Systems and methods for providing an antimicrobial dispensing applicator

A handheld antiseptic dispensing applicator device having a reservoir for storing an antiseptic agent, the reservoir being coupled to an applicator pad, and a defeatable membrane or barrier being interposed between the reservoir and the applicator pad. Embodiments of the device comprise a squeezable reservoir, wherein the internal hydraulic pressure of the squeezable reservoir is increased via user applied forces to thereby defeat the membrane releasing the antiseptic agent contained therein which is then absorbed by the applicator pad. The defeatable barrier or membrane is also removable or may be defeated in connection with other mechanisms according to various embodiments.

FIELD OF THE INVENTION

The present invention relates to systems and methods for providing an antiseptic or antimicrobial dispensing applicator. An antiseptic or antimicrobial dispensing applicator is used to apply an antiseptic agent or an antimicrobial solution to a desired surface thereby preparing the surface for a procedure or treatment.

BACKGROUND OF THE INVENTION

Healthcare Associated Infections (HAIs) are a major patient safety and hospital problem, frequently associated with surgical sites and invasive devices, such as vascular access lines, urinary catheters, patient skin preparation prior to surgery, and ventilators. Accordingly, antiseptic, antibacterial and antimicrobial agents are commonly applied to various surfaces in preparation for sterile or antiseptic procedures. For example, a common pre-operative procedure in the medical industry involves rubbing alcohol, iodine, peroxide or chlorhexidine on a skin surface to kill bacteria and thus reduce the chance of infection. Other common practices include wiping down a chair or table surface with an antiseptic agent prior to exposing a patient or instruments to the surface. Other common uses of antiseptics is in the treatment of various injuries, such as cuts and abrasions.

Typically, an applicator, such as a cotton swab, a swab stick, a foam sponge pad, or a towelette, is soaked with an antiseptic that must be poured from a bottle or other container. This step requires that the user remove the lid of the container and the foil seal to access the antiseptic. In an emergency situation, or in a situation where one of the user's hands is occupied, the user is required to free both hands to access the antiseptic agent. Furthermore, once the bottle or other container is opened, the sterility of the bottle is compromised often resulting in excess waste of otherwise useful antiseptic agent. Alternatively, there are also concerns about the degradation or evaporation of active ingredients in the antiseptic solution in bulk.

Following these steps, the antiseptic is commonly poured into an open, secondary container which provides a pool into which the applicator is dipped or soaked. The open, secondary container may include a dish or small bowl having a large opening through which the applicator is passed. In an emergency situation the user must take caution to prevent bumping or disturbing the secondary container so as to prevent a spill of the antiseptic. In the event that the antiseptic agent is spilled, additional antiseptic must be provided thereby requiring the user to once again access the container or bottle of antiseptic.

In other procedures, an antiseptic agent is applied directly to a surface from the bottle or other container, and is then spread and applied with the applicator. During these procedures, the user must take precautions to control the amount of antiseptic used so as to contain the antiseptic and avoid wasting materials.

For some procedures, a portion of the applicator that contacts the desired surface is held directly in the hand of the user. For example, where the applicator is a wipe or towelette and the surface is a tabletop, the user generally holds the wipe in their hand and rubs the surface with the wipe. The proximity of the user's hand to the table surface presents the danger of contaminating the newly sanitized surface with the user's hand. While the user may choose to wear protective gloves or wash their hands prior to applying the antiseptic, in an emergency situation the user may not have sufficient time to take the necessary precautions.

By way of another example, swab applicators or swab sticks are commonly provided as dry devices containing no antiseptic solution. They are provided in individual or bulk packing containing, for example, one, three, ten, fifty, or a hundred units. Swab sticks are typically used by either dip-soaking the stick in a bulk bottle of antiseptic or applying antiseptic onto a patient's skin first and then using the swab stick to spread the antiseptic. Beyond the challenges already discussed above, the bulk packaging of swab sticks may result in contamination to unused swab sticks every time the common container is accessed. Moreover, even where swab sticks are pre-soaked with antiseptic, the amount cannot be controlled, there are concerns about degradation or effectiveness loss of antiseptics due to prolonged contact between the antiseptics and the material of the applicator pad, and the antiseptics often cover the entire swab stick thereby coming in unwanted contact with the user during use of the swab stick.

Thus, while techniques currently exist that are used for applying an antiseptic agent to a desired surface, challenges still exist. Accordingly, it would be an improvement in the art to augment or even replace current techniques with other techniques.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to a safe and convenient handheld applicator device for delivering an antiseptic solution to a desired surface. Some embodiments of the present invention provide an applicator device including a body having a lumen for receiving an antiseptic agent. According to some embodiments, the body is generally composed of a soft, flexible, or semi-flexible polymer material capable of being compressed, squeezed, folded, or twisted by a user. In other embodiments, the body is composed of a rigid or semi-rigid polymer material. According to some embodiments, the rigid or semi-rigid polymer materials comprising the device are capable of being compressed or squeezed by a user. One end of the lumen defined by the body is configured to receive a fluid and thereby acts as a reservoir containing a desired antiseptic solution. At the other end of the body, the device includes an applicator pad for absorbing and applying the antiseptic solution to a desired surface. The applicator pad generally includes a non-woven or foam pad material suitable for applying the antiseptic solution.

A defeatable membrane or barrier is interposed between the lumen of the body and the applicator, such that the antiseptic agent is prevented from contacting the applicator prior to activation. In some embodiments, the device further includes various activation mechanisms whereby, upon activating the device, the membrane or barrier is defeated thereby permitting the antiseptic agent to flow through the membrane and contact the applicator pad. According to some embodiments, the membrane is defeated by simply compressing the body of the device to increase the pressure within the lumen. The increased pressure is released as the membrane is defeated and the antiseptic agent is permitted to flow through the membrane. In other embodiments, the membrane is defeated by twisting the body of the device in order to sufficiently increase the pressure therein. In still other embodiments, the membrane is replaced with a one-way valve that is defeated by increasing the pressure within the lumen of the body. In yet additional embodiments, the membrane is broken or ruptured by user operation of a rupturing mechanism or user application of partially and predictably destructive opposing torsional forces.

In some embodiments, the membrane separating the tube chamber and the applicator pad is provided with a plastic weld or adhesive seam and is broken by lateral force on the membrane near the applicator pad to allow the antimicrobial solution to flow from the tube chamber to the sponge pad. The thickness of the membrane can be varied depending on the force desired to break the membrane.

In some embodiments of the present invention, the applicator is shaped and configured to apply the antiseptic agent to an orifice, such as a mouth or a respirator tube. In other embodiments, the applicator is shaped and configured to apply the antiseptic agent to a generally flat surface such as an I.V. insertion site, a surgical procedure site, or a table.

