Catheter for placement in ventricular system

Abstract

The present application relates to a catheter (10), in particular an external ventricular drainage catheter, for placement in a ventricular system, in particular a human ventricular system, for draining liquid, in particular cerebrospinal fluid, from the ventricle of the ventricular system. The catheter (10) comprises: a tubular body (11) having an internal drainage lumen (12) extending along the tubular body (11) for draining a liquid; and at least one port (13.1, 13.2, 13.3) arranged in the distal end region (14) of the tubular body (11), the at least one port (13.1, 13.2, 13.3) connecting the drainage lumen (12) with the exterior of the tubular body (11) and the exterior of the catheter (10) for draining liquid from the ventricle to the drainage lumen (12). The catheter (10) further comprises at least one frontal ultrasound sensor (16), in particular at least one frontal ultrasound transducer, for emitting frontal ultrasound waves and detecting frontal ultrasound waves reflected back to the at least one frontal ultrasound sensor (16), in particular for obtaining a sonogram; wherein the at least one front ultrasonic sensor (16) is arranged at a distal tip (17) of the tubular body (11). Furthermore, the present application relates to a combination (3) of a control unit (4) and a conduit (10) of the present application. Furthermore, the present application relates to a device (1) comprising a stylet, in particular a probe (2), and a catheter (10) of the present application.

Description

Field of the Invention

[0001] The present application relates to a catheter, specifically an external ventricular drainage catheter, for placement in the ventricular system, specifically in the human ventricular system, for draining fluid from the ventricles of the ventricular system, specifically cerebrospinal fluid (CSF). The catheter comprises: a tubular body having an internal drainage lumen extending along the tubular body for draining fluid; and at least one port disposed in the distal region of the tubular body, the at least one port connecting the drainage lumen to the exterior of the tubular body and the exterior of the catheter for draining fluid from the ventricle into the drainage lumen. Background Art

[0002] A catheter is a medical device that can be inserted into the body to treat diseases or perform surgical procedures. Such a catheter is advantageously made of a thin and flexible tube. As an example, the puncture of the lateral ventricle and the placement of a flexible catheter in the ventricle of the ventricular system are very common surgical procedures for various indications involving cerebrospinal fluid (CSF) drainage. In such a surgical procedure, a burr hole is typically drilled in the skull using a drill or a burr, and a stylet, specifically a probe, inserted in the catheter lumen is inserted together with the catheter, for example, through the frontal lobe or the posterior occipital lobe of the brain into the ventricle. Once the catheter is introduced into the ventricle, the stylet or probe is removed, and the distal tip of the catheter remains in the anterior horn of the ventricle. Subsequently, cerebrospinal fluid can be withdrawn from the ventricular system through the catheter.

[0003] An example of the configuration of a catheter and a probe in the initially mentioned field of technology is described in WO96 / 29011A1 by John Gilbert. In this example, the probe is a rigid ultrasonic fiber optic probe that provides a longitudinal hole filled with optical fibers and a miniature ultrasonic transducer. Such an ultrasonic fiber optic imaging probe is adapted to the catheter and allows viewing through the end of the catheter. Thus, the probe placed within the catheter allows indirect and direct real-time visualization through the catheter tip. Therefore, the ultrasonic part of the probe enables the surgeon to correctly align the probe and the catheter with the ventricle by providing a two-dimensional echogram view of the ventricle. This also allows the surgeon to keep the probe and the catheter on the correct trajectory or path towards the anterior horn of the lateral ventricle when the probe and the catheter pass through the brain. Once the probe and the catheter puncture the ventricle, the fiber optic part of the probe allows the surgeon to directly view the interior of the anterior horn of the lateral ventricle, thereby confirming correct placement.

[0004] A disadvantage of this known catheter is that once the catheter is placed in the ventricle and the probe is removed to enable drainage of cerebrospinal fluid, the correct position of the catheter in the ventricle cannot be further monitored unless the catheter is held fixed outside the skull.

[0005] In principle, the drainage flow rate of cerebrospinal fluid can also be used as an indicator to control the correct position of the catheter in the ventricle, because if the catheter is displaced from the ventricle, the drainage flow rate of cerebrospinal fluid will decrease or stop. However, this indicator is very unreliable because if the catheter becomes blocked or if the ventricle is emptied, the drainage flow rate of cerebrospinal fluid will also decrease or stop.

[0006] For these reasons, currently known catheters cannot be used very reliably and safely for the drainage of cerebrospinal fluid.

[0007] In this document, the term "and / or" is sometimes used to connect two features. For example, this term is used to connect features A and B in the expression "A and / or B". This expression means that at least feature A or feature B is achieved. In other words, this expression includes the option "A but not B", the option "B but not A", and the option "A and B".

[0008] In this document, the terms "distal", "distally", "proximal", and "proximally" are all used to refer to the catheter. Accordingly, the distal end of the catheter refers to the tip of the catheter inserted into the ventricle, while the proximal end of the catheter refers to the end of the catheter remaining outside the skull. Correspondingly, the distal end of a certain element of the catheter is located on the side of the respective element facing the distal end of the catheter, while the proximal end of the respective element is located on the side of each element facing the proximal end of the catheter. Similarly, the distal region of the catheter refers to the region within the scope of the distal end of the catheter, while the proximal region of the catheter refers to the region within the scope of the proximal end of the catheter. Summary of the Invention

[0010] The object of the present application is to create a catheter, specifically an external ventricular drainage catheter, for placement in the ventricular system, specifically in the ventricular system of a human, for draining fluid, specifically cerebrospinal fluid, from the ventricles of the ventricular system. This catheter relates to the initially mentioned technical field and is capable of being used reliably and safely for the drainage of cerebrospinal fluid.

[0011] The solution of the present application is defined by the features of claim 1. According to the present application, the catheter further comprises at least one front ultrasonic sensor, specifically at least one front ultrasonic transducer, for emitting front ultrasonic waves and detecting the front ultrasonic waves reflected back to the at least one front ultrasonic sensor, specifically for obtaining an acoustic map; wherein the at least one front ultrasonic sensor is arranged at the distal tip of the tubular body.

[0012] According to the present application, the catheter comprises a tubular body having an internal drainage cavity extending along the tubular body for draining fluid. The drainage cavity is advantageously formed by the tubular body. For example, the tubular body can be formed by a tube having an inner cavity, and the inner cavity constitutes the internal drainage cavity.

[0013] In addition, according to the present application, the catheter includes at least one port disposed in the distal region of the tubular body. Advantageously, such at least one port is laterally disposed on the sidewall of the tubular body. However, in addition to the lateral disposition, the at least one port may also be disposed at the distal tip of the tubular body, in the direction of the longitudinal axis of the distal region of the tubular body. Regardless of the position where the at least one port is disposed in the distal region of the tubular body, the at least one port connects the drainage cavity to the outside of the tubular body and the outside of the catheter, so as to drain the liquid from the cerebral ventricle into the drainage cavity. Therefore, each of the at least one port allows cerebrospinal fluid to flow from the cerebral ventricle into the drainage cavity through a respective one of the at least one port.

[0014] According to the present application, the catheter further includes at least one front ultrasonic sensor for emitting front ultrasonic waves and detecting the front ultrasonic waves reflected back to the at least one front ultrasonic sensor, specifically for obtaining a sonogram. Each of the at least one front ultrasonic sensors is advantageously a front ultrasonic transducer. The ultrasonic transducer converts an electrical signal into ultrasonic waves and converts ultrasonic waves into an electrical signal. To achieve such conversion, the ultrasonic transducer can operate in a transmitter mode to convert an electrical signal into a pressure wave of ultrasonic frequency and thus into ultrasonic waves. In addition, to achieve such conversion, the ultrasonic transducer can also operate in a receiver mode for receiving ultrasonic waves and converting the received ultrasonic waves into an electrical signal. The ultrasonic transducer is generally a piezoelectric ultrasonic transducer or a capacitive ultrasonic transducer.

[0015] Based on the emitted front ultrasonic wave signal and the detected front ultrasonic waves reflected back to the at least one front ultrasonic sensor, an ultrasonic image of an interface located in front of the distal tip of the tubular body, such as the interface between brain tissue and cerebrospinal fluid in the cerebral ventricle, can be calculated. These ultrasonic images are sonograms. In addition, in addition to or in combination with obtaining a sonogram based on the emitted front ultrasonic wave signal and the detected front ultrasonic waves reflected back to the at least one front ultrasonic sensor, an acoustic signal representing an image of an interface, such as the interface between brain tissue and cerebrospinal fluid in the cerebral ventricle located in front of the distal tip of the tubular body, can be calculated.

[0016] Therefore, advantageously, the distal tip of the tubular body is also the distal tip of the catheter. Therefore, based on the emitted front ultrasonic wave signal and the detected front ultrasonic waves reflected back to the at least one front ultrasonic sensor, a sonogram (i.e., an ultrasonic image) of an interface located in front of the distal tip of the catheter, such as the interface between brain tissue and cerebrospinal fluid in the cerebral ventricle, and / or an acoustic signal representing an image of an interface, such as the interface between brain tissue and cerebrospinal fluid in the cerebral ventricle, can be calculated.

[0017] Since at least one front ultrasonic sensor is used to emit front ultrasonic waves and detect the front ultrasonic waves reflected back to the at least one front ultrasonic sensor, a real-time visualization and / or acoustic characterization of the interface in front of the catheter can be obtained, such as the interface between the brain tissue in front of the catheter and the cerebrospinal fluid in the cerebral ventricle. Therefore, due to the at least one front ultrasonic sensor, the navigation of the catheter in the brain and the cerebral ventricle is facilitated.

