Tracheoesophageal sounding prosthesis and insertion device for inserting such tracheoesophageal sounding prosthesis

Abstract

A tracheoesophageal sounding prosthesis comprising: a tubular body comprising: a one-way valve, a first protruding element and a second protruding element, where the second protruding element is displaceable along a longitudinal axis of the tubular body at least between: a first position in which the one-way valve is inserted into the first protruding element and a second position in which the one-way valve is inserted into the second protruding element; wherein at least a portion of the outer surface of the tubular body and / or at least a portion of the second protruding element comprises a coupling element configured to couple the second protruding element and the tubular body at least in the first position and the second position.

Description

[0001] The present invention relates to a tracheoesophageal voice prosthesis and an insertion device for inserting the tracheoesophageal voice prosthesis.

[0002] Laryngectomy is a surgery in which the larynx is removed, the trachea and esophagus are separated, and a tracheostomy is an opening in the neck connected to the trachea to provide a new airway. Due to the removal of the larynx and due to the separation of the trachea and esophagus, the patient cannot speak.

[0003] Devices for voice restoration, known as tracheoesophageal voice prostheses, are known in the art. A tracheoesophageal voice prosthesis is placed in a tracheoesophageal puncture, an opening between the trachea and esophagus. The tracheoesophageal voice prosthesis includes a one-way air valve that allows air to pass from the trachea to the esophagus when the tracheostomy is covered or closed. The directed air vibrates the esophageal tissue and / or mucosa in the esophagus, producing a voice-like sound.

[0004] Known tracheoesophageal voice prostheses are available in different sizes. A larger tracheoesophageal voice prosthesis is inserted into the tracheoesophageal puncture when the tracheoesophageal puncture and / or the surrounding tissue of the tracheoesophageal puncture is inflamed and / or irritated. After the inflammation and / or irritation has decreased or subsided, a smaller or previously sized tracheoesophageal voice prosthesis is inserted into the tracheoesophageal puncture. Another disadvantage is that a tracheoesophageal voice prosthesis that is too small can also leak. Furthermore, changing tracheoesophageal voice prostheses results in high medical costs because known prostheses are removed and inserted by medical specialists, typically in a hospital.

[0005] The present invention aims to overcome the above-mentioned disadvantages. Furthermore, the present invention provides a tracheoesophageal voice prosthesis comprising: a tubular body comprising: a first end and a second end, a longitudinal axis extending longitudinally of the tubular body, and a one-way valve configured for selective passage of air between the second end and the first end; a first protruding element protruding in a direction perpendicular to the longitudinal axis and arranged at the first end of the tubular body; and a second protruding element protruding in a direction perpendicular to the longitudinal axis and comprising an opening for passage of at least a portion of the tubular body, wherein the first and second protruding elements are configured to hold the tracheoesophageal voice prosthesis in place when inserted into a tracheoesophageal puncture, wherein the second protruding element is displaceable along the longitudinal axis of the tubular body; an extension element is disposed on an outer surface of the tubular body at a first distance from the first protruding element, and a second position, wherein the second protruding element is disposed on the outer surface of the tubular body at a second distance from the first protruding element, wherein the second distance is less than the first distance; and wherein at least a portion of the outer surface of the tubular body and / or at least a portion of the second protruding element comprises a coupling element configured to couple the second protruding element and the tubular body in at least the first and second positions. The displacement of the second protruding element allows the distance between the first protruding element and the second protruding element to be adjusted.

[0006] The one-way valve can be a one-way air valve that allows air to pass from the second end of the tubular body to the first end, and vice versa. The one-way valve preferably only allows gaseous substances to pass from the second end of the tubular body to the first end. In addition, the one-way valve blocks the passage of fluid from the first end to the second end of the tubular body to prevent fluid from entering the esophagus and ultimately the lungs. The valve can be arranged, for example, in the tubular element or at one of the ends.

[0007] The first end of the tubular body of the tracheoesophageal prosthesis can first be inserted into a tracheostomy. The first protruding element penetrates the tracheoesophageal puncture, for example by being sufficiently flexible to temporarily compress upon insertion through the opening. When the tracheoesophageal prosthesis is inserted into the tracheoesophageal puncture, the first protruding element can be configured to at least partially contact at least a portion of the esophageal wall, typically expanding toward its original size after insertion. It is conceivable that after the insertion process, the second protrusion at least partially contacts at least a portion of the tracheal wall. However, in the event of irritation and / or inflammation, the second protruding element can be displaced distally along the longitudinal axis in a direction away from the first protruding element. As a result, the distance between the first and second protruding elements increases. In the event of a leak, the second protruding element can be displaced medially along the longitudinal axis of the tubular body in a direction toward the first protruding element. As a result, the distance between the first and second protruding elements decreases.

[0008] The second protruding element is slidable along the longitudinal axis of the tubular body. Preferably, the second protruding element is slidably displaceable along the longitudinal axis of the tubular body. The second protruding element is preferably slidable between at least a first position and a second position. Thereby, the second protruding element can be easily displaced along the longitudinal axis of the tubular body. Preferably, in order to displace the second protruding element from the first position to the second position, the second protruding element is pushed along the longitudinal axis of the tubular body in the direction of the first protruding element. In order to displace the second protruding element from the second position to the first position, the second protruding element can be pulled along the longitudinal axis of the tubular body in a direction away from the first protruding element. The tubular body and the second protruding element can, for example, have cooperating teeth that clamp behind each other to fix them to each other in a predetermined position.

