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PubMed2006

Anaerobic biodegradation of natural gas condensate can be stimulated by the addition of gasoline.

Biodegradation of a broad range of linear and branched alkanes, parent and alkyl alicyclic hydrocarbons, and benzene and alkyl-substituted benzenes was observed when sediment and groundwater samples collected from a gas condensate-contaminated aquifer were incubated under methanogenic and especially under sulfate-reducing conditions, even though no exogenous nitrogen or phosphorus was added. This finding expands the range of hydrocarbon molecules known to undergo anaerobic decay and confirms that natural attenuation is an important process at this site. The addition of 1 mul of gasoline to the samples (approximately 10 ppm) had minimal impact on the biodegradation of saturated compounds, but substantially increased the diversity and extent of aromatic compounds undergoing transformation. We attribute this to the promotion or induction of biodegradation pathways in the indigenous microflora following the addition of the gasoline components. The promoting compounds are not precisely known, but may have been present in the initial condensate and reduced in concentration by various mechanisms (dissolution, biodegradation, etc.) such that their concentration in the aquifer fell below necessary levels. A variety of aromatic hydrocarbons would appear to be likely candidates.

Anaerobiosis↗

PubMed2004

Fabrication of microstructures in photosensitive biodegradable polymers for tissue engineering applications.

Combining the MEMS technology and biology requirements for tissue engineering, the fabrication processes of microstructured chambers and microchannels made in biodegradable photosensitive polymers are presented. The fabrication processes, based on softlithography are very fast and flexible. Various single and multistepwise microstructures could be achieved using the biodegradable polymers. Microstructures down to 50microm, which are suitable for liver reconstructs, could be fabricated. As the pCLLA acrylate photosensitive polymer has interesting property for implantable bioreactors, that is, its softness, we examined the ability of various mammalian cells to grow and spread on it. With Hep G2 cells, human umbilical blood vessel endothelial cells (HUVEC), 3T3-L1 mouse fibroblasts, static cultures could be successfully performed on single stepwise microstructures. Then, by using this photosensitive biodegradable polymer, a microstructure with simple fluidic channels is fabricated and a perfusion experiment could be carried out. Both cell cultures and perfusion experiments suggested the possibility to use the present photosensitive polymer as microfluidic supports for biodegradable bioreactors for implantation applications.

3T3-L1 Cells↗

PubMed2005

Understanding the biodegradation of polyurethanes: from classical implants to tissue engineering materials.

After almost half a century of use in the health field, polyurethanes (PUs) remain one of the most popular group of biomaterials applied for medical devices. Their popularity has been sustained as a direct result of their segmented block copolymeric character, which endows them with a wide range of versatility in terms of tailoring their physical properties, blood and tissue compatibility, and more recently their biodegradation character. While they became recognized in the 1970s and 1980s as the blood contacting material of choice in a wide range of cardiovascular devices their application in long-term implants fell under scrutiny with the failure of pacemaker leads and breast implant coatings containing PUs in the late 1980s. During the next decade PUs became extensively researched for their relative sensitivity to biodegradation and the desire to further understand the biological mechanisms for in vivo biodegradation. The advent of molecular biology into mainstream biomedical engineering permitted the probing of molecular pathways leading to the biodegradation of these materials. Knowledge gained throughout the 1990s has not only yielded novel PUs that contribute to the enhancement of biostability for in vivo long-term applications, but has also been translated to form a new class of bioresorbable materials with all the versatility of PUs in terms of physical properties but now with a more integrative nature in terms of biocompatibility. The current review will briefly survey the literature, which initially identified the problem of PU degradation in vivo and the subsequent studies that have led to the field's further understanding of the biological processes mediating the breakdown. An overview of research emerging on PUs sought for use in combination (drug + polymer) products and tissue regeneration applications will then be presented.

Absorbable Implants↗

PubMed2006

Novel solvent-free fabrication of biodegradable poly-lactic-glycolic acid (PLGA) capsules for antibiotics and rhBMP-2 delivery.

