WO2016179280A1 - Système d'aiguille hybride pour accès veineux central - Google Patents

Système d'aiguille hybride pour accès veineux central Download PDF

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Publication number
WO2016179280A1
WO2016179280A1 PCT/US2016/030777 US2016030777W WO2016179280A1 WO 2016179280 A1 WO2016179280 A1 WO 2016179280A1 US 2016030777 W US2016030777 W US 2016030777W WO 2016179280 A1 WO2016179280 A1 WO 2016179280A1
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WO
WIPO (PCT)
Prior art keywords
needle
syringe
cylindrical tube
vasculature
distal tip
Prior art date
Application number
PCT/US2016/030777
Other languages
English (en)
Inventor
Shruthi RAJAN
Madeleine CLEGG
Erin REISFELD
Dhananjay SETHI
Original Assignee
The Johns Hopkins University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Johns Hopkins University filed Critical The Johns Hopkins University
Publication of WO2016179280A1 publication Critical patent/WO2016179280A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3135—Syringe barrels characterised by constructional features of the proximal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A61M2005/31598—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed

Definitions

  • the invention relates generally to medical devices and more specifically to a needle device for venous access.
  • 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.
  • these procedures are carried out blindly. Without an imaging modality, physicians have to estimate the path and the placement of leads.
  • 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.
  • 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.
  • 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.
  • 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:
  • a first cylindrical tube having a central lumen extending along the longitudinal axis from the proximal end toward the distal end;
  • 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;
  • a second syringe having:
  • a second cylindrical tube having a central lumen extending along the longitudinal axis from the proximal end toward the distal end;
  • 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.
  • 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.
  • a method of aspiring fluid from a subject using the device of the present disclosure 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.
  • a method for accessing vasculature of a subject using the device of the present disclosure 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.
  • 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.
  • Figure 2 is a diagram showing the second syringe (20) in one embodiment of the invention.
  • Figure 3 is a diagram showing the first syringe (30) in one embodiment of the invention.
  • 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).
  • 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.
  • 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).
  • Figure 7 is a diagram showing the needle device (10) in one embodiment of the invention in which the device includes particularly sized components.
  • Figure 8 is a diagram showing the needle device (10) in one embodiment of the invention.
  • 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).
  • 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.
  • 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.
  • Figure 12 is a diagram showing a clip type locking mechanism in one embodiment if the invention.
  • 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.
  • the present invention provides a needle device for aspiring fluid from, or providing access to, vascular tissue, such as a blood vessel.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • the device of the present invention includes the following features which are discussed in further detail herein.
  • 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.
  • 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.
  • Double aspiration mechanism that allows for double verification of proper placement into vessel by aspirating the small syringe-needle system twice.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Figure 12 illustrates a clip type locking mechanism.
  • 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.
  • 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.
  • the standard of care protocols involve an aspiration of every syringe once a needle is placed within the body.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the needle shaft employed may be of any suitable gauge.
  • 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.
  • the wall of the needle shaft may also have any suitable wall 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.
  • the shaft may be a fine gauge cannula or needle.
  • the outer diameter of the first and/or second needle may be tapered from a wider needle base toward a narrower needle tip.
  • the needle inner diameter may be tapered from a wider needle base toward a narrower needle tip.
  • both the needle outer and inner diameters may be tapered from a wider needle base toward a narrower needle tip.
  • 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.
  • the sharp, pointed needle tip may provide improved penetration of the needle through fibrillar, fibrous tissue.
  • 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.
  • 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.
  • the needles may be of any type known in the art as described herein.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a method of aspiring fluid from a subject using the device of the present disclosure 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.
  • 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.
  • 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.
  • the first needle has a higher gauge than the second needle.
  • 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.
  • 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.
  • 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.
  • 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.
  • a method for accessing vasculature of a subject using the device of the present disclosure 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.
  • 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.
  • IJV internal jugular vein
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif d'aiguille pour accéder au système vasculaire. Le dispositif comprend des seringues et des aiguilles disposées de manière concentriques afin de faciliter un accès plus aisé, plus sûr et plus contrôlé au système vasculaire, ce qui permet de réduire les douleurs importantes et le risque de mortalité chez le patient.
PCT/US2016/030777 2015-05-04 2016-05-04 Système d'aiguille hybride pour accès veineux central WO2016179280A1 (fr)

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US201562156649P 2015-05-04 2015-05-04
US62/156,649 2015-05-04

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3799896A1 (fr) * 2019-10-04 2021-04-07 Arthrex, Inc Dispositifs et procédés de fabrication de fluides thérapeutiques

Citations (3)

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US4313440A (en) * 1980-09-08 1982-02-02 Ashley Sheldon J Multipurpose double barrel syringe and method of manufacture of same
US6015401A (en) * 1993-08-09 2000-01-18 Brackett; Jacqueline Darlene Methods for vessel cannulation
US20140276592A1 (en) * 2013-03-15 2014-09-18 Merit Medical Systems, Inc. Lockable syringe assemblies and related devices and methods

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US4313440A (en) * 1980-09-08 1982-02-02 Ashley Sheldon J Multipurpose double barrel syringe and method of manufacture of same
US6015401A (en) * 1993-08-09 2000-01-18 Brackett; Jacqueline Darlene Methods for vessel cannulation
US20140276592A1 (en) * 2013-03-15 2014-09-18 Merit Medical Systems, Inc. Lockable syringe assemblies and related devices and methods

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3799896A1 (fr) * 2019-10-04 2021-04-07 Arthrex, Inc Dispositifs et procédés de fabrication de fluides thérapeutiques
US11904144B2 (en) 2019-10-04 2024-02-20 Arthrex, Inc. Devices and methods for making therapeutic fluids

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