SOFT TISSUE REPLACEMENT'

I: SUTURES, SKIN, AND

MAXILLOFACIAL IMPLANTS

In soft tissue implants as in other applications that involve engineering, the

performance of an implanted device depends on both the materials used and the
design of the device or implant. 7he iniiial selection of material should be based
-
on sound materials enanccrinr- , -
oranice. The final iudement on the suitabilitv
of the material depends on observation of the in uiw clinical performance
of the implant. Such observations may require many years. This requirement of
in viw observation represents one of the major problems in the selection of
appropriate materials for use in the human body. Another problem is that the
performance of an implant may also depend on the design rather than the
materials per se.
The success ofson tissue implants has primarily been due to the development
of synthetic polymers. This is mainly because the-polymers can be tailor-made
to match the properties of sort tissues. In addition, polymers can he made into
various physical forms, such as liquid for filling spaces, fibers for suture materials,
films for catheter balloons. knitted fabrics for blood vessel orostheses. and solid
forms for cosmetic and weight-bearing applications.
It should be rewgnized that diflerent applications require different materials
with specific properties. The following are minimal requirements for all soft tissue
implant materials:
1. They should achieve a reasonably dose approximation of physical proper-
ties, especially flexibility and texture.
2. They should not deteriorate or change properties after implantation with
time.
3. They should not cause adverse tissue reaction.
4. They should be noncarcinogenic, nontoxic, nonallcrgenic. and nonim-
munogenic.
 CHAPTER TI
5. They should be s t c r i l i l e .
6. They should be low cost.
Other important factors are feasibility of mass production, aesthetic quality,
etc.
11.1. SUTURES, SURGICAL TAPES. AND ADHESIVES
The most wmmon soft tissue implants are sutures. In reant years, s u a c a l
-
tapes and tissue adhesives have been added to the surpeon's amamentarium.
Although their use in actual surgery is limited lo some surgical procedures, they
are indispensable.
T h m are two t y p e of sutures, dassificd aa lo their long-term physical in
vlw integrity: absorbable and nonabsorbable. They may also be dislinguishcd
by their raw material source: natural sutured (catgut, silk, and cotton) and
synthetic suture8 (nylon, polyethylene, polypropylene, stainless steel, and tan-
talum). Suture8 may slso be classified aaording to their physical form: monofila-
ment and multifilament
The absorbable suture, catgut, is made of collagen derived from sheep
intestinal submucosa. It is usuallv t m t e d with a chromic salt to increase its
strength and is cross-Hnked to retard resorption. Such treatment extends the life
of catgut suture from 3-7 days up to 20-40 days. Table 11-1 gives initial strength
data for catgut sutures according to Uleir sizes. The catgut sutures are preserved
Tabh 11-1. Minlmum Bmskinp Loads for Brtt1.h-Mode Catgur
SOF TISSUE REPIACEMENT I
with needles in a physiological solution in order to prevent drying, which would
make the sutures very brittle and thus not easily usable.
It is interesting to note that the stress concentration at a surgical knot
decreases the suture strength of catgut by half, no matter what kind of knotting
technique is used. If is suggested that the most effectiveknotting technique is the
square knot with three ties to prevent loosening. According to one study there
is no measurable difference in the rate of wound healing whether the suture is
tied loosely or tightly. Therefore, loosesuturingis recommended because it lessens
pain and reduces ~ t t i n gsoft tissues.
Catgut and other absorbable sutures (e.g., polyglycolic acid, PGA: polylactic
acid, PLA) invoke tissue reactions although the effect diminishes as they are
being absorbed. This is true of other natural, nonabsorbable sutures like silk and
coflon, which showed more reaction than synthetic sutures like polyester, nylon,
polyaqlonitrile. etc. as shown in Figure 11-1. As in the case of the wound
healing process (discussed in Chapter 10). the cellular response is most intensive
one day after suturing and subsides in about a week.
As for the risk of infection, if the suture is contaminated even slightly the
incidence of infection increases manyfold. The most significant factor in infeaion
is the chemical structure, not thegeometric configuration ofthesuture. Polypropy-
lene, nylon, and PGA sutures developed lesser degrees of infection than sutures
made of stainless steel, plain and chromic catgut, and polyester. The ultimate

Mamacr (mm) Minimum bratim lwd (IbO

Size Minlmom M*rimum StnigM pull Ovtr knM

F- L A G.Rmn". "Nmnnl M.meti&,~In
Bunoronb.. London. 1951. pm.
'i
0 6 10
TIME idoysl
Flgure 11.1. Cdluler reswnse lo a m r e d maledall. From R. W. Pastlsthwan. J. F. Schaube.
M r m llnd h sunrcni Momid& L Gilb led.).
M. L Dillon, and J. Mowen. 'Wound Hsalinp. II.An Evaluation ot Surgicsl Suture Matsrisl." Svrg.
Gymcol. Obstst, ICU. 55Ew6, 7959.
 248 CHAPTER 11 .
SOFT TISSUE REPLACEMENT I

SOOl
cause of infection is a pathogenic microorganism, not the biomaterial. The role
-
of the suture in infection is to orovide a wnduit for i n m s s of bacteria to
chemically or physically modify the body's immune response, o r to provide an
environment favorable to baaerial growth. BOND
STRENGTH
11.12. Surgical T a p s and Stapler
Surgical tapes are intended to offer a meana of avoiding pressure necrosis,
scar tissue formation.. -oroblema of stitch abscesses. and weakened tissues. The
l~romsl 400 -

P SYIY..

problems with surgical tapes are similar to those experienced with Band-Aids:
(1) - -
. . misaligned wound edges.. .(2). .Door adhesion caused bv moisture or dirlv
wounds. (3) late separation of taper when hematoma, wound drainage, etc. occur. ,
The wound strength and scar formation in the skin may depend on the type
of incision made. If the subcutaneous muscles in the falty tissue are cut and the
overlying skin is closed with tape, then the muscles retract This in turn increases
the scar area, resulting in poor cosmetic appearance wmpared to a suture closun. Re1 *kin
However, with the higher strength of scar tissue, the taped wound has a higher 0
0 2 4 6 11 10 12 14
wound strength than the sutured wounds only if the muscles were not cut. Because,
of this, tapes have not enjoyed the success that WM anticipated when they were TIME (day0
introduced. Flgure 11-2. Bond strength ot wounds vrith dlffsrent ~ l 0 l W amsterlal. Fmm S. Houston, J. W.
Taoes have been used successfully for aasembiina - s m .m of donor skin for Hodgs. Jr.. 0. K Ousterhour,and F. Lsonard.'The Effectof a-Cyanoaoylats on Wound Hsatlnp."
skin graft, correcting nerve tissues for neural regrowth. etc. J. B i o W . M s l Re*.. 3.281-289. 1m9.
Staoln made of metals (Ta. . . stainless steel. and Ti-Ni allov)
- . can be used to
facilitate closure of large surgical incisions produced in procedures such as
-
cesarean sections. intestinal surnerv. -.
.,and surnerv for bone fractures. The tissue cyanoacrylate are most promising. With the addition of some plasticizers and
fillers they are commercially known as Eastman 910". Crazy Cilue'. etc. An
response to the staples is the same as that of synthetic sutures but they are not
used in places where esthetic outlook is important. interesting wmparison is illustrated in Figure 11-2, which shdws that the bond
strength of adhesive-treated wounds is about half that of sutured wounds after
10 days. Because ofthe lower strcngth and lesser predictability of in vivo perform-
The special environment of tissues and their regenerative capacity make the
ance of adhesives. the aoolication
.. -
is limited to use aner trauma on fragile tissues
such as spleen, liver, and kidney or aner an extensive surgery on soft tissues such
develooment of an ideal tissue adhesive difficult. Past exrnrience indicates that as lung. The topical use of adhesives in plastic surgery and fractured teeth has
the ideal tissue adhesive should be able to he wet and bond to tissues, be capable been moderately successful. As with many other adhesives, the end results of the
of rapid polymerization without producing excessive heat or toxic by-products, bond depend on many variables such as thickness, open porosity, and flexibility
be resorbable as the wounds heal.not to interfere with the normal healina process. of the adhesive film. as well as the rate of degradation.
have ease of application during surgery, be sterilizsble. have adequateshelf life; Some workers have tried to use adhesives derived from fibrinogen. which is
and case of large-scale production. one of the clotting elements of blood. This material has sufficient strength
The main atrcngth of tissue adhesion comes from the wvalent bonding . (0.1 MPa) and elastic modulus (0.15 MPa) to sustain the adhesiveness for the
between amine,carboxylic acid, and hydroxyl g r o u p oftissues, and the functional anastomoses of nerve, microvascular surgery. dural closing, bone graft fixation,
groups of adheaives such as skin gran fixation. and other soft tissue fixation. This material is available
I I I I I wmmercially in Europe and will be in the United States pending FDA approval.
R-G--C- -C- R-C- (11.1)
'
o
\ I
N=O
T h e n are several adhesives available of which alkyl-a-cpnoacrylate is beat A nylon suture was implanted in the abdominal cavify of. dog. The autum was removed
sncr 10 and 20 dam and its averale tearite stren@ was measured. T h e strength decreased
known. Among the homologuea of alkyl-cyanoacrylate. the methyl- and ethyl-2-
?M CHAPTER 11 SOT TISSUE REPLACEMENT I ml

