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PubMed2002

Local chemotherapy with cisplatin-depot for glioblastoma multiforme.

Glioblastoma multiforme (GBM) makes up as many as 30% of all primary brain tumors. Despite the employment of multimodal antitumor treatment, the overall survival is less than one year. Between 06/01/1998 and 06/01/2000 17 patients (Group A) with GBM (11 males, 6 females; median age 54.3 years) were administered local chemotherapy with cisplatin incorporated into biodegradable 6-carboxylcellulose polymer (cisplatin-depot (CDDP-D)). After the subtotal removal of GBM, twenty 1.5 x 1.5 cm polymer plates with a total area of 45 cm2 (the density of cisplatin immobilization on 6-carboxylcellulose being 1 mg/cm2, a total cisplatin dose of 45 mg) were implanted into the tumor bed. Group B (21 patients with GBM; 11 males, 10 females; median age 53.2 years) was control: the subtotal tumor ablation without CDDP-D implantation. Two to three weeks after the surgery all the patients of Groups A and B started a course of radiation therapy. A total dose of cranial irradiation was 20 Gy (1 fraction/day, 5 days/week; a daily dose of 2 Gy) followed by a boost tumor bed irradiation (1 fraction/day, 5 days/week; a daily dose of 2 Gy) up to the conventional dose of 60 Gy. Survival data for the patients were processed using the Kaplan-Meier method and analyzed by logrank test. All the patients of Group A tolerated surgical ablation of the brain tumor without side effects (brain edema, seizures, etc.). No patient of Group A had a reduction in blood cell counts during six weeks that would indicate systemic exposure to cisplatin. Blood chemistry and urinalysis did not show evidence of renal injury. No side effects of radiotherapy were registered in Group B either, regarding both the psychoneurological status of the patients and the basic values of homeostasis. Karnofsky performance scale (KPS) score of Group A and Group B patients demonstrated no significant differences before and after the surgery. The median overall survivals for patients of Group A and Group B were 427.5 and 211.0 days respectively (p = 0.00001; overall logrank test). Conclusion. Local chemotherapy of GBM with CDDP-D followed by irradiation is well tolerated and effective.

Absorbable Implants↗

PubMed2004

Usefulness of bioabsorbable thread pins after resection arthroplasty for rheumatoid forefoot reconstruction.

BACKGROUND: Bioabsorbable thread pin has been used for internal fixation of bone. The results of resection arthroplasty of the lesser metatarsophalangeal (MTP) joints using internal intramedullary fixation with bioabsorbable pins have not been reported. METHODS: Resection arthroplasty of the MTP joints of the lesser toes with poly-L-lactic acid (PLLA) thread pins or Kirschner wires was performed at random in reconstruction of the 87 rheumatoid forefeet (62 patients) with a grommet-protected silicone-rubber implant insertion of the first MTP joint. Clinical symptoms, the state of radiographic changes, and complications were assessed 5-10 years (average, 7.7 years) postoperatively. RESULTS: The mean American Orthopaedic Foot and Ankle Society clinical scores at the preoperative and latest points were 31 and 91, respectively, in the operated patients with PLLA pins, while the mean scores were 32 and 82, respectively, in the operated patients with Kirschner wires. The lesser toes treated by bioabsorbable pins did not become rigid, although they were stable. Recurrent dorsal subluxation of the lesser MTP joints was visible on radiographs in three of the 46 feet with PLLA pins, while two feet had three dislocated MTP joints and one subluxated MTP joint postoperatively and recurrent dorsal subluxation of the lesser MTP joints was visible in four of the 41 feet with Kirschner wires. The postoperative hallux valgus did not progress to the preoperative level during the follow-up period in both groups. Two of the 46 feet with PLLA pins and two of the 41 feet with Kirschner wires had radiographic evidence of silicone synovitis without pathological fracture. Three patients with Kirschner wires had wire-track infection, and one patient had severe circulation disturbance of the corrected lesser toes necessitating wire removal. CONCLUSIONS: A new trial of internal fixation with bioabsorbable pins may lead to the establishment of a safe method for enhancing stability of the lesser toes after resection arthroplasty of the lesser MTP joints.

Absorbable Implants↗

PubMed2006

Anterior cruciate reconstruction with bioactive Leeds-Keio ligament (LKII): preliminary report.

