WO2003045444A2

WO2003045444A2 - Protective guards for fingers and thumbs

Info

Publication number: WO2003045444A2
Application number: PCT/US2002/037407
Authority: WO
Inventors: M. Kevin Sorrels
Original assignee: Sorrels M Kevin
Priority date: 2001-11-21
Filing date: 2002-11-21
Publication date: 2003-06-05
Also published as: WO2003045444A3; AU2002365397A8; AU2002365397A1

Abstract

A protective guard (20) for a finger or thumb may be used during a medical procedure. The protective guard may inhibit needle or instrument puncture of a medical practitioner's skin during the medical procedure. The protective guard may include a protective portion (46) and a less protective portion (48). The materials used to form the protective portion and the less protective portion may be chosen so that the guard provides a large degree of penetration resistance while still remaining flexible. The color of the protective portion may be different than the color of the less protective portion to provide a user with a visual indication of the protective area of the protective guard.

Description

TITLE: PROTECTIVE GUARDS FOR FINGERS AND THUMBS

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to protective guards, and embodiments relate to protective guards for fingers and thumbs that inhibit skin penetration by needles and/or instruments.

2. Description of Related Art

Medical practitioners including, but not limited to, doctors, physician assistants, nurses, dentists, and dental assistants may use instruments, implants, and/or needles during medical procedures. Medical procedures may include, but are not limited to, surgical procedures and operations, dental procedures and operations, and injection or drawing of fluids using needles. A risk exists that a medical practitioner's skin may be punctured or penetrated during a medical procedure, resulting in a percutaneous injury. A medical practitioner's skin may also be punctured or penetrated during disposal or cleaning of needles or medical instruments previously used in a medical procedure. The medical practitioner and/or patient may be subject to infection or disease including, but not limited to, staphylococcus, hepatitis, and acquired immunodeficiency syndrome (AIDS) due to an inadvertent skin puncture of the medical practitioner. With or without transmission of a disease or pathogen, a skin puncture or other wound may be traumatic to the medical practitioner. There is a need to protect medical practitioners and patients from the risk of infection and pathogens due to skin punctures or wounds of the medical practitioner during a medical procedure.

Surgical gloves may be used by medical practitioners to lessen the risk of transferring blood-borne and other pathogens during medical procedures. Some medical practitioners use two gloves on each hand to reduce the risk of glove failure and skin punctures during medical procedures. Surgical gloves typically do not provide adequate protection from penetration of skin by sharps. Sharps may include, but are not limited to, hypodermic needles; medical, dental and laboratory instruments; and burs and sharp edges or projections of hard tissue and prostheses. Studies show that puncture wounds of medical practitioners often occur on backs of a medical practitioner's fingers or thumb. Puncture wounds may occur predominantly to the index finger, thumb, and middle finger. For example, a medical practitioner may hold a syringe in a dominant hand while stabilizing, retracting, isolating, or palpating tissue with the other hand. A sudden movement by the patient may cause the medical practitioner to accidentally puncture the back of a finger or thumb of the non-dominant hand.

Finger coverings and or hand protectors may be used to reduce the risk of inadvertent skin punctures in non-medical applications. U.S. Patent No. 3,228,033 issued to Ames et al. discloses a finger guard for use while pinning garments. U.S. Patent No. 4,689,828 issued to Brewer discloses a finger protector for hair stylists' fingers that includes a wristband joined to a two-finger protector. The two-finger protector has open ends for the fingers to extend through. U.S. Patent No. 4,858,245 issued to Sullivan et al. discloses an armored glove finger including a rib knit tubular member having an open end and a closed end.

Finger coverings and/or hand protectors may be used in medical applications. U.S. Patent No. 4,901,372 issued to Pierce, which is incorporated by reference as if fully set forth herein, discloses a trilaminar glove with inner and outer barrier layers and a central foam layer. The trilaminar construction may reduce the risk of a puncture through the glove. U.S. Patent No. 4,985,038 issued to Lyell, which is incorporated by reference as if fully set forth herein, discloses a needle stop surgical instrument comprising a finger housing, a needle receiving space, and a handle. The finger housing receives a finger, and the needle receiving space receives and guides a needle. The handle may be grasped between the remaining fingers of the hand and the palm of the hand to allow maneuvering. U.S. Patent No. 5,070,543 issued to Beck, which is incorporated by reference as if fully set forth herein, discloses surgical gloves having protective pads placed at selected areas of the surgical gloves. The selected areas of the surgical gloves may include the fingertips and the palms.

U.S. Patent No. 5,450,626 issued to Sorrels, which is incorporated by reference as if fully set forth herein, discloses protective finger coverings that have flexible and puncture resistant construction. A finger covering may include a puncture resistant, protective surface on a top side of the covering, which fits over a dorsal portion of the finger. As used herein, dorsal in relation to a finger means that portion of the finger opposite the palm of the hand, and ventral means that portion of the finger adjacent the palm of the hand when a fist is formed. The finger guide may also include a retentive or elastic layer that may function to hold the covering on a user's finger or thumb. The retentive layer may be located on a bottom of the covering, which fits over a ventral portion of the finger. The covering may be open-ended to allow a portion of a user's thumb or finger to extend through the covering. The portion of the user's thumb or finger that extends through the covering may allow the user to retain tactile sense while using the covering. The covering may be rotated during use to change the position of the protective surface.

Finger coverings and/or hand protectors may limit finger and/or hand flexibility of the user. Finger coverings and/or hand protectors may limit a user's sense of touch during a procedure. A user's sense of touch may be important during a medical procedure, especially if palpation of various surfaces of a treatment area is required during the procedure. A medical practitioner may need to retain a tactile sense during a medical procedure to control a patient and to maintain awareness of locations of sharp portions of instruments, inserts, and/or needles. Additionally, the use of finger and/or hand protectors may be limited by the amount of working space available within the patient. For example, a dentist does not have a large amount of working space within a patient's mouth. Also, a doctor typically does not have a large amount of working space within a patient during an invasive medical procedure.

