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Results for “Absorbable Implants”

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PubMed2006

New administration model of trans-chalcone biodegradable polymers for the treatment of experimental leishmaniasis.

The present study was designed to investigate a new administration model and the antileishmanial activity of a semi-synthetic chalcone, benzylideneacetophenone (trans-chalcone). The antileishmanial activity of this product was first tested in vitro against promastigotes of L. braziliensis, L. tropica, L. infantum and L. amazonensis. An in vivo experiment was carried out using subcutaneous administration of trans-chalcone and implants of synthetic biodegradable polymers, polylactic acid (PLA) and polylactic/glycolic acid (PLGA). This compound showed potent inhibitory effects on the growth of all Leishmania strains examinated. Subcutaneous administration of trans-chalcone at a single dose of 4 mg/kg of body weight reduced lesion development in mice infected with L. amazonensis. A similar inhibition of the lesion growth in mice treated with trans-chalcone and pentamidine was observed. PLA and PGLA implants of trans-chalcone at 4 mg/kg were administered to mice infected with L. amazonensis. PLGA implants induced a highest reduction in the lesion size (31.25%) than PLA implants (10.75%). Treatment in vitro with trans-chalcone at IC50, completely inhibited the pathogenicity of this parasite in vivo. The development of this model provides a new practical technique for delivering drugs and can be useful for experimental leishmaniasis treatment.

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PubMed2005

Multiple-channel scaffolds to promote spinal cord axon regeneration.

As molecular, cellular, and tissue-level treatments for spinal cord injury are discovered, it is likely that combinations of such treatments will be necessary to elicit functional recovery in animal models or patients. We describe multiple-channel, biodegradable scaffolds that serve as the basis for a model to investigate simultaneously the effects on axon regeneration of scaffold architecture, transplanted cells, and locally delivered molecular agents. Poly(lactic-co-glycolic acid) (PLGA) with copolymer ratio 85:15 was used for these initial experiments. Injection molding with rapid solvent evaporation resulted in scaffolds with a plurality of distinct channels running parallel along the length of the scaffolds. The feasibility of creating scaffolds with various channel sizes and geometries was demonstrated. Walls separating open channels were found to possess void fractions as high as 89%, with accessible void fractions as high as 90% through connections 220 microm or larger. Scaffolds degraded in vitro over a period of 30 weeks, over which time-sustained delivery of a surrogate drug was observed for 12 weeks. Primary neonatal Schwann cells were distributed in the channels of the scaffold and remained viable in tissue culture for at least 48 h. Schwann-cell containing scaffolds implanted into transected adult rat spinal cords contained regenerating axons at one month post-operation. Axon regeneration was demonstrated by three-dimensional reconstruction of serial histological sections.

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PubMed2005

Tissue-engineered myocardial patch derived from extracellular matrix provides regional mechanical function.

BACKGROUND: Extracellular matrix (ECM), a tissue-engineered scaffold, recently demonstrated cardiomyocyte population after myocardial implantation. Surgical restoration of myocardium frequently uses Dacron as a myocardial patch. We hypothesized that an ECM-derived myocardial patch would provide a mechanical benefit not seen with Dacron. METHODS AND RESULTS: Using a canine model, a full thickness defect in the right ventricle was repaired with either Dacron or ECM. A third group had no surgery and determined baseline RV function. Eight weeks later, global systolic function was assessed by the preload recruitable stroke work relationship. Regional systolic function was measured by systolic area contraction (SAC), calculated by high density mechanical mapping. Tau was used to assess global diastolic function. Recoil rate and diastolic shear were used as measures of regional diastolic function. After functional data acquisition, tissue was fixed for histological evaluation. Global systolic and diastolic functions were similar at baseline and after ECM and Dacron implantation. Regional systolic function was greater in the ECM group compared with the Dacron group (SAC: 4.1+/-0.9% versus -1.8+/-1.1, P<0.05). Regional diastolic function was also greater in the ECM group (recoil rate (degrees sec(-1)): -44+/-7 versus -17+/-2, ECM versus Dacron; P<0.05). Immunohistochemical analysis revealed cardiomyocytes in the ECM implant region, a finding not seen with Dacron. CONCLUSIONS: At 8 weeks, an ECM-derived tissue-engineered myocardial patch provides regional mechanical function, likely related to cardiomyocyte population. These results are in sharp contrast to Dacron, a commonly used myocardial patch.

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PubMed2001

Finite element analysis of a tandem screw configuration in sagittal split osteotomy using biodegradable osteosynthesis screws.

