Patent Description:
Since the early <NUM>'s the use of infusion pumps to administer anesthetics has become common practice for achieving continuous regional and local anesthesia. These pumps are either electro-mechanical pumps or mechanical pumps. Most pumps are designed to be ambulatory, carried by the patient in a pouch or similar holder. Some types of pump are suitable for Patient Control Analgesia (PCA) whereby the patient can add additional medication bolus to the basal flow to address severe pain.

Currently there are two main clinical procedures that are used for continuous long-term postoperative regional/local anesthesia, both are subcutaneous/intramuscular. The first procedure is Surgical Site Infiltration (SSI), wherein the medication is introduced into or nearby the surgical incision by use of a catheter with a long fenestrated segment inserted into the patient tissue. The second procedure is Continuous Peripheral Nerve Block (CPNB), wherein medication is introduced proximate to the nerve that controls the limb that has been operated. When CPNB administration is performed, an efficient pain block is achieved due to medication saturation of an area surrounding the nerve. Therefore maintaining sufficient nerve bathing is essential to gain continuous pain blockage. For example, such sufficient nerve bathing is achieved when a nerve block is performed by manual injection, typically performed prior to surgery. One of the main objectives of the present innovation is to continuously maintain sufficient nerve bathing through implementing an innovative infusion strategy for CPNB and thereby gain an improved post-operative pain therapy.

Automatic pumps for continuous medication insertion are well known in the art, for example, insulin pumps. Such devices are configured to continuously inject small amounts of medication, for example, in the order of <NUM>/hour (<NUM> milliliter/minute), intravenously (IV) into a human venous. The amounts of medication injected intravenously must be closely controlled as not to harm the venous while continuously injecting the medication. Other IV pumps known in the art can inject larger amount of medication even up to <NUM>/min, however such pumps are not designed to endure pressures higher than <NUM> bar. Such pumps do not suit regional/local anesthesia that requires rapid injection of relatively large amount of anesthetic medication at a relative rapid velocity that is administrated through relative thin and long catheter; requires relatively high pressure, for example, volume of more than <NUM> in a velocity of at least <NUM>/min with <NUM> catheter <NUM> to <NUM> long required a pressure of at least <NUM> bar.

<CIT> describes an infusion pump, including: a specially programmed microprocessor; a drip chamber for connection to a source of fluid and to an output tubing; a pumping section including a plurality of fingers and a first actuator, controllable using the microprocessor, for sequentially displacing the plurality of finger to compress a first portion of the output tubing to displace fluid from the drip chamber through the output tubing; an inlet valve disposed between the drip chamber and the pumping section and arranged to compress the output tubing to restrict or block flow through the output tubing; and a second actuator, controllable using the microprocessor, for opening or closing the inlet valve independent of the displacement of the plurality of fingers; or for operating the inlet valve to control a rate of flow of fluid from the drip chamber to the portion of the output tubing. <CIT> describes a hazardous fluid transport container and a hazardous fluid delivery system are disclosed. The hazardous fluid transport container includes a housing enclosing an at least partially shielded enclosure. First and second fluid path elements are disposed within the housing, with the first fluid path element and second fluid path element fluidly coupled together. A pump unit may be provided for dispensing fluid from the first and second fluid path elements optionally into a third fluid path element.

The device of the invention provides infused medication in a continuous pulse flow at a defined volume and frequency and velocity while maintaining a stable and accurate average flow rate. The device is particularly useful for large volume pulses at low frequency.

Embodiments of the invention may be related to a system for administrating an infusion liquid pulse. The system comprises a tubing system having an inlet connected to an external reservoir adapted to contain infusion fluids and an outlet connected to a catheter; the tubing system further comprises a check valve proximate to the inlet and an anti-siphon check valve proximate to the outlet; and an automatic pulse flow generation device. The automatic pulse flow generation device comprises an internal reservoir; a controller; and a bidirectional pump controlled by the controller and configured to pump infusion fluid from the external reservoir to the internal reservoir and further pump an infusion fluid pulse from the internal reservoir to be injected through a catheter, the infusion liquid pulse having a volume of at least <NUM> and a velocity of at least <NUM>/min.

