A tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient

Abstract

Disclosed is a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient.

Description

[0001] A TOOL FOR MEASURING A THICKNESS OF A TRACHEOESOPHAGEAL WALL AND FOR FACILITATING DETERMINATION OF A PEAK PRESSURE IN THE OESOPHAGUS OF A PATIENT

[0002] A tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of 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.

[0006] The characteristics of a good and well-functioning voice prosthesis for the individual user depend on anatomy and physiology of the user. One parameter is the length of the voice prosthesis that should correspond best possible to a thickness of tracheoesophageal wall. Another parameter is the opening pressure of the one-way valve in the voice prosthesis. The valve opening pressure relates to the ability of the valve to withstand phenomena that can cause leaking / aspiration during swallowing and inspiration. Currently, there are no known devices available in the marketplace to help the clinician choose a voice prosthesis with the right opening pressure, hence, it is a trial-and-error situation for the clinician how to choose the right voice prosthesis.

[0007] 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.

[0008] Summary

[0009] In one aspect, the present disclosure provides a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient. In another aspect, the disclosure relates to a system for facilitating selection of a size and opening pressure of a voice prosthesis using a tool as disclosed herein. In yet another aspect, the disclosure relates to a kit of parts including a tool as disclosed herein. The aspects are further defined by the appended claims.

[0010] Brief Description of the Drawings

[0011] 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. 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 and for facilitating determination of a peak pressure in the oesophagus of a patient.

[0014] Figure IB is a schematic view illustrating one implementation of a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient.

[0015] Figure 1C is a schematic, perspective view illustrating one implementation of a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient.

[0016] Figure 2A is a schematic, partially cross-sectional, perspective view of one implementation of a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient.

[0017] Figure 2B is a schematic, perspective view seen from a vantage point on the oesophageal side of a tracheoesophageal wall illustrating one implementation of a tool for measuring a thickness of a tracheoesophageal wall and for facilitating determination of a peak pressure in the oesophagus of a patient.

[0018] Figures 3A-3C are schematic, sectional views of one implementation of the tool showing details thereof.

[0019] Figures 4A and 4D are schematic, partially perspective views of implementations of the tool according to the disclosure positioned in a tracheoesophageal wall of a patient. Figures 4B and 4C are schematic, partially perspective and sectional views of an implementation of the tool according to the disclosure.

[0020] Figure 5 is an enlarged schematic sectional view of one implementation of the tool of the disclosure.

[0021] Figure 6 is a schematic, perspective view illustrating one implementation of a kit of parts including a pressure gauge and a tool as disclosed herein.

[0022] Figure 7 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.

[0023] Figure 8 is a schematic plan view of a kit of parts including a pressure gauge and a tool as disclosed herein.

[0024] 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 person using the tool may be referred to as a health care professional, "HCP", such as a doctor / physician / clinician, nurse, or other person. However, in some cases, the person using the tool may also refer to the patient or user of a voice prosthesis themselves. 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, such as including being perpendicular to. In some sentences, the words "inner" and "outer" may 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".

[0028] 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 something which is closer to, respectively farther away, from the user's body (e.g. skin surface).

[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, such as next to, and / or in contact with [something]." The phrase "complementary" should be interpreted to define something that acts as a complement; i.e., something making up a whole in combination with something else.

[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) surgically 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] Reference is further made to ISO Standard 21917:2021 (EN), which includes a description of a method of measuring performance of a voice prosthesis, opening pressure thereof, and more. The standard prescribes a variety of dimensional information regarding the voice prosthesis which the packaging holding the VP must be supplied with, including shaft length and outer shaft diameter in Charriere / French Gauge (e.g., CH7Fr) and / or in mm of the VP. In addition, the standard also prescribes that the valve opening pressure [hPa] of a voice prosthesis shall be stated in the instructions for use (IFU) supplied with the voice prosthesis (the opening pressure determined in accordance with the test method given in section B.4 of the ISO standard 21917:2021 (EN),

[0034] The standard's definition of a 'voice prosthesis' is: "medical device, introduced into a tracheoesophageal puncture, which allows expiratory airflow into the oesophagus for tracheoesophageal speech but prevents the leakage of fluids into the airway."

[0035] The standard's definition of 'opening pressure' is: (the) "minimal pressure that opens the valve" (of the VP). The opening pressure of the valve gives an indication of the stability of the valve against unintended openings e.g. due to the pressure in the oesophagus during inspiration being lower than that in the trachea.

[0036] In a first aspect, the present disclosure relates to a tool for measuring a thickness of a tracheoesophageal wall in a patient and for facilitating determination of a peak pressure in the oesophagus of 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.

[0037] The flexible housing of the tool includes at least a first group of measurement indicia provided on an external surface of the conduit element distal to the oesophageal flange,

[0038] The tool includes a hollow rigid inserter pin including an open-ended proximal portion and an open-ended distal portion. The hollow rigid inserter pin is adapted to fit and move inside the conduit element. The open-ended proximal portion of the hollow rigid inserter pin is configured for engagement with the proximal end portion of the conduit element. In implementations, the open-ended proximal portion of the of hollow rigid inserter pin includes a fluid communication opening. The proximal end portion of the conduit element is configured to receive the open-ended proximal portion of the hollow rigid inserter pin. The proximal end portion of the conduit element includes an orifice configured to combine with the open-ended proximal portion of the hollow rigid inserter pin to provide fluid communication with the hollow rigid inserter pin.

[0039] The open-ended distal portion of the hollow rigid inserter pin is adapted for connection with a pressure gauge.

[0040] It should be understood that a voice prosthesis is a device to be selected in correspondence with the measurement and determination of the relevant VP parameters for which the tool is used, but which VP can suitably be inserted in a patient in a procedure independent of the use of the tool of the present disclosure.