[0009] The second protruding element is rotatable about the longitudinal axis of the tubular body. Preferably, the second protruding element is rotatable between at least a first position and a second position. Optionally, the second protruding element is rotationally displaceable along the longitudinal axis of the tubular body, preferably at least between the first position and the second position. Thereby, the second protruding element can be easily displaced along the longitudinal axis of the tubular body. Preferably, in order to displace the second protruding element from the first position to the second position, the second protruding element is rotated about the longitudinal axis of the tubular body and displaced in the direction of the first protruding element. In order to displace the second protruding element from the second position to the first position, the second protruding element is rotated about the longitudinal axis of the tubular body and displaced along the longitudinal axis of the tubular body in a direction away from the first protruding element.

[0010] The opening of the second protruding element may have a closed shape. A closed shape may be defined as a closed shape or figure whose line segments and / or curves are connected or meet. The closed shape of the opening of the second protruding element may be a square, a circle, a triangle, a star, a trapezoid, etc. The inner periphery of the closed-shaped opening of the second protruding element is in contact with the outer surface of the tubular body, and preferably, the entire inner periphery of the closed-shaped opening of the second protruding element is in contact with the outer surface of the tubular body. The closed shaped opening of the second protruding element preferably surrounds and / or encloses at least a portion of the tubular body. Preferably, the closed opening of the second protruding element has multiple contact points with the outer surface of the tubular body. This results in the second protruding element being stably positioned on the outer surface of the tubular body, preferably at least in the first position and the second position. The opening of the second protruding element may have a size between 1 mm and 14 mm, preferably between 3 mm and 7 mm, more preferably about 5.5 mm.

[0011] The opening of the second protruding element may have an open shape. An open shape may be defined as a shape or figure having different starting and ending points, in particular, wherein the ends of the open shape opening do not meet. The opening shape of the opening of the second protruding element may be an arc, an arch, a V-shaped opening, a C-shaped opening, or the like. At least a portion of the inner circumference of the opening of the second protruding element contacts the outer surface of the tubular body, and preferably the entire inner circumference of the opening of the second protruding element contacts the outer surface of the tubular body. Preferably, the opening of the second protruding element has multiple contact points with the outer surface of the tubular body. This results in the second protruding element preferably being stably positioned on the outer surface of the tubular body in at least the first position and the second position.

[0012] At least a portion of the opening of the second protruding element may comprise a coupling element. The coupling element of the second protruding element may be configured to interact or co-act with at least a portion of the outer surface of the tubular body, preferably at least in the first position and the second position. Thereby, a stable coupling may be formed between the second protruding element and the tubular body. The coupling element may, for example, comprise a clamping portion, a retaining element, or a fastening element. The coupling element may be configured to at least temporarily couple the second protruding element to or onto the outer surface of the tubular body, preferably at least in the first position and the second position.

[0013] The coupling element on at least a portion of the outer surface of the tubular body may be formed by a ribbed portion. The ribbed portion preferably comprises a plurality of ribs, said plurality of ribs providing resistance to limit the movement of the second protruding element along the longitudinal axis of the tubular body. Preferably, the ribs are arranged in at least a first position and a second position. The second protruding element may be (temporarily) locked or hooked behind at least one rib of the ribbed portion. Optionally, the second protruding element is (temporarily) locked between at least two ribs of the ribbed portion. Preferably, the ribs extend radially of the tubular body. Optionally, the ribs extend at an angle and in a direction away from the longitudinal axis of the tubular body. The ribs may, for example, be configured as teeth, wherein interlocking occurs similar to the locking of, for example, a zipper.

[0014] At least a portion of the coupling element may include a threaded portion. Optionally, the coupling element is threaded. It is contemplated that at least a portion of the opening of the second protruding element and / or the outer surface of the tubular body may include a threaded portion. Preferably, at least a portion of the tubular body between the first position and the second position includes a threaded portion. Thus, the second protruding element can function like a bolt, and the tubular body can function like a screw. The second protruding element can be displaced along the longitudinal axis of the tubular body by rotation about the longitudinal axis. This allows for relatively easy displacement of the second protruding element while providing a stable connection between the second protruding element and the tubular body. The first protruding element may be fixed at the first end of the tubular body. Preferably, the first protruding element is fixed to the outer surface of the tubular body at the first end. Therefore, the first protruding element cannot be displaced along the longitudinal axis of the tubular body. Therefore, the first protruding element does not displace when the second protruding element is displaced. Consequently, the distance between the first and second protruding elements can be easily adjusted within the tracheoesophageal puncture. Furthermore, the first protruding element may form the endpoint of the tracheoesophageal voice prosthesis. The distance between the first protruding element and the second protruding element can be adjusted by displacement of the second protruding element, without requiring displacement of the tubular body. It is conceivable that the first protruding element is adhered to the outer surface of the tubular body. The first protruding element can be adhered to the outer surface of the tubular body using a biocompatible glue, such as a cyanoacrylate glue, more particularly an ethyl cyanoacrylate glue. However, it is preferred that the first protruding element is integrally formed with the tubular body, for example, by molding.

