WO2016179280A1

WO2016179280A1 - Hybrid needle system for central venous access

Info

Publication number: WO2016179280A1
Application number: PCT/US2016/030777
Authority: WO
Inventors: Shruthi RAJAN; Madeleine CLEGG; Erin REISFELD; Dhananjay SETHI
Original assignee: The Johns Hopkins University
Priority date: 2015-05-04
Filing date: 2016-05-04
Publication date: 2016-11-10

Abstract

The present disclosure provides a needle device for accessing vasculature. The device includes concentrically arranged syringes and needles to facilitate easier, safer and more controlled access to vasculature, thereby reducing significant harm or risk of fatality to the patient.

Description

HYBRID NEEDLE SYSTEM FOR CENTRAL VENOUS ACCESS

RELATED APPLICATION DATA

[0001] This application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Serial No. 62/156,649, filed May 4, 2015, the entire contents of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION

[0002] The invention relates generally to medical devices and more specifically to a needle device for venous access.

BACKGROUND INFORMATION

[0003] In the United States, the number of pacemaker implantations performed is around 767 per million persons. However, in developing countries like India, this same ratio is only 17 implantations per million persons. There is a significant gap between the number of patients suspected to have bradycardia and the number of patients receiving appropriate therapies in India. Part of this gap is attributed to improper care for patients with bradycardia in emergency or low-resource settings.

[0004] Invasive temporary pacemakers are most commonly inserted via a transvenous approach, where access to the femoral, internal jugular or subclavian vein is gained, and the lead is directed into the heart. Access via the femoral vein is the technique that is most widely taught and used, with hesitations towards the jugular approach due to the proximity of the carotid artery, and an inclination to preserve the subclavian vein for permanent pacing. However, in emergency situations or when cath labs are not available in ill-equipped facilities, these procedures are carried out blindly. Without an imaging modality, physicians have to estimate the path and the placement of leads. Consequently, complications such as perforation of veins while the lead is being directed, loss of capture and improper placement of the lead in the right ventricle are common. More importantly, when accessing the jugular vein, potential perforation of the carotid artery must be prevented. In order to mitigate these risks, a need exists for a hybrid needle system to help with safe access, placement, and verification into the jugular vein when imaging is not available.

SUMMARY OF THE INVENTION

[0005] The present invention provides a needle device (also referred to herein as a hybrid needle system) for providing access to a blood vessel. A device that facilitates easier, safer and more controlled access to the jugular vein in the neck, by giving reasonable assurance that accidental puncture of the nearby carotid artery will not cause significant harm or risk of fatality to the patient. The device of the present invention creates an initial puncture with a microneedle, which creates a very small access point, wherein bleeding can be stopped by applying pressure to the neck for a short period of time.

[0006] The microneedle allows for preventative measures to be taken even if accidental puncture of the carotid occurs. The small syringe that sits concentrically inside of the large syringe allows for the initial micro puncture and aspiration of blood into the small syringe using the microneedle. The large needle and large syringe, which are connected on the outside of the small syringe-needle pair, are then telescoped over the microneedle and small syringe through a telescoping mechanism, which controls syringe movement and ensures the large needle does not advance past the microneedle. Furthermore, this motion ensures that the microneedle is still placed within the vessel before, during and after the large syringe is telescoped. Once the tips align, the small syringe enables double aspiration for verification once the large needle-syringe system is telescoped down. Lastly, the microneedle and the whole hybrid system can be safely removed, allowing the physician to perform any venous access procedure.

[0007] Accordingly, in one aspect, the present invention provides a needle device for accessing a blood vessel. The device has a proximal end and a distal end disposed along a longitudinal axis, and includes:

a first syringe having:

i) a first cylindrical tube having a central lumen extending along the longitudinal axis from the proximal end toward the distal end; and

ii) a first needle coupled to a distal portion of the first cylindrical tube, the first needle having a shaft with a central lumen extending along the longitudinal axis from the proximal end toward the distal end, and a distal tip; and

a second syringe having:

i) a second cylindrical tube having a central lumen extending along the longitudinal axis from the proximal end toward the distal end; and

ii) a second needle coupled to a distal portion of the second cylindrical tube, the second needle having a shaft with a central lumen extending along the longitudinal axis from the proximal end toward the distal end, and a distal tip.

