Biomedical subjects

Klaus-Peter Schmitz

Publications and source records attributed to Klaus-Peter Schmitz.

13 recordsLinked to original sources

PubMed2006

Influence of femoral head size on impingement, dislocation and stress distribution in total hip replacement.

Dislocation remains a serious complication of total hip replacement. An insufficient range of motion can lead to impingement of the prosthetic neck on the acetabular cup. Together with the initiation of subluxation and dislocation, recurrent impingement can cause material failure in the liner. The objective of this study was to generate a validated finite element (FE) model capable of predicting the dislocation stability of different femoral head sizes with regard to impingement in different implant positions as well as the corresponding stress distribution in the liner. In order to cover posterior and anterior dislocation, two total hip dislocation associated manoeuvres were simulated using a three-dimensional nonlinear finite element model. The dislocation stability of two head sizes was determined numerically and experimentally. After validation, the FE model was used to analyse the dislocation stability of four different head sizes in variable implant positions. Range of motion (ROM) until impingement, the resisting moment that was developed and ROM until dislocation were evaluated. Additionally, stress distribution within the polyethylene liner during impingement and subluxation was determined. For both dislocation modes, a cup position of 45 degrees lateral abduction and 15 degrees up to 30 degrees anteversion resulted in appropriate ROM and dislocation stability. In general, larger head diameters revealed an increase in ROM and higher resisting moments. Stress analysis showed decreased contact pressures at the egress site of the liners with the larger inner diameters during subluxation. The analysis shows that an optimal implant position and a larger head diameter can reduce the risk of dislocation induced by impingement. The finite element model that was developed enables simplification of design variations compared to experimental studies since prototyping and assembling are replaced by prompt numerical simulation.

Arthroplasty, Replacement, Hip↗

PubMed2006

In vitro and in vivo studies on blends of isotactic and atactic poly (3-hydroxybutyrate) for development of a dura substitute material.

Blends of semicrystalline isotactic poly(3-hydroxybutyrate) (PHB) with amorphous atactic PHB (at-PHB) were prepared by solution-casting using 30%, 50% and 70% at-PHB, and were studied for medical applications. The mechanical properties of the blends including the elastic modulus and elongation at break are strongly affected by the blend composition. The elastic modulus decreases with increasing fraction of at-PHB in the blend from 3350 MPa in the case of PHB to 170 MPa of PHB/at-PHB (30/70). In contrast, the elongation at break increases from 2% in pure PHB up to 50% in the case of the blend with 70% at-PHB. The in vitro degradation is changed as well. The molecular weight of PHB/at-PHB (30/70) is reduced to 5% after 2 years storage in phosphate buffer compared to 35% for pure PHB stored at identical conditions. The in vitro cell vitality is slightly reduced depending on the composition. PHB/at-PHB blends with 30% and 50% at-PHB were selected as dura substitute in minipigs based on the results of the in vitro investigation and the mechanical testing. Patch films with a structured surface on one side were fabricated by a dipping-leaching method. Dura defects were clinically and histologically examined 3, 6, and 9 months after implantation, confirming defect closure, prevention of adhesions to brain tissue, and no signs of inflammation or malignant degeneration. The PHB-based patch materials fulfill the requirements which are necessary for a dura substitute.

3-Hydroxybutyric Acid↗

PubMed2006

Iliac anastomotic stenting with a biodegradable poly-L-lactide stent: a preliminary study after 1 and 6 weeks.

PURPOSE: To assess the technical feasibility, thrombogenicity, and biocompatibility of a new biodegradable poly-L-lactic acid (PLLA) anastomotic stent. METHODS: A polytetrafluoroethylene bifurcated graft was implanted in 17 pigs through a midline abdominal incision. After transverse graft incision, 17 316L stainless steel stents and 17 PLLA stents were randomly implanted at both iliac anastomotic sites and deployed with a 6-mm balloon under direct vision without angiography. Intended follow-up was 1 week in 6 pigs receiving oral acetylsalicylic acid (ASA) and in 7 pigs receiving ASA/clopidogrel; 4 pigs receiving ASA/clopidogrel were followed for 6 weeks. At the end of the study, the segments containing the stents were surgically explanted and processed for histology to measure the mean luminal diameter, intimal thickness, and the vascular injury and inflammation scores. RESULTS: Initial technical success of stent placement was achieved in all animals without rupture of the suture. Two pigs died (unrelated to the stent) at 3 days after operation (1 in groups A and B). At 1 week, all PLLA stents showed thrombotic occlusion with the use of ASA alone. In contrast, all PLLA stents remained patent with concurrent administration of ASA/clopidogrel. All metal stents were patent regardless of the antiplatelet regimen. The mean luminal diameter of patent PLLA stents (4.13+/-0.17 mm) was comparable to metal stents (4.27+/-0.35 mm, p=0.78) at 1 week, but significantly diminished at 6 weeks (3.21+/-0.44 versus 4.19+/-0.18 mm, p=0.005). Histological analysis showed no signs of excessive recoil. PLLA stents induced a higher inflammation score (1.79+/-0.56) and more intimal hyperplasia (0.34+/-0.11 mm) compared to metal stents [1.27+/-0.44 mm (p<0.001) and 0.18+/-0.04 mm (p=0.006), respectively] at 6 weeks. Vascular injury was comparable between PLLA and metal stents. CONCLUSION: Biodegradable PLLA stents showed higher thrombogenicity and reduced patency compared to metal stents during early follow-up. Although ASA and clopidogrel prevented thrombotic occlusion, the increased inflammatory response and neointima formation remain major concerns of PLLA stents. A solution to this problem might be the incorporation of anti-inflammatory drugs into the PLLA stent.

