Method and apparatus for reducing dead space in syringes and small-bore devices

Abstract

Methods and apparatus for reducing dead space in syringes and other devices using volume displacement members that occupy space within one or more interior spaces of such devices. The volume displacement members also include one or more internal flow passages that facilitate fluid flow therethrough. The volume displacement members are also adapted to cooperate with features of the device that house them to form air-tight and liquid-tight seals that at least in part determine the fluid path through the device.

Description

Technical Field

[0001] Cross - reference to Related Applications This application is related to the following U.S. provisional patent applications and claims the benefit of the filing dates of the following U.S. provisional patent applications: (1) U.S. Provisional Patent Application No. 63 / 360,809, filed October 29, 2021; (2) U.S. Provisional Patent Application No. 63 / 360,847, filed November 1, 2021; (3) U.S. Provisional Patent Application No. 63 / 361,425, filed December 20, 2021; (4) U.S. Provisional Patent Application No. 63 / 372,045, filed February 7, 2022; and (5) U.S. Provisional Patent Application No. 63 / 415,029, filed October 11, 2022. Each of the provisional patent applications referenced above is hereby incorporated by reference in its entirety.

[0002] The present invention relates to methods and devices for delivering or dispensing fluids or gases, alone or in combination, through one or more small - diameter devices, connectors, fittings, dispensers, or adapters, for medical devices such as intravascular, enteral nutrition, spinal axis, or respiratory systems.

Background Art

[0003] Medical devices such as syringes, catheters, ports, valves, fittings, tubing sets, and IV fluid bags are known in the art for delivering fluids, pharmaceuticals, contrast agents, diluents, anesthetics, nutrients, and gases. Existing delivery devices may include proprietary designs that reduce dead space in fluid pathways or internal through-passages, such as permanently coupled needle / syringe combinations and retractable needle syringes. These devices have limited clinical use because they do not conform to the ISO 10369-7 Luer standard for subcutaneous and intravascular applications and are incompatible with most Luer-based devices, fittings, and adapters widely used in medicine. Additional ISO 80369 standards, including the spinal axial Luer standard (ISO 80369-6) and the enteral Luer standard (ISO 80369-3), have been established to specify the design of small-bore connectors, adapters, and tubing for various different clinical applications as a result of misconnection of tubing that has led to harmful, and even fatal, errors.

[0004] One example of the need for standardization of medical connectors was evident in the 1988 disaster at the U.S. Ramstein Air Base air show in Germany, where poor communication between U.S. military personnel and German emergency responders resulted in the incompatibility of two different intravenous connectors used by first responders, preventing the placement of IV catheters and administration of fluids to injured patients.

[0005] Syringes are widely used in medicine and are supplied sterile in either a refillable or pre-filled configuration. Needles may be integrally attached to the syringe, or the syringe may include a Luer fitting with a press or slip fitting or a threaded Luer-lock fitting for attaching a needle or other Luer-based device. Some enteral Luer syringes are sold in reusable stainless steel configurations.

[0006] Subcutaneous injection needles contain a lubricant such as medical-grade silicone on the needle shaft to reduce penetration resistance when the drug is administered, minimizing patient discomfort. When the same needle is used to fill a syringe (puncture the elastomer stopper of the drug vial) and administer the injection, the lubricant and beveled edge of the needle are damaged. A low-cost filling needle can be used to draw the drug or diluent into a fillable needle / syringe device, which can then be removed and replaced with an unused sterile needle or Luer connector for administering the injection or infusion. Some fillable syringes contain an integrally formed needle or a separate Luer-based needle that attaches to the syringe, and the syringe can be filled with a prescribed dose of drug or diluent. Any air trapped in the drug or fluid within the fillable syringe and needle or in a pre-filled syringe must be pushed out before the fluid is administered to tissue, a port, a needleless valve or infusion flow, or other Luer-based device. To remove air from the fluid within the syringe / needle device, the filled syringe is positioned in an upright manner with the needle or Luer fitting at the top. The syringe is repeatedly tapped at the side, and as the plunger rod advances to a predetermined dose, any air pockets or bubbles from the fluid within the syringe and hub are released or purged, rising and moving upward through the fluid pathway or internal penetration pathway of the syringe and Luer hub, and exiting from the distal end of the device, which may contain a subcutaneous injection needle. The injection or infusion can then be administered.

[0007] The advantage of Luer connectors lies in their interoperability between the male nozzle and female hub, spanning a wide range of medical devices, fields, and procedures. The distal tapered, truncated, or frustoconical cone or nozzle of a male Luer syringe or male Luer connector with an internal cavity is inserted into the internal cavity of the female Luer hub, both forming a combined dead-space internal cavity with an inner diameter exceeding the inner diameter of the penetration path or conduit for the subcutaneous injection needle or infusion line. As the plunger rod / piston of the syringe advances to the distal end of the syringe barrel, most of the drug or fluid moves through the hollow Luer nozzle and female Luer hub, but the combined internal cavity formed during the Luer fitting leaves approximately 7-10% of the 0.5 ml dose as dead space within the Luer device.

[0008] Several U.S. patents and published applications describe medical needles having means for reducing dead space in a fluid path. These include U.S. Publication 2011 / 0282298 (Agian et al), U.S. Patent No. 5,964,737 (Caizza), U.S. Publication 2003 / 004720 (Steube), U.S. Patent No. 5,902,269 (Jentzen), U.S. Patent No. 5,902,277 (Jentzen), U.S. Patent No. 6,010,486 (Carter et al), U.S. Patent No. 6,955,660 (Fisher), and U.S. Patent No. 9,295,788 (Green).

[0009] None of these instructions address the aerodynamics of removing air or bubbles from the fluid in the internal passages of subcutaneous devices before administering an injection or infusion. When a drug or drug bolus is injected from a syringe, safe clinical practice is to remove all air from the fluid in the syringe or infusion device before administration. In a 2012 study on accidental intravenous infusion of air published in the Infusion Nurses Society, Wilkins and Unverdorben observed that even spherical bubbles as small as 0.2 mm could cause detectable cerebral ischemia. The International Electrotechnical Commission (IEC) has published standard Part II:24 1998-02(E):41 Safety of Infusion Administration. Since the IEC standard does not provide an overall safety level for air infusion, there is no maximum safe dose for air infusion. Clinical injection or infusion of air is rare, but it can cause adverse or fatal events.

[0010] Bubbles in a liquid have a strong tendency to combine and merge, naturally expanding to form a spherical shape. When bubbles pass through a smaller, more confined orifice or channel, such as a small-diameter connector or needle, the bubbles(s) are compressed, forming an elliptical shape and acting as an adhesive force, increasing surface tension and causing them to stick to the surface. You can feel the increase in surface tension of a sphere by squeezing and hugging an air-filled beach ball.

[0011] Agian et al.'s Patent No. 298 teaches a coupler comprising a solid dose-saving insert positioned within the tip of a Luer syringe, attached to a female hub with a microneedle for administering intradermal injections. The solid insert, with a closed end, is surrounded by a diametrically formed opening channel between the solid exterior of the insert and the surface of the inner wall of the nozzle at the male syringe tip, and includes a dead-end internal cavity in the female hub outside the channel, with a surface to which air bubbles can adhere. The channel narrows between the distal end of the solid insert and the distal end of the internal cavity in the female Luer hub, forming a bottleneck, restricting fluid flow and compressing any air bubbles present in the fluid, increasing the surface tension and adhesion of any air bubbles to the surfaces of the insert and female hub as the fluid moves through the coupler. Air bubbles(s) may adhere to these surfaces during aspiration and be released during injection or infusion. In Agian et al.'s teaching of the insert, since the injection is administered to the surface of the skin, there is no need to push out any air from the drug.

[0012] The formation and growth of bubbles, as well as their adhesion or detachment from surfaces within the fluid pathway, must be considered in the design of small-bore devices where bubbles (one or more) must be purged before administering or injecting drugs, solutions, anesthetics, etc., to a patient. If bubbles (one or more) are not purged from the device and accidentally enter the venous system, they are filtered as the blood reaches the lungs. The air diffuses across the barrier between the blood flow and the air in the lungs, is pushed out of the blood, and safely leaves our system. However, if bubbles (one or more) accidentally enter the arterial system, they can cause adverse events when they reach the heart, potentially blocking the atria and stopping pumping action, or interrupting blood flow in the brain and causing a stroke. Therefore, any restrictive, stepped, or tapering features within the fluid pathway of a small-bore device or connector must minimize or eliminate any rear-facing interface surfaces that could form dead spots for bubbles (one or more) to adhere to when filling or dispensing fluid from a syringe or infusion device.

[0013] Laminar fluid paths, characterized by smooth or regular trajectories, are preferred in small-diameter devices (one or more) to reduce the possibility of interfacial bubble adhesion and to reduce or eliminate any turbulence.

[0014] Because the radius of a spherical bubble is directly proportional to the surface tension of the orifice, bubbles tend to become elongated and adhere to the surface as they are compressed as they move through the confined space. Irregularities and dead spots in the fluid path of the passage also create undesirable turbulent pockets and circular flows for bubbles(s) to adhere to the surface.

[0015] The teachings of Jentzen's '269 and '277 patents are limited to syringe / needle devices having a unique syringe piston stopper that extrudes a drug within the internal cavity of a male Luer nozzle but leaves the drug in the internal cavity of a female hub. Caizza's '737 patent teaches an elastic member or sleeve with an internal through channel that displaces a portion of the internal cavity at the distal end of a female hub that is formed when a male Luer nozzle is positioned within the female hub. Carter's '486 patent teachings are limited to syringe / needle devices having a unique syringe stopper for extruding a drug after an injection has been administered and for retracting the needle into the syringe barrel. A retractable needle attached to an internal hub, including fragile parts and a puncture member, is required to put the teachings of '486 patents into practice. Additionally, it is known that retractable needles allow fluid to backflow from the needle when the needle and hub are retracted into the syringe barrel, and then allow fluid to seep out from the distal tip.

[0016] Steube's '720 patent teaches a needle-attached syringe having a female Luer hub, which has a needle cavity or conduit attached to an elongated needle support that is attached to the length of an internal chamber of the elongated barrel tip and extends proximal beyond the proximal opening end of the needle hub, and is designed to minimize fluid waste using an internal chamber formed within the elongated barrel tip (Luer nozzle). The elongated needle support includes a proximal end having a length configured to engage with the elastomer tip of the plunger when the fluid is dispensed from the syringe barrel. When the needle hub of the '720 patent is attached to the syringe tip, a dead-end internal cavity is formed between the inner wall of the elongated barrel tip (Luer nozzle) and the outer wall of the needle support, trapping air or bubbles in the fluid within the dead-end internal cavity when the syringe and attached needle hub are positioned with the needle facing upward, as the user is attempting to remove any air from the fluid before use. Air or bubbles trapped within the internal cavity surrounding the needle support can be released and move into the fluid when the syringe position is changed, especially when the needle is pointing downwards, potentially distributing through the needle to the patient or port. Vernacare in the UK produces low-dead-space needles based on Steube's teachings.

[0017] The teachings of Fisher's '660 patent are limited to an adapter comprising three concentrically configured seals, which connect to a syringe having an expansion sleeve with a central hollow conduit formed through a deformable proximal nose having an outer surface when positioned within a Luer syringe nozzle, and which expands to engage with the inner wall of the Luer nozzle to form a first seal when a separate hollow shaft or pipe having a second central conduit and an outer wall is inserted into the first conduit of the expansion sleeve, and which forms a second concentric seal between the outer wall of the pipe and the inner wall of the deformable nose. To put the teachings of '660 patent into practice, the expansion sleeve comprises an outer conical collar disposed around the deformable nose, the inner wall of which forms a third seal disposed concentrically around the outer wall of the Luer nozzle. The outer conical collar of the adapter teachings of '660 patent is not compatible with a female Luer hub according to Part 7, and is therefore ineffective, excluded from any industrial or commercial use, and cannot be put into practice.

[0018] U.S. Patent No. 5,858,000 (Novacek) teaches a multi-piece Luer syringe having a retractable needle that can cooperate with a separate movable adapter, having an elongated distally formed nose adapted to fit into the internal cavity of a female Luer hub positioned within the distal end of a syringe barrel. The adapter, having an open proximal end and an open distal end defining a central axial passage, is formed within a proximal projection in the open proximal end positioned within the syringe barrel, extending to the distal end formed in the nose positioned within the internal cavity of the female Luer hub for engaging the proximal end of a hollow needle. The adapter, having a grooved proximal surface that extends laterally from the distal projection to the outer diameter and communicates with a central passage for venting air from inside the syringe barrel, is positioned within the internal cavity of the syringe barrel. The adapter is rotatably mounted on a piston and attached to a fragile plunger, and can be retracted into the syringe barrel by engaging and rotating the plunger piston into the adapter after injection has been administered. To implement this instruction, an additional seal is required between the outer wall of the movable adapter and the inner wall of the syringe barrel.

[0019] U.S. Patent No. 8,006,953 (Bennett) teaches a one-way valve in a female luer hub. U.S. Patent No. 9,616,214 (Stout et al.) teaches a flush-enhanced luer connector with a flow-expanding channel and flow diverter configured to redirect fluid flow around the connecting female luer space during the flush procedure, thereby increasing mixing and turbulence in the dead space created by the male luer tip. U.S. Patent No. 6,267,154 (Felicelli et al.) teaches a removable plug including a male luer nozzle plug that fits snugly into the inner surface of a female luer lock nozzle. U.S. Patent No. 7,140,592 (Phillips) teaches a self-sealing valve in a luer connector.

[0020] In 2021, a major medical device manufacturer recalled approximately 267 million flush pre-filled saline syringes because the plunger could reintroduce air into the syringe, potentially causing serious adverse consequences.

[0021] The hazardous insulin needle / syringe combination device is manufactured with short needles featuring very small tubing ranging in size from 31G × 5 / 16 inches to 29G × 1 / 2 inches in length, incorporating low dead space or "dose-saving" features, and is useful for niche markets with limited production infrastructure. Intramuscular injection is administered for prophylactic (immunizing) and curative purposes and is typically done with Luer needles / syringes ranging from 25G × 1 inch to 21G × 1.5 inches, sufficient to deliver the dose intramuscularly at a depth prescribed by a physician or pharmacist.

[0022] According to Bloomberg, approximately 12.7 billion doses of COVID-19 vaccine have been administered worldwide as of the filing date. The World Health Organization estimates that the global syringe market was 16 billion units per year before COVID-19, and market reports estimate a CAGR of 10.5% until 2027, so the demand for the global syringe market is expected to grow, increasing to approximately 30 billion units per year over the next five years due to the emergence of COVID-19. Global demand for syringes is expected to continue as bivalent vaccines developed by Moderna and Pfizer, consisting of novel vaccines targeting the original formulation of the coronavirus and the Omicron strains BA.4 and BA.5 subtypes, meet the US FDA's efficacy standards. [Overview of the project]

[0023] The present invention generally relates to small-bore medical devices, adapters, and connectors having reduced volume or low dead-space internal cavities, formed by volumetric displacement members positioned within individual or combined internal cavities of one or more small-bore devices and displacing portions of the individual or combined internal cavities. A liquid-tight and airtight connection or seal is formed by or within one or more mating components where universal interoperability between various medical devices is required to provide clinical care to patients. Outlets may be included to remove air or bubbles from a fluid before injection, infusion, or flushing. Streamlined channels may be configured within the internal cavities or combined cavities of the devices, adapters, and connectors.

[0024] Some embodiments of the present invention disclosed herein are Luer connectors comprising a connector for intravascular or subcutaneous applications (referred to as Part 7 throughout this application) having a male Luer nozzle tip extending beyond the distal end of a Luer lock collar, Part 7 of the Small-Bore Connector for Liquids and Gases in Healthcare, Part 7 of the same designation. Another embodiment disclosed herein is a connector of the same designation (referred to as Part 6 throughout this application) for spinal axis applications, comprising a yellow color code, configured to work with spinal axis or NRfit® connectors and adapters for administering pharmaceuticals into the subarachnoid or epidural space. Another embodiment disclosed herein is a connector of the same designation (referred to as Part 3 throughout this application) for enteral applications, comprising a purple color code, configured to work with enteral or ENfit connectors and adapters for administering nutrients and gases.

[0025] Additional embodiments of the present invention are configured to be used with other small-diameter connectors, fittings, and adapters, including, but not limited to, both Luer and non-Luer type connectors and adapters, for administering, injecting, pumping, mixing, withdrawing, or injecting fluids, pharmaceuticals, vaccines, diluents, gases, nutrients, bone space fillers, etc., for single or combinations of two or more medical devices, for administering, injecting, pumping, mixing, withdrawing, or injecting fluids, pharmaceuticals, vaccines, diluents, gases, nutrients, bone space fillers, etc., for use with other small-diameter connectors, fittings, and adapters, including both Luer and non-Luer type connectors and adapters. The volumetric displacement member may be configured to have a body having a through-passage or aperture with a tapered wall formed as an outlet for discharging or removing air or bubbles from a fluid in one or more devices or apparatus before administering the fluid. A volumetric displacement member can reduce the volume retention of fluid, gas, or air within the internal cavity of one or more connectors, adapters, fittings, or devices, and can filter, regulate, or monitor the flow of fluid or gas within and through the flow channels of one or more connectors, adapters, fittings, or devices.

[0026] One embodiment of the present invention comprises a volume displacement member configured to reduce the amount of drug or diluent remaining in the flow path, internal cavity, or dead space of a luer syringe or male connector nozzle and female luer hub before, during, or after injection or infusion is administered to a patient or transferred to another device such as a syringe or pump, infusion line, IV fluid bag, etc. One embodiment of the present invention comprises a body having an internal through-passage with an outlet or aperture formed to extrude or remove air or bubbles in the pharmaceutical or fluid within the internal cavity before injection or infusion is administered, positioned within the combined internal dead space cavity of the male luer nozzle or female luer hub, configured to reduce the amount of drug or fluid within the combined internal cavity, and a volume displacement member. One embodiment of the present invention comprises a volume displacement member positioned within the combined internal cavity of a male nozzle and female hub female luer hub configured to have an inner through-passage completely separated from the distal internal dead space cavity formed within the female hub. One embodiment of the present invention is configured to optimize the volume of drug or fluid withdrawn from a vial, dispensed into a syringe from a filling device, or added to a pre-filled syringe up to a predetermined dose, leaving more drug within the vial, filling device, or dispenser for subsequent doses.