[0041] For measuring the thickness of the tracheoesophageal wall of a patient using the tool according to the first aspect, in a first step, the hollow 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 open-ended proximal portion of the hollow rigid inserter pin is then brought into engagement with the proximal end portion of the conduit element. It is understood that one or more external surfaces or surface portions of the open- ended proximal portion of the hollow rigid inserter pin is / are received at and engaged with an inside of the proximal end portion of the conduit element, i.e., internally of the flexible housing. For example, the one or more external surface portions of the open- ended proximal portion of the hollow rigid inserter pin can engage one or more inner wall portions of the proximal end portion of the conduit element. In implementations, one or more inner wall portion(s) of the proximal portion of the conduit element is / are adapted to be complementary in shape to one or more external surface portion(s) of the open-ended proximal portion of the hollow rigid inserter pin. Thereby, it should be understood that the proximal end portion of the conduit element and the open-ended proximal portion of the hollow rigid inserter pin are adapted to have mutually matching surface portions (respectively inner and outer surfaces), at least at their proximal end portions.

[0042] In a next step, the flexible housing with the hollow 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 and the substantially perpendicularly extending oesophageal flange locates in the oesophagus. The nature of the flexible housing helps ensure that the proximal end portion of conduit element and 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 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 (removal-) direction of the tool away 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 externally of the patient's body.

[0043] Following this, the clinician is able to determine a thickness of the tracheoesophageal wall by checking the value of that particular (specific) 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, two, two-and-a-half, five or other millimetre lengths or steps, 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 value at each of the steps can be reflecting typical standard lengths of different voice prostheses. In implementations, the measurement indicia can additionally or alternatively include indicator lines wholly or partially circumscribing the conduit element, such as including one indicator line per step value. In implementations, the measurement indicia and / or the indicator lines 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 measurement indicia can additionally or alternatively include one or more elements generating a tactile sensation at each step value. 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.

[0044] In one approach of using the tool according to the disclosure, the next step is for the clinician to remove the tool from the patient after having carried out the measurement of the thickness of the oesophageal wall. To do this, the clinician suitably pulls the hollow rigid inserter pin slightly in the distal direction (and relative to the conduit element, which is kept steady), such that the open-ended proximal portion of the hollow rigid inserter pin is withdrawn from engagement with the inner wall portions of the proximal end portion of the conduit element. Accordingly, the inner wall portions of the proximal end portion of the conduit element are then no longer engaged by the external surface portion(s) of the open-ended proximal portion of the hollow rigid inserter pin.

[0045] By subjecting the flexible housing to a pull-out force (for removal of the tool from the patient), with the open-ended proximal portion of the hollow rigid inserter pin being disengaged from the inside of the proximal end portion of the conduit element (the clinician gently pulling the flexible housing in the distal direction out of the TEP and further out of the tracheostoma), the now "empty" proximal end portion of the conduit element of the flexible housing including the orifice can collapse. The collapsibility of the proximal end portion of the conduit element including the internal volume and the orifice 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. Thus, the oesophageal flange and the proximal end portion including the internal volume and orifice gently slips through the TEP with little or no resistance to the pulling 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. One advantage of the presently disclosed tool is that it greatly reduces the force or stress that the puncture (TEP) in the tracheoesophageal wall is subjected to during removal of the tool, while not affecting the sturdiness (or stiffness) of the tool during insertion because of a reinforcing effect of the hollow rigid inserter pin present during the insertion. Such 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.

[0046] In implementations, the 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.

[0047] Accordingly, in another approach to the measurement of the thickness of the tracheoesophageal wall with a tool according to the disclosure, the conduit element of the flexible housing can be located in the TEP with the oesophageal flange being brought into contact with the oesophageal side of the tracheoesophageal wall in the same manner as described above. However, different to the approach described 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 slides 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 hollow rigid inserter pin inside it is inserted through the tracheostoma and into the TEP of the patient. Thus, in such approach to measuring the thickness of the tracheoesophageal wall, the tool including the flexible housing including the conduit element, the hollow rigid inserter pin, and the measuring sleeve, can be inserted together through the tracheostoma and into (and through) the TEP in a one-step action if desired by the clinician. After such 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.

[0048] Further, in accordance with this 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 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 specific 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 correspond directly to or be used for calculation of 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 of the patient.

[0049] 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 being 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 off 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.

[0050] In implementations, the proximal end portion of the measuring sleeve includes a substantially radially extending tracheal flange. The tracheal flange of the proximal end portion of the measuring sleeve can suitably extend substantially radially to the longitudinal axis from an external wall at the proximal end of the measuring sleeve. The radially extending tracheal flange provides for a safe and reliable positioning and engagement of the proximal end portion of the measuring sleeve for 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.

[0051] 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 level of distancing 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.

[0052] In implementations, the substantially radially extending tracheal flange of the proximal end portion of the measuring sleeve is configured for sealing engagement with tissue of a patient. Thereby, the tracheal flange is adapted to provide a seal between the tool and the trachea (tracheal surroundings of the tool). Thus, implementations can provide the effect that once the tracheal flange is positioned against the tracheal side of the tracheoesophageal wall, the TEP is sealed off from the tracheal side (i.e., any fluid communication (e.g., of air) through the TEP is only possible through an internal lumen of the hollow rigid inserter pin).

[0053] Particularly, in such implementations of the tool configured for sealing engagement against the (tracheal wall) tissue of the patient, the clinician can, in a further approach, advantageously employ further steps to the use of the tool after measurement of the thickness of the tracheoesophageal wall but before removal of the tool from the patient. In such other approach, the clinician can advantageously connect a pressure gauge to the open-ended distal portion of the hollow rigid inserter pin, which can be adapted for connection with the pressure gauge. The pressure gauge is understood to be a device for measurement of pressure. In implementations, the pressure gauge is a re-useable instrument. The pressure gauge can for example be a relative pressure gauge, such as a PPA Compact Manometer from the company SMC (SMC Corporation, JP).

[0054] In implementations, the open-ended distal portion of the hollow rigid inserter pin is adapted for connection with the pressure gauge. In implementations, the open- ended distal portion of the hollow rigid inserter pin includes a barb-fitting. Here, "barbfitting" should be understood as a fitting including one or more continuous ridges or bumps that is / are used to grip the inside diameter of a tube (here a connector tubing or similar of the pressure gauge) and seal the connection therebetween. As the tube is moved onto the fitting, it expands over the barb. Grip and seal occur as the tube relaxes to its original inside diameter behind the barb. Other types of connections, including, but not limited to, luer-lock connections, can be acceptable.