Absorbable Implants↗

PubMed2006

Iliac anastomotic stenting with a sirolimus-eluting biodegradable poly-L-lactide stent: a preliminary study after 6 weeks.

PURPOSE: To assess technical feasibility and biocompatibility of a new biodegradable sirolimus-eluting poly-L-lactide (PLLA) vascular anastomotic stent. METHODS: A polytetrafluoroethylene bifurcated graft was implanted in 9 pigs through a midline abdominal incision. After transverse graft limb incision, 6 unloaded PLLAs, 6 sirolimus-loaded PLLAs, and 6 unloaded stainless steel (316L) stents were randomly implanted at both iliac anastomotic sites. Stents were deployed with a 6-mm balloon under direct vision without the use of angiography. Prior to sacrifice after 6 weeks, contrast-enhanced computed tomography (CT) was performed to determine patency of the target vessels. Stented segments were surgically explanted and processed for histology to measure the mean luminal diameter and intimal thickness and to assign vascular injury and inflammation scores. RESULTS: No animals were lost during the study period. All stented graft limbs were patent on CT and histology. At the anastomotic sites and iliac arteries, the mean luminal diameter of SIR-PLLA stents (4.11+/-0.15 and 4.08+/-0.13 mm, respectively) were comparable to metal stents (4.23+/-0.35 and 4.21+/-0.26 mm, respectively), but significantly higher compared to unloaded PLLA stents [3.32+/-0.56 mm (p<0.001) and 3.29+/-0.39 mm (p=0.013), respectively]. At the iliac arteries, the mean intimal thickness was significantly lower with SIR-PLLA stents (0.09+/-0.02 mm) compared to unloaded PLLA stents (0.31+/-0.15 mm, p<0.001) and metal stents (0.19+/-0.04 mm, p=0.004). Vascular injury scores demonstrated only mild vascular trauma for all stents (SIR-PLLA: 0.42+/-0.63, PLLA: 0.51+/-0.62, metal: 0.50+/-0.62). Only mild inflammatory reaction was noted around SIR-PLLA stent struts (1.14+/-0.46), which was comparable to metal stents (1.27+/-0.45) but significantly lower than PLLA stents (1.79+/-0.56, p<0.001). CONCLUSION: SIR-PLLA stents showed comparable luminal diameter compared to metal stents, so incorporating sirolimus could reduce the inflammatory and neointimal response to PLLA stents. These findings need to be assessed with longer follow-up to confirm maintenance of efficacy.

Absorbable Implants↗

PubMed2005

Three-dimensional ultrasound biomicroscopy, environmental and conventional scanning electron microscopy investigations of the human zonula ciliaris for numerical modelling of accommodation.

PURPOSE: Biomechanical modelling of the accommodation process is a useful tool for studying the mechanism of accommodation and presbyopia and can aid in the development of accommodative lens-replacing materials. Existing biomechanical models, however, use a very simplified zonula structure. The aim of this study was to use three-dimensional ultrasonic imaging and scanning electron microscopy to provide a more detailed, three-dimensional description of the structure of the human zonula to improve the modelling of accommodation. METHODS: Five human eyes were examined without invasive manipulation using a custom-made three-dimensional ultrasonic imaging technique that allows scanning of features with a spatial resolution of 30 microm. Environmental and conventional scanning electron microscopy (SEM) provided information to complement the ultrasonic images for use in development of a more anatomically correct finite-element model of the zonula structures. These data along with the material properties of the ocular tissue structures were used to construct an advanced geometric model for finite-element simulation of the accommodation process. RESULTS: Images were obtained through three-dimensional ultrabiomicroscopy (3D-UBM) of anatomical features heretofore not directly imagable in their native state. Ciliary processes and zonula structures were clearly separated by both the 3D-UBM and the SEM methods. It was found that fibres inserting on the anterior and posterior lens capsule emerge anteriorly at the ciliary body. Fibres emerging near the pars plana insert on the lens and the ciliary body. No X-shaped crossing fibres were found. Modelling of the accommodation process with both the simple and the more complex geometric models produced refractive power changes comparable with in vivo findings. CONCLUSIONS: The 3D-UBM allowed examination of zonula structures in their native state with minimized preparation artefacts. While these data were incorporated into a complex and more anatomically correct finite-element simulation of intraocular features including lens, zonular system and ciliary body it was found that a simplified zonular model is sufficient for the numerical simulation of the accommodation process.