The scaffold type Leeds-Keio artificial ligament (LK) for ligament reconstruction of the knee provides sufficient strength to require minimal sacrifice of autogenous tissue. This implant works not only as prosthesis but also as scaffold onto which natural tissue grows from the synovium. LK has been in clinical use for anterior cruciate ligament (ACL) reconstruction since 1982, although the operative procedure has been modified and has undergone significant development since that time. Recently, we developed radio frequency-generated glow discharge (RFGGD)-treated LK ligament (LKII, previously indicated as Bio-LK) to improve tissue induction and reported that cell proliferation and cell attachment to artificial fibers increased considerably with this hydrophilic treatment. In this study, we report the findings of reconstructed ACL using LKII, which has been in clinical use since 2003. At reconstruction, LKII was covered with the remnant of the original ACL as much as possible in order to preserve the nerve ending system. Thirteen cases with over 12 months' postoperative history were reviewed. Knee stability was regained after reconstruction without any complications such as joint effusion and chronic synovitis. In one case, postoperative arthroscopy showed that the reconstructed ACL was completely covered with newly formed tissue at 8 weeks postoperatively. Biopsy revealed abundant fibroblasts, collagenous fibers, and vessels around the artificial fibers without marked inflammatory findings. Transmission electron microscope study showed abundant thin collagen fibers, which demonstrated regular orientation to some extent. Fibroblasts were observed with extensive amount of rough endoplasmic reticulum. According to these results, we consider LKII to be superior to LK in tissue induction and maturation.

Absorbable Implants↗

PubMed1999

Development of a new biodegradable intravascular polymer stent with simultaneous incorporation of bioactive substances.

OBJECTIVE: Due to the thrombogenicity and permanent implant nature of metallic stents, bioresorable synthetic polymers have been proposed for stents and local drug delivery systems. Bioresorbable polyesters like poly(D,L-lactide) demonstrated excellent biocompatibility in various tissues. This paper describes a novel method for the molding of these polymers. The specific CESP-process (Controlled Expansion of Saturated Polymers) is characterised by the use of the plasticizer carbon dioxide and allows the incorporation of bioactive substances at physiologic temperatures into the polymer bulk and the production of complex designed implants. METHODS: The CESP-process is characterised by the exposure of an amorphous polymer to an inert gas at high pressure with a significant lower glass transition point. The plasticizing effect makes it possible to process polylactides at a temperature close to room temperature. The low process temperature constitutes a key advantage for thermally sensitive polymers and allows the incorporation of thermally sensitive pharmaceutical additives. To obtain some preliminary information on the biocompatibility, in vitro cell toxicity testing as well as drug release assessment was performed. RESULTS: Different polymer sheets were produced using the CESP-process. Cytotoxicity was not observed in any molded polymer material. According to the mechanical and biocompatibility results Poly(D,L-lactide) (P-DL-LA) was investigated in the CESP-process. Finite element analysis was used to test the possible geometry of an adequate stent. A helical design was chosen and a stent-prototype was produced using the CESP-process. Peroxidase activity as an incorporated marker enzyme could be measured over 6 weeks. Different drug release profiles were obtained due to various pore sizes of the polymer. CONCLUSIONS: The new CESP-process can be used to process biodegradable polymers and to mold different stent geometries without inducing cytotoxic effects to the material. Furthermore, this procedure permits the simultaneous incorporation of bioactive substances during the molding process. Drug release kinetics can be regulated by different pore sizes of the material.

Absorbable Implants↗

PubMed2001

In vitro bioactivity and structural features of mildly heat-treated sol-gel-derived silica fibers.

The ability of sol-gel-derived silica fibers heat treated at a low temperature to induce formation of bone-like calcium phosphate (HCA) on their surfaces provides alternatives for the design of novel biomaterials, for example as implants used in tissue guiding or bone repairs. In this study, dry spinning was used to prepare the sol-gel fibers, which were heat-treated at 175 degrees and 250 degrees C. In addition, the differences in the surface topography (in a nanometer scale) of different fibers with respect to their in vitro bioactivity were studied. The structure of the fibers was varied using three different factors: (1) spinnable sols having varying structures and sizes of silica polymers to establish varying viscosity levels; (2) aging of green-state fibers; and (3) heat treatment of fibers. The in vitro bioactivity and solubility tests were done in simulated body fluid (SBF). To monitor surface topography and roughness of the heat-treated silica fibers, a scanning probe microscopy (SPM) with tapping mode AFM was used. Different fibers obtained clearly different properties. The fibers spun at about eta > 3.0 Pas had the best properties with respect to bioactivity, especially when they were heat-treated at 175 degrees C. It was found that surface structure in a nanometer scale was the most important factor controlling the in vitro bioactivity of heat-treated silica fibers. The correct proportions between the peaks and peak distances at the surfaces are suggested to be important with respect to in vitro bioactivity. The results indicate that peak distance distribution between 5-50 nm, especially between 5-20 nm, together with a peak height > or = 1 nm is most favorable for calcium phosphate formation.

