A tool and a kit of parts for measuring a thickness of a tracheoesophageal wall in a patient

Abstract

A tool and a kit of parts for measuring a thickness of a tracheoesophageal wall in a patient.

Description

[0001] A TOOL AND A KIT OF PARTS FOR MEASURING A THICKNESS OF A TRACHEOESOPHAGEAL WALL IN A PATIENT

[0002] A tool and a kit of parts for measuring a thickness of a tracheoesophageal wall in a patient is provided.

[0003] Background

[0004] A total laryngectomy is a surgery performed in the advanced stages of laryngeal cancer. The procedure involves removing the voice box or larynx. After a laryngectomy, breathing happens via an opening in the neck instead of the nose and mouth as there is no longer a connection between the lungs and nose and mouth. Therefore, a neck stoma is created for respiration. To enable speech, the patient can have a puncture created between the esophagus (foodpipe) and the trachea (windpipe). This is done by performing a tracheoesophageal puncture (TEP) procedure. A small hole or puncture is created in the tissue between the trachea and the esophagus, thus called a tracheoesophageal puncture. This can either be done at the time of the total laryngectomy surgery or during a second subsequent surgical procedure.

[0005] In most cases, a suitable device including a one-way valve is inserted in the TEP already during the laryngectomy procedure. Such a device may be known as a voice prosthesis. The one-way valve of the voice prosthesis protects the airway during swallowing but opens under positive pressure on the tracheal side. The voice prosthesis thereby permits a patient to divert air from the lungs into the esophagus and out through the mouth. Speech is created during passage of air through the upper part of the esophagus. The voice prosthesis maintains the puncture open, transfers air from the trachea to the esophagus for voice (speech) production and prevents esophageal leakage into the trachea during swallowing. Safe retention of the voice prosthesis is achieved by the oesophageal and tracheal flanges. The oesophageal flange is placed into the oesophagus, the tracheal flange is placed in the trachea. In order to prevent leakage of food and saliva into the trachea voice prostheses have a one-way valve that opens in the direction of the oesophagus. The characteristics of a good and well-functioning voice prosthesis for the individual user depend on anatomy and physiology of the user. One important parameter is the length of the voice prosthesis that should correspond best possible to a thickness of tracheoesophageal wall.

[0006] Users of voice prostheses and health care professionals alike would welcome improvements in devices for determining and measuring parameters relevant for selecting an optimal voice prosthesis for the individual user.

[0007] Summary

[0008] In one aspect, the present disclosure provides a tool for measuring a thickness of a tracheoesophageal wall in a patient is provided. In another aspect, the disclosure relates to a kit of parts including a tool for measuring a thickness of a tracheoesophageal wall in a patient as described herein. The aspects are further defined by the appended claims.

[0009] Brief Description of the Drawings

[0010] The accompanying drawings are included to provide a further understanding of implementations and are incorporated in and constitute a part of this specification. The figures illustrate implementations and together with the description explain principles of implementations. Other implementations and many of the intended advantages of all implementations will be readily appreciated as they become better understood by reference to the following detailed description.

[0011] Various exemplary implementations and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the implementations. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated implementation needs not have all the effects or advantages shown. An effect or an advantage described in conjunction with a particular implementation is not necessarily limited to that implementation and may be practiced in other implementations even if not so illustrated, or if not so explicitly described.

[0012] The figures can be listed as follows:

[0013] Figure 1A is a schematic view illustrating one implementation of a tool for measuring a thickness of a tracheoesophageal wall in a patient.

[0014] Figure IB is a schematic view illustrating one implementation of a tool for measuring a thickness of a tracheoesophageal wall in a patient.

[0015] Figure 2A is a schematic, cross-sectional view of one implementation of a tool for measuring a thickness of a tracheoesophageal wall in a patient.

[0016] Figure 2B is a schematic perspective view illustrating one implementation of a conduit element of a measuring tool for measuring a thickness of a tracheoesophageal wall in a patient located through a tracheoesophageal puncture of a patient.

[0017] Figures 3A-3C are schematic, sectional views of one implementation of the measuring tool showing a detail thereof.

[0018] Figure 4 is a schematic, perspective view of one implementation of the measuring tool.

[0019] Figure 5 is a schematic, perspective view of one implementation of the measuring tool.

[0020] Figure 6 is a schematic, perspective sectional view illustrating one implementation of a measuring tool positioned in a tracheoesophageal wall of a patient.

[0021] Figures 7-9 illustrate schematic, perspective views of implementations of the measuring tool.

[0022] Figure 10 is an enlarged schematic sectional view of one implementation of the measuring tool of the disclosure.

[0023] Figure 11 is a schematic, cross-sectional view of a model of a head and neck portion of a laryngectomized patient having a voice prosthesis VP inserted in the tracheoesophageal wall TW between the trachea TR and the oesophagus OE.

[0024] Figure 12 is a schematic plan view of a kit of parts including a measuring tool according to the disclosure. Detailed Description

[0025] In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific implementations in which the invention may be practiced. In this regard, directional terminology, such as "top," "bottom," "front," "back," "leading," "trailing," etc., is used with reference to the orientation of the Figure(s) being described. Because components of implementations can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is not necessarily limiting. It is to be understood that other implementations may be utilized, and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0026] It is to be understood that individual features of the various exemplary implementations described herein may be combined with each other, unless specifically noted otherwise.

[0027] In this disclosure, a subject using the tool may be referred to as "patient" or "user". However, in some cases, "user" can also relate or refer to a health care professional (HCP), such as a doctor / physician / clinician, nurse, or other person.

[0028] In this disclosure, 'axially' or 'axial direction' should generally be considered as being along or parallel to a described longitudinal axis of a thing. The radial direction should be understood as being at an angle to the axial direction. In some sentences, the words "inner" and "outer" can be used. These qualifiers should generally be perceived with reference to the radial direction, such that a reference to an "outer" element means that the element is generally farther away from a centre portion of a component than an element referenced as "inner". In addition, "innermost" should be interpreted as the portion of a component forming a centre of the component and / or being adjacent to the centre of the component. In analogy, "outermost" should be interpreted as a portion of a component forming an outer edge or outer contour of a component and / or being adjacent to that outer edge or outer contour. In further analogy this is also the case regarding the use of the words "upper" / "lower" and "uppermost" / "lowermost". In the following, when referring to proximal end of a thing or portion of a thing, the referral is to an end or portion configured for insertion into a user's body, such as through a tracheostoma. Likewise, when referring to the distal end of a thing or portion of a thing, the referral is to the end opposite the proximal (insertion) end, the distal end or portion typically configured for being outside or external to a user's body. In some regards, the use of the wording proximal / distal may also address some part or portion of a thing which is closer to, respectively farther away, from the user's body (e.g. skin surface) at least in use of the thing.

[0029] The use of phrases such as (but not limited to) "substantially" and "approximately" as qualifiers of certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

[0030] The use of the word "generally" as a qualifier to certain features or effects in this disclosure is intended to mean - for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and - for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally some outcomes may not provide the effect.

[0031] The phrase "adjacent" should be interpreted as being "close to and / or in contact with [something]."