The invention, however, both as to organization and method of operation, together with objects, features, a device. The automatic pulse flow generation device comprises an internal reservoir; a controller; and a bidirectional pump controlled by the controller and configured to pump infusion fluid from the external reservoir to the internal reservoir and further pump an infusion fluid pulse from the internal reservoir to be injected through a catheter, the infusion liquid pulse having a volume of at least <NUM> and a velocity of at least <NUM>/min; wherein the actuation apparatus comprises a pull lever that moves along one axis of the bidirectional pump, wherein when the pull lever moves in a first direction the volume of the internal reservoir increases and when the pull lever moves in a second direction the volume of the internal reservoir decreases; and wherein the controller is configured, for each movement cycle, to determine the pumped in volume for movement of the pull lever in the first direction and determine the pumped out volume for movement of the pull lever in the second direction.

In other instances, well-known components have not been described in detail so as not to obscure the present invention.

System <NUM>, which is illustrated in <FIG>, is a stand-alone electro-mechanical infusion system that creates pulsed flow having high volume and high velocity. According to some embodiments of the present invention system <NUM> may allow a user to set the volume of the pulse, the frequency of the pulses and the pulse velocity.

According to one embodiment of the present invention, system <NUM> may include a tubing system <NUM> having an inlet <NUM> connected to an external reservoir <NUM> adapted to contain infusion fluids and an outlet <NUM> connected to a catheter (not illustrated). External reservoir <NUM> may be a fluid medication reservoir; solid, semi-solid container or a bag. System <NUM> may be an automatic pulsed flow generation device <NUM>. According to some embodiments of the present invention, tubing system <NUM> may be a disposable tubing system. Tubing system <NUM> may further include a check valve <NUM> proximate to inlet <NUM> and an anti-siphon check valve <NUM> proximate to outlet <NUM>.

Automatic pulse flow generation device <NUM> may include an internal reservoir <NUM>, for example, in a form of a tube of a syringe, and a bidirectional pump <NUM>. Bidirectional pump <NUM> may include a piston (as illustrated in <FIG>) and a pulse actuation apparatus <NUM>. It should be understood by those skilled in the art that the piston illustrated in <FIG> is given as an example only, and that other bidirectional pumps are in the scope of the present invention. According to other or additional embodiments automatic pulsed flow generation device <NUM> may be programmable by a user such as a medical team and/or a patient. According to yet another embodiment of the present invention, automatic pulsed flow generation device <NUM> may be pre-set. Bidirectional pump <NUM> may be configured to pump infusion fluid from external reservoir <NUM> to internal reservoir <NUM> and further pump an infusion fluid pulse from internal reservoir <NUM> to be injected by the catheter, the infusion liquid pulse may have a volume of at least <NUM> and a velocity of at least <NUM>/min at pulse cycle frequency of <NUM> minutes or longer.

An exemplary automatic pulsed flow generation device <NUM> may comprise an internal pump reservoir <NUM>, such as a syringe, a piston <NUM> and a pulse actuation apparatus <NUM>. During the bidirectional operation syringe <NUM> is filled and emptied during each cycle.

Device <NUM> may further include a controller (not illustrated) configured to control bidirectional pump <NUM> and optionally also valves <NUM> and <NUM>. In some embodiments, the controller may control pulse actuation apparatus <NUM> included in pump <NUM> to control the velocity of the infusion pulse, for example to generate or provide an infusion pulse having a velocity of <NUM>-<NUM>/min (milliliter/minute). In some embodiments, the controller may control pulse actuation apparatus <NUM> included in pump <NUM> to control the volume of the infusion pulse, for example, to generate or provide an infusion pulse having a volume of <NUM>-<NUM> (milliliter). In some embodiments, the controller may control pulse actuation apparatus <NUM> included in pump <NUM> to control a frequency at which the pulses are injected, for example, the pulse may be given to a patient between once in every <NUM> minutes to once in every <NUM> minutes. The controller may further control the internal pressure at which the pulse is injected. A relatively high pressure, for example, of at least <NUM> or <NUM> bar may be required to produce a pulse at a velocity of at least <NUM>/min. The controller may control pump <NUM> to build a pressure of at least <NUM> bar in order to inject the pulse at at least <NUM>/min.

The controller may control pump <NUM> to pump infusion fluid from external reservoir <NUM> to internal reservoir <NUM> while opening valve <NUM>. In another embodiment, the controller may control pump <NUM> to generate an infusion fluid pulse by pumping the infusion fluid from internal reservoir <NUM> to outlet <NUM> while opening anti siphon check valve <NUM>.