[0015] The width of the first protruding element can at least exceed the width of the opening in the esophageal wall at the tracheoesophageal puncture. This is advantageous because the first protruding element preferably contacts at least a portion of the esophageal wall at the tracheoesophageal puncture site. This embodiment prevents the tracheoesophageal voice prosthesis from easily moving in an anterior direction, thereby allowing for better fixation or placement of the tracheoesophageal voice prosthesis during the tracheoesophageal puncture.

[0016] The width of the second protruding element may at least exceed the width of the opening in the tracheal wall of the tracheoesophageal puncture. This is advantageous because the second protruding element preferably contacts at least a portion of the tracheal wall at the tracheoesophageal puncture. This embodiment avoids the tracheoesophageal voice prosthesis from easily moving in a posterior direction. Thereby allowing the tracheoesophageal voice prosthesis to be better fixed or placed in the tracheoesophageal puncture. It is conceivable that the width of the first protruding element exceeds the width of the second protruding element. The width of the second protruding element may be greater than the width of the first protruding element. Optionally, the width of the first protruding element is equal to the width of the second protruding element. The diameter of the second protruding element may be between 10 mm and 30 mm, preferably, the diameter of the second protruding element is 14 mm or 19 mm or 22 mm.

[0017] The first and / or second protruding elements may comprise curved edges, in particular curved outer edges. Preferably, all edges, in particular outer edges, of the first and / or second protruding elements are curved. The curved edges of the first and / or second protruding elements are beneficial because they reduce the likelihood of snagging behind tissue and / or creating wounds during displacement of the second protruding element and during insertion and removal of the tracheoesophageal voice prosthesis.

[0018] The first protruding element can be a flange, typically connected to or integrally formed with the tubular body. The flange can have a curved outer edge, which is beneficial as described above. Furthermore, the flange can include an opening, preferably in contact with the outer surface of the tubular body at a first end. Preferably, the opening of the flange at least partially overlaps with the opening at the first end of the tubular body. This reduces resistance to air passing through the tubular body. The second protruding element can be a flange. The flange can have a curved outer edge, which is beneficial as described above. Furthermore, the flange can include an opening that contacts the outer surface of the tubular body. The opening of the flange of the second protruding element is configured to allow passage of at least a portion of the tubular body. Furthermore, the flange makes it relatively easy to place the second protruding element on the second end of the tubular body. The tracheoesophageal voice prosthesis can also include a third protruding element, which protrudes in a direction perpendicular to the longitudinal axis and is arranged between the first and second ends of the tubular body, in particular, between the first and second protruding elements. The third protruding element preferably includes an opening for passage of at least a portion of the tubular body. Optionally, the third protruding element is a flange. The third protruding element is preferably larger in size than the first and / or second protruding elements. The third protruding element helps reduce, and preferably prevent, leakage through the tracheoesophageal puncture. Preferably, the third protruding element is configured to facilitate passage of the tracheoesophageal puncture in conjunction with the first protruding element. The third protruding element is preferably sufficiently flexible to temporarily compress upon insertion through the opening. When the tracheoesophageal prosthesis is inserted into the tracheoesophageal puncture, the third protruding element can be configured to at least partially contact at least a portion of the esophageal wall, typically expanding toward its original size upon insertion.

[0019] The tubular body can be longer than its width. This allows for relatively easy insertion of a tracheoesophageal puncture via a tracheostomy. The tubular body can be cylindrical or oval. This shape is advantageous because it has a curved outer edge. The curved outer edge is advantageous because it reduces the possibility of snagging behind tissue and / or causing wounds during insertion and / or removal of the tracheoesophageal voice prosthesis. The tubular body can also have a polyhedral shape. Alternatively, the tubular body can be designed to suit the shape of the tracheoesophageal puncture.

[0020] The width of the tubular body (eg measured perpendicularly to its longitudinal axis) may for example be between 4 and 8 mm, preferably between 5 and 6 mm.

[0021] The first and second ends of the tubular body may be open ends for allowing air to pass between the second and first ends. The first and / or second ends preferably form endpoints of the tubular body. Preferably, the first protruding element has an opening corresponding to the size of the opening at the first end of the tubular body.

[0022] The one-way valve can, for example, be at least partially disposed between the first and second ends of the tubular body. Alternatively, the one-way valve can be completely disposed between the first and second ends of the tubular body. In particular, the one-way valve can be housed within the tubular body. This embodiment is advantageous because the tubular body completely encloses the one-way valve. Consequently, the one-way valve does not come into direct contact with the body tissue of the user of the tracheoesophageal voice prosthesis. Another advantage is that it reduces wear on the one-way valve.

[0023] The one-way valve may also be at least partially arranged at the first end of the tubular body. The one-way valve may be at least partially connected to the first protruding element. The first protruding element may include a receiving space configured to receive at least one side of the one-way valve, in particular at least the front side of the one-way valve. This embodiment is advantageous because it provides a simple way of inserting the tracheoesophageal voice prosthesis when using an insertion device. The insertion device can be placed in the tubular body to guide and / or support the tracheoesophageal voice prosthesis during insertion. By placing the one-way valve on the first end and / or the first protruding element, the one-way valve does not have to be in contact with the insertion device. Therefore, the possibility of damaging the one-way valve when placing the tracheoesophageal voice prosthesis is reduced.