Osteomyelitis has been one of the most common causes of post-operative problems and complications despite the advances in surgical techniques and the availability of newly developed antibiotics. Local antibiotic and growth factor delivery devices for treatment of various surgical infections have been studied recently, especially in the case of orthopedic infections. The report was to develop novel solvent-free biodegradable capsules for antibiotics and growth factors delivery. To fabricate a biodegradable capsule, polylactide-polyglycolide copolymers were pre-mixed with vancomycin. The mixture was then compression molded and sintered to form a cylinder with a cover of 8 mm in diameter. After the addition of 1 and 10 microg recombinant bone morphogenetic protein (rhBMP-2) into the core, an ultrasonic welder was used to seal the capsules. An elution method was employed to characterize the in vitro release characteristics of the antibiotics and the rhBMP-2 over a 30-day period. The HPLC analysis and the bacterial inhibition test showed that biodegradable capsules released high concentrations and activity of vancomycin (well above the minimum inhibition concentration) in vitro for the period of time needed to treat bone infection; i.e. 4-6 weeks. In addition, the results of ELISA and ALP tests also suggested that the capsules released active rhBMP-2 for up to 30 days. By adopting this novel technique, we will be able to fabricate biodegradable capsules of various medicines for long-term drug deliveries.

Animals↗

PubMed2005

Self-reinforced biodegradable plates and screws for fixation of zygomatic fractures.

PURPOSE: The aim of this retrospective clinical study was to evaluate zygomatic fracture fixation with the BioSorbFX osteosynthesis system by assessing stability of reduction as well as complications in the first postoperative year and by conducting a survey to document surgeons' opinions on biodegradable osteosynthesis for this indication. MATERIAL: From January to September 2003, 25 patients with displaced non-infected unilateral fracture of the zygoma were operated upon (m:f = 20:5; age 17-81 years; mean 39.4 years) using the BioSorbFX 2.0 and/or 1.5 mm osteosynthesis systems. METHODS: A: Clinical and radiographic examinations were carried out immediately postoperatively and after 1, 3, 6, 9 and 12 months. METHODS: B: Surgeons were asked to participate in a survey critically evaluating their experience with biodegradable osteosynthesis systems. RESULTS: A: All fractures of the zygoma healed uneventfully. An excessive soft tissue reaction due to the degradation process was not seen. Three minor complications which resolved after local therapy occurred in the immediate postoperative phase. RESULTS: B: In the survey, the handling of biodegradable plates in general was rated worse than metal plate osteosynthesis. CONCLUSION: Fixation of fractures of the zygoma with the BioSorbFX system was simple and safe. The fixations remained stable and bony healing was uneventful. Postoperative complications were few, of a minor nature and not related to the process of biodegradation.

Absorbable Implants↗

PubMed2005

Biodegradable polymer microneedles: fabrication, mechanics and transdermal drug delivery.

To overcome the skin's barrier properties that block transdermal delivery of most drugs, arrays of microscopic needles have been microfabricated primarily out of silicon or metal. This study addresses microneedles made of biocompatible and biodegradable polymers, which are expected to improve safety and manufacturability. To make biodegradable polymer microneedles with sharp tips, micro-electromechanical masking and etching were adapted to produce beveled- and chisel-tip microneedles and a new fabrication method was developed to produce tapered-cone microneedles using an in situ lens-based lithographic approach. To replicate microfabricated master structures, PDMS micromolds were generated and a novel vacuum-based method was developed to fill the molds with polylactic acid, polyglycolic acid, and their co-polymers. Mechanical testing of the resulting needles measured the force at which needles broke during axial loading and found that this failure force increased with Young's modulus of the material and needle base diameter and decreased with needle length. Failure forces were generally much larger than the forces needed to insert microneedles into skin, indicating that biodegradable polymers can have satisfactory mechanical properties for microneedles. Finally, arrays of polymer microneedles were shown to increase permeability of human cadaver skin to a low-molecular weight tracer, calcein, and a macromolecular protein, bovine serum albumin, by up to three orders of magnitude. Altogether, these results indicate that biodegradable polymer microneedles can be fabricated with an appropriate geometry and sufficient strength to insert into skin, and thereby dramatically increase transdermal transport of molecules.

