GB2579817A

GB2579817A - Cleft palate and lip surgical simulator

Info

Publication number: GB2579817A
Application number: GB1820421.4A
Authority: GB
Inventors: Echlin Kezia; Pereira Crespo Fiadeiro Rute
Original assignee: Guys And St Thomas Hospital Nhs Found Trust; Guys and St Thomas NHS Foundation Trust
Current assignee: Guys And St Thomas Hospital Nhs Found Trust; Guys and St Thomas NHS Foundation Trust
Priority date: 2018-12-14
Filing date: 2018-12-14
Publication date: 2020-07-08
Anticipated expiration: 2038-12-14
Also published as: GB2579817B; GB201820421D0; GB201908165D0

Abstract

A cleft palate simulator tool (10) includes a base unit (12) provided with first and second couplings (32, 36); a lower jaw unit (18) provided with a lower jaw coupling (24) connectable to the first base unit coupling (32); a palate unit (20) provided with a palate coupling (26) connectable to the second base unit coupling (36). At least one of the jaw coupling (24) and the palate coupling (26) is pivotally coupled to the base unit (12) so as to enable the lower jaw and palate units (18, 20) to be rotated relative to one another. The palate unit (20) may also be movable translationally towards and away from the lower jaw unit (18). Each unit (18, 20) includes an anatomical base element (42, 70) of hard material overlaid with layers representative of soft tissue components. The apparatus also includes a series of moulds (80) for in situ formation of at least the soft tissue layers of the lower jaw and/or palate units (18, 20).

Description

CLEFT PALATE AND LIP SURGICAL SIMULATOR

Technical Field

The present invention relates to a cleft palate and lip surgical simulator tool, to an assembly therefor and to a method of configuring a cleft palate simulator tool for use in training. It is to be understood that references to cleft palate herein are intended to comprise instances of a cleft palate only, of a cleft lip and of both a cleft palate and a cleft lip.

Background of the Invention

Cleft Lip and Palate (CLP) is a split in the upper lip and/or roof of the mouth, due to a failure of fusion of the embryonic facial and palatal processes. It is the most common craniofacial deformity worldwide; currently 1 in 639 babies is born with a cleft lip and/or palate in the United Kingdom. In the developing world, it is estimated that this condition affects more than 750,000 babies per annum. Many of these children do not receive the required surgery, often resulting in stigmatisation and social exclusion. An unrepaired cleft palate will lead to problems with feeding and speech production.

Cleft lip and palate repair are challenging procedures to master because of the fragile tissues and limited space in an infant's oral cavity. Getting the surgery right the first time is paramount in cleft; even subtle errors can lead to a worse outcome for the child. This may require long courses of therapy or multiple further surgeries, which tend to have diminishing returns.

Surgeons benefit from the opportunity to hone their skills on a simulator before performing the surgery on a living patient.

Some exemplary prior disclosed simulator systems are known in US-2017/0358248 and CN-101673481.

Summary of the Invention

The present invention seeks to provide an improved cleft palate and lip surgical simulator tool, an assembly therefor and a method of configuring a cleft palate simulator tool for use in surgical training.

According to an aspect of the present invention, there is provided a cleft palate simulator tool including: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a plurality of soft tissue simulator elements attachable to at least the palate unit.

The tool can provide a simulated mouth anatomical structure, typically an infant's mouth, with the ability to pivot the lower jaw and the palate units relative to one another in effect so as to open the units, for example beyond their normal open mouth configuration, or to close them to a configuration closer to that experienced in a patient's mouth. This has the advantage of enabling a physician to train with the tool and simulated mouth anatomy in a variety of positions, including positions more convenient for basic learning. The tool can then be reused, as explained below, for practicing in a more natural patient configuration or as would be found in patients with more limited mouth opening thus making the surgery more challenging. Thus, the tool allows for a variety of different training modes with the same apparatus.

In the preferred embodiment, both the lower jaw unit and the palate unit are pivotally coupled to the base unit.

