Patent Description:
Medical treatments often include the infusion of a medical fluid (e.g., a saline solution or a liquid medication) to patients using an intravenous (IV) catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an "IV set," to a source of fluid, for example, a syringe. Certain configurations of IV sets may have extended lengths of tubing, for example, in excess of <NUM> feet (<NUM>).

Additionally, tubing may be primed with saline prior to the infusion of a liquid medication. Document <CIT> discloses a drug delivery system provided for mixing various drugs in a controlled manner and for using flow controllers to guide multiple drugs into a single or into multiple catheters. The drug delivery system for controlling a dispensing of a fluid drug to an internal target site of a patient comprises a first reservoir for storing a first fluid and an input port in fluid communication with the first reservoir. The drug delivery system further comprises an output port in fluid communication with the first reservoir and a flow control system for controlling the transfer of the first fluid between the respective ports and the first reservoir.

<CIT> discloses a drug delivery system with multiple syringes, as well as a priming operation to remove gas and flush the gas into a waste reservoir.

In some applications, during the use of IV catheters, saline from the priming process may be delivered to patient before the liquid medication is delivered to the patient.

The disclosed subject matter relates to syringe control assemblies. A syringe control assembly is disclosed that comprises an assembly body comprising a syringe mounting rack; a first syringe releasably coupled to the syringe mounting rack, the first syringe comprising a first syringe body defining a first syringe cavity and a first syringe port, wherein the first syringe port is in fluid communication with the first syringe cavity; a second syringe releasably coupled to the syringe mounting rack, the second syringe comprising a second syringe body defining a second syringe cavity and a second syringe port, wherein the second syringe port is in fluid communication with the second syringe cavity; and a pump assembly coupled to the assembly body, the pump assembly comprising: a first pump unit in fluid communication with the first syringe port via a first pump tubing; and a second pump unit in fluid communication with the second syringe port via a second pump tubing, wherein in a priming configuration the first pump unit is configured to draw fluid flow from the first syringe cavity and the second pump unit is configured to pump fluid flow into the second syringe cavity.

Not part of the invention is a method to deliver medication that comprises pumping medication from a first medication syringe into a delivery flow path of a tubing; and pumping medical fluid from a return flow path of the tubing into a return syringe.

A medication delivery system is disclosed that comprises a syringe control assembly, comprising; an assembly body comprising a syringe mounting rack; a first syringe releasably coupled to the syringe mounting rack, the first syringe comprising a first syringe body defining a first syringe cavity and a first syringe port, wherein the first syringe port is in fluid communication with the first syringe cavity; a second syringe releasably coupled to the syringe mounting rack, the second syringe comprising a second syringe body defining a second syringe cavity and a second syringe port, wherein the second syringe port is in fluid communication with the second syringe cavity; and a pump assembly coupled to the assembly body, the pump assembly comprising: a first pump unit in fluid communication with the first syringe port via a first pump tubing; and a second pump unit in fluid communication with the second syringe port via a second pump tubing; and a tubing defining a delivery flow path and a return flow path, wherein in a priming configuration the delivery flow path is in fluid communication with the first pump unit to pump fluid flow from the first syringe cavity though the delivery flow path and the return flow path is in fluid communication with the second pump unit to pump fluid flow from the return flow path into the second syringe cavity.

The disclosed syringe control assembly incorporates syringes with respective pump units to control the fluid flow of medication and saline. The syringe control assembly can control the delivery and return flow of medical fluids such as medication and saline. By controlling the fluid flow medical fluids, the priming and delivery of medication and other medical fluids can be simplified.

The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. Like components are labeled with identical element numbers for ease of understanding. Reference numbers may have letter suffixes appended to indicate separate instances of a common element while being referred to generically by the same number without a suffix letter.

While the following description is directed to the administration of medical fluid using the disclosed syringe control assembly, it is to be understood that this description is only an example of usage and does not limit the scope of the claims. Various aspects of the disclosed syringe control assembly may be used in any application where it is desirable to provide for the administration of medical fluids.

