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NL2037354B1 - Tracheoesophageal voice prosthesis and an insertion device for inserting such a tracheoesophageal voice prosthesis - Google Patents

Tracheoesophageal voice prosthesis and an insertion device for inserting such a tracheoesophageal voice prosthesis

Info

Publication number
NL2037354B1
NL2037354B1 NL2037354A NL2037354A NL2037354B1 NL 2037354 B1 NL2037354 B1 NL 2037354B1 NL 2037354 A NL2037354 A NL 2037354A NL 2037354 A NL2037354 A NL 2037354A NL 2037354 B1 NL2037354 B1 NL 2037354B1
Authority
NL
Netherlands
Prior art keywords
protruding element
tracheoesophageal
voice prosthesis
tubular body
shaped body
Prior art date
Application number
NL2037354A
Other languages
Dutch (nl)
Inventor
Johannes Wilhelmus Hartjes Leo
Original Assignee
Johannes Wilhelmus Hartjes Leo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johannes Wilhelmus Hartjes Leo filed Critical Johannes Wilhelmus Hartjes Leo
Priority to NL2037354A priority Critical patent/NL2037354B1/en
Priority to CN202510294684.9A priority patent/CN120661277A/en
Application granted granted Critical
Publication of NL2037354B1 publication Critical patent/NL2037354B1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/20—Larynxes; Tracheae combined with larynxes or for use therewith
    • A61F2/203—Larynxes; Tracheae combined with larynxes or for use therewith comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis

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  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Tracheoesophageal voice prosthesis, comprising: a tube shaped body, comprising: an one-way-valve, a first protruding element, and a second protruding element, wherein the second protruding element is displaceable along the longitudinal axis of the tube shaped body, at least between: a first position, and a second position, wherein at least a part of the outer surface of the tube shaped body and/or at least a part of the second protruding element comprises a coupling element configured to couple the second protruding element and the tube shaped body at least in the first position and the second position.

Description

Tracheoesophageal voice prosthesis and an insertion device for inserting such a tracheoesophageal voice prosthesis
The present invention relates to a tracheoesophageal voice prosthesis. The invention further relates to an insertion device for inserting a tracheoesophageal voice prosthesis.
Laryngectomy is the procedure wherein the larynx is removed, the trachea and the oesophagus are separated and wherein a tracheostomy is as 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 the cesophagus, a patient is not able to speak.
Devices for voice restoration, the so-called tracheoesophageal voice prosthesis, are known in the art. A tracheoesophageal voice prosthesis is placed in the tracheoesophageal puncture. The tracheoesophageal puncture is an opening between the trachea and the oesophagus. The tracheoesophageal voice prosthesis comprise an one-way air valve which allows air to pass from the trachea to the oesophagus when the tracheostomy is covered or closed. The directed air vibrates the oesophageal tissue and/or mucosa in the oesophagus creating a voice-like sound.
The known tracheoesophageal voice prostheses are available in different sizes.
Upon inflammation and/or irritation of the tracheoesophageal puncture and/or of the surrounding tissue of the tracheoesophageal puncture a larger sized tracheoesophageal voice prosthesis is inserted in the tracheoesophageal puncture.
After the inflammation and/or irritation is reduced or resolved, a smaller sized or previously sized tracheoesophageal voice prosthesis is inserted in the tracheoesophageal puncture. A further drawback is that a too small tracheoesophageal voice prosthesis furthermore leads to leakage. Furthermore, changing the tracheoesophageal voice prostheses results in high medical costs as they removal and insertion of known protheses is performed by medical specialists, typically in hospitals.
The present invention aims to overcome the abovementioned drawbacks. Thereto it proposes a tracheoesophageal voice prosthesis, comprising: a tube shaped body, comprising: a first end and a second end, a longitudinal axis extending in a longitudinal direction of the tube-shaped body, and an 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 tube shaped body, and a second protruding element protruding in a direction perpendicular to the longitudinal axis and comprising an opening for passaging at least a part of the tube shaped body, wherein the first protruding element and the second protruding element are configured for holding the tracheoesophageal voice prosthesis in place when inserted in a tracheoesophageal puncture, wherein the second protruding element is displaceable along the longitudinal axis of the tube shaped body, at least between: a first position, wherein the second protruding element is arranged on an outer surface of the tube shaped body at a first distance from the first protruding element, and a second position, wherein the second protruding element is arranged on the outer surface of the tube shaped at a second distance from the first protruding element, wherein the second distance is smaller than the first distance, wherein at least a part of the outer surface of the tube shaped body and/or at least a part of the second protruding element comprises a coupling element configured to couple the second protruding element and the tube shaped body at least in the first position and the second position. Displacement of the second protruding element allows the adjustment of the distance between the first protruding element and the second protruding element. Upon irritation and/or inflammation of the tracheoesophageal puncture and/or the tissue surrounding it, the distance between the first protruding element and the second protruding element may be increased.
Leakage from for example fluid or food from the oesophagus to the trachea through the tracheoesophageal puncture may be limited or stopped by decreasing the distance between the second protruding element. In particular, by displacing the second protruding element towards the first protruding element. Therewith, the tracheoesophageal voice prosthesis according to the present invention is adaptable in case of inflammation and/or irritation and/or leakage. Preferably, the second protruding element is displaceable between a plurality of positions. In each position, the second protruding element may have a different distance from the second protruding element. Therewith, a more precise adjustment of the distance between the first protruding element and the second protruding element may be provided and, compared to known protheses, it is able to fulfils the role of multiple differently sized protheses.
The one-way-valve may be an one-way air valve allowing air to passage from the second end to the first end of the tube shaped body or vice versa. The one-way- valve preferably only allows the passaging of gaseous substances from the second end to the first end of the tube shaped body. Furthermore, the one-way-valve blocks the passaging of fluid from the first end to the second end of the tube shaped body to circumvent fluid from entering from the oesophagus to the trachea and eventually the lungs. The valve may for instance be arranged in the tubular element or at one of the ends.
The first end of the tube shaped body of the tracheoesophageal prosthesis may first be inserted in the tracheostomy. The first protruding element passages through the tracheoesophageal puncture, for example by being flexible enough to temporarily compress when inserting through the opening. When the tracheoesophageal prosthesis is inserted in the tracheoesophageal puncture, the first protruding element may be configured to be at least partially in contact with at least a part of the oesophagus wall, typically it expands towards its original size after insertion. It is imaginable that after an insertion procedure, that the second protruding is at least partially in contact with at least a part of the trachea wall.
However, in case of irritation and/or inflammation the second protruding element may be distally displaced in a direction away from the first protruding element along the longitudinal axis. Therewith, the distance between the first protruding element and the second protruding element increases. In case of leakage, the second protruding element may be displaced medially along the longitudinal axis of the tube shaped body in a direction towards the first protruding element. Therewith, the distance between the first protruding element and the second protruding element decreases.