Advantageously, at least one of the lower jaw unit and the palate unit is slidably coupled to the base unit by a sliding mechanism providing for movement thereof towards or away from the other of the lower jaw unit and the palate unit.

This can be achieved by a sliding mechanism providing for movement of the lower jaw unit towards or away from the palate unit. This can be particularly advantageous for early training, for instance where it is desired to space the lower jaw unit and the palate unit away from one another so that a physician can concentrate training on the simulated palate only.

Preferably, the tool includes a locking mechanism for locking the lower jaw unit and the palate unit to the base unit.

Preferably, the lower jaw unit and the palate unit are separate elements.

This provides the tool with greater flexibility and the ability to position the lower jaw and palate units in a greater variety of relative orientations and positions for training optimisation.

Advantageously, at least one of the lower jaw unit and the palate unit includes one or more removable anatomical elements, said anatomical elements including fixings for attachment to the base unit. This enables the device to be modified for different cleft palate and mouth anatomies and also for the tool to be reused.

The lower jaw unit preferably includes a removable lower jaw anatomical element. The palate unit preferably includes at least one removable upper mouth anatomical element. In a practical embodiment, the palate unit includes at least two removable upper mouth anatomical elements, shaped so as to define a cleft profile therebetween. The palate unit preferably includes at least one oral mucosa hard palate element with a nasal lining, and at least one nasal mucosa soft palate element.

The or at least one of the anatomical elements is advantageously formed of a plurality of layered materials, which enables the tool to model the anatomy of a patient's mouth, particularly to simulate the various layers of tissue, muscle, cartilage and bone, as appropriate. Thus, the layered materials preferably include the plurality of soft tissue simulator elements of the palate unit.

In the preferred embodiments" the layered materials have different stiffness characteristics, typically different Shore hardnesses.

It is envisaged that the tool would be provided with a mould for forming the at least one anatomical element. This enables a physician to mould anatomical elements in situ and also to reuse the tool for repeated training attempts and/or for different mouth shapes and cleft palate/lip conditions.

According to another aspect of the present invention, there is provided a method of configuring a cleft palate simulator tool, which tool comprises: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a plurality of soft tissue simulator elements attachable to at least the palate unit; the method comprising the steps of: providing on each of the lower jaw unit and the palate unit an anatomical element; pivoting the lower jaw unit and/or the palate unit to a desired angle therebetween and fixing the lower jaw unit and/or the palate unit to the base unit so as to lock the lower jaw unit and the palate unit relative to one another.

The method preferably includes the step of adjusting a distance of the lower jaw unit and the palate unit relative to one another and then locking the lower jaw unit and the palate unit relative to one another.

In the preferred embodiments, the method includes the step of forming at least one of the anatomical elements in a mould and attaching to the respective lower jaw unit and palate unit.

According to another aspect of the present invention, there is provided a cleft palate simulator tool kit comprising: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a mould configured to produce at least an anatomical element comprising a plurality of soft tissue simulator elements for the palate unit.

Preferably, the kit includes a plurality of polymer materials for moulding layered anatomical elements. These may be provided in the form of flowable materials or as sheets of mouldable material, advantageously colour-coded.

A preferred embodiment provides a cleft palate simulator tool that includes a base unit provided with first and second couplings, a lower jaw unit provided with a lower jaw coupling member connectable to the first base unit coupling; a palate unit provided with a palate coupling member connectable to the second base unit coupling. At least one of the jaw coupling member and the palate coupling member is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another. The palate unit may also be movable translationally towards and away from the lower jaw unit. Each unit includes an anatomical base element of hard material overlaid with layers representative of soft tissue components. The apparatus also includes a series of moulds for in situ formation of at least the soft tissue layers of the lower jaw and/or palate units.

Other aspects and advantages of the teachings herein will become apparent to the skilled person from the specific description and claims that follow.