According to some embodiments, the present invention comprises swab sticks containing antiseptic solution. In such embodiments, the applicator tube is made of soft, flexible, semi-flexible, rigid, or semi-rigid plastic materials. As above, the body of the applicator tube defines a chamber which operates as an antiseptic reservoir. Prior to activation, the reservoir chamber is sealed from the applicator head but has a breakable or defeatable membrane interposed therein designed to be broken or opened easily by squeezing the body of the stick tube. In some embodiments, the defeatable membrane is formed within a wall of the body. Upon activation, the antiseptic flows into the applicator head pad. In some embodiments, the dosage of antiseptics provided is pre-specified and controlled. According to various embodiments, the antiseptic dispensing applicators can be single-packaged or triple-packaged to avoid cross-contamination.

For some implementations of the present invention, additional activation mechanisms are contemplated. For example, in some embodiments, the present invention includes a roller clamp mechanism or actuator configured for manual operation, such as by a user's thumb. In other embodiments, as mentioned above, a pinching or rupturing mechanism in incorporated into the device to facilitate the release of antiseptic fluid from the lumen defined by the body of the device. In still other embodiments, a removable seal is contemplated for temporarily sealing the device, wherein the device is activated as the seal is removed.

Finally, in some embodiments, the device includes a membrane having a scored surface that is partially defeated in response to lateral force. As the lateral force is increased, additional portions of the membrane are defeated thereby permitting increased flow of the antiseptic agent through the membrane. In other embodiments, the membrane includes a plurality of scorings having various thicknesses and dimensions to progressively defeat the membrane in response to progressive increases in lateral force against the membrane.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

As used herein, the term “proximal” refers to a location with respect to the device during normal use that is closest to the clinician and farthest from the patient. Conversely, the term “distal” refers to a location with respect to the device during normal use that is farthest from the clinician and closest to the patient. As used herein, the term “top”, “up” or “upwardly” refers to a location with respect to the device during normal use that is radially away from the longitudinal axis of the device and away from the patient's skin. Conversely, as used herein, the term “bottom”, “down” or “downwardly” refers to a location with respect to the device during normal use that is radially away from the longitudinal axis of the device and toward the patient's skin. As used herein, the term “in” or “inwardly” refers to a location with respect to the device during normal use that is toward the inside of the device. Conversely, as used herein, the term “out” or “outwardly” refers to a location with respect to the device during normal use that is toward the outside of the device.

Referring now toFIG. 1, an implementation of an antiseptic dispensing applicator device100in accordance with some embodiments is shown. Some embodiments of device100generally include a body (or applicator tube)110, having a proximal end112and a distal end114. Body110generally comprises a tube defining a lumen comprising a fluid reservoir to compatibly receive an antiseptic agent or an antimicrobial solution122. In some embodiments, the fluid reservoir or chamber defined by body110contains approximately 0.3-50 mL of the antiseptic agent122. In other embodiments, the fluid reservoir defined by body110contains an alcohol-based antimicrobial solution. According to various embodiments, body110is made of a polymer or plastic material, such as polypropylene (PP), polyethylene (PE), and the like, capable of being heat-sealed at ends112and114. Body110is flexible according to some embodiments, semi-flexible according to other embodiments, semi-rigid according to other embodiments, and rigid according to still other embodiments. Persons of ordinary skill in the art will appreciate that the strength of a given heat seal can be controllably varied such that certain heat seals can be relatively weak by design while others are comparatively much stronger by design. (See alsoFIG. 9). In some embodiments, body110of device100comprises tubing material with sufficient flexibility so as to be capable of being compressed, squeezed, or folded by a user154.

According to some embodiments, the position and length of body portion110is selected to provide a gripping surface to the device100and remove the user's hand from the distal area proximate an applicator pad140. As such, the handle function of the body portion110provides the user with control over the device100while preventing undesired exposure and/or contamination to the treatment site or surface.

Some embodiments of device100generally include a swab or applicator pad140located proximate the distal end114of body110, as illustrated. According to some embodiments, applicator pad140comprises a non-woven material or a foam sponge pad that is attached proximate the distal end114via an adhesive142that is compatible with the antiseptic agent122. In some embodiments, applicator pad140is comprised of cotton or cotton blends. The size, shape, and texture of applicator pad140varies dependent upon the intended application or for applying the antiseptic agent122to a desired surface. For example, applicator pad140is sized and shaped for a variety of uses, such as an oral disinfectant device, a skin or surgical site disinfectant device, a point-of-use catheter disinfectant coating device, an I.V. or catheter access cleaning device, as well as other convenient hand-held antimicrobial delivery systems. In some embodiments, applicator pad140includes an abrasive outer surface to assist in scrubbing and disinfecting an object, such as a piece of machinery or a surface such as a table or bed surface. And in some embodiments, applicator pad140includes a smooth outer surface for applying the antiseptic agent122to disinfect a surface without harsh scrubbing. In yet other embodiments, applicator pad140comprises a layered applicator pad such that contaminated layers of the pad may be removed to provide a fresh, uncontaminated application surface.

In some embodiments, the fluid reservoir defined by body110includes a threaded portion (not shown) for threadedly coupling to compatible threads (not shown) located within applicator pad140. In other embodiments, the fluid reservoir defined by body110is coupled to applicator pad140via a pressure fit, a mechanical interface, or an adhesive.

As mentioned above, device100and applicator pad140are sized and shaped for a variety of uses according to various embodiments. Occasionally, for example, the inner and/or outer surfaces of the mouth must be disinfected, for example, prior to the insertion of a respirator tube, a ventilator system, or other medical device into the mouth or throat. Accordingly, the shape and size of applicator pad140is designed to compatibly insert within the mouth of a patient. For example, an applicator pad140for use as a mouth disinfectant device may include an elongated dome shape having a base diameter that is easily inserted into the patient's mouth. An elongated dome shape eliminates any right angles that may otherwise prevent thorough and even contact between the applicator pad140and the natural, curved surfaces of the inner mouth. Additionally, in some embodiments, the outer surface of applicator pad140includes a small radius that permits application of the applicator to the inner and outer surfaces of a respirator tube or other medical device prior to inserting the device into the mouth of the patient.

Where device100is intended as a skin or surgical site disinfectant device, the shape and size of applicator pad140is selected to provide a broad, flat surface (not shown) to maximize contact between applicator pad140and a generally flat skin surface. Such a configuration is particularly suitable for preparing a surgical site prior to performing surgery and for preparing a patient's skin before insertion of a catheter or I.V.

In other embodiments, device100and applicator pad140may be configured so as to provide a suitable size and shape for providing antimicrobial coatings to I.V. and/or catheter tubing prior to insertion of the same into a target site. For example, in some embodiments, applicator pad140forms a hollow cylindania, forming an elongated, tubular crescent shape slightly larger than the outer diameter of the I.V. or catheter tubing to be coated. In other embodiments, applicator pad140forms a torus so as to completely surround the I.V. or catheter tubing during the coating process.

