Patent Description:
The background of the present disclosure is hereinafter introduced with the discussion of techniques relating to its context. However, even when this discussion refers to documents, acts, artifacts and the like, it does not suggest or represent that the discussed techniques are part of the prior art or are common general knowledge in the field relevant to the present disclosure.

The injection of fluids into patients is commonplace in several medical procedures. For example, a contrast agent (or contrast medium) may be injected, possibly along with a saline solution, to enhance contrast of target (body) features (for example, human body's structures or organs) within the patients during scan examinations thereof. Particularly, in imaging applications (wherein a visual representation of the interior of the patients is created in a non-invasive way without turning to surgery techniques) the use of a contrast agent makes the target features more conspicuous. As a result, target features that would otherwise be less distinguishable from other nearby features (for example, surrounding tissues) are advantageously highlighted. This significantly facilitates the task of clinicians in diagnostic applications, and particularly in the identification and/or characterization of lesions, the monitoring of their evolution or the response to medical treatments. For example, a iodine-based contrast agent (such as comprising iopamidol) is commonly used in Computed Tomography (CT) applications (such as angiography investigations).

The contrast agent is usually injected into a blood vessel of a patient by an (automated) injection system. The injection system pressurizes the contrast agent and injects it into the patient's vasculature or organ under predetermined injection conditions, for example at predetermined flow rate and volume. In this way, the contrast agent may be injected in a controlled, safe and efficient manner.

Therefore, an injection system is typically provided with one or more supply stations for supplying the contrast agent and/or the saline solution from a corresponding container (e.g. a bottle, a bag or a pouch). The injection system is further provided with a delivery arrangement that is in fluid communication with the at least one supply station and a pressurizing unit. Since the delivery arrangement is positioned upstream of the pressurizing unit and, therefore, it is not in direct connection with a patient, with substantially no risk or a very low risk of crosscontamination, generally the delivery arrangement is a disposable element that is changed periodically (for example, every <NUM> or <NUM> hours). This means that the delivery arrangement is not changed when a new patient undergoes an examination and it is typically kept in place for multiple successive injections, till the predetermined period of time designed for the delivery arrangement is fully elapsed.

The powered injection systems known in the art and presently available on the market are divided into two major groups: syringe injectors (like Empower CTA® or Empower CTA®+ manufactured by Bracco Injeneering SA) and syringe-less injectors (like CT Exprès® manufactured by Bracco Injeneering SA).

The present invention is directed to powered syringe-less injectors where the pressurizing unit comprises a peristaltic pump that houses a plurality of rollers, among which a tube is inserted, and then sequentially and alternately squeezed by the rollers for finally injecting a fluid into a patient (typically the fluid is a medical fluid which is a contrast agent or two different contrast agents, a saline solution, a contrast agent and a saline solution mixture, or a medication).

Some specific medical procedures require that the powered injectors provide for particularly demanding hydraulic performances, in particular in terms of pressure and flow rate of the fluid to be injected into a patient. This aspect is particularly critical for syringe-less injectors since, due to their intrinsic design characteristics, they can hardly compete with syringe injectors and provide high pressure and flow rate values.

For example, it is becoming more and more frequent that a powered injector is requested to be connected to insertable devices (e.g. PICC & PORT) which are already implanted in a patient's vasculature and which are used for establishing an intravascular access to a patient.

PICC is a Peripherally Inserted Central Catheter that is typically placed in a patient's arm to allow for a prolonged intravenous access, such as for extended antibiotic treatment or chemotherapy. A PICC is inserted in a peripheral vein (e.g. the cephalic vein, the basilic vein or the brachial vein) and then advanced through increasingly larger veins towards the heart, until the catheter tip rests in the distal superior vena cava or cave-atrial junction while the proximal end of the PICC remains outside of the body. A PICC is typically left in place in the patient's arm for periods ranging from six weeks to one year.

A PORT usually comprises a reservoir (the portal) - that is provided with a septum for needle insertion - and a catheter that goes from the reservoir into a patient's vein. The reservoir is surgically inserted under the skin in the upper chest or in the arm, and the catheter is fully inserted into the vein, i.e. there's no catheter tail outside of the patient's body.

Some patients that need to undergo an imaging examination (e.g. a computed tomography - CT) may already have a PICC in place for other purposes. Therefore, existing multi-lumen PICCs may be used for power injection of diagnostic and/or therapeutic agents. However, the presence of said insertable devices represents a considerable technical constraint for a powered injector (especially for a powered syringe-less injector) that is requested to generate pressure and flow rate values sufficiently high in order to still guarantee the desired and predetermined injection performances, even when such insertable devices are interposed between the injection system and the patient.

The Applicant has thus perceived the need of improving the hydraulic performance of a powered syringe-less injector so that a predetermined injection procedure is not affected by any additional medical device (e.g. PICC & PORT) already inserted in a patient's body and to which the syringe-less injector is requested to be connected.

In detail, the Applicant has perceived the need of improving the fluid flow within the peristaltic pump of a powered syringe-less injection system in order to reduce most of, if not all, the structural constraints that can negatively impact on the overall performance of the injection system, mainly in terms of maximum pressure and maximum flow rate of the injected fluid.

Moreover, the Applicant has also perceived the need of providing an injection system comprising a spike connector which promotes a correct and homogeneous fluid flow through the spike, and which guarantees a gradual and efficient penetration of the spike into a septum (membrane) possessed, for instance, by a delivery arrangement (day set) of said injection system. Patent document <CIT> discloses features falling under the preamble of claim <NUM>.

A simplified summary of the present disclosure is herein presented in order to provide a basic understanding thereof; however, the sole purpose of this summary is to introduce some concepts of the disclosure in a simplified form as a prelude to its following more detailed description, and it is not to be interpreted as an identification of its key elements nor as a delineation of its scope.

