Abstract
The objective of the present work is to allow noninvasive sampling of microbiota, until now, surgery is still needed to collect intestinal liquid samples. Given the recent developments of endoscopic capsules and their added value for the diagnosis and the treatment of gastrointestinal pathologies, the paper is focused on the design of a microbiota sampling capsule. The device has to offer an efficient collection of intestinal liquid and at the same time to protect it from any contamination as the device navigates out of the human body. To ensure this and safety at the same time, a passive capsule is developed based on a bistable mechanical structure actuated by an expanding foam that itself collects the intestinal fluid. The device is developed using additive manufacturing. It is shown that the process is compatible with the production of the complete capsule with biocompatible material, while ensuring the presence of bistability for capsule closing. In-vitro trials validate the operating mode of the capsule. This work represents a significant step toward the creation of simple and yet efficient tools to better understand microbiota impact and future pathology detection.
Issue Section:
Research Papers
References
1.
Sender
,
R.
,
Fuchs
,
S.
, and
Milo
,
R.
, 2016
, “
Revised Estimates for the Number of Human and Bacteria Cells in the Body
,” PLoS Biol.
,
14
(8
), p. e1002533
.10.1371/journal.pbio.10025332.
Round
,
J. L.
, and
Mazmanian
,
S. K.
, 2009
, “
The Gut Microbiota Shapes Intestinal Immune Responses During Health and Disease
,” Nat. Rev. Immunol.
,
9
(5
), pp. 313
–323
.10.1038/nri25153.
Larousse
,
E.
, “
Encyclopédie Larousse en Ligne - Iléon
,” LAROUSSE, Online.4.
Tremaroli
,
V.
, and
Bäckhed
,
F.
, 2012
, “
Functional Interactions Between the Gut Microbiota and Host Metabolism
,” Nature
,
489
(7415
), pp. 242
–249
.10.1038/nature115525.
Qin
,
J.
,
Li
,
Y.
,
Cai
,
Z.
,
Li
,
S.
,
Zhu
,
J.
,
Zhang
,
F.
,
Liang
,
S.
, et al., 2012
, “
A Metagenome-Wide Association Study of Gut Microbiota in Type 2 Diabetes
,” Nature
,
490
(7418
), pp. 55
–60
.10.1038/nature114506.
Swidsinski
,
A.
,
Ladhoff
,
A.
,
Pernthaler
,
A.
,
Swidsinski
,
S.
,
Loening-Baucke
,
V.
,
Ortner
,
M.
,
Weber
,
J.
, et al., 2002
, “
Mucosal Flora in Inflammatory Bowel Disease
,” Gastroenterology
,
122
(1
), pp. 44
–54
.10.1053/gast.2002.302947.
Garrett
,
W. S.
, 2015
, “
Cancer and the Microbiota
,” Science
,
348
(6230
), pp. 80
–86
.10.1126/science.aaa49728.
Valles-Colomer
,
M.
,
Falony
,
G.
,
Darzi
,
Y.
,
Tigchelaar
,
E. F.
,
Wang
,
J.
,
Tito
,
R. Y.
,
Schiweck
,
C.
, et al., 2019
, “
The Neuroactive Potential of the Human Gut Microbiota in Quality of Life and Depression
,” Nat. Microbiol.
,
4
(4
), pp. 623
–632
.10.1038/s41564-018-0337-x9.
Panek
,
M.
,
Paljetak
,
H. Č.
,
Barešić
,
A.
,
Perić
,
M.
,
Matijašić
,
M.
,
Lojkić
,
I.
,
Bender
,
D. V.
,
et al.
, 2018
, “
Methodology Challenges in Studying Human Gut Microbiota–Effects of Collection, Storage, DNA Extraction and Next Generation Sequencing Technologies
,” Sci. Rep.
,
8
(1
), p. 5143
.10.1038/s41598-018-23296-410.
Tang
,
Q.
,
Jin
,
G.
,
Wang
,
G.
,
Liu
,
T.
,
Liu
,
X.
,
Wang
,
B.
, and
Cao
,
H.
, 2020
, “
Current Sampling Methods for Gut Microbiota: A Call for More Precise Devices
,” Front. Cell. Infect. Microbiol.
,
10
, p. 151
.10.3389/fcimb.2020.0015111.
Riccioni
,
M. E.
,
Urgesi
,
R.
,
Cianci
,
R.
,
Bizzotto
,
A.
,
Spada
,
C.
, and
Costamagna
,
G.
, 2012
, “
Colon Capsule Endoscopy: Advantages, Limitations and Expectations. which Novelties?
,” World J. Gastrointest. Endoscopy
,
4
(4
), p. 99
.10.4253/wjge.v4.i4.9912.
Ciuti
,
G.
,
Menciassi
,
A.
, and
Dario
,
P.
, 2011
, “
Capsule Endoscopy: From Current Achievements to Open Challenges
,” IEEE Rev. Biomed. Eng.
,
4
, pp. 59
–72
.10.1109/RBME.2011.217118213.
Gu
,
H. H.
, and
Gu
,
H. L.
, 1999
, “
Intestinal Fluid Sampler
,” U.S. Patent No. 5,971,942.14.