Absorbable Implants↗

PubMed2002

Histologic changes of nonbiodegradable and biodegradable biomaterials used to repair right ventricular heart defects in rats.

OBJECTIVES: Nonbiodegradable synthetic materials have been widely used to repair cardiac defects. Material-related failures, however, such as lack of growth, thrombosis, and infection, do occur. Because a biodegradable scaffold can be replaced by the patient's own cells and will be treated as a foreign body for a limited period, we compared four biodegradable materials (gelatin, polyglycolic acid (PGA), and copolymer made of epsilon-caprolactone and l-lactic acid reinforced with a poly-l-lactide knitted [KN-PCLA] or woven fabric [WV-PCLA]) with a nonbiodegradable polytetrafluoroethylene (PTFE) material. An animal heart model was tested that simulates the in vivo clinical condition to which a synthetic material would be used. METHODS: The five patches were used to repair transmural defects surgically created in the right ventricular outflow tracts of adult rat hearts (n = 5, each patch group). The PTFE patch group served as a control group. At 8 weeks after implantation, the biomaterials were excised. Patch size, patch thickness, infiltrated cell number, extracellular matrix composition, and patch degradation were evaluated. RESULTS: The PTFE patch itself did not change in size except for increasing in thickness because of fibroblast and collagen coverage of both its surfaces. Host cells did not migrate into the PTFE biomaterial. In contrast, cells migrated into the biodegrading gelatin, PGA, and KN-PCLA and WV-PCLA scaffolds. Cellular ingrowth per unit patch area was highest in the KN-PCLA patch. The KN-PCLA patch increased modestly in size and thinness. The WV-PCNA patch did not change in size or thickness. Fibroblasts and collagen were the dominant cellular infiltrate and extracellular matrix formed in the biodegrading scaffolds. The in vivo rates of biomaterial degradation, thinning, and expansion were material specific. All the subendocardial patch surfaces were covered with endothelial cells. No thrombi were seen. CONCLUSIONS: The unique, spongy matrix structure of the PCLA patch favored cell colonization relative to the other patches. The strong, durable outer poly-l-lactide fabric layers in these patches offered physical, biocompatible, and bioresorbable advantages relative to the other biodegradable materials studied. Host cells migrated into all the biomaterials. The cells secreted matrix and formed tissue, which was endothelialized on the endocardial surface. The biomaterial degradation rates and the tissue formation rates were material related. The PCLA grafts hold promise to become a suitable patch for surgical repair.

Absorbable Implants↗

PubMed2006

Effects of growth-promoting agents and season on blood metabolites and body temperature in heifers.

To assess the efficacy of growth-promoting agents among seasons, triiodothyronine (T3), thyroxine (T4), plasma urea nitrogen (PUN), IGF-I, and tympanic temperature (TT) were measured in summer and winter studies. Heifers (n = 9/pen) were allotted to 12 pens in both December and June. Pens were assigned to 1 of 6 growth promotant treatments: control (no growth promotant), estrogenic implant (E), trenbolone acetate implant (TBA), E + TBA (ET), melengestrol acetate (MGA), and ET + MGA (ETM). Blood samples were collected from 4 heifers per pen per study on d 0, 28, 56, and 84 via jugular puncture. Near the midpoint of both studies, TT were obtained from the heifers. There was a season by sample day interaction for all blood metabolites (P < 0.05). During the winter, IGF-I levels peaked on d 28, whereas T3, T4, and PUN peaked on d 56. In the summer, IGF-I levels increased from d 0 to 28 and remained elevated throughout the study. Season by growth promotant interactions (P < 0.05) indicated that in the winter ET increased T3, whereas TBA alone decreased both T3 and T4, compared with control, or ET, and ETM treatment groups. Across seasons, treatments ET and ETM increased (P < 0.05) IGF-I and decreased (P < 0.05) PUN. However, E, TBA, and MGA alone had no effect on IGF-I or PUN concentrations. The maximum TT was greater (P < 0.01) in the summer than in the winter, whereas the minimum TT was lower (P < 0.01) in the summer. Mean TT did not differ among growth-promoting treatments. However, in the summer and over both seasons, the maximum TT was lower (P < 0.05) in E-, MGA-, and ETM-treated heifers. Although limited growth promotant by season interactions existed, changes in blood metabolite levels resulting from the use of growth promotants do not appear to influence seasonal changes in body temperature as measured by TT.