[0027] One embodiment of the present invention provides a stop or lip on the volume displacement member to limit and standardize the depth to which the syringe nozzle can be positioned within the female hub. Some embodiments of the volume displacement member of the present invention displace a significant amount of cubic volume capacity, individually or in combination, within the combined internal dead space cavity of the syringe nozzle and female hub. Additionally, some embodiments of the volume displacement member of the present invention are configured to have a flow path or internal through-passage of a luer-configured device or device to maximize the delivery of the intended fluid or gas dose.

[0028] One embodiment of the present invention may also include a closure cap configured to reduce the amount of drug or fluid within a pre-filled syringe. One embodiment of the present invention is configured to reduce the amount of drug or fluid within the fluid pathway or internal cavity through-passage of a male Luer nozzle. One embodiment of the present invention is configured to reduce the amount of drug or fluid within the fluid pathway or internal cavity of a female Luer hub. Additionally, the present invention is configured to reduce the amount of drug, diluent, or gas remaining within the flow path or internal cavity of one or more Luer connectors or adapters having at least two different inner diameters before, during, or after injection, infusion, or gas administration.

[0029] One embodiment of the present invention includes a single Luer device, and the syringe cap includes a volume displacement member extending within the internal cavity of the Luer nozzle of the pre-filled syringe. Embodiments of the volume displacement, male Luer syringe, or female Luer hub of the present invention can be easily incorporated into an existing multi-cavity Luer tooling by simply upgrading the core to form a volume displacement member within the male Luer nozzle or female Luer hub when a conventional core needs to be replaced. Installing the new core into the existing tooling eliminates the need for an expensive new Luer syringe, Luer connector, or Luer hub tooling.

[0030] Even more cost-effective and time-saving improvements can be achieved by adding a separate volume displacement member of the present invention within the individual or combined internal cavities of the female Luer hub or male Luer nozzle, or at the distal end of the nozzle of the Luer syringe.

[0031] One embodiment of the present invention comprises a volumetric displacement member positioned within the internal cavity of an NRfit® device or connector and configured to reduce the amount of anesthetic remaining in the internal cavity before, during, or after the administration of anesthetic to a patient. Another embodiment of the present invention comprises a volumetric displacement member positioned within the internal cavity of an NRfit® device or connector and configured to form at least one continuous internal seal to reduce the risk of flammable gaseous anesthetic leaking into the surgical environment. Another embodiment of the present invention comprises a volumetric displacement member positioned within the internal cavity of an ENfit device or connector and configured to reduce the amount of liquid nutrition remaining in the internal cavity before, during, or after the administration of liquid nutrition to a patient. One embodiment of the volumetric displacement member of the present invention comprises a through-passage with an inner wall having an inner diameter configured to measure the flow rate of a fluid or gas through the device or apparatus and includes a color-coded system for distinguishing each flow rate parameter.

[0032] The use of volumetric displacement members as disclosed herein significantly reduces insulin waste in Luer needles / syringes used to inject insulin. The number of people with type 2 diabetes worldwide was estimated at 405 million in 2018 and is projected to increase to 510 million by 2030, which means the need for 1,000 IU insulin vials will increase from 516 million vials in 2018 to 633 million vials in 2030. A 10% reduction in insulin waste may be achievable by employing the Luer needles / syringes of the present invention, which translates to approximately 51,600 liters or 13,631 gallons of insulin per year, based on the 516 million vials that could be utilized and injected, unlike those currently disposed of and placed in the medical waste stream.

[0033] According to some embodiments of the present invention, an assembly is provided in which a volumetric displacement member occupies dead space in one spinal axis syringe, hub, connector, fitting, dispenser or adapter according to part 6, or between two or more spinal axis syringes, hubs, connectors, fittings, dispenser or adapters.

[0034] According to some embodiments of the present invention, an assembly is provided in which a volumetric displacement member occupies dead space in one enteral syringe, hub, connector, fitting, dispenser or adapter according to the third part, or between two or more enteral syringes, hubs, connectors, fittings, dispenser or adapters.

[0035] According to some embodiments of the present invention, an assembly is provided in which a volumetric displacement member occupies dead space in one intravascular Luer syringe, hub, connector, fitting, dispenser or adapter according to part 7, or between two or more intravascular Luer syringes, hubs, connectors, fittings, dispenser or adapters.

[0036] According to some embodiments of the present invention, there is a Luer device having a flow path or internal through-path that has reduced turbulence and is free from lateral mixing, swirling, vortices, or byflows within the flow path or internal cavity of one or more Luer connectors, which promotes and optimizes the smooth and orderly movement of a fluid or gas without having bumps, steps, dead ends, or sharp points, and which has an improved laminar flow regime.

[0037] According to several embodiments, a device is provided that includes a female Luer hub and a male Luer syringe, including a connector, adapter, fitting, or device having an internal cavity with a volume displacement member, for intravascular use, formed from a rigid material with an elastic modulus exceeding 3,433 MPa in either flexure or tension, in accordance with Section 3.7 of Part 7; for spinal axis use, formed from a rigid material with a nominal elastic modulus exceeding 950 MPa in either flexure or tension, in accordance with Section 4.2 of Part 6; and for enteral use, formed from a rigid material with a nominal elastic modulus exceeding 700 MPa in either flexure or tension, in accordance with Section 4.2 of Part 3.

[0038] These and other purposes, features and advantages of this disclosure will become apparent when considered in conjunction with the attached drawings and the following detailed description. [Brief explanation of the drawing]

[0039] [Figure 1] This is a complete side view of an example of a prior art Luer lock syringe / needle device joined by a Luer connector. [Figure 2A] Figure 1 is a cross-sectional side view of a prior art Luer lock device having a combination of internal dead space cavities. [Figure 2B] Figure 2A is a cross-sectional side view of the prior art syringe / needle device. [Figure 2C] Figures 1, 2A, and 2B are cross-sectional side views of the prior art female lure hub. [Figure 3A] This is a cross-sectional side view of one embodiment of the low-dead-space Luer needle / syringe device of the present invention in an assembled configuration. [Figure 3B] Figure 3A is an isometric view of the volumetric displacement member. [Figure 3C] This is a complete top view of the volumetric displacement member of Figure 3A, which has at least one radial projection formed on its distal end. [Figure 3D] This is a complete top view of one embodiment of a volumetric displacement member, which has at least one concave recess formed on its distal end. [Figure 3E] Figure 3A is a cross-sectional front view of the low-dead-space needle / syringe device at axis 3E-3E. [Figure 3F] Figure 3A is a cross-sectional front view of the low-dead-space needle / syringe device at axis 3F-3F. [Figure 4A] This is a cross-sectional side view of one embodiment of a low-dead-space needle / syringe device having a volumetric displacement member positioned within a female Luer hub attached to a male Luer nozzle. [Figure 4B] Figure 4A is a complete top view of the volumetric displacement member. [Figure 4C] Figure 4A is a cross-sectional front view of the low dead space lure device along axis 4C-4C. [Figure 5A] This is a cross-sectional side view of one embodiment of a low-dead-space lure device having laminar flow channels configured within a combined internal cavity. [Figure 5B] This is a cross-sectional side view of one embodiment of a low-dead-space lure device, which includes an integrally formed volumetric displacement member joined to a separate volumetric displacement member. [Figure 5C] Figure 5B is a complete top view of a separate volumetric displacement member. [Figure 5D] This is a cross-sectional side view of another volumetric displacement member in Figure 5C, which has multiple internal through passages. [Figure 6A] This is a cross-sectional side view of one embodiment of a low-dead-space lure device, which includes a volumetric displacement member mechanically coupled to a female lure hub attached to a male lure nozzle. [Figure 6B] This is a cross-sectional side view of the volume displacement member shown in Figure 6A, which has at least one annular recess formed at its distal end. [Figure 6C] This is a cross-sectional side view of one embodiment of the volumetric displacement member of the present invention, having an elongated body with at least one convex annular ring formed around the outer diameter of the distal outer wall. [Figure 6D] Figure 6A is a cross-sectional front view of the volume displacement member along axis 6D-6D. [Figure 7A]This is a cross-sectional side view of one embodiment of an assembly process method for positioning a volumetric displacement member within a female luer hub. [Figure 7B] This is a cross-sectional side view of a method for assembling a low-dead-space device using a mandrel that mechanically fixes a volumetric displacement member within a female luer hub. [Figure 7C] This is a cross-sectional side view of a method for assembling a low-dead-space lure device equipped with a volumetric displacement member mechanically fixed within a female lure hub. [Figure 8A] This is a cross-sectional side view of one embodiment of a volumetric displacement member in a female luer hub and a male luer nozzle having a combined internal cavity with a streamlined flow path. [Figure 8B] Figure 8A is an isometric view of the volumetric displacement member. [Figure 8C] This is a cross-sectional side view of one embodiment of a volumetric displacement member having a proximal end with a reduced outer diameter. [Figure 8D] Figures 8A and 8B are complete front views of the volumetric displacement members. [Figure 8E] An embodiment of the two-piece volumetric displacement member of the present invention is illustrated. [Figure 8F] This is a cross-sectional side view of one embodiment of a volumetric displacement member positioned within a female luer hub. [Figure 8G] Figure 8E is a complete side view of one piece of the two-piece volumetric displacement. [Figure 8H] Figure 8A is a cross-sectional front view of the low-dead-space device along axis 8H-8H. [Figure 9] This is a cross-sectional side view of one embodiment of the Luer nozzle of the present invention, which has an internal cavity formed distally with an inner wall having an equal inner diameter. [Figure 10A] This is a complete top view of one embodiment of a single-form, elongated volumetric displacement member of the present invention having an enlarged distal body. [Figure 10B] This is a cross-sectional side view of one embodiment of a low-dead-space lure device in a first pre-assembled position. [Figure 10C]This is a cross-sectional side view of one embodiment of a low-dead-space lure device in a second assembled position. [Figure 10D] Figure 10C is a cross-sectional front view of the low dead space lure device along axis 10D-10D. [Figure 11A] This is a cross-sectional side view of a low-dead-space lure device in a first pre-assembled position. [Figure 11B] This is a cross-sectional side view of the low dead space lure device in the second assembled position. [Figure 11C] This is a complete side view of a volumetric displacement member according to one embodiment, which has an enlarged distal body with an extended proximal portion. [Figure 12A] This is an isometric view of one embodiment of a volumetric displacement member having multiple distal apertures formed within an enlarged distal end. [Figure 12B] This is a cross-sectional side view of a method for an assembly process in which a volumetric displacement member is positioned within a female hub using a male nozzle. [Figure 12C] Figure 12B is a cross-sectional side view of the assembly process method of the low dead space luer device, in which the male nozzle positions the volumetric displacement member within the female hub. [Figure 12D] Figure 12C is a cross-sectional side view of the assembly process of a low-dead-space lure device, which has a volumetric displacement member mechanically locked into the internal cavity of the female lure hub. [Figure 12E] Figure 12C is a cross-sectional front view of the axis 12E-12E of the low dead space lure device, which has multiple elastic radial portions that are compressed concentrically as the elongated member advances within the female lure hub. [Figure 12F] Figure 12D is a cross-sectional front view of the axis 12F-12F of the low dead space luer device, which has a volumetric displacement member inserted into the female luer hub. [Figure 13] This is an isometric view of one embodiment of a volumetric displacement member, which has an elongated body and an enlarged distal end with a plurality of annular rings having a varying outer diameter. [Figure 14A]This is a cross-sectional side view of one embodiment of a low-dead-space Luer device, which includes a volumetric displacement member positioned within the internal cavity of a male Luer nozzle attached to a syringe and within the distal internal cavity of a female Luer hub. [Figure 14B] Figure 13A is a cutaway side view of the volume displacement member. [Figure 14C] This is a cross-sectional side view of one embodiment of a low-dead-space lure device, which includes a volumetric displacement member having at least one distal hook or lip positioned within the internal cavity of a lure nozzle. [Figure 14D] This is an isometric side view of one embodiment of a volumetric displacement member having at least one channel formed along an outer frustoconical wall. [Figure 14E] Figure 14A is a cross-sectional front view of the low-dead-space syringe device along axis 14E-14E. [Figure 15A] This is a cross-sectional side view of one embodiment of a low-dead-space Luer syringe device, which includes a volumetric displacement member positioned within an internal cavity combining a female hub and a syringe nozzle. [Figure 15B] Figure 15A is a complete top view of the volumetric displacement member. [Figure 15C] Figure 15A is a cross-sectional side view of the volumetric displacement member. [Figure 15D] Figure 15A is a cross-sectional front view of the low-dead-space syringe device along axis 15D-15D. [Figure 16A] This is a cross-sectional side view of one embodiment of a low-dead-space Luer syringe device, which includes a volumetric displacement member positioned within a Luer nozzle attached to a female hub. [Figure 16B] This is a complete side view of one embodiment of a volumetric displacement member having an internal through passage and a tapered outer wall formed distally with a distal lip or hook. [Figure 17A] This is a cross-sectional side view of one embodiment of a low-dead-space Luer syringe device, which includes a volumetric displacement member having a frustoconical distal end positioned within a frustoconical recess formed in a Luer nozzle attached to a female hub. [Figure 17B]Figure 17A is a complete side view of the volumetric displacement member, which has an elastic distal end with an expanding tapered body configured to form a recess and lockfit within the syringe nozzle. [Figure 17C] Figure 17A is a cross-sectional side view of the lure nozzle. [Figure 18] This is a cross-sectional side view of one embodiment of a low-dead-space pre-filled Luer syringe equipped with a volumetric displacement member positioned within the Luer nozzle of the syringe. [Figure 19] This is a cross-sectional side view of one embodiment of a low-dead-space pre-filled syringe, which is equipped with a syringe cap that includes a volumetric displacement member and a color-changing leak detection ring or plate that senses fluid or moisture. [Figure 20A] This is a cross-sectional side view of one embodiment of a smart, low-dead-space prefill, tamper-proof Luer syringe device, comprising a syringe cap with a volumetric displacement member and an outer collar with an attached intact, fragile label featuring a fragile wireless RFID tag. [Figure 20B] Figure 20A is a cross-sectional side view of the smart low-dead-space pre-filled Luer syringe device, showing the outer label on the syringe cap torn, with the RFID tag transmitting a signal that the seal has broken. [Figure 21] This is a cross-sectional side view of a low-dead-space Luer syringe device equipped with a female hub attached to a Luer nozzle having an integrally formed volumetric displacement member. [Figure 21A] Figure 21 is a cross-sectional front view of the axis 21A-21A of a low-dead-space Luer syringe device. [Figure 22] This is a cross-sectional side view of a low-dead-space Luer syringe, which includes a female hub attached to a syringe nozzle, with an integrally formed volumetric displacement member positioned between two internal through passages. [Figure 22A] Figure 22 is a cross-sectional front view of the axis 22A-22A of a low dead space Luer syringe device, which includes a volume displacement member integrally formed with the inner wall of the Luer nozzle by two opposing, integrally formed strips or ribbons. [Figure 23] This is a cross-sectional side view of another embodiment of the low dead space Luer syringe of the present invention, which comprises a female Luer hub attached to a syringe nozzle having an integrally formed elongated strip extending the length of an integrally formed volumetric displacement member having a distal end with a chamfered end wall or face. [Figure 23A] Figure 23 is a cross-sectional front view of the axis 23A-23A of a low-dead-space Luer syringe device. [Figure 24] This is a cross-sectional front view of one embodiment of a low-dead-space Luer syringe device, which includes a female Luer hub attached to a male nozzle having an integrally formed volumetric displacement member surrounded by multiple through passages formed by multiple integrally formed elongated strips. [Figure 25] This is a cross-sectional side view of a method for an assembly process according to one embodiment of the present invention, illustrating a cross-sectional side view of a low dead space syringe shown in a first pre-assembled position. [Figure 26] This is a cross-sectional side view of a method for the assembly process of one embodiment of the present invention of a low dead space syringe, shown in a second assembly position with a volumetric displacement member locked in a Luer nozzle. [Figure 27] This is a cross-sectional side view of one embodiment of the low-dead-space syringe of the present invention, ready for use. [Figure 28] This is a cross-sectional side view of a low-dead-space Luer lock injection line device having a first male connector and a second female connector having a volumetric displacement member, which are separated from each other. [Figure 29] This is a cross-sectional side view of a low-dead-space Luer lock injection line connector device, which has a first male connector and a second female connector having a volume displacement member with an enlarged distal body, shown in a second position where they are joined together. [Figure 30]This is a cross-sectional side view of a Luer lock connector device of the prior art according to Part 6 of the ISO standard, having a first male connector and a second female connector in a first separated position, either a spinal axis or an NRfit® configuration. [Figure 31A] This is a cross-sectional side view of the low dead space Luer lock NRfit® connector device of the present invention, which has a first male connector having a first internal cavity joined to a second female connector having a second internal cavity, the second female connector having a second internal cavity which forms a combined internal cavity and in which a volume displacement member is positioned within the combined cavity. [Figure 31B] This is a cross-sectional side view of the low dead space NRfit® volume displacement member of the present invention, which has a main body with proximal and distal ends having different outer diameters, and an intermediate main body having a larger outer diameter. [Figure 31C] Figure 31A is a cross-sectional front view of the volume displacement member along axis 31C-31C. [Figure 31D] Figure 31A is a cross-sectional front view of the volume displacement member along axis 31D-31D. [Figure 32] This is a cross-sectional side view of one embodiment of the low dead space NRfit® device of the present invention, which includes a male luer nozzle attached to a female luer hub having an internal cavity with an integrally formed volumetric displacement member having an internal through passage positioned within the internal cavity of the male luer nozzle. [Figure 33] This is a cross-sectional side view of a prior art Luer lock connector device of the present invention, having a first male connector and a second female connector shown in a first separated position, in an enteral or ENfit configuration or in the third part of the ISO standard. [Figure 34] This is a cross-sectional side view of the low-dead-space ENfit Luer lock connector device of the present invention, which comprises a first male connector having a first internal cavity joined to a second female connector that forms a combined internal cavity, and a volumetric displacement member positioned within the combined cavity. [Figure 34A] Figure 34 is a cross-sectional front view of the volume displacement member along axis 34A-34A. [Figure 35]This is a cross-sectional side view of the ENfit volumetric displacement member of the present invention, which has an enlarged intermediate body formed between an elongated proximal body and an elongated distal body, with opposing through passages formed along the outer wall. [Figure 35A] Figure 35 is a cross-sectional front view of the elongated volumetric displacement member along axis 35A-35A. [Figure 36] This is a cross-sectional top view of the ENfit volumetric displacement member of the present invention, which has an enlarged intermediate body formed between a proximal end and a distal end, with at least one through passage formed within the outer wall of the main body. [Figure 36A] This is a cross-sectional front view of the volume displacement member shown in Figure 36 along axis 36A-36A, which has a main body with opposing through passages formed along the outer wall and passing through the intermediate portion. [Figure 37] This is a cross-sectional side view of the low-dead-space male-to-male luer adapter connector of the present invention, which connects a first syringe to a second syringe. [Figure 37A] Figure 40 is a cross-sectional front view of the low dead space male lure-to-male lure adapter at axis 37A-37A. [Figure 37B] Figure 37 is a cross-sectional front view of the low dead space male lure-to-male lure adapter at axis 37B-37B. [Figure 38] This is a cross-sectional side view of a male Luer syringe attached to a low-dead-space filling needle of the present invention, which has a female Luer hub and a distal blunt-tipped needle configured with an integrally formed volumetric displacement member positioned within an internal cavity. [Figure 38A] Figure 38 is a cross-sectional front view of the shaft 38A-38A of the low dead space forming filling needle. [Modes for carrying out the invention]

[0040] Several low-dead-space syringes and small-bore devices are disclosed herein. In the following description, numerous specific details are given to provide a full understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be carried out without these specific details. In other cases, known structures and processing steps are not shown in specific details to avoid unnecessarily obscuring the invention. In addition, it should be noted that the invention is applicable to a variety of intravascular, enteral nutrition, spinal axis, or respiratory systems, including connectors, adapters, fittings, in-line infusion valves, hubs, needles with sharp distal tips, needles with curved distal tips, Huber needles, any hollow-bore needles with distal tips, needles with blunt tips used as filling needles or to access infusion ports, pipettes used in research, needleless valves, vial adapters, stopcocks, syringe adapters, spike port adapters, or infusion lines used to administer or withdraw fluids, gases, and drugs to or from a patient. Any embodiment of the volumetric displacement member in this application may be formed alone or separately, or combined by several methods including, but not limited to, injection molding, folding clamshell construction, stamping, progressive die processing, extrusion, ultrasonic welding, adhesive bonding, interference fit, press fit, friction fit, compression fit, thermal welding, screw-in means, etc. However, it is recognized that the present invention is not limited to these devices.

