Inflation device for inflating a balloon catheter

Abstract

The present invention relates to an inflation device (2) for inflating a balloon catheter for angioplasty. The inflation device (2) comprises a syringe (4) having a hollow syringe body (6), a syringe opening (8) connected to the syringe body (6) and connectable to the balloon catheter, and a syringe plunger (10) disposed in the syringe body (6). The syringe plunger defines a pressure chamber (12) connected to the syringe opening (8) together with the syringe body wall, and is axially displaceable inside the syringe body (6) to change the volume of the pressure chamber (12). The syringe (4) is partially filled with a contrast agent mixture. The syringe (4) preferably has identifiers (30, 32) in the form of machine-readable codes, and the identifiers (30, 32) contain data regarding the amount of the contrast agent mixture accommodated in the pressure chamber (12) and / or the mixing ratio of the contrast agent mixture.

Description

Technical Field

[0001] The present disclosure relates to an inflation device for inflating a balloon catheter for angioplasty or other medical devices based on balloon catheter technology.

Background Art

[0002] Angioplasty is a medical procedure for (minimally invasively) widening a narrowed or blocked blood vessel by inserting a balloon catheter into the blood vessel and expanding the balloon catheter to expand the blood vessel. This procedure is known as balloon dilation. Angioplasty is usually performed under X-ray control. A contrast agent is injected into the blood vessel via the balloon catheter for the purpose of detecting the narrowed or blocked region of the blood vessel and the position of the balloon catheter within the blood vessel during X-ray imaging.

[0003] Conventionally, a manual inflation syringe has been used for angioplasty. On the one hand, for example, by rotating (manually) the syringe plunger of the inflation syringe via a screw and a high power transmission ratio, a pressure of up to 30 bar can be generated, and on the other hand, for example, by releasing the lock by a ring or a lever, the pressure can be quickly released (without rotating the syringe plunger).

[0004] Manual (excessive) pressure within the inflation syringe results in corresponding balloon catheter inflation or balloon catheter diameter expansion. The correlation between the pressure set within the inflation syringe (and thus within the balloon catheter) and the resulting diameter can be read from a typically paper drawing known as a compliance chart, enabling the user to estimate and set the required pressure according to the target diameter. Information regarding the correspondence between the pressure within the balloon catheter and the diameter of the balloon catheter may also be provided in tabular form, known as a compliance table. In this case, the required values may have to be interpolated from the values specified in the table. Also, to expel air within the balloon catheter while establishing pressure, it is necessary to vent the balloon catheter before inflating it. To perform this, the inflation syringe is connected to the balloon catheter and pulled up, creating a negative pressure within the inflation syringe and sucking air out of the balloon catheter.

[0005] However, manual adjustment has the drawback of being prone to misuse at several points, especially while establishing pressure. For example, due to insufficient pressure limit options, pressures exceeding the allowable range may occur. Further, errors may occur in reading the pressure gauge for displaying (analog) pressure or in reading the drawing, resulting in incorrect pressure setting. Interpolation errors may also occur when using the compliance table.

[0006] Conventionally, it has also been known to monitor with a sensor how much fluid is being supplied from the balloon catheter to the syringe. For example, US 2007 / 0213656 A1 discloses an apparatus for detecting and outputting data during the inflation of an expandable element such as a balloon catheter via a fluid supply section from a reservoir such as a syringe chamber. This apparatus has sensors capable of detecting the pressure, flow rate, and / or volume of the fluid to expand the element. The apparatus also has indicators for qualitatively or quantitatively displaying the pressure, flow rate, and / or volume.

[0007] Furthermore, in the prior art, the contrast agent is manually filled into the inflation syringe before angioplasty. For this purpose, since the mixing ratio affects the radiopacity characteristics, the undiluted contrast agent is diluted until the desired mixing ratio for use in the inflation syringe is obtained. Then, the inflation syringe is expanded with the diluted contrast agent until the required amount of the contrast agent is sucked into the inflation syringe. This amount varies depending on, for example, whether the procedure is angioplasty (percutaneous transluminal angioplasty, PTA) or coronary angioplasty (percutaneous transluminal coronary angioplasty, PTCA). When the negative pressure is released, the evacuated lumen of the balloon catheter is filled with the contrast agent mixture contained in the inflation syringe. If the amount of the contrast agent is too large, it may adversely affect the sufficient contraction of the balloon catheter before angioplasty or cause complications associated with the removal of the balloon catheter due to prolonged contraction of the balloon catheter after angioplasty. Therefore, when manually filling the inflation syringe with the contrast agent, an incorrect selection or setting of the contrast agent may lead to incorrect use.

