WO1991002466A1

WO1991002466A1 - Tear and puncture-resistant hospital examination and surgical glove

Info

Publication number: WO1991002466A1
Application number: PCT/US1990/004809
Authority: WO
Inventors: Charles D. Kennedy
Original assignee: Kennedy Charles D
Priority date: 1989-08-25
Filing date: 1990-08-24
Publication date: 1991-03-07

Abstract

A tear and puncture resistant glove for hospital examinations and surgical procedures. The glove comprises a multilayer fabric, including at least one layer (8) of multifilament fabric made from a polymer of paraphenyline-diamine and terephthalic acid and two layers (6) of polyurethane film, which serve as the outer layers of the glove. The layers are bound together by an adhesive (10) which fixes into place the fibers (8) of multifilament polymeric fabric. The resulting glove provides for up to a fifty fold increase in resistance to puncture from standard hospital and IV needles and other sharp instruments.

Description

TEAR AND PUNCTURE-RESISTANT HOSPITAL EXAMINATION AND SURGICAL GLOVE

FIELD OF THE INVENTION

The present invention relates to surgical and hospital examination gloves and, in particular, to surgical hospital examination gloves comprised of materials which re tears and puncture by standard hospital and IV catheter nee and other sharp instruments.

BACKGROUND OF THE INVENTION

For years conventional surgical and hospital examination gloves have been made of thin synthetic resins as latex. Such gloves, while allowing for maximum tactile sensitivity and manipulation during examining or surgical procedures, provide little or no protection against tears a punctures caused by sharp instruments such as hospital need surgical instruments and the like. Until recently, tears a punctures have been viewed upon as more of an inconvenience than a tremendous health risk by physicians, surgeons and o health care providers. However, with the discovery of the virus and its absolute fatality and the continued mortality caused by the hepatitis virus, it is imperative that all he care providers, particularly physicians and surgeons, avoid contact with the biological fluids of their patients. An attempted solution to problem of torn or punctu examination and surgical gloves consisted of the practice of double-gloving, i.e. , wearing two pairs of gloves. This practice has proved to be quite unsuccessful. Not only doe the wearer of the two gloves lose tactile sensitivity and manipulation, but double-gloving provides virtually no incre in resistance to tears and punctures. Another attempted solution to the problem of torn punctured gloves has been the fabrication of gloves in which the gloves' high stress points, e.g. , fingertips and palms, have been reinforced. One method of reinforcing high stress points is to provide additional synthetic resin to such poin of conventional hospital gloves, in order to form a thicker layer of material. However, it has been found that this solution provides only slight improvements in tear and/or puncture resistance, and causes a decrease in tactile sensitivity and mobility. Still another solution to the problem of tear and puncture was disclosed in U.S. Patent No. 4,742,578, which issued to Seid. This reference discloses a thin, pliable an limp material composed of high strength, tightly interlaced fibers adhesively attached to various portions of the face o surface of a foundation, i.e. , conventional glove comprised thin latex. While the glove disclosed by Seid apparently 1 increases the resistance to puncture and tear up to seven f

2 over a conventional latex rubber surgical glove, such an

3 increase in puncture and tear resistance is still insuffici

4 to provide adequate protection against standard hospital an

5 catheter needles and other sharp instruments.

6 Accordingly, it is an object of the present inven

7 to provide an improved tear and puncture resistant hospital

8 examination and surgical glove.

⁹ Another object of the present invention is to pro 1° an improved tear and puncture resistant hospital examinatio

11 and surgical glove having sufficient tactile sensitivity an

12 mobility for routine hospital examination and surgical

13 procedures.

- - Yet another object of the present invention is to

15 provide an inexpensive, reusable hospital examination and ⁶ surgical glove with increased resistance to tears and

17 punctures.

¹⁸ Still another object of the present invention is

¹⁹ provide for a hospital examination and surgical glove which

²⁰ an up to fifty (50) fold increase in resistance to tear and

21 puncture.

²² The above objects of the present invention will b

²³ more fully understood, and further objects and advantages w

²⁴ become apparent, from the following description of the invention.