According to one embodiment of the present invention, internal reservoir <NUM> is filled using energy provided by the flow from external reservoir <NUM>. It would be appreciated by those skilled in the art that other mechanisms may be used for filling internal reservoir <NUM> with fluid received from external reservoir <NUM>.

According to one embodiment of the present invention, pulsed flow generation device <NUM> may be operated electromechanically, through an electric motor or solenoid (not shown) which may be controlled by an electronic controller (not shown) in actuation apparatus <NUM>. The electronic controller may be programmable or preprogrammed to allow adapting the pulses frequency, the volume and velocity of each pulse of fluid and other parameters in order to tailor these parameters to the needs of each patient.

In some embodiments, device <NUM> may include more than one controller. For example, actuation apparatus <NUM> may comprise a controller for controlling the pulses frequency (not shown). According to another embodiment of the present invention, actuation apparatus <NUM> may comprise another or an additional controller such as a pulsed flow volume controller. Additionally, actuation apparatus <NUM> may comprise a flow velocity controller. It would be appreciated by those skilled in the art that other controllers, optionally of other parameters, may be used.

Pulsed flow generation device <NUM> may pump a defined volume of fluid, for example, <NUM>, received from external reservoir <NUM> to an internal pump reservoir, such as syringe <NUM>. Pump <NUM> (e.g., a piston) may then pump out that defined volume or a smaller volume, for example, <NUM>, entirely or partially, into a catheter (not shown) placed in the body of the patient. These pumping operations may be performed continuously at a selected frequency, for example, once every <NUM> minutes.

According to one embodiment of the invention both internal reservoir <NUM> and pump <NUM> may be parts of a disposable syringe set. Device operation parameters can be preset during manufacturing (pre-programmed) or, in a programmable version, the medical team may have the option to select and set the operational parameters of the device during the course of the therapy and to permanently lock them when needed.

In some embodiments, the device may be an ambulatory type powered by batteries <NUM>. However a stationary device can be used where the patient is unlikely to be moved. Energy may then be supplied through a cord <NUM> connected to the building electric supply via a transformer-rectifier <NUM>.

In some embodiments the system may be operated manually by the patient and/or medical team in addition to the automatically pulses delivery. In some embodiments, the system may be operated manually only by the patient and/or medical team. In some embodiments, when operated manually system <NUM> may be configured to supply an infusion liquid pulse having a volume of at least <NUM> and a velocity of at least <NUM>/min.

<FIG> represents an electromechanical pulsed flow generation device <NUM>. Tubing system <NUM> compromise inlet tube <NUM> that may be connected at one end to external reservoir <NUM> by use of a standard fitting and on the other end to check valve <NUM>. A connector, such as a T shape connector <NUM>, may be positioned between said check valve and an anti-siphon check valve <NUM>. Outlet port <NUM> may be positioned after said anti-siphon check valve. Outlet port <NUM> may have standard fitting to be connected to an NB catheter placed in the patient body or any other fluid insertion apparatus known in the art. The remaining branch of T connector <NUM> opens into variable volume container such as a standard disposable syringe <NUM>. It would be appreciated by those skilled in the art that actuation apparatus <NUM> of device <NUM> may be disposable or reusable, while tubing system <NUM> and external reservoir <NUM> are usually disposable components.

Internal reservoir <NUM> may be connected to electromechanical programmable actuation apparatus <NUM> by mounting the reservoir barrel <NUM> onto a holder <NUM> and the piston rod <NUM> to the pull lever <NUM>.

Check valve <NUM> may further prevent back-flow of fluids from connector <NUM> to external reservoir <NUM>. Anti-siphon check valve <NUM> may further prevent gravity flow from reservoir <NUM> to exit port <NUM> and prevents back flow from exit port <NUM> to connector <NUM>.

Pull lever <NUM> of actuation apparatus <NUM> may move linearly only along one axis of pump <NUM> (in the direction of the double-headed arrow indicated in <FIG>) so that when pull lever <NUM> moves in a first direction, the internal volume of internal reservoir <NUM> increases and when pull lever <NUM> moves in a second direction the volume of internal reservoir <NUM> decreases.