[0018] Since the catheter includes at least one front ultrasonic sensor for emitting front ultrasonic waves and detecting the front ultrasonic waves reflected back to the at least one front ultrasonic sensor, specifically for obtaining a sonogram, and the at least one front ultrasonic sensor is arranged at the distal tip of the tubular body, during the positioning of the catheter in the cerebral ventricle and during the drainage of cerebrospinal fluid from the cerebral ventricle, an ultrasonic image of the area in front of the distal tip of the tubular body of the catheter can be obtained, and thus a sonogram and / or acoustic characterization can be obtained. Therefore, the catheter according to the present application can not only navigate during the movement of the catheter through the brain into the cerebral ventricle, but also monitor the correct position of the catheter in the cerebral ventricle during the cerebrospinal fluid drainage after the catheter is inserted into the cerebral ventricle. Therefore, the present application enables the catheter to be used reliably and safely for draining liquids, specifically cerebrospinal fluid.

[0019] In a preferred variant, the catheter includes exactly one front ultrasonic sensor. The advantage of this is that the production cost of the catheter is lower, while still being able to be used reliably and safely for draining liquids, specifically cerebrospinal fluid. In a preferred variant, however, the catheter includes more than one front ultrasonic sensor. The advantage of this variant is that it realizes a further improvement in the navigation during the movement of the catheter through the brain into the cerebral ventricle, and a further improvement in monitoring the correct position of the catheter in the cerebral ventricle during the cerebrospinal fluid drainage after the catheter is inserted into the cerebral ventricle.

[0020] Advantageously, the tubular body includes an outlet for discharging the liquid from the drainage cavity outside the tubular body, and the outlet is arranged in the proximal region of the tubular body. The advantage of this is that the liquid drained from the drainage cavity is collected in a volume separated from the catheter.

[0021] Alternatively, however, the tubular body may not be provided with an outlet for discharging the liquid from the drainage cavity out of the tubular body. In this alternative, for example, the liquid can be collected in the drainage cavity. In this case, the drainage cavity may include a chamber for collecting the liquid, specifically cerebrospinal fluid.

[0022] Preferably, one of the at least one front ultrasonic sensor is aligned to emit front ultrasonic waves away from the tubular body from the distal tip of the tubular body and along the longitudinal axis direction of the distal region of the tubular body. The advantage of this is that aligning the front ultrasonic sensor to emit front ultrasonic waves away from the tubular body from the distal tip of the tubular body and along the longitudinal axis direction of the distal region of the tubular body allows for obtaining an echogram of the interface between the brain tissue in front of the distal tip of the tubular body and the cerebrospinal fluid in the cerebral ventricle along the longitudinal axis direction of the distal region of the tubular body, and thus obtaining an ultrasonic image and / or an acoustic presentation. Additionally, the advantage of this is that the respective front ultrasonic sensors can detect these interfaces, and thus can improve navigation during the insertion of the catheter into the cerebral ventricle.

[0023] Alternatively, each of the at least one front ultrasonic sensor is aligned, however, which is different from being aligned to emit front ultrasonic waves away from the tubular body from the distal tip of the tubular body and along the longitudinal axis direction of the distal region of the tubular body.

[0024] In a preferred variant, however, the catheter includes more than one front ultrasonic sensor, specifically at least 3 front ultrasonic sensors; wherein all the front ultrasonic sensors or all the front ultrasonic sensors except one are aligned to emit front ultrasonic waves away from the tubular body from the distal tip of the tubular body and along a direction inclined at least 5°, particularly preferably at least 10° with respect to the longitudinal axis of the distal region of the tubular body. In an advantageous variant, the front ultrasonic sensors are also aligned to emit front ultrasonic waves in a direction inclined at least 5°, particularly advantageously inclined at least 10° with respect to each other.

[0025] The advantage of this is that due to the different alignment methods of the different front ultrasonic sensors, by operating the front ultrasonic sensors in B-mode, the area around the longitudinal axis of the distal region of the tubular body can be scanned. Therefore, depending on the alignment of the front ultrasonic sensors, the front ultrasonic sensors can scan the plane containing the longitudinal axis of the distal region of the tubular body, or even scan the conical area around the longitudinal axis of the distal region of the tubular body.

[0026] Advantageously, the at least one front ultrasonic sensor is a piezoelectric ultrasonic transducer. Therefore, advantageously, the at least one front ultrasonic sensor includes a piezoelectric element, specifically a piezoelectric layer. The advantage of this is that the at least one front ultrasonic sensor can be designed to be particularly small, and thus is suitable for being installed at the distal tip of the catheter, specifically at the distal tip of the tubular body.

[0027] In one variant, the at least one front ultrasonic sensor is a capacitive ultrasonic transducer. In yet another example, the at least one front ultrasonic sensor is neither a piezoelectric ultrasonic transducer nor a capacitive ultrasonic transducer. The at least one front ultrasonic sensor may also be other sensors than transducers. For example, the at least one front ultrasonic sensor may include a transmitter and a receiver, the transmitter being used to emit front ultrasonic waves, and the receiver being used to detect the front ultrasonic waves that are reflected back to the receiver and thus reflected back to the at least one front ultrasonic sensor, specifically for obtaining an acoustic map; wherein the receiver is a unit separate from the transmitter. Thus, the unit of the receiver and the unit of the transmitter may be integrally arranged with the at least one front ultrasonic sensor.

[0028] Advantageously, the at least one front ultrasonic sensor is adapted to emit front ultrasonic waves at a specific frequency, specifically the center frequency, in the range of 1 - 20 MHz, particularly advantageously in the range of 5 - 12 MHz. The advantage of this is that it is possible to detect and visualize the interface of the ultrasonic image between the brain tissue and the cerebrospinal fluid within a range not exceeding 4 - 10 cm from the at least one front ultrasonic sensor, and thus in front of the distal tip of the tubular body, specifically in front of the distal tip of the catheter. The advantage of this is that it facilitates navigation during the movement of the catheter through the brain into the ventricle.

[0029] Preferably, the at least one front ultrasonic sensor is adapted to emit front ultrasonic waves whose peak rarefactional pressure is in the range of 0 - 7 MPa. The advantage of this is that brain damage caused by the pressure generated by the front ultrasonic waves can be avoided during the use of the catheter. Alternatively, however, the at least one front ultrasonic sensor may also be adapted to emit front ultrasonic waves with a peak rarefactional pressure exceeding 7 MPa.

[0030] Advantageously, the at least one front ultrasonic sensor is adapted to emit front ultrasonic waves in a pulsed manner, and each pulse contains 1 - 100 cycles. Thus, advantageously, the at least one front ultrasonic sensor is adapted to emit front ultrasonic waves at a pulse repetition frequency in the range of 100 Hz to 20 kHz. However, each pulse may also have more than 100 cycles, and the pulse repetition frequency may be selected to be less than 100 kHz or greater than 20 kHz.

[0031] Advantageously, the at least one front ultrasonic sensor is adapted to generally provide an acoustic output level of 94 mW / cm 2 or lower I SPTA.3 , advantageously 190 W / cm 2 or lower I SPPA 3 , where I SPTA.3 is the global maximum derating ISPTA Strength value, and I SPPA.3 is the mechanical index (or derated ISPPA strength) value indicated in Table 3 of "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", issued by the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, on June 27, 2019. Alternatively, however, the at least one positive ultrasound sensor is adapted to generally provide a higher acoustic output level.

[0032] Alternatively, the at least one positive ultrasound sensor is adapted to emit positive ultrasound waves at a frequency less than 1 MHz or greater than 20 MHz. Advantageously, however, the at least one positive ultrasound sensor is adapted to emit positive ultrasound waves at a frequency greater than 18 kHz and less than 100 MHz, specifically less than 50 MHz.

[0033] Advantageously, the catheter includes at least 5 ports, particularly advantageously at least 10 ports, and most advantageously at least 15 ports, which are arranged in the distal region of the tubular body; the at least 5 ports, at least 10 ports or at least 15 ports respectively connect the drainage cavity in the distal region of the tubular body with the outside of the tubular body and the outside of the catheter for draining liquid from the cerebral ventricle to the drainage cavity. Therefore, each of the at least 5 ports, at least 10 ports or at least 15 ports respectively allows the liquid to flow into the drainage cavity from the cerebral ventricle through one of the respective at least 5 ports, at least 10 ports or at least 15 ports. The advantage of this is that it is possible to efficiently drain liquid (specifically cerebrospinal fluid) from the cerebral ventricle to the drainage cavity.

[0034] Advantageously, the at least 5 ports, the at least 10 ports, or the at least 15 ports are respectively arranged in a port area within the distal region of the tubular body. Particularly advantageously, the port area extends along the tubular body in a length range of about 1 - 2 cm, specifically in the range of about 1.5 - 2.0 cm. However, the port area may extend a length less than about 1 cm or greater than about 2 cm. Advantageously, the catheter comprises fewer than 500 ports arranged within the distal region of the tubular body, and the fewer than 500 ports connect the drainage cavity of the distal region of the tubular body to the exterior of the tubular body and the exterior of the catheter for draining liquid from the ventricle to the drainage cavity. Alternatively, however, the catheter comprises 500 or more ports arranged within the distal region of the tubular body, and the 500 or more ports connect the drainage cavity of the distal region of the tubular body to the exterior of the tubular body and the exterior of the catheter for draining liquid from the ventricle to the drainage cavity.

[0035] Advantageously, the at least 5 ports, the at least 10 ports, or the at least 15 ports are respectively arranged laterally on the sidewall of the tubular body. The advantage of this is that it can achieve efficient drainage of liquid (specifically cerebrospinal fluid) from the ventricle to the drainage cavity, and at the same time, the distal region of the tubular body with at least 5 ports, at least 10 ports, or at least 15 ports can be designed respectively to provide high stability and durability.

[0036] Alternatively, one or more of the at least 5 ports, the at least 10 ports, or the at least 15 ports are not respectively arranged laterally on the sidewall of the tubular body, but are arranged at the distal tip of the tubular body, in the direction of the longitudinal axis of the distal region of the tubular body.

[0037] Preferably, the at least 5 ports, the at least 10 ports, or the at least 15 ports are respectively distributed around the circumference of the tubular body, specifically in all directions towards the circumference of the tubular body. Thus, advantageously, openings are provided on the sidewall of the tubular body through at least one of the at least 5 ports, at least 10 ports, or at least 15 ports in all 360 degrees of the circumference of the tubular body. The advantage of this is that regardless of the orientation in which the catheter is inserted into the ventricle, it can best achieve drainage of liquid (specifically cerebrospinal fluid) from the ventricle to the drainage cavity.

