A two-way needle device (10) for auto-aspiration of the blood and injecting drug and a method thereof

Abstract

A two-way needle device (10) for auto-aspiration of the blood and injecting drug and a method thereof The present disclosure relates to a two-way needle device (10) for auto-aspiration of the blood and injecting drug and a method thereof. The device (10) comprising a tubular central hub (1), and at least one side tube (2) connected to a vacuum chamber (2a), configured at the middle part of the tubular central hub (1), for the auto-aspiration of blood in a separate compartment. The tubular central hub (1) consisting of a conical plug (6), and pair of needles. The method and device solves the problem of checking the anatomical location where needle is directed before injecting the drug for safety, enable auto aspiration of blood in a separate compartment without mixing with the main drug. Further, any change in grip is not required for doing aspiration during the guided injection.

Description

[0001] TITLE

[0002] A two-way needle device (10) for auto-aspiration of the blood and injecting drug and a method thereof

[0003] FIELD

[0004] The present invention relates to the field of medical devices, particularly to a two- way needle device for the auto-aspiration of blood and injecting drug, and a method thereof. In particular, the two-way needle device and method enables auto-aspiration of blood is in separate compartments, followed by injecting the drug in the blood vessel.

[0005] DEFINITION

[0006] As used in the present disclosure, the following term is generally intended to have the meaning as set forth below, except to the extent that the context in which it is used indicates otherwise.

[0007] Systemic toxicity refers to drug related toxicity, upon administration of drug or any other contamination in the blood vessel during injection procedure;

[0008] Guided injection refers to injection procedures wherein the tip of needle is seen in real time reaching the desired anatomical location of injection or aspiration using a imaging modality like ultrasonography, radiography or cone beam computed tomography;

[0009] Aspiration refers to an injection practice to ensure that the tip of needle is located at the desired site, and not accidentally puncture a blood vessel. As per current practices, aspiration is done by pulling the plunger of the syringe back for 5-10 seconds, thereby generating a negative pressure inside the syringe before injecting the drug or medication inside the body. A flash of blood appears into the hub or syringes thereby confirming the position of needle tip inside the body.

[0010] BACKGROUND The background information herein below relates to the present disclosure but is not necessarily prior art.

[0011] The systemic toxicity due to accidental injection of drugs into the systemic circulation during deep injections was reported. Though, the severity of complications depends on the type and amount of drug injected into the circulation, the systemic toxicity are complicated, and may have serious concerns. Ankur Gosalia MD et. al. reported that the accidental intravascular injection of bupivacaine or toxic doses of bupivacaine can induce potentially lethal ventricular dysrhythmias. Such dysrhythmias are characteristically non-reversible and, thus, are frequently fatal.

[0012] Further, in case of injection procedures, wherein the positive blood aspiration is desired, the main drug gets contaminated with the blood. The contaminated drugs are to be discarded and again the procedure is repeated. Further, the operator also needs to change the grip on syringe for aspirating procedure before injecting any drug or medication into the body. The change in grip may deviate the needle tip from the target location which can result in local trauma and pain.

[0013] This is more common, particularly in the case of guided injection procedures like ultrasound or CT guided as the other hand of the operator is used to hold the ultrasound probe, and stabilize the patient respectively. In current practice, the operator needs to aspirate initially as per the standard operating protocols (SOP) before injecting the drug. If blood comes into the drug section of the syringe, then operator needs to throw away the whole setup and start with the new one (and repeats the procedure). This increases the time of procedure and more pricks to the patient which adds to the anxiety of the patient. The prolonged procedure time, or even the failed or incomplete procedures, accidental puncture of blood vessels or nerve bundles, poor sample retrieval causes the delayed diagnosis. Therefore, the use of the conventional syringe for injection and aspiration is largely attributable only to its low cost, widespread availability and lack of an effective alternative. Srikar Adhikari, Michael Blaivas in their book, the Ultimate Guide to Point-of- Care Ultrasound-Guided Procedures, 2020 clearly states that, ‘the clinician should always aspirate before placing the anaesthetic to ensure lack of vascular puncture as well as clearly visualize anechoic aesthetic spread on the ultrasonic screen’, during the guided injection procedures.

