Medical preparation device and methods of use

Abstract

A device (100, 200, 300, 400, 500) for applying a solution to a patient may include an applicator body (110, 210, 310, 410, 510) with a treatment sponge (135, 230, 335, 435, 535) at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body. The device may include a plunger (122, 222, 322, 422, 522) configured to receive a force from a user. A device may include a solution containment portion (111, 211, 311a, 311b, 411, 511) containing a solution and disposed within the internal cavity, wherein the solution container is configured to break or rupture within the cavity. A device may include a handle (120, 220, 320, 420, 520), wherein a force applied by a user to the handle causes the solution containment portion to break or rupture within the cavity and wherein the solution is dispensed to the treatment sponge via a pressure provided by the plunger.

Description

MEDICAL PREPARATION DEVICE AND METHODS OF USECROSS REFERENCE TO RELA TED APPLICA TIONS

[0001] This application claims the benefit of US Provisional Application No. 63 / 674679, titled “MEDICAL PREPARATION DEVICE AND METHOD OF USE” filed on July 23, 2024. The aforementioned application is incorporated by reference herein.TECHNICAL FIELD

[0002] This disclosure is related to device, system, and method for surgical or other medical preparation.BACKGROUND

[0003] Cleaning an area before, during and / or after various medical procedures such as surgical procedures, is generally standard practice in the medical industry. Typically, a solution that has antiseptic and / or anti-microbial qualities is applied to an area before a medical procedure. A number of medical solutions come pre-packaged in a container connected to a sponge or other applicator device. However, there are significant challenges and obstacles with current applicator devices and / or methods. Thus, there is an unmet need for improved devices, systems, and methods for medical preparation.

[0004] One such device includes a container containing a solution and a sponge connected to the container and configured to be wetted by the solution in the container. However, the aforementioned device requires the force of gravity to dispense the solution to the sponge, which frequently causes inconsistencies and difficulties during use, when for example, the device is used upside-down or in other scenarios where the sponge is at a position higher than the solution container.SUMMARY

[0005] The following presents a simplified summary of one or more aspects of the technology disclosed herein in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or allaspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later.

[0006] Aspects of the technology described herein relates to an apparatus for applying a solution to a patient, the apparatus including: an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution container is configured to break or rupture within the cavity: and a handle, wherein a force applied by a user to the handle causes the solution containment portion to break or rupture within the cavity and wherein the solution is dispensed to the treatment sponge via a pressure provided by the plunger.

[0007] Some aspects of the technology described herein relate to an apparatus which may include the features described above and that is further configured to transfer the force applied by the user to the handle to break or rupture of the solution containment portion and additional force applied by the user dispenses the solution to wet the treatment sponge with the solution.

[0008] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the force applied by the user is a squeezing or pressing force applied to the handle.

[0009] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein a biasing force is provided to the plunger via biasing member, and wherein the biasing force applied to the plunger causes the break or rupture of the solution containment portion and dispenses the solution to wet the treatment sponge with the solution.

[0010] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the apparatus further includes a release mechanism configured to release the plunger from a locked state, wherein the force applied by the user causes the release mechanism to release the plunger.

[0011] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the handle is configured to rotate, and the force applied by the user is a rotational force.

[0012] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the plunger is connected to the handle and the plunger is configured to move linearly within the applicator body.

[0013] Some aspects of the technology described herein relate to an apparatus which may include the features described above, further including a filter, wherein the filter is to filter the solution before it is dispensed to the treatment sponge.

[0014] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the solution containment portion includes a first solution containment portion containing a first solution and a second solution containment portion including a second solution.

[0015] Some aspects of the technology described herein relate to an apparatus which may include the features described above, further including a puncturing member for puncturing or breaking the solution containment portion.

[0016] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the treatment sponge is connected to the applicator body via an elongated wand.

[0017] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the treatment sponge is connected to a distal end of the applicator body.

[0018] Some aspects of the technology described herein relate to an apparatus which may include the features described above further including one or more one-way features, wherein the one-way features are configured to allow the plunger to move in a first direction to cause the solution to be dispensed to the treatment sponge and prevent the plunger from moving in a second direction different from the first direction.

[0019] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the second direction is opposite the first direction.

[0020] In some aspects of the disclosure, the technology described herein relates to an apparatus for applying a solution to a patient, the apparatus including: an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution container is configured to break or rupture within the cavity: and a handle that is configured to pivot or bend with respect to the applicator body wherein a force applied by a user to the handle causes the solution containment portion to break or rupture within the cavity and wherein the solution is dispensed to the treatment sponge via a pressure provided by the plunger.

[0021] Some aspects of the technology described herein relate to an apparatus which may include the features described above, wherein the plunger is formed as a unitary structure with the handle.

[0022] Some aspects of the technology described herein relate to an apparatus which may include the features described above, further including a puncturing member configured to puncture or break an outer casing of the solution containment portion to release the solution contained therein into the internal cavity of the applicator body.

[0023] In some aspects of the disclosure, the technology described herein relates to a method for applying a solution to a patient, the method including: providing a treatment device including: an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution container is configured to break or rupture within the cavity; a handle; applying a force to the handle to break or rupture the solution container within the cavity; dispensing the solution to the treatment sponge via a dispensing force to wet the treatment sponge with the solution; and applying the solution to the patient via the treatment sponge.

[0024] Some aspects of the technology described herein relate to a method which may include the features described above further including applying additional force to the handle to provide the dispensing force.

[0025] Some aspects of the technology described herein relate to a method which may include the features described above, further including releasing a biasing member by applying the force to the handle.

[0026] To the accomplishment of the foregoing and related ends, the one or more aspects of the disclosure comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail include certain illustrative features of the one or more aspects. These features are indicative, however, of but a few of the various ways in which the principles of various aspects can be employed, and this description is intended to include all such aspects and their equivalents.BRIEF DESCRIPTION OF THE DRA WINGS

[0027] Features characteristic of aspects if the technology described herein are set forth as follows, in the appended claims, and in the drawings. In the descriptions that follow, like parts are marked throughout the specification and drawings with the same numerals, respectively. The drawing figures are not necessarily drawn to scale and certain figures can be shown in exaggerated or generalized form in the interest of clarity and conciseness. The disclosure itself, however, as well as a preferred mode of use, further objects and advances thereof, will be best understood by reference to the following detailed description of illustrative aspects when read in conjunction with the accompanying drawings.

[0028] Figure 1 shows one example of a preparation device according to aspects of the disclosure.

[0029] Figure 2 shows an example of a preparation device according to another aspect of the disclosure.

[0030] Figure 3 shows an example of a preparation device according to another aspect of the disclosure.

[0031] Figure 4 shows an example of a preparation device according to another aspect of the disclosure.

[0032] Figure 5 shows an example of a preparation device according to another aspect of the disclosure.DETAILED DESCRIPTION

[0033] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts can be practiced without these specific details.I. Terminology

[0034] Reference throughout this specification to “one aspect,” “an aspect,” “one example” or “an example” means that a particular feature, structure or characteristic described in connection with the embodiment or example may be a feature included in at least one example of the present disclosure. Thus, appearances of the phrases in one aspect, in an aspect, one example or an example in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures or characteristics may be combined in any suitable combinations and / or subcombinations in one or more embodiments or examples.

[0035] In the above disclosure, the term “substantially” or “approximately” may be used as a modifier for a geometric relationship between elements or for the shape of an element or component. While the terms substantially or approximately are not limited to a specific metric and may cover any metric that is understood by one of ordinary skill in the art to be an acceptable variation, some examples are provided as follows. In some examples, the terms substantially or approximately may include a variation of less than 10% of the dimension of the object or component, or a variation of less than 5% of the object or component. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits to one of ordinary skill in theart. In this disclosure, terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term at least one. The phrases “at least one of’ and “comprises at least one of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list. All numerical ranges are inclusive of their endpoints and non-integral values between the endpoints unless otherwise stated.

