WO2010107297A2

WO2010107297A2 - Improved surgical glove with lamination of supported liners for better donnability comfort and sweat management and method of manufacturing

Info

Publication number: WO2010107297A2
Application number: PCT/MY2009/000219
Authority: WO
Inventors: Yen Kim Teow
Original assignee: Duramitt Sdn. Bhd
Priority date: 2009-03-20
Filing date: 2009-12-29
Publication date: 2010-09-23
Also published as: MY152855A; EP2408391A4; WO2010107297A3; EP2408391A2

Abstract

A disposable surgical glove comprising a first thin elastomeric layer (1); and a second layer (3) to having a securely bonded, or laminated fabric liner (3) so that the second layer (3) is configured to absorb, excess perspiration or moisture of the skin, wherein both layers (1) (3) are held evenly together by a coagulant and bonded by an adhesive chemical, such that the elastomeric glove (1) and fabric liner (3) may be stretched to whatever extent, without affecting its lamination, and method of manufacturing with the use of a skeletal rubber former (2).

Description

IMPROVED SURGICAL GLOVE WITH LAMINATION OF SUPPORTED LINERS FOR BETTER DONNABILITY COMFORT AND SWEAT MANAGEMENT AND METHOD OF MANUFACTURING FIELD OF THE INVENTION The present invention relates to disposable surgical gloves, and more particularly it relates to a supported elastomeric surgical glove with liner. BACKGROUND OF THE INVENTION

Surgical gloves normally worn by practitioners during medical or surgical procedures are designed to be protective to prevent the transfer of pathogenic organisms or toxic materials to or from a patient, yet at the same time they have to be sufficiently thin walled in order to provide the wearer with an acceptable sense of touch and permits dexterous movement of the hands and fingers besides being comfortable to wear.

As such, these gloves besides being puncture resistant are normally liquid- impermeable to provide a barrier between the wearer and the environment in which the gloves are used. Unfortunately, these desired characteristics of elastomeric gloves create a harsh environment for the wearer's skin. For example, perspiration is a common problem for glove wearers, and the resulting moist environment may lead to various skin problems, including, for example, growth of fungi and yeast, as well as bacterial and viral infections of the skin. In addition, those who utilize elastomeric gloves in the medical field frequently clean their hands with soap or sanitary alcohol formulations. This constant cleaning is harsh on the skin, causing excessive skin dryness that may exacerbate other skin conditions.

In the past, the wearer-contacting surface of elastomeric gloves were treated with powder, to absorb moisture and alleviate some of the problems faced by wearers of the glove. However, while powders may still be acceptable in certain applications, they are typically undesired in surgical or cleanroom type environment. Furthermore, tightly fitting gloves such as surgical and examination gloves may be difficult to don or strip out from hand due to blocking effect of the film surfaces which tends to stick to itself. As a result, surgical gloves often contain a powdered lubricant on the surface that contacts the skin of the wearer to facilitate donning. Most commonly, cornstarch is dusted on the inner surface of the glove during manufacturing. While the use of cornstarch does improve the donning characteristics of the glove, it may not be feasible for all applications. One such situation is the use of powders for surgical glove applications. If some powder inadvertently enters the surgical site, it may cause complications for the patient. For instance, the powder may carry an infectious agent or the patient may be allergic to the powder itself.

Another drawback of the conventional surgical glove is the renowned potential risk resulting from direct contact with latex gloves due to the allergenic protein, powders and even nitrosamine which remains unresolved issue of concerns over the years or even decades. Earlier attempts have been made by those skilled in the art to make thin, pinhole-free surgical gloves with a protective lining on the inner side by deploying similar methodologies conventionally used in making supported-glove.

Early examples of such a surgical glove with a protective liner is found described in UK Patent No. GB2,264,632, wherein the liner is made from synthetic polymer material. The liner is glove- like in shape and may be worn over or under a rubber glove. Although the liner is puncture resistant and liquid impermeable which serves to protect the wearer, it is non-absorbent and thus do not provide for proper sweat management.