[0008] The device is configured such that the first cylindrical tube is slidably disposed within the lumen of the second cylindrical tube, and the first needle is slidably disposed within the lumen of the second needle. The shaft of the first needle is longer than the shaft of the second needle such that when the device is in a first position the distal tip of the shaft of the first needle extends distally beyond the distal tip of the shaft of the second needle. Further, when the device is in a second position, the distal tip of the shaft of the second needle aligns with the distal tip of the shaft of the first needle.

[0009] In another aspect of the invention, a method of aspiring fluid from a subject using the device of the present disclosure is provided. The method includes inserting the distal tip of the first needle into tissue of the subject, the device being in the first position such that the tip of the first needle extends distally beyond the tip of the second needle; aspiring fluid from the tissue via movement of a plunger within the lumen of the first syringe; moving the device from the first position to the second position such that the tip of the first needle and that of the second needle are aligned, e.g., extend distally an equal distance; and aspiring fluid from the tissue via the first and/or second syringe, thereby aspiring fluid from the subject.

[0010] In another aspect of the invention, a method for accessing vasculature of a subject using the device of the present disclosure is provided. The method includes inserting the distal tip of the first needle into tissue of the subject, the device being in the first position such that the tip of the first needle extends distally beyond the tip of the second needle; aspiring fluid from the tissue via movement of a plunger within the lumen of the first syringe; moving the device from the first position to the second position such that the tip of the first needle and that of the second needle are aligned, e.g., extend distally an equal distance; removing the first syringe and needle; and decoupling the second syringe from the second needle and removing the second syringe while the second needle remains within the vasculature, thereby accessing the vasculature of the subject. The method may further include accessing the vasculature with a medical device via the second needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figures 1A-1B are a diagram showing a needle device in one embodiment of the invention, the device having proximal (1 A) and distal (IB) disposed along a longitudinal axis (X). The device is shown in the first position.

[0012] Figure 2 is a diagram showing the second syringe (20) in one embodiment of the invention.

[0013] Figure 3 is a diagram showing the first syringe (30) in one embodiment of the invention.

[0014] Figure 4 is a diagram showing the needle device (10) in one embodiment of the invention in which the device is in a first position wherein the needle tip of the first syringe extends distal to the needle tip of the second syringe. A first aspiration is achieved by proximal movement of the plunger (200).

[0015] Figure 5 is a diagram showing the needle device (10) in one embodiment of the invention in which the device is in a second position wherein needle tips are aligned.

[0016] Figure 6 is a diagram showing the needle device (10) in one embodiment of the invention in which the device is in a second position wherein needle tips are aligned and a second aspiration is achieved by proximal movement the plunger (200).

[0017] Figure 7 is a diagram showing the needle device (10) in one embodiment of the invention in which the device includes particularly sized components.

[0018] Figure 8 is a diagram showing the needle device (10) in one embodiment of the invention.

[0019] Figure 9 is a diagram showing the top view of the second syringe (20) of the device of Figure 8, wherein the second syringe (20) includes a connecting component (300) disposed on the inner wall of the central lumen (105).

[0020] Figure 10 is a diagram showing the first syringe (30) of the device of Figure 8, wherein the first syringe (30) includes a channel (305) for engaging the connecting component of the second syringe shown in Figure 9.

[0021] Figure 11 is a diagram showing a locking mechanism in one embodiment if the invention in which rotational movement of the first and second syringe with respect to one another locks the device such that longitudinal movement of the first syringe and the second syringe with respect to one another is prohibited.

[0022] Figure 12 is a diagram showing a clip type locking mechanism in one embodiment if the invention.