Biocompatible Materials↗

PubMed2006

The stability of maxillary osteotomies fixated with biodegradable mesh in orthognathic surgery.

PURPOSE: This study measures the stability of maxillary osteotomies fixated with 1-mm biodegradable mesh and screws. MATERIALS AND METHODS: This prospective study involved 27 patients who underwent maxillary osteotomies. All cases had fixation with biodegradable mesh and screws (70% l-lactide and 30% D,l-lactide polymers). Lateral cephalometric radiographs were taken preoperatively within 2 months (T1), immediately postsurgically within 1 week (T2), postsurgically between 6 and 12 weeks (T3), and long-term postoperatively between 6 months and 1 year (T4). All cephalometric radiographs were digitized with Dolphin Imaging (Dolphin software version 9.0.0018, Chatsworth, CA). Vertical and horizontal measurements were made to several skeletal landmarks including Sella (S), A point (APT), posterior nasal spine (PNS), and upper incisor (UPI). RESULTS: Twenty patients were completed. Seven patients were not included because lateral cephalometric radiographs were not obtained in the specific time period. It appears that the postsurgical vertical change was not statistically significant, but the horizontal change was significant (P < .01). Relapse was significant in the horizontal dimension. CONCLUSION: There was more relapse in the anteroposterior (horizontal) direction than the superoinferior (vertical) direction in biodegradable mesh and screws. Biodegradable fixation was more stable in vertical surgical change than horizontal surgical change.

Absorbable Implants↗

PubMed2006

The wrapping method using biodegradable felt strips has a preventive effect on the thinning of the aortic wall: experimental study in the canine aorta.

OBJECTIVES: Wrapping methods have been widely used to reinforce the anastomotic site in vascular surgery; however, postoperative changes in the aortic wall wrapped by nonbiodegradable felt have not been well characterized. The purposes of this investigation are to elucidate the sequelae of wrapping with nonbiodegradable felt on the aortic wall and to modify those changes by using biodegradable felt with or without basic fibroblast growth factor (bFGF). METHODS: The descending thoracic aortas of 15 beagles were wrapped with three different materials: nonbiodegradable polytetrafluoroethylene (PTFE) felt, biodegradable polyglycol acid (PGA) material, and PGA with 100 microg bFGF (n = 5 in each group). The descending thoracic aorta was resected after 3 months. The thickness of the aortic wall, vessel density in the media and the adventitia, and the wall strength were assessed. Untreated native aortic wall served as a normal control. RESULTS: The thickness of the media of the PTFE group was lower than that of the PGA + bFGF group (66% +/- 5% vs 85% +/- 6% of control, P < .05). The adventitia-media ratio in the PTFE group decreased compared with controls (59.1% of normal, P < 0.05), whereas those in the PGA and PGA + bFGF groups increased (172.1% and 189.6% of normal, respectively, P < .01). The collagen-smooth muscle ratio in the media was higher in the PTFE group than in the controls (0.14 +/- 0.02 vs 0.07 +/- 0.01, P < .01). The number of vessels in the adventitia was higher in the PGA + bFGF group than those in PTFE or PGA groups (29.6 +/- 2.5/mm2 vs 6.4 +/- 0.8/mm2, 19.0 +/- 1.1/mm2, P < .01). The PGA + bFGF group demonstrated larger failure force than the PTFE group (4.0 +/- 0.3 kgf vs 1.6 +/- 0.3 kgf, P < .01). The failure stress in the PGA and PGA + bFGF groups was larger than that in PTFE group (PTFE:PGA + bFGF = 5.3 +/- 0.9 x10(2) kPa:11.7 +/- 1.7 x 10(2) kPa, P < .01; PTFE:PGA = 5.3 +/- 0.9 x 10(2) kPa:11.2 +/- 1.2 x 10(2) kPa, P < .05). CONCLUSION: The aortic wall wrapped with nonbiodegradable PTFE felt showed a reduced thickness and diminished vessels in the adventitia. Biodegradable felt (PGA), with or without bFGF, modified these histologic changes. The vessel-rich thickened adventitia, after wrapping by PGA with bFGF, was associated with increased aortic wall strength. CLINICAL RELEVANCE: This investigation was conducted in an attempt to elucidate mechanisms underlying the occurrence of late postoperative false aneurysm after aortic surgery. We hypothesized that sustaining compression of the aorta by the felt strip may cause structural derangement and local ischemia on the aortic wall. We used a simple wrapping of the aorta with a felt strip rather than a felt strip at anastomotic sites to simplify the experimental model and to exclude confounding factors brought by technical inconsistency on the surgical anastomosis. We further attempted to find a clue for preventing adverse effects of wrapping with a conventional felt strip. Practically, we pursued a possible application of a biodegradable felt strip to aortic wrapping in our experimental model before we proceed in a clinical application of the new material.

