1

The Basics of Artificial Organs

C H A R L E S G. G E B E L E I N

Department of Chemistry, Youngstown State University, Youngstown, O H 44555

The primary purpose of this paper is to review

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the types of devices that are currently used in the

human body as artificial organs and prosthetic
devices. By definition, an organ is a specialized
structure (e.g. heart, kidney, limb, leaf, flower)
Downloaded via 47.31.151.151 on December 30, 2019 at 11:06:11 (UTC).

in an animal or a plant that can perform some

specialized function. Most parts of the human body
can be classed as organs. These varied parts some-
times become defective and must be replaced by an
artifical organ or a prosthetic device. In almost
all cases, these replacement devices are constructed
of natural or synthetic polymeric materials. Such
biomaterials must exhibit good compatibility with
the blood and the body fluids and tissues with which
they come into contact. In addition, the artificial
device must closely duplicate the function of the
natural organ. In practice, these artificial devices
are constructed from a wide variety of materials such
as metals, ceramics (including glass and carbon),
natural tissues (actually polymeric in nature), and
synthetic polymers. Partly due to the wider range of
properties available, most of these artificial devices
are constructed wholely or partly from natural or
synthetic polymers. Obviously the same polymer could
not be used for all possible artificial organs or
prosthetic devices. Rather, the material to be used
must be matched to the specific use requirements.
Artificial organs can conveniently be classed into
four groups: (I) Bone/Joint Replacements (e.g. hip,
knee, finger, total limb), (II) Skin/Soft Tissue
Replacements (e.g. skin, breast, muscle), (III) Inter-
nal Organs (e.g. heart, kidney, blood vessels, liver,
pancreas), and (IV) Sensory Organs (e.g. eye, ear).
This paper will consider the basic requirements for
some of these artificial organs and will discuss the

0097-6156/ 84/ 0256 0001 $06.00/ 0

© 1984 American Chemical Society

Gebelein; Polymeric Materials and Artificial Organs

ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
2 POLYMERIC MATERIALS A N D ARTIFICIAL ORGANS

various polymeric materials that are used. The

greatest emphasis will be on the chemistry and
biomaterial requirements of the artificial internal
organs.
The primary purpose o f t h i s chapter i s t o review t h e types
of devices t h a t a r e being used i n t h e human body a t t h e present
time as a r t i f i c i a l organs, p r o s t h e t i c devices or general implants.
Subsequent chapters i n t h i s book w i l l consider some o f these
d e v i c e s , e t c . i n more d e t a i l . I n a s i m i l a r manner, other papers
consider t h e various polymeric and non-polymeric m a t e r i a l s t h a t
are used and d i s c u s s t h e s p e c i a l i z e d requirements f o r these ap-
p l i c a t i o n s . These areas a r e covered i n t h i s paper o n l y s l i g h t l y
