Sterile package opening system and methods

Abstract

A system and method to open an antiseptic package includes a bacteria-proof packaging container having a first portion and a second portion that form an interior compartment. A medical implement is positioned within the interior compartment. The packaging container has at least one pocket to receive an end of a tool. The tool is manipulable to separate the first portion from the second portion. A portion of packaging container is removable from the antiseptic wipe to expose the medical implement while an unexposed end of the medical implement is graspable by a user through the packaging container.

Description

[0001]STERILE PACKAGE OPENING SYSTEM AND METHODS This present application is a PCT Internationainlg fil based on U.S. ApplicationSerial No. 18 / 750,371 filed June 21, 2024, whic ah c isontinuation-in-part of U.S.Application Serial No. 17 / 070,770 filed October 1240,20, which itself is a continuation of U.S. Patent Application Serial No. 15 / 957,744 fi Alepdril 19, 2018, now US Patent 10,881,754, granted January 5, 2021, which claiemnsef bit of U.S. Provisional Application Serial No. 62 / 487,324 filed April 19, 2017, title “Ddisposable Antiseptic Wipe Apparatus,” the entire disclosures of which are incorporaterdei hne by reference. The present disclosure is generally related tose apnti c packaging and moreparticularly is related to a system and methoda toin mtain sterility of a medical instrument in an antiseptic package while opening the package. Sterile medical implements are conventionallye sdto irn sterile packaging. For example, antiseptic wipes may be stored in a se foaille pdacket. Other sterile packaging may be similar to “peel pouches.” The peel pouches fo arrmeed from two portions of packaging that are typically adhesively attached along thgee esd to form an interior compartment to hold sterile medical implements. To access a maeld imicplement inside one of these sterile packages, a user is required to tear a portiohne o pf a tckage or grasp the edges of the package and pull portions of the package aparetp toar sate them. FIGS. 1-3 are illustrations of antiseptic wipes in 10 accordance with the prior art. Specifically, FIG. 1 illustrates a conventionalis aenpttic wipe 10 showing the fabric material 12 within the packaging 14 and FIG. 2 illustrathees a tntiseptic wipe 10 in a state where the packaging 14 has been opened to allow contacte to an thtiseptic-infused fabric material 12. FIG. 3 depicts the antiseptic-infused fabric matle 1ri2 after removal from the packaging 14. Commonly, the antiseptic-infused fabric material is 12 a single sheet of material which is folded into layers prior to being placed within t phaeckaging, which can then be unfolded after removal from the packaging 14, as shownG in. F 3I. When antiseptic wipes are used, the fabric material is removed from the packag oinpgt,ionally unfolded, and then rubbed around the injection area of the patient or the po IVrt within the patient to clean the selected area with the antiseptic material infused in thberi fca material. The contact between theantiseptic-infused fabric material 12 and the stel dec area on the patient is generallysuccessful in reducing the possibility of infectio rn sepsis during injection or through the IV port. In another example, an antiseptic wipe infusedh w anit antiseptic material may beinside a foil-lined packet. When antiseptic wip aeres used, the fabric material is typicallyremoved from the packaging, optionally unfoldedd, a thnen rubbed around the injection areaof the patient or the IV port within the patient c tloean the selected area with the antiseptic material infused in the fabric material. The contt baectween the antiseptic-infused fabric material and the selected area on the patientn iesr gaelly successful in reducing the possibility of infection or sepsis during injection r through the IV port. While the antiseptic material rarely causes iriroitnat to the patient’s skin, due to the infrequent use of the antiseptic wipe on the pat’tsie snkin, the antiseptic material can cause significant irritations to the fingers of the nu,rs deoctor, or other medical professional using the antiseptic wipe numerous times a day. In f iat c ist, not uncommon for a medical professional to use an antiseptic wipe 30-50 ti dmaeilsy. With this repeated use, the fingers and thumb of the user are continually and repeyate xdplosed to the antiseptic material, which leads to their fingers and thumb becominge, s hoarving cracked, dry skin whichbleeds, and eventually leads to a decreasing o ffin tghe rprint ridges on their skin. The effecton the user’s fingers is painful and it leads toga ntieve aesthetic issues on the user’s fingers. Some users have attempted to solve this proble wme bayring disposable medical gloves (latex or otherwise) when they need to use ane apnttiics wipe, but using 30-50 gloves eachday is wasteful, inefficient, and expensive. A sdta rnd disposable latex glove costs a medicalfacility approximately $0.06 each. Over a one-y peearriod, a medical professional who uses 50 gloves a day will cost the medical facility aopxpirmately $750. There are also significantnegative environmental consequences of using soy m noan -biodegradable gloves.FIGS. 4-5 are illustrations of peel pouch 20 ino arcdcance with the prior art. Specifically, FIG. 4 illustrates a conventionall p peoeuch 20 showing a first portion 22 and asecond portion 24 of the packaging and a medicpalle im ent 26 within an internal chamber28 created between the two portions of the packga 2g0in. FIG. 5 illustrates a peel pouch 20 partially opened by a medical practitioner by grinagsp a first portion 22 in one hand, a second portion 24 in another hand, and separahtieng fir tst portion 22 from the second portion 24 along a separation structure 30 to eexp thoes medical implement 26. The medical implement 26 may be any type of implement containe sdterile packaging, such as a swab, a wipe, a syringe, or other surgical instrument. The use of a conventional antiseptic peel pouc ihs 2 a0lso not without shortcomings. In a busy surgical environment, a medical pracntietiro or medical professional may have only one hand available to grasp one of the ed agneds, so he or she may have difficultyholding and opening the package. A user may evsen th ueir teeth to grasp an edge toseparate the packaging and access the medicalm imenptle inside. In this type of situation, a sterile implement may come into contact with a nsotenr-ile environment upon opening its package and before it is used on a patient. Further, a medical professional opening the pack maagye need to retain a grasp onthe implement inside the sterile packaging to prrep ita for use on the patient whilemaintaining its sterility. For example, medicarlin syges typically come inside sterile packaging. The syringe within the packaging comtmpeanrt is accessed when a medical professional separates one portion of the packraogme a fnother. Once the syringe is accessible, the medical professional must