FIELD

[0001] The present disclosure relates to a Active Infection Prevention system (AIPS) that provide active protection from microbes by charging an area of interest with micro ampere current thereby killing microorganisms in that area.

BACKGROUND

[0002] A venous catheter, often referred to as an intravenous cannula, is a flexible, hollow, plastic tube that is inserted in a central vein (CVC) or peripheral vein (PVC), most commonly the metacarpal vein of the hand, and alternatively, either the cephalic or basilic vein of the lower forearm. It is typically used for short-term delivery of intravascular fluids and medications. It is an essential element of modem medicine and the most frequent invasive procedure performed in hospital, as most of the hospitalized patients require peripheral venous catheterization. An important and frequent life- endangering complication in connection with the use of intravascular catheters comprises the occurrence of catheter-related bloodstream infection (CRBSI). The infection rate increases the longer the catheter remains in the body. Further, inadequate catheter stabilization or securement can lead to poor attachment of the venous catheter to the skin, allowing movement of the catheter out of the vein, and resulting in partial or complete dislodgement.

[0003] Poor catheter stabilization, particularly if it leads to unscheduled venous catheter re siting, may increase a patient’s risk of infection. In order to be sited, a venous catheter must be inserted through the patient’s skin, which normally acts as a protective barrier against bacteria that might otherwise access the body. Consequently, the catheter may be contaminated during initial insertion or subsequent resifting ’s with a new venous catheter. The most common cause of the CRBSI occurs when the skin has been broken. Micro-organisms can cause local infection and may track along a surface of the venous catheter to contaminate the catheter tip, and then the bloodstream. Micro-motion while the venous catheter is in place may also encourage microbial entry via the venous catheter wound.

[0004] Improper securement of the venous catheter to the skin allows the catheter to move within the vein, which increases the incidence of venous catheter dislodgement, mechanical phlebitis, infiltration, leakage and infection. This movement results in venous catheter failure, an interruption to intravenous therapy and the need to re-site the venous catheter. Repeated re-siting of venous catheter can lead to venous access difficulties, including the need for more frequent venous catheter re-sites or for a central venous catheter, and causing interruption to the delivery of IV therapy and a potential increase in the duration of hospital stay and healthcare costs. Conventional devices a high rate of dislodgment or failure of securement of the IV cannula / venous catheter. [0005] Use of conventional tapes & patches to secure the venous cathether in place provides discomfort for the patient due to pressure of the venous catheter on the skin as well as the securement system. Further, post cannulation, infection rate of the site increases due to improper coverage and absence of antimicrobial agents. There remains a need of an Active Infection Prevention system (AIPS).

SUMMARY

[0006] The disclosed system provide active infection prevention for at catheter insertion sites. The active infection prevention system provide active protection from microbes by charging an area of interest with micro ampere current thereby killing microorganisms in the area. Additionally, the system includes a securement device that secures the catheter firmly onto the skin arresting movement

[0007] In one aspect the Active Infection Prevention System (AIPS) for a securing a cathether comprises terminal contacts, a printed circuit board (PCB), and a power source. The terminal contacts connected to one or more electrodes of the securement device. The securement device covering an area of interest on a subject. The PCB connected to the terminal contacts and the power source to provide current to the one or more electrodes of the securement device through the terminal contacts of the AIPS. The PCB is configured to continuously discharge the current from the power source into the area of interest on the subject to prevent infection at the area of interest.

[0008] In the embodiments, the AIPS comprises a Uight-Emitting Diode (UED) on a cap of the AIPS, connected to the PCB, to indicate a status of the AIPS.

[0009] In the embodiments, the AIPS comprises an adhesive layer to fix the securement device using the adhesive layer.

[0010] In the embodiments, the current is discharged into the area of interest by passing the current through contacts strip embedded into a base of the securement device.

[0011] In the embodiments, the current that passes through the contacts strip is discharged into the area of interest through the adhesive layer, and wherein the adhesive layer comprises conductive adhesive.

[0012] In the embodiments, the contacts strip runs along edges of the base and terminate into the terminal contacts of the AIPS.

[0013] In the embodiments, the adhesive layer is protected by a peelable liner.

[0014] In the embodiments, an amount of the current being discharged into the area of interest is minuscule compared to a size of the subject, and wherein the amount of current is lethal to kill all microbes.

