Inflation device for inflating an angioplasty product, inflation assembly comprising inflation devices, and medical system for angioplasty

Abstract

The invention relates to an inflation device (1; 101) for inflating at least one angioplasty product (6), the inflation device comprising: a product interface (38) which is provided and designed to fluidically connect the at least one angioplasty product (6); a drive unit (30) which is provided and designed to drive a fluid delivery device (10); a pressure detection unit (40) which is provided and designed to detect a pressure; and a control unit (12) which is signal-connected to the drive unit (30) and to the pressure detection unit (40) and which is provided and designed to control the drive unit (30) depending on the detected pressure (p) and on a target pressure (pD) corresponding to a target diameter (D) of the angioplasty product (6), wherein a memory unit (14) is provided in which a mapping of time-dependent target pressure profiles (42, 44, 46, 48, 50, 52) to predetermined angioplasty products (6) is stored in a retrievable form.

Description

[0001] Inflation device for inflating an angioplasty product, inflation arrangement with inflation devices, and medical system for angioplasty

[0002] Description

[0003] Technical field

[0004] The present disclosure relates to an inflation device for the automated inflation of a balloon catheter for angioplasty or for the inflation of other angioplasty products based on the balloon catheter technology, as well as an inflation arrangement with inflation devices and a medical system comprising at least one inflation device or inflation arrangement and an imaging unit.

[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] According to the prior art originating from the applicant, a motor-driven inflation syringe is used for angioplasty. This syringe allows for pressure build-up of up to 30 bar by moving a syringe plunger, for example via a thread, and rapid pressure release, for example via an unlocking mechanism such as a ring or lever. The inflation syringe is only partially filled with contrast medium, so that a negative (return) stroke is available. This stroke allows air to be drawn 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.

[0008] The type of balloon catheter to be 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 is made by the surgeon based on their professional judgment and experience. A pressure-inflation diameter relationship—a so-called compliance chart—is known for each balloon catheter. Based on a pressure measurement of the fluid delivered by the inflation syringe, the balloon's diameter can be determined from the measured pressure. In addition, the inflation diameter is monitored visually using real-time imaging from a device such as a CT scanner.

[0009] The inflation process and the chosen inflation rate are experience-based processes for the surgeon, with a corresponding individual learning curve. Experience with a specific balloon catheter or balloon catheter type is often limited, as the number of available balloon catheters from different manufacturers and in various sizes is enormous, which in turn leads to a low number of repetitions per specific balloon catheter type for the surgeon.

[0010] A key parameter for the long-term success of angioplasty is the rate at which inflation occurs. Furthermore, for the reasons mentioned above, it is difficult for individual surgeons to gain experience. Their experience is essentially limited to interpreting the compliance chart in conjunction with their observations based on C-arm imaging.

[0011] Disadvantages of this knowledge- and experience-based approach include an individual and potentially flat learning curve and possible difficulties in transferring the experience to other surgeons.

[0012] To assist the operator in controlling inflation, a subsequently published document from the applicant, number DE 10 2023 102 573.2, discloses an inflation device in which pressure levels and pressure profiles can be selected, which can then be executed by the inflation device during inflation.

[0013] Summary of Revelation

[0014] In contrast, the purpose of the present disclosure is to provide an inflation device for inflating an angioplasty product, thereby reducing the risk of misuse of the angioplasty product. A further purpose of the present disclosure is to provide an inflation arrangement with inflation devices and a medical system for angioplasty, which reduces the risk of misuse in angioplasty.

[0015] The object of this disclosure is achieved by an inflation device with the features of claim 1, an inflation arrangement with the features of claim 14, and a medical system for angioplasty with the features of claim 15. Advantageous further developments are the subject of the dependent claims and / or are explained below.