furthaenrip mulate the syringe by pulling or pushing and twisting the syringe to remove the c coavpering a needle or to attach a needle to the syringe. Firmly holding onto the medical immpleent while it remains partially in the sterile packaging maintains the sterility of thepl iemment during this manipulation, but holding the implement inside the packaging mayi bffeicu dlt to accomplish after separating the packaging portions to access the implement. Thus, a heretofore unaddressed need exists ind thuest iry to address the aforementioned deficiencies and inadequacies. Embodiments of the present disclosure providet aem sys and method for opening a sterile package. Briefly described, in architec,tu ornee embodiment of the system, among others, can be implemented as follows. A system for opening a package while maintaininegril sitty of a medical implement within a bacteria-proof packaging container has in atenrior compartment. A first portion of the bacteria-proof packaging container is sepalreat farobm a second portion of the bacteria-proof packaging container. A medical implemento is i ptioned within the interiorcompartment. At least one pocket is positionedxi pmroate to a top edge of the bacteria- proof packaging container. A tool is configured o foprening the bacteria-proof packaging container. The tool has at least one end size fidt w toithin the at least one pocket. A first end of the tool is mounted substantially perpenldairc tuo a second end of the tool, and the tool is controllable to separate the first port firoonm the second portion. Further, the bacteria-proof packaging container has a vertiecpaal r sation structure positioned between the first portion and the second portion, and axialolyn ag the bacteria-proof packaging container. Pulling the at least one pocket by to thoel causes the bacteria-proof packagingcontainer to open along the vertical separatiounc stutr e to separate the first portion from thesecond portion. The tool has a first side andc aon sde side. The first and second sides are positionable on opposite sides of the medical impelnet. A member joins the first side to the second side. First and second pockets arhee fru prtositioned on the first and second portions, respectively. Each of the first and snedc poockets are positioned proximate to the top edge of the bacteria-proof packaging contain Tehre. first and second pockets are configured to receive the first and second side tshe of tool, respectively. When the first side and the second side are positioned in the first s aencdond pockets, respectively, the first sideand second side are moveable away from each oth ser p tarate the first portion from thesecond portion. The tool is sized to separatert aio pno of the bacteria-proof packagingcontainer to expose the medical implement in thte ri ionr compartment.The present disclosure can also be viewed as a w tiothol a member that is a housing with a first contact structure on the housing. T fihrset contact structure is sized to accommodate a first finger. An insert is slidea pbolysitionable relative to the housing and operably connected to the first side and the sec soidned. The insert has a second contact structure sized to accommodate a second finge br.ias A mechanism is positioned between the insert and the housing. The bias mechanissmes bi tahe first contact structure away from the second contact structure. Moving the insewrta trods the housing causes the first side and the second side to move away from each other. The present disclosure can also be viewed as pinrogv aid packaging container for maintaining sterility of a medical implement with tihne package during unsealing. A first portion of the bacteria-proof packaging containse sre ialed to and separatable from a second portion of the bacteria-proof packaging contain Tehr.e seal between the first portion andsecond portion creates an interior compartmente be ntw the first portion and the secondportion. A medical implement is positioned with thine interior compartment. At least one pocket is positioned proximate to a top edge of b tahceteria-proof packaging container. The at least one pocket is formed from an overfoldecdtio sne connected along lateral edges thereof to the first portion. The at least onek peotc is located interior of the overfoldedsection and the lateral edges. Further, the ast o lenae pocket has first and second pocketspositioned on the first and second portions, retsivpeelcy. Each of the first and second pockets are positioned proximate to the top edg tehe o bf acteria-proof packaging container.The first and second pockets are configured toiv rec tehe first and second sides of the tool,respectively. When the first side and the secoidned a sre positioned in the first and secondpockets, respectively, the first side and secodned a srie moveable away from each other toseparate the first portion from the second portion. The present disclosure can also be viewed as pinrogv midethods of opening a package while maintaining sterility of a medicalp ilmement within the package. In this regard, one method, among others, can be broamdlym saurized by the following steps: positioning a tool over the medical implement wnith ain interior compartment in a bacteria-resistant packaging container; inserting a firsdt o efn the tool into a pocket proximate to atop edge of the bacteria-resistant packaging cnoenrt;a ai nd actuating the tool to move to a second end of the tool mounted substantially pedripceunlarly to the first end of the tool toward the item, thereby separating a first por otiof n the bacteria-resistant packaging container from a second portion of the bacteriais-traenst packaging container. Other systems, methods, features, and advantag thees p orfesent disclosure will be orbecome apparent to one with skill in the art upxoanm eination of the following drawings and detailed description. It is intended that all su acdhditional systems, methods, features, and advantages be included within this description w, bitehin the scope of the present disclosure, and be protected by the accompanying claims. Many aspects of the disclosure can be better utnodoedrs with reference to the following drawings. The components in the drawin agres not necessarily to scale, emphasis instead being placed upon clearly illustrating p thrienciples of the present disclosure.Moreover, in the drawings, like reference nume draels ignate corresponding partsthroughout the several views. FIGS. 1-3 are illustrations of antiseptic wipes ac incordance with the prior art. FIGS. 4-5 are illustrations of peel pouches in ardcacnoce with the prior art. FIGS. 6-8 are illustrations of a bacteria-proofk paagcing container, in accordance with embodiments of the present disclosure. FIGS. 9A-9C are illustrations of a system havin tgoo al for opening a bacteria-proofpackaging container, in accordance with embodim oefn tthse present disclosure. FIGS. 10A-10B are illustrations of a bacteria-pro poafckaging container, in accordance with embodiments of the present disrcelo.su FIG. 11 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIGS. 