Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Larynx – trachea – tracheobronchial prosthesis or combination...
Reexamination Certificate
1999-09-20
2001-07-03
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Larynx, trachea, tracheobronchial prosthesis or combination...
Reexamination Certificate
active
06254638
ABSTRACT:
The invention relates to a voice prosthesis intended to be positioned in a fistula in the wall between the oesophagus and the trachea, the trachea opening out in the throat via an orifice, which prosthesis comprises a tubular body, which is provided with an internal through-cavity and at both ends has external widened sections for holding the prosthesis with respect to the wall section adjoining the opening, as well as a valve body for closing off the through-cavity.
Voice prostheses of this kind are known. Examples which may be mentioned are the prostheses known from U.S. Pat. Nos. 4,435,853, 4,610,691 and EP-A-507,832. The valve body of these prostheses can be opened under the influence of an excess pressure in the trachea, so that speech can be imitated via the oesophagus and the pharynx. On the other hand, the valve has to close as soon as liquids or solid food move through the oesophagus, so that they cannot pass into the trachea.
Although the valve in the known prostheses is reasonably satisfactory, i.e. it is able to stop even liquids, the problem of choking has nevertheless been found to be difficult to avoid, due to the fact that drops of liquid still penetrate into the trachea. This is because in the long term the liquid has been found to be able to leak along the outside of the prosthesis. The cause of this problem is that the fistula in which the tubular body of the voice prosthesis is situated stretches over the course of time and thus becomes too wide to maintain the desired seal.
The result is that the voice prosthesis has to be removed. Then, it is necessary, by means of a surgical intervention, to restore the old state or, a few days after removal, to install a (larger) voice prosthesis. In both cases, admission to hospital is necessary, making these interventions rather expensive. These procedures are very onerous on the patient: during this time, it is not possible to speak, food is administered artificially by means of a stomach tube and the result of this treatment is frequently disappointing with a high risk of repeat occurrence. Consequently, external leakage is a difficult and expensive medical problem for users of voice prostheses.
As an additional factor, the abovementioned leakage problem occurs in approximately 10% of all patients. It is not possible to assess in advance which patients will be affected, meaning that any preventative measures will have to be taken for all patients, even in those cases in which there would not normally be any problems with leakage. Any solution to this problem therefore has to be simple and inexpensive, since a number of patients will never encounter leakage problems and additional measures are in fact superfluous in these cases.
However, it is known that after a relatively long period of time, the fistula in the tissue has an ever-increasing tendency to become stretched, so that even problem-free users can ultimately still encounter leakage. From a medical point of view, this is extremely undesirable since leakage can lead to liquids and thin food passing into the lungs, where they may cause serious lung complications.
The object of the invention is to provide a voice prosthesis which offers a better seal. This object is achieved in that the external surface of the tubular body, and/or the adjoining surfaces of the widened sections, comprises/comprise local elevations and/or recesses for sealing the prosthesis with respect to the wall section adjoining the opening.
The local elevations or recesses ensure a liquid-tight contact between the voice prosthesis and the wall region around the openings. On the other hand, in view of their relatively small dimensions, they do not lead to that area stretching, so that the seal does not lose its action even in the long term. Joining recesses or elevations to the voice prosthesis represents a comparatively simple adjustment, so that the cost price scarcely need be increased, thus bringing its use within the reach of the total population of patients.
The recesses or elevations may have all kinds of different forms. In the preferred embodiment, the tubular body comprises at least one encircling peripheral rib. A rib of this kind forms only a very localized widening of the tubular body, and will therefore not lead to the opening in which the prosthesis is positioned becoming stretched. On the other hand, the rib does bear reliably in a close-fitting manner against the wall of the opening, so that leakage can be reliably avoided. The tubular body may optionally have a plurality of ribs one behind the other.
Moreover, each peripheral rib, viewed in a section through the axis of the tubular body, may be directed obliquely with respect to the external surface of the tubular body. The oblique position of the rib provides an additional retention action for the voice prosthesis. This is all the more important in view of the fact that in the widened fistulae which cause leakage there is a considerable reduction in the retention action. This can lead to the voice prosthesis being lost in the trachea and/or the lungs.
The direction in which the rib points can be selected as a function of the type of voice prosthesis. In the case of voice prostheses which can be installed via the trachea orifice (front loading), it is preferably provided for each peripheral rib to be situated close to the widened section which is intended to be positioned in the oesophagus, and for it to be directed obliquely towards the other widened section.
Ribs of this kind can also be used in other prostheses, which are positioned via the mouth and the oesophagus.
The dimensions of the ribs are selected such that, on the one hand, they provide an adequate level of seal and, on the other hand, they do not lead to the opening becoming stretched. According to the invention, the height of each rib may preferably lie in the range from 1 mm to 3 mm.
In this connection, the thickness of the ribs is also important; the thickness may preferably lie in the range from 0.2 mm to 1 mm.
In the above text, seals in the form of a rib have been referred to. However, according to the invention the seal can also be obtained if the tubular body comprises at least one encircling peripheral groove.
Although the need for a reliable seal means that preference is given to elevations or recesses on the tubular body, nevertheless these could also be arranged on one of the flanges which are situated at the ends of the tubular body.
REFERENCES:
patent: 3768102 (1973-10-01), Kwan-Gett et al.
patent: 4968294 (1990-11-01), Salama
patent: 4969902 (1990-11-01), Ravo
patent: 5108430 (1992-04-01), Ravo
patent: 5861035 (1999-01-01), Griffth
patent: 6013102 (2000-01-01), Pintauro et al.
patent: 222 509 (1987-05-01), None
patent: WO 89/07916 (1989-09-01), None
Isabella David J.
Phan Hieu
Sughrue Mion Zinn Macpeak & Seas, PLLC
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