Eureka project
NewvoiceImproved rehabilitation of
laryngectomised patients
G.J. VerkerkeUniversity Medical Center Groningen
The Netherlands
Thebe, 18e dynasty(1400 BC)
Nowadaysmedical problemsare still often solved bytechnical solutions.This requires a multidisciplinary approachin which MD’s and engineers co-operate.
Dept of Biomedical Engineering,
University Medical Center Groningen, NL
GJ Verkerke (project leader), HK Schutte, G Rakhorst,
HC van der Mei, TG van Kooten, EB van der Houwen,
MBM van Leeuwen, MJ Gibcus, AJ Knol, J Tack
VU medical center, Amsterdam, NL
HF Mahieu, JM Festen, IM Verdonck, CDL van Gogh
University Medical Centre St. Radboud, Nijmegen, NL
HAM Marres, JA Jansen
University Hospital Groningen, Groningen, NL
FWJ Albers, BFAM van der Laan
University Hospital Dijkzigt Rotterdam, Rotterdam, NL
CA Meeuwis
Intravasc.nl, Groningen, NL
JP van Loon, EJO ten Hallers
Medin Instruments, Groningen, NL
H Leever, A de Jong
SASA, Thesinge, NL
HJ Busscher
Eureka project NewvoiceParticipants
Katharinen Hospital, ENT-department, Stuttgart, D
R HagenAdeva Medical GmbH, Lübeck, D
J GrundeiUniversity of Wales, Cardiff, UK
M WatersPrincipality Ltd, Newport, UK
L Basil
Medical Healthcom s.r.o., Prague, CZ
F ŠramEuropean Hospital, ENT-department, Rome, I
IF HerrmannUniversity of Padova, ENT-department, Padova, I
A StaffieriUniversidad del Pais Vasco, San Sebastian, SP
J Algaba
After laryngectomy
tracheostoma valve
+ HME-filter
Drawbacks
• Voice quality
• Fixation of TSV, HME-filter
• Fixation of shunt valve
• Biofilm formation
Goal of the project
Voice-producing shunt prosthesis
• Shunt valve
• Biofilm-resistant material
• Voice-producing element
• Fixation method for shunt,
TSV-valve,HME-filter
• Integration
• Clinical testing
Biofilm adhesion
Applied coatings
1 C16H19F17O3Si
2 C8H4Cl3F13Si
3 C14H19F13O3Si
4 C10H4Cl3F17Si
5 C20H10F33ClSi
6 C36H76O4Si
7 C7H16O2Si3
8 C3H4Cl3F3Si
A C10H4Cl3F17Si
B C8H18O5Si
PEO chains in water
20 nmglass substrata
1.5
nm
0.2 nm
Supersmooth mold
In-vitro test set-up
1. Grafting of shunt valves2. Biofilm-formation3. Flushing with PBS4. Flushing with medium5. After 8 days
determination of bacteria and yeasts
phosphatebufferedsaline
growthmedium
pump
shunt valve
artificial throat
Micro-organisms
• Candida albicans GBJ 13/4a• Candida tropicalis GB 9/9• Staphylococcus aureus GB 1/2• Staphylococcus epidermidis GB 9/6• Streptococcus salivarius GB 24/9• Rothia dentocariosa GB 52/52b
In-vitro results
0%
20%
40%
60%
80%
100%
120%
140%
coating
% c
olo
ny
fo
rm
ing
un
its
controle
coating 5
coating 6
coating 7
coating 8
coating A
coating B
= Bacteria
= Yeasts
Glass side Brush side
In-vitro results
Advancing water contact angles:
Silicone rubber 115 degrees
Argon plasma treated 15 degrees
After six weeks in vivo
In-vivo results
Goal of the project
Voice-producing shunt prosthesis
• Biofilm-resistant material
• Voice-producing element
• Fixation method for shunt, TSV-valve,HME-filter
• Shunt valve
• Integration
• Clinical testing
Requirements
• Geometry: in shunt valve• Sound
– fundamental frequency: 110 Hz ♂, 210 Hz ♀– SPL: 65 dB - 80 dB at 30 cm – Frequency-variation: +18%, -6%
• Energy source: 0.4 - 1.5 kPa, 180 - 320 ml/s• Power spectrum: decay of 10-12 dB/octave• Reliability
Membrane principle
Numerical simulation
Lung model
In-vitro results
F0 vs. P, for h0l3
0
20
40
60
80