The disclosed syringe control assembly overcomes several challenges discovered with respect to certain conventional syringes. One challenge with certain conventional syringes is that syringes may deliver excess medical fluid, such as saline, to patients. Further, conventional syringes may require manual advancing and retraction in sequence. Because excess medical fluid may delay the delivery of medical fluids and may not be tolerated by fluid restricted patients, such as premature babies, and because manual operation of conventional syringes may be subject to error, the use conventional syringes is undesirable.

Therefore, in accordance with the present disclosure, it is advantageous to provide a syringe control assembly as described herein that eliminates or substantially reduces delivering excess medical fluid to a patient and simplifies the operation of the syringes. The disclosed syringe assembly provides pump units that permit simplified operation while reducing excess medical fluid delivered to the patient.

An example of a syringe control assembly that prevents delivery of excess medical fluid is now described.

<FIG> is a perspective view of a medication delivery system <NUM> in a priming configuration, in accordance with various aspects of the present disclosure. In the illustrated example, the medication delivery system <NUM> delivers medication from the syringe control assembly <NUM> to the patient via catheter <NUM> without delivering excess fluid, such as saline, used to prime the medication delivery system <NUM>.

Optionally, prior to administering or priming medication, delivery flow path 122a of the multi-lumen tubing <NUM> can be primed with saline to remove any air or trapped gasses within the delivery flow path 122a. Saline can be advanced from the syringe control assembly <NUM>, through the delivery flow path 122a and to the valve <NUM>.

The saline from the delivery flow path 122a of the multi-lumen tubing <NUM> can be received within the valve <NUM>. In a priming configuration, the valve <NUM> can prevent saline from the delivery flow path 122a from entering the catheter <NUM> and can instead direct the saline through the return flow path <NUM> to allow primed saline to be returned to the syringe control assembly <NUM>. Similarly, the delivery flow path 122b can be primed with saline.

In the illustrated example, the syringe control assembly <NUM> advances medication within the delivery flow path 122a to prime the delivery flow path 122a. Advantageously, by priming the delivery flow path 122a with medication, the medication can be delivered to the patient via the catheter <NUM> proximal to the patient with less delay and without delivering the saline used to prime the delivery flow path 122a of the multi-lumen tubing <NUM>.

To introduce medication into the delivery flow path 122a, the syringe control assembly <NUM> includes a first medication pump unit <NUM> to pump or draw medication from the first medication syringe <NUM> via tubing <NUM> and pump or direct the medication through the delivery flow path 122a.

In the illustrated embodiment, the first medication administered by the syringe control assembly <NUM> is stored within the first medication syringe <NUM>. Optionally, the first medication syringe <NUM> is disposable. The first medication syringe <NUM> stores first medication within a cavity <NUM> defined within the syringe body. The first medication from the cavity <NUM> is drawn through the port <NUM> by the first medication pump unit <NUM>. The first medication is directed from the port <NUM> to the first medication pump unit <NUM> via tubing <NUM>. In some embodiments, the port <NUM> can include a check valve to prevent the backflow of the first medication, saline, or other medical fluids into the cavity <NUM> of the first medication syringe <NUM>. As illustrated, the first medication syringe <NUM> can be releasably coupled to a syringe mounting rack <NUM>. Optionally, the syringe mounting rack <NUM> can include quick release mounting points to allow for rapid attachment, detachment, or exchange of the first medication syringe <NUM> or other components. The syringe mounting rack <NUM> can be coupled to the assembly body <NUM>.

In some embodiments, the first medication pump unit <NUM> includes a pump to impart fluid pressure to provide fluid flow to the medication from the first medication syringe <NUM>. According to the invention, a rotary pump is used. As shown, the first medication pump unit <NUM> can be coupled to the pump assembly <NUM>. The pump assembly <NUM> can be coupled to the assembly body <NUM>. Optionally, the pump assembly <NUM> can form a portion of the base <NUM> of the syringe control assembly <NUM>.

In some embodiments, operational parameters of the first medication pump unit <NUM> such as the amount of fluid flow and/or the fluid pressure provided can be adjusted either before or during operation. Optionally, in some embodiments, the first medication pump unit <NUM> can function as an on/off valve, permitting flow therethrough when the pump portion is active and preventing flow (including backflow and cross-flow) therethrough when the pump portion is inactive.