[0016] An inflation device according to the present disclosure is provided for inflating at least one angioplasty product, preferably at least one balloon catheter, and has a product interface that is provided and configured for the fluidic connection of the at least one angioplasty product. Furthermore, it has a fluid delivery interface that is fluidically connectable to or connected with the product interface and is provided and configured for the fluidic connection to a fluid delivery device, in particular an inflation syringe. It also has a drive unit that is provided and configured for driving the fluid delivery device, in particular a piston or cylinder of the fluid delivery device.This drive allows fluid to be conveyed from the fluid conveying interface to the product interface when a balloon catheter is connected to the product interface and an inflation syringe is connected to the fluid conveying interface, thereby pressurizing the balloon catheter with fluid and causing it to inflate. Preferably, the inflation device is configured to detect and / or determine the volume conveyed by the fluid conveying device. For this purpose, the inflation device is preferably equipped with an angle or displacement detection unit to detect the angular or displacement position of an actuator of the drive unit or the piston relative to the cylinder. Based on a detected change in the angular or displacement position, the volume of the conveyed, in particular expelled, or drawn-in, fluid can be determined.Furthermore, the inflation device has a pressure sensing unit, which is designed and configured to detect a pressure in a pressure chamber of the fluid delivery device or a pressure dependent thereon, and a control unit, which is signal-connected to the drive unit and the pressure sensing unit and preferably to the angle or displacement sensing unit, and is designed and configured to control the drive unit at least as a function of the detected pressure and a target pressure corresponding to a target diameter of the angioplasty product. In this way, the inflation device can inflate the balloon catheter under control of at least the detected pressure until the target pressure is reached, at which point the balloon catheter has reached its target diameter.According to the present disclosure, the inflation device has a storage unit in which an assignment of time-dependent target pressure profiles to possible, applicable, or foreseeable angioplasty products, in particular angioplasty product types, is stored and can be recalled. Furthermore, the control unit is designed and configured to control the drive unit depending on the assigned, time-dependent target pressure profile, that is, preferably to control it in such a way that the detected pressure follows the time-dependent target pressure profile.

[0017] By means of the inflation device as disclosed, the pressure in the balloon catheter can be precisely controlled or regulated over time, so that misuse of the balloon catheter due to errors in the pressure over time is impossible or at least less likely.

[0018] The inflation device described above allows for the creation of time-dependent pressure profiles that cannot be reproduced manually. This enables clinically optimized time-dependent pressure profiles or time-dependent pressure profiles adapted to a surgeon's preferences.

[0019] One goal of optimized target pressure profiles can be to reduce the time required for blood flow restricted by inflation, to optimize drug release, or to improve stent embedding. By considering the material or plastic properties of the angioplasty product, particularly time-dependent elongation or a target diameter that should not be exceeded, the target diameter can be achieved more quickly and gently.

[0020] Specifically, this prevents inflation that is too slow or too fast, or prohibited intermediate deflation, and allows each possible balloon catheter type – or a stent expanded from it – to be inflated with the optimal, time-dependent target pressure profile for it.

[0021] The disclosed inflation device proves particularly advantageous in the application of drug-releasing angioplasty products. The time-dependent target pressure profile allows for optimal drug release from drug-coated, inflatable angioplasty products.

[0022] According to a possible further development, the inflation device is designed and configured to provide the pressure recorded by the pressure sensing unit during inflation, and preferably other recorded data, to an evaluation unit. In this way, target pressure profiles can be optimized, for example, using big data and machine learning (Kl).

[0023] According to a preferred further development, the control device is designed and configured to adjust the assigned, time-dependent target pressure profile after each inflation or after at least one of the inflations in the case of multiple inflations of an angioplasty product.

[0024] In particular, the adjustment consists of lowering or raising the target pressure, or shifting the target pressure profile downwards or upwards. This ensures that the target diameter is not exceeded, even during multiple inflations, or is always achieved. For example, this allows for adjustments to account for changes in the elongation behavior of balloon catheters during repeated inflation, especially towards a larger inflation diameter at the same pressure or a smaller inflation diameter at the same pressure (changed compliance chart after initial inflation).

[0025] According to a preferred training method, this adjustment is preferably made for angioplasty products with a smaller target diameter.

[0026] According to a preferred further development, the inflation device is designed and configured to indicate if a target diameter can no longer be achieved due to previous inflation(es) or stretching(s), particularly in the case of angioplasty products with a smaller target diameter.

[0027] According to a preferred embodiment, the inflation device has a displacement detection unit for detecting the displacement of the drive unit and / or the fluid delivery system, wherein the fluid volume delivered by the fluid delivery system depends on this displacement. The control unit is signal-connected to the displacement detection unit and, according to the preferred embodiment, is configured to determine the delivered fluid volume as a function of the detected displacement and subsequently to control the drive unit as a function of the delivered fluid volume. Preferably, this volume-dependent control is performed in addition to the control based on the detected pressure, target pressure, and setpoint pressure profile. This combination of volume- and pressure-based control can increase the inflation rate and shorten the duration of the interruption in the blood circulation resulting from the inflation.Optimization can be achieved through the application of machine learning (Kl), in particular by training a neural network. Based on the acquired measurements and a strategy generated by Kl, an optimal inflation rate can be achieved with or without the support of classical control engineering. According to a preferred embodiment, an initial gradient of the time-dependent target pressure profile is at least two orders of magnitude larger than a final gradient of the time-dependent target pressure profile as the target pressure is approached. Preferably, the target pressure profile has a hyperbolic shape. This allows for a maximum inflation rate at the beginning and a lower rate towards the end, as the target diameter or pressure is approached.