[0038] Alternatively, however, the at least 5 ports, at least 10 ports, or at least 15 ports can be respectively distributed differently in the distal region of the tubular body.

[0039] Preferably, the at least one port, the at least 5 ports, at least 10 ports or at least 15 ports are respectively arranged at the proximal end of at least one front ultrasonic sensor. The advantage of this is that at least one front ultrasonic sensor can be arranged at the distal tip of the tubular body, and respectively there is no need to reserve space for the at least one port, the at least 5 ports, at least 10 ports or at least 15 ports. Therefore, there is greater freedom in selecting the shape and size of at least one front ultrasonic sensor. Thus, it is easier to select the optimal at least one front ultrasonic sensor to obtain a sonogram, and thus obtain an ultrasonic image and / or acoustic characterization of an interface (such as the interface between brain tissue in front of the distal tip of the tubular body and cerebrospinal fluid in the cerebral ventricle).

[0040] Alternatively, one or more of the at least one port, at least 5 ports, at least 10 ports or at least 15 ports are respectively not arranged at the proximal end of at least one front ultrasonic sensor.

[0041] Preferably, the catheter further comprises at least one lateral ultrasonic sensor, specifically at least one lateral ultrasonic transducer, for emitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the at least one lateral ultrasonic sensor, specifically for obtaining a sonogram; wherein the at least one lateral ultrasonic sensor is laterally arranged in the distal region of the tubular body. Thus, in one example, the at least one lateral ultrasonic sensor is laterally arranged on the tubular body in the distal region of the tubular body, and thus is arranged on the tubular body outside the tubular body. In another example, the at least one lateral ultrasonic sensor is laterally arranged inside the tubular body in the distal region of the tubular body. For example, the at least one lateral ultrasonic sensor is laterally arranged on the side wall of the tubular body in the distal region of the tubular body. In yet another example, the at least one lateral ultrasonic sensor is arranged behind the side wall of the tubular body in the distal region of the tubular body. In any of the latter two examples, the at least one lateral ultrasonic sensor is advantageously mounted on a support structure.

[0042] Regardless of how the at least one lateral ultrasonic sensor is laterally arranged in the distal region of the tubular body, the at least one lateral ultrasonic sensor is used to emit lateral ultrasonic waves and detect the lateral ultrasonic waves reflected back to the at least one lateral ultrasonic sensor, specifically for obtaining a sound wave map. The advantage is that a sound wave map around the distal region of the catheter tubular body can be obtained, and thus an ultrasonic image can be obtained, and / or an acoustic signal representing an image around the distal region of the catheter tubular body can be obtained, and thus an acoustic representation can be obtained. Therefore, the navigation of the catheter during its movement through the brain into the ventricle is improved. In addition, visualizing the ventricle with the aid of at least one lateral ultrasonic sensor provides important information about the size of the ventricle. This information helps to quickly adjust the drainage volume, which is usually based only on intracranial pressure or external visualization information (such as head computed tomography (CT) or magnetic resonance imaging (MRI)). In addition, this information helps to distinguish the reasons why the catheter cannot drain (due to an empty ventricle, blocked catheter, or catheter displacement), because the drained and empty ventricle and catheter displacement can be visually displayed. In addition, during the drainage of cerebrospinal fluid after the catheter is positioned in the ventricle, the monitoring of the correct position of the catheter in the ventricle can also be improved. Therefore, the catheter can be used more reliably and safely for the drainage of fluids (specifically cerebrospinal fluid).

[0043] Advantageously, the at least one lateral ultrasonic sensor is aligned to emit lateral ultrasonic waves substantially in the direction pointed by the distal tip of the tubular body and away from the tubular body. Thus, the distal tip of the tubular body points along the longitudinal axis direction of the distal region of the tubular body, and when starting from the distal tip of the tubular body, it faces away from the tubular body. Therefore, emitting lateral ultrasonic waves away from the tubular body substantially in the direction pointed by the distal tip of the tubular body preferably means that the lateral ultrasonic waves are emitted in a direction inclined at an angle less than 90°, particularly preferably less than 50°, relative to the direction pointed by the distal tip of the tubular body. Thus, the lateral ultrasonic waves can even be emitted in a direction parallel to the direction pointed by the distal tip of the tubular body, and thus along the tubular body towards the distal tip of the tubular body and beyond the distal tip of the tubular body.

[0044] The at least one lateral ultrasonic sensor is aligned to emit lateral ultrasonic waves from the tubular body substantially in the direction pointed by the distal tip of the tubular body. The advantage of this is that an acoustic map of the area in contact with the distal region of the catheter tubular body can be obtained, and thus an ultrasonic image and / or an acoustic representation can be obtained. Therefore, the navigation of the catheter during its movement through the brain into the ventricle is further improved. In addition, once the catheter is positioned in the ventricle, during cerebrospinal fluid drainage, the monitoring of the correct position of the catheter in the ventricle is improved. Therefore, the catheter can be used more reliably and safely for draining fluids, specifically cerebrospinal fluid. These advantages are particularly evident when each of the at least one lateral ultrasonic sensors is aligned to emit lateral ultrasonic waves from the tubular body substantially in the direction pointed by the distal tip of the tubular body.

[0045] Alternatively, however, the at least one lateral ultrasonic sensor is not aligned to emit lateral ultrasonic waves from the tubular body substantially in the direction pointed by the distal tip of the tubular body.

[0046] Advantageously, the at least one lateral ultrasonic sensor is a piezoelectric ultrasonic transducer. Therefore, advantageously, each of the at least one lateral ultrasonic sensors includes a piezoelectric element, specifically a piezoelectric layer.

[0047] The advantage of this is that the at least one lateral ultrasonic sensor can be designed to be particularly small and is thus suitable for being laterally arranged in the distal region of the tubular body. In one variant, the at least one lateral ultrasonic sensor is a capacitive ultrasonic transducer. In yet another example, the at least one lateral ultrasonic sensor is neither a piezoelectric ultrasonic transducer nor a capacitive ultrasonic transducer. The at least one lateral ultrasonic sensor can also be other sensors other than transducers. For example, the at least one lateral ultrasonic sensor can include a transmitter and a receiver. The transmitter is used to emit forward ultrasonic waves, and the receiver is used to detect the forward ultrasonic waves that are reflected back to the receiver and thus reflected back to the lateral ultrasonic sensor, specifically for obtaining an acoustic map; wherein the receiver is a unit separate from the transmitter. Therefore, the unit of the receiver and the unit of the transmitter can be integrally arranged with the at least one lateral ultrasonic sensor.

[0048] Preferably, the at least one lateral ultrasonic sensor is adapted to emit lateral ultrasonic waves at a frequency in the range of 1 - 20 MHz, particularly preferably in the range of 5 - 12 MHz. The advantage of this is that the interface of the ultrasonic image between the brain tissue and the cerebrospinal fluid can be detected and visualized within a range not exceeding 4 - 10 cm from each of the at least one lateral ultrasonic sensors. The advantage of this is that it facilitates the navigation during the movement of the catheter through the brain into the ventricle.

[0049] Preferably, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves having a peak rarefaction pressure in the range of 0 - 7 MPa. The advantage of this is that brain damage caused by the pressure generated by the front ultrasonic waves during catheter use can be avoided. Alternatively, however, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves having a peak rarefaction pressure exceeding 7 MPa.

[0050] Advantageously, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves in a pulsed manner, and each pulse contains 1 - 100 cycles. Thus, advantageously, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves at a pulse repetition frequency in the range of 100 Hz to 20 kHz. However, each pulse can also have more than 100 cycles, and the pulse repetition frequency can be selected to be less than 100 kHz or greater than 20 kHz.

[0051] Advantageously, the at least one front ultrasound sensor and the at least one lateral ultrasound sensor are adapted to provide an overall acoustic output level of 94 mW / cm 2 or lower I SPTA 3 , advantageously 190 W / cm 2 or lower I SPPA 3 , where I SPTA3 is the global maximum derated ISPTA intensity value, and I SPPA3 is the mechanical index (or derated ISPPA intensity) value indicated in Table 3 of "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", "Guidance for Industry and Food and Drug Administration Staff", issued by the Center for Devices and Radiological Health, Food and Drug Administration, U.S. Department of Health and Human Services on June 27, 2019. Alternatively, however, the at least one front ultrasound sensor and the at least one lateral ultrasound sensor are adapted to provide a higher overall acoustic output level.

[0052] Alternatively, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves at a frequency less than 1 MHz or greater than 20 MHz. Advantageously, however, the at least one lateral ultrasound sensor is adapted to emit lateral ultrasonic waves at a frequency greater than 18 kHz and less than 100 MHz, specifically less than 50 MHz.

[0053] Advantageously, the catheter comprises at least 3 lateral ultrasonic sensors, preferably at least 15 lateral ultrasonic sensors, particularly preferably at least 35 lateral ultrasonic sensors, and most preferably at least 60 lateral ultrasonic sensors, respectively for transmitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, specifically for detecting the lateral ultrasonic waves reflected back to each one of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, specifically for obtaining a sonogram; wherein the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively arranged laterally in the distal region of the tubular body. The advantage of this is that a more complete ultrasonic image of the area around the distal region of the catheter tubular body is obtained. Thus, the navigation of the catheter during its movement through the brain into the ventricle is improved. In addition, once the catheter is positioned in the ventricle, the monitoring of the correct position of the catheter during cerebrospinal fluid drainage will also be further improved. In addition, during the movement of the catheter through the brain into the ventricle, the size of the ventricle can be measured, and once the catheter is positioned in the ventricle, measurements and monitoring can also be carried out. Therefore, the catheter can be used more reliably and safely for draining fluids, specifically cerebrospinal fluid.