SUMMARY OF THE INVENTION

A protective guard for a digit of a hand may include a flexible and penetration resistant construction. A digit may be a finger or a thumb. The protective guard may inhibit punctures or wounds caused by needles, knives, or other sharp instruments. For example, during the utilization of a mechanically engineered syringe, there is window of time before insertion and after withdrawal during which the needle tip is exposed. During this time, the protective guard may inhibit a medical practitioner from receiving an injury to a finger or thumb of the dominant or non-dominant hand while retracting, isolating, or stabilizing the needle tip.

In an embodiment, a protective guard may be formed as an elongated tubular member that covers all or part of the middle and terminal phalanges of a finger or thumb. When the protective guard is positioned on a finger, the protective guard may extend from just beyond the fingertip to just past the medial finger joint. An end of the protective guard nearest the medial joint may be contoured to allow bending of the medial joint. An end of the protective guard nearest the fingertip may be shaped to avoid covering a large portion of the pad of the fingertip. Leaving a large portion of the pad of the fingertip uncovered may promote retention of a user's tactile sense.

A protective guard may include a bottom portion corresponding to a ventral portion of a digit and a top portion corresponding to a dorsal portion of a digit. The bottom portion may include elastic material that functions to retain the protective guard on a medical practitioner's finger or thumb. The top portion may include penetration and puncture resistant material. A protective guard may have a ring-shaped cross-sectional form. An inner diameter of the protective guard may be smaller than a diameter of a finger or thumb upon which the protective guard is placed. The protective guard may form a seal with a user's hand (or a glove on a user's hand) that inhibits fluid from contacting the portion of a user's hand or finger that is covered by the protective guard. The elastic material may be chosen such that the protective guard slides over digits within a range of circumferences. The elastic properties of the material may hold the protective guard on a finger or thumb within the range of circumferences when the guard is positioned on the finger or thumb. The elastic properties of the protective guard and/or the shape of the protective guard may allow the protected finger or thumb to be bent or flexed. In some embodiments, a notch or notches may be formed in a portion of the protective guard to facilitate bending of the guard when the finger or thumb is bent or flexed. The notch or notches may allow the guard to conform to an anatomical shape of the finger or thumb within the range of circumferences while the digit is bent or flexed.

A top portion of a protective guard may be protective material that is puncture and/or penetration resistant. The top portion may include some flexibility so that a medical practitioner may bend a finger or thumb around which the protective guard is positioned. The top portion may include notches that are positioned in the top portion to increase the flexibility of the top portion. Placement of the protective guard may be chosen such that a dorsal portion, a ventral portion, or another portion of a finger or thumb is covered by the protective material. Alternatively, the protective guard may be rotated on a finger or thumb during use to change the location of the protective material.

The color or colors of the protective guard may be different than the color of tissue and/or fluid (e.g., blood) to enhance view of the protective guard. In an embodiment, protective guards may be made in several sizes, with each size distinguished by a particular color. Such color coding may allow rapid visual differentiation between protective guard sizes. In other embodiments, protective material of a protective guard may be dyed a different color than less protective or retentive material of the protective guard. For example, the protective portion of a protective guard may be red, orange, yellow, green, or blue, while the less protective portion of the protective guard may be uncolored or skin colored. A portion of the protective guard may be made of a transparent or semi- transparent material. Alternatively, a protective portion of a protective guard may be painted or otherwise colored a different color than other portions of the protective guard. The color difference between the penetration resistant portion and the less penetration resistant portions of a protective guard may allow a medical practitioner to maintain awareness of the location of a protective portion of the guard during a medical procedure. The protective portion of a protective guard may be any color that contrasts with a user's skin and/or less protective section of the protective guard.

In an embodiment, a protective guard is made from FDA or USDA approved plastics and/or colors, such that the protective guard may be safely used in food preparation, including chopping, slicing, cutting, grating, dicing, paring, trimming, or mincing foods including, but not limited to, meats, vegetables, herbs, and fruits. In an embodiment, a surface of a protective guard may be used as a guide (e.g., as a guiding plane, allowing a knife or other instrument to glide smoothly along the surface while protecting a digit from cuts).

A top portion of a protective guard may have a longer length than a bottom portion of the protective guard. The smaller length of the bottom portion may promote the ability to flex and bend a finger while wearing the protective guard. The smaller length of the bottom portion may also allow a pad of the finger or thumb upon which the protective guard is placed to remain uncovered during use so that the protective guard does not interfere with a user's ability to register tactile sensations through the finger or thumb pad. The bottom portion may include one or more notches to increase the flexibility of the guard.

A bottom or retentive portion of a protective guard may be made of a flexible material with some penetration resistance. The retentive portion of a protective guard may be formed of an elastomeric polyvinyl chloride compound such as, but not limited to, Flexchem®, supplied by Tekni-Plex Co. of New Jersey. In an embodiment, a retentive portion is formed of a 0.75 millimeter thick, 65 Shore A durometer hardness, elastomeric polyvinyl chloride material. The puncture resistance of a material may be compared to the puncture resistance of a latex glove or a double layer of latex gloves. The puncture resistance of a latex glove and/or a double layer of latex gloves may be the standard against which protection is compared. The resistance of the retentive portion of a protective guard to penetration/puncture by a 27 gauge needle may be over four times greater than penetration resistance of a double layer of latex gloves, each glove having a thickness between about 0.05 millimeters and 0.2 millimeters. The penetration resistance of the retentive portion of a protective guard to puncture by a 20 gauge needle may be over eight times greater than the penetration resistance of a double layer of latex gloves, each glove having a thickness between about 0.05 millimeters and 0.2 millimeters.