In order to improve the hydraulic performance of a syringe-less injection system, the Applicant has perceived the need of optimizing the path of the fluid flowing into a patient set assembly of the injection system.

Therefore, according to one aspect of the present disclosure, the Applicant has found that a fluid path optimization can be achieved by suitably designing the connection interface between the patient set assembly and a pressurizing unit of the injection system. In detail, the Applicant has found to provide the casing of a peristaltic pump component of the patient set assembly with a substantially U-shaped configuration in proximity of the peristaltic pump component inlet port so that a substantially straight fluid flow at said connection interface can be obtained, as it will be explained more in detail in the following with reference to the enclosed Figures. In other words, the Applicant has found to change the <NUM>° bending configuration of the prior art into a <NUM>° bending configuration with a large radius, said solution providing a decrease in the total pressure drop within the patient set assembly.

According to a further aspect of the present disclosure, the Applicant has found that the hydraulic performance of the syringe-less injection system can be further improved also by suitably choosing the material of the peristaltic tube on which the peristaltic pump component acts during operation of the syringe-less injection system.

According to a further aspect of the present disclosure, the Applicant has found that the hydraulic performance of the syringe-less injection system can be further improved also by suitably choosing the internal diameter of the delivery tube exiting the patient set assembly with respect to the internal diameter of the peristaltic tube positioned among the rollers of the peristaltic pump component.

Therefore, an aspect of the present disclosure provides for an injection system comprising a peristaltic pump component whose casing, in proximity of the inlet port that fluidically connects the patient set assembly with a delivery arrangement of the injection system, has a substantially U-shaped configuration.

One or more aspects of the present disclosure are set out in the independent claims and advantageous features thereof are set out in the dependent claims, with the wording of all the claims that is herein incorporated verbatim by reference (with any advantageous feature provided with reference to any specific aspect that applies mutatis mutandis to every other aspect).

The solution of the present disclosure, as well as further features and the advantages thereof, will be best understood with reference to the following detailed description thereof, given purely by way of a non-restrictive indication, to be read in conjunction with the accompanying drawings (wherein, for the sake of simplicity, corresponding elements are denoted with equal or similar references and their explanation is not repeated, and the name of each entity is generally used to denote both its type and its attributes, such as value, content and representation). In this respect, it is expressly intended that the figures are not necessary drawn to scale (with some details that may be exaggerated and/or simplified) and that, unless otherwise indicated, they are merely used to illustrate the structures and procedures described herein conceptually. Particularly:.

With reference in particular to <FIG>, a pictorial representation in partially exploded perspective view is shown of an injection system <NUM> wherein the solution according to an embodiment of the present disclosure may be applied.

The injection system <NUM> is used to inject one or more fluids into a patient (not shown in the figure). Particularly, the injection system <NUM> is an automated (powered) syringe-less injector that is used by clinicians to inject contrast agent and saline solution during scan examinations (for example, in radiography applications like CT scans).

The injection system <NUM> shown in <FIG> comprises a first supply station 105a, a second supply station 105b and a third supply station 105c for supplying the fluids to be injected from corresponding receptacles. Particularly, the supply station 105a and the supply station 105b supply a fluid from a bottle 110a and from a bottle 110b, respectively (i.e., a container made from glass or rigid plastic). On the contrary, the supply station 105c supplies a fluid from a pouch 110c (i.e., a container made from soft plastic). The supply stations 105a, 105b may be used to supply one or more contrast agents (to enhance contrast of specific body features within the patient), or a contrast agent and a saline solution (comprising a physiological or isotonic solution) respectively, whereas the supply station 105c may typically be used to supply a saline solution. For example, in CT applications the contrast agent may be a iodine-based contrast agent comprising diatrizoate, ioxaglate, iopamidol, iohexol, ioxilan, iopromide or iodixanol, and the saline solution may be sodium chloride. An example of a commercial contrast agent comprising iopamidol is ISOVUE®, manufactured by Bracco Diagnostics Inc. (trademarks). Each bottle 110a, 110b may contain a single or multiple dose (for example, <NUM>-<NUM>) of different contrast agents (a first contrast agent in the first bottle and a second different contrast agent in the second bottle, the two contrast agents to be supplied according to a predetermined sequence) or of the same contrast agent (to be supplied in succession to increase the duration of the scan examination). The pouch 110c generally contains a bulk of saline (for example, <NUM>-<NUM>,<NUM>) to be supplied before (pre-flush), after (post-flush) or between (interphase) injections of the contrast agent, or alternatively in rapid alternate succession with the contrast agent (to achieve a mixing of the contrast agent and the saline solution within an organ of the patient, for example within the heart). Alternatively, as mentioned above, the supply stations 105a and 105b may be used to supply a contrast agent and a saline solution, respectively. In this latter case the supply station 105c can be eliminated.

More specifically, each supply station 105a, 105b (respectively) comprises a bottle holder 115a, 115b for housing and supporting the bottle 110a, 110b. A protective cover 120a, 120b may be mounted on the bottle holder 115a, 115b to cover the bottle 110a, 110b when it is held thereon, thereby defining a (closed) chamber for housing the bottle 110a, 110b. The bottle holder 115a, 115b and the protective cover 120a, 120b protect the bottle 110a, 110b from external accidental shocks. Moreover, typically the protective cover 120a, 120b is made of a thermally insulating material (for example, polycarbonate) to reduce heat losses, thereby helping to maintain warm (for example, at about the body temperature) the medical fluid contained in the bottle 110a, 110b, which was previously heated in a dedicated device (not shown) separate from the injection system. Typically the supply station 105c comprises a hook 125c for hanging the pouch 110c.

The injection system further comprises a delivery arrangement <NUM> which determines a fluid pathway for delivering the medical fluids from the receptacles 110a, 110b, 110c to a pressurizing unit <NUM>. The tubing of the delivery arrangement is made from a plastic material. Preferably the tubing of the delivery arrangement is made from PVC.

