GB2285981A

GB2285981A - Polymer material for the production of medical artifacts

Info

Publication number: GB2285981A
Application number: GB9500766A
Authority: GB
Inventors: Brian Karet
Original assignee: SHEFFIELD ORTHODONTIC LAB LIMI
Current assignee: SHEFFIELD ORTHODONTIC LAB LIMI
Priority date: 1994-01-27
Filing date: 1995-01-16
Publication date: 1995-08-02
Also published as: GB9401577D0; GB9500766D0

Abstract

A polymer material suitable for the production of medical artifact, comprises a mouldable synthetic polymer which is (i) capable of being laminated, (ii) relatively soft at the temperature of the human or animal body; and (iii) which is rendered radio-opaque and/or ultra sound detectable by having had dispersed therein an additive, in particulate form, which is detectable by external X-ray and/or ultra sound detection means. The artifact may be a mouth guard and the additive may be barium sulphate.

Description

POLYMER MATERIAL SUITABLE FOR THE PRODUCTION OF MEDICAL ARTIFACTS This invention relates to a polymer material suitable for the production of medical artifacts such as mouth guards, or indeed for the production of artifacts usable in any operative procedure involving investigation of a hollow organ within a human or other animal body.

The term "mouth guard" is also to be taken to include bite rehabilitation protection appliances.

Mouth guards are used to protect teeth and supporting structures from traumatic injury which may occur when the wearer is involved in a contact sport such as rugby football, hockey, boxing etc., or in a sports activity, such as skiing or horse-riding, where collision damage can take place with an inanimate object. In detail, a mouth guard is fitted over the teeth of the upper jaw of the wearer with a view to obviating injuries such as tooth damage, tooth penetration of the user's lips or cheeks, lower jaw fracture, concussion etc. Another quite unrelated use is for persons who have a tendency for largely uncontrollable lower jaw movement resulting in grinding of teeth, possibly during sleep, or parafunctional behaviour which might bring teeth into heavy contact.

In the past, mouth guards have been produced in either ethylene vinyl acetate (EVA), which results in a "soft" mouth guard, or an acrylic resin, which results in a "hard" mouth guard, either version being custom made and requiring impressions and/or fittings in a dental surgery.

Whilst such mouth guards provide a reasonable degree of injury protection or mitigation, most mouth guards are radiolucent. Hence a difficulty may arise with say an unconscious person subsequent to a sporting accident, in not knowing whether a missing mouth guard has been swallowed in whole or in part, and hence is in an airway or the stomach of that person, or in not knowing whether a fragmented mouth guard is partially embedded in that person's soft tissue or bone. A known proposal aimed at overcoming such difficulties has been to embed a small aluminium marker strip in the mouth guard, so that the location of say a swallowed mouth guard can be determined.An obvious drawback is that if the wearer bites through the mouth guard and swallows but a fragment of the mouth guard, the swallowed fragment may not be that portion bearing the embedded marker strip, and the location of the missing fragment remains unknown.

Consequently, there is a demand for a polymer material for medical artifact such as mouth guards that is readily detectable, in both whole and fragmented form, by detection means such as X-ray equipment.

According to a first aspect of the present invention there is provided a polymer material suitable for the production of medical artifact, comprising a mouldable synthetic polymer which is (i) capable of being laminated, (ii) relatively soft at the temperature of the human or animal body; and (iii) which is rendered radio-opaque and/or ultra sound detectable by having had dispersed therein an additive, in particulate form, which is detectable by external X-ray and/or ultra sound detection means.

Accordingly to a second aspect of the invention, there is provided a medical artifact produced from the above defined polymer material.

According to a third aspect of the invention, there is provided a mouth guard produced from the above defined polymer material.

Thus, with say a mouth guard produced in accordance with the third aspect of the invention, it is of no consequence whether the mouth guard has been swallowed in whole or in part by the wearer, for due to the dispersion of the detectable additive throughout the polymer material, even the smallest swallowed fragment, being radio-opaque and/or ultra sound detectable, can be immediately detected by the detection means.

Appropriately, EVA is used as the polymer material, which is not only soft at mouth temperature, but is also an excellent shock absorber. Clearly, the additive needs to be not only compatible with EVA, but also non-toxic to the user.

In this respect, barium sulphate, reduced to a suitable particle size, has been found appropriate.

Claims

1. A polymer material suitable for the production of medical artifact, comprising a mouldable synthetic polymer which is (i) capable of being laminated, (ii) relatively soft at the temperature of the human or animal body; and (iii) which is rendered radio-opaque and/or ultra sound detectable by having had dispersed therein an additive, in particulate form, which is detectable by external X-ray and/or ultra sound detection means.

2. A polymer material as claimed in Claim 1, wherein the mouldable synthetic polymer is EVA.

3. A polymer material as claimed in Claim 1 or Claim 2, wherein the additive is barium sulphate reduced to a suitable particle size.

4. A medical artifact produced from the polymer material defined in any one of Claims l to 3.

5. A mouth guard produced from the polymer material defined in any one of Claims 1 to 3.