Movement in the first direction of the pull lever <NUM>, driven by the actuation apparatus <NUM>, draws the pump (e.g., piston) <NUM> in the same first direction, creating a vacuum in the cylinder of syringe which serves as internal intermittent reservoir <NUM>. As a result fluid is drawn from reservoir <NUM> into internal reservoir <NUM>.

Movement of pull lever <NUM> in said second direction applies pressure on the fluid in internal reservoir <NUM> that pumps out the medication from said internal reservoir <NUM> to the patient through anti-siphon check valve <NUM> and through outlet port <NUM>.

Electronic programmable means of actuation apparatus <NUM> may enable to determine the volume that to be pumped into syringe <NUM> every and each movement cycle of pull lever <NUM> (e.g., <NUM>) in the first direction and the volume that is pumped out of syringe <NUM> (e.g., <NUM>) every and each movement of pull lever <NUM> in the second direction. Frequency of pull lever <NUM> movement may also be pre-set and controlled. Similarly, the speed of movement of pull lever <NUM> may also be pre-set and controlled.

According to some embodiments of the present invention, actuation apparatus <NUM> may be equipped with electronic means to store and analyze the infusion data and to sound an alarm when data received and recorded is outside pre-defined limits. For example, when the total pulsed flow volume is beyond a predefined maximum dosage.

<FIG> shows the electromechanical pulse infusion system <NUM>, presenting the system in a situation where the pull lever <NUM> has moved in the second direction to its extremity, i.e. pumping out the fluids within syringe <NUM>. According to the embodiment illustrated in <FIG>, device <NUM> may be arranged to receive power from a wall socket, using a transformer-rectifier <NUM> and a cable <NUM>.

Reference is made to <FIG> that is a schematic illustration of a stationary pulse infusion system <NUM> according to some embodiments of the invention. External reservoir <NUM> in a form of a plastic bag may be placed on a pole near or above a patient's bad. Tubing system <NUM> may connect the bag to system <NUM> and may further be connected to a catheter. System <NUM> may further include a manual pulse flow controlling device <NUM>, allowing the patient and/or medical team member to manually control pulse flow generation device <NUM> to give an additional pulse of medication upon the patient's request (regardless of the administration frequency determined and programed in the automatic pulse flow generation device).

In some embodiments, System <NUM> may be configured to deliver manual pulse flow only.

Reference is made to <FIG> that is a schematic illustration of an ambulatory pulse infusion system <NUM> according to some embodiments of the invention. External reservoir <NUM> may be placed inside or attached to the body of system <NUM> to be carried out by the patient. An ambulatory system <NUM> may further include a tubing system <NUM> and a manual pulse flow controlling device <NUM> as disclosed above.

Reference is now made to <FIG> which is a schematic drawing of another electromechanical embodiment of the present invention. As may be seen in <FIG>, tubing <NUM> is connected to an inlet port <NUM> through an optional one-way valve <NUM>. A connector such as a T shape connector <NUM> leads to an anti-siphon check valve <NUM> and an exit port <NUM>.

Pulse flow generation device <NUM> is also connected to the 'T' connector <NUM>. Pulsed flow generation device <NUM> is equipped with a pump (e.g., piston) <NUM>, an optional spring <NUM>, an electric actuation apparatus <NUM> and a sensor (proximity switch) <NUM>. Syringe <NUM> is filled and discharges through connector <NUM>.

A fluid, such as fluid medicament, may flow from an infusion pump (not shown) through inlet port <NUM>, and through valve <NUM>. The fluid flowing into tube <NUM> between valves <NUM> and <NUM> may cause pressure build-up and push piston <NUM> in the first direction to increase the volume of fluid that may be contained in syringe <NUM>. When the volume of fluid within syringe <NUM> reaches a predefined volume, actuation apparatus <NUM> causes piston <NUM> to start moving in a second direction to pump out the fluid contained in syringe <NUM>. When fluid is pumped out from syringe <NUM> into tube <NUM>, pressure in tube <NUM> increases until pressure check valve <NUM> is opened, and a pulse of fluid may flow through the pressure-activated check valve <NUM> and may exit into a patient's body through outlet port <NUM>.