s i n c e they a r e d i s c u s s e d i n d e t a i l elsewhere.
An a r t i f i c i a l organ c l e a r l y i s a replacement f o r a n a t u r a l
organ i n t h e body. The d i c t i o n a r y d e f i n e s an organ as "a d i f f e r -
e n t i a t e d s t r u c t u r e (as a h e a r t , kidney, l e a f , flower) i n an
animal or p l a n t made up o f various c e l l s and t i s s u e s and adapted
for t h e performance o f some s p e c i f i c f u n c t i o n . . . " Although t h i s
d e f i n i t i o n might be modified somewhat i n a medical textbook, i t
w i l l serve t o cover and i l l u s t r a t e t h e range i n a p p l i c a t i o n s and
p r o p e r t i e s t h a t occur i n t h i s r a t h e r s p e c i a l i z e d f i e l d . Most
parts o f t h e human body can be c l a s s e d as an organ by t h i s d e f i -
n i t i o n and c o u l d , p o t e n t i a l l y , be r e p l a c e d by an a r t i f i c i a l
organ or by a p r o s t h e t i c / b i o m e d i c a l d e v i c e . This c o n s t i t u t e s a
very broad range o f f u n c t i o n s and p r o p e r t i e s which a r e o f t e n o f
an opposing nature and hundreds o f s p e c i f i c devices have been
t r i e d as replacement p a r t s , o f t e n w i t h l i m i t e d success. P a r t o f
t h i s problem i s due t o t h e f a c t t h a t t h e requirements f o r each
device a r e h i g h l y s p e c i f i c and t h e m a t e r i a l s used must meet these
v a r i e d s p e c i f i c a t i o n s . Obviously, t h e m a t e r i a l used t o r e p l a c e a
bone or a j o i n t would not be a l i k e l y candidate f o r an a r t i f i c i a l
s k i n or a s o f t t i s s u e replacement merely on t h e b a s i s o f t h e
d i f f e r e n t p h y s i c a l c h a r a c t e r i s t i c s o f each type o f b i o m a t e r i a l .
Superimposed on t h i s general requirement i s t h e f a c t t h a t t h e
body has been designed t o d e t e c t , a t t a c k and/or r e j e c t any
f o r e i g n m a t e r i a l s t h a t come i n t o contact w i t h t h e bodies t i s s u e s
and most s y n t h e t i c m a t e r i a l s a r e not compatible w i t h t h e v a r i o u s
t i s s u e s , f l u i d and t h e blood o f t h e human body. N a t u r a l mate-
r i a l s , on t h e other hand, u s u a l l y e l i c i t an even more severe
r e j e c t i o n response from t h e body although some n a t u r a l t i s s u e s
have been modified by v a r i o u s chemical treatments which enable
them t o be t o l e r a t e d t o some extent (e.g. treatment o f r e p l a c e -
ment porcine heart valves w i t h g l y c e r o l or an aldehyde). This
problem i s e s p e c i a l l y evident i n the r e l a t e d area o f organ
t r a n s p l a n t a t i o n . P a r t l y f o r t h i s reason, e s s e n t i a l l y a l l t h e
a r t i f i c i a l organs, p r o s t h e t i c devices and/or implants a r e made
from ceramics (which could a l s o i n c l u d e v a r i o u s glasses and some
s p e c i a l forms o f carbon), metals or s y n t h e t i c polymers. Because
the polymeric m a t e r i a l s (both n a t u r a l and s y n t h e t i c ) have a wider