[0055] In implementations, any one or more of the components of the measurement tool can be adapted for and provided as single-use components. This includes in particular the flexible housing including the conduit element, the hollow rigid inserter pin, and the measuring sleeve. By providing these components of a single-use nature the availability of the measurement tool is not dependent on repeated sterilization cycles between uses and the tool can be produced at a lower cost, while also eliminating any risk of cross-contamination between patients.

[0056] By connection to the open-ended distal end portion of the hollow rigid inserter pin the pressure gauge stands in fluid communication with the oesophagus of the patient via a fluid (air) path provided by a combination of the internal lumen extending through the hollow rigid inserter pin, the two open-ended proximal and distal portions of the hollow rigid inserter pin, including a fluid communication opening in the proximal end portion thereof, and the orifice in the proximal end portion of the conduit element. The hollow rigid inserter pin can be understood to include an internal lumen providing a fluid communication path between the open-ended proximal portion and the open- ended distal portion of the hollow rigid inserter pin. Similarly, or additionally, the internal lumen of the hollow rigid inserter pin can be understood to provide a pipe- or channel-like air-passage inside the hollow rigid inserter pin. It is further understood that the substantially radially extending tracheal flange of the proximal end portion of the measuring sleeve, adapted to be positioned against the tracheal side of the tracheoesophageal wall, advantageously can be configured to provide a seal against the tissue to ensure that air does not slip (enter) from the trachea into the oesophagus through the TEP during measurement of the pressure with the pressure gauge. These implementations of the tool provide the clinician with the possibility to measure the peak pressure in the oesophagus of the individual patient while the patient is deep inhaling / swallowing. This will help the clinician to select a voice prosthesis with the most optimal opening pressure for the specific patient. Knowing the peak pressure measured in the oesophagus during swallowing / inspiration guides the clinician to selecting a voice prosthesis with an opening pressure that is higher than the measured peak pressure in order for the valve of the VP to be able to withstand leaking / aspiration through the VP during regular swallowing / inspiration.

[0057] Implementations of the tool according to the disclosure are further advantageous in that they reduce the risk of inadvertent and / or unnecessary openings of the valve, which can otherwise result in gastric bloating when air is swallowed and in mechanical fatigue and premature failure of the valve mechanism.

[0058] To remove the tool from the patient again after having carried out one or both of the measurement of the thickness of the oesophageal wall and the determination of the peak pressure in the oesophagus with the pressure gauge, the clinician may be instructed to first detach the pressure gauge (if used) from the distal end portion of the hollow rigid inserter pin and subsequently pull the hollow rigid inserter pin slightly in the distal direction (and relative to the conduit element, which is kept steady). Thereby, the proximal portion of the hollow rigid inserter pin withdraws from engagement with one or more inner wall portions at the proximal end portion of the conduit element. By subjecting the flexible housing to such pull-out force in the distal direction (out of the TEP and out of the tracheostoma), with the hollow rigid inserter pin disengaged from the proximal end portion of the conduit element, the conduit element including the internal volume and orifice at its proximal end portion can advantageously collapse as already described above.

[0059] Thus, in one aspect, the present disclosure provides implementations of a measurement tool that are particularly advantageous in allowing both for measurement of the thickness of the tracheoesophageal wall, and for determination of the peak pressure in the oesophageal wall using one and the same tool and during the same procedure. This provides a tool which allows a less time-consuming and less invasive (single) procedure for determining the correct voice prosthesis for a patient, which in turn is for the benefit of both the patient and the health care system.

[0060] In implementations, the substantially perpendicularly extending tracheal flange includes a silicone sealing-washer. A 'washer' should be understood generally as a flat annulus, placed at some joint or juncture between parts, to prevent leakage. In implementations, the sealing-washer can include an umbrella-shape to create a soft pretension and ensure a good seal against the tissue. A silicone sealing-washer has been found to be particularly suitable for providing a sealing engagement between the tool and the tracheal wall tissue. Suitable silicone materials for a sealing-washer according to the disclosure include medical grade silicones, such as high consistency rubber (HCR) or liquid silicone rubber (LSR).

[0061] The different components of the disclosed tool can suitably be made from polymer-based materials, thereby facilitating the provision of a single-use tool for measuring and providing a tool with a high level of patient safety, as also mentioned above. This includes elimination of cleaning procedures otherwise necessary with tools with re-useable elements to avoid cross-contamination. Further, the provision of the tool as a single-use device reduces or eliminates the possibility for incorrectly reassembling the components of tools applying one or more re-useable parts. In implementations, the materials for the components of the 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.

[0062] In implementations, the flexible housing of the tool includes a TPE- or a silicone-material providing the flexible housing with a flexural modulus configured to ensure that the housing can be easily bent and / or flexed by subjection to external force. The flexible housing includes a conduit element. The conduit element should be understood to include a pipe- or channel-like passage formed inside the flexible housing. The conduit element extends along a longitudinal axis of the flexible housing (and of the tool as a whole). The longitudinal axis extends between a distal end portion and a proximal end portion of the conduit element.

[0063] In implementations, the flexible housing includes a substantially perpendicularly extending oesophageal flange adjacent to its proximal end portion. 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 tool. The oesophageal flange extends substantially perpendicularly from the flexible housing, meaning that the oesophageal 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.

[0064] In implementations, the conduit element of the flexible housing of the tool can generally (although not exclusively) 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 (size) 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.