by 40 and SOX. rspcuively. How long will it take for the avendh to dcay 6W of i t l
Many variables and factors are involved in the development of percutaneous
original strength7 Assume an exponential decay of alrength.
devices. These are:
Anmwr 1. End-use factors: Transmission of information (biopotentials, temperature,
Sina the strength derrusea exponemially we can asaume pressure, blood Row rate), energy (electrical stimulation, power for heart
assist devices), matter (cannula for blood), and load (attachmerit of
prosthesis)
2. Engineering factors
a. Materials selection: polymers, ceramics, metals, and composites'
where A, B ere constants, r is time (day.). and v, is the atrnyh at time r and cro ia the b. Design variation: button, tube with and without skirt, porous or smooth
original 81renflh. Therefore. surface, etc.
c. Mechanicnl stresses (soft o r hard tissue interface, porous or smooth
interface)
3. Rioloaical
- factors
a. Implant host: man. dog, hog, rabbit, sheep, a c .
b. lmolant location: abdominal. dorsal. forearm. a c .
4. ~ u m a factors
i
a. Postsurgical care
b. Implantation technique
c. Esthetic outlook
Figure 11-3 shows a simplified cross-sectional view of a generalized percutaneous
device (PD), which can be broken down into five regions:
A. lnterface between epidermis and PD should be completely sealed against
invasion by foreign- organisms.
-
11.2. PERCUTANEOUS AND SKIN IMPLANTS B. lnterface between dermis and PD should reinforce the sealing of (A).
as well as resist mechanical stresses. Due to the relatively large thickness
'Ihe need for permtaneoua (tram o r through the skin) implanta haa been of the dermis, the mechanical aspect is more important at this interface.
accelerated by the advent of artificial kidneys and hearts, and by the need for
prolonged injection of drugs and nutrients. Artificial skin (or dressing) is urgently
..
C. lnterface between hwodermis and PD should reinforce the function of
( 8 ) . The immobilization of the PD against piston action is a primary
needed to maintain the body temperature of severely burned patients. Actual function of (C).
permanent replacement of skin by biomaterials is beyond the capability of today's D. Implant material perse should meet all of the requirements of an implant
technology. for soft tissue replacement.
E. The line where epidermis, air. and PD meet is called a three-phase line
which is similar to (A).
The problem of obtaining a functional and 1 viable l n h r f a a between the
tissue (skin) and an imolant (mrmtaneoua) device is ~rimarilydue to the
following factors. First, al;hough~nitialattachment of the tissue intoihe internti=
of the imolant surface occurs. it cannot be maintained for a long-. ocriod of time.
since the dermal tissue cells turn over continuously and dynamically. Furthermore,
FCurs 11-3. Simp116ed cmss-sactionel
downgrowth of epithelium around the implant (extrusion) or overgrowth of
view of PO-Skin intsrfscss. Fmm A. F.
implant (invagination) occurs. Sewnd, any openings large enough for bacteria wn Racum end J. 8. Park, '%r.
to penetrate may result in infection even though initially there is complete sealing CUlIIneo~eDevices." C R C W t Rm. Bio.
between skin and implant. ang.. 6. 37-77. 1979.
 .
SOFT TISSUE REPLACEMENT I

uie of a pin connector with good provision Tor firm tissue attachment sub-
cutaneously.
No PDs have been completely satisfactory. Nevertheless, some researchers
believe that hydroxyavatite may be a solution tothe vroblem. In one ex~erimcntal
trial, hydroxiapati1e-based PDS showed very little epidermal downgrokth (1 mm
aner 17 months versus 4.6 mm afler 3 months for the siliwne rubber cdntrol ~~~ ~~~

mechankal .tresses among st specimens in dona1 skin of canines. see Figure 11-6) and a high level of sucass
the P D l k i n Inlertsu. From A. rate (over 80% versus less than 50% for the wntroll. The amino acid wntcnts~~~~~~- ~

F. van Recum end - -J..-~

8. Park
~
ofthe tissue capsules formed overthesubcutaneous implantsofthesame mai&ials
"Percutensou. Devices:' CRC showed that the hydroxyavatite
.. site had the same comoosition as the oeriosteum
Crh. Rev. Blosng., 6, 37-77, of the femur while the wntrol site showed a similar composition to that found
in pathological tissues. Some researchers have tried to switch to subcutaneous
implants that can be accessed by a needle Tor peritoneal dialysis as shown in
Figure 11-7.
The stresses acnerated between a cylindrical PD and skin tissue can be
simplified as shown in Figure 11-4. The relative motion of the skin and implant
results in shear stresses. which can be avoided if the imolant floats (or moves) 112.2. Artfficisl Sklns
freely. For this reason, P D without
~ connected leads or caiheten funciion longer.
~ h c r have
c hecn many different PD designs to minimize shcarstrcsrcr. All deliens Artificial skin is another example of a percutaneous implant. and hence the
have centered around creating a good skin tissue/implant attachment in order problems are similar to those described in the previous section. Most needed for
to stabilize the implant. This is done by providing felts, veloun, and other porous this application is a material that can adhere to a lame (burned) surface and
- -
materials at the interface. Figure 11-5 shows a dcsinn to minimize the transfer thus prevent the loss of fluids, electrolytes, and other biomoleculca until the
of stresses and strains to the skin. The device includes an air chamber made of
a rubber balloon (a) interposed between skin and PD. and firmer fixation o i t h e
cannula by providing a large surface for tissue ingrowth (band c). Some designs
have tried to minimize the trauma imposed by the external tubes and wires by

F g u n I I 8 Hlslolo8lcal v i e w ot the csnlns dennel l1s.m adjennt m PD mads of hvdrowpatm

Figure 11-6. Schematic drawlng of a Gmsss-Sieltrup PD. F m m C. Grorss-Slemrup,EnMlcWunp

und Kiinische Erprobungwn HeutdurChlsitunpnVst~In~erm~dlzln, Dltsartstlon. Free Univaniiy.
Aok,. U. Ahso. Y Shm. T. Tsukl. and 1 loo- ~
. ~.
v~ - ,.
Dsvics end Its Clinical Applications." M.d A.og. Techno1 12. 113-220, 1887.
-
(Isfl)and silimns rubbe. lrlght) 3 month ~ost~mpl.mmion(ca. IOOr mspnhimion). Fmm H.
-
,---...-tn. .P..nn+.--u.-
- - .Hrdrnrumlulil.
"Smtand

Berlin. 1978.
 CHAPTER 11
Fwun 11-7.S u ~ m o u prhonael
s dimWi8 awsim d d . Fmm C. KaMitr. 1.K ~ I P. .A Dm.
R. L Stephen. and W. J. KoM. "Subsutnnwus Perhow.1 Cath.ur: ?I Yman hpal-."
O w m . 3,210-117.18lS.
wound has healed. Although a permanent skin implant is needed, it is a long
way from being realized for the same reasons given in the case of percutaneous
implants proper. Presently, autografting and homografting (skin transplants) are
the only methods available as a permanent solution.
In one study, wound closure was achieved by controlling thephysicochemical
5Bty<9\ properties of the wound-covering material (membrane). Six ways were s u ~ e s t e d
2 , lo improve certain physiwchemical and mechanical requirements neassazy in
the design of artificial skin. These are shown schematically in Figure 11-8.
Biomechanical and chemical analysis conducted in this study led to the design
of a cross-linked collagen-polysaccharide (cbondroitin 6-sulfate) composite
membrane chosen for the ease in controlling porosity (5- to 15O-rrm diameter),
flexibility (by varying cross-link density). and moisture flux rate.
Several polymeric materials including rewnstituted mllagen have also been
tried as bum dressings. Among them ate the c o.~ o.l y m mof vinyl chloride and
acetate and methyl-2&anoacGlate. The methyl-2-cyanoacrylat; was found to
be too brittle and histotoxic for use as a bum dressing. The ingrowth of tissue
into the p o r n of sponge (lvalon", polyvinyl alcohol), and woven fabric (nylon
and silicone tubber velour) was also attempted without much success. Plastic
tapes have sometimes been used to hold skin g r a b during microtoming (ultrathin
sectioning) and grafting procedures. For severe bums the immersion of the patient
SOIFT TISSUE REPLLICEMENT I
Flgvn 17-8. Schematic repmentation (not
dramtoscab) of certain physicoehsmical and
(b) Flexure1 rlgiditq of grafl la excessive; grafl
does not deform suficienHy under iU ovm
W i g M to mskl) contact wilh dsprsasions in
wound bad surface, and air pockets (arrow)
result. (c) Shear nrssssr (arrows) cauaa buck-
-
mechanical raquirsmants in the design of an Wwnd bed'
sffecliva wound closure. (a) Skin grsft (hatch-
ingl d w r not displace sir pockets ( a m )
efficiently fmm the greft-wound bed intsrfsca.
a
- l 4 & - - h
c
8
, I
7
P
f
8
d '
m6
ling of graft, ruptures of the grsh-wound bed bond. and formnion of air pocXst. (d) Peeling tor-
P iifn grsh away from wound bed. (a) Excsrsivaly Kwh molstun flux mts thmugh grew causes
dehydration and development of shrinkage streesss at edger (arms),which caurs lin-otf sway
fmm wound bed. (1) Vary low moisture flux J causes accumulation (edema) at the graft-wound
bed lntarfscs and pasling off (snows). From I. V. Ysnnas and J. F. Burke. Daslgn of an anifidal
ski-I. Desic design principla. J. Biomsd. Marsr. R e . 14.0561. 1980.
into siliwnc fluid was found to be beneficial for prevention of early fluid loss,
decubitus ulcers, and reduction of pain.
Rapid epithelial layer growth by culturing cells in vilm from the skin of the
bum patient for covering the wound area may offer a better solution.
Anif.
11.3. MAXILLOFACIAL AN0 OTHER SOW-TISSUE AUGMENTATION
In the previous section we have dealt with problems associated with wound
closing and wound/tissue interfacial implants. In this section we will study
(cosmetic) rewnstructive implants. Although son-tissue implants can be divided
into (1) space filler, (2) mechanical support, and (3) fluid carrier or storer. most
have two or more combined functions. For example, breast implants fill space
and provide mechanical support.
11.3.1. Maxlllofaciel lmplanta
There are two types ofmaxillofacial implant (often called prosthetics. which
implies extracomreal attachment) materials: extraoral and intraoral. The latter
is defined as "the a n and science of anatomic, functional or cosmetic reconstruc-
-
tion bv means of artificial substitutes of those renions in the maxilla. mandible.
and face that are missing or defective because of surgical intervention, trauma,
etC.+*
There are many polymeric materials available for the extraoral implank
which requires: (1) color and texture should be matched with those ofthe patient,
(2) it should be mechanically and chemically stable, i.e.. it should not creep or
change colors or initale %kin, and (3) it should be easily fahricaled. ~ o l y ~ i n ~ l
chloride and acetale (5-20%) copolymen. -~olymelhyl
. methamlate. silicone. and
polyurelhane rubbers are currently~used.
 2W CHAPTER 11

