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Biomedical subjects

M Szycher

Publications and source records attributed to M Szycher.

At least 37 records · Page 2Linked to original sources

In vivo testing of a biostable polyurethane.

At present all the commercially available "medical grade" urethane elastomers exhibit a phenomenon known as environmental stress cracking (ESC). This phenomenon is characterized by surface microcracking when the elastomer is elongated while in vivo. The degree of strain that is required to initiate microcracking varies from composition to composition. It has been found that harder compounds generally tend to have a higher strain threshold than corresponding softer ones. We theorized that this degradation occurs when certain enzymes (present only in vivo) attack and break down the ether linkages that link the polymer molecules together. Those elastomers that contain more ether linkages (such as the softer compositions) appear to microcrack more easily than elastomers with fewer ether linkages (such as the harder ones). The molecular composition of ChronoFlex urethane has been chosen so that the finished elastomer will be free of ether linkages; thus, it is expected to be immune from environmental stress cracking.

Animals↗

Polyurethanes in medical devices.

Because of their biocompatible qualities, polyurethanes have found many uses in the medical device field. This article describes several of the better-known polyurethanes and discusses their suitability for use in medical applications such as artificial heart systems, catheters, mammary implants, semiocclusive dressings, and drug delivery systems. The adoption and use of these materials by the medical community is likely to increase as new formulations are developed.

Biocompatible Materials↗

Blood compatible polyurethane elastomers.

Medical applications of blood compatible polyurethane elastomers contribute significantly to the quality and effectiveness of the nation's health system. These projects range from artificial hearts to diagnostic/therapeutic cardiac catheters which are saving the lives of many critically ill patients.

Animals↗

The human heart: vault of the soul or pump?

Medical causes that led to the development of artificial hearts are reviewed. Ventricular assist systems are compared with other designs. A discussion of the functioning and surgical implantation of Thermedics Corporation's ventricular assist pump provides a context for an analysis of technical challenges still to be solved.

Assisted Circulation↗

Thermedics' approach to ventricular support systems.

Temporary and permanent ventricular assist systems, developed by Thermedics, Inc., are described, including rationale, design, operation and surgical applications. Clinical data are presented for pneumatically driven temporary left ventricular assist devices (LVAD). Usefulness of this device rests on the assumption that tissue of a weakened heart can recover if relieved for a time by an LVAD. The surgical implantation of an LVAD is reported in a case where the patient later received a heart transplant. The concept and technology of the subsystems of a permanent ventricular assist system (VAS), now ready for preclinical trials, are discussed. Design of a low-speed, torque-motor driven blood pump is described. Details are presented on transcutaneous energy transmission by means of a transformer, one of whose coils is embedded under the skin. Though less efficient than percutaneous transmission, the method eliminates infection risk. Special types of polyurethanes are analyzed in respect to their biocompatibility. It is concluded that flocking of the polyurethane surface allows the growth of a biological lining which is highly antithrombogenic. Sintered metal powders are found to be most efficient for fabrication of rigid pump components. A lenticular pump design is proposed to solve the problem of pressure differentials in the sealed device. Cardiac endocrine functions are cited in support of using assist devices that leave the heart in place.

Assisted Circulation↗

Spandra: a sustained release battlefield wound dressing.