Brief Description of the Drawings

Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a side elevational view of an embodiment of tool according to an embodiment of the invention; Figure 2 is a view of a pad of the tool of Figure 1 showing the movement of the palate unit of the tool; Figure 3 is an exploded view of an example of palate unit for the tool of Figure 1; Figure 4 is view of a schematic mould for the tool of Figure 1 and the kit taught herein; Figure 5 is view of the schematic mould of Figure 4 for use in the formation of an anatomical structure for the tool of Figure 1; Figure 6 is a bottom plan view of a palate unit showing the hard material anatomical structures of a simulated cleft palate; Figure 7 is a bottom plan view similar to Figure 6, showing the palate unit with soft material anatomical structures of a simulated cleft palate; and Figure 8 shows the stages of moulding of a preferred embodiment of method of forming a simulated cleft palate in accordance with the teachings herein.

Description of the Preferred Embodiments

There are described below embodiments of a cleft lip and palate simulator tool used in training physicians and other medical practitioners. The tool is able to provide a high-fidelity simulator for the intended procedure and it allows the user (trainees and even consultants) to practice surgery on the main types of clefts, using a number of techniques. The tool is configurable and also reusable.

Surgical simulators can assist in improving surgical technique, clinician confidence, patient safety and lead to better surgical outcomes.

In the preferred embodiments, described below, the tool may be provided as a kit with a mould and the materials needed to create anatomical forms to be attached to the tool for training purposes. By such kit, a user is able to make further anatomical forms for further practice and training, for simulating different cleft palate and/or cleft lip conditions and also for repair of the anatomical elements of the tool should these be accidently broken or damaged, for example during transportation, storage or use.

The tool can be made to be operable relatively easily and with minimal instruction, enabling the tool to be used across the world, including in regions where local staffed training facilities may be sparse.

It is to be appreciated that the accompanying drawings are schematic only and intended to highlight the primary components and characteristics of the 30 apparatus.

The accompanying drawings show a tool with anatomical models or elements representative of a cleft palate. It will be appreciated that in other examples, the anatomical models or elements may be provided also with simulated lips, and as appropriate, teeth structures to further aid in training. Such simulated elements can readily be provided with the apparatus described herein including, for example, the moulds and soft tissue raw materials provided.

Referring first to Figure 1, this shows in schematic form a side elevational view of a tool 10 used as a cleft palate surgical simulator. The tool 10 includes a base unit 12 preferably made of a rigid material, such as acrylic, although any other rigid material may be used. It is envisaged that in some embodiments at least the base 12 will be made of a transparent or translucent material to enable visualisation of the other components of the tool, particularly during simulated training.

The base unit 12 is preferably provided with anti-slip feet 14 which may be made of a rubber or similar material. In Figure 1, two anti-slip feet 14 are visible and these may either extend across the width of the unit (into the paper) or there may be provided, for example, four feet 14, one at each corner of the lower surface of the base unit 12.

The base unit 12 includes a hollow internal cavity with an opening at its upper, preferably inclined, wall 16 for accommodating the other components of the tool 10, in particular a lower jaw unit 18 and an upper mouth or palate unit 20. The lower jaw and palate units 18, 20 include, in this embodiment, coupling members 24, 26, which may be in the form of support plates, separate coupling bars or the like. The coupling members 24, 26 are fixed to their relative unit 18, 20 preferably by releasable fixings 28, such as screws, pins, bolts, snap fit connections and so on. Figure 1 shows the releasable fixings as screws that fit through appropriate apertures or bores 30 in the coupling members and then into suitable threaded recesses (not shown in the drawings) in the anatomical formation.

While Figure 1 shows releasable fixings 28 only to the palate unit 20, it is to be understood that similar releasable fixings may be provided for the lower jaw unit 18.

In the embodiment shown, the palate unit 20 is attached via the coupling member 26 to the base unit 12 by means of one or more pins 32 connected to the coupling member 26 and a suitable receiving element in the base unit 12, such as a recess, bore or opening. The coupling member 26, and as a consequence the palate unit 20, are able to pivot about the pins 32 so as to change the angle of orientation of the palate unit 18.

