

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HISTORY AND ORIGIN OF
“CATHETER”

KATHETER, came from KATHIENAI,

kathe- to send down : kat-, kata-, cata- + hienai- to send .

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DEFINITION:
A catheter is a hollow flexible tube that can be inserted into a body
cavity, duct or vessel. Catheters thereby allow drainage or injection of
fluids , distend a passageway or provide access by surgical
instruments.
The process of inserting a catheter is catheterization.
In most uses a catheter is a thin,
flexible tube: a "soft" catheter;
in some uses,
it is a larger, solid tube: a "hard" catheter.

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What is a Catheter made up of ?
Materials:
A range of polymers are used for the
construction of catheters, including silicone rubber
latex and thermoplastic elastomers.
Silicone is one of the most common choices because it
is inert and nonreactive to body fluids and a range of
medical fluids with which it might come into contact.

Materials:
CATHETER:
Polyvinylchloride (PVC)
Polyethylene (PE)
Fluoropolymers (PTFE) (TEFLON)
Polyurethane (PUR)
Silicone (SI) 4
Catheters
• Catheters are medical devices, typically in the form of a
tube, that are inserted into the body to remove fluid,
create an opening, or deliver a drug.
• The biocompatibility of catheters, as with other medical
devices, can be defined as the ability of the device to
perform its intended function without eliciting
undesirable side effects.
• Biocompatibility will be dependent on physical properties
of the device (e.g., rigidity, surface smoothness) and its
chemical nature
• is it allergenic, are there toxic leachables
• body’s reaction to the device SHOULD NOT affect its
function.
Silicones, polyvinyl chloride (PVC),
and latex rubber
• Silicones, one of the most thoroughly tested and widely-used
groups of biomaterials, are well known for their intrinsic
biocompatibility and biodurability
• SILICONE’s inherent chemical and thermal stability, low
surface tension and hydrophobicity
• Silicones have been successfully applied in short- and long-
dwelling catheters,drains, and shunts for over sixty years
• Silicone elastomer is a thermosetting material, capable of
being processed by various molding, dipping, and extrusion
methods. Once cross-linked into the desired configuration,
silicone catheters are thermally stable (-80 °C to +230 °C),
remaining essentially unaffected by repeated autoclaving.
They are usually dry-heat sterilized
• Silicone catheter raw materials are more
expensive than legacy materials such as
latex and PVC
• Urinary tract infections account for over
40% of all nosocomial infections, and
almost all these infections are associated
with indwelling catheters
Silicone use
• Silicone catheters and tubing appear to be less thrombogenic than
standard PVC tubing and catheters
• When silicone was compared to PVC intravenous (IV) catheters for
parenteral nutrition, a lower complication rate , higher rates of IV
therapy completion, and longer service life were demonstrated
• Phlebitis, an inflammation of the veins sometimes associated with
thrombosis, which is far less in silicone catheters than PVC
• silicone catheters were better at maintaining their physical properties
and flexibility over time when compared to the PVC catheters
• The silicone coating helps reducing mineral encrustation on the tip or
within the lumen of the urinary catheter
• all-silicone and silicone-coated catheters remained patent the longest
in urinary use
• formation of encrustations and blockage was significantly less in
patients with silicone catheters as compared to Teflon®-coated latex
or all-latex catheters
• Foley catheters made entirely of silicone had less potential for
bacterial migration compared to latex catheters with various coatings,
including a silver-containing hydrogel
PVC
• Polyvinyl chloride is generally referred to by the abbreviation PVC and has
the IUPAC name polychloroethene
• PVC is thermoplastic, although the pure polymer is hard and stiff addition of
chemicals known as plasticizers makes PVC soft and flexible. These
additives can be extracted in vivo causing several problems:
• -induction of an acute inflammatory reaction to the leached plasticizer,
increased polymer stiffness / brittleness, and an increased failure rate due to
breakage when compared to other biomaterials
• Plasticizer DEHP had produced a range of adverse effects in laboratory
animals, notably liver toxicity and testicular atrophy
• Becoming out dated
IUPAC: International Union of Pure and Applied Chemistry
DEHP: Di(2-ethylhexyl)phthalate – The most common plasticizer
BCF : Bioconcentration factor; HAL-Health advisory level;
MCL: Maximum contaminant level; MCLG: Maximum contaminant level goals; MPC:
Maximum permissible concentration
Latex rubber
• Latex rubber is most often obtained commercially from
the sap of the Pará rubber tree (Hevea brasiliensis),
named for the Brazilian state
• Due to human immunodeficiency virus (HIV) pandemic,
the use of latex gloves and condoms sharply increased
in the 1980s
• increased reports of latex allergies, especially among
healthcare workers
• Latex allergies usually present as a Type I (IgE-
mediated) immediate allergic reaction to proteins
contained in the natural rubber-other than proteins
several other additives are also responsible
• The conversion of medical facilities to “latex-safe”-is
being considered
Catheters produced from silicone

