An intravenous cannulation device for assisting healthcare users in intravenous cannulation

Abstract

Disclosed is an intravenous cannulation device (100) for assisting healthcare users in intravenous cannulation. The device (100) includes a catheter (105) and a needle unit (110) removably disposed within the catheter (105). The needle unit (110) includes a needle (115) and pressure sensors (120) configured for detecting a first pressure generated by a resistance encountered by a needle (115) while piercing a first wall of a target vein and a second pressure generated by a drop in resistance experienced by the needle (115) after puncturing the first wall of the target vein. A microcontroller (125) connected to the pressure sensors (120) measures the detected first pressure and the second pressure, and indicates, on an indicator unit (130), a successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation.

Description

AN INTRAVENOUS CANNULATION DEVICE FOR ASSISTING HEALTHCARE USERS IN INTRAVENOUS CANNULATION TECHNICAL FIELD

[0001] The present disclosure generally relates to the field of medical devices and more particularly to an intravenous (IV) cannulation device for assisting healthcare users in intravenous (IV) cannulation. BACKGROUND

[0002] In the medical field, cannulas are widely used by medical professionals worldwide for a multitude of purposes. These include collecting samples for laboratory analysis and testing, administering medications, providing essential care and therapy, delivering nutrition (known as parenteral nutrition), supplying oxygen, along with safeguarding patients from adverse events, reactions, and blood-borne pathogens during these procedures. Among the various types of cannulas developed till date for diverse medical needs, the intravenous (IV) cannula remains the most commonly employed. However, it is important to note that not all medical facilities or emergency responders possess the same level of expertise and experience in IV cannulation procedure.

[0003] The accurate placement of an IV cannula (that is, an IV cannulation device) on the very first attempt is a source of immense satisfaction for healthcare professionals (users). Conversely, encountering a double-prick (that is, double puncture) scenario, wherein the needle additionally pierces the second (that is, inner) wall of the target vein, brings disappointment and anxiety, particularly in settings like emergency rooms, intensive care units (ICUs), neonatal ICUs (NICUs), pediatric ICUs (PICUs), cancer wards, and geriatric wards. Successfully placing an IV cannula involves several steps such as visualizing and securing the blood vessel, gently piercing the skin and the outer wall of the desired target vein with the needle of the IV cannula, feeling the loss of resistance as the needle of the IV cannula enters the lumen of the desired target vein, retracting the needle of the IV cannula to confirm blood flow into the IV cannula, angulating / positioning the IV cannula andadvancing the IV cannula into the lumen of the desired target vein, and finally, removing the needle of the IV cannula and securing the IV cannula with a plaster. This entire process demands unwavering focus, precision, and attention to detail. Any distractions, patient movements, or undesirable external stimuli can lead to inadvertent double puncture of the vessel, necessitating the repetition of the procedure but with a different target vein. Certain patient populations, such as those who are severely dehydrated, in shock from blood loss, undergoing chemotherapy requiring frequent IV medications, or in prolonged ICU or NICU or PICU care, pose challenges due to difficult venous access. In such cases, double punctures can significantly impact treatment outcomes by causing delays in initiating necessary therapies.

[0004] In critical scenarios like medical emergencies, global pandemics, natural disasters, or during wartime, quick IV cannulation is vital. However, during the above-mentioned situations, ‘quick’ may not imply equal quality and / or best practices of IV cannulation. Training additional staff during such crises is often challenging and may hinder scalability of the required medical aid deployment to the masses affected alike or to varying degrees. Expecting affected individuals to self-cannulate, for example, soldiers are sometimes required to self-cannulate during extraction or war situations, is risky and may worsen their condition due to lack of experience, guidance or supervision. Additionally, any delay in IV cannulation during the above specified scenarios could prove to be fatal. Therefore, while prioritizing swift deployment of medical aid, maintaining high standards and best practices of care are paramount to ensure patient safety.

[0005] Cannulation errors can lead to various medical complications, including infiltration, wherein the medical fluid leaks into surrounding tissues, and extravasation, wherein the leaked medical fluid causes damage to the surrounding tissues. Hematomas, or collection of blood outside blood vessels, may also occur, along with the need for multiple attempts to insert the cannula properly and the potential loss of access to the desired target vein. Therefore, the healthcare professionals (users) must always use proper techniques and are often on the lookout for simpler and practical equipment to minimize these risks.

[0006] Currently, there do exist IV cannulas specifically designed to reduce painful hits and missed insertions by incorporating notch openings in the needle. However, these designs often pose several disadvantages. For example: the catheters of such IV cannulas require mandatory flushing immediately post cannula insertion since if not done so, chances of catheter blockage persist; the flushing process is painful and causes discomfort to the patients; such cannulas may not be comfortable or preferred by the healthcare professionals (users) because of the additional step of flushing. Also, the additional process of flushing is time-consuming and not always feasible, especially during medical emergencies; and though flush tubes are readily available in hospitals or medical facilities, this adds in to the overall cost that often needs to be borne by the patients adding to their overall medical expenses.

[0007] Thus, there exists a long felt need for an intravenous (IV) cannulation device for assisting a healthcare user in IV cannulation. Specifically, there exists a long felt need for an IV cannulation device that assists healthcare users in preventing double punctures of the desired target blood vessels by letting the healthcare professionals (users) know exactly when to stop piercing / pushing / penetrating / advancing the needle of the IV cannulation device further into the target blood vessel (that is, vein). BRIEF SUMMARY

[0008] This summary is provided to introduce a selection of concepts in a simple manner that is further described in the detailed description of the disclosure. This summary is not intended to identify key or essential inventive concepts of the subject matter nor is it intended for determining the scope of the disclosure.

