ARTERIAL SYRINGE ASSEMBLY

An arterial syringe assembly is disclosed. The assembly includes a housing with a proximal end that may couple with a syringe barrel and a distal end that may couple with a needle. A needle cover is coupled with the housing at a hinge that may rotate to position the needle cover relative to the needle and may rotate to an orientation aligned with the needle such that the needle is within the needle cover. A needle plug is coupled to the needle cover at a distal end of the needle cover and may include plug material. The needle plug may slide axially relative to the needle to advance the needle plug at a distal end of the needle. A hydrophobic filter is positioned within the syringe barrel to evacuate air through a proximal end of the syringe barrel after the needle tip extends within the plug material.

FIELD OF THE INVENTION

The present invention generally relates to syringe assemblies and more particularly to syringe assemblies for drawing arterial blood.

BACKGROUND

Arterial blood samples are collected from an artery to determine, for example, arterial blood gas levels. A caregiver obtains a sample using a needle and syringe or through a catheter. Inaccurate samplings may result from a number of factors, including the presence of air in the sample. Accordingly, some arterial syringes are prepared to reduce the amount of air the blood sample may be exposed to when the blood is drawn.

SUMMARY

In many instances of arterial blood sampling, it is desirable not to add or permit air to remain in the blood sample after the blood sample is drawn from the patient. Air in the blood sample, for example, may hinder the ability to accurately measure the oxygen content of the patient's blood sample. However, air bubbles may be commingled with the blood sample during or after the time when the blood sample is collected from the artery. Approaches for minimizing contact of air with the blood sample are desirable.

According to various aspects of the subject technology, an arterial syringe assembly is described. The arterial syringe assembly includes a housing including (i) a proximal end, (ii) a distal end, and (iii) a hinge. The proximal end may couple with a distal end of a syringe barrel. The distal end of the housing may couple with a needle. The arterial syringe assembly includes a needle cover coupled with the housing at the hinge that may rotate about the hinge to position the needle cover relative to the needle and may rotate to an orientation that is axially aligned with the needle such that the needle is received within the needle cover. The arterial syringe assembly includes a needle plug coupled to the needle cover at a distal end of the needle cover that includes a plug material. The needle plug may slide axially relative to the needle cover and the needle to advance proximally within the needle cover when the needle cover is axially aligned with the needle such that a tip of the needle extends within the plug material. The arterial syringe assembly includes a hydrophobic filter positioned within the syringe barrel to evacuate air through a proximal end of the syringe barrel after the needle tip extends within the plug material.

According to various aspects of the subject technology, an arterial syringe assembly is described. The arterial syringe assembly includes a housing including (i) a proximal end, (ii) a distal end, and (iii) a hinge. The proximal end may couple with a distal end of a syringe barrel. The distal end of the housing may couple with a needle. The arterial syringe assembly includes a needle cover coupled with the housing at the hinge and that may rotate about the hinge to position the needle cover relative to the needle and to rotate to an orientation that is axially aligned with the needle such that the needle is received within the needle cover. The arterial syringe assembly includes a needle plug coupled to the needle cover at a distal end of the needle cover and on an outer surface of the needle cover. The needle plug includes a plug material. The needle plug may slide along the outer surface of the needle cover to advance proximally within the needle cover when the needle cover is axially aligned with the needle such that a tip of the needle extends within the plug material. The arterial syringe assembly includes a hydrophobic filter positioned within the syringe barrel to evacuate air through a proximal end of the syringe barrel after the needle tip extends within the plug material.

According to various aspects of the subject technology, a method of operating an arterial syringe assembly is described. The method includes providing an arterial syringe assembly including providing an arterial syringe assembly comprising (i) a proximal end may couple with a distal end of a syringe barrel, (ii) a distal end coupled to a needle, (iii) a hinge coupled with a needle cover, and (iv) a needle plug, which holds a plug material, coupled with the needle cover at a distal end of the needle cover. The method includes rotating the needle cover about the hinge to position the needle cover relative to the needle and to rotate to an orientation that is axially aligned with the needle such that the needle is received within the needle cover. The method includes sliding the needle plug axially relative to the needle cover. When the needle cover is axially aligned with the needle, to advance the needle plug proximally relative to the needle, such that a distal end of the needle extends within and is plugged by the plug material. The method includes evacuating, via a hydrophobic filter positioned within the syringe barrel, air through a proximal end of the syringe barrel after the needle tip extends within the plug material.

