WO2021229567A1

WO2021229567A1 - Apparatus for injection by remote control with feedback, and method

Info

Publication number: WO2021229567A1
Application number: PCT/IL2021/050535
Authority: WO
Inventors: Noam Shaul SHAMAY
Original assignee: EndoWays LTD.
Priority date: 2020-05-12
Filing date: 2021-05-11
Publication date: 2021-11-18

Abstract

An apparatus for injection by remote control with feedback to a user. The apparatus comprises an injection machine, disposed at an in-situ site remote from a user, for performing an injection process by injection of a substance in vivo. The apparatus has an injection simulator, for manual operation, configured to return to the user of a selectable tactile perception replicating a manual in vivo injection. Furthermore, a flow adjustment mechanism, included in the injection simulator INJSIM, is configured to generate a tactile feedback signal, which is proportional to a variation occurring to an injection flow parameter, derived by the injection machine during the injection process, Thereby, the tactile feedback varies according to variations of the flow parameters. Moreover, the by machine generated tactile feedback is a haptic feedback.

Description

APPARATUS FOR INJECTION BY REMOTE CONTROL WITH FEEDBACK,

AND METHOD

Technical Field

The present disclosure is related to remote medical injections, and in particular, to provide a user in real time with a sensory feedback from a remotely performed injection process.

Technical Problem

The problem is how to provide a user performing an injection by machine and by remote control, with a real time tactile feedback simulating a manually performed injection.

Solution to the Problem

The problem is solved by providing the user with a simulated tactile feedback of the injection process. The user is provided with an injection simulator, similar to a couple of medical syringes, which when operated, provides the tactile feeling, or tactile impression, or tactile perception, of performing a real in vivo injection. This impression, is achieved by the creation of a resistance force in the injection simulator, which resistance force is perceived by the user as if ejecting a substance out of a medical syringe. However, changes of value or level of the physical data of the flow parameters derived during the machine performed real in vivo injection are detected by machine sensors supported by the injection machine. Changes of level or value are communicated to the injection simulator where they cause a proportional, increase or decrease of resistance force which is received by the user as a tactile feedback, in addition to the tactile impression, or tactile perception. The in situ measured changes of level or value may also be displayed on display screen(s) and /or sounded audibly by loudspeaker(s) disposed ex situ. Thereby, the user may receive feedback in real time as visual and audible feedback in addition to the tactile impression and tactile feedback.

Advantageous Effects of Invention

Feedback forwarded to a user performing a remote injection may shorten the duration of an invasive intervention, and warn and prevent potential negative effects, and/or danger to a patient. The injection simulator is of simple build, is inexpensive, and though reusable, is cheap enough to be discarded after use.

Brief Description of Drawings

Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments, in conjunction with the figures. The figures are generally not shown to scale and any measurements are only meant to be exemplary and not necessarily limiting. In the figures, identical structures, elements, or parts that appear in more than one figure are preferably labeled with a same or similar number in all the figures in which they appear, in which:

Fig. 1 illustrate an exemplary environment for use of the apparatus APP,

Fig. 2 is a block-diagram of the apparatus APP,

Fig. 3 depicts an exemplary embodiment of the injection simulator INJSIM,

Figs. 3.1 to 3.4 show exemplary embodiments of specific flow-restrictor FLWRS,

Fig. 3.5 depicts an exemplary gradually adjustable restricting opening ORFCE,

Fig. 3.6 shows an exemplary connection between two cylinders of an injection simulator INJSIM,

Fig. 3.7 illustrates an exemplary injection simulator INJSIM supporting a canister,

Figs. 4 shows a schematic exemplary portion of an injection machine INJMCH.

Summary of Invention

There is described an apparatus APP for providing a user with feedback in real time from an injection of a substance SBS made by remote control by an injection machine INJMCH which is disposed at an in situ site INSIT. The user of the apparatus APP may be located ex situ EXSIT, at a remote site REMSIT, while the injection is made at an in-situ site INSIT. There is provided an injection simulator INJSIM, for manual operation, configured to return to the user of a selectable tactile perception replicating a manual in vivo IN VIVO injection as if being made with a conventional medical syringe. When operating the injection simulator INJSIM, the user feels a resistance force which is perceived as if using a medical syringe for making an injection. This resistance force is a reaction to the force the user himself applies onto the syringe-like portion of the injection simulator INJSIM. That force is selectable by the user by choosing an injection simulator INJSIM which requires a higher or a lower force for operation, thus replicating a medical syringe which requires a higher or a lower force to operate.

The injection simulator INJSIM further includes a flow adjustment mechanism ADJMCN, which is configured to generate a tactile feedback as a signal, which is proportional to a variation occurring to an injection flow parameter, derived by the injection machine INJMCH during the injection process. Changes occurring to the flow of fluid injected by the injection machine INJMCH during the injection process are reported to the flow adjustment mechanism ADJMCN. In turn, the flow adjustment mechanism ADJMCN adjusts, thus changes the force, higher or lower, the user has to apply on the injection simulator INJSIM. Such an adjustment, or change of force is thus communicated to the hand of the user as a tactile feedback, which is of valuable information to the user. Thereby, the constant force provided by the tactile perception is modulated by the tactile feedback which varies according to variations detected in the injected flow of fluid, according to ease or difficulty of penetration of the flow of fluid injected into the vasculature VSC.

