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Biomaterials Tutorial

Biomaterials for Cardiovascular Applications

Mª Cristina L. Martins
INEB, Porto, Portugal

A biomaterial can be defined as a material intended to interface with biological systems to evaluate, treat, augment or replace any tissue, organ or function of the body [1]. Many different biomaterials are used clinically as implants or devices for diagnosis or therapy. Cardiovascular (commonly blood-contacting) applications, one of the most important categories of implant materials, include the extracorporeal pump-oxygenator used in many surgical procedures, hollow  fiber hemodialyzers for treatment of kidney failure, catheters for blood access and blood vessel manipulation (e.g., angioplasty), heart assist devices, stents and permanently implanted devices to replace diseased heart valves (prosthetic heart valves) and arteries (vascular grafts) [2-5].  Table 1 has a more comprehensive list of cardiovascular applications for biomaterials.


Table 1

Biomaterials for cardiovascular applications are usually prepared using polymers because these are available in a wide variety of compositions with adequate physical and mechanical properties and can be easy manufactured into products with the desired shape [3,5,6]. However, some metals and ceramics are used in the blood stream. Physical and mechanical properties of the most common synthetic polymers used as cardiovascular biomaterials and the respective application are shown in Table 2 [2,4,5].

Table 2

Polymer

Tensile strength

(MPa)

Tensile modulus

(GPa)

Elong-ation (%)

Tg (ºC)

Tm (ºC)

Water

Absorp-tion (%)

Water contact angle (º)

Cardovascular Aplications2,4-6

Poly(tetrafluoroe-thylene) – PTFE

14-35

0.4

200-400

-10

327

0

110

Oxygenator membrane, vascular graft, catheter coating

Poly(dimethylsilo-xane)

2-10

-

100-600

(-)120 –

(-)123

-

0.02

101-109

Oxygenator membrane, tubing, shunt

Polypropylene

30-38

1.1-1.6

200-700

0

165

<0.01

104

Heart valve structures

Poly(ethylene terephthalate) - PET

59-72

2.8-4.1

50-300

69 - 82

265-270

0.1-0.2

73-78

Vascular grafts, shunt

Polyamides (nylons)

62-68

1.2-2.9

60-300

45 - 75

200-270

1.5

-

Hemodialysis membrane

Poly(ether urethane) (e.g. Pellethane)

35-48*

<0.01

350-600*

(-)43 –

(-)60*

188-204*

-

62-107

Percutaneous leads, catheters, tubings, intraaortic balloons

Poly(ether urethane urea) (e.g. Biomer)

31-41*

<0.01

600-800*

(-)53  -

(-)67

120-150

0.02

63-69

Artificial heart components; heart valve

Low density polyethylene - LDPE

4-16

0.1-0.3

90-800

-20

95-115

<0.01

93-95

Tubing

High density polyethylene - HDPE

21-38

0.4-1.2

20-1000

-125

135-138

<0.01

91

Tubing

Polysulfones

70.3

2.5

50-100

190 - 285

-

0.22

-

Artificial heart components; heart valve

Polyvinylchloride – PVC

35-62

2.4-4.1

2-40

87 - 90

212

0.1-0.4

80

Tubing, blood bags

Poly(2-hydroxyethylmethacrylate) – PHEMA

0.3

0.8

50

115 (dry)

-

-

-

Catheter coating

One of the greatest problems encountered when foreign materials are inserted into blood is the rapid formation of thrombus (an aggregation of blood cells) that could adhere to the surface of the biomaterial (a local effect) or be detached and carried downstream eventually occluding a blood vessel (embolism, a systemic effect) [2,3,7,8]. 

Because many metals tend to be thrombogenic, they are most commonly applied in situations requiring considerable mechanical strength, such as in the struts of mechanical heart valves and as endovascular stents or when electrical conductivity is required as in pacemaker electrodes [5,7].

Many devices are only “safe” when anticoagulant drugs are used (e.g. oxygenators, mechanical heart valves, hemodialyzers). Such anticoagulant use has important implications for health, i.e., risk of internal bleeding2,7Nevertheless, for certain applications there are no devices available at the present that perform adequately, even when antithrombotic drugs are used, as in the case of small-diameter vascular grafts (<5 mm internal diameter) and prostheses for reconstruction of diseased veins [2,3,7,10,11].

In addition to thrombus formation, biomaterials often become colonized with bacteria that cause infections [12-16]. These microorganisms are extremely resistant to antibiotic therapy and infections cannot be fully resolved until the biomaterial is removed [16].

References

  1. Williams DF. The Williams dictionary of biomaterials. Liverpool University Press. 1999.
  2. Didisheim P, Watson JT. Cardiovascular applications. In: Ratner BD, Hoffman AS, Schoen FJ, Lemons JL, editors. Biomaterials science: An introduction to materials in medicine. San Diego, CA: Academic Press Inc; 1996.
  3. Eberhart RC, Huo H, Nelson K. Cardiovascular materials. MRS Bulletin 1991;50-54.
  4. Marchant RE, Wang I. Physical and chemical aspects of biomaterials used in humans. In: Greco RS, editor. Implantation biology: The host response and biomedical devices. CRC Press; 1994. p 13-38.
  5. Helmus MN, Hubbell JA. Materials selection. Cardiovascular Pathology 1993:2(suppl.);53S-71S.
  6. Lee HB, Kim SS, Khang G. Polymeric biomaterials. In: Bronzino JD, editor. The Biomedical Engineering Handbook. CRC Press;1995. p 581-597.
  7. Hanson SR. Blood-material interactions.  In: Black J, Hastings G, editors. Handbook of biomaterial properties. Chapman & Hall; 1998. p 545-555.
  8. Dawids S. Haemocompatibility, what does it mean?, In:  Kluwer DS, editor.  Test procedures for the blood compatibility of biomaterials. The Netherlands: Academic Publisher; 1993. p 3-11.
  9. Lamba NMK, Woodhouse KA, Cooper SL. Polyurethanes in biomedical applications. CRC Press LLC; 1998.
  10. Zdrahala RJ. Small caliber vascular grafts. Part II: Polyurethane revisited. J Biomaterials Applications 1996:11;37-61.
  11. Ramakrishna S, Wintermantel JME, Leong KW. Biomedical applications of polymer-composite materials: A review. Composites Science and Technology 2001:61:1189-1224.
  12. Gottenbos B, van der Mei HC, Busscher HJ. Initial adhesion and surface growth of staphylococcus epidermidis and pseudomonas aeruginosa on biomedical polymers. J Biomat Mater Res 2000:50:208-214.
  13. Hendricks SK, Kwok C, Shen M, Horbett TA, Ratner BD, Bryers JD. Plasma-deposited membranes for controlled release of antibiotic to prevent bacterial adhesion and biofilm formation. J Biom Mater Res 2000:50;160-170.
  14. Boelens JJ, Zaat SAJ, Meeldijk J, Dankert J. Subcutaneous abscess formation around catheters induced by viable and nonviable staphylococcus epidermidis as well as by small amounts of bacterial cell wall components. J Biomat Mater Res 2000:50;546-556.
  15. Barton AJ, Sagers RD, Pitt WG. Bacterial adhesion to orthopedic implant polymers. J Biom Mater Res 1996:30;403-410.
  16. Jawetz E, Melnick JL, Adelberg EA. Review of medical microbiology, 17th ed. Appleton & Lange; 1987.

 

 
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