Patent Description:
Collapse of the patient's blood vessel during blood collection can occur as a result of a pressure differential created by the connection of the evacuated tube to the non-patient needle cannula. This collapse can occur as a result of the blood being removed too quickly from the patient's blood vessel. Physiological conditions such as the elasticity of the blood vessel wall can also contribute to this problem. With a standard evacuated tube, there is an instantaneous introduction of a sharp vacuum pressure when the evacuated tube is attached to the non-patient end of the blood collection device. This strong vacuum results in an initially high flow rate of blood out of the patient's blood vessel. This sharp outflow of blood coupled with the high elasticity of a patient's vessel can lead to the vessel wall being pulled down onto the bevel of the distal end of the patient cannula resulting in flow stoppage. The site for obtaining the blood supply can also be a contributing factor toward vessel collapse. Most typical blood collection sites are in the patient's arm and hand. Because of the one-way valves in the vessel, the supply of blood available for collection resides below the collection site. In-flow of new blood to this area is limited as a result of the capillary blood vessels. In the situations where there is little resident blood, such as a hand collection, the sharp vacuum from the collection tube leads to a high flow rate out of the vessel, which can lead to an outflow rate higher than the inflow rate and a rapid depletion of the resident blood. This scenario can quickly lead to collapse.

One way to avoid this collapse is to use a syringe for blood collection. Syringes can provide a user with greater control over the flow rate of blood out of the patient. The initial spike in pressure from an evacuated tube and the associated high flow rate can be avoided through the use of a syringe collection technique. However, the skill of the user plays a large role with this type of collection as there can be a lot of variability in the amount of force the user exerts on the syringe plunger and the associated flow rates. Also, if not used appropriately, the flow rates can be greater than a standard evacuated tube.

The manual flow regulator of the present invention seeks to minimize the incidence of vessel or vein collapse in patient populations susceptible to this type of condition. The device achieves this by controlling the flow rate of the blood out of the patient's vessel or vein. This is accomplished through the use of a variable flow resistor. The resistor acts to slow down the initial flow rate of blood into the evacuated tube and avoid the initial spike, as well as to slow down the overall collection time to avoid depleting the resident blood in the vessel too rapidly. Prior art specimen collection assembly are disclosed in documents <CIT> and <CIT>.

The present disclosure provides a specimen collection assembly including a flow control member as defined by the features of claim <NUM>. Preferred embodiments are defined within the dependent claims.

In one configuration, the specimen collection assembly further includes a hub at least partially supporting the cannula and defining a collection channel therein, the collection channel adapted for fluid communication with the interior of the evacuated collection container. In another configuration, the flow control member is manually adjustable to alter the effective flow distance. In yet another configuration, the flow control member is rotatable between a maximum flow position, in which the regulation channel has a first effective length, and a minimum flow position, in which the regulation channel has a second effective length, the second effective length being longer than the first effective length. In one configuration, the flow control member includes a hub engaging member engaged with the hub, the hub engaging member defining a through-port extending therethrough, the through-port connecting a portion of the regulation channel defined within a proximal surface of the flow control member to a portion of the regulation channel defined within a distal surface of the flow control member. In one configuration, the specimen collection assembly further includes a spine member engaged with a portion of the hub and a portion of the hub engaging member, wherein the spine member and the hub define a flow space therebetween in fluid communication with the regulation channel and the collection channel. In another configuration, the flow control member and the spine member include opposing detents to limit rotation of the flow control member between a minimum flow position and a maximum flow position. In yet another configuration, the specimen collection assembly further includes a specimen collection container in fluid communication with the lumen of the cannula. In another configuration, the specimen collection assembly further includes a hub engaging member engaged with a portion of the hub and defining a flow-entry port extending therethrough and in fluid communication with the regulation channel. In yet another configuration, the specimen collection assembly further includes a spine member engaged with and positioned between the hub and the hub engaging member, wherein the spine member and hub define a flow space therebetween in fluid communication with the regulation channel and the collection channel, the spine member defining a through-port extending therethrough connecting the flow space and the regulation channel in fluid communication. In one configuration, the spine member through-port and the flow-entry port are axially aligned. In another configuration, the specimen collection assembly further includes at least one gasket defining a gasket through-port aligned with at least one of the through-port and the flow-entry port. In yet another configuration, the flow control member is rotatable about a portion of the hub. In one configuration, the regulation channel is defined radially about a center axis of a hub engaging member engaged with the hub. In another configuration, the specimen collection assembly further includes a holder housing having a distal end and a proximal end defining an internal chamber therebetween, the proximal end being adapted to receive a portion of the evacuated collection container therein, wherein the evacuated collection container is adapted to be pierced by the cannula to establish flow between an internal chamber of the evacuated collection container and the regulation channel. In yet another configuration, the flow control member includes at least one manipulation wing for transition by a user between a minimum flow position and a maximum flow position.

In accordance with another embodiment of the present invention, a specimen collection assembly includes a cannula defining a lumen therein. The specimen collection assembly further includes a housing having a housing wall defining an internal chamber having an inlet port and an outlet port, the inlet port adapted for fluid communication with the lumen, the outlet port adapted for fluid communication with an evacuated collection container, and a flow control member positioned to vary an effective cross-sectional area of at least one of the inlet port and the outlet port.

In one configuration, the flow control member is manually adjustable to alter the effective cross-sectional area. In another configuration, the flow control member is rotatable between a maximum flow position and a minimum flow position. In yet another configuration, the flow control member includes a helical profile disposed about a central axis of the flow control member, wherein, upon rotation of the flow control member, the helical profile is configured to open and/or close at least one of the inlet port and/or the outlet port. In one configuration, the specimen collection assembly further includes a flow control insert disposed at least partially within the internal chamber and configured to cooperate with the flow control member to direct flow from the inlet port to the outlet port.

In accordance with another embodiment of the present invention, a specimen collection assembly includes a cannula, defining a lumen therein. The specimen collection assembly further includes a hub at least partially supporting the cannula and defining a collection channel therein, the collection channel adapted for fluid communication with an interior of an evacuated collection container, and flow control means for altering a flow path between the lumen of the cannula and the interior of the evacuated collection container.

In one configuration, the flow control means includes manually varying a length of the flow path. In another configuration, the flow control means includes manually varying a cross-sectional area of the flow path.

In one configuration, the regulating blood flow occurs by manually varying the effective cross-sectional area of the at least one of an inlet port and an outlet port.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

In the following discussion, "distal" refers to a direction generally toward an end of a syringe assembly adapted for contact with a patient and/or engagement with a separate device such as a needle assembly or IV connection assembly, and "proximal" refers to the opposite direction of distal, i.e., away from the end of a syringe assembly adapted for engagement with the separate device. For purposes of this disclosure, the above-mentioned references are used in the description of the components of a specimen collection assembly in accordance with the present disclosure.

<FIG> illustrate an exemplary embodiment of the present disclosure directed to a manual blood flow regulation device which regulates the flow of blood from the vasculature of a patient by manually varying the length of an orifice or flow path. Referring to <FIG>, a flow regulator system <NUM> includes a tube holder sub-assembly <NUM>, gaskets 104a and 104b, a flow control member or dial <NUM>, a spine <NUM>, a hub <NUM>, a non-patient needle <NUM>, a sleeve <NUM>, and a tube holder <NUM>.