[0036] The terms “first,” “second,” “third,” and “fourth” are used in their relative sense only. In particular, in some aspects certain components may be present in interchangeable and / or identical multiples (e.g., pairs). For these components, the designation of first, second, third, and / or fourth may be applied to the components merely as a matter of convenience in the description of one or more of the aspects of the disclosure.

[0037] The terms “disposed on,” “disposed along,” “disposed with,” or “disposed toward” and variations thereof may define one element can be integral with another element, or that one element can be a separate structure bonded to or placed with or placed near another element.

[0038] The term “at,” for example when referring to something being located at a specific location, is intended to include any one or more of: proximate, on, near, adjacent to, or within the specific location.

[0039] The term "distal end" refers to a portion of a device that is situated farthest from the user or operator during normal operation. In the context of a device intended for insertion into a body, the distal end is the part that is inserted first. This distal end is typically designed to interact with the target area or tissue within the body.

[0040] The term "proximal end" refers to the portion of the medical device that is closest to the user or operator during normal operation. In the context of a device intended for insertion into a body, the proximal end may remain outside the body and may be accessible to the user.

[0041] Additionally, references to “one aspect” or “an aspect” of the present disclosure are not intended to be interpreted as excluding the existence of additional features or components, either described in this application or that would have been understood byone of ordinary skill in the art after reading this disclosure, that also incorporate the recited features.

[0042] For purposes of the disclosure, directional terms are expressed generally with relation to a standard frame of reference when the aspects or articles described herein are in an in-use orientation. In some examples, the directional terms are expressed generally with relation to a left-hand coordinate system.

[0043] Various aspects of the preparation apparatus described herein may be illustrated by describing components that are coupled, attached, and / or joined together. As used herein, the terms “coupled,” “attached,” and / or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being directly coupled, directly attached, and / or directly joined to another component, there are no intervening elements present.

[0044] As used herein, the term “exemplary” means serving as an example, instance, or illustration, and should not necessarily be construed as preferred or advantageous over other embodiments of an antiseptic applicator disclosed herein.

[0045] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred materials and methods are described herein.II. Detailed Examples

[0046] Figure 1 shows one example of a system and apparatus according to aspects of the disclosure. The preparation apparatus 100 may include an applicator or sponge 135 (hereinafter interchangeably referred to as an absorbent applicator). The sponge may for example be formed of any one or combination of rayon, polyester, cotton, polyurethane, polyurethane / polyester blends, polystyrene, polyethylene or any other material suitable for use as a solution applicator. As shown in the example in Figure 1, the sponge 135 may be connected to or may otherwise be fastened to an applicator body. The applicator body 110,may for example include applicator body walls 108. The applicator body walls 108 may be configured to contain a solution and / or may be configured to have a plunger advanced therein as explained in further detail below. For example, the applicator body wall 108 may be substantially a hollow cylinder in shape with a cavity therein and with a sponge interface wall 107 at a distal end thereof. The sponge interface wall may have one or more passages (e.g., indicated by arrows 102) at a distal end 107a thereof that provide a flow path or fluid communication with the inside portion of the applicator body that may function as channels for a solution contained within the applicator body 110 to impregnate, infuse, saturate, and / or wet the sponge 135 to allow a practitioner to apply the solution to a patient.

[0047] At a proximal end 107b of the preparation apparatus 100, the applicator body 110 may have a plunger interface portion or handle 120 that passes through a wall or cap at the proximal end 107b of the applicator body 110. The applicator body 110 may be configured to have a plunger 122 slideably disposed therein that is directly or indirectly mechanically connected to the handle 120 so that when pressure or force (e.g., in direction PP) is applied to the handle 120, the plunger 122 moves (and transfers the force) applied at the handle 120. The plunger 122 may seal with or otherwise provide a sealing interface with the inner walls of the applicator body 110 so that the plunger 122 provides a barrier with the inner wall of applicator body 110 seal off any fluids 114 (e.g., air, gasses, and / or liquids) contained within applicator body 110.

[0048] The preparation apparatus 100 may further include or contain within the applicator body 110 a solution containment portion 111. The solution containment portion 111 may for example be a separately sealed ampule, frangible member, or blister pack within the applicator body 110 that contains a solution 114 therein. The solution containment portion 111 may be formed of a unitary piece of material containing a solution (examples of solutions described in further detail below). Examples of suitable materials from which the solution containment portion 111 may be formed include, but are not limited to polyolefins, polypropylene, polyethylene (e.g., high density polyethylene, low density polyethylene), ethyl ene / propylene copolymers, ethyl ene / butylene copolymers, vinyl and vinyl polymers, acrylic polymers, polyesters (e.g., polyethylene terephthalate (PET), polybutylene terephthalate), polyvinyl alcohol, polyamides, polyvinylchloride, polyvinylidene chloride, ethylene vinyl alcohol, and any combinations or mixtures thereof.Fluorinated polymers, or layers may be employed, such as chlorotrifluoroethylene, polytetrafluoroethylene (PTFE), chlorotrifluoroethylene, polyvinylidene fluoride, copolymers of perfluorinated monomers with partially fluorinated monomers such as copolymers of tetrafluoroethylene / hexafluoropropylene / vinylidene (e.g., THV fluorothermoplastic from Dyneon Co.), and combinations thereof. In an embodiment, a blend of HDPE and polyamide may be employed to form a single layer container body. In some examples, the solution containment portion 111 may be partially formed of a flexible or semi-flexible material with a foil or aluminum foil portion that is configured to be torn or punctured open when pressure is applied to the solution containment portion 111 and / or when punctured by a structure configured to puncture the foil portion. Further, the solution containment portion 111 may be formed of a glass or composites thereof. In some examples, the solution may be sealed within a portion of the applicator body 110 via a polymeric film, aluminum foil or other foil or similar sealing system.

[0049] In some example implementations of the disclosure, the solution containment portion 111 may be stored or otherwise contained within the applicator body 110 between the plunger 122 and the sponge interface wall 107. In some examples (explained in further detail below), the solution containment portion 111 may be between the plunger 122 and one or more puncturing members 113. In one example, the solution containment portion 111 may be connected to or otherwise configured to be in contact with and thus move linearly inside the applicator body 110 with the plunger 122.

[0050] The solution 114 contained within the solution containment portion 111 may be aseptic, meaning it is generally sterile, so as to be free from disease causing contaminants (e.g., bacteria, viruses, fungi, parasites, etc.). The aseptic condition may be achieved through manufacture within a controlled environment, where contaminants are controlled, as well as through sterilization of the applicator once manufactured (e.g., through exposure to ethylene oxide gas). The composition may also be an antiseptic composition, where an antiseptic agent is included therein, so as to allow its application to a treatment area so as to kill microbes, reducing the possibility of infection. Thus, the composition may be aseptic, and also antiseptic. The composition may include any one active or selected from the group comprised of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof. By way of example, the active included in the composition is not particularly limited, and may be chlorhexidine, or a chlorhexidine salt, such aschlorhexidine gluconate, octenidine salts and / or hypochlorite solutions, hypochlorous acid, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride. Other actives (e.g., povidone iodine (PVP-I), iodine, or other iodine complexes may also be used, as well as any other antimicrobial agents. An alcohol may also be included (e.g., methanol, ethanol, isopropyl alcohol, butyl alcohol, combinations thereof, etc.). The composition may be a liquid. In some embodiments, two or more liquid components may mix and / or a liquid may mix with solid, gel, or other liquid components to result in a flowable liquid composition.

[0051] The composition may comprise a dye or colorant to provide a color (e.g., red, purple, green, etc.) to the composition so as to contrast against the skin or other treatment region to which the composition is to be applied and / or indicate coverage on a patient’s skin or other region.