[0023] Figures 13A-13E are a series of diagrams illustrating operation of the device in one embodiment of the invention. Figure 13 A illustrates the initial configuration if the device before insertion into tissue. Figure 13B illustrates the needle of the device inserted into the jugular vein. Figure 13C illustrates the first aspiration after the needle is inserted and the plunger is moved proximally. Figure 13D illustrates movement of the device to a second position wherein needle tips are aligned by longitudinal movement of the first and second syringe relative to one another. Figure 13E illustrates a second aspiration after the needle tips are aligned by proximal movement of the plunger.

DETAILED DESCRIPTION OF THE INVENTION

[0024] The present invention provides a needle device for aspiring fluid from, or providing access to, vascular tissue, such as a blood vessel.

[0025] Before the present compositions and methods are described, it is to be understood that this invention is not limited to particular compositions, methods, and experimental conditions described, as such compositions, methods, and conditions may vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only in the appended claims.

[0026] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, references to "the method" includes one or more methods, and/or steps of the type described herein which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

[0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the preferred methods and materials are now described.

[0028] The present invention is a unique hybrid needle system, which may be set without imaging, to assist with "blind" central venous access. The presently described needle system is comprised of a double syringe and double needle system to help streamline the process and reduce the number of steps involved in central venous access. The system allows for accurate placement and verification of a microneedle within a vessel and then, allows for a large syringe-needle system to be telescoped over the microneedle. The microneedle prevents risk of fatal injuries even during accidental punctures and ensures proper placement while the large needle is telescoped over it. The hybrid system provides confidence and mitigates common risks involved with venous puncture and access.

[0029] A device that facilitates easier, safer and more controlled access to the jugular vein in the neck, by giving reasonable assurance that accidental puncture of the nearby carotid artery will not cause significant harm or risk of fatality to the patient. This needle-syringe system creates an initial puncture with a microneedle (also referred to herein as the first needle), which creates a very small access point, wherein bleeding can be stopped by applying pressure to the neck for a short period of time. The microneedle allows for preventative measures to be taken even if accidental puncture of the carotid occurs. The small syringe that sits concentrically inside of the large syringe allows for the initial micro puncture and aspiration of blood into the small syringe using the microneedle. The large needle and large syringe, which are connected on the outside of the small syringe-needle pair, are then telescoped over the microneedle and small syringe through a telescoping mechanism, which controls syringe movement and ensures the large needle does not advance past the microneedle. Furthermore, this motion ensures that the microneedle is still placed within the vessel before, during and after the large syringe is telescoped. Once the tips align, the small syringe enables double aspiration for verification once the large needle-syringe system is telescoped down. Lastly, the microneedle and the whole hybrid system can be safely removed, allowing the physician to perform any venous access procedure.

[0030] With reference to Figures 1-6, in an aspect, the present invention provides a needle device for accessing a blood vessel. The device has a proximal end (A) and a distal end (B) disposed along a longitudinal axis (X). As shown in Figure 3, the device includes a first syringe (30) which has a first cylindrical tube (50) having a central lumen (55) extending along the longitudinal axis (X) from the proximal end (A) toward the distal end (B). A first needle (60) is coupled to a distal portion of the first cylindrical tube. The first needle has a shaft (65) with a central lumen extending along the longitudinal axis from the proximal end toward the distal end, and a distal tip (70). With reference to Figure 2, the device also includes a second syringe (20) which has a second cylindrical tube (100) having a central lumen (105) extending along the longitudinal axis (X) from the proximal end (A) toward the distal end (B). The second needle (110) is coupled to a distal portion of the second cylindrical tube, the second needle having a shaft (115) with a central lumen extending along the longitudinal axis from the proximal end toward the distal end, and a distal tip (120).