[0028] Preferably, the control device is designed and configured to perform speed control via pressure.

[0029] According to a preferred embodiment, the control device is configured to control the drive unit in such a way that a fluid flow rate greater than 0.3 ml / s, preferably greater than 0.33 ml / s, results.

[0030] Additionally or alternatively, at least one time-dependent target pressure profile is stored in the storage unit and can be called up, which has a pressure increase rate that corresponds to a fluid flow rate greater than 0.3 ml / s, preferably greater than 0.33 ml / s.

[0031] In both of the aforementioned advanced training courses, the inflation rate achievable according to the disclosure is therefore higher than that of a human operator who can achieve a fluid flow rate of approximately 0.3 ml / s through manual operation.

[0032] According to a preferred further development, at least the time-dependent target pressure profile has a maximum above the target pressure, or the time-dependent target pressure profile converges from above the target pressure to the target pressure.

[0033] Preferably, the maximum of the target pressure profile is applied briefly at the beginning of the inflation process. This brief pressure increase above the target pressure at the start of the inflation phase can shorten the inflation time until the target diameter is reached. A spatial arrangement of the pressure sensing unit closer to the fluid delivery interface than to the product interface is advantageous for this. The fluid from the inflation syringe reaches the evacuated balloon catheter only after a certain dead time. The brief maximum / pressure increase therefore does not reach the balloon catheter immediately or in full, but rather with a time delay and in a dampened form. However, the advantage is that – as mentioned above – this shortens the inflation time until the target diameter is reached.

[0034] Following the maximum / excess pressure, the pressure is preferably reduced to the target pressure.

[0035] Alternatively, the target pressure profile can converge with the target pressure from below.

[0036] According to further training, the time-dependent target pressure profile has a, in particular pulsating, sequence of maxima with values ​​approximately equal to the target pressure, whereby the values ​​of the associated or intermediate minima increase as the target pressure is approached.

[0037] In this way, impulsive post-inflation with a brief pressure increase can be performed after reaching the target diameter. Such a target pressure profile is suitable, for example, for compensating for recoil without subjecting the tissue to the expansion to excessive stress.

[0038] According to further training, the time-dependent target pressure profile below the target pressure exhibits at least one local maximum followed by a local minimum - in other words, a pulse with a local maximum and a local minimum.

[0039] The pulsating inflation and thus expansion of the balloon catheter results in pressure increases and decreases, and potentially further pressure increases followed by subsequent pressure decreases. This pulsation enables improved release of medications from the balloon catheter or stent. According to further training, the time-dependent target pressure profile exhibits at least one plateau below the target pressure, and in particular, several plateaus with progressively increasing levels.

[0040] According to a training course, the time-dependent target pressure profile coincides with the target pressure or runs parallel to the target pressure for a predetermined period. At the end of the predetermined period, it drops below the target pressure.

[0041] According to a preferred further development, the control device is designed and configured to adjust the target pressure profile depending on the recoil of the balloon catheter in such a way that the tissue to be dilated is better protected.

[0042] According to a preferred further development, the control device is designed and configured to adjust the target pressure profile so that the pressure is briefly increased to such an extent that the target diameter of a stent is reached, and subsequently the pressure is reduced to such an extent that the stent is kept at the target diameter.

[0043] According to a preferred further development, the control device is designed and configured to reduce the pressure according to physical relationships, in particular according to the material properties of the balloon catheter and / or stent, in such a way as to counteract material fatigue that occurs due to the stretching of the material.

[0044] According to a preferred further development, the control device is designed and configured to detect a leak in the inflation device, which may be caused in particular by product defects or by incorrect connection.

[0045] For this purpose, the control device may be designed and configured to perform an evaluation of the pressure detected by the pressure sensing unit in the pressure chamber of the fluid conveying device against the conveyed volume and to issue or initiate the output of an error message if the detected pressure, in particular a pressure increase, especially taking into account tolerances or predetermined, tolerable factors, is too low for the conveyed volume.

[0046] According to a preferred further development, the inflation device is prepared to compare the inflation or expansion, which theoretically results from the compliance chart, the target pressure profile and the recorded pressure, with recordings from an imaging, in particular radiographic, unit.

[0047] Preferably, processing and storage of data relating to the angioplasty product, the pressure and the image data is provided, in particular for the optimization of future inflations in combination with these three parameters.

[0048] According to a preferred further development, the inflation device has a data interface to an imaging unit, in particular a C-arm, OCT or IVUS. This allows an image of the stenosis to be received by the imaging unit.