In the preferred embodiment, a locking element is provided to lock the coupling member 26 and hence the palate unit 18 in a particular orientation. In the preferred embodiment, the receiving element in the base unit 12 is a circular opening able to receive a butterfly screw or similar. It will be appreciated that any other suitable locking mechanism could be used, including for example an interlocking tooth mechanism. While it is preferred that the apparatus includes a locking device, it is not excluded that in some embodiments the palate unit 20 (and as appropriate the lower jaw unit 18) could be kept in position simply by friction between the coupling member 26 and the base unit 12 and/or pins 32.

In the embodiment shown in Figure 1, the lower jaw unit 18 couples to a pair of oppositely arranged slots 34 in the wall of the base unit 12, which in this embodiment extend substantially parallel to the upper wall 16 of the base unit 12.

The coupling member 24 of the lower jaw unit 18 includes pins 36 that fit into the slots 34.

With reference to Figure 2A, the slots 34 enable the opposing pins 36 to rotate the coupling member 24 relative to the base unit 12, as depicted by arrow 38 in Figure 2, and also for the pins 36 to more translationally, that is horizontally, within the slots 34 and in practice towards and away from the lower jaw unit 18, as depicted by arrow 40 in Figure 2A. A locking mechanism similar to that for the palate unit 20 is preferably also provided for the lower jaw unit 18. By contrast, the palate unit 20 only rotates bout pin 32, as depicted by the arrow 37 in Figure 2B.

In the embodiment of Figures 1 and 2B, the palate unit 20 includes at least one anatomical formation 42, described in further detail below, fitted to the coupling member 26 and also to a support element 44, integral with or connected to the coupling member 26 and which includes at least one depending flange 46. The at least one depending flange 46 provides further support to the anatomical formations 42, as well as an alignment mechanism for aligning the palate unit 20 relative to the base unit 12 and in practice to the lower jaw unit 18. In particular, the flanges 46 provide a solid point of attachment for the soft tissues of the velum (soft palate).

The lower jaw unit 18 also includes an anatomical formation 70, representative of a lower mouth structure.

As it will be apparent from Figure 1, the lower jaw unit 18 and the palate unit 20 are preferably separate elements, that is not connected together as would be the case with a patient's mouth. In this manner, the palate unit 20 and the lower jaw unit 18 can be positioned in a variety of different configurations not necessarily representative of a mouth open configuration, intended to provide much better access to the anatomical formations on the units 20, 18 for training and practice purposes. For instance, in an early training session it may be desired to position the palate unit 20 in a substantially horizontal configuration, as depicted in Figure 1, to provide open and unimpeded access thereto, which typically would not be possible if the palate unit 20 were coupled to the lower jaw unit 18 in a manner mimicking a patient's mouth. Similarly, as the units 18, 20 are not coupled together, the tool 10 enables the units 20, 18 to be spaced from one another at varying distances. This enables, for example, the lower jaw unit 18 to be positioned at a maximum distance from the palate unit 20 in early training sessions and then moved closer to the palate unit 20 once the user has gained sufficient skill, at which point the lower jaw unit 18 may also be pivoted towards the palate unit 20 (in a clockwise direction) so as to locate the units 18, 20 more closely in line with the configuration of a patient's mouth when open.

Referring now to Figure 3, in the preferred embodiments, the palate unit 20 and/or the lower jaw unit 18 include anatomical formations made of a plurality of components and/or a plurality of layers. In Figure 3, the palate unit 20 shown is formed of a number of connected but separable components. More specifically, the anatomical formation of the cleft palate unit 20 includes first and second elements 50, 51 shaped as to be representative of the palate anatomy. In this example they include the palato shelf, the vomer, the inferior turbinates and the aveolar arch and if desired, the bony passages for the descending and greater palato arteries. The elements 50, 51 are connected to the coupling member 26 and also bounded by a support unit 44 having side flanges 46. Screws 28 pass through apertures 52 in the coupling member or plate 26 and into threaded recesses (not shown) in the anatomical formations 50, 51. In other embodiments, the screws 28 could engage with threaded recesses at a rear portion of the flange unit 46.

