Gives details about extra corporeal medical textiles

1. Extracorporeal Devices

2. Extracorporeal devices
• Medical devices that are used externally and not implanted with in the body
are categorized as extra corporeal.
• ECD – Mechanical organs – primarily used for blood purification.
• Major organs that purifies blood – lung, liver, kidney and spleen.
• Organ failure – supported by artificial organs to save life.
• ECD - artificial kidney (dialyzer), the artificial liver, and the mechanical
lung (blood oxygenator) – replaces the functions of natural organ – corrects
the quality and quantity of blood.

3. Artificial Kidney
Function of kidney:
• ~ 625 mL of plasma flows through
each kidney every minute.
• Of this 625 mL, each kidney filters ~
20%, or 125 mL, across the
glomerulus - however, only 1
mL⁄min of urine is excreted to the
bladder.
• After removing so much from the
blood, the human kidney then works
to reabsorb those substances that are
beneficial for homeostasis.

4. Chronic Kidney Disease (CKD)
• Malfunction or failure of the kidney
 Metabolic and dietary waste products
gradually accumulate within the body
(Uremic Toxins)
 Results in malfunction of cells and
organs
 CKD - defined by 5 stages of
decreasing renal function: from Stage 1,
which is defined by a slightly reduced
GFR; to Stage 5, which requires medical
treatment.

5. Current Treatment
• Haemodialysis- widely used in the
treatment of CKD
 Artificial removal processes, to mimic the
natural function of the kidney.
 Artificial kidney consists of a semi-
permeable membrane, a fine medical
textile used to absorb toxins and pures
blood (cartridges), on one side of which
blood passes while a special dialysate
solution is passed along the other.
 The artificial kidney is made of
polyacetate and polysulphone in equal
proportions

6. Raw Materials and manufacturing Technology
• Regenerated cellulose, cellulose triacetate, acrylonitrile copolymer, poly (methyl
methacrylate), ethylene-viyl alcohol copolymer, polysulfone and polyamide which can be
grouped as cellulose and synthetic polymer systems.
• Eighty per cent of the dialyzers use cellulose materials which have excellent permeability
for low molecular substances.
• Pore sizes of membranes vary between 1 - 3 nm for conventional membranes and 4 - 8 nm
for large pore membranes.
• Multilayer fibres composed of numerous layers of needle-punched fabrics with varying
densities may also be used and are designed to remove the waste materials rapidly and
efficiently. The synthetic polymer substitute being experimented with is a polyethylene
glycol-polyethylene terephthalate block copolymer membrane which can selectively filter.
• The development of artificial kidneys depends on the development of hollow fibre
membrane. Polymer can be spun into hollow fibre membrane and can be used for
purification.

7. Criteria for Hollow Polymer
Membrane
• Excellent biocompatibility
• Effective clearance of target solutes
• Larger pore size to aid removal of protein bound uremic toxins and middle to large
molecular weight solutes.
• High molecular weight cut-off, a sharp cut-off curve and a greater capacity for
adsorption.
• Loss of < 3 g/session albumin is allowed with a blood flow rate of 200 ml/min and a
dialysate flow rate of 500 ml/min.

8. How big is the problem?
• Found prevalence of CKD as 13–15.04% with stage 1, 2 and 3 as
6.62%, 5.40% and 3.02% respectively in India.
• The global estimated prevalence of CKD is 13.4% (11.7-15.1%), and
patients with end-stage kidney disease (ESKD) needing renal
replacement therapy, Only cure- kidney transplantation.

9. • Manufacturers
• There are no manufacturers of
artificial kidney in India presently,
except Nipro Corp. Shirwal, Pune
(Japanese company )
• India is a net importer of artificial
kidney.
• The membrane or dialyzers are 100%
technical textile products made up of
polysulphane and polyacetate.
• The Artificial Kidney market industry
is projected to grow from USD 0.16
Billion in 2023 to USD 7.00 Billion by
2032, exhibiting a compound annual
growth rate (CAGR) of 60.33% during
the forecast period (2023 - 2032).
• High time – to look for indigenous
artificial kidney for the betterment of
patient as well as the Nation.