There is also described a method for constructing an apparatus APP for providing a user with feedback from an injection of a substance SBS made by remote control by an injection machine INJMCH which is disposed at an in-situ site INSIT. A user operating from a remote ex situ EXSIT is provided with communication means for operating an in-situ site INSIT disposed injection machine INJMCH for injecting a substance SBS in vivo IN VIVO during an injection process. Furthermore, an injection simulator INJSIM is constructed by coupling a connection tube CONTB between two same syringe-like bodies, respectively BDY1, BD2, for returning a tactile perception to the user upon manual activation of one of both of the bodies BDY1, BDY2 in replication of a manual medical in vivo IN VIVO injection. By containing a fluid matter MAT, which passes via the connection tube CONTB from one syringe body BDY 1 to another syringe body BDY2, and vice versa, from the body BDY2 to the body BDY1, a resistance to the flow of matter MAT is created. By operating manual force on the injection simulator INJSIM in medical syringe-like operation force, a flow of matter MAT is pushed via the restricting opening ORFCE, which is a resistance to the flow of fluid created by the connection tube CONTB. This resistance generates the tactile perception or force which is communicated to the user. Next, advantage is taken from a machine sensor MCHSNS, which is included in the injection machine INJMCH, to derive injection flow parameters from the injection process. Likewise, an adjustable flow adjustment mechanism ADJMCN is included in the connection tube CONTB, for adjusting a restricting opening ORFCE, in proportion to a value or rate of derived variations of the injection flow parameters, whereby the user is provided with a tactile feedback proportional to a rate or level of fluid flow parameter(s) derived from the injection process. The adjustable flow adjustment mechanism ADJMCN is disposed in the interior of the hollow of the connecting tube CONTB to adjust a restricting opening ORFCE wherethrough the operation of the injection simulator INJSIM forces the matter MAT to flow. It is in response to a variation, or change of rate or of value of a monitored flow parameter(s) that the flow adjustment mechanism ADJMCN proportionally adjusts the passage of fluid via the restricting opening ORFCE. This means that the flow adjustment mechanism ADJMCN may for example, widen or restrict the passage of fluid through the restricting opening ORFCE in response to a detected rise or decrease of, for example, a pressure level value. In response to such an adjustment, the user will sense a change or modulation of the tactile impression/perception, and receive feedback in the form of a tactile feedback.

Description of Embodiments

Fig. 1 illustrates an exemplary environment wherein embodiments of the apparatus APP may be used.

Fig. 1 is a schematic prior art illustration of a surgical theater showing a portion of a body BDY which is disposed at an in-situ site INSIT, and into which a catheter device CATDEV is inserted from ex vivo EX VIVO, for injection into a vasculature VSC of a substance SBS, which is not shown in Fig. 1. The catheter device CATDEV has a proximal catheter portion PRXPRT which may support at least one proximal port PRT, and a distal catheter portion DSTPRT which is terminated by a catheter extremity portion EXPRT. The catheter extremity portion EXPRT is shown to be inserted in vivo IN VIVO in the vasculature VSC.

Fig. 2 is a block diagram showing an exemplary distribution of a few elements of the apparatus APP at a conventional in-situ site INSIT of a surgical theater where the injection by machine is performed. Furthermore, Fig. 2 also depicts an ex situ site EXSIT, or remote site REMSIT, from where the user performs the injection by remote control. The user of the apparatus APP is preferably a medical practitioner.

The in-situ site INSIT may include at least an imaging device IMGDEV, an injection machine INJMCH, and a catheter device CATDEV of which the catheter extremity portion EXPRT is inserted in vivo IN VIVO in the vasculature VSC of a patient. The remote site REMSIT, includes an injection monitor INJMON, and the injection simulator INJSM. The remote site REMSIT may also include a remote display screen RDISPL and a remote loud speaker LDSPKR which are made available to the user to provide, respectively, visual and audible feedback from the in vivo IN VIVO injection process.

In Fig. 2, the imaging device IMGDEV is shown to operate in one first direction to irradiate and image the vasculature VSC and the catheter extremity portion EXPRT. In a thereto opposite second direction, the imaging device IMGDEV collects images returned from the vasculature VSC. This optical bidirectional communication is indicated by a line with two arrowheads, one arrowhead at each end of the line. The collected images are then communicated by the imaging device IMGDEV to the ex situ EXSIT disposed, thus remote display RDISPL, disposed at the remote site REMSIT, as visual feedback for the user.

It is noted that in the Figs., lines coupling between elements may represent wired communication and/or wireless communication. The exception is that the injection simulator INJSIM is coupled to other elements of the apparatus APP by wireless communication. Details of the communication devices and methods are not shown and described since being well known to those skilled in the art.

From the remote site REMSIT, the user may operate, and use the injection simulator INJSIM. For the sake of simplicity and clarity of Fig. 2, the injection simulator INJSIM and the injection monitor INJMON are shown in the same rectangle of the block diagram, even though being two different independent units. A communication line couples between the injection monitor INJMON and the user, but with two arrowheads, one arrowhead at each end of the single line since communication is bidirectional: In a first direction the user manually enters injection input commands to the injection monitor INJMON, and in a second direction, opposite the first direction, the injection machine INJMCH may send machine sensor(s) MCHSNS derived signals at least to the injection simulator INJSIM to produce a tactile feedback. The injection simulator INJSIM is described in detail hereinbelow in relation to Fig. 3.

In Fig. 2, for the sake of clarity, the signals derived by the machine sensor(s) MCHSNS for wireless communication to the injection simulator INJSIM, are shown to reach this last one via the injection monitor INJMON even though this is not necessarily so. Actually, data from the machine sensor(s) MCHSNS may be forwarded via the injection machine INJMCH by wireless communication directly to the injection simulator INJSIM.

Further input commands may be selected by the user and communicated to the injection machine INJMCH via the injection monitor INJMON. It is the injection machine INJMCH which actually injects the substance(s) SBS into the vasculature VSC and which may furthermore, provide data derived from the ongoing injection process by the machine sensor(s) MCHSNS. The injection machine INJMCH may thus derive physical data from the flow of the injection process, then process that data and return tactile feedback in real time to the injection simulator INJSIM via wireless communication. Alternatively, the flow data derived by the machine sensor(s) MCHSNS may be processed and returned as tactile feedback to the injection monitor INJMON and then, by wireless communication, to the injection simulator INJSIM. Although not shown in the simplified Fig. 2, the injection monitor INJMON, may be coupled to the injection simulator INJSIM by bidirectional wireless communication.

Bidirectional communication may be established between the injection monitor INJMON and the injection machine INJMCH, as indicated by a line with two arrowheads, one arrowhead at each end of the line. Bidirectional wireless communication may also be established between the injection simulator INJSIM and the injection machine INJMCH, for example, for the user to send a command to start operation of the injection machine INJMCH, and to receive tactile feedback.