For this purpose, in each supply station 105a, 105b a bottle connector 130a, 130b is arranged in a connection port 132a, 132b of the bottle holder 115a, 115b. The bottle connector 130a, 130b comprises a spike for connecting to the bottle 110a, 110b and a connection element (for example, a septum or a male luer lock fitting) in fluid communication with the spike. The spike and the connection element are located at opposite longitudinal ends of the bottle connector 130a, 130b. Typically, the bottle connector 130a, 130b also comprises a filtering unit (not shown in the figure) between its spike and connection element. The bottle connector 130a, 130b is a disposable element for use with a single bottle 110a, 110b (for example, with the spike tip that breaks off and remains inside the bottle 110a, 110b when the bottle connector 130a, 130b is removed in order to prevent any accidental re-use thereof).

The delivery arrangement <NUM> (which is often indicated by the technicians as "Day Set" or "Transfer Set") connects all the supply stations 105a, 105b, 105c to the pressurizing unit <NUM> for transferring the corresponding medical fluids from the receptacles 110a, 110b, 110c to a patient set assembly <NUM> which is received inside the pressurizing unit <NUM>. The delivery arrangement <NUM> comprises a transfer line for each supply station 105a, 105b, 105c. The transfer line of each supply station 105a, 105b comprises a flexible tubing 141a, 141b that is provided (at a distal end thereof with respect to the pressurizing unit <NUM>) with a reservoir (or drip chamber) 142a, 142b and a connection element 143a, 143b for mating with the connection element of the bottle connector 130a, 130b. For example, the connection element 143a, 143b is a spike connector in case the connection element of the bottle connector 130a, 130b is a septum; alternatively, the connection element 143a, 143b is a female luer lock fitting in case the connection element of the bottle connector 130a, 130b is a male luer lock fitting. During operation of the injection system <NUM>, the reservoir 142a, 142b and the connection element 143a, 143b are arranged inside the bottle holder 115a, 115b. Analogously, the transfer line of the supply station 105c comprises a flexible tubing 141c that is provided (at a distal end thereof with respect to the pressurizing unit <NUM>) with a reservoir (or drip chamber) 142c and a spike 143c for connecting to the pouch 110c. All the flexible tubings 141a, 141b, 141c are coupled (at their proximal ends with respect to the pressurizing unit <NUM>) with a T-connector <NUM>, which comprises a plug for insertion into a corresponding port of the pressurizing unit <NUM>.

The pressurizing unit <NUM> comprises an electric motor (not visible in the figure) which acts on a peristaltic pump that pressurizes the medical fluids (received from the receptacles 110a, 110b, 110c via the delivery arrangement <NUM>) for their injection into the patient (for example, up to a pressure of <NUM> bar, or at a flow rate from <NUM> to <NUM>/s).

As already mentioned above, the injection system <NUM> further comprises a patient set assembly <NUM> which connects the delivery arrangement <NUM> to the patient for delivering the pressurized fluids thereto. The patient set assembly <NUM> comprises a delivery tube <NUM> which is provided (at a proximal end thereof with respect to the pressurizing unit) with a peristaltic pump component <NUM>. The latter is introduced into a dedicated port provided in the pressurizing unit <NUM> and it is also put in fluid communication with the T-connector <NUM> of the delivery arrangement <NUM>. The peristaltic pump component <NUM> houses a rotor having a plurality of squeezing rollers, among which a corresponding portion of a peristaltic tube (not visible in <FIG>) is inserted, said peristaltic tube being in fluid communication with the delivery tube <NUM>.

When the patient set assembly <NUM> is of single use type (as shown in <FIG>) for use by a single patient only, the delivery tube <NUM> is quite long and it is provided (at a distal end thereof with respect to the pressurizing unit) with a connection element <NUM> for mating with a respective corresponding connection element (for example, a plug) of a peripheral catheter (not shown) which is inserted through the skin into a peripheral vein of the patient to be treated. The delivery tube <NUM> can be also provided with a clip <NUM> that pinches the tube and closes the delivery line during installation or uninstallation of the peripheral catheter.

When the patient set assembly <NUM> is of multiple use type (as shown in <FIG>) for use with multiple patients, typically the delivery tube <NUM> (delivery line) is quite short and it is provided at the distal end thereof with a connection element <NUM> for mating with a corresponding connection element <NUM> of an additional patient line <NUM> which typically comprises a quite long flexible tube. The additional patient line <NUM> terminates (at its distal end) with a connection element <NUM> for mating with a corresponding connection element possessed by a peripheral catheter (not shown).

The patient set assembly <NUM> is a disposable element which, in case of single use (see <FIG>), is for use entirely with a single patient, while, in case of multiple use (see <FIG>), it is changed periodically (for example, every <NUM> hours), except for the additional patient line <NUM> which is intended for use with a single patient only and thus it is discarded at the end of each injection procedure for a given patient, thereby being substituted with a new one when a new patient is ready to be treated.

According to the embodiment of <FIG> or <FIG>, each supply station 105a, 105b, 105c of the injection system <NUM> further comprises clamping means (not shown in the figures) for engaging the delivery arrangement <NUM>, and thus blocking or unblocking the passage of the fluids flowing there through. Specifically, the clamping means of supply station 105a, 105b is located inside the bottle holder 115a, 115b, while the clamping means of supply station 105c is located in a dedicated seat <NUM> housed in the front part of the injector body. Activation (i.e. clamping and declamping) of the clamping means is controlled automatically by the injector software, i.e. it is part of the injection steps that are carried out by the injector (according to the injection protocols that are loaded on the injector, typically on the injector remote console not shown in the figures).

A control unit <NUM> controls the operation of the injection system <NUM>. For example, the control unit <NUM> comprises a (main PCB) board with a microprocessor, a RAM that is used as a working memory by the microprocessor and a flash E<NUM>PROM that stores information to be preserved even when a power supply is off (particularly, a control program of the injection system <NUM>). Moreover, the control unit <NUM> comprises a touch-screen and several buttons, which are used by an operator to interact with the control unit <NUM>.