Absorbable Implants↗

PubMed2002

Ultrasound biomicroscopy images: long-term results after deep sclerectomy with collagen implant.

PURPOSE: The aim of this study was to understand the long-term outflow pathway mechanisms after deep sclerectomy - when collagen implant is resorbed - using ultrasound biomicroscopy (UBM). METHODS: Forty-three eyes of 32 patients with medically uncontrolled open-angle glaucoma at least 1 year after deep sclerectomy were studied in an observational, non-randomised, consecutive case series. Postoperatively 15 eyes (35.7%) had goniopuncture with the Nd:YAG laser. Four eyes (9.5%) had postoperative subconjunctival injections of mitomycin C and two eyes (4.7%) had an injection of 5-fluorouracil, because of intraocular pressure (IOP) increase. Complete examination and UBM of the filtering site were performed 1-6 years after surgery. The following parameters were assessed: (1) Presence of a subconjunctival filtering bleb; (2) presence and volume of an intrascleral cavity; (3) presence of a suprachoroidal hypoechoic area. RESULTS: Intraocular pressure decreased significantly from 28.1+/-2.5 mmHg preoperatively to 12.4+/-3.8 (range 7-25) mmHg at the time of UBM (at least 1 year after surgery). Forty eyes showed clinically a diffuse filtering bleb. UBM demonstrated a subconjunctival space in all eyes. In 39 eyes (92.8%) an intrascleral cavity was observed. The mean volume of this cavity was 1.8 (range 0.11-6.53) mm(3). In 19 eyes (45.2%) we observed a hypoechoic area in the suprachoroidal space. CONCLUSION: UBM examination demonstrated several aqueous humour drainage pathways. A low-reflective diffuse subconjunctival space meant persistent filtration in all eyes. More than 1 year after surgery 92.8% of eyes had a remaining intrascleral cavity. In almost half of the patients an additional suprachoroidal outflow was observed, significantly correlated with a lower IOP.

Absorbable Implants↗

PubMed2005

Osteoclastic resorption of calcium phosphate coatings applied with electrostatic spray deposition (ESD), in vitro.

Calcium phosphate (CaP) coatings have been applied on titanium implants to improve the bioactivity in order to favor the initial bone healing response. Recently, a new technique has been developed to apply CaP coatings: electrostatic spray deposition (ESD). Although ESD-derived coatings have several benefits, it is not known whether they are degradable. This study was designed to examine the cell-mediated degradation of two ESD-derived coatings with different chemical compositions, that is, beta-tricalcium phosphate (beta-TCP) and carbonate apatite (CA). First, coatings were deposited and analyzed physiochemically. Subsequently, rat bone marrow-derived osteoclastlike cells were seeded on the coatings, and analyzed with osteoclast-specific markers, scanning electron microscopy, and transmission electron microscopy. Results showed that both coatings exhibited porous morphologies, with an average pore size of less than 1 microm (beta-TCP), or larger than 1 microm (CA). After heat treatment, both coatings were crystalline in structure. The Ca/P ratios were 1.4 to 1.5 for the beta-TCP coating, and 1.8 to 2.0 for the CA coating. After 8 and 12 days of culture, multinucleated osteoclastlike cells were observed on both coatings. The osteoclast phenotype was confirmed by tartrate resistant acid phosphatase (TRAP) staining, and immunostaining against the calcitonin receptor. Using scanning electron microscopy, numerous resorption lacunae were observed in both coatings. Finally, transmission electron microscopy of TRAP-positive cells confirmed the osteoclastlike aspect of the cells revealing multiple nuclei and a ruffled border. In conclusion, CaP coatings produced with the ESD process can be degraded by osteoclasts.

Absorbable Implants↗

PubMed2005

Synthesis of degradable poly(L-lactide-co-ethylene glycol) porous tubes by liquid-liquid centrifugal casting for use as nerve guidance channels.