Amoako-Tuffour
,
Y.
,
Jones
,
M. L.
,
Shalabi
,
N.
,
Labbé
,
A.
,
Vengallatore
,
S.
, and
Prakash
,
S.
, 2014
, “
Ingestible Gastrointestinal Sampling Devices: State-of-the-Art and Future Directions
,” Crit. Rev. Biomed. Eng.
,
42
(1
), pp. 1
–15
.10.1615/CritRevBiomedEng.201401084615.
Rehan
,
M.
,
Al-Bahadly
,
I.
,
Thomas
,
D. G.
, and
Avci
,
E.
, 2020
, “
Capsule Robot for Gut Microbiota Sampling Using Shape Memory Alloy Spring
,” Int. J. Med. Rob. Comput. Assisted Surg.
,
16
(5
), pp. 1
–14
.10.1002/rcs.214016.
Jones
,
J. P.
, 2020
, “
Sampling Capsule System and Methods
,” U.S. Patent App. 16/711,342.17.
Waimin
,
J. F.
,
Nejati
,
S.
,
Jiang
,
H.
,
Qiu
,
J.
,
Wang
,
J.
,
Verma
,
M. S.
, and
Rahimi
,
R.
, 2020
, “
Smart Capsule for Non-Invasive Sampling and Studying of the Gastrointestinal Microbiome
,” RSC Adv.
,
10
(28
), pp. 16313
–16322
.10.1039/C9RA10986B18.
Finocchiaro
,
M.
,
Giosuè
,
C.
,
Drago
,
G.
,
Cibella
,
F.
,
Menciassi
,
A.
,
Sprovieri
,
M.
, and
Ciuti
,
G.
, 2021
, “
Design of a Magnetic Actuation System for a Microbiota-Collection Ingestible Capsule
,” IEEE International Conference on Robotics and Automation
, Xi'an, China, May 30–June 5, pp. 6905
–6911
.10.1109/ICRA48506.2021.956114219.
Shokrollahi
,
P.
,
Lai
,
Y. P.
,
Rash-Ahmadi
,
S.
,
Stewart
,
V.
,
Mohammadigheisar
,
M.
,
Huber
,
L.-A.
,
Matsuura
,
N.
, et al., 2020
, “
Blindly Controlled Magnetically Actuated Capsule for Noninvasive Sampling of the Gastrointestinal Microbiome
,” IEEE/ASME Trans. Mechatron.
, 26(5), pp. 2616
–2628
.10.1109/TMECH.2020.304345420.
Thélu
,
J.
,
Cinquin
,
P.
,
Martin
,
D.
,
Soranzo
,
T.
,
Alcaraz
,
J.-P.
, and
Kweter
,
J.-M.
, 2017
, “
Device for Intestinal Fluid Sampling
,” Patent No. FR1760069.21.
Salem
,
M. B.
,
Aiche
,
G.
,
Rubbert
,
L.
,
Renaud
,
P.
, and
Haddab
,
Y.
, 2018
, “
Design of a Microbiota Sampling Capsule Using 3D-Printed Bistable Mechanism
,” 2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC
), Honolulu, HI, July 17–21, pp. 4868
–4871
.10.1109/EMBC.2018.851314122.
Zirbel
,
S. A.
,
Tolman
,
K. A.
,
Trease
,
B. P.
, and
Howell
,
L. L.
, 2016
, “
Bistable Mechanisms for Space Applications
,” PLoS One
,
11
(12
), p. e0168218
.10.1371/journal.pone.016821823.
Chen
,
Q.
, 2010
, “
Microrobotique Numérique Fondée Sur L'utilisation de Modules Bistables: Conception, Fabrication et Commande de Modules Monolithiques
,” Ph.D. thesis,
Université de Franche-Comté
, Besançon, France.24.
Murachanian
,
D.
, 2010
, “
Two-Piece Hard Capsules for Pharmaceutical Formulations
,” J. GXP Compliance
,
14
(3
), pp. 31
–42
.25.
Sayeed
,
V.
, 2015
, “
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
,” U.S. Department of Health and Human Services Food and Drug Administration
,
Guidance for Industry
,
Washington, DC
, p. 10
.26.
Beasley
,
D. E.
,
Koltz
,
A. M.
,
Lambert
,
J. E.
,
Fierer
,
N.
, and
Dunn
,
R. R.
, 2015
, “
The Evolution of Stomach Acidity and Its Relevance to the Human Microbiome
,” PLoS ONE
,
10
(7
), p. e0134116
.10.1371/journal.pone.013411627.
Evans
,
D.
,
Pye
,
G.
,
Bramley
,
R.
,
Clark
,
A.
,
Dyson
,
T.
, and
Hardcastle
,
J.
, 1988
, “
Measurement of Gastrointestinal pH Profiles in Normal Ambulant Human Subjects
,” Gut
,
29
(8
), pp. 1035
–1041
.10.1136/gut.29.8.103528.
Lai
,
S. K.
,
Wang
,
Y.-Y.
,
Wirtz
,
D.
, and
Hanes
,
J.
