Two Polyurethane Adhesives for PVDF Fixation Show Superior Biocompatibility in a Rat Model

Heise, Daniel; Mirlas, Yelyzaveta; Helmedag, Marius; Eickhoff, Roman; Kroh, Andreas; Lambertz, Andreas; Klink, Christian D.; Neumann, Ulf; Klinge, U.; Tolba, René

doi:10.1080/08941939.2020.1833261

Cited by 4 publications

(5 citation statements)

References 30 publications

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“…On the other hand, for research on PU-based tissue adhesive in general, the presented results complete an integral step of the preclinical development of the described PUAS. It has already been demonstrated to be able to overcome material-based shortcomings of other adhesives for different indications as investigated and published in previous research [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. In the present study, the complete degradation of PUAS was documented for the first time.…”

Section: Discussionmentioning

confidence: 99%

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Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing

Bremer

Hagemeister²,

Moss

et al. 2023

JFB

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Tissue adhesives constitute a great possibility to improve conventional wound closure. In contrast to sutures, they enable nearly immediate hemostasis and can prevent fluid or air leaks. In the present study, a poly(ester)urethane-based adhesive was investigated which already proved to be suitable for different indications, such as reinforcing vascular anastomosis and sealing liver tissue. Using in vitro and in vivo setups, the degradation of the adhesives was monitored over a period of up to 2 years, to evaluate long-term biocompatibility and determine degradation kinetics. For the first time, the complete degradation of the adhesive was documented. In subcutaneous locations, tissue residues were found after 12 months and in intramuscular locations, tissue degradation was complete after about 6 months. A detailed histological evaluation of the local tissue reaction revealed good biocompatibility throughout the different degradation stages. After full degradation, complete remodeling to physiological tissue was observed at the implant locations. In addition, this study critically discusses common issues related to the assessment of biomaterial degradation kinetics in the context of medical device certification. This work highlighted the importance and encouraged the implementation of biologically relevant in vitro degradation models to replace animal studies or at least reduce the number of animals in preclinical testing prior to clinical studies. Moreover, the suitability of frequently used implantation studies based on ISO 10993-6 at standard locations was critically discussed, especially in light of the associated lack of reliable predictions for degradation kinetics at the clinically relevant site of implantation.

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Section: Discussionmentioning

confidence: 99%

“…The adhesive can be stored at room temperature and can be easily administered to the target location using the sterile, ready-to-use dual-chamber syringe. It already demonstrated its easy handling and efficacy in different studies ranging from ex vivo studies to in vivo studies [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing

Bremer

Hagemeister²,

Moss

et al. 2023

JFB

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“…In addition, VIVO can be stored at room temperature and processed quickly, whereas fibrin-based glue must be refrigerated and then defrosted and has a short shelf life after defrosting. The biocompatibility and safety of VIVO have been investigated, and it has been demonstrated to be noninferior to fibrin-based glue [11, 20].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of a Novel Medical Adhesive for Sealing Lung Parenchyma: An in vitro Study in Rabbit Lungs

et al. 2021

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Introduction: During thoracic resection procedures, complete hemostasis and aerostasis are priorities. A persistent alveolar air leak is associated with increased morbidity and mortality rates. This study aimed to evaluate whether the novel medical adhesive VIVO (Adhesys Medical GmbH Aachen, Germany) is a reliable alternative sealing technique to routine surgical procedures. Methods: We conducted an in vitro animal study by analyzing 21 lungs of New Zealand (n = 19) and Chinchilla Bastard (n = 2) rabbits (age, 11–18 weeks; weight, 2,400–3,600 g). Three groups, each comprising 7 animals, were evaluated. VIVO (VIVO-group) was compared with standard surgical lung parenchymal lesion closure with a polypropylene suture (Suture-group) and TachoSil® (TachoSil-group). We adopted a stable, pressure-controlled ventilation protocol. After explantation, a surgical incision 0.5-cm deep and 1.5-cm wide was made in the lungs using a customized template. Air leak was measured quantitatively (mL/min) using a respirator and visualized qualitatively by 2 observers who made independent judgments. Next, the leak was closed using VIVO, suture, or TachoSil® as specified by the manufacturer. Subsequently, positive end-expiratory pressure (PEEP) and inspiratory pressure were gradually increased until a maximum of 15 and 30 mbar were attained, respectively. Results: At PEEPs of 8, 10, and 15 mbar, VIVO achieved complete sealing of the profound parenchymal defect in all (n = 7) lungs. After closure of the incision, we observed an air leak variation of 127 ± 114 mL/min (Suture-group), 31 ± 49 mL/min (VIVO-group), and 114 ± 134 mL/min (TachoSil-group). VIVO showed a significantly lower air leak than surgical sutures (p = 0.031) and TachoSil® (p = 0.046). Conclusion: VIVO offers sufficient closure of the lung parenchymal lesions. The novel adhesive enabled significantly better sealing with lower persistent air leakage than TachoSil® or surgical sutures. Further investigation using in vivo models is strongly encouraged to confirm our findings.

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“…Aside from this, the degradation rate of TPU in vivo and the impact of degradation products necessitate further exploration and assessment. [43,71,73] Poly(Vinyl Alcohol): Water-soluble poly(vinyl alcohol) (PVA) can be easily cross-linked into a durable and robust hydrogel with a high resistance, ideal for AWH patch (or CRLs). This is due to the significant amount of repeating hydroxyl groups (Table 1).…”

Section: Nonbiodegradable Polymersmentioning

confidence: 99%

“…Aside from this, the degradation rate of TPU in vivo and the impact of degradation products necessitate further exploration and assessment. [ 43,71,73 ]…”

Section: Awhpms: Selected Materialsmentioning

confidence: 99%

A Review of Advanced Abdominal Wall Hernia Patch Materials

Liang,

Ding,

et al. 2023

Adv Healthcare Materials

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Tension‐free abdominal wall hernia patch materials (AWHPMs) play an important role in the repair of abdominal wall defects (AWDs), which have a recurrence rate of <1%. Nevertheless, there are still significant challenges in the development of tailored, biomimetic, and extracellular matrix (ECM)‐like AWHPMs that satisfy the clinical demands of abdominal wall repair (AWR) while effectively handling post‐operative complications associated with abdominal hernias, such as intra‐abdominal visceral adhesion and abnormal healing. This extensive review presents a comprehensive guide to the high‐end fabrication and the precise selection of these advanced AWHPMs. The review begins by briefly introducing the structures, sources, and properties of AWHPMs, and critically evaluates the advantages and disadvantages of different types of AWHPMs for AWR applications. The review subsequently summarizes and elaborates upon state‐of‐the‐art AWHPM fabrication methods and their key characteristics (e.g., mechanical, physicochemical, and biological properties in vitro/vivo). This review uses compelling examples to demonstrate that advanced AWHPMs with multiple functionalities (e.g., anti‐deformation, anti‐inflammation, anti‐adhesion, pro‐healing properties, etc.) can meet the fundamental clinical demands required to successfully repair AWDs. In particular, there have been several developments in the enhancement of biomimetic AWHPMs with multiple properties, and additional breakthroughs are expected in the near future.

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Two Polyurethane Adhesives for PVDF Fixation Show Superior Biocompatibility in a Rat Model

Cited by 4 publications

References 30 publications

Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing

Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing

Efficacy of a Novel Medical Adhesive for Sealing Lung Parenchyma: An in vitro Study in Rabbit Lungs

A Review of Advanced Abdominal Wall Hernia Patch Materials

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