The second protruding element may be slidable along the longitudinal axis of the tube shaped body. Preferably, the second protruding element is slidable displaceable along the longitudinal axis of the tube shaped body. The second protruding element is preferably slidable at least between the first position and the second position. Therewith, the second protruding element may be easily be displaced along the longitudinal axis of the tube shaped body. Preferably, to displace the second protruding element from the first position to the second position, the second protruding element is pushed in the direction of the first protruding element along the longitudinal axis of the tube shaped body. To displace the second protruding element from the second position to the first position, the second protruding element may be pulled in a direction away from the first protruding element along the longitudinal axis of the tube shaped body. The tube shaped body and the second protruding element may for example have cooperating teeth, that grip behind each other to mutually fixate them in a predetermined position.
The second protruding element may be rotatable around the longitudinal axis of the tube shaped body. Preferably, the second protruding element is rotatable at least between the first position and the second position. Optionally, the second protruding element is rotatably displaceable along the longitudinal axis of the tube shaped body, preferably at least between the first position and the second position.
Therewith, the second protruding element may be easily be displaced along the fongitudinal axis of the tube shaped body. Preferably, to displace the second protruding element from the first position to the second position, the second protruding element is rotated around the longitudinal axis of the tube shaped body and displaced in the direction of the first protruding element. To displace the second protruding element from the second position to the first position, the second protruding element may be rotated around the longitudinal axis of the tube shaped body and displaced in a direction away from the first protruding element along the longitudinal axis of the tube shaped body.
The opening of the second protruding element may have a closed shape. A closed shape may be defined as an enclosed 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 trapezium, and the like. An inner perimeter of the closed shaped opening of the second protruding element is in contact with the outer surface of the tube shaped body, preferably the entire inner perimeter of the closed shaped opening of the second protruding element is in contact with the outer surface of the tube shaped body. The closed shaped opening of the second protruding element preferably surrounds and/or encloses at least a part of the tube shaped body. The closed shape opening of the second protruding element preferably has a plurality of contact points with the outer surface of the tube shaped body. This results in a stable positioning of the second 5 protruding element on the outer surface of the tube shaped 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 and 14 mm, preferably between 3 and 7 mm, more preferably around 5,5 mm.
The opening of the second protruding element may have an open shape. An open shape may be defined as a shape or figure with different starting and ending points, in particular wherein the ends of the open shaped opening do not meet. The open shape of the opening of the second protruding element may be an arc, a bow, a V- shaped opening, a C-shaped opening, and the like. At least a part of the inner perimeter of the open shaped opening of the second protruding element is in contact with the outer surface of the tube shaped body, preferably the entire inner perimeter of the open shaped opening of the second protruding element is in contact with the outer surface of the tube shaped body. The open shape opening of the second protruding element preferably has a plurality of contact points with the outer surface of the tube shaped body. This results in a stable positioning of the second protruding element on the outer surface of the tube shaped body, preferably at least in the first position and the second position.
At least a part 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 with or co-act with at least a part of the outer surface of the tube shaped body, preferably at least in the first position and the second position.
Therewith, a stable coupling can be made between the second protruding element and the tube shaped 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 on the outer surface of the tube shaped body, preferably at least in the first position and the second position.
The coupling element on at least a part of the outer surface of the tube shaped body may be formed by a ribbed portion. The ribbed portion preferably comprises a plurality of ribs providing resistance to limit movement of the second protruding element along the longitudinal axis of the tube shaped body. Preferably, ribs are at least provided in the first position and the second position. The second protruding element may get (temporarily) locked or hooked behind at least one of the ribs of the ribbed portion. Optionally, the second protruding element gets (temporarily) locked between at least two ribs of the ribbed portion. Preferably, the ribs extend in a radial direction of the tube shaped body. Optionally, the ribs extend under an angle and in a direction away from the longitudinal axis of the tube shaped body.
The ribs may, for example be embodied like teeth, where interlocking occurs similar to the lock of zip-ties for example.
At least a part of the coupling element may comprise a screw threaded portion.
Optionally, the coupling element is a screw thread. It is imaginable that the opening of the second protruding element and/or at least a part of the outer surface of the tube shaped body comprises a screw threaded portion. Preferably, at least the part of the tube shaped body between the first position and the second position comprises a screw threaded portion. Hence, the second protruding element may function like a bolt and the tube shaped body as a screw. The second protruding element may be displaced along the longitudinal axis of the tube shaped body by means of rotation around the longitudinal axis. This allows for a relatively easy displacement of the second protruding element while providing a stable coupling between the second protruding element and the tube shaped body.
The first protruding element may be fixed at the first end of the tube shaped body.
Preferably, the first protruding element is fixed to the outer surface of the tube shaped body at the first end. Hence, the first protruding element is not displaceable along the longitudinal axis of the tube shaped body. Therewith, upon displacement of the second protruding element the first protruding element does not displace.
Therefore, the distance between the first protruding element and the second protruding element can easily be adjusted within the tracheoesophageal puncture.
Furthermore, the first protruding element may form the end point of the tracheoesophageal voice prosthesis. The distance between the first protruding element and the second protruding element may be adjusted without displacement of the tube shape body, but by displacement of the second protruding element. It is imaginable that the first protruding element is adhered to the outer surface of the tube shaped body. The first protruding element may be adhered to the outer surface of the tube shaped body by making use of a biocompatible glue, such as cyanoacrylate glue, more in particular an ethyl cyanoacrylate glue . However, it is preferred that the first protruding element is made in one piece with the tube shaped body, for example by a moulding technique.
The width of the first protruding element may at least exceed the width of an opening in an oesophagus wall of a tracheoesophageal puncture. This is advantageous since the first protruding element makes preferably contact with at least a part of the oesophagus wall at the tracheoesophageal puncture. This embodiment circumvents that the tracheoesophageal voice prosthesis is easily moveable in an anterior direction. Therewith allowing a better fixation or placement of the tracheoesophageal voice prosthesis in the tracheoesophageal puncture.
The width of the second protruding element may at least exceeds the width of an opening in a trachea wall of a tracheoesophageal puncture. This is advantageous since the second protruding element makes preferably contact with at least a part of the trachea wall at the tracheoesophageal puncture. This embodiment circumvents that the tracheoesophageal voice prosthesis is easily moveable in posterior direction. Therewith allowing a better fixation or placement of the tracheoesophageal voice prosthesis in the tracheoesophageal puncture. It is imaginable that the width of the first protruding element exceeds the width of the second protruding element. It may be possible that the width of the second protruding element exceeds the width of the first protruding element. Optionally, the width of the first protruding element is equal to the second protruding element. The diameter of the second protruding element may be between 10 and 30 mm, preferably the diameter of the second protruding element is 14 mm or 19 mm or 22 mm.