As described hereinbelow, the user may manually enter input commands via the injection monitor INJMON, which may include a command panel COMPNL, indicated in Fig.2. These input commands may be forwarded to the injection machine INJMCH, and/or to the remote display RDISPL and/or to the loudspeaker LDSPKR disposed at the remote site REMSIT. Thereby, in addition to the physical data derived from the flow of the ongoing injection process, the user may view his own input data which were entered via the injection monitor INJMON. The remote display RDISPL may exhibit that data as images, alphanumeric information, and signals, thus as visual feedback to the user. Evidently, the user may also receive from the in-situ site INSIT, visual feedback on the remote display RDISP, whereon, for example, the radiopaque flow of an injected substance SBS may be shown to develop in response to the remote injection.

The remote loudspeaker LDSPKR, shown in Fig. 2, may be provided for delivery of audible feedback to the user. For the sake of clarity of Fig. 2, the loudspeaker FDSPKR is shown to be coupled to the remote display RDISPF.

Injection simulator

Fig. 3 schematically depicts an exemplary embodiment of the injection simulator INJSIM for the sake of illustration of the principle of operation thereof. The injection simulator INJSIM is designed to be held by hand by the user, and be used in the same manner as a conventional medical injection syringe is held for injection. This means that the user may hold and operate the injection simulator INJSIM with the same fingers as when performing an injection with a commonly well-known medical syringe.

Fig. 3 depicts the injection simulator INJSIM as two same medical injection syringes or syringe-like bodies BDY, which are coupled in face to face assembly, opposite to each other. These two injection syringes are separated apart by a connecting tube CONTB which supports a flow-restrictor FFWRS having a flow restricting opening ORFCE. Each one end of the connecting tube CONTB is coupled to the needle hub of a respective syringe body BDY. By being the same, each one of the two bodies, BDY1 and BDY2, may be held and operated in the same manner.

In Fig. 3, the connecting tube CONTB and each one of the two bodies BDY 1 and BDY of the injection simulator INJSIM may contains matter MAT. Matter MAT contained for example in the first hollow cylinder CYF1 may be forced, via the connecting tube CONTB, into the second hollow CYF2 by pushing the piston PIST1, or plunger PFNGR, of the first cylinder CYF1 towards the second cylinder CYF2. Thereby, the matter MAT will be forced through the flow restrictor FFWRS. As with common medical syringes, the matter- free portions of the cylinders CYL, respectively CYL1 and CYL2, are free to ambient air. Evidently, the matter MAT is void of air and is incompressible.

Each one of the two bodies BDY1 and BDY2 may be held by two fingers, with an index and a middle finger holding a grip GRP, and by the thumb pushing on the rest RST of a respective piston PIST, just as with a common medical syringe. The translation of one piston PIST, say the first piston PIST1, in the injection direction, will cause the opposite piston PIST2 to translate in the same direction as the first piston PIST1, until the first cylinder CYL1 is empty of matter MAT.

The depression of a plunger PLNGR, as if performing an injection, will force matter MAT to pass via the flow restricting opening ORFCE, which in reaction, will cause a resistance to the depression of the plunger PLNGR. It is this resistance in reaction to the depression force imparted to the PLNGR which creates and return a tactile perception to the user, and provides the impression that in fact, an injection process is in progress. Taken alone and by itself, as a standalone independent unit, free of attachment or even coupling by wire, the injection simulator INJSIM, when operated, will deliver to the user a tactile impression which simulates the delivery of a substance by injection. The tactile impression returned to the user is a first tactile feedback.

The resistance force in reaction to the depression of the plunger PLNGR may evidently depend on many parameters including the type of the matter MAT, the viscosity of that matter MAT and the size and/or shape of the restricting opening ORFCE of the flow- restrictor FLWRS. The materials MAT to be selected for use are preferably incompressible and able to flow through the flow restricting opening ORFCE, and may include water and oil for example.

In operation, once a cylinder CYL say the first cylinder CYL1, has been emptied of matter MAT, whereby the second cylinder CYL2 has been filled therewith, the user may flip-over the injection simulator INJSIM and continue to proceed as previously by use of the matter MAT of the second cylinder CYL2. There is no difference to the user which one of both plungers PLNGR is depressed. The injection simulator INJSIM may be operated continuously since matter MAT is permanently present in at least one or both of the same cylinders CYL1 and CYL2. Thus, the total amount or volume of matter MAT contained in both cylinders CYL1 and CYL2, remains equal to the maximum usable volume or maximal filling capacity of the same cylinders CYL1 and CYL2.

The injection simulator INJSIM is thus a dedicated standalone mechanical device, handheld as if being a medical syringe, which is manually operated by the user as if to deliver an injection. By being of simple build and made from simple and readily available materials, the injection simulator INJSIM is inexpensive and therefore disposable, even though being made to be reusable.

To modify the resistance force which simulates the force necessary to eject a liquid out of a syringe, it suffices to change the size of the restricting opening ORFCE of the flow restrictor FLWRST.

Fig. 3.1 depicts an exemplary embodiment of a first exchangeable connection tube CONTB1, indicated as CONTB in Fig. 3, which connects the first hollow cylinder CYF1 to the second hollow CYF2, and supports a flow-restrictor FFWRS having a restricting opening ORFCE 1. To increase resistance to the flow of matter MAT flowing from one cylinder CYF to the other one cylinder CYF, and vice versa, it suffices to exchange the first connection tube CONTB 1, shown in Fig. 3.1, by another, here second connection tube CONTB2, shown in Fig. 3.2, having a second flow-restrictor FFWRS2, which supports a second restricting opening ORFCE2 of smaller size than the first orifice opening ORFCE 1. To achieve a still higher simulated injection resistance, as depicted in Fig. 3.3, a third connection tube CONTB3 may support a third flow-restrictor FFWRS3 having a constricting opening orifice ORFCE3 of size much smaller than the second orifice ORFCE2. The intensity or magnitude of the resistance force returned by the injection simulator INJSIM may thus be modified and be selectable by the user. Thereby, the resistance to flow of a flow-restrictor FFWRS may be modified to obtain a selected force of desired tactile impres sion/perception .

Fig. 3.4 illustrates how the simulated resistance force provided by an injection simulator INJSIM may be modified by simple means, such as by the exchange of a spring for example. Fig. 3.4 depicts a detail of the injection simulator INJSIM showing a helicoidal pressure spring SPRNG which is mounted between the rest RST and the cylinder CYF to provide a simulated resistance force. By help of a screwthread coupling, the rest RST may be reversely detachable from the piston rod PSTROD, whereby the spring SPRNG may be mounted thereabout. The rest RST may then be reattached by screw threading of the male threaded bolt portion BLTPRT thereof into the female screwthread FEMSCR supported by the piston rod PSTROD. The simulated resistance force may now easily be modified by a simple exchange of springs SPRNG, providing either a stronger or a weaker resistance force to pressure applied on the rest RST.