Optionally, the first medication pump unit <NUM> can be configured to pump or dispense a desired volume of medication from the first medication syringe <NUM> into the delivery flow path 122a of the multi-lumen tubing <NUM> that is equivalent to the volume of the delivery flow path 122a. In other words, the first medication pump unit <NUM> can be operated to fill the volume of the delivery flow path 122a up to the valve <NUM> to prime the delivery flow path 122a with the first medication to prime the first medication for administration via the catheter <NUM>.

In some embodiments, the priming of the first medication in to the delivery flow path 122a can be controlled, automated, or otherwise simplified. For example, the operation of the first medication pump unit <NUM> can be controlled or automated to be started, stopped, or sequenced to allow a desired volume of the first medication to be introduced into the delivery flow path 122a.

Optionally, the syringe control assembly <NUM> includes a second medication syringe <NUM> to facilitate the administration of a secondary medication or additional volume of the first medication. As described herein, the secondary medication can be administered simultaneously with the first medication or can be administered sequentially. Similarly, the secondary medication can be advanced within the delivery flow path 122b to prime the delivery flow path 122b.

To introduce medication into the delivery flow path 122b, the syringe control assembly <NUM> includes a second medication pump unit <NUM> to pump or draw medication from the second medication syringe <NUM> via tubing <NUM> and pump or direct the medication through the delivery flow path 122b.

In the illustrated embodiment, the second medication administered by the syringe control assembly <NUM> is stored within the second medication syringe <NUM>. Optionally, the second medication syringe <NUM> is disposable. The second medication syringe <NUM> stores second medication within a cavity <NUM> defined within the syringe body. The second medication from the cavity <NUM> is drawn through the port <NUM> by the second medication pump unit <NUM>. The second medication is directed from the port <NUM> to the second medication pump unit <NUM> via tubing <NUM>. In some embodiments, the port <NUM> can include a check valve to prevent the backflow of the second medication, saline, or other medical fluids into the cavity <NUM> of the second medication syringe <NUM>. As illustrated, the second medication syringe <NUM> can be releasably coupled to a syringe mounting rack <NUM>.

In some embodiments, the second medication pump unit <NUM> includes a pump to impart fluid pressure to provide fluid flow to the medication from the second medication syringe <NUM>. As shown, the second medication pump unit <NUM> can be coupled to the pump assembly <NUM>.

In some embodiments, operational parameters of the second medication pump unit <NUM> such as the amount of fluid flow and/or the fluid pressure provided can be adjusted either before or during operation. Optionally, in some embodiments, the second medication pump unit <NUM> can function as an on/off valve, permitting flow therethrough when the pump portion is active and preventing flow (including backflow and cross-flow) therethrough when the pump portion is inactive.

Optionally, the second medication pump unit <NUM> can be configured to pump or dispense a desired volume of medication from the second medication syringe <NUM> into the delivery flow path 122b of the multi-lumen tubing <NUM> that is equivalent to the volume of the delivery flow path 122b. In other words, the second medication pump unit <NUM> can be operated to fill the volume of the delivery flow path 122b up to the valve <NUM> to prime the delivery flow path 122b with the second medication to prime the second medication for administration via the catheter <NUM>.

In some embodiments, the priming of the second medication in to the delivery flow path 122b can be controlled, automated, or otherwise simplified. For example, the operation of the second medication pump unit <NUM> can be controlled or automated to be started, stopped, or sequenced to allow a desired volume of the second medication to be introduced into the delivery flow path 122b. As can be appreciated, the second medication pump unit <NUM> can be configured to prime the delivery flow path 122b sequentially or simultaneously with the first medication pump unit <NUM>.

As illustrated, as the first medication is introduced into the delivery flow path 122a of the multi-lumen tubing <NUM>, any saline or other medical fluids previous primed through the delivery flow path 122a are displaced. Similarly, as the second medication is introduced into the delivery flow path 122b of the multi-lumen tubing <NUM>, any saline or other medical fluids previous primed through the delivery flow path 122b are displaced. The displaced fluids are directed by the valve <NUM> into the return flow path <NUM>. In some applications, pressure from the first medication pump unit <NUM> and/or the second medication pump unit <NUM> may be sufficient to flow displaced medical fluids to the syringe control assembly <NUM>. In some embodiments, displaced fluids from the return flow path <NUM> can be drawn or pumped by the syringe control assembly <NUM>.