According to one embodiment of the present invention, as piston <NUM> reaches the vicinity of proximity switch <NUM> an electric signal causes actuation apparatus <NUM> to move in a second direction and applies an additional force on compression spring <NUM>. Spring <NUM> in turn pushes liquid out of device <NUM> forcing valve <NUM> to open and release a pulse of fluid medication. Spring <NUM> acts as a buffer between the fast actuation apparatus <NUM> and the slower movement of the piston <NUM>. According to yet another embodiment of the present invention, actuation apparatus <NUM> retracts to its original position after a preset delay, typically between <NUM> and <NUM> seconds. The reduced fluid pressure in syringe <NUM> allows new fluid therein thus starting a new cycle.

It would be appreciated by those skilled in the art that spring <NUM> may not be required and other buffer mechanisms may be used. It would be further realized that a buffer may not be required at all.

Means are provided to change the position of sensor or proximity switch <NUM>, thus adjusting the pulsed fluid volume. Other means for adjusting the volume of fluid released in each pulse may be used.

In an alternative embodiment sensor <NUM> is a component which continuously monitors piston <NUM> position and transmits signals to a programmable controller (PEC) (not illustrated). The PEC is easily set to a desired fluid volume per pulse, and additionally any desired time delay can be programmed therein.

Referring now to <FIG> that is an illustration of a pulse flow generation device <NUM> according to some embodiments of the invention. Device <NUM> of <FIG> is almost identical to that seen in <FIG> except that no sensor (proximity switch) is provided. A PEC (not shown) controls the actuation apparatus <NUM>, generating an electric signal according to a time interval set by the medical team. The signal connects power to the actuation apparatus <NUM> to move in a second direction to pump out fluid from syringe <NUM> and the pulse is generated exactly as described with reference to <FIG>. The time interval set in the PEC may be easily changed, and thus different pulsed volumes can be ejected while using the same basic flow rate.

Turning now to <FIG>, which illustrates an embodiment provided with a syringe <NUM> having an internal container <NUM> made of an elastic material, for example of silicone rubber positioned inside a rigid container <NUM>. Internal container <NUM> has a controlled volume and is beneficial in preventing any leak of a fluid into the pump mechanism. Furthermore, internal container <NUM> reduces the area of contact between the fluid and parts of the pump. In all other respects the present embodiment is identical to the embodiment described with reference to <FIG>.

With regard to <FIG>, which illustrates an embodiment similar to that shown in <FIG>, except that a PEC (not shown) comprised within actuation apparatus <NUM> creates an electric signal according to a time interval set by the user. Therefore switch or sensor <NUM> seen in <FIG> may not be required.

<FIG> illustrate a mechanical pulse device, so there is no electric actuation apparatus <NUM> as was seen in previous embodiments.

Tubing <NUM> is connected to an inlet port <NUM> through an optional one-way valve <NUM>. A connector such as T shaped connector <NUM> leads to a pressure-activated check valve <NUM> and an exit port <NUM>.

Pulsed flow generation device <NUM> is also connected to the 'T' connector <NUM>. Pulsed flow generation device <NUM> may be equipped with a piston <NUM>, a spring <NUM>, and a projection <NUM>.

The normally closed valve <NUM> thus prevents fluid discharge through outlet port <NUM>, wherefore incoming fluid accumulates in syringe <NUM>.

Valve <NUM> may be actuated by a lever <NUM> when pushed by projection <NUM>.

A fluid, such as a fluid medicament may flow from an infusion pump (not seen) through inlet port <NUM>. During pressure build up in connector <NUM> and in the syringe <NUM> piston <NUM> moves in a first direction to increase the volume of fluid contained in syringe <NUM> until projection <NUM> contacts a part of lever <NUM>, opening valve <NUM> and forcing a pulse of liquid through port <NUM>.

The reduced fluid pressure in syringe <NUM> then allows the entry of new fluid into syringe <NUM> thus starting the next cycle.

Means are provided to change the position of the projection <NUM> relative to the dimensions of pulse flow generation device <NUM>, thus adjusting the pulse volume. According to another embodiment, two projections, lower and upper may be used instead of projection <NUM>. The lower projection can be adjusted by the medical team member for varying the pulse volume. It would be appreciated that other means for adjusting the pulsed volume may be used.

Turning now to <FIG> that illustrate the almost identical embodiment shown in previous figures, <FIG>, the only difference being that syringe <NUM> comprises an internal container made of an elastic material, for example of silicone rubber The advantages of this arrangement have been explained with reference to <FIG>.