[0065] According to the disclosure, the tool includes a hollow rigid inserter pin having an open-ended proximal portion and an open-ended distal portion. In implementations, the hollow rigid inserter pin is a relatively rigid component compared to the flexible housing of the tool. The hollow rigid inserter pin is adapted to fit and move inside the conduit element and further 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 hollow rigid inserter pin has an outer diameter slightly smaller than an inner diameter of the conduit element. The open-ended proximal portion of the hollow rigid inserter pin is configured for engagement with the proximal end portion of the conduit element. Thereby it should be understood that the open-ended proximal portion of the hollow rigid inserter pin is adapted and / or shaped to engage, such as sealingly engage, with the insides of the conduit element at the proximal end portion thereof as also described above. In implementations, the open- ended proximal portion of the hollow rigid inserter pin is shaped to form a tapered end portion. By providing the open-ended proximal portion of the hollow 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 hollow rigid inserter pin will result in the generation of a clearance along the tapered surfaces. This is one advantage over conventional tools with cylindrically shaped inserter rods where it is necessary to completely retract / withdraw the inserter rod from the housing to create clearance. In implementations, the tapered end portion of the open-ended proximal portion of the hollow rigid inserter pin is formed as a truncated cone. In implementations, the tapered end portion of the hollow rigid inserter pin is formed as a frustum wherein the truncation plane (corresponding to the plane of the fluid communication opening thereof) is parallel to the cone's base. In implementations, the tapered end portion of the proximal portion of the hollow rigid inserter pin is provided by shaping an external surface of the open-ended proximal portion of the hollow rigid inserter pin at an oblique angle relative to the longitudinal axis of the tool.

[0066] In implementations, the proximal end portion of the conduit element includes an internal volume configured to receive the open-ended proximal portion of the hollow rigid inserter pin. In such implementations, it is understood that the open-ended proximal portion of the hollow rigid inserter pin is received in the internal volume of the proximal end portion of the conduit element inside the flexible housing in accordance with the manner(s) of engagement between the components described above. In implementations, the open-ended proximal portion of the hollow rigid inserter pin substantially fills up the internal volume of the proximal end portion of the conduit element. 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 open-ended proximal portion of the hollow rigid inserter pin to be brought into position at the proximal end portion of the conduit element with the clinician experiencing no or little resistance to the insertion.

[0067] In implementations, the hollow rigid inserter pin includes a radially extending safety flange adjacent to or at the open-ended distal portion. The radially extending safety flange ensures that the hollow rigid inserter pin cannot accidentally slip into the trachea of the patient. In implementations, the radially 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 radially extending safety flange can be provided as an at least partially umbrella-shaped flange protruding outward from an external surface of the body of the hollow rigid inserter pin adjacent to or at the open-ended distal portion thereof. The radially extending safety flange can be understood to be extending radially outwardly, such as perpendicularly extending from the open-ended distal portion of the hollow rigid inserter pin. 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° or other angular continuation portion of the wall of the flexible housing.

[0068] In implementations, the stoppage plate of the safety frame of the flexible housing is adapted to engage with and releasably lock the radially extending safety flange of the open-ended distal portion of the hollow rigid inserter pin. This prevents any relative movement between the flexible housing and the hollow rigid inserter pin (when the safety flange and the stoppage plate are locked together). The stoppage plate of the safety frame of the flexible housing and the radially extending safety flange of the hollow rigid inserter pin thus combine to provide a safety mechanism that prevents the flexible housing (in addition to the hollow rigid inserter pin, as described above) from accidentally slipping into the oesophagus or the trachea of the patient.

[0069] 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.

[0070] In a second aspect, the disclosure relates to a system for facilitating selection of a size and opening pressure of a voice prosthesis, including the tool according to the disclosure of the first aspect above and a pressure gauge. The pressure gauge can suitably be of the kind mentioned above. The system advantageously provides a clinician with the possibility to both perform measurement of the necessary size (length) of a voice prosthesis for the patient and determination / measurement of the peak pressure in the oesophagus, using one and the same tool. This provides for the clinician to be able to perform a less invasive procedure resulting also in a faster selection of a voice prosthesis with the most optimal opening pressure for the patient, as also described above.

[0071] In implementations of the system, the pressure gauge includes a connector portion adapted for connection to the open-ended distal portion of the hollow rigid inserter pin to provide fluid communication between the pressure gauge and the tool. By adapting the connector portion of the pressure gauge for connection to the open- ended distal portion of the hollow rigid inserter pin, the pressure gauge can be conveniently and easily be connected to the hollow rigid inserter pin of the tool while ensuring immediate tightness and security of the seal of the connection to prevent false readings of the peak pressure in the oesophagus.

[0072] In implementations of the system, the pressure gauge includes a connector portion and further includes an adaptor piece, the adaptor piece configured for connection to the open-ended distal portion of the hollow rigid inserter pin and to a connector portion of the pressure gauge to help provide fluid communication between the pressure gauge and the tool. The adapter piece may be included in the system to provide for connection of pressure gauges having not immediately fitting connection dimensions with the available pressure gauge. In a third aspect, the disclosure relates to a kit of parts including the 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 tracheoesophageal wall and / or determining a peak pressure in the oesophagus of a patient as well as to the instructions for its use (IFU).

[0073] In implementations, the kit of parts further includes a packaging. This provides a convenient and safe way of delivering the tool and the instructions for use together to the clinician. In implementations, the packaging includes a sterile compartment for holding sterilized parts of the tool and of the kit of parts and a non-sterile compartment for holding at least the instructions for use.

[0074] In implementations, the kit of parts further includes a pressure gauge. The pressure gauge can suitably be of the kind described above in relation to the first aspect of the disclosure. In implementations, the pressure gauge of the kit of parts includes a connector portion adapted for connection to the open-ended distal portion of the hollow rigid inserter pin to provide fluid communication between the pressure gauge and the tool. By adapting the connector portion of the pressure gauge for connection to the open-ended distal portion of the hollow rigid inserter pin, the pressure gauge can be conveniently and easily connected to the hollow rigid inserter pin of the tool while ensuring immediate tightness and security of the seal of the connection to prevent false readings of the peak pressure in the oesophagus.

[0075] In implementations, the pressure gauge includes a connector portion and further includes an adaptor piece, the adaptor piece configured for connection to the open-ended distal portion of the hollow rigid inserter pin and to a connector portion of the pressure gauge to help provide fluid communication between the pressure gauge and the tool. The adapter piece may be included in the system to provide for connection of pressure gauges having not immediately fitting connection dimensions with the available pressure gauge.

