GB2264632A - Protective liners for surgical gloves - Google Patents

Abstract

The liner is made from a synthetic polymer material which has a puncture strength of at least 1200gf/mm (latex natural rubber sheet was found to have a puncture strength in the region of 1200). The polymer may be, for example, polyether polyurethane, polyester polyurethanes, polyether polyester but many others are mentioned. The liner is glove-like in shape and may be worn over or under a rubber glove.

Description

PROTECTIVE LINERS The present invention relates to protective liners for use with a surgical glove.

Sterile rubber gloves are normally worn by practitioners during medical or surgical procedures to provide a barrier to the transfer of pathogenic organisms or toxic materials to or from a patient.

In procedures, however, such as the stitching of wounds or fixation of bones, needles or wires are used which can easily penetrate a rubber glove and penetrate the skin of the wearer. It would therefore seem desirable to provide the glove wearer with added protection during procedures which involve such sharp devices as needles and wires.

The present invention provides a protective liner for wearing with a surgical glove which liner comprises a synthetic polymer material which has a puncture strength of at least 1200 gf/mm.

The puncture strength of polymer material as used herein as force in gf/mm required by a probe of given dimensions to penetrate a test sample of the polymer material.

The puncture strength of a polymer material can be measured by a test method in which a probe attached by means of holder to a load cell of an Instron Test Machine (a cross-head speed of l00mm/min) is allowed to penetrate a test sample (10 x locum square) located on Gelatine block (circle locum diameter and lcm thick) mounted on slotted plate at angle 450.

In the test the thickness of polymer material and the puncture force at penetration is recorded. The puncture force was measured for nine spaced areas of the test sample and the average puncture force calculated. The puncture strength of a polymeric material can then be determined from the puncture force and sample thickness as follows: The puncture strength = Puncture force (gf) Sample thickness (mm) The puncture strength of polymer material is characterised by the dimensions of the probe used in the test method.

The puncture strengths as mentioned hereinafter were determined using a 1.50mm tungsten probe having a conical end and a 0.17mm width hemispherical tip.

The puncture strength of latex natural rubber sheet as measured by the herein above mentioned test method was in the region of 1200.

Suitable polymer materials for use in the protective liner of the invention should therefore have a puncture strength of at least 1200, favourably at least 2400 which is twice that of latex natural rubber material and preferably 3600 which is three times that of latex natural rubber material.

The term "latex natural rubber" as used herein refers to the cured latex rubber material of conventional surgical gloves.

The synthetic polymeric materials used in the invention will normally comprise a flexible polymer or elastomer to provide the protective liner of the invention with conformability.

Suitable elastomers include thermoplastic elastomers such as polyether polyurethane, polyester polyurethanes, polyether polyester and polyether polyamide block copolymers and block copolymers of the A-B-A type where A is polystyrene and B is polyisoprene, polybutadiene or polybutylene.

An apt polyester polyurethane for use in the r TTM) invention is known as Walopurt No. 2102A available from Wolff Walstrode.

Suitable flexible synthetic polymers other than elastomers include polypropylene, polyethylene, polyvinyl chloride, ethylene vinyl acetate copolymers and polyester.

An apt polyester for use in the invention is a polyethylene terephthalate often known in the Melinexk available from ICI.

Typical puncture strength values for synthetic polymeric materials suitable for use in the invention are given below.

Puncture Strength Polymeric Material (gf/mm) WALOPURj#2l02A (Polyester Polyurethane) 3900 (rtM) TUFTANE [710 (Polyurethane) 2800 (rTm) MELINEX#Polyester) 10400 POLYETHENE 1600 PVC (heat shrinkable grade) 5100 LATEX NATURAL RUBBER 1200 In further tests puncture strengths were measured for a variety of polymeric materials and a variety of thickness and the results were

Samples Samples Thickness Puncture Puncture (pom) Force Strength (gf) (gf/mm) Latex Natural 200 219 1096 Rubber - 1 (10) (18) (92) Layer Walopur - 1 55 311 5601 Layer (1) (37) (779) 1 Layer L.N.R. 252 489 1946 + 1 Layer (12) (49) (247) Walopur 2 Layers 401 565 1410 L.N.R. (10) | (37) (74) L.N.R. = Latex Natural Rubber Means followed by an 1 n = 9 In the above table, L.N.R. represents Latex Natural Rubber; the numbers in brackets represent the standard deviation of error; and puncture force represents the force placed on the sample in order to penetrate it.