Fig. 3.5 depicts yet another exemplary embodiment which provides a gradually adjustable flow resistance orifice opening ORFCE, in contrast to a specific flow restricting orifice opening ORFCE as described in relation to Figs. 3.1 to 3.3. Fig. 3.5 illustrates a tube squeezing device as a flow adjustment mechanism ADJMCN for gradually restricting and/or widening of the restricting opening ORFCE. A male threaded bolt BET, which is coupled to a handle HNDF is shown to engage a female screw thread FEMSCR machined in a sleeve SFV. Turning the handle HNDF may, according to the direction of turn, squeeze or release pressure applied to the flexible connection tube CONTB. Thereby, the size of a flow restricting opening ORFCE may be regulated and controlled to range from a totally flow blocking closure to a full opening allowing a maximal passage of flow of fluid.

Fig. 3.6 schematically depicts a partial view of the tube CONTB coupling between the first cylinder CYF1 to the second CYF2 as another exemplary embodiment of the handheld injection simulator INJSIM. Fig. 3.6 shows a flow-restrictor FFWRS supporting an adjustable flow adjustment mechanism ADJMCN which is formed as a connection tube CONTB tube squeezing device. Furthermore, a rigid connection sleeve CONSFV which may be transparent, schematically illustrates how both cylinders CYF, respectively CYF1 and CYF2, are coupled together to rigidize the injection simulator INJSIM.

In Fig. 3.6, a flexible connection tube CONTB couples a first cylinder CYF1 of an injection simulator INJSIM to a second cylinder CYF2. A male threaded rod MTHRD, which may support a millimetric or sub-millimetric screwthread engages a female screw thread FEMSCR machined in the connection sleeve CONSFV. An electric motor MTR driven by an electric power supply PS such as a (rechargeable) battery, is coupled to the male threaded rod MTHRD, and is configured to provide rotation thereto in clockwise CW and in counterclockwise CCW direction, to squeeze or release pressure applied upon the connection tube CONTB. The motor MTR may be selected as a step motor for example. Thus, the passage of matter MAT, from the first cylinder CYL1 to the second cylinder CYL2, and vice versa, may be controllably adjusted by operation of the motor MTR, to force onto, or retrieve away, of the threaded rod MTHRD from the connection tube CONTB. A rotation command to the motor MTR may be provided by wireless communication received by a receiver or a transceiver TRX which is coupled in communication for operation of the motor MTR. The command to the transceiver TRX may be received from the injection machine INJMCH, which is not shown in Fig. 3.6. Thereby, a change of an in vivo injection flow parameter detected by a machine sensor MCHSNS during an injection process made by the injection machine INJMCH, may be sent via the last one, to the transceiver TRX, to rotate the motor MTR. In turn, the rotation of the motor MTR will cause, in case of pressure detection for example, of an increase or a decrease of resistance to the flow or the passage of matter MAT out say the first cylinder CYL1. Such a change of resistance will be perceived by the user as a tactile feedback. The matter MAT is not shown in Fig. 3.6 for the sake of clarity of the drawing. It is understood that the detection of an increase of flow pressure during the injection process will cause a proportional increase of resistance to be felt by the user performing the simulated injection. Contrary thereto, a decrease of pressure will cause a decrease of resistance. This means that the user may receive different distinguishable kinds of tactile feedback signals. Other flow adjustment mechanisms ADJMCN such as pneumatic, hydraulic, or mechanic, may be implemented to obtain similar or same flow adjustment properties of the restricting opening ORFCE.

In other words, the flow restrictor FLWRST, provides the user with a tactile impression, or tactile perception, or background signal, which is created by the user when operating the injection simulator INJSIM. Furthermore, an adjustment of the flow adjustment mechanism ADJMCN provides the user with a tactile feedback, or modulated signal, which is received from the injection machine INJMCH and is proportional to a change of rate or value detected by the machine sensor(s) MCHSNS. Thereby, the tactile feedback is superimposed on the tactile impression or perception, or background signal, and is received by the user as a modulated tactile feedback. At least one other dedicated kind of tactile feedback signal may be communicated to the user in case of the near-trespassing of a by the user a priori selected threshold limit not to be exceeded. For the same case of pressure detection example, a well discernable succession of closely separated apart sequence of a resistance increase tactile feedback signal and a tactile feedback resistance decrease signal may, indicate a threshold trespassing occurrence. In addition, in case a threshold is trespassed, the injection machine INJMCH may be commanded by a priori entered user instructions, to immediately stop an ongoing injection process.

Fig. 3.7 shows another exemplary configuration of an injection simulator INJSIM supporting one injection syringe indicated as CYL1 for the injection of matter MAT into a canister CNSTR. Contrary to the injection simulator INJSIM having two cylinders CYL, the simulation ends when the single cylinder CYL1 is empty of matter MAT. The difference between the injection simulator INJSIM depicted in the Fig. 3.6 and Fig. 3.7, is that with the last one, the second cylinder CYL2 is replaced by a canister CNSTR.

Other embodiments of the injection simulator INJSIM may also be considered. For example, flow resistors FLWRS having restricting opening ORFCE of different shape, and grips GRP of different shape and dimension, may also be useful. A pistol butt-and-trigger like configuration may also be considered. By being of simple build and made from simple and commonly used and available materials, the injection simulator INJSIM is inexpensive and therefore disposable, even though being made to be reusable.

The apparatus APP may thus be provided with a controllable machine-adjusted mechanism, or flow adjustment mechanism ADJMCN, for controlling the size of the restricting opening ORFCE disposed in the interior flow passage of a flexible connection tube CONTB. A command signal for the adjustment of the size, thus the resistance caused by the restricting opening ORFCE, may be delivered by the injection machine INJMCH in response to parameters derived by the machine sensors MCNSNS thereof from the in vivo IN VIVO flow of injection. For example, the detection of a rise of pressure may command and increase of resistance, thus reduction of flow passage through the restricting opening ORFCE. Hence, the user may receive a tactile feedback, an/or a visual message on the remote display RDISP, and/or an audible message from the loudspeaker LDSPKR, since the injection machine INJMCH may be coupled to the remote display RDISPL, and the user may even read digitally displayed values of increase of, for example, the injection pressure value.