The foregoing has outlined rather broadly the features of the present disclosure in order that the detailed description that follows can be better understood. Additional features and advantages of the disclosure will be described hereinafter, which form the subject of the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

According to some implementations, the subject technology provides an arterial syringe assembly that evacuates air from the syringe barrel after the blood or fluid sample is collected in the needle. In brief, the subject technology relates to an arterial syringe assembly that includes a housing that has a proximal end, a distal end, and a hinge. The proximal end accepts a syringe plunger or a syringe barrel, and the distal end accepts a needle. A needle cover is coupled with the housing at the hinge. The needle cover may rotate about the hinge to position the needle cover relative to the needle. The needle cover may rotate to an orientation that is axially aligned with the needle such that the needle is received within the needle cover. A needle plug, which includes a plug material, is coupled to the needle cover at a distal end of the needle cover. The needle plug is configure to slide axially relative to the needle cover and the needle to advance proximally with the needle cover when the needle cover is axially aligned with the needle such that a tip of the needle extends within the plug material. A hydrophobic filter is positioned within the syringe barrel to evacuate air through a proximal end of the syringe barrel after the needle tip extends within the plug material. In some aspects, because of the operation of the hydrophobic filter, air leaves the syringe barrel, while blood or fluid remains within the syringe barrel.

The arterial syringe assembly may be operated single-handedly. A caregiver using the arterial syringe assembly may operate the arterial syringe assembly, for example to draw and store blood or fluid, in one hand while having his/her other hand free, for example, to hold a bandage and to apply the bandage to the patient.

In some implementations, the needle plug, which includes the plug material, is coupled to the needle cover at a distal end of the needle cover and on an outer surface of the needle cover. The needle plug slides along the outer surface of the needle cover to advance proximally within the needle cover when the needle cover is axially aligned with the needle such that a tip of the needle extends within the plug material.

According to some examples, a locking tab is provided on the needle cover. The locking tab engages the needle plug. With the application (e.g., by a caregiver) of sufficient force, the tab is lifted out of the detent of the needle plug. The tab then rides along the channel between two detents of the needle plug, until the tab extends within the second detent. At this position, the needle has advanced into the plug material that occludes the distal tip of the needle. With the needle tip occluded, a force can be applied against the syringe plunger that will cause the air within the syringe barrel to pass through the hydrophobic filter and be released through a proximal end of the syringe barrel. In these circumstances, air will not escape through the needle tip.

It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

FIG. 1illustrates an example arterial syringe assembly according to some aspects of the disclosure. As shown, arterial syringe assembly100includes luer adapter110, needle cover120, needle plug130, needle140, syringe barrel150, plunger160, and hydrophobic filter170. Arterial syringe assembly100may be operated single handedly, with a caregiver holding and operating the device in a single hand and having the second hand free for other activities, such as applying a bandage to a patient or for pressing on the artery.

In some embodiments, the caregiver inserts needle140through the patient's skin into the patient's artery to draw blood or fluid from the artery. The blood or fluid is drawn, or permitted to flow, from the artery into syringe barrel150. In some examples, plunger160is withdrawn by the caregiver while drawing blood or fluid. In some examples, plunger160is not withdrawn by the caregiver while drawing blood or fluid. The arterial blood pressure may be sufficient to cause the syringe barrel to be filled with blood. After the blood or fluid has filled syringe barrel150to a predetermined level, the caregiver may seal or occlude the distal end of needle140, as described herein, such that blood or air does not flow out of the needle. The caregiver may push plunger160in distal direction to expel air from syringe barrel150. In some embodiments, hydrophobic filter170is positioned within syringe barrel150at the distal end of plunger160and may be coupled with the distal end of the plunger. Hydrophobic filter170is used to evacuate air through a proximal end of syringe barrel150when the caregiver pushes the plunger in the distal direction. In some embodiments, by using hydrophobic filter170, air may be evacuated from the interior of syringe barrel150to the atmosphere or ambient environment outside of arterial syringe assembly100. In some examples, hydrophobic filter170constrains the blood or fluid within the interior of syringe barrel150to prevent the blood or fluid from evacuating the interior of syringe barrel150together with the air.

In some embodiments as shown inFIG. 1, luer adapter110connects needle140, the syringe barrel150, and needle cover120. Hinge portion112adjoins luer adapter110and needle cover120. After the caregiver finishes drawing blood or fluid from the patient's artery into syringe barrel150, the caregiver may rotate needle cover120relative to luer adapter110about hinge portion112. The rotation may make the needle cover120approximately parallel with needle140and the central axis of syringe barrel150or plunger160. As a result, needle cover120covers needle140and the bevel (tip) of needle140may be aligned with needle plug130, into which a plug material, such as clay, may be placed. Relative axial movement between needle140and needle plug130may move a distal end of the needle into the plug material.

In some embodiments, luer adapter110and a hub of the needle140may be keyed to assume a particular orientation upon coupling. For example, a needle hub of needle140may have a protrusion, such as needle hub portion111; and the luer adapter110may have a slot that receives the protrusion. As a result, when needle140and luer adapter110are coupled, needle140and luer adapter110may assume a single orientation. The single orientation may place needle cover120extending at an angle between 45 degrees and 90 degrees, e.g., 90 degrees, from a central axis of the needle. The single orientation may be used by the caregiver to assure that the caregiver is approaching the patient with needle140in the correct orientation. The caregiver may insert needle140into the patient with the bevel of needle140facing upward so that the distalmost point of needle140(i.e., the sharpest point of needle140) is on the bottom side, closest to the patient, to provide better entry into the patient. The orientation of needle cover120, which is at an angle (between 45 degrees and 90 degrees) from the bevel face of needle140, provides a quick indication to the caregiver that needle140is properly oriented.