10. Liver & Its Function
• Liver - largest and remarkable organ of our body -
1.2-1.6kg.
• Hepatic cells (hepatocytes) responsible for liver
functions - Make up 80% of the liver
• Liver is responsible for up to 500 separate
functions
 Removing/excreting body wastes and
hormones as well as drugs and other foreign
substances
 Synthesizing plasma proteins, including those
necessary for blood clotting
 Helping the body fight infection
 Producing bile to aid in digestion
 Storing certain vitamins, minerals, and sugars
• Regenerative - regenerate after severe trauma like
skin – patient can recover from liver disease with
only 20 % functional liver as it grows back.

11. • Complications – alcohol damage, hepatitis A,
B, C, D, E, bile duct infections, cancer, fatty
liver, cirrhosis etc – affects severely – lead
the condition ‘no return’ in which the liver
cannot regenerate – patient – either need a
transplant or under support till gets enough
liver cells to regenerate or a transplant.
• There are 10.4% people affected in the Indian
population with diabetes currently.
Liver failure & Reasons

12. Available Treatments
Liver Transplant
Pros
• Most effective treatment for acute liver failure
• High survival rates
Cons
• Scarcity of donors
• Reduced clotting factors
• Immunosuppressant's increase risk for infection
• Rejection
Bio-artificial Liver (BAL)
Pros
• Keep the patient alive until transplant is available
• Aid in the livers regeneration
Cons
• Are only a temporary fix

13. Current Work in BAL’s
• Molecular Absorbent Recycling System (MARS),
Teraklin - Uses human albumin
• Extracorporeal Liver Assist Device (ELAD), Vitagen
– Uses immortalized human hepatocytes
• HepatAssist 2000 system, Circe Biomedical –
Uses porcine hepatocytes
• Bioartificial Liver Support System (BLSS), Excorp
Medical, Inc., - Uses primary porcine hepatocytes
• LIVERX2000 system, Algenix, Inc., -
Uses porcine hepatocytes
• Modular Extracorporeal Liver System (MELS),
Charite Virchow Clinic-Berlin - Uses human
hepatocytes
• Selective plasma filtration therapy (SEPET)
• Single-pass albumin dialysis (SPAD)
• Radial Flow Bioreactor (RFB)
• TECA-Hybrid Artificial Liver Support System
(TECLA-HALSS)

14. Challenges & raw Materials
• Bio-artificial livers should be able to provide at least 10% of liver functioning
– This requires approximately 1010 hepatocytes
• Very difficult acquiring this many hepatocyte cells
• Controversy over the use of porcine cells due to possible transmission of
infections
• Hepatocytes and plasma have very different physio-chemical properties
– Hepatocytes do not perform well when in contact with plasma
– Have a very high oxygen uptake rate
• Hepatocyte cells undergo a lot of stress inside of bio-artificial liver
– Any stress above 5 dyn/cm2 renders cells useless
• Limited volume of the bioreactor
– maximum blood/plasma that can be safely drawn out of liver failure patient
is one liter
– Difficult to achieve 10% of liver functioning within 1 liter
• Makes Bio-artificial liver designing very difficult
• Membranes used in bio artificial liver systems: Cellulose acetate, Cuprophan,
Hemophan, Polyamide, Polypropylene, Polysulfone, Hollow viscose

15. Market size & future works
• Artificial liver is the fastest growing market segment, at an estimated CAGR of
9.3 % from 2022 to 2030 – 34.3 billion USD to 70.1 billion USD.
• Apollo Hospitals have done more than 500 liver transplantation surgeries in
India.
• Cadaver donation or donation from brain dead patients is still the main source of
transplants.
• The cost of a liver transplantation is around Rs.25-35 Lakh.
• Research in:
– Cell sources
– Bioreactor design
– Filtering techniques
– Packaging for implantable devices