[0009] The present disclosure discloses an intravenous (IV) cannulation device for assisting a healthcare user in IV cannulation. The IV cannulation device includes a catheter, a needle unit removably disposed within the catheter, and one or more pressure sensors disposed in the needle unit. The one or more pressure sensors are configured for detecting a first pressuregenerated by a resistance encountered by a needle of the needle unit while piercing a first wall of a target vein and a second pressure generated by a drop in resistance after puncturing the first wall of the target vein. A microcontroller, also disposed within the removable needle unit and in turn coupled to an embedded battery module, is communicatively connected to the one or more pressure sensors of the same needle unit, already configured for measuring the first pressure and the second pressure, to indicate, on an indicator unit, a successful puncturing of the first wall of the target vein based on the detected and measured first pressure and the second pressure for assisting the healthcare user in IV cannulation.

[0010] Further disclosed is a method for assisting a healthcare user in IV cannulation. The method comprises, measuring a first pressure generated by a resistance encountered by a needle of a cannulation device while piercing a first wall of a target vein, measuring a second pressure generated by a drop in resistance after puncturing the first wall of the target vein, and indicating a successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in IV cannulation.

[0011] The present disclosure further discloses yet another IV cannulation device for assisting a healthcare user in IV cannulation, wherein an enameled (that is, insulated) conductive wire-bearing needle unit is removably disposed within the catheter of the IV cannulation device. The needle unit of this disclosed IV cannulation device includes a needle, a conductive wire disposed inside the needle substantially along the longitudinal axis of the needle and is insulated from an inner surface of the needle, with only the tip of the conductive wire being uninsulated, a battery module, wherein a first terminal of the battery module is electrically coupled to the conductive wire, and an indicator unit electrically connected to a second terminal of the same battery module. During the IV cannulation procedure, a conductive fluid which is blood flowing into the needle from the target vein upon puncture of its first wall, establishes a conductive path thereby completing the electrical circuit between the uninsulated tip of the conductive wire and the needle to activate the indicator unit for assisting the healthcare user in IV cannulation.

[0012] To further clarify and exemplify the advantages and features of the present disclosure, a more detailed description of the disclosure will be rendered by references tospecific embodiments thereof, which is illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the disclosure to facilitate the exemplification of the principles of the disclosure and are therefore not to be considered limiting the broad aspects of the present disclosure or its scopes. The disclosure will be described and explained with additional specificity and detail with the aid of the accompanying figures. BRIEF DESCRIPTION OF THE ACCOMPANYING FIGURES

[0013] The disclosed methods and systems will be described and explained with additional specificity and detail with the aid of the accompanying figures in which:

[0014] Figure 1A illustrates an exemplary intravenous (IV) cannulation device for assisting a healthcare user in IV cannulation, in accordance with an embodiment of the present disclosure;

[0015] Figure 1B illustrates an exploded view of the IV cannulation device, showing the two components, a needle unit bearing the needle, and a catheter, such that the needle unit is removably disposed within the catheter to together form the IV cannulation device, in accordance with an embodiment of the present disclosure;

[0016] Figure 1C illustrates a pressure sensor(s)-bearing needle unit that is to be removably disposed within the catheter of an IV cannulation device for assisting a healthcare user in IV cannulation, in accordance with an embodiment of the present disclosure;

[0017] Figure 1D illustrates a block diagram showing the different components of the pressure sensor(s)-bearing needle unit described in Figure 1C, in accordance with an embodiment of the present disclosure;

[0018] Figure 2 represents a cross-sectional view of a desired target vein;

[0019] Figure 3 shows a flowchart illustrating a method for assisting a healthcare user in IV cannulation, in accordance with an embodiment of the present disclosure;

[0020] Figure 4A illustrates an enameled (that is, insulated) conductive wire-bearing needle unit that is to be removably disposed within the catheter of an IV cannulation device for assisting a healthcare user in IV cannulation, in accordance with yet another embodiment of the present disclosure;

[0021] Figure 4B shows the diagrammatic representation of the needle of the needle unit described in Figure 4A with the insides of the needle having a funnel structure, in accordance with an embodiment of the present disclosure; and

[0022] Figure 4C shows the diagrammatic representation of the needle of the needle unit described in Figure 4A with the insides of the needle having an inverted funnel structure, in accordance with an embodiment of the present disclosure.

[0023] Further, persons skilled in the art to which this disclosure belongs to, will appreciate that elements in the figures are illustrated for simplicity and exemplifications of the principles of the disclosure and may not have been necessarily drawn to scale. Furthermore, in terms of the construction of the various described embodiments of the IV cannula device for assisting a healthcare user in IV cannulation, one or more components of the IV cannula may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those skilled in ordinary art having benefit of the description herein. DETAILED DESCRIPTION

[0024] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scopes of the presented disclosure is thereby intended. Such alterations and further modifications to the disclosure, and such further applications of the principles of the disclosure as described herein being contemplated as would normally occur to one skilled in the art to which the disclosure relates to, are deemed to be a part of this disclosure.

[0025] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the various embodiments of the presented disclosure and are not intended to be restrictive thereof.

[0026] In the present disclosure, relational terms such as first and second, and the like, may be used to distinguish one entity from the other, without necessarily implying any actual relationship or order between such entities.

[0027] The terms "comprises", "comprising", or any other variations thereof, are intended to cover and encompass a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or a method. Similarly, one or more elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other elements, other structures, other components, additional devices, additional elements, additional structures, or additional components. Appearances of the phrases “in an embodiment”, “in another embodiment”, “in yet another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The components, methods, processes, elements, structures, and examples provided herein are illustrative only and not intended to be limiting.

[0029] Various embodiments of the present disclosure will be described below in detail with reference to the accompanying figures.

[0030] Various embodiments of the present disclosure disclose an IV cannulation device having proposed needle units for assisting a healthcare user in IV cannulation. The IV cannulation device bearing proposed needle units assists a healthcare professional (user) in preventing double punctures of the blood vessels by letting the healthcare professionals (users) know exactly when to stop piercing, pushing, penetrating or advancing a needle of the cannulation device further into the target blood vessel.