Referring now to <FIG>, which is an illustration of an arrangement of a mechanical pulse device similar to the devices seen in <FIG>. An elastic band <NUM> may be connected to projections <NUM> while being tensioned over a piston rod <NUM>. The elastic band <NUM> thus replaces the compression spring <NUM> seen in previous embodiments, and being external can be easily replaced when necessary.

The pulsed flow generation device <NUM> can be an integral part of an infusion pump or may be connectable to any infusion pump known in the art.

Reference is now made to <FIG> which is a flowchart of a method for converting a constant flow into a pulse flow which is an example useful for understanding the invention but which does not form part of the claimed subject matter. The method comprising the following steps:.

Releasing a fluid, such as an infusion medicament, from an external reservoir such as an infusion pump [Block <NUM>]. The fluid may than pass through a one-way valve to prevent the fluid from returning to the external reservoir [Block <NUM>].

Since the fluid flowing form the external reservoir is prevented from returning to the reservoir by the one-way valve, and cannot pass another valve, such as an anti-siphon check valve, the fluid enters and contained in an internal reservoir, such as a syringe [Block <NUM>].

When the volume of fluid in the internal reservoir reaches a predefined value, for example, <NUM>, an actuation apparatus applies pressure on the fluid contained in the reservoir and thus releases the contained fluid in an at least one pulsed flow [Block <NUM>].

According to one embodiment of the present invention, the volume of fluid contained in the internal reservoir may be released in several consecutive pulses, each pulse having a volume which is relative to the number of pulses. For example, if the reservoir has been filled with <NUM> of fluid medication, it may be released in one pulse of <NUM>, or may be released in <NUM> consecutive pulses of <NUM>.

Reference is now made to <FIG> which is an illustration of an automatic pulse flow generation device according to some embodiments of the invention. Device <NUM> may include, a device body <NUM>, made for example, from a rigid polymer, a screen <NUM>, a keyboard <NUM> and a housing <NUM> for holding an internal reservoir and bidirectional pump, for example, in the form of syringe <NUM> illustrated in <FIG>. Housing <NUM> may include holder <NUM> for holding the syringe. In some embodiments, holder <NUM> may include more than one component, for example, an internal reservoir holder <NUM> and a bidirectional pump holder <NUM>. In the exemplary embodiment of <FIG>, the internal reservoir holder <NUM> holds a syringe barrel and a bidirectional pump holder <NUM> holds a plunger of a piston. Housing <NUM> may further include a lever <NUM> to support the movement of the piston and a switch <NUM> for verifying that the internal reservoir was inserted into holder <NUM> and that a compatible internal reservoir is being used, for example in order to avoid administration errors such as overdosing or underdoing due to an insertion of a wrong internal reservoir.

<FIG> is a high level block diagram that includes some of the components of device <NUM>. Device <NUM> may further include a motor <NUM> (e.g., a servo motor) and a transmission <NUM> for transmitting a translational (or rotational) movement to lever <NUM> positioned over a shaft <NUM>. Motor <NUM> may be powered by a battery <NUM> via a power supply unit <NUM>. Device <NUM> may further include a controller <NUM>.

Controller <NUM> may be configured to control at least some of the elements included in system <NUM> and device <NUM>, for example, motor <NUM> and lever <NUM>. Controller <NUM> may further be configured to control the bidirectional pump (e.g., pumps <NUM> and <NUM>). Controller <NUM> may include any computation platform that may be configured to control system <NUM> according to code saved in a non-transitory memory associated with the controller, which when executed causes system <NUM> to perform the invention. Additionally or alternatively controller <NUM> may execute instructions received from a user using a user interface associated with controller <NUM>, for example, using keyboard <NUM> and/or screen <NUM>. Screen <NUM> may be a touch screen or any other display known in the art. Controller <NUM> may include a processor (e.g., a CPU, microcontroller, programmable logic controller (PLC) and the like), a non-transitory memory for storing codes that when executed by the processor perform the invention. Controller <NUM> may be associated with a user interface (e.g., a graphical user interface) that may include any devices that allow a user to communicate with the controller.

