Double-chamber Syringes Research Articles

Brief Report on Double-Chamber Syringes Patents and Implications for Infusion Therapy Safety and Efficiency.

This review aimed to map the existing patents of double-chamber syringes that can be used for intravenous drug administration and catheter flush. A search was conducted in the Google patents database for records published prior to 28 October 2020, using several search terms related to double-chamber syringes (DCS). Study eligibility and data extraction were performed by two independent reviewers. Of the initial 26,110 patents found, 24 were included in this review. The 24 DCS that were found display two or more independent chambers that allow for the administration of multiple solutions. While some of the DCS have designated one of the chambers as the flushing chamber, most patents only allow for the sequential use of the flushing chamber after intravenous drug administration. Most DCS were developed for drug reconstitution, usually with a freeze-dried drug in one chamber. Some patents were designed for safety purposes, with a parallel post-injection safety sheath chamber for enclosing a sharpened needle tip. None of the DCS found allow for a pre- and post-intravenous drug administration flush. Given the current standards of care in infusion therapy, future devices must allow for the sequential use of the flushing chamber to promote a pre-administration patency assessment and a post-administration device flush.

Usability Assessment of an Innovative Device in Infusion Therapy: A Mix-Method Approach Study.

Background: Flushing a venous access device is an important procedure to maintain their patency and prevent malfunctioning and complications. An innovative double-chamber syringe was developed, allowing for the assessment of catheter patency, drug delivery and final flush. This study aims to assess the usability of this new device, considering three development stages (concept, semi-functional prototype, functional prototype). Methods: An iterative methodology based on a mix-method design (qualitative and quantitative) enabled the assessment of the devices’ usability by their primary end-users. A usability questionnaire was developed and applied, along with focus groups and individual interviews to nurses. Results: The usability questionnaire integrated 42 items focused on four dimensions (usefulness; ease of use; ease of learning; satisfaction and intention to use). The initial psychometric findings indicate a good internal consistency and the conceptual relevance of the items. The scores seem to be sensitive to the usability evaluation of the medical devices in different stages of product development (with lower values on functional prototype evaluation), and related to nurses’ perceptions about functional and ergonomic characteristics. Conclusions: Quantitative and qualitative data provided a comprehensive overview of the double-chamber syringes’ usability from the nurses’ point of view, informing us of features that must be addressed.

Development of a biodegradable tissue adhesive based on functionalized 1,2-ethylene glycol bis(dilactic acid). II.

In body regions where damage and bleeding must be avoided, a substitute for mechanical tissue fixation by sutures or staplers is needed. Since tissue adhesives provide easy and fast handling they are a promising alternative. The present study reports the development and analysis of a tissue adhesive that consists of two adhesive components: hexamethylene diisocyanate (HDI) functionalized 1,2-ethylene glycol bis(dilactic acid) (ELA-NCO) and chitosan chloride. This composition was chosen based on preliminary studies on several chain elongation agents. The present study evaluates this adhesive system by IR-spectroscopy, tensile tests, and gel point measurements in comparison to fibrin glue. The system's in vitro biocompatibility was tested with mouse fibroblasts (L929) according to ISO 10993-5. Furthermore, an implantation study was performed in SPF-Wistar rats. The adhesive strength of manually applied mixtures or mixtures applied by double chamber syringes with a mixing extruder was determined to be significantly higher than that of fibrin glue on bovine muscle tissue at 37°C. Tensile strength increased further when exposure time of the adhesive was increased from 10 min to 48 h. The rheological gel point determination showed that the mixture of ELA-NCO/DMSO and chitosan chloride offers a time window large enough to readjust the fused joint during surgery, as opposed to fibrin glue. Additionally, the in vitro and in vivo biocompatibility studies of the adhesive system revealed no toxic effects on the surrounding tissue.