For example, to facilitate the flow of displaced medical fluids from the return flow path <NUM>, the syringe control assembly <NUM> includes a return pump unit <NUM> to pump or draw displaced fluids from the return flow path <NUM> and pump or direct the fluids to a return syringe <NUM> via tubing <NUM>.

In the illustrated embodiment, the return pump unit <NUM> includes a pump to impart fluid pressure to displaced fluids within the return flow path <NUM>. As shown, the return pump unit <NUM> can be coupled to the pump assembly <NUM>.

In some embodiments, operational parameters of the return pump unit <NUM> such as the amount of fluid flow and/or the fluid pressure provided can be adjusted either before or during operation. Optionally, in some embodiments, the return pump unit <NUM> can function as an on/off valve, permitting flow therethrough when the pump portion is active and preventing flow (including backflow and crossflow) therethrough when the pump portion is inactive.

Optionally, the return pump unit <NUM> can be configured to facilitate priming operations. For example, the return pump unit <NUM> can be configured to pump or dispense a volume of displaced fluids corresponding to the amount of medication or other fluid introduced during priming. In other embodiments, the return pump unit <NUM> can operate simultaneously during the priming operation of the first medication pump unit <NUM> and/or the second medication pump unit <NUM>.

In some embodiments, the return pump unit <NUM> can be controlled to start, stop, or be sequenced cooperatively with the first medication pump unit <NUM> and/or the second medication pump unit <NUM> until the priming operation is completed.

In the illustrated embodiment, the displaced fluids received by the syringe control assembly <NUM> are stored within the return syringe <NUM>. Optionally, the return syringe <NUM> is disposable. The return syringe <NUM> stores returned fluids within a cavity <NUM> defined within the return syringe body. The returned fluids can be introduced into the cavity <NUM> by a port <NUM> in fluid communication with the return pump unit <NUM>. Tubing <NUM> can direct flow from the return pump unit <NUM> to the port <NUM>. In some embodiments, the port <NUM> can include a check valve to prevent the outflow of the returned fluids from the cavity <NUM>. As illustrated, the return syringe <NUM> can be releasably coupled to the syringe mounting rack <NUM>.

<FIG> is a perspective view of the medication delivery system <NUM> of <FIG> in a delivery configuration, in accordance with various aspects of the present disclosure. In the illustrated example, the syringe control assembly <NUM> dispenses medication to the patient through the catheter <NUM>.

During the delivery operation, the first medication pump unit <NUM> is activated to deliver the first medication from the first medication syringe <NUM> into the primed delivery flow path 122a. As the first medication is delivered into the delivery flow path 122a, the valve <NUM> is actuated to permit the flow of medication from the delivery flow path 122a to the patient via the catheter <NUM>. In some embodiments, the valve <NUM> is actuated by fluid pressure or other actuation mechanisms. Optionally, the valve <NUM> can be located proximally to the patient to minimize the length of the catheter <NUM>, to reduce the amount of saline administered to the patient and to reduce the delivery time for the medication.

Optionally, the second medication pump unit <NUM> is activated to deliver the second medication from the second medication syringe <NUM> into the primed delivery flow path 122b. Similarly, the valve <NUM> can permit the flow of medication from the delivery flow path 122b to the patient via the catheter <NUM>. In some embodiments, the second medication can be delivered to the patient sequentially after the first medication. In some applications, the second medication can be delivered simultaneously with the first medication wherein the first medication and the second medication flow combine at the valve <NUM> to be administered to the patient via the catheter <NUM>.

<FIG> is a perspective view of the medication delivery system <NUM> of <FIG> in a pushing configuration, in accordance with various aspects of the present disclosure. In the illustrated example, the syringe control assembly <NUM> can advance saline through the delivery flow path 122a and/or delivery flow path 122b of the multi-lumen tubing <NUM> to advance the remaining medication to the patient via the catheter <NUM>.