The requirements for the inhnoral implants are the same as for other implant
-
SOFT TISSUE REPLACEMENT I

Handle of rndlena

materials, since they are in fact implanted. For maxillary. mandibular, and facial
bone dcficts, metallic materials s;ch as tantalum, titanium, and C & C ~alloys.
elc. are used. For son tissues like gum and chin, polymer8 such as siliwne rubber,
PMMA, nc. are used for the augmentation.
The use of inicctable siliwncs that . -
wlvmerire In mN has m v e n nartiallv
successful for wrrecting facial deformities. Although this is obviously a bener
approach in terms of the minimal initial surgical damage, this procedure was not
accepted due to the tissue reaction and the cvenlual displacement or migration
of the implant.

11.3.2. Ear end Eys Implants

The use of implants can restore the wnductivc hearing loss from otasclemsis
(a heredity defect that involves a change in the bony tissueofthe ear) and chronic
otitis media (the inflammation of the middle car, which may cause partial or
wmpletc impairment of the ossicular chain: malleus, incus, and stapes). Many
different prostheses are available to wrrect the defects. some of which are shown
in Rgure 11-9. The porous polyethylene total ossicular replacement implant is
-
used to obtain a firm fixation of the imolant bv tissue intnowth. The tilt-ton
implant is designed to retard tissue ingrowth into the section of the shaR which
may diminish sound conduction.
Many different materials have been tried in fabricating implants: polyletra-
fluoroethylenc, polyethylene, siliwne rubber, stainless steel, and tantalum. More
recently, polytetrafluorocthylenc-carbon wmposite (Roplam"), porous poly-
ethylene (Plastipore"), and pyrolytic carbon (Fyrolite') have been shown to be b u m 11-9.Proslheses for ma rscon.trunion d the ossicla. (a) PTFE "piaton" slaps. pronheeis
suitable materials for cochlear (inner ear) implants. of J. J. She.. F. Ssnabda. and 0. D. L. Smyth (Arch O I o i ~ ~ I76.61G-621.
. . 1532).(b) Incus
rsplammem poathsaia d Sharhy [in Hearing Loas--Robbrns in Diagnosis and Traatmsnf I.. R.
Artificial ear implants capable of processing speech have been developed
Boise pd.). W. 8. Saundsn Co.. Philedslphia. 1539,p. 1411. (el J. R. Tabor prostharls for raplaes-
and are undergoing clinical evaluation. These types of mehlear implants have men1 of *ole oasiculsr chain (Arch. Otolaryngoi.. 81. 141-148. 1970).(d) Pomua poWhylsna
electrodes that stimulate the cochlear nerve cells. The implant also has a speech total ossicular rsplacsmml pornhesir (Smith L Nephew. Richard Medlcal Co.. Technical Publ.
processor that transforms sound waves into electrical impulses that can be No. 4140. Memphis. Tenn.. 1980).
conducted through coupled external and internal wils asshown in Figure 11-10. arc again the major drawbacks of intraomlar lens implants, as for the wrneal
The electrical impulses can be transmitted directly by means of a PD. implants. The intraocular lens can damage the soft structures to which it is
Eye implants are used to restore the functionalitv of the wrnca and lens attached, and it can become dislodged. Nevertheless, this type of cataract surgery
when ;hey ;re damaged or diseased. Usually the corn& is transplanted from a has become wmmonplace, and many such implantation procedures are success-
suitable donor rather than implanted since the longevity of the cornea implant fully canducted.
is uncertain because of fixation problems and infection. F i y r e 11-11 s h o w somc Rccentlv. somc researchen have tried to d e v e l o ~an artificial eve for ~ e o ~ l e
. .
of the eve imnlants tried clinicallv. Thev are made from "transnarent" acwlin.
especially PMMA, which has a wmparativcly high refractive index (1.5). In
~<~. who have lost all of the conductive functions of ;he optic nerve- The 'device
cataraa, the lens of the eye becomes cloudy; the lens can then be removed
- 11-12. One of the maior
orovides stimulation to the brain cells as shown in Rnure
problems with this type of total organ replacement is the development of suitable
surgically. The lost optical power can be restored with thick-lens spectacles, hut electrode materials that will last a long time in vivo without changing their
these cause distortion and restriction of the field of view, and somc people o b j M characteristics electrochemically. Another difficulty with the artificial eye is that
to their avpearance.
.. lntraocular lensss are imvlantcd tunically
- . to replace the significant image processing goes on in the retina. Consequently, simple electrical
original eye Icns. and they restore function without the problems assosiatcd with stimulation of the visual cortex of the brain yields a very poor image.
thick spectaclo. The problems or infection and Baation of the lens to the tissues

Flgura 11-10. Bask Eomwnents of anitrial u r implanm. From 8. J. GanU. "Coehbar Implena:
An O m n i n " Acts O r o 6 t v # d Head Neck Surg.. 1,171-200.1@87.
11.3.3. fluid Transfer lmplanta
Ruid transfer implants arc required for cases such as hydrocephalus, urinary
incontinence, and chronic ear infection. Hydrocephalus. caused by abnormally
high pressure of the cerebrospinal fluid in the brain, can he treated by draining
the fluid (essentially an ultrafiltrate of blood) through a cannula as shown in
Figure 11-13. The earlier shunt had two one-way valves at the ends while the
nrun tt.tt. (a) &W.I
lmpiem ot 0. G. MsPhsr-
son and J. M. Andenan
(Br. M d J.. I. 330. 1953).
(b) Corm.1 Impiem of H.
Cardona (Am J. Ophthsl-
md.. &4, 284. 11882). (el
~mnacuimr~enm.(coumw
of Intra-lntsrmedics. Ino..
Pa.sdana. Calif.)
Figure 11.12. Diagram of c ~ c s p oft aniflclal
aye. Television cameras in the glsssss relay the
msssags via micmcompvtan with radio warel
to the array of alsctrodas on the visual cones
of the brain. From W. H. Doballs, M . G.
MlsdeJoraky.end J. P. Ginin. "Anificial Vision
for the Blind: Elsct~clllStimulation of Virus1
Cortex Oflsn Haps for a Functional
Prosthesis." Sehnca. 18). W , 1974.
Ames shunt has simple slits at the discharging end. which opens when enough
fluid pressure is exerted. The Ames shunt empties the fluid in the peritoneum
while others drain into the bloodstream through the right internal jugular vein
or right atrium of the heart. The simpler peritoneal shunt showed less incidence
of infection.
The use of implants for correcting the urinary system has not been s u c ~ ~ ~ s f u l
because of the difficulty of joining a prosthesis to the living system to achieve
fluid tightness. In addition, blockage ofthc passage by deposits from urine and
constant danger of infection have been problematical. Many materials have been
tried includingglass, rubber, silver, tantalum, Vitallium".polycthylene. ~ a c r o n " ,
~ e f l o n polyvinyl
~, alcohol, elc. without much long-term succcss.
The drainage tubes for chronic ear infection can be made from polytctra-
fluoroethylene (~eflon") or other inert materials. These are not permanent
implants.
113.4. Space-Filling Implants
Breast implants are quite common space-filling implants. At one time, the
enlargement of breasts was done with various materials such as paraffin wax.
beeswax, silicone fluids, etc. by direct injection or by enclosure in a rubber
balloon. There have been several problems associated with directly injected
implants, including progressive instability and ultimate loss of original shape and
texture, as well as infection, pain, etc. In the 1960s the FDA banned such practices
by classifying injectable implants such as silicone gel, as drugs.
One of the early effons in breast augmentation was to implant a sponge
made of polyvinyl alcohol. However, soft tissues grew into the pores and then
2BO CHAPTER I t .
SOFT TISSUE REFIACEMENT I

