Patent Description:
Bleeding disorders, and particularly congenital or acquired deficiencies in coagulation factors, are typically treated by factor replacement. Congenital coagulation disorders include hemophilia, a recessive X-linked disorder involving a deficiency of coagulation Factor VIII (hemophilia A) or Factor IX (hemophilia B), and von Willebrand's disease, a rare bleeding disorder involving a severe deficiency of von Willebrand Factor. Hemophilia C is a milder form of hemophilia caused by a deficiency in Factor XI. It is usually asymptomatic, but factor replacement therapy may be required during surgery. Acquired coagulation disorders may arise in individuals without a previous history of bleeding as a result of a disease process. For example, acquired coagulation disorders may be caused by inhibitors or autoimmunity against blood coagulation factors, such as Factor VIII, von Willebrand Factor, Factors IX, V, XI, XII and XIII; or by hemostatic disorders such as caused by liver disease, which may be associated with decreased synthesis of coagulation factors. Conventional therapy for hemophilia A and Factor VIII inhibitor patients is accomplished by therapeutics like recombinant Factor VIII (rFVIII) or procoagulant bypassing agents, for example FEIBA or recombinant Factor Vila. Conventional therapy for von Willebrand's disease is accomplished by therapeutics like recombinant von Willebrand Factor (rVWF).

Some intravenous biologic treatments require administration of multiple consecutive syringes to achieve a desired dose or therapeutic regimen. This could occur <NUM>) because of high fluid volume, <NUM>) when a biologic's properties are negatively impacted by pooling into a single syringe, or <NUM>) when multiple biologic products must be co-administered without pooling into a single syringe.

With increasing frequency, self-administration of biologics in a home setting is preferred over administration by healthcare professionals in a clinical setting. Empowering patients is both cost-effective and reduces overall impact to patient lives. However, the unique case of intravenous administration of multiple syringes presents an ergonomic challenge for patients that self-administer. Once an infusion needle is inserted into a peripheral vein, for example into the hand, performing tasks with that hand becomes difficult. Continued use of that hand may cause significant discomfort or cause the needle to slip out of position.

For example, a single therapy session for von Willebrand's disease typically requires multiple syringes, each filled with the pharmaceutical composition comprising rVWF to be delivered to the patient. For patients who self-administer their therapeutic doses, recharging the syringe or swapping out a syringe attached to the infusion set during therapy can be difficult because the needle or cannula is inserted into the patient's arm, thus limiting the use of that arm during therapy. In <CIT>, there is described a universal catheter stabilization system including a medical article integrated with a securement device. The medical article can comprise one or more of a male luer adapter, a female luer adapter, an integrated extension set, and an integrated mechanical valve. In <CIT>, there is described a female tube connector defining a tapered socket having an open inner end communicating with the lumen of a tube, and a sealing cap proportioned to close the connector and to seal the tapered socket. In <CIT>, there are described ergonomic syringe systems providing attachments that may be used to allow users to dispense or draw in fluid.

Systems and methods for administration of therapeutic fluid are provided. Certain of the systems and methods described herein permit a single user to intravenously administer therapeutic fluid to himself/herself. The subject matter of the present invention involves, in some cases, interrelated products, alternative solutions to particular problem, and/or a plurality of different uses of one or more systems and/or articles.

According to one aspect, a syringe stabilizing apparatus is provided. The syringe stabilizing apparatus includes a base and a syringe support. The syringe support is vertically disposed above the base, elevating a fluid-filled portion of an infusion set vertically above the base and orienting a delivery end of the fluid-filled portion upwardly relative to a horizontal plane to take advantage of a gravitational effect on a fluid during delivery of the fluid from the fluid- filled portion to a patient. The syringe support includes a first retainer and a selectively actuated tube clamp. A rigid portion of the infusion set is received and retained within an opening in the first retainer without further user intervention. In some embodiments, the selectively actuated tube clamp is operatively aligned with the first retainer wherein a flexible tube extending from the rigid portion of the infusion set extends through the tube clamp. A user's first arm is used to release the selectively actuated tube clamp to allow a flow of the fluid from the delivery end of the fluid-filled portion, while a user's second arm remains substantially motionless and provides a stabilizing force against the base as the user receives the flow of fluid into the second arm.