Gebelein; Polymeric Materials and Artificial Organs

ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
1. GEBELEIN The Basics of Artificial Organs 3

range o f p r o p e r t i e s t h a t are needed i n these v a r i e d a p p l i c a t i o n s ,

and because they are a l s o more compatible, i n some cases, w i t h
the body t i s s u e s than the other c l a s s e s o f m a t e r i a l s , polymers
are the most w i d e l y used type o f m a t e r i a l i n t h i s f i e l d .
I t i s not p o s s i b l e t o cover a l l aspects o f a r t i f i c i a l organs
i n t h i s short paper and f u r t h e r i n f o r m a t i o n and references can be
found i n some recent review a r t i c l e s and books (1-18). I n t h i s
paper we w i l l o u t l i n e the nature o f the devices and m a t e r i a l s
c u r r e n t l y used as a r t i f i c i a l organs. For convenience these w i l l
be subdivided i n t o the c a t e g o r i e s of: ( i ) Bone/Joint Replace-
ment; ( I I ) S k i n / S o f t Tissue Replacements; ( i l l ) I n t e r n a l Organs;
and (IV) Sensory Organs.

Type ( i ) - Bone/Joint Replacements

In many cases i t i s necessary t o r e p l a c e a d e f e c t i v e j o i n t

w i t h a p r o s t h e t i c device t o a l l e v i a t e a c o n d i t i o n caused by an
accident or a degenerative disease. J o i n t replacements must meet
some s p e c i f i c requirements i n c l u d i n g : (a) maintainance o f normal
j o i n t space; (b) good, steady, n a t u r a l motion; (c) f i r m and
'permanent' f i x a t i o n ; (d) r e a d i l y l u b r i c a t e d ; (e) s t r e s s and
e r o s i o n r e s i s t a n t ; and ( f ) bi©compatibility.
Most j o i n t replacements u t i l i z e polymers t o some extent.
Finger j o i n t s u s u a l l y are replaced w i t h a p o l y ( d i m e t h y l s i l o x a n e )
i n s e r t and over ^00,000 such replacements are made each year ( l ) .
More r e c e n t l y a poly(l,U-hexadiene) polymer has been t r i e d i n
t h i s a p p l i c a t i o n ( l ) . Many other parts o f the hand, such as t h e
bones, have a l s o been replaced by s i l i c o n e rubber. Other types
of j o i n t s , such as the h i p or the knee, o f t e n i n v o l v e the contact
of a metal b a l l o r r i d e r on a p l a s t i c s u r f a c e which i s u s u a l l y
made from high d e n s i t y , high molecular weight polyethylene. These
metal and p l a s t i c parts are u s u a l l y anchored i n the body u s i n g a
'cement' o f poly(methyl methacrylate) which i s polymerized i n
s i t u . F u l l and p a r t i a l h i p prostheses are implanted about
250,000 times a n n u a l l y w h i l e the knee replacement occurs about
100,000 times each year ( 5 ) . The major problems t h a t occur i n
j o i n t replacement are: (a) wear w i t h p a t i e n t i r r i t a t i o n due t o
the d e b r i s , and (b) loosening o f the p r o s t h e s i s which r e s u l t s i n
unsteady motion and increased wear ( l , 19, 2 0 ) . I n some cases,
i n j u r y , genetic defects or sickness r e q u i r e s the complete or
p a r t i a l replacement o f an upper or lower limb. The d i f f i c u l t y o f
o b t a i n i n g an adequately working p r o s t h e s i s increases markedly
w i t h the amount o f the limb t h a t must be r e p l a c e d . I n other words,
i t i s more d i f f i c u l t t o design a s a t i s f a c t o r y p r o s t h e s i s f o r an
arm than f o r a hand. I n a d d i t i o n , f u n c t i o n a l lower limb r e p l a c e -
ments are more d i f f i c u l t t o achieve than are upper limb r e p l a c e -
ments. This i s due, i n p a r t , t o the f a c t t h a t w h i l e many o f the
upper limb f u n c t i o n s can be done w i t h only one limb, the primary
f u n c t i o n o f the lower l i m b s , walking, cannot. A number o f p a r t i a l
or t o t a l prostheses do, however, e x i s t f o r lower limb replacement

Gebelein; Polymeric Materials and Artificial Organs

ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
4 POLYMERIC MATERIALS AND ARTIFICIAL ORGANS

which can be u t i l i z e d t o permit a reasonable degree of locomo-

t i o n . Some of these devices u t i l i z e h y d r a u l i c knee j o i n t s as
p a r t of the design (21-2U). Upper limb replacement can be e i t h e r
cosmetic and/or f u n c t i o n a l . Normally when only one upper limb i s
r e p l a c e d , the p a t i e n t does the m a j o r i t y of limb f u n c t i o n s w i t h
the other l i m b , even when t h i s had been the non-dominant arm,
because the a r t i f i c i a l limb does not f u n c t i o n n e a r l y as w e l l as
the n a t u r a l one. The more recent m y o e l e c t r i c a c t i v a t e d devices
show much promise toward d u p l i c a t i n g the f u n c t i o n of a n a t u r a l
arm or hand but much remains t o be done i n t h i s area (2^-26).

