WO1995029649A1

WO1995029649A1 - Voice prosthesis and instrument for the application thereof

Info

Publication number: WO1995029649A1
Application number: PCT/SE1995/000481
Authority: WO
Inventors: Jan-Ove Persson
Original assignee: Atos Medical Ab
Priority date: 1994-05-02
Filing date: 1995-05-02
Publication date: 1995-11-09
Also published as: SE9401489L; SE502986C2; SE9401489D0

Abstract

The invention relates to a voice prosthesis to be mounted in a fistula between esophagus and trachea. The voice prosthesis comprises a cylindrical body (10) with a valve member (13) which closes a passage through the body but can be opened. The body has an outside flange (12) projecting radially from one end of the body and having an annular surface to engage the esophagus wall and having such stiffness that the flange in a normal condition prevents the voice prosthesis from being passed through the fistula. A string (14) is provided in the annular surface and extends outside the voice prosthesis so that the string when pulled in the direction from the flange contracts said flange against the extended central axis of the body. The invention also relates to an instrument for insertion of the voice prosthesis into the fistula, which comprises an elongated stem (17) with a cylindrical pin (18) at one end thereof to be inserted into the body (10). An attachment (15) is provided in the stem for locking the string (14) provided on the voice prosthesis with the flange (12) of the body (10) contracted against the extended central axis of the body.

Description

Voice prosthesis and instrument for the application thereof

The present invention relates to a voice prosthesis for connection between trachea and esophagus in a fistula. Voice prostheses are used above all after tumour deceases in the throat necessitating the larynge to be removed by surgery and a stoma to be opened in trachea. By surgery of this type the patient looses the ability to speak. To some extent the ability to speak can be restored by means of a voice prosthesis air being pressed through trachea via a valve of voice prosthesis into esophagus the walls of which are made to vibrate and some sort of speach is produced. Prostheses with such function are described e.g. in US-A-4,435,853, US-A-4, 820, 304 and SE-C-463649. A common feature of the voice prostheses according to said patent specifications is that they are substantially cylindrical and provided with at least one retaining flange. The flange prevents the voice prosthesis from being pushed through the fistula and landing either in esophagus or in trachea.

The flange causes a problem when the voice prosthesis is to be inserted into the fistula. According to US-A- 4,435,853 and US-A-4, 820,304 the flange is made of such a thin and flexible material that it is possible to push the voice prosthesis through the fistula at the flange said flange then after the insertion unfolding in esophagus.

This means, however, that the flange is so weak that the retaining function is not satisfactory. In order to obtain a safer function the flange which is located on the esophagus side of the fistula should be considerably heavier and stiffer. Such an embodiment is described in SE-C-463649. The stiffness of the flange in this embodiment secures that the prosthesis cannot be pushed through the fistula but has to be inserted orally via esophagus; only the other thinner flange in that case has to pass through the fistula. A drawback of this insertion method is that the patient experiences the treatment as annoying.

In order to avoid some of the problems mentioned above it is proposed according to the European patent applicaton No. 93300100.0 a voice prosthesis having an esophagus flange of special construction. According to said patent application the flange is folded by means of a mounting instrument in a cap of a material which is soluble in water. The folded flange included by the cap can be pushed through the fistula. Then, the cap will gradually dissolve and the flange will unfold on the esophagus side. It is, however, difficult technically to displace the cap over the flange. Another problem is that there is some uncertainty as to when and how the cap has dissolved and the flange in fact has unfolded. It is also difficult to obtain in such an embodiment the desired stiffness of the esophagus flange to secure the function of the prosthesis and the position thereof in the fistula.

A purpose of the present invention is to overcome remaining problems and drawbacks of prior art voice prostheses and provide a combination of a voice prosthesis which after having been inserted into the fistula is securely fixed, and means providing a safe method of insertion. The purpose mentioned above is achieved by the voice prosthesis defined in claim 1.

The flange which after the insertion into the fistula shall be located inside esophagus then is relatively stiff, which provides the desired safety. In order nevertheless to make possible insertion through the fistula said flange can be contracted against the central axis of the prosthesis. Accordingly, the flange can be folded so that the outside diameter thereof corresponds substantially to the diameter of the cylindrical portion. Further advantages, purposes, and features of the invention will be apparent from the following description and independent claims.