[0031] With reference to Figures 8-10, in an aspect, the present invention provides a needle device for accessing a blood vessel in which the first syringe and second syringe are slidably engaged along the longitudinal axis (X) and are reversibly coupled together. The device has a proximal end (A) and a distal end (B) disposed along a longitudinal axis (X). Figure 1 illustrates the device including a first syringe (30) slidably disposed within the lumen of a second syringe (20), both syringes extending along the longitudinal axis (X) from the proximal end (A) toward the distal end (B). As illustrated in Figure 9, the second syringe includes a protrusion or component (300) which is configured to engage a channel or elongated notch (305 of Figure 10) disposed along the first syringe (30) thereby coupling the first and second syringes together. The first syringe may further include one or more features that allows for rotational movement of the syringes with respect to one another so that longitudinal movement of the first syringe within the lumen of the second syringe is prohibited. As such, longitudinal movement of the syringes with respect to one another may be locked when the device is in a desired position. [0032] The device of the present invention includes the following features which are discussed in further detail herein.

[0033] Double needle system with small inner syringe with microneedle connected to a large syringe-needle pair to assist in accurate placement and verification into a vessel through a unique, telescoping and aspiration method.

[0034] Concentric double syringe system where the small syringe-needle system acts as the plunger for the large syringe, allowing for the deployment of the large needle within a single system.

[0035] Concentric double needle system where the small needle-syringe acts as a supporting base for the large needle to be telescoped over the small needle without losing placement of the small needle within the vessel.

[0036] Locking mechanism for the double syringe-needle system that prevents premature telescoping and plunging of the large needle over the small needle to avoid inaccurate punctures within vasculature.

[0037] Alignment property built within the mechanical design of the hybrid needle system that ensures accurate tip alignment between the small and large needle when said large needle is telescoped over the small needle.

[0038] Double aspiration mechanism that allows for double verification of proper placement into vessel by aspirating the small syringe-needle system twice.

[0039] Double Syringe Mechanism

[0040] A small diameter syringe (30) attached to a microneedle (60) and a large diameter syringe (20) attached to a large diameter needle (110), wherein said small syringe lies within the large syringe and said large syringe is able to be telescoped, or advanced, over the small syringe. The small syringe contains a plunger (200) for aspiration of the microneedle (60) as well for the large diameter needle (110). The inner diameter of said large syringe is consistent up until a thicker wall portion at the base of the syringe. The small inner diameter stopping mechanism (130) in this portion acts as a hard stop for the rubber plunger or gasket (75) of the inner syringe. This ensures that the needle tips align when the large needle- syringe pair is telescoped over the small needle-syringe pair.

[0041] The plunger for the large (outer) syringe (20) is created by attachment of a rubber stopper or gasket (75) adhered to the tip of the small syringe (30) on its outer surface. With this described plunger system, functional steps would be as follows: microneedle injected into vessel (the device being in the first position) and aspirated the first time via small syringe; large syringe unlocked from secured position provided by the locking mechanism; large syringe-needle pair deployed over outside of small syringe-needle pair via telescoping mechanism; moving the device from the first position to the second position the large needle (110) being telescoped over microneedle (60) until tips of the needles align in the vessel; small syringe aspirated a second time for verification in the vessel.

[0042] Double Needle Telescoping Mechanism

[0043] A small diameter, hollow microneedle (60) attached to a first small (inner) syringe (30) and a large diameter needle (110) attached to second large (outer) syringe (20), wherein said small syringe and needle lie within the large syringe and said large syringe is able to telescope, or advance, large needle over said small needle through a telescoping mechanism.

[0044] In current practices, the microneedle and large needle kits are separate steps and are placed in a vessel alongside each other using approximations. The double needle telescoping mechanism reduces the number of steps needed to place a needle into the vessel. Once the small syringe is placed in the correct vessel and aspirated the first time to verify, the telescoping mechanism employs existing pressure gradient between the whole system and the vein to push the large syringe-needle pair over the microneedle and small syringe pair. As the physician holds the small syringe in place, he or she will use his other hand to progress the large syringe-needle pair. The system is built such that the large needle stops progressing once the needle tips align.