[0031] Figure 1A illustrates an exemplary IV cannulation device for assisting a healthcare professional (user) in IV cannulation, in accordance with an embodiment of the present disclosure. Figure 1B illustrates an exploded view of the IV cannulation device, showing the two components, a needle unit bearing the needle, and a catheter, such that the needle unit is removably disposed within the catheter to together form the IV cannulation device, in accordance with an embodiment of the present disclosure. Referring to Figures 1A and 1B, the IV cannulation device 100 includes a catheter 105, and a needle unit 110, wherein the needle unit 110 includes a needle 115. Referring to Figure 1B, the needle unit 110 is removably disposed within the catheter 105 to together form the IV cannulation device 100, such that the needle 115 passes through the catheter 105 for piercing a target vein of a subject. It is to be noted that the catheter 105 is often connected to a catheter hub, a valve, luer connector, injection port cap, catheter wings, which are out of scope of the present disclosure.

[0032] Figure 1C illustrates a pressure sensor(s)-bearing needle unit that is to be removably disposed within the catheter of the IV cannulation device for assisting a healthcare professional (user) in IV cannulation, in accordance with an embodiment of the present disclosure. Figure 1D illustrates a block diagram showing the different components of the pressure sensor(s)-bearing needle unit illustrated in Figure 1C, in accordance with an embodiment of the present disclosure. As shown, the pressure sensor(s)-bearing needle unit 110 that is to be removably disposed within the catheter 105 of the IV cannulation device 100 includes the needle 115, one or more pressure sensor(s) 120 (shown only one pressure sensor), a microcontroller 125 and an indicator unit 130.

[0033] Further, the needle unit 110 may include other elements such as but not limited to a bushing 135, a needle grip 140, a flashback chamber 145, a luer lock plug 150, a battery module 155, a switch 160, a power-on light 165, and an alert light 170, as shown in Figure 1C or Figure 1D or both Figures 1C and 1D. The battery module 155 supplies the required power to the microcontroller 125 and the indicator unit 130. In an alternative embodiment, the IV cannulation device 100 as a whole along with the described pressure sensor(s)-bearing needle unit 110 removably disposed within the catheter 105, may be connected to an external power source. In construction, in one embodiment of the present disclosure, the needle unit110 having the needle 115 is removably disposed within the catheter 105, as shown in Figure 1A, using the catheter hub (not shown in the figures).

[0034] Referring to Figures 1A and 1B, the catheter 105 is the hollow tube that will be inserted into a target vein to deliver medication, first aid, critical care, and maintenance therapy. Typically, the catheter 105 is made up of medical-grade materials such as polyurethane, silicone, polyvinyl chloride, polyethylene, or Teflon, which are flexible not to collapse. However, the catheter 105 by itself is not sturdy enough to be inserted into the target vein on its own due to its material construct and hence requires the needle 115 to guide the catheter 105 into the desired target vein. The needle 115 is used to puncture the target vein during IV cannulation and to guide the catheter 105 into the target vein. The needle 115 is often made of medical-grade stainless steel and is beveled to allow smooth penetration. The needle 115 of the needle unit 110 is removably disposed inside the catheter 105 by means of catheter hub (not shown in the figures). Further, the bushing 135 is typically made of medical-grade plastic, such as polyethylene or polycarbonate, which are biocompatible and safe for use in medical devices. The bushing 135 is designed to be compatible with both the needle 115 and the catheter hub (not shown in the figures), ensuring a proper fit and secure connection. Further, the bushing 135 provides structural stability and integrity to the needle unit-catheter assembly during insertion, that is, during the IV cannulation procedure, thereby reducing the risk of bending or dislodging and preventing leakages. In one embodiment of the present disclosure, the flashback chamber 145 is used for accommodating one or more of the various components of the needle unit 110. Furthermore, the luer lock plug 150 is a screw connector at the distal end of the needle unit 110 away from the needle 115 and designed to create a leak-free seal and can also be used by healthcare providers to securely connect to other medical devices, such as needles, tubing or other equipment for performing various activities involved in patient care. Further, the switch 160 is used for activating the electronic components of the needle unit 110. Upon switching ON, the power-on light 165 glows indicating the readiness of the IV cannulation device 100 to the healthcare professional (user). Hence, it is to be noted that the pressure sensor(s) 120, the indicator unit 130, the switch 160, the power-on light 165 and the alert light 170 are communicatively connected to the microcontroller 125 and the battery module 155.

[0035] The one or more pressure sensor(s) 120 as described herein include miniature pressure sensor(s) configured in synced unison in a coordinated manner to detect pressure in confined spaces or environments where conventional sensors might be too large or impractical. In one implementation, one or more miniature pressure sensors having compact non-absorbent fluid-resistant design, high accuracy, and low power consumption are used. Typically, such pressure sensors convert the physical pressure experienced by the miniature pressure sensor(s) into electrical signals, which are then processed by the microcontroller 125 for measuring the pressure sensed by the one or more pressure sensor(s) 120.

[0036] In one embodiment, the microcontroller 125 is communicatively connected to the one or more pressure sensor(s) 120 for measuring the detected pressure and connected to the indicator unit 130 for displaying the measured pressures or for indicating a change in pressure to a healthcare professional (user) of the IV cannulation device 100 bearing the needle unit 110. In one implementation, a microcontroller having small size, low power consumption and having an optimally good analog-to-digital converter (ADC) resolution, such as Arduino Nano microcontroller can be used, for example. However, a person skilled in the art may use any other microcontroller suitable for measuring pressure(s) from one or more pressure sensor(s) 120. Such microcontrollers may include battery-enabled microcontrollers, provision for microcontrollers to be connected to external battery modules and / or source(s), self- powered microcontrollers or batteryless microcontrollers utilising a number of energy harvesting technologies like radio frequency energy harvesting, piezoelectric energy harvesting, triboelectric energy harvesting, for example, for the Internet of Things (IoT) and more specifically the Internet of Medical Things (IoMT) enablement. Further, the indicator unit 130 as described herein would serve as display unit and may include but is not limited to one or more display units, indicator lights such as light emitting diodes (LEDs), micro- vibration motors, auditory indicators such as buzzer, etc. The indicator unit 130 is used for indicating successful piercing of a first wall of a target vein of a subject during the IV cannulation procedure. The first wall of a target vein as described herein refers to a wall of the target vein situated below the skin of a subject. Figure 2 represents a cross-sectional view of a target vein. As shown, a wall portion 205 above the dotted line 210 and below the skin (represented by curved line 215) is referred to as the first (that is, outer) wall of the target vein. Further, a wall portion 220 below the dotted line 210 is referred to as a second (that is, inner) wall of the target vein. Furthermore, the region within the target vein bordered by thefirst wall portion 205 and the second wall portion 220 is called the lumen 225 of the target vein. During the IV cannulation procedure, only the first wall 205 of the target vein needs to be pierced since double puncture of the target vein (that is, piercing both the walls 205 and 220) leads to various medical complications and hence necessitates the repetition of the IV cannulation procedure but with a different target vein. Hence an object of the present disclosure is to empower the IV cannulation device 100 bearing the described needle unit 110 to assist healthcare professionals (users) in preventing double punctures of the desired target veins by ensuring and indicating a successful puncturing of only the first wall of the target vein. The manner in which the same is indicated to the healthcare professionals (users) is described in detail in the present disclosure.

