the evolution of central venous cathetersh24-files.s3.amazonaws.com/110213/399918-6xqld.pdf ·...

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THE EVOLUTION OF CENTRAL VENOUS

CATHETERS

Alan C. Press - CEO – KIMAL plc

4th NORDIC EMERGENCY RADIOLOGY COURSE MAY 2013

Content: •  History of central lines •  The making of standard catheters •  M.T. technology •  Power injection flows v. normal flows •  Responsibility


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History of Central Lines •  Earliest references – 3,000 B.C.!! •  Historical text from Greek, Asian,

Syrian amongst others •  Comes from Greek word Kathiénai,

roughly meaning “a stem to let go or send”

•  Earliest materials are reeds (Syria), onion stalks (China), Silver (Roman/Greek) 4th NORDIC EMERGENCY RADIOLOGY COURSE MAY 2013

History of Central lines

In 1597 a German naturalist, Andreas Libavious, proposed in ‘Alchemia’ the concept of transfusing blood from one person to another using ‘silver tubes’. He wrote: “…when joined together the hot and spiritous blood of the young man will pour into the old man as if it were a fountain of life.”


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History of Central Lines The Great Oxford Dons of the 1600’s

•  Much of ‘modern’ medicine began with a remarkable generation of Oxford scientists who lived through the Puritan revolution in Britain

•  William Harvey (described circulatory physiology) •  Robert Boyle (Boyle’s law) •  Thomas Wills •  Christopher Wren (Physiologist and renowned

architect) •  Richard Hooke (Hooke’s law) •  Richard Lower


History of Central Lines

•  Wren, using a quill and pigs bladder, created the first (documented) working IV infusion device in 1658

•  BUT, it was Richard Lower, Wren’s colleague, who devised more workable ‘silver (IV) tubes’ which were malleable and firm, allowing varying sizes and their ends rimmed for anchoring (1655)


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History of Central Lines •  1667 Lower infused a harmless insane

parson who pleaded for “the blood of the lamb”. He survived, leading Lower to transfuse several ounces of lamb’s blood into his own arm at a meeting of Royal Society – “with no inconveniences”.

•  Recognising needed improvements, Lower developed several new and improved devices for the transfusion which remarkably contained all the elements that have evolved into modern syringes, needles and IV catheters (see next slide) 4th NORDIC EMERGENCY RADIOLOGY COURSE MAY 2013


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Because of some severe patient complications, the British Royal Society and the Vatican both banned such transfusions in 1669, setting the evolution of IV devices back another hundred plus years



Between 1818 and 1830, using his newly self designed instruments (including “The Gravitator” – see next slide), Dr. James Blundell a British Obstetrician, performed eleven transfusions (the first between himself and his wife) However only six were documented to be beneficial to his patients (his wife lived!!)


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Catheters and Early Cardiac Procedures

•  In the early 1940’s, Andre Cournand, Richards and Forssmann performed right heart catheterisation and in 1956 shared the Nobel prize for their contributions to the advancement of cardiac catheterisation.

•  In 1947 Zimmerman developed a completely intravascular technique for human left heart catheterisation and performed simultaneous catheterisation of both the left and right heart.


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The Plastic Revolution •  1950: Dr. David Massa (Mayo Clinic) invents

the first “over the needle” IV catheter – The Rochester Plastic Needle sparking an instant catheter revolution.

•  1953: Dr. Sven Ivar Seldinger describes in ‘Acta Radiologica’ a new catheterisation technique using a flexible wire to guide a catheter “to previously unreachable vascular areas of the body”.


The Plastic Revolution – continued/…..

•  David S. Sheridan – dubbed the “Catheter King” by Forbes Magazine. From the 1940’s and for 50 years, he invented various devices i n c l u d i n g t h e d i s p o s a b l e p l a s t i c endotracheal tube.

•  In 1957, Deseret introduce the “Intracath” the first “through the needle” PVC catheter pre-packaged and pre-sterilised (still sold by BD today).


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The Plastic Revolution – continued/….

•  1958: Mason Sones – selective coronary angiography

•  1963: Thomas Fogarty – embolectomy catheter

•  1964: Deseret introduces the “Angiocath” •  1970: Swan, Ganz and Forester – Swan-Ganz

balloon flotation catheter



•  Teflon developed in 1969 •  The 1970’s start a revolution in

catheters – the ‘stickiness’ of catheters/cannulas was dramatically reduced. Teflon was self lubricating, flexible, non-toxic, tissue compatible and tough.


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•  1977 – Arrow introduces the Internal Jugular Puncture Kit. The first company to offer complete steri le kits, with matched components and based upon the Seldinger technique.

•  1979 – Arrow’s first polyurethane CVC •  1982 – the Arrow-Howes multi lumen

catheter is introduced. The number one selling CVC device in the world today!