Most commonly the injection system <NUM> is supported by a stand <NUM>. The stand <NUM> is provided with wheels to facilitate moving the injection system <NUM>; moreover, the wheels have a foot brake to secure the injection system <NUM> in position. According to an alternative embodiment (not shown), the injection system is provided with a ceiling mount which allows installation of the injection system in the ceiling of the intervention/scan room.

<FIG> shows a perspective view of a current (prior art) patient set assembly <NUM> which comprises a peristaltic pump component <NUM> and a delivery tube <NUM>, the latter being provided at its distal end with a connection element <NUM> for fluidically communicate with a patient line (not shown) or directly with a peripheral catheter (not shown) inserted within a patient's vein or artery. The delivery tube <NUM> can also be provided with a clip <NUM> for pinching the tube and closing the delivery line during positioning of the peripheral catheter.

As better shown also in <FIG>, the peristaltic pump component <NUM> comprises two specular mating parts <NUM>, <NUM> which, once assembled together (e.g. preferably by gluing or by welding), define a closed casing for receiving an inlet connector <NUM>, at least a couple of rollers (not shown) of the peristaltic pump and a guiding path <NUM> for suitably guiding a peristaltic tube <NUM> fluidically communicating, respectively, with the inlet connector <NUM> and the delivery tube <NUM>.

According to the embodiment shown in <FIG>, the inlet connector <NUM> is a spike connector comprising a spike <NUM> which, during operation of the injection system <NUM>, penetrates a membrane possessed by the T-connector <NUM> of the delivery arrangement <NUM>, thereby making the fluid connection between the delivery arrangement <NUM> and the patient set assembly <NUM>. Alternatively (not shown in the figures), the inlet connector is a spike-less connector, and a safe and fluidic connection with a corresponding connector of a delivery arrangement is performed by any suitable mechanical means (e.g. a bayonet fitting or a snap-fit mechanism). Typically the inlet connector <NUM> is L-shaped and it is engaged in a protruding portion <NUM> standing out from the substantially rectangular casing main portion of the peristaltic pump component <NUM>. In more detail, the protruding portion <NUM> has a substantially rectilinear development in a direction which is substantially perpendicular to a minor lateral surface of the rectangular casing. The inlet connector <NUM> is located in correspondence of an inlet port <NUM> of the peristaltic pump component <NUM> so that the inlet connector proximal end (i.e. the inlet connector portion provided with the spike <NUM>) protrudes away from the inlet port <NUM>. In order to properly and safely engage and retain the inlet connector <NUM> within the protruding portion <NUM>, clipping members <NUM> are provided at the distal end of the L-shaped inlet connector <NUM>.

As shown in more detail in <FIG>, the guiding path <NUM> comprises a plurality of guiding segments for housing and guiding the peristaltic tube <NUM> from the inlet connector <NUM>, along the rollers (not shown) of the peristaltic pump component <NUM> up to the exit port <NUM> thereof. In <FIG> the guiding path <NUM> is shown only in the first mating part <NUM> of the peristaltic pump component <NUM>; however, an analogous and symmetric guiding path <NUM> is provided also in the second mating part <NUM> of the peristaltic pump component <NUM> so that, once the two mating parts <NUM>, <NUM> are assembled together, the overall guiding path <NUM> defines a predetermined path which substantially encloses the peristaltic tube <NUM> there into. The guiding path <NUM> comprises a curved guiding segment <NUM> which is positioned in the protruding portion <NUM> and which guides the peristaltic tube <NUM> in proximity of the distal end of the inlet connector <NUM>. Moving in the direction towards the exit port <NUM>, the guiding path <NUM> further and successively comprises a first rectilinear guiding segment <NUM>, a curvilinear guiding segment <NUM> and a second rectilinear guiding segment <NUM>, these segments being all contained in the substantially rectangular main portion of the casing of the peristaltic pump component <NUM>. The curvilinear guiding segment <NUM> supports the peristaltic tube <NUM> to stay in contact with the outer surface of at least a couple of rollers (not shown), which are received within the circular area <NUM> of the peristaltic pump component <NUM>, so that the peristaltic tube <NUM> is sequentially squeezed by the rollers against the internal wall of the curvilinear guiding segment <NUM> for suitably advancing the fluid along the peristaltic tube during operation of the peristaltic pump. Typically, the second rectilinear guiding segment <NUM> houses a connector for assembling together the peristaltic tube <NUM> and the delivery tube <NUM>, depending on the specific technical solution that is envisaged, as it will be better explained in the following of the present disclosure.

According to the prior art, as better represented in <FIG>, the longitudinal axis X-X of the inlet port <NUM> is substantially perpendicular to the longitudinal axis Y-Y of the guiding path proximal extremity, i.e. the proximal end of the curved guiding segment <NUM> that is in direct fluid communication with the distal end of the inlet connector <NUM>. This means that the fluid entering the peristaltic pump component <NUM> through the inlet port <NUM> (see arrow A of <FIG>) initially flows (inside the proximal end of the inlet connector <NUM>) in a direction that is substantially parallel to said longitudinal axis X-X, but then it is suddenly forced to turn of about <NUM>° in order to access the distal end of the inlet connector <NUM> and then to enter the peristaltic tube <NUM>, thereby following a direction that is substantially parallel to said longitudinal axis Y-Y.

The Applicant has noticed that said sudden change in direction of the fluid flow while entering the peristaltic pump component <NUM> (i.e. immediately after having crossed the inlet port <NUM>) causes fluid flow disturbances (turbulences) and recirculation which may negatively impact the peristaltic pump performances, especially when very demanding high hydraulic performances are needed due to the presence of already inserted medical devices, such as PICCs & PORTs. Therefore, in order to improve the hydraulic performance of a syringe-less injection system, the Applicant has perceived the need of optimizing the path of the fluid flowing into the patient set assembly of the injection system.

