Catheter placed in the ventricular system

Abstract

The present invention relates to a catheter (10) placed in the ventricular system, particularly an external ventricular drainage catheter, for draining fluid from the ventricles of the ventricular system, particularly the human ventricular system, and especially for draining cerebrospinal fluid. The catheter (10) comprises a tubular body (11) having an internal drainage lumen (12) extending along the tubular body (11) for draining fluid, and at least one port (13.1, 13.2, 13.3) located in the distal region (14) of the tubular body (11), the at least one port (13.1, 13.2, 13.3) connecting the drainage lumen (12) to the outside of the tubular body (11) and to the outside of the catheter (10) in order to drain fluid from the ventricles into the drainage lumen (12). The catheter (10) further includes at least one forward ultrasound sensor, in particular at least one forward ultrasound transducer, the at least one forward ultrasound sensor (16) which emits forward ultrasound and detects forward ultrasound that is reflected back to the at least one forward ultrasound sensor (16), in particular to acquire a sonogram, the at least one forward ultrasound sensor (16) is located at the distal end (17) of the tubular body (11). Furthermore, the present invention relates to a combination (3) of a control unit (4) and the catheter (10) according to the present invention. Furthermore, the present invention relates to a configuration (1) which includes a mandolin, in particular a stylet (2) and the catheter (10) according to the present invention.

Description

[Technical Field]

[0001] The present invention relates to a catheter placed in the ventricular system, particularly an external ventricular drainage catheter, for draining fluid from the ventricles of the human ventricular system, particularly cerebrospinal fluid (CSF), the catheter comprising a tubular body having an internal drainage lumen extending along the tubular body for draining fluid, and at least one port located in the distal region of the tubular body, the at least one port connecting the drainage lumen to the outside of the tubular body and the outside of the catheter in order to drain fluid from the ventricles into the drainage lumen. [Background technology]

[0002] A catheter is a medical device that can be inserted into the body to treat a disease or perform a surgical procedure. These catheters are advantageously formed from thin, flexible tubing. For example, puncture of the lateral ventricle and placement of a flexible catheter into the ventricular system is a very common procedure performed for a variety of indications, including cerebrospinal fluid (CSF) drainage. In these procedures, a hole is typically made in the skull using a twist drill or burr, and a catheter with a mandolin, particularly a stylet, inserted into the lumen is introduced, for example, from the frontal or posterior-occipital lobe of the brain, into the ventricle. Once the catheter is introduced into the ventricle, the mandolin or stylet is removed, and the distal end of the catheter remains in the anterior horn of the ventricle. Cerebrospinal fluid can then be drawn out of the ventricular system through the catheter.

[0003] One example of catheter and stylet placement related to the technical field mentioned earlier is described in John Gilbert's Patent Document 1. In this example, the stylet is a rigid ultrasonic fiber optic stylet providing a longitudinal aperture packed with an optical fiber and a miniature ultrasonic transducer. This ultrasonic fiber optic imaging stylet is fitted into the catheter, allowing viewing through the end of the catheter. Thus, the positioning of the stylet within the catheter enables indirect and direct real-time visualization through the tip of the catheter. The ultrasonic portion of the stylet thus provides the surgeon with a two-dimensional echocardiogram of the ventricle, enabling the surgeon to correctly orient the stylet and catheter toward the ventricle. This also allows the stylet and catheter to be maintained in the correct trajectory or path toward the anterior horn of the lateral ventricle as they pass through the brain. The fiber optic portion of the stylet allows the surgeon to directly view the inside of the anterior horn of the lateral ventricle once the ventricle has been punctured by the stylet and catheter, and thus confirm correct placement.

[0004] This known catheter has the drawback that, once the catheter is positioned within the ventricles and the stylet is removed to allow cerebrospinal fluid drainage, it is no longer possible to monitor whether the catheter is properly positioned within the ventricles, other than by leaving the catheter fixed to the outside of the skull.

[0005] In principle, cerebrospinal fluid (CSF) drainage flow can also be used as an indicator to control the proper positioning of the catheter within the ventricle, because if the catheter moves away from the ventricle, the CSF drainage flow decreases or stops. However, this indicator is not very reliable because the CSF drainage flow also decreases or stops if the catheter is blocked or if the ventricle is drained and empty.