b u n 11-13, 1.) A m n d-bn hydm-

csphalus shunt; (b) A m s shunt in sit".
( c ) VaIm for another shunt. The Amse
shunt b made of ailicons rubber
( ~ i i a s l k @ )snd oonsins of: (A)
translucent doubh-chamber flushing
devlcs. (0) radiopaqua wntrlcular
oathater. (C) redlopaqus cOnnaCtOr tub-
ing, ID) radiopaqua psritonssl oathater.
(El stalnlsss steel connector. (a. bl from
DOW Corniw CO.. Sibstic. Hospital- i n I year. Assume that the leakage is entirely by diffusion rather than by macroscopic
Surglcel Pmductn. Bulletin No. 61-061A. pores. Asrume the silicone oil has a moleculsr weight o f 740 amu. Assume the membrane
Midland. Mich., Dsc. 1972: (c) from F. E. is Imm thick and the surface area is 400 cm'. 'The membrane has a d i f i r i o n mnstant o f
e .... - .- ; Nulasn mnd E. 8. Spltr. "Trsstmanl ot D = 5 x 10.'' cm'lsec. Assume, momover. that the implant has a volume of 1000 cm' and
. < Hydrocephalus by Dire3 Shunt trom a density o f p = I 5 $/cm'.I)iscuss other ways silicone fluid or gel could escape. Dlsmss
.
, ,, I .,a. Ventrlcla to Jugulsr Vein." Svrg. Forum. implications.
. ... .. .. . . ....-. . . . . ., ,. .- ; , 9;
. . 2. 399403. 1951.
Answer
From AcVs fin1 law for diffusion. the flux F i s F = -D(dc/dx) i n which D is the dimsion
calcified w i t h time a n d the so-called marble breast resulted. Although the enlarge- coefficient and c i s the concentration. 'The Rux is mass per unit area per time, so that if
the concentration i s initially zero i n the tissue.
ment o r replacement o f breasts for cosmetic reasons alone is not recommended,
arostheses have been develoved for the patient who has undernone radical
de
hastectomy or who has nonsyhmetrical deformities. he^ are probably beneficial massftime 5 AUX X area = FA = D-400cm2
.- -
for asvcholonical reasons. I n this case a silicone rubber bac " filled w i t h silicone
gel a n d backed w i t h polywfer mesh t o permit tissue ingrowth for fixation, i s a
dx

widely accepted prosthesis as shown in f i g u r e 11-14. ~ h e a n i f i c i a penis,

l testicles, = 5 x lo-"m'fsec
1.5 g/cm3 - 0 400 cm'
and vanina f a l l i n t o the same catenorv as breast implants in that they make use 0.1 cm
o f silicones a n d are implanted f ~ r - ~ s ~ c h o l o ~reasons
ical rather t h a n i o improve
physical health.

Example 11.2
Experience has shown that the silicone membrane used i n the bream implants leaked the
silicone Rvid contained within to the surrounding tissue. Calculate the amount o f leakage
'The body nonnally tolerates silicones well; problem do not usually arise unless pm
amounts are lost and migmtc through the tisriues. Silicone fluid or gel could also escape
into surrounding tissue through porn allowed by inadequate quality control, or from
cracks due to f a t i y c from repeated Rerun o f t h c mcmbme.
 a2 CHAPTER 11 S?FT TISSUE REPLACEMENT I

As of 1992, there have bun some r e p o m o f allerpjc reaction8 t o goss amounts o f

c s u m d silicone .el. Concern o v a s u h u s n has l e d t o revised recommendations that

Wcrcmarkthat the givcnvolume corresponds to a mass m = pV

-
silimns breast i m i l a n l s not be used solelv for ammetic sunmcntation.
-
1.5 k~ correspond-
i n g l o a wcight o f a b u t 3.3 Ib f o r each breast. I f the shape i s hemisphclial. the volume

-
is 2 d 1 3 = 1000cmJ ao that the diameter (twice the radius) i s 15.6~~1. l l ~ area
e
m d ' s u r f a c e is Z d 384cm1. ~ o m m c & a l l y available implant8 are not quite hcmi-
sphcriul. The lsrgen o m made b y one m a n u f a m r e r has a diameter o r 18 cm with a
o f !he

%STRENGTH
volume o f 600cm3. REMAINING

20

PROBLEMS 0
\
. -_
0 7 14 18 21
11-1. A Morngincar h Irying to o n d n m n d tkc Momehanla of a holc -led In the skin f m a IMPCANT PERIOD(days)
tnnmotanrous implant He made I holc using. drcu1.r b i o p n drill i n the d o m l #kin of d q . l l ~ c
doamcor of the drill .1 5 mm. I f lhc hole bec.mr mn cllipc with minor mnd major azis of 3 and

'
(a) I n whlch dlrealon 18 the intern.1 nrm i n the skin greater7
(b) In which direction am the mllsgm f i b m mom oriented7
(cl
.. How u n the bioenpinrcr obtain a cim1.r nthcr than e l l i d i a l holc f m his im~t.mt
(d) Asruming the impl8nt is nondefonnsble compared to the skin, wh.1 poblemr will .ti= M-n DEF:NITIONS
skin end Implant when lomd or f o r e is applied to therkin or implantby h~ndlingsrridmtmlly?
cogur: Absorbable suture m.tetial prepared fmm collagen from healthy
11-2 Design a b l m d a- device for kidney dl.l)nil w a h o Iwl-term llsc mnd #ire .pcdfie
msmmals.
m.tcrlal. selcaed for cash pmn and explain why you chose esch pni-lu m.tcrld.
Chmmic saR: Chcmisl mmpound that is used lo treat mllsgcn to achieve -a-
I1-3. h .I ~
I L .~ n . t ~ or t h t eye .nd label d i e a t rcrmm. linking betwen malrmlsr chains of collagen. Such treatment
increases its strength, but desresrur its ficiibility.
114. ~ n the
v .n.tomy or L. car and 1.be1 SSI~MI rt.t~m. A wlymer used ar a tirrue adhesive sin- i t ran polymerize fan i n
11-5. A brenn implant is msde of dllmne robber mrmbnne Rncd with fflimnc rubber f ~ mDl-u
. the presence of water.
the advanta~esmnd diudvantage ofthis daipn i n comparison with an oil-filled Implam. Polyelhylcnr rercphthslstc polyester that i s made into Abera. I f Ihc
ssme polymer is madc into s film, it l a u l i e d Mylar".
114. Fmpluc@is. m m p i t c or PTFE and u r b o n (pphltc). I r a h mnde o f X%by volume u e h FDA: F m d and Drug Adminirtntion, which regulates the use of mcdiul
and h" 20% porosity, what 18 hl denlily7 E.Iimnt~iw YOY~EI' mndolus. devices i n the United States.
11-7. Compre the &*king nrenlth of a.tyt tumm ('Tsblc 11-1) of- h e e n 710 and 7. what A plasma protein of high m o l m l a r wcight that is mnverted l o fibrin
concloaioru a n yow d n w ? throu~hthe aaion of thrombin. This material is "red lo make
(abrorbrble) tissue adhesives.
11-8. Desim a pnik implanl Ib.1 a n am 10. the m i l e furtalon for pmon r h o has l a 1 that Prrrvloncovr d& (PD): An implant designed to transfer msncr. information, ete. fmm the
capability due UI disease or injory. wh.1 kind o f malrri.lr wonld you need for ID mnnruaionl body to the outride of ,he body tnnreutancously.
11-9. lhc menllon o f tmlk bmaking thr .b.orb.bk svlllra sncr implant8llon is shown ~h~tporrQ: Pomur palycthylcne.
t POA sumre i n Ule =compIying figom.
for chmmic a t ~ oand Polyglycwlic odd (FGA): Polymrr made from glycolic eFid and used to makc aborbsble sumre
or other pmduas.
(4Ex- the n l e of m c n p h d-ae m a t h m m t i ~ l l yfor bnh sum= Blylactic add (PLA): Poiymcr made from Ibaic acid and u u d to make absorbable suture
(b) From the mathemsllul crp-ion. alculnte thc r c m atrenph times. or other produas.
A mmporitc mstcrial madc o f fibrous polrnnAuwoethylrm and
11-10. An i d u l sumre h defined II"handles m r o n a b l y and rumnlly, minimum tissue re.aion,
carbon. 11is uauslly pornusand has low modulusend lawrtrmgth.
.dequatetensilcetrength and knotrmrily, be wl hvonble fwb.arri.1 yDvthand e.dly nrtilirablc,
noneleamlytic, nampillsry, nonallergenic and nonurdnogenic" [C. C. Chu, in B ~ t i b l e . .
Wmlwie carbon.
Material "red in closing a wound with aitche.
P d y m e ~ Melab
. and C o m p s i l q M. Szysher (4.). Chapter 22, Technomic Pub, Weslpon. Cann.. PolytclrafiuorDnhylcnr.
19831. Can you ndd mom to the Iln7
Co-Cr alloy.
?(U CHAPTER I I