A top or protective portion of a protective guard may be made of a penetration resistant material that has some flexibility. The flexibility of the protective portion and the shape of the protective guard may allow a medical practitioner to bend a finger or thumb around which the protective guard is positioned. The protective portion of the protective guard may be formed of an elastomeric polyvinyl chloride compound such as, but not limited to, Unichem®, supplied by Tekni-Plex Co. of New Jersey. In an embodiment, a protective portion is formed of a 0.80 millimeter, 90 Shore A durometer hardness, polyvinyl chloride material. The resistance of the material to puncture by a 27 gauge needle may be over twenty-six times greater than penetration resistance of a double layer of latex gloves, each glove having a thickness between about 0.05 millimeters and 0.2 millimeters. The penetration resistance of the material to penetration/puncture by a 20 gauge needle may be over fifty-one times greater than the penetration resistance of a double layer of latex gloves, each glove having a thickness between about 0.05 millimeters and 0.2 millimeters. In some embodiments, notches may be formed in the protective portion of the guard to increase the flexibility of the guard.

In some applications, a protective guard may be rotated on a thumb or finger to change a position of a primary protective portion of the protective guard. For example, if the protective guard is positioned over a surgical glove, the guard may be rotated during use to change the position of the protective portion of the protective guard from the back of the finger to the front of the finger. A color difference between a protective portion of the protective guard and a less protective portion of the guard may allow a medical practitioner to visually confirm that the protective portion of the guard is positioned as desired.

A protective guard may include a lip at an end that will be closest to a fingertip when the guard is placed on a finger or thumb. The end may contact a fingernail or a fingertip during use to properly position the protective guard and inhibit the guard from advancing too far up a user's finger or thumb. The lip may be an indicator of an insertion depth of the protective guard on a user's finger or thumb.

A portion of a protective guard may be made of a protective material. The protective material may be a polymer. The protective material may include, but is not limited to, an amide (e.g., a polyparaphenylene terephthalamide or similar material) or a polymerized fluorocarbon (e.g, polytetrafluoroethylene or similar material). In embodiments, the protective material may be Kevlar® or Teflon®, available from E.I. du Pont de Nemours and Company of Delaware. The protective material may be positioned only on a selected portion of the protective guard as a layer, or the protective material may form substantially all of a puncture resistant portion of a protective guard. If the protective material is positioned on only a selected portion of the protective guard, the protective layer may be a different color than a puncture resistant portion of the protective guard, which may be of different color than other portions of the protective guard.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will become apparent to those skilled in the art with the benefit of the following detailed description of the embodiments and upon reference to the accompanying drawings in which:

Figure 1 shows a perspective view of a hand with protective guards positioned on an index finger and a thumb.

Figure 2 shows a front view of a protective guard, wherein a protective portion of the guard has a green color.

Figure 3 shows an end view of a protective guard, wherein a protective portion of the guard is thinner than a less protective portion of the guard, and wherein a protective portion of the guard has a pink color.

Figure 4 shows an end view of a protective guard, wherein a protective portion of the guard is thicker than a less protective portion of the guard, and wherein a protective portion of the guard has a blue color.

Figure 5 shows a bottom view of a protective guard, wherein a protective portion of the guard has an outer surface that is green.

Figure 6 shows a cross-sectional view of a protective guard positioned on a finger (the finger is not shown in cross section), taken substantially along plane 6-6 of Figure 1.

Figure 7 shows a front view of a protective guard positioned on a finger, wherein a bottom portion of the protective guard has "V" shaped notches.

Figure 8 shows a perspective view of a hand with protective guards positioned on an index finger and a thumb, with a glove positioned over the protective guards, and wherein the colors of protective portions of the guards are visible through the glove.

Figure 9 shows a perspective view of a hand with a glove, and with protective guards positioned over the glove on an index finger and a thumb.

Figure 10 shows a schematic view of processing equipment that may be used to form a protective guard.

Figure 11 shows a front view of a symmetric protective guard.

Figure 12 shows a front view of a flexible protective guard with a non-undercut end portion, wherein a protective portion of the guard is purple.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. The drawings may not be to scale. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to Figure 1, a protective guard for a finger or thumb is designated by reference numeral 20. A medical practitioner may use protective guard 20 during a medical procedure to reduce the risk of puncturing skin or otherwise producing a percutaneous injury during the medical procedure. Figure 1 shows protective guard 20 positioned on finger 22 of hand 24 and a protective guard positioned on thumb 26 of the hand. Using protective guards 20 to reduce the risks of forming skin openings during medical procedures may reduce the transmission of disease and pathogens between medical practitioners and patients. Preventing a puncture or skin opening in a medical practitioner may prevent emotional trauma associated with producing an accidental opening during a medical procedure. Medical practitioners may be, but are not limited to, doctors, physician assistants, nurses, dentists, dental assistants, oral surgeons, orthodontists, or oral hygienists. A medical procedure may include, but is not limited to, an invasive medical operation, a surgical reduction, a dental cleaning or procedure, an orthodontic procedure, insertion of a needle into a patient to inject or draw fluid, performing laboratory tests on tissue or fluid samples (including cases involving blood-borne pathogens and seroconversions), and cleaning or disposing of used instruments or needles.

Protective guards may be used to inhibit cutting or puncturing of skin by wires, knives, and other sharp or blunt instruments or objects, providing finger/thumb protection to workers including, but not limited to, jewelers, electricians, and carpenters. Protective guards may also be used in food preparation, electronics repair, and mechanical and engineering applications, such as space and aeronautical engineering applications. In some embodiments, protective guards may be used to provide first aid in situations involving cuts sustained on digits of a hand.