[0014] In recent years, a few of the syringes with automatic aspiration or injection procedures have been proposed and developed. A reference can be made to, W02014005058A1 for the aspirating syringe for obtaining fluid samples. The fluid sampling device known consists of the syringe body, a needle connected to the syringe body and fluidly connected to a fluid source. The stem is moving under the force of at least one energized spring, and is creating a vacuum. However do not mention the auto aspiration of the fluid sample, when a drug is injected for the guided injection procedures. The invention does not describe the aspiration procedure done before injecting drug or medication to ensure position of needle tip into the body.

[0015] Further, US20110087173 Al also refers to automatic syringes that can be held with one hand in a pencil-grip in which the fingers (thumb or index finger) operate a forwardly based valve that along with selection of needle diameter and length, control the ingress or egress of fluid from the automatic syringe. The objection of the device is for the method of assembling a syringe, comprising mounting the spring with the plunger body, inserting the plunger body and spring into the barrel, compressing the spring, and engaging the locking mechanism. The automatic syringes can be held with one hand in a pencil grip, in which the fingers operator forwardly based valve that along with selection of needle diameter and length, control the ingress or egress of fluid from the automatic syringe. The invention does not describe the aspiration procedure done before injecting the drugs or medications during the procedure.

[0016] Further, in the disclosure of US3910273, an Aspirating Hypodermic Syringe is presented, wherein a cylindrical ampule having a displaceable plunger which is connectable to a piston rod and indented for closing one of its ends. Although the invention describes as there is no need to change the grip for aspiration before injecting the drug and it uses hand on syringe approach and no separate compartment for blood aspiration exists thereby mixing of blood happens with the main drug in case of positive aspiration. US 2014 / 0058252 also discloses single hand control device for ultrasound guided injections

[0017] Similarly, one commercial auto-aspirating syringe, Aspiject by Ronvig Dental is available. The auto-aspirating syringes come with the pre-loaded drug cartridge system. This makes the solution specific to certain therapies. Also, there is no separate compartment for the positive blood aspiration. Hence the drug needs to be discarded in case of blood mixing with it.

[0018] Furthermore, EP3326673B1 refers to the Syringes, syringe interfaces and syringe plungers for use with medical injectors. However, the syringe and the injection procedure fail to mention the injecting drug and blood aspiration methods to avoid systemic toxicity. The commercially available syringes are designed for injection procedure. Also, many studies conclude that the conventional syringe is a poorly controlled and non-ergonomic device during aspiration.

[0019] Therefore, there is felt a need to provide a solution to minimize the potential risks of systemic toxicity, and also overcome drawbacks in the conventional injection procedures for auto-aspiration of the blood and injecting drug.

[0020] OBJECTS

[0021] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

[0022] An object of the present invention is to provide a two-way needle device for autoaspiration of the blood and injecting drug and a method thereof. Another object of the present invention is to provide a two-way needle device comprising comprising a tubular central hub consisting of consisting of a conical plug along with the axis of the tubular central hub, configured with a first needle having a needle tip, extended towards a second needle.

[0023] Another object of the present invention is to provide a two-way needle device comprising a tubular central hub; and at least one side tube connected to a vacuum chamber, configured at the middle part of the tubular central hub, for the autoaspiration of blood in a separate compartment.

[0024] Another object of the present invention is to provide a two-way needle device, and a method to avoid systemic toxicity and drug contamination during auto aspiration of blood, and drug injection during the injection procedures.

[0025] Still another object of the present invention is to provide a two-way needle device and method to create a differential pressure by the vacuum chamber for autoaspiration of blood when the second needle tip is into the blood vessel before injecting the drug.

[0026] Yet another object of the present invention to provide a two-way needle device with a separate outlet for the vacuum chamber, wherein the second needle reaches the anatomical location and creates a higher a pressure gradient for aspiration of blood before injecting the drug.