[0024] The one-way valve can be adhered to the tubular body and / or the first protruding element, preferably using a biocompatible adhesive, such as cyanoacrylate adhesive. Optionally, the first protruding element includes a receiving space for receiving at least one side of the one-way valve, particularly the front side of the one-way valve. The first protruding element may also include a hollow space or recessed portion for connecting a side of the one-way valve, particularly the upper or lower side of the one-way valve, to the first protruding element. Optionally, one side of the one-way valve includes a protruding element configured to connect to or cooperate with the hollow space or recessed portion. Preferably, the protruding element of the one-way valve is complementary to the hollow space or recessed portion. The protruding element of the one-way valve is preferably disposed on a side of the one-way valve, particularly the upper or lower side of the one-way valve. It is conceivable that one side of the one-way valve is adhered to the first protruding element. Preferably, the one-way valve is adhered to the receiving space. Optionally, the hollow space or recessed portion is configured to receive an adhesive for adhering the one-way valve to the first protruding element, particularly the hollow space or recessed portion. Preferably, the adhesive is provided on the side of the hollow space of the first protruding element that faces the tubular body. It is also possible to form the one-way valve integrally with the tubular body and / or the first protruding element, for example during molding. It is also possible to connect the valve to the tubular body and / or the first protruding element via an articulated connection.

[0025] Optionally, the tracheoesophageal voice prosthesis includes two one-way valves, wherein the primary one-way valve is arranged at the first end of the tubular body, and the secondary one-way valve is arranged on the first protruding element. The primary one-way valve is preferably smaller than the secondary one-way valve. The first end of the tubular body is preferably an open end, on which the primary one-way valve is arranged. Optionally, the first end of the tubular body includes a primary hollow space or a primary recessed portion for connecting one side of the primary one-way valve to the first end of the tubular body, in particular, the upper or lower side of the primary one-way valve. Optionally, one side of the primary one-way valve includes a protruding element configured to connect to or cooperate with the primary hollow space or the primary recessed portion. The protruding element of the primary one-way valve is preferably arranged on one side of the primary one-way valve, in particular, on the upper or lower side of the primary one-way valve. It is conceivable that one side of the one-way valve is adhered to the first end of the tubular body. Preferably, the primary one-way valve is adhered to the primary hollow space or the primary recessed portion. This embodiment helps to reduce, and preferably prevent, the passage of fluid through the tubular body from the first end to the second end or from the esophagus to the trachea.

[0026] The one-way valve may for example be a substantially disc-shaped element, and preferably the first protruding element has a similarly shaped recess to at least partially accommodate the valve.

[0027] The one-way valve may include at least one, preferably at least two, reinforcing ribs to strengthen the valve. In particular, when the valve is made of a relatively flexible material, such ribs help maintain its shape and prevent the valve from curling, particularly around the edges. To this end, the ribs preferably extend over a substantial portion (thus exceeding 50%) of the width, length, or radius of the valve.

[0028] At least a portion of the tracheoesophageal voice prosthesis may be made of a flexible material, such as an elastomer, preferably a thermoplastic elastomer (TPE), such as Evoprene. Conceivably, the elastomer is selected from the group consisting of poly(styrene-butadiene-styrene) (SBS), poly(styrene-ethylene-butylene-styrene) (SEBS), or a combination thereof.

[0029] The material of the tracheoesophageal voice prosthesis may, for example, have a Shore A hardness between 50 and 100 (measured at 23 degrees Celsius according to ISO 868) to strike a balance between rigidity to maintain the prosthesis in place during insertion and flexibility to allow insertion of the prosthesis in the first place. The material may, for example, have a specific gravity of 0.75-1.25 measured according to ISO 2781 (also measured at room temperature of 23 degrees Celsius).

[0030] The first protruding element may be at least partially made of a flexible material to allow insertion of the first protruding element through a tracheoesophageal puncture.The first protruding element may be configured to deform at least in a direction toward the second end of the tubular body, preferably when passing through the tracheoesophageal puncture.

[0031] The tracheoesophageal voice prosthesis may comprise at least one marking for indicating the insertion orientation of the tracheoesophageal voice prosthesis during tracheoesophageal puncture. The marking may, for example, be provided on the tubular body. The marking may indicate the upper side, the lower side, the front side and / or the rear side of the different components of the tracheoesophageal voice prosthesis. The tracheoesophageal voice prosthesis may comprise a plurality of markings, wherein each marking provides the user with different information about the orientation and / or the mutual relationship of the different components of the tracheoesophageal voice prosthesis. This embodiment provides the user with information about how to assemble the various components of the tracheoesophageal voice prosthesis and / or the orientation of the tracheoesophageal voice prosthesis upon insertion.

[0032] The present invention also relates to an insertion device for inserting a tracheoesophageal voice prosthesis according to the present invention, the insertion device comprising an elongated body adapted to be inserted into a tubular body for supporting and / or guiding the tracheoesophageal voice prosthesis during insertion into the tracheoesophageal puncture. The insertion device preferably supports and / or guides the tracheoesophageal voice prosthesis during insertion into the tracheoesophageal puncture. The insertion device may support the interior of the tubular body during placement of the tracheoesophageal voice prosthesis. Optionally, the insertion device comprises a receiving space for receiving at least a portion of the tracheoesophageal voice prosthesis, preferably completely receiving the tracheoesophageal voice prosthesis, for guiding the tracheoesophageal voice prosthesis during insertion into the tracheoesophageal puncture. This is beneficial because the tracheoesophageal puncture is difficult to reach with bare hands.