The first protruding element and/or the second protruding element may comprise a curved edge, in particular a curved outer edge. Preferably, all the edges, in particular the outer edges, of the first protruding element and/or the second protruding element are curved. Curved edge(s) of the first protruding element and/or second protruding element are beneficial, because it decreases the possibility of getting stuck behind tissue and/or creating wounds upon displacement of the second protruding element and upon insertion and removal of the tracheoesophageal voice prosthesis.
The first protruding element may be a flange, typically connected or integrally formed with the tube shaped body. A flange may have curved outer edges, which is beneficial as described above. Furthermore, a flange may comprises an opening which preferably makes contact with the outer surface of the tube shaped body at the first end. Preferably, the opening of the flange overlaps at least partially with the opening of the first end of the tube shaped body. This decreases the resistance of the passaging of air through the tube shaped body. The second protruding element may be a flange. A flange has curved outer edges, which is beneficial as described above. Furthermore, a flange comprises an opening which makes contact with the outer surface of the tube shaped body. The opening of the flange of the second protruding element is configured to passage at least a part of the tube shaped body. Furthermore, a flange provides a relatively easy placement of the second protruding element on the second end of the tube shaped body.
The tracheoesophageal voice prosthesis may further comprise a third protruding element protruding in a direction perpendicular to the longitudinal axis and arranged between the first end and the second end of the tube shaped body, in particular arranged between the first protruding element and the second protruding element. The third protruding element preferably comprises an opening for passaging at least a part of the tube shaped body. Optionally, the third protruding element is a flange. The dimensions of the third protruding element are preferably larger than the first protruding element and/or the second protruding element. The third protruding element contributes to reducing, preferably preventing, leakage through the tracheoesophageal puncture. Preferably, the third protruding element is configured to passage, together with the first protruding element, the tracheoesophageal puncture. The third protruding element is preferably flexible enough to temporarily compress when inserting through the opening. When the tracheoesophageal prosthesis is inserted in the tracheoesophageal puncture, the third protruding element may be configured to be at least partially in contact with at least a part of the oesophagus wall, typically it expands towards its original size after insertion.
The length of the tube shaped body may be greater than its width. This allows an relatively easy insertion via the tracheostomy stoma into the tracheoesophageal puncture. The tube shaped body may be cylindrically or ellipsoidal shaped. This shape is beneficial since it has curved outer edges. Curved outer edges are advantageous, because it decreases the possibility of getting stuck behind tissue and/or creating wounds upon insertion and/or removal of the tracheoesophageal voice prosthesis. The tube shaped body may also be polyhedron shaped.
Optionally, the tube shaped body may be designed upon the shape of the tracheoesophageal puncture.
The width of the tube shaped body (for example measured perpendicular to its longitudinal axis) may be between 4 and 8mm for example, preferably between 5 and 6mm.
The first end and the second end of the tube shaped body may be open ends for allowing air to passage between the second end and the first end. The first end and/or the second end preferably form the endpoints of the tube shaped body.
Preferably the first protruding element has an opening which corresponds to the dimensions of the opening at the first end of the tube shaped body.
The one-way-valve may for example be at least partially arranged between the first end and the second end of the tube shaped body. The one-way-valve may entirely be arranged between the first end and the second end of the tube shaped body. In particular, the one-way-valve may be accommodated in the tube shaped body. This embodiment is advantageous since the tube shaped body surrounds the one-way- valve entirely. Hence, the one-way-valve will not directly be in contact with body tissue of the user of the tracheoesophageal voice prosthesis. A further advantages is that it decreases wear and tear of the one-way-valve.
The one-way-valve may also be at least be partially arranged at the first end of the tube shaped body. The one-way-valve may at least partially connected to the first protruding element. The first protruding element may comprise a receiving space configured to receive at least one side of the one-way-valve, in particular at least a frontal side of the one-way-valve. This embodiment is advantageous since it provides an easy way for inserting the tracheoesophageal voice prosthesis when using an insertion device. An insertion device may be placed in the tube shaped body to guide and/or support the tracheoesophageal voice prosthesis upon insertion. By placing the one-way-valve at the first end and/or on the first protruding element, the one-way-valve is not necessarily in contact with the insertion device.
Therewith, decrease the possibility of breaking the one-way-valve upon placement of the tracheoesophageal voice prosthesis.
The one-way-valve may be adhered to the tube shaped body and/or to the first protruding element, preferably by making use of a biocompatible glue, such as cyanoacrylate glue. Optionally, the first protruding element comprises a receiving space for receiving at least one side of the one-way-valve, in particular a frontal side of the one-way-valve. The first protruding element may further comprise a hollow space or a recessed portion for connecting one side of the one-way-valve to the first protruding element, in particular an upper side or a lower side of the one- way-valve. Optionally, one side of the one-way-valve comprises a protruding element configured to be connected to or to co-act with the hollow space or the recessed portion. Preferably, the protruding element of the one-way-valve is complementary to the hollow space or the recessed portion. The protruding element of the one-way-valve is preferably provided on one side of the one-way- valve, in particular on the upper side or the lower side of the one-way-valve. It is imaginable 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 the recessed portion is configured to receive an adhesive for adhering the one-way-valve to the first protruding element, in particular to the hollow space or the recessed portion. Preferably, the adhesive is provided in at a side of the hollow space of the first protruding element facing the tube shaped body. It is also possible to integrally form the one-way-valve with the tube shaped body and/or the first protruding element, for example during moulding.
It is also possible to connect the valve with the tube shaped body and/or the first protruding element through a hinged connection.
Optionally, the tracheoesophageal voice prosthesis comprises two one-way-valves, wherein a primary one-way-valve is arranged at the first end of the tube shaped body and a secondary one-way-valve is arranged at the first protruding element.
The primary one-way-valve is preferably smaller than the secondary one-way- valve. The first end of the tube shaped body is preferably an open end to which the primary one-way-valve is arranged. Optionally, the first end of the tube shaped body comprises a primary hollow space or a primary recessed portion for connecting one side of the primary one-way-valve to first end of the tube shaped body, in particular an upper side or a lower side of the primary one-way-valve.
Optionally, one side of the primary one-way-valve comprises a protruding element configured to be connected to or to co-act with the primary hollow space or the primary recessed portion. The protruding element of the primary one-way-valve is preferably provided on one side of the primary one-way-valve, in particular on the upper side or the lower side of the primary one-way-valve. It is imaginable that one side of the one-way-valve is adhered to the first end of the tube shaped body.
Preferably, the primary one-way-valve is adhered to the primary hollow space or primary recessed portion. This embodiment contributes to reducing, preferably preventing, passaging of fluid through the tube shaped body from the first end to the second end or from the oesophagus to the trachea.
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 accommodate the valve at least partially.