Type ( I I ) - S k i n / S o f t Tissue Replacement

The s k i n i s the l a r g e s t organ i n the body from the stand-

p o i n t of weight or volume. At the present time t h e r e i s no
m a t e r i a l t h a t can d u p l i c a t e t h i s complex organ i n a l l i t s
f u n c t i o n s but over 100,000 people are h o s p i t a l i z e d a n n u a l l y w i t h
severe s k i n damage (burns, a c c i d e n t s , e t c . ) t h a t r e q u i r e s immedi-
ate treatment t o prevent gross b a c t e r i a l contamination and/or the
l o s s of body f l u i d s and e l e c t r o l y t e s . The most promising ap-
proach t o t h i s problem has u t i l i z e d a composite system c o n s i s t i n g
of a collagen-glycosaminoglycan inner membrane w i t h a s i l i c o n e
rubber outer l a y e r (27). Other approaches have i n c l u d e d dextran
hydrogels (28), v a r i o u s polypeptides (29), and c o l l a g e n (30).
These m a t e r i a l s attempt t o d u p l i c a t e the b a r r i e r p r o p e r t i e s of
the s k i n w i t h good success, but no m a t e r i a l has yet been a b l e t o
d u p l i c a t e the other s k i n f u n c t i o n s and a t r u e a r t i f i c i a l s k i n
does not yet e x i s t .
A l a r g e p o r t i o n of the human body i s composed of s o f t
t i s s u e s i n c l u d i n g muscles, f a t t y t i s s u e s and connective t i s s u e s .
The general area of p l a s t i c and/or r e c o n s t r u c t i v e surgery
i n v o l v e s t h i s type of t i s s u e t o a l a r g e extent. Each year t h e r e
are a t l e a s t 200,000 breast prostheses and/or augumentations (T),
200,000 f a c i a l p l a s t i c s u r g e r i e s ( l ) , and 35,000 h e r n i a r e p a i r s
conducted (15). A s a t i s f a c t o r y s o f t t i s s u e m a t e r i a l must have
s u i t a b l e long-term, p h y s i c a l p r o p e r t i e s ( s o f t and/or r u b b e r y ) ,
and not cause any adverse e f f e c t i n the p a t i e n t . Very few
m a t e r i a l s can meet these general (and some other s p e c i f i c ) r e -
quirements. For example, sponges and t e x t i l e s might have s u i t a b l e
" s o f t n e s s " but the ingrowth of f i b r o u s t i s s u e q u i c k l y renders
these m a t e r i a l s u n s a t i s f a c t o r y s i n c e the implant becomes more
r i g i d or hard a f t e r t h i s ingrowth. While many m a t e r i a l s have
been t r i e d f o r s o f t t i s s u e replacement, the most common one i s
p o l y ( d i m e t h y l s i l o x a n e ) which can be made i n the form of rubbery
1
g e l s , tubes and/or sheets w i t h v a r y i n g degrees of ' s t i f f n e s s
produced by v a r y i n g l e v e l s of c r o s s l i n k i n g . Some l i m i t e d use has
been found f o r p o l y e t h y l e n e , polyurethane and the s y n t h e t i c
rubbers ( l , 15, 31-33).

Gebelein; Polymeric Materials and Artificial Organs

ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
1. GEBELE1N The Basics of Artificial Organs 5

Type ( i l l ) - I n t e r n a l Organs

The area o f a r t i f i c i a l i n t e r n a l organs i n c l u d e s t h e h e a r t ,