[0033] The elongated body may have a higher stiffness than the tubular body of the tracheoesophageal voice prosthesis, wherein preferably the elongated body has a higher stiffness than the tracheoesophageal voice prosthesis. This allows easier insertion of the tracheoesophageal voice prosthesis during insertion, so as to facilitate the placement of the tracheoesophageal voice prosthesis. Preferably, at least one end side of the elongated body comprises a brush for cleaning the tubular body, in particular a part of the interior of the tubular body. This allows cleaning the interior of the tubular body. This is also possible when the tracheoesophageal voice prosthesis has been inserted into a tracheoesophageal puncture. Thereby, dirt, accumulated body matter, such as mucus, which has entered the interior of the tracheoesophageal voice prosthesis can be removed. The present invention will be described by means of several embodiments and with reference to

[0034] Figures, in which:

[0035] - Figure 1a 、 1b shows a side view of a tracheoesophageal voice prosthesis according to the present invention, - Figure 2a 、 2b Schematically showing a side view of a tracheoesophageal voice prosthesis according to the present invention inserted into a tracheoesophageal puncture,

[0036] - Figures 3a-3d Schematically showing the different components of a tracheoesophageal speech prosthesis according to the invention,

[0037] - Figure 4Schematically showing a perspective view of a tubular body and a front view of a one-way valve according to the present invention,

[0038] - Figure 5 schematically shows an insertion device according to the invention, and

[0039] - Figure 6 Another embodiment of an insertion device according to the present invention is schematically shown. In the drawings, like reference numerals correspond to similar or equivalent elements or features.

[0040] Figure 1a and 1b FIG2 shows a side view of a tracheoesophageal voice prosthesis 1 according to the present invention. The tracheoesophageal voice prosthesis 1 comprises a tubular body 2. Figure 1a 、 1b In the embodiment shown, the tubular body 2 is essentially cylindrical. However, other shapes are also conceivable. The tubular body 2 comprises a first end 2a and a second end 2b. The first end 2a and the second end 2b are arranged on opposite sides of the tubular body 2. The first end 2a and / or the second end 2b preferably form the endpoints of the tubular body 2. Preferably, the first end 2a and the second end 2b are open ends for allowing air to pass through the tubular body 2. The tubular body 2 extends in a longitudinal direction or in the direction along the longitudinal axis aL of the tubular body 2. In the embodiment shown, the length L of the tubular body 2 is greater than its width. The tracheoesophageal voice prosthesis 1 further comprises two protruding elements 3, 4. The first protruding element 3 is arranged at or near the first end 2a of the tubular body 2 and is formed integrally with the tubular body 2. The first protruding element 3 protrudes in a direction perpendicular to the longitudinal axis aL of the tubular body 2. In the embodiment shown, the first protruding element 3 protrudes from the longitudinal axis aL in at least two opposite directions. In the embodiment shown, the first protruding element 3 comprises a curved edge. The first protruding element 3 shown has a curved shape, in particular a circular or oval shape. The first protruding element 3 comprises at least one receiving space for receiving one side of a one-way valve (not shown), so that one side of the one-way valve can be connected to the receiving space. It is conceivable that one side of the one-way valve is adhered to the first protruding element 3, in particular to the receiving space. Optionally, the receiving space comprises a hollow space.

[0041] Figure 1aThe second protruding element 4 is shown in a first position p1. In the first position p1, the second protruding element 4 is located at a first distance D1 from the first protruding element 3. In the first position p1, the second protruding element 4 is located at a third distance D3 from the second end 2b of the tubular body 2. Preferably, the sum of the first distance D1 and the third distance D3 is equal to the length L of the tubular body 2. In the illustrated embodiment, the first distance D1 is less than the third distance D3. Thus, the second protruding element 4 is positioned closer to the first protruding element 3 than to the second end 2b of the tubular body 2. The illustrated first position p1, first and third distances D1, D3, respectively, are for illustrative purposes only, as other positions are contemplated. In alternative embodiments, the first position p1 of the second protruding element 4 may be closer to the second end 2b of the tubular body or closer to the first protruding element 3.

[0042] Figure 1b The second protruding element 4 is shown arranged in a second position p2, which is located at a second distance D2 from the first protruding element 3. In the second position p2, the second protruding element 4 is located at a fourth distance D4 from the second end 2b of the tubular body 2. Preferably, the sum of the second distance D2 and the fourth distance D4 is equal to the length of the tubular body 2. The second distance D2 is less than the first distance D1 (see Figure 1a ). Thus, in the second position p2, the second protruding element 4 is positioned closer to the first protruding element 3 than in the first position p1. In the embodiment shown, the second distance D2 is smaller than the fourth distance D4. Thus, the second protruding element 4 is positioned closer to the first protruding element 3 than the second end 2b of the tubular body 2. The fourth distance D4 may be larger than the third distance D3 (see Figure 1a Thus, in the second position p2, the second protruding element 4 can be positioned further away from the second end 2b of the tubular body than in the first position p1. The second position p2, and the second and fourth distances D2 and D4, respectively, are shown for illustrative purposes only, as other positions are contemplated. In another embodiment, the second position p2 of the second protruding element 4 can be closer to the second end 2b of the tubular body or closer to the first protruding element 3.