[0008] When the balloon catheter expands inside the patient, it causes a temporary blockage of the blood vessel. Therefore, during such a transitional period, it is important to ensure that the inflation time is not too long because it may cause pain to a fully conscious patient. Blocking the blood vessel for a long time may also lead to necrosis. Since the undiluted contrast agent has a much higher viscosity than water, the contrast agent is usually diluted to such an extent that a contrast that can be distinguished from the surrounding tissue remains in the X-ray image and is as thin as possible. There is also a very rare case where the balloon catheter becomes clogged in the patient's blood vessel after contraction. In such a case, there must be no gas in the balloon catheter because the gas may cause an explosive expansion and lead to blood vessel rupture. Also, in this case, a high dose of the contrast agent can be serious for the patient's health. Summary of the Invention

[0009] Therefore, the present disclosure aims to solve the drawbacks of the prior art and provide an inflation device for inflating a balloon catheter for angioplasty, which can generate the pressure required for inflation and eliminate or at least reduce the risk of misuse.

[0010] The object of the present disclosure is solved by an inflation device having the features of claim 1. Advantageous further embodiments are the subject matter of the dependent claims.

[0011] Accordingly, the object of the present disclosure is solved by an inflation device comprising a syringe for inflating a balloon catheter for angioplasty. The syringe has a hollow syringe body (syringe cylinder), a syringe opening connected to the cylinder body and connectable to the balloon catheter (i.e., the balloon catheter lumen), and a syringe plunger disposed within the cylinder body.

[0012] Together with the syringe body wall, the syringe plunger defines a pressure chamber of the syringe connected to the syringe opening. This means that the syringe volume configured inside the syringe body wall is divided by the syringe plunger into a pressure chamber and a residual chamber / empty space (residual volume / empty volume). The syringe plunger is axially displaceable within the syringe body to change the volume of the pressure chamber. This means that the size of the pressure chamber changes depending on the axial position of the syringe plunger. This means that overpressure can occur by reducing the size of the pressure chamber, especially meaning that the liquid or gas contained in the pressure chamber can be compressed or discharged outside the syringe through the syringe opening. By expanding the pressure chamber, negative pressure is generated. That is, the liquid or air contained in the pressure chamber can expand or be sucked into the syringe through the syringe opening.

[0013] According to the present disclosure, the syringe is partially filled with a contrast agent mixture. This means that a (certain) amount of the contrast agent mixture, i.e., the contrast agent diluted at a (certain) mixing ratio, is contained in the pressure chamber, and the syringe is not completely filled, thereby having a specific free volume. Therefore, the syringe plunger is positioned at an intermediate axial position (rather than at the end position) and is displaceable axially on both sides from this axial position. Thus, the contrast agent mixture can be compressed or discharged from the pressure chamber, and in particular, air can be sucked into the pressure chamber. The syringe is (already) partially filled / loaded, especially before inflating the balloon catheter and / or in a sealed state, i.e., when it is not completely filled. Furthermore, the syringe according to the present disclosure has a label, and the label contains data regarding the amount (filling amount) of the contrast agent mixture contained in the pressure chamber and / or the mixing ratio of the contrast agent mixture. In particular, the label contains data on the filling amount of the syringe that is partially filled before inflating the balloon catheter and / or in a sealed state. This means that, in particular, the label indicates to what extent the syringe was initially (partially) filled. Preferably, the label can be configured in the form of a machine-readable code such as, for example, a barcode, a QR code, or an RFID transponder.

[0014] Accordingly, the core of the present disclosure lies in that the syringe is pre-filled partially, that is, filled with a volume of contrast agent mixture large enough to create pressure within the balloon catheter and with a large enough residual aspiration volume. Further, the core of the present disclosure lies in that when filled with too much or too little amount, when filled with an inappropriate mixing ratio, or when a partially filled syringe is selected, a label for the user is attached to the syringe so as to eliminate misuse by the user. Accordingly, the user is not only liberated from the syringe filling process where undiluted contrast agent needs to be diluted at an appropriate mixing ratio and an appropriate amount needs to be aspirated with the syringe, but also liberated from identifying the same data, so that use with as few mistakes as possible becomes possible. By using machine-readable codes, it also becomes possible to confirm selection contents and provide automatic assistance.