[0076] Detailed description of the drawings

[0077] Figure 1A is concerned with the 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 (cf. 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. Further visible in Fig. 1A is an open-ended distal portion 40 of a hollow rigid inserter pin 36 adapted for connection with a pressure gauge (not shown). In Fig. 1A, the open-ended distal portion 40 of the hollow rigid inserter pin 36 includes a barb-fitting 51 adapted for connection with the pressure gauge.

[0078] 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 hollow rigid inserter pin 36 of the tool 20 has an open-ended proximal portion 38 (see Figs. 2A and 3A-3C in particular - in Fig. 1A the open-ended proximal portion 38 is located inside the conduit element 24 and therefore not visible) and an open-ended distal portion 40. The hollow rigid inserter pin 36 is adapted to fit and move inside the conduit element 24. The open- ended proximal portion 38 of the hollow rigid inserter pin 36 is configured for engagement with the proximal end portion 28 of the conduit element 24 (cf. Fig. 2A).

[0079] 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.

[0080] Figure 1C is another schematic view of an implementation of the tool 20 with first and second groups of measurement indicia 32, 33, showing a perspective view. Fig. 1C further illustrates an orifice 39 included in the proximal end portion 28 of the conduit element 24 that is configured to combine with an open-ended proximal portion 38 of the hollow rigid inserter pin 36 (best seen in Fig. 2A). It is understood that the orifice 39 and a fluid communication opening 67 (see Figs. 3A-3C) in the open- ended proximal portion 38 of the hollow rigid inserter pin 36 combine to provide a passage that allows for fluid communication with the hollow rigid inserter pin 36, particularly with an inside lumen 37 (Fig. 2A) thereof.

[0081] Further visible in the schematic views of the tool 20 of Figs. 1A-1C, in implementations, the hollow rigid inserter pin 36 includes a radially extending safety flange 56 shown to be provided adjacent to the open-ended distal portion 40 of the hollow rigid inserter pin 36. Also, in implementations, the flexible housing 22 includes a safety frame 58 (see Fig. 2A) 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 extending in a direction transverse to the strand 60. The safety flange 56, safety frame 58, strand 60, and stoppage plate 62 are further described below with regard to Fig. 2A. It should be understood that the safety flange 56, safety frame 58, strand 60, and the stoppage plate 62 are optional elements in implementations of the tool 20 according to the first aspect and are not required in a broadest context of the present invention.

[0082] Figure 2A is a schematic, partly sectional, partly perspective, view of the tool 20 according to the first aspect. The proximal end portion 28 of the conduit element 24 is configured to receive the open-ended proximal portion 38 of the hollow rigid inserter pin 36. Fig. 2A illustrates one implementation of the proximal end portion 28 of the conduit element 24 of the tool 20 with the open-ended proximal portion 38 of the hollow rigid inserter pin 36 of the tool 20 received therein, with the tool 20 extending along longitudinal axis A-A between distal end portion 26 and proximal end portion 28 of the conduit element 24 and inserted through a puncture in the tracheoesophageal wall (the TEP). The flexible housing 22 includes a substantially perpendicularly extending oesophageal flange 30 adjacent to the proximal end portion 28. In Fig. 2A, the hollow rigid inserter pin 36 can be understood to be placed (inserted) proximally as far as possible inside the conduit element 24. This proximal- most positioning of the hollow rigid inserter pin 36 is ideal for allowing the clinician to control the tool 20 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. 2A.

[0083] Fig. 2A further illustrates an orifice 39 included in the proximal end portion 28 of the conduit element 24 that is configured to combine with the open-ended proximal portion 38 of the hollow rigid inserter pin 36. It is understood that the orifice 39 and the fluid communication opening 67 in the open-ended proximal portion 38 of the hollow rigid inserter pin 36 together provide a path that allows for fluid communication with the hollow rigid inserter pin 36, particularly with an inside lumen 37 thereof. Further shown in Fig. 2A is the open-ended distal portion 40 of the hollow rigid inserter pin 36 adapted for connection with a pressure gauge (not shown). In Fig. 2A, the open-ended distal portion 40 of the hollow rigid inserter pin 36 includes a barbfitting 51 adapted for connection with the pressure gauge. The barb-fitting 51 is shown to include a continuous ridge 53 that is used to grip an inside diameter of a connector portion of the pressure gauge and seal the connection therebetween.

[0084] In the implementation of Fig. 2A, the tool 20 includes a first group of measurement indicia (not visible) 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. Fig. 2A further illustrates 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 and is adapted to allow checking of the second group of measurement indicia 33 on the external surface 34 of the conduit element 24.

[0085] Accordingly, in one approach to measuring the thickness "t" of the tracheoesophageal wall TW (cf. Fig. 2A), the clinician 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 20 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 from the second group of measurement indicia 33, which is the indicator value visible closest to the distal end portion 50 of the measuring sleeve 46. In the implementation illustrated in Fig. 2A, 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 (see Fig. IB) of the first group of measurement indicia 32 and a proximal-most indicator value 45 of the second group of measurement indicia 33 (Fig. IB), whereby the 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 (illustrated in Fig. 5) 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.

[0086] In the implementation of Fig. 2A, the proximal end portion 48 of the measuring sleeve 46 includes a substantially radially 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 function together to provide an advantageous tactile sensation indicating correct location of the tool to the clinician for measurement of the thickness "t" by engagement on each their side of the tracheoesophageal wall TW.

[0087] In implementations, such as shown in Fig. 2A, the tracheal flange 52 is configured for sealing engagement with the tissue of the patient, i.e., the tissue of the tracheal side TS of the tracheoesophageal wall TW. In the implementation of Fig. 2A, the tracheal flange 52 is provided in the form of a silicone sealing-washer 52. In the implementation of Fig. 2A, the silicone sealing-washer 52 includes an umbrella-shape to create a soft pretension and ensure a good seal against the tissue at the tracheal side TS.