BIBLIOGRAPHY

I. Blast, B i d e h l P%mnc+ oJMnleriab, Maml Dekkrr, New Y m f 1981.

A. H. Bulbulian, Forlrrl Prosfhew Chmrln C. Tltrllornu Pub.. Sprinlfbdd. 111. 1973.
M. Chvapil. "Considerations on M.oufsnurin8 Rindpls of. Synthcclc Bum hasin#: A Rcrlcv,"
I. Biomrd. M a f . R c r , Voi. 16.245-263. 1982.
W. S. Edwards. Plasdc An&l Grslc~,Charla C. Thorn.. Pub.. Spin#fbcld. Ill.. 1WS.
H. Lee and K. Ncvillc. Handbmlr oJBiomdlml h s l l s r . Chapten 4 and 13, Rudm. Tccbaolog
Rtss. Plsadma. 1971.
W. Lynch. Implanls: R m n # m i n r thr Human M y , Ven N
.os,
.7"&.
U Rdnhold Co.. Rincrton, NJ.,
SOFT TISSUE REPLACEMENT'
G. B. P n h "Bum Wound Corerinp: A Review." Bl-frr. Md. Ddw,AR(I: mly 6.1-3l.1978.
A F. *on Rccvm m d I. 8. Pwk. "Rrruuararu Dsvictr," CRC MI R m h n . . 5.37-77.19l9.
D. F. Williamr (ed.),F L n d a m m r a l & e ~ ~ oJBimmplibllhy, Vols. I snd 11. CRC Reu.Boe. hton. II: BLOOD-INTERFACING
ma.. 1981.
D. F. Williams (4.1. B i - ~ l I M l i v
Fla.. 1982.
1. CWnkcll mdk, Vd.. I sad 11. CRC h. Boe. hlon.
IMPLANTS

Blood-interfacing materials can be divided into two categories: short-term

extracorporeal device5 such aa membranes for artificial organs (kidney and
hcartlluna
. - machine).~.tubes and cathclen forthe transDort ofblood. and lonn-term
-
in siru implants such as vascular implants and implantable artificial organs.
Although pacemakers for the heart are not interfaced with blood directly, they
are considered here since they are devices that help to circulate blood throughout
the bodv.
7he single most important requirement for blood-interfacing implants is
. .
blood wmoatibilitv (review Section 10.3). Blood maeulation is thcmost i m w n a n t
aspect of blood compatibility: the implant should not cause the blood to clot.
In addition, the implant should not damage proteins. enzymes, and formed
elements of blood (red blood cells, white blood cells, and platelets). The implant
should not cause hcmolysis (red blood cell ~ p t u r e or ) initiation of the platelet
release reaction.
Blood is circulated throughout the body according to the sequence shown
- -
in Firure 12-1. Imdants arc usuallv used to e n l a c e or oatch larne arteries and
veins as well as the heart and its valves. Surgical treatment without using implants
is usually preferred. However, there are many unavoidable situations when it is
necessary to anastornose or replace a large segment with implants

12.1. VASCULAR IMPLANTS

lmplants have been used in various circumstances to treat vascular maladies.
E x a m d a include s i m ~ l sutures
e -
for anastomosis aRer removal of vessel seaments.
vessel patches for aneurysms, as well as total replacements for large arteries. Vein

It6
26n CHAPTER 12 SOT TISSUE REPLACEMEKT 1 2e.l

implants have encountered some difficulties because of the collapse ofan adjacent
vein or clot formation, which in turn is due to low blood pressure and atagnant
blood flow in veins as compared to arteries. Vein replacements have not been a
major concern since autografting can be performed for the majority of cases.
Nonetheless, many materials including nylon. PITE, polyester, e t c were fabri-
cated for clinical applications.
Early designs for anerial replacements were solid wall N b n made ofglaar.
aluminum, gold, silver and P M M k All of the implants developed cloU and
became useless. In the early 1950s. porous implants made of fabrics were intro-
duced. which allowed tissue growth into the interstices as shown in Figure 12-2.
The new tissues interface well with blood, and t h u minimize clonink Ironically,
for this type of application thrombogenic materials were found to be more
satisfactory. Another advantage of tissue ingrowth is the fixation of the implant
by the ingrown tissues, which make a viable anchor. The initial leakage through
w r e s is disadvantageous
. but this can be prevented by precloning the outside
surface of the implant prior to placement. Crimping of the prosthesis, sa shown
in Figure 12-3, is done to prevent kinking when the implant is flexed. Also, the
crimping allows expansion ofthe grafi in the longitudinal direction, which reduces
strain on the arosthesis wall. Arteries can exoand circumferentiallv and lonni- -
tudinally to accommodate the pulsatile Row of the blood.

Fipun 12-2.mefimsnsrial g r e made 4 stitching fabrlc.logatha by hend. Fmm C. A. Hufnagel.

"Hintory of Vs.cuBr Grafting:' in Vsaculsr Gmfting: Clhical ~ l i c . t l mand
~ TmhnQws,"
C. W. Wright e l 81. Ids.]. J. Wright. Boston. 1883. pp. 1-12.
 CHAPTER I1
Although the exact sequence of tisaue formation in implants in humans is
not fully documented, quite a bit is known about reactions in animals. Generally.
soon aRer implantation the inner and outer surface of the implant are wvcred
with fibrin and fibrous tissuc, respectively. A layer of fibroblasts r e p l a w the
fibrin, bcwming neoinrima, which is sometime# called pseudointima or
pseudoneointim. The long-term fate of the ncointima varies with the species of
animals; in dogs it stabilizes into a constant thickness while for pigs it will grow
until it occludes the vessel. In man the initial phase of the healing is the same
as for animals but in later stages the inner surlace ia wvered by both fibrin and
a cellular layer of fibroblasts. The sequence for heating of arterial implants in
humans, dogs. and pigs is given in figure 124.
The types of materials and the geomety of the implant influence the rate
and nature of tissue ingrowth. A number of polymer materials a n currently used
to rabricate implants, including nylon, polyester, PTFE,polypropylene, polyacry-
lonitrile, and silicone rubber. However. PTFE. polyester, polypropylene and
silicone rubber are the most favorable materials due to the minimal deterioration
of their physical properties in vim as discussed in Chapter 8. Polyester (par-
ticularly polyethylene tercphthalate, ~ a c r o n @is
) uaually preferred because of
its superior handling properties.
Recently a pyroiyiic carbon-wated arterial gran has been developed by the
technique of ultra-low-temperature isotropic (ULTI) deposition. The nonthrom-
bogenic properties of the pyrolytic carbon may enhance the patency of the graR
.
SOFT TISSUE REPLACEMENT 11
ngum (2.4. Bask hsallng pmern of snwlsl
prosthesis. L,lumen of msthssis: F. RMn. Y. yarn
bundle; G, organiriw granvlstion ttseus: H, b a l e d
fibrous o a p ~ ~ l atissue;
r 0, degonsratlrs fibrous
capsuiar tissue: C. cal~lnedcapsular 118aue. From
S. A. Waaolmkl. C. C. Fries. A. Msnine. end
J. 0. MeMahlln. "Amrial Roehatic Mstsrlals,"
Ann N.Y. Acad. Sci.. 148,325-344. 1988.
made from this material and decrease the need for postsurgical antiwagulant
drugs.
Another interesting arterial graft is made by pressure-injecting Silastic rubber
into premachined molds made of tentacles of sea urchins. The objective is to
achieve a micmporous structure for the tissues to grow into. After the Silastic
rubber is cured. ;he mold is dissolved away by acid Geatment leaving replamine-
forms of the ~ l t r a s t ~ d uas - 12-5. Animal exneriments showed
r cshown in Rnure
promising results.
The geometry of fabrics and porosity have a great influence on healing
characteristics. The preferred porosity is such that 5000 to 10,000ml of water is
passed per cm'offahricper min at a pressurcof 120 mm Hg.The Ruid permeability
depends not only on the oorositr (volume fraction of pores) but also on the size.
shape, and con"ectivity ofpore;. The lower limit wili present excessive ~eakagF
- -
of blood and the higher limit is better for tissue inerowth and healing characteric
tics. Thickness of the implant is directly related to the amount of thrombus
formation: the thinner the wall, the smaller or the thinner the thrombus deposited.
Less thrombus results in faster organization of thcneointima. Also,smaller-caliber
(c5-mm diameter) prostheses can be made more easily with thinner walls.
The long-term testing of vascular prostheses is as important as it is with any
other implants. A simple in vim testing machine is shown~inFigure 12-6 in which
the meudoextracellular Ruid is drawn through -
- valve 'A' and pushed out throonh
valve 'B' of the graft at 96 cycles per minute with a peak pressure at 150 mm Hg
 SOP TISSUE REPIACEMEKT II 271

Figure 12-7. Percent change In tanachy for mo hlpa -9pmnhsses afIer life testing of canlns
implant. From h Botrko. R. Snyder. J. L.rLin. and W. S. Ehvards.."b V i w j i n mm Ufs Tsning
ol Vascular Prostheass." In Cwm#lonand Dagradstbn of Impl#nt Marsri.b A S M STP 884.
B. C. Syren and A. Aohatya (ds.), ASM. Philadelphia. 1979. pp. 7W8.