Controller <NUM> may control system <NUM> and device <NUM> to pump infusion fluid from the external reservoir to the internal reservoir and further pump an infusion fluid pulse from the internal reservoir to be injected by the catheter, the infusion liquid pulse may have a volume of at least <NUM> and a velocity of at least <NUM>/min.

Reference is now made to <FIG> which illustrates an exemplary internal reservoir and bidirectional pump, to be attached to device <NUM> illustrated in <FIG> according to some embodiments of the invention. A syringe <NUM> may include an internal reservoir <NUM>, for example, in the form of a barrel and a bidirectional pump <NUM>, for example, in the form of a plunger pump and a piston located inside internal reservoir <NUM>. Internal reservoir <NUM> may have a volume of <NUM>-<NUM>, for example, <NUM>. A Piston may be connected to a plunger pump (as illustrated) to form the bidirectional pump <NUM>. Bidirectional pump <NUM> may be configured to pump infusion fluid from external reservoir, such as reservoir <NUM>, to internal reservoir <NUM> and further pump an infusion fluid pulse from internal reservoir <NUM> to be injected by the catheter, the infusion liquid pulse may have a volume of at least <NUM> and a velocity of at least <NUM>/min. Controller <NUM> may be configured to cause bidirectional pump <NUM> to pump infusion liquid to or from internal reservoir <NUM>, for example, by controlling motor <NUM> to move lever <NUM> to push or pull the plunger of pump <NUM>. Syringe <NUM> may further include an indicator <NUM> for identifying the syringe, for example, in order to verify that the syringe is in the correct volume or contains the correct substance.

In the embodiment of <FIG>, the internal reservoir and the bidirectional pump are included in a single device, syringe <NUM>. However, in other embodiments of the invention the internal reservoir and the bisectional pump may each be a standalone component connected together via tubing system. The bidirectional pump may be any pump configured to pump liquids to and from a reservoir. For example, the bidirectional pump may include: a plunger pump (as illustrated), a peristaltic pump, a roots-type pump or any other pump known in the art. The internal reservoir may include any container configured to hold infusion fluids. The internal reservoir may have a constant volume or a changeable volume that may vary with the amount of infusion fluid in the reservoir.

Reference is made to <FIG> and <FIG> that are illustrations of tubing systems <NUM> according to some embodiments of the invention. Both systems <NUM> of <FIG> and <FIG> may include one-way check valve <NUM>, Y connector <NUM>, syringe connector <NUM>, patient clamp <NUM>, filer <NUM>, anti-siphon one way check valve <NUM> and outlet port <NUM>. The tubing system of <FIG> further includes piercing device <NUM> at the inlet port proximate to valve <NUM>. The tubing system of <FIG> may further include an external reservoir <NUM>, a medical team clamp <NUM> and a filling port <NUM>.

Reference is made to <FIG> that is an illustration of a manual controller (e.g., controller <NUM>) for controlling device <NUM> to apply a Patient Control Analgesia (PCA) and/or a Clinician Bolus by operating system <NUM> to inject infusion liquid pulse, for example, upon a request from the patient or a decision made by a medical professional. The injected infusion liquid pulse may have a volume of at least <NUM> and a velocity of at least <NUM>/min. The manual controller may include a housing <NUM>, a push button <NUM> to be pushed by the patient, a wire <NUM> and a plug <NUM>. The manual controller may be configured to cause an application of a predetermined amount of medication at a predetermined velocity, for example, <NUM> at <NUM>/min when the patient/clinician pushes button <NUM>, regardless of the frequency of infusion liquid pulse programed in automatic device <NUM>. The manual controller may be operated in addition to the automatic administration programed in automatic device <NUM> or separately when no administration is programed in automatic device <NUM>. It should be appreciated by those skilled in the art that in order to avoid overdosing, a lock time period during which additional pulses cannot be initiated by the patient may be set. It should be further appreciated that the predetermined amount of medication released by the patient and/or clinician may be reduced from the total volume of liquid in the internal reservoir and thus from the total volume of medication given to the patient in a given time interval.

