Inflation device for an angioplasty product and method for an inflation device

Abstract

The invention relates to an inflation device (1) for inflating an angioplasty product (6), comprising: a provided angioplasty product (6) having a marking (KA) which contains an identifier and / or at least one nominal size of the provided angioplasty product (6); and a reader unit (2) which is intended and designed to detect the marking (KA) of at least the provided angioplasty product (6), wherein a memory unit (14) is provided in which a mapping between at least one suitable inflation syringe (10) and the provided angioplasty product (6) is stored, and wherein a control unit (12) of the inflation device (1) is or can be connected for data transmission to the reader unit (2), and is intended and designed to determine the identifier and / or the at least one nominal size of the provided angioplasty product (6) from the marking (KA) of the provided angioplasty product (6), and, depending on the determined identifier and / or the determined at least one nominal size of the provided angioplasty product (6), to determine and output the at least one suitable inflation syringe (10) from the mapping.

Description

[0001] Inflation device for an angioplasty product and method for an inflation device

[0002] Description

[0003] Technical field

[0004] The present disclosure relates to an inflation device for inflating and preferably deflating a balloon catheter for angioplasty or for inflating other angioplasty products based on the balloon catheter technique. Furthermore, the present disclosure relates to a method for configuring an inflation device.

[0005] Background of the Revelation

[0006] Angioplasty is a minimally invasive procedure for widening narrowed or blocked blood vessels. A balloon catheter is inserted into the blood vessel, and the vessel is widened by inflating the balloon, a process known as balloon dilation. Angioplasty is typically performed under X-ray guidance. A contrast agent is injected into the blood vessel via the balloon catheter to visualize any narrowing or blockage, as well as the position of the balloon catheter within the vessel.

[0007] In the current state of the art, angioplasty uses a manually or motor-driven inflation syringe. This syringe, operated by moving a plunger, allows for pressure build-up of up to 30 bar, for example via a threaded mechanism, and rapid pressure release, for example via a ring or lever. The inflation syringe is only partially filled with contrast medium, allowing for a negative (return) stroke. This stroke draws air from the balloon catheter into the inflation syringe for venting. This air can then be expelled from the inflation syringe, for example, via a valve and a positive stroke of the syringe plunger. The specific balloon catheter used depends, among other things, on the type and severity of the stenosis to be dilated and is particularly dependent on the overall condition of the patient's blood vessels.The choice of balloon catheter to be used is therefore the responsibility of the surgeon and their professional judgment. Depending on the procedure they have planned, they will use an inflation syringe that, in their experience and assessment, is suitable in terms of design and performance to deflate and inflate one or more balloon catheters without the need to refill contrast medium or change the syringe.

[0008] Disadvantages of this knowledge- and experience-based approach include an individual and potentially shallow learning curve, as well as possible difficulties in transferring experience to other surgeons. If an unsuitable inflation syringe is chosen for the procedure, this may necessitate a syringe change or refilling of the contrast medium. Even a surgeon's uncertainty as to whether the inflation syringe actually contains a sufficient amount of contrast medium can divert their attention, resulting in a loss of time and an increased risk during treatment.

[0009] State of the art

[0010] To relieve the operator of this burden, the patent application DE 10 2022 113 211 A1, filed by the applicant, discloses an inflation device, a semi-automated inflation device comprising a balloon catheter and an inflation syringe. Both the balloon catheter and the inflation syringe feature machine-readable markings containing data characteristic of angioplasty, such as, in the case of the inflation syringe, a syringe type, the amount of contrast medium contained, a maximum inflation pressure, a batch number, etc., and, in the case of the balloon catheter, a deflation volume, an inflation volume, a pressure-inflation diameter relationship (compliance), intended use, a batch number, and the like.

[0011] To simplify the operator's configuration of the inflation device prior to the planned procedure, the device includes a self-test function. Specifically, based on the detected markings, the type of balloon catheter and the quantity of contrast medium in the inflation syringe are determined. The device then verifies whether the inflation syringe is suitable for fully inflating and deflating the balloon catheter. Additionally, based on the detected markings, the device checks whether the contrast medium mixture in the inflation syringe, as determined by its markings, is suitable for the intended application of the balloon catheter.

[0012] The disadvantage of this is that it does not prevent the surgeon from initially selecting an unsuitable inflation injection.