Referring to <FIG>, tube holder sub-assembly <NUM> includes a body portion <NUM>, a flange portion <NUM> having a superior surface <NUM> and an opposing inferior surface <NUM>, and a flow member <NUM>. Body portion <NUM> extends from superior surface <NUM> of flange portion <NUM> and includes an exterior wall <NUM> and an interior wall <NUM>. Interior wall <NUM> of body portion <NUM> defines a bore <NUM> through tube holder sub-assembly <NUM>. In one embodiment, interior wall <NUM> includes two interior wall components 132a and 132b that define respective opposing slots 134a and 134b. Slots 134a and 134b are sized and shaped to receive respective rails <NUM> (<FIG>) of spine <NUM> to secure tube holder sub-assembly <NUM> to spine <NUM> as will be described in more detail below. In one embodiment, flow member <NUM> is disposed adjacent a portion of exterior wall <NUM> of body portion <NUM>. Flow member <NUM> defines a flow channel <NUM> therein such that flow channel <NUM> extends the extent of tube holder sub-assembly <NUM>. For example, flow channel <NUM> includes a first opening <NUM> at a top portion of flow member <NUM> and a second opening <NUM> (<FIG>) at inferior surface <NUM> of flange portion <NUM>. In this manner, a fluid such as blood is able to flow through tube holder sub-assembly <NUM> via flow channel <NUM> as will be described in more detail below. <FIG> illustrate flow member <NUM> and flow channel <NUM> as elongated cylindrical members, though it is contemplated that other shapes and sizes of flow member <NUM> and flow channel <NUM> may be used. For example, flow member <NUM> and flow channel <NUM> can have other multi-sided polygon cross-sectional shapes, such as square or rectangular cross-sectional shapes.

Referring to <FIG>, inferior surface <NUM> of flange portion <NUM> defines a gasket receiving cavity <NUM> and opposing gasket protuberance apertures <NUM> therein. Gasket receiving cavity <NUM> and gasket protuberance apertures <NUM> are sized and shaped to receive gasket 104b within inferior surface <NUM> of flange portion <NUM> of tube holder sub-assembly <NUM> as shown in <FIG>. In this manner, gasket 104b is able to provide a substantially leak proof seal between tube holder sub-assembly <NUM> and dial <NUM>.

Referring to <FIG>, gasket 104a, 104b includes a gasket body <NUM>, a gasket through-port such as gasket flow aperture <NUM> defined therethrough, and opposing gasket protuberances <NUM>. For the sake of brevity, only one gasket is shown in <FIG> which corresponds to both gasket 104a and gasket 104b as gaskets 104a and 104b each include the same structure.

Referring to <FIG>, gasket 104b is secured to tube holder sub-assembly <NUM> such that gasket body <NUM> is received within gasket receiving cavity <NUM> (<FIG>) with gasket protuberances <NUM> received within respective gasket protuberance apertures <NUM> (<FIG>) of tube holder sub-assembly <NUM>. In this manner, gasket 104b is secured within tube holder sub-assembly <NUM> so that gasket 104b is prevented from rotating relative to tube holder sub-assembly <NUM>. Additionally, gasket 104b is secured to tube holder sub-assembly <NUM> such that gasket flow aperture <NUM> is in alignment with second opening <NUM> (<FIG>) of flow channel <NUM> of tube holder sub-assembly <NUM> as will be described in more detail below.

Referring to <FIG>, flow control member or dial <NUM> includes an upper body portion <NUM>, a lower body portion <NUM>, and a center plate <NUM> disposed therebetween and within body portions <NUM>, <NUM>. The walls of upper body portion <NUM> and lower body portion <NUM> together define center bore <NUM> through dial <NUM>. Dial <NUM> also includes at least one flange <NUM>, such as opposing flanges <NUM>, 160a extending from an exterior surface of upper body portion <NUM> and lower body portion <NUM>. In one embodiment, flanges <NUM>, 160a extend parallel to the longitudinal axis of dial <NUM>. Flanges <NUM>, 160a may be configured for easy grasping of dial <NUM> by a medical practitioner. In this manner, a medical practitioner may easily rotate dial <NUM> relative to flow regulator system <NUM> to adjustably alter a flow path as will be described in more detail below. <FIG> illustrate dial <NUM> having two (<NUM>) flanges <NUM>, 160a, though it is contemplated that other numbers of flanges <NUM> could be provided on dial <NUM>. For example, three (<NUM>) or more flanges <NUM> may be used. Referring to <FIG>, upper body portion <NUM> may also include a plurality of ribs <NUM> extending from an exterior surface. Ribs <NUM> provide a further gripping surface for a medical practitioner.

Referring to <FIG> and <FIG>, center plate <NUM> includes a superior surface <NUM> and an opposing inferior surface <NUM>. Referring to <FIG>, superior surface <NUM> of center plate <NUM> defines through-port or flow aperture <NUM> through center plate <NUM> and a front flow channel <NUM>. In one embodiment, front flow channel <NUM> extends three-hundred sixty (<NUM>) degrees around superior surface <NUM> from flow aperture <NUM> as shown in <FIG>. In this manner, the entirety of front flow channel <NUM> is in fluid communication with flow aperture <NUM>. Flow aperture <NUM> allows a fluid to pass from superior surface <NUM> of center plate <NUM> through center plate <NUM> to inferior surface <NUM>. In other embodiments, front flow channel <NUM> may extend any number of degrees around superior surface <NUM>. For example, front flow channel <NUM> may extend about only a portion of superior surface <NUM>.

Referring to <FIG>, inferior surface <NUM> of center plate <NUM> defines a back flow channel <NUM> and includes flow aperture <NUM>. In one embodiment, back flow channel <NUM> extends one-hundred twenty (<NUM>) degrees around inferior surface <NUM> from flow aperture <NUM> as shown in <FIG>. In this manner, a fluid that passes through flow aperture <NUM> to inferior surface <NUM> can travel within back flow channel <NUM> one-hundred twenty (<NUM>) degrees from flow aperture <NUM> as will be described in more detail below. In other embodiments, back flow channel <NUM> may extend any number of degrees around inferior surface <NUM>. For example, back flow channel <NUM> may extend three-hundred sixty (<NUM>) degrees around inferior surface <NUM>. In such embodiments, a fluid that passes through flow aperture <NUM> to inferior surface <NUM> can travel within back flow channel <NUM> any number of degrees around inferior surface <NUM> from flow aperture <NUM>.

In one embodiment, the length that back flow channel <NUM> extends around superior surface <NUM> of center plate <NUM> corresponds to the degree that dial <NUM> can be rotated relative to system <NUM>. For example, referring to <FIG>, if dial <NUM> can be rotated relative to system <NUM> by one-hundred twenty (<NUM>) degrees, then back flow channel <NUM> correspondingly extends one-hundred twenty (<NUM>) degrees around inferior surface <NUM>. Inferior surface <NUM> also includes detents <NUM> for controlling movement of dial <NUM> relative to spine <NUM> as will be discussed below.

Referring to <FIG>, spine <NUM> includes an axial protrusion or body portion <NUM>, a flange portion <NUM>, and a hub receiving portion <NUM>. The walls of body portion <NUM>, flange portion <NUM>, and hub receiving portion <NUM> together define a center bore <NUM> through spine <NUM>. In one embodiment, hub receiving portion <NUM> may include at least one tab <NUM> (<FIG>). Referring to <FIG>, hub receiving portion <NUM> may include two opposing tabs <NUM>. In one embodiment, tabs <NUM> may be formed of a material that is slightly deformable. Tabs <NUM> provide a mechanism to secure spine <NUM> to tube holder <NUM> such that rotation between spine <NUM> and tube holder <NUM> is prevented (<FIG>) as will be described in more detail below.

Body portion <NUM> of spine <NUM> includes opposing rails <NUM> which are each sized and shaped to be insertable into respective slots <NUM> of tube holder sub-assembly <NUM> to secure tube holder sub-assembly <NUM> to spine <NUM>, i.e., with rails <NUM> of spine <NUM> secured within slots <NUM> of tube holder sub-assembly <NUM>, rotation of tube holder sub-assembly <NUM> relative to spine <NUM> is prevented. Body portion <NUM> of spine <NUM> also defines opposing slots <NUM> at a top portion and gasket protuberance apertures <NUM> at a bottom portion. In one embodiment, opposing slots <NUM> of spine <NUM> provide respective snap arms on the spine component so that tube holder sub-assembly <NUM> and spine <NUM> can be secured together by a snap-fit. Flange portion <NUM> of spine <NUM> includes a gasket receiving surface <NUM> and defines a through-port or spine flow aperture <NUM> therethrough. Flange portion <NUM> also includes a detent <NUM> which is engageable with detents <NUM> of dial <NUM> to control movement of dial <NUM> relative to spine <NUM>.

