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.

References

References
1.
Hol
,
P. K.
,
Lingaas
,
P. S.
,
Lundblad
,
R.
,
Rein
,
K. A.
,
Vatne
,
K.
,
Smith
,
H. J.
,
Nitter-Hauge
,
S.
, and
Fosse
,
E.
,
2004
, “
Intraoperative Angiography Leads to Graft Revision in Coronary Artery Bypass Surgery
,”
Ann. Thorac. Surg.
,
78
(
2
), pp.
502
505
.
2.
Smith
,
R. C.
,
Leung
,
J. M.
, and
Mangano
,
D. T.
,
1991
, “
Postoperative Myocardial Ischemia in Patients Undergoing Coronary Artery Bypass Graft Surgery, S.P.I. Research Group
,”
Anesthesiology
,
74
(
3
), pp.
464
473
.
3.
Elle
,
O. J.
,
Halvorsen
,
S.
,
Gulbrandsen
,
M. G.
,
Aurdal
,
L.
,
Bakken
,
A.
,
Samset
,
E.
,
Dugstad
,
H.
, and
Fosse
,
E.
,
2005
, “
Early Recognition of Regional Cardiac Ischemia Using a 3-Axis Accelerometer Sensor
,”
Physiol. Meas.
,
26
(
4
), pp.
429
440
.
4.
Halvorsen
,
P. S.
,
Espinoza
,
A.
,
Fleischer
,
L. A.
,
Elle
,
O. J.
,
Hoff
,
L.
,
Lundblad
,
R.
,
Skulstad
,
H.
,
Edvardsen
,
T.
,
Ihlen
,
H.
, and
Fosse
,
E.
,
2008
, “
Feasibility of a Three-Axis Epicardial Accelerometer in Detecting Myocardial Ischemia in Cardiac Surgical Patients
,”
J. Thorac. Cardiovasc. Surg.
,
136
(
6
), pp.
1496
1502
.
5.
Tjulkins
,
F.
,
Nguyen
,
A. T.
,
Andreassen
,
E.
,
Aasmundtveit
,
K.
,
Hoivik
,
N.
,
Hoff
,
L.
,
Halvorsen
,
P. S.
,
Grymyr
,
O. J.
, and
Imenes
,
K.
,
2015
, “
Fabrication and Assembly of MEMS Accelerometer-Based Heart Monitoring Device With Simplified, One Step Placement
,”
J. Med. Eng. Technol.
,
39
(
1
), pp.
69
74
.
6.
Tjulkins
,
F.
,
Nguyen
,
A. T. T.
,
Andreassen
,
E.
,
Hoivik
,
N.
,
Aasmundtveit
,
K.
,
Hoff
,
L.
,
Halvorsen
,
P. S.
,
Grymyr
,
O. J.
, and
Imenes
,
K.
,
2014
, “
MEMS-Based Implantable Heart Monitoring System With Integrated Pacing Function
,”
Electronic Components and Technology Conference
, Orlando, FL, pp.
139
144
.
7.
Davis
,
J. R.
, and
ASM International
,
2003
,
Handbook of Materials for Medical Devices
,
ASM International
,
Materials Park, OH
.
8.
Murr
,
L. E.
,
Gaytan
,
S. M.
,
Martinez
,
E.
,
Medina
,
F.
, and
Wicker
,
R. B.
,
2012
, “
Next Generation Orthopaedic Implants by Additive Manufacturing Using Electron Beam Melting
,”
Int. J. Biomater.
,
2012
, p.
245727
.
9.
Murr
,
L. E.
,
Gaytan
,
S. M.
,
Medina
,
F.
,
Lopez
,
H.
,
Martinez
,
E.
,
Machado
,
B. I.
,
Hernandez
,
D. H.
,
Martinez
,
L.
,
Lopez
,
M. I.
,
Wicker
,
R. B.
, and
Bracke
,
J.
,
2010
, “
Next-Generation Biomedical Implants Using Additive Manufacturing of Complex, Cellular and Functional Mesh Arrays
,”
Philos. Trans. R. Soc., A
,
368
(
1917
), pp.
1999
2032
.
10.
Cai
,
H.