Accommodation, Ocular↗

PubMed2005

Comparison of the accommodation theories of Coleman and of Helmholtz by finite element simulations.

PURPOSE: The accommodation process of the human eye is still a controversial subject. Coleman assumes that the lens, together with the zonula fibers, forms a diaphragm which is held in a catenary shape due to the pressure difference between the aqueous and vitreous body of the lens. The aim of the paper is to compare the results of two simulations (according to the Helmholtz and to the Coleman theories) with ultrasonographic data. METHODS: An axisymmetric static finite element model of the lens was generated using the literature data for geometry, material properties and loads. The refractive power of the lens was calculated for two different ages (29 and 45 years). RESULTS: The application of a pressure to the posterior lens surface did not yield an increase in refractive power change during accommodation. Rather a decrease in accommodation related refractive power was found. CONCLUSIONS: Physiologically relevant refractive power changes are obtained by a simulation in accordance with the Helmholtz theory. A simulation in accordance with the Coleman theory does not yield physiological values of refractive power change.

Accommodation, Ocular↗

PubMed2005

Mechanical properties of laser cut poly(L-lactide) micro-specimens: implications for stent design, manufacture, and sterilization.

BACKGROUND: The development of endoluminal stents from polymeric materials requires an understanding of the basic mechanical properties of the polymer and the effects of manufacturing and sterilization on those properties. METHODS: Pure poly(L-lactide) (PLLA) and PLLA containing varying amounts of triethylcitrate (TEC) as a plasticizer (5-10-15%) were studied. The specimens were solution-cast and CO2 laser-cut. Specimen dimensions were adapted to the strut size of polymeric vascular stents. The properties of the PLLA micro-specimens were assessed before and after sterilization (EtO cold gas, H2O2-plasma, beta- and gamma-irradiation). Tensile tests, and creep and recovery tests were carried out at 37 degrees C. Additionally the thermal and thermo-mechanical characteristics were investigated using dynamic-mechanical analysis (DMA) and differential scanning calorimetry (DSC). RESULTS: The results showed the dramatic influence of the plasticizer content and sterilization procedure on the mechanical properties of the material. Laser cutting had a lesser effect. Hence the effects of processing and sterilization must not be overlooked in the material selection and design phases of the development process leading to clinical use. Altogether, the results of these studies provide a clearer understanding of the complex interaction between the laser machining process and terminal sterilization on the primary mechanical properties of PLLA and PLLA plasticized with TEC.

Biocompatible Materials↗

PubMed2004

Biomatrix/polymer composite material for heart valve tissue engineering.

BACKGROUND: Decellularized extracellular matrix has been suggested as a scaffold for heart valve tissue engineering or direct implantation. However, cell removal impairs the physical properties of the valve structure and exposes bare collagen fibers that are highly thrombogenic. Matrix/polymer hybrid valves with improved biological and mechanical characteristics may be advantageous. METHODS: Porcine aortic valves were decellularized enzymatically and impregnated with biodegradable poly(hydroxybutyrate) by a stepwise solvent exchange process. Biocompatibility was tested in vitro using cell proliferation and coagulation assays. Proinflammatory activity was assessed in vivo by implantation of matrix/polymer patches in the rabbit aorta. Biomechanic valve properties and fluid dynamics were tested in a pressure/flow-controlled pulse duplicating system. Matrix/polymer hybrid valves were implanted in pulmonary and aortic position in sheep. RESULTS: Biocompatibility assays indicated that human blood vessel cells survive and proliferate on matrix/polymer hybrid tissue. In vitro activation of cellular and plasmatic coagulation cascades was lower than with uncoated control tissue. After implantation in the rabbit aorta, matrix/polymer hybrid patches healed well, with complete endothelialization, mild leukocyte infiltration, and less calcification than control tissue. Matrix/polymer hybrid tissue had superior tensile strength and suture retention strength, and hybrid valves showed good fluid dynamic performance. The two valves in aortic position performed well, with complete endothelialization and limited inflammatory cell invasion after 12 weeks. Of the two valves in pulmonary position, one failed. CONCLUSIONS: Matrix/polymer hybrid tissue valves have good biological and biomechanic characteristics and may provide superior replacement valves.

Absorbable Implants↗

PubMed2004

Mechanical and structural properties of a novel hybrid heart valve scaffold for tissue engineering.