[0006] For these reasons, known catheters cannot be used very reliably and safely for cerebrospinal fluid drainage. In this text, the terms "and / or" may be used to link two features. For example, this term is used to link feature A and feature B in the expression "A and / or B." Such an expression means that at least feature A or feature B is realized. In other words, this expression includes the options "A but not B," "B but not A," and "A and B."

[0007] In this text, the terms “distal,” “distal side,” “proximal,” and “proximal side” are used in reference to the catheter. Thus, the distal end of the catheter is the tip of the catheter inserted into the ventricle, while the proximal end of the catheter is the end of the catheter remaining outside the skull. Correspondingly, the distal end of a catheter element is the side of that element facing the distal end of the catheter, while the proximal end of a catheter element is the side of that element facing the proximal end of the catheter. Similarly, the distal region of the catheter is the region at the distal end of the catheter, and the proximal region of the catheter is the region at the proximal end of the catheter. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] International Publication No. 96 / 29011 Pamphlet [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] The object of the present invention is to manufacture a catheter, particularly an external ventricular drainage catheter, that is placed in the ventricular system, particularly for draining fluid from the ventricles of the ventricular system, especially the human ventricular system, and that can be used reliably and safely for draining cerebrospinal fluid, relating to the technical field described above. [Means for solving the problem]

[0010] The solution of the present invention is expressed by the features of claim 1. According to the present invention, the catheter further includes at least one forward ultrasound sensor, in particular at least one forward ultrasound transducer, which emits forward ultrasound and detects forward ultrasound that is reflected and returns to at least one forward ultrasound sensor, in particular to acquire a sonogram, the at least one forward ultrasound sensor being located at the distal end of a tubular body.

[0011] According to the present invention, the catheter comprises a tubular body, the tubular body having an internal drainage lumen extending along the tubular body for fluid drainage. This drainage lumen is advantageously formed by the tubular body. For example, the tubular body can be formed by a tube having a lumen that forms the internal drainage lumen.

[0012] Furthermore, according to the present invention, the catheter includes at least one port located in the distal region of the tubular body. Advantageously, this at least one port is positioned laterally on the side wall of the tubular body. However, instead of being positioned laterally, the at least one port may also be positioned at the distal end of the tubular body facing along the longitudinal axis of the distal region of the tubular body. Regardless of where the at least one port is located in the distal region of the tubular body, the at least one port connects the drainage lumen to the outside of the tubular body and the outside of the catheter in order to drain fluid from the ventricles into the drainage lumen. Thus, each port of the at least one port allows cerebrospinal fluid to flow from the ventricles into the drainage lumen through the respective port of the at least one port.

[0013] According to the present invention, the catheter further includes at least one forward ultrasonic sensor, which emits forward ultrasonic waves and detects forward ultrasonic waves that are reflected back to its at least one forward ultrasonic sensor, particularly to obtain a sonogram. Each of the at least one forward ultrasonic sensor is advantageously a forward ultrasonic transducer. An ultrasonic transducer converts electrical signals into ultrasonic waves and ultrasonic waves into electrical signals. To achieve this conversion, the ultrasonic transducer can operate in transmitter mode, which converts electrical signals into pressure waves of ultrasonic frequency, and therefore ultrasonic waves. Furthermore, to achieve this conversion, the ultrasonic transducer can operate in receiver mode, which receives ultrasonic waves and converts the received ultrasonic waves into electrical signals. The ultrasonic transducer is typically a piezoelectric ultrasonic transducer or a capacitive ultrasonic transducer.

[0014] From the emitted forward ultrasound signal and the detected forward ultrasound signal that is reflected and returned to at least one forward ultrasound sensor, an ultrasound image of an interface located anterior to the distal end of the tubular body, such as the interface between brain tissue and cerebrospinal fluid within the ventricles, can be calculated. These ultrasound images are sonograms. Furthermore, instead of acquiring sonograms, or in combination with acquiring sonograms, an acoustic signal representing an image of an interface located anterior to the distal end of the tubular body, such as the interface between brain tissue and cerebrospinal fluid within the ventricles, can be calculated from the emitted forward ultrasound signal and the detected forward ultrasound signal that is reflected and returned to at least one forward ultrasound sensor.

