Patent Description:
Sensors, which are arranged e.g. on a balloon of a catheter, have different sensor signals with the same balloon parameters due to minimal deviations of the balloon shapes and arrangement of the sensor on the respective balloon.

<CIT> describes an in vivo calibration of blood pressure sensors assigned to a balloon using electronically stored correction data. Furthermore, <CIT> discloses a blood pressure measurement based on an infrared sensor mounted on a balloon catheter and a calibration with corresponding data exchange via an analog/digital converter.

<CIT>discloses intravascular devices, systems, and methods. In some embodiments. the intravascular devices include at least one pressure sensing component within a distal portion of the device. In that regard, one or more electrical. electronic, optical. and/or electro-optical pressure-sensing components are secured to an elongated member and the system includes components to process the output signals according to various calibration parameters.

<CIT>discloses a system and method of identifying and communicating with an interventional medical device. The system includes a novel catheter handle operably coupled to the shaft of a catheter at the distal end and an electrophysiology recording system at the proximal end. The catheter handle includes a visual identification system visible through a lens on the catheter handles and a microcontroller with a memory structure, the memory structure including catheter identification information. The visual identification system includes a light emitting diode, which is visible from the outside of the catheter handle through the lens. When a user of the EP recording system selects a desired color for the coupled catheter, the desired color is communicated to the microcontroller in the catheter handle and the microcontroller causes the visual identification to display the requested color so that the desired color is visible by the user.

<CIT>discloses a method and system is provided for using backscattered data and known parameters to characterize vascular tissue. Specifically, methods and devices for identifying information about the imaging element used to gather the backscattered data are provided in order to permit an operation console having a plurality of Virtual Histology classification trees to select the appropriate VH classification tree for analyzing data gathered using that imaging element. In order to select the appropriate VH database for analyzing data from a specific imaging catheter, it is advantageous to know information regarding the function and performance of the catheter, such as the operating frequency of the catheter and whether it is a rotational or phased-array catheter. The present invention provides a device and method for storing this information on the imaging catheter and communicating the information to the operation console. In addition, information related to additional functions of the catheter may also be stored on the catheter and used to further optimize catheter performance and/or select the appropriate Virtual Histology classification tree for analyzing data from the catheter imaging element.

<CIT>discloses a computerized method of tracking a position of an intrabody catheter, comprising: physically tracking coordinates of the position of a distal portion of a physical catheter within the physical body portion of the patient according to physically applied plurality of electrical fields within the body portion and measurements of the plurality of electrical fields performed by a plurality of physical electrodes at a distal portion of the physical catheter; registering the physically tracked coordinates with simulated coordinates generated according to a simulation of a simulated catheter within a simulation of the body of the patient, to identify differences between physically tracked location coordinates and the simulation coordinates; correcting the physically tracked location coordinates according to the registered simulation coordinates; and providing the corrected physically tracked location coordinates for presentation.

Based on the above, the problem to be solved by the present invention is to provide a processing unit and corresponding method so that for different catheters or balloons a reliable processing, for instance calibration, of the measurement data of the sensor is ensured in a user-friendly way.

This task is solved by a processing unit having the features of claim <NUM> and a method having the features of claim <NUM>.

Advantageous embodiments of these aspects of the present invention are indicated in the corresponding sub claims and are described below.

According to claim <NUM>, a processing unit is disclosed that is configured to be connected to a catheter and configured to exchange data with at least one of: a component of the catheter, a database (e.g. implemented on a remote computer network also denoted as cloud), wherein the processing unit is configured to process said data. Particularly, the processing unit can comprise a circuit comprising microprocessor configured to process said data.

Further, the processing unit may comprise a housing configured to be detachably connected to the catheter.

Further the housing of the processing unit may be provided with a connector portion insertable into an opening of a proximal end portion of the catheter. Proximal means that said end portion is closer to a person operating the catheter than an opposite distal end portion of the outer shaft insertable into the patient.

Further the connector portion may be provided with electrically conductive contacts each configured to be electrically connected to an associated contact of the catheter when the connector portion is inserted into said opening of the proximal end portion of the catheter.

Further the connector portion may surround a through opening of the processing unit, the through opening being adapted to open into a lumen of the catheter, e.g. when the connector portion is inserted into said opening of the proximal end portion of the catheter.

