WO2001074436A1

WO2001074436A1 - Surgical prep solution dispenser with attachable container

Info

Publication number: WO2001074436A1
Application number: PCT/US2001/007626
Authority: WO
Inventors: Nicholas R. Baumann; Matthew T. Scholz
Original assignee: 3M Innovative Properties Company
Priority date: 2000-04-03
Filing date: 2001-03-09
Publication date: 2001-10-11
Also published as: AU2001245568A1; AR027755A1

Abstract

A less expensive, yet substantially drip-free applicator for surgical prepping solution which includes a flexible container which then doubles as a handle for the assembled applicator. The applicator includes a spreader element and a container element, the spreader element having a body with a hollow stem. This hollow stem is used to connect to the container element, and preferably is arranged at a convenient angle to the rest of the body. The body also has distribution channels in fluid communication with the hollow stem; conveniently the radiate outward star-fashion from a central point where the hollow part of the stem passes through the rest of the body. A pad is attached to the body adjacent to the distribution channels.

Description

SURGICAL PREP SOLUTION DISPENSER WITH ATTACHABLE CONTAINER

Technical Field This invention relates to liquid applicators having particular utility in the field of antiseptic skin surface preparation prior to surgery. More particularly, this invention relates to articles useful in applying pre-operative surgical scrubs or paints to skin.

Background of the Invention Antiseptic preparation of patient's skin for surgery conventionally includes a 3- 10 minute scrubbing of the affected area with a soap solution followed by the application of a water-soluble antiseptic paint solution. These solutions are generally applied with saturated sponges that arc attached to a blade or held with forceps. These sponges arc often saturated by soaking them in open pans of solution. Sometimes, sponges with attached handles are provided in a plastic pouch containing enough liquid to saturate the sponges. While inexpensive, these techniques are messy and offer little control over inadvertent dripping of the solution into areas where it is undesired. Since many of the available solutions contain active ingredients such as alcohol, and iodine which can be irritating if allowed to pool in areas and left in contact with the skin, good control over the application has long been desirable.

Over the years, devices have been developed in an attempt to prevent the dripping of solution associated with these early techniques, and to reduce the time required for application of the antiseptic solution. In particular, the Duraprep™ products commercially available from 3M Company of St. Paul, MN have enjoyed commercial success by providing substantially drip-free, convenient application. Coassigned U.S. Patent No. 4,925,327, which is hereby incorporated by reference, describes a liquid applicator that incorporates a rigid, porous metering insert to regulate the flow rate of liquid disposed between the applicator handle and a foam sponge covering a major orifice of the handle. The liquid to be dispensed is contained in a rupturable reservoir removably affixed at the other major orifice of the handle. Coassigned U.S. Patent No. 5,658,084, which is also hereby incorporated by reference, further discloses a liquid applicator where the liquid is contained in a frangible ampoule inside the body of the applicator. This ampoule is supported and protected by a deformable element that prevents unintentional breakage of the ampoule from impacts during storage and handling before use. The applicator is actuated by pushing at least a portion of the frangible ampoule through an aperture in the deformable element and into contact with a means for breaking the ampoule.

While these products have provided a considerable advance, they are complex to manufacture, placing them beyond the means of some health care consumers. The art could still benefit from an applicator that could provide convenient, substantially drip-free dispensing of surgical preps at a lower cost.

Summary of the Invention The present invention provides an inexpensive, yet substantially drip-free applicator by providing the surgical propping solution in a flexible container which then doubles as a handle for the assembled applicator. The applicator includes a spreader element and a container element, the spreader element having a body with a hollow stem. This hollow stem is used to connect to the container clement, and preferably is arranged at a convenient angle to the rest of the body. The body also has distribution channels in fluid communication with the hollow stein; conveniently llicy radiate outward star-fashion rom a central point where the hollow part of the stem passes through the rest of the body. A pad is attached to the body adjacent to the distribution channels. When constructed as described below, the applicator is substantially drip-free during use.

The container element is, for example, a tube, conveniently resembling a toothpaste tube. It must be adapted for containing surgical prepping solution, and must be adapted in some way to attach to the stem. Preferred tubes are rigid enough to act as a handle in combination with the stem. In preferred embodiments, the container is impermeable to ethylene oxide gas, which allows the container to be sterilized by conventional ethylene oxide sterilizers without allowing ethylene oxide to penetrate the tube, which has the potential to create toxic products within the surgical prepping solution. Preferred impermeable tubes do not allow more than 100 ppm ethylene oxide into the tube, preferably less than 50 ppm, more preferably less than 25, and most preferably less than 10 ppm. Ideally, the tube is a complete barrier to ethylene oxide (less than 1 ppm, which is the complete detection limit).

Another way of looking at the invention is a method of prepping a patient for surgery. First is the step of providing an applicator for surgical prep solution, of the type just discussed. Then one performs the step attaching the spreader element to the container element. Then one performs the steps of gripping the container element and contacting the skin of the patient with the pad so as to dispense surgical prep solution onto the skin.