[0054] Advantageously, the catheter comprises fewer than 500 lateral ultrasonic sensors for transmitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the fewer than 500 lateral ultrasonic sensors, specifically for detecting the lateral ultrasonic waves reflected back to each one of the fewer than 500 lateral ultrasonic sensors, specifically for obtaining a sonogram; wherein the fewer than 500 lateral ultrasonic sensors are arranged laterally in the distal region of the tubular body. Alternatively, the catheter comprises 500 or more lateral ultrasonic sensors for transmitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the 500 or more lateral ultrasonic sensors, specifically for detecting the lateral ultrasonic waves reflected back to each one of the 500 or more lateral ultrasonic sensors, specifically for obtaining a sonogram; wherein the 500 or more lateral ultrasonic sensors are arranged laterally in the distal region of the tubular body.

[0055] In a preferred variant, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively arranged in a lateral ultrasonic sensor area within the distal region of the tubular body. Particularly preferably, the lateral ultrasonic sensor area extends along the length of the tubular body in a range of about 0.5 - 3 cm, specifically in a range of about 1 - 2 cm. In one variant, however, the lateral ultrasonic sensor area extends along the length of the tubular body less than about 0.5 cm or greater than about 3 cm. Advantageously, each of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors is respectively a lateral ultrasonic transducer. The advantage of this is that each of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors can be designed to be particularly small and thus suitable for lateral arrangement in the distal region of the tubular body.

[0056] Alternatively, not all, or even none, of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively lateral ultrasonic transducers. For example, one, more than one, or even all of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors can respectively include a transmitter and a receiver, the transmitter being for emitting a forward ultrasonic wave, and the receiver being for detecting the forward ultrasonic wave that is reflected back to the receiver and thus reflected back to the lateral ultrasonic sensor, specifically for obtaining an acoustic map; wherein the receiver is a unit separate from the transmitter. Thus, the unit of the receiver and the unit of the transmitter can be integrally arranged with the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors respectively.

[0057] Preferably, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively distributed around the circumference of the tubular body to emit lateral ultrasonic waves away from the tubular body in all directions around the circumference of the tubular body, specifically in all 360-degree directions. The advantage of this is that a more complete ultrasonic image of the area around the distal region of the catheter tubular body can be obtained. Therefore, the navigation of the catheter during its movement through the brain into the ventricle is further improved. In addition, once the catheter is positioned within the ventricle, during cerebrospinal fluid drainage, the monitoring of the correct position of the catheter within the ventricle is further improved. Therefore, the catheter can be used more reliably and safely for draining fluids, specifically cerebrospinal fluid. Advantageously, therefore, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively aligned to emit lateral ultrasonic waves substantially in the direction pointed by the distal tip of the tubular body and away from the tubular body. The advantage of this is that the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors respectively generate cones of lateral ultrasonic waves that open in the direction of the distal tip of the tubular body. The advantage of this is that an ultrasonic field can be generated to obtain a panoramic view of the ventricular system around the tip of the tubular body, enabling the dimensions of the ventricular system to be estimated.

[0058] In a particularly preferred variant, at least 3 of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors respectively provide a tubular shape that covers the circumference of the tubular body to emit lateral ultrasonic waves away from the tubular body in all directions around the circumference of the tubular body, specifically in all 360-degree directions. With this variant, the aforementioned advantages, namely that the lateral ultrasonic sensors are distributed around the circumference of the tubular body to emit lateral ultrasonic waves away from the tubular body in all directions around the circumference of the tubular body, specifically in all 360-degree directions, can be achieved in a particularly simple and easy manner.

[0059] Alternatively, however, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are respectively arranged differently in the distal region of the tubular body.

[0060] At least one front ultrasonic sensor, and possibly at least one lateral ultrasonic sensor, any one of at least 3 lateral ultrasonic sensors, possibly at least 15 lateral ultrasonic sensors, possibly at least 35 lateral ultrasonic sensors, or possibly at least 60 lateral ultrasonic sensors, respectively, is a piezoelectric transducer, then the at least one front ultrasonic sensor, and the possibly at least one lateral ultrasonic sensor, each one of the possibly at least 3 lateral ultrasonic sensors, the possibly at least 15 lateral ultrasonic sensors, the possibly at least 35 lateral ultrasonic sensors, or the possibly at least 60 lateral ultrasonic sensors, respectively, advantageously includes a piezoelectric element, specifically a piezoelectric layer. Examples of piezoelectric ultrasonic transducers including such piezoelectric elements are described in the publication, "Qifa Zhou et al, Piezoelectric single crystal for ultrasonic transducers in biomedical application, Journal Progress, Materials Science, Volume 66, October 2014, Pages 87 to 111".

[0061] At least one front ultrasonic sensor, and possibly at least one lateral ultrasonic sensor, any one of possibly at least 3 lateral ultrasonic sensors, possibly at least 15 lateral ultrasonic sensors, possibly at least 35 lateral ultrasonic sensors, or possibly at least 60 lateral ultrasonic sensors, respectively, is a piezoelectric transducer, then the at least one front ultrasonic sensor, and the possibly at least one lateral ultrasonic sensor, each one of the possibly at least 3 lateral ultrasonic sensors, the possibly at least 15 lateral ultrasonic sensors, the possibly at least 35 lateral ultrasonic sensors, or the possibly at least 60 lateral ultrasonic sensors, respectively, advantageously includes a layer or multiple layers of acoustic impedance matching layer. The purpose of the layer or multiple layers of acoustic impedance matching layer is to minimize the transmission loss caused by the acoustic impedance mismatch between the surface of the piezoelectric ultrasonic transducer and the tissue and / or liquid in which the piezoelectric ultrasonic transducer operates. Advantageously, the piezoelectric element is coated with a layer or multiple layers of acoustic impedance matching layer. Therefore, the layer or multiple layers of acoustic impedance matching layer are advantageously coated on the front side of the piezoelectric element from which ultrasonic waves will be emitted. For example, the layer or multiple layers of acoustic impedance matching layer can be made of polymers such as epoxy resin, polyurethane, polystyrene, or parylene, and can also include other filling materials such as silver particles. Therefore, the silver particles can have an average diameter of, for example, 2 - 3 μm.

[0062] The advantage of the one or more acoustic impedance matching layers is that they provide better energy transfer and thus enable more efficient ultrasonic emission. Thus, parylene, which is a polymer whose main chain consists of p-phenylene rings -C6H4- connected by 1,2-ethanediyl bridges –CH2–CH2–, also has the advantage of simultaneously serving as a protective layer for the respective piezoelectric ultrasonic transducers.

[0063] Regardless of whether the respective piezoelectric ultrasonic transducers include such a single acoustic impedance matching layer or multiple acoustic impedance matching layers, the respective piezoelectric ultrasonic transducers advantageously include an acoustically absorbing backing layer. The advantage of this is that the ultrasonic waves emitted from the back of the piezoelectric element can be absorbed by the acoustically absorbing backing layer. This can prevent the adverse effects caused by the ultrasonic waves emitted from the back of the respective piezoelectric ultrasonic transducers, which may reduce the quality of the ultrasonic images obtainable using the respective piezoelectric ultrasonic transducers. Advantageously, the acoustically absorbing backing layer is coated on the back of the piezoelectric element. In one example, the acoustically absorbing backing layer is made of a viscous epoxy resin containing tungsten particles and silver particles. For example, such an acoustically absorbing backing layer and the method of applying them to a piezoelectric element are described in US6124664 of ScimetLife Systems. In another example, the acoustically absorbing backing layer comprises a composite material of tungsten powder and cerium oxide powder, where the weight percentage of tungsten is 1.0 - 4.5%, and the weight ratio of epoxy resin to the powder is 4:1 to 50:1. An example of such an acoustically absorbing backing layer is described in US4800316 of Shanghai Lamp Factory.

[0064] However, the at least one front ultrasonic sensor, and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors, or the possible at least 60 lateral ultrasonic sensors, can also be constructed differently, respectively.

[0065] Advantageously, the at least one front ultrasonic sensor can be operated in the A mode. In the case where the catheter includes more than one front ultrasonic sensor, the front ultrasonic sensors can advantageously be operated in the A mode or the B mode. In one variant, the at least one front ultrasonic sensor can be operated in another mode, such as the Doppler mode or the harmonic mode.

[0066] Advantageously, the possible at least one lateral ultrasound sensor, the possible at least 3 lateral ultrasound sensors, the possible at least 15 lateral ultrasound sensors, the possible at least 35 lateral ultrasound sensors or the possible at least 60 lateral ultrasound sensors can be operated in mode A or mode B, respectively. In a variant, the possible at least one lateral ultrasound sensor, and the possible at least 3 lateral ultrasound sensors, the possible at least 15 lateral ultrasound sensors, the possible at least 35 lateral ultrasound sensors or the possible at least 60 lateral ultrasound sensors can also be operated in another mode, such as Doppler mode or harmonic mode, respectively.

[0067] Mode A is also known as the amplitude mode, which is used to scan a line through the human body and plot the echoes as a function of depth on the screen. Mode B is also known as the brightness mode, in which a linearly arranged transducer simultaneously scans a plane of the human body, which can be viewed as a two-dimensional image on the screen. This mode is also known as the 2D mode. In the harmonic mode, the transducer emits a fundamental ultrasonic pulse into the human body, and a narrow beam of the main, harmonic overtone is reflected back after passing through the human tissue. When the harmonic mode is turned on, only this narrow beam of pulses is detected. The fundamental ultrasonic pulse and the scattered pulses are removed. Therefore, this mode improves the lateral resolution and the contrast resolution.

[0068] Preferably, the at least one port, at least 5 ports, at least 10 ports or at least 15 ports are arranged away from the at least one lateral ultrasound sensor, at least 3 lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors or at least 60 lateral ultrasound sensors, respectively. The advantage of this is that without inserting the catheter tip too deeply into the ventricle, it is possible to effectively drain the liquid (specifically cerebrospinal fluid) from the ventricle to the drainage cavity. At the same time, it is also possible to obtain the best ultrasound images from the surrounding distal region using the at least one lateral ultrasound sensor, at least 3 lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors or at least 60 lateral ultrasound sensors, respectively.