SUMMARY OF THE INVENTION

The present invention relates to hospital examinati and surgical gloves which provide for an up to fifty (50) fol increase in resistance to standard hospital and IV needles an other sharp instruments. The glove of the present invention comprised of a multilayer fabric, which includes at least one layer of a multifilament fabric made from a polymer of paraphenylene-diamine and terephthalic acid and two layers of polyurethane film. The fabric is layered such that the one o more layers of multifilament polymeric fabric are between th layers of polyurethane film which serve as the outer layers. The layers are bound together with an adhesive which also serves to fix into place the fibers of the multifilament polymeric fabric.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-section of the multilayer fabric used to make the glove of the present invention. FIG. 2 is a schematic representation of the test f tear and puncture resistance. 1 FIG. 3 graphically depicts the puncture resistanc

2 a conventional hospital examination and surgical glove.

3 FIG. 4 graphically depicts the puncture resistanc

4 the multilayer fabric used for the hospital examination and

5 surgical gloves of the present invention.

6 FIG. 5 graphically depicts the puncture resistanc

7 two adhesively bonded layers of the multifilament polymeric

8 fiber which is used as a component of the hospital examinat

9 and surgical gloves of the present invention. 0 1 DETAILED DESCRIPTION OF THE INVENTION 2 3 The tear and puncture resistant glove of the pres 4 invention is comprised of a multilayer fabric which consis 5 at least five different layers, including the adhesive lay 6 which bond the fabric layers. Referring to FIG. 1, the fa 7 from which the gloves of the present invention are made co 8 of outer layers 6 which are affixed to inner layers consis ⁹ of a multifilament, polymeric fabric 8 with a quick drying 0 adhesive material 10. The adhesive material 10 is also us

21 attached a plurality of inner layers 8 to each other.

22 Additionally, the adhesive material must be able to orient

23 fibers of multifilament polymeric fabric.

- - In a preferred fabric from which the gloves of t present invention are made, the outer layers 6 are Scotch® Polyurethane Protective Tape No. 8681, manufactured by the 3 Company of St. Paul, Minnesota. The average physical properties are as follows:

However, polyurethane films as thin as 0.0762 mm or as thick 0.3810 mm are within the acceptable range for use in the present invention.

It is believed that the inner layers 8 of the multifilament polymeric fabric provide much of the resistanc to tear and puncture. For example, the preferred polymeric fabric is comprised of KEVLAR®, a unique fiber composed of a polymer of paraphenylene-diamine and terephthalic acid, sold E.I. duPont de Nemours & Co. of Wilmington, Delaware. The KEVLAR® family of aramid fibers have the highest specific tensile strengths of any continuous fibers commercially available — they are two and one-half times as strong as "E glass, five times as strong as steel and over ten times as strong as aluminum.

To be useful as a component of the puncture resist glove of the present invention, the KEVLAR® or other high tensile strength fabrics must be sufficiently dense, i.e. , must have a sufficiently high count to prevent a standard g

⁴ hospital needle from slipping between the individual fibers

⁵ the material. Since standard hospital needles are between

6 and 27 gauge, i.e. , they have outside diameters of between

⁷ and 0.41 mm, with the majority of such needles being betwee

⁸ 18-23 gauge (outside diameters of between 1.244 and 0.635 m

⁹ it has been determined that the per inch count of the high ° tensile strength, multifilament fabric must be greater than ¹ by 35. Consequently, certain high tensile strength, multifilament fabrics, such as KEVLAR® 5612-58-3A and KEVLA ³ 5612-142-1 are not within the scope of the present inventio * Such fabrics are so loosely woven, having counts per inch o ⁵ by 34 or less, that standard gauge hospital needles can sli between the fibers. Such fabrics do not substantially incr ⁷ the resistance to tears and punctures. ⁸ It has been experimentally determined that the ⁹ preferred materials for the hospital examination and surgi ⁰ gloves of the present invention are densely woven material 1 such as KEVLAR® 5612-30-3 and KEVLAR® 5612-30-4. These KE ² fibers have thicknesses of 4.5 and 4.4 mils, respectively, 3 when woven into the multifilament fabric of the present 4 invention, have counts per inch of approximately 120 by 10 weigh approximately 1.70 ounces per square yard. Fibers of KEVLAR® 5612-30-3, which is 55 denier, have the following additional properties: Density 90 lbs/ft³

Tensile Strength 400,000 lbs/in (ASTM-D885)

