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1.
Sci Rep ; 11(1): 22228, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34782672

RESUMO

A clinical implementation of cell-based bone regeneration in combination with scaffold materials requires the development of efficient, controlled and reproducible seeding procedures and a tailor-made bioreactor design. A perfusion system for efficient, homogeneous, and rapid seeding with human adipogenic stem cells in bone substitute scaffolds was designed. Variants concerning medium inlet and outlet port geometry, i.e. cylindrical or conical diffuser, cell concentration, perfusion mode and perfusion rates were simulated in silico. Cell distribution during perfusion was monitored by dynamic [18F]FDG micro-PET/CT and validated by laser scanning microscopy with three-dimensional image reconstruction. By iterative feedback of the in silico and in vitro experiments, the homogeneity of cell distribution throughout the scaffold was optimized with adjustment of flow rates, cell density and perfusion properties. Finally, a bioreactor with a conical diffusor geometry was developed, that allows a homogeneous cell seeding (hoover coefficient: 0.24) in less than 60 min with an oscillating perfusion mode. During this short period of time, the cells initially adhere within the entire scaffold and stay viable. After two weeks, the formation of several cell layers was observed, which was associated with an osteogenic differentiation process. This newly designed bioreactor may be considered as a prototype for chairside application.

2.
Eur J Med Res ; 26(1): 121, 2021 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-34641963

RESUMO

BACKGROUND: Percutaneous coronary interventions (PCI) of bifurcation stenoses are both complex and challenging. Stenting strategies share that the stents' side cells must be carefully explored and appropriately prepared using balloons or stents. So far, stent manufacturers have not provided any information regarding side-branch expansion capacity of their stent platforms. AIMS: Given that drug-eluting stent (DES) information regarding their mechanical capacity of side-branch expansion is not available, we aimed to evaluate contemporary DES (Orsiro, BIOTRONIK AG; Xience Sierra, Abbott Vascular; Resolute Integrity, Medtronic; Promus Premier Select, Boston Scientific; Supraflex Cruz, Sahajan and Medical Technologies) by their side-branch expansion behavior using in vitro bench testing. METHODS: In this in vitro study, we analyzed five commercially available DES (diameter 3.0 mm), measuring their side-branch expansion following inflation of different high-pressure non-compliant (NC) balloons (balloon diameter: 2.00-4.00 mm), thereby revealing the morphological characteristics of their side-branch expansion capacities. RESULTS: We demonstrated that all tested contemporary DES platforms could withstand large single-cell deformations, up to 4.0 mm. As seen in our side-branch experiments, DES designs consisting of only two connectors between strut rings did not only result in huge cell areas, but also in larger cell diameters following side-branch expansion compared with DES designs using three or more connectors. Furthermore, the stent cell diameter attained was below the balloon diameter at normal pressure. CONCLUSIONS: We recommend that the expansion capacity of side-branches should be considered in stent selection for bifurcation interventions.

3.
BMC Mol Cell Biol ; 22(1): 32, 2021 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-34078283

RESUMO

BACKGROUND: Endothelial healing after deployment of cardiovascular devices is particularly important in the context of clinical outcome. It is therefore of great interest to develop tools for a precise prediction of endothelial growth after injury in the process of implant deployment. For experimental investigation of re-endothelialization in vitro cell migration assays are routinely used. However, semi-automatic analyses of live cell images are often based on gray value distributions and are as such limited by image quality and user dependence. The rise of deep learning algorithms offers promising opportunities for application in medical image analysis. Here, we present an intelligent cell detection (iCD) approach for comprehensive assay analysis to obtain essential characteristics on cell and population scale. RESULTS: In an in vitro wound healing assay, we compared conventional analysis methods with our iCD approach. Therefore we determined cell density and cell velocity on cell scale and the movement of the cell layer as well as the gap closure between two cell monolayers on population scale. Our data demonstrate that cell density analysis based on deep learning algorithms is superior to an adaptive threshold method regarding robustness against image distortion. In addition, results on cell scale obtained with iCD are in agreement with manually velocity detection, while conventional methods, such as Cell Image Velocimetry (CIV), underestimate cell velocity by a factor of 0.5. Further, we found that iCD analysis of the monolayer movement gave results just as well as manual freehand detection, while conventional methods again shows more frayed leading edge detection compared to manual detection. Analysis of monolayer edge protrusion by ICD also produced results, which are close to manual estimation with an relative error of 11.7%. In comparison, the conventional Canny method gave a relative error of 76.4%. CONCLUSION: The results of our experiments indicate that deep learning algorithms such as our iCD have the ability to outperform conventional methods in the field of wound healing analysis. The combined analysis on cell and population scale using iCD is very well suited for timesaving and high quality wound healing analysis enabling the research community to gain detailed understanding of endothelial movement.