[0045] Locking Mechanism

[0046] The hybrid needle system may be paired with different locking mechanisms that prevent premature progression of the large syringe-needle pair and allow for consistent placement of the microneedle (60) and large needle (110) within the vein. Additionally, the locking mechanisms provide the physician with accurate control to hold the small syringe- needle pair while telescoping the large syringe-needle forward. Furthermore, it allows the physician to verify placement after the first aspiration before progressing the large needle into the vein. One type of locking mechanism may be an external lock, such as a swivel clip or button push, which allows the physician to push the lock off with one hand on the external surfaces of the syringes. This allows the physician to have a view of the whole system and use his or her own discretion in terms of maneuvering the lock. Another type of locking mechanism is an internal bayonet lock, which prevents telescoping until the physician twists the external syringe to unlock the double-syringe system. Both the internal and external locks provide extra measures to ensure control and accuracy of deployment for the physician.

[0047] Another type of locking mechanism is shown in Figure 11. Figure 11 illustrates a rotational locking mechanism in which rotational movement of the first and second syringe with respect to one another locks the device such that longitudinal movement of the first syringe and the second syringe with respect to one another is prohibited. Additionally, Figure 12 illustrates a clip type locking mechanism.

[0048] Tip Alignment Mechanism

[0049] In order for the system to provide accurate access into the vein, the design ensures that the tip of the microneedle and the tip of the large needle properly align. The alignment mechanism prevents the large needle from progressing further than the microneedle, which is initially placed in the vein. This ensures that the physician or practitioner has a mechanical gauge to prevent them from perforating the vein or progressing beyond the vein itself. Additionally, by dilating the access point in the same position, the mechanism prevents unnecessary bleeding or enlargement that could injure the patient. The connected syringes are designed such that they can only be telescoped to the same difference in distance between the microneedle and the large needle. As described above, this design involves a portion of the large syringe having a small inner diameter than the rest of the syringe, so that the inner diameter itself acts as a shelf for the rubber plunger around the small syringe to stop against. The microneedle is longer in length, thus the telescoped large needle can only travel the distance needed to line up with the microneedle tip. This alignment also allows for the double aspiration described below. Once the hollow tips align, the two tubes act as one pathway for the second aspiration.

[0050] Double Aspiration Verification Mechanism

[0051] The standard of care protocols involve an aspiration of every syringe once a needle is placed within the body. To accommodate this practice within the hybrid needle system, we have designed a double aspiration mechanism to allow for two aspirations within the internal syringe as the system is used for venous access. The first aspiration occurs after the microneedle is punctured into the vein. The second aspiration is facilitated by the alignment of the microneedle and large needle. Once the hollow tips align, the pathway is created for a second aspiration within the internal syringe. These features allow the physician to confirm placement in the vein twice during the use of the hybrid needle system.

[0052] Needles

[0053] As generally understood, the needles of the device can be manufactured from a variety of metallic based materials, including, but not limited to, nitinol, cobalt chrome, stainless steel, a metal alloy, combinations thereof, or polymeric based materials including, but not limited to poly-ether-ether ketone, polyamide, poyethersulfone, polyurethane, ether block amide copolymers, polyacetal, polytetrafluoroethylene and/or derivatives thereof. [0054] The gauge of both the first and second needle may vary according to the application so long as when the first and second needles are in a concentric configuration, the gauge of the first needle is higher than that of the second needle such that the first needle can be disposed within the shaft lumen of the second needle. In embodiments, the gauge of the first or second needle may be between about 7 and 39, for example, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 26s, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 or 39. In one embodiment, the first needle is 22 gauge and the second needle is 18 gauge although any combination is envisioned so long as the first needle gauge is higher than the second needle gauge when the needles are disposed concentrically.

[0055] As discussed above, the needle shaft employed may be of any suitable gauge. In embodiments, the first needle is a microneedle having a gauge of about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, or about 39. Use of a small needle gauge for the first needle, for example a 20-39 gauge needle, may make the needle track through tissue smaller and may minimize the risk of adverse effects.

[0056] The wall of the needle shaft may also have any suitable wall thickness. For example, in addition to regular wall (RW) thickness, the wall thickness of the conduit may be designated as thin wall (TW), extra/ultra-thin wall (XTW/UTW), or extra-extra thin wall (XXTW). These designations are well known to those of skill in the relevant art. For example, the shaft may be a fine gauge cannula or needle.