[0032] In the present disclosure, the 'larynx' or 'voice box', is to be understood as the part of the respiratory (breathing) tract containing the vocal cords which produce sound. A total laryngectomy means the surgical removal of the larynx and separation of the airway from the mouth, nose, and esophagus. A tracheostoma (or -stoma) is a hole (opening) made in the skin in the front of the neck to allow breathing. The stoma is made at the base of the neck. Air goes in and out of the trachea and lungs through this hole.

[0033] In a first aspect, the present disclosure relates to a tool for measuring a thickness of a tracheoesophageal wall in a patient. The tool includes a flexible housing including a conduit element extending along a longitudinal axis between a distal end portion and a proximal end portion. The flexible housing includes a substantially perpendicularly extending oesophageal flange adjacent to the proximal end portion. The flexible housing of the tool includes at least a first group of measurement indicia provided along an external surface of the conduit element distal to the oesophageal flange.

[0034] The measuring tool includes a rigid inserter pin having a proximal portion and a distal portion. The rigid inserter pin is adapted to fit and move inside the conduit element. The proximal portion of the rigid inserter pin is configured for engagement with the proximal end portion of the conduit element.

[0035] The proximal end portion of the conduit element includes an internal volume. The internal volume of the proximal end portion of the conduit element is configured to receive the proximal portion of the rigid inserter pin.

[0036] The proximal end portion of the conduit element is configured to collapse when the flexible housing is subjected to a pull-out force with the proximal portion of the rigid inserter pin being disengaged from the internal volume of the proximal end portion of the conduit element.

[0037] In a first approach to measuring the thickness of the tracheoesophageal wall of a patient with the tool according to the first aspect the rigid inserter pin is inserted into the distal end portion of the conduit element of the flexible housing (which in use of the tool is the end of the tool typically located external of the patient's tracheostoma). The proximal portion of the rigid inserter pin is then brought into engagement with the proximal end portion of the conduit element. It is understood that the proximal portion of the rigid inserter pin is received in the internal volume of the proximal end portion of the conduit element inside the flexible housing. The proximal portion of the rigid inserter pin engages one or more portions of an inner wall at the proximal end portion of the conduit element. In implementations, the proximal portion of the rigid inserter pin substantially fills up the internal volume of the proximal end portion of the conduit element.

[0038] Next, the flexible housing with the rigid inserter pin located inside the conduit element can be inserted through the tracheostoma in the patient's neck and further inserted through the tracheoesophageal puncture (TEP) in the tracheoesophageal wall such that the proximal end portion of the conduit element including the substantially perpendicularly extending oesophageal flange is located in the oesophagus. The nature of the flexible housing further helps ensure that the proximal end portion of conduit element including the oesophageal flange can be inserted through the TEP with a minimum of discomfort to the patient. The oesophageal flange is easily pliable due to the flexibility of the material of the flexible housing, said material also forming the substantially perpendicularly extending oesophageal flange. Once the proximal end portion of the conduit element is located in the oesophagus, the clinician can make a very gentle movement of the flexible housing in the distal (or removal) direction of the tool from the patient, whereby a distal surface of the substantially perpendicularly extending oesophageal flange is brought into contact with the tissue at the oesophageal side of the tracheoesophageal wall. It is understood that during these steps the distal end portion of the conduit element can be located outside the tracheostoma and thus external of the patient.

[0039] The clinician is now able to determine a thickness of the tracheoesophageal wall by checking the value of that particular indicator of the first group of measurement indicia (on the external surface of the conduit element) which is closest to, and visible on, the tracheal side of the tracheoesophageal wall. The clinician can read off the relevant value of the first group of measurement indicia in the tracheostoma and thereby determine the relevant thickness of the tracheoesophageal wall measured with the tool. The at least first group of measurement indicia suitably includes a plurality of individual indicators having each their value. In suitable implementations, the first group of measurement indicia includes a scale divided into steps of for example one millimetre length or steps of one eighth of an inch length or one quarter of an inch length. Other lengths between the steps of a scale of steps are acceptable. In implementations, the measurement indicia can additionally or alternatively include lines wholly or partially circumscribing the conduit element, such as including one line per step value. In implementations, the measurement indicia can be provided and further visibly enhanced on the external surface of the conduit element by using a colour that is high in contrast to the substrate material of the conduit element (i.e., the material of the flexible housing of the tool). The determination of the parameter 'thickness' of the tracheoesophageal wall can then be used by the clinician to select the best fitting option with respect to the length of the voice prosthesis to be inserted in the TEP.

[0040] To remove the tool from the patient again after having carried out the measurement and determination of the thickness of the oesophageal wall, the clinician can then pull the rigid inserter pin slightly in the distal direction (and relative to the conduit element which is kept steady), such that the proximal portion of the rigid inserter pin withdraws from engagement with one or more portions of the inner wall at the internal volume of the proximal end portion of the conduit element. The space of the internal volume inside the proximal end portion of the conduit element is then no longer taken up by the proximal portion of the rigid inserter pin.

[0041] By subjecting the flexible housing to a pull-out force (i.e., when the clinician desires to remove the measuring tool from the patient and gently pulls the flexible housing in the distal direction out of the TEP and further out of the tracheostoma), with the proximal portion of the rigid inserter pin being disengaged from the internal volume of the proximal end portion of the conduit element, the now-empty space of the internal volume of the proximal end portion of the conduit element can collapse. Particularly, the collapsibility of the proximal end portion advantageously provides room for the body of material of the oesophageal flange of the conduit element to easily deflect and / or stretch as a consequence of the pull-out force being applied and thus the oesophageal flange and the proximal end portion gently slips through the TEP with little or no resistance to the movement, thereby greatly reducing or even eliminating the discomfort known to be experienced by patients during removal when some of the measurement tools for voice prostheses currently available in the market are used. In implementations, this advantageous effect can be further enhanced in combination with adaptation of the flexible nature of the material of the flexible housing. The presently disclosed tool provides a measurement tool that greatly reduces the force or stress that the puncture (TEP) in the tracheoesophageal wall is subjected to during removal while not affecting the sturdiness (or stiffness) of the tool during insertion, which sturdiness is a characteristic desired by clinicians for ease of placement of the tool in the patient as the sturdiness gives the clinician more control and thus a better feel for correctly locating the tool.

[0042] In implementations, the proximal end portion of the conduit element is configured such that a movement of the rigid inserter pin in a range of l-10mm, such as approximately 5mm in the distal direction is sufficient to create enough free space for the proximal end portion of the conduit element to collapse and provide the described beneficial effects during removal.

[0043] In implementations, the measuring tool includes a first group and a second group of measurement indicia, the second group provided on the external surface of the conduit element distal to the first group, and further includes a measuring sleeve of shorter longitudinal extent than the conduit element and adapted to fit over and slide along the external surface of the conduit element and adapted to allow checking of the second group of measurement indicia.