[0069] Such an advantage is particularly significant when each of the at least one port, at least 5 ports, at least 10 ports or at least 15 ports is arranged away from the at least one lateral ultrasound sensor, at least 3 lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors or at least 60 lateral ultrasound sensors, respectively.

[0070] In the case where at least 5 ports, at least 10 ports, or at least 15 ports are respectively arranged in the distal region of the tubular body in the above-mentioned port region, the port region is respectively advantageously arranged distally with respect to at least one lateral ultrasonic sensor, at least 3 lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors. In the case where there are respectively at least 3 lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors, and the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors, or the at least 60 lateral ultrasonic sensors are respectively arranged in the above-mentioned lateral ultrasonic sensor region, the port region is advantageously arranged distally of the lateral ultrasonic sensor region. Therefore, the port region and the lateral ultrasonic sensor region are advantageously separated from each other, and thus any overlap is avoided. In a variant, however, the port region and the lateral ultrasonic sensor region at least partially overlap.

[0071] In a variant, however, the at least one port, the at least 5 ports, the at least 10 ports, or the at least 15 ports are respectively not arranged distally of the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors, or the at least 60 lateral ultrasonic sensors.

[0072] As an alternative to all of the above variants with at least one lateral ultrasonic sensor, the catheter does not have at least one lateral ultrasonic sensor.

[0073] Advantageously, the tubular body is made of a flexible material. Such a flexible material can be, for example, a synthetic material such as polyimide or polyurethane. The advantage of this is that the damage to the brain can be reduced after the catheter is inserted into the cerebral ventricle.

[0074] Alternatively, however, the tubular body is not made of a flexible material but of a rigid material.

[0075] Whether the tubular body is made of a flexible material or not, the tubular body is advantageously coated with an antibacterial coating. The advantage of this is that the risk of infection caused by the use of the catheter can be reduced. For example, a combination of clindamycin and rifampicin, a combination of minocycline and rifampicin, or a coating containing a silver coating can be used as the antibacterial coating. Examples of such coatings have been described in the publication "Clinical review: Efficacy of antimicrobial-impregnated catheters in external ventricular drainage - a systematic review and meta-analysis of Xiang Wang et al., Critical Care 17, 234 (2013)".

[0076] Alternatively, however, the tubular body is not coated with an antibacterial coating.

[0077] Advantageously, the length of the catheter is in the range of 20 - 30 cm. The advantage of this is that the catheter is long enough to reach the ventricle, while not being so long as to be cumbersome.

[0078] Alternatively, however, the length of the catheter can also be less than 20 cm or greater than 30 cm.

[0079] Preferably, the outer diameter of the tubular body is in the range of 2 - 10 mm, and particularly preferably in the range of 2 - 4 mm. The advantage of this is that the internal drainage cavity extending along the tubular body for liquid drainage can be designed to have a large enough diameter to achieve effective liquid drainage, while the catheter still maintains a small enough outer diameter to avoid unnecessary damage to the brain.

[0080] Alternatively, however, the outer diameter of the catheter can also be less than 2 mm or greater than 10 mm.

[0081] Preferably, the inner diameter provided by the drainage cavity is in the range of 1 - 8 mm, and particularly advantageously 1 - 2 mm. The advantage of this is that the internal drainage cavity extending along the tubular body for liquid drainage is large enough to achieve effective liquid drainage. Therefore, the inner diameter of the drainage cavity is advantageously smaller than the outer diameter of the tubular body. Particularly advantageously, the inner diameter of the drainage cavity is at least 0.5 mm smaller than the outer diameter of the tubular body, and more advantageously at least 1.0 mm smaller. The advantage of this is that the tubular body can have sufficient stability. Nevertheless, the outer diameter of the tubular body is preferably less than the inner diameter of the drainage cavity plus 5.0 mm.

[0082] Advantageously, the catheter includes an intracranial pressure sensor for measuring the intracranial pressure when the catheter is inserted into the ventricle. The advantage of this is that the intracranial pressure can be determined during the use of the catheter.

[0083] In an advantageous variant, one of the at least one front ultrasonic sensor or possibly at least one lateral ultrasonic sensor, possibly at least 3 lateral ultrasonic sensors, possibly at least 15 lateral ultrasonic sensors, possibly at least 35 lateral ultrasonic sensors or possibly at least 60 lateral ultrasonic sensors, respectively, simultaneously serves as an intracranial pressure sensor. The advantage of this is that the catheter structure is more compact. However, in another advantageous variant, respectively, the intracranial pressure sensor is a sensor separate from one of the at least one front ultrasonic sensor or the possibly at least one lateral ultrasonic sensor, the possibly at least 3 lateral ultrasonic sensors, the possibly at least 15 lateral ultrasonic sensors, the possibly at least 35 lateral ultrasonic sensors or the possibly at least 60 lateral ultrasonic sensors. The advantage of this is that, respectively, the determination of intracranial pressure can be independent of one of the at least one front ultrasonic sensor or the possibly at least one lateral ultrasonic sensor, the possibly at least 3 lateral ultrasonic sensors, the possibly at least 15 lateral ultrasonic sensors, the possibly at least 35 lateral ultrasonic sensors or the possibly at least 60 lateral ultrasonic sensors.

[0084] In an alternative to these variants, when the catheter is inserted into the ventricle, the catheter does not use an intracranial pressure sensor to measure intracranial pressure.

[0085] Advantageously, the catheter includes wiring that connects the at least one front ultrasonic sensor to a connector for connection to a control unit for controlling the at least one front ultrasonic sensor, and the connector is arranged in the proximal region of the catheter. The advantage of this is that the catheter can be separated from the control unit for maintenance purposes, and when the catheter is used to be placed in the ventricular system, specifically the human ventricular system to drain fluid (specifically cerebrospinal fluid) from the ventricle, the catheter can be connected to the control unit to control the at least one front ultrasonic sensor.

[0086] Alternatively, however, the catheter may not have such a connector. In this case, the catheter advantageously includes wiring that connects the at least one front ultrasonic sensor and the control unit for controlling the at least one front ultrasonic sensor, and the connector is arranged in the proximal region of the catheter.

[0087] When the catheter further comprises the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, which are respectively configured to emit lateral ultrasonic waves and detect the lateral ultrasonic waves reflected back to the at least one lateral ultrasonic sensor, the lateral ultrasonic waves of the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are specifically configured to obtain acoustic maps; wherein the at least one lateral ultrasonic sensor is laterally arranged in the distal region of the tubular body, and the catheter advantageously comprises wiring, and the wiring respectively connects the at least one lateral ultrasonic sensor, the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors to a connector that is connected for controlling the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, and respectively the connector is arranged in the proximal region of the catheter. The advantage of this is that the catheter can be separated from the control unit for maintenance purposes, and when the catheter is used and placed in the ventricular system, specifically the human ventricular system, to drain fluid (specifically cerebrospinal fluid) from the ventricle, the catheter can be connected to the control unit for controlling the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors respectively.

[0088] Therefore, when the catheter also comprises the above-mentioned wiring, the wiring connects the at least one front ultrasonic sensor to a connector that is used to connect to a control unit for controlling the at least one front ultrasonic sensor, and the connector is arranged in the proximal region of the catheter. Advantageously, the connector for connecting to the control unit for controlling the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors is respectively also the connector for connecting to the control unit for controlling the at least one front ultrasonic sensor. In a variant, however, there are two separate connectors.

[0089] Furthermore, in the case where the catheter also contains the above-mentioned wiring, the connection connects the at least one front ultrasonic sensor to a connector, the connector being for connection to a control unit for controlling the at least one front ultrasonic sensor, for controlling the at least one lateral ultrasonic sensor, the control unit for the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, respectively and simultaneously being the control unit for controlling at least one front ultrasonic sensor. In a variant, however, there are two separate control units.

[0090] As an alternative to these variants, however, the catheter does not have such a connector. In this case, the catheter advantageously contains wiring that connects the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors to a control unit, respectively, the control unit being for controlling the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, and the connector is arranged in the proximal region of the catheter.

[0091] In a preferred variant, the catheter contains wiring that connects the at least one front ultrasonic sensor and the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors to a connector, respectively, the connector being for being connected or connected to a control unit for controlling the at least one front ultrasonic sensor and the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, and the connector is arranged in the proximal region of the catheter.

[0092] Whether the control unit for controlling the at least one front ultrasonic sensor and the control unit for controlling the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors are, respectively, the same control unit or separate control units, the control unit is advantageously adapted to respectively control the respective ultrasonic sensor or ultrasonic sensors to respectively emit front ultrasonic waves and / or lateral ultrasonic waves. In addition, the control unit is advantageously adapted to receive the signal of the reflected front ultrasonic waves received from the at least one front ultrasonic sensor, specifically for obtaining an acoustic map; or, respectively, from the at least one lateral ultrasonic sensor, the at least 3 lateral ultrasonic sensors, the at least 15 lateral ultrasonic sensors, the at least 35 lateral ultrasonic sensors or the at least 60 lateral ultrasonic sensors, the signal of the reflected lateral ultrasonic waves received, specifically for obtaining an acoustic map. In addition, the control unit is advantageously adapted to calculate an ultrasonic image based on the received signal and thus calculate an acoustic map, and / or is adapted to calculate an acoustic signal representing the acoustic map based on the received signal. In an advantageous variant, however, the control unit may be connected to a separate computing unit, which is adapted to calculate an ultrasonic image based on the received signal and thus calculate an acoustic map, and / or is adapted to calculate an acoustic signal representing the acoustic map based on the received signal. Therefore, the separate computing unit may be a personal computer (PC), a tablet, a smartphone or any other device containing a processor, which is adapted to calculate an ultrasonic image based on the received signal and thus calculate an acoustic map, or an acoustic signal of the acoustic representation of the acoustic map.

[0093] Advantageously, the wiring of the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors respectively includes at least n + 1 electrical connections, where n is respectively the total number of sensors of the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors.