Elogation % at Break 2.5 (ASTM-D885) The adhesive which binds the polymeric layers of th fabric used to make the gloves of the present invention is a cyanoacrylate. Particularly suited for use in the present invention is an ethy1-2-cyanoacrylate adhesive marketed as KRAZY GLUE® 201, which is manufactured by of Krazy Glue, Inc. of New York, New York. KRAZY GLUE® 201, a colorless adhesive which is insoluble in water, has the following properties: Boiling Point 149°F

Vapor Pressure (at 68°F) 0.17 mm Hg Specific Gravity 1.05

Melting Point -22°F Flash Point (closed cup) 181°F To make the fabric of the present invention, polyurethane tape is laid flat and cyanoacrylate glue is applied uniformly to the upwardly facing surface. The high , tensile strength, multifilament fabric is then stretched over the adhesive layer and allowed to dry, preferably under ambie conditions. Once dry, adhesive is applied to the multifilame fabric surface. Then another piece of multifilament fabric i stretched over the adhesive layer. The process is repeated until a sufficient number of multifilament fabric layers ha been included. Then a second portion of polyurethane tape laid flat upon the upwardly facing adhesive layer and allow to dry, preferably under ambient conditions. Preferably, the present invention is practiced wi three layers of high tensile strength, multifilament fabric. When three sheets of KEVLAR® are used in making the fabric, gloves of the present invention will have an overall thickn of 0.60 mm. Although additional layers of multifilament fa and adhesive can be used and are within the scope of the present invention, it is believed that the advantages of increased puncture resistance are offset by a decrease in tactile sensitivity and mobility. The materials used to make the puncture resistant glove of the present invention are expensive vis-a-vis the latex used in the standard gloves. Moreover, the materials used in the present invention have not been approved by the United States Food and Drug Administration for use in surgi and other hospital procedures. Both of these potential drawbacks to the present invention can be overcome by inclu as part of the present invention a very thin outer glove. an outer glove, having has a maximum thickness of approxima .05 mm, is comprised of vinyl chloride or latex, materials approved for use in hospital examination and surgical glove the FDA. Experimentally, it has been determined that tactil sensitivity and mobility are not diminished by using such disposable gloves. Consequently, the sterility of successiv hospital examinations and/or surgical procedures will be maintained by using a fresh, inexpensive, outer glove with e procedure. Presently, there are no test standards for punctur or tear resistance. While the Izod Impact Test (ASTM-D256) the Notched Izod Impact Test (ASTM-D256) are designed to measure the resistance to breakage by flexural shock of plastics, neither is specific for tear and puncture resistan Moreover, the Izod Tests apparently test for the progation o pre-formed tear in the material. Consequently, in order to show experimentally the increase in tear or puncture resista of the gloves of the present invention the following test ha been devised. Referring to FIG. 2, the tear and puncture resista of materials used in the manufacture of hospital examination and surgical gloves was determined by placing a scale 16 on flat surface 18 and anchoring thereto a standard hospital needle 20. Suspended over the needle in a frame 22 is a sam of the material 24 being tested. Rollers 26 are attached to the four corners of the frame 22, and the rollers 26 fit int rails 28 in vertical rods 30 attached to the flat surface 18 1 Weights 32 are added progressively to the frame 22 containi

2 sample of material 24. The rollers 26 allow the force

³ (weights) applied to the frame 22 to be transferred to the

⁴ material 24 and measured by the scale 16 until the needle 2

⁵ penetrates through the material.

⁶ Experimental Results

⁷ To determine the puncture resistance of standard

⁸ hospital examination and surgical gloves, samples of .10 mm

⁹ thick latex material were placed in frame 22. 1-1/4 inch

¹° needles 20 were then used to determine the puncture resista of the material as a function of the gauge of the needles (

12 14 to 25 gauge). The results, graphically depicted in FIG. ³ show that under no more than one-half pound of pressure, -* standard hospital needles puncture the material used in

1⁵ standard hospital examination gloves. Moreover, the tests

¹⁶ that fine point needles, i.e. , those with a gauge of 23 or

¹⁷ more, will puncture such gloves when less than 0.2 pounds o

¹⁸ pressure is applied. Consequently, the tests show that the

¹⁹ is a high risk that the gloves worn by health care provider

²⁰ will be punctured under very beneign conditions.