[0027] Yet another object of the present invention to provide and a two-way needle device and method based on two concentrically arranged needles of different gauzes for auto aspiration of blood in a middle chamber, followed by drug injection.

[0028] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

[0029] SUMMARY The present disclosure relates to a two-way needle device (10) for auto-aspiration of blood and injecting drug and a method thereof.

[0030] The two-way needle device (10) for auto-aspiration of blood and injecting drug comprising of a tubular central hub (1), consisting of a conical plug (6) at the centre, along with the axis of the tubular central hub (1), configured with a first needle, the second needle (3) and side tube (2) connected to a vacuum chamber (2a). The first needle is having a needle tip (6a), extended towards a second needle (3). The second needle (3) at a distal end (la) consisting of a needle tip (3b), and proximal end of needle (3a). Optionally, there is at least one syringe in a syringe hub at the proximal end (lb) of the tubular central hub (1).

[0031] The device comprises at least one side tube (2) connected to a vacuum chamber (2a), configured at the middle part of the tubular central hub (1), for the autoaspiration of blood in a separate compartment. The first and the second needle are concentrically arranged. The first needle of smaller gauge size is concentrically extended, inside the proximal end (3a) of the second needle (3) of higher gauge size.

[0032] The conical plug (6) further comprises a middle chamber (8), as a separate compartment configured for the appearance of flash of blood in case the needle tip (3b) of the second needle (3) enters the blood vessels.

[0033] The side tube (2) comprising a side locking arm (4); a cylindrical plug (4a); a rubber ring (4b); an open coil spring (7); and an end plug (5).

[0034] The method for auto-aspiration of blood and injecting drug comprising the steps of loading a drug using a syringe hub at the proximal end (lb) of tubular central hub (1) for a filled syringe. Further, the filled syringe is attached to the two-way needle device (10). The second needle is injected and there is waiting for time period up to 1 to 5 seconds for the flash of blood appearing in the middle compartment (08), before injecting the drug. The side arm (4) is activated in case of the critical anatomical location and the smaller vessels. The drug is injected upon confirmation of the position of the second needle tip (3b) inside the blood vessel. The method is an auto-aspiration of blood in the middle chamber (8), as the separate compartment and injecting drug into the desired anatomical site.

[0035] The two-way needle device (10) and the method are for blind procedures and guided injection procedure. The device avoids systemic toxicity, and drug-blood mixing during the injection procedures.

[0036] DESCRIPTION OF THE ACCOMPANYING DRAWING

[0037] The two-way needle device (10) and method of the present disclosure will now be described with the help of the accompanying drawing, in which:

[0038] Figure 1 illustrates two-way needle device (10) for auto-aspiration of blood and injecting drug in accordance with the present disclosure;

[0039] The central hub (1) is a tubular structure, which is attached to a syringe hub at proximal end (lb), while a modified step second needle (3) is attached to the distal end (la). The central hub at its middle part opens a side tube (2). The side tube is connected to a vacuum chamber (2a). This vacuum chamber creates a differential pressure in the middle chamber of the central hub which can draw the blood via a first needle tip into blood vessels.

[0040] Figure 2 illustrates bottom view of two-way needle device (10) in accordance with the present disclosure;

[0041] The conical plug (6) is fixed in the centre of the central hub along the long axis of the central hub (1). The conical plug (6) is has a first needle tip (6a) extending to few millimetres at the centre towards the outer needle (3).

[0042] Figure 3 illustrates top view of two-way needle device (10) in accordance with the present disclosure;

[0043] Figure 4 illustrates cross-sectional view of two-way needle device (10) in accordance with the present disclosure; A conical plug (6) is fixed in the centre of the central hub along the long axis of the central hub. This plug forms a separate compartment as a middle chamber (8) for the flash of blood appearing in cases of needle tip entering the blood vessels. The conical plug 6 is has a needle tip 6a extending to few millimetres at the centre towards the outer needle 3. This needle is of smaller gauge 6a (24 gauge) and enters concentrically inside the bigger gauge needle 3a of central hub connected at the distal end la. The modified step needle 3 is specially designed with a large gauge needle 3a (17 gauge), which continue to a lesser gauge 3b needle. The size of the lesser gauge needle 3b varies from 21 gauges to 26 gauges and with various lengths, as suited for different procedures like injections or body fluid aspirations. Both this needles are concentrically arranged with some overlapping, creating a unique arrangement so that the injecting drug or medication does not enter the side tube.

