Angioplasty device

Abstract

The invention relates to an angioplasty device (1; 101; 201; 301) that is connected or connectable to a balloon catheter (2), wherein the angioplasty device (1; 101; 201; 301) has an inflation syringe (22). The angioplasty device (1; 101; 201; 301) has an electric suction actuator (16) and a control unit (18) electronically connected thereto, which are prepared and configured for automatically evacuating the balloon catheter (2). The angioplasty device (1; 101; 201; 301) also has a central component through which air (4) and pressurised fluid (6) can flow and which has at least one inflation syringe connection (24) and a catheter connection (10) and one or two air connections.

Description

[0001] Angioplasty device

[0002] Description

[0003] Technical field

[0004] The present disclosure relates to an angioplasty device that is connectable to or connected to a balloon catheter and that includes an inflation syringe. The inflation syringe is used to inflate a balloon catheter or other medical devices based on the balloon catheter technology.

[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] State of the art

[0008] In the current art, a manual inflation syringe is used for angioplasty. This syringe allows for two purposes: firstly, by manually rotating a syringe plunger or plunger, a pressure of up to 30 bar can be built up, for example via a thread and a high leverage; and secondly, (without rotation) rapid pressure release can be achieved, for example via a ring or lever. The pressure is then transmitted via a tube to the balloon.

[0009] To prepare for the insertion or use of the balloon catheter, it must be evacuated as much as possible, i.e., pumped out of air. Firstly, this minimizes the balloon's size during the procedure, and secondly, it prevents the compressible air from causing a jet of fluid against the vessel wall in the event of a leak, which could lead to injury.

[0010] It is known from the prior art that the surgeon performs the venting using the inflation syringe, which is already filled with pressurized fluid, by first manually withdrawing its plunger. The aspirated air and the pressurized fluid must then separate in the syringe cylinder while the surgeon points the tip of the inflation syringe upwards (in the direction of gravity). After separation, the surgeon can manually switch a three-way stopcock or three-way valve and then reinsert the plunger to expel the aspirated and collected air. The surgeon then manually switches the three-way stopcock or three-way valve again before inserting the balloon catheter and finally inflating the balloon, which has been guided to the constriction, using the pressurized fluid.

[0011] This manual venting is inconvenient, and it has been shown in particular that some hydraulic fluid is always lost.

[0012] Brief description of the Revelation

[0013] The purpose of the present disclosure is to create an angioplasty device which avoids the aforementioned disadvantages.

[0014] This problem is solved by the combination of features of claim 1.

[0015] The angioplasty device according to the disclosure is connectable to, or connected to, a balloon catheter. The angioplasty device has an inflation syringe. The angioplasty device is electrically operated and has an electric suction actuator and an electrically connected control unit, which together are prepared and configured for the automatic evacuation or suction of the balloon catheter. The electric suction actuator can drive a plunger of the inflation syringe or a separate venting syringe. The angioplasty device further comprises a central component through which air and the pressurized fluid can flow. The central component has at least one inflation syringe connection, one catheter connection, and one or two air connections for the passage of air.

[0016] The angioplasty device is designed to automatically and therefore conveniently evacuate the balloon catheter before it is pressurized with the pressure fluid, in particular a saline solution and / or a contrast agent. Examples of suitable contrast agents include lopromide, lodixanol, loxaglate, lohexol, lopamidol, lomeprol, lomeron, gadodiamide, or gadolinium. For dilution, the contrast agent is preferably diluted with the saline solution, e.g., 0.9% NaCl. Gadodiamide or gadolinium can also be used undiluted. A contrast agent to diluent ratio of 1:1 to 1:3, preferably approximately 1:2, is suitable.

[0017] If the pressurised fluid is or contains the contrast agent, the inflation syringe can be referred to as the contrast agent syringe and the inflation syringe connection as the contrast agent syringe connection.

[0018] One or both air connections can be formed by an air manifold to which an active venting syringe or a venting pump driven by the suction actuator is fluidically connected. This allows the extracted air to be separated from the inflation syringe. The venting syringe can be a disposable product.

[0019] In this advanced training system, the central component is a four-way valve, with the other air inlet being an air outlet through which the four-way valve can be connected to the environment. One valve body of the four-way valve can be automatically switched between a first and a second position (e.g., by rotating or sliding) by means of an electric valve actuator. The valve actuator is also electrically connected to the control unit.