In addition, in some examples when needle140is being used to draw blood from an artery of a patient, needle cover120may extend at a 45-90 degree angle from a central axis of plunger160, the syringe barrel150, and the needle140(by the operation of the hinge portion112). As a result, needle cover120does not interfere with the insertion of needle140into the patient, as needle cover120is angled away from the patient's skin.

As described, arterial syringe assembly100may be operated single-handedly. In some examples after blood or fluid is drawn, needle cover120may be closed over needle140. Needle cover120may be closed by pressing the needle cover against a hard surface, such as a bed rail, a wall, a table, or a chair, until the needle snaps into place with an engagement tab of the cover. Similarly, the evacuation of air from the syringe barrel150, by use of the hydrophobic filter170, can be performed using a single hand, as the caregiver applies pressure to plunger160to push plunger160into syringe barrel150. The pressure may be applied by stretching a finger of the hand holding arterial syringe assembly100to plunger160or by pushing the plunger against a hard surface.

As shown inFIG. 1, syringe barrel150may be transparent or translucent. Because of the transparent or translucent nature of syringe barrel150, the caregiver may be able to see, through syringe barrel150, plunger160and/or hydrophobic filter170. Thus, the caregiver may view the blood or fluid drawn from the patient and stored within the syringe barrel and may be able to visually verify that arterial syringe assembly100is correctly arranged and operated. In some examples, arterial syringe assembly100comprises housing180. Housing180may include a proximal end coupled to syringe barrel150, luer adapter110with hinge portion112, and a distal end coupled to needle140via needle hub portion111.

FIG. 2Aillustrates a side view of an example arterial syringe assembly200, according to some aspects of the disclosure.FIG. 2Billustrates a bottom view of an example arterial syringe assembly250, according to some aspects of the disclosure. As shown, arterial syringe assemblies200and250include luer adapter210, needle cover220, and needle plug230that are consistent with luer adapter110, needle cover120, and needle plug130ofFIG. 1. Needle plug230may be coupled to needle cover220. Luer adapter210has first cover hinge portion212that couples with second cover hinge portion222at one end of needle cover220that is opposite to another end of needle cover220that is coupled to needle plug230. In some examples, first cover hinge portion212and second cover hinge portion222together make up hinge portion112shown inFIG. 1. In some examples, second cover hinge portion222snaps in first cover hinge portion212to make up the hinge portion. In some embodiments, luer adapter210connects between a distal end of syringe barrel150and a needle or needle hub (not shown inFIGS. 2A-2B). Needle cover220also has locking tab224which, when connected to needle plug230, locks needle plug230into place.

FIG. 3Aillustrates an example arterial syringe assembly with a needle locked and ready for shut off, according to some aspects of the disclosure.FIG. 3Ashows arterial syringe assembly300that is consistent with arterial syringe assembly200ofFIG. 2A. Arterial syringe assembly300includes luer adapter210, needle cover220, and needle plug230that are connected with needle340inside needle cover220. Locking tab224for needle plug230is in a first (outer) stage position, as needle plug230has not yet been pushed proximally into needle cover220. Needle stop228of needle cover220ensures that the needle340is positioned at a proper angle relative to needle cover220. In some examples, a caregiver (e.g., a medical professional) may push needle plug230into the needle cover220to fully lock the arterial syringe assembly—to place the arterial syringe assembly100into the configuration ofFIG. 3B, discussed below.

FIG. 3Billustrates the fully locked and shut off configuration of an example arterial syringe assembly, according to some aspects of the disclosure.FIG. 3Bshows arterial syringe assembly350that is consistent with arterial syringe assembly300ofFIG. 3A. As shown, arterial syringe assembly350includes luer adapter210, the needle cover220, and the needle plug230are connected with the needle340inside the needle cover220. In some examples as shown inFIG. 3B, locking tab224for the needle plug230is in a final (inner) stage position and needle plug230is pushed into needle cover220and over needle340. Needle plug230has been locked into needle cover220. In some embodiments, needle-locking tab226of needle cover220locks the needle340into place.

FIG. 4Aillustrates an interior view of an example arterial syringe assembly, according to some aspects of the disclosure.FIG. 4Ashows diagram400of an arterial syringe assembly that is consistent with arterial syringe assembly200ofFIG. 2A. The arterial syringe assembly includes luer adapter210, needle cover220, and needle plug230. In some embodiments, needle plug230is included in needle cover220. As shown, needle cover220includes outer sleeve440and inner sleeve450. Needle plug230may include internal chamber234and inlet port232. In some examples, needle340accesses internal chamber234through hole420or an aperture provided for the needle. As shown, a distal end of needle cover220includes inlet port232to insert, e.g., to inject, a plug material. The distal end of needle cover220is described with respect toFIG. 4E.