[0044] The central hub at its middle part opens a side tube 2. The side tube is connected to a vacuum chamber 2a. This vacuum chamber creates a differential pressure in the middle chamber of the central hub which can draw the blood is needle tip is into blood vessels. However, in cases of smaller blood vessels where the vacuum is not able to create the pressure gradient, negative pressure can be generated using an open coils spring 7 activated piston assembly positioned in the side tube 2a.

[0045] The vertical part 2a of the side tube in embodiment 1 contains a vacuum tube while in embodiment 2 contain a cylindrical plug 4a with a rubber ring 4b. There is a side arm 4 existing out of the vertical side tube through an elongated slot 9. Herein an open coil spring 7 is placed in at the distal side of the cylindrical plug 4b. The cylindrical plug is moved at locked at a more distal end of the elongated slot, which energies the open coil spring.

[0046] Figure 5 illustrates side view of the cylindrical plug with side arm of the two-way needle device (10) in accordance with the present disclosure; Figure 6 illustrates side view of the conical plug (6) of two-way needle device (10) in accordance with the present disclosure;

[0047] Figure 7 illustrates side view of the modified step needle of two-way needle device (10) in accordance with the present disclosure; and

[0048] Figure 8 illustrates the explosion view of two-way needle device (10) in accordance with the present disclosure.

[0049] Reference Numerals:

[0050] DETAILED DESCRIPTION

[0051] Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well- known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0052] The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

[0053] There are lots of cases reported with systemic toxicity due to accidental injection of drug into the systemic circulation during the deep body injections. The severity of such complications depends on the type and amount of drug injected into the circulation. Further, in case of positive blood aspiration the main drug gets contaminated which needs to be discarded and again the procedure is to be repeated. The operator needs to change the grip on syringe for the aspirating procedure before injecting the drug into the body. The change in grip may also deviate the needle tip from the target location which results in the mishaps during injection procedures, and also leads to inadequate therapeutic response. This is more common in the case of the guided injection procedures like ultrasound or CT, as the other hand of the operator is used to hold the ultrasound probe or stabilize the patient respectively. In current practice, the operator needs to aspirate initially as per the standard operating protocols (SOP) before injecting the drug. If blood comes into the drug section of the syringe, then operator needs to throw away the whole setup and start with the new one (and repeats the procedure). This increases the time of procedure and more pricks to the patient which adds to the anxiety of the patient. The present invention refers to the practices of injecting drug using hypodermic syringes. Injections are used to administer drugs or medication, through puncturing the skin using syringes with hypodermic needles of different size. The same syringe is also used to aspirate body fluids like blood, amniotic fluid, intrathecal fluid etc., in different volumes from various anatomical sites into the body. Therefore, the present disclosure provides a two-way needle device (10) for auto-aspiration of the blood and injecting drug and a method thereof.

[0054] In an aspect of the present disclosure, there is provided two-way needle device (10) for auto-aspiration of blood and injecting drug.

[0055] In an embodiment, the two-way needle device (10) for auto-aspiration of blood and injecting drug comprising: a. a tubular central hub (1) consisting of: i. a conical plug (6) at the centre, along with the axis of the tubular central hub (1), configured with a first needle having a needle tip (6a), extended towards a second needle (3); and ii. the second needle (3) at a distal end (la) having a needle tip

[0056] (3b), and proximal end of needle (3a); iii. optionally, at least one syringe in a syringe hub at the proximal end (lb), and b. at least one side tube (2) connected to a vacuum chamber (2a), configured at the middle part of the tubular central hub (1), for the auto-aspiration of blood in a separate compartment, wherein, the first and the second needle are concentrically arranged. In an embodiment, the conical plug (6) further comprises a middle chamber (8), as a separate compartment configured for the appearance of flash of blood in case the needle tip (3b) of the second needle (3) enters the blood vessels.