In some embodiments, the first retainer is a longitudinal slot in an upper surface of the syringe support which frictionally engages the rigid portion of the infusion set with a resistant force sufficient to secure a syringe barrel joined to the rigid portion of the infusion set as a plunger disposed within the barrel is forced downwardly towards the delivery end. The syringe support may include a transverse slot intersecting the longitudinal slot so that the tube clamp resides within and is slidable within the transverse slot. The tube clamp may include a tube receiver having an opening alignable with the longitudinal slot and a clamping section generally transverse to the longitudinal slot. The clamping section may have a cross-sectional area configured for pinching a flexible tube of the infusion set as the tube clamp is slid within the longitudinal slot in a direction transverse to the longitudinal slot. A cross-sectional area of the clamping section may be less than a cross-sectional area of the tube receiver. The transverse slot may have a concave recess extending in a direction parallel to a length of the transverse slot and wherein the tube clamp has a convex keeper snap fit within the recess and traversable in the slot during actuation of clamping and releasing of the flexible tube within the tube clamp. The longitudinal slot may have a first segment having a first transverse cross-sectional area configured for receiving and retaining the rigid portion of the infusion set and a second segment having a second transverse cross-sectional area configured to receive and retain the flexible tube.

In some embodiments, the transverse slot may intersect the second segment of the longitudinal slot. The base may be portable and may include an ergonomic handset such that the user stabilizes the syringe stabilizing apparatus against a work surface with the second hand by engaging the ergonomic handset.

In some embodiments, the ergonomic handset may be located on an upper surface of the base having a surface area greater than a surface area of an upper surface of the syringe support. The base may have an engagement surface sized and shaped to be supported by a generally planar work surface on which the user's second arm rests. To simplify production, the syringe support is integrally joined with the base by a vertically oriented stem. The syringe support may further include an upper surface having a longitudinal slot therein configured to accept a portion of an infusion set and retain the portion of the infusion set.

In some embodiments, a syringe barrel of the infusion set is oriented at an angle above a horizontal axis such that a delivery end of the syringe barrel is vertically offset below a syringe plunger and the syringe barrel is retained in an elevated position relative to the base. The angle may be greater than <NUM> degrees and less than <NUM> degrees. Frictional engagement between the portion of the infusion set and the longitudinal slot is sufficient to maintain a position and an orientation of the syringe barrel as a plunger disposed within the barrel is forced downwardly towards the delivery end. The syringe stabilizing apparatus also includes a removable fitting receiver within the syringe support having slots configured to receiving and retaining portions of an infusion set fitting.

According to another aspect, a syringe stabilizing apparatus includes a portable base and a syringe support. The portable base has an engagement surface supporting the syringe stabilizer against a work surface and an ergonomic handset. Vertically disposed above the base, the syringe support includes a first channel, a second channel, and a selectively actuated tube clamp. In the first channel, a lengthwise opening is configured to accept a portion of an infusion set and retain the portion of the infusion set so that a syringe barrel of the infusion set is oriented at an angle above a horizontal axis. In this configuration, a delivery end of the syringe barrel is vertically offset below a syringe plunger and the syringe barrel is retained in an elevated position relative to the base. Furthermore, the referred angle is greater than <NUM> degrees and less than <NUM> degrees. Also, the second channel is transverse to and intersects the first channel, and the tube clamp is slidably disposed within the second channel. The tube clamp includes a tube receiver having an opening alignable with the first channel and a clamping section generally transverse to the first channel. A cross-sectional area of the clamping section is configured for pinching a flexible tube of the infusion set as the tube clamp is slid within the second channel in a direction transverse to the first channel.

In some embodiments, the tube clamp is releasable by a user's first arm to allow a flow of the fluid from the delivery end of the barrel of the syringe while the user's second arm remains substantially motionless. In addition, the stabilizer provides a stabilizing force against the ergonomic handset of the base as the user receives the flow of fluid into the second arm. The syringe support may be integrally joined with the base by a vertically oriented stem forming a single-piece, uni-body construction therewith. The syringe stabilizing may further comprise a removable fitting receiver within the syringe support having slots configured to receiving and retaining portions of an infusion set fitting therein.