, 2009
, “
Micro- and Macrorheology of Mucus
,” Adv. Drug Delivery Rev.
,
61
(2
), pp. 86
–100
.10.1016/j.addr.2008.09.01229.
Terry
,
B. S.
, 2012
, “
Mechanical Characterization of the Small Intestine for In Vivo Robotic Capsule Endoscope Mobility
,” Ph.D. thesis, University of Colorado at Boulder, Boulder, CO.30.
Berg
,
R. D.
, 1996
, “
The Indigenous Gastrointestinal Microflora
,” Trends Microbiol.
,
4
(11
), pp. 430
–435
.10.1016/0966-842X(96)10057-331.
Fireman
,
Z.
,
Paz
,
D.
, and
Kopelman
,
Y.
, 2005
, “
Capsule Endoscopy: Improving Transit Time and Image View
,” World J. Gastroenterol.
,
11
(37
), p. 5863
.10.3748/wjg.v11.i37.586332.
Bansal
,
N.
,
Sachdeva
,
M.
,
Jain
,
P.
,
Ranjan
,
P.
, and
Arora
,
A.
, 2013
, “
Anorectal Manometry: Current Techniques and Indications
,” J. Int. Med. Sci. Acad.
,
26
(3
), pp. 169
–170
.https://www.researchgate.net/publication/287275913_Anorectal_manometry_Current_techniques_and_indications33.
Kuchaiyaphum
,
P.
,
Euaklang
,
S.
,
Raksanti
,
A.
, and
Chotichayapong
,
C.
, 2019
, “
High Absorbable Cassava Starch/Poly (Vinyl Alcohol) Sponge for Medical Applications
,” Curr. Appl. Sci. Technol.
,
19
(2
), pp. 89
–101
.https://li01.tcithaijo.org/index.php/cast/article/view/15203634.
Vangbo
,
M.
, 1998
, “
An Analytical Analysis of a Compressed Bistable Buckled Beam
,” Sens. Actuators A: Phys.
,
69
(3
), pp. 212
–216
.10.1016/S0924-4247(98)00097-135.
Hussein
,
H.
, 2015
, “
Contribution to Digital Microrobotics: Modeling, Design and Fabrication of Curved Beams, U-Shaped Actuators and Multistable Microrobots
,” Ph.D. thesis, Université de Franche-Comté, Besançon, France.36.
Qiu
,
J.
, 2003
, “
An Electrothermally-Actuated Bistable MEMS Relay for Power Applications
,” Ph.D. thesis, Massachusetts Institute of Technology, Cambridge, MA.37.
Mohamed
,
O. A.
,
Masood
,
S. H.
, and
Bhowmik
,
J. L.
, 2015
, “
Optimization of Fused Deposition Modeling Process Parameters: A Review of Current Research and Future Prospects
,” Adv. Manuf.
,
3
(1
), pp. 42
–53
.10.1007/s40436-014-0097-738.
Chia
,
H. N.
, and
Wu
,
B. M.
, 2015
, “
Recent Advances in 3D Printing of Biomaterials
,” J. Biol. Eng.
,
9
(1
), p. 4
.10.1186/s13036-015-0001-439.
Culmone
,
C.
,
Smit
,
G.
, and
Breedveld
,
P.
, 2019
, “
Additive Manufacturing of Medical Instruments: A State-of-the-Art Review
,” Addit. Manuf.
,
27
, pp. 461
–473
.10.1016/j.addma.2019.03.01540.
Salem
,
M. B.
, 2020
, “
Développement D'une Capsule de Prélèvement de Microbiote Intestinal Utilisant un Mécanisme Bistable et Exploitant la Fabrication Additive
,” Ph.D. thesis,
Université Montpellier
, Montpellier, France.41.
Dahlgren
,
D.
,
Venczel
,
M.
,
Ridoux
,
J.-P.
,
Skjöld
,
C.
,
Müllertz
,
A.
,
Holm
,
R.
,
Augustijns
,
P.
,
Hellström
,
P. M.
, and
Lennernäs
,
H.
, 2021
, “
Fasted and Fed State Human Duodenal Fluids: Characterization, Drug Solubility, and Comparison to Simulated Fluids and With Human Bioavailability
,” Eur. J. Pharm. Biopharm.
,
163
, pp. 240
–251
.10.1016/j.ejpb.2021.04.00542.
Gayer
,
C. P.
, and
Basson
,
M. D.
, 2009
, “
The Effects of Mechanical Forces on Intestinal Physiology and Pathology
,” Cell. Signalling
,
21
(8
), pp. 1237
–1244
.10.1016/j.cellsig.2009.02.01143.
Sabiston
,
D. C.
,
Townsend
,
C. M.
,
Beauchamp
,
R.
,
Evers
,
B.
, and
Mattox
,
K.
, 2001
, Sabiston Textbook of Surgery: The Biological Basis of Modern Surgical Practice
,
WB Saunders
,
Philadelphia, PA
.44.
U.S. Food and Drug Administration
, 2018
, “Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
,” U.S. Food and Drug Administration, Rockville, MD.https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluationmedical-devices-part-1-evaluation-andCopyright © 2022 by ASME
You do not currently have access to this content.