In an embodiment, protective guard 20 may be an elongated tubular member that extends generally from medial joint 28 of finger 22 or thumb 26 to an end of the finger or thumb. Figure 2 shows a front view of an embodiment of protective guard 20. Figures 3 and 4 show end views of embodiments of protective guards 20. Figure 5 shows a bottom view of protective guard 20. Protective guard 20 may be a semi-rigid structure. Protective guard 20 may have a shape that does not cover creases formed by the portion of medial joint 28 on ventral surface 30 of finger 22 or thumb 26, as shown in Figure 6. Alternatively, protective guard 20 may cover a portion of the third metatarsal of finger 22 or a portion of the second metatarsal of thumb 26. Figure 6 shows an embodiment of protective guard 20 positioned on finger 22. A top portion of protective guard 20 may cover the creases or stop in the creases of medial joint 28 on dorsal surface 32 of finger 22. The shape of protective guard 20 may allow a medical practitioner to retain flexibility of medial joint 28 when the guard is placed on finger 22.

Top portion 34 of protective guard 20, shown in Figures 2-6, may extend beyond a fingertip of finger 22 when the guard is placed on a finger or thumb. Protective guard 20 may optionally include lip 36, as shown in the embodiments in Figures 2 and 5. The lip may advantageously limit an insertion depth of the protective guard on a user's finger or thumb. Contact of lip 36 against fingernail 38 (shown in Figure 6) or end surface of a fingertip may inform a user that protective guard 20 is fully positioned on finger 22. Lip 36 may also inhibit protective guard 20 from sliding up finger 22 during use. In some embodiments, such as the embodiment shown in Figure 6, protective guards 20 do not include lips.

Bottom portion 40 of protective guard 20 may not cover creases of distal joint 42 on ventral surface 30 of finger 22 or thumb 26, as shown in Figure 6. A medical practitioner may retain flexibility of distal finger joint 42 when protective guard 20 is placed on finger 22. Protective guard 20 may have a shape at a fingertip end or thumb tip end of the guard that allows pad 44 of medical practitioner's finger 22 or thumb 26 to remain uncovered when protective guard 20 is placed on the finger or thumb. Leaving pad 44 uncovered by protective guard 20 may advantageously allow the medical practitioner to retain the ability to register tactile sensations through pad 44 during a medical procedure. The ability to flex finger joints 28, 42 while wearing protective guard 20 and the ability to feel tactile sensations may allow a medical practitioner to palpate and manipulate tissue during a medical procedure while wearing the protective guard Bottom portion 40 of protective guard 20 may be positioned between medial joint 28 and distal joint 42 when the protective guard is positioned on finger 22 or thumb 26

An advantage of certain embodiments of a protective guard is that the guard includes a puncture/penetration resistant protective portion and a retentive less protective portion The protective portion may include some flexibility and the retentive portion may include puncture/penetration resistance The protective portion and the less protective portion may result in a protective guard that provides a large degree of puncture and penetration resistance while still remaining easy to manipulate during a medical procedure

As shown in Figure 5, top portion 34 of protective guard 20 may have a longer length than bottom portion 40 of the protective guard The shorter length of bottom portion 40 may facilitate bending and flexing of user's finger 22 or thumb 26 when protective guard 20 is positioned on the finger or thumb The shorter length of bottom portion 40 may also allow a portion of the user's finger or thumb pad to remain uncovered when protective guard 20 is positioned on user's finger 22 or thumb 26, as shown in Figures 1, 8 and 9

An advantage of certain embodiments a protective guard may be that the guard has a substantial amount of flexibility Such flexibility may be provided by the materials that are used to make the guard In other embodiments, one or more notches may be used to provide increased flexibility

As shown in Figure 2, bottom portion 40 may include one or more notches 80 Notches 80 may have various shapes Notch shapes may be, but are not limited to, rectangular, arcuate, or "V" shaped Notches 80 may pass partially or completely through bottom portion 40 Notches 80 may increase the flexibility of the guard, facilitate conformation of top portion 34 to the digit, and inhibit the end of the top portion from flaring away from the digit when the digit is bent The substantial amount of flexibility may allow the protective guard to comfortably conform to a user's finger or thumb when the finger or thumb is flexed

Protective guard 20 may be configured to be placed on finger 22 of a medical practitioner Alternatively, protective guard 20 may be configured to be placed on thumb 26 of a medical practitioner During a medical procedure, a medical practitioner may place protective guard 20 on one or more fingers 22 and/or on thumb 26 of hand 24 In a typical application, protective guards 20 are placed on a non-dominant hand of the medical practitioner Protective guard 20 for thumb 26 may have a shorter length and a wider diameter to account for a size difference between a thumb and finger 22 Several different sizes of protective guards 20 for fingers 22 and for thumbs 26 may be produced to accommodate various sizes of fingers and thumbs Protective guards 20 may be removed and discarded after use

Protective guard 20 may include protective portion 46 and less protective portion 48 Protective portion 46 may be resistant to punctures, penetrations, and tears In an embodiment, protective portion 46 may include top portion 34 of protective guard 20, and less protective or retentive portion 48 may include bottom portion 40 of the protective guard Less protective portion 48 of protective guard 20 may be formed of an elastic material One or more notches may be cut in the elastic material Less protective portion 48 may extend between medial finger joint 28 and distal finger joint 42 when protective guard 20 is placed on finger 22 Less protective portion 48 may be a retentive portion of protective guard 20 that keeps the guard on user's finger 22 or thumb 26 A circumference of inner surface 50 (shown in Figures 3 and 5) of protective guard 20 may be smaller than an outer circumference of finger 22 or thumb 26 that the guard is to be placed on The elastic material may expand when the protective guard is positioned on finger 22 or thumb 26 The elastic material may exert compressive force on finger 22 or thumb 26 to hold protective guard 20 on the finger or thumb The elastic properties of the material may form a seal between finger 22 or thumb 26 and protective guard 20. The seal may inhibit fluid from contacting the skin of the digit protected by the guard. Notches may be formed in the elastic material to allow for increased flexibility of the protective guard.