<FIG> shows a perspective view of a patient set assembly <NUM> according to an embodiment of the present disclosure. The patient set assembly <NUM> comprises a peristaltic pump component <NUM> and a delivery tube <NUM>, the latter being provided at its distal end with a connection element <NUM> for fluidically communicate with a patient line (not shown) or directly with a peripheral catheter (not shown) inserted within a patient's vein or artery. The delivery tube <NUM> is typically provided also with a clip <NUM> for pinching the tube and closing the delivery line during positioning of the peripheral catheter.

As better shown in <FIG>, the peristaltic pump component <NUM> comprises two specular mating parts <NUM>, <NUM> which, once assembled together (e.g. preferably by gluing or by welding), define a closed casing for receiving an inlet connector <NUM> and at least a couple of rollers <NUM> (shown in <FIG>) of the peristaltic pump. The two mating parts <NUM>, <NUM> also define a guiding path <NUM> for suitably guiding a peristaltic tube <NUM> fluidically communicating, respectively, with the inlet connector <NUM> and the delivery tube <NUM>.

According to the embodiment shown in <FIG>, the inlet connector <NUM> is a spike connector comprising a spike <NUM> which, during operation of the injection system <NUM>, penetrates a membrane (septum) possessed by the T-connector <NUM> of the delivery arrangement <NUM>, thereby making the fluid connection between the delivery arrangement <NUM> and the patient set assembly <NUM>. The inlet connector <NUM> is positioned in correspondence of an inlet port <NUM> of the peristaltic pump component <NUM> so that the inlet connector proximal end (i.e. the inlet connector portion provided with the spike <NUM>) protrudes away from the inlet port <NUM>.

According to an embodiment of the present disclosure, the casing of the peristaltic pump component <NUM> comprises a protruding portion <NUM> which contributes in defining a substantially U-shaped extension of the casing. In other words, according to the present disclosure, in proximity of the inlet port <NUM>, the casing of the peristaltic pump component <NUM> has a substantially U-shaped configuration for an improved accommodation of the inlet connector <NUM> and of the peristaltic tube <NUM> as better explained in the following of the present description.

According to the present disclosure the inlet connector <NUM> is a straight-type connector and clipping members <NUM> are provided within the protruding portion <NUM>, in proximity of the inlet port <NUM>, for properly and safely engaging and retaining the inlet connector <NUM> within the casing of the peristaltic pump component <NUM>.

As shown in detail in <FIG>, the guiding path <NUM> comprises a plurality of guiding segments for housing and guiding the peristaltic tube <NUM> from the inlet connector <NUM>, along the rollers <NUM> (shown in <FIG>) of the peristaltic pump component <NUM> and finally up to the exit port <NUM> thereof. <FIG> shows a perspective view of only the first mating part <NUM> of the peristaltic pump component <NUM>, while <FIG> shows a plan top view of both mating parts <NUM>, <NUM> within which the guiding path 420is suitably designed and defined.

In detail, the guiding path <NUM> comprises a substantially U-shaped guiding segment <NUM> which is mainly obtained inside the protruding portion <NUM> and which guides the peristaltic tube <NUM> to the distal end of the inlet connector <NUM>. More precisely, the substantially U-shaped guiding segment <NUM> is contained in the protruding portion <NUM> for the majority of its extension while only a small portion of the substantially U-shaped guiding segment <NUM> is received within the rectangular portion of the casing of the peristaltic pump component <NUM>. In more detail, the substantially U-shaped guiding segment <NUM> comprises a first straight branch 421a positioned in proximity of the clipping members <NUM> for retaining the inlet connector <NUM>, a curved segment 421b connected to the first straight branch 421a and whose curvature substantially corresponds and matches the curvature of the protrusion portion <NUM>, and a second straight branch 421c connected to the curved segment 421b.

Moving in the direction towards the exit port <NUM>, the guiding path <NUM> further and successively comprises a first rectilinear guiding segment <NUM>, a curvilinear guiding segment <NUM> and a second rectilinear guiding segment <NUM>, these segments being all contained in the substantially rectangular portion of the casing of the peristaltic pump component <NUM>. The curvilinear guiding segment <NUM> supports the peristaltic tube <NUM> to stay in contact with the outer surface of at least a couple of rollers <NUM> (three rollers <NUM> being shown in <FIG>), which are received within the circular area <NUM> of the peristaltic pump component <NUM>, so that the peristaltic tube <NUM> is sequentially squeezed by the rollers against the internal wall of the curvilinear guiding segment <NUM> for suitably advancing the fluid along the peristaltic tube during operation of the peristaltic pump. Typically, the second rectilinear guiding segment <NUM> houses a connector for assembling together the peristaltic tube <NUM> and the delivery tube <NUM>, depending on the specific technical solution that is envisaged, as it will be better explained in the following of the present disclosure.

According to the present disclosure, as better represented in <FIG>, the longitudinal axis Z-Z of the inlet port <NUM> is substantially parallel to (if not even coinciding with) the longitudinal axis of the inlet connector <NUM> (which is a straight-type connector) and to the longitudinal axis of the first straight branch 421a of the substantially U-shaped guiding segment <NUM> that is in direct fluid communication with the inlet connector <NUM>.

In comparison with the prior art solution described with reference to <FIG> (for instance), the Applicant has found that the U-shaped configuration of the protruding portion <NUM> (and thus of the corresponding U-shaped guiding segment <NUM>) according to the present disclosure allows the fluid entering the peristaltic pump component <NUM> through the inlet port <NUM> (see arrow B of <FIG>) to regularly and smoothly flow into the inlet connector <NUM> and then into the peristaltic tube <NUM> (housed within the guiding path <NUM>) with substantially no occurrence of undesired turbulent phenomena, thereby improving the injection system overall hydraulic performance.