Example 12-1
The material properties o f arterial prostheses change followin8 i n p w t h oftissun In dm.
A porous silicone rubber arterial prosthesis wss implanted i n dog9 and i t was found that
Fiours 12.6. Se.nnhg slectmn mlcm-pk vbw of th.npl.mm(m SIIeslii amrial prW. Fmm
one-halfofthe~oresbecamcfilled with tissueafter3 monthsofim~lantation.Thcumsthcsis
L F. HIReka. J. A. Gwken. R.A. Whka. end C. 8. Wright, "In V h a Compsrhon d Rspl.minetam.
has a 5-mm inside diameter. s wall thickness o f 1 mm. and a porosity of 30%. The solid
sllanio mnd Bbsl.odc Pohlumhsns Ansrial G n f n . " Arch. Suw.. 114. OEa702. 1078.
silicone from which the prosthesis i s derived has a Young'a modulus of 1 0 M R . Answer
the follow in^:
(a) Determine the Young's modulus of the pomua silicone.
at 37OC. Various @ a h were tested and compared w i t h in uEoo implantation results
as shown in Figure 12-7. I t can b e seen that the Teflone k n i t graft did n o t lose
-
. . Find the elastic modulus o f the ~msthcsiafollowinn tissue inrrowlh.
(b) "
i n g r o m tissue is similar l o the natural sncrial wall ( E = 0.1 MPa).
Aasurnc that the

i t a tenacity (a measure of normalized strength). ' l h e i n i t i a l values of tenacity for (c) Determine the wall tcnaion sssurning s (high) blood pressure of 200mm HI.
Teflon" and Dacron" knit prostheses are about 1.3 and 3.0 ddenier, respectively.
' l h e Dacron'grahs showed i n i t i a l decreases and stabilized after 6 months under
both in u h and in u i f m conditions.
(a) There are sncral relationship thmt u n be used for the dnomination o f propmies
o f porous materials. For example, we may consider the empirical rclstionship

i n which V i s the porosity (volume fmdion o f pores) and &,is the clanic modulus
of the solid without porosity. Thus,

Flgun 1 2 d . S ~ d l . g n m o f a r t . r i d g d I l h n n n .
From K. Botlko, R. Snyder. J. L.rUn.end W. S. Edrvards.
"In W / i n Yltm UfeTeMlc-~of Vameulmr Pmsthesn." in Alternatively, we may consider the model o f Gibson and Ashby, which hms bath
CormIon and D q r s d # t h d Impl#nt M#teri.h ASTM empirical and theoretical justification:
STP BB1. 8. C. Syren and A. Acharye ( d s . ) . ASTM. RIII-
adelphll, 1878, pp. 784E.
 CHAPTER
The density ratio is plp,, -: 1 - V so thmt
The actual clmtic modulus will depend on the shape oftheparea and their orientation.
(b) This is n rsthcr mmplicated sptem. Obviously. the muimum elastic modulus for this
problem would be 10 MPa if the wres were filled with an identical silicone rubber.
4.90 + 0.1 x 0.3-
we may approximate the modulus (using the scmad value above) as E =
12.2. HEART VALVE IMPLANTS
There are lour valves in the ventricles ofthe human heart aa shown in Figure
12-8 (cf. Fig. 12-11, In the majority of cases. the len ventricular valves (mitral
and aortic) become incompetent more freauently than Ule riaht ventricular valver
as the result of higher left ventricular pkssurc Most imp&nt and frequently
critical is the aortic valve since it is the last gate the blood haa to go through
before being circulated in the body.
There have been many different types ol valve implants. me early ones in
the 1960s were made of flexible leaflets that mimicked the natural valves. Invari-
ably the leaflets could not withstand fatigue for more than 3 years. In addition
F i ~ u r e114. Circuletlon of Mood in th. hean. C c m p n W h F b u n 12-1,
I1
.
SOFT TISSUE REPLACEMEM 11 273
to h;molysis, regurgitation and incompetence were major problems. Later. but-
t e d y leaflets and ball- or disk-in-the-cage were introduced. Some of them e n
shown in Figure 12-9.The material requirements for valve implants arc the same
as for vascular implants. Some additional requirements are related to the blood
flow and pressure, i.e., the fonned elements of blood should not be damaged
and the blood pressure should not drop below a clinically significant value. Also.
valve noise should be minimal, for psychological reasons.
Figure 12-10 shows a tissue valve made from collagen-rich material such as
pericardial tissues. Basically the pericardium is madeup ofthree layers ofcollligen
fibers oriented 60' from each layer and about 0.5 mm thick in the case of bovine
pericardium. It can be cross-linked by formaldehyde. During this treatment, the
cell viability is destroyed and the proteins are denatured. Therefore, the implant
does not provoke immunological reactions. Also, porcine xenogran valves have
been used. They are treated with a chemical process that denatures the proteins
and kills any living cells.
All valves have a sewing ring that is covered with various polymeric fabrics.
This helps during initial fixation of the implant. Later, the ingrown tissue will
render the fixation viable in a manner similar to the porous vascular implants.
The cage itself is usually made of metals and covered with fabrics. to reduce
noise, or with pyrolytic carbons for a nonthrombogenic surface (the disk or bail
is also coated with pyrolytic carbon at the same time). The practice of covering
Kalhe -Llllrhoi Dish typo
Figure 11.9. Schematic dlagrem of verbus m a of hsan v s h l
 SOW-TISSUE REPLACEMENT 11 276

STRESS
(MPd

(b) The secondary modulus is, fmm the slope of the grsph.
Figure t2.10. lonalcu-Shll.y pericerdhl r;encwrefl hean v e b . fcouneoy d Sh1l.y. lnc. Itvine.
Calif.)

the struts with fabrics has been abandoned since the fabric fatigued and broke
into pieces. (e) Thetoughness is the area under the curve up tolhc failurestrain. It canbeapproximated
The ball (or disk) is usually made as a hollow structure wmposed of solid by a triangle.
(nonporous) polymers (polypropylene, polyoxymethylenc, polychlorotrifluoro-
ethylene, ctc.). metals (titanium, Co-Cr alloy), or pyrolytic carbon deposited on
Toughness = IS MPa x
0.62 - 021 = 3.1 MPa rn
-
a graphite substrate. The early use o f a silicone rubber poppet was found 2 m
undesirable due to lipid absorption and subsequent swelling and dimensional
changes. This problem has been corrected in modern valves. Although this was MNm Nm
an unfortunate episode (some were fatal), it helped to reinforce the realization = 3 . r T = w -
m m'
that the in virro experiment alone is not sufficient to predict all circumstances
that arise during in viw use, no matter how carefully one tries to predict. This
is true of any implant research even with very simple devices.
12.3. HEART AND LUNG ASSIST DEVICES

The function of the heart in pumping blood can be temporarily taken over
The bovine pericardium has been tested for its mechanical pmpenies. The slrcss-strain by a mechanical pump. This procedure is most uscful in cardiac surgery in which
curve of bovine perifardium is shown in the diagram opposite. Answer the following: a surgical field free of blood is required. The pump must propel the blood at the
(4CsI~lstcthe initial modulus. correct pressure and Row rate, and its internal parts must be compatible with
(b) Calsulatc the secondav mmodulu.
blood. Moreover, damage to the red blood corpuscles should be minimized. Use
(4 What is Ihe toughnear?
of artificial devices to take over the function of the lungs is also common on
Anmr thoracic surgery. The human heart actually contains two pumps, one for the
systemic circulation and one for the pulmonary (lung) circulation. Therefore.
(a) The initial modulus is, from thc slope of the graph. even if a cardiac patient has normal lung function, it is usual to assume lung
function by a machine, to simplify wnnectionsbetween the pump and the patient's
circulatory system. The combination of a blood pump and an oxygenator is
known as the heart and lung machine.
 278 CHAPTER I2 SOFT
- TISSUE REPLACEMENT I1

Table 12-1. Physical Characteristics of Natural versus Artificial Lung'

277

Them are basically t h m types of oxygenators as ahown in R g u n 12-11. In

all cases oxygen gas is allowed to ditfuse into the blood and simultaneously waste
gas (C02) is removed. In order to increase the rate of gas exchanges at the
blood/gas surface of the bubble oxygenator, the gas is broken into small bubbles Pulmonary (lor (liren/min) 5 5
(about I-mm diameter; if smaller, it is hard to remove them from b l d ) to Held pressure (mm Hg) 12 0-200
Pulmonary blood volume (litm) I 1-4
increase the surface contact area. Sometimn the blood is spread thinly as a film Blood lraruit lime (set) 0.1-03 3-30
and exposed to the oxygen. This is called a film oxygenator. A membrane Blood film thieknrss (mm) 0.005-0.010 0.1-3.0
oxygenalor is similar to the membrane-type artificial kidney to be discussed later. Length of apillsry (mm) 0.1 20-200
The main difference is that the oxygenator membrane is permeable to gases only, Pulmonary ventiiellsn (iitcnlmln) 7 2-10
while the kidney membrane is also prmeable to liquids. Exchangc s u d a a (m') 50-100 2-10
V c n ~ s l v ~0,
l ~gradient
r (mm H#) 40-50 650
Membrane and bubble oxygenators each have advantag-. The membrane Vcn-alveolar CO, srsdicnt (mm HII) 3-5 30-50
oxygenator is wnsidemd physiologically superior in view or the f a n that them ~ ~ -- p~

is no blood-gas interface and as a result t h e n is lcss hemolysis induced by ' Fmn D. 0. C-y, Biaedk3l En* tin+* M.r..l Dckkn. N c r Y a k , 1976.
turbulence and bencr platelet function than with the bubble oxygenator.
Moreover. the membrane oxygenator d o n not introduce any microbubbles or a n used for prolonged procedures, however; for short surgeries, bubble oxy-
microemboli in the blood. Control of exchange of oxygen and carbon dioxide genators a n preferred since they arc simpler to operate and consequently lcss
according lo the needs of :he patient is readily achieved, and t h e n is no need expensive.
for antifoam agents such as with the bubble oxygenator. Membrane oxygenators Some of the mechanical and chemical charaneriotics of the nstural and
artificial lung.(oxygenalor)
.. arc com~arcdin Table 12-1. The surface area of the
a
cot artificial membrane is about ten times larger than the natural lung since the
amount of oxygen transfer through a membrane is proportional to the surface
area, pressure, and transit time but inversely proportional to the (blood) film
thickness. The blood film thickness for the artificial membrane is about 30 times
larger than in the natural lung. This has to be compensated for by increased
transit time (16.5 sec) and higher pressure (650mm Hg) to achieve the same
amount of oxygen transfer through the artificial lung.