[0044] Accordingly, in a second approach to measuring a thickness of the tracheoesophageal wall, the conduit element of the flexible housing can be located in the TEP with the oesophageal flange brought into contact with the oesophageal side of the tracheoesophageal wall in the same manner as described above, but contrary to the above the clinician does not read off the thickness of the tracheoesophageal wall in the tracheostoma. Instead, the clinician fits the measuring sleeve over the external surface of the conduit element by firstly mounting a proximal end portion of the measuring sleeve over the distal end portion of the conduit element and then slide the measuring sleeve along the external surface of the conduit element through the tracheostoma until the clinician determines that the proximal end portion of the measuring sleeve contacts the tracheal side of the tracheoesophageal wall. It should be understood that, alternatively, the measuring sleeve can be fitted over the external surface of the conduit element already before the flexible housing with the rigid inserter pin inside it is inserted through the tracheostoma and into the TEP of the patient. Thus, taking the second approach, the tool including the flexible housing including the conduit element, the rigid inserter pin, and the measuring sleeve can be inserted together through the tracheostoma and into the TEP in one step if desired by the clinician. After this "one-step" insertion, the measuring sleeve can then be slid along the external surface of the conduit element until the proximal end portion of the measuring sleeve comes into contact with the tracheal side of the tracheoesophageal wall.

[0045] Still, in accordance with the second approach, when the clinician has established that the tool is located in the TEP and with the proximal end portion of the measuring sleeve in contact with the tracheal side of the tracheoesophageal wall, the second group of measurement indicia provided on the external surface of the conduit element can then combine with a distal end portion of the measuring sleeve to allow the clinician to determine the thickness of the tracheoesophageal wall external of the tracheostoma (outside the patient's body). The clinician does this by reading off the value of the indicator visible closest to the distal end portion of the measuring sleeve. By providing the measuring sleeve with a specific and known length (longitudinal extent), the value of the indicator read off from the second group of measurement indicia on the external surface of the conduit element can either be used for calculation of, or correspond directly to, the thickness of the oesophageal wall between the oesophageal flange of the conduit element and the proximal end portion of the measuring sleeve. The determination of the parameter 'thickness' of the tracheoesophageal wall can then be used by the clinician to select the best fitting option with respect to the length of the voice prosthesis to be inserted in the TEP.

[0046] In implementations, the longitudinal extent of the measuring sleeve corresponds to a distance between a proximal-most indicator value of the first group of measurement indicia and a proximal-most indicator value of the second group of measurement indicia. In such implementations, the thickness parameter of the tracheoesophageal wall is directly determinable by reading off the relevant and proximal-most visible indicator value of the second group of measurement indicia externally of the tracheostoma (i.e., the value can be read off by the clinician on the external surface of the conduit element outside the patient's body), as also described above. This option provides an additional advantage to the clinician as determination of the thickness parameter can be done faster and more conveniently outside the patient's body than when being read in the tracheostoma. Moreover, using the measuring sleeve and reading off the measurement value outside of the tracheostoma further provides additional security against misreading the value.

[0047] In implementations, the proximal end portion of the measuring sleeve includes a substantially perpendicularly extending tracheal flange. The tracheal flange of the proximal end portion of the measuring sleeve can suitably extend substantially perpendicular to the longitudinal axis from an external wall at the proximal end of the measuring sleeve. The tracheal flange provides for a safe and reliable positioning and engagement of the proximal end portion of the measuring sleeve in its contact with the tracheal side of the tracheoesophageal wall. This further helps provide the clinician with a tactile indication of the measuring sleeve being correctly located against the tracheal side of the tracheoesophageal wall.

[0048] In implementations, the first group of measurement indicia provided on the external surface of the conduit element is distanced / spaced from the second group of measurement indicia provided on the external surface of the conduit element by a distance selected in a range of about 10mm - about 40mm, such as 20mm. This provides a clear and intuitive separation between the first and second groups of measurement indicia, thus further prompting the clinician towards selecting between using the measuring sleeve to determine the thickness parameter outside the tracheostoma or not using the measuring sleeve and instead read off the parameter in the tracheostoma.

[0049] The different components of the disclosed measuring tool can suitably be made from polymer-based materials, thereby facilitating the provision of a single-use measuring tool and providing a tool with a high level of patient safety. This includes elimination of cleaning procedures otherwise necessary with tools with re-useable elements to avoid cross-contamination. Further, the provision of the measuring tool as a single-use device reduces or eliminates the possibility for incorrectly re-assembling the components of measuring tools applying one or more re-useable parts. In implementations, the materials for the components of the measuring tool are suitably capable of withstanding relevant sterilization measures / processes that are carried out before packaging the tool in a sterile packaging environment. In implementations, at least the rigid inserter pin is made by an injection moulding process and can include one or more materials such as, but not limited to, thermosetting materials, such as, but not limited to, polypropylene (PP), polyethylene (PE), or polyoxymethylene (POM). Additionally, the measuring sleeve can suitably be made by an injection moulding process (a similar or other process as the rigid inserter pin) and can include one or more materials such as, but not limited to, thermosetting materials, such as, but not limited to, PE, PP, or POM. The flexible housing of the tool including the conduit element can be made by an injection moulding process and can suitably include one or more materials selected from thermoplastic elastomers (TPE) or silicones.

[0050] In implementations, the flexible housing is made from a material having a hardness in the range of 30-80 Shore A. This advantageously provides flexibility to allow stretch and flexibility when the tool is pulled out, while simultaneously providing enough retention force for the clinician to be able to determine the correct location of the oesophageal flange.

[0051] In implementations, the flexible housing includes a thermoplastic elastomer (TPE) or a silicone material. The material can be selected to suitably provide the flexible housing with a flexural modulus adapted to provide a housing that is easily pliable and with low resistance to bending and / or flexing by subjection to external force. Effects of this include that removal of the proximal end portion of the conduit element through the TEP is gentler on the patient compared to existing options.

[0052] In accordance with the first aspect of the disclosure, the flexible housing of the tool includes a conduit element. The flexible housing provides a housing for the conduit element. The conduit element can be understood to include a passage formed inside the flexible housing, e.g., in the form of a pipe- or channel-like corridor. The conduit element extends along a longitudinal axis of the flexible housing. The longitudinal axis of the flexible housing can be understood to be coinciding with and forming a longitudinal axis of the tool as such. The conduit element extends between a distal end portion and a proximal end portion thereof along the longitudinal axis. Adjacent to the proximal end portion the flexible housing includes a substantially perpendicularly extending oesophageal flange. The designator "oesophageal" means that the flange is configured to locate in the oesophagus, i.e., on the oesophageal side of the tracheoesophageal wall during use of the measuring tool. The oesophageal flange extends substantially perpendicularly from the flexible housing, meaning that the flange substantially stretches radially outward from the external surface of the conduit element of the flexible housing. In implementations, the oesophageal flange includes a circular or rounded outer peripheral contour. However, other shapes of the peripheral contour may be acceptable. In implementations, the oesophageal flange includes a circular outer peripheral contour and has a radial extent being selected from a range of about 1mm - about 7mm, such as about 5mm, such as preferably about 3mm. In implementations, the insertion of the tool can advantageously be facilitated by providing a gel capsule on the proximal end portion where the oesophageal flange may be folded forward (proximal direction) and kept tight along the longitudinal axis of the tool until the gel capsule is dissolved (and the oesophageal flange folds out). In implementations, an external longitudinal extent of the proximal end portion of the conduit element corresponds to the length of the portion of the flexible housing which is proximal to the oesophageal flange. In implementations, the external longitudinal extent of the proximal end portion of the conduit element is selected from a range of about 4mm - about 15mm, such as about 7mm.