The processing unit may comprise a through opening being adapted to open into a lumen of the catheter. Thereby the processing unit can be easily coupled to the catheter. Usually the proximal end portion of a catheter comprises a hub or Luer connector providing access to at least one lumen of the catheter. The processing unit can be attached to the proximal end of the catheter in a way, that the through opening of the processing unit opens into said lumen of the catheter and thereby the lumen could be accessed via the processing unit. Thereby the catheter can be easily equipped with the processing unit without changing the performance or the handling of the catheter.

Further, according to a design of the processing unit, the connector portion may form s a Luer connector. In this embodiment the processing unit itself provides a standard Luer connections. In particular, if the catheter already comprises a Luer connector, the processing unit can be attached to the Luer connector of the catheter and thereby providing a Luer connection as well.

In a preferred embodiment the connector portion is insertable into an opening of a proximal end portion of the outer shaft of the catheter.

Furthermore the connector portion surrounds a through opening of the processing unit, the through opening may be adapted to open into an inflation lumen or a guidewire lumen of the catheter, e.g. when the connector portion is inserted into said opening of the proximal end portion of the catheter.

Particularly, according to an embodiment, the processing unit is configured to be mechanically connected to the catheter in a releasable fashion. The mechanical connection of the processing unit to the catheter in a releasable fashion allows the combination of one processing unit with multiple catheters of different types. The processing unit is therefore configured as a reusable processing unit.

According to an embodiment, the processing unit is configured to be mechanically connected to a balloon catheter, a catheter suitable for implanting an intraluminal prosthesis, in particular a stent, a catheter suitable for implanting a valve prosthesis, in particular a heart valve prosthesis or a venous valve prosthesis, or a catheter suitable for implanting a closure device.

Furthermore, according to an embodiment, said component is one or more of: a sensor of the catheter, an inflation pump of the catheter for inflating a balloon of the catheter.

Particularly, in an embodiment, the sensor can be a sensor configured to measure a parameter of the balloon, in particular one of the following: a circumference, a radius, a volume. The parameter may also be a parameter derived from one of the said afore-mentioned parameters. In particular, the sensor may be a strain gauge. Furthermore, the sensor may be designed to measure an impedance in an embodiment. Furthermore, the sensor can be a force sensor that measures a force acting on the balloon. Other sensors are also conceivable. The processing unit could be configured to exchange data with one or more components (sensors) of the same or of a different kind.

Further, according to an embodiment of the processing unit, the latter is configured to recognize the catheter (among a plurality of different catheters to which the processing unit is releasably connectable) using an identifier code of the catheter when the catheter is connected to the processing unit.

Furthermore, according to an embodiment, the processing unit comprises a memory for storing information relating to different catheters to which the processing unit is connectable.

Further, in an embodiment, the processing unit is configured to match the identifier code with information stored in said memory of the processing unit. Alternatively or in addition, the processing unit is configured to match the identifier code with information stored in a remote database implemented on a computer network (i.e. cloud) to recognize the catheter among a plurality of different catheters to which the processing unit is releasably connectable.

Further, according to an embodiment, the processing unit is configured to retrieve information on the recognized catheter from the memory of the processing unit and/or from the remote database and to transmit said retrieved information to a computer device to display said information on a display of the computer device to the user (e.g. physician) that operates the catheter.

Furthermore, according to an embodiment, the processing unit is configured to retrieve calibration data corresponding to the recognized catheter from a memory of the processing unit or from the remote database, and to calibrate the measurement data of the sensor using the calibration data.

According to a further aspect, a system is disclosed, the system comprising a processing unit according to the present invention and a catheter comprising a sensor for measuring a parameter relating to the catheter. The system comprises two major parts, a processing unit and a catheter. Since the processing unit is connected to the catheter in a releasable fashion, the processing unit is reusable with various catheters. The catheter and the processing unit of the invention are configured for a releasable mechanical connection between each other.

In particular the catheter is a balloon catheter, a catheter suitable for implanting an intraluminal prosthesis, in particular a stent, a catheter suitable for implanting a valve prosthesis, in particular a heart valve prosthesis or a venous valve prosthesis, or a catheter suitable for implanting a closure device.