[0043] Figure 2a 、 2bA side view of a tracheoesophageal voice prosthesis 1 according to the present invention is schematically shown, inserted into a tracheoesophageal puncture 12 or fistula tract 12. The tracheoesophageal voice prosthesis 1 can be inserted into the tracheoesophageal puncture 12 via a tracheostomy 17. The tracheostomy 17 is an opening in the neck (not shown) and the front side of the tracheal wall 13. The tracheoesophageal puncture 12 is an opening between the back side of the tracheal wall 14 and the front side of the esophageal wall 15. The back side of the esophageal wall 16 is not opened. During insertion, the first end 2a of the tubular body 2 of the tracheoesophageal voice prosthesis 1 is passed through the trachea 10 via the tracheostomy 17. The first end 2a of the tubular body and the first protruding element 3 are passed through the tracheoesophageal puncture 12 or fistula tract 12 so that at least the first protruding element 3 is located in the esophagus 11. The back side of the esophageal wall 16 preferably does not come into contact with the tracheoesophageal voice prosthesis 1. The first protruding element 3 is preferably made of a flexible material so that the first protruding element 3 can be (temporarily) elastically deformed so that the first protruding element 3 can relatively easily pass through the tracheoesophageal puncture 12 or fistula tract 12. The first protruding element 3 can be elastically deformed at least (temporarily) in the direction toward the second end 2b of the tubular body 2. The second protruding element 4 passes through the tracheostomy 17 into the trachea 10. The second protruding element 4 does not pass through the tracheoesophageal puncture 12 or fistula tract 12, but remains in the trachea 10. The tracheoesophageal voice prosthesis 1 includes a one-way valve 9 on the first end 2a of the tubular body 2, in particular on the first protruding element 3. The one-way valve 9 is configured to

[0044] Figure 2a Second protruding element 4 is shown in a first position p1. In first position p1, second protruding element 4 is located at a first distance D1 from first protruding element 3. Second protruding element 4 of the illustrated embodiment is located in trachea 10 at a distance from tracheal walls 13 and 14. Second protruding element 4 is configured to be displaced along the longitudinal axis of tubular body 2. First protruding element 3 of the illustrated embodiment is located in esophagus 11 at a distance from esophageal walls 15 and 16. The illustrated first position p1 and first distance D1 are shown for illustrative purposes only, as other positions are contemplated. In another embodiment, first position p1 of second protruding element 4 may be located closer to second end 2b of tubular body 2 or closer to first protruding element 3.

[0045] Figure 2bThe second protruding element 4 is shown positioned in a second position p2, located at a second distance D2 from the first protruding element 3. The second distance D2 is less than the first distance D1. In the illustrated embodiment, the second protruding element 4 contacts the tracheal wall 14. The second protruding element 4 has not yet passed through the tracheoesophageal puncture 12 or fistula tract 12. The first protruding element 3 contacts the esophageal wall 15. In particular, the first protruding element 3 is located on opposite sides of the tracheoesophageal puncture 12 relative to the second protruding element 4. Preferably, the first protruding element 3 and the second protruding element contact the tissue surrounding the tracheoesophageal puncture 12 to hold the tracheoesophageal voice prosthesis 1 in place. Thus, the tracheoesophageal voice prosthesis 1 limits, and preferably prevents, leakage. Optionally, the second protruding element 4 can be shifted from the second position p2 to the first position p1 to increase the distance between the first protruding element 3 and the second protruding element 4. This can be beneficial in situations where the tissue at and / or surrounding the tracheoesophageal puncture 12 is irritated and / or swollen, preferably to reduce pressure on the tissue at and / or surrounding the tracheoesophageal puncture 12 or fistula tract 12. Preferably, the first protruding element 3 is fixed to the first end 2a of the tubular body 2. Thus, the first protruding element 3 cannot be displaced along the longitudinal axis of the tubular body 2. The second position p2 and second distance D2 shown are for illustrative purposes only, as other positions are contemplated. In alternative embodiments, the second position p2 of the second protruding element 4 can be closer to the second end 2b of the tubular body or closer to the first protruding element 3.

[0046] Figures 3a-3d The different components of a tracheoesophageal speech prosthesis according to the invention are schematically shown. Figure 3a A side view of the tubular body 2 is schematically shown, and Figure 3b A perspective view of the tubular body 2 is schematically shown. A first protruding element 3 is arranged at the first end 2a of the tubular body 2. The first protruding element 3 includes an opening 3a so that air can pass through the tubular body 2 from the second end 2b to the first end 2a. Preferably, the size of the opening 3a of the first protruding element 3 is equal to the size of the first end 2a of the tubular body 2. Optionally, the size of the opening 3a is smaller than the size of the first end 2a of the tubular body. The first protruding element 3 of the illustrated embodiment also includes a receiving space 30, which is configured to receive at least a portion of the one-way valve 9. The receiving space 30 is preferably configured to receive at least a portion of the front side F of the one-way valve 9, more preferably to receive the entire front side F of the one-way valve 9.