12A and 12B are illustrations of a bacterrioao-pf packaging container, in accordance with embodiments of the present disrcelo.su FIG. 13 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIG. 14 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIG. 15 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIG. 16 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIG. 17 is an illustration of a bacteria-proof pagcikng container and a system having a tool interacting with the bacteria-prooafck paging container, in accordance with embodiments of the present disclosure. FIG. 18 is an illustration of a bacteria-proof pagcikng container and a tool interacting with the bacteria-proof packaging coinnetar, in accordance with embodiments of the present disclosure. FIG. 19 is an illustration of a bacteria-proof pagcikng container and a tool interacting with the bacteria-proof packaging coinnetar in accordance with embodiments of the present disclosure. FIG. 20 is an illustration of a bacteria-proof pagcikng container, in accordance with embodiments of the present disclosure. FIGS. 21-22 are illustrations of a tool, in acconrcdea with embodiments of the present disclosure. FIG. 23 is an illustration of a bacteria-proof pagcikng container and a tool interacting with the bacteria-proof packaging coinnetar, in accordance with embodiments of the present disclosure. FIGS. 24A-24C are illustrations of a tool, in acdcaonrce with embodiments of the present disclosure. FIG. 25 is an illustration of a tool interactingth wi a bacteria-proof packaging container, in accordance with embodiments of theese pnrt disclosure. FIGS. 26A-26B are illustrations of a tool, in acdcaonrce with embodiments of the present disclosure. FIG. 27 is an illustration of a tool interactingth wi a bacteria-proof packaging container, in accordance with embodiments of theese pnrt disclosure. FIGS. 28A-28C are illustrations of a tool interancgti with a bacteria-proof packaging container, in accordance with embodiments of theese pnrt disclosure. FIGS. 29-30 are illustrations of a tool, in acconrcdea with embodiments of the present disclosure. FIGS. 31A-31B are illustrations of a tool interancgti with a bacteria-proof packaging container, in accordance with embodiments of theese pnrt disclosure. FIG. 32 is an illustration of a tool interactingth wi a bacteria-proof packaging container, in accordance with embodiments of theese pnrt disclosure. FIG. 33 is an illustration of a medical professilo unsaing a tool to open a bacteria- proof packaging container and use a medical impnletm one a patient, in accordance with embodiments of the present disclosure. FIG. 34 is a diagrammatical flowchart illustrati ang method of opening a sterile package using a tool, in accordance with embodism oefn tthe present disclosure. FIG. 6 is a perspective illustration of a bacteprriao-of packaging container 40, in accordance with embodiments of the present disrcelo.s FuIG. 7 is an end view illustration of the bacteria-proof packaging container of FIG.n 6 a,c icordance with this example of the present disclosure. With reference to FIGS. 67 a,n tdhe bacteria-proof packaging container 40, which may be referred to as “packaging 40”u indcels a bacteria-proof packaging container having a first portion 42 and a seconrdtio pno 50. The first portion 42 of the bacteria-proof packaging container may be seale thde to second portion 50 of the bacteria- proof packaging container. The seal, which may fo brmeed adhesively between the first portion 42 and second portion 50, creates ano inrte croimpartment 74 between the first portion and the second portion. The first port mioany be separatable from the second portion along a vertical separation structure A 44 m. edical implement 76 may be positioned within the interior compartment 74. The medicall iemmpent 76 is exemplary, in that the medical implement may be any type of sterile meld imicaplement, including for example a swab, a wipe, a syringe, or a surgical instrume Onnt.e skilled in the art would recognize that more than one medical implement may be containethdin w ai single interior compartment 74. The first portion 42 may have a first flap 4n6d a the second portion may have a second flap 48. The first flap and the second flap may g braespable by a medical professional inpreparation to unseal or separate the first por ftrio mn the second portion along the verticalseparation structure. The first portion 42 maye hav first pocket 52 positioned proximate to a top edge 78 of the packaging 40. FIG. 8 is another perspective illustration of pagciknag 40. In FIG. 8, the first portion 42 may be sealed to a second portion along aa vel srteicparation structure 44. The seal joining the first portion 42 to a second portion m 50ay have a top seam 80 forming a top of an interior compartment containing medical implemt 7e6n. In this example, the first portion42 may be overfolded to create first flap 46. Thve r ofolded portion may be connectedproximate to lateral edges of first portion 42 foinrmg a lateral seam 82 proximate to the lateral edge of the overfolded portion. Lateralm se 82 may run the entire length of the overfolded portion. In this example, part of theer ofvolded portion is not sealed proximate to the medical implement 76. The overfolded porti soena,led edges, and open edge form first pocket 52. A second portion 50 may be connecte thde to first portion 42 and has an overfolded structure to create second flap 48 aencdon sd pocket 54. FIGS. 9A-9C are illustrations of a tool 90 interinagct with a bacteria-proof packaging container consistent with packaging 40. The to0o hl a 9s a first side 92 and a second side 94 mechanically connected by a member 102 which isitio ponsed at least partially between thefirst side 92 and the second side 94. The firdset s 9i2 of the tool has a first end of the firstside 96 and a second end of the first side 98.ila Srilmy, the second side 94 of the tool has a first end of the second side 106 and a secondf e tnhde o second side 108. The first ends may be shaped to insert into the pockets of packag0in.g T 4he first end of the first side 96 mayinteract with the first pocket 52 of the first pior nt 42. The first end of the second side 106may interact with the second pocket 54 of the sdec poonrtion 50. First side 92 and second side 94 may be made of metal, plastic, wood, caarrddb,o or any material or combination of materials with sufficient rigidity to separate t fir psortion 42 from second portion 50. The member 102 that connects the first side 92 toe thceon sd side 94 may be flexible, rigid, or a combination thereof. The member 102 may conne tchte to first side 92 and the second side 94 in any number of ways, including with hinges e olarstomeric connections, combinations thereof, or any other mechanical connections.n Fsotra ince, it may be possible to form member 102 from a plastic material which has ang liv hiinge formed therein, such thatportions of the member 102 actuate about the liv hiing e when the first side 92 and secondside 94 