Particularly, the sensor can be one of the sensors stated above. According to a further embodiment, the catheter can comprise an inflation pump configured to inflate a balloon of the catheter. Furthermore, the catheter can comprise a plurality of sensors, particularly different sensors. The respective sensor can e.g. be one of the above stated sensors.

According to an embodiment of the system, the system further comprises said computer device, wherein the computer device is configured to communicate with the processing unit (particularly in a wireless fashion). The communication is not necessarily bi-directional but a bi-directional communication is preferred.

Particularly, the computer device is a mobile hand-held device such as a smartphone, but can also be any other suitable computer such as a laptop, a tablet or a desktop computer.

The computer device comprises a user interface and a display [configured for graphically displaying information]. Particularly, for conducting user input into user interface and for displaying information on the display, the computer device can be configured to execute a corresponding computer program.

Further, according to an embodiment, the computer device is configured to scan the identifier code from the catheter or a package of the catheter, to which catheter the processing unit is to be connected or to which the processing unit is connected (or connectable). Alternatively, or in addition, the user interface is configured for receiving the identifier code as an (e.g. manual) user input.

According to a further embodiment of the system, the latter further comprises a database executed on a computer network (the system may also comprise the computer network and the database thereon).

Particularly, the processing unit is configured to compare match the identifier code with information stored in said database to recognize the catheter among a plurality of different catheters to which the processing unit is releasably connectable.

Further, according to an embodiment of the system, the processing unit is configured to transmit the retrieved information relating to the catheter to the computer device, which is configured to display said information via said display.

According to an embodiment, said retrieved information comprises at least one of: a designation of the catheter, instruction for use of the catheter, a type of the catheter, a list of measurements that the catheter is configured to carry out (e.g. using the sensor).

Furthermore, according to an embodiment, the user interface is configured to receive an input by the user to confirm use of the recognized catheter, and particularly to start a procedure guided by the system during which the recognized catheter is used.

According to a further embodiment of the system, the processing unit is configured to transmit measurement data received from the sensor of the recognized catheter to the computer device to display the measurement data on said display during operation of the catheter. Furthermore, in an embodiment of the system, the processing unit is configured to store the measurement data received from the sensor and/or data relating to a procedure performed with the catheter in the memory of the processing unit and/or in said database.

Yet another aspect of the present invention relates to a method using a system according to the present disclosure, wherein the method comprises at least the steps of:.

Particularly, the measurement data is continuously displayed on the display during operation of the catheter so that the system can be efficiently used to guide the procedure or use of the catheter.

According to an embodiment of the method, the step of automatically recognizing the catheter comprises the further step of comparing, particularly matching, the identifier code with information stored in the memory of the processing unit and/or in the database.

According to an embodiment, the method comprises the further step of scanning the identifier code from the catheter or from a package of the catheter (e.g. by means of the computer device or a scanner connected thereto) or inputting the identifier code into the user interface of the computer device.

According to an embodiment, the method comprises the further step of displaying the retrieved information about the recognized catheter on the display of the computer device, particularly before the step of displaying said measurement data.

According to an embodiment, the method comprises the further step of confirming the displayed information using the user interface of the computer device (e.g. so as to start a procedure using the recognized catheter), particularly before the step of displaying said measurement data.

According to a further embodiment, said measurement data of the sensor and or data relating to a procedure performed using the catheter is also stored in the memory of the processing device and/or in the database.

According to a further embodiment, the method comprises the further step of analyzing data transmitted to the database.

In the following, the embodiments as well as further features and advantages of the present invention will be explained with reference to the Figures, wherein:.

<FIG> shows an embodiment of a processing unit <NUM>.

The processing unit <NUM> is configured to be connected to a catheter <NUM> in a releasable fashion and configured to communicate and in particular exchange data with at least one of: a component of the catheter <NUM>, a database <NUM>, a computer network <NUM> (cf. also <FIG> and <FIG>), a computer device <NUM>, wherein the processing unit <NUM> comprises an integrated circuit 10a for processing said data. The communication is not necessarily bi-directional but preferred in this embodiment. The integrated circuit 10a can be a microprocessor or can comprise such a processor or a comparable means.