An advantage of certain embodiments of a protective guard is that the protective guard may be multicolored. Protective portion 46 of protective guard 20 may be a different color than less protective portion 48 of the guard. Figures 1, 8, and 9 show embodiments of protective guards 20 in which protective portions 46 of the guards are different in color than less protective portions 48 of the guards. Figure 1 shows protective guards 20 positioned on finger 22 and thumb 26 of hand 24. Figure 8 shows protective guards 20 positioned on finger 22 and thumb 26 with surgical glove 52 positioned over the guards. Figure 9 shows protective guards 20 positioned over a surgical glove on index finger 22 and thumb 26 of hand 24. In an alternative embodiment, hand 24 may be covered by surgical glove 52 with one protective guard 20 located under the glove, and with a second protective guard positioned over the glove. For example, protective guard 20 may be positioned on thumb 26, glove 52 may be pulled over hand 24, and a second protective guard may be positioned on an index finger and/or middle finger.

Material that forms protective portion 46 of protective guard 20 may be dyed a different color than the material that forms less protective portion 48. Alternatively, protective portion 46 may be painted a different color than less protective portion 48. In some embodiments, the color of protective portion 46 may be a vivid color that results in a marked contrast with the color of less protective portion 48 of protective guard 20, and with the color of user's finger 22 or thumb 26. The color of protective portion 46 may be chosen from, but is not limited to, FDA approved reds, oranges, yellows, greens, or blues. The color of less protective portion 48 may be the natural color of the material used to form the portion or any color that provides a noticeable contrast with the color of protective portion 46 and/or a noticeable contrast with the color of a user's skin. The colors of protective portion 46 and less protective portion 48 of protective guard 20 provide a contrast that allows a medical practitioner to distinguish between the two portions when the protective guard is covered by surgical glove 52 or other covering. The colors of protective portion 46 and less protective portion 48 may contrast with the skin color of user's finger 22 and/or thumb 26, so that a user may easily visualize the limits of protection afforded by protective guard 20.

Protective portion 46 and less protective portion 48 of protective guard 20 may be made of biocompatible materials. Protective guard 20 may be made of inexpensive materials. Protective guards 20 used during a medical procedure may be disposed of after the medical procedure. Protective portion 46 and less protective portion 48 of protective guard 20 may include elastomeric materials. The material used to form protective portion 46 of protective guard 20 may include, but is not limited to, UniChem® polyvinyl chloride. The material used to form less protective portion 48 of protective guard 20 may include, but is not limited to, FlexChem® polyvinyl chloride. UniChem® and FlexChem® may be obtained from Tekni-Plex Co. of New Jersey. Protective portion 46 and less protection portion 48 may be made of chemically similar materials so that a strong bond is formed between the two portions at interfaces between the two materials during formation of protective guard 20. The strong bond may inhibit separation of the two materials. If protective portion 46 and less protective portion 48 do not bond well together, a bonding agent may be used to ensure that a strong bond is formed at interfaces between the two portions. The inside of protective guard 20 may be coated with a lubricant (e.g., talc or a surfactant) to ease positioning of the protective guard on a user's finger or thumb.

Protective portion 46 may include or be a protective material such as, but not limited to, Kevlar® (a polyparaphenylene terephthalamide or similar material) or Teflon® (a polytetrafluoroethylene or similar material). Kevlar® and Teflon® may be obtained through E.I. du Pont de Nemours and Company of Delaware. If protective guard 20 includes a layer of a protective material within protective portion 46, the layer may be a different color, tint, or shade than other sections of the protective portion. Less protective portion 48 may also include a layer or layers of protective material.

In some embodiments, protective guards may taper from a large end to a smaller end A taper of protective guard 20 may substantially correspond to a taper of finger 22. The small end of protective guard 20 may be positioned near a fingertip, and the large end may be positioned near or over medial joint 28 of finger 22 when the protective guard is positioned on a user's finger Tapering protective guards 20 may be formed by any formation technique including, but not limited to, injection molding or reaction injection molding In some embodiments, protective guard 20 may be substantially untapered.

In some embodiments, protective guards may be formed using a single extrusion procedure. The protective guard may include one or more layers of material. The protective guard may be formed as a tube. The tube may be cut to desired lengths and desired end patterns The protective guards may be tapered, or the protective guards may be substantially untapered.

In an embodiment of a protective guard made during a single extrusion, the material used to form the guard may be thicker on a protective side of the guard than on a retentive side of the guard. The material used to form the protective portion and the retentive portion may be the same material (e g., a polymer) with the same Shore A durometer. In an embodiment, the protective portion of the guard may be thicker than the retentive portion of the protective guard. The retentive portion and/or a portion of the protective portion may include a notch or notches that allows a user to flex a finger or thumb that has a protective guard positioned on the finger or thumb In some embodiments, the protective portion may have a thickness greater than about 0 25 mm and less than about 2.0 mm In some embodiments, the retentive portion may have a thickness greater than about 0.05 mm and less than about 1 5 mm In an embodiment, the protective portion may have a thickness of about 0.9 mm and the retentive portion may have a thickness of about 0.4 mm The retentive portion of the protective guard embodiment may also include two or more notches to facilitate flexure of a digit protected by the protective guard.

In some embodiments, protective guard 20 may be cut from tube 54 formed using a dual extrusion procedure. Figure 10 shows a schematic diagram of processing equipment that may be used to form tube 54. The processing equipment may include first extruder 56 that is coupled to second extruder 58. First and second extruders 56, 58 may form tube 54. Storage vessel 60 may supply a first material to extruder 56. First dye storage vessel 62 may supply dye that is mixed with the first material The first material may form protective portion 46 of protective guard 20 The color of protective portion 46 may contrast with a user's skin color and with a color of material used to form less protective portion 48 of protective guard 20 Storage vessel 64 may supply a second material to extruder 58 for forming less protective portion 48. Second dye storage vessel 66 may supply dye that is mixed with the second material to change the color of less protective portion 48.