In some examples as shown inFIG. 4A, needle cover220includes second cover hinge portion222. Second cover hinge portion222may snap into first cover hinge portion212of the luer adapter210shown inFIGS. 2A and 3Bto put needle cover220into place. The needle cover220also includes needle-locking tab430, which secures the needle when the needle is forced into needle cover220of arterial syringe assembly. As further shown inFIG. 4A, stop surface410of needle cover220keeps the needle parallel to the walls of needle cover220when the needle plug is snapped into needle-locking tab430.FIG. 4Billustrates a top view of an example arterial syringe assembly, according to some aspects of the disclosure. Diagram425ofFIG. 4Bincludes luer adapter210, needle cover220, and needle plug230. In some examples,FIG. 4Ais a cross-sectional view along surface A-A ofFIG. 4B.FIG. 4Cillustrates a detailed view of locking tabs of the example arterial syringe assembly ofFIG. 4A, according to some aspects of the disclosure. As shown inFIG. 4C, the needle cover includes outer sleeve440and inner sleeve450. Outer sleeve440and inner sleeve450connect to one another through locking tabs, i.e., a locking tab460on the inner sleeve450and a locking tab470on the outer sleeve440. Outer sleeve440and inner sleeve450are described with respect toFIGS. 5A and 5B.

FIG. 4Dillustrates a side view of an example arterial syringe assembly having an inner sleeve and an outer sleeve, according to some aspects of the disclosure.FIG. 4Eillustrates a cross sectional view of a distal end of an example arterial syringe assembly, according to some aspects of the disclosure. In some examples, diagram495ofFIG. 4Eis a cross-sectional view along surface E-E ofFIG. 4D. Diagram495shows inlet port232of the distal end of needle cover220that may be used of inserting the plug material into internal chamber234. The plug material may be clay or some other plug material. Internal chamber234may retains plug material for needle shut off configuration.

FIG. 5Aillustrates a top view of components of an example arterial syringe assembly, according to some aspects of the disclosure. Diagram500ofFIG. 5Aillustrates inner sleeve450, outer sleeve440, needle plug230, and plug material510.FIG. 5Billustrates a top view of components of an example arterial syringe assembly, according to some aspects of the disclosure. Diagram550ofFIG. 5Billustrates luer adapter210, inner sleeve450, outer sleeve440, needle plug230, and plug material510. Plug material510may be placed inside needle plug230to plug the needle340shown inFIGS. 3A, 3B, and 4A. Plug material510may be clay or some other plug material that may occlude the distal tip of the needle. Diagrams500and550ofFIGS. 5A and 5Bare consistent with diagrams400,425, and475ofFIGS. 4A, 4B, and 4C.

As illustrated inFIGS. 4A-4D and 5A-5B, needle cover220may comprise of an inner sleeve450and an outer sleeve440. Inner sleeve450and outer sleeve440are separate components that couple together, as shown inFIGS. 4A-4D. The inner sleeve450and the outer sleeve440may connect with one another through at least one locking tab of the outer sleeve, e.g., locking tab470and at least one locking tab of the inner sleeve, e.g., locking tab460. In some embodiments, needle plug230may reside at a distal end of outer sleeve440. In some embodiments, inner sleeve450is rotationally coupled through the hinge to luer adapter210and permits outer sleeve440to slidingly couple with inner sleeve450. In some embodiments, needle cover220may be a single unit that does not include multiple sleeves.

FIGS. 6A-6Dillustrate components of a hinge of an example arterial syringe assembly, according to some aspects of the disclosure.FIGS. 6A-6Dillustrate operations of hinge portion612, which locks inner sleeve450of the needle cover220to luer adapter210. Hinge portion612may correspond to first cover hinge portion212and/or second cover hinge portion222inFIGS. 2A-2B.FIG. 6Aillustrates a top view600andFIG. 6Billustrates a cross section view625of luer adapter210, hinge portion612, and needle cover220. Cross section view625also shows locking tab620. As shown inFIG. 6A, hinge portion612is designed to snap into locking tab620of luer adapter210.FIG. 6Cillustrates an angled view650of luer adapter210, hinge portion612, and needle cover220. As shown inFIG. 6C, the hinge portion612holds together luer adapter210and the needle cover220.FIG. 6Dillustrates a close-up view675of luer adapter210having hinge portion612and locking tab620. In some embodiments, locking tab620may be a dual positive locking tab, which resists tampering when fully engaged.