Brief Description of the Drawings

Fig. lis a perspective view of the elements of the applicator according to the present invention;

Fig. 2 is a perspective view of the elements of Fig. 1 in an assembled condition; Fig. 3 is a detailed bottom view of the body of the spreader element with the foam pad removed; and

Fig. 4 is a detailed bottom view of an alternate embodiment of the body of the spreader element with the foam pad removed.

Detailed Description Referring now to Fig. 1, a perspective view of the applicator 10 according to the present invention is illustrated. The applicator 10 includes a spreader element 12 and a container element 14. The spreader element 12 includes a body 16 and a stem 18. The stem 18 has a hollow passage 20 therein. The container element 14 conveniently has a cap 22 held by threads out of the spout of the tube. In that the container element 14 must attach to the stem 18, it is convenient that the threads that hold the cap 22 also engage complementary threads 24 within the stem 18. It will be readily apparent to the artisan, however, that there are a number of mechanical expedients such as snap fittings or tapered press fittings that can be used to attach the container element 14 in a fluid tight configuration. The spreader element 12 also includes a pad 26 that will be the part that actually contacts the patient. Pad 26 may be any suitable pad that will absorb the prep and allow it to be delivered to the patient's skin Pieferred pads are open cell foams Most preferred pads are open celled polyurethane foams

Referring now to Fig 2. a perspective view of the elements of Fig 1 in an assembled condition is illustrated The cap 22 has been removed, and the container element has been fitted onto the stem 18 so that the contents of the container element 14 can pass through the stem to wet the pad 26

Referring now to Fig. 3. a detailed bottom view of the body 16 of the spreader element 12 with the pad 26 removed is illustrated In this view a series of distribution channels 28 which are in fluid communication with the passage 20 in the stem 18 can be seen It is considered particularly convenient to have the distribution channels 28 radiate outward star-fashion from the passage 20, although this is not a requirement of the invention It is necessary to distribute the surgical prepping solution sufficiently so that no one portion of the pad becomes so soaked that it will drip Importantly, the pad preferable is sealed around the outer periphery of the spreader element to prevent prep solution from dnpping out the edges Suitable seals include hot melt, piessuie sensitive, and cuiablc adhesives, RF weldable gaskets, ultrasonic welding, thermal welding, and the like

Referring now to Fig. 4. a detailed bottom view ol an alternate embodiment of the body 16 of the spreader element 12, with the foam pad 26 removed, is illustrated The view is similar to that oi Fig 3. but in this embodiment a liquid impermeable adhesive c oaled l ilm patc h 30 has been adliei e to t he iuulc sidc ol th body I t) so lli.it t he sui gic .il prepping solution must travel along at least some of one of the distribution channels 28 before it can begin to soak into the pad Alternatively, the film patch 30 can be placed on or adhere to the pad directly in front of passage 20 of Fig 3 With a 5 x 5 cm open-celled polyurethane sponge, a 1 75 cm diameter patch has proven useful This patch is thus about 35 percent of the width of the pad Patches that are 25-50 percent of the pad width are considered suitable. This arrangement ensures drip-free operation in the face of surgical prepping solutions of very low surface tension.

Suitable containers 14 for use in the present invention must fulfill three important functions First, the container must retain the contents even when aged at 50°C for 28 days with no more than 2 percent net weight loss This can be especially difficult with hydroalcoho c prepping compositions Secondly, the container 14 should be a barrier to ethylene oxide such that the outside of the tube can be sterilized in conventional ethylene oxide sterilizers without toxic ethylene oxide entering the tube Ethylene oxide, if allowed to enter the tube, can loi m toxic by-pioducts This is especially ti tle with iodine preparations since 2-ιodoethanol (lodohydπn) can be formed We have found that polymer/aluminum foil laminates are exceptional barriers to isopropanol/water mixtures as well as ethylene oxide Finally, the third important function of tube 14 is to serve as a handle in combination with stem 1

Surprisingly, we have found that a polyethylene aluminum foil laminate tube with or without a foil seal over the opening satisf ies all thiec icquiicincnts

Example 1 A body generally as depicted in the drawing was machined from two pieces of Delπn plastic such that the stem extended away from the rest of the body at an angle of about 45 degrees The main plane of the body was approximately 5 cm by 5 cm, and the stem was about 4 8 cm in length The stem was thicaded to accept complcmentaty threads on the container element. Distribution channels were machined into the body by end milling 0 29 cm diameter giooves in the body in such a way as to cieate a eight individual paths from the center of the body nearly to its edge The artisan will perceive that injection molding will be a preferred method of labi icating the body in quantity, and that other polymers, such as polyolefins, will be suited to such manufacturing

A foam pad, commercially available from Illbruck, Minneapolis, MN and identified as P 90 Z Beige Clickable foam pad was adhesively attached to the body using a hot melt adhesive. A bead of hot melt adhesive was applied to the perimeter of the loam pad and the pad and Delπn plastic connector were brought into contact with one another for about 30 seconds.