[0037] In one embodiment of the present disclosure, the one or more pressure sensor(s) 120 are disposed in the needle unit 110, wherein the one or more pressure sensor(s) 120 are configured for detecting a first pressure generated by a resistance encountered by the needle 115 of the needle unit 110 while piercing a first wall of a target vein. Further, the one or more pressure sensor(s) 120 are also configured for detecting a second pressure generated by a drop in resistance after puncturing the first wall of the target vein. In one implementation, the pressure sensor(s) 120 is / are disposed within the needle 115, and in between the needle 115 and the bushing 135. However, the one or more pressure sensor(s) 120 may be suitably disposed at or near the tip of the needle 115 or along the needle 115 or at a junction of the needle unit 110 and the needle 115, for example. In another embodiment, the one or more pressure sensor(s) 120 may be suitably disposed in the bushing 135 region of the needle unit 110. Figure 1C illustrates a single pressure sensor suitably disposed in the bushing 135 region of the needle unit 110.

[0038] As described, the pressure sensor(s) 120 sense(s) the pressure experienced and convert(s) the experienced pressure into electrical signals which are communicated to the microcontroller 125 for further processing. During the IV cannulation procedure, the needle 115 encounters resistance, resulting in a first pressure which is a maximum pressure (high pressure), while piercing the first wall of the target vein. Once the needle 115 punctures the first wall, the resistance drops, resulting in a second pressure which is a lower pressure. Hence, when a healthcare professional (user) starts the IV cannulation procedure using the IV cannulation device 100 housing the the pressure sensor(s)-bearing needle unit 110 and startspiercing the first wall of the target vein, the pressure sensor(s) 120 sense(s) the first pressure (that is, high pressure) generated by a resistance encountered by the needle 115 while piercing the first wall of the target vein and communicates the measured value to the microcontroller 125. Further, the pressure sensor(s) 120 sense(s) the second pressure (that is, lower pressure) perceived by a drop in resistance after puncturing the first wall of the target vein and communicates the measured value to the microcontroller 125.

[0039] In yet another embodiment of the present disclosure, the microcontroller 125 is configured to measure the first pressure (that is, high pressure) and the second pressure (that is, lower pressure) and indicates a successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare professional (user) in IV cannulation. That is, on receiving the electrical signals equivalent of the first pressure and the second pressure, the microcontroller 125 determines the first pressure (that is, high pressure) and the second pressure (that is, lower pressure) and compares the measured high pressure (that is, first pressure) and the lower pressure (that is, second pressure). Then, if a drop in pressure is detected after the initial resistance, the microcontroller 125 indicates a successful puncture of the first wall of the target vein on the indicator unit 130 to provide feedback to the healthcare professional (user). In other words, the microcontroller 125 aids in indicating successful puncturing of the first wall of the target vein if the second pressure is lower than the first pressure, after the needle 115 encountered a maximum resistance while piercing a first wall of the target vein.

[0040] An extended use case scenario can be further developed which will aim to ensure that the expected range of resistances anticipated by the first wall of any desirable target vein commonly used in medical practice can be determined and pre-set (that will be stratified by age, gender, target vein itself, and several other relevant factors), so that even an inadvertent puncture of surrounding tissues apart from the desired target vein’s first wall, displays an alert message regarding the incorrect puncture site. This expected range can also be decided based on actual real-life testing and then incorporated in the IV cannula device 100 accordingly. Proposal of incorporation of this attribute to yet another embodiment of the present disclosure is based on scenarios encountered routinely in obese subjects and patients with pathologically thick skin, those with burns, thick scars, or those suffering from psoriasis,ichthyosis, eczema, and other diseases, wherein the target veins are not clearly visible through the skin for easy access for IV cannulation.

[0041] Accordingly, in another implementation in the form of yet another embodiment of the present disclosure, indicating the successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare professional (user) in IV cannulation includes, comparing the first pressure and the second pressure, and indicating the successful puncturing of the first wall of the target vein if a result of comparison is greater than a predefined pre-set threshold pressure. That is, on measuring the first pressure and the second pressure, the configured microcontroller 125 determines the difference in pressure between the first pressure and the second pressure. Then the configured microcontroller 125 compares the result, that is, the difference in pressure with a predefined pre-set threshold pressure value. If, the difference in pressure (that is, pressure drop) is greater than the predefined pre-set threshold pressure value, then the configured microcontroller 125 indicates the successful puncturing of the first wall of the target vein on the indicator unit 130. If the pressure drop is insufficient, either there will be no indication on the indicator unit 130 which remains inactive or the microcontroller 125 may be configured to indicate on the indicator unit 130 by means of displaying a text message, for example, that the needle 115 has not entered the target vein.

[0042] In yet another implementation, the microcontroller 125 is configured to display the first pressure and the second pressure on the indicator unit 130 serving as the display unit as well. In such an implementation, the healthcare professional (user) may realize the successful puncturing of the first wall of the target vein by reading the pressure values displayed on the display unit. Further, it is to be noted that the one or more implementations may be combined so as to ensure successful puncturing of only the first wall of the target vein.