[0094] Advantageously, the wiring of the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors is, respectively, a printed circuit board (PCB), specifically a high density interconnect printed circuit board (HDI PCB). Thus, the printed circuit board advantageously comprises a flexible substrate. The flexible substrate can be made of polyimide, polyester, polyethylene naphthalate, polytetrafluoroethylene (PTFE) or aramid. Particularly advantageously, the flexible substrate is made of a polyimide film, a polyester film, a polyethylene naphthalate film, a polytetrafluoroethylene (PTFE) film or an aramid film. An example of a polyimide film is Kapton. Advantageously, the polyimide film has a thickness of less than 200 μm, particularly less than 100 μm.

[0095] The printed circuit board is advantageously terminated by a connector. Thus, the connector can be a custom connector or a standard connector for electrical connection to a control unit.

[0096] Alternatively, however, the wiring of the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors is, respectively, not a printed circuit board (PCB), but made of wires.

[0097] Advantageously, the catheter is compatible with magnetic resonance imaging, specifically safe for magnetic resonance imaging. Thus, the catheter can advantageously be used for patients in a magnetic resonance imaging (MRI) device. Thus, the magnetic resonance imaging (MRI) device is advantageously a magnetic resonance imaging (MRI) device with a magnetic field of up to 3 Tesla. In such a magnetic field, the catheter does not heat up, does not move within the patient's brain and thus does not cause harm to the patient in the magnetic resonance imaging (MRI) device. In addition, the catheter does not generate artifacts in the images obtained using the magnetic resonance imaging (MRI) device. In an alternative, however, the catheter is not compatible with magnetic resonance imaging.

[0098] Regardless of how the wiring is prepared, the control unit for controlling the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors, and the catheter of the present application can advantageously be used and sold in combination. Thus, the combination of such a control unit with the above catheter is advantageous.

[0099] Respectively, the control unit is advantageously adapted to control the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors. Thus, when connected to the catheter, the control unit is advantageously adapted to apply an excitation signal to each of the at least one front ultrasonic sensor and the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors, with a preset amplitude and with phase information. Further, the control unit is advantageously adapted to receive a signal from at least one front ultrasonic sensor, the signal containing information about the front ultrasonic waves reflected back to the at least one front ultrasonic sensor and detected by the at least one front ultrasonic sensor. Further, respectively, the control unit is advantageously adapted to receive a signal from the possible at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors, respectively the signal containing information about the lateral ultrasonic waves reflected back to the at least one lateral ultrasonic sensor, each of the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors and respectively the lateral ultrasonic waves detected by each of the at least one lateral ultrasonic sensor, the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors.

[0100] The control unit is advantageously adapted to operate at least one front ultrasonic sensor in mode A. In the case where the catheter comprises a plurality of front ultrasonic sensors, the control unit is advantageously adapted to operate the front ultrasonic sensors in mode A or mode B. Thus, in an advantageous variant, the control unit is adapted to operate at least one front ultrasonic sensor in mode B to provide an ultrasonic image focused on a plane perpendicular to the longitudinal axis of the distal region of the tubular body and at a certain distance from the distal tip of the tubular body. Thus, the control unit is advantageously adapted to scan this distance to obtain ultrasonic images at different distances during the scanning of this distance.

[0101] In another variant, the control unit is adapted to operate at least one front ultrasonic sensor in another mode, such as in Doppler mode or harmonic mode.

[0102] The control unit is advantageously adapted to operate the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors in mode A or mode B, respectively. Thus, in an advantageous variant, the control unit is adapted to operate the possible at least 3 lateral ultrasonic sensors, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors in mode B to provide an ultrasonic image focused on a plane perpendicular to the longitudinal axis of the distal region of the tubular body and located at a certain distance from the distal tip of the tubular body. Thus, the control unit is advantageously adapted to scan this distance to obtain ultrasonic images at different distances during the scanning of this distance. In another variant, the control unit is adapted to operate the possible at least one lateral ultrasonic sensor, the possible at least 15 lateral ultrasonic sensors, the possible at least 35 lateral ultrasonic sensors or the possible at least 60 lateral ultrasonic sensors in another mode, such as in Doppler mode or in harmonic mode, respectively.

[0103] Furthermore, the control unit is advantageously adapted to calculate the ultrasonic image and thus the sonogram in real time based on the received signal, and / or to calculate the acoustic signal representing the sonogram based on the received signal in real time.

[0104] In the case where the control unit is adapted to calculate the sonogram in real time, the control unit advantageously includes a display for displaying the calculated sonogram. In one variant, however, the control unit can be directly or indirectly connected to a separate display for displaying the calculated sonogram. In the case where the control unit is adapted to calculate the acoustic signal representing the sonogram in real time, the control unit advantageously includes an audio output for outputting the calculated acoustic signal. Thus, the audio output can be a speaker or headphones, or an output for directly or indirectly connecting to a speaker or headphones.

[0105] In an advantageous variant, however, the control unit can be connected to a separate computing unit adapted to calculate the ultrasonic image and thus the sonogram based on the received signal, and / or to calculate the acoustic signal representing the sonogram based on the received signal. Thus, the separate computing unit can be a personal computer (PC), a tablet, a smartphone or any other device including a processor adapted to calculate the ultrasonic image and thus the sonogram based on the received signal, or to calculate the acoustic signal acoustically represented by the sonogram

[0106] Alternatively, the control unit and the catheter may also be sold separately.

[0107] Advantageously, the catheter of the present application is used in a device comprising a stylet (specifically a probe) and a catheter. Thus, the stylet serves as a guide for the catheter. Advantageously, the stylet is a rigid wire or probe inserted into the tube, providing shape and stiffness to the catheter when passing through the brain into the ventricle. Thus, advantageously, the device comprises a stylet (specifically a probe) and the catheter of the present application. In an advantageous variant, the device further comprises the above-mentioned control unit. Thus, the device advantageously comprises a stylet (specifically a probe) and a combination of the above-mentioned control unit and catheter.

[0108] Alternatively, however, the combination of the control unit and the catheter may be used without the stylet. Further, the catheter may be used and sold independently of the stylet and the control unit.

[0109] Other advantageous embodiments and combinations of features can be derived from the following detailed description and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0110] The drawings used to explain the embodiments show the following:

[0111] Figure 1 is a simplified schematic view of the device of the present application, the device comprising a probe and a combination of a control unit and a catheter,

[0112] Figure 2 is through Figure 1 is a simplified cross-sectional view of the catheter shown in, wherein the cross-section is located at a position within the lateral ultrasound sensor region in the distal region of the catheter tubular body, and

[0113] Figure 3 is a simplified cross-sectional view of another catheter of the present application, wherein the cross-section is located at a position within the lateral ultrasound sensor region in the distal region of the catheter tubular body.

[0114] In the drawings, the same components are denoted by the same reference numerals.

[0115] PREFERRED EMBODIMENTS

[0116] Figure 1 is a simplified schematic view of the device 1 of the present application, the device 1 comprising a probe 2 and a combination 3 of the control unit 4 and the catheter 10 of the present application. Thus, the device 1 comprises the probe 2 and the catheter 10.

[0117] The catheter 10 is for placement in the ventricular system, specifically in the human ventricular system, for draining fluid from the ventricles of the ventricular system, specifically cerebrospinal fluid (CSF). More precisely, the catheter 10 is an external ventricular drainage catheter. The catheter 10 includes a tubular body 11 having an internal drainage lumen 12 extending along the tubular body 11 for draining fluid. Thus, the tubular body 11 is made of a flexible material. More precisely, the tubular body 11 is made of polyimide. In one variant, the tubular body 11 is made of a different material such as polyurethane. In yet another variant, the tubular body 11 is made of a rigid material. Regardless of the material the tubular body is made of, in Figure 1 the embodiment shown, the tubular body 11 can be formed by a tube having an inner lumen that forms the drainage lumen 12. Thereby, the tubular body 11 is coated with an antibacterial coating 23. In one variant, the tubular body of the catheter 10 is not coated with an antibacterial coating.

[0118] The tubular body 11 includes 16 ports 13.1, 13.2, 13.3 that are arranged in a port region 14 of the distal region 15 of the tubular body 11. These 16 ports 13.1, 13.2, 13.3 are laterally disposed in the sidewall of the tubular body 11. Each of these 16 ports 13.1, 13.2, 13.3 connects the drainage lumen 12 to the exterior of the tubular body 11 and the exterior of the catheter 10 for draining fluid from the ventricle into the drainage lumen 12. These 16 ports 13.1, 13.2, 13.3 are distributed around the circumference of the tubular body 11 in all directions towards the circumference of the tubular body 11. Thus, over all 360 degrees of the circumference of the tubular body 11, at least one of the 16 ports 13.1, 13.2, 13.3 provides an opening in the sidewall of the tubular body 11.

[0119] The port region 14 extends along the length of the tubular body 11 in a range of about 1 - 2 cm. In one variant, the port region 14 extends along the length of the tubular body 11 in a range of about 1.5 - 2.0 cm.

[0120] In a variant, the catheter can also include more than 16 ports or fewer than 16 ports. In one instance, the catheter includes only one port. In another instance, the catheter includes 4 ports. In yet another instance, the catheter includes 6 ports. In yet another instance, the catheter includes 10 ports.

[0121] As Figure 1 shown, the tubular body 11 includes an outlet 18 for discharging the fluid from the drainage lumen 12 outside the tubular body 11, and the outlet 18 is arranged in the proximal region 19 of the tubular body. Thus, a fluid collection volume (not shown here) can be connected to the outlet 18 for discharging the fluid from the drainage lumen 12.

[0122] The catheter 10 further includes a forward ultrasonic sensor 16 for transmitting forward ultrasonic waves and detecting the forward ultrasonic waves reflected back to the forward ultrasonic sensor 16. Such a forward ultrasonic sensor 16 is aligned to transmit forward ultrasonic waves away from the tubular body 11 from the distal tip 17 of the tubular body 11 and in the direction of the longitudinal axis of the distal region 15 of the tubular body 11. Such a forward ultrasonic sensor 16 is a forward ultrasonic transducer and is arranged at the distal tip 17 of the tubular body 11, which is also the distal tip of the catheter 10. More precisely, the forward ultrasonic transducer is a piezoelectric ultrasonic transducer and is adapted to transmit forward ultrasonic waves at a frequency in the range of 5 - 12 MHz. In one variant, the forward ultrasonic sensor 16 is adapted to transmit forward ultrasonic waves at other frequencies such as 20 kHz, 15 MHz, 18 MHz or 50 MHz. Regardless of the frequency, the forward ultrasonic sensor 16 can also be another type of sensor, such as a capacitive ultrasonic transducer.