[0052] The solution containment portion 111 may be configured to puncture, rupture, or break when force is applied to the solution containment portion 111 via the plunger 122 when a user applies a force to the handle 120 (e.g., in a direction indicated by arrow PP). For example, the solution containment portion 111 may have weakened portion or a portion that is otherwise intended to burst or open when a predetermined pressure or pressure range is applied thereto. As noted above, the preparation apparatus 100 may further include within the applicator body 110 one or more puncturing members 113. The one or more puncturing members 113 may be configured to puncture or otherwise tear open and / or break open the solution containment portion 111 when the solution containment portion 111 is pressed against the one or more puncturing members 113. Thus, once the solution containment portion I l l is punctured and / or fractured the solution contained therein can pass through the one or more passages 102 and wet or soak into / saturate the sponge 135. Once the solution containment portion 111 is broken, a user can further advance the handle 120 and thus the plunger 122 in direction PP and apply pressure to the solution within the applicator body 110 to pressurize the solution and forcing solution to saturate the sponge 135 and / or forcing the solution from the sponge 135 to an area to be treated. Thus, even if the sponge 135 and / or the area that the practitioner wishes to apply the solution is higher than the solution in the applicator body 110, solution can still be dispensed through the openings or passages 102 to the sponge 135.

[0053] In some examples, the applicator body 110 may include a filter 101 and / or a oneway valve or diaphragm. The filter 101 may prevent any debris from the broken solution containment portion 111 from clogging or passing through the openings 102 and / or may restrict flow through the openings 102 to limit the flow rate of fluid through the openings 102 or otherwise prevent an excessive amount of solution from being forced through the openings 102 due to excessive force being applied to the handle 120 by a practitioner. Further as noted above, a one-way valve may be implemented with or as an alternative to the filter, to prevent any fluids from flowing from the sponge 135 back into the applicator body 110, which may prevent contamination of the solution within the applicator body 110. The filter 101 may for example be comprised of one or more porous films(s) and / or microporous film(s).

[0054] The applicator body 110 may further include one or more piercing members 113 for piercing, breaking, or otherwise causing the solution 114 within the solution containment portion 111 to release into the applicator body 110. The one or more puncturing members 113 may for example be pointed or spike shaped. In some examples, the one or more puncturing members 113 may be shaped as a blade. The one or more puncturing members 113 may be formed of any appropriate material which may include but is not limited to any one or combination of metals, plastics, and / or semi-rigid or rigid rubber, to name a few examples. As noted above, the one or more puncturing members 113 may correspond with or may be positioned to specifically contact a weakened or decreased strength portion of the solution containment portion 111. For example, the one or more puncturing members 113 may be positioned to contact (and puncture) a seal or foil (e.g. aluminum foil) portion of the solution containment portion 111. The one or more puncturing members 113 may for example be mounted to the sponge interface wall 107 (see e.g., sponge interface wall mount 113a) and / or the side walls of the applicator body 110 (see e.g., wall interface mount 113b).

[0055] The preparation apparatus 100 may further include one-way features that lock the plunger 122 as the practitioner presses the handle 120 and advances the plunger 122 during use. The one-way features may allow the plunger 122 to be advanced in direction PP and may lock or otherwise prevent the plunger 122 from moving in a direction opposite direction PP. The one-way features may progressively lock the plunger 122 thus ensuring that the plunger does not retract (i.e., move in a direction opposite direction PP) causingan unintentional pressure decrease of the solution within the applicator body 110. Further, the aforementioned one-way features may reduce strain on the practitioner by not requiring the practitioner to apply constant pressure to the handle 120 to dispense the solution. Figure 1 shows one non-limiting example of a one-way features 112, which may for example be a series of grooves or protrusions on an inside wall surface of the applicator body 110 that are configured to engage with a corresponding groove or protrusion 123 on the plunger 122. In one example, the groove and / or protrusion may be barb-shaped and / or include a ramp on a first side and a step on the second side allow the plunger 122 to be easily advanced in direction PP (i.e., via the ramp) while not allowing the plunger 122 to easily retract in a direction opposite direction PP (i.e., once engaged with the step portion).

[0056] The applicator body 110 may be formed of any suitable material. Some non-limiting examples include any one or combination of polyethylene terephthalate (PET or PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), polypropylene (PP) and / or even glass or ceramics. In some examples the applicator body 110 may be transparent, semi-transparent or semi-opaque to allow a practitioner to quickly recognize if the solution containment portion I l l is properly punctured and / or fractured and / or to view how much solution is left in the applicator body 110. In some cases, the applicator body 110 may include measurement markings to indicate to a practitioner how much solution has been dispensed.

[0057] Figure 2 shows another example of a preparation apparatus 200 according to aspects of the disclosure. The device 200 may share any one or more features with or may be analogous with the preparation device 100 in Figure 1, the preparation device 300 in Figure 3, the preparation device 400 in Figure 4 and / or the preparation device 500 in Figure 5. The example device of Figure 2 includes an extended wand for preparation of an orifice, body cavity, or surgical cavity to name a few non-limiting examples. The device 200 of figure 2 may include a wand with a distal end 232a and a proximal end 232b. Further, the device 200 may include a sponge 230 (hereinafter interchangeably referred to as a treatment sponge) at a distal end of the wand 232. The applicator body 210 of the device 200 of Figure 2 may be in fluid communication with the wand 232, and the wand 232 may have an inner passage to channel solution from applicator body 110 to the sponge 230 (e.g., as indicated by the dashed arrows 229 in Figure 2). The distal end of the wand 232a may for example have one or more fluid passageways 231 (e.g., a series of openingsor other passages) to allow solution to saturate or infuse the sponge 230 due to pressure applied by a practitioner (i.e., applied via the handle 220 to advance the plunger 222 toward interface wall 207). In an alternative example, the wand 232 and / or the solution container applicator portion 210 may be separate components from the sponge 230. In another alternative example, the wand 232 and the applicator portion 210 may be a single, integral (i.e., not separate) component. The wand 232 may be inserted into the sponge 230 to provide solution contained in the solution container 220 to the sponge 230.

[0058] The sponge 230 may for example be formed of any one or combination of rayon, polyester, cotton, polyurethane, polyurethane / polyester blends, polystyrene, polyethylene or any other material suitable for use as a solution applicator.

[0059] The applicator body walls 208 may be configured to contain a solution and / or may be configured to have a plunger advanced therein as explained in further detail below. For example, the applicator body wall 208 may be substantially a hollow cylinder in shape with a sponge interface wall 207 at a distal end thereof. The sponge interface wall may have one or more passages 202 at a distal end thereof that provide a flow path or fluid communication with the inside portion of the applicator body 210 that may function as channels for a solution contained within the applicator body 110 to flow through the wand 232 and through passages at the sponge 230 to saturate, impregnate, infuse, and / or wet the sponge 230 to allow a practitioner to apply the solution to a patient.

[0060] At a proximal end of the preparation apparatus 200, the applicator body 210 may have a plunger interface portion or handle 220 that passes through a wall or cap at the proximal end of the applicator body 210. The applicator body 210 may be configured to have a plunger 222 slideably disposed therein that is directly or indirectly mechanically connected to the handle 220 so that when pressure or force (e.g., in direction PP shown in Figure 1) is applied to the handle 220, the plunger 222 moves (and transfers the force) applied at the handle 120. The plunger 222 may seal with or otherwise provide a sealing interface with the inner walls of the applicator body 210 so that the plunger 222 provides a barrier with the inner wall of applicator body 210 seal off any fluids 214 (e.g., air, gasses, and / or liquids) contained within applicator body 210 and to allow pressure to be applied to any fluid therein by pressing the handle 220.

[0061] The preparation apparatus 200 may further include or contain within the applicator body 210 a solution containment portion 211. The solution containment portion 211 may for example be a separately sealed ampule, frangible member, or blister pack within the applicator body 210. The solution containment portion 211 may be formed of a unitary piece of material containing a solution (examples of solutions described in further detail below). Examples of suitable materials from which the solution containment portion 211 may be formed include but are not limited to the examples provided above with respect to Figure 1.