Figure 3 also shows the pin 36 that couples the palate unit 20 to the base unit 12. In this embodiment, the pin 36 is in the form of a screw or bolt that engages a threaded bore 58 in the coupling member 26. The screw 36 includes a screw head 60, which may be a butterfly head or other suitable finger grip. The screw head enables a user to tighten or loosen the screw 36 manually to lock or release movement of the palate unit 20 relative to the base unit 12. It will be appreciated that an equivalent pin structure may be provided at the other side of the coupling member 26, although only a single locking element may be provided for each unit 18, 20.

Also shown in Figure 3 is a cleft lip element 62 provided, in this example, with a plurality of snap-fit fasteners 64 that fit into suitable recesses or apertures 54 in the depending flanges 46, enabling the cleft lip formation 62 to be releasably fitted to the palate unit 20 so as to simulate, with the palate anatomical formation 42, a cleft lip and cleft palate combination.

It is envisaged that at least some of the anatomical formations could be pre-formed for use with the tool, for example in a manufacturing facility, although it is not excluded that in some embodiments these components may be formed in-situ by way of one or more moulds as described below.

It is preferred that at least the lower jaw unit 18 includes an anatomical formation 70 that is pre-formed and permanently attached to the coupling bar 24 and that this maybe formed, for example by moulding or 3-D printing. The formation 70 could be made of a Vero material typical in 3-D printing technology. Any other suitable materials, for example polymeric or ceramic, may be used. While the formation 70 is preferably rigid it may be provided with one or more layers of pliable material to replicate soft tissue and muscle components of the lower jaw.

Similarly with the palate element 20, this preferably includes an anatomical formation 42 that includes a base structure preformed, that is at a manufacturing facility, although again it is not excluded that this may be formed in-situ, for example, with a suitable mould. In the case of pre-formation, the hard components of the anatomical formation 42 may be 3-D printed and similarly made of a suitable Vero material or any other suitable material. In other embodiments, the anatomical formation 42, and equally that of the lower jaw unit 18, may be injection moulded, vacuum cast or formed by any other suitable process.

The other elements of the anatomical formation 42 of at least the palate unit are preferably moulded in-situ by means of a mould of which an example is shown in Figures 4 and 5. It will be appreciated that the mould 80 shown in these drawings is a schematic example only and that in practice would include a mould chamber 82 shaped to the palate 20, specifically to the anatomical formation 42. The mould 80 is made of a relatively rigid material able to accommodate the constituent elements used for the soft tissue and muscle components of the palate unit 20, which may be produced for example by silicone casting. In other examples, this may be by chemical hardening or heat formed.

Referring now to Figures 6 and 7, these show an example of the hard anatomical formations of the palate unit 20, that is of the formations 50, 51 shown in Figure 3. These are shaped to be representative of a typical cleft palate and provided with a gap therebetween. In particular, a first of the formation 50 is shaped to representative of the palato shelf, the aveolar arch, the vomer and also the descending palato artery. The other formation 51 includes features representative of the inferior turbinates.

With reference to Figure 7, formed onto the rigid anatomical formation elements there are preferably provided layers representative of the softer anatomical components of a palate, including the oral mucosa of hard palate, for example made of a silicone rubber, particularly a platinum silicone rubber such as Dragon SkinTM FX-PRO (provided by Smooth-on Inc.). There is also provided the oral mucosa of soft palate which may also be a platinum-catalysed silicone such as Ecoflex TM 00-30, an element representative of the nasal mucosa of soft palate, also made of platinum-catalysed silicone but preferably Ecoflex 00-10 and oral muscle, also preferably made of a platinum catalysed silicone such as Ecoflex 0010 with Slacker. The oral mucosa of hard palate, soft palate, the nasal mucosa of soft palate and the oral muscle are preferably formed in a mould, either all in the same mould or in separate moulds and then affixed to the hard anatomical formations 50, 51.