With continued reference toFIG. 1, various embodiments of device100also include a pinching actuator device150, which pinching device is made of rigid materials capable of rupturing or puncturing the distal end114of body110. Pinching device150is located adjacent distal end114inside applicator pad140but outside distal end114and is retained in its orientation and position by the interaction between applicator pad140and body110. Pinching device150includes one or more edges156. According to some embodiments, for example, edge(s)156are relatively sharp edge(s) or point(s) that can pierce or puncture tube110to release solution122. In other embodiments, two or more opposing sharp edges156can be formed offset relative to the functional axis158of pincher150such that operation of pincher150by user154(applying lateral forces130) results in the application of shear cutting forces to tube110to thereby rupture or open the distal end114thereof. In still other embodiments, distal end114comprises a seal that is ruptured when lateral force130is applied to body110via edges156of pincher150. During operation of pincher150, blunt edges156transfer lateral force130applied by user154so as to apply pressure to distal end114to thereby compromise, rupture, or otherwise open the seal at distal end114.

By way of further explanation, in some embodiments, device100comprises a self-containing antiseptic applicator wherein the fluid reservoir defined by body110is pre-filled during the manufacturing process with antiseptic solution122. In such embodiments, body110is pre-filled with antiseptic solution122after distal end114is heat-sealed but before proximal end112is heat-sealed such that the fluid reservoir defined by body110containing antiseptic solution122is separated or sealed from applicator pad140prior to use. Upon use, user154compresses pincher150by applying lateral forces130in order to compromise or defeat the membrane at distal end114. Upon being defeated, antiseptic solution122is released from tube body110in order to saturate or moisten applicator pad140for disinfectant use. As mentioned above, in some embodiments, device100is configured to release antiseptic solution122by utilizing mechanisms such as shearing cut, puncturing, or hydraulic pressure. In other embodiments, alternative mechanisms, such as twisting mechanisms (discussed in greater detail below), are contemplated.

According to some embodiments, device100comes pre-packaged (not shown). In such embodiments, user154pinches the head of applicator pad140so as to compress pincher150while device100remains inside the packaging. After antiseptic solution122is released from tube body110in the manner previously described, user154removes device100from its package for use. In this way, the sterility of device100is not compromised prior to use.

In some embodiments, an antiseptic or antimicrobial solution122in accordance with the present invention includes a 50-95% alcohol solution which further includes additional antimicrobial agents such as CHG, PCMX, triclosan, octenidine, hexachlorophene, PVP-1, iodine, and/or quaterium compounds in the range of 0.05% to 5% w/w of the antimicrobial solution. The alcohol is generally selected from at least one of ethyl alcohol, isopropyl alcohol, n-propanol alcohol, and mixtures thereof. In some embodiments, the solution further contains dimethicone, glycerin, cationic polymer such as PVP, cellulose, docosanol, BTMS, behenyl alcohol and/or poloxamer. In a preferred embodiment, a base antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin or surgical site preparation, and 0.12% CHG in 11% alcohol and water for mouth disinfecting and oral care. One of skill in the art will appreciate that other ingredients, including those mentioned above, may be added to each of the base antimicrobial solutions to provide a desired antimicrobial or antiseptic agent122for a specific application.

With continued reference toFIG. 1, according to some embodiments, body110is vented at air vent106such that antiseptic agent or fluid122is permitted to flow out of the punctured or ruptured membrane proximate distal end114even when user applied forces130are withdrawn or relaxed. In this way, once body110has been preliminarily ruptured or punctured, antiseptic agent or fluid122is permitted to flow out of body110without compression or continued squeezing due to the lumen defined by body110being vented. In some embodiments, as illustrated, air vent106is distal the point at which body110is punctured or otherwise ruptured. For example, in some embodiments, vent106is located proximal relative to the tip of distal end114but distal the point at which body110is punctured. In other embodiments, air vent106may be located at any suitable location, including adjacent the proximal end112of body110. According to various embodiments, air vent106permits body110to be vented without creating a vacuum or otherwise pulling previously dispensed fluid122back into the lumen defined by body110when forces130are withdrawn or relaxed.

In various embodiments, air vent106comprises a one-way air valve. In such embodiments, vent106maintains the integrity of body110such that, prior to activation, fluid122is retained within the lumen defined by body110. Upon activation of the device, fluid122is released at the puncture point(s) associated with edges156. When forces130are subsequently reduced or eliminated, vent106permits air to flow into the lumen defined by body110. According to some embodiments, a one-way air valve106generally comprises a flexible or semi-flexible polymer material that is secured within body110. In some embodiments, the one-way air valve106includes a slit, a duck bill, or an umbrella valve. For example, in some embodiments, the one-way air valve106includes a slit that is biased to a closed position when outward force or pressure is exerted thereon from within the lumen defined by body110so as to prevent a fluid pathway there through. However, as discussed and disclosed herein, when a reverse or inward pressure is exerted on air vent106, the one-way valve is defeated such that the slit opens to provide air communication from outside body110to the inside thereof. It is contemplated that vent106may be employed with any or all of the various embodiments disclosed herein.

In still other embodiments, air vent106comprises a dual direction air vent. According to some embodiments, for example, air vent106is formed of a micro porous hydrophobic material, such as Tyvek.

Referring now toFIGS. 2A-2F, various alternative embodiments of an antiseptic dispensing applicator device employing a body having one or more defeatable zones(s) or rupture point(s) forming a defeatable barrier in accordance with representative embodiments of the present invention are shown. With reference toFIG. 2A, a cross-sectional view of an antiseptic dispensing applicator device200having defeatable barriers162defining a weak area in accordance with some embodiments is shown.FIG. 2Adepicts device200prior to activation. In some embodiments, one or more defeatable barrier(s)162may be located at any suitable locality on distal end114of body110(see alsoFIG. 2D) so long as defeatable barrier(s)162are located within the region of body110enclosed by applicator pad140such that, upon use, antiseptic fluid122is released from tube body110in order to saturate or moisten applicator pad140for disinfectant use. In other embodiments, defeatable barriers162comprise a weakened area, such as a circumferential groove or annulus that traverses the outer diameter of body110(seeFIG. 2C). In still other embodiments, points, scoring, groves, lines, or cross-hatching patterns are formed in and/or around distal end114so as to diminish the structural integrity thereof thereby rendering distal end114in a weakened state so as to encourage distal end114to break or defeat in a predictable manner in response to increased pressure within body110(seeFIGS. 2E and 2F).

With respect to some embodiments, defeatable barriers162comprises a defeatable membrane interposed between the lumen of body110and applicator pad140, such that antiseptic agent122is prevented from contacting applicator pad140prior to activation. According to some embodiments, defeatable barrier(s)162is/are formed in one or more wall(s) of body110proximate the distal end thereof.

In various embodiments, the one or more defeatable barrier(s)162can take various patterns as illustrated inFIGS. 2A-2F. Moreover, defeatable barrier(s)162can be pre-formed in body110via laser cutting or laser drilling, ultrasonic cutting, using a heated blade or pin, or otherwise formed during the manufacturing and assembly process. In still other embodiments, defeatable barriers162are preformed by scoring body110such that the wall thickness of body110is weakened in a predictable pattern, which weakened pattern defines defeatable barrier162.

Some embodiments of device200further generally include a retention ring160located proximate the distal end114of body110as illustrated. According to some embodiments, retention ring160is comprised of a rigid plastic material having protruding tabs, bumps, or arête type formations164. Retention ring160is located adjacent distal end114inside applicator pad140but generally on the distal side of the pre-cut groove or defeatable barrier162and is retained in its orientation and position by the interaction and adhesive142between applicator pad140and body110as well as additional adhesive144between applicator pad140and retention ring160.