16. Heart – Lung machine
• Heart-Lung Machine – blood pumping machine that takes
over the functions of the heart and lungs during surgery
(i.e. open-heart surgery).
Uses
• Coronary artery bypass surgery
• Cardiac valve repair or replacement
• Repair large septal defects
• Repair of congenital heart defects
• Transplantation
• Repair of large aneurysmns
• Pulmonary thromboendarterectomy (PTE)
• Pulmonary thrombectomy
• Most commonly used to perform a cardiopulmonary
bypass (CPB)
• CPB allows for the heart to stop beating, which makes it
easier to operate on, and surgeons can operate in a blood-
free area

17. Components of Heart & Lung Machine
• CBM, “The Pump”
• Six main partsCannulae
• Reservoir
• Oxygenator (medical textile product)
• Temperature Control
• Filter
• Roller/Centripetal Pump
• Connected by a series of silicone or
PVC tubes

18. Oxygenator
• Takes place of the lungs
• Exchanges O2 for CO2 in the blood pumped from the
reservoir
• Three types:
Bubble
Membrane
Heparin-coated
Heart is Stopped
Blood diverted
through
tubes and is
pumped
to maintain flow
Temperature
regulation
of blood and
gaseous
exchange is
done
Blood circulated
systemically
bypassing the
heart
and lungs
Principle & Necessity of Oxygenator

19. Membrane Oxygenators
• Thin gas permeable membrane
separates blood and gas flow
• The membrane purifies 3-5 L
blood / min.
• Gas flow is 60% of blood flow
• Blood contacts membrane
direct oxygenation

20. The Future
Improvements for the future
• Lifebridge B2T
• First portable heart-lung machine
• Been around since 2007
• Weighs 17.5 kilograms
• Can be used by emergency room physicians and
paramedics on the site, for critical patients
• MiniHLM
• Miniaturized heart- lung machine for infants
• Functions of the machine are integrated, to make the
machine small and compact

21. Membrane oxygenators in current use & Market
Size
• Hollow polypropylene fibre.
• Hollow silicone membrane.
• The oxygenators market is expected to
register a CAGR of 5.4% during the
forecast period 2022-2027
• The global oxygenators market size
reached US$ 244.2 Million in 2022.
Looking forward, IMARC Group expects
the market to reach US$ 348.4 Million by
2028, exhibiting a growth rate (CAGR)
of 5.9% during 2023-2028.

22. HME filters
• Heat and moisture exchangers (HMEs) are
intended to conserve a portion of the patient’s
exhaled heat and moisture, and condition
inspired gas by warming and humidifying it.
• Breathing system filters are intended to reduce
the transmission of microbes and other
particulate matter in breathing systems
• Five types of device are available.
• These are:
 heat and moisture exchanger with no filter
(HME)
 electrostatic filter only
 pleated filter only
 electrostatic filter with HME
 pleated filter with HME.

23. HME filters Raw material & Market size
• These are the materials used in the
manufacturing
of HME filters
 Polyethersulphone (PES)
 Cellulose Acetate
 Teflon (Polytetrafluoroethylene)
 Polyamide (Nylon)
 Cellulose Nitrate (Collodion)
 Polycarbonate
• The HME filters market is expected to register
a CAGR of 4% during the forecast period
2022-2032 and the expected revenue of USD
269.2 million from to cross USD 398.4
million in 2032

24. Summary
• The Global Artificial Organ Market size is expected to grow from USD 26.21 billion
in 2023 to USD 39.83 billion by 2028, at a CAGR of 8.73% during the forecast
period (2023-2028).
• The key drivers of the market for artificial organs and bionics are the increasing
number of transplants, coupled with the rising number of people waiting for donors.
• As many as 3.17 lakh patients are waiting for a kidney, liver, heart, lung or pancreas
transplant in the country as per the data released by the Indian Society of Organ
Transplants (ISOT).
• Key players
Abbott Diabetes Care, Asahi Kasei Kuraray Medical Co. Ltd, Gambro AB,
AbioMed, Baxter International, Otto Bock Healthcare, Thoratec Corporation,
WorldHeart Corporation, and SynCardia Systems, Inc.