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.
authors.affiliation: Department of Otorhinolaryngology and Head & Neck Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands. O.tenHallers@kno.umcn.nl
authors.forename: E J Olivier
authors.initials: EJ
authors.lastname: ten Hallers
authors.forename: Eduard B
authors.initials: EB
authors.lastname: Van der Houwen
authors.forename: Henri A M
authors.initials: HA
authors.lastname: Marres
authors.forename: Gerhard
authors.initials: G
authors.lastname: Rakhorst
authors.forename: John A
authors.initials: JA
authors.lastname: Jansen
authors.forename: Harm K
authors.initials: HK
authors.lastname: Schutte
authors.forename: Theo G
authors.initials: TG
authors.lastname: Van Kooten
authors.forename: Jan-Paul
authors.initials: JP
authors.lastname: Van Loon
authors.forename: Gijsbertus J
authors.initials: GJ
authors.lastname: Verkerke
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects; D005260:Female; D006041:Goats; D006801:Humans; D007831:Larynx, Artificial / Q000009:adverse effects; D008422:Materials Testing; D008855:Microscopy, Electron, Scanning; D011126:Polypropylenes; D011474:Prosthesis Design; D012826:Silicone Elastomers; D013072:Speech, Esophageal; D014025:Titanium; D014139:Tracheostomy
chemical_list: D001672:Biocompatible Materials; D011126:Polypropylenes; D012826:Silicone Elastomers; D014025:Titanium