The invention will now be described in more detail by way of illustrative embodiments reference being made to the accompanying drawings in which

FIG. 1 discloses a voice prosthesis according to the invention in transverse cross-sectional view as well as a tool for insertion of the voice prosthesis. FIG. 2 is a transverse cross-sectional view of the voice prosthesis according to FIG. 1 with the prosthesis in condition for application the flange being folded,

FIG. 3 discloses diagrammatically how the voice prosthesis according to the invention is inserted or applied in the throat, and

FIG. 4 discloses diagrammatically the voice prosthesis according to the invention located in the throat before removal of the insertion tool. The voice prosthesis according to FIG. 1 is intended to be located in a fistula between esophagus and trachea with a cylindrical body 10 passing through the fistula. A first end of body 10 is provided with a first radially projecting outside flange 12 which after the voice prosthesis having been inserted into the fistula engages the esophagus wall. The other end of body 10 forms a second flange 11 which after the insertion of the prosthesis into the fistula engages the trachea wall (see also FIGS. 3 and 4) . The voice prosthesis operates as a valve and comprises a valve member 13 in the body, said valve member controlling a cylindrical passage through the body. In the embodiment shown valve member 13 comprises a flap which in a normal position closes the passage by engaging a seat in the body. The flap can be opened by increased air pressure in the passage in the direction from said second flange 11 towards said first flange 12 or from trachea to esophagus.

For the insertion of the voice prosthesis into the fistula in the throat there is preferably used an instrument according to FIG. 1. The instrument is at a first end thereof formed as an elongated stem 17 and is at the other end thereof formed as a cylindrical pin 18 the outside dimensions of which correspond to the inside dimensions of the body. The instrument accordingly can be inserted into the voice prosthesis at pin 18. The insertion of the pin into the body is limited by a shoulder 19 which is provided between stem 17 and pin 18 to engage said second flange 11. A tail 16 can be used in an alternative insertion method and will be described further below. The first flange 12 is relatively stiff securing that the voice prosthesis after the insertion into the fistula will remain there and will not slide into trachea. The dimensions of flange 12 therefore are larger than the dimensions of the fistula in the transverse direction so that the voice prosthesis cannot slide out of the fistula. In order that the voice prosthesis nevertheless can be inserted to the correct position flange 12 can be folded together. Folding of the flange is effected by means of a string 14 which passes through several apertures in the annular surface of the flange. String 14 is extended past the valve member 13 and through a depression 20 in stem 17 and extends outside the instrument. By pulling string 14 flange 12 will be contracted to the shape shown in FIG. 2. In order to maintain the flange in contracted condition string 14 can be locked in the retracted position by means of a lock member 15. Preferably lock member 15 is formed by a slot in the stem. Lock member 15 can be constructed in another manner and can be left out if the string is kept retracted manually when the voice prosthesis is being inserted into the fistula. In FIG. 2 string 14 has been retracted a certain distance; flange 12 as a consequence thereof has been folded together to a shape similar to a tulip. The outside dimensions of flange 12 as a consequence thereof correspond substantially to the inside dimensions of the cylindrical body and, therefore, the flange does not prevent insertion of the voice prosthesis into the fistula. As will be seen from FIG. 2 string 14 after retraction has been pressed into the slot of lock member 15 so that flange 12 will be maintained in the contracted condition. In the condition disclosed in FIG. 2 the voice prosthesis is prepared for insertion into the throat of the patient. In an alternative embodiment string 14 is locked by means of a socket which is displaceable on stem 17. Then, stem 17 preferably is made slightly conical or forms a portion of larger diameter. If string 14 extends through the socket and this socket is displaced towards a portion of stem 17 having a larger diameter string 14 will be clamped between socket and stem. FIG. 3 discloses a voice prosthesis directly after the insertion into the fistula between esophagus 21 and trachea 22 of a patient. The insertion has been made by means of the instrument. During the insertion the flange 12 has been contracted by means of string 14. When the person who has effected the application of the voice prosthesis estimates that the voice prosthesis has reached the desired position string 14 is loosened from lock member 15. As a consequence thereof flange 12 will unfold and attain the normal condition thereof. Then, string 14 is withdrawn completely from the voice prosthesis.

