In vivo experiments with tracheostoma tissue connector prototypes

E.J. Olivier ten Hallers, Eduard B. van der Houwen, Henri A.M. Marres, Gerhard Rakhorst, John A. Jansen, Harm K. Schutte, Theo G. van Kooten, Gijsbertus Jacob Verkerke, Jan-Paul van Loon

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)

Abstract

In cancer patients who have undergone total surgical removal of the larynx, ideally voice rehabilitation should be performed using a shunt valve (placed in a fistula of the tracheo-esophageal wall) and a tracheostoma valve (TSV) to enable hands-free tracheo-esophageal speech. A tracheostoma is created by suturing the trachea into the lower anterior part of the neck, and a TSV is a device that can be placed at the stoma. Unfortunately, many patients are unable to use a TSV, mainly due to fixation difficulties. To improve the fixation of the TSV, tracheostoma tissue connector (TS-TC) prototypes have been designed. Prototype 1 consisted of a titanium ring, inner diameter 30 mm, with a circular polypropylene mesh glued to it with silicone adhesive. Four holes had been drilled into the ring for the insertion of sub- and percutaneous screws. Prototype 2 consisted of a silicone rubber ring, inner diameter 30 mm, combined with polypropylene mesh and four titanium inserts that functioned as a base plate for the insertion of sub- and percutaneous screws. In adult female goats a tracheostoma was created and the prototypes were implanted. After 6 weeks of subcutaneous implantation, percutaneous screws were inserted. After twelve weeks, the experiment was terminated and the implants with the surrounding tissues were processed and examined histologically. The clinical appearance during weeks 7-12 varied from very poor to relatively good. Histologically, the implants showed a uniform inflammatory response. We found that all the tissue surrounding the screws showed signs of epithelial down growth. It was concluded that the two-stage implantation procedure of our prototype TS-TCs in this animal model was unsuccessful. Additional research efforts are necessary to improve tissue immobilization and to devise reliable fixation systems for TSVs.
Original languageUndefined
Pages (from-to)67-72
Number of pages6
JournalJournal of biomedical materials research. Part A
Volume82
Issue number1
DOIs
Publication statusPublished - 2007

Keywords

  • voice rehabilitation
  • soft-tissue implant
  • tracheostoma valve
  • Laryngectomy
  • Goat
  • METIS-244719
  • IR-72320

Cite this

ten Hallers, E. J. O., van der Houwen, E. B., Marres, H. A. M., Rakhorst, G., Jansen, J. A., Schutte, H. K., ... van Loon, J-P. (2007). In vivo experiments with tracheostoma tissue connector prototypes. Journal of biomedical materials research. Part A, 82(1), 67-72. https://doi.org/10.1002/jbm.a.31074
ten Hallers, E.J. Olivier ; van der Houwen, Eduard B. ; Marres, Henri A.M. ; Rakhorst, Gerhard ; Jansen, John A. ; Schutte, Harm K. ; van Kooten, Theo G. ; Verkerke, Gijsbertus Jacob ; van Loon, Jan-Paul. / In vivo experiments with tracheostoma tissue connector prototypes. In: Journal of biomedical materials research. Part A. 2007 ; Vol. 82, No. 1. pp. 67-72.
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title = "In vivo experiments with tracheostoma tissue connector prototypes",
abstract = "In cancer patients who have undergone total surgical removal of the larynx, ideally voice rehabilitation should be performed using a shunt valve (placed in a fistula of the tracheo-esophageal wall) and a tracheostoma valve (TSV) to enable hands-free tracheo-esophageal speech. A tracheostoma is created by suturing the trachea into the lower anterior part of the neck, and a TSV is a device that can be placed at the stoma. Unfortunately, many patients are unable to use a TSV, mainly due to fixation difficulties. To improve the fixation of the TSV, tracheostoma tissue connector (TS-TC) prototypes have been designed. Prototype 1 consisted of a titanium ring, inner diameter 30 mm, with a circular polypropylene mesh glued to it with silicone adhesive. Four holes had been drilled into the ring for the insertion of sub- and percutaneous screws. Prototype 2 consisted of a silicone rubber ring, inner diameter 30 mm, combined with polypropylene mesh and four titanium inserts that functioned as a base plate for the insertion of sub- and percutaneous screws. In adult female goats a tracheostoma was created and the prototypes were implanted. After 6 weeks of subcutaneous implantation, percutaneous screws were inserted. After twelve weeks, the experiment was terminated and the implants with the surrounding tissues were processed and examined histologically. The clinical appearance during weeks 7-12 varied from very poor to relatively good. Histologically, the implants showed a uniform inflammatory response. We found that all the tissue surrounding the screws showed signs of epithelial down growth. It was concluded that the two-stage implantation procedure of our prototype TS-TCs in this animal model was unsuccessful. Additional research efforts are necessary to improve tissue immobilization and to devise reliable fixation systems for TSVs.",
keywords = "voice rehabilitation, soft-tissue implant, tracheostoma valve, Laryngectomy, Goat, METIS-244719, IR-72320",
author = "{ten Hallers}, {E.J. Olivier} and {van der Houwen}, {Eduard B.} and Marres, {Henri A.M.} and Gerhard Rakhorst and Jansen, {John A.} and Schutte, {Harm K.} and {van Kooten}, {Theo G.} and Verkerke, {Gijsbertus Jacob} and {van Loon}, Jan-Paul",
year = "2007",
doi = "10.1002/jbm.a.31074",
language = "Undefined",
volume = "82",
pages = "67--72",
journal = "Journal of biomedical materials research. Part A",
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ten Hallers, EJO, van der Houwen, EB, Marres, HAM, Rakhorst, G, Jansen, JA, Schutte, HK, van Kooten, TG, Verkerke, GJ & van Loon, J-P 2007, 'In vivo experiments with tracheostoma tissue connector prototypes', Journal of biomedical materials research. Part A, vol. 82, no. 1, pp. 67-72. https://doi.org/10.1002/jbm.a.31074