[0088] As also seen in the schematic view of the tool 20 of Fig. 2A, and in Figs. 1A-1C, in implementations, the hollow rigid inserter pin 36 includes a radially extending safety flange 56. In the implementation of Fig. 2A, the safety flange 56 is shown to be provided adjacent to the open-ended distal portion 40 of the hollow rigid inserter pin 36. The radially extending safety flange 56 ensures that the rigid inserter pin 36 cannot accidentally slip into the trachea of the patient. In the view of Fig. 2A, the radially extending safety flange 56 is provided as a T-bar with a curved cross-bar of the 'T' forming the safety flange 56. As also seen in Fig. 2A (and Figs. 1A-1C), 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 extending in a direction transverse to the strand 60 at a distal end 64 of the strand. In Fig. 2A, 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. In implementations, the stoppage plate 62 of the safety frame 58 of the flexible housing 22 is adapted to engage with and releasably lock the radially extending safety flange 56 of the rigid inserter pin 36. In the illustration of Fig. 2A the stoppage plate 62 includes a cut-out corresponding to the shape of the safety flange 56 in which the safety flange 56 may fit in holding or locking engagement. Such holding or locking engagement prevents any relative movement between the flexible housing 22 and the hollow rigid inserter pin 46. The stoppage plate 62 of the safety frame 58 and the safety flange 56 of the hollow rigid inserter pin 36 combine to prevent the flexible housing 22 (in addition to the safety flange 56 of the hollow rigid inserter pin 36 itself) from accidentally slipping into the oesophagus or the trachea of the patient.

[0089] Fig. 2A further schematically illustrates the situation when the flexible housing 22 with the hollow 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 oesophageal flange 30 is located in the oesophagus). The oesophageal flange 30 is pliable and flexible due to the flexibility of the material of the flexible housing 22 and therefore easily moved through the TEP. As illustrated in Fig. 2A, the clinician can make a slight movement of the flexible housing 22 in the distal direction, such that a distal surface 43 of the oesophageal flange 30 engages with the tissue at the oesophageal side OS of the tracheoesophageal wall TW.

[0090] Figure 2B is a schematic, perspective view illustrating one implementation of the tool 20 according to the disclosure. Fig. 2B schematically shows the tool 20 sitting in the TEP from a vantage point on the oesophageal side OS of the tracheoesophageal wall TW. Fig. 2B shows the proximal end portion 28 of the conduit element 24 extending through the TEP and located at the oesophageal side of the TW. Adjacent to the proximal end portion 28 of the conduit element 24 is the oesophageal flange 30 of the flexible housing 22. A distal side or surface (not visible) of the oesophageal flange 30 is configured to engage with the oesophageal side OS of the tracheoesophageal wall TW. The proximal end portion 28 of the conduit element 24 includes an orifice 39 that is configured to combine with a fluid communication opening 67 (Fig. 3C) in the open-ended proximal portion 38 of the hollow rigid inserter pin 36 (open-ended proximal portion 38 somewhat visible through the orifice 39). It is understood that the orifice 39 and the fluid communication opening 67 in the open- ended proximal portion 38 of the hollow rigid inserter pin 36 are configured to combine to provide a path that allows for fluid communication into and through the inside lumen 37 (Fig. 2A) of the hollow rigid inserter pin 36 and therethrough further to the open-ended distal portion 40 of the hollow rigid inserter pin 36, which in turn is adapted for connection with a pressure gauge (cf. Fig. 6).

[0091] As also visible in the schematic view of Fig. 2B, the oesophageal flange 30 can suitably include a circular or rounded outer peripheral contour. In implementations, the oesophageal flange 30 includes a circular outer peripheral contour and has a radial extent of about 3mm (i.e., the flange extends annularly and about 3mm outward from the external surface 34 of the conduit element 24 of the flexible housing 22). Moreover, in implementations such as illustrated in the schematic view of Fig. IB, an external longitudinal extent "q" of the proximal end portion 28 of the conduit element 24 corresponds to a length of the portion of the flexible housing 22 which is proximal to the oesophageal flange 30. In the exemplary view of Fig. IB, the external longitudinal extent "q" can be considered about 7mm.

[0092] Referring now to the schematic, sectional views of Figs. 3A-3C, the proximal portion 38 of the hollow 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 open-ended proximal portion 38 of the hollow rigid inserter pin 36 sealingly engages with the inside of the proximal end portion 28 of the conduit element 24. Figs. 3A-3C show implementations wherein the open-ended proximal portion 38 of the hollow rigid inserter pin 36 is shaped to form a tapered (or tapering) end portion 66. In Figs. 3A-3C, the tapered end portion 66 is formed as a truncated cone. The truncation plane of the tapered end portion 66 corresponds to a plane of a fluid communication opening 67 in the open-ended proximal portion 38 of the hollow rigid inserter pin 36. In the implementations of Figs. 3A-3C, the tapered end portion 66 of the open-ended proximal portion 38 of the hollow 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 20. As further illustrated in Figs. 3A-3C, and particularly visible in Fig. 3C, in implementations, the conduit element 24 at the proximal end portion 28 thereof is adapted to receive the open-ended proximal portion 38 of the hollow rigid inserter pin 36 and thus the elements can combine in engagement with each other, such as by sealing engagement with each other as seen in Fig. 3A. Particularly in the view of Fig. 3C, the proximal end portion 28 of the conduit element 24 can be seen to include a tapering inner wall portion 70 extending to the orifice 39 in the proximal end portion 28 of the conduit element 24. It is understood that the orifice 39 is configured to combine with the fluid communication opening 67 in the open-ended proximal portion 38 of the hollow rigid inserter pin 36. It is understood that the orifice 39 and the fluid communication opening 67 together provide a passage that allows for fluid communication into and through the inside lumen 37 of the hollow rigid inserter pin 36.