This condition is shown in FIG. 4 which also discloses clearly that the oustide dimensions of flange 12 are considerably larger than the dimensions of the fistula. This guarantees that the prosthesis will not slide from the fistula towards the trachea. The second flange 11 in a corresponding manner guarantees that the voice prosthesis cannot slide in the other direction towards esophagus. The voice prosthesis then can be made to operate immediately after removal of the instrument from the voice prosthesis. This is effected simply by the person who has inserted the voice prosthesis into the fistula grips stem 17 and withdraws the instrument from the voice prosthesis. String 14 passes through the apertures of flange 12 and therefore can be removed in a simple way by an end of the string being withdrawn from the voice prosthesis and stem 17. Preferably, this takes place directly after the string having been loosened from lock member 15 and it has been ascertained that the prosthesis is located correctly.

Tail 16 can be used if the insertion into the fistula in the direction from trachea towards esophagus is not possible. In such a case the insertion of the voice prosthesis takes place via the mouth and esophagus tail 16 being used as attachment for an insertion instrument.

According to the invention flange 12 is made with such stiffness and such outside dimensions that the risk of the voice prosthesis unintentionally falling out of the fistula and landing in trachea is substantially completely eliminated. A suitable material for the voice prosthesis is silicon or similar material flange 12 being slightly stiffened in relation to the other flange 11 of the prosthesis. String 9 preferably is made of a material having relatively low friction in relation to the voice prosthesis and having high strength, e.g. polytetrafluorethylene or nylon. The material of string 14 preferably also is hard in relation to the material of flange 12.

In th preferred embodiment flange 12 is made with apertures mutually spaced peripherally on the annular surface of the flange. Other embodiments having special eyelets or the like positioned on the annular surface of flange 12 are also conceivable within the scope of the invention. String 14 can have different shape and appearance. It is essential that the string can effect folding or contraction of flange 12 in connection with the insertion of the voice prosthesis and then make possible unfolding of flange 12 to the normal condition after insertion. The string preferably is withdrawn in direction towards trachea but it is of course also possible that the string is removed from valve member 13 in another manner. However, string 14 should not impede on the function thereof. Within the scope of the invention several elements can be made in another way than that shown and described.

Claims

1. Voice prosthesis to be mounted in a fistula between esophagus and trachea, comprising a cylindrical body (10) , an outside flange (12) projecting radially from one end of the body (10) and having an annular surface to engage the esophagus wall, and a valve member (13) in the body (10) , which closes a passage through the body (10) but can be opened, c h a r a c t e r i z e d in that the flange (12) is made with such stiffness that the flange in a normal condition prevents passage of the voice prosthesis through the fistula, that a string (14) is mounted in the annular surface of the flange (12) , and that the string (14) extends outside the voice prosthesis so that the string when pulled in the direction from the flange (12) contracts said flange against the extended central axis of the body (10) .

2. Voice prosthesis according to claim 1, c h a r a c t e r i z e d in that the string (14) is mounted peripherally in the annular surface of the flange (12) .

3. Voice prosthesis according to claim 1, c h a r a c t e r i z e d in that the string is displaceable in relation to the flange (12) .

4. Voice prosthesis according to claim 1, c h a r a c t e r i z e d in that a plurality of apertures are provided peripherally in the annular surface of the flange (12) and are mutually spaced, and that the string passes through said apertures.

5. Voice prosthesis according to claim 1, c h a r a c t e r i z e d in that the string is made of a material of high strength and low friction in relation to the material of the flange (12) .

6. Instrument for the insertion of a voice prosthesis into a fistula between esophagus and trachea said voice prosthesis comprising a cylindrical body (10) , an outside flange (12) projecting radially from one end of said body (10) and having an annular surfce to engage the esophagus wall, and a valve member (13) in the body (10) , which closes a cylindrical passage through the body (10) but can be opened, c h a r a c t e r i z e d in that a first end of the instrument is made as an elongated stem (17) , that a second end is made as a cylindrical pin (18) to be received in said body (10) , and that an attachment (15) is provided in the stem (17) for locking a string (14) mounted in the annular surface of the flange (12) .

7. Instrument according to claim 6, c h a r a c t e r i z e d in that the attachment is made as a slot in the stem (17) .

8. Instrument according to claim 6, c h a r a c t e r i z e d in that the stem (17) forms a longitudinal depression (20) for reception of the string (14) .