Referring to <FIG>, gasket 104a is secured to spine <NUM> such that gasket body <NUM> is received on gasket receiving surface <NUM> of spine <NUM> with gasket protuberances <NUM> received within respective gasket protuberance apertures <NUM> of spine <NUM>. In this manner, gasket 104a is secured to spine <NUM> so that gasket 104a is prevented from rotating relative to spine <NUM>. Additionally, gasket 104a is secured to spine <NUM> such that gasket flow aperture <NUM> is in alignment with spine flow aperture <NUM> of spine <NUM> as will be described in more detail below. Gaskets 104a, 104b provide a substantially leak proof seal between spine <NUM> and dial <NUM> and tube holder sub-assembly <NUM>.

Referring to <FIG>, hub <NUM> includes a needle receiving member <NUM>, a flange portion <NUM> having a superior surface <NUM> (<FIG> and <FIG>) and an inferior surface <NUM> (<FIG>), a wall assembly <NUM> extending from inferior surface <NUM>, and a spine connection portion <NUM> extending from superior surface <NUM>. Needle receiving member <NUM> defines a flow collection channel <NUM> through hub <NUM> and includes a flow entrance aperture <NUM> (<FIG>) at a bottom surface of spine connection portion <NUM>. Needle receiving member <NUM> is sized and shaped to receive non-patient needle <NUM> therein as shown in <FIG>.

Referring to <FIG>, <FIG>, tube holder <NUM> includes a distal end <NUM>, a proximal end <NUM>, and a flange <NUM> at proximal end <NUM>. Tube holder <NUM> defines an interior cavity <NUM> between distal end <NUM> and proximal end <NUM>.

Referring to <FIG>, to assemble flow regulator system <NUM> spine connection portion <NUM> (<FIG>, and <FIG>) of hub <NUM> may be received within hub receiving portion <NUM> of spine <NUM> as shown in <FIG>, and <FIG>. Spine <NUM> and hub <NUM> can be secured together using a standard fabrication technique such as welding or bonding. In one embodiment, spine <NUM> and hub <NUM> can be ultrasonically welded together. With spine <NUM> and hub <NUM> secured together as shown in <FIG>, <FIG>, <FIG>, and <FIG>, spine <NUM> is prevented from rotating relative to hub <NUM>. Next, referring to <FIG>, non-patient needle <NUM> can be secured within needle receiving member <NUM> (<FIG>) of hub <NUM> such that the lumen of needle <NUM> is in fluid communication with flow collection channel <NUM> (<FIG>) and flow entrance aperture <NUM> (<FIG>) of hub <NUM>. Referring to <FIG>, in one embodiment, sleeve <NUM> can be provided over needle <NUM> to prevent accidental needle stick injuries to a user of system <NUM>.

Referring to <FIG>, spine <NUM>, hub <NUM>, and needle <NUM> (disposed within sleeve <NUM>) may be engaged with tube holder <NUM>. For example, hub receiving portion <NUM> (<FIG>, <FIG>, and <FIG>) of spine <NUM> may be inserted into distal end <NUM> of tube holder <NUM>. Force exerted on spine <NUM> moves spine <NUM> within interior cavity <NUM> of tube holder <NUM> until the bottom surface of flange portion <NUM> (<FIG>) of spine <NUM> contacts the end surface of the wall of tube holder <NUM> at distal end <NUM>. In this manner, tabs <NUM> and hub receiving portion <NUM> contact the interior surface of the wall of tube holder <NUM> so that spine <NUM> is secured to tube holder <NUM> such that rotation between spine <NUM> and tube holder <NUM> is prevented as shown in <FIG>.

In an alternative embodiment, spine <NUM> may be engaged with tube holder <NUM> by threadingly engaging a threaded portion of spine <NUM> to a threaded portion of tube holder <NUM>. In other embodiments, spine <NUM> may be engaged with tube holder <NUM> using a ball detent, locking tabs, spring loaded locking mechanism, latch, adhesive, snap fit mechanism, or other similar mechanism. In all embodiments, spine <NUM> is locked, secured, or engaged with tube holder <NUM>, i.e., significant relative movement or rotation between spine <NUM> and tube holder <NUM> is prevented.

Referring to <FIG>, with spine <NUM> and hub <NUM> engaged with tube holder <NUM>, gasket 104a may then be secured to spine <NUM> as described above. Referring to <FIG>, dial <NUM> may then be assembled to spine <NUM>. Dial <NUM> is engaged with spine <NUM> so that dial <NUM> is rotatable relative to spine <NUM>. In one embodiment, detents <NUM> (<FIG>) of dial <NUM> are configured to control the degree that dial <NUM> can rotate relative to spine <NUM>. For example, detents <NUM> of dial <NUM> and detent <NUM> of spine <NUM> together define the boundaries of rotation of dial <NUM> relative to spine <NUM>, i.e., rotation of dial <NUM> in a first direction is limited to a position in which a first detent <NUM> of dial <NUM> engages detent <NUM> (<FIG>) of spine <NUM> and rotation of dial <NUM> in a second direction is limited to a position in which a second detent <NUM> of dial <NUM> engages detent <NUM> of spine <NUM>. In this manner, the configuration and position of detents <NUM> of dial <NUM> can be varied to determine the amount of rotation of dial <NUM> relative to spine <NUM> that is desired. Referring to <FIG>, and <FIG>, dial <NUM> is prevented from being removed from spine <NUM> by the securement of tube holder sub-assembly <NUM> to spine <NUM> as will be described below.

Referring to <FIG>, before tube holder sub-assembly <NUM> is secured to spine <NUM>, gasket 104b is secured to tube holder sub-assembly <NUM> as described above. Referring to <FIG>, with gasket 104b (<FIG>) secured to tube holder sub-assembly <NUM>, tube holder sub-assembly <NUM> can be secured to spine <NUM> by aligning respective slots 134a, 134b (<FIG>) of tube holder sub-assembly <NUM> with respective rails <NUM> (<FIG>) of spine <NUM> and then tube holder sub-assembly <NUM> can be slidably received over spine <NUM>. In this manner, tube holder sub-assembly <NUM> is secured to spine <NUM>, i.e., with rails <NUM> (<FIG>) of spine <NUM> secured within slots 134a, 134b (<FIG>) of tube holder sub-assembly <NUM>, such that rotation of tube holder sub-assembly <NUM> relative to spine <NUM> is prevented.

In one embodiment, corresponding locking features, such as a snap fit mechanism, are included on tube holder sub-assembly <NUM> and spine <NUM>, respectively, to further secure tube holder sub-assembly <NUM> to spine <NUM>. For example, tube holder sub-assembly <NUM> and spine <NUM> may respectively include a ball detent system, locking tabs, spring loaded locking mechanism, latch, adhesive, snap fit mechanism, or other similar mechanisms. Tube holder sub-assembly <NUM> may be secured to spine <NUM> with center plate <NUM> of dial <NUM> positioned between tube holder sub-assembly <NUM> and spine <NUM> as shown in <FIG> and <FIG>. In this manner, dial <NUM> is secured to tube holder <NUM> while being rotatable relative to tube holder sub-assembly <NUM> and spine <NUM> as will be described in more detail below. Referring to <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, assembled flow regulator system <NUM> is shown with dial <NUM> being rotatable relative to tube holder sub-assembly <NUM> and spine <NUM>.