[0043] As described, the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within the catheter 105 explained in the present disclosure aids in IV cannulation by providing real-time feedback to the healthcare professionals (users), helping to ensure accurate and successful target vein puncture thereby also facilitating prevention of puncture of the second wall 220 of the target vein. The proposed IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110that is removably disposed within its catheter 105 enhances the safety and efficiency of the IV cannulation procedure, particularly for the healthcare professionals (users) who may be less experienced or in situations where visibility in general is limited, or in scenarios where gaining access to patient target vein itself is challenging wherein injury cannot be afforded to the vein found with difficulty. The successful puncturing of only the first wall of the target vein, that is a successful IV cannulation, may be indicated by various means using the indicator unit 130 which can also serve as a display unit. For example, the successful puncturing of only the first wall of the target vein may be indicated by various means such as by turning on a green light, by generating a feedback sound, by generating vibrations, or by displaying a text message on the indicator unit 130 serving as display unit.

[0044] In one embodiment of the present disclosure, the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within the catheter 105, is further configured for indicating an alert mechanism against a possible scenario of double puncturing of the target vein. During an IV cannulation procedure, there is a possibility of double puncturing of the target vein (that is, piercing of the second inner wall 220 in addition to the first outer wall 205) due to distractions, patient movements, or due to an external stimulus in the form of any untoward, undesirable accidental or deliberate further push of the needle 115 which can lead to inadvertent double puncture of the target vein. In such a scenario, the pressure sensor(s) 120 is / are enabled and equipped to detect the third pressure, which is higher than the second pressure detected earlier, generated by a resistance encountered by a needle 115 of the needle unit 110 when it comes across the second wall 220 of the target vein. The microcontroller 125 is further configured to then measures this detected increased pressure (that is, third pressure) and indicates the alert against a possible double puncturing of the same target vein to the healthcare professionals (users) which may be indicated either by glowing of the alert light 170 as shown in Figure 1C, or by displaying an alert text message in the indicator unit 130, or by glowing a red alert indication in the indicator unit 130, or all simultaneously together as well, for example, thereby enabling the healthcare professionals (users) from avoiding the double puncture of the target vein wherein the healthcare professionals (users) will either stop pushing any further or check for the source of the accidental push to the needle 115 thereby preventing the act of puncturing the second wall 220 of the desired target vein.

[0045] In yet another embodiment of the present disclosure, the indicator unit 130 includes indicator lights for indicating the intended successful puncturing of only the first wall 205 of the target vein. In this proposed embodiment, the microcontroller 125 is further configured to light up the aforementioned indicator lights of the indicator unit 130 in a predefined sequence corresponding to each step during the IV cannulation procedure thereby providing confirmation of completion of each of the IV cannulation steps in the entire process sequentially to ascertain that double puncture, that is, puncture of the second wall 220 of the desired target vein, is avoided and restricted. In one implementation, indicator lights of four colours – yellow, orange, green and red are used to indicate stages of the IV cannulation procedure, for example. Further in one embodiment, the switch 160 as shown in Figure 1C is provided for activating the electronic components of the needle unit 110 and to switch on the enablement of the above-described steps of the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within the catheter 105. When the switch 160 is switched ON, upon the connection being established to the inbuilt battery module 155 serving as the power source, the programmed or configured indicator lights-bearing indicator unit 130 will first display yellow indicator light indicating the device readiness for going ahead with the IV cannulation procedure. When the tip of the needle 115 establishes contact with the first wall 205 of the desired target vein via the healthcare professional (user), the pressure sensor(s) 120 sense(s) the first pressure (that is, high pressure) generated by a resistance encountered by the needle 115 while piercing the first wall of the target vein and send(s) signals to the microcontroller 125 which is programmed or configured to light up the next orange indicator light, for example. Further, the orange indicator light being switched on indicates that the desired target vein has been located and reached at successfully. Next, when the needle 115 of the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within its catheter 105, pierces / punctures the first wall 205 of the target vein, the pressure sensor(s) 120 sense(s) the second pressure (that is, lower pressure) perceived by a loss or drop in resistance from puncturing the first wall 205 of the target vein and send(s) signals to the microcontroller 125 programmed or configured to light up the next green indicator light, for example, indicating the successful entry of the needle 115 into the lumen 225 of the target vein. This green indicator light getting switched on will be the final step required as the confirmation of the puncture of only the first wall 205 of the target vein. The needle 115 of this cannulationdevice 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within its catheter 105, may at this stage be angulated, lowered, or positioned more appropriately accordingly to advance further into the lumen 225 of the target vein for better positioning of the IV cannulation device 100, and the needle 115 may be removed thereafter thereby completing the entire desired cannulation procedure successfully. Further, the next and the last red light indicator is provisioned to be turned on for indicating an alert mechanism against a possible scenario of double puncturing of the target vein (that is, piercing of the second inner wall 220 in addition to the first outer wall 205) due to distractions, patient movements, or due to an external stimulus in the form of any untoward, undesirable accidental or deliberate further push of the needle which can lead to inadvertent double puncture of the target vein during the IV cannulation procedure. It is to be mentioned here that the red light is only intended to serve as an alert mechanism provisioned or configured to light up as the last light after all the other above-described lights have turned on earlier sequentially and only when further push is applied accidentally or deliberately to the needle via an external force to an extent that it encounters the second wall 220 of the target vein. Furthermore, it is to be mentioned here that the red light is not provisioned to indicate successful IV cannulation procedure, that is, the puncture of only the first wall 205 of the target vein, but is instead provisioned to come into play only when chance of puncture of the second wall 220 of the same target vein gets created or appears after the intended successful IV cannulation procedure has been achieved, so that the healthcare professional (user) is alerted to restrict, restrain, avoid and prevent double puncturing of the same target vein from occurring. Therefore, when the green light gets switched on, the IV cannulation procedure can be considered to be successful, and the healthcare professional (user) need not wait for the red light to be switched on or try to push the needle 115 any further to test for the red alert light to be switched on. The lighting up of the green light after the orange light, which in turn had turned on after yellow light, marks the successful culmination of the IV cannulation procedure, with the needle 115 of the cannulation device 100 housing the pressure sensor(s)- bearing needle unit 110 that is removably disposed within the catheter 105, having successfully reached and lodged into the lumen 225 of the desired target vein upon puncturing only its first wall 205 of the target vein.