,
2015
, “
Application of 3D Printing in Orthopedics: Status Quo and Opportunities in China
,”
Ann. Transl. Med.
,
3
(
Suppl 1
), p.
S12
.
11.
Kondor
,
S.
,
Grant
,
G.
,
Liacouras
,
P.
,
Schmid
,
J. R.
,
Parsons
,
M.
,
Rastogi
,
V. K.
,
Smith
,
L. S.
,
Macy
,
B.
,
Sabart
,
B.
, and
Macedonia
,
C.
,
2013
, “
On Demand Additive Manufacturing of a Basic Surgical Kit
,”
ASME J. Med. Devices
,
7
(
3
), p.
030916
.
12.
Rosborough
,
D. M.
,
Fisher
,
D. G.
, and
Cohn
,
L. H.
,
1998
, “
Outcomes of a Critical Pathway for Uncomplicated Cardiac Surgical Patients
,”
Cardiovascular Outcomes: Collaborative, Path-Based Approaches
,
1st ed.
,
D. F.
Flarey
and
S. S.
Blancett
, eds.,
Aspen Publishers
,
Gaithersburg, MD
, p.
265
.
13.
Luczak
,
S.
,
Oleksiuk
,
W.
, and
Bodnicki
,
M.
,
2006
, “
Sensing Tilt With MEMS Accelerometers
,”
IEEE Sens. J.
,
6
(
6
), pp.
1669
1675
.
14.
You
,
I.
,
Kang
,
S. M.
,
Byun
,
Y.
, and
Lee
,
H.
,
2011
, “
Enhancement of Blood Compatibility of Poly(Urethane) Substrates by Mussel-Inspired Adhesive Heparin Coating
,”
Bioconjugate Chem.
,
22
(
7
), pp.
1264
1269
.
15.
Wood
,
N. K.
,
Kaminski
,
E. J.
, and
Oglesby
,
R. J.
,
1970
, “
The Significance of Implant Shape in Experimental Testing of Biological Materials: Disc vs. Rod
,”
J. Biomed. Mater. Res.
,
4
(
1
), pp.
1
12
.
16.
Bhattacharjee
,
T.
,
Barlingay
,
M.
,
Tasneem
,
H.
,
Roan
,
E.
, and
Vemaganti
,
K.
,
2013
, “
Cohesive Zone Modeling of Mode I Tearing in Thin Soft Materials
,”
J. Mech. Behav. Biomed. Mater.
,
28
, pp.
37
46
.
17.
Dalmiya
,
V.
,
Tandon
,
S.
,
Mohanraj
,
P.
, and
Devarajan
,
V.
,
2007
, “
Determination of Key and Driving Points of a Beam Model for Tissue Simulation
,”
Stud. Health Technol. Inf.
,
125
, pp.
106
108
.
18.
Eggen
,
M. D.
,
Grubac
,
V.
, and
Bonner
,
M. D.
,
2015
, “
Design and Evaluation of a Novel Fixation Mechanism for a Transcatheter Pacemaker
,”
IEEE Trans. Biomed. Eng.
,
62
(
9
), pp.
2316
2323
.
19.
Grymyr
,
O. J.
,
Remme
,
E. W.
,
Espinoza
,
A.
,
Skulstad
,
H.
,
Elle
,
O. J.
,
Fosse
,
E.
, and
Halvorsen
,
P. S.
,
2015
, “
Assessment of 3D Motion Increases the Applicability of Accelerometers for Monitoring Left Ventricular Function
,”
Interact. Cardiovasc. Thorac. Surg.
,
20
(
3
), pp.
329
337
.
20.
Grymyr
,
O.-J. H. N.
,
Nguyen
,
A.-T. T.
,
Tjulkins
,
F.
,
Espinoza
,
A.
,
Remme
,
E. W.
,
Skulstad
,
H.
,
Fosse
,
E.
,
Imenes
,
K.
, and
Halvorsen
,
P. S.
,
2015
, “
Continuous Monitoring of Cardiac Function by 3-Dimensional Accelerometers in a Closed-Chest Pig Model
,”
Interact. Cardiovasc. Thorac. Surg.
,
21
(
5
), pp.
573
582
.
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