Phlebotomy procedures are often carried out using a blood collection device, such as an evacuated blood collection container. The manual blood flow regulation device of the present invention may be used with blood collection devices such as a blood collection device <NUM> shown in <FIG>. Referring to <FIG>, blood collection device <NUM> includes a needle assembly <NUM> with a cannula <NUM> that has a proximal end <NUM>, a pointed distal end <NUM>, and a lumen <NUM> extending between the ends. The needle assembly <NUM> also includes a hub <NUM> with a proximal end <NUM>, a distal end <NUM>, and a passage <NUM> extending between the ends. The proximal end <NUM> of the cannula <NUM> is mounted in the passage <NUM> of the hub <NUM> so that the lumen <NUM> through the cannula <NUM> communicates with the passage <NUM> through the hub <NUM>. A shield <NUM> may be provided for shielding the cannula pointed distal end <NUM> after use. The blood collection device <NUM> may also include a wingset <NUM> that projects transversely from the hub <NUM> or from the shield <NUM>. Wings <NUM> of the wingset <NUM> can be folded into face-to-face relationship with one another to define a handle that facilitates manipulation of the needle assembly <NUM>. The wings <NUM> can then be rotated away from one another and held against the skin of the patient.

Blood collection device <NUM> also includes a length of flexible plastic tubing <NUM>. The tubing <NUM> has a distal end <NUM> that is connected to the proximal end <NUM> of the hub <NUM> and communicates with the lumen <NUM> of the needle cannula <NUM>. The end of the plastic tube, i.e., a proximal end <NUM> of tubing <NUM>, remote from the needle cannula <NUM> may include a fitting or fixture <NUM> for connecting the needle cannula <NUM> to a blood collection tube or other receptacle. The specific construction of the fixture <NUM> will depend upon the characteristics of the receptacle to which the fixture is to be connected.

Phlebotomy procedures often employ evacuated tubes, such as the VACUTAINER® brand of evacuated tubes sold by Becton, Dickinson and Company, the assignee of the present invention. Evacuated tubes often are used with a tube holder <NUM> that has a proximal end <NUM>, a distal end <NUM>, and a tubular side wall <NUM> extending between the ends. The proximal end <NUM> of the holder <NUM> is widely open and is configured for slidably receiving the evacuated tube. The distal end <NUM> of the holder <NUM> typically includes an end wall with a mounting aperture. The tube holder <NUM> may be used with a non-patient needle assembly that has a non-patient hub configured for cooperation with the mounting aperture of the holder <NUM>. The non-patient needle assembly further includes a non-patient cannula extending proximally from the hub and into the tube holder <NUM>.

The blood collection device <NUM> may be used by mounting the fitting <NUM> at the proximal end <NUM> of the flexible plastic tubing <NUM> to the distal end of the hub of the non-patient needle assembly. The pointed distal end <NUM> of the cannula <NUM> is urged into a targeted blood vessel, such as a vein, by gripping of the wings <NUM> of the wingset <NUM> for manipulation of the cannula <NUM>. The wings <NUM> then may be folded into engagement with the skin of the patient and may be taped in position. An evacuated tube then is urged into the open proximal end <NUM> of the blood collection tube holder <NUM> so that the proximal end of the non-patient needle pierces the stopper of the evacuated tube. As a result, the blood vessel of the patient is placed in communication with the interior of the evacuated tube, and the pressure differential between the blood vessel and the evacuated tube will generate a flow of blood through the cannula <NUM>, through the passage <NUM> of the hub <NUM>, through the flexible tubing <NUM>, through the non-patient hub, and finally through the non-patient needle and into the evacuated tube.

In one embodiment, flow regulator system <NUM> (<FIG> and <FIG>) may be used with blood collection device <NUM> to regulate the flow rate of the blood between the blood vessel of the patient and the evacuated tube. For example, in one embodiment, flexible plastic tubing, such as tubing <NUM> shown in <FIG>, may be secured to tube holder sub-assembly <NUM> so that the tubing is in fluid communication with flow regulator system <NUM> via flow channel <NUM> of tube holder sub-assembly <NUM>. The other end of the tubing may be secured to a needle assembly, such as needle assembly <NUM> shown in <FIG>, which can be inserted in the vein of a patient for blood collection as described above. Additionally, an evacuated tube may be positioned into open proximal end <NUM> and into interior cavity <NUM> of tube holder <NUM> so that a proximal end of non-patient needle <NUM> pierces a stopper of the evacuated tube. As a result, the blood vessel or vein of the patient is placed in communication with the interior of the evacuated tube for a phlebotomy procedure. In this manner, a medical clinician or patient can perform a blood collection procedure in a standard manner using flow regulator system <NUM> to modulate the flow of blood coming from the vein of a patient by manually varying the effective length of an orifice or flow path, e.g., fluid flow path FFP. In another embodiment, flow regulator system <NUM> may be positioned directly on a tube holder, such as tube holder <NUM> as shown in <FIG>, with a patient needle extending from distal end <NUM> of tube holder <NUM>. In this manner, the tubing, e.g., tubing <NUM> (<FIG>), and the wingset, e.g., wingset <NUM> (<FIG>), may be eliminated.

In another embodiment, a flow regulator system <NUM> (<FIG>) may be used with blood collection device <NUM> (<FIG>). For example, flow regulator system <NUM> may be positioned between distal end <NUM> (<FIG>) and proximal end <NUM> (<FIG>) of tubing <NUM> to regulate the flow rate of the blood between the blood vessel of the patient and the evacuated tube as will be described in more detail below.

Referring to <FIG>, the use of flow regulator system <NUM> to adjustably alter a flow path will now be described. Flow regulator system <NUM> is capable of acting to slow down the initial flow rate of blood into an evacuated blood collection device as a result of the application of a strong vacuum pressure from the evacuated blood collection device on the patient's accessed vasculature. The flow regulator system <NUM> is responsive to the initial spike in vacuum pressure from the evacuated blood collection device and slows down the draw of blood in order to avoid rapid depletion of blood from the patient to prevent the collapse of the patient's blood vessel during blood collection. In the embodiment shown in <FIG>, the flow of blood coming from the vein of a patient is modulated by manually varying the effective length of the fluid flow path FFP of the regulator as shown in <FIG> and <FIG>.

Referring to <FIG>, with flow regulator system <NUM> in a maximum flow position, a minimum flow position, or any position therebetween, flow channel <NUM> (<FIG>) of tube holder sub-assembly <NUM> is aligned with a gasket flow aperture <NUM> of a first gasket 104b (<FIG>). Additionally, flow channel <NUM> (<FIG>) of tube holder sub-assembly <NUM> is aligned with a gasket flow aperture <NUM> of a second gasket 104a (<FIG>) and flow aperture <NUM> (<FIG>) of spine <NUM>. To adjustably alter a flow path using flow regulator system <NUM>, dial <NUM> is rotated relative to tube holder sub-assembly <NUM> and spine <NUM>, i.e., flow aperture <NUM> of dial <NUM> is rotated relative to flow channel <NUM> of tube holder sub-assembly <NUM> and flow aperture <NUM> of spine <NUM>.

Referring to <FIG> and <FIG>, flow regulator system <NUM> is shown in a maximum flow position. In this position, flow aperture <NUM> of dial <NUM> is aligned with flow channel <NUM> of tube holder sub-assembly <NUM> and flow aperture <NUM> of spine <NUM> as shown in <FIG> and <FIG>. In this manner, an effective flow distance is minimized and the flow of a fluid, such as blood, is not impeded.

Referring to <FIG>, the fluid flow path FFP of a fluid, such as blood, through flow regulator system <NUM> with system <NUM> in the maximum flow position will now be described. If the device is provided in the maximum flow position as shown in <FIG>, blood flows along the fluid flow path FFP from the vein of a patient to flow channel <NUM> of tube holder sub-assembly <NUM>. With system <NUM> in the maximum flow position (<FIG>) as described above, the blood then flows through flow channel <NUM> of tube holder sub-assembly <NUM> and out second opening <NUM> (<FIG> and <FIG>) of flow channel <NUM> to gasket flow aperture <NUM> of a first gasket 104b. The blood then flows directly through flow aperture <NUM> of dial <NUM> and gasket flow aperture <NUM> of a second gasket 104a to flow aperture <NUM> of spine <NUM> as shown by fluid flow path FFP in <FIG>. The blood will then flow between spine <NUM> and hub <NUM> along a bottom surface of spine connection portion <NUM> of hub <NUM> and through flow entrance aperture <NUM> (<FIG>) to flow collection channel <NUM> of hub <NUM> as shown in <FIG>. The blood may then travel through flow collection channel <NUM> of hub <NUM> to the lumen of needle <NUM> for collection in an evacuated tube secured to needle <NUM> as described above. In one embodiment, the bottom surface of spine connection portion <NUM> of hub <NUM> may include a concave surface or may be curved inward to facilitate the flow of blood through flow entrance aperture <NUM> to flow collection channel <NUM> of hub <NUM>.