[0123] In one variant, however, the catheter includes more than one forward ultrasonic sensor for transmitting forward ultrasonic waves and detecting the forward ultrasonic waves reflected back to the forward ultrasonic sensor. In one example, the catheter includes 3 forward ultrasonic sensors for transmitting forward ultrasonic waves and detecting the forward ultrasonic waves reflected back to these 3 forward ultrasonic sensors. These 3 forward ultrasonic sensors are aligned to transmit forward ultrasonic waves away from the tubular body from the distal tip of the tubular body and in a direction inclined at least 5° with respect to the longitudinal axis of the distal region of the tubular body, and these 3 sensors are inclined at least 5° with respect to each other.

[0124] The one or more forward ultrasonic sensors are respectively adapted to transmit forward ultrasonic waves having a peak rarefaction pressure of 1 MPa. In one variant, the one or more forward ultrasonic sensors are respectively adapted to transmit forward ultrasonic waves having a peak rarefaction pressure of 3 MPa. In yet another variant, the one or more forward ultrasonic sensors are respectively adapted to transmit forward ultrasonic waves having a peak rarefaction pressure of 6 MPa.

[0125] In addition, the one or more front ultrasonic sensors are respectively adapted to emit front ultrasonic waves in a pulsed manner, and each pulse contains 1 cycle. Therefore, the one or more front ultrasonic sensors are respectively adapted to emit front ultrasonic waves at a pulse repetition frequency of 100 Hz. In a variant, the one or more front ultrasonic sensors are respectively adapted to emit front ultrasonic waves at a pulse repetition frequency of 1 kHz. In another variant, the one or more front ultrasonic sensors are respectively adapted to emit front ultrasonic waves at a pulse repetition frequency of 10 kHz. In yet another variant, the one or more front ultrasonic sensors are respectively adapted to emit front ultrasonic waves at a pulse repetition frequency of 20 kHz.

[0126] Based on the emitted front ultrasonic waves and the signals of the front ultrasonic waves reflected back to the front ultrasonic sensor 16, the ultrasonic image of the interface (such as the interface between the brain tissue and the cerebrospinal fluid in the cerebral ventricle) located in front of the distal tip 17 of the tubular body 11 can be calculated by the calculation unit 4. These ultrasonic images are sonograms. In addition, in addition to obtaining sonograms, based on the emitted front ultrasonic wave signal and the signals of the front ultrasonic waves reflected back to the front ultrasonic sensor 16, the acoustic signal of an image representing the interface (such as the interface between the brain tissue and the cerebrospinal fluid in the cerebral ventricle) located in front of the distal tip 17 of the tubular body 11 can be calculated by the calculation unit 4.

[0127] Since the front ultrasonic sensor 16 is used to emit front ultrasonic waves and detect the front ultrasonic waves reflected back to the front ultrasonic sensor 16, real-time visualization and acoustic characterization of the interface in front of the catheter 10 (such as the interface between the brain tissue in front of the catheter 10 and the cerebrospinal fluid in the cerebral ventricle) can be obtained. Therefore, due to the front ultrasonic sensor 16, it is convenient for the catheter 10 to navigate in the brain and cerebral ventricle.

[0128] The 16 ports 13.1, 13.2, 13.3 are arranged at the proximal end of the front ultrasonic sensor 16. Therefore, the port area 14 is arranged at the proximal end of the front ultrasonic sensor 16.

[0129] The catheter 10 further includes 36 lateral ultrasonic sensors 20.1, 20.2, 20.3 for transmitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the lateral ultrasonic sensors 20.1, 20.2, 20.3. These lateral ultrasonic sensors 20.1, 20.2, 20.3 are lateral ultrasonic transducers, i.e., piezoelectric lateral ultrasonic transducers, and are laterally arranged in a lateral ultrasonic sensor area 21 of a distal region 15 of the tubular body 11. Thus, the lateral ultrasonic sensor area 21 extends along the tubular body 11 in a length range of about 0.5 - 3 cm. In one variant, the lateral ultrasonic sensor area 21 extends along the tubular body in a length range of about 1 - about 2 cm. Regardless of the length of the lateral ultrasonic sensor area 21, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are laterally arranged on the side wall of the tubular body 11 and are mounted on a support structure 22 as shown in Figure 2 and Figure 3 shown.

[0130] The lateral ultrasonic sensors 20.1, 20.2, 20.3 are circumferentially distributed around the tubular body to transmit lateral ultrasonic waves away from the tubular body 11 in all directions around the circumference of the tubular body 11, specifically in all 360-degree directions. In one variant, however, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are located circumferentially around the catheter in less than 360 degrees, or even only on one side of the catheter. In addition, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are aligned to transmit lateral ultrasonic waves away from the tubular body 11 in a direction inclined 45° with respect to the direction pointed by the distal tip 17 of the tubular body. Thus, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are aligned to transmit lateral ultrasonic waves away from the tubular body 11 substantially in the direction pointed by the distal tip 17 of the tubular body 11. Thus, the distal tip 17 of the tubular body 11 points in the direction of the longitudinal axis of the distal region 15 of the tubular body 11 and, starting from the distal tip 17 of the tubular body 11, in a direction away from the tubular body 11. In variants, the alignment of the lateral ultrasonic sensors 20.1, 20.2, 20.3 is different. In one example, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are aligned to transmit lateral ultrasonic waves away from the tubular body 11 in a direction inclined 50° with respect to the direction pointed by the distal tip 17 of the tubular body 1. In another example, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are aligned to transmit lateral ultrasonic waves away from the tubular body 11 in a direction inclined 85° with respect to the direction pointed by the distal tip 17 of the tubular body 11.

[0131] The lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves at a frequency in the range of 5 - 12 MHz. In a variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit frontal ultrasonic waves at another frequency, such as 20 kHz, 15 MHz, 18 MHz or 50 MHz. Regardless of the frequency, the lateral ultrasonic sensors 20.1, 20.2, 20.3 can also be another type of sensor, such as a capacitive ultrasonic transducer.

[0132] The lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves having a peak rarefaction pressure of 1 MPa. In another variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves having a peak rarefaction pressure of 3 MPa. In yet another variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves having a peak rarefaction pressure of 6 MPa. In addition, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves in a pulsed manner, and each pulse contains 1 cycle. Thus, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 100 Hz. In a variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 1 kHz. In yet another variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 10 kHz. In yet another variant, the lateral ultrasonic sensors 20.1, 20.2, 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 20 kHz.

[0133] One of the lateral ultrasonic sensors 20.1 is simultaneously used as an intracranial pressure sensor for measuring intracranial pressure when the catheter is inserted into the ventricle. However, in a variant, the intracranial pressure sensor is a sensor separate from the frontal ultrasonic sensor and the lateral ultrasonic sensors. In yet another variant, when the catheter is inserted into the ventricle, the catheter does not have an intracranial pressure sensor for measuring intracranial pressure.

[0134] In a variant, the catheter contains only one lateral ultrasonic sensor. In another variant, the catheter contains 15 lateral ultrasonic sensors. In another variant, the catheter contains 60 lateral ultrasonic sensors. In another variant, the catheter contains 72 or even more lateral ultrasonic sensors.

[0135] Regardless of the number of lateral ultrasonic sensors, the 16 ports 13.1, 13.2, 13.3 are all arranged at the distal ends of the 36 lateral ultrasonic sensors 20.1, 20.2, 20.3. Therefore, the port region 14 is arranged at the distal end of the lateral ultrasonic sensor region 21. Therefore, the port region 14 and the lateral ultrasonic sensor region 21 are separated from each other and thus avoid any overlap.

[0136] The length of the catheter 10 is 30 cm. However, in one variant, the length of the catheter exceeds 30 cm. In another variant, the length of the catheter 10 is 25 cm. In yet another variant, the length of the catheter 10 is 20 cm. In other variants, the length of the catheter 10 is less than 20 cm. The outer diameter of the tubular body 11 is 4 mm, and the inner diameter of the drainage cavity 12 is 2 mm. However, the outer diameter of the tubular body 11 can also be less than or greater than 4 mm. As an example, the outer diameter of the tubular body 11 can be 2 mm, 5 mm, 6 mm, 8 mm or 10 mm. Similarly, the inner diameter of the drainage cavity 12 can also be less than or greater than 2 mm. As an example, the inner diameter of the drainage cavity 12 can be 1 mm, 4 mm, 5 mm, 6 mm or 8 mm. Advantageously, however, the inner diameter of the drainage cavity 12 is at least 0.5 mm smaller than the outer diameter of the tubular body 11, and even at least 1.0 mm smaller.

[0137] As Figure 1 described, the catheter 10 includes a wiring 24 that connects the front ultrasonic sensor 16 and the lateral ultrasonic sensors 20.1, 20.2, 20.3 to a connector 25, and the connector is used to connect to a control unit 4 for controlling the front ultrasonic sensor 16 and for controlling the lateral ultrasonic sensors 20.1, 20.2, 20.3. Therefore, the connector 25 is arranged in the proximal region 19 of the catheter 10.

[0138] The wiring 24 of the front ultrasonic sensor 16 and the 36 lateral ultrasonic sensors includes 38 electrical connections. Therefore, the wiring 24 includes n + 1 electrical connections, where n is the total number of sensors of the sum of the front ultrasonic sensor 16 and the 36 lateral ultrasonic sensors. The wiring 24 is a high-density interconnect printed circuit board (HDIPCB) that includes a flexible substrate made of Kapton with a thickness of 125 μm. In a variant, however, the construction of the wiring 24 is different. For example, the HDIPCB can include a different flexible substrate or a rigid substrate. In yet another variant, the wiring can be made of individual wires instead of a printed circuit board.