Furthermore, the processing unit <NUM> can comprise a housing <NUM> for accommodating components of the processing unit <NUM> such as the integrated circuit 10a, wherein the housing <NUM> may comprise a connector <NUM> for connecting the housing <NUM> of the processing unit <NUM> in a releasable fashion (e.g. mechanically) to the catheter <NUM> (e.g. at a proximal end of the catheter <NUM>). The catheter <NUM> can be a balloon catheter that comprises a balloon <NUM> (e.g. for performing an angioplasty or implanting an expandable implant into a body lumen). However, the invention applies to all kinds of catheters <NUM>. According to <FIG>, said component <NUM> can be a sensor <NUM> that measures a parameter relating to the catheter <NUM>, such as a diameter of the balloon <NUM> or another quantity of interest.

Particularly, for using the processing unit <NUM>, the latter is mechanically connected to the catheter <NUM> using e.g. said connector <NUM>, which preferably also establishes the necessary electrical connections between the sensor <NUM> and the processing unit <NUM>. However, data transfer between the sensor <NUM> and the processing unit <NUM> may also be conducted in a wireless fashion or in other ways.

After (or shortly before) connecting the processing unit <NUM> to the catheter <NUM>, the processing unit <NUM> automatically recognizes the catheter <NUM> using a unique identifier code ID. This code ID may be provided on the catheter <NUM> or on a package of the catheter <NUM> and may be input manually into a user interface 4a of a computer device <NUM> that communicates with the processing unit <NUM> or may be scanned by means of the device <NUM> (or by means of a separate scanner connected to the device <NUM>).

Particularly (cf. also <FIG> and <FIG>), the identifier code ID may be matched to information provided in a remote database <NUM> that can be maintained on a computer network <NUM> (so-called cloud) or to information that is provided in a memory 10b of the processing unit <NUM> itself.

Once the catheter <NUM> is identified in this way, the processing unit <NUM> is allowed to retrieve information on the recognized catheter <NUM> and transmits this information to the computer device <NUM> for displaying it on its display <NUM>. The physician/user of the catheter <NUM> can confirm the displayed information via a user input into the user interface 4a of the device <NUM> so as to start a procedure during which the physician will operate the catheter <NUM> guided by the processing unit <NUM> / system <NUM>. During operation of the catheter <NUM>, the measurement data of the sensor <NUM> will be send to the processing unit <NUM> which calibrates the measurement data M based on calibration data C provided in the database <NUM> and/or in the memory 10b. Particularly, actual (calibrated) measurement data M of the sensor <NUM> or quantities derived therefrom can be shown on the display <NUM> in real-time to guide the physician during the procedure using the catheter <NUM>.

Particularly, the information retrieved by the processing unit <NUM> and shown on the display <NUM> can contain information about the make and model of the catheter <NUM>, instructions for use (IFU) regarding the catheter <NUM>, the type of the catheter (e.g. balloon catheter for angioplasty etc.), a list of the measurements that can be performed with the catheter <NUM> or a list of the sensor(s) <NUM> provided on the catheter <NUM>. For instance, the information can state that the catheter <NUM> allows to measure an outer diameter of the balloon <NUM> using the sensor <NUM>.

<FIG> shows an embodiment of a system <NUM>, wherein the system <NUM> comprises a processing unit <NUM>, a database <NUM> (e.g. provided on a computer network <NUM>), a computer device <NUM> comprising a display <NUM>, and particularly a catheter <NUM> not shown in <FIG>.

Particularly, the processing unit <NUM> is configured to receive data D comprising e.g. codes for identifying a type of the catheter <NUM> and its type of sensor(s) <NUM> as well as instructions of use (IFU) relating to the catheters. Furthermore, the processing unit <NUM> is configured to receive the measurement data or values M coming from the sensor(s) <NUM> of the catheter <NUM>. Particularly, the catheter <NUM> can be a balloon catheter comprising a sensor <NUM> measuring a parameter that correlates well with the outer diameter of the balloon. However, the processing unit <NUM> may also be paired with an ablation catheter or any other catheter.

Furthermore, the processing unit <NUM> is configured to use the provided codes D to calibrate the measurement data M using its integrated circuit 10a / processor 10a. The calibrated measurement data M is transmitted to the computer device <NUM> and displayed on the display <NUM> of the device <NUM> during operation of the catheter <NUM>. The device <NUM> / display <NUM> is also configured to show information about the catheter <NUM> such as the maximal pressure of a balloon <NUM> of the catheter <NUM> (in case the catheter <NUM> is a balloon catheter) as well as information contained in the instructions for use (IFU).