[0020] It is particularly preferred that, in the first position of the valve body, the catheter port is connected to the air collection port, while the inflation syringe port is connected to the air outlet. In the second position of the valve body, the inflation syringe port is connected to the catheter port, while the air collection port is connected to the air outlet. In the first position, air can then be aspirated from the catheter via the catheter port and the air collection port. In the second position, air from the venting syringe can be released to the environment via the air collection port and the air outlet, while simultaneously the pressurized fluid from the inflation syringe is delivered into the catheter via the inflation syringe port and the catheter port.

[0021] In another advanced design, the central component is a three-way valve with only one air connection, where one valve body of the three-way valve is automatically switchable between a first and a second position by means of an electric valve actuator, e.g., by rotation or displacement. In this advanced design as well, the valve actuator is electrically connected to the control unit.

[0022] In a preferred embodiment, one air inlet is formed by an air outlet through which the three-way valve can be connected to the environment. In the first position of the valve body, the catheter port is connected to the inflation syringe port, while the air outlet is closed. In the second position of the valve body, the inflation syringe port is connected to the air outlet, while the catheter port is closed. In this position, the venting syringe or venting pump can be omitted, and the electric suction actuator can also be coupled to the inflation syringe. This effectively transforms it into an electric plunger actuator for a plunger of the inflation syringe with a reversible direction of movement. This also allows pressurized fluid to be pumped from a syringe cylinder of the inflation syringe to the three-way valve.

[0023] In a previously known embodiment, an air collection chamber for the air aspirated from the balloon catheter can be created or arranged in the syringe cylinder of the inflation syringe. This air collection chamber adjoins a pressurized fluid chamber, which can also be created or arranged in the syringe cylinder of the inflation syringe. The two fluids are thus, at least temporarily, contained together in the syringe cylinder of the inflation syringe. Then, in conjunction with the disclosed three-way valve, in its first position, air can be drawn from the catheter into the inflation syringe via the catheter port and the inflation syringe port, and in the second position, air can be released from the inflation syringe to the environment via the inflation syringe port and the air outlet. Again in the first position, the catheter can then be pressurized by the inflation syringe.

[0024] If a fluid sensor is installed at the air outlet and electronically connected to the control unit, then the approach or arrival of the pressurized fluid at the air outlet can be detected, and the control unit can stop the piston movement. The directional control valve can then be switched.

[0025] If a filter is provided at the air outlet, then the ingress of contaminants from the environment into the pressurized fluid can be prevented. This allows the pressurized fluid to be drawn back from the air outlet area and thus reused.

[0026] A semipermeable membrane at the air outlet prevents the pressurized fluid from escaping. This membrane allows extracted air to pass through while retaining the pressurized fluid.

[0027] In another embodiment of the angioplasty device with a three-way valve, in the first position of the valve body, the catheter port is connected to the air collection port, to which the active venting syringe or the venting pump is connected. In this position, the inflation syringe port, and thus the inflation syringe, is closed. In the second position of the valve body, the inflation syringe port is connected to the catheter port, while the air collection port, and thus the active venting syringe or the venting pump, is closed. Then, in the first position, air can be drawn from the catheter into the venting syringe or the venting pump, and in the second position, the catheter can be pressurized with the pressurized fluid. In a technically and application-wise simple embodiment of this further development with the air collection port and the venting syringe or pump, the following applies:The central component of the venting pump is a T-piece with a chamber that has no active switching options. The air collection port is located at the top of the chamber (when viewed from the direction of gravity), while the catheter and inflation syringe ports are located at the bottom. This allows air to be continuously extracted even while the pressurized fluid is being pumped.

[0028] A semipermeable membrane is particularly preferred in the air collection port to prevent pressurized fluid from penetrating through the air collection port to the venting syringe or venting pump.

[0029] The angioplasty device according to the disclosure has an electric suction actuator and an electrically connected control unit, which are prepared and configured for the automatic evacuation of the balloon catheter. The angioplasty device further comprises a central component through which air and pressurized fluid can flow. The inflation syringe is connected to an inflation syringe port of the central component. The balloon catheter is connected to a catheter port of the central component. The central component also has one or two air ports for the passage of air. The central component is preferably a passive T-piece or a valve, in particular a three-way valve or a four-way valve. In the first two cases, only one air port is provided. In the latter case, two air ports are provided.If a directional control valve is installed, it can be automatically switched by a valve actuator, which is connected to the control unit.