[0015] In the embodiments, the AIPS is automatically activated as soon as the AIPS (100) is mounted on the secure device.

[0016] In the embodiments, the securement device comprises a MEMS Coriolis flow sensor to actively monitor a flow rate of an IV line.

[0017] In the embodiments, the power source is embedded in a cell carriage. [0018] In the embodiments, the AIPS comprises a case comprising the terminal contacts.

[0019] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF FIGURES

[0020] The embodiments herein will be better understood from the following description with reference to the drawings, in which:

[0021] FIG. 1 illustrates a securement device mounted onto a cannula & placed on a skin after insertion without the AIPS, according to the embodiments as disclosed herein;

[0022] FIG. 2 illustrates a securement device mounted onto the cannula for retrofit application, according to the embodiments as disclosed herein;

[0023] FIG. 3 illustrates a securement device mounted onto a cannula & placed on a skin after insertion with an AIPS, according to the embodiments as disclosed herein;

[0024] FIG. 4 illustrates a construction of the AIPS, according to the embodiments as disclosed herein; and

[0025] FIGS. 5a and 5b illustrate construction of the securement device placed along with the AIPS, according to the embodiments as disclosed herein.

DETAILED DESCRIPTION

[0026] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. Also, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments. The term “or” as used herein, refers to a non-exclusive or, unless otherwise indicated. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein can be practiced and to further enable those skilled in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein. [0027] The accompanying drawings are used to help easily understand various technical features and it should be understood that the embodiments presented herein are not limited by the accompanying drawings. As such, the present disclosure should be construed to extend to any alterations, equivalents and substitutes in addition to those which are particularly set out in the accompanying drawings. Although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are generally only used to distinguish one element from another.

[0028] FIG. 1 illustrates a securement device (100) mounted onto a cannula (200) and placed on an area of interest [102] of a subject after insertion, according to the embodiments as disclosed herein. Even though the securement device (100) is described in conjunction with cannula (200), this can be any device for example, an article that can be placed on or covering an area of interest on the subject according to other embodiments. Thus, for example, the securement device may be an article that can be positioned covering skin of the subject.

[0029] The cannula (200) is secured onto the area of interest 102 (i.e. surface of the skin) after injecting the cannula (200) into the vein. The area of interest here is skin area around the site of cannulation. FIG. 1 shows the completed procedure and installed view of the securement device (100) on the skin. The securement device (100) can be retrofit onto the cannula (200) such as ‘Venflan” or be a part of the cannula (200) as an OEM fitment. In case of an OEM fit system the securement device (100) is mounted onto the cannula (200) at the factory level (cannula manufacturer). In an embodiment, the combined system (securement device (100) & cannula (200)) can be available to the clinician for use. As per standard clinical protocols the cannula (200) is inserted into the peripherals vein with one hand, while the other is holding the patient wrist, hand or the cannulation body part. Once the cannula (200) is in, the clinician pulls the main tab and removes the liner exposing underneath portion of the cannula wing area. The clinician now presses the cannula (200) onto the skin. For example, the cannula (200) is placed exactly at the position where it has entered the vein. The adhesive between the cannula (200) and the skin hold the cannula (200) in place. The complete underside of the wings of the cannula (200) will be in contact with the skin. Then the clinician removes the two tabs on the long tails of the securement device (100) and crosses them over the needle entry point and presses them onto the skin. This completes the securing procedure of the cannula (200) on the skin. No additional tapes or patches are required to hold the cannula (200). The system now allows the clinician to collect flashback blood, change to IV lines or infuse drugs into the cannula (200) with the fear of dislodging it.

[0030] FIG. 2 illustrates the securement device (100) mounted onto the cannula (200) for retrofit application, according to the embodiments as disclosed herein. If the securement device (100) is retrofit, then the clinician will have to open the securement device (100) from its own sterile packaging, then peel the tab to expose the adhesive. The clinician has now placed a bottom side of the cannula (wing area) onto the top surface of the securement device (100) and gently press it. As shown in the FIG. 2, the securement device (100) is now a part of the cannula (200) and the clinician can go about the cannulation procedure as explained above. An Active Prevention System [AIPS] 300 is also shown here in FIG. 2 but will be described with respect to FIG. 3.