Flow restrictor adjustment

It is the injection machine INJMCH which commands the adjustment of the size, away from the nominal size thereof, of the restricting opening ORFCE supported by the flow restrictor FLWRS of the injection simulator INJSIM. The injection machine INJMCH commands a size adjustment by operation of the flow adjustment mechanism ADJMCN, of the injection simulator INJSIM, via wireless communication, upon detection of a change of in vivo injection flow parameters which are detected by the machine sensors MCHSNS. These machine sensors MCHSNS may include for example, one or more of a pressure sensor, a rate of flow sensor, a differential pressure sensor, a dose meter, as well as other sensors well known to those skilled in the art. With the injection simulator INJSIM in operation, it is the adjustment, thus change of size of the restricting opening ORFCE, which creates the change of resistance to the flow of matter MAT passing between the cylinders CYF1 and CYF2. In other words, the change of resistance is forwarded to the injection simulator INJSIM and is received by the user as a tactile feedback.

Data communication between the elements of the apparatus APP may be unidirectional or bidirectional, and may be operated in a first mode and/or in a second mode of, respectively, wired communication and/or wireless communication. However, the injection simulator INJSIM is restricted to coupling by wireless communication.

From the in-situ site INSIT, unidirectional communication may couple the imaging device IMGDEV to the remote display RDISPF by either one of the first mode and/or the second mode communication. Still from the in-situ site, the injection machine INJMCH is coupled to the injection monitor INJMON via bidirectional communication, by the either one of the first mode and/or the second mode communication.

Furthermore, the injection machine INJMCH may be coupled to the injection simulator INJSIM by wireless communication, and depending on the selected embodiment, either in unidirectional or in bidirectional communication. Should the command of start of the injection process by the injection machine INJMCH be performed by means other than from the injection simulator INJSIM, then unidirectional wireless communication from the injection machine INJMCH to the injection simulator INJSIM may suffice. Other means to command the start of the injection process may be provided by the injection monitor INJMON and/or by use of a smartphone. Alternatively, since the injection machine INJMCH is already coupled to the injection monitor INJMON, the injection machine INJMCH may also be coupled to the injection simulator INJSIM via the injection monitor INJMON, and thereby, communication may be simpler and cheaper to achieve. This means that wireless communication may couple between the injection monitor INJMON and the injection simulator INJSIM. Again, should the command of start of the injection process by the injection machine INJMCH be performed by means other than the injection simulator INJSIM, then unidirectional wireless communication from the injection machine INJMCH to the injection simulator INJSIM may suffice.

The injection machine INJMCH and the injection monitor INJMON may be coupled to the remote display RDISPL and to the loudspeaker LDSPKR in unidirectional communication by wired communication and/or wireless communication.

As described, the user may receive a sensory real time tactile feedback while commanding an injection process operated by remote control via a remote injection machine INJMCH. A real time tactile feedback is received by the user upon the detection of a change of a fluid flow parameter of the injection process. Detection of pressure deviation: these are fed back to the user as a tactile feedback which results from an adjustment of the flow adjustment mechanism ADJMCN. When a machine sensor MCHSNS of the injection machine INJMCH detects that the from in vivo injection flow derived pressure rises above the nominal pressure, the latter may emit a wireless signal to the injection simulator INJSIM to reduce the size of the opening ORFCE. For a drop of the in vivo derived pressure below the nominal pressure, the INJMCH may emit a wireless signal to the injection simulator INJSIM to increase the size of the restricting opening ORFCE. The mere change of size of the opening ORFCE produces a change of resistance to the flow between the two cylinders CYF of the injection simulator INJSIM, which resistance generates the tactile feedback signal which is reported to the user. Detection of rate of flow deviations are fed back to the user as a tactile feedback which results from an adjustment of the flow adjustment mechanism ADJMCN. When the from in vivo derived rate of flow rises above a predetermined step value selected a priori by the user, the injection machine INJMCH may emit a wireless signal to the injection simulator INJSIM to increase the size of the restricting opening ORFCE. For a drop of the in vivo derived rate of flow below a predetermined step value selected a priori by the user, the INJMCH may emit a wireless signal to the injection simulator INJSIM to decrease the size of the restricting opening ORFCE. Hence the mere change of size of the restricting opening ORFCE produces a tactile feedback to the user. Further detected changes may be returned as tactile feedback according to feedback steps inherent to the injection machine by being loaded a priori therein, or according to feedback steps predetermined by the user via the injection monitor INJMON at time of the preliminary settings.

The detection of a threshold excess by the injection machine INJMCH may stop the injection process and command the obstruction, or blockage, of the orifice opening ORFCE, whereby tactile feedback of such a blockage is provided to the user. Simultaneously, visual and audible alarm warning may be, respectively, displayed on the remote display RDISPF and/or sound by the loudspeaker FDSPKR.

Operation The operation of a remote injection process may require the following steps. It is assumed that the elements of the apparatus APP which are disposed at the in-situ site INSIT and at the remote ex situ site EXSIT are attended to and are ready to operate.

User preliminary settings may be entered via the console or command panel COMPNF, of the injection monitor INJMON, whereby the user may select safety measures and threshold values not to be trespassed, and for example, nominal values to start the injection machine INJMCH with. For example, nominal injection pressure, nominal rate of flow, maximum rate of flow, dose volume, and threshold values of parameters monitored from the in vivo flow of the injection process, may be detected by the machine sensors MCHSNS of the injection machine INJMCH. Furthermore, the user may enter a selected resolution for the steps of change of rate or of value to be returned as a tactile feedback. Moreover, the user may enter the selected ports PRT of the catheter device CATDEV and the predetermined substance(s) SBS to be used with the injection process, and the allowed maximum dose(s) of these substance(s) SBS.