According to yet another aspect, the present syringe stabilizing apparatus includes a base and a syringe support. The syringe support is vertically disposed above the base, elevating a fluid-filled portion of an infusion set vertically above the base and angling the fluid-filled portion upwardly at an angle less than <NUM> degrees relative to a horizontal plane to take advantage of a gravitational effect on a fluid during delivery of the fluid from the fluid- filled portion to a patient. The syringe support may include a first retainer and a selectively actuated tube clamp. An opening in the first retainer may receive and retain a rigid portion of the infusion set without further user intervention. The selectively actuated tube clamp may be operatively aligned with the first retainer so that a flexible tube extending from the rigid portion of the infusion set extends through the tube clamp. An arrangement of the base and syringe support respective positions may orient and retain the fluid-filled portion of the infusion set such that a patient who is self-administering a therapeutic fluid is able to manipulate the tube clamp and the fluid-filled portion with a first arm while receiving the therapeutic fluid into a second arm via the infusion set as the second arm remains substantially motionless and provides a stabilizing force against the base.

Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures.

Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures:.

Some aspects of the invention relate to the administration of therapeutic fluid. According to some aspects, an apparatus that allows a single user to intravenously administer therapeutic fluid to himself/herself is provided.

Described herein is a syringe stabilizer provided, in some embodiments, to solve the problems discussed above and other problems, and to provide advantages and aspects not provided by prior therapeutic delivery devices. A full discussion of the features and advantages of the present syringe stabilizer is deferred to the following detailed description, which proceeds with reference to the accompanying drawings.

Referring generally to the figures, syringe stabilizing apparatuses, or simply syringe stabilizers, <NUM> are illustrated. The syringe stabilizer <NUM> has a base <NUM> and a syringe support <NUM> vertically disposed above the base <NUM>, generally by a stem <NUM> or other structure suitable for attaining the desired position relative to a work surface as will be explained in more detail below. In one embodiment, the syringe support <NUM> is integrally joined with the base <NUM> by the vertically oriented stem or arm <NUM> forming a single-piece, uni-body, monolithic construction.

According to one aspect, in some embodiments, a general purpose of the syringe stabilizer <NUM> is to allow a patient or user to self- administer a fluid therapy or medicine through an infusion set while keeping a first arm relatively motionless or still while manipulating the medicine-carrying syringe using a second arm. In this way, the syringe stabilizers <NUM> may elevate, support, and orient a medicine-carrying vessel (i.e. a syringe) while also regulating medicine delivery therefrom. These syringe stabilizers <NUM> may be ergonomic, generally portable, and configured, as in sized, shaped, and structured, for tabletop use.

In some embodiments, the stem <NUM> sets the height of the syringe stabilizer <NUM>. The height of the syringe stabilizer is generally chosen to place a syringe at a comfortable user level where the user can actuate a plunger on the syringe while a needle or cannula from an infusion set is within an arm of the patient/user. In some embodiments, the height of the syringe stabilizer may between <NUM> inches and <NUM> inches (<NUM> to <NUM>).

In an embodiment illustrated in <FIG>, the base <NUM> has an upper surface <NUM> and an opposite lower surface <NUM>. In this embodiment, the base <NUM> has an oval shape, which may be an ovate oval shape, and further may be a broad ovate shape as illustrated. This base <NUM> shape has a length greater than a width to provide stability, and the broad ovate shape shown in <FIG> has a major axis and a minor axis which intersect approximately at the stem <NUM>.

The lower surface <NUM> has a ring <NUM> within a seat <NUM>. The ring <NUM> may be produced from a softer elastic material which increases friction between the base <NUM> and a work surface upon which the base <NUM> is supported. The ring may be secured to the base by friction or mechanical fit, adhesive bonding, welding, or multi-shot molding. Thus, the ring <NUM> may provide an engagement surface against the work surface, which is generally planar and horizontally oriented so that a user may rest his/her arm thereon.

In some embodiments, the upper surface <NUM> may have an ergonomic feature or handset <NUM>. This ergonomic feature <NUM> is located such that a user can brace, support, or steady the syringe stabilizer <NUM> during use. The ergonomic feature <NUM> illustrated in <FIG> is provided by the ovate shape of the base <NUM>. The ovate shape naturally expands the surface area of the upper surface <NUM> along the major axis forming a duckbill or tongue which is easily accessed by a user's hand or arm to provide a force against the upper surface <NUM> to brace the syringe stabilizer against unwanted or undesirable movement during use. Here, the upper surface <NUM> of the base <NUM> has a surface area greater than a surface area of an upper surface of syringe support <NUM>.

In other embodiments, which are illustrated in <FIG>, the ergonomic feature or handset is one or more finger receivers, such as finger rings <NUM>.