[0062] In some examples, the solution containment portion 211 may be stored or otherwise contained within the applicator body 210 between the plunger 222 and the sponge interface wall 207. In some examples (explained in further detail below), the solution containment portion 211 may be between the plunger 222 and one or more puncturing members 213. In one example, the solution containment portion 211 may be connected to or otherwise configured to be in contact with and thus move linearly inside the applicator body 210 with the plunger 222.

[0063] The solution contained within the solution containment portion 211 may be any one or combination of the solutions described above with respect to Figure 1 and may further include a dye or colorant as described above.

[0064] The solution containment portion 211 may be configured to puncture, rupture, or break when force is applied to the solution containment portion 211 via the plunger 222 when a user applies a force to the handle 220. For example, the solution containment portion 211 may have a weakened portion or a portion that is otherwise intended to burst or open when a predetermined pressure or pressure range is applied thereto. The preparation apparatus 200 may further include within the applicator body 210 one or more puncturing members 213. The one or more puncturing members 213 may be configured to puncture or otherwise tear open and / or break open the solution containment portion 211 when the solution containment portion 211 is pressed against the one or more puncturing members 213. Thus, once the solution containment portion 211 is punctured and / or fractured, the solution contained therein can pass through the wand 232 and wet / saturate or soak into the sponge 230. Once the solution containment portion 211 is broken or pierced, a user can further advance the handle 220 and thus the plunger 222 in direction PP (Figure 1) and apply pressure to the solution within the applicator body 210 topressurize the solution and forcing solution to saturate or soak into the sponge 230. Thus, even if the sponge 230 and / or the area that the practitioner wishes to apply the solution is higher than the solution in the applicator body 210, solution can still be dispensed to the sponge 230.

[0065] In some examples, the applicator body 210 may include a filter 201 and / or a oneway valve or diaphragm. The filter 201 may prevent any debris from the broken solution containment portion 211 from clogging or passing through the wand 232 and / or may restrict flow through the wand 232 to limit the flow rate of fluid or otherwise prevent too much of the solution from being forced into the sponge 230 due to excessive force being applied to the handle 220 by a practitioner. Further as noted above, a one-way valve may be implemented with or as an alternative to the filter to prevent any fluids from flowing from the sponge 230 and / or wand 232 back into the applicator body 210, which may prevent contamination of the solution within the applicator body 210. The filter may for example be comprised of one or more porous films(s) and / or microporous film(s).

[0066] The applicator body 210 may further include one or more piercing members 213 for piercing, breaking, or otherwise causing the solution within the solution containment portion 211 to release into the applicator body 210. The one or more puncturing members 213 may for example be pointed or spike shaped. In some examples, the one or more puncturing members 213 may be shaped as a blade. The one or more puncturing members 213 may be formed of any appropriate material of which non-limiting examples are described above with respect to Figure 1. As noted above, the one or more puncturing members 213 may correspond with or may be positioned to specifically contact a weakened or decreased strength portion of the solution containment portion 211. For example, the one or more puncturing members 213 may be positioned to contact (and puncture) an aluminum foil portion of the solution containment portion 211. The one or more puncturing members 213 may for example be mounted to the sponge interface wall 207 via a wall mounting portion 213a and / or the side walls of the applicator body 210 via a sidewall mounting portion 213b.

[0067] The preparation apparatus 200 may further include one-way features that lock the plunger 222 as the practitioner presses the handle 220 and advances the plunger 222 during use. The one-way features may allow the plunger 222 to be advanced in direction PP (Figure 1) and may lock or otherwise prevent the plunger 222 from moving in a directionopposite direction PP. The one-way features may progressively lock the plunger 222 thus ensuring that the plunger does not retract (i.e., move in a direction opposite direction PP) causing an unintentional decrease in pressure within the applicator body 210. Further, the aforementioned one-way features may reduce strain on the practitioner by not requiring the practitioner to apply constant pressure to the handle 220 to dispense the solution. Figure 2 shows one non-limiting example of a series of one-way features 212, which may for example be a groove or protrusion on an inside wall surface of the applicator body 210 that is configured to engage with a corresponding groove or protrusion 223 on the plunger 222. In one example, the groove and / or protrusion may be barb-shaped and / or include a ramp on a first side and a step on the second side allow the plunger 222 to be easily advanced in direction PP (i.e., via the ramp) while not allowing the plunger 222 to easily retract in a direction opposite direction PP (i.e., once engaged with the step portion).

[0068] The applicator body 210 may be formed of any suitable material. Some non-limiting examples of materials are described above with respect to Figure 1. In some examples, the applicator body 210 may be clear or semi-opaque to allow a practitioner to quickly recognize if the solution containment portion 211 is properly punctured and / or fractured and / or to view how much solution is left in the applicator body 210. In some cases, the applicator body 210 may include measurement markings to indicate to a practitioner how much solution has been dispensed.

[0069] Figure 3 shows one example of a system and apparatus according to aspects of the disclosure. The device 300 described below may share any one or more features with or may be analogous with any one or combination of the preparation device 100 in Figure 1, the preparation device 200 in Figure 2, the preparation device 400 in Figure 4 and / or the preparation device 500 in Figure 5. As described in further detail below, the preparation device 300 shown in Figure 3 may include two or more solution containment portions 311a and / or 311b.

[0070] The preparation apparatus 300 of Figure 3 may include an applicator or sponge 335 (hereinafter interchangeably referred to as an absorbent applicator). The sponge may for example be formed of any one or combination of the materials described above with respect to Figures 1 and 2. As shown in the example in Figure 3, the sponge 335 may be connected to or may otherwise be fastened to an applicator body. The applicator body 310, may for example include applicator body walls 308. The applicator body walls 308 maybe configured to contain a solution and / or may be configured to have a plunger advanced therein as explained in further detail below. For example, the applicator body wall 308 may be substantially a hollow cylinder in shape with a sponge interface wall 307 at a distal end thereof. The applicator body walls may form an inner cavity for containing the solution containment portions and / or the solution. The sponge interface wall may have one or more passages (e.g., indicated by arrows 302) at a distal end 309a thereof that provide a flow path or fluid communication with the inside portion of the applicator body that may function as channels for a solution contained within the applicator body 310 to impregnate, saturate, infuse, and / or wet the sponge 335 to allow a practitioner to apply the solution to a patient.

[0071] At a proximal end 309b of the preparation apparatus 300, the applicator body 310 may have a plunger interface portion or handle 320 that passes through a wall or cap at the proximal end 309b of the applicator body 310. The applicator body 310 may be configured to have a plunger 322 slideably disposed therein that is directly or indirectly mechanically connected to the handle 320 so that when pressure or force (e.g., in direction PPP) is applied to the handle 320, the plunger 322 moves (and transfers the force) applied at the handle 320. The plunger 322 may seal with or otherwise provide a sealing interface with the inner walls of the applicator body 310 so that the plunger 322 provides a barrier with the inner wall of applicator body 310 seal off any fluids 314 (e.g., air, gasses, and / or liquids) contained within applicator body 310 and to allow pressure to be applied to any fluid therein by pressing the handle 320.

[0072] The preparation apparatus 300 may further include or contain within the applicator body 310 two or more solution containment portions 311a and / or 311b. Each one of the solution containment portions 311a and / or 311b may for example be a separately sealed ampule, frangible member, or blister pack within the applicator body 310. Each one of and / or any one of the solution containment portions 311a and / or 311b may be formed of a unitary piece of material containing a solution (examples of solutions described in further detail below). In some examples, the first solution containment portion 311a may contain a different solution than the second solution containment portion 311b. Further, the first solution containment portion 311a and / or the second solution containment portions may be formed of the same or different materials.