[0041] With respect to syringes and female hubs, the low-dead-space syringes and small-bore devices disclosed herein are understood to be easily adaptable to all types of other devices in which needles, connectors, adapters, infusion lines or fittings may be used, including but not limited to injection needles, infusion sets, anesthesia and nutritional supplies, and to flush infusion lines.

[0042] Figures 1-2B illustrate the conventional Luer needle / syringe combination 1, which is the most widely used syringe configuration worldwide due to its wide range of applications (injection, infusion, flushing, etc.), interoperability and connectivity to numerous Luer connectors, fittings, adapters and devices, and ease of filling with any variety of drugs, vaccines, therapeutic fluids or gases, and is relatively inexpensive to manufacture and easy to produce using important existing production lines already in place worldwide. Two Luer configurations are shown: the Luer lock configuration shown in Figures 1-2B and other drawings of this application, and the Luer slip configuration shown in Figures 3A and 4A and other drawings of this application.

[0043] Figure 1 illustrates a complete side view of a prior art Luer lock syringe / needle device 1, which includes a hollow, elongated needle 12 having a sharp distal tip 11 attached to a female Luer hub 2 rotated on a distal Luer lock collar 4 of a syringe 3, wherein the needle hub 2 has at least one elongated rib 5 formed to engage with a sheath to facilitate rotational mounting or detachment of the hub 2 from the syringe 3.

[0044] Figure 2A includes a cross-sectional side view of the prior art Luer needle / syringe device 1 of Figure 1, which comprises a Luer lock syringe 3 having a hollow barrel cavity 16 with an elongated needle 12 attached, and a male Luer nozzle 13 having a first internal cavity 6 positioned within an internal cavity 26 of a female Luer hub 2 as shown in Figure 2C. The elongated needle 12 has a distal sharp end 11 and a hollow conduit 10 having a first internal diameter parameter D1 that varies according to the needle gauge, which is mounted within a distal conduit 65 of the female hub 2. The female hub 2 comprises an inner side wall 7 having a nominal frustoconical taper of 6%, defining an internal cavity 26 which includes an open proximal end 35 and a second distal internal cavity 26c formed by an end wall 34 that communicates with a stop or lip 17 for positioning the proximal end of the needle within the distal conduit 65. The mass-produced syringe body, male connector, and female hub are actually translucent to allow any air or bubbles to be observed and removed from the fluid or drug before delivery to the patient, port, or infusion line. The female hub 2 includes at least one proximal flange or lug 9 for mechanically engaging with the inner locking threads 8 of the distal Luer lock collar 4 by rotating the female hub 2 onto the nozzle 13. The female hub 2 may include a threaded portion instead of a lug 9 for securing the hub 2 to a Luer lock syringe 3, or to a male Luer connector having a port, port adapter, needleless valve, intravenous tube connector, intravenous fluid bag, etc.

[0045] The hollow barrel cavity 16 must be filled with a pharmaceutical product from a vial, or with an automatic syringe filler to which the needle 12 is attached after the syringe barrel cavity 16 is filled. When the vial is used, air is drawn into the syringe barrel cavity by moving the plunger rod 15 and piston 14 away from the needle by an approximate amount of the desired dose, and then the air is injected into the vial through the needle, creating a positive pressure that displaces the fluid as the desired dose is drawn from the vial through the needle into the syringe barrel cavity. The elastomer piston 14 forms an annular seal with the inner barrel wall and is selectively slidable within the barrel cavity 16. The syringe nozzle 13 has a frustoconical tapered outer side wall 18 and an inner side wall 41 with a distal opening 41a that defines an internal cavity 6 formed from an open proximal end 24, terminating at a distal end 25 having an end wall or face 25a. The internal cavity 6 may be tubular in shape, having an inner wall with a constant inner diameter along its length, or it may include an inner side wall with a variable tapered inner diameter as shown herein. The proximal opening end 24 of the internal cavity 6 has an inner side wall 41 formed with a second inner diameter parameter D2, which measures between a minimum of 2.9 mm or 0.114 inches according to Part 7 and an estimated maximum of 3.68 mm or 0.145 inches in practice. The distal opening of the syringe nozzle is formed with a third inner diameter parameter D3, which measures between an actual minimum of 1.14 mm or 0.045 inches and a maximum of 2.9 mm or 0.114 inches according to Part 7. The syringe nozzle 13 is used in clinical practice and is constructed to have substantially equal wall thicknesses 47 as shown in Figure 2B, as shown throughout this application, to avoid curing shrinkage or deformation problems during the injection molding process and to ensure that an airtight and liquid-tight seal 33 is formed between the conical mating surface of the outer frustoconical sidewall 18 of the male nozzle 13 and the inner frustoconical sidewall 7 of the female hub 2 when the connector and adapter are joined together.

[0046] ISO 7886-1:2017 specifies requirements and test methods for validating the design of empty, sterile, disposable subcutaneous syringes, with or without needles, made of plastic or other materials, intended for aspiration and injection of fluid after filling by the end user. The maximum allowable dead space within the internal cavity of a Luer nozzle under ISO 7886-1:2017 is as follows: 1 ml to 3 ml syringes = 0.07 ml, 5 ml syringes = 0.075 ml, and 10 ml syringes = 0.10 ml. The present invention is configured to significantly reduce the allowable dead space within the internal cavity of a Luer syringe nozzle, to ensure additional doses, and to enable administration from multi-dose vials.

[0047] For syringes, needles, IV tube sets, holding mechanisms, IV catheters, IV catheter ports, stopcocks, adapters, and drug compounding adapters, the flow rate between the female connector and male connector, according to Table D.1 in Part 7, is in the range of 0 ml / min to 1,200 ml / min.

[0048] Figure 2B illustrates a cross-sectional side view of the prior art Luer lock needle / syringe device of Figure 2A, which comprises a Luer syringe 3 having a male nozzle 13 with an internal cavity 6 forming a first dead space, positioned within an internal cavity 26 of a female hub 2 as shown in Figure 2C. Here, a distal internal cavity 26c is formed between the inner end wall 34 of the female hub 2 and the outer end wall 25a of the syringe nozzle 13, forming a second dead space where, when the syringe 3 is filled with fluid, air or bubbles in the fluid may become trapped or retain and adhere to the inner wall formed along the flow path. Any air or bubbles that adhere to the inner wall or remain trapped in the distal internal cavity may then be released into the fluid that is injected, flushed, or injected into the patient. A detour or changing through-passage channel 38, indicated by a dashed line, is formed between the syringe barrel cavity 16 and the internal cavity 6 of the male nozzle 13, swirls within the internal cavity 26c, and advances through the aperture 32 into the needle conduit 110.

[0049] The distal end 25 of the nozzle 13 is configured, according to Part 7, with an outer wall 18 having an outer diameter parameter D7 measured at position L4 where the male taper of the outer diameter of the tip of the nozzle 13 is measured 0.75 mm or 0.0295 inches (basic dimension) from the distal end wall 25a of the tip of the nozzle 13, with a minimum of 3.97 mm to a maximum of 4.035 mm or 0.156 inches to 0.159 inches for rigid materials, and a minimum of 3.97 mm to a maximum of 4.072 mm or 0.156 inches to 0.160 inches for semi-rigid materials.

[0050] The tapered outer wall 18 of the proximal end 24 of the syringe nozzle 13 has an outer diameter parameter D6, which is measured at position L3, 7.5 mm or 0.295 inches (basic dimension) from the distal end wall 25a according to Part 7, with a minimum of 4.375 mm to a maximum of 4.440 mm, or 0.172 inches to 0.1748 inches for rigid materials, and a minimum of 4.375 mm to a maximum of 4.447 mm, or 0.172 inches to 0.1762 inches for semi-rigid materials. The projection of the nozzle 13 has a length of L6, measured at a minimum of 2.1 mm or 0.083 inches from the distal end of the threaded collar 4 to the distal end wall 25 according to Part 7.

[0051] Figure 2C is a cross-sectional side view of the prior art female luer hubs of Figures 2A and 2B, which have a distal inner cavity 26c as shown in Figure 2B, and an inner wall 7 having a fourth distal inner diameter parameter D4, which is measured at position L5 where the inner diameter of the hub 2 is measured at 7.5 mm or 0.295 (basic dimension) from the proximal opening end 35, ranging from a minimum of 3.820 mm to a maximum of 0.3.865 mm, or 0.150 inches to 0.152, for rigid materials, and from a minimum of 3.793 mm to a maximum of 0.3.893, or 0.149 inches to 0.153, for semi-rigid materials.

[0052] The proximal end 35 of the opening of the internal cavity 26 has a fifth internal diameter parameter D5, where the internal diameter of the female taper is measured at position L4, 0.75 mm or 0.0295 inches (basic dimension) from the proximal end 35 of the opening, according to the seventh part, ranging from a minimum of 4.225 mm to a maximum of 4.270 mm, or from 0.166 inches to 0.168 inches for rigid materials, and from a minimum of 4.198 mm to a maximum of 4.298 mm, or from 0.165 inches to 0.169 inches for semi-rigid materials.

[0053] The internal cubic volume of the distal internal cavity 26 of the female hub 2 varies depending on the internal configuration of each manufacturer, how securely the needle hub 2 is fixed to the nozzle 13 of the syringe 3, and how precisely the parts are injection molded. While the amount of pharmaceutical or fluid remaining in the internal cavity 6 of the prior art Luer nozzle and the internal cavity 26 of the Luer needle hub 2 may appear small, collectively, the adoption of the low dead space Luer device or apparatus of the present invention allows for more accurate filling of fillable Luer syringes, pre-filled Luer syringes, and single and multi-dose vials of pharmaceuticals without including additional fluid volumes to accommodate the various internal cavity configurations that form dead space in current Luer devices. Additionally, fluids or pharmaceuticals held in the dead space of prior art Luer devices, connectors, or apparatus are disposed of in a medical waste stream and require additional energy to evaporate the fluid before combustion occurs during incineration.

[0054] Figures 3A-3F illustrate the syringe device 101 of the low dead space syringe / needle device 101 of the present invention, in a ready-to-use state, together with a male Luer slip syringe 3b joined to a female Luer needle hub 102 having a separate, individually formed volumetric displacement member 120 positioned within the combined internal cavity of the device. The volumetric displacement member 120 has an elongated body 122 with an outer wall 137 having an outer diameter D8 as shown in Figure 3B, which is smaller than the inner diameter D3 of the distal aperture 41a of the syringe nozzle 13 as shown in Figure 2A. The volumetric displacement member 120 has a closed proximal end 130 and an internal through passage 121 that begins at the outer wall 137 and ends at the open distal end wall 144. During use, a channel 138, indicated by a dashed line, is formed between the syringe barrel cavity 16, the inner side wall 41 of the male nozzle 13, the outer wall 137 and inner through passage 121 of the volume displacement member 120, the distal internal cavity 126c of the female hub 102, and the needle conduit 110. The volume displacement member 120 is configured to reduce the internal stereovolume within the combined internal cavity, and the inner through passage is configured to discharge or remove air or bubbles from the fluid within the combined internal cavity. Embodiments of the volume displacement member or male or female small-bore connector of the present invention throughout this application may be formed from rigid materials manufactured from medical-grade plastic resins, including but not limited to blends of metal, polycarbonate, or resin, or from semi-rigid or elastic materials manufactured from medical-grade plastic resins, including but not limited to blends of polypropylene, silicone, polyurethane, polyethylene, polyester, or resins that can provide excellent sealing interfaces between components. As an example, polypropylene is a self-lubricating plastic resin with a low coefficient of friction and hydrophobic properties.

[0055] Luer lock syringes, Luer slip syringes, resistance-relieving Luer syringes, Luer flush syringes, or Luer syringes used in clinical practice or having elastic blow-fill, collapsible barrels or reservoirs as shown throughout this application are interchangeable with each other and with the hubs, needles, connectors, adapters, and fittings disclosed herein. The volumetric displacement members of the present invention may be formed within or added to elastic blow-fill, collapsible barrels or reservoirs, or syringes consisting of pre-filled syringes, small-bore connectors, infusion lines, adapters, or fittings, and the female hubs of the present invention may consist of needles, filling needles, tubes, adapters, connectors, etc.

[0056] Figures 3A to 3F illustrate other embodiments of the volumetric displacement member 120. In the example in Figure 3A, the volumetric displacement member 120 is shown to be part of the needle / syringe device 101.

[0057] According to one embodiment of the present invention, Figure 3A shows a cross-sectional side view of a low dead-space Luer syringe / needle device 101 ready for use, comprising a volumetric displacement member 120 positioned within an internal cavity 106 of a male nozzle 13. The volumetric displacement member 120 has an outer wall 137 having an outer diameter D8, as shown in Figure 3B, which is measured to be smaller than the inner diameter D3 of the distal opening 41a of the syringe nozzle 13, as shown in Figure 2A. The female hub 102 includes a mounted elongated needle 112 having a hollow conduit 110 with an inner diameter D1 and a sharp distal tip 111. The female hub 102 is shown in a deployable position and is coupled to the male nozzle 13 of a Luer slip syringe 3b, which includes a plunger rod 15 and a piston 14 that are movable within the syringe barrel cavity 16 to fill or empty the syringe 3b. The volumetric displacement member 120 comprises an elongated body 122, as shown in Figure 3B, which includes a closed proximal end 130 and an internal through passage 121 separating a first elastic distal end 131a and a second elastic distal end 131b, terminating at distal end walls or surfaces 144a and 144b, respectively. The elastic distal ends are mechanically fixed to a distal nest 145 formed within the internal cavity of the female hub by press-fit or compression-fit. A flow path 138, shown by a dashed line, is formed within the combined internal cavity, including the internal cavity 126c of the female hub 102, and is configured to move fluid and air into the needle aperture 132 and conduit 110 as the plunger 15 and piston 14 advance toward the needle 112.

[0058] When syringe 3b is fitted with female hub 102, the outer wall 18 of the Luer nozzle 13 forms a liquid-tight and airtight seal 133 with the inner side wall 107 of the female hub 102. After the fluid in the syringe is distributed through the needle, a reduced volume or amount of pharmaceutical remains in the internal cavity of the Luer nozzle. When the needle hub is attached to a conventional Luer syringe, the volume displacement member of the present invention displaces most of the cubic volume of fluid, minimizing dead space in the internal cavity of the Luer nozzle. Syringes illustrated in the present invention may include multi-chamber syringes or multi-barrel syringes. The closed, solid proximal end of the volume displacement member of the present invention may be formed in several ways to fit, cooperate with, and form a seal with the distal end of the syringe piston when the syringe plunger advances to the distal end of the syringe barrel cavity to push fluid or pharmaceutical out of any syringe described and disclosed in this application.

[0059] The outer wall of the distal end of the volume displacement member of the present invention may be joined to the inner wall of the distal nest of the female hub by several processes or methods, including but not limited to ultrasonic welding, adhesive bonding, interference fit, press fit, friction fit, compression fit, thermal welding, mutual lock interface, and threading.

[0060] Embodiments of the volume displacement member of the present invention may be manufactured or configured to include any number of shapes, including but not limited to elongated, annular, radial, geometric, polyhedral, tubular, shrinking, or expanding, and may include at least one through-passage or side passage, forming at least one liquid or gas flow path or internal through-passage together with or inside at least one Luer connector, adapter, or fitting, and may be configured to discharge air or bubbles from the liquid or gas inside the Luer connector or connector before use, and to reduce the cubic volume inside the internal cavity of the small diameter connector or the combined cavity of the small diameter connector before, during, or after use.

[0061] Figure 3B is an isometric view of the volume displacement member 120 of Figure 3A, which comprises an elongated body 122 having an outer wall 137 having an outer diameter D8, a closed proximal end 130, and at least one through passage 121 starting from the outer wall 137 and ending at distal end walls 144a and 144b, the through passage 121 separating the first elastic distal end 131a and the second elastic distal end 131b.

[0062] Figure 3C is a complete side view of the volume displacement member 120 of Figure 3A, having an elongated body 122 with a first arched projection or geometrically configured projection 158a formed around a first radially configured elastic distal end 131a and a second arched projection or geometrically configured projection 158b formed around a second radially configured elastic distal end 131b, which are formed to mechanically fix and fit the volume displacement member 120 into a female luer hub including a nest with an inner wall having a concave recess not shown in this application. The projections 158a and 158b are configured to engage with the distal end 552 of the mandrel 550 to form a lip configured to assist in the assembly of the volume displacement member 120 into the female luer hub 102, as shown in Figure 7B.