Reported to improve patient comfort and


reduce total patient cost by reducing the:
• 1. Occurrence of allergic responses
• 2. Incidence of phlebitis
• 3. Frequency of sepsis
• 4. Number of catheter insertions
• 5. Likelihood of mineral encrustations
• 6. Potential for bacterial migration
• 7. Occurrence of premature balloon deflation
• 8. Potential for nosocomial infections
Ideal characteristics of catheters
 Better Torque Control

 Strength

 Radiopacity

 Flexible

 Atraumatic Tip

 Low Surface frictional resistance for good trackability


over guide wire.

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PARTS OF A CATHETER
BODY

 HUB

 BODY
HUB TIP
 TIP

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MEASUREMENT:

FRENCH CATHETER SCALE:


The French catheter scale (most correctly abbreviated as Fr, but also often
abbreviated as FR or F) is commonly used to measure the outer diameter of
cylindrical medical instruments including catheters ,needles etc.

In the French Gauge system as it is also known, the diameter in millimeters of


the catheter can be determined by dividing the French size by 3, thus an
increasing French size corresponds with a larger diameter catheter. The
following equations summarize the relationships:

D(mm) = Fr/3 or Fr = D(mm)*3

 Most commonly in adult Diagnostic Catheters of 5 – 7 Fr is used.


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TYPES OF CATHETERS:
CLASSIFICATION :
Catheters can be classified depending on
 SIDE of HOLES :
-: Single Hole at the end
-:End Hole with side holes.
-:Blocked end with side holes only.
 SIZES :
Abdominal – 6-80 cm
 Thoracic or Carotid Arteries – 100-120 cm
 NOTE: Size depends on :
> age of the patient
> selective or super selective study
> size of the vessels.
NOTE: Ideal practice is to use the smallest diameter catheter feasible for any
particular study to minimize the risk of arterial damage by the procedure.
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Balloon Catheters:

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Butterfly Catheters Foleys Catheter
(1way, 2way or
3way)

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Some Other Types of Catheters:
 Hydrophilic Catheters :
Hydrophilic-coated catheters have a layer of polymer
coating that is bound to the catheter surface.
The polymer absorbs and binds water to the catheter,
resulting in a thick, smooth and slippery surface.

 Intermittent Catheters:
Intermittent catheters are hollow tubes used to drain
urine from the bladder.

 Pediatric Catheters:
Usually its around 80cm.

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TYPES OF CATHETERS

 SHAPES

 Straight Catheter

 Pigtailed Catheter

 Cobra Shaped Catheter

 Side Winder Catheters (Shepherd)

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Different Catheter Curves
For Different Purposes:
> Judkins Left (JL)

> Judkins Right ( JR)

> Judkins Left Short Tip

> Judkins Right Short Tip

> Amplatz Left ( AL)

> Amplatz Right ( AR)

> Left Coronary

> Right Coronary

> Cardiac Pigtail

> Multipurpose
Judkins Left Judkins Right

Amplatz Left Amplatz Right

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CATHETERS CAN BE BROADLY CLASSIFIED
UNDER THESE GROUPS:
 DIAGNOSTIC CATHETERS
Used for Angiographs .

 GUIDING CATHETERS
Used for Angioplasty.
• Guiding catheters are like angiography catheters only difference is that
guiding catheters are more stiffer & firm as it carries Balloon catheters, PTCA
wires and stent delivery system.
• Mild stiffness comes due to the wire braided design.
• Good Push ability .
• Good Tractability.