[0073] Examples of suitable materials from which either one of or both the solution containment portion 311a and / or 311b may be formed include, but are not limited to polyolefins, polypropylene, polyethylene (e.g., high density polyethylene, low density polyethylene), ethyl ene / propylene copolymers, ethyl ene / butylene copolymers, vinyl and vinyl polymers, acrylic polymers, polyesters (e.g., polyethylene terephthalate (PET), polybutylene terephthalate), polyvinyl alcohol, polyamides, polyvinylchloride, polyvinylidene chloride, ethylene vinyl alcohol, and any combinations or mixtures thereof. Fluorinated polymers, or layers may be employed, such as chlorotrifluoroethylene, polytetrafluoroethylene (PTFE), chlorotrifluoroethylene, polyvinylidene fluoride, copolymers of perfluorinated monomers with partially fluorinated monomers such as copolymers of tetrafluoroethylene / hexafluoropropylene / vinylidene (e.g., THV fluorothermoplastic from Dyneon Co.), and combinations thereof. A blend of HDPE and polyamide may be employed to form a single layer container body. In some examples, either one of or both of the solution containment portions 311a and / or 311b may be partially formed of a flexible or semi-flexible material with a foil or aluminum foil portion that is configured to be torn or punctured open when pressure is applied to either one of or both the containment portions 31 la-b and / or when punctured by a structure configured to puncture the foil portion. Further, either one of or both the solution containment portions 311a and / or 311b may be formed of a glass or composites thereof. In some examples, two separate solutions may be sealed within a portion of the applicator body 310 via a polymeric film, foil (e.g., aluminum foil) or similar sealing system.

[0074] In some examples, the solution containment portions 31 la and / or 311b may be stored or otherwise contained within the applicator body 310 between the plunger 322 and the sponge interface wall 307. Further, as (explained in further detail below), the solution containment portions 311a and / or 311b may be located between the plunger 322 and one or more puncturing members 313a and / or 313b. In one example, the solution containment portions 311a and / or 311b may be connected to or otherwise configured to be in contact with and thus move linearly inside the applicator body 310 with the plunger 322.

[0075] As noted above, the first solution containment portion 311a and the second solution containment portion 311b may contain different solutions. In some examples, the two solutions may be configured to mix within the applicator body 310, which may provide a solution that provides advantages for preparation. This example may be especiallyadvantageous in cases where the combination of two different solutions is desired for treatment / preparation, but the two solutions may not be stable if mixed / combined for long periods of time during storage of the preparation device. For example, the first solution containment portion 311a could contain a solution of chi orhexi dine gluconate and the second solution containment portions 311b could contain a tint or other coloring agent (such as Yellow 6). If the two aforementioned solutions are not kept separated, the tint or other coloring agent could precipitate the chi orhexi dine if left in the same solution for an extended period of time. Thus, the configuration described in Figure 3 provides for separation of the two solutions and for mixing to occur at use.

[0076] In another example, the applicator body 310 may include two separate chambers with two respective plungers or plunger halves therein. Each one of the solutions may be dispensed separately (e.g., a solution in a first containment portion 31 la may be dispensed first) for an initial preparation by pressing a first half of the handle 320 indicated by the dashed line in Figure 3 with a first half handle portion 320a. A second solution contained within the second solution containment portions 311b may be dispensed afterwards by pressing the second half of the handle 320b.

[0077] While any appropriate solution may be contained within either one of or both the solution containment portions 311a and / or 311b, some examples my include aseptic solutions, meaning generally sterile, so as to be free from disease causing contaminants (e.g., bacteria, viruses, fungi, parasites, etc.). The aseptic condition may be achieved through manufacture within a controlled environment, where contaminants are controlled, as well as through sterilization of the applicator once manufactured (e.g., through exposure to ethylene oxide gas). The composition may also be an antiseptic composition, where an antiseptic agent is included therein, so as to allow its application to kill microbes, reducing the possibility of infection. Thus, the composition may be aseptic, and also antiseptic. The composition may include any one active or selected from the group comprised of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof. By way of example, the active included in the composition is not particularly limited, and may be chlorhexidine, or a chlorhexidine salt, such as chlorhexidine gluconate, octenidine salts and / or hypochlorite solutions, hypochlorous acid, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride. Other actives (e.g., povidone iodine (PVP-I), iodine, or other iodine complexes may also be used, as well as any otherantimicrobial agents. An alcohol may also be included (e.g., methanol, ethanol, isopropyl alcohol, butyl alcohol, combinations thereof, etc.). The composition may be a liquid. In some embodiments, two or more liquid components may mix and / or a liquid may mix with solid, gel, or other liquid components to result in a flowable liquid composition.

[0078] The compositions above may comprise a dye or colorant to provide a color (e.g., red, purple, green, etc.) to the composition so as to contrast against the skin or other treatment region to which the composition is to be applied and / or indicate coverage on a patient’s skin or other treatment region. As noted above, the solution containment portions 311a and / or 311b may comprise different color dyes, some non-limiting examples of which are provided above. In one example, either of the solution containment portions 31 la or 31 lb may contain a dye that is configured to mix with a solution in the other of the solution containment portions.

[0079] Either one of or both the solution containment portions 311a and / or 311b may be configured to puncture, rupture, or break when force is applied thereto via the plunger 322 when a user applies a force to the handle 320 (or to the corresponding half of the plunger / handle in the example provided above). For example, the solution containment portions 311a and / or 311b may have weakened portions or a portion that is otherwise intended to burst or open when a predetermined pressure or pressure range is applied thereto. The preparation apparatus 300 may further include within the applicator body 310 one or more puncturing members 313a and / or 31 lb. The one or more puncturing members 313a and / or 311b which may be configured to puncture or otherwise tear open and / or break open the solution containment portions 311a and / or 311b when the corresponding solution containment portions 311a and / or 311b are pressed against the corresponding one of the one or more puncturing members 313a and / or 311b. Thus, once the solution containment portion 311a and / or 311b are punctured and / or fractured, the solution contained therein can pass through the one or more passages 302 and saturate or wet / soak into the sponge 335. Once either one or combination of the solution containment portions 311a and / or 311b are broken, a user can further advance the handle 320 and thus the plunger 322 in direction PPP and apply pressure to the solution within the applicator body 310 to pressurize the solution and force solution to soak into the sponge 335. Thus, even if the sponge 335 and / or the area that the practitioner wishes to apply the solution is higherthan the solution in the applicator body 310, solution can still be dispensed through the openings or passages 302 to the sponge 335.

[0080] In some examples, the applicator body 310 may include a filter 301 and / or a oneway valve or diaphragm. The filter 301 may prevent any debris from the broken solution containment portion 311a and / or 311b from clogging or passing through the openings 302 and / or may restrict flow through the openings 302 to limit the flow rate of fluid through the openings 302 or otherwise prevent too much of the solution from being forced through the openings 302 due to excessive force being applied to the handle 320 by a practitioner. Further as noted above, a one-way valve may be implemented with or as an alternative to the filter to prevent any fluids from flowing from the sponge 335 back into the applicator body 310, which may prevent contamination of the solution within the applicator body 310. The filter may for example be comprised of one or more porous films(s) and / or microporous film(s).

[0081] The applicator body 310 may further include one or more piercing members 313a and / or 313b for piercing, breaking, or otherwise causing the solution within the solution containment portions 311 and / or 31 lb to release into the applicator body 310. Either one or more of the puncturing members 313a and / or 313b may for example be pointed or spike shaped. In some examples, the one or more puncturing members 313a and / or 313b may be shaped as a blade. The one or more puncturing members 313a and / or 313b may be formed of any appropriate material which may include but is not limited to any one or combination of metals, plastics, and / or semi-rigid or rigid rubber, to name a few examples. As noted above, the one or more puncturing members 313a and / or 313b may correspond with or may be positioned to specifically contact a weakened or decreased strength portion of the solution containment portions 311a and / or 311b. For example, the one or more puncturing members 313a and / or 313b may be positioned to contact (and puncture) an aluminum foil portion of the corresponding solution containment portions 311a and / or 311b. The one or more puncturing members 313a and / or 313b may for example be mounted to the sponge interface wall 307 and / or the side walls of the applicator body 310 (e.g. not shown in Figure 3 to prevent obscuring the view, but shown as sponge interface wall mount 113a and / or 213a and wall interface mount 113b and / or 213b above).