[0063] Figure 3D is a complete side view of one embodiment of a volume displacement member 120a having an elongated body 122a, which includes a first concave recess 146a formed around a first radially configured elastic distal end 131a and a second concave recess 146b formed around a second radially configured elastic distal end 131b. The concave recesses 146a and 146b are configured to engage with a convex annular ring 158d formed on the inner wall 141d of the distal nest 145d of the female hub 102d, as shown in Figure 7C.

[0064] Figure 3E is a cross-sectional front view of the low dead space Luer syringe / needle device 101 of Figure 3A along axis 3E-3E, illustrating the Luer nozzle 13 attached to the needle hub 102, where the volumetric displacement member 120 is positioned within the internal cavity 106 of the syringe nozzle 13 to reduce its cubic volume. A portion of the flow path 138 is formed between the inner side wall 41 of the male nozzle 13 and the outer wall 137 of the volumetric displacement member 120, allowing the movement of air and fluid between the syringe barrel cavity 16 and the needle passage 110 as the plunger rod 15 and piston 14 move within the syringe 3b, as shown in Figure 3A.

[0065] Figure 3F is a cross-sectional front view of the Luer syringe device of Figure 3A along axis 3F-3F, which has a volumetric displacement member positioned within the syringe nozzle 13 and reducing the cubic volume of the internal cavity 106 of the syringe nozzle 13. A portion of the flow path 138 is formed between the inner through passage 121 of the volumetric displacement member 120 and the internal cavity 106 of the male nozzle 13, allowing the movement of air and fluid between the syringe barrel cavity 16 and the needle passage 110 as the plunger rod 15 and piston 14 move within the syringe 3b, as shown in Figure 3A.

[0066] Figures 4A to 4C illustrate other embodiments of the volume displacement member 120b.

[0067] Figure 4A is a cross-sectional side view of one embodiment of the low dead space needle / Luer slip syringe device 101A of the present invention, which has a single-formed volumetric displacement member 120b securely positioned within a female hub 102a having an internal distal nest 145a with an internal side wall 141a having an inner diameter configured to form a press-fit or compression-fit with the outer arched walls 137a and 137b of the distal ends 131a and 131b as shown in Figure 4B. The volumetric displacement member 120b is composed of an elongated body 122b and a closed proximal end 130b, with opposing internal through passages 121b and 121d converging with a through passage 121a terminating at distal end walls 144a and 144b as shown in Figure 4B. The first internal through passage 121b and the second opposing internal through passage 121d are separated by at least one appendage 160 having opposing internal walls 169 and 169d. A channel 138a, shown by a dashed line, is formed from the syringe barrel cavity 16 through the internal cavity 106 of the Luer nozzle 13 and follows the through passages 121b, 121d and 121a of the volume displacement member 120b, as well as the internal cavity 126c and aperture 132 of the female hub 102a, and the conduit 110 of the needle 112. It is configured to discharge air or gas 115 from the fluid 116 as the plunger rod 15 and piston 14 advance toward the distal end of the syringe 3b, thereby reducing the cubic volume within the device 101A. The tapered inner wall 134b of the distal nest 145a is configured to deliver fluid 116 and air 115 from the through passage 121a into the aperture 132 and needle conduit 110.

[0068] FIG. 4B is a complete top view of the displacement member 120b of FIG. 4A having an elongated body 122b, with outer walls 137a and 137b configured to have an outer diameter ≧ D3 at distal ends 131a and 131b to form a press fit or a compression fit when located within the distal opening 41a of male nozzle 13 as shown in FIG. 4A. The outer walls 137a and 137b of the proximal closed end 130b may be configured to have an outer diameter < D3 to facilitate placement of the elongated body 122b within the distal opening 41a of male nozzle 13. Rounded or chamfered outer corners may be formed at the proximal end of the displacement member of embodiments of the present invention to facilitate assembly within a luer nozzle.

[0069] FIG. 4C is a cross-sectional front view taken along axis 4C-4C of the low dead space needle / syringe device 101A of FIG. 4A having a displacement member 120b positioned concentrically within the internal cavity 106 of male nozzle 13 which is in turn positioned within the distal internal cavity 126c of female hub 102a. The first inner through passage 121b and the second inner through passage 121d form a part of the flow path 138a as shown in FIG. 4A within the internal cavity 106 of syringe nozzle 13. The outer walls 137a and 137b of distal ends 131a and 131b as shown in FIG. 4B also form the inner sidewall 41 at the distal opening 41a having an inner diameter D3 of male nozzle 13, the first radial interface 23a and the second radial interface 23b.

[0070] FIGS. 5A and 5B illustrate the luer devices 101B and 101C of the low dead space syringe or small bore connector of the present invention, with a male luer nozzle attached to a female luer hub having an internal cavity, together with an integrally formed displacement member positioned within the distal opening 41a of male nozzle 13.

[0071] According to one embodiment of the present invention, Figure 5A is a cross-sectional side view of a low dead space luer device 101B, in which a small-diameter connector is joined, comprising a male luer nozzle 13 attached to a female luer hub 102b having a needle 112 attached to a distal conduit 165, and opposing integrally formed volume displacement members 120c having a body 122c formed in a distal internal cavity 126c. The body 122c of the volume displacement member 120c is formed having an outer wall 137c, and the proximal end 130c of the opening, having a tapered inner wall 117, defines an internal cavity 121c that communicates with a concentrically centered through passage or conduit 110 with a diameter 121e and needle 112. The outer wall 137c has an outer diameter that forms a liquid-tight and airtight seal 123 with the inner diameter D3 of the distal aperture or opening 41a of the male nozzle 13. The low-dead-space Luer device 101B is formed between the syringe barrel cavity 16, the internal cavity 106 of the Luer nozzle 13, and the internal cavity 121c and through passage 121e of the female hub 102b, and comprises a combined internal cavity with a streamlined or laminar flow channel 138b, indicated by a dashed line, which continues into the conduit 110 of the needle 112, and is configured to move air or bubbles and fluid into or out of the device 101B. The tapered inner wall 117 of the internal cavity 121c is configured as an outlet for discharging air or bubbles and fluid out of the device 101B. The volume displacement member 120c is configured to reduce both the internal cubic volume within the combined internal cavity and the fluid or gas remaining in the flow channel 138b after use. The channel 138b is separated from and bypassed from the distal internal dead space cavity 126c formed between the distal end 25 of the Luer nozzle 13 and the distal end wall 134c of the female hub 102b. A tube or the like can be assembled within the conduit 165 of the female hub 102b before packaging, sterilization, and use, rather than a needle 112.

[0072] A common or combined internal cavity with a forward-configured flow path is formed within one or more small-bore devices, devices, or connectors of the present invention, preferably formed between the hollow barrel cavity of a syringe or hollow tube, the internal cavity of a male nozzle, at least one internal through-passage of a volumetric displacement member, and the aperture of a needle hub, and continues into other components that can be installed in the conduit of a needle or hollow tube, or in the distal conduit of a female hub configured as an outlet, to deliver and remove air or bubbles and fluid from the combined internal cavity.

[0073] According to one embodiment of the present invention, Figure 5B is a cross-sectional side view of a two-piece volumetric displacement member located within a low-dead-space Luer device 101C, comprising a male Luer nozzle 13 attached to a female Luer hub 102c having a first integrally formed volumetric displacement member 120d joined to a second separate volumetric displacement member 120e. The first volumetric displacement member 120d includes an internal cavity 121c having a tapered end wall 117a formed within a proximal male nozzle 145b, which has an outer wall 145c formed within a distal internal cavity 126c, and is attached to a second separate volumetric displacement member 120e having a distal female collar 131e with an inner wall 139e defining a nest 121f, with an inner diameter D9 configured to form a press-fit or compression-fit with the outer diameter of the outer wall 145c of the male nozzle 145b forming a first liquid-tight and airtight seal 143c. The attachment of the female collar 131e to the male nozzle 145b may include ultrasonic welding, adhesive bonding, interference fit, friction fit, heat welding, and matching threads. The outer wall 137d of the volumetric displacement member 120d has an outer diameter that forms a liquid-tight and airtight seal 123a with the inner diameter D3 of the distal aperture 41a of the male nozzle 13 and isolates the streamlined channel 138c, shown by the dashed line, from the distal internal dead space cavity 126c of the female hub 102c. As shown in Figure 5C, the outer wall 137e of the volumetric displacement member 120e has an outer diameter that, together with the inner diameter of the distal aperture 41a of the male nozzle 13, forms a second liquid-tight and airtight seal 123b. A streamlined or laminar flow channel 138c, indicated by a dashed line, is formed between the syringe barrel cavity 16, the internal cavity 106 of the Luer nozzle 13, the internal cavities 121b and 121d of the volume displacement member 102e as shown in Figure 5D, and the internal cavity 121c and through passage 121e of the female hub 102c, and is configured to move air or bubbles and fluid into or out of the device 101C. The tapered inner wall 117a of the internal cavity 121c is configured as an outlet for discharging air or bubbles and fluid from the device 101C. The volume displacement member 120e is configured to reduce both the internal cubic volume within the combined internal cavities and the fluid or gas remaining in the flow channel 138c after use.

[0074] When the volume displacement members 120d and 120e are joined together, the opposing tapered distal inner walls 117c and 117d, as shown in Figure 5D, are configured to deliver fluid and air from the internal cavity 106 of the syringe nozzle 13 into the opposing through passages 121b and 121d, into the internal cavity 121c and through passage 121e, and into the needle conduit 110 or the conduit of the tube attached to the female hub 102c. The volume displacement member 120e is configured to have at least one inner appendage 160e formed by the tapered inner walls 117c and 117d and the opposing inner walls 169c and 169d that define the opposing inner through passages 121b and 121d.

[0075] Figure 5C is a complete top view of the volumetric displacement member 120e of Figure 5B, which has an elongated body 122e comprising an outer wall 137e with at least one intermediate inner through passage or opening 121b and a distal collar 131e with a distal end wall 144e.

[0076] Figure 5D is a cross-sectional side view of the volume displacement member 120e having an elongated body 122e with an outer wall 137e as shown in Figure 5C, and at least one inner appendage 160e, as shown in Figure 5B, is formed by opposing distal tapered inner walls 117c and 117d and opposing inner walls 169c and 169d defining two opposing intermediate inner through passages 121b and 121d, and merges into an open distal nest 121f formed within the distal female collar 131e as shown in Figure 5C by an inner wall 139e having an inner diameter D9.

[0077] Figures 6A to 6D illustrate a luer device 101D of one embodiment of the low dead space luer syringe of the present invention, which includes a single, separately formed volumetric displacement member 120f mechanically positioned within the internal cavity 126c of the female luer hub 102d.

[0078] Figure 6A is a cross-sectional side view of one embodiment of the low dead space Luer device 101D of the present invention, which includes a single, separately formed volumetric displacement member 120f positioned within the internal cavity 126c of the female Luer hub 102d and the internal cavity 106 of the male Luer nozzle 13. The female Luer hub 102d includes an inner wall 141d with an annular ring 158d having a convex profile forming a distal nest distal 145d, and an attached needle 112 with a conduit 110. The volumetric displacement member 120f includes a single, elongated body 122f, which is configured to have an outer wall 137f, a closed proximal end 130f, a distal end 131f, and opposing through passages 121b and 121d starting from the outer wall 137f and merging with a concentrically centered distal through passage 121e terminating at the distal end wall 144f, as shown in Figure 6B. The outer wall 137f of the main body 122f has an outer diameter configured to form a first liquid-tight and airtight seal 123c with the distal opening 41a having an inner diameter D3 of the male Luer nozzle 13, and a second liquid-tight and airtight seal 143f is formed by the inner wall 141d of the distal nest 145d of the female Luer hub 102d and the outer wall 137f of the distal end 131f. The inner diameter of the nest 145d may be larger or smaller than the inner diameter D3 of the male nozzle 13, and may form a liquid-tight and airtight seal with a substantially matching outer diameter of the outer wall 137f of the distal end 131f of the volume displacement member 120f.

[0079] The volumetric displacement member 120f includes at least one recessed recess 146d formed within and around the distal outer wall 137f, as shown in Figure 6B, configured to lockfit and engage with an annular recessed projection or ring 158d formed within the distal nest 145d of the female hub 102d. A smooth or laminar flow channel 138d, indicated by a dashed line, formed between the syringe barrel cavity 16, the internal cavity 106 of the male nozzle 13, the through passages 121b, 121d, and 121e of the volumetric displacement member 120f, the aperture 132 of the needle hub 102d, and the conduit 110 of the needle 112, is configured to move air or bubbles and fluid into or out of the device 101D. The tapered inner walls 117c and 117d of the internal cavity 121c are configured as outlets for discharging air or bubbles and fluid from the device 101D. The volume displacement member 120f is configured to reduce both the internal cubic volume within the combined internal cavity and the fluid or gas remaining in the flow path 138d after use. The flow path 138d is separated from and bypassed from the distal internal dead space cavity 126c formed within the female hub 102d.

[0080] Figure 6B is a cross-sectional side view of one embodiment of the volume displacement member of Figure 6A, comprising an elongated body 122f and a first inner through passage 121b and a second opposing through passage 121d, as shown in Figure 6A, separated by at least one inner appendage 160f having opposing side walls 169b and 169b that merge with an axial through passage 121e terminating at a distal end wall 144f. The body 122f includes two opposing tapered inner walls 117c and 117d that define the distal ends of the inner through passages 121b and 121d formed between the outer wall 137f and the axial through passage 121e.

[0081] Figure 6C is a cross-sectional side view of the volumetric displacement member 120g of the present invention, which has an elongated body 122g comprising a distal end wall 144g and at least one annular ring 158e having a convex profile formed around the distal outer wall 137e. The at least one annular ring 158e of the volumetric displacement member 120g is configured to engage with an annular convex recess formed in a nest of a female hub not shown in this application, thereby forming a mechanical connection between the volumetric displacement member 120g and the female hub.

[0082] Figure 6D is a cross-sectional front view along axis 6D-6D of the volume displacement member 120f of Figure 6A, which has an elongated body 122f as shown in Figure 6B, and an internal through passage 121e positioned within the internal cavity 106 of the distal opening 41a of the male nozzle 13 as shown in Figure 6A. The outer wall 18 of the nozzle 13 forms a first liquid-tight and airtight seal 133 with the internal side wall 107 of the female hub 102d, and the outer wall 137f of the volume displacement member 120f forms a second liquid-tight and airtight seal 123c with the internal wall 41 of the male nozzle 13.

[0083] Figures 7A-7C illustrate one embodiment of a method for loading and assembling the volume displacement member 120f of Figure 6A into the female hub 102d using a mandrel 550. Any embodiment of the volume displacement member of the present invention can be assembled into a well-configured female luer hub of the present invention, and other components, including but not limited to subcutaneous needles, blunt needles, hollow tubes, valves, extension sets, etc., can be used before, during, or after joining each device or apparatus.

[0084] Figure 7A is a cross-sectional side view of one embodiment of a method for assembling a low dead space luer device 101D of the present invention, which has a volumetric displacement member 120f ready to be placed in an internal cavity 556 of a mandrel 550 having an outer wall 551 and a distal end wall 552, with the volumetric displacement member 120f and female luer hub 102d shown in a first position separated from each other.

[0085] Figure 7B is a cross-sectional side view of the assembly process method of the luer device 101D of Figure 7A, shown in a second position where the volumetric displacement member 120f is positioned within the female luer hub 102d by the mandrel 550. The distal end 144f of the volumetric displacement member 120f is now mechanically locked into the internal nest 145d as shown in Figure 7A by a fitting engagement between the annular ring 158d of the distal inner wall 141d of the female hub 102d and the annular recess 146d of the outer wall 137f of the body 122f, as shown in Figure 7A.

[0086] Figure 7C is a cross-sectional side view of the assembly process method of the low dead space Luer device 101D shown in Figures 7A and 7B, in which the volumetric displacement member 102f locks into the female hub 102d, thereby allowing the proximal end of a needle, tube, etc., to be positioned and fixed within the distal conduit 165 of the female hub 102d as shown in Figure 7, before packaging, sterilization, and use.

[0087] Figures 8A to 8D illustrate one embodiment of the low-dead-space Luer syringe device 301 of the present invention, which has a one-piece volumetric displacement member 320 or 320c formed in the internal cavity 126c of the female Luer hub 102g and which can be positioned on the male nozzle 345.

[0088] According to one embodiment of the present invention, Figure 8A is a cross-sectional side view of a ready-to-use low-dead-space Luer device 301A of the present invention, which includes a syringe 3b with a male Luer nozzle 13 attached to a female Luer hub 102g, with a single-unit (monolithic) volumetric displacement member 320 positioned within the internal cavity 106 of the male nozzle 13 and the distal dead-space internal cavity 126c of the female Luer hub 102g. According to another embodiment, the volumetric displacement member 320 does not have to be a monolithic structure and may include multiple parts. The volumetric displacement member 320 includes an elongated body 322 having an outer wall 337, a closed proximal end 330, and a distal collar 331 formed by an inner wall 341a that communicates with the outer wall 341b and the through passage 321e, defining a distal hollow interior / female nest 321f as shown in Figure 8B. The distal collar 331 is cooperative and matable with the collar / male nozzle 342, which is located surrounded by an annular groove / nest 345 of the distal internal cavity 126c of the female Luer hub 102g. As shown in Figure 8A, according to some embodiments, the collar 342 is formed as part of the female Luer hub 102g. When the collar 331 is joined to the collar 342, a first liquid-tight and airtight seal 343a is formed between the inner wall 341a of the collar 331 and the outer wall 339 of the collar 342. The female Luer hub 102g includes an internal dead space cavity 126c formed between the distal end wall 25a of the syringe nozzle 13 and the distal end wall 134 of the female hub 102g. According to some embodiments, at least one forward-configured streamlined or laminar flow channel 138e is formed between the hollow cavity 16, the internal cavity 106 of the male nozzle 13, and through passages 321b, 321d, and 321e formed within the volume displacement member 320 and continuing through the needle conduit 110, and is configured to allow fluid and any trapped air or bubbles to move out of the device 301A through the distal end 111 of the needle 12. The tapered inner walls 317b and 317d of the through passages / openings 321b and 321d are configured as outlets for discharging air or bubbles and fluid from the device 301A.The volumetric displacement member 320 is configured to reduce both the internal cubic volume within the internal cavity 106 of the male nozzle 13 and the fluid or gas remaining in the flow path 138e after use. The flow path 138e is separated from and bypassed from the distal internal dead space cavity 126c formed within the female hub 102g.

