GB2567739A - A tongue retractor - Google Patents

Abstract

An intraoral tongue retractor is formed as a plastic moulding and comprises a plate 10 formed with a groove 11 to receive a lingual frenulum and an elongated handle 13 that can be gripped by the user of the retractor. The plate 10 has a convex upper surface and a concave lower surface. The plate may be connected to the handle by a moulded flexion point 12. The handle may have a serrated portion which is spaced from the plate by a portion 14 that is not serrated. The retractor may be moulded from polypropylene. The plate is typically 30.5mm in length with a width of 18.5mm. The groove is typically 2.2mm in width. The device may be a single-use, biocompatible retractor for neonatal or paediatric use, for example in a lingual frenulotomy.

Description

Field of the Invention

The present invention relates to a tongue retractor of novel design and construction, designed to control and direct the neonatal human tongue during paediatric intraoral diagnostic soft tissue and dental assessment and during interventional surgical procedures, specifically but not limited to, “lingual frenulotomy”, the surgical division of the lingual frenulum, the membrane that connects the inferior aspect of the tongue to the floor of the mouth, for the treatment of neonatal tongue tie.

Background Art

Babies who are diagnosed with “tongue-tie” are born with a congenitally short lingual frenulum. In extreme cases, this can result in a severe restriction of the baby’s ability to move their tongue. In the short term, tongue tie can cause severe problems with breastfeeding, and in the longer term, if left untreated, can cause significant problems with feeding and babies’ ability to vocalise sounds and ultimately their speech.

Traditional medical opinion has determined that tongue tie issues will normally correct themselves naturally within the first twelve months of life, as the relationship between the position of the tongue and the lower jaw evolves. However, if the problem persists, some paediatric surgeons will consider performing a frenulotomy, - a procedure that divides the frenulum from the base of the mouth, whilst others will not perform surgery unless the child develops speech problems and has not responded to speech therapy (by which time the child will require a general anaesthetic for the procedure).

However, contemporary medical research suggests that there is a strong case for a more proactive approach to the treatment of tongue tie. It is currently estimated that between five and ten percent of new-born babies are affected by this condition. One of the leading clinical researchers in this field has reported that the actual incidence of tongue tie is significantly higher than is reported in medical textbooks, as most were written before breastfeeding became more common. It has also now been demonstrated in the clinical literature that performing a frenulotomy before the age of three months enabled around 60 per cent of babies to breast-feed successfully for at least three months following the procedure. This rapid, straightforward procedure can be successfully performed between ten days and 26 weeks post partum without the need for any form of anaesthesia, thereby significantly reducing the potential morbidity associated with performing the procedure under general anaesthesia, which would be required should the procedure be delayed beyond 26 weeks.

Frenulotomy consists of rapidly dividing the lingual fraenum using a pair of blunt-tip surgical scissors to achieve freedom of movement of the baby’s tongue. This procedure is performed by clinical professionals skilled in the art, typically paediatric surgeons, midwives or lactation practitioners or dental surgeons.

One of the key clinical aspects of performing lingual frenulotomy safely and effectively is to ensure the stability of the baby’s tongue immediately prior to division of the frenulum, to avoid the possibility of inadvertent trauma to the tongue and adjacent soft tissues.

There are two traditional means of achieving tongue stability during lingual frenulotomy :

Either: The operating clinician may gently insert one or more fingers of their non-operating hand under the inferior aspect of the tongue, and the frenulum divided using blunt tip scissors.

Or: Many clinicians elect to use an instrument such as a Brodie

Director, a grooved stainless steel instrument with a midline slit to isolate the frenulum and to lift the tongue prior to its division.

In addition to conventional surgical division of the frenulum, a small number of clinicians are now performing laser-assisted frenulotomy. The efficacy of this approach is yet to be established in the clinical literature.

Clinical Issues Associated with Current Background Art o Clinical opinion is divided as to whether it is safer and more efficacious for both baby and operator to use either the operating clinician’s finger ora tongue retraction instrument such as a Brodie Director to facilitate effective tongue retraction.

o Issues associated with the use of the clinician’s finger include :

a. Inadvertent trauma to the finger and/or the floor of the baby’s mouth and inferior aspect of the tongue, resulting in excessive postoperative bleeding, ulceration or infection

b. Significantly reduced visibility of the frenulum immediately before, during and after the frenulotomy, resulting in poorly performed division of the frenulum, and thereby the potential need for a subsequent repeat procedure o Issues associated with the use of a Brodie Director include:

a. A Brodie Director is a surgical instrument manufactured entirely from surgical stainless steel, comprising a pearshaped paddle with central slit, and a thin, grooved handle. This instrument was originally developed for use during the treatment of ano-rectal fistula, and although not strictly fit for purpose, it has also been used more recently for stabilising the tongue during frenulotomy, as the central slit adapts approximately to the lingual frenulum.

b. Brodie Directors were not originally designed to be used in contact with the delicate soft tissues of the mouth, not least a neonatal mouth. A Brodie Director is manufactured from thin cross-sectional stainless steel with exposed leading edges, all of which are potential sources of iatrogenic soft tissue laceration and trauma, when held in direct contact with intra oral soft tissues.

o Brodie Directors are typically designed to be reusable instruments, and thereby pose problems with managing patient safety, sub-optimal infection prevention and control, costly ongoing maintenance, and present a risk of cross-contamination as a consequence of being repeatedly processed through wash/decontamination/sterilisation cycles.

o Feedback from clinicians from the range of clinical specialties currently performing frenulotomy and who currently utilise Brodie Directors for tongue stabilisation during these procedures have indicated a significant need to design and develop a medical device designed for this specific purpose.

