title: Biocompatibility of a novel tissue connector for fixation of tracheostoma valves and shunt valves.
abstract: Rehabilitation after laryngectomy often includes the use of a shunt valve and a tracheostoma valve to restore voice. To improve the fixation method of these valves, a new tissue connector has been developed, basically consisting of a ring that will be integrated into surrounding tracheal soft tissue. The valves can be placed in the ring. To test the principle of the tissue connector, a prototype consisting of a subcutaneous polypropylene mesh and a percutaneous titanium stylus was implanted into the backskin of 10 rats by a two-stage surgical procedure. We reasoned that if a firm connection can be realized with the skin, a firm connection with the trachea will also be possible. The subcutaneous part was implanted first, followed by the percutaneous part after 6 weeks. The complete tissue connector with surrounding tissue was removed 8 weeks later and examined histologically. The principle of the new tissue connector proved to be effective: hardly any epithelial downgrowth appeared, and adhesion of soft tissue was demonstrated. No infection or severe inflammation reaction was detected. The tissue connector seems appropriate for its intended use.
authors.affiliation: BioMedical Engineering, Division of Artificial Organs, Faculty of Medicine, University of Groningen, Netherlands. a.a.geertsema@med.rug.nl
authors.forename: A A
authors.initials: AA
authors.lastname: Geertsema
authors.forename: H K
authors.initials: HK
authors.lastname: Schutte
authors.forename: M B
authors.initials: MB
authors.lastname: van Leeuwen
authors.forename: G
authors.initials: G
authors.lastname: Rakhorst
authors.forename: J M
authors.initials: JM
authors.lastname: Schakenraad
authors.forename: M J
authors.initials: MJ
authors.lastname: van Luyn
authors.forename: G J
authors.initials: GJ
authors.lastname: Verkerke
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D001672:Biocompatible Materials; D011126:Polypropylenes; D019736:Prostheses and Implants; D051381:Rats; D017207:Rats, Sprague-Dawley; D012867:Skin / Q000166:cytology; D013525:Surgical Instruments; D013526:Surgical Mesh; D014025:Titanium; D014139:Tracheostomy / Q000295:instrumentation* / Q000379:methods
chemical_list: D001672:Biocompatible Materials; D011126:Polypropylenes; D014025:Titanium