[0013] Summary of Revelation

[0014] In contrast, the purpose of the present disclosure is to provide an inflation device for inflating and venting an angioplasty product, thereby reducing the risk of misuse in angioplasty. A further purpose of the present disclosure is to provide a method for the inflation device, thereby reducing the risk of misuse in angioplasty.

[0015] The problems described in this disclosure are solved by an inflation device having the features of claim 1 and by a method having the features of claim 7. Advantageous embodiments are the subject of the dependent claims.

[0016] An inflation device as disclosed is provided for inflating and preferably deflating an angioplasty product, in particular a balloon catheter for angioplasty. The angioplasty product is positioned / inserted according to a diagnosed stenosis requiring treatment. For unambiguous identification of the specific type / model of angioplasty product, the product is marked, preferably in the form of a machine-readable code. The marking includes an identifier, for example, an angioplasty product type or article number, and / or at least a nominal size, for example, a pressure-inflation diameter ratio."Included" in the context of the disclosure means that the identifier and / or at least one nominal size is assigned to the marking, such that the identifier and / or at least one nominal size can be determined from the marking. Furthermore, the inflation device has a reading unit that is designed and configured to capture the marking of at least the intended angioplasty product. According to the disclosure, a storage unit is provided in which the assignment of at least one suitable inflation syringe to the intended angioplasty product is stored. A control unit of the inflation device is data-connectable to or connected to the reading unit. The control unit is designed and configured to determine the identifier and / or at least one nominal size of the intended angioplasty product from its marking.Furthermore, the control unit is designed and equipped to determine and dispense, in particular to suggest, at least one suitable inflation syringe based on the assignment depending on the identified identifier and / or at least one nominal size of the angioplasty product.

[0017] Since the inflation device, as disclosed, recognizes the intended angioplasty product (hereinafter referred to as the balloon catheter) and, based on the stored assignment, determines and suggests a suitable inflation syringe, it is no longer solely up to the surgeon to select the appropriate inflation syringe for the intended / inserted balloon catheter. Rather, the surgeon is assisted in their selection. As disclosed, such an inflation device is provided for inflating the balloon catheter, thereby reducing the risk of misuse during angioplasty.

[0018] Examples of angioplasty products mentioned in the disclosure, besides the balloon catheter, include a stent system, DEB or DES.

[0019] The storage unit can be located locally, in particular at a treatment station where the inflation device is located. Alternatively, it can be network-based, preferably online in the form of a cloud or a server, in particular a server of a service provider.

[0020] In the network-based scenario, an allocation table and / or a database can be accessed via a preferably secure connection over the internet. For this purpose, the inflation device is equipped with an interface such as USB, LAN, WLAN, Bluetooth, or a mobile data interface (UMTS, LTE, 5G).

[0021] Preferably, the inflation device is configured to record or document the course of the angioplasty. This can be done redundantly on the local or network-based storage unit, or on both.

[0022] Preferably, the inflation device is set up to save or document the progress while removing personal patient data.

[0023] Preferably, the documentation regarding the inflation device, relating to a specific procedure or across multiple procedures, includes: inflation pressures of the angioplasty products used; the inflation syringe used and the number of applications; malfunctions of the inflation device during the angioplasty; the version of the inflation device; the number of operating hours of the inflation device; the number of applications per day, week, and month; the type and number of applications of the procedure; the pressure, time, and cycles of the applications; and a record of the procedure (e.g., "what happened before," "what happened after," etc.)."Pre-procedure, predilation, then DCB, then stent"); a composition of the inflation medium, especially the contrast agent, depending on the recorded marking of the inflation syringe ("contrast-free angioplasty"); a time interval from the connection of the angioplasty product to inflation; a time interval from the creation of the vacuum to inflation; a time interval from deflation to disconnection; a recording in manual mode; a recording of when and if a maximum permissible pressure is exceeded; a logging of treated lesions (LAD, complex PCI, plaque, etc.); a visualization of images from an imaging device, especially a C-arm, together with data from an inflation pump ("what was before", "what was after"); a comparison via a connection with a patient data management system or the imaging device; a maintenance prediction by means of a projection of applications / cycles per year.Patient data is not stored in the inflation device's storage unit, but rather in the patient management system of a medical or clinical facility or hospital. Inflation device data is shared with a data processing system and sent to the patient data management system (Patient XY).