For example, after the first medication is expelled from the syringe control assembly <NUM>, the first medication may remain in the volume of the delivery flow path 122a. To ensure that the medication is fully delivered to the patient in the desired dosage, the syringe control assembly <NUM> can be utilized to administer a saline "push" to continue to advance the medication through the delivery flow path 122a after the medication within the first medication syringe <NUM> is exhausted. In some applications, saline can be administered through the delivery flow path 122a until the medication is fully administered to the patient. Similarly, saline can be administered through the delivery flow path 122b until medication is fully administered to the patient.

In some embodiments, the syringe control assembly <NUM> includes a saline syringe <NUM> to facilitate the administration of a saline push within the delivery flow path 122a and/or delivery flow path 122b to advance any remaining medication therein.

To introduce saline into the delivery flow path 122a and/or delivery flow path 122b, the syringe control assembly <NUM> includes a saline pump unit <NUM> to pump or draw saline from the saline syringe <NUM> via tubing <NUM> and pump or direct the saline through the delivery flow path 122a and/or the delivery flow path 122b.

In the illustrated embodiment, saline administered by the syringe control assembly <NUM> is stored within the saline syringe <NUM>. Optionally, the saline syringe <NUM> is disposable. The saline syringe <NUM> stores saline within a cavity <NUM> defined within the syringe body. The saline from the cavity <NUM> is drawn through the port <NUM> by the saline pump unit <NUM>. The saline is directed from the port <NUM> to the saline pump unit <NUM> via tubing <NUM>. In some embodiments, the port <NUM> can include a check valve to prevent the backflow of the medication, saline, or other medical fluids into the cavity <NUM> of the saline syringe <NUM>. As illustrated, the saline syringe <NUM> can be releasably coupled to a syringe mounting rack <NUM>.

In some embodiments, the saline pump unit <NUM> includes a pump to impart fluid pressure to provide fluid flow to the medication from the saline syringe <NUM>. As shown, the saline pump unit <NUM> can be coupled to the pump assembly <NUM>.

In some embodiments, operational parameters of the saline pump unit <NUM> such as the amount of fluid flow and/or the fluid pressure provided can be adjusted either before or during operation. In some embodiments, the saline pump unit <NUM> may be in fluid communication with, and operated simultaneously as the first medication pump unit <NUM> and/or the second medication pump unit <NUM>. Optionally, in some embodiments, the saline pump unit <NUM> can function as an on/off valve, permitting flow therethrough when the pump portion is active and preventing flow (including backflow and cross-flow) therethrough when the pump portion is inactive.

Optionally, the saline pump unit <NUM> can be configured to pump or dispense a desired volume of saline from the saline syringe <NUM> into the delivery flow path 122a and/or the delivery flow path 122b of the multi-lumen tubing <NUM> that is sufficient to push or administer the desired amount of medication to the patient. In some embodiments, the pushing of the medication in the delivery flow path 122a and/or the delivery flow path 122b can be controlled, automated, or otherwise simplified. For example, the operation of the saline pump unit <NUM> can be controlled or automated to be started, stopped, or sequenced to allow a desired volume of the saline to be introduced into the delivery flow path 122a and/or the delivery flow path 122b.

In some embodiments, the saline pump unit <NUM> directs saline from the saline syringe <NUM> to a saline manifold <NUM> to distribute the saline to the delivery flow path 122a and/or the delivery flow path 122b. In some embodiments, the saline manifold <NUM> can be coupled to or formed with the assembly body <NUM>. Optionally, the saline manifold can be disposed between the syringe mounting rack <NUM> and the pump assembly <NUM>. As illustrated, the saline manifold <NUM> receives saline flow from the saline pump unit <NUM> at the manifold inlet <NUM> via the manifold inlet tubing <NUM>. Saline flow within the saline manifold <NUM> is directed to the first medication pump unit <NUM> by a first manifold outlet 137a via a manifold outlet tubing 169a and to the second medication pump unit <NUM> by a second manifold outlet 137b via a manifold outlet tubing 169b. As described herein, the first medication pump unit <NUM> and the second medication pump unit <NUM> can permit or prevent flow therethrough.