FIGS. 7A-7Dillustrate components of an example arterial syringe assembly, according to some aspects of the disclosure.FIG. 7Aillustrates locking tab620of luer adapter210and inner sleeve arm452of inner sleeve450. As shown inFIG. 7A, inner sleeve arm452creates a slight side force on locking tabs620, holding hinge portion612and causing the luer adapter210to be held in place.FIG. 7Billustrates luer adapter210and inner sleeve arm452. As shown, luer adapter210has angle stop710, into which the inner sleeve arm452may be frictionally fit to create a hinge consistent with hinge portion612ofFIGS. 6A-6D.

FIG. 7Cillustrates a detailed view of luer adapter210. As shown, angle stop710of luer adapter210controls the amount of angle travel allowed by inner sleeve arm452(not shown inFIG. 7C). Adjacent to angle stop710is cut out712. Cut out712creates a spring clip that applies a positive force to inner sleeve arm452after the inner sleeve arm452is installed into angle stop710.

FIG. 7Dillustrates a detailed view of housing780that is consistent with housing180ofFIG. 1. Housing780includes luer adapter210coupled to hinge portion612. Inner sleeve450is coupled through inner sleeve arm452to luer adapter210. As shown inFIG. 7D, stop surface720that is consistent with stop surface410ofFIG. 4A, is used when the needle is in its locked position. Stop surface720may be used for the rotational travel of the inner sleeve450about the hinge portion612. The hinge portion612engages the top of the luer adapter210when the hinge portion612is in the locked position. The engagement of inner sleeve450with luer adapter210provides a stop to limit rotational travel of the inner sleeve450about hinge portion612.

FIG. 8A-8Dillustrate components of an example arterial syringe assembly, according to some aspects of the disclosure.FIG. 8Aillustrates an inside view of outer sleeve440ofFIG. 5B, which includes a locking tab470for connecting to inner sleeve450and also includes slot820for installing the inner sleeve and allowing inner sleeve450to move into the outer sleeve440.FIG. 8Billustrates an inside view of inner sleeve450ofFIG. 5B, which also includes locking tab460for connecting to outer sleeve440.

FIG. 8Cillustrates the distal end of the outer sleeve440ofFIG. 8Ain detail.FIG. 8Ccorresponds to a section ofFIG. 8Amarked by a circle C.FIG. 8Cshows a distal end of needle cover220that includes an inlet port232to inject the plug material. In some examples, inlet port232leads to the internal chamber234that retains the plug material that is injected through inlet port232. Hole420of internal chamber234is provided for the needle (not shown inFIG. 8C) to access the plug material inside the internal chamber234.

FIG. 8Dillustrates a fully locked and shut off state of the arterial syringe assembly. As shown inFIG. 8D, locking tab470of the outer sleeve440locks the outer sleeve440to the inner sleeve450, after the outer sleeve440and the inner sleeve450have been rotated around the hinge to align with the needle, and the outer sleeve440has been withdrawn or pressed proximally to slide over the inner sleeve450. Locking tab460of the inner sleeve450locks the inner sleeve450to the outer sleeve440. The needle340is locked into place by the needle-locking tab226of the inner sleeve450. In some embodiments, luer adapter210includes a stop surface840to control the angle of locking of luer adapter210to the inner sleeve450or the outer sleeve440. Stop surface840connects the inner sleeve450to the hinge portion612and engages the outer surface of the luer adapter210to prevent further rotation of the inner sleeve450. Stop surface840ensures that the inner sleeve450, when locked, is in the proper orientation for sliding the outer sleeve440axially in the proximal direction in order to seal the distal end of needle340. As shown, needle340extends into the internal chamber234, which is filled with plug material, which plugs needle340.

FIG. 9illustrates a flow diagram of an example process of operating an arterial syringe assembly, according to some aspects of the disclosure. Notably, one or more steps of process900described herein may be omitted, performed in a different sequence, and/or combined with other processes for various types of applications contemplated herein. Process900can be performed to operate arterial syringe assembly100ofFIG. 1. Prior to beginning the process900, the arterial syringe assembly may be delivered to a caregiver from the manufacturer (possibly via an intermediary, such as an online store or a brick-and-mortar store) in tamper-proof packaging.

The process900begins at step910, where the caregiver removes the arterial syringe assembly from the packaging. The packaging may be plastic packaging and may include additional protective material (e.g., additional plastic or cotton covering) around the needle. The packaging may include a warning label to prevent the caregiver from opening or tampering with the arterial syringe assembly before use.

In step920, the caregiver orients the arterial syringe assembly through the needle cover relative to the patient. The needle may be inserted directly into the patient at an angle of approximately 30 degrees relative to the patient's skin at the point of injection or at another angle. The needle cover may be oriented to make an angle of at least 45 degrees, e.g., 90 degrees, relative to the needle bevel surface, so as not to disturb the patient's skin and the needle as the needle is injected through the patient's skin into the patient's artery. The needle cover may point away from the patient's skin. Prior to inserting the needle into the patient, the caregiver may pull back the plunger to loosen the plunger, as the plunger may have become tightly fitted within the syringe barrel since the manufacture of the arterial syringe assembly.

