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PubMedDate not supplied

Male hormonal contraception: suppression of spermatogenesis by injectable testosterone undecanoate alone or with levonorgestrel implants in chinese men.

Monthly injections of testosterone undecanoate (TU) act as a male contraceptive by reversibly suppressing spermatogenesis to azoospermia or severe oligoazoospermia in 95% of Chinese men. In 5% of Chinese men, however, monthly TU administered alone fails to suppress spermatogenesis into contraceptive ranges, or sperm "rebound," leading to occurrences of pregnancy during treatment. Since combinations of progestins and androgens are associated with greater degrees of sperm suppression in white men, we hypothesized that the combination of TU and the progestin levonorgestrel (LNG) would result in improved spermatogenic suppression in Chinese men. Sixty-two healthy Chinese men were randomly assigned to one of the following 3 regimens: group I (n = 21) received 4 LNG rods (75 mg each), which were followed 4 weeks later by 500 mg of TU by intra-muscular (IM) injection every 8 weeks for 24 weeks; group II (n = 20) received 4 LNG implants, which were followed 4 weeks later by 1000 mg of TU by IM injection every 8 weeks for 24 weeks; and group III (n = 21) received TU 1000 mg by IM injection every 8 weeks for 24 weeks. Sperm counts, serum testosterone (T), luteinizing hormone, follicle-stimulating hormone, and LNG were measured every 2 weeks before, during, and after treatment. During treatment, group II demonstrated a trend toward a greater attainment of azoospermia than groups I and III (90% vs 62% [group I] vs 67% [group III]; P =.09). Attainments of either azoospermia or oligozoospermia (sperm density, <3 x 10(6)/mL) were 95%, 100%, and 86% for groups I, II, and III, respectively (P >.05 for comparisons between groups). Spermatogenesis in all subjects returned to the normal range after the implants were removed. No serious adverse events and no significant changes in serum chemistry occurred during the study. These results demonstrate that the combination of IM injections of high-dose TU every 2 months and LNG implants is associated with marked suppression of spermatogenesis in Chinese men. The combination of high-dose TU every 2 months and LNG implants is a promising candidate for future large-scale efficacy studies of hormonal male contraception in Chinese men.

Absorbable Implants↗
PubMed2003

In vivo degradation characteristics of poly(glycerol sebacate).

We have developed a series of biodegradable elastomers, poly(glycerol sebacate) (PGS), based on glycerol and sebacic acid. The polymers are potentially useful in soft tissue regeneration and engineering. To evaluate the performance of PGS in a physiological environment, we compared their degradation profiles with poly(DL-lactide-co-glycolide) (50:50, carboxyl ended, M(w) 15,000) in vivo. Among the parameters examined are changes in weight and mechanical strength with time, implant geometry, surface characteristics, and degree of swelling. Unlike poly(DL-lactide-co-glycolide), PGS primarily degrades by surface erosion, which gives a linear degradation profile of mass, preservation of geometry and intact surface, and retention of mechanical strength.

Absorbable Implants↗
PubMed2006

Improvement of peripheral nerve regeneration by a tissue-engineered nerve filled with ectomesenchymal stem cells.

Ectomesenchymal stem cells (EMSCs) originate from the cranial neural crest. They are a potential source of neuronal and Schwann cells (SCs) of the peripheral nervous system (PNS) during embryonic development. The third passage of EMSCs enzymatically isolated from the mandibular processes of Sprague-Dawley rats were cultured in forskolin and bovine pituitary extract for 6 days to generate functional Schwann cell phenotypes. Next, 10-mm defects in the sciatic nerves were bridged with an autograft, tissue-engineered nerve filled with differentiated cells in collagen, or a PLGA conduit alone in 18 rats, and the nerve defects of another four rats were left untreated. The regenerated nerves were evaluated by the sciatic functional index (SFI) monthly and by histological analysis 4 months after grafting. The recovery index of the sciatic nerve improved significantly in the autograft and tissue-engineered nerve groups, both of which were superior to the PLGA group. In animals transplanted with the EMSCs, there was greater regeneration than with conduit alone during the same period of implantation. These results show that when EMSCs are transplanted to a peripheral nerve defect they differentiate into supportive cells that contribute to the promotion of axonal regeneration.

Absorbable Implants↗
PubMed2002

Experimental ASD closure using autologous cell-seeded interventional closure devices.