Assuntos
Rastreamento de Células/métodos , Aprendizado Profundo , Cicatrização , Endotélio Vascular/citologia , Humanos
4.
Dtsch Arztebl Int ; 118(5): 59-65, 2021 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-33785117

RESUMO

BACKGROUND: Since the beginning of 2020 the SARS-CoV-2 virus has spread to nearly every country in the world. The mainly airborne pathogen has led to large numbers of deaths, principally in elderly and vulnerable segments of the population. Protective vaccines have recently become available, but it is not yet clear whether and when population-wide immunity will be achieved. The existence of evidence for the protective effect of masks covering the mouth and nose is a topic of public debate. METHODS: A selective literature search was carried out in PubMed. Data from the German Robert Koch Institute and the Centers for Disease Control and Prevention were also taken into account. RESULTS: When talking, as many as 20 000 droplets ranging in size from 20 to 500 µM are released every second. According to PCR tests, the amount of virus exhaled is highest immediately before the onset of symptoms. No randomized trials have been conducted on the effect of masks covering the mouth and nose. A metaanalysis of 29 studies on infection with SARS-CoV-2, SARS, or MERS revealed that type N-95 masks (corresponding approximately to FFP-2), surgical masks, or similar multilayer cotton masks can greatly reduce the infection risk for the wearers (RR 0.34 [0.26; 0.45], with moderate heterogeneity [I2 = 48%]). Model experiments and case reports suggest that masks covering the mouth and nose afford considerable protection against transmission of SARS-CoV-2 and other airborne diseases by reducing release of and exposure to potentially infectious droplets; in addition, infections that do occur take a milder course. A limitation of the studies analyzed is that in most cases, this effect cannot be viewed in isolation from the protective impact of other measures (distancing, hygiene precautions). CONCLUSION: It can plausibly be assumed that consistent use of masks covering the mouth and nose can play an important role in containing the spread of SARSCoV- 2.


Assuntos
COVID-19 , Idoso , Humanos , Máscaras , SARS-CoV-2 , Estados Unidos
5.
Dtsch Arztebl Int ; 118(Forthcoming)2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33634786

RESUMO

BACKGROUND: Since the beginning of 2020 the SARS-CoV-2 virus has spread to nearly every country in the world. The mainly airborne pathogen has led to large numbers of deaths, principally in elderly and vulnerable segments of the population. Protective vaccines have recently become available, but it is not yet clear whether and when population-wide immunity will be achieved. The existence of evidence for the protective effect of masks covering the mouth and nose is a topic of public debate. METHODS: A selective literature search was carried out in PubMed. Data from the German Robert Koch Institute and the Centers for Disease Control and Prevention were also taken into account. RESULTS: When talking, as many as 20 000 droplets ranging in size from 20 to 500 µM are released every second. According to PCR tests, the amount of virus exhaled is highest immediately before the onset of symptoms. No randomized trials have been conducted on the effect of masks covering the mouth and nose. A meta-analysis of 29 studies on infection with SARS-CoV-2, SARS, or MERS revealed that type N-95 masks (corresponding approximately to FFP-2), surgical masks, or similar multilayer cotton masks can greatly reduce the infection risk for the wearers (RR 0.34 [0.26; 0.45], with moderate heterogeneity [I2 = 48%]). Model experiments and case reports suggest that masks covering the mouth and nose afford considerable protection against transmission of SARS-CoV-2 and other airborne diseases by reducing release of and exposure to potentially infectious droplets; in addition, infections that do occur take a milder course. A limitation of the studies analyzed is that in most cases, this effect cannot be viewed in isolation from the protective impact of other measures (distancing, hygiene precautions). CONCLUSION: It can plausibly be assumed that consistent use of masks covering the mouth and nose can play an important role in containing the spread of SARS-CoV-2.