Biodegradable nerve guidance channels are advantageous, obviating the need for their removal after regeneration; however, most channels lack the appropriate mechanical properties for soft tissue implantation and/or degrade too quickly, resulting in reduced regeneration and necessitating the need for the design of polymers with tunable degradation profiles and mechanical properties. We designed a series of biodegradable polymeric hydrogel tubes consisting of L-lactide (LLA) and polyethylene glycol (PEG) where both the ratio of LLA to PEG and PEG molar mass were varied. By adjusting the PEG:LLA ratio and the molecular weight of the PEG oligomer we were able to control degradation and mechanical properties of our polymers. By incorporating methacrylate (MA) groups on both termini of the linear oligomers, porous tubes were synthesized by a redox-initiated free radical mechanism during a liquid-liquid centrifugal casting process. The tube wall had a bead-like morphology, as determined by SEM, which was reminiscent of previous porous hydrogel tubes synthesized by the same method. Tubes swelled with degradation to 160 vol%, or 640 wt%, and an increased radius calculated at 1.26 times. Those tubes with greater PEG content and PEG molar mass degraded faster than those with greater LLA content, as was expected. Interestingly, the wall morphology changed with degradation to a fiber-like structure and the mechanical properties decreased with degradation. By correlating the accelerated degradation study to a physiologic one, these porous hydrogel tubes were stable for an equivalent of 1.5 months, after which the mechanical properties began to deteriorate. This study demonstrates how porous hydrogel tubes can be designed to meet tissue regeneration criteria by tuning the formulation chemistry and specifically how the ratio of hydrophobic/crystalline LLA and hydrophilic/amorphous PEG impact tube properties.

Absorbable Implants↗

PubMed2001

Polydioxanone biodegradable pins in the knee: MR imaging.

OBJECTIVE: Biodegradable solid implants have been developed as an alternative to metallic orthopedic fixation. In animal models, implants degrade within and are replaced by bone. This study documents the resorption of these devices in human patients with MR imaging. SUBJECTS AND METHODS: One hundred seventy-five 1.3-mm biodegradable pins made of polydioxanone were used to secure a total of 59 osteochondral allografts of the knee. Patients with the pins underwent scanning on a 1.5-T unit with 3.3- to 4-mm contiguous T1-weighted spin-echo (TR/TE, 600/15), fat-saturated proton density-weighted (3000/40), T2-weighted fast spin-echo (3000/63), and three-dimensional spoiled gradient-recalled (47/7; flip angle, 60 degrees ) sequences at 3, 6, 12, 24, or 36 months after surgery. Eighty-nine pins were imaged on multiple occasions. Two osteoradiologists interpreted the MR examinations. RESULTS: More than 80% of the pin channels were visible at 3 and at 6 months after surgery. By 24 months, only 20% of the pin channels were visible, with the remainder having been replaced by bone. At 3 months, nearly 40% of the pins were associated with adjacent marrow edema. Edema generally diminished, involving less than 20% of pins at later time points. Focal cartilage defects were evident at 32% of the pin insertion sites during the first 6 months, but these defects were present in only 4% of the insertion sites thereafter. CONCLUSION: Biodegradable polydioxanone pins usually resorb completely by 24 months. Marrow edema, presumably representing inflammation related to pin resorption, is infrequent and tends to resolve. Cartilage defects related to pin placement heal spontaneously.

Absorbable Implants↗

PubMed2003

Expansion and fixation properties of a new braided biodegradable urethral stent: an experimental study in the rabbit.

PURPOSE: Biodegradable spiral urethral stents have been used with favorable results combined with thermal treatments of the prostate and for recurrent urethral strictures but the configuration of the helical spiral is not ideal. We developed a new tubular mesh configuration for the biodegradable urethral stent and evaluated its expansion and locking properties in the rabbit urethra. MATERIALS AND METHODS: The stents were made of self-reinforced polylactic acid polymer (Bionx Implants, Ltd., Tampere, Finland) blended with BaSO (Alfa Chem, New York, New York) to achieve radiopacity. Two braiding patterns, that is 1 over 1 and 2 over 2 + 1, were used to produce a tubular mesh structure. Stainless steel stents (pattern 1 over 1) served as controls. The stents were inserted into the posterior urethra of 27 male rabbits. The animals were sacrificed after 1 week, 1 and 6 months, respectively. X-rays were done immediately after stent insertion and at sacrifice. Longitudinal movement and expansion were assessed on the x-rays.(4) RESULTS: All stents maintained position in the urethra without fixation. Macroscopic disorientation of the structure of the 2 over 2 + 1 braided self-reinforced polylactic acid polymer stents began before 1 month, while 1 over 1 braided stents retained their construction. At 6 months 3 of 6 biodegradable stents were degraded. Average longitudinal movement was 2 mm. (range 1 to 3) in the 1 over 1 self-reinforced polylactic acid polymer group, 2 mm. (range 0 to 7) in the 2 over 2 + 1 polylactic acid group and 3 mm. (range 3 to 3) in controls at 1 month. CONCLUSIONS: Biodegradable polymers are suitable materials for braided urethral stents. The expansion properties of the 2 braiding models tested in this study sufficed to fix the stents in situ in the prostatic urethra. However, the 1 over 1 braiding pattern was superior to the 2 over 2 + 1 pattern, in that it retained its macroscopic construction until the degradation of single self-reinforced polylactic acid polymer fibers.