In 1981, our laboratories developed a family of elastomers which could be cured by ultraviolet (UV) radiation. Curing by UV radiation was a significant advance in chemistry, since it allowed ultra-fast curing of elastomers in a matter of seconds, as compared to several hours at 110 degrees C for conventional heat curing. We applied for a patent based on this technology, and the patent was allowed in mid-1984 [29]. Based on this technology, Thermedics submitted a proposal to the US Army for the development of a sustained-release battlefield wound dressing containing antibiotics and coagulants. The drugs were evenly distributed in the oligomer matrix, and subsequently cured in seconds under UV illumination, without the use of heat, organic solvents or water. Because delicate drugs are not subjected to heat, organic solvents or water, the pharmacological activity of the drugs is insured. Therefore, theoretically any drug may be incorporated into our dressing. Sustained release dressings were first developed at Thermedics in 1983, spurred by a contract from the US Army Medical Research and Development Command. Under this contract, the Company developed a new type of wound dressing capable of accelerating the healing process, retarding infection, and minimizing pain. Based on our TECOFLEX materials technology, the dressing performs like temporary artificial skin. Its transmission properties for oxygen, carbon dioxide, and water vapor are similar to those of intact skin. Thus, while excluding bacteria from the wound site, the dressing maintains an optimal moist environment for the promotion of rapid healing. The new drawing shown in Figure 10 minimizes pain during healing by preventing dehydration and shrinkage in the wound. Patient comfort is also enhanced by the incorporation of a special fabric which imparts flex properties to the bandage that are almost identical to those of human skin, with greater stretch in one direction than in another. This also facilitates application to complex body contours by only one attendant, an important feature in both hospital and emergency situations. Materials currently in use in hospitals are difficult to handle, requiring two or three nurses to apply large dressings. Thermedics' military wound dressing not only has the significant advantage of ease of application, but this dressing can also be used for delivery of drugs to a specific site.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Cutaneous↗

Development of a nonthrombogenic collagenous blood-prosthetic interface.

Investigations to develop an implantable assist pump for prolonged circulatory support have been impeded by accumulation of friable thrombus on the prosthetic interface, with subsequent embolization. To circumvent this problem, the textured, fibril surface of a polyurethane pump chamber (mat thickness 430 microns) was inoculated with cultured bovine fetal fibroblasts (labelled with thymidine-14C) prior to animal implantation. The pneumatically actuated device (stroke volume 75 ml), maintained a pulsatile blood flow throughout each study. In 20 calf experiments, extending up to 335 days, 30 X 10(6) fibroblasts (in 50 ml media) derived from a single Holstein fetus were distributed on the urethane surface (360 +/- 50 cells/mm2) by rotation of a sealed device for three hours (12 revolutions/hour). Following connection to the circulation, cell washout was minimal. Resultant biologic linings, examined after animal sacrifice, were densely adherent to the underlying polymer matrix, and varied in thickness from 250 micron-1.5 mm. Microscopically, fibroblasts were identified from the surface to base, accompanied by numerous collagen bundles and abundant ground substance. Amino acid analysis in 10/20 pumps implanted for 31--335 days, revealed 50 +/- 5 Hydroxyproline residues/1000 residues (50% collagen) and scant elastin. Donor fibroblasts were identified by radioautography and karyotyping. Lack of immunologic response in 12 Hereford pump recipients as confirmed by serial fibroblast cytotoxicity assays. In conclusion, an induced collagenous-blood interface permitted prolonged mechanical circulatory support in animals without thromboembolic complications.

Animals↗

Development of collagenous linings on impermeable prosthetic surfaces.

In an effort to accelerate development of a biologic lining on the fibrillar surface of a left ventricular assist pump, the blood-contacting interface was covered with bovine fetal fibroblasts immediately prior to implantation into the animal. Selection of these syngeneic cells was based on their demonstrated prolificacy and abundant collagen production. Comparative studies, carried out in 17 Holstein calves, indicated that an adherent, thin, collagenous lining developed on the fibroblast-seeded polyurethane pump chamber in nine animals. Similar implantations of eight non-cell-seeded (control) devices resulted in formation of a predominantly acellular, fibrinous membrane, varying in thickness from 1 to 8 mm. Pump chamber compliance was significantly reduced when the histologic surface exceeded 3 mm in thickness, resulting in impaired filling and an inadequate stroke volume. The use of 14C-thymidine-labeled fibroblasts permitted later identification of the donor cells in the collagenous linings by radioautography. Serial immunologic studies undertaken to detect evidence of rejection in recipient Holstein calves were negative.

Amino Acids↗