The syringe support <NUM> according to the embodiments illustrated in <FIG> is structurally configured to maintain an infusion set <NUM> in a desired position throughout a therapeutic delivery of the fluid to a user or patient. This includes retaining a syringe <NUM> while the user actuates a plunger <NUM> to force fluid from the syringe barrel through tubing <NUM> and into the user via a cannula or needle <NUM>.

As shown in <FIG> and <FIG>, the syringe support <NUM> may orient the syringe <NUM> at an angle such that a delivery end <NUM> of the syringe <NUM> is positioned at a vertical height above the base <NUM> that is lower than a vertical height above the base of an opposing end <NUM> through which the plunger <NUM> is inserted. This positioning takes advantage of gravitational effect while placing the plunger <NUM> in a location and position that is advantageous for the user in accessing and actuating the plunger <NUM> in terms of comfort and ease of use, ergonomically speaking.

In some embodiments, the syringe support <NUM> has a retainer such as a first channel in which a rigid portion of the infusion set <NUM> is received. The first channel is configured to accept and retain this rigid portion of the infusion set <NUM>, generally the delivery end <NUM> of the syringe <NUM> or a fitting, by frictional engagement, such as a snap fit arrangement. The first channel's configuration may orient a syringe barrel <NUM> of the infusion set <NUM> at an angle above a horizontal axis such that the delivery end <NUM> of the syringe <NUM> is vertically offset below the syringe plunger <NUM>, and the syringe barrel <NUM> is retained in an elevated position relative to the base <NUM> wherein the angle a is greater than <NUM> degrees and less than <NUM> degrees, in some embodiments between <NUM> degrees and <NUM> degrees, and in some embodiments about <NUM> degrees.

As illustrated in <FIG>, in some embodiments, the first channel is a longitudinal first slot <NUM> in an upper surface <NUM> of the syringe support <NUM>. Accordingly, the first slot <NUM> has a lengthwise opening configured to accept a portion of an infusion set, typically a narrow extension of a fitting <NUM>, such as a tube connector, attached to the syringe barrel <NUM> such as a Luer-type fitting. The first slot <NUM> may be tapered such that its shape is complementary to a shape of the narrow extension of the fitting. In one embodiment, the first slot <NUM> has a first segment having a first transverse cross-sectional area configured to receive and retain the rigid portion of the infusion set <NUM> therein and a second segment having a second transverse cross- sectional area configured to receive and retain the flexible tube <NUM> therein.

As illustrated, for example in <FIG>, in some embodiments, a fitting receiver <NUM> may be located within the first channel or in communication therewith to further retain the syringe <NUM> within the syringe support <NUM>. The fitting receiver <NUM> is configured, as in sized and shaped, to receive portions of the fitting. For example, the fitting receiver <NUM> illustrated has opposing slots <NUM> separated by a center arcuate section <NUM>. This arrangement of the fitting receiver <NUM> complements a winged fitting <NUM> wherein opposing wings located on the fitting <NUM> can be inserted within the slots <NUM> while an arcuate center segment of the fitting <NUM> is received within the arcuate section <NUM> of the fitting receiver <NUM>. This fitting receiver <NUM> may be provided as a removable insert which is snap-fit within the syringe support <NUM> wherein the fitting receiver <NUM> may be swapped out with a different fitting receiver <NUM> to accept structurally diverse infusion set fittings <NUM>. For example, the slots <NUM> and arcuate section <NUM> of the fitting receiver <NUM> can be configured, as in sized, oriented and shaped, to accept a particular infusion set fitting <NUM> (compare <FIG> and <FIG>).

As illustrated in <FIG>, in some embodiments, a raised flat abutment surface <NUM> at the front of the arcuate section <NUM> provides a visual queue to guide set assembly. The fitting <NUM> is inserted into the fitting receiver <NUM> until it abuts against this surface <NUM>. The abutment surface <NUM> may be marked in a contrasting color to make it more obvious to the user where and how deep they are instructed to fit the fitting <NUM>.

In some embodiments, the syringe support <NUM> also has a second channel transverse to and intersecting the first channel. In one embodiment, the second channel intersects the second segment of the first slot <NUM>. In some embodiments, a selectively actuated tube clamp <NUM> is disposed within the second channel and is slidable therein. In the embodiments illustrated in the figures, the second channel is a second slot <NUM>. The second slot <NUM> has a concave recess <NUM> in an upright side wall <NUM>. The recess <NUM> runs lengthwise within the second slot <NUM> such that it is transverse to the first slot <NUM> and spans the entire length of the second slot <NUM>, thus extending in a direction parallel to, or complementary with, a length of the second slot <NUM>.