[0024] Preferably, the inflation device has a coded application counter that can be read by a user or operator only at the inflation device and can be used for analysis and comparison of database data.

[0025] According to a particularly preferred embodiment, which further increases safety against misuse, the inflation device can verify the suitability of a pairing of angioplasty product and the provided inflation syringe. For this purpose, an inflation syringe is provided / inserted. Preferably, it has a hollow syringe body, a syringe opening connected to the syringe body and connectable to the angioplasty product, in particular the balloon catheter, and a syringe plunger arranged in the syringe body. This plunger, together with a wall of the syringe body, defines a pressure chamber connected to the syringe opening and is axially displaceable within the syringe body to change the volume of the pressure chamber. The inflation syringe also has a marking, preferably in the form of a machine-readable code, which contains at least one identifier and / or at least one nominal size of the provided inflation syringe.The reading unit is designed and configured to also detect the markings on the intended inflation syringe. According to the disclosure, the control unit is designed and configured to verify, based on the assignment and / or the nominal sizes of the angioplasty product and the inflation syringe, whether the intended inflation syringe actually fits the intended angioplasty product and then output a corresponding test result. Since the inflation device thus recognizes the intended / inserted inflation syringe in addition to the intended / inserted angioplasty product, it can determine, based on the stored assignment and / or by comparing the nominal sizes of the angioplasty product and the inflation syringe, whether the inflation syringe fits the angioplasty product. In this way, the surgeon is notified of an incompatible selection and can correct it.

[0026] According to the disclosure, such an inflation device is provided for inflating the balloon catheter, which can reduce the risk of misuse in angioplasty.

[0027] In one configuration, the reading unit comprises a single reader for capturing both markings, provided that both markings are based on the same capture technology. Alternatively, one reader can be provided for each marking, particularly if the markings use different capture technologies.

[0028] Suitable identification methods include a barcode, QR code, data matrix, alphanumeric representation, data matrix-like encrypted printed images readable by infrared camera, RFID from short-range to long-range technology, a coded magnetic stripe, a contacted chip without a transponder, a transponder with radio technology, encoding via magnetic fields, Bluetooth with integrated power supply or with power supply coupled via connection, or with power supply coupled via induction, a mechanical encoding or geometry, such as dots or Braille characters, a contour or binary coded information.

[0029] Optical detection can be achieved using the aforementioned technologies, or it can be independent of the marking, for example, based on the recognition of product geometries, markings, or label and packaging information of the angioplasty product and the inflation syringe. The reading unit can be permanently installed, particularly on a receptacle of the inflation device. It can also be portable, for example, as a handheld scanner, with a wireless or wired signal connection to the storage unit.

[0030] In one scenario, the reading unit can be a standard computer. Specifically, this includes a PC, tablet, or smartphone. For example, the identification markings can be captured using the standard computer's integrated camera and apps that can read barcodes, QR codes, or via NFC.

[0031] According to a preferred further development, the identifiers and nominal sizes of possible, applicable or foreseeable angioplasty products and inflation syringes and / or the assignment of suitable inflation syringes to angioplasty products are provided to be stored as a database or as at least one assignment table in the storage unit and made accessible.

[0032] In the absence of knowledge of the identifier of the intended angioplasty product or of both identifiers, the appropriate inflation syringe is preferably determined by comparing relevant nominal sizes of the angioplasty product with relevant nominal sizes of the inflation syringe.

[0033] Knowing the identifier of the intended angioplasty product or both identifiers, the appropriate inflation syringe is preferably determined based on the assignment.

[0034] The database or mapping table of the storage unit is preferably updatable, for example via service updates, updates via a service network or via a secure internet connection.

[0035] The database or mapping table of the storage unit is preferably designed for data connection with a regulatory database or cloud containing information on potential recalls, discontinuations, or bans regarding applicable angioplasty products and inflation syringes. Preferably, the control unit is designed and configured to consider previously used angioplasty products and inflation syringes, along with the inflation pressures applied, to determine the appropriate inflation syringe.

[0036] According to a preferred embodiment, possible nominal sizes of the angioplasty product include an article number, a venting volume, a contrast medium loss volume per venting, a maximum inflation volume, a pressure-inflation diameter relationship (preferably in the form of a compliance table), an intended application, a contrast medium mixture ratio specific to the intended application, and a batch number. As mentioned above, the marking of the angioplasty product may include one or more of these nominal sizes.