Table 12-2. Gas Permeability of Teflon and Silicone Rubber Mernbranss..'

Blood Carbon
cot 1 (mil) Oxysra dioxide Nisqen Helium

-.
Silimnr rubber 3 391 2072 184 224
4 306 1605 159 187
5 206 1112 105 133
7 159 802 81 94

' Fmm D. 0. COonV. Blar6Col E l m u n ( n # M*r.M.rc4 h k k e r . N n Y o h 1976.

08 'R m e a ~ i o n
rites or oxylm. ca*on dtoside. nilrosm. ..d hcllvn ~cnnn and SIIO- mhbo
mrmbrana of l i v e n thann-. on mt,mnn-m'..tm ISTP).
Rgure 11.1 1. Schematls diepram. d d l f f e ~ o ~ . n a t o n1.): rmmbr.m. (b) bubble. and ( c )Rim.

Aorta Lell otvturn
Rgun 11-11. Schematic dlegnm ol b s r t a ~ s t ad-8. (a)D e 8 . k ~ Mi wmrleulsr m s s . (b)
Bernard-1- esalst pump. From H. k and K. Nevllla. H a n d ~ o f 8 l o m s d k a t P I . s t ( c aPesadsna
,
Techmlw h . 8 . Paeadaa. CaIL. 1871.
The membranes are usually made of siliwne rubber or mFE. The gas
permeability of these materials is given in Table 12-2.Silimne rubber is 40 and
80 times more permeable to O2 and CO,. rcspeaively, than PTFE but the latter
can be made about 20 times thinner due to its higher strength. Therefore, siliwne
rubber is only 2 and4 times betterthan PlTEfor 0,and C 0 2transfer,respeclively.
Polyurethane, natural and siliwne rubbers have been used for wnstructing
balloon-type assist devices such as the lefl ventricular assist device (LVAD) as
ahown in Figure 12-12 as well as for coating the inner surfaces of the total artificial
heart. This in because these materials arethromboresislant. Sometimn therurfaces
are coated with heparin and other nonthrombogenic molecules. The feltlike velour
surface was tried-but was not successful du; to the uneven or minimal tissue
attachment.
12.4. ARTIFICIAL ORGANS
The ultimate triumph of biomateriala science and technology would be to
make imolanta behave or function the same wav M the ornana or tissucs thev - which increases threshold electrical resistance at the point of tissue contact. The
replace without affecting other tissues or organs, and without any negative effect
on the patient's mental condition. True regeneration ofthe natural organ would
SOFT T 5 S U E REPLACEMENT I1 279
of course be superior to any artificial one. but that is beyond the scope of
biomaterials. ~ s ~ m e n t i o n eind the introduction, most implants are designed to
substitute mechanical functions,. or . ~ a s s i v ediffusive functions. The electrical
functions can be taken over by some implants (pacemakers) and some primitive
yet \,ital chemical functions (passive diffusion) can also be delegated to implants
(kidney dialysis machine and oxygenator). Most ofthe artificial heart and heart
assist devices use a simple balloon and valve system. In all cases a balloon o r
membrane is used to displace blood. A simpler heart device is the intra-aonic
balloon, which is placed in the descending aorta. During the diastolic phase of
the heart, the balloon is inflated to prevent back flow.
12.4.1. Artificial Hearts
Several artificial hearts are shown in Figure 12-13. Although the design
principle and material requirements are the same as those for assist devices, the
power consumption (about 6 watts) is too high for the device to be completely
implanted at this time. In current devices the Dower is introduced t h r o u-~ ha
percutaneous device (Senion 11.2.1) in the form oTcompressed air or electricity.
Such an external Dower unit was used with the first heart reolacement done for
Dr. B. Clark at the University of Utah in 1982. The artificial hiart kept the patient
alive for 112 days, but the external power unit restricted his movemenB. Current
artificial hearts are not considered practical as permanent implants since they
damage the blood and release emboli into the circulation. They may be useful
for short-term use in keeping patients with end-stage heart disease alive until a
transplant heart becomes available.
12.4.2. Cardiac Pacemake!
A cardiac pacemaker is used to assist the regular contraction rhythm of heart
muscles. The sinoatrial (SA) node of the heart originates the electrical impulses
that pass through the bundle of His to the atrioventricular (AV) node. In the
majority of cases, the pacemakers are used to correct the conduction problem in
the bundle of His. Basically the pacemakers should deliver an cxact amount of
electrical stimulation to the heart at varying heart rates. The pacemaker consists
of conducting electrodes attached to a stimulator as shown in Figure 12-14.
The electrodes are well insulated with rubber (usuallv silicone or
polvurethanc) cxccpl for the tips. which are sutured or directly embcddcd into
thecardiacwallasshown in Finure 12-I5.Thctiois usuallv madeofa noncorrosive
noble metal with reasonablemechanical strength such-as h-lO%Ir alloy. The
-
most sienificant -
vroblems are the fatime o f the electrodes (thev
. .
are wiled like
springs to prevent this) and the formation of collagenous scar tissue at the tip,
battery and electronic components are sealed hermetically by a titanium case
while the electrode outlets are sealed by a polypropylene cuff.
1110 CHAPTER 11

nourn 1l-ts.Arttf1~lelheam. (a) Schumadtsr-Bunne*otmhydnuUc h w . ( b ) Sehm.Hodl.gnm

and phmognph of the Jarvik Mart. (a) Fmm H. Ln end K. NsuRIe. Hendbook of Blomsdk#l
Fiestic.. Pasadena Technology Ptsms, Ponadana. C.IH.. 1W1: (bJfrom W. J. Kolff, Artlficisl O w n * .
J. W l s y and Sons. New Y o h 18711. and W. J. KoM, "ArtlUoI11 0lp.n. end Their Impect." In
Rolymen in Msdiclns and Surgery. R. L Kronsmhsl, 2. Oler, and E. Mmrtln (sds.). Plsnum Press,
N m Y o h 1876, pp. 1-28.

Pacemakers are usually changed aRer 2-5 years due to the limitation of the
w w e r source. A nuclear energy-powered pacemaker is commercially available.
klthough this and other new p&&r p a c b (such as lithium bancry) may lenkhen floum 12-14. A typical pseamaksr c o n s l m of a pomr -cs and electronic c l n u n y sncaasd In
-
the life of the w w e r source. the fatinue of the wires and diminishing- conductivity solid plastlc. The electrical wlmr are mated with a ll@rlbleWWmsr, usually a ailicon. wbbsr.
(Counssy of Msdtronle. IN.)
due to tissue thickening limit the maximum life of the pacemaker to lesa than 10
ZUl CHAPTER 12
Agum 12-16. D M . m yp. ol -aka dr.
aod.s. (a) Bmllpolnt &ctmds (Cordk). The ball
has m 1-mmdlamemr.nd the eurlace8rssI.8 mm'.
(b) S m - I n alsctmds (Medtmnk). (c) Details of
an artsrlml electrode (Msdtmnlc 6-1). From W.
Greatbmch. "Metal Electrodes in Bioenglnasdng:
CRC Crit. R n . Blwng.. 5, 1-30. 1881.
Fhum 11-18. AmundssnICPI pomue slectroda. Fmm 0. Amundsan. W. MsAhur.and M. Masher-
rafa. "A N a Pomus Elanmda for Endocardial SHmulation: Paw. ?
. 40. 1919.
yean. A porous electrode at the tip of the wins may be fixed to the cardiac
muscles by tissue ingrowth as in the case of a vascular prosthesis. This may
diminish the interfacial problems as shown in Figure 12-16.
12.4.3. Artificial Kidney Dlalysis Membrane
The primary function of the kidney is to remove metabolic waste products.
This is accomplished by passing blood through the glomerulus (Figure 12-17)
under a pressure of about 75 mm Hg. The glomerulus contains up to 10 primary
branches and 50 secondary loops to filter the load. The glomemli are contained
 SOFT TISSUE REPLACEMENT I1
*

in Bowman's capsule. which in turn Is a part of the ncphron. the functionat unit
of the kidney (see Figure 12-17). The main filtrate is urea (70 times the urea
content of normal blood), sodium, chloride, bicarbonate, potassium, glucose.
matinine, and umnic acid.
The artificial kidney uses a synthetic semipermeable membrane to perform
the filtering anion in a way similar to that of a natural kidney. m e membrane
is the key component of the artificial kidney machine. In fa& the hrst attempt
to filter o r dialyze blood with a machine failed due to an inadquate membrane.
In addition to a membrane filter, the kidney dialyzer consists of a bath of saline
fluid into which the waste produns diffuse out from the blood. and a pump to
circulate blood from an artery and return the filtered blood to a vein as shown
in Figure 12-18.
There are basically t h m types of membranes for the kidney dialper. shown
in Figure 12-19. The Rat late-type membrane was the first to be develo~ed.and
can have two o r four laiers. Th; blood pluses through the s p a a s beticen the
membrane lavers while the dialvsate is oasscd thmuuh the s o a a s between the
membrane add the restraining bkrds. The second an2 most widely used type is
the coil membrane in which two cellophane t u b a (each 9 cm in circumference
and 108 cm long) are flattened and wiled with an open-mesh spacer material
made of nylon. The newest type of kidney ia made of hollow fibem. Each fiber
has dimensions of 255 and 28.5 p m inside and outside diameter, respeclively. and
is 13.5 cm long. Each unit contains up to 11,000 hollow fibers. The blood flows
through the fibers while the dialysate ia paa~edthrough the outside of the fibem.
The operational charancristia of the various dialyzen are given in Table 12-3.
 ZW CHAPTER 12