[0053] In implementations, the conduit element of the flexible housing of the tool can generally be provided in two different sizes. A first type covering an external diameter of the conduit element from size 17 FR to size 20 FR and another type covering an external diameter of the conduit element from size 20 FR to size 22.5 FR. FR (or French size or Charriere (Ch)) is a standard gauge for catheters approximately corresponding to the outer circumference in mm. This gauge is regularly also used for other, different kinds of medical devices with an internal lumen. More accurately, the outer diameter in mm corresponds to the size FR divided by 3. Thus 17 FR corresponds to a conduit element with an outer diameter of 5.7 mm and 22.5 FR corresponds to a conduit element with an outer diameter of 7.5 mm.

[0054] The measuring tool includes a rigid inserter pin having a proximal portion and a distal portion. In implementations, the rigid inserter pin is a relatively rigid component compared to the flexible housing of the tool. The rigid inserter pin is adapted to fit and move inside the conduit element and helps provide adequate stiffness or sturdiness to control the tool during insertion. It is understood that if the tool is too flimsy, insertion through the tracheostoma and further through the TEP becomes cumbersome. In implementations, the rigid inserter pin is provided as a sturdy, solid component (lacking holes or hollow portions). In implementations, the rigid inserter pin has an outer diameter slightly smaller than an inner diameter of the conduit element. The proximal portion of the rigid inserter pin is configured for engagement with the proximal end portion of the conduit element. Thereby it should be understood that the proximal portion of the rigid inserter pin is adapted and / or shaped to engage, such as fittingly engage, with the insides of the conduit element at the proximal end portion thereof. Thus, in implementations, the proximal portion of the rigid inserter pin is shaped to form a tapered end. By providing the proximal portion of the rigid inserter pin (and potentially also providing the internal surface of the proximal end portion of the conduit element with a corresponding tapering) any small retraction of the rigid inserter pin will result in the generation of a clearance along the tapered surface. This is advantageous compared to conventional tools with cylindrically shaped inserter rods where it is needed to completely retract / withdraw the inserter rod from the proximal end of the housing to create clearance. In implementations, the tapered end shape of the proximal portion of the rigid inserter pin is formed as a truncated cone. In implementations, the tapered end shape of the rigid inserter pin is formed as a frustum wherein the truncation plane is parallel to the cone's base. In implementations, the proximal portion of the rigid inserter pin is adapted to be solid. In implementations, the tapered end shape of the proximal portion of the rigid inserter pin is provided by shaping an external surface of the proximal portion of the rigid inserter pin at an oblique angle relative to the longitudinal axis of the tool. In implementations, the tapered end shape of the proximal portion of the rigid inserter pin is achieved by attaching a separate taper-shaped nose component to the proximal portion of the rigid inserter pin. The separate taper-shaped nose component can suitably be formed from a TPE material and can comprise a distal end portion configured for press-fitting engagement with the proximal portion of the rigid inserter pin.

[0055] In implementations, the insides of the conduit element at the proximal end portion thereof are adapted to receive the proximal portion of the rigid inserter pin. Thereby it should be understood that the insides of the conduit element at the proximal end portion thereof and the proximal portion of the rigid inserter pin are adapted to combine in engagement with each other. In implementations, the insides of the conduit element at the proximal end portion thereof and the proximal portion of the rigid inserter pin are adapted to fittingly engage with each other. In implementations, this fitting engagement is tailored to be 'complete', i.e., leaving no pockets of air or other spaces between the surfaces of the conduit element and the rigid inserter pin when they are put into engagement with each other.

[0056] According to the first aspect of the disclosure, the proximal end portion of the conduit element includes an internal volume. The internal volume of the proximal end portion of the conduit element is configured to receive the proximal portion of the rigid inserter pin. In this context, the phrasing "configured to receive" should be understood to mean that the internal volume of the proximal end portion of the conduit element provides space for the proximal portion of the rigid inserter pin to be brought into position at the proximal end portion of the conduit element while perceiving no or little resistance thereto. It should further be understood that any engagement between the proximal portion of the rigid inserter pin and the proximal end portion of the conduit element can be implemented e.g. as in the implementations described above.

[0057] In implementations, the internal volume of the proximal end portion of the conduit element is adapted to form a space that is complementary to the tapered end shape of the proximal portion of the rigid inserter pin. Thereby, it should be understood that the internal volume of the proximal end portion of the conduit element and the tapered end shape of the proximal portion of the rigid inserter pin are adapted to have entirely matching surface portions.

[0058] Further according to the first aspect of the disclosure, the proximal end portion of the conduit element is configured to collapse. During removal of the tool from the patient after having measured the thickness and determined the necessary size of the voice prosthesis to be inserted in the TEP, the rigid inserter pin is disengaged from the proximal end portion of the conduit element thereby leaving the internal volume of the proximal end portion of the conduit element as a free space. This free space can be understood to be prone to "fall in" or "cave in" on itself when a removal force is applied to the conduit element. This also allows for the oesophageal flange of the flexible housing to easily flex which makes the withdrawal of the oesophageal flange and thus the removal of the tool from the patient including through the TEP much gentler on the patient.

[0059] In implementations, the distal portion of the rigid inserter pin includes an outwardly extending safety flange. The outwardly extending safety flange ensures that the rigid inserter pin cannot accidentally slip into the trachea of the patient. In implementations, the outwardly extending safety flange can be provided as a T-bar (i.e., with the cross-bar of the 'T' forming the extending flange). Alternatively, the outwardly extending safety flange can be provided as an umbrella-shaped flange protruding outward from an external surface of the body of the rigid inserter pin at the distal portion thereof. Moreover, in implementations, the outwardly extending safety flange can be radially extending, such as perpendicularly extending from the distal portion of the rigid inserter pin.

[0060] In implementations, the flexible housing includes a safety frame including at least one strand extending distally from the distal end portion of the conduit element in a direction parallel to the longitudinal axis and a stoppage plate extending in a direction transverse to the strand at a distal end of the strand. In implementations, the strand can be formed as a distally extending continuation of a partial portion of the wall of the flexible housing. In implementations, the safety frame includes two separate strands each extending distally from the distal end portion of the conduit element in a direction parallel to the longitudinal axis. In implementations, the safety frame includes more than two strands each extending distally from the distal end portion of the conduit element in a direction parallel to the longitudinal axis. In implementations, the safety frame includes one strand extending distally from the distal end portion of the conduit element in a direction parallel to the longitudinal axis and formed as a 180° angular continuation portion of the wall of the flexible housing. Alternatively, the one strand can be formed as a 90° angular continuation portion of the wall of the flexible housing.

[0061] In implementations, the stoppage plate of the safety frame of the flexible housing is adapted to engage with and releasably lock the outwardly extending safety flange of the rigid inserter pin. This prevents any relative movement between the flexible housing and the rigid inserter pin (as long as the safety flange and the stoppage plate are locked together). The stoppage plate of the safety frame of the flexible housing and the outwardly extending safety flange of the rigid inserter pin thus combine to provide a safety mechanism that prevents the flexible housing (in addition to the rigid inserter pin as described above) from accidentally slipping into the oesophagus or the trachea of the patient.