The goal of the present study was to determine the mechanical stability of selected osteosynthesis screws in a paired linear configuration in cases of bilateral sagittal split osteotomy of the mandible. A mandible model was created that consisted of 22,846 elements and 4,879 nodes. The following screws were tested in the tandem screw configuration: the poly-L-lactic acid (PLLA) in accordance with Harada and Enomoto, the Isosorb screw (Aesculap, Germany), the BioSorbFX screw (Bionix Implants, Finland), and the Lactosorb screw (WL. Lorenz, USA). The mechanical parameters of the materials studied were adopted from the literature or were based on manufacturer information. With the precondition that the materials each be stressed to the ultimate tensile strength, the following chewing forces could be neutralized: 100 N by 2.0-mm titanium mini-screws, 117.5 N by PLLA screws in accordance with Harada and Enomoto, 90.0 N by Isosorb screws, 89.0 N by BioSorbFX screws, and 35.0 N by Lactosorb screws. Here the peri-implant bone was stressed within limiting values with the titanium miniscrew, and the PLLA screw according to Harada and Enomoto, but not the osteosynthesis material itself. The finite element method (FEM) appears suitable for simulating complex mechanical stress situations in the maxillofacial area. As a result, significant time and materials (animal tests) can be saved when developing new or modified materials

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PubMed2001

Biocompatibility of silver nitrate and ofloxacine coated bioabsorbable SR-PLLA rods.

The purpose of this study was to evaluate the biocompatibility of silver nitrate and ofloxacine coatings of bioresorbable self-reinforced poly-L-lactic acid (SR-PLLA) rods. SR-PLLA rods coated with pure poly(caprolactone-co-L-lactide) or blended with silver nitrate (10, 5 or 2 weight-%) or ofloxacine (5 or 2 weight-%) were implanted in the dorsal muscles of 25 male rabbits. Tissue reactions caused by implantation trauma were seen 1 week after implantation. The positive control and 10 w-% silver nitrate coating showed the most marked reactions 1 month after implantation. Only sparse reactions were seen 6 months after implantation. Tissue reactions were scored semi-quantitatively. As a result of this study, we concluded that silver nitrate or ofloxacine coatings up to five w-% did not alter the good biocompatibility of SR-PLLA essentially. The method may lead to the possibility of preventing bacterial adhesion to urological stents during insertion.

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PubMed2004

Design, synthesis and properties of a degradable polyurethane scaffold for meniscus regeneration.

Longitudinal lesions in menisci are among the most frequent orthopedic problems of the knee. Repair by simple techniques is only limited to the vascular part of the meniscus. For repair of the avascular part of the meniscus a scaffold, which will assist the body in the formation of new meniscus cell tissue, might be applicable. In this study a biomedical segmented polyurethane with poly(epsilon-caprolactone) as soft segment and 1,4-butanediisocyanate and 1,4-butanediol as uniform hard segments has been synthesised. The material has a micro phase separated morphology and excellent mechanical properties. A porous scaffold was prepared via a combination of liquid-liquid phase separation and salt leaching. The foams prepared combined a very high interconnectivity and porosity with the desired compression modulus. After six months of implantation in the knees of beagles full ingrowth with cells was obtained and it was found that meniscus like tissue had been formed in the scaffold. Moreover, compression behaviour appeared to be comparable to native meniscus tissue.

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PubMed2002

Single-stage craniofacial distraction using resorbable devices.

We report on the use of a new type of internal bone distraction devices designed for craniofacial applications. These resorbable devices allow a single operative procedure for device placement, eliminating the need for a second open operative procedure for hardware removal. We report on three models of resorbable devices. The midface orbital frontal device was used for midface and monoblock advancement. The mandibular adolescent device was used in older children and adolescents. In neonates and young children, the mandibular infant device was used. Twenty-one patients (9 female, 12 male) aged 6 days to 15 years (mean = 53 months) underwent bony expansion of the craniofacial skeleton over a 2-year period. A total of 39 devices were implanted: 32 in the mandible, 3 in the maxilla alone, and 4 in the maxilla and frontal bones. Expansion distances ranged from 15 to 30 mm. Expansion took place at 1 to 2 mm/d. Latency periods ranged from 48 to 72 hours. There were no device structural failures and no major complications.

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PubMed2005

The future of drug eluting stents.

In-stent restenosis (ISR) is the major drawback of percutaneous coronary interventions, occurring in 10-40% of patients. Drug eluting stents (DES) are successful in a large majority of patients in preventing restenosis for the first year after implantation. Recently, new stents have emerged that are loaded with anti-inflammatory, antimigratory, antiproliferative, or pro-healing drugs. These drugs are supposed to inhibit inflammation and neointimal growth and subsequently ISR. The future of DES lies in the development of better stents with new stent designs, better polymers including biological polymers and biological biodissolvable stent coatings, and new, better drugs.

