Versatile Endoscopic Capsule for gastrointestinal TumOr Recognition and therapy
  Funded by the European Commission, Sixth Framework Programme, Information Society Technologies Priority

Spin-off device: Bleeding detection implant

Introduction
A device for recognizing bleeding as an indicator for GI malignancies has been investigated within the development scheme of the VECTOR capsule project. In particular, an optical blood detection sensor has been developed and evaluated as spin-off device within the scope of WP15.
Acute bleeding is a medical problem with high clinical and socio-economic impact world-wide. GI bleeding is the most frequent gastroenterologic emergency with an incidence of 15 to 150 cases per 100.000 inhabitants per year [Silverstein FE, et al., Arch Intern Med 1981]. The two main causes, peptic ulcer (59%) and upper GI varices (10%) involve high letality and recurrence rate after treatment (peptic ulcer: 15-35%, upper GI varices: up to 70%). A sensor that facilitates continuous monitoring of a lesion with a high risk of bleeding could significantly improve the treatment pathway of GI bleeding and even lower the high letality rate associated with this health disorder by immediately indicating the occurrence of bleeding and thus facilitating an immediate treatment.
Within the scope of WP15, a telemetric implant containing a blood recognition sensor has been developed that could have significant impact in monitoring lesions such as varices or peptic ulcers. These lesions might cause severe bleeding that can lead to a life-threatening situation for the patient. This is supported by the high letality of 7-10% for peptic ulcer and 25-30% for upper GI varices, respectively [Krige JEJ, et al., World J Surg 2005]. Nowadays, bleeding in the GI tract is recognized by means of the clinical symptoms, such as bloody vomiting or anemia, which occur with a certain delay. With a device for monitoring such critical lesions from inside the GI tract, the occurrence of bleeding could be detected immediately causing an alarm signal.

Application scenario
The main application scenario is the anchoring of a telemetric, battery-driven bleeding detection implant to the stomach wall endoscopically in patients with lesions bearing high risk of acute bleeding. This can be patients with peptic ulcers or upper GI varices (short-term monitoring) or high-risk patients due to intake of anticoagulating agents due to cardiovascular health disorders (long-term monitoring).

diagramm

In this application scenario, the implant is placed directly after endoscopic treatment of a bleeding lesion. For this purpose, the system comprises special endoscopic instrumentation that allows for easy and safe introduction of the implant into the patient and reliable anchoring to the GI tract wall using a NiTinol endoscopic clip (OTSC® System, Ovesco Endoscopy GmbH). The implant then observes the stomach content to detect the presence of blood during the period of high risk for recurrent bleeding. In case of endoscopically treated peptic ulcers or varices, the surveillance time is approx. 3 to 4 days. When the presence of blood is detected, the implant transmits an alert signal to an extra-corporeal receiver unit that signalizes an event to the patient and the clinical staff. With this early detection mean, the patient can undergo screening endoscopy even before clinical symptoms of bleeding are evident.

image

The first prototype of the bleeding detection implant is battery-powered and contains the blood recognition sensor, a microcontroller for signal processing, and a transmitter unit for transmitting an event signal. The implant is encapsulated in medical-grade polyurethane. With the small dimensions of 25 mm in length and 5.4 mm in diameter, the implant can be introduced through a 6 mm working channel or, alternatively, using an introduction device in front of a standard flexible endoscope.
The bleeding detection sensor has been developed as integrated module of a VECTOR capsule endoscope within WP8. The sensor principle exploits special optical absorption properties of blood to detect the presence of blood through a simplified absorption spectrography. This derivative technology thus is the basis for the bleeding detection implant as one spin-off device of the VECTOR project.


Contact
novineon Healthcare Technology Partners GmbH
Dipl.-Ing. (FH) Sebastian Schostek
Dorfackerstr. 26
72074 Tuebingen / Germany
Phone: +49 70 71.77 04-5 14
Fax: +49 70 71.76 35 74
E-mail: sebastian.schostek@novineon.com
www.novineon.com