[0057] In an embodiment, the side tube (2) comprising a side locking arm (4); a cylindrical plug (4a); a rubber ring (4b); an open coil spring (7); and an end plug (5).

[0058] In an embodiment, the vacuum chamber (2a) creates a differential pressure for auto-aspiration of blood when the second needle tip (3b) is into the blood vessel before injecting the drug, wherein the second needle (3) reaches the anatomical location and creates a higher a pressure gradient for aspiration of blood before injecting the drug.

[0059] In an embodiment, the anatomical location is selected from the joint space, tendons, nerves, and the like.

[0060] In an embodiment, the negative pressure is generated in case of smaller blood vessels, the open coil spring (7) and the side locking arm (4) lock is released

[0061] In an embodiment, the first needle is having a needle tip (6a) with a gauge size in the range of 22 gauge to 26 gauge; and the second needle (3) at the distal end (3b) is having a gauge size in the range of 18 gauge to 30 gauge, and the proximal end (3a) of the second needle (3) is having gauge size in the range of 15 gauge to 17 gauge

[0062] In an embodiment, the first needle of smaller gauge size is concentrically extended, inside the proximal end (3a) of the second needle (3) of higher gauge size In an embodiment, the the conical plug (6) having a needle tip (6a) is extended to a length in the range of 2mm to 10mm at the centre towards the proximal end (3a) of the second needle (3), wherein the inner smaller gauze first needle extends to the half-length of the outer bigger gauze second needle

[0063] In an embodiment, the injection technique while performing deeper injection and injecting drugs or medications with significant systemic complication, if the drug is directly injected into the blood vessels or systemic circulation.

[0064] In the second aspect of the present disclosure, there is provided a method for autoaspiration of blood and injecting drug.

[0065] In an embodiment, the method for auto-aspiration of blood and injecting drug comprising the steps of: loading a drug using a syringe hub at the proximal end (lb) of tubular central hub (1) for a filled syringe; attaching the filled syringe to the two-way needle device (10); injecting the second needle and waiting for time period up to 1 to 5 seconds for the flash of blood appearing in the middle compartment (08), before injecting the drug. activating the side arm (4) in case of the critical anatomical location and the smaller vessels; and injecting the drug upon confirmation of the position of the second needle tip (3b), wherein the method is an auto-aspiration of blood in the middle chamber (8), as the separate compartment and injecting drug into the desired anatomical site.

[0066] In an embodiment, the auto-aspiration of blood and injecting drug as claimed in claim 9, wherein the side tube having a cylindrical plug is with a side locking arm, positioned at distal end energies the open coil spring; and the lock is released when needle reaches the desired anatomical location to create higher pressure gradient for the aspiration before injecting drug.

[0067] In an embodiment, in case of critical sites with smaller blood vessels, the side tube with energies open coil spring are activated by pressing the finger pad on the side arm of the cylindrical plug to creates more pressure gradient to aspirate blood.

[0068] In an embodiment, the two-way needle device (10) for auto-aspiration of blood and injecting drug is for blind procedures and guided injection procedures.

[0069] In an embodiment, the two-way needle device (10) for auto-aspiration of blood and injecting drug avoids systemic toxicity, and drug-blood mixing during the injection procedures.

[0070] In an embodiment, the two-way needle hub is attached to the syringe filled with drug or medication. After entering the body and if the desired anatomical site is reached the operator waits for 3-5 seconds, for the blood to appear in the middle compartment of the two-way hub and ensure the position of the needle tip inside the body. However, in critical areas / using more cytotoxic drugs / areas with smaller blood vessels the side tube with energies open coil spring can be activated by pressing the finger pad 4 on the side arm 4a of the cylindrical plug 4b. This further creates more pressure gradient to aspirate blood in critical cases. Therein, after confirming the safe position of the needle tip at the desired anatomical location the intended drug or medication can be injected into the body as per the functioning of the syringe. Therein due to concentric needle arrangements and overlapping the drug do not enter the side tube during the procedure.