[0030] Brief description of the characters

[0031] Figure 1 is an angioplasty device according to a first embodiment of the present disclosure; Figure 2 is a further representation of the first embodiment of the angioplasty device from Figure 1;

[0032] Figure 3 is an angioplasty device according to a second embodiment of the present disclosure;

[0033] Figure 4 is a further illustration of the second embodiment of the angioplasty device from Figure 3;

[0034] Figure 5 is a further illustration of the second embodiment of the angioplasty device from Figures 3 and 4;

[0035] Figure 6 is an angioplasty device according to a third embodiment of the present disclosure; and

[0036] Figure 7 is an angioplasty device according to a fourth embodiment of the present disclosure.

[0037] Description of the exemplary implementations

[0038] Four embodiments of the present disclosure are described below, based on the accompanying figures.

[0039] Figure 1 shows an angioplasty device 1 with a venting device according to a first embodiment of the present disclosure. Only a proximal section (towards the surgeon) of a balloon catheter 2 is shown. Air 4 is to be aspirated from the balloon catheter 2 or from the shown section of tubing before the operation. The balloon (not shown) is then positioned at the constriction of the patient's vessel, whereupon pressurized fluid 6, e.g., contrast medium, is injected into the balloon catheter 2 or into the shown section of tubing. This builds up pressure in the balloon catheter 2 and, in particular, in the balloon, causing it to dilate the constriction in the patient's vessel. In the first embodiment shown, a central component designed as a four-way valve 8 is provided for venting. In the first position of its valve body shown in Figure 1, its catheter port 10 is connected to its air collection port 12.An active venting syringe 14 is connected to the air collection port 12, the plunger of which can be withdrawn from a syringe cylinder of the venting syringe 14 via an electric linear suction actuator 16 as indicated by the arrow. This occurs depending on an electronic control unit 18, which is connected to the suction actuator 16 via a signal.

[0040] When the air 4 has been largely withdrawn from the balloon catheter 2, the control unit 18 sends a signal to a valve actuator of the four-way valve 8, which in the illustrated embodiment is designed as a rotary electric motor M, by means of which the valve body is rotated to the second position shown in Figure 2.

[0041] Figure 2 shows a further illustration of the first embodiment of the angioplasty device 1 from Figure 1. In the second position, the venting syringe 14 is connected via the air collection port 12 and the valve body to an air outlet 20 of the four-way valve 8, which releases the collected air 4 to the environment via a filter 28 and a semipermeable membrane 30. For this purpose, the control unit 18 sends a signal to the suction actuator 16, causing it to retract the plunger of the venting syringe 14.

[0042] At the same time, an inflation syringe 22 is connected to the balloon catheter 2 via an inflation syringe connection 24 and the valve body and via the catheter connection 10, so that after positioning the balloon at the constriction, it can be pressurized and enlarged by means of the plunger of the inflation syringe 22.

[0043] To further increase user comfort, the plunger of the inflation syringe 22 can also be driven by a (dashed line) linear plunger actuator, which is then also connected to the control unit 18 via a signal. Thus, the first embodiment according to Figures 1 and 2 has a concept with two syringes, namely the inflation syringe 22 and the separate venting syringe 14. In this first embodiment, the venting device is therefore largely separated from the rest of the angioplasty device 1.

[0044] In the second embodiment according to Figures 3 to 5, the venting device is more further integrated into the rest of the angioplasty device 101 compared to the first embodiment (from Figures 1 and 2). More precisely, an air collection area 26 or an air collection chamber for the air 4 aspirated from the balloon catheter 2 is integrated into the syringe cylinder of the inflation syringe 22, i.e., it is not physically separated from the pressurized fluid 6, which collects below it in a pressurized fluid chamber 27 due to gravity.

[0045] Figure 3 shows the angioplasty device 101 according to the second embodiment of the present disclosure. Only one syringe, namely the inflation syringe 22, is provided, which is connected to an inflation syringe port 24 of a three-way valve 108. According to this embodiment, the central component is therefore the three-way valve 108. This valve also has a catheter port 10 and an air outlet 20. A fluid sensor 29 is arranged at the air outlet 20, and downstream of it, a filter 28 and a semipermeable membrane 30 are located.