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PUNCTURE NEEDLES:
Used to cannulate or puncture the artery.

Usual Sizes include


18 ga, 19 ga , 20ga, 21 ga. Seldinger Needle
The selection of the Size depends on
the guide wire going to be inserted
through that needle port.

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Cannulas Lines
This is a an IV cannula. It is used to give IV
fluids and IV drugs.
If you wish to give the fluid quickly, the
cannula must be short and large bore
(Poiseuille’s law – flow is proportional to the
fourth power of the internal radius of the
tube and inversely proportional to the
length).
Emergencies (265ml/min)
Generally insert a 18G (green) or higher
when giving drugs. Emergency should be
brown (14G) which has a flow rate of about
265ml/min. Use antecubital fossae in
emergencies.
Lines
Cannulas
Blue 22G

Pink 20G

Green 18G

White 17G

Grey 16G

Brown 14G
Lines
Triple lumen Central Venous Pressure Catheter
• Inserted into either the
right subclavian vein or
internal jugular vein.
• Used for Central Venous
Pressure monitoring and to
administer drugs
(chemotherapy drugs),
taking blood, not good for
fluids.
• Single or triple lumen
Triple lumen Central Venous Pressure Catheter
• Inserted using Seldinger technique.:
Lines
• Lie patient flat. Infiltrate skin with LA 5ml of lignocaine
• Assemble the catheter and flush all the lumina
• Introduce needle and syringe 1cm below the junction of the middle
and medial thirds of the clavicle. Aim the needle to the sternal notch
and advance. Aspirate as you advance the needle.
• Once blood enters the syringe, remove the syringe keeping the needle
still in its position.
• Insert the guide wire, remove the needle, feed the dilator over the
guide wire, remove dilator, insert central line, remove guide wire
• Stitch in place, Order CXR to check position and exclude pneumotharax
Lines
Triple lumen Central Venous Pressure Catheter
• Complications of a central line insertion:

• Immediate: pneumothorax, haemothorax, damage to adjacent
vessels e.g. carotid arteries, primary haemorrhage

• Early: infection (skin commensals), secondary haemorrhage,
haematoma formation

• Late: thrombosis, catheter blockage.
GUIDE WIRE:
Diagnostic guide wires are used to traverse vascular anatomy to aid in
placing catheters and other devices. Guide wires are used for both
Cardiology and Radiology angiographic procedures.

• Guide wires are relatively simple spring type wires that


provides necessary firmness and the control to the site where
Angiogram will be taken.

• A the name suggests it ‘ Guides’ the catheter.

• PTFE coated Soft tip for the smoothness during the insertion

• Less trauma to the intimal wall of the artery

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Shape of the Tip :
J Tip / Straight Tip

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 In1929 Werner Forssmann
demonstrated that a simple
Rubber catheter could be passed to
the pulmonary artery through the
Anti- Cubital Vein and
An angiographic film could be
obtained using radiographic
contrast.

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In 1953 ,
Sven –Ivar Seldinger invented
The technique of gaining access
Percutaneusly into an artery
without An arteriotomy.

Sven- Ivar Seldinger

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TECHNIQUE OF INSERTING A CATHETER
SELDINGER TECHNIQUE :

The technique of catheter insertion via


double-wall needle puncture and guide-wire is
known as
The SELDINGER TECHNIQUE.

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4
1

2 5

3
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COMPLETE APPARATUS:

> Needle

 Guide Wire

 Sheath

 Catheter

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USES & APPLICATION s OF CATHETERS:
Placement of a catheter into a particular part of the body may allow:

 Draining urine from the urinary bladder as in urinary


catheterization, e.g., the Foley catheter.

 Drainage of urine from the kidney pelvis by percutaneous


nephrostomy.

 Drainage of fluid collections, e.g. an abdominal abscess.

 Administration of intravenous fluids, medication or


parenteral nutrition with a peripheral venous catheter.

 Angioplasty , angiography , balloon septostomy, balloon


angioplasty. Often Seldinger technique is used. 37
CONTD…

 Direct measurement of blood pressure in an artery or vein.

 Direct measurement of intracranial pressure.