In vivo experiments with tracheostoma tissue connector prototypes. / ten Hallers, E.J. Olivier; van der Houwen, Eduard B.; Marres, Henri A.M.; Rakhorst, Gerhard; Jansen, John A.; Schutte, Harm K.; van Kooten, Theo G.; Verkerke, Gijsbertus Jacob; van Loon, Jan-Paul.

In: Journal of biomedical materials research. Part A, Vol. 82, No. 1, 2007, p. 67-72.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - In vivo experiments with tracheostoma tissue connector prototypes

AU - ten Hallers, E.J. Olivier

AU - van der Houwen, Eduard B.

AU - Marres, Henri A.M.

AU - Rakhorst, Gerhard

AU - Jansen, John A.

AU - Schutte, Harm K.

AU - van Kooten, Theo G.

AU - Verkerke, Gijsbertus Jacob

AU - van Loon, Jan-Paul

PY - 2007

Y1 - 2007

N2 - In cancer patients who have undergone total surgical removal of the larynx, ideally voice rehabilitation should be performed using a shunt valve (placed in a fistula of the tracheo-esophageal wall) and a tracheostoma valve (TSV) to enable hands-free tracheo-esophageal speech. A tracheostoma is created by suturing the trachea into the lower anterior part of the neck, and a TSV is a device that can be placed at the stoma. Unfortunately, many patients are unable to use a TSV, mainly due to fixation difficulties. To improve the fixation of the TSV, tracheostoma tissue connector (TS-TC) prototypes have been designed. Prototype 1 consisted of a titanium ring, inner diameter 30 mm, with a circular polypropylene mesh glued to it with silicone adhesive. Four holes had been drilled into the ring for the insertion of sub- and percutaneous screws. Prototype 2 consisted of a silicone rubber ring, inner diameter 30 mm, combined with polypropylene mesh and four titanium inserts that functioned as a base plate for the insertion of sub- and percutaneous screws. In adult female goats a tracheostoma was created and the prototypes were implanted. After 6 weeks of subcutaneous implantation, percutaneous screws were inserted. After twelve weeks, the experiment was terminated and the implants with the surrounding tissues were processed and examined histologically. The clinical appearance during weeks 7-12 varied from very poor to relatively good. Histologically, the implants showed a uniform inflammatory response. We found that all the tissue surrounding the screws showed signs of epithelial down growth. It was concluded that the two-stage implantation procedure of our prototype TS-TCs in this animal model was unsuccessful. Additional research efforts are necessary to improve tissue immobilization and to devise reliable fixation systems for TSVs.

AB - In cancer patients who have undergone total surgical removal of the larynx, ideally voice rehabilitation should be performed using a shunt valve (placed in a fistula of the tracheo-esophageal wall) and a tracheostoma valve (TSV) to enable hands-free tracheo-esophageal speech. A tracheostoma is created by suturing the trachea into the lower anterior part of the neck, and a TSV is a device that can be placed at the stoma. Unfortunately, many patients are unable to use a TSV, mainly due to fixation difficulties. To improve the fixation of the TSV, tracheostoma tissue connector (TS-TC) prototypes have been designed. Prototype 1 consisted of a titanium ring, inner diameter 30 mm, with a circular polypropylene mesh glued to it with silicone adhesive. Four holes had been drilled into the ring for the insertion of sub- and percutaneous screws. Prototype 2 consisted of a silicone rubber ring, inner diameter 30 mm, combined with polypropylene mesh and four titanium inserts that functioned as a base plate for the insertion of sub- and percutaneous screws. In adult female goats a tracheostoma was created and the prototypes were implanted. After 6 weeks of subcutaneous implantation, percutaneous screws were inserted. After twelve weeks, the experiment was terminated and the implants with the surrounding tissues were processed and examined histologically. The clinical appearance during weeks 7-12 varied from very poor to relatively good. Histologically, the implants showed a uniform inflammatory response. We found that all the tissue surrounding the screws showed signs of epithelial down growth. It was concluded that the two-stage implantation procedure of our prototype TS-TCs in this animal model was unsuccessful. Additional research efforts are necessary to improve tissue immobilization and to devise reliable fixation systems for TSVs.

KW - voice rehabilitation

KW - soft-tissue implant

KW - tracheostoma valve

KW - Laryngectomy

KW - Goat

KW - METIS-244719

KW - IR-72320

U2 - 10.1002/jbm.a.31074

DO - 10.1002/jbm.a.31074

M3 - Article

VL - 82

SP - 67

EP - 72

JO - Journal of biomedical materials research. Part A

JF - Journal of biomedical materials research. Part A

SN - 1549-3296

IS - 1

ER -

ten Hallers EJO, van der Houwen EB, Marres HAM, Rakhorst G, Jansen JA, Schutte HK et al. In vivo experiments with tracheostoma tissue connector prototypes. Journal of biomedical materials research. Part A. 2007;82(1):67-72. https://doi.org/10.1002/jbm.a.31074