In some embodiments, the tube clamp <NUM> is disposed within the second slot <NUM>. The tube clamp is illustrated individually in <FIG>. The tube clamp <NUM> has a tube receiver <NUM> which has an opening <NUM> that is alignable with the first slot <NUM> upon relative movement between the tube clamp <NUM> and the first slot <NUM>. The opening <NUM> is large enough to accept a length of a cross- section of a tube residing within the first slot <NUM>. The tube receiver <NUM> further has a clamping section <NUM> in communication with the opening <NUM> and generally transverse thereto.

The clamping section <NUM> has a slot-like structure having a cross-sectional area that is substantially less than a cross-sectional area of a flexible tubing <NUM> of the infusion set <NUM>. Here, the term "substantially" refers to the size of the cross-sectional area of the clamping section <NUM> being smaller than the cross-sectional area of the tubing <NUM> wherein the tubing <NUM> is pinched and closed to restrict or eliminate a fluid flow through the tubing when the tubing <NUM> is located within the clamping section <NUM>. The slot-like structure of the clamping section <NUM> is oriented at an angle to the upright wall <NUM>, and, in some embodiments a right angle thereto.

<FIG> shows the tube clamp <NUM> in an open condition. The therapeutic fluid within the syringe barrel <NUM> can flow to the user when the tube clamp <NUM> is in the open condition. <FIG> shows the tube clamp <NUM> transferred to the closed condition. In the closed condition, the therapeutic fluid cannot be delivered to the patient and any flow of blood from the user is also restricted because the tube <NUM> is pinched within the clamping section <NUM> of the tube clamp <NUM>.

The tube clamp <NUM> has a convex keeper <NUM> that is retained within the concave recess <NUM> in the second slot <NUM> upright wall <NUM>. The combination of the keeper <NUM> within the recess <NUM> maintains the tube clamp <NUM> in the proper location and orientation within the second slot <NUM> while allowing the tube clamp <NUM> to be within same.

In some embodiments, an angle β of an upper surface of the tube clamp <NUM> is generally equal to an angle of the upper surface <NUM> of the syringe support <NUM>. This structural arrangement may provide a smooth transition between the tube clamp <NUM> within the second slot <NUM> of the syringe support <NUM> and adjacent portions of the upper surface <NUM> of the syringe support <NUM>.

As illustrated in <FIG> and <FIG>, the syringe stabilizer <NUM> of <FIG> may be used in the following manner. With the base <NUM> supported on a stable, generally horizontal work surface, a syringe <NUM> having a fluid-filled barrel <NUM> with a tubing <NUM> connected thereto by a fitting <NUM> is inserted with the first slot <NUM> while the fitting <NUM> is inserted within the fitting receiver <NUM>. The tube receiver <NUM> of the tube clamp <NUM> is aligned with the first slot <NUM> such that tubing <NUM> is received therein. The tube clamp <NUM> is selectively actuated by sliding it within the second slot <NUM> in a direction transverse to the first slot <NUM> and opposite to the direction of the clamping section <NUM>. Relative movement between the tube clamp <NUM> and the first slot <NUM> causes the tubing <NUM> to be pinched and closed. In this example, engagement between the tube <NUM> and the first slot <NUM> fixes the tubing <NUM> in a stationary position as the clamping section <NUM> engages the tubing <NUM> and the disparity between the cross-sectional areas of the clamping section <NUM> and the tubing <NUM> causes the tubing <NUM> to pinched within the clamping section <NUM> to prevent fluid flow within the tubing <NUM>. This may elevate, clamp, orient, and retain the syringe <NUM> in a desirable position relative to a user as he/she begins the process of administering a therapy via the infusion set <NUM>. The user's arms are now free to insert the cannula or needle <NUM> in a first arm <NUM> while manipulating the cannula <NUM> with a second arm <NUM>. Thus, an arrangement of the base and syringe support positions, orients and retains the fluid-filled portion of the infusion set <NUM> such that a patient self-administering a therapeutic fluid is able to manipulate the tube clamp <NUM> and the fluid-filled portion with the first arm <NUM> while receiving the therapeutic fluid into the second arm <NUM> via the infusion set as the second arm <NUM> remains substantially motionless and provides a stabilizing force against the base <NUM>. The stabilizing force must be great enough to withstand movement of the syringe stabilizer <NUM> along a work surface during manipulation of the tube clamp <NUM>, in one example, sliding of the tube clamp <NUM> within the second slot <NUM>, at least through actuation of the plunger <NUM> by the first arm <NUM> of the user.