Start of injection process: The remote user may initiate the start of the in situ INSIT injection process and activate the injection simulator INJSIM. The injection machine INJMCH may be initiated remotely by wireless communication. An injection initiation command may be entered via the injection monitor INJMON, and/or by a smartphone using an application program, not shown in the drawings, and/or by the use of a switch SWT supported by the injection simulator INJSIM, as shown in Fig. 3.6. An appropriate communication COMDEV may be selected as a transmitter or as a transceiver,

The injection switch SWT may thus trigger a thereto coupled wireless communication device COMDEV, such as an emitter, or a transceiver TRX, to emit a start signal to another communication device COMDEV, such as a receiver or a transceiver TRX, which is coupled to the injection machine INJMCH to command the start of injection(s). The user then has to operate the handheld injection simulator INJSIM in a manner which replicates the operation of a common medical injection syringe. A transceiver is considered as being a communication device for both reception and emission. Thus, at start, the injection machine INJMCH injects at a predetermined nominal pressure and the user operates the injection simulator INJSIM.

Injection of substances

As described hereinabove with respect to Fig. 1, the in situ disposed injection machine INJMCH which is coupled to the in vivo disposed catheter device CATDEV, responds to user input commands received from the remotely disposed injection monitor INJMON, for delivery of one or more than one substance SBS into one or more proximal ports PRT of the catheter device CATDEV.

Fig. 4 is a schematic exemplary representation of a portion of an injection machine INJMCH showing a disposition of three substance containers SBSCNT holding substances SBS marked as SBS1, SBS2, and SBS3. The substances SBS, being the same or different, are dispensed via injection tubes INJTUB, for injection, for example, in three ports PRT, indicated as PRT1, PRT2, and PRT3, of a catheter device CATDEV. A substance container SBSCNT may be implemented as a syringe-like device with a piston PST for expelling the substance SBS via an injection tube INJTUB into a port PRT. The piston PST may be driven by a male threaded rod MTHRD which when rotated in a stationary female threaded nut FTHNT, pushes the piston rod PSTROD. For control of the amount of substance SBS expelled out of a substance container SBSCNT, of the rate of injection and other parameters, a count of rotation of the male threaded rod MTHRD is advantageous. The male threaded rod MTHRD may support a millimetric or sub millimetric screwthread, which when rotated into the female threaded nut FTHNT, allows precise control of the translation of the piston PST. An electric motor, not shown, such as a step motor, may rotate the male threaded rod MTHRD to push the piston rod PSTROD and expel substance SBS out of the container SBSCNT for injection into a selected port PRT. For example, as shown in Fig. 4, a first substance SBS1 may be injected into a first port PRT1 of a catheter device CATDEV via an injection tube INJTUB. Fikewise, a second substance SBS2 may be injected into a second port PRT2, and a third substance may be injected into a third port PRT. A port PRT may be selected as a lumen or as a Fuer device. At the in-situ site INSIT, an assistant may attend to the filling of substances SBS in the containers SUBCNT, and with the handling of the disposition of the injection tubes INJTUB in the ports PRT of the catheter device CATDEV.

A port PRT may be marked port i, where i is a positive integer. The injection machine INJMCH may dispense one or more types or kinds of substances SBS such as for example, an embolization substance, a contrast substance, a saline substance, and gasses, such as air for example. A substance may include substances having different physical states of matter, such as liquid(s), gas(es)and solid(s). For example, a mixture may contain a plurality of different liquids containing solids, such as for example miniature beads, microspheres, and various kinds of particles.

By being coupled to the proximal portion PRXPRT of the in vivo disposed distal portion DSTPRT of the catheter device CATDEV, the injection machine INJMCH may inject at least one controlled dose of a substance SBS into at least one port PRT thereof. Controlled dose here means a dose defined according to input commands delivered by the user via the injection monitor INJMON prior to the start of an injection. A port PRT may be injected simultaneously with various controlled doses of a plurality of substances SBS. For example, a port PRT of the catheter device CATDEV may be injected simultaneously with a controlled dose of first substance SBS1 for embolization, a second controlled dose of a second substance SBS2 which is a contrast substance, and with a third controlled dose of a third substance SBS3 which is a saline substance. Furthermore, the injection machine INJMCH may be coupled to a plurality of ports PRT of the catheter device CATDEV, and may inject in each one port PRT at least one controlled dose of a substance SBS. For example, a first port PRT1 of the catheter device CATDEV may pertain to the distal microcatheter portion thereof, and may be injected with a controlled dose of a first substance SBS1, and a second port PRT2 which may pertain to the more proximal guiding catheter portion, may be injected with a second substance SBS2.

Similarly, for a plurality of ports PRT supported by different types of catheter devices CATDEV, each one port PRT may be injected with a controlled dose of a different substance SBS. A first substance SBS1 may be injected in one lumen of a guiding catheter portion, and another port PRT may be injected with another substance SBS2 which is appropriate to inflate a balloon of a guiding catheter or is appropriate for a stent delivery system. For inflation of a balloon at a pressure ranging between 0.5 and 30 atmospheres, the readings of a high precision pressure sensor supported by the injection machine INJMCH may be reported at least by visual feedback to the remote user. In the same manner as for a catheter devices CATDEV with a plurality of ports PRT, the injection machine INJMCH may for example be coupled to a first port PRT1 and inject a saline substance therein for flushing, to eliminate backflow. The injection machine INJMCH may also be coupled to a second port PRT2 to inject a contrast substance to flow through a guiding catheter, and also be coupled to a third port PRT3 for contrast flushing through a microcatheter.

On the Internet, at Wikipedia, under “Haptic technology”, haptic is described as being an experience of touch created by applying forces, vibrations or motions to a user. Since the injection process is performed by a remote machine, here the injection machine INJMCH, the user does not receive and feel a sensory cue from the injection process. It is the injection machine INJMCH which commands the flow adjustment mechanism ADJMCN to generate a simulated tactile feedback signal. Hence, the tactile feedback is a haptic feedback.

There has thus been described an apparatus APP wherein the injection simulator INJSIM includes two same syringe-like bodies BDY1, BD2, and wherein each one of these two bodies BDY1, BD2, has a same cylinder CYL maximal filling capacity. The two bodies BDY1, BD2, are jointly filled with a volume of matter MAT which is equal to the cylinder CYL maximal filling capacity of one body BDY. Thereby the two bodies BDY jointly have a volume free of matter MAT that is equal to the maximal filling capacity.