[0031] FIG. 3 illustrates the securement device ( 100) mounted onto the cannula (200) & placed on a skin after insertion with an Active Infection Prevention system (AIPS) (300), according to the embodiments as disclosed herein. The AIPS (300) provides continuous active infection prevention at the site of the cannulation (200). FIG. 3 shows the securement device (100) with an extend AIPS patch holder (400) according to an embodiment. Once the cannulation procedure is completed and the cannula (200) is secured, the clinician peels of a tab to expose adhesive and terminal contacts as illustrated in FIG. 4. Now the clinician places the AIPS (300) onto the patch holder (400) and presses it lightly. The adhesive on the patch holder (400) secures the AIPS (300). In an embodiment, the AIPS [300] may be a part of securement device (100) and need not be placed on to the AIPS patch holder (400) by the clinician.

[0032] The FIG. 4 illustrates a construction of the AIPS (300), according to the embodiments as disclosed herein. The AIPS (300) comprises terminal contacts (302), printed circuit board (PCB) (304), power source (306), a Light-Emitting Diode (LED) (308), a cell carriage (310), a cap (312) and a case (314). The terminal contacts (302) connected to one or more electrodes (104) of the securement device (100) covering an area of interest on the subject. The case (314) comprising the terminal contacts (302). The PCB (304) connected to the terminal contacts (302). The LED (308) on the cap (312) of the AIPS (300), connected to the PCB (304), to indicate a status of the AIPS (300). The power source (306) is embedded in the cell carriage (310). The power source (306), connected to the PCB (304), supplies current to the one or more electrodes ( 104) of the securement device ( 100) through the terminal contacts (302) of the AIPS (300). The printed circuit board (304) is configured to continuously discharge the current from the power source (306) into the area of interest on the subject to prevent infection at the area of interest. The amount of current being discharged into the area of interest is minuscule compared to a size of the subject, and wherein the amount of current is lethal to kill all microbes. In an embodiment, the amount of current supplied to the area of interest can be controlled by the AIPS (300). The AIPS (300) switches on automatically to indicate it is functioning or supplying current. For example, LED (308) may glowing e.g. a green color. If the AIPS [300] is not supplying power, then LED [308] may not glow or may glow in a different color to indicate that it is not supplying power. The continuous contact strip runs all across the securement device (100) and terminate at electrodes (104) placed in the middle of the securement device ( 100) as shown in the FIG. 3. A small voltage for example, 3 volts with micro amperage of current (e.g. 100 - 300ma) may pass through this strip and exit the electrodes (104) into the patient’s skin. As the current passes through the skin it kills microbes in it ways. Since the point of discharge is next to the cannula (200) entry point the site is protected from any microbial activity. Moreover, it eliminates the use of any external antimicrobial agents (liquid / solid) to remove the microbes at the area of interest. The adhesive in the securement device ( 100) is electrically conductive and hence allow the terminal contacts (302) and the electrodes (104) to discharge electricity onto the skin. The micro current passing through the skin is too weak to damage any human tissue but strong enough to destroy microorganisms. The AIPS (300) can work for hours. For example, the AIPS (300) consists of a lithium button cell (like CR 2032) connected to the terminals via a mini PCB (pulse modulator). When the cell runs low the LED [308] turns red or any other color indicating a need for recharging or replacing of the cell.

[0033] The two major components of the AIPS [300] is the PCB (304) with a circuit to modulate the pulse of the incoming current and a power source [306] The PCB [304] is mounted onto the bottom of the power source (306). For example, a lithium ion power cell with low voltage capacity (e.g. 2-3 volts) and a current capacity of may be 200 to 300 micro amperes is fixed as the power source (306) on top ofthe PCB (304). The power source (306) provides power to the PCB [304] The output of the PCB [303] is connected to the terminal contacts (302). As explained earlier, the LED indicator (308) connected to the PCB (304) indicate that the AIPS [300] is functioning or not. The direct current is sent to the terminal contacts (302) that is then circulated down the contacts strips (shown in FIG. 5b) of the electrodes (104) running through the base (106) of the securement device (100). The current that passes through these contact strips is discharged into the skin through the conductive adhesive. Since the middle section of the cannula (200) entry site and the cross tapes cover the entry site adequately, the discharge of current into that area is significant. The amount of current being discharged into the skin is minuscule compared to the size of the human being, but at the same time this small amount of current is lethal to all microorganisms such as bacteria, fungi and viruses. The discharge of current forms a field around the cannula entry point or around the area of interest and protects the broken skin (i.e. area of interest) and its surrounding from contamination by microorganisms. As long as enough current is being applied to that area by the AIPS (300), the area of interest is free from infection. Moreover, due to continuous supply of current there is no possibility of evaporation of chemicals or sweat cleansing or depletion of antimicrobial liquid over the skin as conventional infection prevention is done using known antimicrobial liquids. The current discharge is minimum and so the AIPS (300) can operate for many days.