For example, as illustrated in <FIG>, with cannula <NUM> inserted in the second arm <NUM>, the user may steady the base <NUM> by engaging some portion of the base <NUM>, such as the ergonomic feature <NUM>, with the second arm <NUM>, typically a hand. Using the first arm <NUM>, the user may selectively actuate the tube clamp <NUM> by creating relative movement between the tube clamp <NUM> and a remaining portion of the syringe support <NUM>. Here, the user slides the tube clamp <NUM> within the second slot <NUM> to release the tube clamp <NUM> from pinching the tubing <NUM>. The user may then use the first arm <NUM> to actuate the plunger <NUM> to force fluid to the cannula <NUM> and into the second arm <NUM>. This allows a flow of the fluid from the delivery end <NUM> of the fluid-filled portion of the syringe <NUM> while the user's second arm/hand <NUM> remains substantially motionless and provides a stabilizing force against the base <NUM> as the user receives the flow of fluid into the second arm <NUM>. It follows that the frictional engagement between the infusion set <NUM> and the first slot <NUM> provides a resistance force sufficient to maintain a position and an orientation of a syringe barrel <NUM> joined to the rigid portion of the infusion set <NUM> as the plunger <NUM> disposed within the barrel <NUM> is forced downwardly towards the delivery end <NUM> of the syringe <NUM>.

According to one embodiment illustrated in <FIG>, the arcuate section <NUM> of the fitting receiver <NUM> accepts a portion or hub of the Luer fitting <NUM> of the infusion set <NUM> with minimal clearance. An opening in the arcuate section <NUM> has a chamfer edge, making it easier for users to engage/insert the Luer hub into this area. This may position the Luer approximately <NUM> inches to <NUM> inches (<NUM> to <NUM>) above a table surface and angles it slightly up (<NUM> to <NUM> degrees above horizontal), allowing users to comfortably operate an attached syringe <NUM> either with hand <NUM>,<NUM> elevated off or resting on the table surface.

Wings on the Luer fitting <NUM> may be received within the opposing slots <NUM> adjacent to the arcuate section <NUM> to prevent free spin (i.e. resist torque) during connection or disconnection of a syringe <NUM> from the fitting <NUM>. In some cases, excessive clearance at the wing and the arcuate section <NUM> may increase risk of damage to wings of the fitting <NUM>. The inventors determined through testing that the opposing slot <NUM> in the <NUM> o'clock and <NUM>'o'clock configuration shown in, for example, <FIG>, may be used. In other embodiments, other slot <NUM> configurations may be used, such as an "X" slot pattern or a "+" pattern.

The abutment surface <NUM> at the front of the arcuate section <NUM> provides a visual queue to guide use of the stabilizer <NUM>. The Luer hub is inserted until it bottoms out against this abutment <NUM>.

In some embodiments, the base <NUM> is approximately <NUM> inches x <NUM> inches (<NUM> x <NUM>) oblong shape. This feature sits firmly on a flat table surface. It extends approximately <NUM> inches to <NUM> inches (<NUM> to <NUM>) both left and right of the stem <NUM>. A slightly larger extension of <NUM> inches to <NUM> inches (<NUM> to <NUM>) behind the stem <NUM> improves comfort for resting the second arm <NUM> not operating the syringe <NUM> (see FIGS. Users may rest fingers/hand either around or beside the stem <NUM>. An even larger extension of <NUM> inches to <NUM> inches (<NUM> to <NUM>) in front of the stem <NUM> counterbalances weight of an attached, filled syringe <NUM> up to 30cc. This also provides a large surface suitable for branding/artwork, graphical instructions, or other desired marks by pad printing, embossing, laser marking, etc. Alternatively, the second arm <NUM> can be placed on this section as illustrated in <FIG>.

In some embodiments, the height of the lower base <NUM> may be low, and edges may be rounded, e.g., for hand comfort. The bottom surface <NUM> of the base <NUM> may incorporate a perimeter groove <NUM> sized to securely press-fit the elastomeric ring <NUM>. The purpose of the ring <NUM> is to prevent sliding of the syringe stabilizer <NUM> relative to the table surface. In this embodiment, Marco Rubber part number SB1000-<NUM> (Standard Size S152, 70A black buna square ring) may fit into the groove <NUM>. Other ring cross-sections are possible, such as an O-ring. The ring formulation may be adjusted and/or cleaning processes may further increase tackiness, as needed. The groove height may allow full contact between an exposed square ring and the table surface. A pattern of ribs radiating from center to perimeter may be added to increase structural rigidity.