[0071] The present invention embodies a unique arrangement of needles, and an aspirating mechanism in separate compartment while injecting the drug or medication. The innovation aims to prevent such potential risks of systemic toxicity due to such injection procedures. Also, in provides separate compartment for the aspirated blood during the injection which prevents patient from multiple pricks, saves drug from contamination and saves the time involved in the procedure.

[0072] The two-way needle hub facilitates the aspiration of blood before injection in separate compartment with previously activated plunger located in a side tube of two-way needle hub.

[0073] The arrangement separates the compartment for blood coming if aspiration is positive without mixing with the filled drug or medication. Further the injection procedure is done in the same go without the drug or medication entering the side compartment.

[0074] The operator can perform the procedure with the same pen grip ensuring highest stability of syringe and ease during the procedures. The present invention is not only limited to blind injection procedure but also for guided injection procedures using ultrasound, cone beam computed tomography or radiographs.

[0075] The arrangement creates two chambers, one for aspirated blood 8 and other for injecting drug or medication. In the present invention, in cases of positive aspiration of blood before injection, the blood does not mix with the main drug or medication. Hence, now the operator can redirect the needle tip, ensure the correct position of needle and continue to inject the drug or medication safely. The problem with other conventionally available syringes is that in instances of positive blood aspirations, blood mixes with the main drug or medication causing its contamination which needs to be discarded and again the procedure is repeated, involving one more prick for the patients. Hence the present invention addresses this problem, and the intended use is not limited to injection procedures but also to aspiration of body fluids from the body. Therein, the aspiration can be done in the main connected syringe and the aspirate does not enter the side tube due to higher pressure gradient at the syringe side.

[0076] The design of the present invention meets the technical requirement as per injection moulding method and is further simplifies as per user comfort and no need to change the grip for aspiration during the procedure. The invention is not limited to the described mechanism of generating pressure gradient at the side tube.

[0077] The present invention applied for both blind procedures as well as guided procedures. Guided procedures are used widely now a day, due to the fact of visualizing the exact anatomical sites of injection in real time, minimally invasive and inherent less complications. Due to the above fact there is increasing adopting for guided procedure and changing government policies for such procedures.

[0078] The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

[0079] The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial / commercial scale and the results obtained can be extrapolated to industrial scale.

[0080] EXPERIMENTS

[0081] Example 1: Method for auto-aspiration of blood and injecting drug

[0082] A drug was loaded using a syringe hub at the proximal end (lb) of tubular central hub (1) for a filled syringe. The filled syringe was attached to the two-way needle device (10). The second needle was injected, and after waiting for minimum 5 seconds for the flash of blood appearing in the middle compartment (08) and the drug was injected. Example 2: Method for auto-aspiration of blood and injecting drug

[0083] A drug was loaded using a syringe hub at the proximal end (lb) of tubular central hub (1) for a filled syringe. The filled syringe was attached to the two-way needle device (10). The side arm (4) of the device was activated. The side locking arm, positioned at distal end energies the open coil spring; and the lock was released when the second needle reaches the desired anatomical location including the joint space to create higher pressure gradient for the aspiration of blood before injecting drug. The drug was injected upon confirmation of the position of the second needle tip inside the blood vessel. The auto-aspiration of blood is in the middle chamber, as the separate compartment.

[0084] TECHNICAL ADVANCEMENTS

[0085] The present disclosure described hereinabove has several technical advantages including, but not limited to, the realization for device and method, which:

[0086] • aspirates blood during the injection;

[0087] • prevents the patient from multiple pricks;

[0088] • Injection procedure to avoid contamination, and

[0089] • saves the time involved in the injection procedure.

[0090] Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising, will be understood to imply the inclusion of a stated element, integer or step,” or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications to the formulation of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of this invention.