In this manner, an effective flow distance that the blood travels is minimized, the flow of the blood is not impeded, and the flow rate of the blood is maximized. Accordingly, in the position shown in <FIG>, system <NUM> is in a maximum flow position. Referring to <FIG>, with system <NUM> in a minimum or reduced flow position, an effective flow distance that the blood travels is increased to impede the flow of the blood and reduce the flow rate of the blood as will be described below. The configuration of flow aperture <NUM> of dial <NUM> allows for the effective length of the fluid flow path FFP of the regulator (as shown in <FIG> and <FIG>) to be manually varied to modulate the flow of blood coming from the vein of a patient and through system <NUM>.

During blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, the medical clinician is part of the feedback loop and it is the medical clinician's judgment to determine an appropriate flow rate from a particular patient. The medical clinician would be able to set a position of dial <NUM> prior to blood collection and would then have the ability to manually adjust dial <NUM> to manipulate or vary the flow rate during blood collection. For example, referring to <FIG> and <FIG>, with flow regulator system <NUM> in a maximum flow position (<FIG>), the medical clinician may determine that the flow rate should be reduced. Accordingly, the clinician may rotate dial <NUM> in a direction generally along arrow C to the position shown in <FIG>. In this manner, the flow rate may be reduced as will now be described. Rotation of dial <NUM> to the position shown in <FIG> causes flow aperture <NUM> of dial <NUM> to move out of alignment with flow channel <NUM> of tube holder sub-assembly <NUM> and flow aperture <NUM> of spine <NUM> as shown in <FIG>. In this manner, an effective flow distance that the blood travels is increased and the flow of blood is impeded. Accordingly, the flow rate of the blood is reduced.

With system <NUM> in a minimum flow position as shown in <FIG>, flow aperture <NUM> of dial <NUM> is not in alignment with flow channel <NUM> of tube holder sub-assembly <NUM> and flow aperture <NUM> of spine <NUM>. The fluid flow path FFP of a fluid, such as blood, through flow regulator system <NUM> with system <NUM> in the minimum flow position will now be described. With the device in the minimum flow position as shown in <FIG>, blood flows along the fluid flow path FFP from the vein of a patient to flow channel <NUM> of tube holder sub-assembly <NUM>. With system <NUM> in the minimum flow position (<FIG>) as described above, the blood then flows through flow channel <NUM> of tube holder sub-assembly <NUM> and out second opening <NUM> (<FIG> and <FIG>) of flow channel <NUM> to gasket flow aperture <NUM> of a first gasket 104b. The blood then flows through gasket flow aperture <NUM> of the first gasket 104b to a portion of front flow channel <NUM> (<FIG>) of dial <NUM>. Front flow channel <NUM> provides a flow channel for the blood to travel along. The only passage that allows the blood to flow through center plate <NUM> of dial <NUM> to spine <NUM> is flow aperture <NUM> of dial <NUM>. Because flow aperture <NUM> of dial <NUM> is not in alignment with flow channel <NUM> of tube holder sub-assembly <NUM> in the minimum flow position, the blood must flow along front flow channel <NUM> as shown in <FIG> to flow aperture <NUM> of dial <NUM>. In this manner, the effective length of the fluid flow path FFP of the regulator is increased and the flow rate of the blood through flow regulator system <NUM> is reduced. The greater the distance that the blood must travel along front flow channel <NUM> of dial <NUM> to reach flow aperture <NUM>, the greater the reduction of the flow rate of the blood through flow regulator system <NUM>.

Once the blood travels to flow aperture <NUM>, the blood is then able to flow through flow aperture <NUM> of dial <NUM> and to back flow channel <NUM> (<FIG>) of dial <NUM>. Because flow aperture <NUM> of dial <NUM> is not in alignment with flow aperture <NUM> of spine <NUM> in the minimum flow position, the blood must flow along back flow channel <NUM> (<FIG>) of dial <NUM> as shown in <FIG> to reach flow aperture <NUM> of spine <NUM>. In this manner, the effective length of the fluid flow path FFP of the regulator is increased and the flow rate of the blood through flow regulator system <NUM> is reduced. The greater the distance that the blood must travel along back flow channel <NUM> of dial <NUM> to reach flow aperture <NUM> of spine <NUM>, the greater the reduction of the flow rate of the blood through flow regulator system <NUM>. Once the blood travels to flow aperture <NUM> of spine <NUM>, the blood flows from back flow channel <NUM> of dial <NUM> through gasket flow aperture <NUM> of a second gasket 104a to flow aperture <NUM> of spine <NUM> as shown in <FIG>. The blood will then flow between spine <NUM> and hub <NUM> along a bottom surface of spine connection portion <NUM> of hub <NUM> and through flow entrance aperture <NUM> (<FIG>) to flow collection channel <NUM> of hub <NUM> as shown in <FIG>. The blood may then travel through flow collection channel <NUM> of hub <NUM> to the lumen of needle <NUM> for collection in an evacuated tube secured to needle <NUM> as described above. In one embodiment, the bottom surface of spine connection portion <NUM> of hub <NUM> may include a concave surface or may be curved inward to facilitate the flow of blood through flow entrance aperture <NUM> to flow collection channel <NUM> of hub <NUM>.

In this manner, an effective flow distance that the blood travels is increased, the flow of the blood is impeded, and the flow rate of the blood is reduced. Accordingly, in the position shown in <FIG>, system <NUM> is in a minimum or reduced flow position.

As described above, during blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, the medical clinician may determine that the flow rate should be shut off. Accordingly, the clinician may rotate dial <NUM> in a direction generally along arrow C (<FIG>) to a shut off position. In the shut off position, no portion of back flow channel <NUM> of dial <NUM> is in alignment with aperture <NUM> of spine <NUM>. In this manner, the blood is not able to reach aperture <NUM> of spine <NUM> and thus the flow of blood is prevented from flowing to spine <NUM>.

As described above, during blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, from a shut off position or the minimum flow position of <FIG>, the medical clinician may determine that the flow rate should be turned back on or that the flow rate should be increased. Accordingly, referring to <FIG>, the clinician may rotate dial <NUM> in a direction generally along arrow D to increase the flow rate in the manner as described above. In this manner, system <NUM> allows the clinician to rotate dial <NUM> in the direction generally along either arrow C (<FIG>) or arrow D (<FIG>) to incrementally or linearly move system <NUM> from the position shown in <FIG> to the position shown in <FIG> and to all positions in between, or to a shut off position if desired. Dial <NUM> of system <NUM> allows for precise, incremental, or linear control of the flow rate of a fluid through system <NUM>.

In one procedure, initially a medical clinician will set a position of dial <NUM> so that flow regulator system <NUM> is in a reduced flow position with an effective flow distance that the blood travels is increased so that the flow rate of the blood is reduced to counteract the strong vacuum effect upon initial access of the evacuated tube. The medical clinician may then decrease the effective flow distance that the blood travels through flow regulator system <NUM>, i.e., the medical clinician may increase the flow rate of the blood through flow regulator system <NUM>, to allow better flow once initial draw is equalized.

<FIG> illustrate another exemplary embodiment of the present invention directed to a manual blood flow regulation device which regulates the flow of blood from the vein of a patient by manually varying the cross-sectional area of an orifice of the regulation device. Referring to <FIG>, a flow regulator system <NUM> includes a flow control dial <NUM>, a flow control insert <NUM>, a housing <NUM>, and an optional label or plate <NUM> with indicia.