[0015] In contrast to other syringe uses, such as drug administration, for balloon catheter inflation, it is not as important to accurately administer and always ensure liquid delivery via the syringe to avoid incorrect administration or sudden termination of liquid delivery for patient safety. On the other hand, when inflating the balloon catheter, it is essential that the amount of the contained contrast agent mixture is large enough to provide the residual volume required for ventilation on the one hand and to quickly discharge the contrast agent mixture previously supplied to the balloon catheter on the other hand, but at the same time small enough. Therefore, using the balloon catheter for inflation cannot be compared with other syringe uses where the residual aspiration volume is not important and the syringe is usually filled completely for cost reasons.

[0016] As the contrast agent, for example, iopromide, iodixanol, ioxaglate, iohexol, iopamidol, iomeprol, iomeron, gadodiamide, or gadolinium etc. may be used. Regarding dilution, it is preferable to dilute the contrast agent with physiological saline, for example, 0.9% NaCl. Gadodiamide or gadolinium can also be used without dilution. The mixing ratio of the contrast agent and the diluent is suitable at 1:1 to 1:3, preferably about 1:2.

[0017] According to a preferred embodiment, the syringe opening may have a sealed closure body. Thereby, it is possible to avoid a situation where the data included in the label does not match the actual filling amount in the syringe when sealed with the closure body. Thereby, once the syringe is filled and sealed with the contrast agent mixture, there is an advantage that it becomes impossible to change the filling content (especially remove a part of the contrast agent mixture) without that fact becoming apparent. Also, contamination of the syringe or the filling can be prevented.

[0018] According to a preferred embodiment, the syringe may be configured as a single-use (disposable) product. This means that for reasons such as sterility and patient safety, the syringe itself is not suitable for reprocessing or multiple uses (for different patients). However, the syringe may be used to inflate multiple balloon catheters in sequence, for example, when inserting balloon catheters of different sizes in sequence.

[0019] According to a preferred embodiment, the syringe may be filled with the contrast agent mixture up to 10 - 80%, preferably 15 - 70%, more preferably 20 - 60%, and particularly preferably 25 - 50% of the total volume of the syringe body, especially before inflating the balloon catheter and / or with the syringe in a sealed state. The syringe may have a syringe diameter of 5 - 50 millimeters, preferably 15 - 30 millimeters. Further, the syringe may have a total filling volume, i.e., a maximum filling amount, of 10 - 250 milliliters, preferably 20 - 100 milliliters (with the syringe plunger fully extended / retracted). These sizes and filling amounts have been proven to be particularly suitable for inflating balloon catheters used in angioplasty.

[0020] According to a preferred embodiment, the label may include syringe type data of the syringe. For example, the syringe type data may be product-specific data regarding the use of the syringe, such as data on (total) filling volume, batch number, part number, and / or maximum allowable pressure. Thereby, the proper use of the syringe can be simplified, the risk of misuse can be reduced, and the use of the inflation device can be partially or fully automated. The syringe may have a single label (identification code) that includes both data regarding the syringe type and the contrast agent mixture, or may have a plurality (e.g., two) of individual labels (identification codes) that separately include data regarding the syringe type and the contrast agent mixture. For example, the individual labels may be readable in different ways.

[0021] According to a preferred embodiment, the inflation device may include a pressure sensor (pressure plunger) disposed particularly within the syringe plunger for detecting the pressure within the pressure chamber. According to an alternative preferred embodiment, the pressure chamber may be connectable to a pressure sensor (separate measuring instrument), particularly via a terminal connected to the syringe opening, preferably in the form of a three-way stopcock, for detecting the pressure within the pressure chamber. This means that the pressure within the pressure chamber is not only directly displayed and read via a manual pressure gauge, but is also automatically measured and preferably automatically processed. This means that reading errors by the user can be eliminated. Also, a sterilizing filter may be disposed particularly between the (external) pressure sensor and the pressure chamber to avoid contamination of the contrast agent mixture.

[0022] According to a preferred embodiment, the inflation device may have a control device. A pressure sensor is connected to the control device to transmit the detected pressure, for example, wirelessly by radio or by cable. Thereby, the pressure can be read and preferably further processed for automatic control.