By way of further explanation, in some embodiments, device200comprises a self-containing antiseptic applicator wherein the fluid reservoir defined by body110is pre-filled during the manufacturing process with antiseptic solution122. Upon use, user154holds device200against a flat surface170at the distal surface of applicator pad140. As depicted inFIG. 2B, user154continues by applying an axial force to tube body110in the direction132thereby pushing tube body110toward flat surface170as well as the distal end of applicator pad140. As user154continues to apply axial force in direction132, thereby displacing body110axially, retention ring160is oriented such that bumps164are located just distally of defeatable barriers or grooves162. User154continues by applying lateral forces130to tube body110, which comprises a sufficiently rigid but semi-flexible tubing material capable of being compressed or squeezed by user154while simultaneously having axial force132applied thereto. As user154laterally squeezes body110, liquid solution122is pushed in the distal direction thereby resulting in the transfer of user-generated pressure throughout body110. As the internal hydraulic pressure increases, region162B expands while region162A is substantially held in place, or held in a pre-activation position, via retention ring160and tabs164. In some embodiments, tabs164generally retain the radial dimension of body110against expansion or enlargement during activation of device200. User154continues to apply lateral forces130and axial forces132until defeatable barrier162fails or ruptures due to stress concentrations under shear load thus resulting in opening166.

FIG. 2Bdepicts device200following activation. Following activation, and upon the defeat of defeatable barrier162, antiseptic solution122is released from tube body110via opening166in order to saturate or moisten applicator pad140for disinfectant use. User154can continue to apply lateral force130as necessary to displace a sufficient or desired quantity of antiseptic solution122from body110into applicator pad140.

Those of skill in the art will appreciate the relative thickness of the walls of body110and the depth of defeatable barrier or groove162both necessary and sufficient to accomplish the above-recited construction and operation of device200.

According to various embodiments disclosed herein, a defeatable area formed within a wall of body110, represented by defeatable barrier162in distal end114, is interposed between the fluid contents of the reservoir defined by body110and applicator pad140. Defeatable barrier162is provided to prevent fluid communication between the reservoir defined by body110and applicator pad140prior to activation or use. Defeatable barrier162comprises a scored or weakened area of body110so as to encourage defeatable barrier162to break or defeat in a predictable manner upon activation. In some embodiments, defeatable barrier162is located such that, as body110is actuated, shearing forces are applied to defeatable barrier162thereby causing defeatable barrier162to defeat along the scored pathway, as shown inFIG. 2B. Once defeated, opening166provides a fluid communication pathway between body110and applicator pad140.

FIGS. 2C-2Fillustrate additional embodiments of the present invention. Such embodiments function as generally described with reference toFIGS. 2A and 2B. As illustrated, defeatable barriers162may take a variety of shapes or configurations suitable for practicing the present invention. For example, the defeatable barrier162ofFIG. 2Ccomprises an annular ring or groove formed around the circumference of body110at the distal end thereof. Alternatively,FIG. 2Dillustrates a defeatable barrier162comprising a weakened point located at the distal extremity or face of body110.FIG. 2Eillustrates yet another embodiment wherein defeatable barrier162comprises scoring the distal end of body110with a predictable failure pattern. Similarly,FIG. 2Fillustrates an alternative scoring pattern forming defeatable barrier162.

Turning now toFIG. 3, a cross-sectional view of an antiseptic dispensing applicator device300having a defeatable tip162positioned on a cone-shaped or narrowing, pointed distal end114in accordance with some embodiments is shown. In such embodiments, the tip116of tube body110includes a scored surface that may be defeated in response to increased internal fluid pressure. As in other embodiments, device300comprises a self-containing antiseptic applicator having a fluid reservoir defined by body110that is pre-filled with antiseptic solution122. Upon use, a user applies lateral forces130to tube body110near the proximal end112thereof. In such embodiments, body110comprises a semi-flexible tubing material capable of being compressed or squeezed by a user while simultaneously having sufficient axial rigidity so as to substantially maintain its axial shape and dimension. As a user laterally squeezes body110, liquid solution122is pushed in the distal direction thereby resulting in the transfer of user-generated pressure throughout body110. Once the internal hydraulic pressure is large enough to overcome the structural integrity of the defeatable tip162, tip116of the cone-shaped distal end114ruptures due to stress concentrations at the defeatable tip162. Persons of skill in the art will appreciate the manner of determining the required pressure, tube body110thickness, and radius necessary to cause the body110material to yield as desired. Following activation and the defeat of defeatable tip162, antiseptic solution122is released from tube body110via an opening (not shown) in order to saturate or moisten applicator pad140for disinfectant use. A user can continue to apply lateral force130as necessary to displace a sufficient or desired quantity of antiseptic solution122from body110into applicator pad140.

As mentioned above, persons of skill in the art will appreciate the manner of determining the required pressure, tube body110thickness, and radius necessary to cause the body110material to yield as desired. The following mathematical equations or formulas are generally applicable relative to various embodiments disclosed herein, as will be understood by persons of ordinary skill in the art:τ=F/A=F/(t×L), where τ represents the shear stress expressed as the shear load F (proportional to internal pressure p) divided by the cross-sectional area A expressed as thickness of the tube t multiplied by the length of the defeatable barrier L that is under shear.σ1=(pr2/(R2−r2))(R2/x2+1) and σ3=−(pr2/(R2−r2))(R2/x2−1), where r≦x≦R, and where the hoop stress σ1and the radial stress σ3are expressed relative to internal pressure p, outer radius of the tube R, and inner radius of the tube r, and the hoop and radial stress both reach their maximum when x=r and decrease as x approaches R.σ1=pr/t, where σ1is the approximate hoop stress for a cylinder according to thin-wall tube theory, and p is the internal pressure, r is the inner radius of the tube and t is the tube wall thickness.σ1=pr/2t, where σ1is the approximate hoop stress for a sphere according to thin-wall tube theory, and p is the internal pressure, r is the inner radius of the tube and t is the tube wall thickness.

Referring now toFIGS. 4A and 4B, an antiseptic dispensing applicator device having one or more weak area(s) or rupture point(s) and a roller clamp in accordance with various representative embodiments of the present invention is shown. With reference toFIG. 4A, a cross-sectional view of an antiseptic dispensing applicator device400having pressure sensitive defeatable barriers162defining a weak area in accordance with some embodiments is shown. In such embodiments, the one or more defeatable barriers162are similar to the weakened points, grooves, or areas discuss previously.FIG. 4Adepicts device400prior to activation.