Furthermore, according to <FIG> data measurement data M could be transmitted to database <NUM> as well. The database could possibly transmit measurement data M derived from similar catheters to the processing unit. Such data could be used to suggest and display an optimal use of the catheter via the computer device <NUM> and the display <NUM>. Furthermore calibration data C could be transferred to the processing unit and stored there, which makes more catheters or type of catheters compatible with the processing unit. In the same way calibration data C could be deleted from the processing unit, if the corresponding type of catheter is no longer used.

<FIG> shows a further embodiment of a system <NUM>, wherein the system <NUM> comprises a processing unit <NUM>, a database <NUM> (e.g. provided on a computer network <NUM>), a computer device <NUM> comprising a display <NUM>, and particularly a catheter <NUM> not shown in <FIG>.

Particularly, the processing unit <NUM> is configured to be mechanically connected to the catheter <NUM>, e.g. via suitable one or more suitable connectors <NUM>
According to the embodiment shown in <FIG>, the bulk of the data is preferably stored/provided in the remote database <NUM> / computer network <NUM>. Particularly, the identifier code ID for identifying / recognizing the respective catheter <NUM> to which the processing unit <NUM> shall be connected can be input into the processing unit <NUM>, particularly into the memory 10b, via a user input into a user interface 4a of computer device <NUM> or by scanning the identifier code ID as described in conjunction with <FIG>.

During the procedure, the measurement data M from the sensor <NUM> is calibrated by the processing unit <NUM> using calibration data C retrieved from the database <NUM>. The calibrated measurement data M is passed to the device <NUM> for displaying the measurement data M in a preferably continuous fashion during a procedure using catheter <NUM>.

Furthermore, the measurement data M is also stored in the memory 10b of the processing unit and/or passed to the databank <NUM> for storage and/or later analysis.

Particularly, the processing unit <NUM> is configured to retrieve information on the recognized catheter <NUM> denoted as incoming data IN from the databank <NUM> such as IFU information, particularly work instruction(s) about the recognized/identified catheter <NUM>, the type of the catheter, the purpose of use of the catheter <NUM> and the type of measurement that the catheter <NUM> is configured to perform (using e.g. the sensor <NUM>), the type of sensor(s), calibration data C for calibrating the sensor(s) / measurement data M.

Furthermore, the processing unit <NUM> is configured to upload outgoing data OUT to the databank <NUM>, wherein the outgoing data OUT can comprise data such as the measurement data M, the type of the catheter <NUM>, other procedural info, for example a duration of the procedure performed with the catheter <NUM>.

<FIG> shows a schematic representation of an embodiment of a processing unit <NUM>.

As before, the processing unit <NUM> is configured for use with a catheter <NUM> that may comprise an inflatable a balloon <NUM> (e.g. in order to expand a stent in the radial direction in the vessel during angioplasty and to anchor it therewith). Furthermore, the processing unit <NUM> preferably comprises a processor/integrated circuit 10a for processing measurement data M of a sensor <NUM> arranged on the balloon <NUM> of the catheter <NUM>, wherein the processing unit <NUM> is designed to transmit the processed measurement data M via a data link V to a display <NUM> for displaying the processed measurement data. The sensor <NUM> can in particular be designed to provide measured values with regard to the radial expansion of the balloon <NUM>.

Furthermore, the processing unit <NUM> comprises a housing <NUM> which accommodates the processor <NUM> to protect it, the housing <NUM> being designed to be releasably connected to the catheter <NUM> in such a way that a mechanical connection is established between the catheter <NUM> and the housing <NUM> and an electrical connection is established between the sensor <NUM> and the processing unit <NUM> via which measurement data M can be transmitted from the sensor <NUM> to the processing unit <NUM>.

To establish the mechanical connection, the housing can have <NUM> latching lugs 15a, which can engage with latching lugs 15b on the catheter. Alternatively, latching lugs 15b can be fitted on catheter <NUM>; the housing <NUM> then has corresponding latching recesses 15a. Other positive and/or non-positive fasteners can also be used. The fact that the mechanical connection between the housing <NUM> and the catheter <NUM> is releasable means in particular that processing unit <NUM> can be manually released from catheter <NUM> (and preferably without using a tool) without damaging the processing unit <NUM> or the catheter <NUM>.