[0082] The preparation apparatus 300 may further include one-way features that lock the plunger 322 (and or corresponding half-plunger as described above) as the practitionerpresses the handle 320 (or either of 320a and / or 320b) and advances the plunger 322 during use. The one-way features may allow the plunger 322 or aforementioned half plunger to be advanced in direction PPP and may lock or otherwise prevent the plunger 322 from moving in a direction opposite direction PPP. The one-way features may progressively lock the plunger 322 thus ensuring that the plunger does not retract (i.e., move in a direction opposite direction PPP) causing an unintentional pressure decrease of the solution within the applicator body 310. Further, the aforementioned one-way features may reduce strain on the practitioner by not requiring the practitioner to apply constant pressure to the handle 320 to dispense the solution. Figure 3 shows one non-limiting example of a one-way feature 312, which may for example be a groove or protrusion on an inside wall surface of the applicator body 310 that is configured to engage with a corresponding groove or protrusion 323 on the plunger 322. In one example, the groove and / or protrusion may be barb-shaped and / or include a ramp on a first side and a step on the second side allowing the plunger 322 to be easily advanced in direction PPP (i.e., via the ramp) while not allowing the plunger 322 to easily retract in a direction opposite direction PP (i.e., once engaged with the step portion).

[0083] The applicator body 310 may be formed of any suitable material. Some non-limiting examples are described above with respect to Figure 1. In some examples the applicator body 310 may be clear or semi-opaque to allow a practitioner to quickly recognize if the solution containment portions 311a and / or 311b is properly punctured and / or fractured and / or to view how much solution is left in the applicator body 310. In some cases, the applicator body 310 may include measurement markings to indicate to a practitioner how much solution has been dispensed.

[0084] Figure 4 shows another example of a system and apparatus according to aspects of the disclosure. The device 400 described below may share any one or more features with or may be analogous with the preparation device 100 in Figure 1, the preparation device 200 in Figure 2, the preparation device 300 in Figure 3 and / or the preparation device 500 in Figure 5. As described in further detail below, the preparation device 400 shown in Figure 4 may include a spring or other biasing member 480 for activating or otherwise puncturing or fracturing the solution containment portion 411 and / or for applying pressure to the solution within the applicator body 410 (and thus dispensing solution through sponge 435).

[0085] The preparation apparatus 400 of Figure 4 may include an applicator or sponge 335 (hereinafter interchangeably referred to as an absorbent applicator). The sponge may for example be formed of any one or combination of the materials described above with respect to Figures 1-3. As shown in the example in Figure 4, the sponge 435 may be connected to or may otherwise be fastened to an applicator body. The applicator body 410, may for example include applicator body walls 408. The applicator body walls 408 may be configured to contain a solution and / or may be configured to have a plunger advanced therein as explained in further detail below. For example, the applicator body wall 408 may be substantially a hollow cylinder in shape with a cavity therein and with a sponge interface wall 407 at a distal end thereof. The sponge interface wall may have one or more passages (e.g., indicated by arrows 402) at a distal end 409a thereof that provide a flow path or fluid communication with the inside portion of the applicator body that may function as channels for a solution contained within the applicator body 410 to saturate, impregnate, infuse, and / or wet the sponge 435 to allow a practitioner to apply the solution to a patient.

[0086] At a proximal end 409b of the preparation apparatus 400, the applicator body 340 may have a plunger interface portion or handle 420 that passes through a wall or cap at the proximal end 409b of the applicator body 410. The applicator body applicator body 410 may be configured to have a plunger 422 slideably disposed therein that is directly or indirectly mechanically connected to the handle 420 so that when pressure or force (e.g., a rotation force RR and or pressing force PPPP) is applied to the handle 420, the plunger 422 moves (and transfers the force) applied at the handle 420. In one example, the applicator body 410 may contain therein a biasing member or spring 480 that is configured to apply a force in direction PPPP. The biasing member or spring 480 may for example be provided in a compressed or semi-compressed state and a release mechanism may contain or otherwise provide a counterforce to prevent the biasing member of spring 480 from causing the puncturing and / or breaking of the solution containment portion 411 until the handle 420 is rotated in direction RR. For example, the release mechanism may include a first retaining feature as one or more protrusion(s) 481 that protrudes from a portion of the inner wall of the applicator body walls 408. The protrusion(s) 481 may be configured to fit within or otherwise engage with one or more second retaining feature(s) 482 as a groove connected to or as a portion of the plunger 422. Thus, when the release mechanism is in afirst state or retaining state, the second retaining feature(s) 482 may be captively engaged with the protrusion(s) 481, which prevents the plunger 422 from moving in direction PPPP and provide a counter force to the force provided by compressing biasing member 480. When the handle 420 is rotated (e.g., in direction RR, the second retaining feature 482 rotates out of the protrusion 481, which then allows the plunger 422 to freely move or more freely move in direction PPPP. Thus, once the handle 420 is rotated the counterforce provided by the release mechanism is released causing the biasing member 480 to move the plunger 422 in direction PPPP, which then causes the plunger 422 to apply a pressure to the solution containment portion 411, which may cause the solution containment portion 411 to fracture or otherwise puncture or tear as described below and / or also provides a pressure to the solution within the solution containment portion 411 to cause the solution to saturate, impregnate, infuse and / or wet the sponge 435. This example implementation may be advantageous because once a rotation force or release force is applied by a practitioner, the practitioner may no longer need to apply pressure to the handle 420. In some examples, the practitioner may still be able to apply pressure to the handle 420 if for example more solution is needed than what is supplied by the pressure of the spring 480 alone.

[0087] The preparation apparatus 400 may further include or contain within the applicator body 410 a solution containment portion 411. The solution containment portion 411 may for example be a separately sealed ampule, frangible member, or blister pack within the applicator body 410. The solution containment portion 411 may be formed of a unitary piece of material containing a solution (examples of solutions described in further detail below). Examples of suitable materials from which the solution containment portion 411 may be formed include but are not limited to the examples provided above with respect to Figures 1-3. As noted above, in some examples, the solution containment portion 411 may be partially formed of a flexible or semi-flexible material with a foil or aluminum foil portion that is configured to be torn or punctured open when pressure is applied to the solution containment portion 411 and / or when punctured by a structure configured to puncture the foil portion. Further, the solution containment portion 411 may be formed of a glass or composites thereof. In some examples, the solution may be sealed within a portion of the applicator body 410 via a polymeric film or aluminum foil or other foil or similar sealing system.

[0088] In some examples, the solution containment portion 411 may be stored or otherwise contained within the applicator body 410 between the plunger 422 and the sponge interface wall 407. In some examples (explained in further detail below), the solution containment portion 411 may be between the plunger 422 and one or more puncturing members 413. In one example, the solution containment portion 411 may be connected to or otherwise configured to be in contact with and thus move linearly inside the applicator body 410 with the plunger 422.

[0089] The solution contained within the solution containment portion 411 may be any one or combination of the solutions described above with respect to Figures 1-3 and may further include a dye or colorant as described above.

[0090] The solution containment portion 411 may be configured to puncture, rupture, or break when force is applied to the solution containment portion 411 via the plunger 422 when a user applies a force to the handle 420. For example, the solution containment portion 411 may have weakened portion or a portion that is otherwise intended to burst or open when a predetermined pressure or pressure range is applied thereto. The preparation apparatus 400 may further include within the applicator body 410 one or more puncturing members 413. The one or more puncturing members 413 may be configured to puncture or otherwise tear open and / or break open the solution containment portion 411 when the solution containment portion 411 is pressed against the one or more puncturing members 413. Thus, once the solution containment portion 411 is punctured and / or fractured the solution contained therein can pass through passages 402 and wet or soak into / saturate the sponge 430. Once the solution containment portion 411 is broken, the spring 480 can further advance the plunger 422 in direction PPPP and apply pressure to the solution within the applicator body 410 to pressurize the solution and forcing solution to soak into the sponge 435. Thus, even if the sponge 435 and / or the area that the practitioner wishes to apply the solution is higher than the solution in the applicator body 410, solution can still be dispensed to the sponge 435. As noted in the examples above, the solution containment portion 411 may include multiple separate solution containment portions containing multiple solutions that are configured to mix within the applicator body 410 once they are ruptured or punctured.