It is an object of the present invention to provide a fit for purpose injection-moulded polymeric medical device of custom design and manufacture designed specifically for retracting the neonatal/paediatric tongue, and to effectively address the clinical and design shortcomings presented by instruments currently in use.

Summary of the Invention

According to the present invention there is provided an intraoral tongue retractor as claimed in Claim 1.

The retractor is specifically designed to be placed into the neonatal/paediatric oral cavity to retract and stabilise the tongue during diagnostic assessments of the oral cavity, and during invasive surgical procedures performed within the oral cavity including, but not restricted to, lingual frenulotomy.

Brief Description of the Drawings

Figure 1 is a plan view of the device;

Figure 2 is a side elevation view of the device; and

Figure 3 is an isometric view of the device.

Description of the Preferred Embodiment

As shown in the drawings, the intraoral tongue retractor includes an anatomically sympathetic, atraumatic contoured tongue retractor plate 10 with an integral groove 11 designed to accommodate varying thicknesses of lingual frenulum without causing trauma to the surrounding intraoral soft tissues. The device includes a moulded flexion point 12 designed to provide the plate 10 with the optimal balance of flexion and rigidity when in clinical use, and there is a serrated grip handle 13 with the serrations spaced from the plate 10 by means of a serration-free zone 14 to eliminate potential trauma to the tongue and lower lip when the device is in clinical use.

Figure 2 highlights the contoured profile of the plate 10 and, as can be seen, the upper convex surface of the plate 10 approximates to the anatomical profile of the inferior surface of the tongue and the lower concave profile creates the space which the operating clinician needs to visualise, access and section the frenulum in the optimal position.

Figure 3 is an isometric view detailing the anatomically contoured paddle, highlighting that area of the plate 10 which has been designed specifically to be free from any potential moulding flash when the device is ejected from the injection moulding tool during manufacture, to ensure that all surfaces in contact with intraoral soft tissues are entirely smooth and atraumatic.

The present invention thus provides a neonatal/paediatric intraoral tongue retractor manufactured entirely from an injection moulded polymer such as, but not restricted to, medical grade polypropylene homopolymer. The retractor comprises an anatomically sympathetic, atraumatically contoured paddle-shaped retractor plate 10 with a convex upper surface and a concave lower surface, as most clearly shown in Figure 2, and an integral groove 11 designed to accommodate a range of anatomical variants of the lingual frenulum and to eliminate trauma to the surrounding intraoral soft tissues. The plate 10 is typically 30.5 mm. in length with a width of, for example, 18.5 mm. The groove 11 is typically 2.2 mm. in width,

The tongue retractor includes an injection-moulded flexion feature 12 at the point at which the serration free zone 14 joins the plate 10, so that the cross-section thickness is reduced at the point indicated by the arrow 12 in the drawings. This provides a point flex under applied load, designed specifically to provide the appropriate balance of flexion and rigidity required for the effective stabilisation and retraction of the tongue

The handle 13 of the injection-moulded retractor includes a serrated portion which is preferably, but not restricted to, approximately 8 cm. in length to provide stability in the operator’s hand and to eliminate potential slippage in use. There is also a “serration-free zone” 14, which is preferably, but not restricted to, 30 mm. in length and is designed specifically to provide an atraumatic interfacing surface with the delicate mucous membranes of the lower lip.

The injection moulding tooling used for production of the retractor is designed specifically to ensure that the atraumatically contoured paddleshaped tongue retractor plate 10 is manufactured with no residual mould flash, i.e. there is a “flash-free” zone around the plate 10 to ensure that the retractor does not traumatise intraoral soft tissues in clinical use.

The neonatal/paediatric intraoral tongue retractor is manufactured entirely from an injection moulded polymer which is pigmented preferably, but not restricted to, lilac (colour reference RAL 310 40 40) to provide a calming, non-threatening appearance for the instrument, to enhance the “acceptability” of its appearance for use with conscious newborn patients and their carers.

The device shown in the drawings is a single use neonatal/paediatric intraoral tongue retractor which is manufactured from an injection moulded biocompatible polymer which is capable of being sterilised, thereby eliminating the significant risk of cross-contamination associated with a reusable tongue retraction device.

Claims (4)

Claims:-

1. An intraoral tongue retractor formed as a plastic moulding comprising a plate formed with a groove to receive a lingual frenulum and an elongated handle that can be gripped by the user of the retractor, the plate having a convex upper surface and a concave lower surface.

2. A tongue retractor as claimed in Claim 1, in which the plate is connected to the handle by a moulded flexion point.

3. A tongue retractor as claimed in either of the preceding claims, in which the handle has a serrated portion that is spaced from the plate by a portion that is not serrated.

4. A tongue retractor as claimed in any one of the preceding claims, which is moulded from polypropylene.