In step930, the caregiver inserts the needle within the patient. The needle is then used to draw blood or fluid from the patient's artery into the syringe barrel of the arterial syringe assembly. During the drawing of blood or fluid, the caregiver may slowly pull back the plunger to reduce pressure within the syringe barrel and, thereby, cause blood or fluid to flow into the syringe barrel. In some instances, the arterial blood pressure is sufficient to evacuate air from the syringe barrel through the hydrophobic filter such that withdrawal of the needle while blood is being drawn into the syringe barrel is not necessary. The syringe barrel may be a graduated cylinder with markings on the side to allow the caregiver to visually determine an amount of blood or fluid that has been drawn and to remove the needle after a predefined amount of blood or fluid has been drawn. In instances when the plunger is drawn proximally, the plunger may be withdrawn with the same hand that is holding the arterial syringe assembly by stretching a thumb or forefinger of that hand to the plunger and pushing that thumb or forefinger away from the needle.

In step940, the caregiver withdraws the needle from the patient after noticing that a predefined amount of blood or fluid has been drawn from the patient's artery. The caregiver closes the needle cover over the needle, causing the tip of the needle to extend into the plug material (e.g., clay) within the needle plug. The closing of the needle cover over the needle may be accomplished with the single hand that is holding the needle by pressing the needle cover against a hard surface until the needle cover snaps into place over the needle. The hard surface may be any hard surface available near the caregiver, such as a bed rail, a wall, a table or a chair. In some examples, the caregiver may use his/her other hand for a different task, such as applying a bandage to the patient.

In step950, the caregiver applies an axial force on a distal end of the needle cover. The axial force may be applied using a single hand, for example, by pushing the distal end of the needle cover against a hard surface. According to some embodiments, the axial force causes the distal end to slide inside the cover to occlude the tip of the needle with the needle plug. According to other embodiments, the axial force causes the distal end of an outer sleeve (e.g., outer sleeve440) of the needle cover to slide over an inner sleeve (e.g., inner sleeve450) of the needle cover to occlude the tip of the needle with the needle plug.

In step960, the caregiver keeps the arterial syringe assembly oriented to reduce contact of the fluid within the syringe barrel with the hydrophobic filter. For example, the caregiver may hold the arterial syringe assembly such that the hydrophobic filter is at the top of the syringe barrel (relative to the Earth or gravitational forces) and the fluid is pulled to the bottom of the syringe barrel by gravity. This orientation of the arterial syringe assembly may be accomplished by rotating the arterial syringe assembly using a single hand.

In step970, the caregiver presses the plunger into the syringe barrel to evacuate the air from within the syringe barrel. When pressing the plunger, the hydrophobic filter at the distal end of the plunger allows air to escape through the hydrophobic filter, while preventing the escape of fluid. Neither air nor fluid escapes through the needle because the tip of the needle is occluded with the needle plug, which includes a plugging material, such as clay. After step970, the process900ends.

FIG. 10Aillustrates a side view of an example arterial syringe assembly, according to some aspects of the disclosure.FIG. 10Ashows syringe assembly1000that is consistent with a portion of arterial syringe assembly100ofFIG. 1. Arterial syringe assembly1000includes luer adapter110, needle cover120, needle plug130, and needle140that are consistent with corresponding elements of arterial assembly100. Arterial syringe assembly1000further includes needle cap141that may prevent accidental needle stick. Arterial syringe assembly1000may be used similar to Arterial syringe assembly100and as described with respect to process900.

In addition, differences between the arterial syringe assembly1000and the arterial syringe assembly100are described. In some embodiments, needle cap141includes needle cap end142and syringe plug end143opposite the needle cap end142. Needle cap141may provide a protective covering for needle140before use, and includes a hollow portion extending from needle cap end142to syringe plug end143. The needle cap end142may interface with a needle hub portion111of luer adapter110. For example, needle hub portion111may have one or more ridges and needle cap end142may have corresponding grooves that can fit into the ridges. In some embodiments, syringe plug end143is shaped like luer adapter110. Thus, syringe plug end143may interface with syringe barrel150for sealing the syringe barrel150when the luer adapter110is removed.

In some embodiments, luer adapter110may be formed as a single piece with needle140. Luer adapter110may be integrated with the needle hub portion111and the hinge portion112. Hinge portion112may include one or more locking tabs with holes for receiving needle cover120. Locking tabs are described at least with respect toFIGS. 10B, 11B, and 12B.

FIG. 10Billustrates a side view of an example arterial syringe assembly, according to some aspects of the disclosure. In some examples,FIG. 10Bis a different view ofFIG. 10Aand includes luer adapter110, needle cover120, needle plug130, needle140, hinge portion112, needle cap end142, and syringe plug end143.