[0091] In some examples, the applicator body 410 may include a filter 401 and / or a oneway valve or diaphragm. The filter 401 may prevent any debris from the broken solutioncontainment portion 411 from clogging or passing through the passages 402 and / or may restrict flow through the passages 402 to limit the flow rate of fluid or otherwise prevent too much of the solution from being forced into the sponge 435. Further as noted above, a one-way valve may be implemented with or as an alternative to the filter to prevent any fluids from flowing from the sponge 435 back into the applicator body 410, which may prevent contamination of the solution within the applicator body 410. The filter may for example be comprised of one or more porous films(s) and / or microporous film(s).

[0092] The applicator body 410 may further include one or more piercing members 413 for piercing, breaking, or otherwise causing the solution within the solution containment portion 411 to release into the applicator body 410. The one or more puncturing members 413 may for example be pointed or spike shaped. In some examples, the one or more puncturing members 413 may be shaped as a blade. The one or more puncturing members 413 may be formed of any appropriate material of which non-limiting examples are described above with respect to Figures 1-3. As noted above, the one or more puncturing members 413 may correspond with or may be positioned to specifically contact a weakened or decreased strength portion of the solution containment portion 411. For example, the one or more puncturing members 413 may be positioned to contact (and puncture) an aluminum foil portion of the solution containment portion 411. The one or more puncturing members 413 may for example be mounted to the sponge interface wall 407 and / or the side walls of the applicator body 410. Further, as noted in the example of Figure 3, one or more puncturing members 413 may correspond with separate solution containment portions (e.g., 311a and / or 311b described above).

[0093] The applicator body 410 may be formed of any suitable material. Some non-limiting examples of materials are described above with respect to Figures 1-3. In some examples, the applicator body 410 may be clear or semi-opaque to allow a practitioner to quickly recognize if the solution containment portion 411 is properly punctured and / or fractured and / or to view how much solution is left in the applicator body 410. In some cases, the applicator body 410 may include measurement markings to indicate to a practitioner how much solution has been dispensed.

[0094] Figure 5 shows another example of a system and apparatus according to aspects of the disclosure. The device 500 described below may share any one or more features with or may be analogous with the preparation device 100 in Figure 1, the preparation device200 in Figure 2, the preparation device 300 in Figure 3 and / or the preparation device 400 in Figure 4. The preparation apparatus 500 may include an applicator or sponge 535 (hereinafter interchangeably referred to as an absorbent applicator). The sponge may for example be formed of any one or combination of the materials described above. As shown in the example in Figure 5, the sponge 535 may be connected to or may otherwise be fastened to an applicator body. The applicator body may include applicator body walls configured to contain a solution and / or may be configured to have a pivoting plunger or pressurizing portion 521 advanced therein (it is noted that throughout this disclosure, the terms pressurizing portion and plunger may be used interchangeably). For example, the applicator body walls may be substantially a hollow cylinder in shape with a cavity therein and a sponge interface wall 507 at a distal end thereof. The sponge interface wall may have one or more passages (e.g., indicated by arrows 502) at a distal end 507a thereof that provide a flow path or fluid communication with the inside portion of the applicator body that may function as channels for a solution contained within the applicator body 510 to saturate, impregnate, infuse, and / or wet the sponge 535 to allow a practitioner to apply the solution to a patient.

[0095] At a proximal end 509b of the preparation apparatus 500, the applicator body 110 may have a plunger interface portion or handle 520 and / or an applicator body handle 575. The applicator body 510 may be configured to have a plunger 522 pivotably mounted (e.g., via pivot portion 577) to the applicator body that is directly or indirectly mechanically connected to the handle 520 so that when pressure or force (e.g., in direction RRR) is applied to the handle 520, the plunger 522 moves (and transfers the force) applied at the handle 520 as force RR. It is noted that the pivot portion 577 mentioned above and shown in the example implementation of Figure 5 may for example be a mechanical pivot (i.e., with a shaft that is rotatably contained within one or more bushings) and / or may be a flexible material that is configured to elastically or plastically deform allowing the handle 520 to rotate about the pivot portion 577.

[0096] fhe preparation apparatus 500 may further include or contain within the applicator body 510 a solution containment portion 511. The solution containment portion 511 may for example be a separately sealed ampule, frangible member, or blister pack within the applicator body 510. The solution containment portion 511 may be formed of a unitary piece of material containing a solution (examples of solutions described in further detailbelow). Examples of suitable materials from which the solution containment portion 511 may be formed are provided as examples in the description of Figure 1 above).

[0097] In some examples, the solution containment portion 511 may be stored or otherwise contained within the applicator body 510 between the plunger 522 and the sponge interface wall 507. In some examples (explained in further detail below), the solution containment portion 511 may be between the plunger 522 and one or more puncturing members 513. In one example, the solution containment portion 511 may be connected to or otherwise configured to be in contact with and thus move inside the applicator body 510 with the plunger 522.

[0098] The solution contained within the solution containment portion 511 may be aseptic, meaning it is generally sterile, so as to be free from disease causing contaminants (e.g., bacteria, viruses, fungi, parasites, etc.). The aseptic condition may be achieved through manufacture within a controlled environment, where contaminants are controlled, as well as through sterilization of the applicator once manufactured (e.g., through exposure to ethylene oxide gas). The composition may also be an antiseptic composition, where an antiseptic agent is included therein, so as to allow its application to a treatment region to kill microbes, reducing the possibility of infection. Thus, the composition may be aseptic, and also antiseptic. The composition may include any one active or selected from the group comprised of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof. By way of example, the active included in the composition is not particularly limited, and may be chlorhexidine, or a chlorhexidine salt, such as chlorhexidine gluconate, octenidine salts and / or hypochlorite solutions, hypochlorous acid, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride. Other actives (e.g., povidone iodine (PVP-I), iodine, or other iodine complexes may also be used, as well as any other antimicrobial agents. An alcohol may also be included (e.g., methanol, ethanol, isopropyl alcohol, butyl alcohol, combinations thereof, etc.). The composition may be a liquid. In some embodiments, two or more liquid components may mix and / or a liquid may mix with solid, gel, or other liquid components to result in a flowable liquid composition. Further, as noted above, the solution containment portion 511 may have multiple chambers or may comprise multiple solution containment portion(s) that are configured to mix when the multiple solution containment portions are punctured, ruptured, or broken.

[0099] The composition may comprise a dye or colorant to provide a color (e.g., red, purple, green, etc.) to the composition so as to contrast against the skin or other treatment region to which the composition is to be applied and / or indicate coverage on a patient’s skin or other treatment area.

[0100] The solution containment portion 511 may be configured to puncture, rupture, or break when force is applied to the solution containment portion 511 via the plunger 522 when a user applies a force to the handle 520. For example, the solution containment portion 511 may have weakened portion or a portion that is otherwise intended to burst or open when a predetermined pressure or pressure range is applied thereto. The preparation apparatus 500 may further include within the applicator body 510 one or more puncturing members 513. The one or more puncturing members 513 may be configured to puncture or otherwise tear open and / or break open the solution containment portion 511 when the solution containment portion 511 is pressed against the one or more puncturing members 513. Thus, once the solution containment portion 511 is punctured and / or fractured the solution contained therein can pass through the one or more passages 502 and wet or soak into / saturate the sponge 535. Once the solution containment portion 511 is broken, a user can further advance the handle 520 and thus the plunger 522 in direction RRR and apply pressure to the solution within the applicator body 510 to pressurize the solution and forcing solution to soak into the sponge 535. Thus, even if the sponge 535 and / or the area that the practitioner wishes to apply the solution is higher than the solution in the applicator body 510, solution can still be dispensed through the openings or passages 502 to the sponge 535.