•  1992 – the first “coated” CVC

Arrow introduced their Arrow Gard Blue antimicrombial surface treatment (silver sulphadiazine and chlorhexadine)


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The Making of Standard Catheters




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MT Technology


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M T Technology

Altius Animation



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M T Technology



KIMAL Pressure CVCs versus Other Pressure CVCs

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10

15

20

25

30

4 5 6 7 8 9 10 11 12 Contrast media Viscosity cP @ 37C

Flow

rate m

l/sec @ 300 PSI

Kimal Double 8FR Other Double 8FR Kimal Triple 7FR Other Triple 7FR Kimal Quad 8FR Other Quad 8.5FR

Burst Pr 305PSI

Burst Pr 345PSI

Burst Pr 448PSI

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Dist Med Prox TOT Dist Med Prox TOT Dist Med Prox TOT Dist Med Prox TOT 11cm 15cm 20cm 30cm

Others 62 51 43 156 57 37 38 132 52 25 27 104 38 17 18 73 Altius 130 43 43 216 108,3 33,3 33,3 174,9 86,7 29,2 29,2 145,1 75 22,5 22,5 120

0

50

100

150

200

250

Flow

Rat

e m

l/min

7FR Triple (3) Lumen Central Venous Catheters

Change

38% 33% 39% 64%


Dist Med Prox TOT Dist Med Prox TOT 15cm 20cm

Others 63,1 141,3 60,7 265,1 58,8 125,9 54,8 239,5 Altius 225 58,3 108,3 391,6 208,3 55 86,7 350

0

50

100

150

200

250

300

350

400

450

Flow

Rat

e m

l/min

8.5FR Triple (3) Lumen Central Venous Catheters

Change

48% 46%

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Dist Prox TOT Dist Prox TOT Dist Prox TOT 5cm 8cm 13cm

Others 10 18 28 9 16 25 10 8 18 Altius 38 17,3 55,3 33 14 47 26 11,5 37,5

0

10

20

30

40

50

60

Flow

Rat

e m

l/min

4FR Paediaric Double (2) Lumen Central Venous Catheters

Change 96% 88% 105%


Dist Med Prox TOT Dist Med Prox TOT Dist Med Prox TOT 15cm 20cm 30cm

Others 7FR 57 37 38 132 52 25 27 104 38 17 18 73 Altius 6FR 96,7 21 21 138,7 75 18,3 18,3 111,6 62,5 15 15 92,5

0

20

40

60

80

100

120

140

160

Flow

Rat

e m

l/min

Triple (3) Lumen Central Venous Catheters

Change 5% 8% 26%

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Power Injection ‘Normal’ CVC flows in ITU •  Multiple infusion lines connected •  Parenteral nutrition – 80 mls/hr •  Vasoactive drugs/sedation/antibiotics

infused at a range of 2.23ml/hr to 60ml/hr mean value of 11.5 ml/hr

THESE ARE THE TYPES OF FLOWS ‘NORMAL’ CVC’S ARE DESIGNED FOR


Power Injection

•  Contrast enhanced (power) injection needs flows of circa 5-10 mls/sec

•  (equivalent to 18,036 litres/hr) •  Needs a high pressure injector to

deliver

SUCH FLOW RATES ARE OUTSIDE OF THE DESIGN CRITERIA FOR ‘NORMAL’ CVC’S


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Responsibility The British Medicines and Healthcare Regulatory Agency (MHRA) states:

“If you can’t take the pressure……… Intravenous catheters such as CVC’s and PICC’s are now available which are indicated for use with powered injectors for CT scanning. •  Always check the manufacturers’ instructions and/or

labelling to determine whether the catheter is suitable (e.g. maximum pressure and/or maximum flow rate). Do not exceed the catheter’s capabilities as this may cause rupture of the catheter, resulting in air embolism and/or leakage.”


MHRA continued/….

“In essence, you will be required to check that the catheter (peripheral, central etc.) specification will allow for use at such pressures/flow. This information should be available in the instructions for use and by contacting the manufacturer.”


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Responsibility

Instructions for use/warnings enclosed with the standard Kimal Altius CVC: Do not use catheter for contrast meda injection otherwise the catheter may rupture and leak. For this special purpose use the Altius Ultra pressure resistant type catheter


Responsibility

Instructions for use/warnings enclosed with the market leading CVC


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Responsibility

FOR CATHETERS AND CATHETER LUMENS THAT DO NOT CARRY THE PRESSURE INJECTABLE INDICATION ……catheters are designed so that every central venous lumen can withstand an internal pressure of at least 50 psi. Every catheter is tested to 50 psi during manufacturing…… Non pressure injectable catheters and catheter lumens are not designed to withstand the higher pressure associated with contrast media during CT scans……allows for the purpose of hand injection done with a 10 cc or larger syringe……


Responsibility

1. The use of central venous catheters for Intravenous Contrast Injection for CT examinations

AAO Plumb & G Murphy – Manchester Br. J. Radiology

March 2011 “……This review summarises the available evidence for the safe and effective use of these devices to assist the radiologist in balancing the relative risks and benefits of their use for contrast medium injection”


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2. The use of ……examinations Some findings: •  There are no published UK recommendations •  Considerable variability in practise •  Various device warnings and alerts have

been published •  Multiple reports of catheter damage and

adverse incidents •  Catheters can often withstand far higher

pressures than rated by the manufacturer •  Risk of adverse events seems to be low


Responsibility

In Summary: •  Finding specific instruction/warnings

can be a problem •  Most CVC’s/PICC’s are NOT designed

or tested to accept high pressure contrast injection

•  High pressure catheters are now available


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