OBJECTIVE: Atrial septal defect (ASD) occluders are permanent implants in paediatric cardiology which serve as mechanical shields until complete overgrowth and incorporation of the occluding device by autologous tissue has occurred. Thereafter, the foreign body material making up the device is dispensable and bears potential long-term adverse effects. Rapid, firm and complete incorporation into the atrial septal wall should be a prerequisite for biodegradable devices. In this study, the feasibility of using autologous cell-seeded devices was investigated by (a) testing the influence of a collagen coating on cellular stress resistance in vitro and (b) comparing the short-term effects between cell-seeded, collagen-coated and acellular ASD occluders in vivo. METHODS: Native and collagen-coated Dacon fabrics and Starflex-devices were pre-seeded with autologous fibroblasts (skin biopsy) and evaluated using various mechanical stress tests. In a sheep model interventionally created ASDs were closed using either autologous pre-seeded or conventional (acellular) Starflex-devices. RESULTS: ASD closure devices were successfully pre-seeded with autologous cells. The incubation period needed, the cellular density achieved and the mechanical stability of the cytolayer after mechanical stressing (implantation) were improved by applying a collagen matrix on the fabric. Compared to the thin layer of ingrown tissue seen on conventional occluders after 30 days in vivo, a thicker layer of organising, newly formed granulation tissue on pre-seeded collagen-coated devices embedded not only the Dacron fabric, but also completely covered the spring arms of the device underneath a layer of neo-endothelium. CONCLUSION: Autologous cell pre-seeding of interventional closure devices is feasible since the cells survive the mechanical stress encountered during implantation. Rapid, firm and complete ingrowth of occluder devices into a thicker layer of young fibrous granulation tissue can be achieved, but an increased thrombogenicity currently limits the in vivo application.

Absorbable Implants↗
PubMed2003

New synthetic biodegradable polymers as BMP carriers for bone tissue engineering.

Bone morphogenetic proteins (BMPs) are biologically active molecules capable of inducing new bone formation and are expected to be used clinically in combination with biomaterials such as bone-graft substitutes to promote bone repair. The carrier materials for BMPs have to not only secure the BMPs in the local area and diffuse them afterwards, but also to provide scaffolding for the newly formed bone. Since synthetic, biodegradable polymers with optimal properties are considered most desirable, we synthesized polylactic acid and its derivatives. Some of these were found to consistently induce ectopic bone formation when combined with BMP and implanted into the muscles of experimental animals. It was also found that the three-dimensional configuration of BMP-induced bone mass could be controlled. This means that our attempt to construct synthetic biomaterials which can induce controllable bone formation was successful.

Absorbable Implants↗
PubMed2003

Renal tissue reconstitution by the implantation of renal segments on biodegradable polymer scaffolds.

Renal units were created in vivo by transplanting isolated renal segments on three-dimensional, biodegradable polymer scaffolds. Renal segments, freshly isolated from rat kidneys, were seeded on polymer scaffolds and subcutaneously implanted in athymic mice for two and four weeks. Three-dimensional renal reconstructs were formed with glomeruli and tubules, showing a possibility of reconstituting renal structures by transplanting renal segments.

Absorbable Implants↗
PubMed2006

Stability of craniofacial PLLA/PGA copolymer bioabsorbable screws.

The behavior of bioabsorbable plates and screws after implantation is a dynamic process that results in dimensional changes of the devices after surgery. Bioabsorbable plates frequently are recognized as changing because of their size, but bioabsorbable screws are less appreciated in this regard. How bioabsorbable screws may change after placement and whether their manufacturing method has an influence on size and shape after implantation needs further study. Using 1.5-mm diameter screws made of an oriented copolymer of 82% poly-L-lactic acid and 18% polyglycolic acid (LactoSorb copolymer), screw dimensions were measured before and after soaking in an in vitro pH 7.4, 37 degrees C buffer environment. After 33 days of exposure to buffer, there were no changes in the physical appearance of the screws, and there was no change in dimensions or shape. The orientation of polymer materials in a bioabsorbable screw device improves its strength and can retard the rate of hydrolysis. However, the residual stresses in oriented screws theoretically can potentiate dimensional shift in the implants during hydrolysis. That such shift did not occur during the early phase of hydrolysis provides further evidence of the mechanism by which these types of screws can maintain biomechanical function throughout the bone-healing phase of the craniofacial skeleton.