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PubMed2006

Amelogenin gene splice products A+4 and A-4 implanted in soft tissue determine the reorientation of CD45-positive cells to an osteo-chondrogenic lineage.

Several molecules such as bone morphogenetic protein-7, bone sialoprotein (BSP), or amelogenin gene splice products (A+4 or A-4) have been shown to induce reparative dentin formation in a rat model. However, at the moment, the origin and the mechanism of differentiation of the pulp cells stimulated by the bioactive molecules remain poorly understood. The present investigation was undertaken to validate an ectopic oral mucosal mouse model to evaluate the effects of amelogenin gene splice product implantation in a non-mineralizing tissue. Agarose beads, alone or coated with amelogenin gene splice products, were implanted in the mucosa of the cheeks in mouse. An immunohistochemical characterization of the recruited cells was undertaken for 3 days, 8 days, and 30 days after the implantation. The results showed that the implantation of agarose beads in mucosa induced the recruitment of inflammatory CD45 positive cells. When the beads were coated with amelogenin gene splice products (A+4 or A-4), the expression of osteo-chondrogenic markers (RP59, Sox9, or BSP) was also observed. However, no mineralization nodule was observed, even after 30 days of implantation. The present investigation suggests that amelognin gene splice products have the capacity of recruiting among inflammatory cell mesenchymal progenitors that eventually differentiate into osteo-chondrogenic cells. Altogether, the results obtained in the pulp model and the present data suggest the existence of different pathways of cell recruitment and differentiation in different cellular environments.

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PubMed2002

Complications after meniscal repair with bioabsorbable arrows: two cases and analysis of literature.

Biodegradable implants were introduced in the middle 1990s as a new technique for the arthroscopic treatment of reparable meniscal tears. We have used these implants since 1999 and present two cases of failure of biodegradable meniscal repair implants. One foreign-body reaction with granuloma and one fresh meniscus tear after renewed trauma in the case of receding meniscus arrows with a chondral lesion. We also performed a review of the literature with the Medline database. Meniscus refixation with bioabsorbable arrows is considered reliable but shows various other complications that must be borne in mind.

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PubMed2005

Soft tissue response of the larynx to silicone, Gore-Tex, and irradiated cartilage implants.

OBJECTIVE: The aim of the study is to compare the efficiency of three different materials (Silicone, Gore-Tex, and irradiated cartilage) used in medialization laryngoplasty. Local tissue reaction to implants in laryngeal skeleton has been examined for this purpose. STUDY DESIGN AND METHODS: In this prospective study, New Zealand rabbits were used. Different materials have been implanted in the paraglottic space of both sides of the larynx to enable a better comparison of the different materials used. Limited medialization was applied. Special care has been taken not to narrow the airway and cause breathing problems. The reaction of the tissue in this region against the materials used has been studied. Each material was implanted 14 times in total. The rabbits were killed 6 months after the implementation to study their larynx. For each material, the fibrous capsule formation, histiocyte infiltration, foreign body giant cell infiltration, eosinophil infiltration, neutrophil infiltration, and lymphoplasmacytic infiltration levels were investigated histologically. RESULTS: Best fibrous capsule formation has been observed around silicone. Allergic reactions and inflammatory responses were minimal for this material. Fibrous capsule formation was more limited with Gore-Tex. Some degree of chronic inflammatory response (in few cases) has been observed against this material. Severe allergic response was observed against irradiated cartilage, and the implant material was resorbed completely in most cases. CONCLUSION: According to histopathologic results of this study (tissue compatibility of three materials), silicone is the most suited material among the study materials for medialization. Gore-Tex can also be used for this purpose. Irradiated cartilage, on the other hand, appears not to be a suitable material for medialization laryngoplasty.

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PubMed2003

Suitability of bioresorbable cages for anterior cervical fusion.

OBJECT: The authors conducted a pilot study to determine whether a bioresorbable intervertebral fusion device composed of 85/15 polylactide-polyglycolide (PLA-PGA) copolymer packed with bone autograft is a suitable alternative to promote arthrodesis after anterior cervical discectomy (ACD) in a caprine model. METHODS: The caprine cervical spine model has been used to evaluate interbody healing and fusion after application of bone grafts and instrumentation. Whether a bioresorbable device is suitable for facilitating intervertebral bone union has not been determined. Twelve goats underwent two-level ACD and fusion; eight received bioresorbable cages packed with autologous bone, and four received autologous bone alone. Goats were maintained without an orthosis and after 12 weeks underwent physical, radiographic, and histological evaluation. Cages had structurally degraded, and two had become extruded. Stable intervertebral union developed in three (19%) of 16 cage-implanted interspaces, and one (14%) of seven bone autograft-implanted interspaces; each was judged manually to be rigid (Grade 2), radiographically to be bridged by new osseous densities (Grade 2), and histologically to have marked new bone formation (Grade 3). A primarily fibrous union, however, stabilized the cage-implanted interspaces, and eight (50%) had developed a 4 to 6-mm foreign body granuloma. These interposed soft tissues were not present in the stable autologous bone-implanted interspace, which had successfully become fused. CONCLUSIONS: Interbody cages composed of 85/15 PLA-PGA copolymer contributed to a stable fibrous union, degraded. and produced granuloma after 12 weeks. Additional evaluations are necessary to determine whether other copolymer mixtures, or other bioresorbable materials, can contribute to an arthodesis without deleterious consequences.