are biased towards or away from each o Mthe mr.ber 102 may also disconnect thefirst side 92 from the second side 94 upon actuna otifo the tool 90. Disconnection of member 102 upon actuation may offer an advantag thea itn it may make the tool 90 single- use. Disconnection of member 102 may also offenru mfaacturing advantages in the design of the connection of member 102 to the first sid2e an 9d the second side 94. The connection of the first side 92 to the second side 94 by merm 1b0e2 may offer an advantage to a medical professional who may open sterile or baiac-tperroof packaging with only one hand. The member 102 may enable control of relative pioonssit of the first side 92 and the second side 94 to enable the first side and the seconed t soid be inserted within the first pocket 52 and the second pocket 54 using only one hand.he Fru,r tthe member 102 may enable control of the positions of the first side 92 and the sedc soinde 94 during the opening of packaging40. Thus, the member 102 may be configured tol en aa mb edical professional to controlthe first side 92 and the second side 94 of too tlo 9 s0eparate the first portion 42 from the second portion 50 of the bacteria-proof packagionngta ciner 40, for example simultaneously, or by use of only one hand. In operation, tool 90 may be positioned on eithideer s of a medical implement 76 within a bacteria-proof packaging container. Tihrset f end of the first side 96 may be inserted in the first pocket 52 and the first enf d th oe second side 106 may be inserted in the second pocket 54. FIG. 9A shows the tool 90 inesde wrtith the packaging closed or sealed. To open the bacteria-proof packaging container, se thceond end of the first side 98 and the second end of the second side 108 may be movedrd to ewaach other, pulling on the first pocket 52 and the second pocket 54, thereby seinpgar tahte first portion 42 from the second portion 50 along vertical separation structure 4 F4IG.. 9B shows the packaging after the tool was actuated to open the packaging 40 by separ tahtein fgirst portion 42 from the second portion 50. FIG. 9C shows the system after seipnagra thte first portion 42 from the second portion 50, where medical implement 76 may be eexdpo asnd manipulable by a medical professional. FIGS. 10A-10B are illustrations of the bacteria-opfr poackaging container 100 consistent with an example of the present inven.ti Ionn this example, the packaging container 100 has a hole 112 between top seamd 8 p0o acnket 54. Hole 112 may be sized to accommodate medical implement 76. A closed pacnkga cgointainer 100 with hole 112 is shown in FIG. 10A. In FIG. 10B, first portion 42a my be separated from second portion by peeling first pocket 52 away from second pocke tto 5 e4xpose medical implement 76 in the packaging. This design may be advantageous,t i,n a tfhtear the first portion of the bacteria- proof packaging container is separated from theon sdec portion of the bacteria-proof packaging container, hole 112 allows the separ paotertdions to lay flat so the medical professional may manipulate the medical impleme6n wt 7hile it is still in the packaging,allowing the medical implement 76 to remain in s thte rile packaging while the medicalprofessional prepares to use it on a patient. FIG. 11 is an illustration of a bacteria-proof pagcikng container 110, in accordance with another example of the present disclosureG.. F 1I1 shows a bacteria-proof packaging container after separation of a first portion 4o2m fr a second portion 50 along a verticalseparation structure 44. The separation may heaevne e bffected by moving first pocket 52away from second pocket 54. In FIG. 11 the med imicapl ement 76 is represented as asterile syringe with a cap protecting the needle th oef syringe. A hole 112 may be sized to accommodate the syringe, allowing the medical psrsoiofenal to firmly grasp the syringe and the syringe to remain in the sterile packaginge wh thile cap is removed from the needle. FIGS. 12A and 12B are illustrations of a packag 1in2g0 and a packaging 40, inaccordance with additional examples of the pre dsiesnctlosure. In FIG. 12A, a first portion 42 of the packaging 120 may be connected to as riegcidond portion 122. A medical implement 76 may be positioned within an interihoarm cber 74 formed between the first portion 42 and the second portion 122. A pocke mt 5a2y be formed from an overfolded section of the first portion positioned above toepam s 80. Thus, the packaging 120 may be opened along vertical separation structure 44 bpyar saeting the first portion 42 from the rigid second portion 122 by pulling pocket 52. In theam exple shown in FIG. 12B, a first portion 42 of the packaging 40 may be connected to secorntidon p 50, which may be positioned proximate to a rigid surface 124. A medical impelenmt 76 may be positioned within an interior chamber 74 formed between the first ponrt 4io2 and the second portion 122. A pocket 52 may be formed from an overfolded sec otifo tnhe first portion positioned above top seam 80. A user may apply pressure to at o lenaest of the medical implement 76 or the packaging 40 to create pressure that allows po 5c2ke tot be pulled away from the second portion 50. Second portion 50 may be flexibleig oird r or any combination thereof. Thus, the packaging 120 may be opened along verticalra steiopna structure 44 by separating the first portion 42 from the second portion 50 posniteiod proximate to the rigid surface 124 by pulling pocket 52 away from the rigid surface 124. FIG. 13 is an illustration of a packaging 130,c inco ardance with another example of the present disclosure. In packaging 130, asc inka pgaing 40, first portion 42 may be connected to second portion 50 along vertical saetipoanr structure 44. However, in packaging 130 the overfolded portion of the firosrtti pon 42 may be folded toward the second portion 50, forming a pocket 52 between fir tshte portion and the second portion instead of on the outside of the first portion.m Silairly, second pocket 54 is also formed between the first portion 42 and the second por 5ti0o.n In this example, access to the pocket may be through hole 132 formed in first portion b 4e2tween top seam 80 and top edge 78.Positioning hole 132 between top seam 80 and togpe e 7d8 may be advantageous to retainsterility of a medical implement positioned with thine bacteria-proof packaging container. A similarly positioned hole in the second portion m 5a0y allow access to pocket 54. This design may have manufacturing advantages, ind thhaets aive applied to the packaging to form first pocket 52 and second pocket 54 may n toee bde only on one side of the packaging. Overfolding ends that have adhesive applied on onely side to form a pocket may be lessexpensive to manufacture than applying adhesiv me o rne than one side of packaging toform a pocket. FIG. 14 is an illustration of a packaging 140,c inco ardance with an example of the present disclosure. In packaging 140, as in painckga 4g0, pocket 52 may be formed from an overfolded part of first portion 42. However, ianc