Aneurysm, False↗

PubMed2006

Preliminary experience with tissue engineering of a venous vascular patch by using bone marrow-derived cells and a hybrid biodegradable polymer scaffold.

OBJECTIVE: Currently available synthetic polymer vascular patches used in cardiovascular surgery have shown serious shortcomings, including thrombosis, calcification, infection, and lack of growth potential. These problems may be avoided by vascular patches tissue-engineered with autologous stem cells and biodegradable polymeric materials. The objective of this study was to develop a tissue-engineered vascular patch by using autologous bone marrow-derived cells (BMCs) and a hybrid biodegradable polymer scaffold. METHODS: Hybrid biodegradable polymer scaffolds were fabricated from poly(lactide-co-epsilon-caprolactone) (PLCL) copolymer reinforced with poly(glycolic acid) (PGA) fibers. Canine bone marrow mononuclear cells were induced in vitro to differentiate into vascular smooth muscle cells and endothelial cells. Tissue-engineered vascular patches (15 mm wide x 30 mm long) were fabricated by seeding vascular cells onto PGA/PLCL scaffolds and implanted into the inferior vena cava of bone marrow donor dogs. RESULTS: Compared with PLCL scaffolds, PGA/PLCL scaffolds exhibited tensile mechanical properties more similar to those of dog inferior vena cava. Eight weeks after implantation of vascular patches tissue-engineered with BMCs and PGA/PLCL scaffolds, the vascular patches remained patent with no sign of thrombosis, stenosis, or dilatation. Histological, immunohistochemical, and scanning electron microscopic analyses of the retrieved vascular patches revealed regeneration of endothelium and smooth muscle, as well as the presence of collagen. Calcium deposition on tissue-engineered vascular patches was not significantly different from that on native blood vessels. Immunofluorescent double staining confirmed that implanted BMCs survived after implantation and contributed to regeneration of endothelium and vascular smooth muscle in the implanted vascular patches. CONCLUSIONS: This study demonstrates that vascular patches can be tissue-engineered with autologous BMCs and hybrid biodegradable polymer scaffolds.

Absorbable Implants↗

PubMed2001

Repetitive subcutaneous implantation of different types of (biodegradable) biomaterials alters the foreign body reaction.

In the present study two biodegradable materials (cross-linked collagens) and two non-biodegradable materials (polyurethane and silicone) were applied in a repetitive subcutaneous implantation model in rats. In contrast to the first challenge, the second challenge with the same type of material, but at a different subcutaneous site of the same animal, induced an increase of macrophages and giant cells inside the biodegradable materials. Additionally, only after the second challenge clusters and accumulations of plasma cells were present in the surrounding tissue of each type of material. In the same areas an increase of MHC II expression was measured by immunocytochemistry. Differences in the numbers of macrophages and T cells were not observed around the explants. Undifferentiated B cells or NK cells were not present at any time point. The results indicate that alterations observed after the second challenge did not depend on biodegradation of the materials. Significance of these findings should be considered in view of increased and repetitive use of the same type of biomaterial (possibly for different application sites) for implantation in patients.

Animals↗

PubMedDate not supplied

Synthesis and characterization of sugar-bearing chitosan derivatives: aqueous solubility and biodegradability.