[0062] In implementations, at least the second group of measurement indicia includes grooves provided in the external surface of the conduit element and the measuring sleeve includes protrusions adapted to engage with the grooves. The protrusions on the measuring sleeve are configured to slide along the external surface of the conduit element until the proximal end of the measuring sleeve engages with the tissue on the tracheal side of the oesophageal wall of the patient. Once the measuring sleeve engages the tracheal wall the protrusions of the measuring sleeve engage with a relevant groove of the second group of measurement indicia and thereby provides the clinician with a tactile response indicating that the measuring sleeve is steadily located. Thereafter, the relevant measurement can be read off from the measurement indicia by the clinician who can then determine the right size (length) of the voice prosthesis to be provided to the patient. In implementations, the measuring sleeve is adapted to allow checking of the second group of measurement indicia at a distal end of the measuring sleeve. In implementations, the protrusions of the measuring sleeve are provided to extend radially inward from an internal surface of the measuring sleeve at the distal end portion thereof.

[0063] In a second aspect, the disclosure relates to a kit of parts including the measuring tool described above in relation to the first aspect and further including a set of instructions for use. Thereby, the clinician has easy access to the tool for measuring the size of the TEP as well as to the instructions for its use (IFU).

[0064] In implementations, the kit of parts further includes a packaging. This provides a convenient and safe way of delivering the measuring tool and the instructions for use together to the clinician.

[0065] Detailed description of the drawings

[0066] Figure 1A is concerned with a first aspect of the present invention and is a schematic view illustrating one implementation of a tool 20 for measuring a thickness "t" of a tracheoesophageal wall TW in a patient (see Fig. 2A). The tool 20 includes a flexible housing 22 including a conduit element 24 extending along a longitudinal axis A-A between a distal end portion 26 and a proximal end portion 28. The flexible housing 22 includes a substantially perpendicularly extending oesophageal flange 30 adjacent to the proximal end portion 28.

[0067] In the view of Fig. 1A, the flexible housing 22 of the tool 20 includes a first group of measurement indicia 32 provided along an external surface 34 of the conduit element 24 distal to the oesophageal flange 30. The measuring tool 20 further includes a rigid inserter pin 36 having a proximal portion 38 (in Fig. 1A located inside the conduit element 24 and not visible) and a distal portion 40. The rigid inserter pin 36 is adapted to fit and move inside the conduit element 24. The proximal portion 38 of the rigid inserter pin 36 is configured for engagement with the proximal end portion 28 of the conduit element 24 (cf. Fig. 2A).

[0068] Figure IB is another schematic view illustrating one implementation of a tool 20 wherein the flexible housing 22 of the tool 20 includes a first group of measurement indicia 32 and a second group of measurement indicia 33 provided along the external surface 34 of the conduit element 24.

[0069] In the implementations illustrated in Figs. 1A and IB the proximal end portion 28 of the conduit element 24 includes an internal volume (cf. reference number 42 in Figs. 3A-3C showing various degrees of retraction of the rigid inserter pin) configured to receive the proximal portion 38 of the rigid inserter pin 36. Moreover, the proximal end portion 28 of the conduit element 24 is configured to collapse when the flexible housing 22 is subjected to a pull-out force with the proximal portion 38 of the rigid inserter pin 36 being disengaged from the internal volume of the proximal end portion 28 of the conduit element 24. When the proximal portion 38 of the rigid inserter pin 36 is disengaged from the internal volume of the proximal end portion 28 by retracting the rigid inserter pin 36 (withdrawing it and moving it in the distal direction), a clearance is created between the external surface of the proximal portion 38 of the rigid inserter pin 36 and the internal surface of the proximal end portion 28 of the conduit element 24.

[0070] Figure 2A is a schematic, cross-sectional view of the tool 20 according to the first aspect. The proximal end portion 28 of the conduit element 24 includes an internal volume 42, cf. also Figures 3A-3C. The internal volume 42 of the proximal end portion 28 of the conduit element 24 is configured to receive the proximal portion 38 of the rigid inserter pin 36. In the implementation shown in Fig. 2A, the engaging surfaces of the proximal portion 38 of the rigid inserter pin 36 and the proximal end portion 28 of the conduit element are provided with complementary tapers making them fit close to each other.

[0071] Figures 3A-3C are schematic views of one implementation of the tool 20 illustrating the proximal end portion 28 of the conduit element 24 with the proximal portion 38 of the rigid inserter pin 36 of the tool 20 received therein and inserted through the puncture in the tracheoesophageal wall (the TEP). Fig. 3A corresponds to the situation illustrated in Fig. 2A as described above, wherein the proximal portion 38 of the rigid inserter pin 36 is engaged with the proximal end portion 28 of the conduit element 24 and is received in the internal volume 42 of the proximal end portion 28. The rigid inserter pin 36 can here be understood to be located proximally as far as possible inside the conduit element 24. This proximal-most position of the rigid inserter pin 36 is ideal for allowing the clinician to control the tool during insertion through the tracheostoma (not shown) and subsequently through the TEP. A thickness "t" of the tracheoesophageal wall TW is also indicated in Fig. 3A.

[0072] Figure 3B illustrates a situation wherein the rigid inserter pin 36 has been pulled slightly in the distal direction thereby disengaging the proximal portion 38 of the rigid inserter pin 36 from the insides (such as from one or more inner walls or portions thereof) of the proximal end portion 28 of the conduit element 24. Fig. 3B further illustrates how the retraction (movement in distal direction) and disengagement of the proximal portion 38 of the rigid inserter pin 36 from the insides opens a space or clearance 44 forming at least a portion of the internal volume 42 of the proximal end portion 28 of the conduit element 24. Fig. 3C illustrates a situation wherein the rigid inserter pin 36 has been retracted or withdrawn even further from the proximal end portion 28 of the conduit element (than in the view of Fig. 3B), thereby showing the internal volume 42 of the proximal end portion 28 of the conduit element 24. According to the first aspect of the disclosure, the proximal end portion 28 of the conduit element 24 is configured to collapse when the flexible housing 22 is subjected to a pull-out force with the proximal portion 38 of the rigid inserter pin 36 being disengaged from the internal volume 42 of the proximal end portion 28 of the conduit element 24, i.e., corresponding to the position of the rigid inserter pin 36 as shown in Fig. 3C. Thus, using the tool 20 according to the disclosure, it is understood that when the clinician subjects the flexible housing 22 to a pull-out force, i.e., distally retracts the flexible housing 22 including the conduit element 24 from the TEP and the tracheostoma, the internal volume 42 configures the proximal end portion 28 of the conduit element 24 to collapse, thus making the force required to pull out the proximal end portion 28 including the oesophageal flange 30 through the TEP significantly smaller and makes hence the removal procedure more gentle on the tissue of the patient.