First extruder 56 may form a first material into arcuate protective portion 46 with angle A (shown in Figure 3) from end to end between about π/2 radians (or about 90°) and about 2π radians (or about 360°). In some embodiments, angle A is within an angular range from end to end between about π radians (or about 180°) and 3π/2 radians (or about 270°), and in an embodiment, the angular range from end to end is about 5π/4 radians (or about 225°). Protective portion 46 may taper or be irregular so that the angular range of the protective portion varies along a length of protective guard 20 The second material may be formed in an arcuate shape so that protective portion 46 and less protective portion 48 form substantially ring-shaped protective guard 20 when bonded together. As the first material and the second material are bonded together, bead 68 may form at the intersection of the two materials. Bead 68 may be an overlapping layer of the second material. Bead 68 may be formed along a length of a tube formed by extruders 56, 58.

After formation of tube 54 by extruders 56, 58, the tube may be sent to cutting machine 70. Tube 54 formed by extruders 56, 58 may automatically be sent to cutting machine 70, or a tube may be manually transferred to the cutting machine. Bead 68 between protective portion 46 and less protective portion 48 of tube 54 may serve as a guide for cutting machine 70 to inhibit rotation of the tube and to ensure that the tube is properly oriented relative to a cutter or cutters of the cutting machine. Bead 68 may also inhibit tearing or separation of formed protective guard 20 at an interface between protective portion 46 and less protective portion 48.

Cutting machine 70 may form an intermediary protective guard that may be further trimmed to a desired shape, or the cutting machine may produce formed protective guard 20. Figure 11 shows an embodiment of protective guard 20 after the guard has passed through cutting machine 70. Cutting machine 70 may produce an embodiment of protective guard 20 that has a symmetrical shape about axis 72. Other cutting machines 70 may produce protective guards 20 that do not have symmetrical shapes, such as the embodiment of protective guard 20 shown in Figure 2. In the protective guard embodiment shown in Figure 11, angle B between bottom 40 of protective guard 20 and end 76 of the protective guard may range between 160° to about 90°. In other embodiments, angle B may be between about 120° and 140°, or about 135°. B

Notches 80 may be cut out of bottom portion 40 using cutting machine 70 or a separate cutting tool (e.g., punch and die). Bead 68 may be used as a guide for cutting notches 80.

Materials with different properties may be chosen to form protective and less protective portions 46, 48 of protective guard 20. Table 1 shows some properties for materials that may be used to form protective guard 20. The penetration load is the maximum load that the material resists before being penetrated by a needle of the indicated gauge. Two representative needle sizes were used in the puncture/penetration tests: a thick needle size (20 gauge) and a thin needle size (27 gauge). The first material in Table 1 is a double layer of latex gloves, included as a reference for puncture resistant properties of other materials.

Materials for protective guard 20 may be chosen based in part upon resistance to puncture and flexibility. The material for protective portion 46 and less protective portion 48 of protective guard 20 may be chosen so that the material has a penetration resistance to a 20 gauge needle that is greater than about 1.0 N and a penetration resistance to a 27 gauge needle greater than about 0.4 N. Less or greater puncture resistance limits may be chosen for the protective and less protective portions 46, 48 of protective guard 20. For example, the material for protective portion 46 may be chosen so that the material has a penetration resistance to a 20 gauge needle greater than about 2.0 N and a penetration resistance to a 27 gauge needle greater than about 1.3 N. Protective portion 46 and less protective portion 48 may be made of material that ranges in Shore A durometer hardness from about 45 to about 110. TABLE 1

Thicknesses of materials for protective guard 20 may be chosen so that the protective guard has desired penetration and flexibility properties. A thickness of protective portion 46 of protective guard 20 may be less than, equal to, or greater than a thickness of less protective portion 48. For example, Figure 3 shows an end view of an embodiment of protective guard 20 that has thinner protective portion 46 and thicker less protective portion 48. Less protective portion 48 may be formed of 90 Shore A durometer/0.80 mm polyvinyl chloride elastomer, and protective portion 46 may be formed of 85 Shore A durometer/0.50 mm polyvinyl chloride elastomer. Figure 4 shows an end view of an embodiment of protective guard 20 that has thicker protective portion 46 and thinner less protective portion 48. Less protective portion 48 may be formed of 85 Shore A durometer/0.50 mm polyvinyl chloride elastomer, and protective portion 46 may be formed of 65 Shore A durometer/0.75 mm polyvinyl choride elastomer. The values in the last two rows of Table 1 indicate the ratio of maximum penetration load to bending load for 20 gauge and 27 gauge needles, respectively. These ratios may identify the degree to which flexibility is compromised for increased penetration resistance in protective guard 20. For example, large ratios such as 70 (20 gauge needle) and 45 (27 gauge needle) for 85 Shore A durometer/0.50 mm thick material identify a material that may provide increased protection with minimal compromise in flexibility. Small ratios such as 29 (20 gauge needle) and 13 (27 gauge needle) for 90 Shore A durometer/0.80 mm thick material identify a material that may provide increased protection but may also be stiff or relatively inflexible. Materials that are protective as well as flexible allow protective guard 20 to provide increased penetration resistance and conform to user's finger 22 or thumb 26 during use, even when the user bends or flexes the finger or thumb.