A polymcr/foil/polymci three-layer tube, wheie the foil is aluminum and the polymer is polyethylene, available from Expac Corporation, Montvale, NJ was used as the container element to contain 26 ml of Duraprep brand surgical prepping solution comprised of isopropanol/water, acrylate terpolymer, iodine and sodium iodine, commercially available from 3M Company The tube was provided with threads adjacent the spout complementary to those provided on the stem. The tube was heat sealed using conventional methods.

The sealed tube of surgical prep is opened by removing the cap, and for the case where an induction sealed foil covers the opening, the foil seal is perforated, and the tube of surgical prep was then attached to the spreader element connector by the threading the spout into the threads in the stem. The container element was gripped in the manner of a handle, and the applicator was used to spread the surgical prepping solution onto the torso of a patient A smooth, even application was achieved without dripping.

Example 2 About 21g of DuraprepTM Surgical Solution (A hydroalcoho c solution containing 74% w/w isopropyl alcohol and 0.7% available iodine) was filled into 1 oz Expac poly Film/foil/polyfilm laminate tubes available from Expac Corp. of Hopkins, Minnesota, as model number 5485X. The exact weight of the tube before and after filling was lecoided to 4 decimal places The tubes weie heat sealed. Two sets ol 10 tubes weie prepared. The Set A had a foil seal welded over the tip The Set B did not. Both sets of tubes had a polycap screwed on tightly over the tip. The tubes were placed in a recirculated oven at 50°C for 28 days. The tubes were removed periodically and weighed The weight was recorded to four decimal places. The following results were obtained:

% Weight Loss After Aging At 50C

The data indicates that even after 28 days at 50°C the mean value of the set A samples with the foil seal was only 0.0900% while the set without the seal was only

0. 1 155%. This proves that this poly/loil consti uction is an exceptional barnei to watei and alcohol even under exaggerated conditions

Example 3

The same tube construction used in Ex. 2 was filled with 26g water Ten tubes were sealed and capped without the foil cap seal. The tubes were ETO sterilized in a 3M Steπvac Model 4XL ethylene oxide sterilizer The tubes weie then aerated for one hour twenty minutes in a 3M model XL Aei ati a cabinet This icsiilts in ΛU exposuie to ethylene oxide gas for about four hours and ten minutes at 500 millibars and an aeration time of one hour and twenty minutes. The samples were sent to Biotest Labs in Minneapolis, Minnesota, for testing. The contents of the tubes by gas chromatogiaphy for residue of ethylene oxide, ethylene chlorohydπn and ethylene glycol The presence of these compounds in the contents ol the tubes would indicate that the lube allowed some ol the ethylene oxide steπlant to enter the tube during the sterilization cycle.

Results: All of the tubs were lound to have non-detectable levels ol ethylene chloiohydi m and ethylene glycol. 6 of 10 Expac tubes were evaluated to have non-detectable levels of ethylene oxide 4 of 10 Expac tubes were evaluated to have 1 part-per-mil on (ppm) of ethylene oxide, corresponding to 0.021 mg of ethylene oxide per 26 ml of tap water The detection limit of the gas chromatograph used to complete the analysis is 1 ppm The reference document under which the test was conducted was ANSI/AAMI/ISO

10993-7 BIOLOGICAL EVALUATION OF MEDICAL DEVICES- PART 7. ETHYLENE OXIDE STERILIZATION AND ANSI / AAMI ST30: DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES. The tubes appear to provide an effective barrier to ethylene oxide sterilization.

Claims

What is claimed is:

1. An applicator for surgical prepping solution, comprising: a spreader element and a container element, the spreader element comprising: a body having a hollow stem and having distribution channels in fluid communication with the hollow stem, and a pad attached to the body adjacent to the distribution channels, and the container element comprising a tube for containing surgical prepping solution, and a spout adapted to attach to the stem.

2. The applicator of claim 1 wherein the body is sealed to the pad around the entire periphery.

3. The applicator according to claim 1 wherein the container is impermeable to ethylene oxide gas.

4. The applicator of claim 1 wherein the pad is an open cell polyurethane foam.

5. A method of prepping a patient for surgery, comprising the steps of: (a) providing an applicator for surgical prep solution comprising a spreader element and a container element, the spreader element comprising a body having a hollow stem and having distribution channels in fluid communication with the hollow stem, and a pad attached to the body adjacent to the distribution channels, and the container element comprising a tube for containing surgical prepping solution, and a spout adapted to attach to the stem of said spreader element; (b) attaching the spreader element to the container clement;

(c) gripping at least part of the container element;

(d) dispensing the prepping composition from the container through the stem into the pad;

(e) contacting the skin of the patient with the pad so as to dispense surgical prep solution onto the skin.

6. The method according to claim 5 wherein the pad and the distribution channels are such that after the attaching step, the foam pad is substantially drip-free.