Referring to <FIG>, <FIG>, <FIG>, and <FIG>, flow control dial <NUM> includes a head portion <NUM>, a body portion <NUM>, and an annular groove <NUM> defined therebetween. Head portion <NUM> of flow control dial <NUM> includes at one of the radial ends a finger flange <NUM> and at the other radial end a point portion <NUM>. Point portion <NUM> can be tapered to a point to form a pointer or indicator for pointing to a graduated scale disposed on a portion of system <NUM> or otherwise provided on the plate <NUM> to indicate the flow rate of a fluid through flow regulator system <NUM>. Referring to <FIG>, body portion <NUM> of flow control dial <NUM> includes a flow control portion <NUM> which defines an open flow recess <NUM> and includes a helical profile or tapered groove <NUM> which extends from a maximum width portion <NUM> (<FIG> and <FIG>) to a minimum width portion <NUM> (<FIG> and <FIG>) and terminates in an aperture blocking portion <NUM>. Flow control portion <NUM> also defines a cavity <NUM> at a bottom end thereof which includes a protruding member <NUM> for securement to flow control insert <NUM> as will be described in detail later. Flow control portion <NUM> provides a means for manually varying the open cross-sectional area of a flow orifice <NUM> of housing <NUM> as will be described in more detail below. In one embodiment, open flow recess <NUM> of flow control dial <NUM> is sized relative to flow orifice <NUM> of housing <NUM> so that with open flow recess <NUM> in alignment with flow orifice <NUM> of housing <NUM>, no portion of flow orifice <NUM> is covered or blocked by flow control portion <NUM> of flow control dial <NUM>.

Referring to <FIG> and <FIG>, flow control insert <NUM> includes a body <NUM>, an annular protrusion <NUM> extending around a periphery of body <NUM>, an inlet fluid channel <NUM> defined at a first end of body <NUM> and an opposing outlet fluid channel <NUM> defined at an opposite end of body <NUM>, and a center bore <NUM> defined in body <NUM> at a top end. In one embodiment, inlet fluid channel <NUM> is disposed one-hundred eighty (<NUM>) degrees from outlet fluid channel <NUM>. In other embodiments, inlet fluid channel <NUM> may be disposed any number of degrees from outlet fluid channel <NUM>. Fluid channels <NUM>, <NUM> of flow control insert <NUM> define a part of flow path FP (<FIG>, <FIG>, <FIG>, <FIG>, and <FIG>) as will be described in more detail below. Center bore <NUM> of flow control insert <NUM> is sized to accept protruding member <NUM> of flow control dial <NUM> such that a fluid, e.g., blood, can flow from an inlet duct <NUM> to an outlet duct <NUM> of housing <NUM> via flow control dial <NUM> and flow control insert <NUM> as will be described in more detail below.

Referring to <FIG>, <FIG>, <FIG> and <FIG>, housing <NUM> includes a continuous exterior sidewall <NUM> which defines an interior cavity <NUM> therein. Inlet duct <NUM> and outlet duct <NUM> extend from respective opposing ends of sidewall <NUM> of housing <NUM> and are in fluid communication to one another via interior cavity <NUM> of housing <NUM>. Inlet duct <NUM> is in fluid communication with interior cavity <NUM> of housing <NUM> via an inlet port <NUM>. Additionally, outlet duct <NUM> is in fluid communication with interior cavity <NUM> of housing <NUM> via outlet port or flow orifice <NUM>. In one embodiment, outlet duct <NUM> is in fluid communication with interior cavity <NUM> of housing <NUM> via flow orifice <NUM> and a slot <NUM>. Slot <NUM> is located below flow orifice <NUM> and is disposed within the interior surface of a portion of sidewall <NUM> of housing <NUM>. At an upper end of housing <NUM>, an upper plate <NUM> extends from sidewall <NUM> around a periphery of sidewall <NUM>. Upper plate <NUM> includes a lip <NUM> thereby forming a receiving portion to receive label <NUM> which may contain indicia to indicate a graduated scale indicating the flow rate of a fluid through flow regulator system <NUM> as will be described in more detail below. The uppermost portion of housing <NUM> further includes a plurality of upper walls <NUM> having slots <NUM> defined between adjacent upper walls <NUM>. The plurality of upper walls <NUM> together define a center bore <NUM>. An annular protrusion <NUM> extends from the interior surface of upper walls <NUM> and into bore <NUM>.

Flow control insert <NUM> may be inserted into center bore <NUM> of housing <NUM>. The outside diameter or annular protrusion <NUM> of flow control insert <NUM> is sized relative to the interior surface of sidewall <NUM> of housing <NUM> so that flow control insert <NUM> is secured within housing <NUM> by a sliding fit. In one embodiment, a lubricant may be disposed between flow control insert <NUM> and the interior surface of sidewall <NUM> of housing <NUM> to create a fluid seal between flow control insert <NUM> and housing <NUM>. Upper walls <NUM> of housing <NUM> include slots <NUM> respectively therebetween to allow the upper portion of housing <NUM> to slightly deform so that flow control insert <NUM> can be inserted within housing <NUM> as shown in <FIG>. Next, flow control dial <NUM> can be inserted within center bore <NUM> of housing <NUM> such that protruding member <NUM> is received within center bore <NUM> of flow control insert <NUM> as shown in <FIG>. The engagement between protruding member <NUM> of flow control dial <NUM> within center bore <NUM> of flow control insert <NUM> allows flow control dial <NUM> to be rotatable relative to flow control insert <NUM> and housing <NUM>, and also allows a fluid, such as blood, to flow between flow control dial <NUM> and flow control insert <NUM> as will be described in more detail below.

As described above with respect to flow control insert <NUM> and housing <NUM>, upper walls <NUM> of housing <NUM> include slots <NUM> respectively therebetween to allow the upper portion of housing <NUM> to slightly deform so that flow control dial <NUM> can be inserted within housing <NUM>. Referring to <FIG>, <FIG>, and <FIG>, flow control dial <NUM> is inserted in housing <NUM> such that body portion <NUM> of flow control dial <NUM> is located past annular protrusion <NUM> of upper walls <NUM> of housing <NUM> and annular protrusion <NUM> of housing <NUM> occupies annular groove <NUM> of flow control dial <NUM> as shown in <FIG>. In this manner, flow control dial <NUM> is secured within housing <NUM>, i.e., flow control dial <NUM> cannot be unintentionally displaced from housing <NUM>, and flow control dial <NUM> may be rotatable relative to housing <NUM> and flow control insert <NUM>, as will be described below.

Referring to <FIG>, the use of flow regulator system <NUM> to adjustably alter a flow path will now be described. Flow regulator system <NUM> is capable of acting to slow down the initial flow rate of blood into an evacuated blood collection device as a result of the application of a strong vacuum pressure from the evacuated blood collection device on the patient's accessed vasculature. The flow regulator system <NUM> is responsive to the initial spike in vacuum pressure from the evacuated blood collection device and slows down the draw of blood in order to avoid rapid depletion of blood from the patient to prevent the collapse of the patient's blood vessel during blood collection. In the embodiment shown in <FIG>, the flow of blood coming from the vein of a patient is modulated by manually varying the effective cross-sectional area of an orifice of the regulation device, e.g., flow orifice <NUM> of housing <NUM>.