In an embodiment, protective portion 46 of protective guard 20 may be made of 85 Shore A durometer/0.50 mm thick material, and less protective portion 48 of the guard may be made of 65 durometer/0.75 mm thick material. The color of protective portion 46 may be green. Less protective portion 48 may be a transparent or semi-transparent color that is distinctly different than the color of protective portion 46. Because the thickness of protective portion 46 is less than the thickness of less protective portion 48, the difference in color between the two portions may indicate to a user of protective guard 20 that the protective portion is actually the thin portion of the protective guard. Protective portion 46 may provide over 14 times the protection of doubled latex gloves to puncture from 20 gauge needles and over 11 times the protection of doubled latex gloves to puncture from 27 gauge needles. Less protective portion 48 may provide over 8 times the protection of doubled latex gloves to puncture from 20 gauge needles and over 4 times the protection of doubled latex gloves to puncture from 27 gauge needles.

In another embodiment, protective portion 46 and less protective portion 48 may be each be formed of 70 Shore A durometer polyvinyl chloride elastomer that is 0.75 mm thick. Protective portion 46 and less protective portion 48 may provide over 8 times the protection of doubled latex gloves 52 to puncture from 20 gauge needles and over 4 times the protection of doubled latex gloves to puncture from 27 gauge needles. Using a relatively soft material for the protective portion may increase the flexibility of the guard and allow the guard to better adapt to bending of the digit.

The values shown in Table 1 are illustrative of several materials that may be used to form protective guards 20 that inhibit or prevent skin penetration during medical procedures by percutaneous injury-causing devices. Other materials may be chosen based upon a number of factors including, but not limited to, comfort, elasticity, allergenic properties of the material, and penetration/puncture resistance of the material. An advantage of a protective guard may be that the protective guard has a layer or layers of additional protective material.

In an embodiment, the materials used to form protective guard 20 may have a flexibility that allows an end of the protective guard that is placed adjacent to medial joint 28 to have a substantially cylindrical shape without undercut portions. In other words, angle B (shown in Figure 11) for an end of protective guard 20 may be about 90°. The substantially cylindrical shape may obviate the need to shape the end of protective guard 20 to provide a user the ability to bend a finger at medial joint 28. Figure 12 shows an embodiment of protective guard 20 in which the protective guard is made of materials that allow the protective guard to remain substantially flexible. In this embodiment, an end of the guard does not need to include an undercut portion to allow a user to flex a protected finger.

In an embodiment shown in Figure 7, a material or materials used to form a protective portion of protective guard 20 may be sufficiently flexible and sufficiently penetration resistant that the entire protective guard may be formed only of the material or materials of the protective portion. Notches 80 may be formed in a portion of the body to increase the flexibility of protective guard 20. Notches 80 may facilitate flexing of protective guard 20 when the finger or thumb of the user is bent. In an embodiment, protective guard 20 may be of single piece construction, with a thicker protective portion and a thinner retentive portion. For example, the thicker protective portion may be about 0.5 mm thick, while the thinner retentive portion may be about 0.25 mm thick.

Protective guard 20 may be placed on finger 22 or thumb 26 immediately adjacent to skin. Alternatively, protective guard 20 may be placed over surgical glove 52 or other covering surrounding a user's skin. A user may pull protective guard 20 on finger 22 or thumb 26. Protective guard 20 may provide protection against penetration or opening of the medical practitioner's skin during a medical procedure, yet the protective guard may still allow the user the ability to flex and bend a protected digit. During the medical procedure, protective guard 20 may be rotated on the digit to protect a desired portion of the digit. Alternatively, initial placement of protective guard 20 may be chosen such that protective portion 46 protects a dorsal portion, a ventral portion, or another portion of the digit. A difference in color between protective portion 46 and less protective portion 48 may allow a user to know where the protective portion of protective guard 20 is located during the medical procedure. Protective guard 20 may be placed on finger 22 or fingers of hand 24 of a user. Protective guard 20 may also be placed on thumb 26 of a user. Typically, the protective guards are placed on selected digits of a non- dominant hand of the user, although protective guards may also be placed on a user's dominant hand. Protective guards 20 may protect the user against inadvertent skin penetrations from sharps during a medical procedure while still allowing the user to retain tactile sensations from finger 22 or thumb 26. For example, during utilization of a mechanically engineered syringe there is a window of time, before insertion and after withdrawal, when the needle tip is exposed. During this time, a healthcare worker may receive an injury to a finger or thumb of the non- dominant hand while retracting, isolating, or stabilizing the needle tip. As an example of use, protective guards 20 positioned on a user's non-dominant hand may inhibit inadvertent skin penetration from needles held and positioned with the user's dominant hand during a procedure. As another example of use, protective guards 20 positioned on a user's non-dominant hand may inhibit inadvertent skin penetration from a dental sealer if the user's protected finger inadvertently slips from contact with a patient's tooth or gum while the user is removing buildup from a tooth with the dental sealer.

Protective guard 20 may be formed using an extrusion process. In an embodiment, a polyvinyl chloride material that forms protective portion 46 of protective guard 20 and a polyvinyl chloride material that forms less protective portion 48 are simultaneously extruded to form the protective guard. The similar properties of the materials may allow portions 46, 48 of protective guard 20 to bond together during the extrusion process. In alternative embodiments, protective portion 46 is formed separately from less protective portion 48, and the two portions are subsequently bonded together. Portions 46, 48 may be bonded together by methods including, but not limited to, heat welding, sonic welding, solvent welding, or gluing. After protective portion 46 and less protective portion 48 are bonded together, the resulting material may be cut and shaped to form individual protective guards 20. An undercut may be formed at an end of protective guard 20 to allow a portion of pad 44 of user's finger 22 or thumb 26 to remain uncovered by the protective guard when the guard is placed on the finger or thumb. An undercut may be formed at an opposite end of protective guard 20 to allow the user to bend medial finger joint 28. Other processes may also be used to produce protective guards 20 including, but not limited to, injection molding and reaction injection molding.