[0089] The distal collar 331 includes an outer wall 341b having an outer diameter configured to form a second liquid-tight and airtight seal 343 with the inner wall 341c of the distal nest 345 of the female luer hub 102g. A third liquid-tight and airtight seal 323 is formed between the outer wall 337 of the body 322 and the inner wall (diameter D3) of the distal opening 41a of the male nozzle 13. The outer wall 337 may include an annular ring with a convex profile or projection 358, which engages with the distal end wall 25a of the male nozzle 13 to form a fourth liquid-tight and airtight seal 343b and may include a proximal end wall 349 configured to further separate the distal internal dead space cavity 126c from the combined internal cavity of the flow path 138e before, during, or after use. The projection 358 also acts as a stopper to limit the depth to which the male luer nozzle 13 can be positioned within the internal cavity 126 of the female luer hub 102g, thereby reducing the possibility of overtightening the female hub onto the male nozzle of the luer lock device or connector. The annular ring or geometrically configured projection 358 is formed on the outer wall of the body of any embodiment of the volumetric displacement member of the present invention as described herein, and can form a liquid-tight and airtight seal with the distal end wall of the male luer nozzle, thereby limiting and controlling the depth to which the male luer nozzle can be positioned within the internal cavity of the female luer hub.

[0090] Low dead space Luer devices of some embodiments of the present invention described herein include a combined internal cavity characterized by a smooth or laminar flow path that extends from the syringe barrel cavity, through the internal cavity of the Luer nozzle, through at least one internal through passage of a volumetric displacement member, through the conduit of an attached needle or tube, and bypasses a larger diameter internal dead space cavity formed in the distal female Luer hub of the male nozzle.

[0091] Figure 8B is an isometric view of a single-form volumetric displacement member 320 of Figure 8A, having an elongated body 322, which includes a distal collar 344 with an inner wall 341a that defines a hollow nest / interior 321f communicating with concentrically formed through passages 321e branching into opposing through passages 321d and 321b, as shown in Figure 8A, and an outer wall 341b and a distal end point 337b of length L7 from the distal end wall 344. The body may include an annular ring 358 having a convex or geometric profile formed between the end point 337b and the distal end wall 344. The outer wall 337 portion formed between the distal end wall 344 and the end point 337b has an outer diameter configured to form a liquid-tight and airtight seal 323 with the inner diameter D3 of the distal opening 41a of the male nozzle 13, as shown in Figure 8A. The proximal end 330 may include a reduced outer diameter configured as a lead-in, as shown in Figure 8C, to facilitate the insertion of the volumetric displacement member of the male Luer nozzle into the distal aperture before selective attachment to the female Luer hub.

[0092] Figure 8C is a cross-sectional side view of one embodiment of the volumetric displacement member 320a of the present invention, which has an elongated body 322a having a proximal end 330a with an outer wall 337a having an outer diameter of less than D3, formed as a lead-in to facilitate the placement of the volumetric displacement member to a male nozzle or another male connector, as shown throughout this application. The annular projection 358a having a convex or geometric profile may be formed on the outer wall 337b between the distal end 344 and the endpoint 337b, as shown in Figure 8B, and may be segmented into a plurality of radial arcs.

[0093] Figure 8D is a complete front view of the volumetric displacement member of Figure 8A, and the distal collar 331 is configured to have a distal nest 312f formed with at least one inner through passage 321e of the volumetric displacement member 320, as shown in Figure 8B, and an annular projection 358 formed on the outer wall 337.

[0094] Figure 8E is a cross-sectional side view of a two-piece volumetric displacement member of the present invention, comprising a first volumetric displacement member 320c joined to a second separate volumetric displacement member 320d. The first volumetric displacement member 320c includes a distal collar 331c with a hollow distal nest 321f, which is formed having an internal cavity 321 with an internal through passage 321e and an internal proximal wall 371 formed within the proximal end of the opening 330c. The collar 331c is configured to have an outer wall 337b having an outer diameter less than D3, which increases to an outer diameter 337c configured to form a liquid-tight and airtight seal with the inner diameter D3 of the inner opening 41a of the male nozzle 13 as shown in Figure 8A. The second volumetric displacement member 320d includes a body 322d as shown in Figure 8G, comprising an outer wall 337d having substantially matching outer diameters 337c as shown in Figure 8G, a closed proximal end 330d, and a distal appendage 360d with outer walls 369b and 369d. An intermediate outer wall 337e is formed between the proximal end 330d and the appendage 360d and includes an outer diameter configured to form a press-fit or compression-fit with the inner diameter of the inner wall 371 of the open proximal end 330c that joins the first volumetric displacement member 320c and the second volumetric displacement member 320d together.

[0095] Figure 8F is a cross-sectional side view of a ready-to-use low-dead-space Luer device 301B of one embodiment of the present invention, which includes a syringe 3b with a male Luer nozzle 13 attached to a female Luer hub 102h, with a single-unit (monolithic) volumetric displacement member 320e positioned within the internal cavity 106 of the male nozzle 13 and the distal dead-space internal cavity 126c of the female Luer hub 102h. According to other embodiments, the volumetric displacement member does not have to include a monolithic structure and instead may include multiple parts fitted together. The volumetric displacement member 320e comprises an elongated body 322e, a closed proximal end 330e, and an open end comprising a distal collar 331e with a distal nest / internal 345e. The distal internal cavity 126c of the female luer hub 102h is configured with a collar 342e which may be formed having a tapered inner wall 317e defining the proximal internal cavity 321c. The proximal end wall formed perpendicular to the needle conduit 110 axis may replace the tapered inner wall 317e at the proximal end of the nozzle 342e. The collar 331e is press-fitted or compression-fitted onto the collar 342e formed in the distal internal cavity 126c of the female hub 102h, so that the inner wall 341e of the distal collar 331e is cooperative and matable with the outer wall 339e of the collar 342e, forming a first liquid-tight and airtight seal 343e. A second liquid-tight and airtight seal 323e is formed between the outer wall 337e of the body 322e and the inner wall (diameter D3) of the distal opening 41a of the male nozzle 13. A forward-facing channel 138g, indicated by a dashed line, is formed between the hollow cavity 16, the inner cavity 106 of the male nozzle 13, and the through passages / openings 321b and 321d and the internal cavity 321c of the volume displacement member 320e, and continues through the needle conduit 110, and is configured to move air or bubbles and fluid into or out of the device 301B. The tapered inner wall 317e of the internal cavity 321c is configured as an outlet for discharging air or bubbles and fluid out of the device 301B. The volume displacement member 320e is configured to reduce both the internal cubic volume within the combined internal cavity and the fluid or gas remaining in the channel 138g after use.The channel 138g is separated from and bypassed from the distal internal dead space cavity 126c formed within the female hub 102h.

[0096] Figure 8G is a complete side view of the volume displacement member 320d of Figure 8E, which comprises a main body 322d having an outer wall 337d, a closed proximal end 330d, and a distal appendage 360d with outer walls 369b and 369d. The intermediate outer wall 337e includes an outer diameter configured to form a press-fit or compression-fit with the inner diameter of the inner wall 371 of the open proximal end 330c of the first volume displacement member 320c, as shown in Figure 8E.

[0097] Figure 8H is a cross-sectional front view of the low dead space device of Figure 8A along axis 8H-8H, which has a volumetric displacement member 102g configured to have at least one internal through passage 321e separated from the internal dead space cavity 126c of the female hub 102g.

[0098] Figure 9 is a cross-sectional side view of the Luer nozzle 113c of the present invention having an elongated distal opening 141a and a frustoconical tapered outer wall 118 according to Part 7. The inner side wall 141c defines a first proximal frustoconical internal cavity 106c formed by opening to a second distally formed elongated internal cavity 106d, which has an inner side wall 141b having a consistent inner diameter D3 and a length L10 formed proximal to a maximum of 3 mm or 0.118 inches within the syringe nozzle 113c. The consistent distal inner diameter D3 is configured to increase the length of a liquid-tight and airtight seal, or any other mating seal in this application, formed between the inner wall 141b of the distal opening 141a of the male nozzle 113c and the outer wall of the embodiment of the volume displacement member of the present invention.

[0099] Figures 10A to 10D show one embodiment of the low dead space luer device 201 of the present invention, which has a one-piece volumetric displacement member 220 with an enlarged distal body 231 that can be positioned within the internal cavity 106 of the luer nozzle 13 and the internal cavity 226 of the female luer hub 202.

[0100] Figure 10A is a complete top view of one embodiment of a single-form volumetric displacement member 220 of the present invention, having an elongated body 222, which comprises an outer wall 237 having a first outer diameter ≤ D3 and a closed proximal end 230, and an inner through passage 221 formed by an inner appendage 260, as shown in Figure 10B, with opposing side walls 269b and 269d, as shown in Figure 10B, terminating at the distal end wall 244 of an enlarged distal body 231 having an outer wall 237a. The outer wall 237a of the distal body 231 may include a frustoconical taper that narrows from the proximal end wall 249 to the distal end wall 244.

[0101] Figure 10B shows a cross-sectional side view of the low dead space luer device 201 of Figure 10A in a first position before assembly, which includes a female luer hub 202 having a proximal open end 235, a distal side wall 241, and a frustoconical inner side wall 207 defining an internal cavity 226 which communicates with a distal internal cavity 226c formed by a closed end wall 234 with an aperture 232 connected to the conduit 210 of the needle 212. The volume displacement member 220 is configured with an elongated body 222 having an inner through passage 221 formed by an inner attachment 260 with opposing side walls 269b and 269d, terminating at the distal end wall 244 of an enlarged distal body 231 as shown in Figure 10A, which has an outer wall 237 and a closed proximal end 230 having a first outer diameter ≤ D3, and an outer wall 237a having a second outer diameter substantially equal to D4. The female hub 202 has an inner distal side wall 241 formed distal to at least one annular ring 205 configured as a stop or projection 257 to form a mechanical lockfit for holding the proximal end wall 249 of the enlarged distal body 231 of the volume displacement member 220 within the internal cavity 226c. The volume displacement member 220 has an elongated body 222 having a first outer diameter ≤ D3 with a closed proximal end 230, and at least one through passage 221 extending from the outer wall 237 to the distal end wall 244 of at least one enlarged distal body 231 having a second outer diameter substantially equal to D4, and an outer side wall 237a that is sealably cooperative and matable with the inner side wall 241. The distal end wall 244 may also form an additional liquid-tight and airtight seal with the end wall 234 of the hub 202 when the enlarged body 231 is positioned within the internal cavity 226c.

[0102] Figure 10C is a cross-sectional side view of one embodiment of the low dead space luer device 201A of the present invention in a second assembled position, which has a single-form volumetric displacement member 220b comprising an elongated body 222b with an outer wall 237b having a first outer diameter ≥ D3, and at least one enlarged distal body 231a having a second outer diameter substantially equal to D4, positioned within the distal internal cavity 226c of the female luer hub 202a. The volumetric displacement member 220b is formed having a first internal through passage 221b and a second opposing through passage 221d, separated by at least one internal appendage 260a formed by opposing side walls 269b and 269d, which converge together and communicate with a concentrically centered through passage 221e, and terminate at the distal end wall 244a of the distal body 231a. The elongated body 222b has an outer wall 237b having an outer diameter configured to form a first annular liquid-tight and airtight seal 223 with an inner diameter D3 of the distal opening 41a of the male nozzle 13, and a second liquid-tight and airtight seal 243a formed by the outer wall 237c of the enlarged distal body 231a, and the inner side wall 241 and end wall 234 of the distal internal cavity 226c in the female Luer hub 202a, as shown in Figure 10B. At least one flow path 138f, indicated by a dashed line, is formed between the hollow cavity 16, the internal cavity 106 of the male nozzle 13, and through passages 221b, 221d, and 221e formed in the volume displacement member 220b and continuing through the needle conduit 110. The flow path 138f is configured as an outlet to remove air or gas from the fluid in the device and reduce the internal cubic volume of the combined internal cavity. During use, the flow path 138f is physically isolated from the distal dead space cavity 226c, which is then displaced by the enlarged body 231b. The female hub 202a includes an inner side wall 241 with at least one annular ring or projection 205, which forms a stop 257 configured to hold the enlarged distal body 231a of the volume displacement member 220b within the distal cavity 226c, forming a mechanical lockfit with the proximal end wall 249 as shown in Figure 10B.

[0103] Figure 10D is a cross-sectional front view along axis 10D-10D of the low dead space Luer device 201A of the present invention, which has a distal body 231a positioned within the distal internal cavity 226c of the female hub 202a as shown in Figure 10C and displacing the cubic volume. The outer wall 237c of the enlarged distal body 231a forms a liquid-tight and airtight seal 243a around the inner wall 241 of the distal internal cavity 226c. An internal through passage 221e within the Luer device 201A bypasses the distal internal cavity 226c of the female Luer hub 202a, as shown in Figure 10C.

[0104] Figure 11A shows a cross-sectional side view of one embodiment of the Luer device 401 of the present invention, comprising a female Luer hub 402 and a separate volumetric displacement member 420c in a first position before assembly. The female Luer hub 402 has an inner side wall 407, and the proximal open end 435 and distal end wall 434 define a distal internal cavity 426c, which comprises an internal cavity 426 and an aperture 432 formed in the end wall 434 that communicates with the conduit 410 of the needle 412. The distal internal cavity 426c has an inner side wall 441 comprising a first annular ring 405a and a second annular ring 405b having a first annular diameter that can be continuous or segmented, formed on both sides of an intermediate annular recess 446a having a second larger inner diameter. A second annular recess 446b, as shown in Figure 11B, having a second inner diameter, is formed distal to the annular ring 405b. The volumetric displacement member 420c is composed of an elongated body 422c, as shown in Figure 11B, having an outer wall 437c formed with an outer diameter ≤ D3, and having two distal enlarged opposing elastic arc portions or bodies 431a and 431b, separated by an inner through passage 421, which has a proximal end wall 449c and an outer wall 437d with one radially formed concave recess 445 formed between convex arcs 458b and 458c. The through passage 421 begins at the outer wall 437c of the elongated body 422c and ends at the distal end wall 444a of the arc portion 431a and the distal end walls 444b of the arc bodies 431a and 431b. The annular recesses 446a and 446b have substantially equal outer diameters to D4, which are configured to engage with radial arcs 458b and 458c in order to lock-fit the volumetric displacement member 420c with the female hub 402, as shown in Figure 11B.

[0105] Figure 11B is a cross-sectional side view of the low dead-space Luer device of Figure 11A, shown in a second assembly position attached to a Luer syringe 3b, having a volumetric displacement member 420c positioned within the cavity 426c of the female Luer hub 402, as shown in Figure 11A, thereby mechanically fixing and lock-fitting the enlarged distal bodies 431a and 431b of the volumetric displacement member 420c within the distal cavity 426c of the hub 402 by a stopper 457 that engages with the end wall 449c of the arcuate portion 458c, as shown in Figure 11A. The distal end walls 444a and 444b, as shown in Figure 11A, engage with the end wall 434 of the hub 402. The through passage 421 of the volume displacement member 420c is configured to discharge air or gas from the fluid inside the device and reduce the internal cubic volume of the combined internal cavity.

[0106] Figure 11C is a complete side view of a single-form elongated member 420b having a proximal body 422b and a closed end 430b formed with a proximal body 422b, which has a proximal body 422b and a proximal extending portion or body 470 having a proximal end wall 449b configured to displace an additional portion of the internal cavity 426 of the female hub 402 as shown in Figures 11A and 11B.

[0107] Figure 12A is an isometric view of a volume displacement member 420 of one embodiment of the present invention, comprising an elongated body 422 having an outer wall 437 having a first outer diameter ≤ D3, formed by a closed proximal end 430 and four elastic arc-shaped distal portions 431a, 431b, 431c, and 431d separated by internal through passages 421a and 421b. The elastic distal portions are configured with an outer wall 437 having an outer diameter substantially equal to D4, and a radially formed concave recess 445 is formed between radially formed convex arcs 458b and 458c. An internal through passage 448 begins in the elongated body 422 and communicates with the through passages 421a and 421b.

[0108] Figures 12B to 12F illustrate one embodiment of a method for loading and assembling an elongated volumetric displacement member 420 into a female hub 402 using a male nozzle 13.

[0109] Figure 12B is a mixed cross-sectional and full side view of a method for assembling the low dead space luer device 401B of the present invention, shown in a first position with its components separated. The male nozzle 13 has a distal end wall 25a that can cooperate with a proximal end wall 449 of a volume displacement member 420 having multiple apertures 421a and 421b, shown in a first uncompressed position as an opening or width L8, forming and separating four elastic arc-shaped distal portions 431a, 431b, 431c, and 431d that advance into the female luer hub 402.

[0110] Figure 12C is a cross-sectional side view of a method of assembly process for the low dead space luer device 401B of Figure 12B in a second position, which has a nozzle 13 that holds the volume displacement member 420 and advances it axially into the internal cavities 426 and 426c of the female hub 402. The internal cavity 426c is composed of an inner annular ring 405a and 405b separated by an intermediate recess 446a, which has an inner wall 441 configured and sized to bias and concentrically compress the outer radial wall 437a of the distal portions 458c and 458b of the elastic distal segments 431a, 431b, 431c and 431d of the volume displacement member 420 as the distal portions 458c and 458b move through the inner diameter of the annular rings 405 and 405b.

[0111] Figure 12D is a cross-sectional side view of the assembly process of the low dead space luer device shown in Figure 12C, which is ready to be attached to a needle 112, tube, etc., having elastic radial portions 431a, 431b, 431c, and 431d positioned and seated within the distal internal cavity 426c of the female luer hub 402 by a first interference fit or lock fit formed between the stop portion 457 and the end wall 449 in the annular convex ring 405a and a second interference fit or lock fit between the annular convex ring 405b and the concave recess 445, as shown in Figure 12B.

[0112] Figure 12E is a cross-sectional front view along axis 12E-12E of the low dead space luer device of Figure 12C, which has a volume displacement member 420 with through passages 421a and 421b separating the elastic radial portions 431a, 431b, 431c and 431d at a second concentrically compressed position C, as indicated by the arrows, with through passages 421a and 421b having a narrowed opening span L9 as the radial portions 431a, 431b, 431c and 431d of the volume displacement member 420 advance and insert into the female hub 402.