[0023] According to a preferred embodiment, the inflation device may have a pressure relief device for limiting the maximum pressure in the pressure chamber. Preferably, the pressure relief device may be configured to prevent depressurization of the pressure chamber as soon as the pressure in the pressure chamber reaches the maximum allowable pressure of the syringe. For example, the pressure relief device may prevent overpressure by suppression, especially when the pressure measured by the pressure sensor reaches the maximum allowable pressure that can be read from the label. Thus, preferably, misuse can be prevented in an automatic / automated manner.

[0024] According to a preferred embodiment, the inflation device may have a position sensor for detecting the position of the syringe plunger. Thereby, the advantage is obtained that the filling level / degree of filling of the syringe (and thus the amount of the contrast agent mixture discharged from the pressure chamber) can also be monitored. Furthermore, this can prevent the syringe plunger from moving to the end position.

[0025] According to a preferred embodiment, the inflation device may have a drive unit that is mechanically connected to or connectable to the syringe plunger to axially displace the syringe plunger to expand and contract the pressure chamber. The drive unit is connected to the syringe plunger and is configured to achieve force adjustment and rapid adjustment. During force adjustment, a pressure of 6 to 30 bar can be applied to the syringe plunger. For example, the force can be adjusted by rotating the syringe plunger, and the force is converted into axial displacement via a screw. Force adjustment is required, especially for inflating itself, i.e., for supplying the contrast agent mixture to the balloon catheter under high pressure. This means, in particular compared to rapid adjustment, advancing the syringe plunger or contracting the pressure chamber with a strong force / (significantly) large force. In rapid adjustment, a speed of at least one of the syringe adjustments of length / second can be achieved. For example, rapid adjustment can be achieved by loosening the engagement of the screw. Rapid adjustment is required, especially for deflating the balloon catheter and for ventilating the balloon catheter. This means, in particular compared to force adjustment, that the syringe plunger contracts or the pressure chamber expands at a high speed / (significantly) large speed. In other words, the drive unit is preferably configured to have a component for applying force and a component for rapid displacement.

[0026] According to a preferred embodiment, the inflation device may be connectable to a ventilation valve, in particular via a terminal connected to a terminal or syringe opening, preferably in the form of a three-way stopcock or with a three-way stopcock, for venting the pressure chamber. Thus, the deflation of the balloon catheter can be achieved particularly easily by first establishing a connection between the syringe opening and the balloon catheter, in particular by opening the terminal of the three-way stopcock connected to the balloon catheter and retracting the syringe plunger. Thereby, the air contained in the balloon catheter is sucked out from the balloon catheter into the pressure chamber. Next, the connection between the syringe opening and the balloon catheter is blocked, in particular by closing the terminal of the three-way stopcock connected to the balloon catheter. A connection is established between the syringe opening and the ventilation valve, in particular by opening the terminal of the three-way stopcock connected to the ventilation valve. The syringe plunger is advanced, whereby the air contained in the pressure chamber is released from the pressure chamber through the ventilation valve into the surrounding environment. This ventilation process may be performed multiple times until the balloon catheter is completely deflated. Then, inflation occurs by supplying a contrast agent mixture to the balloon catheter.

[0027] Thus, the balloon catheter deflates by establishing a connection between the syringe opening and the balloon catheter, whereby the air contained in the balloon catheter is sucked out from the balloon catheter into the pressure chamber. While subsequently inflating the balloon catheter by supplying a contrast agent mixture, the air remains contained within the pressure chamber. By positioning the syringe such that the syringe is held with the syringe opening facing downward during inflation, the air contained in the pressure chamber is prevented from being supplied again. Thereby, the air is present only at the upper part of the pressure chamber, and only the contrast agent mixture located at the lower part of the pressure chamber is supplied to the balloon catheter.

[0028] Alternatively, the balloon catheter may be deflated by establishing a connection between the syringe opening and the balloon catheter and retracting the syringe plunger. Thereby, the air contained in the balloon catheter is sucked out from the balloon catheter into the pressure chamber, and the air sucked out from the balloon catheter into the pressure chamber is discharged from the pressure chamber through the semipermeable membrane.

