Method of making a disposable non-latex tourniquet

Package making – Methods – With contents treating

Reexamination Certificate

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Details

C053S435000, C053S428000, C053S473000

Reexamination Certificate

active

06250047

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a tourniquet and more particularly to a disposable non-latex tourniquet that minimizes slippage and discomfort to the patient and to facilitate ease of use in knotting and releasing the tourniquet. More particularly, the present invention relates to a disposable non-latex tourniquet for intravenous procedures and similar procedures for restricting venous blood flow to be used in lieu of conventional rubber or latex tourniquets. The disposable non-latex tourniquet of the present invention substantially minimizes discomfort to the patient and also reduces risk of transmission of infection to the patient, phlebotomist and other medical personnel.
2. Description of Related Art
A tourniquet is typically used to occlude a patient's vein and enable medical personnel to successfully perform a variety of intravenous procedures. These include, but are not limited to, routine medical procedures such as phlebotomy, intravenous catheter insertion, dialysis, blood transfusion, donation, intravenous therapy and infusion set insertion. Historically, tourniquets have been made from latex in various shapes, such as flat strips or tubing and approximately 18 inches in length. Latex tourniquets are commonly reused until they become visibly and unacceptably contaminated or lost.
Tourniquets are used in medical practice for example, when obtaining a blood sample. The medical technician or phlebotomist will normally place the tourniquet about the upper arm of the patient and apply pressure by tightening and slip knotting the tourniquet to induce swelling in the veins in the lower arm (to cause the veins to stand out). An appropriate venipuncture site is then selected and a needle inserted, the blood sample removed and the needle withdrawn. Thereafter, the tourniquet is removed usually by giving the tourniquet a quick pull to release the slip knot.
Drawbacks of existing latex tourniquets is that patients or phlebotomists may have allergic sensitivity to contact with latex. Also latex tourniquets may pinch the patient's skin and pull the body hair of the patient due to the low elastic modulus and the high recovery of the tourniquet latex material.
Therefore, it is desirable to produce an inexpensive, throw-away or disposable tourniquet which can be easily used and which would avoid problems experienced with existing latex tourniquets.
While the prior art discloses various tourniquet arrangements, some of them disposable, they are complicated designs which make them unsuitable for inexpensive manufacturing. In addition, many of the prior art tourniquets either have a surface which allows some slippage when positioned about the limb of a patient or a surface which will cause pinching or uncomfortable pulling of body hair or skin when used and some are inefficiently elastic. In addition, many of the prior art tourniquets are made of latex.
SUMMARY OF THE INVENTION
The present invention is a disposable non-latex tourniquet for restricting venous blood flow. The disposable non-latex tourniquet of the present invention desirably comprises a thermoplastic elastomer and an additive comprising slip and anti-block components.
Preferably, the thermoplastic elastomer includes, but is not limited to polyolefin blends, dynamically vulcanized blends, copolyesters, styrenics, styrenic/polyolefin blends, nylons, polyurethanes and metallocene polymers. Most preferably, the thermoplastic elastomer is a metallocene polymer.
Metallocene polymers are produced by single site catalyst technology and are available with a variety of comonomers including octene, butene and hexane. Most preferably, the metallocene polymer of the present invention is an octene based metallocene polymer. This particular metallocene polymer comprises about 15% to about 30% octene and most preferably about 24% octene. Octene based metallocene polymers exhibits excellent elastic properties, such as low modulus and high recovery.
Alternatively, the thermoplastic elastomer may be a metallocene based foam copolymer.
Preferably, the additive comprises slip and anti-block components.
Preferably, the additive comprises a slip component of an oil, wax or stearic acid. Most preferably the slip component is wax. The slip component is in the additive to provide the surface of the tourniquet with selected frictional characteristics so that the tourniquet will not slip when placed about the limb of a patient but released when the knot is released. In addition, the slip component substantially minimizes trauma to the patient by reducing the tendency of the tourniquet to pinch or pull body hair both when knotted and when released.
Preferably, the additive comprises an anti-block component of silica or carbon. Most preferably the anti-block component is silica. The anti-block component is in the additive to provide certain characteristics to the tourniquet including but not limited to allowing the metallocene polymer to be extruded into a film and wound into roll form without the film adhering to itself.
The disposable non-latex tourniquet of the present invention is most preferably formed as follows:
(a) cast extruding an octene based metallocene polymer and an additive into a film;
(b) master roll forming the film;
(c) unrolling the film; and
(d) roll converting the film into disposable tourniquets.
The roll converting process comprises the following steps:
(a) perforating the film into tape like strips;
(b) slitting the film into tourniquet width size so that it may be wound onto individual cores;
(c) winding the tourniquets onto individual cores; and
(d) packaging the wound cores into individual bags or boxes with means to allow the tourniquets to be separated individually.
Optionally, a message may be printed on the film after the perforating step.
Optionally, a corona treatment may be applied to the film after the cast extruding step and before the unrolled film is perforated.
Optionally, a lacquer coating may be applied to one or both sides of the film after the printing step.
The disposable non-latex tourniquet of the present invention consists of frictional characteristics so as to minimize slip when it is placed about the limb of a patient and which will also substantially minimize trauma to the patient by reducing the tendency of the tourniquet to pinch or pull body hair or skin when knotted and when released.
Primary advantages of the tourniquet of the present invention is that it is disposable, non-latex and more comfortable to the patient and is inexpensive to manufacture.


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patent: WO 94/13213 (1994-06-01), None

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