6.
Klin Monbl Augenheilkd ; 237(9): 1117-1123, 2020 Sep.
Artigo em Inglês, Alemão | MEDLINE | ID: mdl-32967033

RESUMO

BACKGROUND: Glaucoma is one of the most common causes of blindness worldwide. The only evidence-based treatment to slow down the progression of glaucoma is the reduction of intraocular pressure (IOP) using local medication or through surgery. During the last years, a large number of microinvasive glaucoma surgery techniques (MIGS) has been developed, in order to reduce the IOP in glaucoma patients safely and effectively. Until now, efficacy of MIGS has been assessed mainly according to the postoperative IOP and the number of medications used. Results from long-term studies are rare or not available in the majority of the cases. In order to better evaluate the functionality of MIGS, a new examination method has been developed with the help of a new oculopressor device. In this study the efficacy of different MIGS techniques will be examined using the new oculopressor. MATERIAL/METHODS: At first, glaucoma patients that had previously received a MIGS surgery (iStent inject, XEN Stent, ELT) were examined with the new oculopression test. Their results were compared with those of non-operated patients and healthy individuals. Overall, 38 healthy subjects (group 1), 10 non-operated patients (group 2), 19 patients after iStent inject implantation (group 3), 14 patients after XEN Stent implantation (group 4) and 5 patients after ELT (group 5) were examined. The new examination measures the IOP-reduction that occurs after oculopression and can be seen as an indirect measurement of the outflow facility of the eye. RESULTS: The IOP-reduction after oculopression differed among the study groups. Non-operated patients showed a significantly lower IOP-reduction compared to healthy individuals. Patients after iStent inject and XEN stent implantation showed a larger reduction of IOP after oculopression in relation to non-operated patients and their results approximated those of healthy individuals. These patients needed fewer medications postoperatively in relation to non-operated patients. Patients after ELT showed postoperatively a smaller reduction of IOP after oculopression compared to iStent inject and XEN stent patients. CONCLUSION: MIGS can increase the outflow facility of the eye in patients with glaucoma. Though ELT had the lowest impact on the aqueous outflow among the studied procedures in this study. The new test can help in the evaluation of current and further development of new MIGS in the future.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma/cirurgia , Teste de Esforço , Humanos , Pressão Intraocular , Stents , Resultado do Tratamento
7.
Radiologe ; 60(Suppl 1): 70-79, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32926194

RESUMO

Three-dimensional (3D) imaging has been available for nearly four decades and is regarded as state of the art for visualization of anatomy and pathology and for procedure planning in many clinical fields. Together with 3D image reconstructions in the form of rendered virtual 3D models, it has helped to better perceive complex anatomic and pathologic relations, improved preprocedural measuring and sizing of implants, and nowadays enables even photorealistic quality. However, presentation on 2D displays limits the 3D experience. Novel 3D printing technologies can transfer virtual anatomic models into true 3D space and produce both patient-specific models and medical devices constructed by computer-aided design. Individualized anatomic models hold great potential for medical and patient education, research, device development and testing, procedure training, preoperative planning, and fabrication of individualized instruments and implants. Hand in hand with 3D imaging, medical 3D printing has started to revolutionize medicine in certain fields and new applications are developed and introduced regularly. The demand for medical 3D printing will likely continue to rise, as it is a promising tool for plastic preparation of medical interventions. However, there is ongoing debate on the appropriateness of medical 3D printing and further research on its efficiency is needed. As experts in 3D imaging, radiologists are not only capable of advising on adequate imaging parameters, but should also become adept in 3D printing to participate in on-site 3D printing facilities and randomized controlled trials on the topic, thus contributing to improving patient outcomes via personalized medicine through patient-specific preparation of medical interventions.


Assuntos
Imageamento Tridimensional , Modelos Anatômicos , Plásticos , Impressão Tridimensional , Humanos , Radiologistas , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
Biomed Tech (Berl) ; 64(3): 251-262, 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-29933242

RESUMO

Bioresorbable scaffolds (BRS) promise to be the treatment of choice for stenosed coronary vessels. But higher thrombosis risk found in current clinical studies limits the expectations. Three hemodynamic metrics are introduced to evaluate the thrombosis risk of coronary stents/scaffolds using transient computational fluid dynamics (CFD). The principal phenomena are platelet activation and effective diffusion (platelet shear number, PSN), convective platelet transport (platelet convection number, PCN) and platelet aggregation (platelet aggregation number, PAN) were taken into consideration. In the present study, two different stent designs (thick-strut vs. thin-strut design) positioned in small- and medium-sized vessels (reference vessel diameter, RVD=2.25 mm vs. 2.70 mm) were analyzed. In both vessel models, the thick-strut design induced higher PSN, PCN and PAN values than the thin-strut design (thick-strut vs. thin-strut: PSN=2.92/2.19 and 0.54/0.30; PCN=3.14/1.15 and 2.08/0.43; PAN: 14.76/8.19 and 20.03/10.18 for RVD=2.25 mm and 2.70 mm). PSN and PCN are increased by the reduction of the vessel size (PSN: RVD=2.25 mm vs. 2.70 mm=5.41 and 7.30; PCN: RVD=2.25 mm vs. 2.70 mm=1.51 and 2.67 for thick-strut and thin-strut designs). The results suggest that bulky stents implanted in small caliber vessels may substantially increase the thrombosis risk. Moreover, sensitivity analyses imply that PSN is mostly influenced by vessel size (lesion-related factor), whereas PCN and PAN sensitively respond to strut-thickness (device-related factor).