[0091] The numerical values given for various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention unless there is a statement in the specification to the contrary. While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

WE CLAIM:

1. A two-way needle device (10) for auto-aspiration of blood and injecting drug comprising: a. a tubular central hub (1) consisting of: i. a conical plug (6) at the centre, along with the axis of the tubular central hub (1), configured with a first needle having a needle tip (6a), extended towards a second needle (3); and ii. the second needle (3) at a distal end (la) having a needle tip(3b), and proximal end of needle (3a); iii. optionally, at least one syringe in a syringe hub at the proximal end (lb), and b. at least one side tube (2) connected to a vacuum chamber (2a), configured at the middle part of the tubular central hub (1), for the auto-aspiration of blood in a separate compartment, wherein, the first and the second needle are concentrically arranged.

2. The two-way needle device (10) as claimed in claim 1, wherein the conical plug (6) further comprises a middle chamber (8), as a separate compartment configured for the appearance of flash of blood in case the needle tip (3b) of the second needle (3) enters the blood vessels.

3. The two-way needle device (10) as claimed in claim 1, wherein the side tube (2) comprising a side locking arm (4); a cylindrical plug (4a); a rubber ring (4b); an open coil spring (7); and an end plug (5).

4. The two-way needle device (10) as claimed in claim 1, wherein the vacuum chamber (2a) creates a differential pressure for auto-aspiration of blood when the second needle tip (3b) is into the blood vessel before injecting the drug.wherein the second needle (3) reaches the anatomical location and creates a higher a pressure gradient for aspiration of blood before injecting the drug.

5. The two-way needle device (10) as claimed in claim 1, wherein a negative pressure is generated in case of smaller blood vessels, the open coil spring (7) and the side locking arm (4) lock is released.

6. The two-way needle device (10) as claimed in claim 1, wherein the first needle is having a needle tip (6a) with a gauge size in the range of 22 gauge to 26 gauge; and the second needle (3) at the distal end (3b) is having a gauge size in the range of 18 gauge to 30 gauge, and the proximal end (3a) of the second needle (3) is having gauge size in the range of 15 gauge to 17 gauge.

7. The two-way needle device (10) as claimed in claim 1, wherein the first needle of smaller gauge size is concentrically extended, inside the proximal end (3a) of the second needle (3) of higher gauge size.

8. The two-way needle device (10) as claimed in claim 1, wherein the conical plug (6) having a needle tip (6a) is extended to a length in the range of 2 mm to 10 mm at the centre towards the proximal end (3 a) of the second needle (3), wherein the inner smaller gauze first needle extends to the half-length of the outer bigger gauze second needle.

9. A method for auto-aspiration of blood and injecting drug comprising the steps of: loading a drug using a syringe hub at the proximal end (lb) of tubular central hub (1) for a filled syringe; attaching the filled syringe to the two-way needle device (10);injecting a second needle of device and waiting for time period up to 1 to 5 seconds for the flash of blood appearing in the middle compartment (08), before injecting the drug. activating the side arm (4) in case of the critical anatomical location and the smaller vessels; and injecting the drug upon confirmation of the position of the second needle tip (3b), wherein the method is an auto-aspiration of blood in the middle chamber (8), as the separate compartment and injecting drug into the desired anatomical site.

10. The method for auto-aspiration of blood and injecting drug as claimed in claim 9, wherein the side tube having a cylindrical plug (4a) is with a side locking arm, positioned at distal end energies the open coil spring; and the lock is released when needle reaches the desired anatomical location to create higher pressure gradient for the aspiration before injecting drug.

11. The method for auto-aspiration of blood and injecting drug as claimed in claim 9, wherein in case of critical sites with smaller blood vessels, the side tube with energies open coil spring are activated by pressing the finger pad on the side arm of the cylindrical plug (4a) to creates more pressure gradient to aspirate blood.

12. The two-way needle device (10) for auto-aspiration of blood and injecting drug as claimed in claim 1 is for blind procedures and guided injection procedures.

13. The two-way needle device (10) for auto-aspiration of blood and injecting drug as claimed in claim 1 avoid systemic toxicity, and drug-blood mixing during the injection procedures.

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