Moreover, the Applicant has also found that the solution according to the present disclosure is particularly advantageous since the tolerances in size of the peristaltic tube (in particular the tolerances of the peristaltic tube length) can be less severe and less strict thanks to the U-shaped guiding segment <NUM> of the guiding path <NUM>. In fact, the U-shaped portion of the guiding path allows to suitably arrange peristaltic tubes which can be shorter or longer than the predetermined tolerance ranges. This aspect is particularly relevant since it considerably reduces the design constraints which are requested to be met by the tube manufacturers.

Furthermore, the Applicant has found that the solution according to the present disclosure is particularly advantageous also in terms of ergonomics and easiness of use during operation of the injection system. In fact, the presence of the substantially U-shaped protruding portion <NUM> of the peristaltic pump component <NUM> according to the present disclosure has sensibly increased the overall size thereof, especially in correspondence of the area that is used by the operator to manipulate the peristaltic pump component <NUM>, i.e. mainly to load and unload the latter into/from the pressurizing unit <NUM> of the injection system <NUM>. The increased area can be well appreciated by the operator, in particular when the peristaltic pump component <NUM> has to be disengaged from the pressurizing unit <NUM>. In fact, in this particular condition, most part of the peristaltic pump component <NUM> resides internally to the injector head and typically only a small portion of the peristaltic pump component <NUM> is available to the operator for grabbing it and discharging the patient set assembly. On the contrary, thanks to the solution of the present disclosure, during operation a major part of the substantially U-shaped protruding portion <NUM> protrudes out from the pressurizing unit <NUM> and the operator can easily access and grab the peristaltic pump component <NUM> for disengagement thereof.

According to an embodiment of the present disclosure (as represented in <FIG>), the peristaltic tube <NUM> is connected to the delivery tube <NUM> by means of a connector <NUM> which is safely and properly positioned within the peristaltic pump component <NUM> in proximity of the exit port <NUM>. The connector <NUM> is suitably kept in place and correctly positioned within the peristaltic pump component <NUM> by means of an additional clipping member <NUM>.

According to an embodiment of the present disclosure, the internal diameter of the delivery tube <NUM> is selected to be lower than the internal diameter of the peristaltic tube <NUM>. According to an alternative embodiment of the present disclosure, in order to further improve the hydraulic performance of the injection system <NUM>, the delivery tube <NUM> and the peristaltic tube <NUM> are selected to have the same internal diameter so that any tube cross-section restriction is substantially avoided when the fluid flows from the peristaltic tube into the delivery tube and no drop pressure will occur.

According to an embodiment of the present disclosure, in order to further improve the hydraulic performance of the injection system <NUM>, the delivery tube <NUM> is selected to have a hardness value higher than the hardness value of the peristaltic tube <NUM> in order to avoid blowing of the tube as a consequence of the pressure increase.

According to an alternative embodiment of the present disclosure (not shown in the figures), the delivery tube <NUM> is cut to be very short and a connection element is provided at its distal end so that a more versatile solution is provided. In fact, the connection element (e.g. a Luer connector) can be used for connecting a patient line that, based on the applicable law and regulatory rules of each specific country, can be of the single-use (i.e. for a single patient only) or of the multi-use (i.e. for multiple patients) type. This versatile solution is particularly advantageous since said patient set assembly can be easily adapted to and satisfy very specific needs on a case by case basis. For example, if a child or a baby is requested to be injected, a particularly tiny delivery tube would be associated to the connection element of the patient set assembly; on the contrary, for cardiac applications typically a bigger delivery tube is needed and thus would be associated to the connection element of the patient set assembly. Therefore, it is apparent that the patient set assembly according to such versatile solution can be considered as a standard component which can be used in any application, while only the distal portion of the delivery tube will be changed and selected on the basis of the very specific application/patient needs or requirements.

According to a further alternative embodiment of the present disclosure (not shown in the figures), the peristaltic tube <NUM> and the delivery tube <NUM> are exactly the same tube, thereby resulting in a less complex and less expensive patient set assembly <NUM>.

Preferably, the peristaltic tube <NUM> is made from polyurethane since this material can be pretty easily deformed by the rollers of the peristaltic pump, but, at the same time, it also fully and quickly recovers its original shape when it is not squeezed by the rollers, thereby ensuring that the predetermined fluid volumes are properly loaded within the peristaltic tube portions enclosed between two successive rollers and then advanced along the peristaltic tube and the delivery tube.

Alternatively, the peristaltic tube <NUM> is a multilayer tube which favorably combines the mechanical properties of different materials for an improved overall performance of said peristaltic tube. For instance, the multilayer tube comprises an inner layer made from TPE (Thermoplastic Elastomers) and an outer layer made from polyurethane, thereby combining the above mentioned advantages of polyurethane with a good behavior with respect to aging of TPE.