[0037] According to a preferred embodiment, possible nominal sizes of the inflation syringe include an article number, an available venting volume or available negative stroke volume, a filling volume, an intended application, a contrast agent mixture ratio specific to the intended application, and a batch number. As mentioned above, the marking of the inflation syringe can include one or more of these nominal sizes.

[0038] In most cases, an angioplasty procedure (procedure = angioplasty in exactly one patient) does not use just a single balloon catheter. If the narrowing is severe and the target diameter is large, the stenosis is first dilated with one or more thinner balloon catheters (predilation or lesion preparation) before the final angioplasty product is inserted and expanded to the target diameter. This stepwise approach necessitates multiple uses of the inflation syringe with each successive balloon catheter, requiring each new catheter to be deflated via the inflation syringe. Preferably, the inflation device is designed and configured to store and limit the number of uses of the inflation syringe. Limiting the number of uses helps to prevent the introduction of air into the inflation syringe during the procedure.The introduced air is permanent if, during angioplasty, the inflation syringe is always pointed downwards with its syringe opening facing downwards and the air volume drawn into the inflation syringe when the balloon catheter is deflated is not removed from the inflation syringe.

[0039] Preferably, the inflation device is designed and configured to limit the use of the inflation syringe to exactly one procedure, particularly for hygienic reasons. For this purpose, the inflation device is preferably designed and configured to store the individual identifier of the inflation syringe, preferably a syringe body ID, as locked in the memory unit after the procedure, or to write a lock message to a chip, storage medium, RFID, or EEPROM located on the syringe body. Preferably, the lock is not reversible. Thus, when the inflation syringe is reinserted, the device detects that it has already been used and is locked by reading the syringe's identification.

[0040] However, if the venting volume drawn into the inflation syringe during the venting of the angioplasty product is pushed out of the inflation syringe during the procedure,

[0041] - in this case, the inflation syringe has an upward tendency to vent.

[0042] - a volume of contrast agent is always lost, and the filling volume of the inflation syringe is thereby gradually reduced.

[0043] Preferably, the inflation device is designed and configured to store a number of applications of the inflation syringe with the angioplasty products during the procedure and to sum up the contrast medium loss volumes of the applications.

[0044] According to a particularly preferred embodiment, the control unit is designed and configured to sum the contrast agent loss volumes of the successively applied angioplasty products in an angioplasty procedure that includes successive applications of several angioplasty products, to subtract the loss volume from the original filling volume, and to determine a residual filling volume in order to issue a message or to lock the procedure if a stored, predetermined lower limit of the residual filling volume is undershot.

[0045] Preferably, the inflation device, in particular its control unit, has a data interface, in particular a data connection, to an external server, an external cloud, a patient data management system and / or to a C-bow.

[0046] According to preferred embodiments of the inflation device, it is provided and equipped with at least one of the following procedures or connections and / or one of the following elements: to limit the number of inflations of an angioplasty product identified as a drug-coated balloon catheter according to the disclosure to a specific or predetermined number, e.g., to exactly one, and / or to block an intermediate deflation and a subsequent inflation; to remove such a block, in particular by a release procedure in which a warning is displayed to the user, which the user can acknowledge by entering a value and thus override the block, in particular the automatic one;to provide deflation monitoring, in particular to issue a "Safe to be removed" message as soon as the angioplasty product passes through a sheath, and to release the disconnection of the angioplasty product with a "Removal" message; to have a control element to which a "Product Complaint" function is assigned and which is in data connection with an interface to a manufacturer or service provider of the angioplasty product, the inflation syringe, or the inflation device; to have an escalation connection in order to transmit a data flow to a server of a manufacturer or service provider in the event of a failure (e.g., in the case of a pinhole or rupture of the angioplasty product); to provide a printout of a procedure protocol including medication; to report a procedure protocol to the hospital's patient data management system;to specify a guideline or procedure tailoring, for example, to block a predetermined angioplasty product depending on the type of stenosis, or to specify only angioplasty products with a suitable diameter depending on the type of stenosis, while filtering out those with an unsuitable diameter; to enable detection of the angioplasty product via a lookup table and a barcode, and a compliance chart; to allow or block vacuum retraction before stent application depending on the angioplasty product; to generate recommendations for treatment with products and pressures, both for stenoses defined by manually defined stenoses and for stenoses defined by a combination of examination data from different sources (CT, MRI, IVUS, OCT). The recommendations incorporate, in particular, the user's or surgeon's application history. Communication for necessary calculations takes place via data interfaces.to demonstrate a strategy for maintaining a diameter by time-dependent pressure adjustment, taking into account the properties of the balloon catheter material.