Referring to <FIG>, flow regulator system <NUM> is shown in a maximum flow or fully open position. In this position, flow recess <NUM> (<FIG>) of flow control dial <NUM> is aligned with flow orifice <NUM> (<FIG>) of housing <NUM> as shown in <FIG>. Referring to <FIG>, in one embodiment, plate <NUM> includes a scale of indicia thereon to indicate to a user the flow rate of a fluid flowing through flow regulator system <NUM>. For example, label <NUM> may include indicia indicating the flow rate of a fluid through system <NUM> in milliliters per hour (mL/hr). Point portion <NUM> of flow control dial <NUM> may be tapered to form a point so that point portion <NUM> points to particular indicia on label <NUM> to indicate a current flow rate through system <NUM>. Referring to <FIG>, <FIG>, in one embodiment, point portion <NUM> is configured relative to open flow recess <NUM> of flow control dial <NUM> so that with flow recess <NUM> of flow control dial <NUM> aligned with flow orifice <NUM> of housing <NUM>, point portion <NUM> of flow control dial <NUM> is indicated at a first position (<FIG>) and system <NUM> is in a maximum flow position. In such an embodiment, point portion <NUM> of flow control dial <NUM> points to indicia that indicates system <NUM> is at a maximum flow position. Referring to <FIG>, in such an embodiment, point portion <NUM> is also configured relative to aperture blocking portion <NUM> (<FIG>) of flow control dial <NUM> so that with aperture blocking portion <NUM> of flow control dial <NUM> aligned with flow orifice <NUM> (<FIG>) of housing <NUM>, point portion <NUM> of flow control dial <NUM> is indicated at a second position (<FIG>) and system <NUM> is in a fully closed or reduced flow position. In such an embodiment, point portion <NUM> of flow control dial <NUM> points to indicia that indicates system <NUM> is at a reduced flow or off position.

In one embodiment, flow regulator system <NUM> (<FIG>) may be used with blood collection device <NUM> (<FIG>). For example, flow regulator system <NUM> may be positioned between distal end <NUM> (<FIG>) and proximal end <NUM> (<FIG>) of tubing <NUM> to regulate the flow rate of the blood between the blood vessel of the patient and the evacuated tube. In one embodiment, flexible plastic tubing, such as tubing <NUM> shown in <FIG>, may be secured to inlet duct <NUM> and outlet duct <NUM> of housing <NUM>, respectively, so that the tubing secured to inlet duct <NUM> and the tubing secured to outlet duct <NUM> are in fluid communication together via system <NUM>. The other end of the tubing secured to inlet duct <NUM> may be securable to a needle assembly which can be inserted in the vein of a patient for blood collection. Additionally, the other end of the tubing secured to outlet duct <NUM> may be securable to a tube holder and an evacuated tube for a phlebotomy procedure. In this manner, a medical clinician or patient can perform a blood collection procedure in a standard manner using system <NUM> to modulate the flow of blood coming from the vein of a patient by manually varying the cross-sectional area of flow orifice <NUM> of housing <NUM>.

Referring to <FIG>, the flow path FP of a fluid, such as blood, through flow regulator system <NUM> with system <NUM> in a maximum flow or fully open position will now be described. If the device is provided in the maximum flow position as shown in <FIG>, blood flows along the flow path FP from the vein of a patient to inlet duct <NUM> of housing <NUM>. The blood may then travel through inlet duct <NUM> and past inlet port <NUM> into interior cavity <NUM> (<FIG>) of housing <NUM> adjacent the bottom portion of body <NUM> of flow control insert <NUM>. The blood may then travel up flow control insert <NUM> by flowing within inlet fluid channel <NUM> of insert <NUM> and past annular protrusion <NUM> of insert <NUM>. The blood may then travel within the gap between the top surface of body <NUM> of flow control insert <NUM> and the top surface of cavity <NUM> (<FIG>) of flow control dial <NUM>. The blood may then travel down flow control insert <NUM> by flowing within outlet fluid channel <NUM> of insert <NUM>. As the blood travels down flow control insert <NUM> by flowing within outlet fluid channel <NUM> of insert <NUM>, the blood may also flow along annular protrusion <NUM> of insert <NUM> within the track of tapered groove <NUM> of flow control dial <NUM> and then the blood may travel through open flow recess <NUM> of flow control dial <NUM> and out flow orifice <NUM> of housing <NUM>.

Additionally, with the device provided in the position shown in <FIG>, blood may flow along a second flow path FP2. The flow path that the blood may take through flow regulator system <NUM> depends on the rotational position of flow control insert <NUM> relative to housing <NUM>. Blood may flow along flow path FP2 from the vein of a patient through inlet duct <NUM> and past inlet port <NUM> into interior cavity <NUM> of housing <NUM> adjacent the bottom portion of body <NUM> of flow control insert <NUM>. The blood may then travel up flow control insert <NUM> by flowing within inlet fluid channel <NUM> of insert <NUM> and past annular protrusion <NUM> of insert <NUM>. The blood may then travel along annular protrusion <NUM> of insert <NUM>, within the track of tapered groove <NUM> of flow control dial <NUM>, and then the blood may travel through open flow recess <NUM> of flow control dial <NUM> and out flow orifice <NUM> of housing <NUM>.

Once the blood has traveled through flow orifice <NUM>, the blood travels through outlet duct <NUM> and to the tubing secured to outlet duct <NUM> and to an evacuated tube, for example, for collection. With flow recess <NUM> of dial <NUM> aligned with flow orifice <NUM> of housing <NUM>, the blood is allowed to flow through flow orifice <NUM>. In the maximum flow position, in one embodiment, the entirety of flow recess <NUM> is aligned with flow orifice <NUM> and thus the greatest cross-sectional area of flow orifice <NUM> is available to allow blood to flow past. As will be described below, the configuration of flow recess <NUM>, tapered groove <NUM>, and blocking portion <NUM> (<FIG>) of flow control dial <NUM> allows for the cross-sectional area of flow orifice <NUM> to be manually varied to modulate the flow of blood coming from the vein of a patient and through system <NUM>.

During blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, the medical clinician is part of the feedback loop and it is the medical clinician's judgment to determine an appropriate flow rate from a particular patient. The medical clinician would be able to set the flow control dial <NUM> of system <NUM> prior to blood collection and would then have the ability to manually adjust flow control dial <NUM> to manipulate or vary the flow rate during blood collection. For example, referring to <FIG> with flow regulator system <NUM> in a maximum flow position, the medical clinician may determine that the flow rate should be reduced. Accordingly, the clinician may rotate flow control dial <NUM> in a direction generally along arrow A to the position shown in <FIG>. In this manner, the flow rate is reduced as will now be described. Rotation of flow control dial <NUM> to the position shown in <FIG> causes open flow recess <NUM> (<FIG>) of flow control dial <NUM> to rotate in the direction generally along arrow A so that open flow recess <NUM> is no longer in alignment with flow orifice <NUM> of housing <NUM>. In the position of <FIG>, the portion of tapered groove <NUM> adjacent open flow recess <NUM> of flow control dial <NUM>, i.e., maximum width portion <NUM> (<FIG>) of tapered groove <NUM>, is aligned with flow orifice <NUM> of housing <NUM> as shown in <FIG>.

Referring to <FIG>, the flow path FP of a fluid, such as blood, through flow regulator system <NUM> with system <NUM> in the partially open flow position shown in <FIG> will now be described. In the flow position as shown in <FIG>, as the medical clinician or patient performs blood collection, blood flows along the flow path FP from the vein of a patient through the tubing secured to inlet duct <NUM> and to inlet duct <NUM> of housing <NUM>. Next, as described above, the blood travels through inlet duct <NUM> and past inlet port <NUM> into interior cavity <NUM> (<FIG>) of housing <NUM> adjacent the bottom portion of body <NUM> of flow control insert <NUM>. Next, as described above, the blood travels up flow control insert <NUM> by flowing within inlet fluid channel <NUM> of insert <NUM> and past annular protrusion <NUM> of insert <NUM>. Next, as described above, the blood travels within the gap between the top surface of body <NUM> of flow control insert <NUM> and the top surface of cavity <NUM> (<FIG>) of flow control dial <NUM>. Next, as described above, the blood travels down flow control insert <NUM> by flowing within outlet fluid channel <NUM> of insert <NUM>. As the blood travels down flow control insert <NUM> by flowing within outlet fluid channel <NUM> of insert <NUM>, the blood may also flow along annular protrusion <NUM> of insert <NUM> within the track of tapered groove <NUM> of flow control dial <NUM> and then the blood may be forced through slot <NUM> of housing <NUM>. In this manner, the blood is forced to step through slot <NUM> before flowing out flow orifice <NUM> of housing <NUM>. In one embodiment, the effective cross-sectional area of slot <NUM> is determined by slot <NUM> and the helical shoulder of flow control dial <NUM>. As described above, once the blood has traveled through flow orifice <NUM>, the blood travels through outlet duct <NUM> and to the tubing secured to outlet duct <NUM> and to an evacuated tube, for example, for collection.