According to a further embodiment of the present disclosure, as better shown in <FIG>, the inlet connector <NUM> is a spike connector comprising a spike <NUM>. In detail, the spike <NUM> comprises a cylindrical hollow shaft <NUM> (which defines an internal fluid passage) and a substantially rounded, cone-shaped portion <NUM> provided at the distal end of the shaft <NUM>, said portion terminating in a substantially rounded and solid tip <NUM>. The spike <NUM> further comprises a plurality of elongated inlet openings <NUM> (e.g. three openings are shown in <FIG>) which, according to the embodiment shown in <FIG>, partially extend along the shaft and the substantially rounded, cone-shaped portion, said elongated inlet openings being in fluid communication with the internal fluid passage defined by the cylindrical hollow shaft <NUM>. Since the substantially rounded, cone-shaped portion <NUM> is closed at its distal tip <NUM>, the fluid can enter the spike <NUM> only through the elongated inlet openings <NUM>. According to the embodiment shown in the figures, said elongated inlet openings <NUM> have a substantially rectangular shape and their longitudinal extension is substantially parallel to the spike longitudinal axis W-W, at least for the part of the elongated inlet opening that extends along the spike cylindrical shaft. Moreover, in order to homogeneously distribute the fluid flow into the internal cavity of the spike <NUM>, the elongated inlet openings are circumferentially arranged to be equally distanced from each other along the lateral surface of the cylindrical hollow shaft <NUM>, and their distribution as well as their configuration is suitably designed for increasing the maximum area available for the fluid passage. Therefore, the implementation of laterally and circumferentially arranged elongated inlet openings (instead of one central opening) favorably improves the fluid inflow into the inlet connector <NUM>. Furthermore, the substantially rounded, cone-shaped portion <NUM> at the distal tip <NUM> of the spike <NUM> has been designed for improving the penetration efficacy of the spike through the membrane (septum) possessed by the T-connector <NUM> of the delivery arrangement <NUM>. In fact, the Applicant has perceived the need of providing a spike design which can contribute not only in promoting a correct and important fluid flow through the spike, but also in guaranteeing a gradual and efficient penetration of the spike into the T-connector membrane in order to preserve the integrity thereof after multiple spike insertions, especially taking into consideration that the delivery arrangement ("Day Set") is designed to remain in operation for a whole working day. Finally, the substantially rounded, cone-shaped portion <NUM> of the spike <NUM> has also the advantage of facilitating the operator during the insertion of the spike <NUM> through the membrane (septum) of the T-connector <NUM> (that is provided with a suitable cut at its central portion for better guiding and facilitating the spike insertion) since the spike end rounded surface encounters less resistance to penetration in comparison with a cylindrical hollow spike that is traditionally possessed by the spike connectors <NUM> of current patient set assemblies <NUM>.

Therefore, according to one embodiment of the present disclosure, the patient set assembly <NUM> comprises at least one improved inlet connector <NUM> provided with the new modified spike <NUM>.

According to a further embodiment of the present disclosure, the patient set assembly <NUM> comprises at least one improved inlet connector <NUM> provided with the new modified spike <NUM>.

According to a further embodiment of the present disclosure, the delivery arrangement <NUM> comprises at least one improved inlet connector <NUM> provided with the new modified spike <NUM>. According to this embodiment, the connection elements 143a, 143b of <FIG> and <FIG> are substituted with the improved inlet connectors <NUM>, whose spikes <NUM> penetrate a septum (membrane) possessed by corresponding bottle connectors 130a, 130b.

In operation, for each injection to be performed, the operator positions the injection system <NUM> close to the patient to be examined and then turns the injection system on. If not already done, the operator installs the delivery arrangement <NUM> by inserting each drip chamber 142a, 142b and each connection element 143a, 143b into the corresponding bottle holder 115a, 115b, thereby releasably blocking them therein (for example, by means of a snap-fit mechanism). When the pouch 110c (containing the saline solution) is not installed, the control unit <NUM> displays a message on its screen prompting the operator to do so. If the pouch 110c is to be used, the operator pierces a seal of the pouch 110c with the spike 143c, hangs the pouch 110c from the hook 125c and fills the reservoir 142c completely with the saline solution (by repeatedly squeezing it). At this point, the operator programs the control unit <NUM> (either at the control unit <NUM> or at an injector remote console not shown in the figures) by entering specific information relating to the saline solution of the pouch 110c (for example, its brand name and volume). Otherwise, if the pouch 110c is not used, the operator enters a corresponding command to the control unit <NUM> (or the remote console). In both cases, when the bottle 110a (with the contrast agent) is not installed, the control unit <NUM> displays a message on its screen prompting the operator to do so. In response thereto, the operator generally takes the bottle 110a from a separate warmer (not shown in the figures), wherein the bottle 110a has been pre-warmed to a target temperature. The target temperature is typically set to a value high enough to allow injecting the contrast agent efficiently (for example, at the desired flow rate) and comfortably for the patient, but not too high to be harmful for the patient. Typically the target temperature is in a range from <NUM> to <NUM>. Alternatively, this procedure is not performed and thus the contrast agent is not pre-warmed being injected at room temperature. The operator pierces a seal of the bottle 110a with the spike of the bottle connector 130a. Then he turns the bottle 110a (with the bottle connector 130a connected thereto) up-side-down, he inserts the bottle connector 130a into the connection port 132a (so as to connect its connection element to the connection element 143a), he mounts the protective cover 120a on the bottle holder 115a (so as to protect and thermally insulate the bottle 110a) and then he fills the drip chamber 142a with the contrast agent (by repeatedly manually squeezing the reservoir 142a). At this point, the operator programs the control unit <NUM> (either at the control unit <NUM> or at the injector remote console) by entering specific information relating to the contrast agent of the bottle 110a (for example, its brand name and volume). The operator repeats the same operations, if necessary, to install the other bottle 110b (which may contain the same contrast agent of bottle 110a or a different contrast agent or even a saline solution). The control unit <NUM> then displays a message on its screen prompting the operator to install the patient set assembly <NUM>. Therefore the operator can introduce the peristaltic pump component <NUM> into the dedicated slot of the pressurizing unit <NUM>, connect the peristaltic pump component <NUM> to the T-connector <NUM> and arm the injector which will be ready to run a predetermined selected injection procedure.

In case the patient set assembly <NUM> is for multiple use (as shown in <FIG>), the operator further connects the connection element <NUM> of the additional patient line <NUM> to the connection element <NUM> of the delivery tube <NUM>.