[0093] In the implementation of Fig. 3A, the sealing engagement between the hollow rigid inserter pin 36 and the conduit element 24 is 'complete' with no pockets of air or other space or clearance between the inside surfaces of the conduit element 24 and the tapered end portion 66 of the open-ended 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 tapered end portion 66 of the open-ended 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 forms a space 44 or clearance (Fig. 3B) for the proximal portion 38 of the hollow rigid inserter pin 36 at the proximal end portion 28 of the conduit element 24, such that the hollow rigid inserter pin 36 can be brought into position to be ready for the insertion of the tool 20 in the patient with no or little resistance to the engagement of the components with each other. The space or clearance 44 formed in an internal volume 42 of the proximal end portion 28 of the conduit element 24 is suitably complementary to the tapered end portion 66 of the open-ended proximal portion 38 of the hollow rigid inserter pin 36, e.g., the components can be considered to have entirely matching surfaces. With reference to the situation in Fig. 3A, it is further understood that the fluid communication opening 67 in the in the open-ended proximal portion 38 of the hollow rigid inserter pin 36 here is substantially flush with the orifice 39 in the proximal end portion 28 of the conduit element 24.

[0094] Figure 3B further illustrates a situation wherein, for removal of the tool 20 after measurement of a peak pressure in the oesophagus (using the pressure gauge, see Fig. 6), the hollow rigid inserter pin 36 has been pulled slightly in the distal direction thereby disengaging the open-ended proximal portion 38 of the rigid inserter pin 36 from 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 hollow rigid inserter pin 36 from inside the proximal end portion 28 of the conduit element 24 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 hollow rigid inserter pin 36 has been retracted or withdrawn even further from the proximal end portion 28 of the conduit element, thereby better illustrating the space or clearance 44 between the hollow rigid inserter pin 36 and the proximal end portion 28 of the conduit element 24. According to 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 hollow 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 somewhat 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 (flexible) oesophageal flange 30 through the TEP significantly smaller and makes hence the removal procedure more gentle on the tissue of the patient. With reference to the schematic, perspective view of Figure 4A, showing the conduit element 24 located through the TEP in the tracheoesophageal wall TW, the tool 20 allows a clinician to determine a thickness of the TW by checking the value of that particular indicator of the second group of measurement indicia 33 on the external surface 34 of the conduit element 24, which is closest to, and visible on, the tracheal side of the TW. In the views of Fig. 4A (and Fig. 5) the indicator value indicates a thickness of the tracheoesophageal wall TW of approximately 8mm. In the illustrated 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. 7). The clinician reads off the relevant indicator value (8mm) of the second group of measurement indicia 33 and thereby determines the relevant thickness "t" of the tracheoesophageal wall TW using the tool 20. The second group of measurement indicia 33 is shown to suitably include a plurality of individual indicators having each their value. In the view of Fig. 4A, the second group of measurement indicia 33 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. 4A further illustrates that the second group of measurement indicia 33 additionally includes at least partially circumscribing indicator lines 72 on the conduit element 24 with one line per indicator value step.

[0095] Figures 4B, 4C and 4D 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. 4A-4D 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. 4C) and adapted to allow checking of the second group of measurement indicia 33 on the external surface 34 of the conduit element 24.

[0096] In one approach to measuring a thickness of a tracheoesophageal wall TW as illustrated in the schematic views of Figs. 4A and 4D, 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 is 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. 4D 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. 4A- 4D, 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. 4B) of the first group of measurement indicia 32 and a proximal-most indicator value 45 of the second group of measurement indicia 33 (Fig. 4B), whereby the 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.

[0097] In implementations as illustrated in the views of Figs. 4A-4D, 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.

[0098] In implementations as illustrated in the schematic perspective view of Figure 4B, 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. 4B, 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.

[0099] Figure 5 is an enlarged schematic sectional view of one implementation of the tool 20 of the disclosure. In Fig. 5, the sectional view shows a portion of the 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 includes an indicator line 72 including 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. 5, each of the protrusions 76 of the measuring sleeve 46 extends radially inward from an internal surface of the measuring sleeve 46 at the distal end portion 50 thereof. In Fig. 5, the distal end portion 50 of the measuring sleeve 46 includes a series of flaps 77 formed by cut-outs 78 separating the flaps 77. 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 (by a protrusion 76 entering a groove 74). 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 VP to be provided to the patient. In the view of Fig. 5, the relevant indicator value 49 indicates a thickness of the tracheoesophageal wall TW of approximately 8mm.

[0100] Figure 6 is a schematic, perspective view illustrating one implementation of a system 100 for facilitating selection of a size and the opening pressure of a voice prosthesis, including a tool 20 in accordance with the first aspect of the disclosure and a pressure gauge 102. In implementations of the system 100, such as illustrated in Fig. 6, the pressure gauge 102 includes a connector portion 104 adapted for connection to the open-ended distal portion 40 of the hollow rigid inserter pin 36 to provide fluid communication between the pressure gauge 102 and the tool 20 (and in turn to the oesophageal side of the tracheoesophageal wall TW via the inside lumen 37 (Fig. 2A) of the hollow rigid inserter pin 36 and the fluid communication opening 67 (not visible) in the open-ended proximal portion 38 thereof (not visible) combining with the orifice 39 provided in the proximal end portion 28 of the conduit element 24). In the implementation of Fig. 6, the connector portion 104 suitably includes a hose component 106 including a coupling end 108 for connection to the open-ended distal portion 40 of the hollow rigid inserter pin 36. As in the implementation of Fig. 2A, the open-ended distal portion 40 of the hollow rigid inserter pin 36 can include a barbfitting 51 (Fig. 2A) for example including a continuous ridge 53 (Fig. 2A) that is used for gripping an inside diameter of the coupling end 108 of the connector portion 104 of the hose component 106 and seal the connection between the open-ended distal portion 40 of the hollow rigid inserter pin 36 and the hose component 106.

[0101] Figure 7 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 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.

[0102] Figure 8 is a schematic plan view of a kit of parts 81 including a tool 20 shown in a sectional view and further including a set of instructions for use (IFU) 82. In the implementation illustrated in Fig. 8, the tool 20 includes a flexible housing 22 including a conduit element 24 including at least a second group of measurement indicia 33, a hollow rigid inserter pin 36 and a measuring sleeve 46. In the implementation shown in Fig. 8, the kit of parts 81 further includes a packaging 84 including at least one sterile compartment 86 for holding sterilized parts of the kit of parts and a non-sterile compartment 88 for holding at least the instructions for use 82. In the implementation shown in Fig. 8, the kit of parts 81 further includes a pressure gauge 102 including a connector portion 104. The pressure gauge 102 is adapted to be connected to the open-ended distal portion 40 of the hollow rigid inserter pin 36 of the tool 20, via the connector portion 104, e.g., facilitated by coupling end 108 of the hose component 106, and adapted to facilitate measurement of a peak pressure in the oesophagus of a patient during swallowing to determine the right opening pressure of a voice prosthesis.