In this patent, certain U.S. patents, U.S. patent applications, and/or other materials (e.g., articles) have been incorporated by reference. The text of such U.S. patents, U.S. patent applications, and other materials is, however, only incorporated by reference to the extent that no conflict exists between such text and the other statements and drawings set forth herein. In the event of such conflict, then any such conflicting text in such incorporated by reference U.S. patents, U.S. patent applications, and other materials is specifically not incorporated by reference in this patent.

Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.

Claims

WHAT IS CLAIMED IS:

1. A guard for a digit of a hand, comprising: a protective body; and wherein the protective body comprises at least one notch.

2. The guard of claim 1, wherein a notch comprises a profile that is substantially arcuate.

3. The guard of claim 1, wherein a notch comprises a profile that is substantially V-shaped.

4. The guard of claim 1, wherein a notch comprises a profile that is substantially rectangular.

5. The guard of claim 1, wherein at least a portion of the protective body is formed of an elastomeric material.

6. The guard of claim 1 , wherein the protective body comprises polyparaphenylene terephthalamide.

7. The guard of claim 1, wherein the protective body comprises an amide.

8. The guard of claim 1, wherein the protective body comprises polytetrafluoroethylene.

9. The guard of claim 1, wherein the protective body comprises a fluorocarbon.

10. The guard of claim 1, wherein the protective body comprises a Shore hardness greater than about 45 and less than about 110.

11. The guard of claim 1, wherein at least a portion of the protective body is penetration resistant, and at least a portion of the protective body is flexible.

12. The guard of claim 1, wherein a first portion of the protective body is visually distinguishable from a second portion of the protective body.

13. The guard of claim 1, wherein at least a portion of the protective body is penetration resistant and flexible.

14. A guard for a digit of a hand, comprising: a body; a protective portion of the body configured to be penetration resistant; a less protective portion of the body adjacent to the protective portion; and wherein the less protective portion of the body comprises at least one notch.

15. The guard of claim 14, wherein the protective portion is of a different color than the less protective portion.

16. The guard of claim 14, wherein a notch comprises a profile that is substantially arcuate.

17. The guard of claim 14, wherein a notch comprises a profile that is substantially V-shaped.

18. The guard of claim 14, wherein a notch comprises a profile that is substantially rectangular.

19. The guard of claim 14, wherein the protective portion of the body comprises a Shore hardness greater than about 45 and less than about 110.

20. The guard of claim 14, wherein the less protective portion of the body comprises an elastomeric material.

21. The guard of claim 14, wherein the protective body comprises an amide.

22. The guard of claim 14, wherein the protective body comprises a fluorocarbon.

23. The guard of claim 14, wherein at least a portion of the protective body is penetration resistant, and a least a portion of the protective body is flexible.

24. The guard of claim 14, wherein at least a portion of the protective body is penetration resistant and flexible.

25. A guard for a digit of a hand, comprising: a body comprising a top portion and a bottom portion; wherein the top portion of the body is a different color than the bottom portion of the body; and wherein at least the bottom portion of the body comprises at least one notch.

26. The guard of claim 25, wherein a color of the top portion is visibly distinguishable from a color of the bottom portion.

27. The guard of claim 25, wherein a notch comprises a profile that is substantially arcuate.

28. The guard of claim 25, wherein a notch comprises a profile that is substantially V-shaped.

29. The guard of claim 25, wherein a notch comprises a profile that is substantially rectangular.

30. The guard of claim 25, wherein the first protective portion of the body comprises a Shore hardness greater than about 45 and less than about 110.

31. The guard of claim 25, wherein the top portion of the body comprises an elastomeric material.

32. The guard of claim 25, wherein the bottom portion of the body comprises an elastomeric material.

33. The guard of claim 25, wherein the protective body comprises an amide.

34. The guard of claim 25, wherein the protective body comprises a fluorocarbon.

35. The guard of claim 25, wherein at least a portion of the protective body is penetration resistant, and at least a portion of the protective body is flexible.

36. The guard of claim 25, wherein at least a portion of the protective body is penetration resistant and flexible.

37. A method, comprising: extruding material to form a tube; and cutting the tube to form a guard for a digit of a hand.

38. The method of claim 37, wherein the tube includes tapered portions.

39. The method of claim 37, further comprising forming at least one notch in the guard.

40. The method of claim 37, wherein the tube comprises a first arcuate portion and a second arcuate portion, and wherein a thickness of the first arcuate portion is greater than a thickness of the second arcuate portion.

41. The method of claim 37, further comprising forming an indention in an end of the guard that facilitates bending of a medial joint of the digit.

42. The method of claim 37, further comprising forming a lip at an end of the guard, the lip configured to provide an indication of insertion depth of the guard on the digit.

43. The method of claim 37, further comprising coloring an arcuate portion of the guard so that the colored portion contrasts with a color of the digit.

44. A method, comprising: extruding a first material in a first arcuate portion; extruding a second material in a second arcuate portion; bonding the first arcuate portion and the second arcuate portion together to form a tube; and cutting the tube to form a guard for a digit of a hand.

45. The method of claim 44, further comprising cutting at least one notch in the guard.

46. The method of claim 44, further comprising extruding the material such that the tube comprises a thinner first arcuate portion and a thicker second arcuate portion.

47. The method of claim 44, further comprising forming an indention in an end of the guard that facilitates bending of a medial joint of the digit.

48. The method of claim 44, further comprising forming a lip at an end of the guard, the lip configured to provide an indication of insertion depth of the guard on the digit.

49. The method of claim 44, further comprising coloring the first arcuate portion of the guard so that the colored portion contrasts with a color of the digit.

50. The method of claim 44, further comprising coloring the second arcuate portion of the guard so that the colored portion contrasts with a color of the digit.