[0057] In some variations, the outer diameter of the first and/or second needle may be tapered from a wider needle base toward a narrower needle tip. In another example, the needle inner diameter may be tapered from a wider needle base toward a narrower needle tip. In yet another example, both the needle outer and inner diameters may be tapered from a wider needle base toward a narrower needle tip.

[0058] The distal tip of the first and/or second needle will generally be configured to be sharp, beveled, or otherwise capable of penetrating tissue, e.g., the skin and vasculature. The conduits may have a sharp, pointed tip, or a rounded one as in conventional needles. The pointed needle tip is formed by the lateral side surfaces that are straight at the point of their convergence into the tip, and at the point of their convergence forming a bevel angle (the angle formed by the bevel and the shaft of the needle), which may range from between about 5 degrees and about 45 degrees, between about 5 degrees and about 30 degrees, between about 13 degrees to about 20 degrees, or between about 10 degrees and about 23 degrees.

[0059] The sharp, pointed needle tip may provide improved penetration of the needle through fibrillar, fibrous tissue. Thus, such a needle tip during its penetration through tissue may create less resistance and, thus, decrease the impact force that is transmitted to tissue structures, such as the wall of an artery or vein, in turn causing less damage.

[0060] In some variations, the needles are injection needles having one or more flat surface planes, as well as one or more side-cutting surfaces. The needles may also be bi- beveled, i.e., have two bevels facing about 180 degrees from each other that is located on the opposite sides of the shaft. The needles may also be coated (e.g., with silicone, PTFE, and the like) to facilitate its penetration through tissue.

[0061] In various embodiments, the needles may be of any type known in the art as described herein. For example, the first and/or second needle is a non-coring side bore needle with one or more holes traversing the length of the needle (e.g., having one or more side holes but no hole at the proximal end of the needle). Additionally, the first and/or second needle may have any number greater than 1 additional opening or hole on the side of the shaft up to as many as can be added without impairing the rigidity or structural integrity of the needle cannula.

[0062] Additionally, any combination of needle lengths may be employed so long as their lengths are configured such that upon injection into tissue when the device is in the first position, the first needle tip enters tissue first.

[0063] Syringes

[0064] The size of both the first and second syringes may vary according to the application so long as when the first and second syringes are in a concentric configuration, the central lumen of the second syringe can receive the diameter if the first syringe. In embodiments, the first or second syringe may be between about 0.5 and 100 mL, for example, 0.5. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100 mL. In one embodiment, the first syringe is 3 mL and the second syringe is 5 mL although any combination is envisioned so long as the diameter of the central lumen of the second syringe is sufficiently large to accommodate the first syringe.

[0065] Methods of Use

[0066] In another aspect of the invention, a method of aspiring fluid from a subject using the device of the present disclosure is provided. The method includes inserting the distal tip of the first needle into tissue of the subject, the device being in a first position as shown in Figures 13A and 13B. In the first position, the tip of the first needle (22 G) extends distally beyond the distal tip of the second needle such that the first needle penetrates tissue first during insertion into tissue. In one embodiment the first and second needles are concentric, the first needle being disposed within the lumen of the second needle such that when the device is in the first position, the tip of the first needle extends distally out of the tip of the second needle. As such the first needle has a higher gauge than the second needle. For example, the first needle may be a microneedle so that the patient experiences reduced pain upon insertion. When in the first position, the first needle penetrates tissue while the second needle does not.

[0067] Next, fluid is aspired from the tissue through the first needle via proximal movement of the plunger within the lumen of the first syringe as shown in Figure 13C. The device is then transitioned from the first position to a second position wherein the tip of the microneedle and the tip of the larger needle are aligned and both are inserted into the patient's tissue as shown in Figure 13D. This is achieved by movement of the first syringe within the lumen of the second syringe toward the distal end of the device. Additional fluid is then aspired from the tissue via proximal movement of the plunger within the lumen of the first syringe as shown in Figure 13E.