The one-way-valve may comprise at least one, preferably at least two, strengthening ribs, to strengthen the valve. In particular when the valve is made of a relatively flexible material, such ribs help to maintain its shape and prevent curling of the valve, in particular around the edged. To that end, the ribs preferably extend over the majority (so over 50%) of the width, length or radius of the valve.
At least a part of the tracheoesophageal voice prosthesis may be made from a flexible material, such as an elastomer, preferably a thermoplastic elastomer (TPE), such as Evoprene. It is imaginable that the elastomer is chosen from the group consisting of: poly(styrene-butadiene-styrene) (SBS), poly(styrene-ethylene- butylene-styrene) (SEBS), or a combination thereof.
The material of the tracheoesophageal voice prosthesis may for example have a hardness Shore A (measured according to ISO 868 at 23 degrees Celsius) between 50 and 100, to find a balance between rigidity to stay in place one inserted and flexibility to allow insertion of the prosthesis in the first place. The material may have a specific gravity (also measured at room temperature of 23 degrees Celsius) of 0.75-1.25, for example measured according to ISO 2781.
The first protruding element may at least be partially made from a flexible material to allow insertion of the first protruding element through a tracheoesophageal puncture. The first protruding element may be configured to at least deform in a direction towards the second end of the tube shaped body, preferably upon passaging the tracheoesophageal puncture.
The tracheoesophageal voice prosthesis may comprise at least one marker for indicating an orientation of insertion of the tracheoesophageal voice prosthesis in a tracheoesophageal puncture. The marker may for example be provided on the tube shaped body. The marker may indicate the upper side, lower side, front side and/or back side of different components of the tracheoesophageal voice prosthesis. The tracheoesophageal voice prosthesis may comprise a plurality of markers, wherein each marker provides the user with different information about the orientation and/or interrelationship of the different components of the tracheoesophageal voice prosthesis. This embodiments provides a user with information on how to assemble the various components of the tracheoesophageal voice prosthesis and/or the orientation of the tracheoesophageal voice prosthesis upon insertion.
The invention further relates to an insertion device for inserting a tracheoesophageal voice prosthesis according to the present invention, comprising an elongated body suitable to be inserted in the tube shaped body for supporting and/or guiding the tracheoesophageal voice prosthesis upon insertion in a tracheoesophageal puncture. An insertion device preferably supports and/or guides the tracheoesophageal voice prosthesis upon insertion in a tracheoesophageal puncture. The insertion device may support the interior of the tube shaped body upon placement of the tracheoesophageal voice prosthesis. Alternatively, the insertion device comprises a receiving space for receiving at least a part of,
preferably entirely receiving, the tracheoesophageal voice prosthesis for guiding the tracheoesophageal voice prosthesis upon insertion in a tracheoesophageal puncture. This is beneficial since the tracheoesophageal puncture is hard to reach by bare hands.
The elongated body may have a higher stiffness than the tube shaped body of the tracheoesophageal voice prosthesis, wherein preferably the elongated body has a higher stiffness than the tracheoesophageal voice prosthesis. This allows for an easier insertion of the tracheoesophageal voice prosthesis upon insertion to facilitate placement of the tracheoesophageal voice prothesis.
Preferably, at least one end side of the elongated body comprises a brush for cleaning the tube shaped body, in particular a part of the interior of the tube shaped body. This allows for cleaning the interior of the tube shaped body. This is also possible when the tracheoesophageal voice prosthesis is already inserted in the tracheoesophageal puncture. Therewith, dirt, accumulated body substances, such as mucus, which entered the interior of the tracheoesophageal voice prosthesis can be removed.
The invention will be further elucidated by several examples and with reference to the appended figures, wherein: - figure 1a, 1b show a side view of a tracheoesophageal voice prosthesis according to the invention, - figure 2a, 2b schematically show a side view of a tracheoesophageal voice prosthesis according to the invention inserted in a tracheoesophageal puncture, - figure 3a-3d schematically show different components of the tracheoesophageal voice prosthesis according to the invention, - figure 4 schematically shows a perspective view of the tube shaped body and a front view of the one-way-valve according to the invention, - figure 5 schematically shows an insertion device according to the present invention, and - figure 6 schematically shows another embodiment of an insertion device according to the present invention.
Within these figures, similar reference numbers correspond to similar or equivalent elements or features.
Figure 1a and 1b show a side view of a tracheoesophageal voice prosthesis 1 according to the present invention. The tracheoesophageal voice prosthesis 1 comprises a tube shaped body 2. In the shown figures 1a, 1b, the tube shaped body 2 is substantially cylindrically shaped. Other shapes are, however, also imaginable. The tube shaped body 2 comprises a first end 2a and a second end 2b.
The first end 2a and the second end 2b are provided on opposite sides of the tube shaped body 2. The first end 2a and/or the second end 2b preferably form the endpoints of the tube shaped body 2. Preferably, the first end 2a and the second end 2b are open ends for allowing air to passage the tube shaped body 2. The tube shaped body 2 extends in a longitudinal direction or in a direction along a longitudinal axis a, of the tube shaped body 2. In the shown embodiment, the length L of the tube shaped 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 close to the first end 2a of the tube shaped body 2 and is integrally formed with the tube shaped body 2. The first protruding element 3 protrudes in a direction perpendicular to the longitudinal axis a of the tube shaped body 2. In the shown embodiment, the first protruding element 3 protrudes at least in two opposite directions from longitudinal axis ac. In the shown embodiment, the first protruding element 3 comprises curved edges.
The shown first protruding element 3 has a curved shape, in particular a round or an elliptical shape. The first protruding element 3 comprises at least one receiving space for receiving a side of an one-way-valve (not shown), such that a side of the one-way-valve can be connected to the receiving space. It is imaginable that a 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 18 or a recessed portion 18 configured to receive an adhesive. It is possible that a side of the one-way-valve (not shown) comprises a fastening element which is complementary to the hollow space 18 or recessed portion 18 for connecting the side of the one-way-valve to the first protruding element 3. This may be done with or without the application of an adhesive to and/or in the hollow space 18 or recessed portion 18 and/or to the one-way-valve. The second protruding element 4 is arranged on an outer surface of the tube shaped body 2. The second protruding element 4 protrudes in a direction perpendicular to the longitudinal axis a, of the tube shaped body 2. In the shown embodiment, the second protruding element 4 protrudes at least in two opposite directions from longitudinal axis ar.
Preferably, the second protruding element 4 comprises curved edges.
The shown second protruding element 4 has a curved shape, in particular a round or an elliptical shape.
The second protruding element 4 comprises an opening 5 for passaging at least a part of the tube shaped body 2. The second protruding element 4 may be a flange.