[0103] 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.

[0104] Index of reference numbers

[0105] 20 tool

[0106] 22 flexible housing

[0107] 24 conduit element

[0108] 26 distal end portion (of conduit element 24)

[0109] 28 proximal end portion (of conduit element 24)

[0110] 30 oesophageal flange

[0111] 32 first group of measurement indicia

[0112] 33 second group of measurement indicia

[0113] 34 external surface (of conduit element 24)

[0114] 35 proximal-most indicator value (of first group of measurement indicia 32)

[0115] 36 hollow rigid inserter pin

[0116] 37 inside lumen (of hollow rigid inserter pin 36)

[0117] 38 open-ended proximal portion (of hollow rigid inserter pin 36)

[0118] 39 orifice (of proximal end portion 28 of conduit element 24)

[0119] 40 open-ended distal portion (of hollow rigid inserter pin 36)

[0120] 42 internal volume

[0121] 43 distal side or surface (of oesophageal flange 30)

[0122] 44 space or clearance

[0123] 45 proximal-most indicator value (of second group of measurement indicia 33)

[0124] 46 measuring sleeve

[0125] 48 proximal end portion (of measuring sleeve 46)

[0126] 49 indicator value

[0127] 50 distal end portion (of measuring sleeve 46)

[0128] 51 barb-fitting

[0129] 52 tracheal flange / silicone sealing-washer (of proximal end portion 48)

[0130] 53 continuous ridge

[0131] 56 safety flange

[0132] 58 safety frame

[0133] 60 strand

[0134] 62 stoppage plate

[0135] 64 distal end of strand 60 66 tapered end portion (of open-ended proximal portion of hollow rigid inserter pin 36)

[0136] 67 fluid communication opening

[0137] 68 external surface (of tapered end portion 66)

[0138] 70 tapering inner wall portion

[0139] 72 indicator lines

[0140] 74 grooves

[0141] 76 protrusions

[0142] 77 flaps

[0143] 78 cut-outs

[0144] 79 skin-adhesive component

[0145] 80 HME device

[0146] 81 kit of parts

[0147] 82 instructions for use

[0148] 84 packaging

[0149] 86 sterile compartment of packaging

[0150] 88 non-sterile compartment of packaging

[0151] 100 system

[0152] 102 pressure gauge

[0153] 104 connector portion

[0154] 106 hose component

[0155] 108 coupling end

[0156] IFU instructions for use

[0157] OE oesophagus

[0158] OS oesophageal side

[0159] TEP tracheoesophageal puncture

[0160] TO tracheostoma

[0161] TR trachea

[0162] TS tracheal side

[0163] TW tracheoesophageal wall

[0164] VP voice prosthesis

Claims

CLAIMS:

1. A tool for measuring a thickness of a tracheoesophageal wall in a patient and for facilitating determination of a peak pressure in the oesophagus of 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 hollow rigid inserter pin comprising an open-ended proximal portion and an open-ended distal portion, the hollow rigid inserter pin adapted to fit and move inside the conduit element, where the open-ended proximal portion of the hollow 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 is configured to receive the open-ended proximal portion of the hollow rigid inserter pin and comprises an orifice configured to combine with the open-ended proximal portion of the hollow rigid inserter pin to provide fluid communication with the hollow rigid inserter pin, and wherein the open-ended distal portion of the hollow rigid inserter pin is adapted for connection with a pressure gauge.

2. The tool of claim 1, wherein the tool comprises 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 overand 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 radially extending tracheal flange.

5. The tool of claim 4, wherein the substantially radially extending tracheal flange of the proximal end portion of the measuring sleeve is configured for sealing engagement with tissue of a patient.

6. The tool of any one of claims 4-5, wherein the substantially radially extending tracheal flange comprises a silicone sealing-washer.

7. The tool of any one of the preceding claims, wherein one or more inner wall portion(s) of the proximal portion of the conduit element is / are adapted to be complementary in shape to one or more external surface portion(s) of the open-ended proximal portion of the hollow rigid inserter pin.

8. The tool of any one of the preceding claims, wherein the proximal end portion of the conduit element comprises an internal volume configured to receive the open- ended proximal portion of the hollow rigid inserter pin.

9. The tool of any one of the preceding claims, wherein the hollow rigid inserter pin comprises a radially extending safety flange adjacent to or at the open-ended distal portion.

10. 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 thedistal 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.

11. The tool of claim 10, when dependent on claim 9, wherein the stoppage plate of the safety frame of the flexible housing is adapted to engage with and releasably lock the radially extending safety flange of the open-ended distal portion of the hollow rigid inserter pin.

12. The tool of any one of claims 2-11, 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.

13. The tool of any one of the preceding claims, wherein the open-ended proximal portion of the of hollow rigid inserter pin comprises a fluid communication opening.

14. A system for facilitating selection of a size and opening pressure of a voice prosthesis, comprising the tool according to any one of claims 1-13 and a pressure gauge.

15. The system according to claim 14, wherein the pressure gauge comprises a connector portion adapted for connection to the open-ended distal portion of the hollow rigid inserter pin to provide fluid communication between the pressure gauge and the tool.

16. The system according to claim 14, wherein the pressure gauge comprises a connector portion and further comprises an adaptor piece, the adaptor piece configured for connection to the open-ended distal portion of the hollow rigid inserter pin and to a connector portion of the pressure gauge to help provide fluid communication between the pressure gauge and the tool.

17. A kit of parts comprising the tool of any one of claims 1-13, further comprising a set of instructions for use.

18. The kit of parts of claim 17, further comprising a packaging.

19. The kit of parts of any one of claims 17-18, further comprising a pressure gauge.

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