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Design Innovation Paper

An Implantable Accelerometer-Based Heart-Monitoring Device With Improved Positional Stability

[+] Author and Article Information
Fjodors Tjulkins

IMST—Department of Micro and
Nano Systems Technology,
HBV—Buskerud and
Vestfold University College,
Raveien 205,
Borre 3184, Norway
e-mail: fjodort@gmail.com

Anh-Tuan Thai Nguyen

IMST—Department of Micro and
Nano Systems Technology,
HBV—Buskerud and
Vestfold University College,
Raveien 205,
Borre 3184, Norway
e-mail: Anh.Thai.nguyen@hbv.no

Erik Andreassen

Department of Polymer and
Composite Materials,
SINTEF Materials and Chemistry,
P.O. Box 124 Blindern,
Oslo 0314, Norway
e-mail: Erik.Andreassen@hbv.no

Lars Hoff

IMST—Department of Micro and
Nano Systems Technology,
HBV—Buskerud and
Vestfold University College,
Raveien 205,
Borre 3184, Norway
e-mail: Lars.Hoff@hbv.no

Ole-Johannes Grymyr

The Intervention Centre,
Oslo University Hospital
(Oslo Universitetssykehus), Rikshospitalet,
Postboks 4950 Nydalen,
Oslo 0424, Norway
e-mail: olegry@ous-hf.no

Per Steinar Halvorsen

The Intervention Centre,
Oslo University Hospital
(Oslo Universitetssykehus), Rikshospitalet,
Postboks 4950 Nydalen,
Oslo 0424, Norway
e-mail: sthalvor@ous-hf.no

Kristin Imenes

IMST—Department of Micro and
Nano Systems Technology,
HBV—Buskerud and
Vestfold University College,
Raveien 205,
Borre 3184, Norway
e-mail: ki@hbv.no

Manuscript received October 19, 2015; final manuscript received August 28, 2016; published online September 14, 2016. Assoc. Editor: John LaDisa.

J. Med. Devices 10(4), 045002 (Sep 14, 2016) (6 pages) Paper No: MED-15-1281; doi: 10.1115/1.4034574 History: Received October 19, 2015; Revised August 28, 2016

This paper reports recent results from an ongoing effort to develop an implantable accelerometer-based heart-monitoring device for ischemia monitoring. The latest device prototype utilizes a new and more compact accelerometer (1.2 × 1.5 × 0.8 mm3), a prototype device from Bosch SensorTec, Reutlingen, Germany. This paper presents the fabrication and testing of the device, including an explorative study of the effect of the capsule shape on the stability of the implanted device in the heart tissue. The stability study indicated sufficient stability of the device and a higher resistance to retraction for one of the capsule designs. The device was able to carry out acceleration monitoring and it meets the leakage current requirements of the IEC60601 standard.

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Figures

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Fig. 1

Schematic drawing of the complete heart-monitoring device: A—cable, B—joint between capsule and cable, C—three-axis accelerometer inside a capsule (the transparent “window” in the drawing is only for showing the components inside the capsule), D—stainless steel capsule, and E—needle and thread attached to the capsule

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Fig. 2

(a) Round capsule, (b) capsule with flattened sides, and (c) capsule with flanges (all dimensions in millimeter)

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Fig. 3

Pull-in (a) and pull-out (b) tests conducted on the phantom

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Fig. 4

The adhesive joint endurance test: (a) leakage current test and (b) cyclic loading

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Fig. 5

The experimental setup from the second experiment with five sensors

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Fig. 6

(a) A schematic illustration of the potential rotation of the device in the YZ plane, around the X axis and (b) the motion in the YZ plane

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Fig. 7

Images from the first animal experiments (a) beginning of the experiment; the arrow shows group of device capsules under evaluation, (b) the capsule that retracted at the end of experiment, and (c) the blood clot that anchored the cable to the ribcage

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Fig. 8

The sensor angles (in the YZ Plane) during the first and second observation periods. Top lines represent the first observation period, and bottom lines represent the second observation period (after a 30 min waiting period), except in the second case where bottom line represents the starting angle and top line represents the angle after the wait period.

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