Successively the operator separately primes each transfer line 141a, 141b and 141c by selecting a corresponding priming function on the control unit <NUM> (or at the remote console), so as to eliminate air bubbles that are possibly present within the transfer lines 141a, 141b and 141c, the delivery tube <NUM> and/or the (possible) additional patient line <NUM>. Alternatively and preferably, the priming phase is advantageously automatically performed by the injection system without the need for the operator to execute it manually. Once this priming phase has been terminated (and no air is sensed in the injection system <NUM>), the operator finally connects the connection element <NUM> of the patient set assembly <NUM> (in case the patient set assembly is for a single use) or the connection element <NUM> of the additional patient line <NUM> (in case the patient set assembly is for multiple use) to the connection element of a peripheral catheter (not shown in the figures) which has already been inserted into the patient's vasculature.

Then the operator programs the control unit <NUM> (or the remote console) by entering or selecting information related to the injection examination to be performed (for example, the needle gauge of the peripheral catheter, the injection protocol comprising one or more injection phases, each injection phase being defined by the type, volume and flow rate of the medical fluids to be injected, possibly selected among pre-defined injection protocols for different types of injection procedures and correlated scan examinations).

The injection protocol (i.e. the number of injection phases, the sequence of injection phases, the injection parameters like flow rate and duration time, contrast agent and saline details, needle gauge) specific for a given patient to be examined can be manually introduced by the operator through the control unit <NUM> (or the remote console). Alternatively, the operator can download a desired injection protocol from a removable memory, such as a USB flash drive. Alternatively, the operator can download a desired injection protocol, as well as the relevant data of the patient to be examined, from a server which can connect more than one injection system <NUM> and, in case, also a plurality of clinical premises.

Finally the operator can start the scan examination which combines the functionalities of the injection system with the functionalities of the imaging device, the latter being operated in conjunction with the injection system that provides for the contrast agent activity which is used during the scan procedure. At the end of the scan examination, the injection system <NUM> stops automatically and the operator disconnects the patient set assembly <NUM> or the additional patient line <NUM> from the peripheral catheter.

As mentioned above, if the patient set assembly <NUM> is of the single-use type, the operator disengages the peristaltic pump component <NUM> and he discards the used patient set assembly <NUM>. On the contrary, if the patient set assembly <NUM> is of the multiple-use type and its usage time (typically <NUM> hrs) has not elapsed yet, the operator keeps the peristaltic pump component <NUM> - and the peristaltic tube <NUM> as well as the delivery tube <NUM> loaded therein - within the pressurizing unit <NUM> and he finally removes and discards only the used additional patient line <NUM>. At this point the injection procedure of the examined patient can be considered completed.

As mentioned above, if the delivery arrangement <NUM> is a disposable element that is required to be changed every <NUM> hours, at the end of the injection procedure the delivery arrangement <NUM> is not discarded if its usage time has not elapsed yet, and it remains installed on the injector, ready for a new patient to be injected and a new injection procedure to be started.

The injection system <NUM> of <FIG> and <FIG> comprises three separate supply stations 105a, <NUM>, 105c. However, the present disclosure can be applied to an injection system that is provided with a single supply station (not shown). Analogously, the present disclosure can be applied to an injection system that is provided with two separate supply stations (not shown).

In order to satisfy local and specific requirements, a person skilled in the art may apply many logical and/or physical modifications and alterations to the present disclosure. More specifically, although this disclosure has been described with a certain degree of particularity with reference to one or more embodiments thereof, it should be understood that various omissions, substitutions and changes in the form and details as well as other embodiments are possible. Particularly, different embodiments of the present disclosure may even be practiced without the specific details (such as the numerical values) set forth in the preceding description to provide a more thorough understanding thereof. Conversely, well-known features may have been omitted or simplified in order not to obscure the description with unnecessary particulars. Moreover, it is expressly intended that specific elements and/or method steps described in connection with any embodiment of the present disclosure may be incorporated in any other embodiment as a matter of general design choice. In any case, each numerical value should be read as modified by the term about (unless already done) and each range of numerical values should be intended as expressly specifying any possible number along the continuum within the range (comprising its end points). Moreover, ordinal or other qualifiers are merely used as labels to distinguish elements with the same name but do not by themselves connote any priority, precedence or order. The terms include, comprise, have, contain and involve (and any forms thereof) should be intended with an open, non-exhaustive meaning (i.e., not limited to the recited items), the terms based on, dependent on, according to, function of (and any forms thereof) should be intended as a non-exclusive relationship (i.e., with possible further variables involved), the term a/an should be intended as one or more items (unless expressly indicated otherwise), and the term means for (or any means-plus-function formulation) should be intended as any structure adapted or configured for carrying out the relevant function.

In an embodiment, the injection system is for injecting one or more fluids into a patient. However, the fluids may be in any number and of any type (for example, whatever medical fluid to be used in a generic medical application for diagnostic or therapeutic purposes, such as a drug or a body fluid, or more generally to be used in any other treatment, such as for cosmetic purposes); moreover, the fluid may be injected in any way (for example, intra-arterially) into any (human or animal) patient.

In an embodiment, the injection system comprises one or more supply stations each one for supplying one of the fluids to be injected. However, the injection system may comprise any number of supply stations (down to a single one) for supplying the same or different fluids (in any combination).

Claim 1:
An injection system (<NUM>) comprising:
- at least one supply station (105a; 105b; 105c) for supplying a fluid to be injected into a patient's vasculature;
- a pressurizing unit (<NUM>) comprising a motor for pressurizing the fluid received from said at least one supply station;
- a delivery arrangement (<NUM>) in fluid communication with said at least one supply station;
- a patient set assembly (<NUM>) in fluid communication with said delivery arrangement, said patient set assembly comprising:
- a delivery tube (<NUM>) for delivering the pressurized fluid to the patient, and
- a peristaltic pump component (<NUM>) comprising a casing (<NUM>, <NUM>) which includes an inlet port (<NUM>) and an exit port (<NUM>), the inlet port being in fluid communication with the delivery arrangement, and the exit port being in fluid communication with the delivery tube,
characterized in that, in proximity of said inlet port, the casing of the peristaltic pump component (<NUM>) has a substantially U-shaped configuration.