[0046] Figure 3 shows a flowchart illustrating a method for assisting a healthcare professional (user) in IV cannulation, in accordance with an embodiment of the present disclosure. Initially during the IV cannulation procedure, a healthcare professional (user) selects a target vein of a subject and positions the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within its catheter 105. In one implementation, the cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within its catheter 105, may be equipped with near-infrared (NIR) light to illuminate the target vein, thereby aiding in optimal visualization. Then the healthcare professional (user) applies gentle pressure and begins to prick the first wall 205 of the target vein with the needle 115 of the cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 that is removably disposed within the catheter 105. As the needle 115 begins to prick the first wall of the target vein, the pressure sensor(s) 120 sense(s) the first pressure generated by the resistance encountered by the needle 115, as shown at step 305, and the sensed pressure is communicated to the microcontroller 125.

[0047] Once the needle 115 pricks the first wall 205 of the target vein, the resistance drops and hence the pressure as well accordingly. At step 310, the pressure sensor(s) 120 detects the second pressure generated as a drop in resistance after puncturing the first wall 205 of the target vein and the sensed pressure is communicated to the microcontroller 125.

[0048] On measuring the sensed (that is, detected) first pressure and the second pressure values, the microcontroller 125 indicates a successful puncturing of only the first wall 205 of the target vein based on the detected and measured first pressure and the second pressure for assisting the healthcare user in IV cannulation. In one implementation, the microcontroller 125 indicates the successful puncturing of only the first wall 205 of the target vein upon measuring the second pressure, lower than the first pressure, after the needle 115 encountered a maximum resistance while piercing a first wall 205 of the target vein. In another implementation, the microcontroller 125 compares the first pressure and the second pressure and indicates the successful puncturing of only the first wall 205 of the target vein if the result of comparison is greater than a predefined pre-set threshold pressure. The successful puncturing of only the first wall 205 of the target vein is indicated as feedback to the healthcare professional (user) via a corresponding indication on the indicator unit 130 as described in the present disclosure.

[0049] Embodiments of the present disclosure further disclose a needle unit illustrated in Figure 4A for use with an IV cannulation device for assisting a healthcare professional (user) in IV cannulation. The disclosed needle unit illustrated in Figure 4A, may be used with the IV cannulation device 100 disclosed in the present disclosure by replacing its pressure sensor(s)- bearing needle unit 110 or may be used with any known IV cannulation devices, with minor or no modifications.

[0050] Figure 4A illustrates an enameled (that is, insulated) conductive wire-bearing needle unit that is to be removably disposed within the catheter of an IV cannulation device for assisting a healthcare professional (user) in IV cannulation, in accordance with yet another embodiment of the present disclosure. It is to be noted that the enameled (that is, insulated) conductive wire-bearing needle unit 400 illustrated in Figure 4A may be used with the catheter 105 shown in Figures 1A and 1B. As shown, in one embodiment of the present disclosure, the needle unit 400 includes a needle 405, a conductive wire 410 having its tip (that is, one end) 410-A left uninsulated or non-enameled while its major portion 415 till its other end portion 410-B kept insulated or enameled and mounted on an insulating material 420. The needle unit 400 further includes a battery module 425 and an indicator unit 430. Further, the same described needle unit 400 may include other elements such as but not limited to a bushing 435, a needle grip 440, a flashback chamber 445 and a luer lock plug 450 as shown. In one embodiment of the present disclosure, the conductive wire 410 is disposed inside the needle 405 substantially along the longitudinal axis of the needle 405. Further, the conductive wire 410 is insulated or enameled from an inner surface of the needle 405, with only the tip (that is, one end) 410-A of the conductive wire 410 being left uninsulated or non- enameled. The portion of the conductive wire 410 extends beyond the insulated or enameled portion 410-B and insulating material 420 as an uninsulated or non-enameled end 410-C to be electrically connected to the battery module 425.

[0051] Further, a first terminal (either positive or negative terminal) of the battery module 425 is electrically coupled to the conductive wire 410 at extended uninsulated or non- enameled end 410-C as mentioned earlier, and a second terminal (that is, the other negative or positive terminal accordingly) of the battery module 425 is electrically connected to the indicator unit 430. Furthermore, the placement of conductive wire 410 within the needle 405is achieved in a manner that it is mounted at its insulated or enameled portion 410-B on an insulating material 420 joined at the other (that is, ‘rear’ or ‘distal’) end of the needle 405 such that the uninsulated or non-enameled tip part 410-A of conductive wire 410 is not in contact at all with an inner wall of the conductive needle 405 of the needle unit 400. The other (that is, the ‘rear’ or ‘distal’) end of the needle 405 where the insulated or enameled portion 410-B of the conductive wire is to be mounted, is a sealed dead-end such that the blood after puncture of the desired target vein upon entry into the needle 405 cannot flow further to reach the flashback chamber 445. That is, only the extended uninsulated or non- enameled end 410-C of the conductive wire 410 is allowed entry beyond the insulating material 420 into the flashback chamber 445 that accommodates the battery module 425 and indicator unit 430, with the indicator unit 430 electrically connected to the battery module 425. During the IV cannulation procedure, when the healthcare professional (user) pricks the first wall 205 of the target vein, the blood from the target vein flows into the needle 405. The blood flowing into the needle 405 establishes a conductive path thereby completing the electrical circuit between the uninsulated or non-enameled tip part 410-A of the conductive wire 410 and the needle 405 to activate the indicator unit 430. The indicator unit 430 may be an indicator light, for example. Hence, the disclosed needle unit 400 provides real-time feedback to the medical professional (user) on the successful puncturing of the first wall 205 of the target vein, thereby negating the urge from the medical professional’s (user’s) end to push further to eventually prevent double puncturing of the target vein.