The extended use of chitosan in biomedical fields has been limited by its insoluble nature in a biological solution. To endow the water solubility in a broad range of pH, chitosan derivatives were prepared by the covalent attachment of a hydrophilic sugar moiety, gluconic acid, through the formation of an amide bond. These sugar-bearing chitosans (SBCs) were further modified by the N-acetylation in an alcoholic aqueous solution. Thereafter, the effect of the gluconyl group and the degree of N-acetylation (DA) on the water solubility at different pHs and on the biodegradability of chitosan were investigated. The SBCs showed the water solubility in a broader range of pH than chitosan, whereas they were still insoluble at neutral and alkali pH. The N-acetylation of SBCs significantly affected the water solubility, for example, the SBCs with the DA, ranging from 29% to 63%, were soluble in the whole range of pH. This might result from the improved hydrophilicity by the gluconyl group, accompanied by the role of the N-acetyl group that disturbed the hydrogen bonding between amino groups of chitosan. From the biodegradation tests, determined by the decrease in the viscosity of a polymer solution exposed to lysozyme, it was evident that the gluconyl group attached to chitosan improved the biodegradability. Thus, it was possible to control the biodegradability of chitosan by adjusting the amounts of gluconyl and N-acetyl groups in the chitosan backbone. The N-acetylated SBCs, soluble in the broad range of pH, might be useful for various biomedical applications.

Biocompatible Materials↗

PubMed2006

Biodegradation of short-chain n-alkanes in oil sands tailings under methanogenic conditions.

The biodegradation of a mixture of low molecular weight n-alkanes (C6, C7, C8, and C10) was assessed under methanogenic conditions using mature fine tailings (MFT) produced by the oil sands industry in Alberta, Canada. Microorganisms present in the MFT mineralized the added n-alkane mixture, producing 16.2 (+/- 0.3) or 20.5 (+/- 0.1) mmol of methane in the headspace of microcosms spiked with 0.2% or 0.5% w/v n-alkanes, respectively, during 29 weeks of incubation. The spiked n-alkanes biodegraded in the sequence C10 > C8 > C7 > C6. Degradation of 100% C10, 97% C8, 74% C7, and 44% C6 occurred in a mixture of n-alkanes in the MFT spiked at 0.2% after 25 weeks of incubation. The same pattern of biodegradation was also observed in the MFT spiked with 0.5% n-alkanes. Stoichiometric calculations confirmed the mineralization of the degraded n-alkanes to methane. This study showed that the short-chain n-alkanes, which comprise a significant portion of the unrecovered naphtha used in bitumen extraction and released into the settling basins, can be biodegraded into methane. These findings may influence decisions regarding extraction processes and long-term management of MFT, and they suggest that intrinsic, methanogenic metabolism of these n-alkanes may occur in other anoxic environments.

Alkanes↗

PubMed2000

Biodegradable polyester, poly[alpha-(4-aminobutyl)-L-glycolic acid], as a non-toxic gene carrier.

PURPOSE: The aim of this study was to develop a non-toxic polymeric gene carrier. For this purpose, biodegradable cationic polymer, poly[alpha-(4-aminobutyl)-L-glycolic acid] (PAGA) was synthesized. PAGA was designed to have ester linkage because polyesters usually show biodegradability. METHODS: Degradation of PAGA in an aqueous solution was followed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). PAGA/DNA complexes were characterized by gel electrophoresis, atomic force microscopy (AFM), dynamic light scattering (DLS). The transfection was measured by using the beta-galactosidase reporter gene. RESULTS: PAGA was degraded in aqueous solution very quickly and the final degradation product was a monomer (L-oxylysine). Formation of self-assembling biodegradable complexes between PAGA and DNA at a charge ratio 1:1 (+/-) was confirmed by gel band shift assay and AFM. In these studies, controlled release of DNA from the complexes could be seen. The complexes showed about 2-fold higher transfection efficiency than DNA complexes of poly-L-lysine (PLL), a structural analogue of PAGA, which is the most commonly used poly-cation for gene delivery. The polymer did not show cytotoxicity, possibly because of its degradability and the biocompatibility of the monomer. CONCLUSIONS: The use of the biodegradable poly-cation, PAGA, as a DNA condensing agent will be useful in safe gene delivery.