[0015] This is advantageous because the distal end of the tubular body is simultaneously the distal end of the catheter. Thus, from the emitted forward ultrasound signal and the detected forward ultrasound signal that is reflected back to at least one forward ultrasound sensor, it is possible to calculate a sonogram, which is an ultrasound image of an interface located anterior to the distal end of the catheter, such as the interface between brain tissue and cerebrospinal fluid in the ventricles, and / or an acoustic signal representing an image of an interface, such as the interface between brain tissue and cerebrospinal fluid in the ventricles.

[0016] With at least one forward ultrasound sensor, which emits forward ultrasound and detects the forward ultrasound that is reflected and returns to at least one forward ultrasound sensor, it is possible to obtain real-time visualization and / or acoustic representation of the interface in front of the catheter, such as the interface between brain tissue and cerebrospinal fluid in the ventricles in front of the catheter. As a result, at least one forward ultrasound sensor facilitates the navigation of the catheter in the brain and ventricles.

[0017] The catheter includes at least one forward ultrasonic sensor, which emits forward ultrasonic waves, especially for obtaining a sonogram, and detects the forward ultrasonic waves that are reflected and return to at least one forward ultrasonic sensor. Since at least one forward ultrasonic sensor is arranged at the distal tip of the tubular body of the catheter, while the catheter is positioned in the ventricle, during the drainage of cerebrospinal fluid from the ventricle, an ultrasonic image of the region in front of the distal tip of the tubular body of the catheter can be obtained, thus a sonogram and / or an acoustic representation can be obtained. Therefore, the catheter according to the present invention not only enables the navigation of the catheter while moving the catheter through the brain to the ventricle, but also enables the monitoring of the proper positioning of the catheter in the ventricle during the drainage of cerebrospinal fluid after the catheter is positioned in the ventricle. Therefore, with the invention according to the present invention, the catheter can be used reliably and safely for the drainage of fluids, especially cerebrospinal fluid.

[0018] In a preferred variant, the catheter includes exactly one forward ultrasonic sensor. This has the advantage that the catheter can be manufactured at a lower cost, while still being able to be used reliably and safely for the drainage of fluids, especially cerebrospinal fluid. However, in a preferred variant, the catheter includes two or more forward ultrasonic sensors. Such variants have the advantage that they can achieve further improved navigation of the catheter while moving the catheter through the brain to the ventricle and further improved monitoring of the proper positioning of the catheter in the ventricle during the drainage of cerebrospinal fluid after the catheter is positioned in the ventricle.

[0019] Advantageously, the tubular body includes an outlet for discharging the liquid from the drainage lumen to the outside of the tubular body, and the outlet is arranged in the proximal region of the tubular body. This has the advantage that the drainage from the drainage lumen can be collected in a volume separate from the catheter.

[0020] However, as an alternative, the tubular body does not include an outlet for discharging the liquid from the drainage lumen to the outside of the tubular body. In such an alternative form, the liquid may be collected, for example, within the drainage lumen. In this case, the drainage lumen can include a chamber for collecting the liquid, particularly cerebrospinal fluid.

[0021] Preferably, at least one of the at least one forward ultrasonic sensor is aligned to emit forward ultrasonic waves in a direction away from the tubular body from the distal tip of the tubular body in a direction along the longitudinal axis of the distal region of the tubular body. This has the advantage that a sonogram of the interface between the brain tissue and the cerebrospinal fluid within the cerebral ventricle in front of the distal tip of the tubular body in a direction along the longitudinal axis of the distal region of the tubular body, and thus an ultrasonic image and / or an acoustic representation can be obtained by a forward ultrasonic sensor aligned to emit forward ultrasonic waves in a direction away from the tubular body from the distal tip of the tubular body in a direction along the longitudinal axis of the distal region of the tubular body. Further, this has the advantage that each of the forward ultrasonic sensors can detect these interfaces, thus enabling improved navigation during the insertion of the catheter into the cerebral ventricle.