Some embodiments of device400further generally include a roller clamp assembly or actuator180located near the proximal end112of body110prior to activation as illustrated. According to some embodiments, roller clamp180further includes a slidable frame or mounting assembly182, an axially configured rolling mechanism184, a guide or groove186, and an axle or roller shaft188. In some embodiments, roller clamp assembly180is permanently slidably coupled or attached to body110. In other embodiments, roller clamp assembly180is removable and reusable with multiple additional antiseptic dispensing applicator devices. Further, according to some embodiments, roller clamp assembly180is slidably mounted so as to fully close body110upon activation of roller clamp assembly180. In other embodiments, roller clamp assembly180is configured to only partially close body110upon activation of roller clamp assembly180. Body110comprises a semi-flexible tubing material capable of being compressed or squeezed in full or in part by roller clamp assembly. In some instances, rolling mechanism184is advanced manually to compress body110, such as via the thumb of user154. In other embodiments, rolling mechanism184is advanced via automated means, such as a small electric motor.

According to some embodiments, user154manually advances roller clamp assembly180by rotating rolling mechanism184distally in direction134to activate device400. As roller clamp assembly180moves distally under the manual rotational force134, the internal hydraulic pressure inside body110gradually increases and liquid solution122is pushed distally. Once the internal hydraulic pressure is large enough to overcome the structural integrity of the one or more defeatable barriers162, distal end114ruptures due to stress concentrations at the defeatable barriers162.

According to some embodiments, as the internal hydraulic pressure increases within body110, region162B expands while region162A remains static owing to the shape and formation of the annulus groove or defeatable barrier162, as shown inFIG. 4B. User154continues to advance roller clamp assembly180via application of rotational force134until defeatable barrier162fails or ruptures due to stress concentrations thus resulting in opening166. Following activation, antiseptic solution122is released from tube body110via opening166and saturates or moistens applicator pad140for disinfectant use. User154may continue to apply rotational force134as necessary to displace additional antiseptic solution122from body110into applicator pad140.

As illustrated inFIGS. 4A and 4B, guide or groove186is oriented relative to body110at an angle according to some embodiments. In such configurations, as roller clamp assembly180is advanced distally, the pressure within body110and the stress concentration at defeatable barrier162increases gradually until defeatable barrier162fails and antiseptic solution122escapes via opening166.

Turning now toFIG. 5, an embodiment of an antiseptic dispensing applicator device500is shown comprising a helical score that is defeated by torsional force136. As shown, device500includes various elements common to other embodiments, including body110that defines a fluid reservoir pre-filled with antiseptic fluid122, proximal end112, distal end114, and applicator pad140. As in other embodiments, body110is sealed prior to activation such that the fluid contents122of body110are not in fluid communication with applicator pad140prior to activation. In some embodiments, device500further includes a pre-cut helical groove168along body110located proximate the distal end114thereof. Helical groove168may is generally located within the region of body110enclosed by applicator pad140such that, upon use, antiseptic fluid122is released from tube body110in order to saturate or moisten applicator pad140for disinfectant use. Pre-cut helical groove168can be pre-formed in body110via laser cutting, laser drilling, ultrasonic cutting using a heated blade or pin, or otherwise formed during the manufacturing process. In some embodiments, helical groove168comprises a 45-degree (45°) helix.

Upon use, according to some embodiments, a user activates device500by manually applying opposing torsional forces136and138to tube body110. In such embodiments, body110comprises a semi-rigid tubing material or materials. As a user applies opposing torsional forces136and138, helical groove168is defeated in a predictable manner along the path defined by helical groove168. Once defeated, antiseptic solution122is released from tube body110via the helical opening in order to saturate or moisten applicator pad140for disinfectant use.

According to some embodiments, device500comes pre-packaged. In such embodiments, a user activates device500by manually applying opposing torsional forces136and138to body110so as to create a fluid communication path between the fluid reservoir defined by body110and applicator pad140while device500remains inside the packaging. After antiseptic solution122is released from tube body110in the manner previously described, the user removes device500from its packaging for use. In this way, the sterility of device500is not compromised prior to use.

With reference now toFIG. 6, another embodiment of an antiseptic dispensing applicator device600comprising a distal squeeze chamber190is illustrated. As shown, device600includes various previously discussed elements, including defeatable barrier162. In some embodiments, device600further includes a distal squeeze chamber190located proximate the distal end114of body110. Distal squeeze chamber190may be located anywhere along distal end114so long as the distal end192of distal squeeze chamber190is located generally within the region of body110enclosed by applicator pad140and proximal relative to defeatable barrier162. User154activates device600by manually compressing distal squeeze chamber190to thereby apply lateral forces in direction130in order to increase internal hydraulic pressure and thereby compromise defeatable barrier162such that antiseptic solution122is released from body110. In such embodiments, distal squeeze chamber190comprises a semi-flexible tubing material capable of being compressed or squeezed by user154. Following activation, antiseptic solution122is released from body110to saturate or moisten applicator pad140for disinfectant use. As with other embodiments, device600is capable of being activated while contained within the manufacturer packaging such that the sterility of device600is not compromised prior to use. User154may continue to apply lateral force in direction130to displace additional antiseptic solution122from body110into applicator pad140.

In some embodiments, distal squeeze chamber190is enlarged relative to body110such that distal squeeze chamber190has a larger diameter193than the diameter195of body110so as to restrict or discourage the flow of fluid122proximal of distal squeeze chamber190during compression of distal squeeze chamber190. In some embodiments, body110is formed by a two-step process. In some embodiments, body110having diameter195is extruded. Then, according to various embodiments, body110is cut to length and subjected to a blow molding process to form diameter193of distal squeeze chamber190.

FIG. 7illustrates an alternative embodiment of device600. Specifically, according to some embodiments, device600further includes a flow restrictor portion194formed in body110. In such embodiments, body110of device600comprises tubing material with sufficient rigidity to maintain the flow restrictor194formation while being semi-flexible so as to be compressible or squeezable by user154. Flow restrictor194is generally located at the axial midpoint of body110such that it is between squeeze chamber190and a proximal portion196of tube body110. In various embodiments, flow restrictor194may be forward or aft of the axial midpoint of body110. Flow restrictor194generally comprises a pinched or narrowed neck. In use, flow restrictor194restricts the proximal flow of antiseptic fluid122upon the application of lateral force in the direction130such that fluid122is forced distally causing defeatable barrier162to rupture in order to activate device600.

FIG. 8illustrates yet another variation on device600according to some embodiments of the present invention. As illustrated, according to some embodiments, flow restrictor portion194is generally flat so as to form a foldable axis198located at the approximate midpoint of body110. As above, in some embodiments, flow restrictor194may be forward or aft of the axial midpoint of body110. In such embodiments, body110of device600comprises semi-flexible tubing material with sufficient flexibility so as to permit user154to fold body110in the direction199such that body110folds at axis198and is capable of being compressed or squeezed in a folded orientation. In use, flow restrictor194restricts, or wholly eliminates, the proximal flow of antiseptic fluid122from squeeze chamber190upon the application of lateral forces in direction130such that fluid122is forced distally causing defeatable barrier162to rupture in order to activate device600.