As can be seen from the above table the puncture GrTM) strength of the Walopurlis approximately 5 to 6 times that of the natural rubber latex. Consequently, a liner which is approximately one quarter of the thickness of a latex natural rubber glove will provide at least the same resistance to puncture. Equally, it can be seen that the puncture strength of a layer of latex natural (rT) rubber and Walopurtif far greater than that of 2 layers of latex natural rubber.

In another aspect the present invention provides a method of providing increased protection to a hand against sharp devices used in medical or surgical procedures which comprises applying a protective liner of the invention and a rubber glove to the hand so that the liner is positioned under or over the rubber glove.

The liner can conveniently be in the form of a glove. The glove liner will normally be adapted is use to comfortably fit the hand to which it is to be applied. A glove liner, however, which is intended to be worn under a rubber glove will tend to take the shape of the rubber over glove.

The synthetic polymer material of the protective liner of the invention favourably provides a barrier to liquid water and organisms such as bacteria and viruses.

In preferred embodiments the protective liner is made of synthetic polymeric material such as a polyether - polyurethane to render the liner moisture vapour permeable.

The protective liner can be made by any convenient process used for making polymer gloves.

Suitable processes include a latex or solvent dipping processes, moulding processes such as blow moulding or compression moulding and sealing processes in which two shaped sheet materials are peripherally joined together using a conventional adhesive or heat sealing technique. The shape sheets can be formed by a conventional cutting process such as a stamping process.

A protective liner of the invention of a pair of such liners can be packed in suitable pack such as a pouch and sterilised therein by conventional sterilisation method to render the liner sterile in a bacteria-proof pack.

The protective liner of the invention can not only provide increased protection against sharp devices used in medical or surgical procedures but it can also provide a non-allergenic liner for a rubber glove worn over the liner.

Example A pair of sheets of glove shape were stamped out (@TM) of a film (5Opm thick) of polyurethane (Walopur#2102A available from Wolff Walstrode.

The sheets were then joined at their peripheral margins by heat sealing to form a glove shaped liner with an opening for insertion of a hand.

The polyurethane film of the glove liner had a puncture strength (gf/mm) of 3900 which is greater than that normally measured for latex natural rubber (1200).

The polyurethane film had a moisture vapour transmission rate of 421 g/m2/24h at 370C and a relatively humidity difference of 100 to 10% when measured (upright) by the Payne Cup method.

The glove liner of this Example was found to be flexible and comfortable to wear.

The glove liner when used under or over a rubber glove was found to give improved protection to the penetration of sharp devices such as needles and K wires.

Claims (16)

1) A protective liner for wearing with a surgical glove which liner comprises a synthetic polymer material which has a puncture strength of at least 1200 gf/mm.

2) A liner according to claim 1 in which the puncture strength of the polymer material at least 3600 gf/mm.

3) A liner according to any of the preceding claims, in which the polymer material comprises an elastomer.

4) A liner according to claim 3, in which the elastomer a polyether polyurethane, a polyester polyurethane, a polyether polyester or a polyether polyamide block copolymer or block copolymers of A-B-A type wherein A is polystyrene and B is polyisoprene, polybutadiene, polybutylene or blends thereof.

5) A liner according to claim 1 or 2, in which the polymer is a polypropylene, a polyethylene, a polyvinyl chloride, a ethylene vinyl acetate copolymers and a polyester.

6) A liner according to claim 6 in which the polyester is polyethylene terephthalate.

7) A liner according to any of the preceding claims, in which the liner is in the form of a glove.

8) A liner according to any of the preceding claims, in which the polymer material serves as a barrier to liquid water and organisms.

9) A liner according to claim 10, in which the polymer material is polyether polyurethane.

10) A method of providing increased protection to a hand against sharp devices used in a medical or surgical procedure which comprises applying a protective liner according to any of the proceding claims to a rubber glove so that the liner is positioned under or over the rubber glove.

11) A puncture resistant glove comprising in combination a glove means and a protective liner which liner comprises a synthetic polymer material which has a puncture strength of at least 1200 gf/mm.

12) A method of making a protective liner for a glove including the steps of moulding a suspension or solution of synthetic polymer material around a glove shaped mould; curing the moulded material; and removing the thus formed liner from the mould.

13) A method of making a protective liner for a glove including the steps of:- cutting or stamping out at least two glove shaped sheets of material and laminating the sheets or material together at their peripheral edges.

14) A method according to claim 15, in which the laminating is a form of heat sealing.

15) A protective liner according to any of the preceding claims in which the liner is packed in a sterilised pouch.

16) A protective liner according to claim 1 and as hereinbefore described with reference to the examples.