Absorbable Implants↗
PubMed2005

Extracellular matrix scaffold for cardiac repair.

BACKGROUND: Heart failure remains a significant problem. Tissue-engineered cardiac patches offer potential to treat severe heart failure. We studied an extracellular matrix scaffold for repairing the infarcted left ventricle. METHODS AND RESULTS: Pigs (n=42) underwent left ventricular (LV) infarction. At 6 to 8 weeks, either 4-layer multilaminate urinary bladder-derived extracellular matrix or expanded polytetrafluoroethlyene (ePTFE) was implanted as full-thickness LV wall patch replacement. At 1-week, 1-month, or 3-month intervals, pigs were terminated. After macroscopic examination, samples of tissue were prepared for histology, immunocytochemistry, and analysis of cell proportions by flow cytometry. One-week and 1-month patches were intact with thrombus and inflammation; at 1 month, there was also tissue with spindle-shaped cells in proteoglycan-rich and collagenous matrix. More alpha-smooth muscle actin-positive cells were present in urinary bladder matrix (UBM) than in ePTFE (22.2+/-3.3% versus 8.4+/-2.7%; P=0.04). At 3 months, UBM was bioresorbed, and a collagen-rich vascularized tissue with numerous myofibroblasts was present. Isolated regions of alpha-sarcomeric actin-positive, intensely alpha-smooth muscle actin-immunopositive, and striated cells were observed. ePTFE at 3 months had foreign-body response with necrosis and calcification. Flow cytometry showed similarities of cells from UBM to normal myocardium, whereas ePTFE had limited cardiomyocyte markers. CONCLUSIONS: Appearance of a fibrocellular tissue that included contractile cells accompanied biodegradation of UBM when implanted as an LV-free wall infarction patch. UBM appears superior to synthetic material for cardiac patching and trends toward myocardial replacement at 3 months.

Absorbable Implants↗
PubMedDate not supplied

Biodegradable nanomats produced by electrospinning: expanding multifunctionality and potential for tissue engineering.

With increasing interest in nanotechnology, development of nanofibers (n-fibers) by using the technique of electrospinning is gaining new momentum. Among important potential applications of n-fiber-based structures, scaffolds for tissue-engineering represent an advancing front. Nanoscaffolds (n-scaffolds) are closer to natural extracellular matrix (ECM) and its nanoscale fibrous structure. Although the technique of electrospinning is relatively old, various improvements have been made in the last decades to explore the spinning of submicron fibers from biodegradable polymers and to develop also multifunctional drug-releasing and bioactive scaffolds. Various factors can affect the properties of resulting nanostructures that can be classified into three main categories, namely: (1) Substrate related, (2) Apparatus related, and (3) Environment related factors. Developed n-scaffolds were tested for their cytocompatibility using different cell models and were seeded with cells for to develop tissue engineering constructs. Most importantly, studies have looked at the potential of using n-scaffolds for the development of blood vessels. There is a large area ahead for further applications and development of the field. For instance, multifunctional scaffolds that can be used as controlled delivery system do have a potential and have yet to be investigated for engineering of various tissues. So far, in vivo data on n-scaffolds are scarce, but in future reports are expected to emerge. With the convergence of the fields of nanotechnology, drug release and tissue engineering, new solutions could be found for the current limitations of tissue engineering scaffolds, which may enhance their functionality upon in vivo implantation. In this paper electrospinning process, factors affecting it, used polymers, developed n-scaffolds and their characterization are reviewed with focus on application in tissue engineering.

Absorbable Implants↗
PubMed2002

[Bioresorbable barrier membranes for guided bone regeneration around dental implants].

