Apparatus and method for simulating surface bleeding
A simulator, blood technology, applied in the medical field, can solve problems such as not being suitable for hemostasis success/failure, determining the severity of bleeding, etc.
Active Publication Date: 2020-01-17
帝隆技术股份有限公司
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Problems solved by technology
However, it is not clear how to determine the severity of bleeding during the intraoperative inclusion / exclusion assessment prior to randomization (especially prior to investigative device placement)
Furthermore such a scale does not appear to be suitable for use consistently to assess the success / failure of a product on hemostasis
Method used
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[0093] The following description focuses on the determination, recognition, and assessment of superficial hemorrhages, particularly for determining the severity of such superficial hemorrhages. However, all corresponding teachings can be applied to any secretion of bodily fluids, in particular any secretion of bodily fluids that has to be identified and / or evaluated for medical or scientific purposes, such as bile.
[0094] Reliable and reproducible assessment of superficial bleeding requires the development of a scale for identifying the severity of superficial bleeding for any target bleeding site (TBS) that can be used similarly for any surgical specialty, i.e. independent of the severity of superficial bleeding in that specialized surgical specialty. Blood loss results during the procedure.
[0095] Such a scale - known as SBSS (Surface Bleeding Severity Scale) - enables a consistent assessment of bleeding applicable to any surgical procedure, e.g. for evaluating medical pro...
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Abstract
The invention relates to a device for simulating superficial hemorrhage, comprising: a blood source, in particular synthetic blood or blood removed from the human body; a pump system connected to the blood source and configured to provide a controlled flow of said blood; a wound simulator, It has an open chamber connected to a pump system to receive controlled blood flow, wherein the wound simulator includes a set of interchangeable plates, each plate having a plurality of plates arranged according to a specific pattern across the plate. holes, wherein the specific pattern is different for each plate in the set of interchangeable plates, and each plate is adapted to be removably mounted on the wound simulator to close the open chamber to allow blood to pass through the mounting The hole in the plate on the wound simulator flows out of the chamber. The invention also relates to a method for using such a simulation device.
Description
technical field [0001] The present invention relates to the medical field, and more particularly to the assessment of the severity of superficial bleeding, for example to determine the efficacy of a hemostatic agent on a wound. Background technique [0002] Evaluating the efficacy of a product, especially a medical product, is meaningful when the protocol used to validate a specific product in a consistent and comparable manner is reliable and reproducible. [0003] However, such reliable and repeatable protocols are not always available. For example, the assessment of the haemostatic properties of a product is very difficult because there is no method available for consistently assessing the severity of bleeding from a wound. Furthermore, no method is available for any surgical procedure used, for example, in clinical studies evaluating the performance of hemostatic agents. [0004] Estimation of total intraoperative blood loss is an integral part of any surgical procedur...
Claims
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IPC IPC(8): G09B23/30G09B23/34G01N33/49G09B23/32
CPCG09B23/303G09B23/34
Inventor W.斯波特尼茨P.弗里斯特C.威特曼V.古约特S.皮科特
Owner 帝隆技术股份有限公司