The second protruding element 4 is configured to be arranged on the outer surface of the tube shaped body 2. The second protruding element 4 is displaceable along the longitudinal axis a, or along the longitudinal direction of the tube shaped body 2. Preferably, the second protruding element 4 is displaceable between the second end 2b and the first protruding element 3. In the shown embodiment, the outer surface of the tube shaped body 2 comprises a coupling element 7 configured to couple the second protruding element 4 and the tube shaped body 2. In the shown embodiment, the coupling element is a ribbed region 7. The ribbed region 7 comprises a plurality of ribs 6 configured to couple the second protruding element 4 and the tube shaped body 2 on different positions along the longitudinal axis a, preferably at predetermined positions.
It is imaginable that the ribbed region 7 is provided on the entire outer surface of the tube shaped body 2. The ribs 6 are preferably configured to limit movement of the second protruding element 4 along the longitudinal axis a.
Hence, the ribbed region 7 may comprise a ribbed surface.
Adjacent ribs 6 of the ribbed region 7 from an angle a for allowing both the displacement of the second protruding element 4 and for coupling the second protruding element 4 on the outer surface of the tube shaped body 2 at least in a first position pt and a second position p2. Angle a is preferably between 20-60 degrees, preferably between 25-40 degrees.
The tracheoesophageal voice prosthesis 1 may further comprise at least one marker 8 indicating the desired orientation of the tracheoesophageal voice prosthesis 1 for insertion and/or after insertion.
For example, the marker 8 may indicate the upper side and/or the lower side of the tracheoesophageal voice prosthesis 1. Preferably, such that the user and/or the medical professional is provided with information on the orientation of the tracheoesophageal voice prosthesis 1 for insertion.
In the shown embodiment, the marker 8 is provided on the outer surface of the tube shaped body 2. However, the marker 8 may be provided elsewhere on the tracheoesophageal voice prosthesis 1. Optionally, the tracheoesophageal voice prosthesis 1 is provided with a plurality of markers for indicating a plurality of orientation characteristics of the different elements of the tracheoesophageal voice prosthesis.
Figure 1a shows the second protruding element 4 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 tube shaped body 2. Preferably, the sum of the first distance D1 and the third distance
D3 equals the length L of the tube shaped body 2. In the shown embodiment, the first distance D1 is smaller than the third distance D3. Hence, the second protruding element 4 is positioned closer to the first protruding element 3 than to the second end 2b of the tube shaped body 2. The shown first position p1, the first and third distance D1, D3, respectively, are for illustrative purposes only, since other position(s) are imaginable. In another embodiment, the first position p1 of the second protruding element 4 may be located closer to the second end 2b of the tube shaped body or closer to the first protruding element 3.
Figure 1b shows the second protruding element 4 provided in a second position p2 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 tube shaped body 2. Preferably, the sum of the second distance D2 and the fourth distance D4 equals the length of the tube shaped body 2. The second distance D2 is smaller than the first distance D1 (see figure 1a). Hence, in the second position p2 the second protruding element 4 is positioned closer to the first protruding element 3 than in the first position pt. In the shown embodiment, the second distance D2 is smaller than the fourth distance
D4. Hence, the second protruding element 4 is positioned closer to the first protruding element 3 than to the second end 2b of the tube shaped body 2. The fourth distance D4 may be larger than the third distance D3 (see figure 1a). Hence, the second protruding element 4 may be positioned further away from the second end 2b of the tube shaped body in the second position p2 than in the first position p1. The shown second position p2, the second and fourth distance D2, D4, respectively, are for illustrative purposes only, since other position(s) are imaginable. In another embodiment, the second position p2 of the second protruding element 4 may be located closer to the second end 2b of the tube shaped body or closer to the first protruding element 3.
Figures 2a, 2b schematically show a side view of a tracheoesophageal voice prosthesis 1 according to the invention which is inserted in a tracheoesophageal puncture 12 or fistula tract 12. The tracheoesophageal voice prosthesis 1 can be inserted in the tracheoesophageal puncture 12 via a tracheostomy 17. The tracheostomy 17 is an opening in the neck (not shown) and the anterior side of the trachea wall 13. The tracheoesophageal puncture 12 is an opening between the posterior side of the trachea wall 14 and the anterior side of the oesophagus wall 15. The posterior side of the oesophagus wall 16 is free from an opening. During insertion, the first end 2a of the tube shaped body 2 of the tracheoesophageal voice prosthesis 1 is passed through the trachea 10 via the tracheostomy 17. The first end 2a of the tube shaped body and the first protruding element 3 are passed through the tracheoesophageal puncture 12 or fistula tract 12, such that at least the first protruding element 3 is located in the oesophagus 11. The posterior side of the oesophagus wall 16 is preferably free from contact with the tracheoesophageal voice prosthesis 1. The first protruding element 3 is preferably made from a flexible material such that the first protruding element 3 can (temporarily) elastically deform, such that the first protruding element 3 can relatively easily pass through the tracheoesophageal puncture 12 or fistula tract 12. The first protruding element 3 may at least (temporarily) elastically deform in a direction towards the second end 2b of the tube shaped body 2. The second protruding element 4 is passed through the tracheostomy 17 into the trachea 10. The second protruding element 4 does not pass the tracheoesophageal puncture 12 or fistula tract 12, but stays in the trachea 10. The tracheoesophageal voice prosthesis 1 comprises an one-way-valve 9 on the first end 2a of the tube shaped body 2, in particular on the first protruding element 3. The one-way-valve 9 is configured for allowing air to passage from the second end 2b to the first end 2a. The one-way-valve 9 is preferably configured to block passaging of fluid from the first end 2a to the second end 2b of the tube shaped body 2. It is imaginable that the length of the tube shaped body 2 can be shortened once the tracheoesophageal voice prosthesis 1 is inserted for example by means of cutting.
Figure 2a shows the second protruding element 4 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. The second protruding element 4 of the shown embodiment is located in the trachea 10 at a distance from the trachea walls
13, 14. The second protruding element 4 is configured to be displaced along the longitudinal axis of the tube shaped body 2. The first protruding element 3 of the shown embodiment is located in the oesophagus 11 at a distance from the oesophagus walls 15, 16. The shown first position p1 and the first distance D1 are shown for illustrative purposes only, since other position(s) are imaginable. In another embodiment, the first position p1 of the second protruding element 4 may be located closer to the second end 2b of the tube shaped body 2 or closer to the first protruding element 3.
Figure 2b shows the second protruding element 4 provided in a second position p2 located at a second distance D2 from the first protruding element 3. The second distance D2 is smaller than the first distance D1. In the shown embodiment, the second protruding element 4 makes contact with the trachea wall 14. The second protruding element 4 has not passed through the tracheoesophageal puncture 12 or fistula tract 12. The first protruding element 3 makes contact with the oesophagus wall 15. In particular, the first protruding element 3 is located at the opposite side of the tracheoesophageal puncture 12with respect to the second protruding element 4. Preferably, the first protruding element 3 and the second protruding element make contact with the tissue around the tracheoesophageal puncture 12to keep the tracheoesophageal voice prosthesis 1 in place. Therewith, the tracheoesophageal voice prosthesis 1 limits, preferably circumvents, leakage.