The aim of this study was to evaluate the efficacy of two bioresorbable barriers especially produced for guided bone regeneration. Six beagle dogs were used in this investigation. At the beginning of the study, all mandibular premolars were extracted and after a healing period of three months three screw-type machined implants were inserted in each side of the mandible. At the buccal aspect of each implant bed a dehiscence type defect with a coronoapical and mesiodistal extension of 5 mm was created. Then, one of the following four methods for defect treatment was applied: 1) guided bone regeneration (GBR) with a bioresorbable barrier (poly-L/DL-lactide) (test group 1), 2) GBR with a bioresorbable composite barrier [poly-L/DL-lactide reinforced with tricalciumphosphate (TCP)] (test group 2), 3) GBR with an expanded polytetrafluoroethylene barrier (GTAM) (control group 1), and 4) no treatment (control group 2). The animals were sacrificed six months after implant installation. During the healing period the most common problems encountered in the test groups 1 and 2 were soft tissue dehiscences and bioresorbable membrane exposures. Retrieved tissue specimens were processed for histological and histometric evaluation. The mean amount of vertical bone regeneration at the defect areas was 1.75 mm for test group 1, 1.82 mm for the test group 2, 2.38 mm for control group 1, and 1.93 mm for control group 2. When the amount of bone regeneration in contact to the implant surface was evaluated, the regeneration result was 1.45 mm for test group 1, 1.49 mm for test group 2, 2.08 mm for control group 1, and 0.91 mm for control group 2. For both measurements, no statistically significant differences could be observed between the different groups. The present animal experiment showed that the treatment of dehiscence type defects around machined implants with the two bioresorbable barriers showed only slightly superior results compared to the treatment without barriers (control group 2). The best results--although not statistically significant different from the other treatment groups--were obtained when nonresorbable barriers were used.

Absorbable Implants↗
PubMed2007

Biodegradation of high-toughness double network hydrogels as potential materials for artificial cartilage.

This study evaluated biodegradation properties of four novel high-toughness double network (DN) hydrogels as potential materials for artificial cartilage. Concerning each DN gel material, a total of 12 specimens were prepared, and 6 of the 12 specimens were examined to determine the mechanical properties without any treatments. The remaining 6 specimens were implanted into the subcutaneous tissue, using 6 mature female rabbits. At 6 weeks after implantation, the mechanical properties and the water content of the implanted specimens were measured. In the poly(2-acrylamide-2-methyl-propane sulfonic acid)/poly(N,N'-dimethyl acrylamide) DN gel, the ultimate stress and the tangent modulus were significantly increased from 3.10 and 0.20 MPa, respectively, to 5.40 and 0.37 MPa, respectively, with a significant reduction of the water content after implantation (94 to 91%). In the poly(2-acrylamide-2-methyl-propane sulfonic acid)/polyacrylamide DN gel and the cellulose/poly(dimethyl acrylamide) DN gel, the stress (11.4 and 1.90 MPa, respectively) and the modulus (0.30 and 1.70 MPa, respectively) or the water content rarely changed after implantation (90 and 85%, respectively). In the bacterial cellulose/gelatin DN gel, the ultimate stress was dramatically reduced from 4.30 to 1.98 MPa with a significant increase of the water content after implantation (78 to 86%). This study implied that these DN gels except for the cellulose/gelatin DN gel are potential materials that may meet the requirements of artificial cartilage.

Absorbable Implants↗
PubMed2000

Evaluation of sepramesh biosurgical composite in a rabbit hernia repair model.

BACKGROUND: In cases such as incisional hernia repair, polypropylene mesh (PPM) can be exposed to the underlying viscera and cause adhesions to the mesh. In this study, a composite prosthesis that was designed to be less susceptible to adhesion formation than PPM was evaluated in a rabbit incisional hernia repair model. MATERIALS AND METHODS: A 5 x 7-cm full-thickness defect was created in the abdominal wall of 30 female New Zealand White rabbits. Ten animals each were repaired with PPM, Bard Composix (PP/ePTFE), or Sepramesh biosurgical composite-a polypropylene mesh coated on one side with chemically modified sodium hyaluronate and carboxymethylcellulose (HA/CMC). The animals were sacrificed after 28 days and the overall performance, including adhesion formation and tissue integration by histology and mechanical testing, was evaluated. RESULTS: In the Sepramesh group, there was a significant reduction in the percentage of surface area covered by adhesions and a significant increase in the percentage of animals with no adhesions compared to standard materials. The tissue integration strength and overall cellular response were similar in all groups. A partially remesothelialized peritoneal surface was often apparent overlying the Sepramesh implant. CONCLUSIONS: Sepramesh biosurgical composite effectively repaired abdominal wall defects in rabbits and reduced adhesion development to the mesh compared to the use of a PPM and a PP/ePTFE composite.

Absorbable Implants↗
PubMed2004

Ectopic bone formation in rats: the importance of vascularity of the acceptor site.