Absorbable Implants↗

PubMed2002

Living, autologous pulmonary artery conduits tissue engineered from human umbilical cord cells.

BACKGROUND: Tissue engineering represents a promising approach to in vitro creation of living, autologous replacements with the potential to grow, repair, and remodel. Particularly in a congenital operation, there is a substantial need for such implantation materials. We previously demonstrated fabrication of completely autologous, functional heart valves on the basis of peripheral vascular cells. Presently the feasibility of creating pulmonary artery conduits from human umbilical cord cells was investigated. METHODS: Human umbilical cord cells were harvested and expanded in culture. Pulmonary conduits fabricated from rapidly bioabsorbable polymers were seeded with human umbilical cord cells and grown in vitro in a pulse duplicator bioreactor. Morphologic characterization of the generated neo-tissues included histology, transmission, and scanning electron microscopy. Characterization of extracellular matrix was comprised of immunohistochemistry. Extracellular matrix protein content and cell proliferation were quantified by biochemical assays. Biomechanical testing was performed using stress-strain and burst-stress tests. RESULTS: Histology of the conduits revealed viable, layered tissue and extracellular matrix formation with glycosaminoglycans and collagens I and III. Cells stained positive for vimentin and alpha-smooth muscle actin. Scanning electron microscopy showed confluent, homogenous tissue surfaces. Transmission electron microscopy demonstrated elements typical of viable myofibroblasts, such as collagen, fibrils, and elastin. Extracellular matrix proteins were significantly lower compared with native tissue; the cell content was increased. The mechanical strength of the pulsed constructs was comparable with native tissue; the static controls were significantly weaker. CONCLUSIONS: In vitro fabrication of tissue-engineered human pulmonary conduits was feasible utilizing human umbilical cord cells and a biomimetic culture environment. Morphologic and mechanical features approximated human pulmonary artery. Human umbilical cord cells demonstrated excellent growth properties representing a new, readily available cell source for tissue engineering without necessitating the sacrifice of intact vascular donor structures.

Absorbable Implants↗

PubMed2004

The beginning of a new era in tissue expansion: self-filling osmotic tissue expander--four-year clinical experience.

The osmotic tissue expander is a new device made of a hydrogel expanding skin that does not require external fillings. Once implanted, it absorbs body fluids, which leads to a gradual swelling of the device. The swelling phase is completed in 6 to 8 weeks and results in skin gain. Different shapes and sizes are available, and the devices can be used in almost every area of the body. Over a 4-year period, the osmotic tissue expander was used in 58 patients in different areas of the body. A round osmotic tissue expander was mainly used in breast reconstruction, and a rectangular expander was used for defect coverage after excision (i.e., of scars and tumors). The mean age of the patients was 49.34 years (range, 4 to 76 years). During the expansion phase, the patients noted only a little discomfort and pain for the first few days. Without a silicone membrane in the first-generation expander, the rate of successful explantation and good final result was 81.5 percent. In a few cases, rapid swelling of the device led to the introduction of a silicone membrane that encloses the expander and leads to a slower, more gradual, and consistent swelling. After introduction of the silicone envelope, the success rate improved to 91 percent. The expander is now used with a silicone membrane in every case. The osmotic tissue expander has many advantages compared with the conventional expander: there is no need for painful external fillings and the risk of external infections is avoided. The expander is 10 percent of its final volume and only requires a short incision and a small pocket. An operation can easily be performed under local anesthesia, with minimal tissue mobilization in older children and compliant patients.

Adolescent↗

PubMed2006

In vitro fabrication of a tissue engineered human cardiovascular patch for future use in cardiovascular surgery.