lungs, l i v e r , kidneys, pancreas, blood v e s s e l s and the g a s t r o -
i n t e s t i n a l t r a c t . I n a d d i t i o n t o t h e obvious requirements o f
blood and t i s s u e c o m p a t i b i l i t y , these replacements o f t e n have
h i g h l y s p e c i a l i z e d f u n c t i o n s which are almost impossible t o
d u p l i c a t e w i t h man-made m a t e r i a l s . N e v e r t h e l e s s , i t i s o f t e n
necessary t o augment or r e p l a c e t h e f u n c t i o n o f these organs.
Over 100,000 pacemakers are implanted a n n u a l l y t o r e g u l a t e
the heart beat and these devices a r e u s u a l l y polymer coated t o
p r o t e c t t h e e l e c t r o n i c p o r t i o n s from t h e body f l u i d s . Pace-
makers have been used e x p e r i m e n t a l l y i n animals s i n c e 1932 and
have been used i n humans s i n c e 1952 t o t r e a t Stokes-Adams
disease (heart b l o c k ) . Implantable pacemakers were f i r s t used i n
1958. The more recent v e r s i o n s o f these devices are capable o f
v a r y i n g t h e heart beat r a t e (3^, 35).
While t h e r e a r e four valves i n t h e h e a r t , almost a l l t h e
replacements a r e done on e i t h e r t h e a o r t i c or m i t r a l v a l v e s . A
wide v a r i e t y o f designs have been devised f o r these v a l v e r e -
placements u t i l i z i n g many n a t u r a l and s y n t h e t i c polymers. The
major types o f m a t e r i a l s used are p o r c i n e v a l v e s , which have been
p r e t r e a t e d w i t h g l y c e r o l or an aldehyde t o reduce immune
responses, polymeric m a t e r i a l s , such as s i l i c o n e rubber, t e t r a -
f l u o r o e t h y l e n e and Dacron®, metals and some ceramics ( e s p e c i a l l y
c e r t a i n types o f carbon). The most common designs f o r t h e
devices u s i n g s y n t h e t i c polymers c o n t a i n a b a l l i n a cage or some
form o f a d i s c i n a cage. I n some cases, human dura mater has
been u t i l i z e d as a v a l v e m a t e r i a l . Over 30,000 heart v a l v e
replacements a r e made a n n u a l l y . I n n e a r l y a l l cases, t h e p a t i e n t
must r e c e i v e r e g u l a r a n t i - c o a g u l a n t medication f o r the remainder
of t h e i r l i f e i n order t o avoid blood c l o t s ( l , 30, 36-38).
In 1980, over 110,000 coronary a r t e r y bypass operations were
performed i n t h e United States alone ( 5 ) . I n a d d i t i o n , t h e r e
were a l a r g e number o f other blood v e s s e l replacements and/or
r e p a i r s done w i t h t h e t o t a l being i n excess o f 200,000. While
much o f t h i s surgery i s done u s i n g n a t u r a l m a t e r i a l s (autogeneous
blood v e s s e l s when p o s s i b l e ) , a l a r g e p o r t i o n o f t h i s surgery
u t i l i z e s s y n t h e t i c polymers. These a r e u s u a l l y Dacron®, i n t h e
form o f k n i t t e d or woven tubes, or p o l y t e t r a f l u o r o e t h y l e n e , i n
the form o f a 'micro-expanded tube.' While t h e n a t u r a l blood
v e s s e l s might seem p r e f e r a b l e , i n cases of advanced disease t h e
other v e s s e l s o f t h e body are o f t e n d e f e c t i v e and would not be
s u i t a b l e replacement m a t e r i a l s . A good example would be t h e
saphenous v e i n s , which are commonly used i n heart bypass surgery,
but f r e q u e n t l y a r e t o o weak or blocked t o be used i n some
p a t i e n t s . For t h i s reason s y n t h e t i c m a t e r i a l s a r e e s s e n t i a l .
The use o f woven or k n i t t e d Dacron® blood v e s s e l prostheses dates
from t h e p i o n e e r i n g work of DeBakey i n 1951 and t h i s m a t e r i a l i s
f r e q u e n t l y t h e p r o s t h e s i s o f choice among many heart surgeons