 Administration of anesthetic medication into the epidural


space, the subarachnoid space, or around a major nerve bundle
such as the brachial plexus.

 Subcutaneous administration of insulin or other medications.

 A central venous catheter is a conduit for giving drugs or


fluids into a large-bore catheter positioned either in a vein near
the heart or just inside the atrium.

 A Swan - Ganz catheter is a special type of catheter placed


into the pulmonary artery for measuring pressures in the heart.38
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Lines
Swan-Ganz Catheter
Inserted into
pulmonary artery,
this is a diagnostic
catheter used to
detect heart failure,
sepsis, monitor
pressures in right
atrium, right ventricle
and pulmonary
artery
Lines
Tesio Line

For Renal Dialysis


Nasogastric Tube Lines
• This is a feeding NG tube. It is used
for enteral nutrition in patients.
• It has a fine bore and is soft
(comfortable for patients), unlike the
Ryle’s NG tube which is wide bore.
Note the end has a cap (not present
in Ryle’s NG tube). It is made from
silastic, which tends to block less
often.
• Another indication is oesophageal
obstruction.
Drains

• A surgical drain is a tube • Types of drainage systems


used to remove pus, blood
or other fluids from a
–Closed
wound.
–Open
•Broadly classified as: –Passive
– Tube Drains –Active
– Corrugated Drains
Drains
Yates Tissue Drain

• Row of tubes
• For big cavity drains
• It is an open drainage system
Drains
•Bottle to which the chest drain is attached.
Chest Drain Bottle
• There is a line called prime level which is filled
with sterile water.
• The chest drain tubing is connected to a tube
which is under the sterile water and therefore
acts as a water seal.
•After a chest drain has been inserted you can see
bubbling in the water as the air leaves the pleural
space.
•The chest drain bottle can be used to collect air,
blood, fluid and pus from the pleural space.
•The system can be driven by attaching suction to
the top of the bottle making it an example of a
active closed drainage system
Surgical Instruments
Rigid Sigmoidoscope
• Used for the inspection of the rectum and
lower sigmoid colon.
• After explaining to the patient what you
are about to do, you must attach a light
source and a air pumping device.
• The patient is placed in the left lateral
position and a digital rectal examination is
performed.
• The sigmoidoscope is then lubricated with
jelly and inserted pointing towards the
umbilicus.
• Air is pumped into the rectum to allow
you see the direction of the rectal lumen.
• Biopsies can also be taken of rectal
mucosa through the sigmoidoscope eg in
a case of ulcerative colitis
Drains
Vacuum Drain bottle (Redivac)

•Used to drain areas where fluid or blood


may collect or where the surgery has left
a cavity which is closed by the suction
from the vacuum drain.

•This is an example of an active closed


drainage system.
Surgical suction
Operating room
Sterile Area Non Sterile Area

Suction source
Yankauer

Pre-cutted tube
Operating table
Bubble tube

Collection Chamber
Sep-T-Vac
Main Features
• Collection chamber
• Airtight cap: Connections for yankauers and
suction source
• Filter

• Product range
– 100% Disposable 0.8 l/1.2 l/2.0 l/3.0 l
– Liners 1.2 l/2.0 l/ 3.0 l
Sep-T-Vac
Collection chamber
Sep-T-Vac
Filter
• Sep-T-Vac filter:
– Gore Tex Hydrophobic shut-off filter. Gore Tex is
moisture sensitive and it automatically stops
aspiration when collected liquid is at the top of
the chamber.
– It is not a mechanical system an it prevents also
micro-particles and aerosol leakages
Surgical Suction
Objectives
• Operating Room: To remove biological fluids
and clean the operating field during and after
surgical procedures

• Generic Wards: To continue to drain and


monitor liquids after surgical procedure and
generally to collect biological fluids
Surgical Suction

• Vacuum source
• Connecting tubes (from wall collection
systems and from collection systems to the
cannula

• Collection systems (Sep-T-Vac)

• Suction Cannulas (Yankauers)