Turning toFIG. 9, a method is disclosed for forming certain heat-seals, including defeatable barriers162, at the distal end114of body110of devices100,200,300,400,500and600in accordance with various embodiments of the present invention. According to some embodiments, defeatable barrier162is formed using a set of heated elements102to press against distal end114of body110to thereby soften and partially melt the material of body110so as to form a joint therein. During this process, the material of body110is stretched at the joint and forms a defeatable barrier162. In some embodiments, the wall thickness of body110at or near defeatable barrier162is smaller or thinner than in other areas. According to some embodiments, the set of heated elements102have an optimized offset, which is designed based on the wall thickness of tube body110, the relevant material properties of the material comprising body110, the desired width or shape of defeatable barrier162, and other factors understood by those of skill in the art. The formation of defeatable barriers162in the manner set forth above facilitates the failure of defeatable barriers162as discussed herein.

Accordingly to some embodiments, heated elements102may be any desirable shape and/or dimensions, including a pin having a relatively blunt point, a square edge, a chamfered edge, a rounded edge, and any other desirable shape suitable to form a desired defeatable barrier162. Additional plastic welding processes understood to those of skill in the art are contemplated herein.

Turning now toFIG. 10, another embodiment of an antiseptic dispensing applicator device700comprising a weakly sealed pop-open or squeeze-open distal tip118is shown.FIG. 10depicts device700during or following activation. In some embodiments, body110is extruded or otherwise formed from a semi-rigid material. Distal end114of body110is cut to a desired shape, such as square, rounded or convex, chamfered, crescent or concave, or any other suitable shape. The two opposing sides of body110comprising118A and118B, respectively, are sealed. In some embodiment, sides118A and118B are sealed via plastic welding, adhesive, or other sealing means. The bond strength at sealed distal tip118is just enough to seal the tube body110and to sustain internal pressure from antiseptic solution122prior to activation.

User154activates device700by manually squeezing or compressing distal end114of body110until sufficient lateral forces are applied in direction130so as to overcome the bond strength of sealed distal tip118. Once sufficient lateral forces are applied, the bond of sealed distal tip118is defeated such that sides118A and118B generally resume their pre-sealed orientation resulting in an open fluid pathway between the contents of the fluid reservoir defined by body110and applicator pad140. In some embodiments, body110comprises a semi-flexible tubing material with sufficient structural rigidity or memory so as to bias sides118A and118B in their pre-sealed, open orientation after the bond of sealed distal tip118is defeated. In some embodiments, body110is further comprised of semi-flexible tubing material capable of being compressed or squeezed by user154. In this manner, following activation of device700(as depicted inFIG. 10), antiseptic solution122is released from tube body110via opening166in order to saturate or moisten applicator pad140for disinfectant use. User154may continue to apply lateral force130to displace additional antiseptic solution122from body110into applicator pad140. In other embodiments, device700is inverted to permit or otherwise encourage antiseptic agent122to flow into applicator pad140due to gravitational forces. Finally, it should be understood that a weakly sealed pop-open or squeeze-open distal tip118as shown and discussed can be employed on a variety of different embodiments previously discussed or otherwise disclosed herein.

With reference now toFIG. 11, another embodiment of an antiseptic dispensing applicator device800comprising a proximal squeeze chamber190′ is illustrated. As shown, device800includes various previously discussed elements, including defeatable barrier162. In some embodiments, device800further includes a proximal squeeze chamber190′ located conterminally with proximal end112of body110. User154activates device800by manually compressing proximal squeeze chamber190′ to thereby apply lateral forces in the direction130in order to increase internal hydraulic pressure and thereby defeat defeatable barrier162and release antiseptic solution122from tube body110. In such embodiments, proximal squeeze chamber190′ comprises a semi-flexible tubing material capable of being compressed or squeezed by user154. Following activation, antiseptic solution122is released from body110in order to saturate or moisten applicator pad140for disinfectant use. User154may continue to apply lateral forces as necessary to displace additional antiseptic solution122from body110into applicator pad140.

In some embodiments, proximal squeeze chamber190′ is enlarged relative to body110such that proximal squeeze chamber190′ has a larger diameter193′ than the diameter195′ of body110. In such configurations, proximal squeeze chamber190′ contains a large quantity of antiseptic solution122and enables user generation of internal pressure sufficient to defeat defeatable barrier162. In some embodiments, body110is formed by a two-step process. In some embodiments, body110having a diameter195′ is extruded. Then, according to various embodiments, body110is cut to length and subjected to a blow molding process to form diameter193′ of proximal squeeze chamber190′.

FIG. 12illustrates another embodiment of an antiseptic dispensing applicator device900comprising a twisting configuration. As shown inFIG. 12, according to some embodiments, device900includes, among other things, body110, distal end112, proximal end114, antiseptic fluid122, defeatable barrier162, and applicator pad140. Some embodiments of device900further include complimentary vertically sealed ends112′ and114′. According to some embodiments, ends112′ and114′ are orthogonal relative to each other, i.e., ends112′ and114′ are 90 degrees (90°) relative to each other. In still other embodiments, device900further includes one or more pre-formed twisting grooves or patterns104extending axially along the surface length of body110as illustrated. In such embodiments, body110comprises a tubing material capable of being twisted by a user without rupturing or failing along twisting grooves104. In some embodiments, for example, low-density polyethylene (LDPE) is a suitable material for body110of device900. Pre-formed twisting grooves104can be formed in body110via laser cutting, laser drilling, ultrasonic cutting using a heated blade or pin, or otherwise formed during the manufacturing process.

A user activates device900by manually applying opposing torsional forces136′ and138′ to tube body110. As opposing torsional forces136′ and138′ are applied, twisting grooves104and complimentary orthogonal sealed ends112′ and114′ enable body110to be twisted thereby axially compressing body110and increasing the internal hydraulic pressure thereof. Once the internal hydraulic pressure is sufficiently large, defeatable barrier162is defeated and the antiseptic fluid is allowed to flow into applicator pad140. Following activation, or once defeatable barrier162is defeated, antiseptic solution122is released from body110. According to some embodiments, an ergonomic handle or grip is bonded or formed at distal end112of device900to facilitate the application of manual torsional force to device900. As elsewhere, in some embodiments, device900is capable of being activated while contained within the manufacturer packaging such that the sterility of device900is not compromised prior to use.

Referring now toFIGS. 13A-13D, various alternative embodiments of an antiseptic dispensing applicator device employing a body having a defeatable barrier are shown. For example, some embodiments of a device consistent with the present invention include one or more defeatable barrier(s)162located at tip116′ of distal end114. In some embodiments, defeatable barriers162comprise the weakest point within body110such that, upon a sufficient increase in internal hydraulic pressure within body110, defeatable barriers162will be defeated in a predictable manner. According to some embodiments, defeatable barriers162are created by material softening and thinning using heated elements, such as elements102(FIG. 9), for soft or semi-flexible plastics. In other embodiments, defeatable barriers162are created by cutting or laser drilling for semi-rigid or rigid plastics. In various embodiments, one or more defeatable barrier(s)162may be located at any suitable locality on distal end114of body110so long as defeatable barrier(s)162is/are located within the region of body110enclosed by applicator pad140. For example,FIG. 13Adepicts a defeatable protruding point at the distal extremity of body110,FIG. 13Bdepicts a defeatable notch cut in the lip of distal end114,FIGS. 13C and 13Eillustrate alternative defeatable protruding points at the distal end of body110, andFIGS. 13D and 13Fshow additional alternative defeatable notches formed in the lip of distal end114.