[0029] Another aspect of the present disclosure preferably exists in combination with a partially filled and labeled syringe, but may exist independently. According to this another aspect, the inflation device may comprise a balloon catheter connected to or connectable to the syringe opening. The balloon catheter may have a label containing data of the type of the balloon catheter. Preferably, the label may be configured in the form of a machine-readable code, such as a barcode, a QR code, or an RFID transponder, for example. For example, the type of the balloon catheter may be product-specific data related to the use of the balloon catheter, such as the deflated volume, the maximum inflated volume, the pressure-inflation diameter relationship, the intended use or the mixing ratio of the contrast agent mixture intended for the use, the batch number, and / or the part number. Thereby, the proper use of the balloon catheter can be simplified, the risk of misuse can be reduced, and the use of the inflation device can be automated or partially automated.

[0030] According to a preferred embodiment, the inflation device can be configured to recognize whether a syringe is suitable for fully inflating the balloon catheter and / or ventilating the balloon catheter according to the type of the balloon catheter and the amount of the contrast agent mixture or the position of the syringe plunger contained therein. Depending on the type of the balloon catheter, a certain small difference amount of the contrast agent mixture is required to be able to inflate the balloon catheter to a desired / specified target diameter. Also, to ventilate the balloon catheter, depending on the type of the balloon catheter, a certain minimum free volume is required so that it can be sucked out from the balloon catheter by pulling back the syringe plunger, especially when it is impossible to reduce the pressure chamber, so that the balloon catheter can be completely deflated. Thereby, it becomes easy to recognize whether a selected syringe, which is pre-partially filled, is suitable for the selected balloon catheter, thereby simplifying or partially automating / automating its use.

[0031] According to a preferred embodiment, the inflation device is configured to recognize whether a syringe is suitable for the intended use of the balloon catheter according to the type of the balloon catheter and the mixing ratio of the contrast agent mixture. To ensure appropriate radiopacity, depending on the type of the balloon catheter, it is necessary to set the mixing ratio of the agent mixture to a certain value. Thereby, it becomes possible to easily recognize whether the radiopacity of a selected syringe, which is pre-partially filled, is suitable for the selected balloon catheter, simplifying or partially automating / automating their use.

[0032] In other words, the present disclosure relates to an inflation device composed of two components, namely an electromechanical basic unit and a disposable product in the form of a syringe equipped with a pressure body / piston. The basic unit has a mechanical drive through which the piston can be displaced within the cylinder / body (of the syringe). The pressure generated is determined by the applied force. The pressure can be controlled via the force acting on the piston. Also, position measurement may be provided to detect the position of the piston within the cylinder / body. This enables monitoring of the filling sequence of the syringe and also prevents the piston from moving to the end position. Further, a pressure sensor connected to or connectable to the syringe, for example via an integrated three-way stopcock, may be provided, by which the pressure within the syringe can be measured or the measured pressure can be corrected. The syringe may be provided with a product-specific QR code or barcode that can be scanned by the basic unit, whereby the corresponding product is selected. In addition to or instead of this, the corresponding product may be selected via the operating elements of the basic unit. Furthermore, a valve may be connectable to or connected to the syringe, for example via an integrated three-way stopcock, by which the line can be vented or opened in the event of an emergency / failure such as a power outage. The three-way stopcock is arranged at the tip / aperture of the one-way unit / syringe, thereby enabling connection of the catheter, pressure measurement unit, and valve to the basic unit.

[0033] Preferably, the one-way unit / syringe may be provided in a pre-filled state with a contrast agent to ensure the same characteristics with respect to the filling volume and X-ray visibility. In that case, the catheter is filled or emptied according to certain rheological characteristics. The piston is designed to have a diameter of 5 to 50 mm, preferably 15 to 30 mm. The maximum stroke amounts to a filling volume of 10 to 250 ml, preferably 20 to 100 ml. In the disposable product, the contrast agent is filled in an amount of 5 to 50 ml, preferably 10 to 25 ml.

[0034] To contract the one-way unit / syringe, the three-way stopcock is rotated so that the syringe volume is connected to the catheter lumen, and the piston is withdrawn (to the maximum). Then, the piston contracts rapidly, i.e., in less than 5 seconds, preferably less than 2 seconds, and the contrast agent is guided into the catheter lumen. After contraction, high pressure acts. For this purpose, the mechanism needs to be appropriately designed. Also, rapid displacement is required, which is usually blocked by a large force.