FIGS. 11A-11Billustrate side views of arterial syringe assembly ofFIG. 10Awith the needle cover in a fully open position, according to some aspects of the disclosure.FIGS. 11A-11Bincludes needle cover120, luer adapter110, needle cap141having needle cap end142and syringe plug end143, and needle plug130. Needle cover120has inner sleeve122that is consistent with inner sleeve450ofFIGS. 5A-5Band outer sleeve129that is consistent with outer sleeve440ofFIGS. 5A-5B. Inner sleeve122includes one or more arms121that are consistent with inner sleeve arm452. Inner sleeve122may interface with the holes of the tabs of the hinge portion112to form a hinge about which the needle cover120rotates.

In some embodiments, outer sleeve129includes one or more windows133. Windows133may function as ridges, which may enhance grip for holding and sliding outer sleeve129. Windows133also provide openings for viewing locked indicator131and the unlocked indicator132. When outer sleeve129is in the unlocked position, which may be distal from inner sleeve122, only unlocked indicator132may be visible through windows133. When outer sleeve129is in the locked position, which may be proximate to inner sleeve122, only locked indicator131may be visible through windows133. Unlocked indicator132may be a visual indicator, such as green or other color, pattern, icon, etc., which indicates that outer sleeve129is in the unlocked position. The locked indicator131may be a visual indicator, such as red or other color, pattern, icon, etc., which indicates that outer sleeve129is in the locked position. When in the locked position, the plug material510inside the needle plug130engages the needle140.

FIG. 11Cillustrates a side cutaway view of the arterial syringe assembly ofFIG. 10A, according to some aspects of the disclosure.FIG. 11Cincludes same components described above forFIGS. 11A-11B. AdditionallyFIG. 11Cshows needle hub portion111, needle140, and locking tab113of hinge portion112that is consistent with lock tab620ofFIG. 7C.

FIG. 11D-11Eillustrate side views of arterial syringe assembly ofFIG. 10A, according to some aspects of the disclosure.FIGS. 11D-11Einclude needle cover120, luer adapter110, needle140including needle hub portion111, and needle plug130. Needle cover120has inner sleeve122and outer sleeve129. Inner sleeve122includes one or more arms121that may interface with the holes of the tabs of the hinge portion112to form a hinge about which the needle cover120rotates.

FIG. 11Fillustrates arterial syringe assembly ofFIG. 10Ain the locked position, according to some aspects of the disclosure.FIG. 11Fadditionally shows locked indicator131and unlocked indicator132that may be visible through windows of needle cover120. In some embodiments, locked indicator131is proximal and unlocked indicator132is distal.

FIG. 12A-12Billustrate side views of arterial syringe assembly ofFIG. 10Ahaving the needle cover in a locked position, according to some aspects of the disclosure. As shown inFIG. 12A, hinge portion112includes locking tab113. As shown inFIG. 12B, hinge portion112includes locking tab113and backstop portion114. In some embodiments, arms121include one or more notches123, which engage with locking tab113of the hinge portion112. In some examples, notches123may be positioned such that notches123engage the locking tab113at specified angles of the needle cover120with respect to the needle140, e.g., at zero degrees when needle cover120is closed. In addition, backstop portion114of the hinge portion112prevents arms121from rotating further beyond backstop portion114(angle stop), to establish a maximum position stop for needle cover120. In some examples, back stop portion114is consistent with angle stop710ofFIG. 7C. In some examples, needle-locking tab125which is consistent with needle-locking tab226ofFIG. 3Bengages needle140when needle cover120is closed, to secure needle140and prevent needle cover120from opening.

In some examples, outer sleeve129slides over the inner sleeve122. Tab127of the outer sleeve129engages the inner locking tab124to prevent outer sleeve129from sliding completely off inner sleeve122. Tab128of the outer sleeve129provides friction to engage slot126of the inner sleeve122when outer sleeve129is moved into the locked position to prevent outer sleeve129from sliding. In some examples, arterial syringe assembly1000operates in two stages. In a first stage, needle cover120is rotated towards needle140, capturing and locking needle140to prevent accidental needle stick. The bottom of needle cover120is open to allow needle cover120to rotate over needle140. Needle-locking tab125slides over and engages needle140. Inner sleeve122may include additional spines to further guide and surround needle140. In some embodiments, notch123engages locking tab113to prevent needle cover120from rotating out.

In a second stage, the outer sleeve129may move from the unlocked position to the locked position. Plug material510may be pushed into needle140. Tab128engages slot126to lock outer sleeve129. Unlocked indicator132is obscured and locked indicator131is made visible through one of windows133.

FIG. 12Cillustrates a side view of arterial syringe assembly ofFIG. 10Ain the locked position, according to some aspects of the disclosure. As shown unlocked indicator132is obscured and locked indicator131is made visible to indicate the locked position.