With combined reference toFIGS. 14 and 14A, an antiseptic dispensing applicator device1000having one or more defeatable barrier(s)162′ in accordance with various representative embodiments is shown. Turning first toFIG. 14, device1000includes defeatable barrier162′, which defines a weak or defeatable area. In some embodiments, defeatable barrier162′ is similar to defeatable barriers162discuss previously. In other embodiments, defeatable barrier162′ comprises a one sided membrane. In still other embodiments, as illustrated inFIG. 14A, defeatable barrier162′ comprises a two sided membrane. As with other embodiments discussed previously, defeatable barrier162′ defines a weakest point that bursts open when the internal hydraulic pressure of tube body110exceeds the barrier strength. According to some embodiments, defeatable barrier162′ is created by material softening and thinning using heated pins for soft or semi-flexible plastics. In other embodiments, defeatable barrier162′ is created by cutting or laser drilling for semi-rigid or rigid plastics. Following activation, antiseptic solution122is released from tube body110to saturate or moisten applicator pad140for disinfectant use.

According to some embodiments, as illustrated inFIGS. 14 and 14A, defeatable barrier162′ comprises a web pattern163having a general disk shape with a uniform depression on one side or two sides of the disk. In such embodiments, the thickness of defeatable barrier162′ is lesser at the depression. In this way, when the internal hydraulic pressure of body110is sufficiently increased via any of the methods disclosed and discussed herein, the web pattern163breaks along the depressions forming a gate vale acting as flow control valve. User154is capable of controlling the amount of the antimicrobial solution122which passes through the flow control valve defined by web pattern163by virtue of controlling the external forces applied to body110. In such embodiments, web pattern163is easily broken by the application of user generated lateral forces in the direction130, which forces squeeze or compress tube body110to thereby increase the internal hydraulic pressure therein and separating or tearing the disk membrane at a predetermine pressure level. User154may continue to apply lateral force to displace additional antiseptic solution122from body110into applicator pad140.

By way of additional explanation, and with continued reference toFIGS. 14 and 14A, in some embodiments, the scoring associated with defeatable barrier162′ comprises a webbed pattern163featuring a plurality of scorings having varying dimensions and yield strengths. For example, in some embodiments, portions of defeatable barrier162′ are scored at varying depths or graduated depths to provide various yield strengths across the defeatable barrier162′. Thus, when compressed with a lateral force, defeatable barrier162′ breaks along some of the scored surface163to form a gate valve as indicated above. Since only some of the scored surfaces163are defeated, the partially defeated defeatable barrier162′ controls flow of the antiseptic agent122through the defeatable barrier162′. However, upon the application of additional lateral force to the reservoir defined by body110, additional portions of the scored surfaces163are defeated thereby increasing the amount of antiseptic agent122permitted to flow through the defeatable barrier162′.

As mentioned above, in some embodiments, defeatable barrier162′ is disk-shaped having a uniform depression or scoring163that is broken or defeated by applying lateral force thereto. In some embodiments, scoring163is broken by applying an external force to the applicator pad140, whereby the force is transferred to defeatable barrier162′, such as striking or pressing applicator pad140against an object proximate defeatable barrier162′. In other embodiments, scoring163is broken from internal pressure resulting from compressing or squeezing the fluid reservoir defined by body110to increase the pressure within the reservoir beyond the strength of the scored surface163. Once defeated, antiseptic solution122within the reservoir flows through defeatable barrier162′ and is absorbed by applicator pad140. The thickness of defeatable barrier162′ and the depth of scoring163may be varied dependent upon the calculated force desired to defeat defeatable barrier162′.

With reference now toFIGS. 15, 16 and 16A, additional alternative embodiments of an antiseptic dispensing applicator device employing a removable pull-tab seal are shown. Turning first toFIG. 15, a side elevation view in cross section of an antiseptic dispensing applicator device1100having pull-tab2is shown.FIG. 15depicts device1100prior to activation. As illustrated, according to various embodiments, body110of device1100includes one or more pre-formed openings4disposed therein. Absent pull-tab2, openings4comprise a fluid communication pathway between applicator pad140and the fluid contents122of body110. Openings4may be located at any suitable point on distal end114of body110so long as openings4are located within the region of body110enclosed by applicator pad140. Upon removal of pull-tab2, antiseptic fluid122is released from tube body110in order to saturate or moisten applicator pad140for disinfectant use. Openings4may be formed in any suitable shape, such as, but not limited to, circular, elliptical, rectangular, oval, crescent, triangular, square and so forth. Similarly, openings4may be formed in any suitable patterns, such as a series of smaller holes or perforations forming a desired pattern.

As illustrated inFIG. 15, prior to activation, pull-tab2is attached or affixed to the exterior of body110so as to sealingly cover opening(s)4. In this way, prior to the removal of pull-tab2, pull-tab2interposes a temporary fluid seal or defeatable barrier between the fluid contents122of the lumen defined by body110and applicator pad140. According to various embodiments, pull-tab2is attached to the exterior of body110via removable adhesive that is compatible with the antiseptic agent122. In some embodiments, as illustrated inFIG. 15, pull-tab2extends from the distal end thereof, where it is sealingly engaged with body110adjacent opening(s)4, proximally through applicator pad140and to a sufficient length so as to render pull-tab2easily graspable. As illustrated inFIG. 15, in such embodiments, device1100is activated by the application of force in the direction6. In other embodiments, as illustrated inFIG. 16, pull-tab2extends from the proximal end thereof, where it is sealingly engaged with body110adjacent opening(s)4, distally through applicator pad140and to a sufficient length so as to render pull-tab2easily graspable. As illustrated inFIG. 16, in some embodiments, device1100is activated by the application of force in the direction6′. Pull-tab2may have any suitable shape or dimensions so as to be capable of sealingly covering opening(s)4and having a suitable gripping length and surface.

As mentioned above, in some embodiments, device1100is activated as the user grasps the proximal tail or end of pull-tab2and applies removing force thereto. In this way, the bond strength of the adhesive between pull-tab2and the exterior of body110is overcome by the application of force in the direction6and the user continues to apply removing force until pull-tab2is fully removed proximally and discarded. In other embodiments, as shown inFIG. 16, device1100is activated as the user grasps the distal tail or end of pull-tab2and applies removing force in the direction6′ until pull-tab2is fully removed distally and discarded.FIG. 16Adepicts device1100following activation via removal of pull-tab2.

In some embodiments, pull-tab2extends through an opening or cavity8formed through applicator pad140. The opening or cavity8can be formed on the distal end of applicator pad140, as illustrated inFIGS. 16 and 16A. In alternative embodiments, opening or cavity8can be formed on the proximal end of applicator pad140, as illustrated inFIG. 15. In still other embodiments, applicator pad140comprises a two-piece applicator pad having a gap between the two halves thereof through which pull-tab2extends.

As with previous embodiments discussed and disclosed herein, device1100can be squeezed or compressed following removal of pull-tab2such that the fluid contents122thereof are encouraged to flow through opening4and into applicator pad140for use. Other features discussed in connection with the embodiments disclosed herein can be employed in concert with opening(s)4and/or pull-tab2.