pkaging 140 the overfolded portion of the first portion 42 may be sealed proximate to topm se 8a0. Access to pocket 52 may be through hole 132 in the overfolded part of port 4io2n. In reference to FIG. 15 and FIGS. 9A-9C, FIG. 1s5 a hna illustration of a packaging150, in accordance with yet another example of p trheesent disclosure. In packaging 150, as in packaging 40, first portion 42 is connectede toco snd portion 50. However, in packaging 150 the first end of the first side 96 of tool 9fr0om ( FIGS. 9A-9C) may be inserted through hole 132 in the first portion 42 positioned betwe toepn seam 80 and top edge 78. The first end of the second side 106 of tool 90 may be iendse trhtrough hole 152 in the second side of the second portion 50. The tool would interac otp toen packaging 150 by pulling on the interiors of the first portion 42 and the secondrti poon 50 instead of being inserted into andinteracting with pockets. This design of the intvioen may have manufacturing advantages,as not requiring an overfold may have comparativ f e wlyer steps in the manufacturingprocess, and therefore be less expensive to matunruefa tchan an overfolded design. FIG. 16 is an illustration of a packaging 160,c inco ardance with another example of the present disclosure. In packaging 160, asc inka pgaing 40, first portion 42 may be connected to second portion 50 forming interiorm cbhear 74. Medical implement 76 may be positioned within interior chamber 74. In packag 1in6g0 top seam 80 has dimensions of about 5 millimeters (mm). First pocket 52 may boesit pioned about 2 millimeters from second pocket 54. FIG. 17 is an illustration of a packaging 170,c inco ardance with another example of the present disclosure. In packaging 170, tool m 25a0y be inserted into a pocket formed bya piece 172 that may be connected proximate tora la etedges 174 of first portion 42. Tool250 may accommodate medical implement 76 positio wniethdin the packaging. Second end of first side 98 of tool 250 may be positioned aebo mvedical implement 76. The tool 250 may be controllable to move the second end of s fiirdset 98 of tool 250 toward the medical implement 76, exerting pressure on piece 172, aunllding p on first portion 42. Themovement of tool 250 may be a rocking motion, at rio nt , or any combination of motionsthat pulls the first portion 42. Piece 172 may m baede from the same material as first portion 42 or from any number of different matesri oalr combination of materials that may be connected to first portion 42. The first end fir osft side 96 (FIG. 18) of tool 250 may be connected to the second end of first side 98 b leya astt one corner 252 that may be rounded, smooth, or angular or any combination thereof.ou An rded or smooth corner 252 may be preferred to facilitate motion of the second end th oef first side 98. FIGS. 18 and 19 are illustrations of a packagin0g, 1 in8 accordance with an exampleof the present disclosure. In packaging 180, 2 to5o0l may be inserted into a pocket formedby a band 182. The band 182 may be made of the o sarm different material as the first portion 42. Band 182 may be a thinner versionie ocfe p 172. Band 182 may be connected on lateral edges 174 of first portion 42 or mayrc peie first portion 42 and may terminate or connect to itself between first portion 42 and snedc poortion 50. First end of first side 96 of tool 250 may be sized to be positioned within tahend b. When second end of first side 98 oftool 250 is moved toward the medical implement t 7o6o,l 250 exerts pressure on band 182,pulling on first portion 42 and opening the ster pilaeckage. In FIG. 18, the band 182 may be positioned between the top edge 78 and the top s8e0a,m centrally on first flap 46. In FIG. 19, the band 192 may be positioned proximate to ed togpe 78. The first end of first side 96 of tool 250 may extend proximate to or beyond tdogpe e 78. Extension of tool 250 beyond top edge 78 may offer advantages in that it maoyw a tlhl e medical practitioner flexibility to open less than all of the packaging 40. By extnegnd thie tool 250 beyond edge 78, less of first portion 42 will be separated from secondi poonrt 50, which may thereby expose less than all of the medical implement 76. The openig dne psroximate to top edge 78 may allow the medical practitioner to customize the portiof n pa ockaging opened. FIG. 20 is an illustration of a packaging 200,c inco ardance with yet another exampleof the present disclosure. In packaging 200, 2 to5o0l may be inserted into a pocket formedby a loop 202. The loop 202 may be made of thee s oarm different material as the first portion 42. Loop 202 may be connected centralolyxi pmrate to top edge 78 of first portion 42. Loop 202 may be sized to accommodate firdst o efn first side 96 of tool 250 (FIGS. 17- 19) or tool 210 (FIGS. 21-22). Packaging 180 and 200 may optimally interact wit oho al 210 with a hook 212 proximate to first end of first side 96 and diredc bteack toward the second end of first side 98 of a tool 210. FIGS. 21 and 22 are illustrastion f a tool 210, in accordance with examples of the present disclosure. FIG. 21 idse a p srofile view of tool 210 showing the first end of first side 96 directed back towardo snedc end of first side 98 forming the hook of first side 212. Second end of first side 98 may ad bdeitionally shaped to accommodate a medical implement within the packaging by formin pgo artion of second end of first side 98 such that when second end of first side 98 is mo tovwedard a medical implement, first shaped end 218 may fit around the medical imple,m aellnotwing the tool 210 to open thebacterial-proof packaging container to a largerre deg than a tool without first shaped end218. FIG. 22 is a perspective view of tool 210w sihnog an accommodation to fit around amedical implement. Tool 210 may be made of me ptlal s,tic, wood, cardboard, or anymaterial or combination of materials of suitablgeid ri ty that can supply sufficient pressure toopen packaging 180, 190, or 200. FIG. 23 is an illustration of a system 230, in arcdcaonce with examples of the present disclosure. In system 230, hook 212 of tool 21I0G (SF. 21-22) catches band 192 of packaging 190. When second end of first side 9 m8o ivsed toward medical implement 76, tool 210 exerts pressure on band 192, opening pgaincgka 190. FIGS. 24A-24C are illustrations of a tool 240,c inco ardance with additionalexamples of the present disclosure. Tool 240 h fairs t a end of first side 96 and a second endof first side 98 that are positioned angularlya toch e other. Second end of first side 98 may optimally have a first shaped end 218 that mayiz beed s to accommodate a medical implement 76 positioned within a bacteria-proofk paagcing container. FIG. 24A shows the tool 240, which when rotated may be the tool 24 F0I iGn. 24B. FIG. 24C shows the tool 240 in a position similar to FIG. 24B and illustersat how the first shaped end 218 may accommodate a medical implement 76 when the to pools isitioned with an opened bacteria- proof packaging container. FIG. 25 is an illustration of a tool 250, in accaonrdce