BACKGROUND: One approach to tissue engineering has been the development of in vitro conditions for the fabrication of functional cardiovascular structures intended for implantation. In this experiment, we developed a pulsatile flow system that provides biochemical and biomechanical signals in order to regulate autologous, human patch-tissue development in vitro. METHODS: We constructed a biodegradable patch scaffold from porous poly-4-hydroxy-butyrate (P4HB; pore size 80 to 150 microm). The scaffold was seeded with pediatric aortic cells. The cell-seeded patch constructs were placed in a self-developed bioreactor for 7 days to observe potential tissue formation under dynamic cell culture conditions. As a control, cell-seeded scaffolds were not conditioned in the bioreactor system. After maturation in vitro, the analysis of the tissue engineered constructs included biochemical, biomechanical, morphologic, and immunohistochemical examination. RESULTS: Macroscopically, all tissue engineered constructs were covered by cells. After conditioning in the bioreactor, the cells were mostly viable, had grown into the pores, and had formed tissue on the patch construct. Electron microscopy showed confluent smooth surfaces. Additionally, we demonstrated the capacity to generate collagen and elastin under in vitro pulsatile flow conditions in biochemical examination. Biomechanical testing showed mechanical properties of the tissue engineered human patch tissue without any statistical differences in strength or resistance to stretch between the static controls and the conditioned patches. Immunohistochemical examination stained positive for alpha smooth muscle actin, collagen type I, and fibronectin. There was minor tissue formation in the nonconditioned control samples. CONCLUSIONS: Porous P4HB may be used to fabricate a biodegradable patch scaffold. Human vascular cells attached themselves to the polymeric scaffold, and extracellular matrix formation was induced under controlled biomechanical and biodynamic stimuli in a self-developed pulsatile bioreactor system.

Absorbable Implants↗

PubMed2002

Tissue engineering of functional trileaflet heart valves from human marrow stromal cells.

BACKGROUND: We previously demonstrated the successful tissue engineering and implantation of functioning autologous heart valves based on vascular-derived cells. Human marrow stromal cells (MSC) exhibit the potential to differentiate into multiple cell-lineages and can be easily obtained clinically. The feasibility of creating tissue engineered heart valves (TEHV) from MSC as an alternative cell source, and the impact of a biomimetic in vitro environment on tissue differentiation was investigated. METHODS AND RESULTS: Human MSC were isolated, expanded in culture, and characterized by flow-cytometry and immunohistochemistry. Trileaflet heart valves fabricated from rapidly bioabsorbable polymers were seeded with MSC and grown in vitro in a pulsatile-flow-bioreactor. Morphological characterization included histology and electron microscopy (EM). Extracellular matrix (ECM)-formation was analyzed by immunohistochemistry, ECM protein content (collagen, glycosaminoglycan) and cell proliferation (DNA) were biochemically quantified. Biomechanical evaluation was performed using Instron(TM). In all valves synchronous opening and closing was observed in the bioreactor. Flow-cytometry of MSC pre-seeding was positive for ASMA, vimentin, negative for CD 31, LDL, CD 14. Histology of the TEHV-leaflets demonstrated viable tissue and ECM formation. EM demonstrated cell elements typical of viable, secretionally active myofibroblasts (actin/myosin filaments, collagen fibrils, elastin) and confluent, homogenous tissue surfaces. Collagen types I, III, ASMA, and vimentin were detected in the TEHV-leaflets. Mechanical properties of the TEHV-leaflets were comparable to native tissue. CONCLUSION: Generation of functional TEHV from human MSC was feasible utilizing a biomimetic in vitro environment. The neo-tissue showed morphological features and mechanical properties of human native-heart-valve tissue. The human MSC demonstrated characteristics of myofibroblast differentiation.

Absorbable Implants↗

PubMedDate not supplied

Smart hydrogels for in situ generated implants.

The objective of this study was to explore the use of reverse thermo-responsive (RTG) polymers for generating implants at their site of performance, following minimally invasive surgical procedures. Aiming at combining syringability and enhanced mechanical properties, a new family of injectable RTG-displaying polymers that exhibit improved mechanical properties was created, following two different strategies: (1) to synthesize high-molecular-weight polymers by covalenty joining poly(ethylene glycol) and poly(propylene glycol) chains using phosgene as the coupling molecule and (2) to cross-link poly(ethylene oxide) (PEO)-poly(propylene oxide) (PPO)-PEO triblocks after end-capping them with triethoxysilane or methacrylate reactive groups. While the methacrylates cross-linked rapidly, the triethoxysilane groups enabled the system to cross-link gradually over time. The chain-extended PEO/PPO copolymers had molecular weights in the 39 000-54 000 interval and exhibited improved mechanical properties. Reverse thermo-responsive systems displaying gradually increasing mechanical properties were generated by cross-linking triethoxysilane-capped (EO)(99)-(PO)(67)-(EO)(99) (F127) triblocks. Over time, the ethoxysilane groups hydrolyzed and created silanol moieties that subsequently condensated. With the aim of further improving their mechanical behavior, F127 triblocks were reacted with methacryloyl chloride and the resulting dimethacrylate was subsequently cross-linked in an aqueous solution at 37 degrees C. The effect of the concentration of the F127 dimethacrylate on the mechanical properties and the porous structure of the cross-linked matrixes produced was assessed. Rheometric studies revealed that the cross-linked hydrogels attained remarkable mechanical properties and allowed the engineering of robust macroscopic constructs, such as large tubular structures. The microporosity of the matrixes produced was studied by scanning electron microscopy. Monolayered conduits as well as structures comprising two and three layers were engineered in vitro, and their compliance and burst strength were determined.