Optionally, the second protruding element 4 can be displaced from the second position p2 to the first position pt to increase the distance between the first protruding element 3 and the second protruding element 4. This is beneficial in case the tissue of and/or around the tracheoesophageal puncture 12is irritated and/or swells, preferably to decrease pressure on the tissue of and/or around the tracheoesophageal puncture 12 or fistula tract 12. Preferably, the first protruding element 3 is fixed on the first end 2a of the tube shaped body 2. Hence, the first protruding element 3 is not displaceable along the longitudinal axis of the tube shaped body 2. The shown second position p2 and the second distance D2 are for illustrative purposes only, since other position(s) are imaginable. In another embodiment, the second position p2 of the second protruding element 4 may be located closer to the second end 2b of the tube shaped body or closer to the first protruding element 3.
Figures 3a-3d schematically show different components of the tracheoesophageal voice prosthesis according to the present invention. Figure 3a schematically shows a side view of the tube shaped body 2 and figure 3b schematically shows a perspective view of the tube shaped body 2. A first protruding element 3 is arranged at the first end 2a of the tube shaped body 2. The first protruding element 3 comprises an opening 3a, such that air can passage through the tube shaped 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 equals the size of the first end 2a of the tube shaped body 2. Optionally, the size of the opening 3a is smaller than the size of the first end 2a of the tube shaped body. The first protruding element 3 of the shown embodiment further comprises a receiving space 30 configured to receive at least a part of an one-way-valve 9. The receiving space 30 is preferably configured to receive at least a part of a frontal side F of the one-way-valve 9, more preferably an entire frontal side F of the one-way-valve 9.
Figure 3c shows an enlarged view of the first protruding element 3. The first protruding element 3 has rounded or curved edges. The shown first protruding element 3 has a substantially ellipsoidal shape. An upper side of the first protruding element 3 comprises a hollow space 18 or a recessed portion 18. At least a part of the one-way-valve 9 may be connected to or inserted in the hollow pace or the recessed portion 18. Optionally, the one-way-valve 9 comprises a protruding element (not shown) for connecting the one-way-valve 9 to the first protruding element 3, in particular to the hollow space or recessed portion 18. The hollow space or recessed portion 18 may be configured to receive an adhesive to adhere a side of the one-way-valve 9 to the hollow space or recessed portion 18, in particular the protruding portion of the one-way-valve 9. The point where the one- way-valve 9 and the first protruding element 3 are connected may form a connection point of the one-way-valve 9 and the first protruding element 3. Aside from the connection point, the one-way-valve 9 may not be connected to the first protruding element 3 or the tube shaped body 2. Therewith, the one-way-valve 9 may swivel or pivot around the connection point, in particular 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 tube shaped body 2. In the open position, the one-way-valve 9 makes an angle with respect to the first protruding element 3 to allow air to passage from the second end 2b to the first end 2a of the tube shaped body 2. in the open position,
the one-way-valve 9 is directed away from the tube shaped body 2 and from the first protruding element.
Figure 3d shows a frontal view of an embodiment of the one-way-valve 9 according to the invention. The dimensions of the one-way-valve 9 preferably correspond to the receiving space 30 of the first protruding element 3. The one- way-valve 9 may comprises at least one strengthening rib 19. In the shown embodiment, the one-way-valve 9 comprises two strengthening ribs 19. The strengthening ribs 19 are configured to strengthen the one-way-valve 9. The shown strengthening ribs 19 are preferably provided on the frontal side F of the one-way- valve 9. The shown strengthening ribs 19 have an equal length. It is, however, imaginable that the dimensions, such as the length, of the on the one-way-valve applied strengthening ribs 19 differ from each other.
Figure 4 schematically shows a perspective view of the tube shaped body 2 on the left and an one-way-valve 9 on the right according to the present invention. The tube shaped body 2 comprises on the first end 2a a first protruding element 3. The first protruding element 3 comprises a hollow space 18 or a recessed portion 18.
The one-way-valve 9 comprises a protruding element 20 or a fastening element 20 complementary to the hollow space 18 or recessed portion 18 for connecting the one-way-valve 9 to the first protruding element 3. This may be done with or without the application of an adhesive to and/or in the hollow space 18 or recessed portion 18 and/or to the one-way-valve 9. Preferably, the fastening element 20 is first inserted in the hollow space 18, whereafter an adhesive is applied in the hollow space 18. The adhesive is preferably at least partially applied in the hollow space 18 on a side of the first protruding element 3 facing the second end 2b of the tube shaped body 2.
In addition to or instead of attaching the one-way-valve 9 to the first protruding element, a primary one-way-valve 9 may be connected to the tube shaped body 2. The tube shaped body 2 may comprise a primary hollow space 21 or a primary recessed portion 21 complementary to a protruding element 20 or a fastening element 20 of a primary one-way-valve 9. The primary one-way-valve 9 may be connected to the tube shaped body 2 with or without the application of an adhesive to and/or in the primary hollow space 21. Preferably, the protruding element 20 of the primary one-way-valve 9 is firstly inserted in the primary hollow space 21, whereafter an adhesive is applied in the secondary hollow space 21.
Figure 5 schematically shows a side view of an embodiment of an insertion device 40 according to the present invention. The insertion device 40 comprises an elongated body 41. Preferably, the elongated body 41 is longer than it is width. In the shown embodiment, the elongated body 41 may be divided in three portions 41a, 41b, 41c. The length of the first 41a and third portion 41c of the elongated body 41 are smaller than the length of the second portion 41b. The second portion 41b is located in between the first portion 41a and the second portion 41c. The second portion 41b is wider than the first portion 41a and the third portion 41c. The first portion 41a and the third portion 41c of the shown embodiment each comprise a transition area 41d. The transition area 41d is downwardly inclined in a direction away from the second portion 41b. The transition area 41d provides a transition from the second portion 41b to the first portion 41a and the third portion 41c. The transition area 41d allows for a relatively low resistance upon insertion in and/or removal from the tube shaped body of the tracheoesophageal voice prosthesis. At least one end side 42, 43 of the elongated body 41 comprises a brush 44 or a brushed portion. In the shown embodiment, the end side 42 of the first portion 41a comprises a brush 44. The brush 44 allows cleaning of the interior of the tube shaped body of the tracheoesophageal voice prosthesis. The elongated body 41 preferably has a higher stiffness than at least a part of the tracheoesophageal voice prosthesis, in particular of the tube shaped body, such that it can support the tracheoesophageal voice prosthesis upon insertion in a tracheoesophageal puncture or a fistula tract.