Surgical suction
Yankauers: Product range

Yankauer Select Trol Rigid yankauers

Flexible yankauer Poole set


CASE STUDY Yankauers
suction cath Main Features
• Tip: different shapes and distal hole section
to better fit customers needs
– Fine: Accurate aspirations with low quantity of
fluids (mini-invasive surgical procedures. ie:
neurosurgery and ophthalmic)
– Regular: General surgery
– Large: High suction volume (to use after
washing procedures and with high volume to
drain)
Yankauers
Main Features
– Extra Large: to suction high volume of fluids, blood
clots, bony fragments in short time
– Sump tip: to avoid the bony fragments and organic
residuals suction (preferred in orthopaedic surgery)
– Bulb tip:it is used as dissector and retractor
instrument
– Flat tip:indicated for suctioning in difficult
manoeuvrability situations and to suction in short
places
Connecting tubes
Tyco Product Range

Argyle conn. tube Sure Grip


Connecting tubes with Sure grip
Features and Benefits

Features Benefits
Wide range of sizes To fit to all hospital needs
Female molded connectors or Flexibility to answer to all
integral connector hospital needs
Clear Pvc formulation with striated
antistatic walls Safety for the patient
Flexibility to answer to all
Funnel or sure grip connector
hospital needs
Minimal coil memory To minimize hospital costs
Steri-guard package with sterile
inner pouch and two labels Two avoid money waste
Non conductive and conductive
types available Safety for the patient
Universal bubble tubing
Features and Benefits

Features Benefits
Clear bulk tubing
Can be cut to the exact length Savings for the hospital
Bubble every 91 cm can be cut to
form integral tapered or funnel Flexibility for the customer
connectors
Dispensed in single roll case Flexibility for the customer
Bronchial Suctioning
Anatomy
Bronchial Suctioning
Objectives

• To suction mucus from


the bronchi and trachea
(to guarantee the correct
lung ventilation and
“blood oxygenation” vs
nosocomial infections
and atelectasia)
Bronchial Suctioning
What you need
• Vacuum source

• Connecting tubes

• Suction catheters

• Mucus trap
Suctioning
Type of…..
• Naso-Tracheal suctioning

• Endo-Tracheal suctioning

• Tracheostomy suctioning
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Ballard Suction Catheter
• Suction catheter contained within plastic
sheath
• System remains “closed”
• Be sure catheter is completely withdrawn
when finished
• Suction ‘OFF’

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Lock/ Unlock
Control Valve
Black Line

To
Suction

Patient Wye

ETT

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Lock/ Unlock Control Valve

LOCK
Unlock
To Apply
Suction

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Yankauer (tonsil sucker)

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Connecting
Tubing

Suction Lukens
Catheter Sputum Trap Suction Unit
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Suction catheters
Main features
• Tip: It is related to the efficiency in
aspiration (speed and suctioning capacity of
viscous mucus) and tissue damage

• Connector to vaccum
• With Touch Trol or Funnel or Sure Grip
Suction catheters

• Type of suction catheter systems:


– Opened systems
• Through nose/mouth
• Through endotracheal tube
• Through tracheostomy
– Closed systems
• Prevention of pulmonary infections
Suction catheters
Open systems
Suctioning through a tracheostomy
Suction catheters
Tyco Product Range

• Commodities products: Touch Trol


Scotsman
Sure Grip
• High quality and exclusive products:
Aero-Flo
Gentle Flo
Suction catheters
Overall Features and Benefits
Features Benefits
To minimize the risk of cross
Disposable
infections. Sfaety for the patient
Slide Tex coating To aid in positioning procedures
Complete product range with
Flexibility in customer choise and
different sizes, holes and tip shape
comfort for the patient
Prevent Nosocomial Infections
Costs of NI
• UTI: from 200 to 1,000 US $
• Wound infection: from 2,000 to 4,000 US $
• Airway infection: from 1,200 to 8,000 US $
• Blood infections: from 2,500 to 27,000 US $

Italian Society studies on Nosocomial Infection


(European panel)
Mucus traps
Objectives

• Objective:
to collect mucus for
clinical analysis

De lee/Lukens for Specimen Trap


neonatal use for broncoscopy use
Suctioning
• Endotracheal
• Nasotracheal
• Open vs Closed Suction Systems
• Sputum sample

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Rationale
• To remove secretions from lower airway
when patient intubated or trached
• Or cannot cough effectively
• To obtain sputum sample for culture and
sensitivity

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Suctioning
• Advance plastic tube down ETT or trach
• Apply vacuum to evacuate secretions

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Applying O2 Across Mouth of ETT

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SX SX

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With proper sized suction
catheter, catheter mid-position in ETT
draws approximately equal amounts from
both ends
of ETT.