Absorbable Implants↗

PubMed2002

Fixation of mandibular fractures with biodegradable plates and screws.

OBJECTIVE: Little data exist regarding the use of biodegradable plates and screws for the internal fixation of human mandibular fractures. The purpose of this study was to evaluate the stability of biodegradable, self-reinforced poly-L-lactide plates and screws for the internal fixation of fractures of the human mandible. STUDY DESIGN: Twenty-two individuals (14 male, 8 female; average age, 26.3 years) with a variety of fracture patterns of the mandible underwent management with a biodegradable fixation system. After surgery, maxillomandibular fixation was applied in 3 cases. Images (panoramic radiograph, computed tomographic scan) were taken immediately after surgery and at the 4-week, 8-week, 12-week, and 24-week intervals. The follow-up period averaged 49.1 weeks (range, 22 to 78 weeks). RESULTS: Mucosal dehiscences over the resorbable devices were present in 2 patients. In 1 of these 2 cases, the material had to be replaced with titanium plates. Mucosal healing and consolidation of the fracture were normal in all other patients. CONCLUSION: Self-reinforced biodegradable osteosynthesis materials provide a reliable and sufficient alternative to conventional titanium plate systems.

Absorbable Implants↗

PubMed2001

Stabilization of the posterior limb of the medial canthal tendon using biodegradable tag anchors: a cadaveric model.

PURPOSE: This study describes and tests in a cadaveric model a new method of fixation designed for potential stabilization of the posterior limb of the medial canthal tendon, using biodegradable Tag anchors. METHODS: Study of the possibility of performing surgery to repair medial ectropion using biodegradable polyglyconate Tag anchors was commenced in the sheep cadaveric head model, and in the whole dry human skull model. This was then performed using five preserved human cadaveric whole heads, and pullout tensions were estimated in four of these. Computed tomography and magnetic resonance imaging were obtained for this model in the fifth head, and computed tomography was performed on the whole dry human skull. Dissections were carried out to establish the site of the bony defect in each of the heads. RESULTS: It was possible to obtain good Tag anchor fixation in bone overlying the maxillary and ethmoidal sinuses of the sheep, and in a young human skull. It was also possible to place adequately the anchor in the medial wall of the orbit close to the posterior lacrimal crest in all cases in the human cadaveric model. Pullout strengths were evaluated and found to range from 3.5 N to 12.4 N (mean, 7.5 N). Computed tomography and magnetic resonance imaging failed to demonstrate the biodegradable anchors in both the dry human whole skull and in the fifth cadaveric head, but did demonstrate the bony defects in the medial orbital walls through which the anchor passed. CONCLUSIONS: We have shown, for the first time, the stability of biodegradable Tag anchor fixation in a human cadaveric head model using pullout tensions and dissection studies. This method would allow adequate strength and stability to provide for control of fixation of the medial end of the lower eyelid in patients with medial ectropion and medial canthal tendon laxity.

Absorbable Implants↗

PubMed1993

Biodegradable starch microspheres for cerebral arterial embolization.

RATIONALE AND OBJECTIVES: Various materials have been used to perform intracerebral and cervical arterial embolization for head and neck tumors and vascular malformations. This preliminary prospective study was designed to analyze the clinical and histopathologic consequences of arterial embolization into the brain using biodegradable starch microspheres. METHODS: A new arterial embolization procedure which ensured the integrity of the common and internal carotid arteries, without modifying the arterial flow, was designed. The procedure allowed for cerebral arterial microembolization in 20 Sprague-Dawley rats. Various amounts of biodegradable starch microspheres (Spherex) were introduced into the brain via the left external carotid artery. RESULTS AND CONCLUSIONS: Clinical and histopathologic results suggested that: 1) consequences of cerebral embolization using biodegradable starch microspheres are related to the amount of material embolized; and 2) Spherex microspheres behave differently from degradable microspheres in the brain. Despite the rapid biodegradability of the material, permanent damage from ischemia to the brain was noted.