Figure 6 schematically shows a side view of an alternative embodiment of an insertion device 60 according to the present invention. The insertion device 60 comprises a hollow body 61 configured to receive at least part of a tracheoesophageal voice prosthesis to be inserted in a tracheoesophageal puncture. The shown insertion device 60 is configured to guide at least a part of the tracheoesophageal voice prosthesis. The shown insertion device 60 has a tapered first end side 62 configured to guide at least a first protruding element of a tracheoesophageal voice prosthesis to, preferably through, the tracheoesophageal puncture. The end sides 62, 63 of the hollow body 61 are preferably open ends. A tracheoesophageal voice prosthesis may pass through the hollow body 61 between a first end 62 and a second end 63. A tracheoesophageal voice prosthesis is preferably inserted in the hollow body 61, wherein the first end of the tube shaped body of the tracheoesophageal voice prosthesis is provided at a first end side 62 of the hollow body 61 and the second end of the tube shaped body of the tracheoesophageal voice prosthesis is provided at a second end side 63 of the hollow body 61 of the insertion device 60. Once the insertion device 61 is close to or provided in the tracheoesophageal puncture, the insertion device 60 and the tracheoesophageal voice prosthesis can be mutually displaced, in particular such that the tracheoesophageal voice prosthesis displaces posterior in a direction towards the tracheoesophageal puncture and/or the insertion device 60 moves distally in a direction away from the tracheoesophageal puncture. Optionally, the insertion device 60 is configured to be displaced the along the longitudinal axis of the tube shaped body. In particular, the insertion device 60 can be displaced along the longitudinal axis of the tube shaped body from the first end to the second end and/or in a distal direction from the tracheoesophageal puncture. At least a first protruding element of a tracheoesophageal voice prosthesis passes through the tracheoesophageal puncture.
The above described figures are meant for illustrative purposes and are not limitative to the invention as claimed in the following claims. It is conceivable that individual inventive concepts may be applied without, in so doing, also applying other details of the described example. It is not necessary to elaborate on examples of all conceivable combinations of the above-described inventive concepts, as a person skilled in the art will understand numerous inventive concepts can be (re)combined in order to arrive at a specific application.
It will be apparent that the invention is not limited to the working examples shown and described herein, but that numerous variants are possible within the scope of the attached claims that will be obvious to a person skilled in the art.
The verb “comprise” and conjugations thereof used in this patent publication are understood to mean not only “comprise”, but are also understood to mean the phrases “contain”, “substantially consist of”, “formed by” and conjugations thereof.

Claims (29)

ConclusiesConclusions 1. Tracheoesofageale stemprothese, omvattende: - een buisvormig lichaam, omvattende: o een eerste eind en een tweede eind, o een longitudinale as die zich uitstrekt in een longitudinale richting van het buisvormige lichaam, en o een éénrichtingsklep ingericht voor het selectief doorvoeren van lucht tussen het tweede eind en het eerste eind, - een eerste uitstekend element dat in een loodrechte richting op de longitudinale as uitsteekt en is aangebracht aan het eerste eind van het buisvormige lichaam, en - een tweede uitstekend element dat in een loodrechte richting op de longitudinale as uitsteekt en een opening omvat voor het doorvoeren van ten minste een deel van het buisvormige lichaam, - waarbij het eerste uitstekende element en het tweede uitstekende element zijn ingericht voor het op zijn plek houden van de tracheoesofageale stemprothese wanneer ingebracht in een tracheoesofageale punctie, waarbij het tweede uitstekende element verplaatsbaar is langs de longitudinale as van het buisvormige lichaam, ten minste tussen: o een eerste positie, waarbij het tweede uitstekende element is aangebracht op een buitenoppervlak van het buisvormige lichaam op een eerste afstand van het eerste uitstekende element, en o een tweede positie, waarbij het tweede uitstekende element is aangebracht op het buitenoppervlak van het buisvormige lichaam op een tweede afstand van het eerste uitstekende element, waarbij de tweede afstand kleiner is dan de eerste afstand, waarbij ten minste een deel van het buitenoppervlak van het buisvormige lichaam en/of ten minste een deel van het tweede uitstekende element een koppelelement omvat ingericht voor het koppelen van het tweede uitstekende element en het buisvormige lichaam ten minste in de eerste positie en de tweede positie.1. Tracheoesophageal voice prosthesis, comprising: - a tubular body, comprising: o a first end and a second end, o a longitudinal axis extending in a longitudinal direction of the tubular body, and o a one-way valve adapted to selectively pass 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 passing at least a portion of the tubular body, - the first protruding element and the second protruding element being adapted to retain the tracheoesophageal voice prosthesis in place when inserted into a tracheoesophageal puncture, the second protruding element being movable along the longitudinal axis of the tubular body at least between: o a first position, the second protruding element being arranged at an outer surface of the tubular body at a first distance from the first protruding element, and o a second position, the second protruding element being disposed on the outer surface of the tubular body at a second distance from the first protruding element, the second distance being less 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 coupling member adapted to couple the second protruding element and the tubular body at least in the first position and the second position. 2. Tracheoesofageale stemprothese volgens conclusie 1, waarbij het tweede uitstekende element schuifbaar is langs de longitudinale as van het buisvormige lichaam.2. The tracheoesophageal voice prosthesis of claim 1, wherein the second projecting element is slidable along the longitudinal axis of the tubular body. 3. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het tweede uitstekende element roteerbaar is rond de longitudinale as van het buisvormige lichaam.A tracheoesophageal voice prosthesis according to any preceding claim, wherein the second projecting element is rotatable about the longitudinal axis of the tubular body. 4. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de opening van het tweede uitstekende element een gesloten vorm heeft.4. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the opening of the second protruding element has a closed shape. 5. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de opening van het tweede uitstekende element een open vorm heeft.5. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the opening of the second protruding element has an open shape. 6. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij ten minste een deel van de opening van het tweede uitstekende element een koppelelement omvat.6. A tracheoesophageal voice prosthesis according to any preceding claim, wherein at least a portion of the opening of the second projecting element comprises a coupling element. 7. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het koppelelement op ten minste een deel van het buitenoppervlak van het buisvormige lichaam gevormd wordt door een geribbeld deel.7. Tracheoesophageal voice prosthesis according to any one of the preceding claims, wherein the coupling element is formed on at least a part of the outer surface of the tubular body by a ribbed portion. 8. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij ten minste een deel van het koppelelement een schroefdraaddeel omvat.8. A tracheoesophageal voice prosthesis according to any preceding claim, wherein at least part of the coupling element comprises a threaded portion. 9. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste uitstekende element op het eerste eind van het buisvormige lichaam gefixeerd is.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. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de breedte van het eerste uitstekende element ten minste de breedte van een opening in een oesophaguswand van een tracheoesofageale punctie overschrijdt.10. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the width of the first protruding element at least exceeds the width of an opening in an esophageal wall of a tracheoesophageal puncture. 11. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de breedte van het tweede uitstekende element ten minste de breedte van een opening in een tracheawand van een tracheoesofageale punctie overschrijdt.A tracheoesophageal voice prosthesis according to any preceding claim, wherein the width of the second protruding element at least exceeds the width of an opening in a tracheal wall of a tracheoesophageal puncture. 12. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste uitstekende element en/of het tweede uitstekende element een gekromde rand omvat.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. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste uitstekende element een flens is.A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first protruding element is a flange. 14. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het tweede uitstekende element een flens is.A tracheoesophageal voice prosthesis according to any preceding claim, wherein the second protruding element is a flange. 15. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de lengte van het buisvormige lichaam groter is dan zijn breedte.15. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the length of the tubular body is greater than its width. 16. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het buisvormige lichaam cilindrisch of ellipsoïde gevormd is.16. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the tubular body is cylindrical or ellipsoidal in shape. 17. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het buisvormige lichaam veelvlakvormig is.17. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the tubular body is polyhedral. 18. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste eind en het tweede eind van het buisvormige lichaam open einden zijn om lucht door te laten tussen het tweede eind en het eerste eind.18. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the first end and the second end of the tubular body are open ended to allow air to pass between the second end and the first end. 19. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de éénrichtingsklep ten minste gedeeltelijk is aangebracht tussen het eerste eind en het tweede eind van het buisvormige lichaam.19. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is at least partially disposed between the first end and the second end of the tubular body. 20. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de éénrichtingsklep ten minste gedeeltelijk is aangebracht aan het eerste eind van het buisvormige lichaam.20. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is at least partially disposed at the first end of the tubular body. 21. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de éénrichtingsklep ten minste gedeeltelijk met het eerste uitstekende element verbonden is.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. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de éénrichtingsklep aan het buisvormige lichaam en/of aan het eerste uitstekende element is gehecht.22. A tracheoesophageal voice prosthesis according to any preceding claim, wherein the one-way valve is attached to the tubular body and/or to the first protruding element. 23. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste uitstekende element een ontvangstruimte omvat voor het ontvangen van een zijde van de éénrichtingsklep, in het bijzonder een frontale zijde van de éénrichtingsklep.23. Tracheoesophageal voice prosthesis according to any of the preceding claims, wherein the first protruding element comprises a receiving space for receiving a side of the one-way valve, in particular a frontal side of the one-way valve. 24. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij de éénrichtingsklep ten minste één, bij voorkeur ten minste twee, verstevigingsribben omvat, voor het verstevigen van de klep.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 for reinforcing the valve. 25. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, waarbij het eerste uitstekende element ten minste gedeeltelijk uit een flexibel materiaal is vervaardigd om het inbrengen van het eerste uitstekende element door een tracheoesofageale punctie toe te staan.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 insertion of the first protruding element through a tracheoesophageal puncture. 26. Tracheoesofageale stemprothese volgens één van de voorgaande conclusies, omvattende ten minste één markering voor het aangeven van een oriëntatie van inbrenging van de tracheoesofageale stemprothese in een tracheoesofageale punctie.26. A tracheoesophageal voice prosthesis according to any preceding claim, comprising at least one marking for indicating an orientation of insertion of the tracheoesophageal voice prosthesis in a tracheoesophageal puncture. 27. Inbrenginrichting voor het inbrengen van een tracheoesofageale stemprothese volgens één van de voorgaande conclusies, omvattende een langwerpig lichaam geschikt om ingebracht te worden in het buisvormige lichaam voor het steunen en/of geleiden van de tracheoesofageale stemprothese bij het inbrengen in een tracheoesofageale punctie.27. An insertion device for inserting a tracheoesophageal voice prosthesis according to any one of the preceding claims, comprising an elongated body adapted to be inserted into the tubular body for supporting and/or guiding the tracheoesophageal voice prosthesis during insertion into a tracheoesophageal puncture. 28. Inbrenginrichting volgens conclusie 27, waarbij het langwerpige lichaam een hogere stijfheid heeft dan het buisvormige lichaam van de tracheoesofageale stemprothese, bij voorkeur waarbij het langwerpige lichaam een hogere stijfheid heeft van de tracheoesofageale stemprothese.28. An insertion device according to claim 27, wherein the elongated body has a higher stiffness than the tubular body of the tracheoesophageal voice prosthesis, preferably wherein the elongated body has a higher stiffness than the tubular body of the tracheoesophageal voice prosthesis. 29. Inbrenginrichting volgens één van de conclusies 27-28, waarbij ten minste één uiteinde van het langwerpige lichaam een borstel omvat voor het schoonmaken van het buisvormige lichaam, in het bijzonder een deel van de binnenzijde van het buisvormige lichaam.29. An insertion device according to any one of claims 27 to 28, wherein at least one end of the elongated body comprises a brush for cleaning the tubular body, in particular a part of the inside of the tubular body.
NL2037354A 2024-03-28 2024-03-28 Tracheoesophageal voice prosthesis and an insertion device for inserting such a tracheoesophageal voice prosthesis NL2037354B1 (en)

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NL2037354A NL2037354B1 (en) 2024-03-28 2024-03-28 Tracheoesophageal voice prosthesis and an insertion device for inserting such a tracheoesophageal voice prosthesis
CN202510294684.9A CN120661277A (en) 2024-03-28 2025-03-13 Tracheoesophageal sounding prosthesis and insertion device for inserting such a tracheoesophageal sounding prosthesis

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4614516A (en) * 1982-04-30 1986-09-30 Hansa Medical Products, Inc. Voice prosthesis device
US4911716A (en) * 1982-04-30 1990-03-27 Hansa Medical Products, Inc. Surgical implant for a voice prosthesis
EP1736119A2 (en) * 2005-06-06 2006-12-27 Helix Medical, Inc. Voice prosthesis device
US20090054979A1 (en) * 2005-09-23 2009-02-26 Protip Sas Phonatory Implant
US20120046690A1 (en) * 2009-05-06 2012-02-23 Hansa Medical Products, Inc. Self-adjusting medical device
FR3079740A1 (en) * 2018-04-04 2019-10-11 Remi Nay DEVICE FOR CLEANING A PHONATORY IMPLANT

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4614516A (en) * 1982-04-30 1986-09-30 Hansa Medical Products, Inc. Voice prosthesis device
US4911716A (en) * 1982-04-30 1990-03-27 Hansa Medical Products, Inc. Surgical implant for a voice prosthesis
EP1736119A2 (en) * 2005-06-06 2006-12-27 Helix Medical, Inc. Voice prosthesis device
US20090054979A1 (en) * 2005-09-23 2009-02-26 Protip Sas Phonatory Implant
US20120046690A1 (en) * 2009-05-06 2012-02-23 Hansa Medical Products, Inc. Self-adjusting medical device
FR3079740A1 (en) * 2018-04-04 2019-10-11 Remi Nay DEVICE FOR CLEANING A PHONATORY IMPLANT

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