[0035] Therefore, the basic functions (and components) of the inflation device are to generate a negative pressure for venting the catheter system, to achieve and maintain a (product-specific) static pressure, to set an appropriate pressure, to enable emergency or rapid drainage (emergency stop) of the catheter, to achieve a pressure of at least 6 atmospheres and at most 30 atmospheres, and to provide a syringe pre-filled with 10 - 30 ml of contrast agent.

[0036] Alternatively, the pressure sensor and / or valve in the base unit may be omitted, and / or the three-way stopcock in the one-way unit may be omitted. The one-way unit or the base unit may be configured to be swingable, and may also be rotatable manually or automatically, and the one-way unit can be made reusable by venting the syringe plunger. In this case, the catheter must not be connected.

Brief Description of the Drawings

[0037]

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0038] Hereinafter, embodiments of the present disclosure will be described based on the attached drawings.

[0039] FIG. 1 shows the basic principle of the inflation device 2 according to the present disclosure. The inflation device 2 is used to inflate a balloon catheter (not shown) for angioplasty.

[0040] The inflation device 2 has a syringe 4. The syringe 4 has a hollow syringe body / syringe cylinder 6. The syringe 4 also has a syringe opening 8 connected to the syringe body 6, and the syringe opening 8 can be connected to the balloon catheter. Further, the syringe 4 has a syringe plunger 10 disposed in the syringe body 6. Together with the syringe body wall, the syringe plunger 10 defines a pressure chamber 12 that leads to the syringe opening 9. Preferably, the pressure chamber 12 is sealed via a seal (in this case, in the form of two seal rings) between the syringe body wall and the syringe plunger 10. The syringe plunger 10 is axially movable inside the syringe body 6 and changes the volume of the pressure chamber 12 (syringe volume). Preferably, the syringe 4 can be configured as a disposable product.

[0041] The inflation device 2 has a drive unit 14. The drive unit 14 is mechanically coupled to the syringe plunger 10 in order to axially displace the syringe plunger 10. The drive unit 14 has a rotatable / rotationally drivable drive shaft 15, and its rotation causes the rotation of the syringe plunger 10 (around its longitudinal axis). In the illustrated embodiment, the drive shaft 16 has a mating shape 18, here an external hexagonal shape, and the mating shape 18 engages with a corresponding mating shape 20, here an internal hexagonal shape, configured on the syringe plunger 10. Thereby, torque can be transmitted from the drive shaft 16 to the syringe plunger 10 by form fit.

[0042] In addition, the drive unit 14 has two gears 22 arranged on opposite sides of the syringe plunger 10. The gears 22 are engaged (or may be engaged) with an (external) thread 24 formed on the syringe plunger 10. The gears 22 are fixed with respect to the axial direction of the syringe plunger 10. When the syringe plunger 10 is rotationally driven (by the drive shaft 16) around its longitudinal axis, and / or when the gears 22 are rotated around their longitudinal axes by meshing with the gears 22, the syringe plunger 10 is displaced axially, for example, like a worm gear.

[0043] This means that the syringe plunger 10 can be extended (thus expanding the pressure chamber 12) by rotating the drive shaft 16 in one rotational direction, and can be contracted (thus shrinking the pressure chamber 12) by rotating the drive shaft 16 in the other rotational direction. When rotating one or both of the gears 22 simultaneously in a direction opposite to the force applied by the drive shaft 16, that is, when at least one gear 22 is actively driven, the axial movement of the syringe plunger 10 may be accelerated. The axial movement of the syringe plunger 10 may be accelerated by simultaneous rotation in a direction opposite to the force applied by the gears 22, or when the drive shaft 16 is stationary.

[0044] In addition, the inflation device 2 may have a sensor 26 connected to the pressure chamber 12 for measuring the reaction force, and the pressure in the pressure chamber 12 can be measured or determined via this sensor 26.

[0045] Furthermore, although only shown in FIG. 1, the inflation device 2 may have a position sensor 28 for detecting the position of the syringe plunger 10.

[0046] FIG. 3 shows a preferred embodiment of the inflation device 2 according to the present disclosure, and its structure corresponds to the basic principle described with reference to FIG. 1. The illustration of the drive device 14 is omitted in the conceptual diagram of FIG. 3.