For example, to provide a saline push of the medication within the delivery flow path 122a, the first medication pump unit <NUM> may operate to permit saline flow from the saline manifold <NUM> to the delivery flow path 122a, advancing medication therethrough. To prevent the backflow of saline, the saline pump unit <NUM> may be overdriven or otherwise configured to provide a greater fluid output than the first medication pump unit <NUM>. Optionally, to provide a saline push of the medication within the delivery flow path 122b, the second medication pump unit <NUM> may operate to permit saline flow from the saline manifold <NUM> to the delivery flow path, advancing the medication therethrough. Similarly, to prevent the backflow of saline, the saline pump unit <NUM> may be overdriven or otherwise configured to provide a greater fluid output than the second medication pump unit <NUM>.

<FIG> is a reverse perspective view of the syringe control assembly <NUM> of <FIG>, in accordance with various aspects of the present disclosure. <FIG> is a partial cross sectional view of the syringe control assembly <NUM> of <FIG>, in accordance with various aspects of the present disclosure. In some embodiments, the syringe control assembly <NUM> can include a first medication pump unit <NUM>, a second medication pump unit <NUM>, a saline pump unit <NUM>, and/or a return pump unit <NUM> to control and direct fluid flow for the medication delivery system <NUM>. While <FIG> and <FIG> depict the first medication pump unit <NUM>, features described with respect to embodiments of the first medication pump unit <NUM> can be included with respect to embodiments of a second medication pump unit <NUM>, a saline pump unit <NUM>, and/or a return pump unit <NUM>.

As illustrated, the first medication pump unit <NUM> includes a rotary pump <NUM> to pressurize and provide fluid flow for medical fluids. Optionally, the rotary pump <NUM> can be disposable. During operation, the pump cavity <NUM> can receive fluid flow from the first medication syringe <NUM>. When actuated, the rotary pump <NUM> can pressurize fluid within the pump cavity <NUM> to provide fluid flow.

The rotary pump <NUM> can be rotated by a motor <NUM>. The shaft of the motor <NUM> can be coupled to the rotary pump <NUM> to transmit rotation with a coupling <NUM>. The coupling <NUM> can be secured with a set screw <NUM>. In some embodiments, the coupling <NUM> can be biased with a spring <NUM> to provide a desired preload to the connection between the rotary pump <NUM> and the motor <NUM>. In some embodiments, the motor <NUM> is a stepper motor to allow for control of the position of the rotary pump <NUM> and allow for precise dispensing of medication.

Terms such as "top," "bottom," "front," "rear" and the like if used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

Various items may be arranged differently (e.g., arranged in a different order, or partitioned in a different way) all without departing from the scope of the subject technology.

Claim 1:
A syringe control assembly (<NUM>), comprising:
an assembly body (<NUM>) comprising a syringe mounting rack (<NUM>);
a first syringe (<NUM>) releasably coupled to the syringe mounting rack, the first syringe comprising a first syringe body defining a first syringe cavity (<NUM>) and a first syringe port (<NUM>), wherein the first syringe port is in fluid communication with the first syringe cavity;
a second syringe (<NUM>) releasably coupled to the syringe mounting rack, the second syringe comprising a second syringe body defining a second syringe cavity (<NUM>) and a second syringe port (<NUM>), wherein the second syringe port is in fluid communication with the second syringe cavity; and
a pump assembly coupled to the assembly body, characterised in that the pump assembly comprises
a first pump unit (<NUM>) in fluid communication with the first syringe port via a first pump tubing (<NUM>), wherein the first pump unit comprises:
a rotary pump (<NUM>) comprising a pump cavity (<NUM>) in fluid communication with the first syringe port; and
a motor (<NUM>) coupled to the pump, wherein the motor is configured to rotate a portion of the rotary pump; and
a second pump unit (<NUM>) in fluid communication with the second syringe port via a second pump tubing (<NUM>), wherein in a priming configuration the first pump unit is configured to draw fluid flow from the first syringe cavity into the first pump tubing and the second pump unit is configured to pump fluid flow from the second pump tubing into the second syringe cavity and a valve (<NUM>) is configured to direct fluid from the first pump tubing into the second pump tubing during priming to displace trapped gasses within the first pump tubing.