[0052] In one embodiment of the present disclosure, the tip of the needle 405 includes a funnel structure to its proximity to converge the blood entering the needle 405 from the pierced target vein and to direct it towards the uninsulated or non-enameled tip 410-A of the conductive wire 410. Figure 4B shows the diagrammatic representation of the needle 405 of the needle unit 400 described in Figure 4A with the insides of the needle 405 having a funnel structure 455, in accordance with an embodiment of the present disclosure. As shown, the needle 405 includes a funnel structure 455 near its tip, wherein a wider mouth of the funnel structure 455 is towards the proximal end (which punctures / pierces the desired target vein) of the needle 405 and a narrow end of the funnel structure 455 is towards the distally located uninsulated or non-enameled tip 410-A of the conductive wire 410. When the healthcare professional (user) pierces the first wall of the target vein, the blood entering the needle 405from the pierced target vein gets converged and all the entered blood is directed towards the uninsulated or non-enameled tip 410-A of the conductive wire 410. With this whole set-up being connected to the battery module 425 and the indicator unit 430 as explained earlier, the indicator unit 430 gets activated wherein for example, the indicator unit 430 may be an indicator light, thereby indicating the successful piercing of only the first wall of the target vein.

[0053] The funnel structure 455 is aimed to hasten the process of confirmation of the puncture / piercing of the first wall of the desired target vein as the blood entering the needle 405 from the punctured / pierced target vein with great pressure will get channelized towards the uninsulated or non-enameled tip 410-A of the conductive wire 410.

[0054] The funnel structure 455 is chosen so that it helps to avoid sudden changes in the flow direction of the blood as it starts to move into the needle 405 from the punctured / pierced desired / target vein. This funnel design is a part of the needle 405 itself, wherein using micro- drilling technique for example, a desired funnel design is achieved to facilitate rapid confirmation of the successful puncture of the first wall of the desired target vein.

[0055] In another embodiment of the present disclosure, the tip of the needle 405 includes an inverted funnel structure to its proximity which directs the blood entering the needle 405 from the pierced target vein towards the uninsulated or non-enameled tip 410-A of the conductive wire 410 with greater pressure. Figure 4C shows the diagrammatic representation of the needle 405 of the needle unit 400 described in Figure 4A with the insides of the needle 405 having an inverted funnel structure 460, in accordance with an embodiment of the present disclosure. As shown, the needle 405 includes an inverted funnel structure 460 near its tip, wherein a narrower end of the inverted funnel structure 460 is towards the proximal end (which punctures / pierces the desired target vein) of the needle 405 and a wider mouth of the inverted funnel structure 460 is towards the distally located uninsulated or non-enameled tip 410-A of the conductive wire 410. The uninsulated or non-enameled tip 410-A of this enameled conductive wire 410, is mounted at its portion 410-B on the insulating material 420 joined at the other (that is, ‘rear’ or ‘distal’) end of the needle 405. The portion of the conductive wire 410 extends beyond the insulated or enamelled portion 410-B and insulating material 420 as the uninsulated or non-enameled end 410-C to be electrically connected to thebattery module 425 which in turn is electrically coupled to the indicator unit 430. The uninsulated or non-enameled tip 410-A of this enameled conductive wire 410 will be provisioned to be protruding into the wider mouth of the inverted funnel structure 460 facing the piercing / puncturing end of the needle 405 waiting to come in contact with the conductive blood entering the needle 405 from the pierced / punctured target vein. When the healthcare professional (user) pierces the first wall of the target vein, the blood entering the needle 405 from the pierced target vein enters the narrower end of inverted funnel structure 460 and gets directed with pressure towards the uninsulated or non-enameled tip 410-A of the conductive wire 410. With this whole set-up being connected to the battery module 425 and the indicator unit 430 as explained earlier, the indicator unit 430 gets activated wherein for example, the indicator unit 430 may be an indicator light, thereby indicating the successful piercing of the first wall of the target vein.

[0056] The inverted funnel structure 460 is aimed to hasten the process of confirmation of the puncture / piercing of the first wall of the target vein even in cases of IV cannulas bearing shorter needle diameters wherein blood entering the needle from the punctured / pierced target vein with great pressure, meets the protruding uninsulated or non-enameled tip 410-A of the enameled conductive wire 410 instantly.

[0057] As described, the pressure sensor(s)-bearing needle unit 110 that is to be removably disposed within the catheter 105 of an IV cannulation device 100 disclosed in the present disclosure includes one or more pressure sensor(s) 120 which sense(s) pressure generated by resistance (first pressure) encountered by the needle 115 of the needle unit 110. Further, the one or more pressure sensor(s) 120 are also configured for detecting a second pressure generated by a drop in resistance after puncturing the first wall of the target vein. These sensed (that is, detected) pressures are measured using the microcontroller 125 and the microcontroller 125 provides real-time feedback to the healthcare professional (user) on successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare professional (user) by ensuring accurate and successful required puncture of the target vein (that is, IV cannulation procedure) thereby also facilitating prevention of puncture of the second wall of the target vein.

[0058] The described inbuilt battery modules 155 in Figure 1C, Figure 1D, or both, and 425 in Figure 4A (that is, the power unit powering the microcontrollers, switch, power-on light, alert light, display on the indicator units, indicator units in the described embodiments) essentially having a low voltage will in no manner affect the electrical conductivity of the heart and / or the cardiovascular system, or the body functions which are the physiological functions of the various body systems, and the body in general, and is therefore perceived to be safe for operation and use.

[0059] In one embodiment of the present disclosure, a quick response (QR) code or a barcode or the cannulation device labelling approach can be printed / embossed / assigned on IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 or an enameled conductive wire-bearing needle unit 400 that is to be removably disposed within its respective catheter so that a unique code gets assigned to the IV cannulation device. The unique code assigned will facilitate the tracking and retrieving information on usage, which may be used for audit purposes as and when required. This will even ensure compliance of usage as well as aid to nullify inappropriate usages of the IV cannulation devices.