with another example of the present disclosure. In FIG. 25, tool 250 may h aav fierst side 92 and a second side 94. First side 92 has a first end of first side 96 and an sdec eond of first side 98. Second side 94 has a second end of second side 108. The first siden 9d2 s aecond side 94 may be mechanically connected by member 102. The mechanical conne ocfti monember 102 to at least one of thefirst side and the second side may be moveablena tbol e motion of a first end and a secondend, for example, by a rocking motion. The firnsdt e of the first side 96 may be inserted into first pocket 52 of packaging 40. Packaging 40 a ha firsst portion 42 and a second portion 50. Tool 250 may be shaped to accommodate me idmicpalelment 76 positioned between first portion 42 and second portion 50. FIGS. 26A and 26B are an illustration of a tool, 2 i6n0 accordance with preferred examples of the present disclosure. In FIG. 26oAol, 2 t60 has a first side 92 and a second side 94. First side 92 has a first end of firdste s 9i6 and a second end of first side 98. Second end of first side 98 has a first shaped 2 e1n8d. Second side 94 has a first end of second side 106 and a second end of second sid.e S 1e0c8ond end of second side 108 mayfurther have a second shaped end 268. Membero 1n0n2e c ts first side 92 to second side 94at first connection 262 and second connection 2 In64 F.IG. 26A, tool 260 may be in its closed position, where first end of first side 9n6d a first end of second side 106 may be inserted into pockets of packaging. In FIG. 26hBe, t tool may be in its open position, where second end of first side 98 and second end of sde sciodne 108 may have been moved toward each other. This position of the second endso olf 2 t6o0 may move the first end of first side 96 and first end of second side 106 away from e oathcehr. This movement of first ends of the tool 260 away from each other while the firnsdts e are inserted into pockets may open the packaging. Member 102 may keep first sideo 9n2ne ccted to second side 94 at firstconnection 262 and second connection 264. Thee ccotinon s may be any connection thatallows the motion of the tool, for example elastorimc e connections or hinges. Member 102 may also disconnect first side 92 from second 9 s4ide when the tool is actuated. When second end of first side 98 is positioned clos see tcoond end of second side 108 in tool 260 open position, the first shaped end 218 and se schoanpded end 268 may be positioned around a medical implement. FIG. 27 is an illustration of a system 270, in arcdcaonce with another example of the present disclosure. In FIG. 27, first end of fi srisdte 96 of tool 260 may be inserted into pocket 52 formed from the first portion 42 of pagciknag 40. Member 102 connects the first side 92 of tool 260 to the second side 94 (FIG.) 2 o6fA tool 260 at first connection 262. The first end of the second side 106 (FIG. 26A) of t 2o6o0l may be inserted into pocket 54 formed from the second portion 50 of package 40e.di Mcal implement 76 may be positioned between first portion 42 and secondio pnor 5t0. Tool 260 may be positioned around medical implement 76. First shaped end m 2a1y8 accommodate medical implement 76 when tool 260 is moved into an open position ac btyuating the tool to move second end of first side 98 toward the second end of the sdec soidne 108 (FIG. 26B) to open packaging 40 by moving first pocket 52 away from second potc 5k4e using the inserted first ends of tool 260. FIGS. 28A-28C are illustrations of a tool 280,c inco ardance with examples of thepresent disclosure. FIG. 28A shows a perspectiievwe o vf a first side 92 of tool 280, whichhas a first end of first side 96, a second endirs otf s fide 98. The first end of first side 96 and second end of first side 98 may be positioned a atn agnle 282 to each other. Second end offirst side 98 may have a first shaped end 218.. F 2I8GB shows the top view of the first sideof tool 280 where the angle between the first efn fdirs ot side 96 and the second end of first side 98 is a right angle. The angle may be a c,u arv rieght angle, or any angle that allows the tool 280 to be actuated to open packaging 40. F28IGC. shows an end-on view of the tool280 with opened packaging 40. FIG. 28C showss at s fir de 92 of tool 280 connected to asecond side 94 by member 102. Member 102 conn toec fitrs t side 92 through firstconnection 262. Member 102 connects to second 9 s4id therough second connection 264. First side 92 may be positioned on top of firstti poonr 42 of packaging 40. First end of first side 96 may be positioned within first pocket 52 fir osft portion 42 of packaging 40. Second side 94 may be positioned below second portionf 5 p0ac okaging 40. Medical implement 76 may be between first portion 42 and second por 5ti0o.n First end of second side 106 may be positioned within second pocket 54 of second pnor 5ti0o. In a preferred configuration, first shaped end 218 and second shaped end 268 may aoccdoamtem medical implement 76 when tool 280 may be in the open position, which maoyw al flirst end of first side 96 and first end of second side 106 to move farther away from eathcehr o than if first shaped end 218 and second shaped end 268 do not accommodate medipclaelm iment 76. FIGS. 29 and 30 are illustrations of a tool 290 a,c incordance with additionalexamples of the present disclosure. Tool 290 h fairs t a side 92 and a second side 94. Firstside 92 has a first end of the first side 96 an sdec aond end of the first side 98. First side 92 is connected to housing 296 by first connection.2 H62ousing 296 is connected to second side 94 through second connection 264. Housing m 2a9y6 have a first contact structure. The first contact structure 292 may be sized to accomdamteo a first finger. Second side 94 has a first end of the second side 106 and a secondf e tnhde o second side 108. Housing 296 may have an insert 298 that may be slidably positioena rebllative to the housing 296. Insert 298 may be operably connected to the first side 92 th aend second side 94. Insert 298 may havea second contact structure 294 that may be siz aecdc to mmodate a second finger. Insert298 also may contain a bias mechanism 295 that b mea pyositioned between the insert 298 and the housing 296. The bias mechanism may beia fsirs tht contact structure 292 away from the second contact structure 294. Bias mechan9is5m m 2ay be a spring, elastomer, or any other structure that may bias the first contacutc stutrre 292 away from the second contact structure 294. Moving the insert 298 towards tohues hing 296 may cause the first end of the first side 96 and the first end of the second s 1i0d6e to move away from each other. FIG. 29 is a side view of tool 290. FIG. 30 is a top vi oefw tool 290 and shows first end of first side 96 inserted into pocket 52 of the first portion o 4f2 packaging 40. In FIG. 30, housing 296 may be cut away to show an example of an operaobnlnee cction 302 of the first side 92 to the insert 298. FIGS. 31A and 31B are illustrations of a system, 3 in10 accordance with examples of the