Animals↗

PubMed2001

Augmentation of anterior vertebral body screw fixation by an injectable, biodegradable calcium phosphate bone substitute.

STUDY DESIGN: A biomechanical study to evaluate the effects of a biodegradable calcium phosphate (Ca-P) bone substitute on the fixation strength and bending rigidity of vertebral body screws. OBJECTIVES: To determine if an injectable, biodegradable Ca-P bone substitute provides significant augmentation of anterior vertebral screw fixation in the osteoporotic spine. SUMMARY OF BACKGROUND DATA: Polymethylmethacrylate (PMMA) augmented screws have been used clinically; however, there is concern about thermal damage to the neural elements during polymerization of the PMMA as well as its negative effects on bone remodeling. Injectable, biodegradable Ca-P bone substitutes have shown enhanced fixation of pedicle screws. METHODS: Sixteen fresh cadaveric thoracolumbar vertebrae were randomly divided into two groups: control (no augmentation) (n = 8) and Ca-P bone substitute augmentation (n = 8) groups. Bone-screw fixation rigidity in bending was determined initially and after 10(5) cycles, followed by pullout testing of the screw to failure to determine pullout strength and stiffness. RESULTS: The bone-screw bending rigidity for the Ca-P bone substitute group was significantly greater than the control group, initially (58%) and after cyclic loading (125%). The pullout strength for Ca-P bone substitute group (1848 +/- 166 N) was significantly greater than the control group (665 +/- 92 N) (P < 0.01). Stiffness in pullout for the Ca-P bone substitute groups (399 +/- 69 N/mm) was significantly higher than the control group (210 +/- 51 N/mm) (P < 0.01). CONCLUSION: This study demonstrated that augmentation of anterior vertebral body screw fixation with a biodegradable Ca-P bone substitute is a potential alternative to the use of PMMA cement.

Absorbable Implants↗

PubMed1999

Xenotransplantation of cells using biodegradable microcapsules.

BACKGROUND: The use of immunoisolation to protect transplanted cells from the immune system of the host has broad application to the treatment of major diseases such as diabetes and a wide range of other disorders resulting from functional defects of native cell systems. In most cases, limitations in functional cell longevity will necessitate periodic replenishment of the cells. We describe a hydrogel-based microcapsule that breaks down at a rate that can be adjusted to correspond to the functional longevity of the encapsulated cells. These injectable capsules can be engineered to degrade over several weeks to months for short-term drug delivery, or to remain intact and immunoprotective for more extended periods. When the supply of cells needs to be replenished, no surgery will be required to localize and remove the old capsules. METHODS: Porcine and bovine islets were immobilized in "composite" microcapsules fabricated from alginate and low-relative molecular mass (Mr) poly (L-lysine[PLL]) (Mr exclusion <120 Kd) and implanted into the peritoneum of normal and streptozotocin-induced diabetic rats. In addition to demonstrating long-term islet viability and function, a series of in vitro studies were carried out to determine the permeability and biodegradability of the microcapsules used in the present system. RESULTS: Xenogeneic islets implanted in nonimmunosuppressed rats remained in excellent condition indefinitely (>40 weeks)(viability was comparable to that of preimplant control specimens). In contrast, no islets survived in uncoated alginate spheres after 2 weeks postimplantation. By changing the concentration of the alginate, it was possible to vary the rate of capsule breakdown in rats from mechanically unstable (outer matrix <0.5-0.75% alginate) to stable for >1 year (> or =1.5% alginate). In addition to in vivo breakdown studies, the biodegradability of the capsular components was verified in vitro using a mixture of tritosomes (enzymes isolated from animal cells). CONCLUSIONS: We have designed a microcapsule system with controllable biodegradability which allows breakdown and absorption of implants when the cells die or become functionally inactive. These results may have application to other alginate-PLL encapsulation systems. The ability to cross species lines using these biodegradable microcapsules has the potential to expand dramatically the number of patients and the scope of diseases that can be successfully treated with cellular therapy.

Absorbable Implants↗