The stem <NUM> extends vertically from the base <NUM>. In some embodiments, the diameter of the stem is approximately <NUM> inches to <NUM> inches (<NUM> to <NUM>) and large enough for adequate structure and small enough that users are able to rest fingers around the stem <NUM>. A stem height of <NUM> inches to <NUM> inches (<NUM> to <NUM>) with <<NUM> blend radius may allow adequate clearance for hands while minimizing overall size of the assembly.

In some embodiments, the syringe support <NUM> sits above the stem <NUM>. The first slot <NUM> is chamfered opening to accept the tubing <NUM>. The second slot <NUM> accepts the tube clamp <NUM> component, which is assembled at the manufacturing plant by a downward push that engages one-way snap fit features. Snap-fit geometry and material selections may permit easy removal of the clamp, e.g. for improved cleanability. In an alternative embodiment, the degree of engagement can be increased and snap-fit angles adjusted for a one-way snap configuration. The sides of the mount area may be substantially cored out (i.e., material removed) and drafted for improved manufacturability by injection molding.

In some embodiments, the tube clamp <NUM> includes a flat upper surface that sits approximately flush with upper surface <NUM> of the syringe support <NUM>. The surface may allow easily readable (approximately <NUM> to <NUM> tall) printed or embossed text and symbols, such as "OPEN" and an arrow indicating the open clamp position. This wider clamp surface may also prevent incorrect clamp orientation during manufacturing. The tube clamp <NUM> may be molded in a bold or contrasting color from the base.

In some embodiments, the opening <NUM> in the tube receiver <NUM> is about <NUM> inches to <NUM> inches (<NUM> to <NUM>). The opening <NUM> aligns with the first slot <NUM> when the clamp is in open position as illustrated in <FIG>. The clamp opening <NUM> leads to the clamping section <NUM> which is a narrowed slot that pinches tubing (approximately <NUM> inches to <NUM> inches (<NUM> to <NUM>)) when a user slides the clamp <NUM> fully to the closed position. Edges in this region may be blended to reduce risk of cutting tubing during clamping. Clamping may occur because flexible tubing walls are collapsed to occlude/restrict flow. Limited friction (clamp to base, clamp to tube) may allow clamp operation with little force, for example up to <NUM> pounds. Clamping the tubing may both block flow and prevent axial movement of the set in the stabilizer assembly.

In some embodiments, flat pads approximately <NUM> inches x <NUM> inches (<NUM> x <NUM>) at opposite ends of the clamp <NUM> provide comfortable and intuitive surfaces to operate the clamp <NUM>. Edges in this region, and all exposed edges of the stabilizer assembly, are blended for user comfort.

Polyolefin materials (polyethylene, polypropylene) or other cost-effective plastic resins (ABS, PC, polystyrene, etc.) may be used for the base <NUM> and clamp components. In some embodiments, sterilization is not required. High density polyethylene may be used as a material because of its cleanability, possibly even in dishwasher cycles, and general compatibility with household cleaning solutions. A variety of materials may be used for the ring component, including rubber, silicone, or thermoplastic elastomer. Similar function could be achieved by <NUM>-shot or overmolding elastomer material to the bottom surface of the base component.

According to one aspect, the stabilizer device <NUM> may enhance an infusion experience by improving ease of use. As illustrated in <FIG>, it simplifies handling/injecting multiple syringes <NUM> of therapeutic fluid. The arrows on <FIG>, show that the syringe <NUM>, threadably attached to the Luer fitting <NUM>, can be rotated counterclockwise to remove the syringe <NUM> in the direction of the lower arrow outwardly from the Luer fitting <NUM>. A new syringe <NUM> can be threadably attached to the Luer fitting <NUM> by inserting it into the Luer fitting in the direction of the upper arrow and rotating the syringe <NUM> in a clockwise direction.

More specifically, the syringe stabilizer <NUM> can be used as follows. A user slides the tube clamp <NUM> to an open position (shown, for example, in <FIG>) and places the infusion set <NUM> tubing <NUM> into the first slot <NUM>. The user slides wings of the Luer fitting <NUM> into the slots <NUM> of the fitting receiver <NUM> opening until the Luer fitting fits tightly within the syringe support <NUM>.