present disclosure. In system 310, tool 29IG0. (F 29) interacts with packaging 40. FIG. 31A shows the tool 290 prepared to open the panckga 4g0i. FIG. 31B shows tool 290opening packaging 40. FIG. 31A shows a medicale imp ent 76 positioned withinpackaging 40. Packaging 40 may have a first pnor 4ti2o and a second portion 50 connectedby separation structure 44. First portion 42 m ha vye a pocket 52. Similarly, secondportion 50 may have a second pocket 54. First o efn thde first side 96 of tool 290 may be positioned within pocket 52. Second end of firidste s 98 of tool 290 may be positioned at an angle to first end of first side 96. First end s oefcond side 106 of tool 290 may be positioned inside pocket 54. Second end of second side 10y8 b mea positioned at an angle to first end of second side 106. When the tool 290 is actua fitresdt, end of first side 96 may move away from first end of second side 106 and second en fidrs otf side 98 may move toward second end of second side 108. First end of first side m 9a6y move away from first end of second side 106, pulling pocket 52 to open packaging S 40im.ilarly, first end of second side 106 may move away from first end of first side 96, pinugll pocket 54 to open packaging 40. FIG. 31B shows a partially opened packaging 40 wpoitchkets 52 and 54 separated from each other to expose medical implement 76. FIG. 32 is an illustration of a system 320, in arcdcaonce with an example of the present disclosure. In system 320, tool 260 mtaeyra inct with packaging 130. Medical implement 76 may be positioned between the firsrttio pno 42 and the second portion 50 (FIG. 13) of packaging 130. First end of the fi srisdte 96 of tool 260 may access pocket 52through hole 132. Member 102 may connect the s fir dset 92 (FIG. 26A) of tool 260 to thesecond side 94 (FIG. 26A) of tool 260. The firnsdt e of the second side 106 (FIG. 26A) oftool 260 may similarly access pocket 54 throughol ae h in the pocket. When the tool isactuated to move first shaped end 218 toward mle idmicpalement 76, the package may open and first shaped end 218 may position around mle idmicpalement 76. FIG. 33 is an illustration of a medical professilo unsaing a system 330 with tool 90 and packaging 40 in another example of the pre dsiescnltosure. In this example, tool 90 may be used to open packaging 40 and apply the me idmicpalelment 76, which may be anantiseptic wipe, to a patient’s skin 332 while m the dical implement may be partially inpackaging 40. In FIG. 33, the medical professio mna yl have used one hand to actuate tool90 to pull pocket 52 of first portion 42 away fro pmocket 54 of second portion 50. The atleast partially opened package exposes the anitcis weipt e, which may have an unexposedportion remaining in the packaging 40. The med picraolfessional may grasp the medical implement through the packaging while the tool rienmsa in contact with the packaging. Themedical professional can then apply the medicale imp ent 76 to a patient without having totouch the medical implement, thereby limiting exuproes of the medical professional to an antiseptic solution on the sterile wipe. The to0ol m 9ay hold the packaging 40 at least partially open while the medical professional aepspl tihe medical implement 76 to the patient’s skin 332. The one-handed operation of the system 330 to a op beancteria-proof packaging container 40 may offer several advantages overe cnotniovnal sterile packaging systems. For example, one-handed operation of the system 330 in mcareyase efficiency in the medical care setting by freeing a medical professionalc’son sed hand to perform any number of other tasks, including continuing patient care. A sec eoxnadmple of an advantage of one-handed operation of the system is facilitating the open oinfg a bacteria-proof packaging container by a physically disabled medical professional, ther ienbcyreasing the number of medical professionals available to provide patient carhe.ou Tgh one-handed operation may provide certain advantages, two hands may be also usepde troat oe the system 330 and still retain the advantage of limiting exposure of the medical immpelent to the medical professional and the advantage of holding the packaging open to exphoese m tedical implement. FIG. 34 is a flowchart 340 illustrating a method o tpoen a package while maintaining sterility of a medical implement within the packa inge accordance with an example of the disclosure. It should be noted that any processcr dipetions or blocks in flow charts should be understood as representing modules, segmen sttse,p osr that include one or more instructions for implementing specific logical futinocns in the process, and alternate implementations are included within the scope oef p thresent disclosure in which functionsmay be executed out of order from that shown ocru dsis ed, including substantially concurrently or in reverse order, depending on fu thnectionality involved, as would be understood by those reasonably skilled in thef a trhte o present disclosure. Step 342 includes positioning a tool over the maeld imicplement within an interior compartment in a bacteria-resistant packaging cinoenrt.a Step 344 includes inserting a first end of the tinotool a pocket proximate to an edge of the bacteria-resistant packaging container. Step 346 includes actuating the tool to move teoc aon sd end of the tool mountedsubstantially perpendicularly to the first endh oef t ool toward the item, thereby separating afirst portion of the bacteria-resistant packaginognt cainer from a second portion of the bacteria-resistant packaging container. The painckga cgontainer may be torn, pulled apart, peeled, or otherwise separated to expose the mle imdipclaement. In one example, the opened packaging container may expose less tha onf t ahlel medical implement. This may allow a user to grip the medical implement whilein ugs or manipulating the medical implement. The unexposed end may still be cov beyre ad portion of the packaging container, thereby retaining sterility, and allogwi mnanipulation of the medical implement. A medical professional may apply the medical impelenmt to the patient without removing the medical implement from the packaging, thereimbyiti lng exposure of the medical professional to the medical implement. Any number of additional steps, functions, procse,s oser variants thereof may be included in the method, including any disclosedat rievel to any other figure of this disclosure. It should be emphasized that the above-describebdod eim ents of the presentdisclosure, particularly, any “preferred” embodimtse,n are merely possible examples of implementations, merely set forth for a clear unsdtaenrding of the principles of the disclosure. Many variations and modifications m baey made to the above-described embodiment(s) of the disclosure without departiunbgs stantially from the spirit and principles of the disclosure. All such modificantsio and variations are intended to be included herein within the scope of this disclos aunred the present disclosure and protected by the following claims.