[0034] FIGS. 5a and 5b illustrate construction of the securement device (100) placed along with the AIPS (300), according to the embodiments as disclosed herein. The base (106) of the securement device (100) is made of a stretchable material that can conform to undulated surfaces. The base (106) is precut to a certain shape as illustrated in the FIG. 5a. This shape is unique to the type of cannula that is being used. All other components of the system are mounted onto the base. The base can be divided into 3 major parts. The center part of the securement device (100) is the part that is attached to the venous catheter or the Cannula (200). This top part of this section has an adhesive coating (110) with superior adhesive properties. It is strong enough to adhere to any type of plastic used to make venous catheter / Cannulas. The adhesive coating is protected with a shape cut liner (112) (i.e. plastic base). The liner will have a tab at one end so that the clinician can pull it out before installing it onto the venous catheter / Cannula (in case of retrofit application). The bottom part of the center section also has an adhesive coating (114). This coating is a skin friendly coating and the adhesive may have repositionable property i.e. it retains its tack and adhesion property as long as its initial shape is intact. The moment the shape is deformed, it loses its adhesion property. A Plastic based liner(l 12) protects this coating while not in use. This liner may have a special shape as shown in the FIG. 5b. There is a pull tab that extends like a long arm. This pull tab fold back to one side of the liner as shown. Once the clinician inserts the cannula into the patient (the cannula fitted with the securement device), the clinician can pull on the tab to remove the same. Since the tab is folded back, it delaminates from the system in ‘face down’ position making it simpler for the clinician to perform a one-handed operation.

[0035] Further, the securement device (100) comprises a pair of long extended arms or cross tapes. The cross tapes have adhesive on the top side. This adhesive coating is also skin friendly and has superior adhesion properties. After the clinician completes securing the base of the cannula to the skin, the clinician pulls the liner tabs of the cross tapes and removes it. The tapes are then crossed over the cannula (200) and placed over a cannula entry point. Pressed with some pressure the tapes will secure and seal the cannula (200) from moving or displacing. This step and the cross tapes are an additional measure to keep the cannula from moving though middle portion of the securement device (100) itself would help in keeping the cannula in place. Also, the current practice of crisscrossing tapes on the cannula entry provides confidence to the clinician and hence the device also is provided with the inbuilt tapes that can be used for the same function.

[0036] In order to enable the AIPS (300), the base (106) of the securement device (100) has a few additional parts inbuilt into it as illustrated in the FIGS. 5a and 5b. These parts include copper or gold foil contacts embedded into the base (106). The contacts run along the edges of the base (106) and terminate into the terminal contacts (302) at the AIPS patch holder(400). The AIPS patch holder (400) has an adhesive coating (318) on the top along with a liner (316) to protect it. After the entire device in placed on the skin, the clinician removes the liner (316) and affixes the AIPS (300) (explained further) in an embodiment. The terminal contacts (302) of the AIPS (300) and the terminal points of the AIPS patch holder (400) should line up and be in contact with each other. The contacts run along through the AIPS patch holder (400) and into the middle base section. However at the comers where the long arms (cross tapes) begin, the contact pass through the base and come out on the other side of the cross tapes. This is because, when the tapes are crossed onto the cannula entry point, the contacts will be facing the skin. As shown in FIGs. 5a and 5b, 2 electrodes (104) (e.g. ferrite electrodes) are also introduced in the middle section of the base (106) of the securement device [100] All the adhesive coating over the running contact (108) strips have conductive properties so as to allow electricity to pass through into the skin. Therefore, unlike the conventional system, the securement device that secures an intravenous Cannula firmly onto the skin arresting movement in all axis and provide active protection from microbes by charging the area of the interest (i.e. cannula site) with micro ampere current thereby killing microorganisms in that area. [0037] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.