[0060] In one preferred embodiment, the battery module powering the indicator unit, and the indicator unit are included within the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 or an enameled conductive wire-bearing needle unit 400 that is to be removably disposed within the catheter 105 of the cannulation device 100. However, said elements, that is the battery module powering the indicator unit, and the indicator unit as well may also be configured to be external to the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 or an enameled conductive wire- bearing needle unit 400 that is to be removably disposed within its catheter 105, and communicated using wired or wireless communication means. In such cases, the requirement of external standalone batteries or battery modules and power sources along with external indicator lights are to be provisioned and hence the described IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 or an enameled conductive wire- bearing needle unit 400 that is to be removably disposed within its catheter described in the present disclosure now devoid of inbuilt battery units or battery modules and indicator lights, will be dependent on external battery source (that is, battery units and modules) and indicator lights to confirm puncture / piercing of only the first wall of the desired target vein andfacilitate subsequent prevention of puncture of the second wall of the same desired target vein.

[0061] Additional provision for all the previously described embodiments of the IV cannulation device 100 housing the pressure sensor(s)-bearing needle unit 110 or an enameled conductive wire-bearing needle unit 400 that is to be removably disposed within its catheter 105 may be added or arranged with wired or wireless connectivity to pair with mobile phones, desktops, laptops, iPads, digital notebooks, tablets, etc. for further processing, data analyses, cloud computing and data storage as well as to export the data to the health records management systems of the patients or the patients’ healthcare practitioners (HCPs) located at any geographical location.

[0062] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught and described herein.

[0063] The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any block diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure(s), dimension(s), and / or use of material(s), are possible. The scope of the described embodiments is at least as broad as given by the following claims.

Claims

I Claim:

1. An intravenous cannulation device (100) for assisting a healthcare user in intravenous cannulation, the device (100) comprises: a catheter (105); a needle unit (110) removably disposed within the catheter (105); one or more pressure sensors (120) disposed in the needle unit (110), wherein the one or more pressure sensors (120) are configured for detecting a first pressure generated by a resistance encountered by a needle (115) of the needle unit (110) while piercing a first wall of a target vein and a second pressure generated by a drop in resistance after puncturing the first wall of the target vein; and a microcontroller (125) communicatively connected to the one or more pressure sensors (120), wherein the microcontroller (125) is configured for: measuring the detected first pressure and the second pressure; and indicating, on an indicator unit (130), a successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation.

2. The intravenous cannulation device (100) as claimed in claim 1, wherein the microcontroller (125) and the indicator unit (130) are disposed on the needle unit (110).

3. The intravenous cannulation device (100) as claimed in claim 1, wherein the one or more pressure sensors (120) are disposed at or proximate to the tip of or along the needle (115) of the needle unit (110), or at a junction of the needle unit (110) and the needle (115), or in the bushing (135) of the needle unit (110), or in between the needle (115) and the bushing (135).

4. The intravenous cannulation device (100) as claimed in claim 1, wherein the indicator unit (130) comprises one or more of a display unit, one or more of indicator lights, one or more of vibrators, and one or more of auditory indicators.

5. The intravenous cannulation device (100) as claimed in claim 1, wherein indicating the successful puncturing of the first wall of the target vein based on the measured firstpressure and the second pressure for assisting the healthcare user in intravenous cannulation comprises: indicating the successful puncturing of the first wall of the target vein upon measuring the second pressure, lower than the first pressure, after the needle (115) encounters a maximum resistance while piercing a first wall of the target vein.

6. The intravenous cannulation device (100) as claimed in claim 1, wherein indicating the successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation comprises: comparing the detected and measured first pressure and the second pressure; and indicating the successful puncturing of the first wall of the target vein if a result of comparison is greater than a predefined pre-set threshold pressure for that target vein.

7. The intravenous cannulation device (100) as claimed in claim 1, wherein the removably disposable needle unit (110) comprises: a flashback chamber (145) accommodating the battery module (155) and the indicator unit (130); and a luer lock plug (150) coupled to the flashback chamber (145).

8. A method for assisting a healthcare user in intravenous cannulation, the method comprises: measuring a first pressure generated by a resistance encountered by a needle of a cannulation device while piercing a first wall of a target vein; measuring a second pressure generated by a drop in resistance after puncturing the first wall of the target vein; and indicating a successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation.

9. The method as claimed in claim 8, wherein indicating the successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation comprises: indicating the successful puncturing of the first wall of the target vein upon measuring the second pressure, lower than the first pressure, after the needle (115) encounters a maximum resistance while piercing a first wall of the target vein.

10. The method as claimed in claim 8, wherein indicating the successful puncturing of the first wall of the target vein based on the measured first pressure and the second pressure for assisting the healthcare user in intravenous cannulation comprises: comparing the detected and measured first pressure and the second pressure; and indicating the successful puncturing of the first wall of the target vein if a result of comparison is greater than a predefined pre-set threshold pressure.

11. A needle unit (400), for use with a cannulation device, for assisting a healthcare user in intravenous cannulation, the needle unit (400) comprises: a needle (405); a conductive wire (410) disposed inside the needle (405) substantially along the longitudinal axis of the needle (405) and is insulated from an inner surface of the needle (405), with only the tip (410-A) of the conductive wire (410) being uninsulated; a battery module (425), wherein a first terminal of the battery module (425) is electrically coupled to the conductive wire (410); and an indicator unit (430) electrically connected to a second terminal of the battery module (425); wherein a conductive fluid flowing into the needle (405) establishes a conductive path thereby completing the electrical circuit between the uninsulated tip (410-A) of the conductive wire (410) and the needle (405), to activate the indicator unit (430).

12. The needle unit (400) as claimed in claim 11, wherein the conductive fluid is blood.

13. The needle unit (400) as claimed in claim 11, wherein the needle (405) comprises a funnel structure (455).

14. The needle unit (400) as claimed in claim 11, wherein the needle (405) comprises an inverted funnel structure (460).

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