Table 72-3. Comparison of the Plate and Artificial Kidneys'

n.1 coil
(2 Inyen) (twin)

Mcmbnrr n r a (ma) BLOOD SYSTEM DIALYSIS SYSTEM

Riming volume (liten)
h m p needed?
BIO& now n t c (rn~lmin)
Dialysale now n t c (litcnlmin)
Blood channel thisknns (mm)
Treatment lime (hr)

Fmm D. 0. Coom. Bhwdhlh- R * l r ( k Marcel Dckkrr. Nor York 1976.

The fiben can also be made from (soda-lime) glass. which is made porous by
phase separation techniques. This type of glassfiber.has an advantage over th;
organic fiber in that it can be reused after cleaning and sterilizing.
Recently there have been some efforts to improve the dia&n by using
charcoals. The blood can be circulated directly over the charwal or the charcoal
can be made into microcapsulates incorporating enzymes or other drugs. One .__.______.___.__------
.----.
____.-'.
drawback of activated carbon filtering is its ineffective absorption ofurea, which
is one of the major by-products to be eliminated by the dialysis.
The majority of dialysis membranes are made from cellophane, which is
derived from cellulose. Ideally, the membrane should selectively remove all of
the metabolic wastes as does the normal kidney. Specifically, the membrane
should not selectively sequester materials from dialyzing fluid, should be blood
compatible so that an anticoagulant is not needed, and should have sufficient
wet strength to pennit ultrafiltration without significant dimensional changes. It
should allow . - of low-molecular-weight
passages
passage of plasma proteins.
- waste ~ r o d u c t swhile oreventing -
There are two clinical-grade cellophanes available. Cupmphane' (Bemberg
Co., Wuppertal, Germany) and Visking" (American Viscose Co., Fredcricksburg.
Va.). The cellophane films contain 2.5-ymdiameter pores which can filter
molecules smaller than 4000 g/mol.
There have been many attempti to improve the allophane membrane wet
strength by cross-linking, wpolyrneriration, and reinfonxment with other poly-
m e n such as nylon fibers. Also. the surface was coated with heparin in order to
prevent clotting. Other membranes such as copolymers of glycol
and polyethylene terephthalate (PET)can filter selectively due to their alternate
hydrophilic and hydrophobic segments. Besides improving the membrane for Re- 12-20. (a) Dl.enm of w a m b l e aniflclal k l d w : (b) . ~ M s t k
a n n g s m a t of the sinph.
. . the main thrust of kidney research is to make the kidnev machine
better dialvsis. needle dialvais of Or. Klaue Kwp. The pump owrat- oontinu-hl or IntermittentlyMlchmnizad
more compact (portable or wearable kidney. Figure 12-2Oa) and less costly (home with the inflow end o f l a of blood. (a) From W. J. Kalff. "Artifids1 Organs and Their Impan:
In P o W r s in Medicine sndSurgsw. R. L Kronsnthel. Z 0 - 7 . and E. Manin (sda.). Plenum Press.
dialysis, reusable or disposable filters, etc.).
Nsw Yo*, 1975,pp. 1-28; (b) Fmm W. J. KoM. AnilicialOgsns, J. Wilsy end Sons, N w Ywk, 1978.
The other important factor in dialysis is the cannula, which is used to gain
access to the blood vessels. In order to minimize the repeated trauma on-the
blood vessels the cannula can be implanted for a long period for chronic kidney
 288 CHAPTER 12
.
SOFT n s s u E REPLACEMENT 11

'
289

Recently a s o r b e n l c a r t r i d g e t h a t regenerates t h e dialysis R u i d f o r reuse has

patients. For t h e same r e a s o n a single-needle dialysis technique h a s b e e n
been a d v a n a d . T h e c a r t r i d g e was o r i g i n a l l y developed f o r hemodialysis a n d
developed as s h o w n in F i g u r e 12-ZOb.
wuld r e d u c e t h e w a t e r r e q u i r e m e n t substantially, m a k i n g dialysis m o r e portable.
In a d d i t i o n to h e m o d i a l y s i s b y a machine. dialysis c a n also b e c a r r i e d o u t
A schematic d i a g r a m of t h e sorbent regenerated cartridge is s h o w n in F i g u r e
by using t h e patient's o w n peritoneum, w h i c h i s a-semipermeable membrane.
12-21. I t i s interesting to n o t e t h a t i n o r d e r t o remove urea, enzymolysis i s c a r r i e d
-
T h e b l o o d is brounht to t h e m e m b r a n e through t h e m i c r o c i r c u l a t i o n of t h e
~ ~~~~

out b y urcase since c a r b o n cannot absorb u r e a effectively as m e n t i o n e d before.

p e r i t o n e u m w h i l e dialysatc is i n t r o d u c e d i n t o t h e peritoneal cavity t h r o u g h a
catheter, o n e of w h i c h i s s h o w n in F i g u r e 11-7 implanted in t h e a b d b m i n a l wall.
T h e dialysate is d r a i n e d t h r o u g h t h e same catheter a f t e r solute exchange takes

--
p l a c e a n d i s replaced by a fresh bottle. G l u c o s e i a a d d e d to t h e dialysate to Cslcuiate the number of ions released i n a year i m m a platinum pacemaker tip. Assume
-
increase i t s o s m o t i c oressure gradient for u l l r a f i l t r a t i o n since it i s i m w s s i b l e to that the average cumm flow is 10 p A and thst Ule surface arcs is 1 em'.
o b t a i n a h i g h h y d r o s t a t i c pressure gradient.
Answer
R + Rf+ 2c-. so that the number o f atoms per year is
REGENERATED DIALYSATE
TO DIALYZER wul 3.15 x lo7sccfyr
10 x lod- = 1.97 x 10" c l a m n s l y r
sec 1.6 x 1 0 - ' 9 c o u l / c l c a m

ACTIVATED CARBON
CREATININE, URICACID, PROBLEMS
OROANIC WASTE
12-1. What will be the b l w d urea nitrogen m n a n t n t i o n a n n 5 and 1 0 h n of dialysis i f the initis1
concentration is lODmg% (m#% is mn~cnrrationi n mg per 100ml)lThe concentration aner dialysis
HYDRATED ZIRCONIUM OXIDE
PHOSPHATE. FLUORIDE can be ex- exponentially.

i n which C. is the original dialpate mnenastion. p, is the blood now rate, r is time, v is the
volume of body Ruid (60% ofbody weight). and b b a conrtonl delmnimcdby mass tnnsfer-ffidcnt
(XI, a.
and sufiea a n ( A ) of the membrane by cxp(KA/Q.) aomrding to Cooncy (BiomrdImI
&n.fimnhg Rimcipln. M-i Detkcr. New Y o 4 1976, p.332).
12-2. S c l m the mosl rrlatcd match.
(a) low m r f f i d m t of M d o n 1. b o r n ( )
(b) lmsile force lnnsmission 2. skin ( )
PURIFICATION LAYER (4 Laplaa equalion 3. lmdon ( )
HEAVY METALS ICu.Pb,.ls.l (dl Havemian sytem 4. .Rev ( )
OXlD121N0 SUBSTANCES (el elastin 5. iigammmm nochae ( )
( 0 Langcr's line 6. carlilese ( )

----- - DIALYSATE WITH

WASTE PRODUCTS
(9) A124
(b) hydmryapatile
(c) pymlytic carbon
I.R u l d i i d bed ( )
2. morb.blc arsmic ( )
3. upphim ( )
(d) calcium phorpbalc 4. minenl phua of bone ( )
Flgure 12-21. SehaaHe dlwrarn of a aarbsnt mgemntion cartridge. Fmm R. A Wnd, "lnvsstiga-
(4Biog1ass0 5. picrorlmrlc ( )
lion of the Risk and Hazards vrlth Dsvicas Assoelated vrith Pornonam1 D l s b i s and Sorbent ( n barium titanate
Regsnerated Oislysata Oetivey Sy.1.m~:' FDA Contract NO.22Ml-WOt. rsviwd draft repon. 6. Si0,-C.0-Na,O-P,O, ( )
)I( gnpbite 7. rubnntr o f heart valve disk ( )
1882.