[0047] When using an external input device to control inflation, such as a digital inflation syringe, pressure build-up can be supported by information-driven control. For example, the pressure can be limited to prevent accidental overloading of the inflation device or the angioplasty product. A pressure build-up curve can be smoothed, or a creeping growth of the balloon diameter can be automatically prevented during pressurization.

[0048] When using an analog input device, such as an inflation syringe with a pressure sensor, measures to smooth pressure fluctuations and to limit pressure can be implemented. With either an analog or a digital input device, the function of the inflation device can also be simplified so that only the pressure is controlled and the inflation process is automated.

[0049] The inflation device can be designed and configured to receive an inflation target via input of a target pressure or target diameter. Alternatively or additionally, it can be designed and configured to receive an inflation target via an interface from a C-arm that has determined a target diameter or on which the operator has measured a target diameter.

[0050] Alternatively or additionally, the inflation device is provided and configured to drive a drive unit that drives the inflation syringe according to the inflation target, based on a target value from the pressure-inflation diameter relationship of the intended angioplasty product.

[0051] Alternatively or additionally, the inflation device is provided and set up to determine a trend curve from the target value and the type of angioplasty product and to control the drive unit accordingly.

[0052] Alternatively or additionally, the inflation device is equipped with a manual mode - i.e., a so-called unprotected mode or manual-override mode - which gives the operator the possibility to control the drive unit with values ​​deviating from the pressure-inflation diameter ratio, in order, for example, to intentionally burst the balloon catheter if it could not otherwise be withdrawn.

[0053] According to the disclosure, an inflation arrangement can be provided which has at least two inflation devices configured according to at least one aspect of the preceding description. The control units of the inflation devices of the inflation arrangement are wired or wirelessly signal-connected, and at least one of these control units is configured to synchronize the respective inflations, and preferably deflations. In this way, the operator can be assisted in the case of stenoses at bifurcations or trifurcations (kissing balloon inflation).

[0054] A disclosed method for configuring an inflation device intended for performing angioplasty using an angioplasty product and an inflation syringe, and designed according to at least one of the preceding aspects, comprises the following steps: providing an angioplasty product, in particular by an operator; capturing the marking of the intended angioplasty product via the reading unit; and transmitting the marking of the angioplasty product to the control unit that is data-connectable or data-linked to the reading unit.

[0055] According to the disclosure, it comprises the following steps: determining the identifier and / or at least one nominal size of the intended angioplasty product from its marking via the control unit, determining the inflation syringe suitable for the intended angioplasty product from the assignment depending on the determined identifier and / or at least one determined nominal size of the intended angioplasty product via the control unit, and issuing, in particular suggestions, of the inflation syringe determined to be suitable.

[0056] According to a preferred embodiment, the method includes steps to verify the suitability of a pairing of the intended / inserted angioplasty product and the intended / inserted inflation syringe: providing an inflation syringe, particularly by the operator; capturing the marking of the intended inflation syringe via the reading unit; transmitting the marking of the inflation syringe to the control unit that is data-connectable to or linked to the reading unit; and determining the identifier and / or at least one nominal size of the intended inflation syringe from its marking via the control unit. The disclosure also includes the following steps: checking the suitability of the intended inflation syringe for the intended angioplasty product based on the assignment and / or the nominal sizes via the control unit; and outputting a test result, preferably via an output / display unit.

[0057] The procedure as disclosed is completed before the patient is connected to the inflation device.

[0058] Brief description of the characters

[0059] Fig. 1 is a schematic representation of an inflation device for angioplasty according to a first embodiment of the present disclosure, connected to a network environment;

[0060] Fig. 2 is a schematic representation of the inflation device for angioplasty according to the first embodiment of the present disclosure, connected to a network environment;

[0061] Fig. 3 is a schematic representation of an inflation device according to a second embodiment of the present disclosure, connected to a network environment; and

[0062] Fig. 4 is a schematic representation of a method for configuring an inflation device according to the present disclosure.

[0063] Detailed description of preferred embodiments

[0064] The following describes embodiments of the present disclosure on the basis of the associated figures.