[0046] In a first position of the valve body according to Figure 3, the catheter port 10 is connected to the inflation syringe port 24, so that the balloon catheter 2 is vented by pulling out the plunger. The plunger is driven by a linear plunger actuator, which serves on the one hand as an automatic suction actuator 16 of the angioplasty device 101 and on the other hand also as an automatic actuator for pressure build-up in the balloon using the hydraulic fluid.

[0047] Figure 4 shows the second embodiment of the angioplasty device 101 from Figure 3, in which the valve body of the three-way valve 108 has been rotated into a second position by the electric motor M controlled via the control unit 18. In this position, the balloon catheter 2 is closed and the inflation syringe connection 24 is connected to the air outlet 20. Once this switching state has been established, the suction actuator 16 can push the plunger in until all the air 4 has been displaced from the air outlet 20 and pressurized fluid 6 is detected by the fluid sensor 29. The suction actuator 16 can then optionally withdraw the plunger a short distance to remove the pressurized fluid 6 from the air outlet 20 and possibly also from the valve body.

[0048] Figure 5 shows in a further illustration of the second embodiment that the valve body is then automatically moved back to the first position, so that the hydraulic fluid 6 is pumped into the balloon catheter 2 via the plunger retracted by the actuator 16.

[0049] Figure 6 shows an angioplasty device 201 according to a third embodiment of the present disclosure. This concept again has two separate syringes, namely the inflation syringe 22 and the venting syringe 14, the latter being solely associated with the venting device. In this embodiment, the central component is formed by a T-piece 208, which is simpler in terms of device design than the directional control valves 8; 108 of the two preceding embodiments. Viewed in the direction of gravity, the T-piece 208 has the air collection port 12 at the top and, opposite each other in the direction of gravity, the inflation syringe port 24 and the catheter port 10 at the bottom.

[0050] The plunger of the venting syringe 14 is withdrawn by the suction actuator 16 during the preparatory evacuation of the balloon catheter 2. In this embodiment, however, the plunger of the venting syringe 14 is also subjected to a continuous tensile force during the pressurization of the balloon catheter 2 with the pressurizing fluid 6, so that any air 4 that may occur during the inflation of the balloon catheter 2 can be suctioned out.

[0051] To prevent pressurised fluid 6 from being drawn into the vent syringe 14 via the air collection port 12, particularly during the second air extraction process, a semipermeable membrane 30 is arranged in the T-piece 208 in the area of ​​the air collection outlet 12.

[0052] Figure 7 shows an angioplasty device 301 according to a fourth embodiment of the present disclosure. This concept is related to the first embodiment according to Figures 1 and 2. Again, two separate syringes are provided, namely the inflation syringe 22 and the venting syringe 14, the latter being solely associated with the venting device. The central component is formed by a three-way valve 308, which, in addition to the catheter port 10 and the inflation syringe port 24, has only one air collection port 12, to which (comparable to the first embodiment from Figures 1 and 2) the active venting syringe 14 is connected. Compared to the first embodiment, the fourth valve port, formed as an air outlet 20, is therefore omitted.

[0053] Instead of the active venting syringe 14 according to embodiments 1, 3 and 4, a venting pump driven by a rotary electric motor can also be provided.

[0054] An angioplasty device 1 ; 101 ; 201 ; 301 is disclosed, comprising an electrically operated automatic venting device. The venting device can form an air collection area that is automatically generated and enlargeable, and which is contained in an inflation syringe 22 of the angioplasty device or is formed by a venting syringe 14. Alternatively, venting can also be effected by a venting pump.