ETT X

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Argyle
whistle tip

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Coudé tip suction catheter

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Thumb Control

Connecting
tubing to
20 - 22 suction
inches
long
14 Fr

Coude -
Angled tip
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Pathway of NT suction catheter

Sinus

Turbinate

Eustachian Tube

Uvula
Tongue
Epiglottis

Larynx

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Airway Instruments
Laryngoscope
• A laryngoscope has a
handle and a curved blade,
usually fitted with a light, it
moves the tongue and
epiglottis aside in order to
inspect the larynx.

• It is used to aid insertion of


an endotracheal tube or
for examination.
Laryngeal mask Airway
• Sits on top of the larynx and therefore
does not intubate the trachea.

• It is used to assist a patient with


impaired breathing. It can also be used
as an airway during short operations
e.g. day cases.

• It is inserted and then the inflatable cuff


over the larynx can be pumped, by
pushing air from a syringe, into the blue
lumen.
Closed Suction Systems
• Use swivel adapter
• Use Ballard suction catheter

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Swivel Adapter
port

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Airway Instruments
Oropharyngeal / Guedel Airway
• This is essentially a rigid, curved
plastic tube. It is an airway adjunct
• It is used to provide an airway for
a patient where there is an
impaired level of consciousness.
• It is sized by measuring the
distance from the angle of the
mandible to the patient’s mouth.

• It is inserted upside down into the


mouth and rotated downwards
when it is past the tongue within
the oral cavity.
Airway Instruments
Endotracheal Tube
• Used to provide a definitive airway for
patients. This means a cuff is inflated
to prevent aspiration. Used for long
operations, (laparotomy) and in cases
of inhalation injury, (burns)

• Indications:
– Depressed consciousness
– Hypoxemia
– Airway Obstruction
Airway Instruments
Endotracheal Tube
• Then check the tube is in the trachea by:
– Auscultating: ensure bilateral breath
sounds
– Auscultate over the stomach (epigastric
region) to ensure no gurgling (that would
indicate oesophageal intubation)
– Measure end tidal CO2 tension: since
CO2 is produced in the lung, you can
confirm that the tube is in the trachea by
measuring the end tidal CO2 tension. If
the tube is in the oesophagus, then the
CO2 gas pattern would be absent.
– Do CXR and look for metallic mark
Airway Instruments
Endotracheal Tube
• Complications:
– Broken Teeth, lacerations of the
tissues of the upper airway,
– Intubation of the Oesophagus
Airway Instruments
Tracheostomy Tube
• Definitive airway
• Tracheostomy = surgical
opening into the trachea.
• Can be temporary or
permanent.
• It involves placing the
tracheostomy in between the 2
and 4th tracheal rings.
• Usually done in theatre under
GA.
Airway Instruments
Tracheostomy Tube
• Indications
– Patients who require long term intubation (>2
weeks) – better tolerated than ETT
– Severe maxillofacial injury (unable to
intubate)
– Post-laryngeal surgery (e.g. laryngectomy for
malignancy)
– Lung disease (e.g. COPD) to reduce dead
space and allow effective ventilation
– Obstructive sleep apnoea
– Upper airway obstruction
• Complications
– Tracheostomy stenosis,
– Infection
– Blocked tube,
– Tracheoesophageal fistula
– Surgical emphysema.
Parts of Tracheostomy Tube
Types of Tracheostomy Tubes
Bivona TTS Trach Tube Portex Cuffed Trach Tube

Shiley Double Cannula Trach Tube Uncuffed Shiley DC Trach Tube


With different inner cannula’s
Speaking Valves
Speaking valve placement
Cuff must be deflated when valve is on trach tube
Air flows around tube on expiration and passes over vocal cords
– Patient can speak
– Swallowing ability can be assessed by Speech Language
Pathologist
Removed for suctioning or resp. distress
Surgical Instruments
Trucut Biopsy Needle