Claims

AMENDED CLAIMS received by the International Bureau on 17 September 2025 (17.09.2025)What is claimed is:

1. A system for opening a package while maintaining sterility of a medical implement within the package, comprising: a bacteria-proof packaging container having an interior compartment; a first portion of the bacteria-proof packaging container separatable from a second portion of the bacteria-proof packaging container; a medical implement positioned within the interior compartment; at least one pocket positioned proximate to a top edge of the bacteria- proof packaging container; and a tool configured for opening the bacteria-proof packaging container, wherein the tool has at least one end sized to fit within the at least one pocket, and wherein a first end of the tool is angularly connected to a second end of the tool, wherein the tool is controllable to separate the first portion from the second portion.

2. The system of claim 1, wherein the bacteria-proof packaging container further comprises a vertical separation structure positioned between the first portion and the second portion, and axially along the bacteria-proof packaging container, wherein pulling the at least one pocket by the tool causes the bacteria-proof packaging container to open along the vertical separation structure to separate the first portion from the second portion.

3. The system of claim 1, wherein the tool further comprises: a first side and a second side, wherein the first and second sides are positionable on opposite sides of the medical implement; a member joining the first side to the second side; and wherein the at least one pocket further comprises first and second pockets positioned on the first and second portions, respectively, wherein each of the first and second pockets are positioned proximate to the top edge of the bacteria-proof packaging container, and wherein the first and second pockets are configured to receive the first and second sides of the tool, respectively, and wherein when the first side and the second side are positioned in the first and second pockets, respectively, the first side and second side are moveable away from each other to separate the first portion from the second portion.

4. The system of claims 1, 2, or 3, wherein the tool is sized to separate a portion of the bacteria-proof packaging container to expose the medical implement in the interior compartment.

5. The system of claims 1, 2, or 3, wherein the second portion of the bacteria-proof packaging container is rigid.

6. The system of claims 1, 2, or 3, wherein the at least one pocket further comprises an overfolded section of the first portion connected proximate to lateral edges thereof.

7. The system of claims 1, 2, or 3, wherein the at least one pocket further comprises a loop connected proximate to the top edge of the bacteria-proof packaging container.

8. The system of claim 7, wherein the tool is positionable through the loop and proximate the top edge of the bacteria-proof packaging container.

9. The system of claims 1, 2, or 3, wherein the first end of the tool further comprises a hook.

10. The system of claims 1, 2, or 3, wherein the second end of the tool further comprises a shaped end, and wherein the shaped end is sized to accommodate the medical implement.1 1. The system of claims 1 , 2, or 3, wherein the tool further comprises a corner connected between the first side and the second side, and wherein the corner is rounded to facilitate a rocking motion of the tool to open the bacteria-proof packaging container.

12. The system of claim 3, the member further comprising: a housing; a first contact structure on housing, the first contact structure sized to accommodate a first finger; an insert slideably positionable relative to the housing and operably connected to the first side and the second side, the insert having a second contact structure sized to accommodate a second finger; and a bias mechanism positioned between the insert and the housing, the bias mechanism biasing the first contact structure away from the second contact structure, wherein moving the insert towards the housing causes the first side and the second side to move away from each other.

13. A method to open a package while maintaining sterility of a medical implement within the package, comprising: positioning a tool over the medical implement within an interior compartment in a bacteria-resistant packaging container; inserting a first end of the tool into a pocket proximate to a top edge of the bacteria-resistant packaging container; and actuating the tool to move to a second end of the tool mounted substantially perpendicularly to the first end of the tool toward the item, thereby separating a first portion of the bacteria-resistant packaging container from a second portion of the bacteria-resistant packaging container.

14. The method of claim 13, further comprising: positioning the bacteria-proof packaging container proximate to a rigid surface; and using the tool to pull the pocket away from the rigid surface, thereby separating the first portion of the bacteria-proof packaging container from the second portion of the bacteria-resistant packaging container.

15. The method of claims 13 or 14, wherein actuating the tool to move to a second end of the tool toward the item further comprises using a single hand, whereby the tool is held with the single hand and at least one finger of the single hand causes movement of the second end of the tool.[0001][0002]STATEMENT UNDER ARTICLE 19(1)[0003]Claim 8 has been amended to correct a typographical error where it depended on itself. The dependency of claim 8 has been corrected from claim 8 to claim 7. No new matter has been entered. Basis for the correction can be found in at least page 22, lines 10-13, where it can be seen that claim 7 requires “a loop” and claim 8 requires that ‘'the tool is positionable through the loop,” such that it is evident that the dependency of claim 8 upon itself is an obvious typographical error. Additional basis for the amendment can be found on at least page 14, lines 6-11 , where the application teaches “[l]oop 202 may be sized to accommodate first end of first side 96 of tool 250 (FIGS. 17-19) or tool 210 (FIGS. 21-22).”[0004]27

Images