Bone graft substitutes (BGS) can be fabricated by the combination of three key ingredients: (1) competent bone-forming cells, (2) a suitable framework or scaffold, and (3) the presence of biological stimulants. Although much research has been done to develop the ideal BGS, still the results are not very consistent. In view of this, the cellularity and vascularity of the recipient site are supposed to be important for the osteoinductive capacity of BGS. Therefore, we hypothesized that a muscle recipient site could favor bone formation in a cell-based BGS compared to a subcutaneous recipient site due to the higher vascularity of muscle tissue. To prove this hypothesis, 48 titanium fiber mesh implants were seeded with rat bone marrow stromal cells (RBM) and implanted subcutaneously and intramuscularly in the adductor thigh muscle of rats. The amount of bone formation after 1, 3 and 6 weeks was evaluated by histology and histomorphometry as well as by calcium content. Analysis revealed that the bone formation increased during implantation. However, bone formation did not exceed 12% of the implant surface, both for the intramuscular and subcutaneous recipient site. Also, no significant differences in bone amount between these two sites existed. Consequently, our hypothesis could not be confirmed.

Absorbable Implants↗
PubMed2000

Nonmetallic fixation in elective maxillofacial surgery.

Resorbable fixation technology offers several benefits, including easily cut and shaped plates, strong and predictable resorption qualities, and improved patient acceptance and expectations. Moreover, resorbable fixation implants can be completely reabsorbed into the body, eliminating the need for subsequent removal. This article describes the use of this innovative technology in orthognathic surgery, including preoperative and postoperative patient needs, intraoperative patient care, and potential complications.

Absorbable Implants↗
PubMed2001

A survey of clinical members of the Association of Dental Implantology in the United Kingdom. Part III. The use of augmentation techniques in dental implant surgery.

The aims of the survey were to: (1) determine the use of the staged and simultaneous augmentation techniques; (2) determine trends in the use of barrier membranes; (3) establish the perceived reliability of techniques used to monitor implants that have undergone simultaneous augmentation; and (4) assess the use of biopsy techniques to confirm the histologic outcome of bone augmentation. One hundred seventy-two respondents replied to this section of the survey and indicated that the "staged" and "simultaneous" augmentation techniques were used in roughly equal numbers during 1997, and a wide range of complications was reported with the latter. The majority used barrier membranes to correct defects of between 5 and 10 mm3, and resorbable membranes were preferred. With regard to clinical techniques used to monitor augmented implants, these were mainly considered to be "adequate" or "poor." Tissue biopsy was recognized as an important tool for determining the outcome of augmentation procedures but was rarely used. The use of resorbable membranes is likely to increase. The diagnostic tools currently used to monitor augmented implants are considered to have limited reliability, and they should be evaluated by prospective, comparative studies. More widespread use of biopsy techniques might help establish an evidence base for the histologic outcome of augmentation materials and techniques.

Absorbable Implants↗
PubMed2002

Spinal applications of bioabsorbable implants.

With the increasing use of bioabsorbable implants in a variety of clinical conditions, potential advantages in selected spinal applications are now being realized. Newer polymers with biomechanical properties relevant to the requirements of specific spinal implants and resorption rates appropriate for specific spinal applications are being developed. These new materials offer the necessary biomechanical stability of conventional spinal implants without the sequelae associated with metallic implants such as long-term loosening, implant migration, and imaging interference. At this time, the majority of clinical applications for these new polymers have involved tension band plating in the lumbar and anterior cervical spine, anterior spinal interbody reconstruction, posterior bone graft containment, and bone graft harvest site reconstruction.

Absorbable Implants↗
PubMed2002

Spinal applications of bioabsorbable implants.

With the increasing use of bioabsorbable implants in a variety of clinical conditions, potential advantages in select spinal applications are now being realized. Newer polymers with biomechanical properties relevant to the requirements of specific spinal implants and resorption rates appropriate for specific spinal applications are being developed. These new materials offer the necessary biomechanical stability of conventional spinal implants without the sequelae associated with metallic implants such as long-term loosening, implant migration, and imaging interference. At this time, the majority of clinical applications for these new polymers have involved tension band plating in the lumbar and anterior cervical spine, anterior spinal interbody reconstruction, posterior bone graft containment, and bone graft harvest site reconstruction.

Absorbable Implants↗