FIGS. 13A-13Billustrate side views of an arterial syringe assembly, according to some aspects of the disclosure.FIGS. 13A and 13Billustrate arterial syringe assembly1100, which may be consistent with arterial syringe assembly1000. Arterial syringe assembly1100may be used in conjunction with shorter needles than those of the arterial syringe assembly1000. For example, arterial syringe assembly1000may be used with 1 inch needles whereas arterial syringe assembly1100may be used with ⅝ inch needles. Arterial syringe assembly1100includes luer adapter110, needle cover120, needle plug130, needle140, and needle cap141. Needle cover120of the arterial syringe assembly1100may be shorter than needle cover120of the arterial syringe assembly1000. In some examples, operation of the arterial syringe assembly1100may be similar to the two-stage operation of arterial syringe assembly1000, as described above.

In some embodiments, needle cap141includes needle cap end142that may interface with needle hub portion111of the luer adapter110. In some embodiments, needle cap141includes syringe plug end143that is opposite of needle cap end142may interface with the syringe barrel150for sealing the syringe barrel150when luer adapter110is removed. Similar to arterial syringe assembly1000, luer adapter110of arterial syringe assembly1100may be integrated with needle hub portion111and hinge portion112.

In some embodiments, needle cover120includes inner sleeve122and outer sleeve129. Inner sleeve122includes one or more arms121, needle-locking tab125, and slot126. Outer sleeve129includes tab128that is coupled to needle plug130. Arms121may interface with the holes of the tabs of hinge portion112to form a hinge about which needle cover120rotates. Arms121include one or more notches123, which engage locking tab113of the hinge portion112. For example, notches123may be positioned such that notches123engage locking tab113at specified angles, such as 0 degrees (e.g., when the needle cover120is closed and covering the needle140), and/or 45 degrees. In some embodiments, backstop portion114of hinge portion112prevents arms121from rotating further, to establish a maximum position stop for needle cover120. Needle-locking tab125engages needle140when needle cover120is closed, to secure needle140and prevent needle cover120from opening.

In some embodiments, outer sleeve129slides over inner sleeve122. Tab128of outer sleeve129engages slot126of inner sleeve122when the outer sleeve129is moved into the locked position to prevent outer sleeve129from sliding. Slot126may be a ball detent. In some embodiments, tab128and slot126may be on both sides of the needle cover120. Outer sleeve129and inner sleeve122may include corresponding rails and/or grooves to guide movement. When outer sleeve129is in the unlocked position, which may be distal from inner sleeve122, plug material510inside needle plug130is separated from the needle140. When outer sleeve129is in the locked position, which may be proximate to inner sleeve122, plug material510inside the needle plug130engages the needle140.

FIGS. 14A-16Billustrate side views of an arterial syringe assembly, according to some aspects of the disclosure.FIGS. 14A-16Billustrate arterial syringe assembly1200, which may be consistent with arterial syringe assembly1000. Arterial syringe assembly1200includes luer adapter110, needle cover120, needle plug130, needle140, and needle cap141. In some examples, operation of the arterial syringe assembly1200may be similar to the two-stage operation of the arterial syringe assembly1000as described above.

In some embodiments, needle cap141includes the needle cap end142that may interface with needle hub portion111of luer adapter110. Needle cap141may also include syringe plug end143opposite the needle cap end142that may interface with syringe barrel150for sealing syringe barrel150when luer adapter110is removed. Similar to arterial syringe assembly1000, luer adapter110of arterial syringe assembly1200may be integrated with needle hub portion111and hinge portion112.

In some embodiments, needle cover120includes the inner sleeve122that is coupled to needle plug130. In some embodiments, one of inner sleeve122or outer sleeve129includes needle plug130. Inner sleeve122may include one or more arms121, needle-locking tab125, and tab128. Needle plug130includes slot126and plug material510. Arms121may interface with the holes of the tabs of hinge portion112to form a hinge about which needle cover120rotates. Needle cover120may also include a shoulder135having one or more ridges136. Shoulder135provides a surface that may be pushed by hand or a finger. Ridges136provide a gripped surface for shoulder135. In addition, shoulder135acts as a backstop, to establish a maximum position stop for needle cover120. Needle-locking tab125engages needle140when the needle cover120is closed, to secure needle140and prevent needle cover120from opening.

In some embodiments, needle plug130slides within inner sleeve122. When in the locked position, tab128engages the slot126of needle plug130. In the locked position, plug material510is pushed into needle140.

In some embodiments, arterial syringe assembly1200operates in two stages. In the first stage, needle cover120is rotated towards needle140, capturing and locking needle140to prevent accidental needle stick. The bottom of needle cover120is open to allow needle cover120to rotate over needle140. Needle-locking tab125slides over and engages needle140. Inner sleeve122may include additional spines to further guide and surround needle140.

In the second stage, needle plug130is moved from the unlocked position to the locked position. Plug material510is pushed into needle140. The tab128engages the slot126to lock needle plug130.

It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.