In order to meet the requirement of reduction of moisture against the skin for proper sweat management, later disclosures found in US Patent No. 5,036,551 describes a moisture permeable glove made of a laminate of an elastic non-woven fabric, hydrophilic layer and microporous polymeric membrane with the two laminates sealed together in the form of a glove. However, the hydrophilic polymer gloves swell and tends to weaken with exposure with water and the laminate gloves are not sufficiently elastic to conform to the hand and the construction is such that it makes a continuous liquid and microorganism barrier unlikely.

Alternatively, in US Patent No. 5,043,209 the solution is to provide for a two component system consisting of a moisture permeable inner liner and an outer protective glove, which permits passage of sweat vapour in one direction while preventing liquid from returning in the opposite direction by providing an inner layer that is permeable to vapour but not to liquid and thereby transfers moisture to an absorptive outer layer, wherein the liner may effectively remove moisture from the skin. However, the outer layer may be bulky and become heavy with collected moisture, making it very unsuitable for the purpose of surgical use.

A better solution for sweat management in supported gloves can be obtained by the use of fabric liners made from cotton, nylon, polyester or wool, although for surgical gloves specifically, which generally requires a thinner material, nylon yarn would be most preferable. However, much difficulty is encountered in the manufacturing of such thin walled surgical gloves with a prelaminated fabric liner for better comfort and sweat management.

Traditionally, attempts made by those skilled in the art to pre-laminate a fabric liner onto a disposable surgical glove, was made with the latex surgical glove first inverted to expose the wearer's side to the outside and then worn onto a piece of ceramic or porcelain hand mould or former. Glue or adhesive is then applied on the surface of the latex glove to laminate the fabric liner which is then worn over the latex glove. While the size of the latex glove must correspond to the exact size and contour of the ceramic former, latex glove is often overstretched in order to enable it to be worn properly onto the ceramic former. This increases the tendency for latex glove to get torn easily due to overstretching. Also, when glove is overstretched and worn, the film of latex glove are easily abraded against the hard surface of the ceramic former. This causes the film to be weak and susceptible to tear easily. Another failure of this process is that the wearing of latex glove onto a ceramic former is very time- consuming and latex glove may not necessarily conform to the contour of a ceramic former.

Yet another setback of this process is that the fabric liner may not be properly laminated over the latex glove which is more likely to cause the formation of creases between the laminated layer of polymeric shell and the liner. Furthermore, the inner liner provides stretch resistance and stiffness which is both unfavorable & atypical to that of a surgical glove, besides limiting the total stretchability of the latex gloves which is essential in surgical gloves. Moreover, such method does not ensure a liquid- proof barrier that is of paramount importance to a surgical glove due to thin or weak areas or pinholes resulting from poor physical integrity of a thin polymeric shell with protruding fibers of the liner. Still another disadvantage of such earlier attempt is the use of ceramic formers which are easily broken or cracked, adding cost to manufacturing. Yet still another disadvantage is the consumption of energy in the curing of gloves whereby more energy is required to heat-up the ceramic former which is almost 98% of the substrate to be heated up as compared to the core essential of only 2% attributed to latex gloves.

As such, a need currently exists for an improved, yet inexpensive and economically manufactured disposable surgical glove that is capable of relieving the said problems that might stem from the harsh environment to which the wearer's hand is exposed during use and yet capable of providing proper moisture management, hand dexterity and functional fit including its process of manufacturing. SUMMARY OF THE INVENTION

To overcome the aforesaid shortcomings, the present invention is directed towards an improved disposable surgical glove that meets the requirements of providing adequate protection to the wearer, without sacrificing the dexterity, strength, characteristics, feel and comfort of his hands and fingers.