Gebelein; Polymeric Materials and Artificial Organs

ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
6 POLYMERIC MATERIALS AND ARTIFICIAL ORGANS

(39). These Dacron® prostheses can only be used f o r v e s s e l s 6 mm

or l a r g e r . The mode of operation i n v o l v e s i m p l a n t i n g the pros-
t h e s i s whose open pores r a p i d l y become f i l l e d or clogged w i t h a
thrombus (blood c l o t ) which i s then g r a d u a l l y r e p l a c e d by a new
t i s s u e c a l l e d neointima. I t i s t h i s neointima t h a t e v e n t u a l l y
contacts the blood r a t h e r than the thrombogenic Dacron®. The
neointima appears t o be s i m i l a r i n i t s composition t o the n a t u r a l
blood v e s s e l m a t e r i a l . In tubes much s m a l l e r than 6 mm, the
neointima blocks o f f the v e s s e l t o a great extent.
The use of expanded t e t r a f l u o r o e t h y l e n e (PTFE) prostheses
(Gore-Tex®) has permitted the replacement of v e s s e l s as s m a l l as
k mm. The neointima l a y e r i s t h i n n e r i n t h i s system. E x p e r i -
mental work i n dogs has used PTFE v e s s e l s as s m a l l as 3 mm
s u c c e s s f u l l y (k0
9 hi). U n f o r t u n a t e l y , most of the blood v e s s e l s
i n the human body are s m a l l e r than t h i s s i z e and no s u i t a b l e
m a t e r i a l i s yet a v a i l a b l e although many experimental m a t e r i a l s
show considerable promise. These i n c l u d e various hydrogels (12)
and c e r t a i n polyether polyurethane ureas (PEUUs) (^2, 43).
Over a m i l l i o n deaths occur a n n u a l l y i n the USA due t o heart
disease and over 500,000 are h o s p i t a l i z e d each year w i t h heart
a t t a c k s ( l ) . C e r t a i n l y one of the most s p e c t a c u l a r type of
operations i n v o l v e s the t o t a l replacement of the heart. Most
g e n e r a l l y , t h i s i s done by means of a t r a n s p l a n t from a human
donor. For obvious reasons, the replacement organ i s not r e a d i l y
a v a i l a b l e . Animal hearts (or other organs) are r a p i d l y r e j e c t e d
by the human body. Much research has been done t o develop a
t o t a l a r t i f i c i a l heart (TAH) or a p a r t i a l a s s i s t device ( l e f t
v e n t r i c u l a r a s s i s t d e v i c e ; LVAD) and some success has been
achieved i n t h i s area. For example, cows have been kept a l i v e
for over seven months w i t h a TAH. In most cases, the TAH c o n s i s t s
of a p a i r of LVADs. The LVAD i t s e l f i s designed t o permit a
p a r t i a l r e s t f o r a working heart and thereby permit h e a l i n g t o
occur more r e a d i l y . While the LVADs and TAHs are u s u a l l y implant-
ed, the devices are powered and c o n t r o l l e d e x t e r n a l l y . Many
d i f f e r e n t polymeric m a t e r i a l s have been t r i e d i n these d e v i c e s ,
but the most w i d e l y used one, at present, i s a p o l y e t h e r p o l y -
urethane which i s used i n the pumping diaphram and the l i n i n g of
the pump chamber which contacts the blood. This polyether p o l y -
urethane has f a i r blood c o m p a t i b i l i t y and does show s u f f i c i e n t
d u r a b i l i t y t o undergo the 36+ m i l l i o n f l e x i n g s which would occur
i n a blood pump each year of use. (Most m a t e r i a l s cannot achieve
t h i s v a l u e ; the d e s i r e d d u r a t i o n of use i s p r o j e c t e d t o be at
l e a s t t e n y e a r s , or 360+ m i l l i o n f l e x i n g s . ) Other s y n t h e t i c
polymers t h a t have been t r i e d f o r t h i s a p p l i c a t i o n i n c l u d e
s i l i c o n e rubber, p o l y v i n y l c h l o r i d e ( p l a s t i c i z e d ) , n a t u r a l rubber
and some s y n t h e t i c rubbers such as p o l y ( 1 , 4 - h e x a d i e n e ) .
The TAH has been used three times i n humans. In the f i r s t
two cases (1969 and 1981) the TAH was used t o maintain l i f e u n t i l
a heart t r a n s p l a n t could be made a few days l a t e r . The t h i r d
case, Dr. Barney C l a r k , i n v o l v e d the permanent replacement of the

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1. GEBELEIN The Basics of Artificial Organs 1