The mouldable elements of the palate unit 20 are preferably replaceable components and most preferably done so in-situ by a clinician or other user, making use of one of more supplied moulds 80.

Referring now to Figure 8, this shows five primary steps (1 to 5) in the manufacture of a palate unit 20 in accordance with the teachings herein. It is to be understood that the diagrams of Figure 8 are schematic only and that in practice the anatomical formations may be removed from the holding unit 26, 46 and only attached thereto once the formations have been completed.

With reference to Figure 8.1, in the preferred method, the bare bone palate, which may be in two elements as shown, is formed preferably by 3D printing using for example Vero materials, although may be injection moulded, cast or formed in any other suitable manner and with suitable materials.

With reference to Figure 8.2, the or each formation from Figure 8.1 is placed in a suitable mould 80 having a shaped chamber representative of the oral mucosa of hard palate and Dragon Skin FX-ProTM, in liquid or otherwise flowable form, is poured into the mould and allowed to set. With reference to Figure 8.3, the combination from the step of Figure 8.2 is then placed into a mould having a chamber shaped to be representative of the oral muscle and Ecoflex 00-10, is poured into the mould cavity so as to form the oral muscle. With reference to Figure 8.4, in the next step of the procedure the formation of Figure 8.3 is placed in a mould in a chamber shaped to be representative of the oral mucosa of soft palate and Ecoflex 00-30 is poured into the mould chamber. With reference to Figure 8.5, the formation of Figure 8.4 is then placed into a mould with a chamber having a shape representative of the nasal mucosa of a soft palate and Ecoflex 00-10 with Slacker is poured in.

The end result is an anatomical formation 42 shown in Figure 8.5 and representative of the cleft palate upon which training can then be carried out. It will be appreciated that in cases where the cleft palate is formed in two parts that each part will be treated by the process of Figure 8.

It is preferred, for training purposes, that each of the moulded formations is of a material of different colour, facilitating the recognition of these anatomical components.

For user ease, the apparatus may comprise moulds having colours matched to the colours of the materials used for the various mouldable anatomical formations, making it therefore easier for the user to apply the right material to the right mould in the formation of the simulated cleft palate. Many other ways of ensuring accurate matching of materials and moulds can be readily devised by the skilled person. Equally or in the alternative, the moulds could be made of different colours to assist in identifying them.

It is envisaged that the apparatus will be provided as a kit to use with a tool as shown in Figure 1 and one or more moulds as shown in Figure 4 and the raw materials to make the various portions of the simulated palate. This provides a cost effective training tool, the ability of the user to make further components for repeated training, the ability to replace broken or otherwise damaged components and also the ability for the user to modify components to simulate particular cleft palate formations.

While the examples of Figures 6 to 8 only depict a simulated palate, the skilled person will readily appreciate how to produce teeth formations (for example by 3-D printing) and simulated lips (for example with a suitable mould). Any of the materials indicated above can be used for the lip formations or any other suitable materials.

The lower jaw unit 18 could likewise be made by the process of Figure 8. It will be appreciated that the materials referred to above in the described 25 examples are exemplary only and that other materials may be used, with which the person skilled in the art will be familiar. The materials should, of course, have characteristics that are able to simulate those of the anatomical element in question, as well as providing a suitable basis upon which to carry out surgical training exercises, including cutting, suturing and so on.

In summary, the preferred tool offers an anatomically correct cleft lip and palate simulator model with replaceable components to be used for cleft palate surgery training. The tool preferably contains different layers built in different colours and materials, resins for hard tissues and silicones for soft tissues, to simulate real-life conditions. The different pieces that constitute the model can be assembled and disassembled to offer the possibility for users to reuse some of the components.

The apparatus also allows the user to self-manufacture and replace the soft tissues by providing the silicones and moulds.

the kit would include the model with hard and soft tissue simulators, moulds and silicones.