Turning now toFIGS. 17A through 17D, additional alternative embodiments of an antiseptic dispensing applicator device employing a low peel strength seal are shown. The aforementioned figures depict side elevation views in cross section of various antiseptic dispensing applicator devices1200having low peel strength seal9according to various embodiments. As illustrated, according to some embodiments, body110of device1200includes one or more pre-formed openings4disposed therein. In such embodiments, seal9operates as a defeatable barrier.

Prior to activation, one end9A of low peel strength seal9is attached or affixed to the interior of applicator head or pad140and the other end9B of seal9is attached or affixed to the exterior of body110so as to sealingly cover opening(s)4. In this way, prior to the removal thereof, seal9interposes a temporary fluid seal or defeatable barrier between the fluid contents122of the lumen defined by body110and applicator pad140. According to various embodiments, seal9is attached to the exterior of body110at9B using a relatively low bond strength, removable adhesive that is compatible with the antiseptic agent122. End9A, on the other hand, is attached to the interior of applicator pad140using a relatively high bond strength and/or generally permanent adhesive that is also compatible with antiseptic agent122. The adhesive employed at9A has a bond strength that exceeds the adhesive employed at9B. As depicted inFIGS. 17A through 17D, seal9is attached in a folded configuration with a leading or peeling end9C configured to facilitate activation of device1200.

With reference toFIGS. 17A and 17B, seal9is attached between applicator pad140and the exterior of body110about opening(s)4as described above. As depicted, in some embodiments, seal9is oriented such that the leading or pealing edge9C is generally parallel with the longitudinal axis of body110. In this way, according to some embodiments, device1200is activated by opposing rotational forces5and5′. As shown inFIGS. 17A and 17B, device1200is activated as the user grasps applicator pad140with one hand and body110with the other hand and applies opposing rotational forced5and5′ such that the relatively weak bond strength adhesive at9B is overcome as seal9remains attached to applicator pad140at9A and, therefore, rotationally moves with applicator pad140until seal9is fully or partially removed at9B. In some embodiments, device1200is capable of being grasped and activated as described while still fully or partially in its original packaging.

In other embodiments, as depicted inFIGS. 17C and 17D, seal9is oriented such that the leading or pealing edge9C is generally transverse or perpendicular relative to the longitudinal axis of body110. In this way, according to some embodiments, device1200is activated by opposing longitudinal forces7and7′. In such embodiments, seal9is induced to fail or release at9B due to the application of opposing longitudinal forces7and7′ as seal9moves longitudinally with applicator pad140until seal9is fully or partially removed at9B. In some embodiments, device1200is activated as the distal end of applicator pad140is held against a stationary surface and a user applies longitudinal force7, which force is equally and oppositely opposed by the stationary surface supplying opposing longitudinal force7′. In this way, device1200can be activated using a one-handed operation or technique.

As with previous embodiments discussed and disclosed herein, device1200can be squeezed or compressed following removal of seal9at9B such that the fluid contents122thereof are encouraged to flow through opening4and into applicator pad140for use. Other features discussed in connection with the embodiments disclosed herein can be employed in concert with seal9.

The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein. For example, in some embodiments, a one-way valve (not shown) may be incorporated into the distal end114of body110of devices100-1200. In such embodiments, the one-way valve is interposed between the contents of the fluid reservoir defined by body110and applicator pad140. Such a one-way valve generally comprises a flexible or semi-flexible polymer material that is secured within the distal end114of body110proximate applicator pad140. In some embodiments, the one-way valve includes a duckbill or an umbrella valve. In other embodiments, the one-way valve includes a slit that is biased to a closed position so as to prevent fluid communication between the fluid reservoir defined by body110and applicator pad140prior to activation. However, as discussed and disclosed herein, when a pressure within body110exceeds the threshold pressure of the one-way valve, the one-way valve is defeated such that the slit opens to provide fluid communication between the fluid reservoir defined by body110and applicator pad140.

For example, as discussed at length previously, in some embodiments the body portion110of devices100-1200comprises a semi-flexible tubing material capable of being compressed or squeezed by the user. Thus, as the user compresses the body portion110, the pressure within the inner lumen thereof increases to exceed the threshold pressure of the one-way valve. When this occurs, the one-way valve is defeated and the antiseptic agent122is permitted to bypass the one-way valve, via the slit, and flow into applicator pad140. When the pressure subsides, the valve closes to prevent further flow of antiseptic fluid122into applicator pad140. In some embodiments, the one-way valve is replaced with a mechanical valve (not shown) that the user directly manipulates, such as a flapper or sliding valve. In other embodiments, the defeatable barrier162and/or162′ discussed herein is replaced with a small hole that would allow antiseptic agent122to flow from the inner lumen defined by body110into applicator pad140when body portion110is compressed. However, fluid would not be permitted to flow without compression due to the inner lumen being unvented and due to the surface tension of the antiseptic agent122.

While applying positive pressure to the body portion110of the devices100-1200is one method to defeat the one-way valve as well as defeatable barrier162and/or162′, one of skill in the art will appreciate that other methods may be used to equally defeat the one-way valve as well as the weakened membrane. For example, in some embodiments, the fluid chamber defined by body110is modified to include a vacuum source whereby the pressure within the fluid chamber defined by body110is decreased below the threshold pressure of the one-way valve. In other embodiments, body110itself comprises a syringe (not shown) containing an antiseptic agent122. As the syringe is compressed, antiseptic agent122is injected directly into applicator pad140and the user maintains precise control over the amount of antiseptic agent supplied. In still other embodiments, a syringe (not shown) is attached to body110in order to manually depress the syringe plunger and thereby controllably increase the pressure within body110. When the pressure within the inner lumen defined by body110exceeds the threshold pressure of the one-way valve and/or defeatable barrier162and/or162′, the valve and/or membrane is defeated and the antiseptic agent122flows into applicator pad140.

In yet additional embodiments, body110includes two or more internal lumens separated by internal axial membranes. In such embodiments, the multiple lumens of body110are configured to contain the same or different solutions. Different solutions may be useful for procedures requiring a two-step preparation. For example, in some embodiments, the first lumen contains a detergent solution while the second lumen contains a disinfectant solution. According to some embodiments, the lumens of body110release their contents simultaneously via a single action. In other embodiments, the lumens of body110release their contents in stages requiring a unique action associated with each individual lumen.

In various embodiments, body110is configured to ergonomically enhance the user's grip. For example, in some embodiments, body110is sized and shaped to as to provide an adequate gripping surface and length. In other embodiments, body110is formed with ergonomic shapes complimentary to the user's grip. In still other embodiments, body110includes an external treatment, texture, or contours so as to increase the coefficient of friction between body110and a user's hand to thereby facilitate a user's grip. Finally, according to various embodiments, body110is sized and shaped to enhance manual dexterity and the functionality of devices100-1200suitable to the procedure being performed. For example, the size of body110may be increased for procedures requiring a large volume of antiseptic agent122. Alternatively, the size of body110may be decreased to ensure adequate control over the device by a desired grip.