[0073] Referring again to Fig. 2A, the figure schematically illustrates the situation when the flexible housing 22, with the rigid inserter pin 36 located inside the conduit element 24, has been inserted through the tracheostoma in the patient's neck (not shown) and further inserted through the TEP in the tracheoesophageal wall TW such that the proximal end portion 28 of the conduit element 24, including the substantially perpendicularly extending oesophageal flange 30, is located on the oesophageal side OS of the tracheoesophageal wall TW (i.e., the flange 30 is in the oesophagus). The oesophageal flange 30 is pliable due to the flexibility of the material of the flexible housing 22 and therefore easily brought through the TEP. As illustrated in Fig. 2A, the clinician has made a slight movement of the flexible housing 22 in the distal direction, such as to make sure that a distal surface 43 of the oesophageal flange 30 engages with the tissue at the oesophageal side OS of the tracheoesophageal wall TW.

[0074] With reference to the schematic perspective view of Figure 2B, showing the conduit element 24 located through the TEP with its proximal end portion 28 including the oesophageal flange 30 on the oesophageal side OS of the tracheoesophageal wall TW, the tool 20 provides for the clinician to determine a thickness of the TW by checking the value of that particular indicator of the first group of measurement indicia 32 on the external surface 34 of the conduit element 24 which is closest to, and visible on, the tracheal side TS of the TW. In the view of Fig. 2B the indicator value indicates a thickness "t" of the tracheoesophageal wall TW of approximately 8mm. In this implementation, this indicator value can be understood to basically correspond to the optimal length of a voice prosthesis VP to be inserted in the TEP (cf. Fig. 11). The clinician reads off the relevant indicator value (8mm) of the first group of measurement indicia 32 in the tracheostoma (not shown) and thereby determines the relevant thickness "t" of the tracheoesophageal wall TW using the tool 20. The first group of measurement indicia 32 suitably is shown to include a plurality of individual indicators having each their value. In the view of Fig. 2B, the first group of measurement indicia 32 includes a scale divided into steps of 2.0- and 2.5-millimetres length, the value at each of the steps reflecting typical standard lengths of voice prostheses. Fig. 2B further illustrates that the first group of measurement indicia 32 additionally includes indicator lines at least partially circumscribing the conduit element 24 with one line per indicator value step.

[0075] Figures 4 and 5 are schematic perspective views illustrating implementations of the measuring tool 20 including a first group of measurement indicia 32 and a second group of measurement indicia 33, the second group 33 provided on the external surface 34 of the conduit element 24 distal to the first group 32. Figs. 4 and 5 further illustrate that the tool 20 in this implementation includes a measuring sleeve 46 of shorter longitudinal extent than the conduit element 24 (measured along longitudinal axis A-A). The measuring sleeve 46 is adapted to fit over and slide along the external surface 34 of the conduit element 24 (as indicated by arrow P in Fig. 5) and adapted to allow checking of the second group of measurement indicia 33 on the external surface 34 of the conduit element 24.

[0076] Accordingly, in a second approach to measuring a thickness of a tracheoesophageal wall TW as illustrated in the schematic perspective view of Figure 6, the clinician instead fits the measuring sleeve 46 over the external surface 34 of the conduit element 24 and slides the measuring sleeve 46 along the external surface 34 of the conduit element 24 until the clinician determines that the proximal end portion 48 of the measuring sleeve 46 contacts the tracheal side TS of the tracheoesophageal wall TW. When the clinician has established that the tool is located in the TEP with the proximal end portion 48 of the measuring sleeve 46 in contact with the tracheal side TS of the tracheoesophageal wall TW, the second group of measurement indicia 33 provided on the external surface 34 of the conduit element 24 combines with the distal end portion 50 of the measuring sleeve 46 and allows the clinician to determine the thickness "t" of the tracheoesophageal wall TW. This approach is particularly suitable for an easy and convenient reading off of the indicator value from the second group of measurement indicia 33 externally of the tracheostoma (i.e., external the skin surface of the patient's neck). The clinician does so by reading off the relevant value of the indicator (in Fig. 6 indicated by reference number 49), which is the indicator value visible closest to the distal end portion 50 of the measuring sleeve 46. In the implementations illustrated in Figs. 4-6, the measuring sleeve 46 is provided with a specific and known length (longitudinal extent along axis A-A) corresponding to a distance between a proximal-most indicator value 35 (Fig. 4) of the first group of measurement indicia 32 and a proximal-most indicator value 45 of the second group of measurement indicia 33 (Fig. 4), whereby an indicator value 49 read off the second group of measurement indicia 33 on the external surface 34 of the conduit element 24, at the distal end portion 50 of the measuring sleeve 46 (Fig. 6), corresponds directly to the thickness "t" of the tracheoesophageal wall TW between the oesophageal flange 30 of the conduit element 24 and the proximal end portion 48 of the measuring sleeve 46.

[0077] In implementations as illustrated in the views of Figs. 4-6, the proximal end portion 48 of the measuring sleeve 46 includes a substantially perpendicularly extending tracheal flange 52. The tracheal flange 52 of the proximal end portion 48 of the measuring sleeve 46 can suitably extend substantially perpendicular to the longitudinal axis A-A from an external wall of the measuring sleeve 46 at its proximal end. The tracheal flange 52 provides for a safe and reliable positioning and engagement of the proximal end portion 48 of the measuring sleeve 46 in contact with the tracheal side TS of the tracheoesophageal wall TW. It is further understood that the tracheal flange 52 of the measuring sleeve 46 and the oesophageal flange 30 of the flexible housing 22 can combine to provide an advantageous tactile sensation indicating correct location of the measuring tool to the clinician for measuring the thickness "t" of the tracheoesophageal wall TW. In implementations as illustrated in the schematic perspective view of Figure 4, the first group of measurement indicia 32 is spaced from the second group of measurement indicia 33 by a distance "d". The distance "d" can suitably be selected in a range of about 10mm - about 40mm. In the example of Fig. 4 the distance "d" can be considered approximately 20mm (figures not to scale). Providing a distance "d" between the first 32 and second 33 groups of measurement indicia gives a clear and intuitive separation of the two groups, which separation helps prompt the clinician to selecting between using the measuring sleeve 46, and thus determining the thickness parameter outside the tracheostoma (not shown) or not using the measuring sleeve and instead read off the indicator value in the tracheostoma.

[0078] With reference to the views of figures 2A and 7, these views further illustrate implementations of the measuring tool 20 in accordance with the disclosure. The tool 20 includes the flexible housing 22 of the tool including the conduit element 24. In these implementations the conduit element 24 can be understood to include a passage formed inside the flexible housing 22, e.g., in the form of a pipe- or channellike corridor 54. The conduit element 24 extends along the longitudinal axis A-A. The conduit element 24, including the pipe- or channel-like corridor 54, extends between the distal end portion 26 and the proximal end portion 28. As can be understood from the figures and the disclosure in general, the proximal end portion 28 of the conduit element 24 terminates with a closed proximal end 29. Thus, there is no passage or opening in the proximal end portion 28 of the conduit element 24. Adjacent to its proximal end portion 28 the flexible housing 22 includes the substantially perpendicularly extending oesophageal flange 30. The oesophageal flange 30 substantially stretches radially outward from the external surface 34 of the conduit element 24 of the flexible housing 22. In the implementations of Figs. 2A and 7, the distal end portion 26 of the conduit element 24 provides an open distal end 31 (Fig. 7).