[0113] Figure 12F is a cross-sectional front view of a method of assembly process on axis 12F-12F of the luer device of Figure 12D, shown in a third position, having a volumetric displacement member 420 inserted into the female luer hub 402. When the volumetric displacement member 420 is positioned and seated in the distal cavity 426c of the hub 402, the elastic portions 431a, 431b, 431c and 431d unfold and spring back to their manufacturing or initially formed positions, coinciding with the first configuration position in Figure 12B.

[0114] Figure 13 is an isometric view of one embodiment of the volumetric displacement member 220d of the present invention, which has an elongated body 222d and at least one internal through passage 221b starting from an outer wall 237d and communicating with a distal through passage 231e terminating at a distal end wall 244d. The outer diameter of the elongated body 222d is configured to have an outer diameter ≤ D3. The volumetric displacement member 220d has an enlarged distal body 231d which includes a distal nozzle 272d, an intermediate recess 245d formed between annular rings 258b and 258c, a proximal end 270c, a proximal end wall 249d, and a tapered outer side wall 237c configured to have an outer diameter substantially equal to D4. The distal annular rings 258b and 258c may have equal or different outer diameters.

[0115] Figures 14A-14C and 14E illustrate the low-dead-space Luer device 501 of the present invention, which includes a Luer slip syringe 3b attached to a female Luer hub 102. A volumetric displacement member 520 or 520b can be assembled into the internal cavity of the male nozzle through a hollow cavity 16 by a mandrel or plunger / piston, as shown in Figure 27.

[0116] Figure 14A is a cross-sectional side view of one embodiment of the Low Dead Space Luer Device 501 of the present invention, shown in a ready-to-use state, which includes a volumetric displacement member 520 positioned within the internal cavity 106 of the nozzle 13 and the distal internal cavity 126c of the female hub 102 of the Luer slip syringe 3b. The separate volumetric displacement member 520, as shown in Figure 14B, comprises an elongated body 522 having an internal through passage or conduit 527 extending from the proximal end 530 of the opening to the distal end 531 of the opening, and includes an end wall 544 and an outer side wall 566 having a frustoconical taper configured to form a compression fit or slip fit that forms a first liquid-tight and airtight seal 523 along the length of the frustoconical taper of the inner wall 41 of the nozzle 13. When the syringe device 501 is positioned with the needle 112 facing upward, the frustoconical end wall 517 of the proximal end 530 is configured to expel air from the fluid in the syringe barrel cavity 16 into the inner through passage 527 as the plunger rod 15 and piston 14 advance toward the female hub 102. The distal end wall 544 extends beyond the distal end wall 25a of the nozzle 13 and engages and cooperates with the distal end wall 134 of the internal cavity 126c of the female hub 102, forming a second liquid-tight and airtight seal 543, except for any communication between the through passage 527 and the internal cavity 126c of the Luer hub 102. A laminar flow channel 538, shown by a dashed line, is formed between the syringe barrel cavity 16, the inner through passage 527, and the needle conduit 110. The volumetric displacement member 520 is configured to reduce both the internal cubic volume within the distal cavity 126c of the hub 102 and the internal cavity 106 of the syringe nozzle 13, and the amount of fluid or gas remaining in the flow path 538 after use.

[0117] Figure 14B is a cutaway view of the volume displacement member of Figure 14A, which includes an internal through passage 527 formed from the proximal end 530 to the distal end 531 of the opening.

[0118] Figure 14C is a cross-sectional side view of one embodiment of the low dead space male syringe device of the present invention, which includes a Luer slip syringe 3b with a separate volumetric displacement member 520b positioned within an internal cavity 106 of a male nozzle 13. The volumetric displacement member 520b is configured to have an elastic distal end 531b with at least one distal hook, lip, or projection 558 having a proximal surface or end wall 549 configured to lockfit and form a liquid-tight and airtight seal 543 with the end wall 25a of the nozzle 13. After at least one lip 558 is compressed and advances through the distal inner opening 41a of the syringe nozzle 13, at least one portion 558 springs back and unfolds to a position consistent with its pre-assembly manufacturing configuration. The inner wall 41 of the nozzle 13 is configured to form a second liquid-tight and airtight seal 523b with the outer wall 566b of the volumetric displacement member 520b. The through passage 527 may include an inner diameter having a frustoconical profile that tapers from the proximal end 530b to the distal end 531b in order to assist core extraction during the manufacturing process.

[0119] Figure 14D is an isometric view of one embodiment of the volumetric displacement member 520c of the present invention, which comprises an elongated body 522c having a distal end wall 544c and at least one through passage, slot, or channel 527b formed axially along the outer wall 566c, extending from the proximal end 530c to the distal end 531c. The outer wall 566c may be configured to include a substantially 6% frustoconical taper.

[0120] Figure 14E is a cross-sectional front view of the axis 14E-14E of the low dead space syringe device of Figure 14A, which has a volumetric displacement member 520 positioned within a male nozzle 13 having an inner diameter D3 formed within the distal opening 41a of the male nozzle 13, as shown in Figure 14A. The inner wall 107 of the female hub 102 is configured to form a first liquid-tight and airtight seal 33 with the outer wall 18 of the syringe nozzle 13, and the inner wall 41 of the nozzle 13 is configured to form a second liquid-tight and airtight seal 523 with the outer wall 566 of the volumetric displacement member 520.

[0121] FIG. 15A is a cross-sectional side view of one embodiment of a low dead space luer syringe device 601 of the present invention, comprising a volume displacement member 620 positioned within an inner cavity 106 of a male luer nozzle 13 attached to a syringe 3b and a distal inner cavity 126c of a female luer hub 102. The volume displacement member 620 comprises a body 622 having an outer wall 637 with opposing inner through-passages 621b and 621d that merge with a concentrically centered through-passage 621e formed distally and terminate at an end wall 644 having an outer diameter <D3, as shown in FIG. 15C. The distal end 631 of the volume displacement member 620 is configured with an outer wall 666 that tapers in a frustoconical shape to form a first liquid-tight and air-tight seal 623 with an inner opening 41a of the male nozzle 13. The seal 623 forms a friction fit or a compression fit to maintain the position of the volume displacement member 620 within the male nozzle 13, either before, during, or after use. The distal end 631 extends beyond the distal end 25a of the male nozzle 13, and the distal end wall 644 engages with the distal end wall 134 of the female hub 102 to form a second liquid-tight and air-tight seal 643, excluding any communication between the through-passage 621e and the inner cavity 126c of the luer hub 102. As shown in FIG. 15C, the body 622 includes two opposing tapered distal inner walls 617c and 617d and an inner appendage 660 formed by tapered inner walls 669 and 669a, and defines inner through-passages 621b and 621d having a through-passage 621e configured to convey fluid and air or bubbles into or out of the low dead space device 601. A smooth or laminar flow path 638, indicated by a dashed line, is formed between the syringe barrel cavity 16, the inner cavity 106 of the male nozzle 13, the through-passages of 621b, 621d, and 621e of the volume displacement member 620, and the conduit 110 of the needle 112.

[0122] FIG. 15B is a complete top view of the volume displacement member of FIG. 15A, comprising an elongated body 622 with a closed proximal end 630 as shown in FIG. 15A, having at least one inner through-passage / opening 621b with an outer diameter ≧D3 and at least one inner appendage 660.

[0123] Figure 15C is a cross-sectional side view of the volume displacement member of Figures 15A and 15B, which comprises an elongated body 622 formed by opposing distal tapered inner walls 617c and 617d and at least one inner attachment 660 formed by opposing inner walls 669 and 669a that define two opposing inner through passages 621b and 621d that merge with a distal through passage 621e formed distally and terminated at a distal end wall 644 as shown in Figure 15A.

[0124] Figure 15D is a cross-sectional front view of the axis 15D-15D of the low dead space syringe device of the present invention of Figure 15A, which has a volumetric displacement member 620 separated from the internal dead space cavity 126c of the female hub 102 and having at least one internal through passage 621e passing through it.

[0125] Figure 16A is a cross-sectional side view of one embodiment of the low dead space syringe device 601B of the present invention, shown in a ready-to-use state, which includes a volumetric displacement member 620c positioned within the internal cavity 106 of a male Luer nozzle 13 attached to a syringe 3b and within the distal internal cavity 126c of a female Luer hub 102. The volumetric displacement member 620c comprises a distally formed tapered frustoconical outer wall portion 666c configured to form a wedge-fit liquid-tight and airtight seal 623a with the inner wall 41 of the nozzle 13 by first compression, and a distal lip portion 658 configured to hook over the distal end wall 25a of the syringe nozzle 13 and form a lock fit.

[0126] Figure 16B is a complete side view of one embodiment of the volume displacement member 620b of the present invention, which has an elongated body 622b with an internal through passage 621b separating a first distal arc-shaped end 631a with an end wall 644a and a second opposing distal arc-shaped end 631b with an end wall 644b.

[0127] Figure 17A is a cross-sectional side view of one embodiment of the low dead space syringe device 701 of the present invention, shown in a ready-to-use state, comprising an internal cavity 806 of a male Luer nozzle 813 attached to a syringe 3c and a volume displacement member 720 positioned within the distal internal cavity 126c of a female Luer hub 102. The syringe nozzle 813 comprises an inner wall 841 and a distal frustoconical recess 806c, as shown in Figure 17C, formed by an inner wall 809 with a proximal inner corner 805 configured to fit and engage with the outer wall 776 and proximal end wall 749 of the distal body 737 of the volume displacement member 720, as shown in Figure 17B. The volumetric displacement member 720 is formed having at least one through passage 721, as shown in Figure 17B, configured to discharge air or gas from the fluid inside the device 701 and to reduce the internal cubic volume of the internal cavities 806 and 806c of the nozzle 813, as shown in Figure 17C.

[0128] Figure 17B is a complete side view of the volume displacement member 720 of Figure 17A, which has an elongated body 722 comprising a closed proximal end 730, a first distal arc-shaped end 731a with an end wall 744a, a second opposing arc-shaped end 731b with a side wall or end wall 744b, an internal through passage 721 separating them, and an enlarged distal portion or head 737 with a frustoconical tapered wall 776 and a proximal end wall 749 that narrow distally.

[0129] Figure 17C is a cross-sectional side view of the syringe nozzle of Figure 17A, which comprises a Luer slip syringe 803 having a syringe nozzle 813 with a distal end 825, an internal cavity 806, and an enlarged internal cavity 806c formed by the distal tapered inner wall 809 and the proximal side or corner portion 805 of the syringe nozzle 813.

[0130] Figure 18 is a cross-sectional side view of one embodiment of the pre-filled low-dead-space Luer syringe device 901 of the present invention, which comprises a Luer slip syringe 3b having a nozzle 25 closed by a selectively removable low-dead-space syringe cap 900 having a volume displacement member 920 at a first sealing position within the internal cavity 106 of the male nozzle 13. The cap 900 is configured to have a volume displacement member 920 having an elongated body 922 with an outer wall 937, and the distal end 931 has an outer diameter configured to form a first liquid-tight and airtight seal 923 with the inner diameter D3 of the inner wall 41 of the distal opening 41a of the syringe nozzle 13. The end wall 25a of the nozzle 13 forms a second liquid-tight and airtight seal 943 with the distal inner end wall 934 of the syringe cap 900. The cap 900 comprises a proximal outer, annular sleeve or collar 954 having an inner wall 907a configured to fit with the outer frustoconical wall 18 of the male nozzle 13 to form a third liquid-tight and airtight seal 933. The first seal 923 is complemented by a second seal 943 and a third seal 923 to maintain multiple contact surfaces that keep the fluid 116a sterile within the syringe nozzle 13 before use. The syringe nozzle 13 and syringe cap 900 may be configured to have multiple seals 923, 933 and 943 for sealing the fluid together with the syringe 3b, but may include at least one seal necessary to maintain the sterility of the fluid 116a within the syringe 3b.

[0131] Figure 19 is a cross-sectional side view of one embodiment of the smart leak-sensing pre-filled low-dead-space Luer syringe device 901B of the present invention, which comprises a Luer-lock syringe 3 having a nozzle 13 closed and sealed by a selectively removable low-dead-space syringe cap 900b having a volume displacement member 920 at a first position within the internal cavity 106 of the nozzle 13. The cap 900b is configured to have at least one proximal lug or threaded portion 9 so as the cap 900b is rotated onto the syringe 3, it forms a mechanical attachment with a thread 8 formed in the distal Luer-lock collar 4. The syringe 3 or syringe cap 900b may include an annular or segmented leak detection member 960 having a fluid-sensitive pigment that changes color. It is essential that the drug, therapeutic agent or vaccine 116a in the hollow cavity 16 of the syringe 3 remain sterile before use. The leak detection component 960 contains an irreversible hydrochromic pigment (typically black or blue) such that any change in color visually alerts individuals in the supply chain that at least one seal 923, 933, or 943 between the syringe nozzle 13 and the syringe cap 900b is leaking and damaged. The leak detection component 960 may include a lint-free fabric or a lint-free cellulose-based substrate formed, printed, or impregnated with the irreversible hydrochromic pigment. The syringe nozzle 13 and syringe cap 900b may be configured to have multiple seals 923, 933, and 943 for sealing the fluid 116a together with the syringe 3, but may include at least one seal necessary to maintain the sterility of the fluid 116a in the syringe 3. The seals 923, 933, and 943 in Figure 19 are configured to have the same contact surfaces formed at the interface described in the nozzle 13 and cap 900 in Figure 18. Since the pre-filled cap 900b is usually made of a plain material and the syringe 3 is usually made of a translucent material, the leak sensing member 960 is positioned in a location visible through the syringe collar 4.The leak sensing member or ring 960 is positioned within the distal internal cavity 126c of the female hub disclosed in this application, allowing for visual identification of the failure of at least one liquid-tight and airtight seal formed on the outer diameter of the volumetric displacement member of the present invention.

[0132] Figure 20A is a cross-sectional side view of one embodiment of the smart tamper-proof, capped, pre-filled low-dead-space Luer syringe device 901C of the present invention, in a first, sealed, capped position. The internal cavity 106 of the syringe nozzle 13 is closed by a selectively removable low-dead-space syringe cap 900c, which has an elastic volumetric displacement member 920 with a distal end 931 having an outer wall 937 that forms a liquid-tight and airtight seal 923 with the inner wall 41 of the distal opening 41a of the syringe nozzle 13. The volumetric displacement member 920 is shown in the first sealed position within the internal cavity 106 of the Luer nozzle 13. The syringe nozzle 13 and syringe cap 900c may be configured to have a plurality of seals 923, 933 and 943 for sealing fluid together with the syringe, but may include at least one seal necessary to maintain the sterility of the fluid in the syringe. The seals 923, 933, and 943 in Figure 20A are constructed having the same contact surfaces formed at the interface described on the nozzle 13 and cap 900 in Figure 18. The syringe device 901C includes an RFID tag 973 attached to a fragile adhesive-backed label 970, which has a proximal end 971 and a distal end 972. The fragile label 970 wraps around the circumference of the cap 900c and syringe 3, keeping the components joined together. The label 970 may include machine-readable and human-readable data information in accordance with the Health Industry Bar Code Supplier Labeling Standard, providing a unique device identification system that specifies the device, expiration date, sterilization method, catalog number, manufacturer, and contents within the syringe 3. An intact label 970 indicates that the cap 900c has not been repositioned or removed from the syringe 3. Syringe device 901C may also include a leak detection component 960 of syringe device 901B. Readable data establishes a chain of control, making syringes and pharmaceuticals traceable from their source and identifying the patient to whom the pharmaceuticals were administered.

[0133] A radio frequency identification system (RFID) comprises two components: a reader and a tag. The RFID tag emits radio waves containing its identification information and other data to the reader, which has an antenna. Passive RFID tags do not contain a battery and are powered by the reader. Active RFID tags are powered by a battery.

[0134] Figure 20B is a cross-sectional side view of the smart, low-dead-space pre-filled Luer syringe device of Figure 20A, comprising a Luer-lock syringe 3 and a syringe cap 900c in a second opening position. When the syringe cap 900c is removed from the syringe 3, the RFID tag 973 transmits or broadcasts a decodeable signal 980 to the RFID reader 981 indicating that the label 970 has been torn and one or more seals 923, 933, and 943 between the syringe 3 and the syringe cap 900c have been broken or damaged. The signal 980 may also be transmitted from the RFID tag 973 on the distal portion 972 of the label 970 on the cap 900c.

[0135] Figure 21 is a cross-sectional side view of the low dead space Luer syringe device 1001 of the present invention, which comprises a Luer slip syringe 1003 having a hollow barrel 16 formed together with an internal cavity 1006 of the nozzle 1013, and having at least one integrally formed volumetric displacement member 1020 formed within the syringe nozzle 1013 and connected together by at least one integrally formed strip 1068 shown between two dashed lines, which is formed within the syringe nozzle 1013 and connected together with at least one integrally formed strip 1068 shown between two dashed lines, and which has at least one integrally formed volumetric displacement member 1020 formed at the distal end 1025 by the inner wall 1041 of the nozzle 1013 and the outer wall 1037 of the volumetric displacement member 1020. The volumetric displacement member 1020 comprises an elongated body 1022, a closed proximal end 1030, and a distal end 1031 having at least one distal aperture 1021 that communicates with at least one through passage 1027, which is formed along the axial length of the inner wall 1041 of the nozzle 1013 and the outer wall 1037 of the elongated member 1020 and forms a flow path 1038 for discharging air and fluid from the inner cavity of the syringe device. The inner side wall 1041 of the Luer nozzle 1013 of the present invention may be formed in a cylindrical configuration having a consistent outer diameter that forms a hollow cavity between it and the outer wall 1037 of the volumetric displacement member 1020.

[0136] At least one integrally formed strip 1068 and at least one through passage 1027, formed along the axial length of the inner wall 1041 of the nozzle 1013 and the outer wall 1037 of the elongated body 1022, enable the volume displacement member 1020 to be injection molded and formed in a single shot and cycle together with and within the nozzle 1013. Additionally, a substantially uniform thickness wall section 1047 of the nozzle 1013 can be molded and evenly cured to form the required smooth conical mating surface outer wall 1018, ensuring that an airtight and liquidtight seal is formed with the conical mating surface inner wall 107 of the female Luer hub 102.

[0137] FIG. 21A is a cross-sectional front view in the axis 21A-21A of the syringe device of FIG. 20A, comprising a female luer hub 102 attached to a male nozzle 1013 as shown in FIG. 21, integrally formed with a connection strip 1068 and an outer wall 1037 of an elongated body 1022 having an outer diameter <D3>. At least one axially extending through-passage 1027 is formed along the lengths of the inner wall 1041 of the nozzle 1013 and the outer wall 1037 of the volume displacement member 1020, as shown in FIG. 21.