[0049] The control unit is preferably configured to determine and / or suggest the target diameter necessary to correct the stenosis based on the image, and / or to monitor the approach of the actual diameter to the target diameter, and / or to monitor the maintenance of the target diameter. In particular, the control unit is equipped with suitable technology, especially machine vision or machine image recognition.

[0050] For the treatment of stenoses at a vascular bifurcation (bifurcation or trifurcation), it may be necessary to use two or three angioplasty products simultaneously. This is either because multiple stenoses are present in the area of ​​the furcation, or because one vessel in the furcation does not have a stenosis, but a balloon catheter must be positioned there to prevent damage to the vessel from the adjacent balloon catheter.

[0051] According to a particularly preferred embodiment, the inflation device therefore has at least one further product interface, fluid conveying interface, drive unit, and pressure sensing unit for the inflation of at least one further angioplasty product. Accordingly, the control unit is designed and configured to control the drive units in a time-coordinated manner, in particular simultaneously and / or in temporal sequence or order, with or without temporal overlap, and in particular at least in each case depending on the assigned, time-dependent target pressure profile of the respective angioplasty product.

[0052] At the furcation, the risk of complications such as plaque shift or displacement of an angioplasty product can be particularly well prevented if, according to advanced training, the inflation device is designed and configured to control the drive units and pressures simultaneously and / or sequentially. This ensures optimal results for angioplasty at the furcation.

[0053] Alternatively, several inflation devices can be used in parallel to treat stenoses of vessel bifurcations (bifurcations or trifurcations). Preferably, the inflation devices are designed and configured to communicate with each other and thus control the timing of the individual inflations. Each inflation device processes the target pressure profile of the respective angioplasty product it is intended to use or connected to.

[0054] In the case of multiple inflation devices, preferably one of the inflation devices is prioritized and coordinates the other inflation devices, or another control device is provided to perform this task.

[0055] According to an advantageous embodiment, the inflation device has a reading unit designed and configured to detect a marking of the at least one intended angioplasty product, preferably a marking in the form of a machine-readable code containing an identifier of the angioplasty product, in particular its type. According to this embodiment, the control unit is designed and configured to determine the intended angioplasty product, in particular its type, from this marking, to determine the time-dependent target pressure profile assigned to the intended angioplasty product, in particular its type, and to provide the determined, assigned, time-dependent target pressure profile for controlling the at least one drive unit and / or to display it to an operator for selection, in particular to suggest it.

[0056] Preferably, the storage unit contains a further assignment of suitable inflation syringes to angioplasty products, and the control device is designed and configured to determine and output at least one suitable inflation syringe from the further assignment, in particular to suggest one, depending on the identified angioplasty product, in particular the identified angioplasty product type.

[0057] Preferably, the reading unit is provided and configured to detect a marking of a provided fluid conveying device, in particular an inflation syringe, preferably a marking in the form of a machine-readable code which contains an identifier of the inflation syringe, and the control device is provided and configured to check the suitability of the provided inflation syringe for the provided angioplasty product based on the further assignment and to output a test result.

[0058] An inflation arrangement according to the present disclosure comprises several inflation devices, at least two, three, or four, configured according to an aspect of the preceding description. The control units of the inflation devices are wired or wirelessly signal-connected or signal-linked for the coordinated inflation of several angioplasty products. According to the present disclosure, one of the control units may be provided and configured as a master control unit or may be selected as such. The master control unit may be provided and configured to control the other control units to perform the inflation of the angioplasty products in a time-synchronized and / or time-coordinated manner. In this way, angioplasty at bifurcations or trifurcations can be performed, for example, using a "kissing balloon" method.

[0059] A medical system for angioplasty, as disclosed, comprises at least one inflation device and / or inflation arrangement configured according to the preceding description and an imaging unit for preoperative and / or real-time imaging of a stenosis. The imaging unit is preferably a C-arm, OCT, or IVUS. A data interface of the inflation device is data-connectable to, or connected to, the imaging unit to receive the image(s).

[0060] In this way, image-based monitoring of inflation is possible, and it is particularly easy to control the inflation rate based on the real-time measurement of the diameter of the angioplasty product.

[0061] In particular, image-based monitoring allows for precise control of the inflation rate until the angioplasty product makes contact with the vessel wall. This protects the drug coating of the angioplasty product during inflation.

[0062] Image-based monitoring also enables precise maintenance of the diameter at the target size. Time-dependent pressure adjustment can be performed based on the diameter detected by the images. If the diameter decreases, the pressure increases; if it increases, the pressure decreases.