[0068] In embodiments, once the device is inserted into tissue in the first position, a first aspiration is performed by movement of the plunger within the lumen of the first syringe. Correct placement of the first needle within a blood vessel may then be confirmed by inspection of fluid flow and fluid color within the lumen of the first syringe. As the device is transitioned to the second position and both needles are inserted into tissue, correct placement of the needle tips may be secondarily confirmed. While the second needle is advanced during transition to the second position, fluid will begin to collect in the second syringe to provide a secondary confirmation of placement.

[0069] In various embodiments, aspiration may be achieved by movement of the plunger within the lumen of the first needle or by movement of the first syringe within the lumen of the second syringe. As such, it is envisioned that aspiration using the first syringe and the second syringe may occur simultaneously or separately.

[0070] In another aspect of the invention, a method for accessing vasculature of a subject using the device of the present disclosure is provided. The method includes inserting the distal tip of the first needle into tissue of the subject, the device being in the first position such that the tip of the first needle extends distally beyond the tip of the second needle; aspiring fluid from the tissue via movement of a plunger within the lumen of the first syringe; moving the device from the first position to the second position such that the tip of the first needle and that of the second needle are aligned, e.g., extend distally an equal distance; removing the first syringe and needle; and decoupling the second syringe from the second needle and removing the second syringe while the second needle remains within the vasculature, thereby accessing the vasculature of the subject. The method may further include accessing the vasculature with a medical device via the second needle.

[0071] Utilizing the device to access vasculature is illustrated as follows with reference to accessing the internal jugular vein (IJV). While the method is illustrated by accessing the IJV, one of skill in the art would understand that the method could be utilized to other types of vascular tissue.

[0072] The physician first utilizes four fingers to curl laterally around the carotid artery and ensure the entire artery is covered with the fingers. While the fingers are curled the device in the first position is inserted into the appropriate area of the neck at a 45 degree angle to the neck. Keeping the needle at 45 degrees, the first microneedle is advanced into the IJV and the plunger is used to aspirate blood by moving the plunger within the lumen of the first syringe. Once blood flows into the first syringe, correct placement into the IJV is confirmed by inspecting blood flow and blood color in the first syringe.

[0073] After confirmation of access into the IJV, the larger outer second syringe is grasped with one hand and the larger second needle is advanced into the skin and vein, e.g., the device is transitioned to the second position. While advancing the larger second needle, blood will begin to collect in the second syringe to give a secondary confirmation of jugular placement. After confirming the larger second needle is properly in the IJV, the smaller first syringe and needle is removed. The larger second syringe is then decoupled from the second needle via an intermediate luer lock. An appropriate access for a medical device remains. For example the IJV may be accessed with a guide wire, sheath, and lead for temporary pacing.

[0074] Although the invention has been described with reference to the above example, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.

Claims

What is claimed is:

1. A needle device having a proximal end and a distal end disposed along a longitudinal axis, the device comprising:

a) a first syringe comprising:

b) a second syringe comprising:

ii) a second needle coupled to a distal portion of the second cylindrical tube, the second needle having a shaft with a central lumen extending along the longitudinal axis from the proximal end toward the distal end, and a distal tip;

wherein the first cylindrical tube is slidably disposed within the lumen of the second cylindrical tube, and the first needle is slidably disposed within the lumen of the second needle,

and wherein the shaft of the first needle is longer than the shaft of the second needle such that when the device is in a first position the distal tip of the shaft of the first needle extends distally beyond the distal tip of the shaft of the second needle.

2. The device of claim 1, wherein when the device is in a second position, the distal tip of the shaft of the second needle aligns with the distal tip of the shaft of the first needle.

3. The device of claim 2, wherein the device is operable to aspirate fluid through the first needle, but not the second needle, via a plunger disposed within the central lumen of the first cylindrical tube when the device is in the first position.