[0065] Figure 1 shows a schematic representation of an inflation device 1 according to the present disclosure, connected to a network environment 2 according to a first embodiment. The inflation device 1 has a reading unit 2 with a first reader 4 for detecting a marking KA of an angioplasty product 6 to be inflated, in particular a balloon catheter (hereinafter referred to as balloon catheter 6), and a second reader 8 for detecting a marking KS of an inflation syringe 10 suitable for inflating the balloon catheter 6.

[0066] The marking KA or KS contains as a minimum information an identifier of the balloon catheter 6 or the inflation syringe 10, or at least an angioplasty-relevant nominal size of the balloon catheter 6 or the inflation syringe 10.

[0067] The identifier must be at least an ID, type, or article number by which the intended balloon catheter 8 or inflation syringe 10 can be uniquely identified, so that the nominal size(s) of the balloon catheter 8 or inflation syringe 10 can also be determined. In other words: knowing the marking KA or KS, the identifier can be uniquely determined, and knowing the identifier allows for the unambiguous determination of the nominal size(s) of the intended balloon catheter 8 or inflation syringe 10.

[0068] For the balloon catheter 6, examples of angioplasty-relevant parameters include: a deflation volume, a contrast agent loss volume per deflation, a maximum inflation volume, a pressure-inflation diameter ratio, and the like. For the inflation syringe 10, examples of angioplasty-relevant parameters include: an available deflation volume or available negative stroke volume, a filling volume, an intended application, a contrast agent mixture ratio specified for the intended application, and the like.

[0069] The readers 4, 8 are connected to a control unit 12 of the inflation device 1 via signal and data. The control unit 12, in turn, is connected to a storage unit 14 via signal and data. The storage unit 14 contains a retrievable assignment of suitable inflation syringes 8 to designated balloon catheters 6.

[0070] The mapping is preferably designed as a database or as at least one mapping table.

[0071] The assignment is preferably provided such that the IDs of suitable inflation syringes 10 are assigned to the IDs of provided balloon catheters 6.

[0072] Alternatively or additionally, the assignment is provided such that relevant nominal size(s) of suitable inflation syringes 10 are assigned to the IDs of the balloon catheters 6 provided.

[0073] Alternatively or additionally, the allocation is provided such that relevant nominal sizes of suitable inflation syringes are allocated to 10 relevant nominal sizes of intended balloon catheters.

[0074] According to the disclosure, the inflation device 1 is designed and configured, by means of the control unit 12 and the assignment stored in the storage unit 14, to uniquely identify the identifier and thus the nominal size(s) of the intended balloon catheter 8 or the intended inflation syringe 10 based on the marking KA or KS, and / or to uniquely identify a type of the intended balloon catheter 8 or the intended inflation syringe 10 based on at least one nominal size.

[0075] As shown in Figure 1, the inflation device 1 has an output / display unit 16, which is data-connected to the control unit 12, serving as an information interface to an operator. The output / display unit 16 is designed, at a minimum, to display the detected, intended balloon catheter 6 and a suggestion for a suitable inflation syringe 10, determined from the assignment, that matches the balloon catheter 6. Furthermore, the control unit 12 is data-connected to an external server 18 and an external cloud 20, preferably via an internet connection.

[0076] According to Figure 1, only the balloon catheter 6 is provided; that is, a preliminary examination on the patient resulted in the use of a balloon catheter 6 with specific angioplasty-relevant nominal sizes in a procedure on the patient. This balloon catheter 6 of specific type, specific ID and with its specific nominal sizes is thus provided on the inflation device 1, for example by being inserted into an angioplasty product receptacle of the inflation device 1.

[0077] According to Figure 1, the inflation device 1 is now configured to carry out a method as disclosed in Figure 4.

[0078] In this process, if no inflation injection 10 (dashed line) is yet planned, a suitable inflation injection is proposed depending on the KA marking detected by the first reader 4. The procedure has the following steps:

[0079] Starting SO of the inflation device 1 by an operator SO; Provisioning S1.1 of the balloon catheter 6 resulting from the above preliminary examination; Acquisition S2.1 of the identification KA of the provided balloon catheter 6, via the reading unit 2 (the first reader 4); and transmission S3.1 of the identification KA of the provided balloon catheter 6 to the control unit 12 connected to the data-linked reading unit 2.