[0138] FIG. 22 is a cross-sectional side view of the low dead space luer syringe device 1001B of the present invention, comprising a syringe 1003b in a ready-to-use state, with a distal nozzle 1013b formed integrally with elongated strips 1068a and 1068b, surrounded by opposing through-passages 1027a and 1027b formed along the axial lengths of the outer walls 1037 of the nozzle 1013b and the volume displacement member 1020b, as shown in FIG. 22A, molded within an internal cavity 1006b. The axial length of the elongated member 1020b can be formed by shortening the distal end 1031b to form a bowl, pocket, or nest recessed within the distal opening 1041a of the nozzle 1013b. The shortened distal ends 1031, 1031b, or 1031c, forming nests recessed within the distal openings 1041a, 1041b, or 1041c of the nozzles 1013, 1013b, and 1013c, respectively, are compatible with some currently used intravenous connectors for injecting a drug or the like into an injection line. The distal end 1031b of the volume displacement member 1020b may be formed proximal, equal, or distal to the distal end 1025b of the nozzle 1031b.

[0139] Figure 22A is a cross-sectional front view of the axis 22A-22A of the low dead space syringe device of Figure 22, which includes a female Luer hub 102 attached to a Luer syringe 1003b equipped with a nozzle 1013b, as shown in Figure 22, integrally formed with a volume displacement member 1020b having a first connecting strip 1068a and a second connecting strip 1068b, and a plurality of axially extending through passages 1027a and 1027b formed along the main body 1022b. As shown in Figure 22, the distal opening 1041b of the nozzle 1013b is configured to have an inner diameter D3.

[0140] Figure 23 is a cross-sectional side view of another embodiment of the low dead space Luer syringe device 1001C of the present invention, which comprises a Luer slip syringe 1003c having a hollow barrel 16 formed with an internal cavity 1006c of a nozzle 1013c with a distal end 1025c and at least one integrally formed elongated strip 1068c extending the length of a volume displacement member 1020c, shown between two dashed lines, and reducing the cubic volume within the internal cavity 1006c. At least one through passage 1027 is formed along the integrally formed volume displacement member 1020c, communicating with at least one distal aperture 1021c, as shown in Figure 23A, which is formed in a distal cavity 1050, and forms a fluid and gas path configured as an outlet for removing air or bubbles from the fluid in the syringe 1003c before the fluid is distributed to a patient or other Luer device.

[0141] Figure 23A is a cross-sectional front view along axis 23A-23A of the Luer syringe device of Figure 23, which includes a female Luer hub 102 attached to a Luer syringe 1003c equipped with a syringe nozzle 1013c, which has at least one through passage 1027, a distal cavity 1050, and a distal aperture 1021c, and at least one single-form axial strip 1068c extending the length of a single-form volumetric displacement member 1020c, and a distal aperture 1021c.

[0142] The present invention provides a method for monolithically forming hubs 1003, 1003b, 1003c, or 1003d and luer nozzles 1013, 1013b, 1013c, or 1013d and volume displacement members 1020, 1020b, 1020c, or 1020d, which comprises, firstly, filling the first cavity-forming hubs 1003, 1003b, 1003c, or 1003d and luer nozzles 1013, 1013b, 1013c, or 1013d with molten plastic resin, and secondly, The method includes, thirdly, filling molten plastic resin into at least one cavity that forms at least one strip 1068, 1068b, 1068c, and 1068d, and thirdly, filling molten plastic resin into cavities that form elongated bodies 1022, 1022b, 1022c, and 1022d of volume displacement members 1020, 1020b, 1020c, or 1020d as the molten plastic resin displaces air within the cavities.

[0143] Figure 24 is a cross-sectional front view of one embodiment of the low-dead-space syringe device of the present invention, which includes a female Luer hub 102 attached to a Luer nozzle 1013d, having a plurality of individually formed axial strips 1068a, 1068b, and 1068c that may be formed along part or the entire length of an integrally formed volume displacement member 1020d to reduce the internal cubic volume within the internal cavity 1006d. Through passages 1027d, 1027e, and 1027f are formed along the axial length of the volume displacement member 1020d.

[0144] Figures 25 and 26 illustrate Luer syringe devices 601 and 601D of the present invention, which include a method of assembling a separate volumetric displacement member 620 or 620b into the internal cavity 106 of a syringe nozzle 13 by advancing a plunger rod 15 and a piston 614 configured to have a cavity or pocket 605 for releasably holding the proximal end 630 of the volumetric displacement member 620 or 620b. As the plunger 15, piston 614, and volumetric displacement member 620 or 620b move to the distal end of the syringe 3b, the distal end 631 of the elongated member 620 is positioned within the internal cavity 106 of the syringe nozzle 13. This embodiment of the assembly method eliminates the need for a separate, time-consuming assembly step of using a mandrel to position the volumetric displacement member within the Luer nozzle of the present invention. A 3-second reduction in cycle time for assembling 100,000,000 volumetric displacement members of this invention into an equivalent number of syringe nozzles translates to a reduction of approximately 9.5 years in assembly time.

[0145] Figure 25 illustrates the low dead space Luer syringe device 601 of Figure 15A, which includes a Luer slip syringe 3b with a hollow barrel 16 having a plunger rod 15 and a piston 614 having a cavity or pocket 605, in a first position located at the proximal end of the hollow inner cavity 16, with the cavity 605 releasably holding the proximal end 630 of the elongated body 622 of the volume displacement member 620. The plunger rod 15, piston 614, and volume displacement member 620 are axially movable "M" within the barrel 16.

[0146] Figure 26 illustrates the low dead space Luer syringe device 601B of the present invention, which comprises a plunger rod 15 and a Luer slip syringe 3b with a hollow barrel 16, shown in a second assembled, ready-to-fill position where a piston 614 having a cavity or pocket 605 is disposed at the distal end of the syringe 3b, with the volume displacement member 620b of Figure 16B positioned and locked in place within the internal cavity 106 of the syringe nozzle 13 as shown in Figure 25. The distal end 631b of the volume displacement member 620b has a tapered outer wall 666b that forms a liquid-tight and airtight seal 633b by compression with the inner wall 41 of the syringe nozzle 13. A lockfit is formed between the end wall 25a of the nozzle 13 and the lip 658b of the volume displacement member 620b.

[0147] Figure 27 illustrates the Luer low dead space syringe device 501B of the present invention in a ready-to-use state. The volumetric displacement member 520b is assembled and lock-fitted within the internal cavity 106 of the syringe nozzle 13 of the syringe 3b. The plunger rod 15 is fixed to a piston 514 which has a distal elongated member 522d configured to push the fluid 116a in the through passage 527 from the syringe 3b into an attached needle, port, or injection line when the barrel 16 is empty. The through passage 527 of the volumetric displacement member 520b is releasably positioned on the elongated member 522d during the assembly process. As the plunger rod 15 and piston 514 advance toward the distal end of the hollow barrel 16, the volumetric displacement member 520b is pushed through the internal cavity 106 of the nozzle 13, and the distal lip 558b extends beyond the end wall 25a of the nozzle 13, locking the volumetric displacement member 520b within the internal cavity 106 of the nozzle 13.

[0148] FIG. 28 is a cross-sectional side view of a low dead space luer lock connector device 1101 of another embodiment of the present invention, with a first male connector 1103 separated from a second female connector 1100. The male connector 1103 communicates with an internal cavity 1106 of a frustoconical male nozzle 1113 configured to have an inner diameter D3 formed within an inner sidewall 1141 and an outer sidewall 1118, the frustoconical male nozzle 1113 having a distal end portion 1125 and an end wall 1125a. The male connector 1103 is attached to a hollow tube 1142a having an inner diameter D22 within a conduit 1110a. A distal collar 1104 includes an internal thread 1108 for receiving a thread or lug of a separate female luer lock connector. A second female luer hub 1102 is configured to have an inner sidewall 1107 and a distal end wall 1134 defining a frustoconical internal cavity 1126. A volume displacement member 1120 is configured to have an elongate body 1122 with an outer diameter <D3 and a closed proximal end 1130, an outer sidewall 1137, and a distal end 1131 with an inner through passage 1121, and is positioned within the internal cavity 1126. The female hub 1102 is attached to a rear hollow tube 1142b with a conduit 1110b having an inner diameter D22 in communication with an internal cavity 1126c. The volume displacement member 1120 is positioned within the cavity 1126 of the hub 1102 and can reduce the internal cubic capacity of the cavity 1126. The hub 1100 is attachable onto the hub 1103 by rotating an external thread 1109 within the thread 1108 of the collar 1104.

[0149] Figure 29 is a cross-sectional side view of the low dead space Luer lock connector device 1201 of the present invention, which includes a first connector 1203 joined to a second connector 1200, with the volume displacement member 220 of Figure 10A positioned within the internal cavity 1206 of a male nozzle 1213 configured to reduce the volumetric capacity within the internal cavities of connectors 1200 and 1203. The volume displacement member 220 is composed of an elongated body 222 having a closed proximal end 230, an enlarged distal end 231 having a through passage 221 communicating with the internal cavity 1206 and the conduits 1210b of pipe 1242b and 1210a of pipe 1242a, an outer wall 237a, and an end wall 244. A first liquid-tight and airtight seal 1233 is formed between the outer wall 1218 of the male nozzle 1213 and the inner wall 1207 of the hub 1202, and a second liquid-tight and airtight seal 1243 is formed between the outer wall 237a of the expanding head 231 and the inner wall 1234 of the internal cavity 1226c. The flow rates between the female connector 1100 or 1200 and the male connectors 1103 and 1203 are configured on the inner diameter D3 of the pipes 1242a and 1242b, respectively, and range from 0 ml / min to 1,200 ml / min in accordance with Table D.1 of Part 7. The volumetric displacement member may be configured to have a through-hole diameter that forms a laminar flow path between the proximal pipe 1110a and the distal pipe 1110b, and as shown in the volumetric displacement member 520 in Figure 14A, the outer wall of the volumetric displacement member enables the formation of a liquid-tight and airtight seal with the inner wall of the male nozzle and the inner wall of the distal internal cavity of the female hub.

[0150] Figure 30 shows a cross-sectional side view of a prior art Luer lock connector device 1301 for spinal axis applications, as shown in the spinal axis or NRfit® configuration, comprising a male connector 1303 separated from a female connector 1300, according to the ISO standard - Small diameter connectors for liquids and gases in healthcare applications - Part 6: Connector 1300. The male connector 1303 is configured to have a proximal conduit 1310a comprising an internal cavity 1306 of a male nozzle 1313 having an internal side wall 1341. The nozzle 1313 includes a conical mating surface outer side wall 1318 with a proximal end 1324 and a distal end 1325 with an end wall 1325a, surrounded by a fixed outer collar 1304 having an internal thread 1308 for receiving threads or lugs 1309 as shown in the female Luer hub connector 1300. The female connector 1300 is configured with a proximal hub 1302 having a conical mating surface inner wall 1307a formed between an opening proximal end 1335 and a distal end wall 1334, defining an internal cavity 1326 and an intermediate internal cavity 1326c. The distal male nozzle 1313b is configured with an inner wall 1307b formed together with the end wall 1334 and a distal end or nozzle 1325b defining a distal internal cavity 1365. The intermediate internal cavity 1326c opens and connects to internal cavities 1365 and 1326. The female hub connector 1300 may include at least one fin 1305, not shown herein, to rotate the hub connector 1300 onto the male connector 1303. When connectors 1303 and 1300 are joined together, dead space is formed within the combined internal cavities 1306, 1326c, and 1365. The male connector 1303 and female connector 1300 are configured in a Luer lock configuration, thereby, when the female connector 1300 rotates on the male connector 1303, the lugs or threads 1309 of the female hub 1302 form a lock fit with the threads 1308 of the outer collar 1304. The female and male connectors may also include a slip-fit ​​configuration, thereby omitting the lugs 1309 of the female connector 1300 and the threaded collar 1304 of the male connector 1303.

[0151] According to Part 6, the male nozzle 1313 is configured to have an internal cavity 1306 with an inner side wall 1341 and a distal inner opening 1341a having an inner diameter parameter D13 measured between 1.15 mm / 2.30 mm or 0.0455 inches / 0.0905 inches. The male connector 1303 can be configured using a syringe, female hub, adapter, or another Luer device. The male nozzle 1313 is configured with an outer wall 1318 having a 5% nominal taper with a distal end 1325 having an outer diameter parameter D14, which is measured at position L14 between 3.17 mm / 3.21 mm / 3.25 mm or 0.1358 inches / 0.1381 inches / 0.1405 inches, where the male taper of the outer diameter of the distal end 1325 of the nozzle 1313 is measured at 0.5 mm or 0.0196 inches (basic dimension) from the distal end wall 1325a. The outer wall 1318 of the proximal end 1324 of the male nozzle 1313 is configured to have an outer diameter parameter D15, which is measured at position L15 between a minimum / nominal / maximum diameter of 3.45 mm / 3.51 mm / 3.57 mm or 0.1358 inches / 0.1381 inches / 0.1405 inches, where the male taper of the outer diameter of the proximal end 1324 is measured from the distal end wall 1325a at 6.5 mm or 0.2559 inches (basic dimension). The overall length of the nozzle 1313 is configured with a length parameter L16, which is measured between a minimum / nominal / maximum length of 8.13 mm / 8.38 mm / 8.63 mm or 0.320 inches / 0.3299 inches / 0.3397 inches, and the length of the 5% tapered conical fitting surface of the outer wall 1318 is configured to measure a minimum / nominal length of 8.00 mm / 8.30 mm or 0.3149 inches / 0.3267 inches within the rotatable collar device. The inner opening 1341a or distal end wall 1325a is recessed, equal to, or longer than the distal end of the collar 1304 and is configured with a length parameter L13, which is measured between a minimum / nominal / maximum length of -0.40 / 0.00 / 0.40 mm or -0.0155 / 0.00 / 0.0155 inches.

[0152] With or without the lug 1309, the depth of the 5% female taper of the internal cavity 1326 and distal internal cavity 1326c of the female hub 1302 is configured to have a length parameter L12 measured between a minimum / nominal / maximum length of 8.20 mm / 8.45 mm / 8.70 mm or 0.3228 inches / 0.3326 inches / 0.3425 inches between the proximal opening end 1335 and the end wall 1334. The proximal opening end 1335 of the internal cavity 1326 of the hub 1302 is configured to have an internal diameter parameter D10, which is measured at position L17 between a minimum / nominal / maximum length of 3.40 mm / 3.43 mm / 3.46 mm or 0.133 inches / 0.135 inches / 0.136 inches, where the internal diameter female taper of the hub 1302 is measured at 0.5 mm or 0.0196 inches (basic dimension) from the proximal end 1335 of the female hub 1302. The distal internal cavity 1326b of the female hub 1302 is configured with an internal diameter parameter D11, which is measured at position L11 between a minimum / nominal / maximum diameter of 3.07 mm / 3.13 mm / 3.19 mm or 0.1208 inches / 0.1232 inches / 0.1255 inches, where the female taper of the internal diameter of the female hub 1302 is measured at 6.5 mm or 0.2559 inches (basic dimension) from the proximal opening end of the hub 1302 of the lock connector hub 1300. The internal cavity 1365a formed in the distal nozzle 1313b is configured with an internal diameter parameter D12, which is measured between a nominal / maximum diameter of 1.5 mm / 2.3 mm or 0.059 inches / 0.0905 inches.

[0153] Figure 31A is a cross-sectional side view of the low dead space Luer lock connector device 1301A of the present invention in a Part 6, spinal axis, or NRfit® configuration, having a male connector 1303 joined to a female connector 1300. A volumetric displacement member 1320 is positioned within combined internal cavities 1306, 1326c, and 1365 as shown in Figure 30, and includes a through passage 1327 connecting a proximal conduit 1310a to a distal conduit 1310b. The volumetric displacement member 1320 is composed of an elongated body 1322 having an open distal end 1331 with an outer wall 1337b and an open proximal end 1330 with an internal cavity 1321c formed by a conical inner wall 1317 for supplying fluid or gas into the through passage 1327. An annular ring 1358 having a convex or geometric profile may be formed on the outer wall 1337a of the body 1322 as a stopper or lip to limit and standardize the depth to which the nozzle 1313 can be positioned within the female hub 1302. The annular ring 1358 may also be configured to engage with the distal end wall 1325a of the nozzle 1313, as shown in Figure 30, when the volume displacement member 1320 is assembled within the female hub 1302. The proximal end 1330 includes an outer wall 1337a having an outer diameter configured to form a first liquid-tight and airtight seal 1323 with the inner diameter D13 of the inner wall 1341 of the nozzle 1313, as shown in Figure 30, and the distal end 1331 includes an outer wall 1337b configured to form a second liquid-tight and airtight seal 1343 with the inner diameter D12 of the inner wall 1307b of the distal nozzle 1313b. A laminar flow channel 1138 is formed between the proximal conduit 1310a of the male connector 1303, the internal cavity 1321c and through passage 1327 of the volumetric displacement member 1320, and the distal internal cavity 1365 and distal conduit 1310b of the female connector 1300, separating the dead space formed within the internal cavity 1326c from the flow channel 1338. The seals 1323 and 1343 formed by the volumetric displacement member 1320 also reduce the potential hazard that may arise when anesthetic gases or reagents such as divinyl ether, ethyl chloride, ethyl ether, and ethylene leak from the patient's anesthetic breathing circuit into the operating room air during anesthesia delivery, forming a flammable and explosive mixture with air, oxygen, or nitrous oxide.

[0154] Figure 31B is a cross-sectional side view of the low dead space NRfit® volume displacement member 1320b of the present invention, which comprises a proximal end 1330b having an outer diameter substantially equal to D13 and a distal end 1331b having an outer diameter substantially equal to D12, wherein the intermediate body 1358b has a larger outer diameter configured to displace a portion of the internal cavity 1326c of the female hub 1302.

[0155] Figure 31C is a cross-sectional front view of the low dead space NRfit® device of Figure 31 along axis 31C-31C, where the through passage 1327 of the volume displacement member 1320 is separated from and bypassed from the dead space formed in the internal cavity 1326c. A first liquid-tight and airtight seal 1323 is formed between the outer wall 1337a of the volume displacement member 1320 and the inner wall 1341 of the nozzle 1313. A second liquid-tight and airtight seal 1333 is formed between the outer wall 1318 of the nozzle 1313 and the inner wall 1307a of the female hub 1302.