4. The device of claim 2, further comprising a gasket disposed between an outer surface of the first cylindrical tube and a surface of the lumen of the second cylindrical tube, wherein the gasket is coupled to and radially extends around the outer surface of the first cylindrical tube.

5. The device of claim 4, wherein the gasket is disposed on a distal portion of the first cylindrical tube.

6. The device of claim 4, wherein the second syringe comprises a stopping mechanism configured to stop proximal movement of the gasket upon movement of the device from the first position to the second position.

7. The device of claim 4, wherein the device further comprises a locking mechanism configured to lock the device in the first position.

8. The device of claim 7, wherein the locking mechanism is locked or unlocked by reversibly rotating the second syringe about the longitudinal axis relative to the first syringe.

9. The device of claim 1, wherein the device further comprises a locking mechanism configured to prohibit longitudinal or rotational movement of the first syringe relative to the second syringe.

10. The device of claim 9, wherein the locking mechanism is locked or unlocked by reversibly rotating the second syringe about the longitudinal axis relative to the first syringe.

11. The device of claim 1, wherein the first cylindrical tube of the first syringe comprises a channel extending along an outer surface of the first cylindrical tube.

12. The device of claim 11, wherein the second syringe comprises a protrusion for engaging the channel of the first cylindrical tube.

13. The device of claim 1, wherein the second cylindrical tube and the second needle are coupled via a luer lock connection.

14. The device if claim 1, wherein the first syringe is a 3 mL syringe and the second syringe is a 5 mL syringe.

15. The device if claim 1, wherein the first needle is 22 gauge and the second needle is 18 gauge.

16. The device if claim 1, further comprising a plunger slidably disposed within the central lumen of the first cylindrical tube.

17. A method of aspiring fluid from a subject using the device of any of claims 1-16, comprising:

a) inserting the distal tip of the first needle into tissue of the subject, the device being in the first position;

b) aspiring fluid from the tissue via the first syringe into the central lumen of the first cylindrical tube;

c) transitioning the device from the first position to the second position; and d) aspiring fluid from the tissue via the first or second syringe, thereby aspiring fluid from the subject.

18. The method if claim 17, wherein the aspiring of (b) or (d) comprises aspiring fluid from the tissue by movement of the plunger within the central lumen of the first cylindrical tube.

19. The method if claim 17, wherein (d) comprises aspiring fluid via the first and second syringe.

20. The method of claim 17, further comprising confirming insertion of the distal tip of the first needle into the tissue prior to (c).

21. The method of claim 17, further comprising confirming insertion of the distal tip of the second needle into the tissue prior to (d).

22. The method of claim 17, wherein the tissue is a blood vessel.

23. The method of claim 17, wherein the fluid is blood.

24. The method of claim 17, further comprising unlocking the locking mechanism prior to

(b) .

25. A method of accessing vasculature of a subject using the device of any of claims 1-16, comprising:

a) inserting the distal tip of the first needle into the vasculature of the subject, the device being in the first position;

b) aspiring fluid from the vasculature via the first syringe;

c) moving the device from the first position to the second position;

d) removing the first syringe and needle; and

e) decoupling the second syringe from the second needle and removing the second syringe while the second needle remains within the vasculature, thereby accessing the vasculature of the subject.

26. The method if claim 25, wherein the aspiring of (b) comprises aspiring fluid from the vasculature by movement of the plunger within the central lumen of the first cylindrical tube.

27. The method if claim 25, further comprising aspiring fluid via the second syringe prior to (d).

28. The method of claim 25, further comprising confirming insertion of the distal tip of the first needle into the vasculature prior to (c).

29. The method of claim 25, further comprising confirming insertion of the distal tip of the second needle into the vasculature prior to (d).

30. The method of claim 25, wherein the vasculature is a blood vessel.

31. The method of claim 25, wherein the fluid is blood.

32. The method of claim 25, further comprising unlocking the locking mechanism prior to

(c) .

33. The method of claim 25, further comprising accessing the vasculature with a medical device.

34. The method of claim 33, wherein the medical device is a lead, guidewire, sheath, or combination thereof.