To swap syringes <NUM>, the tube clamp <NUM> is moved or slid within the second slot <NUM> to a closed position (shown, for example, in <FIG>) in which the tubing <NUM> is pinched closed within the clamping section <NUM> of the tube clamp <NUM>. The empty syringe <NUM> threadably attached to the Luer fitting <NUM> is removed from the Luer fitting <NUM> by rotating the syringe <NUM> counterclockwise with the first arm <NUM> while supporting or stabilizing the base <NUM> with the second arm <NUM>. In this manner, the infusion set <NUM> cannula <NUM> does not need to be removed from the user's second arm <NUM> as the syringes <NUM> are swapped or changed. To connect a new or replacement syringe <NUM> fully loaded with a therapeutic fluid, the delivery end <NUM> is inserted into the Luer fitting <NUM> using the first arm <NUM> while the second arm <NUM> stabilizes the base <NUM>, and it is threadably attached thereto by rotating the syringe <NUM> in a clockwise direction. The user then slides the tube clamp <NUM> to the open position using the first arm <NUM> while the second arm <NUM> is used to stabilize the base <NUM>. The user may then use the first arm <NUM> to force the plunger <NUM> towards the delivery end <NUM> of the syringe <NUM> to force fluid to the second arm <NUM> while the second arm stabilizes the base <NUM>.

According to one aspect, the stabilizer device <NUM> allows users to connect and disconnect multiple syringes <NUM> to an infusion set <NUM> with one hand, without directly handling the set with the other. The stabilizer effectively anchors a Luer fitting <NUM> of the infusion set <NUM> in a fixed, raised position above a table surface.

According to one aspect, the stabilizer <NUM> helps users minimize risk of leaks from an open set (i.e. due to blood pressure) and risk of touch contaminating an open set during syringe exchanges. In some embodiments, the stabilizer device <NUM> includes a tube clamp <NUM> that, when activated, occludes and anchors tubing <NUM> in the device <NUM>. Less direct handling of the Luer fitting <NUM> is required for a fitting that is supported by the stabilizer <NUM>. In some embodiments, when closed, the tube clamp prevents fluid flow through the infusion set while exposed to a pressure of about <NUM> mmHg (<NUM> psi) at the needle.

According to one aspect, the stabilizer <NUM> can support weight of filled syringe <NUM> in a stable and hands-free manner when the user releases grip on that syringe <NUM>.

According to one aspect, the stabilizer <NUM> allows adequate position of and clearance around an attached syringe <NUM>, such that the user can comfortably operate the attached syringe <NUM>. For example, a user could alternatively elevate a hand <NUM> operating the syringe <NUM> above a table surface or rest that hand <NUM> on the table during administration.

According to one aspect, the stabilizer <NUM> is in non-fluid contact. Therefore, this simple accessory is reusable and does not require sterilization. Stabilizer materials and design result in a lightweight, portable, cleanable, recyclable, and low-cost system.

Claim 1:
A syringe stabilizing apparatus (<NUM>) comprising:
a base (<NUM>);
a tube clamp (<NUM>), wherein the tube clamp is movable to a closed position to pinch a tubing (<NUM>) within the tube clamp closed using a user's first arm, and wherein the tube clamp is movable to an open position using the user's first arm while the user's second arm stabilizes the base;
a fitting (<NUM>) attached to the syringe stabilizing apparatus, from which a first syringe (<NUM>) is threadably detachable using the user's first arm while the base of the syringe stabilizing apparatus is stabilized with the user's second arm such that an infusion set cannula (<NUM>) remains attached to the second arm, and to which a second syringe (<NUM>) is threadably attachable using the user's first arm while the user's second arm stabilizes the base;
a syringe support (<NUM>) vertically disposed above the base for elevating the second syringe vertically above the base and orienting a delivery end of the second syringe upwardly relative to a horizontal plane to take advantage of a gravitational effect on a fluid during delivery of a fluid from syringe to a user, the syringe support comprising:
a first retainer having an opening in which a rigid portion of an infusion set (<NUM>) is received and retained therein without further user intervention,
the tube clamp being operatively aligned with the first retainer, and wherein the tubing comprises a flexible tube extending from the rigid portion of the infusion set and extending through the tube clamp,
wherein the tube clamp is releasable by a user's first arm to allow a flow of the fluid from the delivery end of the fluid-filled portion while a user's second arm remains substantially motionless and provides a stabilizing force against the base as the user receives the flow of fluid into the second arm.