Additionally, with the device provided in the position shown in <FIG>, blood may flow along a second flow path FP2. The flow path that the blood may take through flow regulator system <NUM> depends on the rotational position of flow control insert <NUM> relative to housing <NUM>. Blood may flow along flow path FP2 from the vein of a patient through inlet duct <NUM> and past inlet port <NUM> into interior cavity <NUM> of housing <NUM> adjacent the bottom portion of body <NUM> of flow control insert <NUM>. The blood may then travel up flow control insert <NUM> by flowing within inlet fluid channel <NUM> of insert <NUM> and past annular protrusion <NUM> of insert <NUM>. The blood may then travel along annular protrusion <NUM> of insert <NUM>, within the track of tapered groove <NUM> of flow control dial <NUM>, and then the blood may be forced through slot <NUM> of housing <NUM>. In this manner, the blood is forced to step through slot <NUM> before flowing out flow orifice <NUM> of housing <NUM>.

As described above, during blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, the medical clinician may determine that the flow rate should be reduced even farther below the flow rate with the system in the position of <FIG>. Accordingly, the clinician may rotate flow control dial <NUM> in a direction generally along arrow A to the position shown in <FIG>. In this manner, the flow rate is reduced to a level below the flow rate with the system in the position of <FIG> as will now be described. <FIG> illustrate flow control dial <NUM> in an exemplary position and it is contemplated that flow control dial <NUM> may be rotated to any of a plurality of positions relative to housing <NUM>. In this manner, flow regulator system <NUM> allows for precise control of the flow rate of a fluid through system <NUM>.

Rotation of flow control dial <NUM> to the position shown in <FIG> causes the effective cross-sectional area of slot <NUM>, which is determined by slot <NUM> and the helical shoulder of flow control dial <NUM>, to be reduced. In this manner, the blood is forced to step through slot <NUM> before flowing out flow orifice <NUM> of housing <NUM>. Because the effective cross-sectional area of slot <NUM> is reduced with flow control dial <NUM> in the position shown in <FIG>, the flow rate of a fluid through system <NUM> is reduced to a level below the flow rate of a fluid with the system <NUM> in the position shown in <FIG>. In other words, with system <NUM> in the partially open flow position shown in <FIG>, the flow path FP of a fluid, such as blood, through flow regulator system <NUM> is the same as described above except that the blood is forced to step through slot <NUM> having a reduced effective cross-sectional area which thereby reduces the flow rate of the fluid within system <NUM>.

In one procedure, initially a medical clinician will set a position of flow control dial <NUM> so that flow regulator system <NUM> is in a reduced flow position, as will be described in more detail below, so that the flow rate of the blood is reduced to counteract the strong vacuum effect upon initial access of the evacuated tube. The medical clinician may then increase the flow rate of the blood through flow regulator system <NUM> to allow better flow once initial draw is equalized.

In the manner described above for system <NUM>, rotation of flow control dial <NUM> in a direction generally along arrow A from the maximum flow position (<FIG>) allows the flow rate to be modulated.

In some embodiments, system <NUM> may allow for precise, incremental control of the flow rate of a fluid, such as blood, through system <NUM>. In other embodiments, profile <NUM> may include a stepped or other configuration to allow for incremental adjustment of system <NUM>.

As described above, during blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, the medical clinician may determine that the flow rate should be shut off. Accordingly, the clinician may rotate flow control dial <NUM> in a direction generally along arrow A (<FIG>) to the position shown in <FIG> illustrate flow control dial <NUM> in an exemplary position and it is contemplated that flow control dial <NUM> may be located in other positions, and system <NUM> configured accordingly, and the system <NUM> may be in a fully closed position.

Rotation of flow control dial <NUM> to the position shown in <FIG> causes aperture blocking portion <NUM> of flow control dial <NUM> to rotate in the direction generally along arrow A (<FIG>) such that aperture blocking portion <NUM> is placed in alignment with flow orifice <NUM> of housing <NUM> as shown in <FIG>. In the position of <FIG>, aperture blocking portion <NUM> provides a physical barrier that blocks the entirety of flow orifice <NUM> of housing <NUM> and thus prevents any blood from flowing past flow orifice <NUM>.

As described above, during blood collection, system <NUM> allows a medical clinician to manually vary the flow of blood from the vein of a patient and through system <NUM> based on the condition of the patient. For example, from the fully closed position of <FIG>, the medical clinician may determine that the flow rate should be turned back on. Accordingly, referring to <FIG>, the clinician may rotate flow control dial <NUM> in a direction generally along arrow B to open flow orifice <NUM> in the manner as described above. In this manner, the clinician may rotate flow control dial <NUM> in the direction generally along arrow B (<FIG>) to incrementally or linearly move system <NUM> from the position shown in <FIG> to the position shown in <FIG> (maximum flow position) and to all positions in between. Similarly, with system <NUM> in the maximum flow position, the clinician may rotate flow control dial <NUM> in the direction generally along arrow A (<FIG>) to incrementally or linearly move system <NUM> from the position shown in <FIG> to the position shown in <FIG> and to all positions in between. As described above, flow regulator system <NUM> allows for precise, incremental, or linear control of the flow rate of a fluid through system <NUM>.

In one embodiment, a protrusion (not shown) may be disposed on the interior wall of interior cavity <NUM> of housing <NUM> to form a rotation limiting abutment member for preventing rotation of dial <NUM> beyond the maximum flow position or the fully closed position. In such embodiments, a portion of dial <NUM> may protrude out from body portion <NUM> or extend beyond a bottom surface of flow control portion <NUM> so that a portion of dial <NUM> may engage the protrusion disposed on the interior wall of interior cavity <NUM> of housing <NUM>. In this manner, system <NUM> is configured so that once dial <NUM> reaches either the maximum flow position or the fully closed position, a portion of dial <NUM> engages the protrusion of interior cavity <NUM> of housing <NUM> to prevent movement beyond the maximum flow position or the fully closed position.

<FIG> and <FIG> illustrate another exemplary embodiment of the present invention. The embodiment illustrated in <FIG> and <FIG> includes similar components to the embodiment illustrated in <FIG>, and the similar components are denoted by a reference number followed by the letter A. For the sake of brevity, these similar components and the similar steps of using flow regulator system 300A (<FIG> and <FIG>) will not all be discussed in conjunction with the embodiment illustrated in <FIG> and <FIG>.

Referring to <FIG> and <FIG>, flow regulator system 300A, having a flow control insert 304A and plate 308A, is used to adjustably alter a flow path in a manner similar to the embodiment shown in <FIG>, e.g., the flow of blood coming from the vein of a patient is modulated by manually varying the cross-sectional area of an orifice. In one embodiment, flow regulator system 300A may provide a system that has a smaller and more ergonomic design than the embodiment shown in <FIG>. Flow regulator system 300A may also include finger plates <NUM> disposed on opposing sides of housing 306A. In this manner, a user is provided with a place to more easily hold housing 306A while rotating flow control dial 302A in a direction generally along arrow B (<FIG>) to open a flow orifice as described above.

Claim 1:
A specimen collection assembly comprising:
a cannula (<NUM>), defining a lumen (<NUM>) therein;
a hub (<NUM>) at least partially supporting the cannula (<NUM>) and defining a collection channel (<NUM>) therein, the collection channel adapted for fluid communication with an interior of an evacuated collection container; and
flow control means (<NUM>, <NUM>) engaged with the hub, characterized in that the flow control means being rotatable with respect to the hub and the evacuated collection container to alter a flow path between the lumen of the cannula (<NUM>) and the interior of the evacuated collection container and/or the collection channel (<NUM>) of the hub (<NUM>).