[0101] In some examples, the applicator body 510 may include a filter (e.g., not shown in Figure 5 but shown as filter 101 in Figure 1, 201 in Figure 2, 301 in Figure 3 and 401 in Figure 4) and / or a one-way valve or diaphragm. The filter may prevent any debris from the broken solution containment portion from clogging or passing through the openings and / or may restrict flow through the openings to limit the flow rate of fluid through the openings 502 or otherwise prevent too much of the solution from being forced through the openings 502 due to excessive force being applied to the handle 520 by a practitioner. Further as noted above, a one-way valve may be implemented with or as an alternative to the filter to prevent any fluids from flowing from the sponge 535 back into the applicator body 510, which may prevent contamination of the solution within the applicator body510. The filter may for example be comprised of one or more porous films(s) and / or microporous film(s).

[0102] The applicator body 510 may further include one or more piercing members 513 for piercing, breaking, or otherwise causing the solution within the solution containment portion 511 to release into the applicator body 510. The one or more puncturing members 513 may for example be pointed or spike shaped. In some examples, the one or more puncturing members 513 may be shaped as a blade. The one or more puncturing members 513 may be formed of any appropriate material which may include but is not limited to any one or combination of metals, plastics, and / or semi-rigid or rigid rubber, to name a few examples. As noted above, the one or more puncturing members 513 may correspond with or may be positioned to specifically contact a weakened or decreased strength portion of the solution containment portion 511. For example, the one or more puncturing members 513 may be positioned to contact (and puncture) an aluminum foil portion of the solution containment portion 511. The one or more puncturing members 513 may for example be mounted to the sponge interface wall 507 and / or the side walls 508 of the applicator body 510. Further, as noted in the example of Figure 3, one or more puncturing members 413 may correspond with separate solution containment portions (e.g., 311a and / or 311b described above).

[0103] The preparation apparatus 500 may further include one-way features that lock the plunger 522 as the practitioner squeezes the handle 520 and advances the plunger 522 during use. The one-way features may allow the plunger 522 to be advanced in direction RR and may lock or otherwise prevent the plunger 522 from moving in a direction opposite direction RR. The one-way features may progressively lock the plunger 522 thus ensuring that the plunger does not retract (i.e., move in a direction opposite direction RR) causing an unintentional pressure decrease of the solution within the applicator body 510. Further, the aforementioned one-way features may reduce strain on the practitioner by not requiring the practitioner to apply constant squeezing pressure to the handle 520 to dispense the solution. Figure 5 shows one non-limiting example of a one-way features 512, which may for example be a groove or protrusion on an inside wall surface of the applicator body 510 that is configured to engage with a corresponding groove or protrusion 523 on the plunger 522. In one example, the groove and / or protrusion may be barb-shaped and / or include a ramp on a first side and a step on the second side allow the plunger 522 to be easilyadvanced in direction RR (i.e., via the ramp) while not allowing the plunger 522 to easily retract in a direction opposite direction RR (i.e., one engaged with the step portion).

[0104] The applicator body 510 may be formed of any suitable material. Some non-limiting examples include any one or combination of polyethylene terephthalate (PET or PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), polypropylene (PP) and / or even glass or ceramics. In some examples the applicator body 510 may be clear or semiopaque to allow a practitioner to quickly recognize if the solution containment portion 511 is properly punctured and / or fractured and / or to view how much solution is left in the applicator body 510. In some cases, the applicator body 510 may include measurement markings to indicate to a practitioner how much solution has been dispensed.

[0105] It is noted that while several examples are provided above, one of ordinary skill in the art would understand that many alternative configurations are contemplated and would become apparent with the benefit of this disclosure. For example, the examples described above could be applied to multi-step preparation. For example, any one or combination of the apparatuses or aspects described above could be used to provide two or more solutions. For example, a first apparatus could be used to provide a PVP-I solution, and a second apparatus could be used to provide a rinse such as a saline solution. In some examples the first and second apparatus could be connected or otherwise mechanically held together. In another aspect, the first and second apparatus could be packaged together with application indicators or instructions.

[0106] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described herein that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited inthe claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

Claims

CLAIMSWhat is claimed is:

1. An apparatus for applying a solution to a patient, the apparatus comprising: an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution containment portion is configured to break or rupture within the internal cavity; and a handle, wherein a force applied by a user to the handle causes the solution containment portion to break or rupture within the internal cavity and wherein the solution is dispensed to the treatment sponge via a pressure provided by the plunger.

2. The apparatus of claim 1, wherein the apparatus is configured to transfer the force applied by the user to the handle to break or rupture of the solution containment portion and additional force applied by the user dispenses the solution to wet the treatment sponge with the solution.

3. The apparatus of claim 2, wherein the force applied by the user is a squeezing or pressing force applied to the handle.

4. The apparatus of claim 1, wherein a biasing force is provided to the plunger via biasing member, and wherein the biasing force applied to the plunger causes a break or rupture of the solution containment portion and dispenses the solution to wet the treatment sponge with the solution.

5. The apparatus of claim 4, wherein the apparatus further comprises a release mechanism configured to release the plunger from a locked state, wherein the force applied by the user causes the release mechanism to release the plunger.

6. The apparatus of claim 5, wherein the handle is configured to rotate and the force applied by the user is a rotational force.

7. The apparatus of claim 1, wherein the plunger is connected to the handle and the plunger is configured to move linearly within the applicator body.

8. The apparatus of claim 1, further comprising a filter, wherein the filter is to filter the solution before it is dispensed to the treatment sponge.

9. The apparatus of claim 1, wherein the solution containment portion comprises a first solution containment portion containing a first solution and a second solution containment portion comprising a second solution.

10. The apparatus of claim 1, further comprising a puncturing member for puncturing or breaking the solution containment portion.

11. The apparatus of claim 1, wherein the treatment sponge is connected to the applicator body via an elongated wand.

12. The apparatus of claim 1, wherein the treatment sponge is connected to a distal end of the applicator body.

13. The apparatus of claim 1 further comprising one or more one-way features, wherein the one-way features are configured to allow the plunger to move in a first direction to cause thesolution to be dispensed to the treatment sponge and prevent the plunger from moving in a second direction different from the first direction.

14. The apparatus of claim 13, wherein the second direction is opposite the first direction.

15. An apparatus for applying a solution to a patient, the apparatus comprising: an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution containment portion is configured to break or rupture within the internal cavity: and a handle that is configured to pivot or bend with respect to the applicator body wherein a force applied by a user to the handle causes the solution containment portion to break or rupture within the internal cavity and wherein the solution is dispensed to the treatment sponge via a pressure provided by the plunger.

16. The apparatus of claim 15, wherein the plunger is formed as a unitary structure with the handle.

17. The apparatus of claim 15, further comprising a puncturing member configured to puncture or break an outer casing of the solution containment portion to release the solution contained therein into the internal cavity of the applicator body.

18. A method for applying a solution to a patient, the method comprising: providing a treatment device comprising:an applicator body with a treatment sponge at or near a distal end of the applicator body; wherein the treatment sponge is configured to be in fluid communication with an internal cavity of the applicator body; a plunger configured to receive a force from a user; a solution containment portion containing a solution and disposed within the internal cavity, wherein the solution containment portion is configured to break or rupture within the internal cavity; a handle; applying a force to the handle to break or rupture the solution containment portion within the internal cavity; dispensing the solution to the treatment sponge via a dispensing force to wet the treatment sponge with the solution; and applying the solution to the patient via the treatment sponge.

19. The method of claim 18, further comprising applying additional force to the handle to provide the dispensing force.

20. The method of claim 18, further comprising releasing a biasing member by applying the force to the handle.

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