[0047] The syringe 4 is partially filled with a contrast agent mixture. The contrast agent mixture is accommodated in the pressure chamber 12. Preferably, the syringe can be filled with the contrast agent mixture up to 10% to 80%, preferably 15% to 70%, more preferably 20% to 60%, and particularly preferably 25% to 50% of the total volume of the syringe body 6. This means that there is a residual volume / residual aspiration volume in which no contrast agent mixture is accommodated, and that the syringe is full in the region of the pressure chamber 12 and empty in the region of the residual volume.

[0048] The syringe 4 has a label 30 containing data on the amount of the contrast agent mixture accommodated in the pressure chamber 12 and / or on the mixing ratio of the contrast agent mixture. In the illustrated embodiment, the label 30 is attached to the outside of the syringe body 6. Preferably, the label 30 is configured in the form of a machine-readable code, such as a barcode, a QR code, or an RFID transponder. In the illustrated embodiment, the label 30 is configured in the form of an RFID transponder, and via the RFID transponder, the amount of the contrast agent mixture and / or the mixing ratio of the contrast agent mixture can be clearly identified.

[0049] The syringe 4 has an additional label 32, which contains data on the syringe type of the syringe. In the illustrated embodiment, the label 32 is attached to the outside of the syringe body 6. Preferably, the label 32 is configured in the form of a machine-readable code, such as a barcode, a QR code, or an RFID transponder. In the illustrated embodiment, the label 32 is configured in the form of a CR code. The data on the syringe type are, for example, the (total) filling volume, the batch number, the part number, and / or the maximum allowable pressure of the syringe 2.

[0050] Furthermore, the syringe opening may have a sealed closure body (not explicitly shown).

[0051] In the embodiment illustrated in FIG. 3, the pressure sensor 26 is configured as a pressure plunger, and the pressure plunger is disposed on the side of the syringe plunger 10 facing the pressure chamber. The pressure sensor 26 is read out via a data line 34, for example, by a control unit (not shown). Alternatively, the pressure sensor 26 may be read out wirelessly, for example, via radio or the like.

[0052] The syringe 4 has a three-way stopcock 26. The first terminal of the three-way stopcock 26 is connected to the syringe opening 8.

[0053] The second terminal 38 of the three-way stopcock 26 can be connected to, or is connected to, an (external) pressure sensor and / or a ventilation valve. The third terminal 40 of the three-way stopcock 26 can be connected to, or is connected to, a balloon catheter. The second terminal 38 and the third terminal 40 may be configured in the form of, for example, a Luer adapter / Luer lock 42.

[0054] In particular, the balloon catheter is first collapsed by establishing a connection between the syringe opening 8 and the balloon catheter, specifically by opening the third terminal 40 and preferably rapidly retracting the syringe plunger 10. As a result, the air contained in the balloon catheter is sucked from the balloon catheter into the pressure chamber 12. Next, the connection between the syringe opening 8 and the balloon catheter is blocked, specifically by closing the third terminal 40, and the connection between the syringe opening 8 and the ventilation valve is established, specifically by opening the second terminal 38. Then, the syringe plunger 10 advances. As a result, the air contained in the pressure chamber is released from the pressure chamber 12 to the ambient environment via the ventilation valve. This ventilation process may be performed several times until the balloon catheter is completely deflated.

[0055] In particular, the balloon catheter is inflated (after deflating the balloon catheter) by establishing a connection between the syringe opening 8 and the balloon catheter, specifically by opening the third terminal 40 and preferably advancing the syringe plunger 10 with a large force. A pressure of 6 to 30 bar is established, and the balloon catheter can expand to the desired target diameter according to the pressure-inflation diameter ratio inherent to the balloon catheter.

[0056] In particular, the balloon catheter is deflated by preferably rapidly retracting the syringe plunger 10 (after the blood vessel has dilated as a result of the balloon catheter inflating). As a result, the contrast agent mixture previously supplied to the balloon catheter is sucked from the balloon catheter into the pressure chamber 12, the balloon catheter reduces in diameter, and it becomes possible to withdraw the balloon catheter from the blood vessel.

[0057] To quickly release the patient from the pressure, it is also possible to first quickly withdraw the syringe plunger 10. Even after this quick release, a residual volume still remains in the balloon catheter. Therefore, the syringe plunger 10 can be further withdrawn, for example slowly, whereby the residual volume / residual pressure of the balloon catheter can be actively discharged and the diameter of the deflated balloon catheter can be made as small as possible, so that the balloon catheter can be removed / withdrawn from the patient as easily as possible.