Due to the releasable mechanical connection and in particular due to the fact that processing unit <NUM> can adapt the measurement data M of sensor <NUM> using integrated circuit 10a, the processing unit <NUM> can be used multiple times, i.e., can be used for different catheters <NUM>, wherein the measurement data is calibrated by the processing unit <NUM> and displayed to the user / physician via the display <NUM>.

Also here, calibration data used for calibration of the measurement data can be downloaded from a database <NUM> of a remote computer network <NUM> or may be provided in a memory of the processing unit <NUM>.

In addition to the measurement data of the sensor <NUM>, the physician is preferably shown all further information about the catheter <NUM> (e.g. operating instructions, size, etc.) on display <NUM>. The selection of which parameters should be displayed can preferably be determined individually by the physician or hospital staff. All measurement data is preferably not only displayed, but sent to the database of the computer network <NUM>, stored and thus documented.

As can be seen from <FIG> and <FIG>, the processing unit <NUM> preferably comprises a connector portion <NUM> provided on the housing <NUM>, which can be inserted into an opening <NUM> of a proximal end section <NUM> of an outer shaft <NUM> of catheter <NUM>. The connector portion <NUM> and the opening <NUM> can form a two-part Luer system.

Furthermore, it is preferably provided that the connector portion <NUM> has electrically conductive contacts <NUM> which are each configured to contact an associated contact <NUM> of the catheter <NUM> in order to establish the electrical connection when the connector portion <NUM> is inserted into the opening <NUM>.

The signals of the sensor <NUM> are transmitted along the outer shaft <NUM> via the contacts <NUM>, <NUM> to the processing unit <NUM>. At the same time, the sensor <NUM> can be supplied with power via this connection and can record measurement data accordingly. These analog lines are preferably routed to the end of a hypotube of the outer shaft <NUM>.

In particular, the entire electronics of the processing unit <NUM> can be accommodated in integrated circuit 10a according to an embodiment. This applies in particular to an A/D conversion, an amplifier, a filter, a communication unit for establishing the data connection with the computer device <NUM> or with the computer network <NUM>, an energy storage as well as an integrated circuit for the calibration/processing of the measurement data of the sensor <NUM>.

As further shown in <FIG>, the housing <NUM> can have a first projection 12a projecting along the connector portion <NUM> according to an embodiment of the processing unit <NUM>, which can positively engage in a first recess 22a of the proximal end section <NUM> to guide the connector portion <NUM>. The housing <NUM> may also have a second projection 12b adapted to engage and lock into a second recess 22b of the end portion <NUM> to provide a snap-in connection to the catheter <NUM>.

In both embodiments as shown in <FIG> and <FIG>, the connector portion <NUM> and the housing <NUM>, respectively, of the processing unit <NUM> each surround a through-opening <NUM>, the through-opening <NUM> being adapted to open into a lumen 2a of the catheter <NUM> when the connector portion <NUM> is inserted into the opening <NUM> of the catheter <NUM>. In this sense, the housing <NUM> of the processing unit <NUM> is especially ring-shaped. Balloon <NUM> and inner shaft <NUM> are shown in <FIG> with dashed lines.

Claim 1:
A processing unit (<NUM>) configured to be connected to a catheter (<NUM>) in a releasable fashion and configured to exchange data (M, C) with a component of the catheter (<NUM>), a database (<NUM>) of a computer network (<NUM>) and a computer device (<NUM>), wherein the processing unit (<NUM>) comprises an integrated circuit (10a) for processing the data and a memory (10b) for storing the data, and wherein the processing unit (<NUM>) is further configured to:
- recognize the catheter (<NUM>) using an identifier code (ID) of the catheter (<NUM>);
- retrieve information (I, C) about the catheter (<NUM>) from the memory (10b) of the processing unit (<NUM>) or from the database (<NUM>); characterized in that the processing unit (<NUM>) is further configured to:
- transmit measurement data (M) from the component of the catheter (<NUM>) to the computer device (<NUM>); and
- store the measurement data (M) and the identifier code (ID) of the catheter (<NUM>) and data relating to a procedure performed with the catheter (<NUM>) on the database (<NUM>) of the computer network (<NUM>).