The injection simulator INJSIM of the apparatus APP may include two same syringe like bodies, BDY1, BDY2, each one of which is configured to contain a variable amount of matter MAT, and is coupled in fluid flow communication for a mutual exchange of matter MAT. The injection simulator INJSIM is operated by the user who applies a force thereon, which force causes the exchange of matter MAT from one body BDY to the other body BDY, and vice versa, whereby the force creates the tactile perception.

The injection simulator INJSIM of the apparatus APP is configured to contain matter MAT and includes two same syringe-like bodies BDY1, BD2, which are mutually coupled in exchangeable fluid flow communication of matter MAT, and wherein each one body BDY1, BD2 has a same cylinder CYL maximal filling capacity. Both bodies BDY1, BD2, are jointly filled with an amount of matter MAT which totals the cylinder CYL maximal filling capacity, and thereby, at least one of both bodies BDY1, BD2, is constantly filled with matter MAT to permit continuous operation of the injection simulator INJSIM.

The injection simulator INJSIM includes two same syringe-like bodies BDY1, BD2, which are coupled in mutual fluid flow communication. A selectable flow resistor FLWRS is disposed intermediate the two bodies BDY1, BD2, wherethrough a flow of matter MAT is forced to pass, and causes a selectable resistance force which is felt by the user as the tactile perception.

An injection monitor INJMON which is disposed ex situ EXSIT and is coupled to the injection machine INJMCH, is configured to accept input command parameters entered therein by the user, for conducting the injection process, and to communicate the derived injection flow parameters to the injection simulator INJSIM. The injection simulator INJSIM is configured to have two same syringe-like bodies BDY1, BD2, and each one of these two bodies BDY1, BD2, is configured to be manually held by the user, to contains matter MAT, and to be coupled in exchangeable fluid flow communication of matter MAT. Each one body BDY1, BD2 has a same cylinder CYL maximal filling capacity, contains matter MAT, and includes two same syringe-like bodies BDY1, BD2, which are coupled in fluid flow communication and are configured to be manually held by one of the bodies BDY1, BD2. Furthermore, each one body BDY1, BD2, has a same cylinder CYL maximal filling capacity, and both bodies BDY1, BD2, are jointly filled with an amount of matter MAT which totals the cylinder CYL maximal filling capacity, Thereby, when one of the bodies BDY1, BD2 is emptied of matter MAT, the other body BDY is filled with matter to the maximal filling capacity. Thereupon, the user switches between bodies BDY and operates the body BDY filled with matter MAT. The injection simulator INJSIM is as an independent dedicated device which is configured to receive wireless communication from at least one of the injection machine INJMCH and the injection monitor INJMON.

The injection monitor INJMON of the apparatus APP is configured to receive user input commands which are communicated to the injection machine INJMCH for performance of the injection process. This includes indication of substance(s) SBS to be injected, specific port(s) PRT for injection therein of the substance(s) SBS, and doses of each substance(s) SBS to be injected.

At the remote ex situ site EXSIT, the injection monitor INJMON is coupled to a remote display screen RDISPL which is coupled to an in situ INSIT disposed imaging device IMGDEV. At the remote ex situ site EXSIT, the user receives a tactile feedback from the injection simulator INJSIM, a visual feedback from the remote display screen RDISPL which is coupled in communication with at least one of the injection monitor INJMON and the injection machine INJMCH, and an audible feedback from the loud speaker LDSPKR which received data from at least one of the injection monitor INJMON and the injection machine INJMCH.

The method for constructing an apparatus APP for injection by remote control with feedback to a user, comprises providing an injection monitor INJMON coupled in bidirectional communication with the injection machine INJMCH for: receiving input commands selected by the user for operating the injection machine INJMCH, and for receiving from the injection machine INJMCH of derived variations of the injection flow parameters for adjusting the flow adjustment mechanism ADJMCN. Moreover, according to the method, the injection simulator INJSIM is coupled to the injection machine INJMCH by one of a wired and a wireless communication means. Thereby, the injection simulator INJSIM is operable as close by and as far away from the injection machine INJMCH as permitted by available communication means.

In addition, the method further comprises coupling the injection simulator INJSIM by wireless communication to at least one of the injection simulator INJSIM and the injection machine INJMCH, and providing the injection simulator INJSIM for manual holding and operating from both the in-situ site INSIT and the ex situ site EXSIT.

The method also comprises providing a canister CNSTR for receiving therein matter MAT injected therein by operating the at least one syringe portion CYL1 which is coupled in fluid communication with the canister CNSTR. Furthermore, method comprises including a flow adjustment mechanism ADJMCN in the injection simulator INJSIM for generating a tactile feedback signal proportional to a variation of level or rate derived from flow parameter communicated by the injection machine INJMCH. Thereby, the tactile perception changes according to variations of the flow parameters. It is noted that the tactile feedback is a haptic feedback.

Moreover, the injection simulator INJSIM is operable to a distance away from at least one of the injection machine INJMCH and the injection monitor INJMON, as limited by wireless communication.

Industrial application The apparatus APP, and in particular the injection simulator INJSIM, may be constructed by the medial apparatus industries for users such as medical practitioners. List of reference signs

Claims

1. An apparatus APP for injection by remote control with feedback to a user, the apparatus APP comprising: an injection machine INJMCH, disposed in situ INSIT remote from a user, for performing an injection process by injection of a substance SBS in vivo INVIV, the apparatus APP being characterized by comprising: an injection simulator INJSIM, for manual operation, configured to return to the user of a selectable tactile perception replicating a manual in vivo IN VIVO injection, and a flow adjustment mechanism ADJMCN, included in the injection simulator INJSIM, configured to generate a tactile feedback signal, proportional to a variation occurring to an injection flow parameter, derived by the injection machine INJMCH during the injection process, whereby the tactile feedback varies according to variations of the flow parameters.

2. The apparatus APP of claim 1, wherein: the injection simulator INJSIM includes two same syringe-like bodies BDY1, BD2, wherein each one of these two bodies BDY1, BD2, has a same cylinder CYL maximal filling capacity, and the two bodies BDY1, BD2, are jointly filled with a volume of matter MAT which is equal to the cylinder CYL maximal filling capacity of one body BDY, whereby the two bodies BDY jointly have a volume free of matter MAT that is equal to the maximal filling capacity.