[0080] According to the disclosure, the following steps are now performed: Determining S4.1 the identifier and / or at least one nominal size from the marking KA of the intended balloon catheter 6 via the control unit 12; Determining S5.1 the suitable inflation syringe 10 for the intended balloon catheter 6 from the assignment depending on the determined identifier and / or at least one determined nominal size of the intended balloon catheter 6 via the control unit 12; Outputting S6, in particular suggestions, of the suitable inflation syringe 10 via the output / display unit 16; and Terminating S9 the procedure before the patient is connected to the inflation device 1. Figure 2 shows the inflation device 1 according to Figure 1, connected to a network environment that is extended by a patient data management system 22 and a C-arm 24.

[0081] In this way, real-time image data of the stenosis(es) can be transmitted from the C-arm 24 to the control unit 12. Additionally, target diameters measured by the surgeon can be transmitted to the control unit 12 within a single display of the C-arm 24.

[0082] Procedure data recorded by the control unit 12 during a procedure, such as the sequence of the angioplasty products 6 used with their IDs, the applied inflation pressures, and incidents before, during and after the procedure, can be stored in the data-linked patient data management system 22 for patient-specific documentation.

[0083] The procedure data recorded during the procedure can be stored on the external server 18 in a patient-independent manner and can be retained, in particular, for later analysis.

[0084] The inflation device 1 is preferably designed and equipped to determine the appropriate inflation syringe 10 on the basis of the image data of the stenosis(es) transmitted by the C-arm 24 and the balloon catheter 6 determined in accordance with the disclosure, and to dispense / suggest it at the output unit / display unit 16.

[0085] Furthermore, the inflation device 1 according to Figures 1 and 2 is designed to continue the method disclosed according to Figure 4 in order to test the suitability of the inflation syringe 10 for the balloon catheter 6 provided / inserted.

[0086] As a starting point in Figure 2, it is therefore assumed that the inflation injection 10 is also provided / inserted (solid line representation of the inflation injection 10) and not based on the previously described, disclosed proposal of the control unit 12, but freely chosen.

[0087] After the start SO, steps S1.2 to S4.2 are carried out in parallel to steps S1.1 to S4.1 described above. Therefore, steps S1.1 to S4.2 are not described again, and reference is made to the description in Figure 1. According to Figures 2 and 4, the following steps are performed as disclosed: S1.2 provision of an inflation syringe 10, in particular by the operator; S2.2 acquisition of the marking KS of the provided inflation syringe 10 via the reading unit 2 (second reader 8); S3.2 transmission of the marking of the provided inflation syringe 10 to the control unit 12, which is data-connected to the second reader 8; and S4.2 determination of the identifier and / or at least one nominal size from the marking KS of the provided inflation syringe 10 via the control unit 12.According to the disclosure, the following steps now follow: Checking S7 of the intended inflation syringe 10 for suitability for the intended balloon catheter 6 based on the assignment and / or on the nominal sizes via the control unit 12 and outputting S8 a test result, preferably via the output unit / display unit 16.

[0088] Figure 3 shows a schematic representation of an inflation device 1 according to a second embodiment of the present disclosure, connected to a network environment. In addition to the first embodiment according to Figures 1 and 2, a pressure sensor 26 for detecting the inflation pressure and a displacement sensor for detecting a syringe plunger stroke of the inflation syringe 10 are provided. Both sensors are signal-connected to the control unit 12. In this way, inflation pressure control is enabled, in particular, as a function of the detected inflation pressure and the detected syringe plunger stroke.

[0089] The external server 18 is preferably intended and configured for documenting maintenance-relevant data of the inflation device 1. For example, the status of the inflation device 1, information about the angioplasty products 6, the reading unit 4, 8, and print data can be stored here. By analyzing the data, a possible or necessary maintenance appointment can be determined and / or scheduled in advance.