[0063] In the case of further processing with the imaging unit, the pressure can be automatically increased within a pressure range approved for the angioplasty product in order to achieve the target diameter – specified either by the surgeon or by the control unit of the inflation device. Limits of the angioplasty product with respect to a maximum inflation pressure and a maximum inflation diameter are taken into account. According to a preferred embodiment of the medical system, the at least one control unit – or at least one of the control units – is designed and configured to detect, depending on the measured pressure and the delivered volume and / or the delivered volume and the image(s) of the imaging unit, a leak in the at least one inflation device, which may be caused in particular by product defects or by incorrect connection.

[0064] Preferably, for this purpose, at least one control device is provided and configured to perform an evaluation of the pressure detected by the pressure sensing unit in the pressure chamber of the fluid conveying device against the conveyed volume and to issue an error message or to initiate the output of an error message if the detected pressure, in particular a pressure increase, especially taking into account tolerances or predetermined, tolerable factors, is too low for the conveyed volume.

[0065] Alternatively or additionally, at least one control unit is provided and configured for this purpose to perform an evaluation of the image(s) acquired by the imaging unit against the delivered volume and to issue or initiate the output of an error message should the acquired image(s), in particular a diameter increase of the angioplasty product determined by the control unit using machine vision based on the image(s), be too small for the delivered volume. In particular, the control unit is equipped with suitable technology, especially machine vision or machine image recognition.

[0066] The data interface to the imaging unit preferably enables the evaluation of image data from the procedure. Using AI, particularly based on the training of an artificial neural network or machine learning algorithms, it is possible to automatically identify the vessel requiring treatment or to allow the surgeon to select it. By evaluating as much image data as possible, especially from different perspectives and using various methods, an optimal target diameter is determined and an optimal angioplasty product is suggested.

[0067] A computer-aided design (CA) system can collect data on the inflation performed using the inflation device. This includes, for example, the pressure as a function of the fluid flow rate, the diameter of the angioplasty product as a function of time (captured from image data), or manual adjustments by the surgeon. In this way, the medical system can continuously adapt to changing properties of angioplasty products without requiring access to current product data, such as compliance charts.

[0068] By combining examination data from various sources, such as CT, MRI, IVUS, OCT, of the vascular segment to be treated, the type of area to be treated, such as calcification, can be diagnosed and treated with the optimal inflation strategy.

[0069] The storage device 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.

[0070] In the network-based scenario, the respective mapping (mapping 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 in the form of USB, LAN, WLAN, Bluetooth, or a mobile data interface (UMTS, LTE, 5G).

[0071] Preferably, the inflation device is configured to store or document the course of the angioplasty. This can be done on the local or network-based storage unit, or redundantly on both. Preferably, the inflation device is configured to store or document the course while removing personal patient data. In one embodiment, the reading unit comprises a single reader for capturing both identifiers, provided that the same capture technology underlies both identifiers. Alternatively, one reader can be provided for each identifier, particularly when different capture technologies are used for the identifiers.

[0072] 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.

[0073] Brief description of the characters

[0074] Fig. 1 is a schematic representation of a medical system for angioplasty with an inflation device for inflating an angioplasty product, according to an embodiment of the present disclosure;

[0075] Fig. 2 is a diagram of the inflation pressure of an angioplasty product as a function of the fluid volume delivered into the angioplasty product;

[0076] Figure 3 shows time-dependent target pressure profiles of various angioplasty products, stored in a storage device of the inflation device according to Figure 1, according to an embodiment of the present disclosure;

[0077] Fig. 4 is a further time-dependent target pressure profile of an angioplasty product, stored in the memory device of the inflation device according to Fig. 1 and retrievable, according to an embodiment of the present disclosure; Fig. 5 is an inflation device for inflating several angioplasty products, according to an embodiment of the present disclosure; and

[0078] Fig. 6 is an inflation arrangement with several inflation devices for the time-coordinated inflation of several angioplasty products, according to an embodiment of the present disclosure.

[0079] Detailed description of preferred embodiments

[0080] The following describes embodiments of the present disclosure on the basis of the associated figures.

[0081] Figure 1 shows a schematic representation of a medical system 100 for angioplasty.

[0082] The medical system 100 has as its central component an inflation device 1 according to the present disclosure, connected to a network environment and to an imaging unit designed as a C-arm 24.

[0083] The inflation device 1 has a reading unit 2. The reading unit 2 has 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). The reading unit 2 has a second reader 8 for detecting a marking KS of a fluid delivery device designed as an inflation syringe 10, which is intended for inflating the balloon catheter 6. The marking KS is preferably provided on the fluid delivery device itself.