Assuntos
Doença da Artéria Coronariana/cirurgia , Vasos Coronários/cirurgia , Implantes Absorvíveis , Doença da Artéria Coronariana/fisiopatologia , Hemodinâmica , Humanos , Stents , Trombose , Resultado do Tratamento
9.
Klin Monbl Augenheilkd ; 235(12): 1360-1365, 2018 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-30566996

RESUMO

PURPOSE: Evaluation of the long-term efficiency of MIGS implants is still challenging, due to the lack of standardized clinical studies of stand-alone procedures. Moreover, the different mechanisms of the various glaucoma drainage devices are not adequately considered. The current study focusses on the development of a method for oculopression to evaluate the efficiency of glaucoma drainage devices. METHODS: Explanted porcine eyes were subjected to pressure or weight load using three oculopressors with different modi operandi. The time-dependent intraocular pressure was measured using an anterior chamber maintainer. The Honan Balloon exerts variable pressure onto the eye via an air bellows, whereas the Taylor oculopressor applies a defined weight loading on the eye. A novel oculopressor with a weight loading of 60 g was developed and manufactured by means of 3-D-printing. RESULTS: The intraocular pressure changes observed during the experiments were similar for all tested oculopression devices, varying only in the absolute pressure values. The Honan Balloon was not suitable for the intended purpose, due to poor standardisation of the applied pressure. Oculopression using a defined weight appeared more suitable. The Taylor oculopressor, however, created intraocular pressure values of up to 203.3 ± 38.4 mmHg, which precludes its use with glaucoma patients. On the basis of these data, the new oculopression device was used in a preliminary trial with healthy human subjects, thereby preparing its use in a clinical trial. CONCLUSIONS: Oculopression represents a potentially suitable tool to analyse the efficiency of glaucoma drainage devices. Commercially available oculopression devices are not directly applicable for this task. Difficult handling, high intraocular pressure, and lack of standardisation complicate the use for glaucoma patients. These difficulties were overcome with the newly designed oculopressor that facilitates a well defined increase in intraocular pressure. The device is currently being used in a clinical study to evaluate the efficiency of MIGS implants.


Assuntos
Implantes para Drenagem de Glaucoma , Glaucoma , Animais , Câmara Anterior , Drenagem , Humanos , Pressão Intraocular , Suínos
10.
Biosci Rep ; 38(4)2018 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-30061178

RESUMO

To prevent implant failure due to fibrosis is a major objective in glaucoma research. The present study investigated the antifibrotic effects of paclitaxel (PTX), caffeic acid phenethyl ester (CAPE), and pirfenidone (PFD) coated microstent test specimens in a rat model. Test specimens based on a biodegradable blend of poly(4-hydroxybutyrate) biopolymer and atactic poly(3-hydroxybutyrate) (at.P(3HB)) were manufactured, equipped with local drug delivery (LDD) coatings, and implanted in the subcutaneous white fat depot. Postoperatively, test specimens were explanted and analyzed for residual drug content. Fat depots including the test specimens were histologically analyzed. In vitro drug release studies revealed an initial burst for LDD devices. In vivo, slow drug release of PTX was found, whereas it already completed 1 week postoperatively for CAPE and PFD LDD devices. Histological examinations revealed a massive cell infiltration in the periphery of the test specimens. Compact fibrotic capsules around the LDD devices were detectable at 4-36 weeks and least pronounced around PFD-coated specimens. Capsules stained positive for extracellular matrix (ECM) components. The presented model offers possibilities to investigate release kinetics and the antifibrotic potential of drugs in vivo as well as the identification of more effective agents for a novel generation of drug-eluting glaucoma microstents.