Claims

Claims 1. Inflation device (1) for inflating, and preferably for deflating, an angioplasty product (6), in particular a balloon catheter (6) for angioplasty, comprising: a provided angioplasty product (6) with a marking (KA), preferably in the form of a machine-readable code containing an identifier and / or at least a nominal size of the provided angioplasty product (6), and a reading unit (2) which is provided and configured to detect the marking (KA) of at least the provided angioplasty product (6), characterized in that a storage unit (14) is provided in which an assignment of at least one suitable inflation syringe (10) to the provided angioplasty product (6) is stored, and that a control unit (12) of the inflation device (1) is data-connectable or data-linked to the reading unit (2), and is provided and configured for this purpose.to determine the identifier and / or at least one nominal size of the intended angioplasty product (6) from the marking (KA) of the intended angioplasty product (6) and, depending on the identified identifier and / or at least one nominal size of the intended angioplasty product (6), to identify and issue at least one suitable inflation syringe (10) from the allocation, in particular to propose.

2. Inflation device (1) according to claim 1, characterized in that an inflation syringe (10) is provided which has a marking (KS) which contains at least one identifier and / or at least one nominal size of the provided inflation syringe (10), and that the reading unit (2) is provided and configured to detect the marking (KS) of the provided inflation syringe (10), and that the control unit (12) is provided and configured to check the suitability of the provided inflation syringe (10) for the provided angioplasty product (6) based on the assignment and / or on the nominal sizes of the angioplasty product (6) and the inflation syringe (10) and to output a test result.

3. Inflation device (1 ) according to claim 1 or 2, characterized in that the identifiers and nominal sizes of possible, applicable or foreseeable angioplasty products (6) and inflation syringes (10) and / or the assignment are provided to be stored as a database or as at least one assignment table in the storage unit (14) in a manner that can be accessed.

4. Inflation device (1) according to one of the preceding claims, characterized in that the at least one nominal size of the angioplasty product (6) is an article number, and / or a venting volume, and / or a contrast medium loss volume per venting, and / or a maximum inflation volume, and / or a pressure-inflation diameter ratio, preferably as a compliance table, and / or an intended application, and / or a mixing ratio of contrast medium mixture intended for the intended application, and / or a batch number, and / or that the at least one nominal size of the inflation syringe (10) is an article number, and / or an available venting volume or available negative stroke volume, and / or a filling volume, and / or an intended application, and / or a mixing ratio of contrast medium mixture intended for the intended application, and / or a batch number.

5. Inflation device (1) according to claim 4, characterized in that the control unit (12) is provided and configured to sum the contrast medium loss volumes of the successively applied angioplasty products (6) to a loss volume during an angioplasty procedure comprising successive applications of several angioplasty products (6), to subtract the loss volume from the filling volume and to determine a residual filling volume in order to issue a message or to lock the procedure if a stored, predetermined lower limit of the residual filling volume is undershot.

6. Inflation device (1) according to one of the preceding claims, characterized in that a data connection to an external server (18, 20), a patient data management system (22) and / or to an imaging system (24), in particular to a C-arm, is provided.

7. Method for configuring an inflation device (1) for performing angioplasty using an angioplasty product (6) and an inflation syringe (10), wherein the inflation device (1) is configured according to any one of claims 1 to 6, comprising steps: - (S1.1) Provision of an angioplasty product (6), in particular by a surgeon, - (S2.1) Capturing the identification (CA) of the intended angioplasty product (6) via the reading unit (2), - (S3.1 ) Transmitting the identification (CA) of the angioplasty product (6) to the control unit (12) that can be data-connected or data-linked to the reading unit (2), characterized by steps: - (S4.1) Determining the identifier and / or at least one nominal size from the marking (KA) of the intended angioplasty product (6) via the control unit (12), - (S5.1) Determining the inflation syringe (10) suitable for the intended angioplasty product (6) from the assignment depending on the determined identifier and / or the at least one determined nominal size of the intended angioplasty product (6) via the control unit (12), - (S6) Spending, in particular proposals, the appropriate inflation injection (10).

8. Method according to claim 7, comprising steps: - (S1.2) Provision of an inflation injection (10), in particular by the operator, - (S2.2) Detecting the identification (KS) of the intended inflation injection (10) via the reading unit (2), - (S3.2) Transmitting the identification (KS) of the inflation syringe (10) to the control unit (12) that is data-connectable or data-linked to the reading unit (2), - (S4.2) Determining the identifier and / or at least one nominal size of the intended inflation syringe (10) from the marking (KS) of the intended inflation syringe (10) via the control unit (12), characterized by steps: - (S7) Checking the intended inflation syringe (10) for suitability for the intended angioplasty product (6) based on the assignment and / or on the nominal sizes via the control unit (12), and - (S8) Output of a test result, preferably via an output unit / display unit (16).

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