Claims

1. An inflation device (2) for inflating a balloon catheter for angioplasty, comprising: a syringe (4) having a hollow syringe body (6); a syringe opening (8) connected to the syringe body (6) and connectable to the balloon catheter; a syringe plunger (10) disposed inside the syringe body (6) and defining a pressure chamber (12) connected to the syringe opening (8) together with the syringe body wall, the syringe plunger (10) being axially displaceable inside the syringe body (6) to change the volume of the pressure chamber (12); and the syringe (4) is partially filled with a contrast agent mixture, particularly before and / or in a sealed state before inflating the balloon catheter, and the syringe (4) preferably has a label (30, 32) in the form of a machine-readable code, such as a barcode, a QR code (32), or an RFID transponder (30), and the label (30, 32) contains data regarding the amount of the contrast agent mixture contained in the pressure chamber (12), particularly the filling amount of the syringe partially filled before and / or in a sealed state before inflating the balloon catheter, and / or the mixing ratio of the contrast agent mixture; characterized in that it is an inflation device (2).

2. The inflation device (2) according to claim 1, characterized in that the syringe opening (8) has a sealed closure body.

3. The inflation device (2) according to claim 1 or 2, characterized in that the syringe (4) is filled with the contrast agent mixture to 10-80%, preferably 15-70%, more preferably 20-60%, particularly preferably 25-50% of the total volume of the syringe body (6), particularly before and / or in a sealed state before inflating the balloon catheter.

4. The inflation device (2) according to any one of claims 1 to 3, characterized in that the label (30, 32) contains data regarding the syringe type of the syringe, preferably data regarding the filling volume, batch number, product number, and / or maximum allowable pressure.

5. ​ ​ ​ When the inflation device (2) comprises a pressure sensor (26) arranged in particular on the syringe plunger (10) in order to detect the pressure in the pressure chamber (12), or when the pressure chamber (12) can be connected to a pressure sensor connected via a terminal (38), in particular to the syringe opening (8), preferably in the form of a three-way stopcock, in order to detect the pressure in the pressure chamber (12). The inflation device (2) according to any one of claims 1 to 4.

6. The inflation device (2) has a control device to which the pressure sensor (26) can be connected, for example wirelessly or by cable, in order to transmit the detected pressure, and / or the inflation device (2) has a pressure relief device for limiting the maximum pressure in the pressure chamber (12). The inflation device (2) according to claim 5.

7. The inflation device (2) is characterized in that it comprises a position sensor (28) for detecting the position of the syringe plunger (10). The inflation device (2) according to any one of claims 1 to 6.

8. The inflation device (2) has a drive unit (14) mechanically connected or connectable to the syringe plunger (10) for axially displacing the syringe plunger (10) to reduce and enlarge the pressure chamber (12), the drive unit (14) being coupled to the syringe plunger (10) and configured to effect adjustment of the force for applying a pressure of 6 to 20 bar and rapid adjustment. The inflation device (2) according to any one of claims 1 to 7.

9. The inflation device (2) is connectable to a vent valve for venting the pressure chamber (12), in particular via the terminal (38) connected to the terminal or to the syringe opening (8), preferably in the form of a three-way stopcock or by means of the three-way stopcock (36). The inflation device (2) according to any one of claims 1 to 8.

10. When the inflation device (2) has a balloon catheter connected to or connectable to the syringe opening (8), the balloon catheter preferably has a machine-readable code in the form of, for example, a barcode, a QR code, or an RFID transponder label, and the label contains data on the balloon catheter type of the balloon catheter, preferably the shrinkage volume, the maximum inflation volume, the pressure-inflation diameter relationship, the intended use or the mixing ratio of the contrast agent mixture intended for that use, the batch number, and / or the part number. The inflation device (2) is preferably configured to recognize whether the syringe (4) is suitable for complete inflation of the balloon catheter and / or ventilation of the balloon catheter depending on the type of the balloon catheter and the amount of the contrast agent mixture or the position of the syringe plunger accommodated in the syringe, and / or to recognize whether the balloon catheter is suitable for the intended use depending on the type of the balloon catheter and the mixing ratio of the contrast agent mixture. The inflation device (2) according to any one of claims 1 to 9.

Images