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PubMed2003

Guided bone regeneration using an absorbable membrane combined with a one-stage implant into a recent extraction site: a case report.

Guided bone regeneration using an absorbable membrane combined with one-stage implants was used to treat a 45-year-old woman. Two months following tooth extraction, two implants were placed--one in the extraction site and one in a healed site. An absorbable membrane was applied to cover the bony defect in this recent extraction site. After a 24-month follow-up, probing depths were normal, increased radiopacity was seen in the extraction site, and the implant was still clinically stable.

Absorbable Implants↗

PubMed2004

[Tissue engineering of the urinary bladder].

In tissue engineering of the urinary bladder with autologous cell transplantation, high differentiation of the cells cultivated in vitro on biocompatible membranes is essential for the functionality of the tissue constructs after implantation. The terminal differentiation of superficial urothelial cells has a key role because of the barrier function of these cells against urine. The aim of this study was to determine optimized conditions for the creation of terminally differentiated urothelium to cover large membrane surfaces. This can bring us closer to the goal of using functioning tissue constructs in clinical trials.

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PubMed2004

The effect of scaffold degradation rate on three-dimensional cell growth and angiogenesis.

Even though degradation products of biodegradable polymers are known to be largely non-cytotoxic, little detailed information is available regarding the degradation rate-dependent acidic byproduct effect of the scaffold. In vitro and in vivo scaffold degradation rate could be differentiated using a fast degrading polymer (e.g., poly D, L-lactic-glycolic acid co-polymer, PLGA, 50:50) and a slow degrading polymer (e.g., poly epsilon-caprolactone, PCL). We applied a new method to develop uniform 10 microm thickness of high porous scaffolds using a computer-controlled knife coater with a motion stage and exploiting phase transition properties of a combination of salts and water in salt-leaching method. We then verified in vitro the effect of fast degradation by assessing the viability of primary mouse aortic smooth muscle cell cultured in the three-dimensional scaffolds. We found that cell viability was inversely related to degradation rate and was dependent on the depth from the seeding (upper) surface toward the lower surface. The pH measurement of culture medium using fluorescence probes showed time-dependent decrease in pH in the PLGA scaffolds, corresponding to PLGA degradation, and closely related to cell viability. In vivo analysis of scaffolds implanted subcutaneously into the back of mice, showed significant differences in inflammation and cell invasion into PLGA vs. PCL. Importantly, these were correlated with the degree of the functional angiogenesis within the scaffolds. Again, PLGA scaffolds demonstrated less cell mobilization and less angiogenesis, further supporting the negative effect of the acidic environment created by the degradation of biocompatible polymers.

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PubMed2005

A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand.

PURPOSE: Our purpose was to study the recovery of sensory nerve function after treatment of traumatic peripheral nerve lesions with a biodegradable poly(DL-lactide-epsilon-caprolactone) Neurolac nerve guide (Polyganics B.V., Groningen, the Netherlands) versus the current standard reconstruction techniques. METHODS: Thirty patients with 34 nerve lesions were included in this randomized, multicenter trial. RESULTS: Both groups were comparable considering their demographics. After a small learning curve the nerve guide could be implanted easily. There were more complications in the experimental group but none of them was directly device related. Recovery of sensibility in the nerve guide group was at least as good as in the control group. CONCLUSIONS: These results indicate that the Neurolac nerve guide is suitable for the repair of transected peripheral nerves in the hand.

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↗

PubMedDate not supplied

Bioabsorbable implants in orthopaedics: new developments and clinical applications.

The use of bioabsorbable implants in orthopaedic surgical procedures is becoming more frequent. Advances in polymer science have allowed the production of implants with the mechanical strength necessary for such procedures. Bioabsorbable materials have been utilized for the fixation of fractures as well as for soft-tissue fixation. These implants offer the advantages of gradual load transfer to the healing tissue, reduced need for hardware removal, and radiolucency, which facilitates postoperative radiographic evaluation. Reported complications with the use of these materials include sterile sinus tract formation, osteolysis, synovitis, and hypertrophic fibrous encapsulation. Further study is required to determine the clinical situations in which these materials are of most benefit.

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