Absorbable Implants↗

PubMed2006

Effect on infection resistance of a local antiseptic and antibiotic coating on osteosynthesis implants: an in vitro and in vivo study.

The purpose of this study was to acquire information about the effect of an antibacterial and biodegradable poly-L-lactide (PLLA) coated titanium plate osteosynthesis on local infection resistance. For our in vitro and in vivo experiments, we used six-hole AO DC minifragment titanium plates. The implants were coated with biodegradable, semiamorphous PLLA (coating about 30 microm thick). This acted as a carrier substance to which either antibiotics or antiseptics were added. The antibiotic we applied was a combination of Rifampicin and fusidic acid; the antiseptic was a combination of Octenidin and Irgasan. This produced the following groups: Group I: six-hole AO DC minifragment titanium plate without PLLA; Group II: six-hole AO DC minifragment titanium plate with PLLA without antibiotics/antiseptics; Group III: six-hole AO DC minifragment titanium plate with PLLA + 3% Rifampicin and 7% fusidic acid; Group IV: six-hole AO DC minifragment titanium plate with PLLA + 2% Octenidin and 8% Irgasan. In vitro, we investigated the degradation and the release of the PLLA coating over a period of 6 weeks, the bactericidal efficacy of antibiotics/antiseptics after their release from the coating and the bacterial adhesion of Staphylococcus aureus to the implants. In vivo, we compared the infection rates in white New Zealand rabbits after titanium plate osteosynthesis of the tibia with or without antibacterial coating after local percutaneous bacterial inoculations at different concentrations (2 x 10(5)-2 x 10(8)): The plate, the contaminated soft tissues and the underlying bone were removed under sterile conditions after 28 days and quantitatively evaluated for bacterial growth. A stepwise experimental design with an "up-and-down" dosage technique was used to adjust the bacterial challenge in the area of the ID50 (50% infection dose). Statistical evaluation of the differences between the infection rates of both groups was performed using the two-sided Fisher exact test (p < 0.05). Over a period of 6 weeks, a continuous degradation of the PLLA coating of 13%, on average, was seen in vitro in 0.9% NaCl solution. The elution tests on titanium implants with antibiotic or antiseptic coatings produced average release values of 60% of the incorporated antibiotic or 62% of the incorporated antiseptic within the first 60 min. This was followed by a much slower, but nevertheless continuous, release of the incorporated antibiotic and antiseptic over days and weeks. At the end of the test period of 42 days, 20% of the incorporated antibiotic and 15% of the incorporated antiseptic had not yet been released from the coating. The antibacterial effect of the antibiotic/antiseptic is not lost by integrating it into the PLLA coating. The overall infection rate in the in vivo investigation was 50%. For Groups I and II the infection rate was both 83% (10 of 12 animals). In Groups III and IV with antibacterial coating, the infection rate was both 17% (2 of 12 animals). The ID50 in the antibacterial coated Groups III and IV was recorded as 1 x 10(8) CFU, whereas the ID50 values in the Groups I and II without antibacterial coating were a hundred times lower at 1 x 10(6) CFU, respectively. The difference between the groups with and without antibacterial coating was statistically significant (p = 0.033). Using an antibacterial biodegradable PLLA coating on titanium plates, a significant reduction of infection rate in an in vitro and in vivo investigation could be demonstrated. For the first time, to our knowledge, we were able to show, under standardized and reproducible conditions, that an antiseptic coating leads to the same reduction in infection rate as an antibiotic coating. Taking the problem of antibiotic-induced bacterial resistance into consideration, we thus regard the antiseptic coating, which shows the same level of effectiveness, as advantageous.

Absorbable Implants↗