human heart w i t h t h e TAH, and t h e device kept him a l i v e f o r about

three a d d i t i o n a l months. (Death was due t o other causes r a t h e r
than f a i l u r e o f t h e TAH.) I t i s h i g h l y l i k e l y t h a t t h i s , o r
s i m i l a r d e v i c e s , w i l l be used many times i n t h e f u t u r e ( l , 11,
U5-U7).
The most w i d e l y used heart a s s i s t d e v i c e , other than t h e
h e a r t - l u n g machine r o u t i n e l y used i n surgery, i s t h e i n t r a a o r t i c
b a l l o o n pump (IABP) which c o n s i s t s o f a PEUU b a l l o o n mounted on a
hollow c a t h e t e r . The IABP i s i n s e r t e d i n t o t h e a o r t a v i a t h e
femoral a r t e r y and i s then expanded and c o n t r a c t e d by an e x t e r n a l
pumping system t o match t h e heart beat. While t h i s device does
provide s i g n i f i c a n t improvement i n c i r c u l a t i o n and a l s o allows
the heart t o r e s t p a r t i a l l y a f t e r a myocardial i n f a r c t i o n , t h e
m o r t a l i t y r a t e i s s t i l l 65"90% ( 4 8 ) .
Over 40,000 people i n t h e United S t a t e s , and over 100,000
people worldwide, were maintained on d i a l y s i s u n i t s i n 1982 ( l ) .
In a d d i t i o n , many others were placed on t h i s d e v i c e , which i s
commonly c a l l e d an a r t i f i c i a l kidney, f o r b r i e f periods o f time
i n order t o c o r r e c t a temporary problem. The a r t i f i c i a l kidney
i s an e x t r a c o r p o r e a l device which c o n s i s t s o f a d i a l y s i s membrane
u n i t and various t u b i n g , pumping and r e g u l a t i n g equipment, which
i s used t o remove t h e waste m a t e r i a l s from t h e blood and thereby
mimics t h e o p e r a t i o n o f a h e a l t h y kidney. The p r e f e r r e d t r e a t -
ment f o r a d e f e c t i v e kidney i s a c t u a l l y t r a n s p l a n t a t i o n , which
was f i r s t done i n 1954. Although a person can f u n c t i o n s a t i s -
f a c t o r i l y w i t h only one kidney, a t r a n s p l a n t e d organ w i l l be
r e j e c t e d by t h e r e c i p i e n t unless c a r e f u l t i s s u e matching i s done.
While t h e newer immunosuppressant drugs, such as c y c l o s p o r i n , have
aided g r e a t l y i n p e r m i t t i n g greater success i n organ t r a n s p l a n t a -
t i o n , t h e number o f a v a i l a b l e organs remains w e l l below t h e
demand. For t h i s reason alone, many p a t i e n t s remain on d i a l y s i s
f o r many years. I n recent y e a r s , p o r t a b l e or wearable devices
have been developed which a l l o w t h e p a t i e n t c o n s i d e r a b l e m o b i l i t y
compared w i t h t h e past but t h e d i a l y s i s device leaves much t o be
d e s i r e d as an i d e a l replacement f o r t h e kidney. U n f o r t u n a t e l y ,
i t appears u n l i k e l y t h a t a s a t i s f a c t o r y , implantable 'true'
a r t i f i c i a l kidney w i l l be developed i n t h e near f u t u r e . The
present devices u t i l i z e polymers i n t h e t u b i n g ( u s u a l l y s i l i c o n e
rubber, p o l y ( v i n y l c h l o r i d e ) or p o l y e t h y l e n e ; t h e t u b i n g i s
e i t h e r t r e a t e d w i t h heparin o r heparin i s added t o t h e blood
d u r i n g use t o prevent c l o t t i n g ) and i n t h e membrane i t s e l f
( u s u a l l y c e l l u l o s i c although p o l y a c r y l o n i t r i l e has been used i n
the hollow f i b e r type) ( l , 9, 11, I T ) .
The pancreas serves s e v e r a l f u n c t i o n s which i n c l u d e s t h e
s e c r e t i o n o f t h e enzyme i n s u l i n which c o n t r o l s blood glucose
metabolism l e v e l . Over a m i l l i o n d i a b e t i c persons must take
i n s u l i n i n j e c t i o n s on a r e g u l a r b a s i s ( l ) . The metabolism con-
t r o l by t h i s method i s e r r a t i c and s e v e r a l r e s e a r c h groups have
been experimenting w i t h polymeric i n f u s i o n pumps i n order t o
c o n t r o l the i n s u l i n l e v e l (and thus t h e glucose l e v e l ) more

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ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
8 POLYMERIC MATERIALS AND ARTIFICIAL ORGANS