Hybrid heart valve scaffolds were fabricated from decellularized porcine aortic heart valve matrices and enhanced with bioresorbable polymers using different protocols: (i) dip coating of lyophilized decellularized matrices, and (ii) impregnation of wet decellularized matrices. The following polymers were evaluated: poly(4-hydroxybutyrate) and poly(3-hydroxybutyrate-co4-hydroxybutyrate). Tensile tests were conducted to assess the biomechanical behavior of valve leaflet strips. Suture retention strength was evaluated for the adjacent conduit. A pulse duplicator system was used for functional testing of the valves under physiological systemic load conditions. The properties of the hybrid structures were compared with native, decellularized, and glutaraldehyde-fixed specimens. Mechanisms of the polymer impregnation process were studied with IR spectroscopy, fluorescent microscopic imaging, and SEM. Altogether this study demonstrates the feasibility and improved biomechanical function of a novel hybrid heart valve scaffold for an application in tissue engineering.

Animals↗

PubMed2002

Biomaterial implants induce the inflammation marker CRP at the site of implantation.

Following implantation of biomaterial patches into the gastrointestinal tract, we analyzed the host's response towards the foreign material. Asymmetric patches of polydioxanone covered Vicryl or poly-3-hydroxybutyrate were sutured onto the rat stomach. Tissue samples were generated at distinct time intervals after surgery, and RNA profiles were compared by Differential Display. RT-PCR analysis of gene candidates that seemed differentially expressed showed that vitamin D binding protein mRNA was induced in stomach tissue after implantation of the biomaterial patches. In parallel, the amount of C-reactive protein mRNA was found to be increased transiently as well. Implants induce a tissue response that is specific for a given material.

Absorbable Implants↗

PubMed2002

Biomaterial patches sutured onto the rat stomach induce a set of genes encoding pancreatic enzymes.

Asymmetric patches of polyhydroxybutyric acid with one smooth and one rough surface were produced by a dipping procedure. These patches were implanted into the rat gastrointestine and tissue samples were generated at distinct time intervals after surgery. The host's response towards the foreign material was analyzed by Differential Display and RNA profiles were compared to each other. One to two weeks after surgery a group of mRNAs encoding pancreatic enzymes was transiently present after biomaterial implantation.

Animals↗

PubMed2002

In vitro and in vivo degradation studies for development of a biodegradable patch based on poly(3-hydroxybutyrate).

For the development of a resorbable gastrointestinal patch, the in vitro degradation of solution-cast films of poly(3-hydroxybutyrate) (PHB), modifications of PHB expected to influence its degradation time, as well a poly(L-lactide) (PLLA) was examined. The molecular weight of pure PHB decreased by one-half after 1 year in buffer solution (pH 7.4, 37 degrees C). Acceleration in molecular weight decrease was observed by blending with atactic PHB, whereas no influence was found with low-molecular weight PHB. Leaching of a water-soluble additive led to a slight acceleration of PHB degradability. In contrast, a deceleration in degradation rate was observed with the addition of a hydrophobic plasticizer. In vitro tests indicated an accelerating effect of pancreatin on PHB degradation, whereas PLLA degradation remained essentially uninfluenced. In comparison to simple hydrolysis, the degradation rate of PHB was accelerated about threefold. From the in vitro results, a PHB/atactic PHB blend was selected for repair of a bowel defect in Wistar rats. A patch film was fabricated by a dipping/leaching method. Twenty-six weeks post-implantation, material remnants were found in only one of four animals. The bowel defects were closed in all cases. It could be assessed that the patch material resists the intestinal secretions for a sufficiently long time but that it finally degrades completely.

Animals↗

PubMed2002

Anti-inflammatory prodrugs as plasticizers for biodegradable implant materials based on poly(3-hydroxybutyrate).

Salicylic and acetylsalicylic acid esters were tested as plasticizers for biodegradable poly(3-hydroxybutyrate) (PHB). The aim is the combination of plasticizing and anti-inflammatory properties in the fabrication of implant materials. Solution-cast films made of mixtures of PHB and 30% ester showed plasticization accompanied by a decrease of elastic modulus and an increase in elongation at break in comparison with pure PHB films. However, the number of usable plasticizers from the group of the salicylic acid and acetylsalicylic acid esters is limited. Short-chain derivatives are volatile while long-chain compounds tend to crystallize. In both cases PHB films embrittle within short time. Moreover, some derivatives show a fast release in an aqueous environment. As alternative nonsteroidal anti-inflammatory prodrugs arylpropionic acid esters were tested as plasticizers. The addition of ketoprofen ethyl ester led to PHB films with decreased brittleness. In summary, various esters of anti-inflammatory drugs show plasticizing effects on solution-cast PHB films comparable with those of commonly used citric acid esters.

Journal Article↗