[0047] Figure 3cAn enlarged view of the first protruding element 3 is shown. The first protruding element 3 has rounded or curved edges. The illustrated first protruding element 3 has a substantially oval shape. The upper side of the first protruding element 3 includes a hollow space 18 or recess 18. At least a portion of the one-way valve 9 can be connected to or inserted into the hollow passage or recess 18. Optionally, the one-way valve 9 includes a protruding element (not shown) for connecting the one-way valve 9 to the first protruding element 3, particularly to the hollow space or recess 18. The hollow space or recess 18 can be configured to receive an adhesive to adhere one side of the one-way valve 9 to the hollow space or recess 18, particularly the protruding portion of the one-way valve 9. The point at which the one-way valve 9 and the first protruding element 3 are connected can form a connection point between the one-way valve 9 and the first protruding element 3. Apart from the connection point, the one-way valve 9 may not be connected to the first protruding element 3 or the tubular body 2. Thus, the one-way valve 9 can rotate or pivot about the connection point, particularly between a closed position and an open position. In the closed position, the one-way valve 9 closes the opening 3a of the first protruding element 3 and / or the opening of the first end 2a of the tubular body 2. In the open position, the one-way valve 9 is angled relative to the first protruding element 3 to allow air to pass from the second end 2b to the first end 2a of the tubular body 2. In the open position, the one-way valve 9 is directed away from the tubular body 2 and the first protruding element.

[0048] Figure 3d A front view of an embodiment of a one-way valve 9 according to the present invention is shown. The dimensions of the one-way valve 9 preferably correspond to the accommodation space 30 of the first protruding element 3. The one-way valve 9 may include at least one reinforcing rib 19. In the illustrated embodiment, the one-way valve 9 includes two reinforcing ribs 19. The reinforcing ribs 19 are configured to reinforce the one-way valve 9. The illustrated reinforcing ribs 19 are preferably disposed on the front side F of the one-way valve 9. The illustrated reinforcing ribs 19 have equal lengths. However, it is conceivable that the dimensions, such as the length, of the reinforcing ribs 19 applied to the one-way valve may differ from one another.

[0049] Figure 4 A perspective view schematically illustrates a tubular body 2 on the left and a one-way valve 9 on the right according to the present invention. The tubular body 2 includes a first protruding element 3 at a first end 2a. The first protruding element 3 includes a hollow space 18 or a recessed portion 18. The one-way valve 9 includes a protruding element 20 or a fastening element 20 complementary to the hollow space 18 or recessed portion 18 for attaching the one-way valve 9 to the first protruding element 3. This can be accomplished with or without applying adhesive to the hollow space 18 or recessed portion 18 and / or to the one-way valve 9. Preferably, the fastening element 20 is first inserted into the hollow space 18, and then the adhesive is applied to the hollow space 18. The adhesive is preferably applied at least partially into the hollow space 18 on the side of the first protruding element 3 facing the second end 2b of the tubular body 2.

[0050] In addition to or as an alternative to attaching the one-way valve 9 to the first protruding element, the primary one-way valve 9 can be connected to the tubular body 2. The tubular body 2 can include a primary hollow space 21 or a primary recessed portion 21 that is complementary to the protruding element 20 or the fastening element 20 of the primary one-way valve 9. The primary one-way valve 9 can be connected to the tubular body 2 with or without applying an adhesive to and / or in the primary hollow space 21. Preferably, the protruding element 20 of the primary one-way valve 9 is first inserted into the primary hollow space 21, and then the adhesive is applied to the secondary hollow space 21.

[0051] Figure 5 A side view of an embodiment of an insertion device 40 according to the present invention is schematically shown. The insertion device 40 includes an elongated body 41. Preferably, the length of the elongated body 41 is greater than its width. In the illustrated embodiment, the elongated body 41 can be divided into three sections 41a, 41b, and 41c. The lengths of the first section 41a and the third section 41c of the elongated body 41 are less than the length of the second section 41b. The second section 41b is located between the first section 41a and the second section 41c. The second section 41b is wider than the first section 41a and the third section 41c. In the illustrated embodiment, the first section 41a and the third section 41c each include a transition region 41d. The transition region 41d slopes downward away from the second section 41b. The transition region 41d provides a transition from the second section 41b to the first section 41a and the third section 41c. The transition region 41d allows for relatively low resistance during insertion and / or removal from the tubular body of the tracheoesophageal voice prosthesis. At least one end side 42, 43 of the elongated body 41 includes a brush 44 or a brushed portion. In the illustrated embodiment, the end side 42 of the first portion 41a includes the brush 44. The brush 44 allows for cleaning of the interior of the tubular body of the tracheoesophageal voice prosthesis. The elongated body 41 preferably has a higher stiffness than at least a portion of the tracheoesophageal voice prosthesis, particularly the tubular body, so that it can support the tracheoesophageal voice prosthesis during insertion into a tracheoesophageal puncture or fistula.