[0084] The marking KA or KS contains, as a minimum, an identifier for 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. The identifier must be at least an ID, type, or article number by which the intended balloon catheter 8 or the intended inflation syringe 10 can be uniquely identified, so that the nominal size(s) of the balloon catheter 8 or the inflation syringe 10 can also be determined. In other words, knowing the marking KA or KS, it is possible, as disclosed, to unambiguously determine the identifier, and knowing the identifier allows for unambiguous determination of the nominal size(s) of the intended balloon catheter 8 or the intended inflation syringe 10.

[0085] The inflation syringe 10 has a hollow cylindrical syringe body 26 in which a syringe plunger 28 is axially displaceable. The syringe plunger is coupled to a motor drive unit 30, which can drive the syringe plunger in both directions. A pressure chamber 32, containing contrast medium as a fluid, is bounded by the syringe plunger 28 and the hollow cylindrical syringe body 26. The inflation syringe 10 is partially filled so that, with a positive stroke, fluid can be expelled from the pressure chamber 32 towards the balloon catheter 6, and with a negative stroke, fluid—or air—can be drawn from the balloon catheter 6 into the pressure chamber 32. To detect a stroke or travel of the syringe plunger 28, the inflation device 1 has a displacement detection unit 34.

[0086] The inflation device 1 has a fluid delivery interface 36, to which the inflation syringe 10 is fluidically connected, and a product interface 38, to which the balloon catheter 6 is connected. The interfaces 36 and 38 are fluidically connected so that the balloon catheter 6 can be pressurized with fluid by the inflation syringe 10.

[0087] Alternatively, interfaces 36 and 38 can be directly connected to each other, preferably detachably connected, particularly preferably without tools, detachably connected.

[0088] The inflation device 1 has a control unit 12 to which the readers 4, 8, a display unit 16 (serving as an information input and output interface for an operator), and a storage unit 14 are connected via signals and data. According to the disclosure, the storage unit 14 contains a retrievable assignment of time-dependent target pressure profiles to angioplasty products, in particular angioplasty product types, that can be inflated by the inflation device 1. In other words, the storage unit 14 assigns at least one specific, time-dependent target inflation pressure profile to each of the possible balloon catheters 6 that can be inflated by means of the inflation device 1.

[0089] In this way, the balloon catheter 6 intended to correct the stenosis can be inflated with an optimal pressure-time profile, regardless of the surgeon's experience. If the first reader 4 recognizes the inserted balloon catheter based on the marking KA, which is preferably provided on the balloon catheter and more preferably on the hub or port (i.e., at the catheter insertion point) of the balloon catheter, the control unit 12 determines the corresponding target pressure profile from the assignment stored in the memory unit 14 and displays it on the display unit 16 – preferably as a suggestion to the surgeon.

[0090] The operator can then decide whether to let the control unit 12 manage the time course of inflation, or whether to manage the time course of inflation manually.

[0091] According to the disclosure, the control device 12 is designed and configured to control the drive unit 30 depending on the time-dependent target pressure profile assigned to the balloon catheter 6.

[0092] Additionally, a further assignment is stored in the storage unit 14, which includes the inflation syringes 10 suitable for use with the designated balloon catheters 6. Thus, after recognizing the balloon catheter 6 and its type, the control unit 12 can suggest a suitable inflation syringe 10 to the operator on the display unit 16.

[0093] The assignments are preferably provided as a database or in the form of assignment tables. Preferably, the inflation device 1 has a manual mode that overrides the automated control of the inflation based on the proposed and selected target pressure profile.

[0094] Preferably, manual mode is activated as soon as the operator uses a control device for manually controlling inflation, for example, an analog or digital inflation syringe (not shown). This allows the operator to intervene in the inflation process at any time and change the inflation rate specified by the target pressure profile.

[0095] Furthermore, the control unit 12 is data-connected to a server 18, a cloud 20 and a patient management system 22, and together with the C-arm 24 forms the medical system 100 for angioplasty.

[0096] Using the C-arm 24, real-time images and image data of the stenosis(es) can be transmitted to the control unit 12 and displayed on the display unit 16. Additionally, target diameters D measured by the surgeon within a single image taken with the C-arm 24 can be transmitted to the control unit 12.

[0097] Figure 2 shows a time-dependent actual pressure profile of the inflation pressure p detected by the pressure sensing unit 40, which results at a constant drive speed of the drive unit 30 and thus at a constant fluid delivery rate of the inflation syringe 10 according to Figure 1.

[0098] It is clearly evident that, due to the relatively low and constant fluid flow rate, the pressure increase is initially very slow. Therefore, a considerable amount of time must be spent inflating the previously evacuated balloon catheter. However, it is generally advantageous to keep the inflation time short.