[0079] As particularly visible in the schematic perspective views of figures 8-9, the oesophageal flange 30 can suitably include a circular or rounded outer peripheral contour. In implementations, such as exemplified in Figs. 8-9, the oesophageal flange 30 includes a circular outer peripheral contour and has a radial extent of about 3mm (l,e., the flange extends annularly and about 3mm outward from the external surface of the flexible housing). In implementations such as illustrated in the schematic view of Fig. 7, an external longitudinal extent "q" of the proximal end portion 28 of the conduit element 24 corresponds to the length of the portion of the flexible housing 22 which is proximal to the oesophageal flange 30. In the exemplary view of Fig. 7, the external longitudinal extent "q" is about 7mm. Fig. 9 further indicates a proximal side or surface 41, and a distal side or surface 43, of the oesophageal flange 30.

[0080] Figures 7-9 further illustrate schematic perspective views of the measuring tool 20 including rigid inserter pin 36 having a proximal portion 38 and a distal portion 40. The rigid inserter pin 36 is relatively rigid compared to the flexible housing 22 and adapted to fit and move inside the conduit element 24. The rigid inserter pin 36 helps provide adequate sturdiness to control the tool 20 during insertion. In implementations such as illustrated in Figs. 7-9, an outer diameter DI of the rigid inserter pin 36 is slightly smaller than an inner diameter of the conduit element 24. Fig. 8 illustrates the measuring tool 20 in a situation wherein it is not inserted into a patient and with the measuring sleeve 46 in a proximal position rendering the second group of measurement indicia 33 on the external surface 34 of the conduit element 24 visible. Fig. 9 illustrates the measuring tool 20 in a situation wherein it is not inserted into a patient and with the measuring sleeve 46 in a distal position rendering the full first group of measurement indicia 32 on the external surface 34 of the conduit element 24 visible.

[0081] As best seen in the schematic perspective views of the tool 20 of Figs. 8 and 9, in implementations, the distal portion 40 of the rigid inserter pin 36 includes an outwardly extending safety flange 56. The outwardly extending safety flange 56 ensures that the rigid inserter pin 36 cannot accidentally slip into the trachea of the patient. In the views of Figs. 8-9, the outwardly extending safety flange 56 is provided as a T-bar with a curved cross-bar of the 'T' forming the flange 56.

[0082] As best seen in the schematic perspective view of the tool 20 of Fig. 7, in implementations, the flexible housing 22 includes a safety frame 58 including at least one strand 60 extending distally from the distal end portion 26 of the conduit element 24, in a direction parallel to the longitudinal axis A-A, and a stoppage plate 62 (cf. also Figs. 8-9) extending in a direction transverse to the strand 60 at a distal end 64 of the strand. In Fig. 7, the strand 60 is formed as a continuation of a partial portion of the wall of the flexible housing 22 extending distally from the distal end portion 26 of the conduit element 24. As further illustrated in the schematic perspective views of the tool 20 of Figs. 8 and 9, in implementations, the stoppage plate 62 of the safety frame 58 (Fig. 7) of the flexible housing 22 is adapted to engage with and releasably lock the outwardly extending safety flange 56 of the rigid inserter pin 36. Such locking prevents any relative movement between the flexible housing 22 and the rigid inserter pin 46. The stoppage plate 62 of the safety frame 58 and the safety flange 56 of the rigid inserter pin 36 combine to prevent the flexible housing 22 (in addition to the safety flange 56 of the rigid inserter pin 36 itself, Figs. 8 / 9) from accidentally slipping into the oesophagus or the trachea of the patient.

[0083] Referring again to the schematic, sectional views of Figs. 3A-3C, the proximal portion 38 of the rigid inserter pin 36 is configured for engagement with the proximal end portion 28 of the conduit element 24. Particularly, as shown in Fig. 3A, in implementations the proximal portion 38 of the rigid inserter pin 36 fittingly engages with the insides of the proximal end portion 28 of the conduit element 24. Figs. 3A-3C show implementations wherein the proximal portion 38 of the rigid inserter pin 36 is shaped to form a tapered (or tapering) end 66 (or end portion). In Figs. 3A-3C, the tapered end 66 is formed as a solid, truncated cone. In Figs. 3A-3C, the tapered end 66 of the proximal portion 38 of the rigid inserter pin 36 includes an external surface 68 (Fig. 3C) which is at an oblique angle relative to the longitudinal axis A-A of the tool. As further illustrated in Figs. 3A-3C, and particularly visible in Fig. 3C, in implementations, the insides of the conduit element 24 at the proximal end portion 28 thereof are adapted to receive the proximal portion 38 of the rigid inserter pin 36 and thus are adapted to combine in engagement with each other, such as adapted to fittingly engage with each other as best seen in Fig. 3A. The 'insides' can be seen (Fig. 3C) to include at least a tapering inner wall portion 70 and a generally straight inner end portion 72 of the conduit element 24. In the implementation of Fig. 3A, the fitting engagement is 'complete' with no pockets of air or other spaces or clearance between the inside surfaces of the conduit element 24 and the tapered end 66 of the proximal portion 38 of the rigid inserter pin 36. In the implementations of Figs. 3A-3C, the tapering inner wall portion 70 of the conduit element 24 can extend at a same (or otherwise entirely complementary) oblique angle to the longitudinal axis A-A as the external surface 68 of the proximal portion 38 of the rigid inserter pin 36. As further illustrated in the implementations of Figs. 3A-3C, the proximal end portion 28 of the conduit element 24 includes an internal volume 42. The internal volume 42 is configured to receive the proximal portion 38 of the rigid inserter pin 36, that is, the internal volume 42 further provides a space or clearance 44 for the proximal portion 38 of the rigid inserter pin 36 at the proximal end portion 28 of the conduit element 24, such that the rigid inserter pin 36 can be brought into position for the insertion of the tool 20 in the patient with no or little resistance to the engagement of the components. The space or clearance 44 formed in the internal volume 42 is suitably complementary to the tapered end 66 of the proximal portion 38 of the rigid inserter pin 36, e.g., the components can be considered to have entirely matching surface portions.

[0084] Figure 10 is an enlarged schematic sectional view of one implementation of the measuring tool of the disclosure. In Fig. 10, the sectional view shows a portion of flexible housing 22 including the second group of measurement indicia 33 and the distal end portion 50 of the measuring sleeve 46. Each indicator value of the second group of measurement indicia 33 is shown to include a groove 74 provided in the external surface 34 of the conduit element 24. The distal end portion 50 of the measuring sleeve 46 includes protrusions 76 adapted to engage with a groove 74 in the external surface 34 of the conduit element 24. In the view of Fig. 10, each of the protrusions 76 of the measuring sleeve 46 extend radially inward from an internal surface of the measuring sleeve 46 at the distal end portion 50 thereof. In Fig. 10, the distal end portion 50 of the measuring sleeve 46 includes a series of flaps separated from each other by cut-outs 78. The protrusions 76 on the measuring sleeve 46 are configured to slide along the external surface 34 of the conduit element 24 until the proximal end of the measuring sleeve 46 engages with the tissue on the tracheal side of the oesophageal wall of the patient. Once located there, the protrusions 76 of the measuring sleeve 46 engage with a relevant groove 74 of the second group of measurement indicia 33 to provide the clinician with a tactile response. Thereafter, the relevant measurement can be read off from the second group of measurement indicia 33 by the clinician who can then determine the right size (length) of the voice prosthesis to be provided to the patient.