[0052] Figure 6A side view of an alternative embodiment of an insertion device 60 according to the present invention is schematically shown. The insertion device 60 includes a hollow body 61 configured to receive at least a portion of a tracheoesophageal voice prosthesis to be inserted into a tracheoesophageal puncture. The illustrated insertion device 60 is configured to guide at least a portion of the tracheoesophageal voice prosthesis. The illustrated insertion device 60 has a tapered first end 62 configured to guide at least a first protruding element of the tracheoesophageal voice prosthesis, preferably through the tracheoesophageal puncture. The end sides 62 and 63 of the hollow body 61 are preferably open. The tracheoesophageal voice prosthesis can be passed through the hollow body 61 between the first end 62 and the second end 63. The tracheoesophageal voice prosthesis is preferably inserted into the hollow body 61, with the first end of the tubular body of the tracheoesophageal voice prosthesis disposed at the first end 62 of the hollow body 61 and the second end of the tubular body of the tracheoesophageal voice prosthesis disposed at the second end 63 of the hollow body 61 of the insertion device 60. Once the insertion device 61 is close to the tracheoesophageal puncture or is positioned in the tracheoesophageal puncture, the insertion device 60 and the tracheoesophageal voice prosthesis can be displaced relative to each other, in particular so that the tracheoesophageal voice prosthesis is displaced posteriorly in a direction towards the tracheoesophageal puncture and / or the insertion device 60 is moved distally in a direction away from the tracheoesophageal puncture. Optionally, the insertion device 60 is configured to be displaced along the longitudinal axis of the tubular body. In particular, the insertion device 60 can be displaced along the longitudinal axis of the tubular body from the first end to the second end and / or in a direction away from the tracheoesophageal puncture. At least the first protruding protein The above-mentioned figures are intended for illustrative purposes and do not limit the invention as claimed in the attached claims. It is conceivable that individual inventive concepts can be applied and, in doing so, the other details of the described examples will not apply. It is not necessary to elaborate on examples of all conceivable combinations of the above-mentioned inventive concepts, as those skilled in the art will understand that many inventive concepts can be (re)combined to achieve specific applications.

[0053] It is obvious that the invention is not limited to the working embodiments shown and described herein, but that many variations are possible within the scope of the appended claims, which will be obvious to a person skilled in the art.

[0054] The verb "to comprise" and its conjugations as used in this patent disclosure are understood to mean not only "including," but also the phrases "containing," "consisting essentially of," "formed of," and their conjugations.

Claims

1. Tracheoesophageal voice prosthesis, including: Tubular body, comprising: The first end and the second end, a longitudinal axis extending longitudinally along the tubular body, a one-way valve configured to selectively allow air to pass from the second end to the first end, a first protruding element extending in a direction perpendicular to the longitudinal axis and disposed at a first end of the tubular body, a second protruding element extending in a direction perpendicular to the longitudinal axis and comprising an opening for receiving at least a portion of the tubular body, The first protruding element and the second protruding element are used to fix the tracheoesophageal voice prosthesis in place after insertion into the tracheoesophageal puncture. Wherein, the second protruding element is movable along the longitudinal axis of the tubular body, comprising at least: First position: the second protruding element is disposed on the outer surface of the tubular body and is a first distance away from the first protruding element. Second position: the second protruding element is disposed on the outer surface of the tubular body, and the second distance is smaller than the first distance. Wherein, at least a portion of the outer surface of the tubular body and / or at least a portion of the second protruding element comprises a connecting element for connecting the second protruding element to the tubular body at least at a first position and a second position.

2. The tracheoesophageal voice prosthesis according to claim 1, wherein the second protruding element is slidable along the longitudinal axis of the tubular body.

3. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the second protruding element is rotatable about the longitudinal axis of the tubular body.

4. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the opening of the second protruding element is of closed shape.

5. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the opening of the second protruding element is open in shape.

6. A tracheoesophageal voice prosthesis according to any preceding claim, wherein at least part of the opening of the second protruding element comprises a connecting element.

7. A tracheoesophageal voice prosthesis according to any preceding claim, wherein at least part of the connecting elements of the outer surface of the tubular body are formed by rib-like structures.

8. A tracheoesophageal voice prosthesis according to any preceding claim, wherein at least part of the connecting element comprises a threaded structure.

9. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first protruding element is fixed to the first end of the tubular body.

10. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the width of the first protruding element exceeds at least the width of the tracheoesophageal puncture opening in the esophageal wall.

11. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the width of the second protruding element exceeds at least the width of the tracheoesophageal puncture tracheal wall opening.

12. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first protruding element and / or the second protruding element comprises a curved edge.

13. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first protruding element is a flange.

14. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the second protruding element is a flange.

15. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the tubular body is longer than it is wide.

16. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the tubular body is cylindrical or oval in shape.

17. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the tubular body is polyhedral in shape.

18. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first and second ends of the tubular body are open ends to allow passage of air.

19. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is at least partially arranged between the first and second ends of the tubular body.

20. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is at least partially provided at the first end of the tubular body.

21. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is at least partially connected to the first protruding element.

22. Tracheoesophageal voice prosthesis according to any of the preceding claims, wherein the one-way valve is fixed to the tubular body and / or the first protruding element.

23. Tracheoesophageal voice prosthesis according to any of the preceding claims, wherein the first protruding element comprises a receiving structure for accommodating a side, in particular a front side, of the one-way valve.

24. Tracheoesophageal voice prosthesis according to any of the preceding claims, wherein the one-way valve comprises at least one, preferably at least two, reinforcing ribs.

25. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first protruding element is at least partially made of a flexible material to allow its insertion through a tracheoesophageal puncture.

26. A tracheoesophageal speech prosthesis according to any preceding claim, comprising at least one marking for indicating the direction of insertion.

27. An insertion device for inserting a tracheoesophageal voice prosthesis according to any preceding claim, comprising an elongate body insertable into the tubular body for supporting and / or guiding the voice prosthesis during insertion.

28. An insertion device according to claim 27, wherein the elongated body has a higher stiffness than the tubular body of the voice prosthesis, preferably a higher stiffness than the voice prosthesis as a whole.

29. Insertion device according to any one of claims 27-28, wherein at least one end of the elongated body comprises a brush head for cleaning the tubular body, in particular the inner surface thereof.

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