[0099] In order to optimize the inflation time for the optimal application of the angioplasty product and to keep it as short as possible (reducing the interruption of blood flow), as disclosed, 6 different target pressure profiles 42, 44, 46, 48, 50, 52 (see Figures 3 and 4) are stored in the storage unit 14 for different balloon catheters or balloon catheter types, which can be called up by the control unit 12.

[0100] All target pressure profiles 42, 44, 46, 48, 50, 52 shown in Figures 3 and 4 exhibit a comparatively large initial gradient (compared to the actual pressure profile at a constant fluid flow rate according to Figure 2). This initial gradient is achieved by initially configuring the control of the drive unit 30 for a particularly high fluid flow rate. In this way, a dead volume of the balloon catheter 6 is quickly filled.

[0101] Rapid, direct inflation to the target pressure pD is enabled by the target pressure profile 44, which converges from below towards the target pressure pD. The fluid flow rate is always positive here.

[0102] Alternatively or additionally, a target pressure profile 42 is provided, which exceeds the target pressure pD at a maximum and then converges from above towards the target pressure pD. The decrease after the maximum can be achieved by means of a negative fluid flow rate.

[0103] Alternatively or additionally, a target pressure profile 46 is provided with a sequence of maxima, each reaching the target pressure pD. Between the maxima, the target pressure profile 46 drops to minima, with the respective drop between the maxima becoming weaker over time, meaning that the minima approach the target pressure pD until the target pressure profile 46 finally converges to the target pressure pD.

[0104] Alternatively or additionally, a target pressure profile 48 with a sequence of local maxima and minima, a target pressure profile 50 with a plateau below the target pressure pD, or a target pressure profile 52 with a plateau at the target pressure pD (see Figure 4) is provided. The pressure profile 52, in particular, represents an adaptive pressure profile with which it is possible to maintain the actual diameter d at the target diameter D.

[0105] Figure 5 shows a further embodiment of an inflation device 101 in a highly schematic representation. The inflation device 101 differs from that of Figure 1 only in that several angioplasty products 6, 6', 6" can be inflated simultaneously or sequentially. The control unit 12 takes over the control and coordination of the drive units 30, so that the associated inflation syringes 10, 10', 10" are driven in a coordinated manner, either simultaneously or sequentially.

[0106] The drive units 30, 30', 30" can then be individually and coordinated according to the selected target pressure profile, resulting in an individual actual pressure profile for each of the angioplasty products 6, 6', 6". In this way, angioplasties at bifurcations or trifurcations can be performed gently.

[0107] As an alternative to the inflation device 101 according to Figure 5, which enables the inflation of several angioplasty products simultaneously or in succession, several inflation devices 1 according to Figure 1 can be provided, each enabling the inflation of only one angioplasty product.

[0108] Figure 6 shows an inflation arrangement 200 according to the disclosure, with several inflation devices 1 , 1 ', 1" for the temporally coordinated inflation of several angioplasty products 6, 6', 6", according to an embodiment of the present disclosure.

[0109] The control units 12, 12', 12" of the inflation devices 1, 1', 1" of the inflation arrangement 200 are interconnected by signal, with one of the control units 12, 12', 12" being provided and configured to control the other control units 12', 12" respectively. The control unit 12, 12', 12" shown in the center of Figure 6 is such a master control unit 12, which controls the other two control units 12', 12" to enable time-optimized inflation of the angioplasty products 6, 6', 6" at a bi- or tri-furcation.

Claims

Claims 1. Inflation device (1; 101) for inflating at least one angioplasty product (6), in particular at least one balloon catheter (6), comprising: a product interface (38) which is provided and configured for the fluidic connection of the at least one angioplasty product (6), a fluid delivery interface (36) which can be fluidically connected or connected to the product interface (38) and which is provided and configured for the fluidic connection to a fluid delivery device (10), in particular to an inflation syringe (10), a drive unit (30) which is provided and configured for driving the fluid delivery device (10), in particular a piston (28) or cylinder of the fluid delivery device (10), a pressure sensing unit (40) which is provided and configured for sensing a pressure, in particular inflation pressure, in a pressure chamber (32), and a control device (12).which is signal-connected to the drive unit (30) and the pressure sensing unit (40) and is designed and configured to control the drive unit (30) depending on the detected pressure (p) and a target pressure (pD) corresponding to a target diameter (D) of the angioplasty product (6), characterized in that a storage unit (14) is provided in which an assignment of time-dependent target pressure profiles (42, 44, 46, 48, 50, 52) to foreseeable angioplasty products (6), in particular angioplasty product types (6; 6, 6', 6"), is stored in a retrievable manner, and that the control device (12) is designed and configured to control the drive unit (30) depending on the assigned, time-dependent target pressure profile (42, 44, 46, 48, 50, 52).