c l o s e l y . I f such a device would be coupled w i t h an implanted

glucose sensor, the extent o f c o n t r o l could approach t h a t o f a
h e a l t h y pancreas, except f o r i n s u l i n s y n t h e s i s ( l , 4 9 ) .
No implantable, a r t i f i c i a l lungs e x i s t a t t h i s time but some
research has been done on polymeric membranes t h a t could be used
i n such a device. E x t r a c o r p o r e a l blood oxygenators a r e , however,
used i n excess o f 100,000 times a year ( l ) and c o n t a i n a t h i n ,
polymeric membrane t h r u which O2 and CO2 are exchanged. These
oxygenators, which e x i s t i n s e v e r a l d i f f e r e n t s t y l e s are w i d e l y
used i n by-pass and other operations. The main polymers used
are s i l i c o n e rubber but p o l y ( a l k y l s u l f o n e s ) and some others show
promise ( l , 50, 5 l ) .
The l i v e r i s the main d e t o x i f i c a t i o n organ i n the body and
t h e r e f o r e comes i n t o contact w i t h n e a r l y every poison and t o x i n
t h a t enters the body. These m a t e r i a l s could occur i n case o f
p o i s o n i n g , drug overdose, acute h e p a t i t i s , and a l l e r g i e s . While
no t r u e a r t i f i c i a l l i v e r has been developed, and t r a n s p l a n t a t i o n
i s r a r e and d i f f i c u l t , s e v e r a l approaches have been attempted t o
r e p l a c e and/or a s s i s t the f u n c t i o n o f the l i v e r . The most
common method i s hemoperfusion i n which the blood i s passed
through a column or bed o f some sorbent m a t e r i a l which can remove
the poisons. The sorbents t h a t have been used i n c l u d e c h a r c o a l ,
ion-exchange r e s i n s , a f f i n i t y chromatography r e s i n s , immobilized
enzymes and hepatic m a t e r i a l or pieces o f l i v e r enclosed i n
' a r t i f i c i a l c e l l s ' (9, 52).
Various types o f p l a s t i c t u b i n g have been used t o r e p l a c e
s e c t i o n s of the g a s t r o - i n t e s t i n a l t r a c t or other t u b e - l i k e p a r t s
of the body. These seldom have any f u n c t i o n other than connect-
ing one p a r t of the body w i t h the other. Because of the complex
v a r i e t y o f chemical operations i n v o l v e d , i t i s u n l i k e l y t h a t a
t r u e a r t i f i c i a l GI t r a c t w i l l be developed i n the near f u t u r e
(1,15).

Type (IV) - Sensory Organs

Polymeric m a t e r i a l s have been used t o r e p l a c e the e x t e r n a l

p a r t of the ear ( u s u a l l y s i l i c o n e s ) and a l s o t o r e p l a c e the
o s s i c l e s (PTFE, p o l y e t h y l e n e , s i l i c o n e s ) as w e l l as s e r v i n g as
drainage tubes f o r the ear ( l l ) . In a d d i t i o n some research has
been done i n which e l e c t r o d e s are implanted i n t o the cochlea and
are connected t o an e x t e r n a l microphone. Such devices have been
able t o r e s t o r e a s i g n i f i c a n t amount o f hearing t o deaf people.
P l a s t i c s are used i n these p r i m a r i l y as coatings f o r the wires and
e l e c t r o n i c parts ( l 4 , 53, 5 4 ) .
The most common use o f polymeric m a t e r i a l s i n the eye i s i n
contact lenses which are worn by s e v e r a l m i l l i o n people. Most
s o f t contact lenses are hydrogels made from homo- or copolymers
of hydroxyethyl methacrylate; hard contacts are u s u a l l y made from
p o l y (methyl methacrylate). I n t r a o c u l a r lenses are put i n t o about
600,000 people a n n u a l l y ( 5 ) . These are u s u a l l y made from p o l y

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ACS Symposium Series; American Chemical Society: Washington, DC, 1984.
1. GEBELEIN The Basics of Artificial Organs 9

(methyl methacrylate) although hydrogels are being explored f o r

t h i s use (55). Some research i s a l s o being done t o enable a
b l i n d person t o have some ' s i g h t ' by d i r e c t s t i m u l a t i o n o f t h e
v i s u a l area o f the b r a i n w i t h electrodes connected t o a TV type
camera. At t h e present, t h i s i s l i m i t e d t o t h e c r e a t i o n o f s m a l l
points o f l i g h t ( l 4 , 53, 56).
L i t t l e , i f any, research i s being conducted on the senses o f
s m e l l , touch or t a s t e t h a t involves polymers.
In c o n c l u s i o n , we note that many types o f a r t i f i c i a l organs
have been developed u s i n g a v a r i e t y o f polymeric m a t e r i a l s but
a l l these devices a r e g e n e r a l l y l e s s s a t i s f a c t o r y than t h e
o r i g i n a l , healthy organ. I n most cases, however, t h e a r t i f i c i a l
organ functions s i g n i f i c a n t l y b e t t e r than the d e f e c t i v e organ i t
r e p l a c e s . Much more research i s needed i n t h i s area. The
u l t i m a t e s o l u t i o n w i l l i n v o l v e t h e c r e a t i o n o f newer polymers and
a l s o b e t t e r a r t i f i c i a l organ designs.

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RECEIVED April 23, 1984

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ACS Symposium Series; American Chemical Society: Washington, DC, 1984.