According to a preferred embodiment of the present invention, there is a disposable surgical glove comprising a first thin elastomeric layer; and a second layer to be nearer to the hand than the first layer having a securely bonded, or laminated fabric liner, preferably lint free, continuous, filament nylon yarn, to be in contact with a hand, when glove is worn. The second layer is configured to absorb, when the glove is worn, excess perspiration or moisture of the skin, thereby maintaining a less moist environment than normally occurring with normal disposable gloves. Both layers are held by a coagulant and thereafter bonded by an adhesive such that the elastomeric glove and fabric liner may be stretched to whatever extent, without affecting its lamination.

The second layer is thus particularly designed to ease and facilitate the donning and doffing of surgical glove liners. A poorly donnable glove may take some time to be worn and adjusted to fit the hand. This is especially the case when a surgeon has to compromise with the time spent and wasted in an attempt to wear a

^• surgical glove in an Emergency Room or Operation Theater.

The primary advantage of this present invention is the sweat management of the surgeon's hands. Moist and perspirations can be effectively absorbed into the fabric liner. For example, a surgeon may continuously wear gloves during a surgical procedure for up to 40 minutes or more during which frequent changing of glove takes place due to sweaty palms. This hampers a surgeon's focus and concentration besides wasting precious time in saving a life.

Due to the apparent discomfort of perspiration and the increasing fear of direct contact with powder, allergenic proteins and even nitrosamine from latex gloves, many surgeons are now preferring an inner fabric liner be to worn prior to donning a latex surgical glove. Normally such practice requires a surgeon to peal off a sealed bag of fabric liners. Put on each piece for donning onto one hand, follow by another piece onto the other hand. This is then followed by the donning of surgical glove on both hands. The present practice is very time consuming and is critical especially when working inside an Emergency Room / Operation Theater.

The difficulty that arises in the manufacture of such an improved surgical glove is overcome by first fitting an inverted thin walled elastomeric glove over a skeletal former, preferably made from rubber, which can then be filled with air to expand the said glove. The expanded glove is then dipped in a solution of a coagulant and thereafter lifted up to blow dry. The air is then released in order to collapse the glove to allow the knitted liner, preferably lint free continuous filament nylon yarn of between 15 - 18 gauge to be then fitted over the said inverted glove. The unit is then thereafter re-inflated with air to expand fully and to blow up the said glove with the liner intact, It is then further submerged into a tank of adhesive chemical to help evenly bond the parts together in such a way so that the supported glove may be able to be stretched unlimitedly, to whatever extent, without affecting its lamination, when it is then finally allowed to dry either by itself or with the aid of an oven.

It is an object of the present invention to develop a new surgical glove with a supported liner that absorbs sweat and keeps the hand dry.

It is another object of the present invention to provide surgical glove with a supported liner which is thin enough not to interfere with the hand dexterity, feel and comfort of the wearer.

It is a further object of the present invention to produce a surgical glove with a supported liner that offers functional fit and better donnability.

It is yet another object of the present invention to provide a surgical glove with a supported liner that can be stretched unlimitedly without affecting its lamination. Other objectives, advantages and novel features of the present invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION QF THE DRAWINGS

FIGURE 1 shows the rubber former being fully inflated with air and fitted with the inverted thin- walled elastomeric glove of the present invention. FIGURE 2 shows the rubber former fully inflated with air and fitted with the inverted thin-walled elastomeric glove together with the fabric liner on top of the elastomeric glove of the present invention.