²¹ To show the significant increase in puncture

22 resistance provided by the gloves of the present invention

23 samples of the multilayered fabric, i.e. , outer layers of

²* polyurethane and three inner layers of KEVLAR® 5612-30-3 (bonded together with KRAZY GLUE® 201) , were placed in frame and needles 20 having gauges between 14 and 25 were used to determine the puncture resistance. The results, graphically depicted in FIG. 4, show that standard gauge hospital needle will not puncture a glove constructed with the fabric of the present invention until at least four (4) pounds of pressure applied. In fact, several of the needles used in the experiments bent from the pressure applied during the tests before puncturing the material. Table 1 provides a comparison of the puncture resistance of standard hospital examination and surgical glo material and the material of the present invention. TABLE 1 Pressure to Puncture (lbs) % Improvement of Needle Gau e Standard Present Invention Present Invention (

5.0 20

4.5 10+

4.0 9

4.1 16+

4.1 41

While it is believed that the multifilament woven polymeric fabric, e.g. , KEVLAR®, provides the bulk of the puncture resistance, the presence of the polyurethane which serves as a backing material is quite important to the increased puncture resistance. For example, FIG. 5 provides the results of puncture resistance tests using 1-1/4 inch needles having various gauges of two sheets of KEVLAR® 5612 30-3, which have been bonded together with KRAZY GLUE 201®. Without the inclusion of polyurethane film, the increase in puncture resistance of the KEVLAR® versus the standard Late fabric, which is less than half as thick, is approximately percent. Consequently, it is believed that the polyurethan film acts to distribute the force of the needle or other sh object to a large number of fibers within the multifilament fabric. Or, to put it another way, the polyurethane appear spread the forces of the sharp object over a larger area of underlying high tensile strength, multifilament fiber netwo which causes there to be less force on any individual fiber The reduction in the per fiber force causes an increase in resistance to puncture for a force of a given magnitude. The glove of the present invention will be manufactured according to standard techniques and to meet t standard specifications for such gloves, i.e. , ASTM-D8577 f surgical gloves and ASTM-D3578 for examination gloves. For typical hospital examination purposes, the entire glove wil consist of one or more layers of multifilament polymer fabr and two outer layers of polyurethane. However, for certain specialized surgical application, e.g. , to facilitate the palpitation of veins for intravenous access, an alternate embodiment of the present invention should be considered. I such uses, one glove of each pair of gloves of the present invention is constructed with a circular (approximately 10 m diameter) section of multilayer fabric removed from the palm side of the fingertip of the index finger. While such a glo will provide no resistance to puncture in the area of the ti of one index finger, the increased tactility required intravenous access procedures is provided. While the present invention has been disclosed as not only its best mode but also variants thereof, it will be understood that additional variations and modifications obvi to those of ordinary skill in the art are possible. Such additional variations and modifications are considered to be within the spirit and scope of the present invention and the appended claims.

Claims

What is claimed is:

1. A tear and puncture resistant hospital examination and surgical glove comprising multiple inner layers of densely woven, high tensile strength, multifilament fabric and oute layers comprises of a polyurethane film bound together by a adhesive, wherein said adhesive further fixes into place th fibers of the polymeric fabric.

2. The glove as defined by claim 1, wherein said multifila fabric is made from paraphenylene-diamine and terephthalic polymer.

3. The glove as defined by claim 1, which further comprise thin outer glove.

4. The glove as defined by claim 3, wherein said thin oute glove has a maximum thickness of 0.05 mm.

5. The glove as defined by claim 3, wherein the fabric use make the thin outer glove is selected from the group consis of latex and vinyl chloride.

6. The glove as defined by claim 1, wherein the thickness said glove is between .40 mils and .90 mils.

7. The glove as defined by claim 6, wherein the thickness of said glove is approximately .60 mils.

8. The glove as defined by claim 1, wherein the number of inner layers of said densely woven fabric is between one and five.

9. The glove as defined by claim 8, wherein the number of inner layers of said densely woven fabric is three.

10. The glove as defined in claim 2, wherein said densely woven fabric is KEVLAR®.

11. The glove as defined in claim 1, wherein said densely woven fabric has a fiber count per inch of at least 35 by 35.

12. The glove as defined in claim 1, wherein said adhesive used to fix the fibers of said densely woven fabric is ethyl- 2-cyanoacrylate.