[0139] The control unit 4 is adapted to control the front ultrasonic sensor 16 and the lateral ultrasonic sensors 20.1, 20.2, 20.3. Thus, when connected to the catheter 10, the control unit 4 is adapted to apply an excitation signal to each of the front ultrasonic sensor 16 and the lateral ultrasonic sensors 20.1, 20.2, 20.3 with a preset amplitude and with phase information. In addition, the control unit 4 is adapted to receive a signal from the front ultrasonic sensor 16, the signal containing information about the front ultrasonic waves reflected back to the front ultrasonic sensor 16 and detected by the front ultrasonic sensor 16. Thus, the control unit 4 is adapted to operate the front ultrasonic sensor 16 in A-mode. To achieve this, the front ultrasonic sensor 16 can be operated in A-mode. However, in a variant where the catheter mentioned contains a plurality of front ultrasonic sensors, the control unit is adapted to operate the front ultrasonic sensors in A-mode or B-mode. To achieve this, the front ultrasonic sensors can be operated in A-mode or B-mode. Thus, the control unit 4 is adapted to operate the front ultrasonic sensor in B-mode to provide an ultrasonic image focused on a plane perpendicular to the longitudinal axis of the distal region 15 of the tubular body 11 and located at a certain distance from the distal tip 17 of the tubular body 11. Thus, the control unit 4 is adapted to scan this distance to obtain ultrasonic images at different distances during the scanning of this distance.

[0140] In addition, the control unit 4 is adapted to receive signals from the lateral ultrasonic sensors 20.1, 20.2, 20.3. These signals contain information about the respective one of the lateral ultrasonic sensors 20.1, 20.2, 20.3 that the ultrasonic waves are reflected back to and the lateral ultrasonic waves detected by the respective one of the lateral ultrasonic sensors 20.1, 20.2, 20.3. Thus, the control unit 4 is adapted to operate the lateral ultrasonic sensors 20.1, 20.2, 20.3 in A-mode and to operate the lateral ultrasonic sensors 20.1, 20.2, 20.3 in B-mode. Thus, the lateral ultrasonic sensors 20.1, 20.2, 20.3 can be operated in A-mode or in B-mode. Thus, the control unit 4 is adapted to operate the lateral ultrasonic sensors 20.1, 20.2, 20.3 in B-mode to provide an ultrasonic image focused on a plane perpendicular to the longitudinal axis of the distal region 15 of the tubular body 11 and located at a certain distance from the distal tip 17 of the tubular body 11. Thus, the control unit 4 is adapted to scan this distance to obtain ultrasonic images at different distances during the scanning of this distance.

[0141] The control unit 4 is adapted to calculate an ultrasound image in real time based on the received signals and thus calculate an acoustic map, and is adapted to calculate an acoustic signal representing the acoustic map in real time based on the signals received from the front ultrasound sensor 16 and the lateral ultrasound sensors 20.1, 20.2, 20.3. The control unit 4 further includes a display 26 for displaying the calculated acoustic map, and a speaker 27 for outputting the acoustic signal.

[0142] Figure 2 shows a simplified cross-sectional view through Figure 1 the catheter 10 shown in. Thus, this cross-section is located at a certain position along the tubular body 11 within the lateral ultrasound sensor area 21 in the distal region of the catheter tubular body 11. Thus, Figure 2 shows that the support structure 22 on which the ultrasound sensor 20.1 is mounted has a square cross-section and surrounds a drainage cavity 12 having a circular cross-section and extending along the tubular body 11. Thus, the ultrasound sensor 20.1 is mounted on the outer surfaces of the four sides of the support structure 22 and is thus distributed around the circumference of the tubular body 11 to emit lateral ultrasonic waves away from the tubular body 11 in all directions around the circumference of the tubular body, specifically in all 360-degree directions.

[0143] Figure 3 shows a simplified cross-sectional view of another catheter 110 of the present application, where this cross-section is located at a certain position along the tubular body 111 within the lateral ultrasound sensor area 121 in the distal region of the catheter tubular body 111. This catheter 110 is the same as the catheter 10 shown in Figure 1 in most parts. However, in the catheter 110, the support structure 122 on which the ultrasound sensor 120.1 is mounted has a triangular cross-section and surrounds a drainage cavity 112 having a circular cross-section and extending along the tubular body 111.

[0144] The present application is not limited to the embodiments shown in the drawings. Other variants and changes are readily available to those skilled in the art.

[0145] In summary, it should be noted that the catheter created herein, specifically an external ventricular drainage catheter, is for placement in the ventricular system, specifically in the human ventricular system, for draining fluid (specifically cerebrospinal fluid) from the ventricles of the ventricular system. This catheter relates to the initially mentioned technical field and can be used reliably and safely for draining cerebrospinal fluid.

Claims

1. A catheter (10, 110), specifically an external ventricular drainage catheter, for placement in a ventricular system, specifically in a human ventricular system, for draining fluid, specifically cerebrospinal fluid, from a ventricle of the ventricular system, the catheter (10, 110) comprising: a) A tubular body (11, 111) having an internal drainage lumen (12, 112) extending along the tubular body (11, 111) for draining fluid; and b) At least one port (13.1, 13.2, 13.3) disposed in the distal region (14) of the tubular body (11, 111), the at least one port (13.1, 13.2, 13.3) connecting the drainage lumen (12, 112) to the exterior of the tubular body (11, 111) and the exterior of the catheter (10, 110) for draining fluid from the ventricle into the drainage lumen (12, 112), It is characterized in that The catheter (10, 110) further comprises at least one front ultrasonic sensor (16), specifically at least one front ultrasonic transducer, for transmitting front ultrasonic waves and detecting the front ultrasonic waves reflected back to the at least one front ultrasonic sensor (16), specifically for obtaining an acoustic map; wherein the at least one front ultrasonic sensor (16) is disposed at the distal tip (17) of the tubular body (11).

2. The catheter (10, 110) according to claim 1, characterized in that, The at least one front ultrasonic sensor (16) is aligned to transmit front ultrasonic waves from the distal tip (17) of the tubular body (11, 111) away from the tubular body (11, 111) and along the longitudinal axis direction of the distal region (15) of the tubular body (11, 111).

3. The catheter (10, 110) according to claim 1 or 2, characterized in that, The at least one front ultrasonic sensor (16) is adapted to transmit front ultrasonic waves at a frequency in the range of 1 - 20 MHz, specifically 5 - 12 MHz.

4. The catheter (10, 110) according to any one of claims 1 - 3, characterized in that, The catheter comprises at least 5 ports (13.1, 13.2, 13.3), advantageously at least 10 ports (13.1, 13.2, 13.3), particularly advantageously at least 15 ports (13.1, 13.2, 13.3), the ports being disposed in the distal region (15) of the tubular body (11, 111), the at least 5 ports (13.1, 13.2, 13.3), at least 10 ports or at least 15 ports (13.1, 13.2, 13.3) respectively connecting the drainage lumen (12, 112) of the distal region (15) of the tubular body (11, 111) to the exterior of the tubular body (11, 111) and the exterior of the catheter (10, 110) for draining fluid from the ventricle into the drainage lumen (12, 112).

5. The catheter (10, 110) according to any one of claims 1-4, characterized in that, The at least one port (13.1, 13.2, 13.3) is disposed proximal to the at least one front ultrasonic sensor (16).

6. The catheter (10, 110) according to any one of claims 1-5, characterized in that, The catheter(s) (10, 110) further comprises at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1), specifically at least one lateral ultrasonic transducer, for emitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1), specifically for obtaining an acoustic map; wherein the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) is laterally arranged in the distal region (15) of the tubular body (11, 111).

7. The catheter (10, 110) according to claim 6, characterized in that, Align the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) to emit lateral ultrasonic waves away from the tubular body (11, 111) and substantially in the direction pointed by the distal tip (17) of the tubular body (11, 111).

8. The catheter (10, 110) according to claim 6 or 7, characterized in that, The at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) is adapted to emit lateral ultrasonic waves at a frequency in the range of 1 - 20 MHz, specifically 5 - 12 MHz.

9. The catheter (10, 110) according to any one of claims 6 - 8, characterized in that, The catheter(s) (10, 110) comprises at least 3 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), preferably at least 15 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), particularly preferably at least 35 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), and most preferably at least 60 lateral ultrasonic sensors, respectively for emitting lateral ultrasonic waves and detecting the lateral ultrasonic waves reflected back to the at least 3 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), the at least 15 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), the at least 35 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1) or the at least 60 lateral ultrasonic sensors, specifically for obtaining an acoustic map; wherein the at least 3 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), the at least 15 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1), the at least 35 lateral ultrasonic sensors (20.1, 20.2, 20.3, 120.1) or the at least 60 lateral ultrasonic sensors are respectively laterally arranged in the distal region (15) of the tubular body (11, 111).

10. The catheter (10, 110) according to any one of claims 6-9, characterized in that, The at least one port (13.1, 13.2, 13.3) is arranged at the distal end of the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1).

11. The catheter (10, 110) according to claim 10, characterized in that, Each of the at least one port (13.1, 13.2, 13.3) is arranged at the distal end of the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1).

12. The catheter (10, 110) according to any one of claims 1-11, characterized in that, The tubular body (11, 111) is coated with an antibacterial coating (23).

13. The catheter (10, 110) according to any one of claims 6 - 12, characterized in that, The catheter(s) (10, 110) includes a wiring (24) that connects the at least one front ultrasonic sensor (16) and the at least one lateral ultrasonic sensor(s) (20.1, 20.2, 20.3, 120.1) to a connector (25) for connection to a control unit (4) that controls the at least one front ultrasonic sensor (16) and the at least one lateral ultrasonic sensor(s) (20.1, 20.2, 20.3, 120.1), and the connector (25) is arranged in the proximal region (19) of the catheter(s) (10, 110).

14. A combination (3) of a control unit (4) and a catheter (10, 110) according to any one of claims 1 - 13.

15. A device (1) comprising a stylet, specifically a probe (2), and a catheter (10, 110) according to any one of claims 1 - 13.

Images