• Used to take histological


specimens from lesions
– eg breast lumps or liver.
• The procedure can be
performed under local
anaesthetic
Surgical Instruments
Laparoscopic Port

• Used during laparoscopic procedures


eg Lap Chole

• Ports allow the surgeon to insert


telescopes/Cameras/instruments
PRODUCT DESIGN
• Great product design and development are the keys to any
product's success.
• Specialized experience in designing and delivering reliable,
surgical devices that withstand harsh environments
• Goal is to continually evolving and adapting the design
process in an effort to meet the constantly changing ISO
and FDA guidelines.
• Supported by a comprehensive documentation system that
consists of project planning timelines, design element
checklists, project phase design reviews, verification and
validation test plans, as well as a complete and compliant
design history file.
Human Factor
• FDA regulations appropriate to see evidence of the
integration of Human Factors Engineering can be a
challenging task for device makers.
• The “Cross-Phase Usability Assessment Tool” allows
a project manager to ensure that all HF concerns
are considered during every phase of development,
from the initial collection of user needs, to
verification and validation.
• Human Factors and Industrial Design are
complementary fields, when they are tightly
integrated, results in a smarter and safer device,”
Case Study
• Surgical instruments should arrive in the surgeon’s hands in the
operating theatre at the right moment, correctly assembled,
completely sterile and without delay. The delivery systems need to
be improved
• Surgical instruments are transferred into the operating theatre in
containers referred to as ‘delivery systems’ or ‘trays’. They hold the
instruments during the sterilisation process and protect them
during transport and storage.
• The trays are handled by a range of hospital and medical personnel
and need to meet different performance criteria. If these containers
do not keep the instruments clean or secure, operations could be
cancelled and surgery delayed with resulting financial costs to the
hospital and health implications for the patient.
Cont.
• A wide variety of research methods were employed,
including observation, video ethnography and
interviews.
• To thoroughly investigate the processes related to
delivery systems, employees from the Central Sterile
Services Department who handle trays on a daily
basis were observed, and interviews with the facility
managers were conducted.
• Relevant technical information was collated through
desk research and contact with tray manufacturers.
Critical Focus
• Six areas of critical focus were defined from this study: How
the trays are handled throughout the cycle of use
How information regarding content and sterility can be
provided by the container
The labelling-Investigated the wrapping of the container to
maintain sterility and help medical staff identify the type of
tools inside
Addressed the issue of moisture residue after the washing
and sterilising process
Assessed how well the containers need to work in the
confined spaces of the surgical theatre
The layout of the instruments inside the container.

Cont.
• Two design concepts generated to address these issues, for
further development from many::
**.Consists of generic clips arranged within a light weight
aluminium base, fixing all the instruments inside the tray. The
shape of the clip allows for the secure capture of instruments
of varying shapes and sizes. Images of instruments are
provided to aid placement. The lightweight external cover
includes handles that enable the trays to be carried easily
when wrapped and allows for labelling or branding.
**a metal sheet stamped into the shape of the instruments,
placed directly into a simple wire basket with silicone handles
for heat insulation. This allows for easier location of the
instruments which can be washed in-situ. The concept is
durable and quick to dry. A lid keeps the instruments in place.
Case Study
• Design of two surgical tools that use improvements in plastics
technology to cut manufacturing costs and time spent in the
operating room.
• The tools can be customised to the surgeon's individual way of
working; they improve accuracy and simplify the controls so
that the process involves less risk to the patient.
• Preparation and disposal - addressed as the instruments come
preassembled, have fewer working parts and can be made
from disposable and recyclable materials. Both tools allow for
one-handed operation and enable surgeon and nurse to work
side-by-side.
• Extensive feedback from surgeons and nurses led to the
design of second-generation tools, which then went into
cadaver trials
Case Study
• End users must be involved in the early stages of
product development and concepts, and prototypes
must be tested in the real time environment (or
close simulation).
• The rising cost of surgery has put pressure on
manufacturers to innovate in the design of surgical
tools. Exploration of a new design methodology for
instruments that are safer and easier to use - and
less costly to make.
• Redesign adding value to operating procedures,
enhancing surgeon comfort and improving patient
safety.