FIGURE 3 shows the completed supported surgical glove with the laminated fabric liner. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGURE 1, a thin walled elastomeric glove (1) is first inverted and fitted over a skeletal former (2), preferably made of thicker rubber, which can be inflated with air to fully expand said elastomeric glove (1). The entire unit is then fully dipped into a solution of coagulant comprising preferably ethanol and thereafter the entire unit is lifted up to blow dry. The air inside the rubber former (2) is then sufficiently released, in order to collapse the elastomeric glove (1) to allow a knitted fabric liner (3), preferably made from lint free, continuous, filament nylon yarn of between 15 - 18 gauge to be then easily fitted over the inverted elastomeric glove (1). The entire unit now is re-inflated with air to blow up and to expand fully once again the glove (1) with the liner (3) intact as illustrated in FIGURE 2. The whole unit is now further submerged into a tank of adhesive chemical, preferably comprising polyisoprene to help bond the parts evenly together. Finally, the finished product as shown in FIGURE 3 which is a disposable surgical glove comprising :-

(a) a first thin elastomeric layer (1); and (b) a second layer (3) to be nearer to the hand than the first layer (1) having a securely bonded, or laminated fabric liner (3), to be in contact with a hand, when the glove is worn, so that the second layer (3) is configured to absorb, when the glove is worn, excess perspiration or moisture of the skin, thereby maintaining a less moist environment than normally occurring with normal disposable gloves, wherein both layers (1) (3) are held evenly together by a coagulant and bonded by a adhesive chemical, such that the elastomeric glove (1) and fabric liner (3) may be stretched to whatever extent, without affecting its lamination, is allowed to dry either by itself or with the aid of an oven to speed up the drying process.

The process described herein may also be effectively applied to other bonding of elastomeric gloves with knitted liner which comprises fabric fabricated from cotton, nylon, polyester, Kevlar, Spectra and Dyneema for industrial applications.

In this disclosure there is shown and described a preferred embodiment of the invention and suggested various alternatives and modifications thereof, but it is to be understood that these are not intended to be exhaustive and that other changes and modifications can be made within the scope of the invention. These suggestions herein are selected and included for purposes of illustration in order that others skilled in the art will more fully understand the invention and the principles thereof and will be able to modify it, each as may be best suited in the condition of a particular case.

Claims

1. A disposable surgical glove comprising :-

(a) a first thin elastomeric layer (1); and

(b) a second layer (3) to be nearer to the hand than the first layer (1) having a securely bonded, or laminated fabric liner (3), to be in contact with a hand, when the glove is worn, wherein the second layer (3) is configured to absorb, when the glove is worn, excess perspiration or moisture of the skin, thereby maintaining a less moist environment than normally occurring with normal disposable gloves characterized in that both layers (1) (3) are held evenly together by a coagulant and bonded by an adhesive chemical, such that the elastomeric glove (1) and fabric liner (3) may be stretched to whatever extent, without affecting its lamination.

2. The disposable surgical glove as claimed in Claim 1 characterized in that the adhesive chemical is polyisoprene.

3. The disposable surgical glove as claimed in Claim 1 or Claim 2 characterized in that the coagulant chemical is ethanol.

4. The disposable surgical glove as claimed in any of the preceding claims wherein the fabric liner (3) is made of link free, continuous, filament nylon yarn.

5. A method of manufacturing a disposable surgical glove supported by a securely bonded, or laminated fabric liner that is configured to absorb, when the glove is worn, excess perspiration or moisture of the skin, thereby maintaining a less moist environment than normally occurring with normal disposable gloves characterized by

(a) fitting an inverted thin walled elastomeric glove (1) over a rubber former (2) which can be filled with air to expand the elastomeric glove (1), which is then dipped in a solution of an coagulant and thereafter lifted up to blow dry;

(b) the air is then released in order to collapse the elastomeric glove (1) to allow the knitted fabric liner (3) to be then fitted easily over the inverted elastomeric glove (1);

(c) the whole unit is then thereafter re-inflated with air to expand fully and to blow up the elastomeric glove (1) with the liner (3) intact; (d) to be further submerged into a tank of adhesive chemical to help evenly bond the parts together, so that the elastomeric glove (1) and fabric liner (3) may be stretched to whatever extent, without affecting its lamination;

(e) when the finished product is then finally allowed to dry either by itself or with the aid of an oven.