[0055] Reference symbol list

[0056] 1; 101; 201; 301 Angioplasty device

[0057] 2 balloon catheters

[0058] 4 Air

[0059] 6 Hydraulic fluid

[0060] 8 Four-way valve

[0061] 10 Catheter connection 12 Air collection connection

[0062] 14 venting syringe

[0063] 16 Extraction actuator

[0064] 18 Control unit

[0065] 20 Air outlet

[0066] 22 Inflation injection

[0067] 24 Inflation syringe connection

[0068] 26 Air collection area

[0069] 27 Compressed fluid area

[0070] 28 filters

[0071] 29 Liquid sensor

[0072] 30 semipermeable membrane

[0073] 108; 308 Three-way valve

[0074] 208 T-piece

[0075] 210 Chamber

[0076] M electric motor

Claims

Claims 1. Angioplasty device (1 ; 101 ; 201 ; 301 ) which is connectable to or connected with a balloon catheter (2), wherein the angioplasty device (1 ; 101 ; 201 ; 301 ) has an inflation syringe (22), characterized by an electric suction actuator (16) and an electronically connected control unit (18) which are prepared and set up for automatic evacuation of the balloon catheter (2), wherein the angioplasty device (1 ; 101 ; 201 ; 301) further comprises a central component through which air (4) and pressurized fluid (6) can flow, and which has at least one inflation syringe connection (24) and one catheter connection (10) and one or two air connections.

2. Angioplasty device (1 ; 101 ; 301 ) according to claim 1 , characterized in that one air connection or one of the two air connections is formed by an air collection connection (12) to which a venting syringe (14) driven by the suction actuator (16) or a venting pump driven by the suction actuator (16) is fluidically connected.

3. Angioplasty device (1) according to claim 2, characterized in that the central component is a four-way valve (8), the other air port of which is formed by an air outlet (20) via which the four-way valve (8) can be connected to the environment, wherein a valve body of the four-way valve (8) can be automatically switched between a first position and a second position by means of an electric valve actuator, wherein the valve actuator is electronically or electrically connected to the control unit (18).

4. Angioplasty device (1) according to claim 3, characterized in that in the first position of the valve body the catheter connection (10) is connected to the air collection connection (12), while the inflation syringe connection (24) is connected to the air outlet (20), and that in the second position of the valve body the inflation syringe connection (24) is connected to the catheter connection (10), while the air collection connection (12) is connected to the air outlet (20).

5. Angioplasty device (101; 301) Claim 1 , characterized in that the central component is a three-way valve (108; 308) with only one air connection, wherein a valve body of the three-way valve (108; 308) can be automatically switched between a first position and a second position by means of an electric valve actuator, wherein the valve actuator is electronically or electrically connected to the control unit (18).

6. Angioplasty device (101) according to claim 5, characterized in that one air connection is formed by an air outlet (20) via which the three-way valve (108) can be connected to the environment, wherein in the first position of the valve body the catheter connection (10) is connected to the inflation syringe connection (24) while the air outlet (20) is closed, and wherein in the second position of the valve body the inflation syringe connection (24) is connected to the air outlet (20) while the catheter connection (10) is closed.

7. Angioplasty device (101) according to claim 5 or 6, characterized in that the electric suction actuator (16) is further developed into an electric plunger actuator for a plunger of the inflation syringe (22), wherein one direction of movement of the plunger actuator is reversible, whereby pressurised fluid (6) can be conveyed from the inflation syringe to the three-way valve (108).

8. Angioplasty device (101) according to one of claims 5 to 7, characterized by an air collection area (26) for the air (4) aspirated from the balloon catheter (2), which can be generated or arranged in the inflation syringe (22), wherein the air collection area (26) borders a pressure fluid area (27) which can also be generated or arranged in the inflation syringe (22).

9. Angioplasty device (101) according to one of claims 6 to 8, characterized in that a liquid sensor (29) is arranged at the air outlet (20) which is electronically connected to the control unit (18).

10. Angioplasty device (1 ; 101 ) according to claim 3 or 4 or according to one of claims 6 to 9, characterized in that a filter (28) is provided at the air outlet (20).

11. Angioplasty device (1 ; 101 ) according to claim 3 or 4 or according to one of claims 6 to 10, characterized in that a semipermeable membrane (30) is provided in the air outlet (20).

12. Angioplasty device (301) according to claims 2 and 5, characterized in that in the first position of the valve body the catheter connection (10) is connected to the air collection port (12) while the inflation syringe connection (24) is closed, and that in the second position of the valve body the inflation syringe connection (24) is connected to the catheter connection (10) while the air collection port (12) is closed.

13. Angioplasty device (201) according to claim 2, characterized in that the central component is a T-piece (208) with a chamber (210), wherein the air collection port (12) is arranged or formed at an upper region of the chamber (210) viewed in the direction of gravity, while the catheter port (10) and the inflation syringe port (24) are arranged or formed at a lower region of the chamber (210).

14. Angioplasty device (201) according to claim 13, characterized in that a semipermeable membrane (30) is provided in or on the air collection port (12).

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