3. The apparatus APP of claim 1, wherein: the injection simulator INJSIM includes two same syringe-like bodies, BDY1, BDY2, each one of which being configured to contain a variable amount of matter MAT, and being coupled in fluid flow communication for a mutual exchange of matter MAT, and the injection simulator INJSIM is operated by the user applying a force thereon, which force causes the exchange of matter MAT from one body BDY to the other body BDY, whereby the force creates the tactile perception.

4. The apparatus APP of claim 1, wherein: the injection simulator INJSIM is configured to contain matter MAT and includes two same syringe-like bodies BDY1, BD2, which are mutually coupled in exchangeable fluid flow communication of matter MAT, and wherein each one body BDY1, BD2 has a same cylinder CYL maximal filling capacity, and both bodies BDY1, BD2, are jointly filled with an amount of matter MAT which totals the cylinder CYL maximal filling capacity, whereby at least one of both bodies BDY1, BD2, is constantly filled with matter MAT to permit continuous operation of the injection simulator INJSIM.

5. The apparatus APP of claim 1, wherein: the injection simulator INJSIM includes two same syringe-like bodies BDY1, BD2, which are coupled in mutual fluid flow communication, and a selectable flow resistor FLWRS disposed intermediate the two bodies BDY1,

BD2, wherethrough a flow of matter MAT is forced to pass, causes a selectable resistance force which is felt by the user as the tactile perception.

6. The apparatus APP of claim 1, wherein: an injection monitor INJMON disposed ex situ EXSIT and coupled to the injection machine INJMCH, is configured to accept input command parameters, entered therein by the user, for conducting the injection process, and to communicate the derived injection flow parameters to the injection simulator INJSIM.

7. The apparatus APP of claim 1, wherein: the injection simulator INJSIM is configured to have two same syringe-like bodies BDY1, BD2, wherein each one of these two bodies BDY1, BD2, is configured to be manually held by the user, to contains matter MAT, and to be coupled in exchangeable fluid flow communication of matter MAT, and wherein each one body BDY1, BD2 has a same cylinder CYL maximal filling capacity, and contains matter MAT and includes two same syringe-like bodies BDY1, BD2, which are coupled in fluid flow communication and are configured to be manually held by one of the bodies BDY1, BD2, wherein each one body bodies BDY1, BD2, has a same cylinder CYL maximal filling capacity, and both bodies BDY1, BD2, are jointly filled with an amount of matter MAT which totals the cylinder CYL maximal filling capacity, whereby when one of the bodies BDY1, BD2 is emptied of matter MAT, the other body BDY is filled with matter to the maximal filling capacity, whereupon the user switches between bodies BDY and operates the body BDY filled with matter MAT.

8. The apparatus APP of claim 1, wherein: the injection simulator INJSIM is as an independent dedicated element configured receive wireless communication from at least one of the injection machine INJMCH and the injection monitor INJMON.

9. The apparatus APP of claim 1, wherein the injection monitor INJMON is configured to receive user input commands which are communicated to the injection machine INJMCH for performance of the injection process, including indication of substance(s) SBS to be injected, specific port(s) PRT for injection therein of the substance(s) SBS, and doses of each substance(s) SBS to be injected.

10. The apparatus APP of claim 1, wherein: at the remote ex situ site EXSIT, the injection monitor INJMON is coupled to a remote display screen RDISPL which is coupled to an in situ INSIT disposed imaging device IMGDEV, and at the remote ex situ site EXSIT, the user receives a tactile feedback from the injection simulator INJSIM, a visual feedback from the remote display screen RDISPL which is coupled in communication with at least one of the injection monitor INJMON and the injection machine INJMCH, and an audible feedback from the loud speaker LDSPKR which received data from at least one of the injection monitor INJMON and the injection machine INJMCH.

11. A method for constructing an apparatus APP for injection by remote control with feedback to a user, the method comprising: providing a user operating from a remote ex situ EXSIT with communication for operating an in situ INSIT disposed injection machine INJMCH for injecting a substance SBS in vivo IN VIVO during an injection process, the method being characterized by comprising: constructing an injection simulator INJSIM by coupling a connection tube CONTB between two same syringe-like bodies BDY1, BD2, for returning a tactile perception to the user upon manual activation of one of both of the bodies BDY1, BD2 in replication of a manual medical in vivo IN VIVO injection, including a machine sensor MCHSNS in the injection machine INJMCH for deriving injection flow parameters from the injection process, and including an adjustable flow adjustment mechanism ADJMCN in the connection tube CONTB for providing the user with a tactile feedback proportional to a derived variation of the injection flow parameters.

12. The method of claim 11, further comprising: providing an injection monitor INJMON coupled in bidirectional communication with the injection machine INJMCH for: receiving input commands selected by the user for operating the injection machine INJMCH, and receiving from the injection machine INJMCH of derived variations of the injection flow parameters for adjusting the flow adjustment mechanism ADJMCN.

13. The method of claim 11, wherein: the injection simulator INJSIM is coupled to the injection machine INJMCH by one of a wired and a wireless communication means, whereby the injection simulator INJSIM is operable as close by and as far away from the injection machine INJMCH as permitted by available communication means.

14. The method of claim 11, further comprising: coupling the injection simulator INJSIM by wireless communication to at least one of the injection simulator INJSIM and the injection machine INJMCH, and providing the injection simulator INJSIM for manual holding and operating from both the in situ site INSIT and the ex situ site EXSIT.

15. The method of claim 11, further comprising: providing a canister CNSTR for receiving therein matter MAT injected therein by operating the at least one syringe portion CYL1 which is coupled in fluid communication with the canister CNSTR, and including a flow adjustment mechanism ADJMCN in the injection simulator INJSIM for generating a tactile feedback signal proportional to a variation of level or rate derived from flow parameter communicated by the injection machine INJMCH, whereby the tactile perception changes according to variations of the flow parameters.

16. The apparatus APP of claim 1, wherein the tactile feedback is a haptic feedback.

17. The apparatus APP of claim 1, wherein the injection simulator INJSIM is operable to a distance away from at least one of the injection machine INJMCH and the injection monitor INJMON, as limited by wireless communication.