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DVT-IMP device- conceptual model

June 7th, 2007

Here are some notes about the conceptual model of the D-dimmer medical diagnosis device, based on the project activities to date, with the aim to ensure that the consortium are working towards a common goal and with shared understanding. Inside this conceptual model are international standards relating to electrical equipment, in-vitro diagnostic devices, communication between devices and the handling of patient information, standards or directives for e-health and technical considerations for the integration of the various components of the device.

We divided discussions with other to four basic, but functionally indivisible compounds of device:
1, the biosensor - component where D-dimer is bound to specific capture antibodies that are bound to an electrode component,
2, the cartridge component in which the addition, movement and analysis of the whole blood sample to be tested is facilitated. The biosensor component is held within the cartridge,
3, the reader - component where measurements made within the cartridge are processed and displayed to the operator. All functions of the complete device are controlled and managed by the reader.
4, software - component where information from the reader may be transferred in a bidirectional manner allowing action to be taken based on the information from the reader.

After 8 month discussions we put together with others all basics point to one material with general technical and methodical description of our newly formed device on 26 pages.

The main points from this material are:
The biosensor will be composed of a set of impedance electrodes housed within a unit that can be installed into the complete cartridge during manufacture. 6-His tag anti-D-dimer reduced antibody is immobilized on top of the electrode functionalized with NTA polypyrrole according to the following scheme, copper ion being a link between polypyrrole and antibody.

The cartridge is considered to be the component where sample is applied and processed through to an area where measurement can take place. Due to the predefined limits of this project it is considered that testing will be done on a biological sample in an in-vitro situation. The measurement principle to be employed will be based upon impedance-electrodes coated with antibodies forming a D-dimer specific biosensor. The cartridge is to be considered as disposable after a single use.

The reader is considered to be the component that is used to house the cartridge component and perform the measurement. The reader will be used to control the functionality of the cartridge resulting in the collection of measurement data from the cartridge. The reader will process measurement data display results to the user and be able to communicate in a bi-directional manner with the software component. During the measurement phase the cartridge and the reader should provide all the functionalities as one compound system. In order to carry out the measurement there must be a connection established between the cartridge and the reader. Therefore the cartridge must be inserted into the reader whereas different kinds of connections are established between the cartridge and the reader.

The software is the component that is to allow communication between the operator (either professional or patient) in a remote situation and the clinician. The scope of this is to be further defined but could include the following elements: User station interface, clinician station interface, communication protocols, patient demographic database, user results database, user results analysis and display, clinical interpretation protocols and connection with hospital main systems (LIS / LIMS). The software should take into consideration emerging e-health standards and protocols, these are to be further defined.

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Initial design of the microfluidic cartridge

May 29th, 2007

The microfluidic cartridge is one of the key elements of the DVT-IMP concept. It constitutes the interface between the impedimetric biosensor and the reader unit and is responsible for sample and reagent handling and transport.

To focus activities within the DVT-IMP development project, information on cartridge design, materials and functionality have to be available. Therefore, efforts within the cartridge development theme have emphasized the development of an initial design. This design has been made available to the consortium in an internal deliverable at the end of May 2007.

Extensive discussions with all other Themes have led to a compilation of demands and requirements for the cartridge, which have been taken into account in the initial design. Constraints on the cartridge design include bio-compatibility, time of reaction, bio-sensing, volume of sample, fabrication steps and interconnectivity with the sensors and the reader.

The interfaces for the fluid collection (sample and buffer) should be compatible with the volume of sample and the washing steps. Dedicated ports constitute the interfaces.

The electric interface as well as a mechanical docking make up the outer boundaries of the cartridge. The electrode pads are contacted by spring connectors with the reader. An asymmetric layout for the cartridge allows a uni-directional fitting and perfect docking of the cartridge into the reader.

The initial cartridge design does not consist exclusively of the cartridge layout. In addition, an initial technology flow, taking into account high throughput manufacturing, as well as an initial assay protocol are now in place.

Initial prototype for the microfluidic element of the cartridge:

The bottom element consists of the sensing element:

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Launch of AntiCoagulation discussion forum

May 1st, 2007

The DVT-IMP project and AntoCoagulation Europe have recently launched a discussion forum to provide an online environment to discuss any aspect of anticoagulation therapy, share views and provide information.

The forum can be found at www.diagnosingdvt.com/forum/

AntiCoagulation is working with the project team as both an advisor and observer and have recently re-launched it’s website www.anticoagulationeurope.org

Welcome to the diagnosing dvt blog

May 1st, 2007

I’d just like to welcome you all to the new diagnosing dvt project blog, launched during May 2007.

All partners who are involved in the project will regularly update this blog with project announcements and up to date information about how the project is progressing.

Enjoy!

Project info

April 26th, 2007

DVT-IMP, a Framework Programme 6 project, is innovating a highly reliable, accurate, portable and handheld prototype medical diagnostic device that promises to revolutionise the speed, accuracy and reliablity with which DVT and related blood clot conditions can be diagnosed - at the point of first contact.

The 3 year project, which started on 1st September 2006, aims to improve the reliability and accuracy of early-stage assessment of patients suspected of DVT and PE.

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Cartridge and technology design completed

DVT-IMP device- conceptual model

Initial design of the microfluidic cartridge

Launch of AntiCoagulation discussion forum

Welcome to the diagnosing dvt blog

Project info

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