Reference is made to <FIG> which is a flowchart of a method of administrating an infusion liquid pulse which is an example useful for understanding the invention but which does not form part of the claimed subject matter. The method of <FIG> (which does not form part of the claimed subject matter) may be performed by pulse infusion system <NUM>, disclosed above. In box <NUM> the method may include automatically pumping an infusion liquid from an external reservoir (e.g., reservoir <NUM>) to an internal reservoir (e.g., internal reservoirs <NUM> or <NUM>) included in a pulse infusion system, the external reservoir may be adapted to contain infusion fluids. System <NUM> may automatically pump the infusion liquid from the external reservoir every predetermined amount of time, for example, at least once in every <NUM> minutes, or every shorter periods of time. The infusion liquid may be pump using bidirectional pump.

In box <NUM>, the method (which does not form part of the claimed subject matter) may include automatically generating the infusion liquid pulse by pumping a predetermined volume of an infusion liquid from the internal reservoir and injecting the predetermined volume at a predetermined velocity, the predetermined volume may be at least <NUM> and the predetermined velocity may be at least <NUM>/min. The infusion liquid pulse may be generated using the bidirectional pump. The infusion liquid pulse may be injected to a patient via a catheter. In some embodiments, the predetermined volume may be between <NUM> to <NUM>. In some embodiments, the predetermined velocity may be between <NUM>/min to <NUM>/min. In some embodiments, the pressure of the infusion liquid pulse inside the internal reservoir may be any predetermined pressure to enable injecting the predetermined volume at a predetermined velocity, for example in the range of <NUM>-<NUM> bars.

In box <NUM>, the method (which does not form part of the claimed subject matter) may include manually generating the infusion liquid pulse by pumping a predetermined volume of an infusion liquid from the internal reservoir and injecting the predetermined volume at a predetermined velocity, the predetermined volume may be at least <NUM> and the predetermined velocity may be at least <NUM>/min. The infusion liquid pulse may be generated by controlling a manual controller (e.g., by pushing button <NUM>) to operate the bidirectional pump. The infusion liquid pulse may be injected to a patient via a catheter. In some embodiments, the predetermined volume may be between <NUM> to <NUM>. In some embodiments, the predetermined velocity may be between <NUM>/min to <NUM>/min. In some embodiments, the pressure of the infusion liquid pulse inside the internal reservoir may be any predetermined pressure to enable injecting the predetermined volume at a the predetermined velocity, for example, in the range of <NUM>-<NUM> bars.

In some embodiments, the method (which does not form part of the claimed subject matter) may include repeating the automatic generation of the infusion liquid pulse every predetermined duration of time, for example, at least once in every <NUM> minutes. In some embodiments, the method may include repeating the automatically pumping the infusion liquid from the external reservoir and automatic generation of the infusion liquid pulse every the same predetermined amount of time.

Claim 1:
A pulse infusion system (<NUM>), comprising:
a tubing system (<NUM>) having an inlet (<NUM>) connected to an external reservoir (<NUM>) adapted to contain infusion fluids and an outlet (<NUM>) connected to a catheter,
the tubing system (<NUM>) further comprises a check valve (<NUM>) proximate to the inlet (<NUM>) and an anti-siphon check valve (<NUM>) proximate to the outlet (<NUM>); and
an automatic pulse flow generation device (<NUM>) comprising:
an internal reservoir (<NUM>);
a controller (<NUM>); and
a bidirectional pump (<NUM>), controlled by the controller (<NUM>) and comprising a pulse actuation apparatus (<NUM>), wherein the bidirectional pump (<NUM>) is configured to pump infusion fluid from the external reservoir (<NUM>) to the internal reservoir (<NUM>) and further pump an infusion fluid pulse from the internal reservoir (<NUM>) to be injected by the catheter, the infusion liquid pulse having a volume of at least <NUM> milliliter (ml) and a velocity of at least <NUM> milliliter/minute (ml/min),
wherein the controller (<NUM>) is to control the pulse actuation apparatus (<NUM>) to control the velocity of the infusion pulse,
characterized in that:
the actuation apparatus (<NUM>) comprises a pull lever (<NUM>) that moves along one axis of the bidirectional pump (<NUM>), wherein when the pull lever (<NUM>) moves in a first direction the volume of the internal reservoir (<NUM>) increases and when the pull lever (<NUM>) moves in a second direction the volume of the internal reservoir (<NUM>) decreases, and
wherein the controller (<NUM>) is configured, for each movement cycle, to determine the pumped volume for movement of the pull lever (<NUM>) in the first direction and determine the pumped volume for movement of the pull lever (<NUM>) in the second direction.