Assuntos
Ácidos Cafeicos/administração & dosagem , Sistemas de Liberação de Medicamentos/instrumentação , Stents Farmacológicos , Paclitaxel/administração & dosagem , Álcool Feniletílico/análogos & derivados , Piridonas/administração & dosagem , Animais , Ácidos Cafeicos/farmacocinética , Ácidos Cafeicos/uso terapêutico , Fibrose , Glaucoma/terapia , Masculino , Paclitaxel/farmacocinética , Paclitaxel/uso terapêutico , Álcool Feniletílico/administração & dosagem , Álcool Feniletílico/farmacocinética , Álcool Feniletílico/uso terapêutico , Piridonas/farmacocinética , Piridonas/uso terapêutico , Ratos , Ratos Wistar
11.
Biomed Microdevices ; 19(4): 78, 2017 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-28844120

RESUMO

Within this paper we analyzed the technical feasibility of a novel microstent for glaucoma therapy. For lowering of intraocular pressure, the flexible polyurethane (PUR) implant is designed to drain aqueous humour from the anterior chamber of the eye into subconjunctival, or alternatively suprachoroidal, space. The microstent includes a biodegradable, flow resisting polymer membrane serving as temporary flow resistance for the prevention of early postoperative hypotony. A biodegradable local drug delivery (LDD)-device was designed to prevent fibrous encapsulation. Biodegradable components were made of flexible, nonwoven membranes of Poly(4-hydroxybutyrate) (P(4HB)). Polymer samples and microstent prototypes were manufactured by means of dip coating, electrospinning and femtosecond-laser micromachining and characterized in vitro with regard to structural and fluid mechanical properties, degradation behavior and drug release. Bending stiffness of PUR-tubing (62.53 ± 7.57 mN mm2) is comparable to conventional glaucoma drainage devices in a tube-plate design. Microstent prototypes yield a flow resistance of 2.4 ± 0.6 mmHg/µl min-1 which is close to the aspired value corresponding to physiological pressure (15 mmHg) and aqueous humour flow (2 µl min-1) conditions inside the eye. Degradation of electrospun P(4HB) specimens was found to be almost completely finished after six months in vitro. Within this time frame, flow capacity of the microstent increases, which is beneficial to compensate potentially increasing flow resistance of fibrous tissue in vivo. Fast drug release of the LDD-device was found. One microstent prototype was implanted into a porcine eye ex vivo. Future preclinical studies will allow further information about Microstent performance.


Assuntos
Implantes Absorvíveis , Implantes de Medicamento , Glaucoma/terapia , Teste de Materiais , Poliésteres , Stents , Animais , Implantes de Medicamento/química , Implantes de Medicamento/farmacologia , Glaucoma/metabolismo , Glaucoma/fisiopatologia , Humanos , Poliésteres/química , Poliésteres/farmacologia , Suínos
12.
Cardiovasc Revasc Med ; 17(6): 375-83, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27266902

RESUMO

BACKGROUND/PURPOSE: Biodegradable polymers are the main materials for coronary scaffolds. Magnesium has been investigated as a potential alternative and was successfully tested in human clinical trials. However, it is still challenging to achieve mechanical parameters comparative to permanent bare metal (BMS) and drug-eluting stents (DES). As such, in vitro tests are required to assess mechanical parameters correlated to the safety and efficacy of the device. METHODS/MATERIALS: In vitro bench tests evaluate scaffold profiles, length, deliverability, expansion behavior including acute elastic and time-dependent recoil, bending stiffness and radial strength. The Absorb GT1 (Abbott Vascular, Temecula, CA), DESolve (Elixir Medical Corporation, Sunnyvale, CA) and the Magmaris (BIOTRONIK AG, Bülach, Switzerland) that was previously tested in the BIOSOLVE II study, were tested. RESULTS: Crimped profiles were 1.38±0.01mm (Absorb GT1), 1.39±0.01mm (DESolve) and 1.44±0.00mm (Magmaris) enabling 6F compatibility. Trackability was measured depending on stiffness and force transmission (pushability). Acute elastic recoil was measured at free expansion and within a mock vessel, respectively, yielding results of 5.86±0.76 and 5.22±0.38% (Absorb), 7.85±3.45 and 9.42±0.21% (DESolve) and 5.57±0.72 and 4.94±0.31% (Magmaris). Time-dependent recoil (after 1h) was observed for the Absorb and DESolve scaffolds but not for the Magmaris. The self-correcting wall apposition behavior of the DESolve did not prevent time-dependent recoil under vessel loading. CONCLUSIONS: The results of the suggested test methods allow assessment of technical feasibility based on objective mechanical data and highlight the main differences between polymeric and metallic bioresorbable scaffolds.


Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Metais/química , Polímeros/química , Stents , Tecidos Suporte , Força Compressiva , Doença da Artéria Coronariana/diagnóstico por imagem , Elasticidade , Análise de Falha de Equipamento , Humanos , Teste de Materiais , Pressão , Desenho de Prótese , Falha de Prótese , Resistência à Tração , Fatores de Tempo
13.
Transl Vis Sci Technol ; 4(3): 14, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26175960

RESUMO

PURPOSE: A novel glaucoma drainage device (GDD) with local drug delivery (LDD) system was created and characterized for safety and effectiveness after implantation into the suprachoroidal space (SCS) of rabbit eyes. METHODS: Thin films of two different polymers, Poly(3-hydroxybutyrate) (P(3HB)) and Poly(4-hydroxybutyrate) (P(4HB)), containing the drugs mitomycin C (MitC) or paclitaxel (PTX) were attached to silicone-tubes to create LDD devices. The release kinetics of these drugs were explored in vitro using high performance liquid chromatography (HPLC). Twenty-four New Zealand white rabbits, randomly divided into eight groups, were implanted with different kinds of microstents into SCS. The intraocular pressure (IOP) was monitored noninvasively. After 6 weeks, rabbits were sacrificed and enucleated eyes were used for anterior segment optical coherence tomography (OCT), micro magnetic resonance imaging (MRI), and histology. RESULTS: In vitro, faster drug release from both polymers was observed for MitC compared to PTX. Comparing polymers, the release from P(3HB) matrix was slower for both drugs. MRI and OCT showed all implants maintained a proper location. An effective IOP reduction was observed for up to 6 weeks in eyes with microstents combined with a drug-releasing LDD system. Overall, the surrounding tissue revealed mild-to-moderate inflammation. No pronounced fibrosis was observed in any of the groups. However, both drugs caused damage to the neighboring retina. CONCLUSIONS: The suprachoroidal microstent reduced IOP with mild inflammation in rabbit eyes. To avoid negative effects on the retina, it is necessary to identify novel drugs with less cytotoxicity. Future studies are needed to explore the fibrotic process over the long-term. TRANSLATIONAL RELEVANCE: The presented data serve as a proof of principle study for the concept of a suprachoroidal drug eluting microstent. Future device improvements will be focused on the design of LDD systems and the use of specific anti-inflammatory or antifibrotic agents with less cytotoxicity compared to MitC or PTX. Long-term animal studies using a reliable glaucoma model will be a further step towards clinical application and improvement of surgical glaucoma therapy.

14.
Biomed Microdevices ; 14(5): 907-20, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22711457

RESUMO

This paper describes methods for design, manufacturing and characterization of a micro-mechanical valve for a novel glaucoma implant. The implant is designed to drain aqueous humour from the anterior chamber of the eye into the suprachoroidal space in case of an elevated intraocular pressure (IOP). In contrast to any existing glaucoma drainage device (GDD), the valve mechanism is located in the anterior chamber and there, surrounded by aqueous humour, immune to fibrosis induced failure. For the prevention of hypotony the micro-mechanical valve is designed to open if the physiological pressure difference between the anterior chamber and the suprachoroidal space in the range of 0.8 mmHg to 3.7 mmHg is exceeded. In particular the work includes: (i) manufacturing and morphological characterization of polymer tubing, (ii) mechanical material testing as basis for (iii) the design of micro-mechanical valves using finite element analysis (FEA), (iv) manufacturing of microstent prototypes including micro-mechanical valves by femtosecond laser micromachining and (v) the experimental fluid-mechanical characterization of the manufactured microstent prototypes with regard to valve opening pressure. The considered materials polyurethane (PUR) and silicone (SIL) exhibit low elastic modulus and high extensibility. The unique valve design enables a low opening pressure of micro-mechanical valves. An ideal valve design for PUR and SIL with an experimentally determined opening pressure of 2 mmHg and 3.7 mmHg is identified. The presented valve approach is suitable for the inhibition of hypotony as a major limitation of today's GDD and will potentially improve the minimally invasive treatment of glaucoma.


Assuntos
Implantes para Drenagem de Glaucoma , Glaucoma/cirurgia , Microfluídica/instrumentação , Microfluídica/métodos , Câmara Anterior/cirurgia , Humor Aquoso , Corioide/cirurgia , Desenho de Equipamento , Análise de Elementos Finitos , Pressão Intraocular , Modelos Teóricos , Poliuretanos/química , Silicones/química , Tonometria Ocular/instrumentação , Tonometria Ocular/métodos
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