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