All optional and preferred features and modifications of the described embodiments and dependent claims are usable in all aspects of the invention taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments are combinable and interchangeable with one another.

The disclosure in the abstract accompanying this application is incorporated herein by reference.

Claims

CLAIMS1. A cleft palate simulator tool including: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a plurality of soft tissue simulator elements attachable to at least the palate unit.
2. A cleft palate simulator tool according to claim 1, wherein both the lower jaw unit and the palate unit are pivotally coupled to the base unit.
3. A cleft palate simulator tool according to claim 1 or 2, wherein at least one of the lower jaw unit and the palate unit is slidably coupled to the base 20 unit by a sliding mechanism providing for movement thereof towards or away from the other of the lower jaw unit and the palate unit.
4. A cleft palate simulator tool according to claim 3, wherein the lower jaw unit is slidably coupled to the base unit by a sliding mechanism providing for 25 movement thereof towards or away from the lower jaw unit.
5. A cleft palate simulator tool according to any preceding claim, including a locking mechanism for locking the lower jaw unit and the palate unit to the base unit.
6. A cleft palate simulator tool according to any preceding claim, wherein the lower jaw unit and the palate unit are separate elements.
7. A cleft palate simulator tool according to any preceding claim, wherein at least one of the lower jaw unit and the palate unit include one or more removable anatomical elements, said anatomical elements including fixings for attachment to their respective lower jaw coupling and/or palate coupling.
8. A cleft palate simulator tool according to claim 7, wherein the lower jaw unit is removable form the tool.
9. A cleft palate simulator tool according to claim 7 or 8, wherein the palate unit includes at least one removable upper mouth anatomical element.
10. A cleft palate simulator tool according to claim 9, wherein the palate unit includes at least two removable upper mouth anatomical elements, shaped so as to define a cleft profile therebetween.
11. A cleft palate simulator tool according to claim 10, wherein the palate unit includes at least one oral mucosa hard palate element with a nasal lining, at least one nasal mucosa soft palate element, at least one soft palate oral mucosa 20 element and/or at least one muscle element.
12. A cleft palate simulator tool according to any one of claims 7 to 11, wherein the or at least one of the anatomical elements are formed of a plurality of layered materials.
13. A cleft palate simulator tool according to claim 12, wherein the layered materials have different stiffness characteristics.
14. A cleft palate simulator tool according to claim 13, wherein the layered materials include the plurality of soft tissue simulator elements of the palate unit.
15. A cleft palate simulator tool according to any one of claims 7 to 14, including a mould for forming that at least one anatomical element.
16. A method of configuring a cleft palate simulator tool, which tool comprises: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a plurality of soft tissue simulator elements attachable to at least the palate unit; the method comprising the steps of: providing on each of the lower jaw unit and the palate unit an anatomical element; pivoting the lower jaw unit and/or the palate unit to a desired angle therebetween and fixing the lower jaw unit and/or the palate unit to the base unit so as to lock the lower jaw unit and the palate unit relative to one another.
17. A method according to claim 16, including the step of adjusting a distance of the lower jaw unit and the palate unit relative to one another and then locking the lower jaw unit and the palate unit relative to one another.
18. A method according to claim 16 or 17, including the step of forming at least one of the anatomical elements in a mould and attaching to the respective lower jaw unit and palate unit.
19. A cleft palate simulator tool kit comprising: a base unit provided with first and second couplings; a lower jaw unit provided with a lower jaw coupling connectable to the first base unit coupling; a palate unit provided with a palate coupling connectable to the second base unit coupling; wherein at least one of the jaw coupling and the palate coupling is pivotally coupled to the base unit so as to enable the lower jaw and palate units to be rotated relative to one another; and a mould configured to produce at least an anatomical element comprising a plurality of soft tissue simulator elements for the palate unit.
20. A kit according to claim 19, including a plurality of polymer materials for moulding layered anatomical elements.