2. Inflation device (1 ; 101) according to claim 1 , characterized in that the control device (12) is provided and configured to adjust the associated time-dependent target pressure profile (42, 44, 46, 48, 50, 52) of the angioplasty product (6) after at least one of the inflations in the event of multiple inflations.

3. Inflation device (1; 101) according to claim 1 or 2, characterized in that a displacement detection unit (34) is provided and configured for detecting a displacement of the drive unit (30) and / or the fluid conveying device (10), wherein a conveyed fluid volume depends on the displacement, and that the control device (12) is signal-connected to the displacement detection unit (34) and is provided and configured to determine the conveyed fluid volume as a function of the detected displacement and to control the drive unit (30) as a function of the conveyed fluid volume.

4. Inflation device (1 ; 101 ) according to one of claims 1 to 3, characterized in that an initial gradient of the time-dependent target pressure profile (42, 44, 46, 48, 50, 52) is at least two orders of magnitude larger than a final gradient of the time-dependent target pressure profile (42, 44, 46, 48, 50, 52) as it approaches the target pressure (pD).

5. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the control device (12) is configured to control the drive unit (30) in such a way that a fluid flow rate greater than 0.3 ml / s, preferably greater than 0.33 ml / s, results, and / or that at least one of the time-dependent target pressure profiles (42, 44, 46, 48, 50, 52) is stored in the storage unit (14) in a callable manner, which has a gradient or a pressure rise rate that corresponds to a fluid flow rate greater than 0.3 ml / s, preferably greater than 0.33 ml / s.

6. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (42) has a maximum above the target pressure (pD).

7. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (42) converges with the target pressure (pD) from above the target pressure (pD), or from below (44, 46, 48, 50).

8. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (46) has a sequence of maxima with values ​​approximately equal to the target pressure (pD) and values ​​of the associated minima increase as the target pressure (pD) approaches.

9. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (48) has at least one local maximum below the target pressure (pD), followed by a local minimum.

10. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (50) has at least one plateau below the target pressure (pD), in particular several plateaus rising in stages.

11. Inflation device (1 ; 101 ) according to one of the preceding claims, characterized in that the time-dependent target pressure profile (52) coincides with the target pressure (pD) over a time period and consequently falls below the target pressure (pD).

12. Inflation device (1; 101) according to one of the preceding claims, characterized in that a reading unit (4, 8) is provided and configured to detect a marking (KA) of the at least one intended angioplasty product (6; 6, 6', 6"), and that the control unit (12) is provided and configured to determine the intended angioplasty product (6), in particular its angioplasty product type (6; 6, 6', 6"), from the marking (KA), to determine the time-dependent target pressure profile assigned to the intended angioplasty product (6), in particular the angioplasty product type (6; 6, 6', 6"), from the assignment, and to provide the determined, assigned, time-dependent target pressure profile for controlling the at least one drive unit (30; 30, 30', 30"), and / or to display it to an operator for selection, in particular to suggest it.

13. Inflation device (1) according to one of the preceding claims, characterized in that a data interface to an imaging unit (24), in particular a C-arm, OCT or IVUS, is provided and configured to receive an image of a stenosis from the imaging unit (24), and that the control unit (12) is configured to determine and / or suggest the target diameter (D) based on the image and / or to monitor the approach of the actual diameter (d) to the target diameter (D).

14. Inflation arrangement (200) with several inflation devices (1 , T, 1"), which are configured according to one of the preceding claims, and whose control devices (12, 12', 12") are signal-connectable or signal-linked for the coordinated inflation of several angioplasty products (6, 6', 6"), characterized in that one (12) of the control devices (12, 12', 12") is provided and configured to control the respective other control device(s) (12', 12"), so that, in particular at a furcation, the inflation of the angioplasty products (6, 6' , 6") is time-aligned and / or time-coordinated.

15. Medical system (100) for angioplasty comprising at least one inflation device (1; 101) configured according to claim 13 and / or inflation arrangement configured according to claim 14 and comprising an imaging unit (24) for preoperative or real-time acquisition of an image of a stenosis, in particular a C-arm, OCT or IVUS, wherein the data interface of the inflation device (1; 101) is data-connectable or data-linked to the imaging unit (24) in order to receive the image.

16. Medical system (100) according to claim 15, characterized in that the at least one control device (12) is provided and configured to detect, depending on the detected pressure and the delivered volume and / or the delivered volume and the recording or recordings of the imaging unit (24), a leak in the at least one inflation device (1), which may be caused in particular by product defects or by incorrect connection.

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