[0085] Figure 11 is a schematic, cross-sectional view of a model of a head and neck portion of a laryngectomized patient having a voice prosthesis VP inserted in the tracheoesophageal wall TW between the trachea TR and the oesophagus OE. A tracheostoma TO is provided in the patient's neck (not visible but approximate location indicated in punctured line) and is surrounded by a skin adhesive component 79 onto which a heat- and moisture-exchange (HME) device 80 is attached. By closure of a valve in the HME device 80, speech is enabled by directing exhalation air from the trachea TR through the open one-way valve of the voice prosthesis VP via the oesophagus OE and out through the oral cavity and the mouth of the patient.

[0086] Figure 12 is a schematic plan view of a kit of parts 81 including a measuring tool 20 described above in relation to the first aspect and further including a set of instructions for use (IFU) 82. In the implementation illustrated in Fig. 12, the measuring tool 20 includes a flexible housing 22 including at least a first group of measurement indicia 33, a rigid inserter pin 36 and a measuring sleeve 46. In the implementation shown in Fig. 12, the kit of parts 81 further includes a packaging 84. In the implementation shown in Fig. 12, the packaging 84 includes a sterile compartment 86 for holding sterilized parts of the measuring tool 20 and of the kit of parts and a non- sterile compartment 88 for holding at least the instructions for use 82.

[0087] Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the scope of the claimed invention. The specification and drawings are, accordingly to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents.

[0088] Index of reference numbers

[0089] 20 measuring tool

[0090] 22 flexible housing

[0091] 24 conduit element

[0092] 26 distal end portion (of conduit element 24)

[0093] 28 proximal end portion (of conduit element 24)

[0094] 29 closed proximal end (of conduit element 24)

[0095] 30 oesophageal flange

[0096] 31 open distal end (of conduit element 24)

[0097] 32 first group of measurement indicia

[0098] 33 second group of measurement indicia

[0099] 34 external surface (of conduit element 24)

[0100] 35 proximal-most indicator value (of first group of measurement indicia 32)

[0101] 36 rigid inserter pin

[0102] 38 proximal portion (of rigid inserter pin 36)

[0103] 40 distal portion (of rigid inserter pin 36)

[0104] 41 proximal side or surface (of oesophageal flange 30)

[0105] 42 internal volume

[0106] 43 distal side or surface (of oesophageal flange 30)

[0107] 44 space or clearance

[0108] 45 proximal-most indicator value (of second group of measurement indicia 33)

[0109] 46 measuring sleeve

[0110] 48 proximal end portion (of measuring sleeve 46)

[0111] 49 indicator value

[0112] 50 distal end portion (of measuring sleeve 46)

[0113] 52 tracheal flange (of proximal end portion 48)

[0114] 54 pipe- or channel-like corridor

[0115] 56 safety flange

[0116] 58 safety frame

[0117] 60 strand

[0118] 62 stoppage plate

[0119] 64 distal end of strand 60 66 tapered end (of proximal portion 38 of rigid inserter pin 36)

[0120] 70 tapering inner wall portion

[0121] 72 straight inner end portion

[0122] 74 grooves

[0123] 76 protrusions

[0124] 78 cut-outs

[0125] 79 skin-adhesive component

[0126] 80 HME device

[0127] 81 kit of parts

[0128] 82 instructions for use

[0129] 84 packaging

[0130] 86 sterile compartment of packaging

[0131] 88 non-sterile compartment of packaging

[0132] IFU instructions for use

[0133] OE oesophagus

[0134] OS oesophageal side

[0135] TEP tracheoesophageal puncture

[0136] TO tracheostoma

[0137] TR trachea

[0138] TS tracheal side

[0139] TW tracheoesophageal wall

[0140] VP voice prosthesis

Claims

CLAIMS:

1. A tool for measuring a thickness of a tracheoesophageal wall in a patient, comprising:- a flexible housing comprising a conduit element extending along a longitudinal axis between a distal end portion and a proximal end portion, the flexible housing comprising a substantially perpendicularly extending oesophageal flange adjacent to the proximal end portion, and- at least a first group of measurement indicia provided on an external surface of the conduit element distal to the oesophageal flange,- a rigid inserter pin having a proximal portion and a distal portion, the rigid inserter pin adapted to fit and move inside the conduit element, where the proximal portion of the rigid inserter pin is configured for engagement with the proximal end portion of the conduit element, wherein the proximal end portion of the conduit element comprises an internal volume configured to receive the proximal portion of the rigid inserter pin, and wherein the proximal end portion of the conduit element is configured to collapse when the flexible housing is subjected to a pull-out force with the proximal portion of the rigid inserter pin being disengaged from the internal volume of the proximal end portion of the conduit element.

2. The tool of claim 1, comprising a first group and a second group of measurement indicia, the second group provided on the external surface of the conduit element distal to the first group, and further comprising a measuring sleeve of shorter longitudinal extent than the conduit element and adapted to fit over and slide along the external surface of the conduit element and adapted to allow checking of the second group of measurement indicia.

3. The tool of claim 2, wherein the longitudinal extent of the measuring sleeve corresponds to a distance between a proximal-most indicator value of the first group of measurement indicia and a proximal-most indicator value of the second group of measurement indicia.

4. The tool of any one of claims 2-3, wherein a proximal end portion of the measuring sleeve comprises a substantially perpendicularly extending tracheal flange.

5. The tool of any one of the preceding claims, wherein the proximal portion of the rigid inserter pin is shaped to form a tapered end.

6. The tool of claim 5, wherein the tapered end shape of the proximal portion of the rigid inserter pin is formed as a truncated cone.

7. The tool of any one of the preceding claims, wherein insides of the conduit element at the proximal end portion thereof are adapted to receive the proximal portion of the rigid inserter pin.

8. The tool according of any one of claims 5-7, wherein the internal volume of the proximal end portion of the conduit element is adapted to form a space that is complementary to the tapered end shape of the proximal portion of the rigid inserter pin.

9. The tool of any one of the preceding claims, wherein the flexible housing is made from a material having a hardness in a range of 30-80 Shore A.

10. The tool of any one of the preceding claims, wherein the flexible housing comprises a thermoplastic elastomer (TEP) or a silicone material.

11. The tool of any one of claims 2-10, wherein at least the second group of measurement indicia comprises grooves provided in the external surface of the conduit element and the measuring sleeve comprises protrusions adapted to engage with the grooves.

12. The tool of any one of the preceding claims, wherein the distal portion of the rigid inserter pin comprises an outwardly extending safety flange.

13. The tool of any one of the preceding claims, wherein the flexible housing comprises a safety frame comprising at least one strand extending distally from the distal end portion of the conduit element in a direction parallel to the longitudinal axis and a stoppage plate extending in a direction transverse to the strand at a distal end of the strand.

14. The tool of claim 13, when dependent on claim 12, wherein the stoppage plate of the safety frame of the flexible housing is adapted to engage with and releasably lock the outwardly extending safety flange of the rigid inserter pin.

15. A kit of parts comprising the tool of any one of claims 1-14, further comprising a set of instructions for use.

16. The kit of parts of claim 15, further comprising a packaging.

Images