Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Larynx – trachea – tracheobronchial prosthesis or combination...
Patent
1999-04-06
2000-12-12
Milano, Michael J.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Larynx, trachea, tracheobronchial prosthesis or combination...
606108, A61F 220
Patent
active
061592439
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
This invention relates to the implantation of voice prostheses to restore the voice in patients on whom a laryngectomy has been performed or patients who have no vocal cords, in particular but not exclusively by means of a secondary tracheo-oesophageal puncture. A secondary puncture of this type is employed if the voice prosthesis is implanted only some time after the laryngectomy has been carried out. This is in contrast to the primary puncture, according to which the voice prosthesis is implanted immediately after the laryngectomy.
According to the traditional treatment method, the patient is placed under general anaesthesia for the secondary puncture, which necessitates the patient spending a few days in the hospital as an in-patient. This treatment method is consequently fairly time-consuming and involves relatively high costs.
SUMMARY OF THE INVENTION
The aim of the invention is to simplify the post-laryngectomy implantation of voice prostheses by means of a secondary puncture. This aim is achieved by means of a kit for the implantation of a voice prosthesis to restore the voice in a patient on whom a laryngectomy has been performed, comprising: until the leading end or tip of the leader element is located close to the location where the voice prosthesis has to be implanted, at which tip of said leader element coupling means are located, the level of the tracheostome, and hollow cutting element which is located in the cut which has been made, can be brought into interaction with the coupling means at the tip of the leader element, and the other end of which carries attachment means for attaching a voice prosthesis, which is to be implanted, to the guide element.
With the aid of a kit of this type the patient can be treated without general anaesthesia being necessary. Instead of the latter, the patient is locally anaesthetised by means of local and infiltration anaesthesia of tracheostome and oesophagus. The leader element is then introduced, after which the cut is made, by means of the hollow cutting element or trocar, to form an opening in the tracheo-oesophageal wall in which the voice prosthesis has to be implanted.
Via the cut made in this way it is possible, if appropriate after removing the cutting part of the trocar, to couple the guide element to the coupling means of the leader element. By then withdrawing the leader element together with the guide element, which has now been coupled up, the voice prosthesis attached to said guide element can be implanted directly in the opening, the cut concerned being widened at the same time.
Finally, the attachment between prosthesis and guide element can be released by pulling free and withdrawing the guide element via the mouth. Implantation of the voice prosthesis is thus complete.
Successful performance of the abovementioned operation is highly dependent on making the cut in the correct manner, that is to say as soon as the tip of the leader element is at the location desired for the voice prosthesis. With a view to simplifying these activities, the leader element preferably has a light source close to its tip. The light source is detectable through the tracheo-oesophageal wall, so that it is possible to establish immediately whether the tip of the leader element is in the correct position, immediately behind the region where the cut will be made.
Contact with the rear wall of the oesophagus must, of course, be avoided when making the cut in the tracheo-oesophageal wall. Since the oesophagus is usually flat, the risk that the trocar nevertheless unintentionally comes into contact with the rear wall is fairly high. This risk can be appreciably reduced by means of a construction wherein the leader element comprises an expansion element which carries the coupling means for coupling to the guide element.
In the expanded state, the expansion element produces a certain cavity in the oesophagus, such that the trocar can be inserted without the oesophagus being damaged.
An expansion element of this type can be constructed in va
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patent: 5728068 (1998-03-01), Leone et al.
patent: 5735817 (1998-04-01), Shantha
patent: 5976151 (1999-11-01), Siegbahn
Milano Michael J.
Pellegrino Brian E
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