100
120
140
0,00 0,50 1,00 1,50 2,00
P (kPa)
F0 (Hz)
h0l3I
h0l3II
h0l3III
Linear (h0l3I)
Linear (h0l3II)
Linear (h0l3III)
JW Tack, Annals Biomed Eng, 2006
In-vitro results
JW Tack, Head Neck, 2007 (in press)
In-vivo results
Goal of the project
Voice-producing shunt prosthesis
• Biofilm-resistant material
• Voice-producing element
• Fixation method for shunt, TSV-valve,HME-filter
• Shunt valve
• Integration
• Clinical testing
Voice rehabilitation after total laryngectomy:
Background
• Shunt valve
• Tracheostoma valve & Heat and Moisture Exchange (HME) filter
Fixation problems:
• Discrepancies between shunt valve and TE fistula
• Difficulties in long-term attachment of tracheostoma valve and/or HME filter to the peri-stomal skin
ten Hallers EJO, Acta Otolaryngol, 2005
• Ring: CP Titanium grade 2
• Stop: Silicon rubber
• Mesh:
– Knitted monofilament polypropylene(Bard® Marlex®)
– Or titanium, 50 micron thick sintered fibers, porosity 80%, 500g/m2. (Bekaert)
Design: E.B. van der Houwen
Tracheo-EsophagealTissue Connector
or
• Ring:
– CP Titanium grade 2
– or silicon elastomer (MED-6033, NuSil)
with titanium inserts that function as a
base plate for screws.
• Mesh:
– Knitted monofilament polypropylene
(Bard® Marlex®) mesh
• Screws:
• 4 phase-1 small screws (subcutaneous)
– 4 phase-2 longer screws (percutaneous)
Tracheostoma Tissue Connector
Design: E.B. van der Houwen
3.0 cm
Animal experiments
Sagital section of goat head & neck with tracheostomy and
Tissue Connectors implanted
ten Hallers EJO, Biomaterials, 2004
Sterile conditions, general anesthesia
Median incision Trachea separationand resection
ImplantationTissue Glue
Closing after implantation
End of procedure X-rays
Methods, Materials and AnimalsSurgical Procedure
ResultsMacroscopyGeneral:
- Wide range in geometry of trachea
- 100% survival of surgical procedure
- Several complications due to tracheostomy
• Pneumonia and lung edema
• Airway obstruction with mucus
• Pressure necrosis caused by canula
Tracheostoma TC
- Week 0-6 mild inflammatory
reactions
- Week 7-12 also infections
Tracheo-Esophageal TC
- Firm implant fixation
- Pilot study: Tracheal punction technical
feasible
ten Hallers EJO, Laboratory Animals, 2006.
ResultsMacroscopy
9 weeks
5 weeksLateral X-ray
Post-mortem Embedded in resin
ResultsMicroscopy
- Volume increase of silicone rubber after chemical reaction withmethylmetacrylate (MMA)
- Difficult to determine tissue adhesion due to artefacts
- Sufficient fibrous tissue reaction for firm fixation
Tracheo-Esophageal TC
Silicone
rubberTi
CapsulePP Mesh
Glue
ten Hallers EJO, Head Neck, 2006
ResultsMicroscopy
AA`
Prototype 1 Prototype 2
Tracheostoma TC
Silicone rubber
Ti insert
- Profound epithelial downgrowth up tonear complete marsupialization
- Persisting infections
ten Hallers EJO, J Biomed Mater Res A, 2007
Conclusions
Tracheo-Esophageal TC:
• Successful firm implant fixation
• Further tests are needed with separate tracheal and esophageal punction to determine its feasibility
Tracheostoma TC:
• Not a feasible concept in this animal model
• Insufficient tissue stabilization results in classic percutaneous implant failure, sooner or later
This tracheostomy animal model is suitable for short-term tests only with intensive care
Future work
Future work
Future work
1
EB van der Houwen
Future work
EB van der Houwen
Eureka project Newvoice