[0156] Figure 31D is a cross-sectional front view of the axis 31D-31D of the low dead space NRfit® device of Figure 31, where the through passage 1327 is formed within the volume displacement member 1320. A liquid-tight and airtight seal 1343 is formed between the distal outer wall 1337b of the volume displacement member 1320 and the inner wall 1307b of the distal nozzle 1313b.

[0157] Figure 32 is a cross-sectional side view of one embodiment of the low dead space NRfit® device 1301B of the present invention, which includes a male connector 1303 attached to a female connector 1300a having a male nozzle 1313 attached to a female Luer hub 1302c having a distal internal cavity 1326c having an integrally formed volume displacement member 1320a having a body 1322a having a distal internal cavity 1326c having a female Luer hub 1302c having a male nozzle 1313. The volume displacement member 1320a is configured to have a body 1322a having an opening proximal end 1330a and a tapered inner wall 1317a that defines a conical internal cavity 1321c having a through passage 1327a that communicates with a conduit 1365a formed in the distal nozzle 1313b of the female hub 1302c. The tapered wall 1317a is configured to deliver and direct pressurized anesthetic fluid or gas from the proximal conduit 1310a through the internal through passage 1327a into the distal conduit 1365 formed in the distal nozzle 1313b. The volumetric displacement member 1320a reduces the internal cubic volume of the combined internal cavity formed between the male and female connectors. The outer diameter of the main body 1322a is configured to form a first liquid-tight and airtight seal 1323a between the outer wall 1337a of the volumetric displacement member 1320a and the inner diameter D13 of the inner wall 1341 of the distal opening 1341a of the nozzle 1313, as shown in Figure 30, and a second liquid-tight and airtight seal 1333 is formed between the outer wall 1318 of the nozzle 1313 and the inner wall 1307a of the female hub 1302c. A laminar flow channel 1338a is formed between the proximal conduit 1310a of the male connector 1303, the internal cavity 1306 of the nozzle 1313, the internal cavity 1321c, the through passage 1327, and the distal conduit 1310b of the female hub 1302c.

[0158] In accordance with Table D.1 of Part 6, the flow rates of spinal axis components / partitions to which Luer connectors are applied are as follows: the flow rate in and between the spinal needle (bolus) or epidural / regional nerve block needle (bolus) of the present invention having a volume displacement member is 0 ml / h to 3,600 ml / h; the flow rate in and between the catheter connector (bolus) or catheter connector (injection) of the present invention having a volume displacement member is 0 ml / h to 1,500 ml / h; the flow rate in and between the filter (injection) or filter (bolus) or injection line of the present invention having a volume displacement member is 0 ml / h to 600 ml / h; the flow rate in and between the wound infiltration component or standard syringe of the present invention having a volume displacement member is 0 ml / h to 3,600 ml / h; and the flow rate in and between the resistance-relieving syringe of the present invention having a volume displacement member is 0 ml / h to 10,000 ml / h.

[0159] Figure 33 illustrates a cross-sectional side view of a prior art Luer lock connector device 1401, shown in an enteral or ENfit configuration, according to the ISO standard - Small diameter connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications with a male connector 1403 separated from a female connector 1400. The male connector 1403 is configured to have an internal cavity 1406 of a male nozzle 1413 having an internal side wall 1441. The nozzle 1413 includes a conical mating surface outer side wall 1418 with a proximal end 1424 and a distal end 1425 with an end wall 1425a, surrounded by a fixed outer collar 1404 having internal threads 1408 for receiving threads or lugs of a female Luer hub connector 1400. The female connector 1400 is configured with a proximal hub 1402 having a conical mating surface inner wall 1407 formed between an opening proximal end 1435 and a distal end wall 1434, defining an internal cavity 1426 and an intermediate internal cavity 1426c. The distal male nozzle 1413b is configured with an inner wall 1407b formed together with an end wall 1434 defining an internal cavity 1410b. The internal cavity 1426c is formed, opening and connecting between internal cavities 1410b and 1410b. The female connector 1400 may include at least one fin 1405, not shown herein, to rotate the female hub 1402 on the nozzle 1413 of the male connector 1403. When connectors 1403 and 1400 are joined together, dead space is formed within the combined internal cavities 1406, 1426c and 1410b. The male connector 1403 and the female connector 1400 are configured in a Luer lock configuration, so that when the female connector 1400 rotates on the male connector, the lugs or threads 1409 of the female hub 1402 form a lock fit with the threads 1408 of the outer collar 1404. The female and male connectors may also include a slip-fit ​​configuration, so that the lugs 1409 of the female connector 1400 and the threaded collar 1404 of the male connector 1403 are not included.

[0160] According to Part 3, the male nozzle 1413 is configured to have an internal cavity 1406 comprising an inner side wall 1441 and a distal inner opening 1441 having an inner diameter parameter D16, which is measured between a nominal / maximum diameter of 0.00 mm / 2.90 mm / 2.95 mm or 0.00 inch / 0.114 inch / 0.116 inch. The male connector 1403 can be configured using a syringe, female hub, adapter, or another Luer device. The outer wall 1418 at the tip of the 6% male taper of the nozzle 1413 is configured to have an outer diameter parameter D17, which is measured between a minimum / nominal / maximum diameter of 5.36 mm / 5.41 mm / 5.46 mm or 0.211 inch / 0.213 inch / 0.215 inch. The length parameter L18 of the outer wall 1418 from the distal tip of the 6% male taper of the nozzle 1413 to the inner end of the collar 1404 is configured with a minimum length of 6.82 mm or 0.268 inches, with no nominal or maximum length, and the distal end of the 6% taper is formed with a distal frustoconical tip configured with angles having minimum / nominal / maximum parameters of 40° / 45° / 50°.

[0161] With or without the lug 1409, the depth of the female taper of the internal cavity 1426 of the female hub 1402 is configured with a length parameter L19 that measures between a minimum / nominal / maximum length of 7.04 / 7.14 mm / 7.24 mm or 0.277 inches / 0.281 inches / 0.285 inches from the proximal opening end 1435 to the intermediate end wall 1434. The proximal opening end 1435 of the internal cavity 1426 of the hub 1402 is configured with an internal diameter parameter D18 that measures between a minimum / nominal / maximum length of 5.64 mm / 5.69 mm / 5.74 mm or 222 inches / 0.224 inches / 0.226 inches. The distal conduit 1410b of connector 1400 is configured to have an inner side wall 1407b having an inner diameter parameter D16 that is measured between 2.90 mm / 2.95 mm or 114 inches / 0.116 inches in nominal / maximum diameter.

[0162] Figure 34 is a cross-sectional side view of one embodiment of the low dead space ENfit device 1401A of the present invention, which is attached to a female Luer connector 1400 having a male Luer connector 1403 having a proximal conduit 1410a and an opposing male nozzle 1413, with an internal cavity 1406 formed in the inner wall 1441 and outer wall 1418, as shown in Figure 33, and a volume displacement member 1420 having a distal internal cavity 1426c with an internal cavity 1406 formed in the inner wall 1441 and outer wall 1418, as shown in Figure 33, with an internal cavity 1406 as shown in Figure 33, with a male Luer connector 1403 having a proximal conduit 1410a and an opposing male nozzle 1413. The volumetric displacement member 1420 is configured to have an opening proximal end 1430 and a tapered inner wall 1417 that defines an internal cavity 1421c formed by a through-path 1427 communicating with the proximal conduit 1410a and the distal conduit 1410b formed within the distal nozzle 1413b of the female hub 1402. The tapered wall 1417 is configured to deliver fluid, nutrients, or gas and direct them from the proximal conduit 1410a through the volumetric displacement member 1420 into the distal conduit 1410b. The outer diameter of the main body 1422 is configured to form a first liquid-tight and airtight seal 1423 between the outer wall 1437 of the volume displacement member 1420 and the inner diameter D16 of the inner wall 1441 of the nozzle 1413, and a second liquid-tight and airtight seal 1433 is formed between the outer wall 1418 and the inner diameter D16 of the inner wall 1407b of the distal internal cavity 1410b of the nozzle 1413b. A laminar flow channel 1438 is formed between the proximal conduit 1410a of the male connector 1403, the through-passage 1427 of the volume displacement member, and the distal conduit 1410b of the female connector 1400.

[0163] Figure 34A is a cross-sectional front view of the low dead space ENfit device of Figure 34 along axis 34A-34A, which includes a volumetric displacement member 1420 positioned within the distal conduit 1410b of the female hub 1402. The through passage 1427 traverses through the distal internal cavity 1426c of the female hub 1402 and is separated therefrom, as shown in Figure 34. A liquid-tight and airtight seal 1443 is formed between the outer wall 1437 of the volumetric displacement member 1420 and the inner diameter D16 of the inner wall 1441 of the nozzle 1413b.

[0164] Figure 35 is a cross-sectional side view of the ENfit volume displacement member 1420a of the present invention, which has an elongated body 1422a with a proximal end 1430a and a distal end 1431a, with an enlarged intermediate body 1458a having opposing through passages 1427a and 1427b formed along the outer wall 1437a.

[0165] Figure 35A is a cross-sectional front view of the volume displacement member of Figure 35 along axis 35A-35A, which has opposing through passages 1427a and 1427b formed along the outer wall 1437a and the enlarged intermediate body 1458a.

[0166] Figure 36 is a cross-sectional side view of the ENfit volumetric displacement member 1420b of the present invention, which has an elongated body 1422b with an enlarged intermediate body 1458b having opposing through passages 1427c and 1427d formed alongside the outer wall 1437b.

[0167] Figure 36A is a cross-sectional front view of the volume displacement member of Figure 36 along axis 36A-36A, which has opposing through passages 1427c and 1427d formed alongside the outer wall 1437b.

[0168] In accordance with Table F.1 of Part 3, the flow rates of enteral components / partitions to which Luer connectors are applied are as follows: Flow rates within and between the first and second connectors of the present invention, which are configured with volumetric displacement members, are a minimum of 0.1 ml / hour (h) to a maximum of 3000 ml / hour for water, bolus (plunger): 200 ml / hour (minimum) to a maximum of 3000 ml / h for water, gravity (0.5 kPa) (without plunger): 3000 ml / h.

[0169] According to one embodiment of the present invention, Figure 37 is a cross-sectional side view of a low-dead-space Luer-to-male Luer adapter connector 1501 of the present invention that connects a first Luer-lock syringe 3b to a second Luer-lock syringe 3b. The adapter 1500 is configured to have a through passage 1521 formed between a first female hub 1502a having an inner conical side wall 1507a and a distal end wall 1534a forming a first internal cavity 1526a, and an opposing female hub 1502b having an inner conical side wall 1507b and a distal end wall 1534b forming a second internal cavity 1526b. The first volume displacement member 1520a is configured to have a proximal body 1522a integrally formed within the internal cavity 1526a by the distal end wall 1534a. The main body 1522a is formed with an outer wall 1537a as shown in Figure 37B, which is configured to form a first liquid-tight and airtight seal 1523a with the inner diameter D3 of the opening 41a of the male nozzle 13 of the first syringe, as shown in Figure 2A, and to separate the internal cavity 1526a from the through passage 1521. A second opposing volume displacement member 1520b, which has a distal main body 1522b, is integrally formed within the internal dead space cavity 1526b in the distal end wall 1534b. A second liquid-tight and airtight seal 1523b is formed between the outer wall 1537b of the volume displacement member 1520b and the inner diameter D3 of the inner opening 41a of the male nozzle 13 of the second syringe, which mirrors the first liquid-tight and airtight seal 1523a, as shown in Figure 2A, separating the internal dead space cavity 1526b from the through passage 1521. The through passage 1521 is formed through the body 1522 of the adapter 1500, which extends from the proximal end of the first volume displacement member 1520a to the distal end of the second volume displacement member 1520b. A first elongated channel 1527a is configured along the outer wall 1537a, including a tapered inner wall 1517a, and connects to a through passage 1521 to form an outlet configured to discharge fluid and air through the flow path 1538 when the first filled syringe nozzle is facing upward and before the second syringe is attached to the distal female hub 1502b to complete the transfer or mixing of drug or diluent between the syringes.The second volume displacement member may also include an elongated channel 1527b configured along the outer wall 1537a, includes a tapered inner wall 1517b, and is connected to the through-passage 1521. The volume displacement members 1520a and 1520b reduce the volume capacity of the flow path 1538 formed within the internal cavities of the syringe nozzle and the female hub.

[0170] FIG. 37A is a cross-sectional front view taken along axis 37A-37A of the low dead space male Luer - male Luer adapter of FIG. 37, with the volume displacement member 1520a positioned within the male nozzle 13. The volume displacement member 1520a is configured to have a body 1522a with an outer diameter <D3 and an elongated through-passage 1521. At least one elongated channel 1527b connected to the through-passage 1521 and the internal cavity 106a of the male nozzle 13 is configured to form a flow path for moving fluid and air or bubbles transferred from syringe to syringe through the Luer adapter 1500. A liquid-tight and air-tight seal 133 is formed between the outer wall 18 of the nozzle 13 and the inner wall 1507a of the female hub 1502a.

[0171] FIG. 37B is a cross-sectional front view of the low dead space device taken along axis 37B-37B of FIG. 37, with the volume displacement member 1520a positioned within the inner diameter <D3 of the distal opening 41a of the male nozzle 13 with a liquid-tight and air-tight seal 1523a formed between the outer wall 1537a and the inner opening 41a of the nozzle 13. The through-passage 1521 is formed within the volume displacement member 1520a.

[0172] Figure 38 is a cross-sectional side view of the low dead space filling needle adapter 1601 of the present invention, which comprises a filling needle 1600 comprising a female Luer hub 1602, a distal needle 1612 with a blunt tip 1611, and a hollow conduit 1610 conduit connected to a through passage 1621 of an opposing, integrally formed volumetric displacement member 1620 formed within an internal cavity 1626 of the female hub 1602. The male nozzle 13 of the syringe 3 is shown within the internal cavity 1626 of the female hub 1602. The volumetric displacement member 1620 includes an elongated body 1622 with an internal through passage 1621 formed with at least one opening channel 1627 configured along an outer wall 1637 that opens and connects to the internal cavity 106 of the male nozzle 13. The channel 1627 includes a tapered end wall 1617 configured as an outlet for discharging and moving fluid and air or bubbles transported through the filling needle 1601. The volume displacement member 1620 is configured to reduce the cubic volume within the internal cavity 1626 of the female hub 1602 and the internal cavity 106 of the male nozzle 13. The body 1622 is formed with an outer wall 1637 configured to form a liquid-tight and airtight seal 1623 with the inner diameter D3 of the opening 41a of the male nozzle 13 of the syringe 3, as shown in Figure 2A, separating the internal cavity 1626c from the through passage 1621. The volume displacement members 120a, 120b, 120d / 210e, 120f, 120g, 320, 320a, 320c / 320d, or 320e of the present invention may be positioned within the filling needle 1600 to reduce dead space within the internal cavity 106 of the male nozzle 13 and the internal cavity 1626c of the female hub 1602.

[0173] Figure 38A is a cross-sectional front view of the axis 38A-38A of the low dead space device of Figure 38, in which a volumetric displacement member 1620 is positioned within the inner diameter D3 of the distal opening 41a of the male nozzle 13, with a first liquid-tight and airtight seal 1623 formed between the outer wall 1637 and the inner opening 41a of the nozzle 13, and a second liquid-tight and airtight seal 133 is formed between the inner side wall 1607 of the female hub 1602 and the outer wall 18 of the nozzle 13. A through passage 1621 is formed within the volumetric displacement member 1620.

[0174] Numerous exemplary embodiments are disclosed and described herein. However, it should be recognized that the present invention should by no means be construed as being limited to these examples.

Claims

1. It is a syringe, A hollow barrel configured to store the liquid in the flow path in an internal cavity, A male nozzle, which extends distally from the hollow barrel and has an internal cavity defined by the internal wall of the male nozzle, A female luer hub having a distal end having a conduit configured to accommodate the proximal end of a needle, wherein the female luer hub has an internal cavity in which at least a portion of the male nozzle is contained, the distal end of the internal cavity is at least partially defined by the distal end wall of the female luer hub, and the distal end wall is positioned opposite and spaced apart from the distal end wall of the male nozzle, A volumetric displacement member disposed within the internal cavity of the male nozzle and configured to reduce the cubic volume of the internal cavity of the male nozzle capable of containing the liquid, comprising a body having a through passage having a first opening and a second opening distal to the first opening, the first opening being in fluid communication with the internal cavity of the hollow barrel through a flow path, the first opening being located distal to the proximal end of the volumetric displacement member, and the volumetric displacement member having an elastic distal end having an end wall facing and abutting the distal end wall of the female luer hub, forming an airtight and liquidtight seal between the distal end of the volumetric displacement member and the distal end wall of the female luer hub, Syringe.

2. The internal cavity of the male nozzle has an opening proximal end and a distal end, and the opening proximal end has an inner diameter larger than the outer diameter of the proximal end of the body of the volume displacement member. The syringe according to claim 1.

3. The flow path is configured to accommodate the flow of the liquid between the outer wall of the proximal end of the main body of the volume displacement member and the portion of the inner wall of the male nozzle, and the flow path is located proximal to the first opening of the through passage. The syringe according to claim 2.

4. A portion of the volumetric displacement member is positioned within the internal cavity of the male nozzle, and a first liquid-tight and airtight seal exists between the outer wall of the main body of the volumetric displacement member and the inner wall of the male nozzle, and the first liquid-tight and airtight seal is located distal to the first opening of the through passage of the volumetric displacement member. The syringe according to claim 1.

5. The distal end portion of the volume displacement member includes a radial projection having a proximal surface that abuts against the distal outer end wall of the male nozzle, and a liquid-tight and airtight seal exists between the proximal surface of the radial projection and the distal outer end wall of the male nozzle. The syringe according to claim 1.

6. The hollow barrel further comprises a plunger located within the internal cavity and capable of translation in the distal and / or proximal directions. The syringe according to claim 1.

7. The device further comprises a needle, the proximal end of which is housed in the conduit of the distal end portion of the female lure hub, and the needle having a conduit that opens into the internal cavity of the female lure hub. The syringe according to claim 1.

8. The syringe is a Luer lock syringe, further comprising a distal collar configured with an internal locking thread formed around the male nozzle, and having at least one proximal flange or threaded portion configured to mechanically engage with the locking thread of the distal collar when the female Luer hub is rotated on the male nozzle. The syringe according to claim 6.

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