[0022] However, as an alternative, each forward ultrasonic sensor of the at least one forward ultrasonic sensor is aligned differently from being aligned to emit forward ultrasonic waves in a direction away from the tubular body from the distal tip of the tubular body in a direction along the longitudinal axis of the distal region of the tubular body.

[0023] However, in a preferred modification, the catheter includes two or more forward ultrasound sensors, in particular at least three forward ultrasound sensors, where all of the forward ultrasound sensors, or all but one of the forward ultrasound sensors, are positioned to emit forward ultrasound away from the distal end of the tubular body, in a direction inclined at an angle of 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 modification, the forward ultrasound sensors are further positioned to emit forward ultrasound in directions inclined at at least 5°, particularly advantageously at least 10°, relative to each other.

[0024] This has the advantage that by operating the forward ultrasonic sensor in B mode through different alignments of different forward ultrasonic sensors, it is possible to scan the area around the longitudinal axis of the distal region of the tubular body. Thus, depending on the alignment of the forward ultrasonic sensor, the forward ultrasonic sensor can scan a plane containing the longitudinal axis of the distal region of the tubular body, or even a cone around the longitudinal axis of the distal region of the tubular body.

[0025] Advantageously, at least one forward ultrasonic sensor is a piezoelectric ultrasonic transducer. Therefore, advantageously, at least one forward ultrasonic sensor includes a piezoelectric element, particularly a piezoelectric layer. This has the advantage that at least one forward ultrasonic sensor can be designed to be particularly small and thus suitable for placement at the distal end of a catheter, particularly at the distal end of a tubular body.

[0026] In one variation, at least one forward ultrasonic sensor is a capacitive ultrasonic transducer. In yet another example, at least one forward ultrasonic sensor is neither a piezoelectric ultrasonic transducer nor a capacitive ultrasonic transducer. Also, at least one forward ultrasonic sensor can be a sensor separate from the transducer. For example, at least one forward ultrasonic sensor may include a transmitter that emits forward ultrasonic waves and a receiver that detects forward ultrasonic waves reflected back to the receiver, and thus to at least one forward ultrasonic sensor, in particular to obtain a sonogram, and the receiver is a separate unit from the transmitter. Thus, the receiver unit and the transmitter unit can be located in exactly the same at least one forward ultrasonic sensor.

[0027] Advantageously, at least one forward ultrasound sensor is adapted to emit forward ultrasound at frequencies in the range of 1 MHz to 20 MHz, particularly favorably 5 MHz to 12 MHz, especially at the center frequency. This has the advantage that the interface between brain tissue and cerebrospinal fluid can be detected and visualized in ultrasound images at a distance of 4 cm to 10 cm from at least one forward ultrasound sensor, and therefore anterior to the distal end of the tubular body, particularly anterior to the distal end of the catheter. This has the advantage that it facilitates the navigation of the catheter as it is moved through the brain to the ventricles.

[0028] Preferably, at least one forward ultrasound sensor is fitted to emit forward ultrasound at a peak rarefactional pressure in the range of 0 MPa to 7 MPa. This has the advantage of avoiding brain injury during catheter use caused by the pressure induced by the forward ultrasound. However, alternatively, at least one forward ultrasound sensor is fitted to emit forward ultrasound at a peak rarefactional pressure greater than 7 MPa.

[0029] Advantageously, at least one forward ultrasonic sensor is adapted to emit forward ultrasonic waves in a pulsed manner of 1 to 100 cycles per pulse. Thus, advantageously, at least one forward ultrasonic sensor is adapted to emit forward ultrasonic waves at pulse repetition frequencies in the range of 100 Hz to 20 kHz. However, more than 100 cycles per pulse may be employed, and the pulse repetition frequency may be selected to be less than 100 kHz or greater than 20 kHz.

[0030] Advantageously, at least one forward-facing ultrasonic sensor can produce a total of 94 mW / cm². 2 The following is audio output level I SPTA.3 , advantageously 190W / cm 2 The following I SPPA.3 It is adapted to provide, and here I SPTA.3 This is the overall maximum attenuation correction I SPTA This is an intensity value, I SPPA.3 This refers to the mechanical index (or attenuation correction I) shown in Table 3 of the "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" and "Guidance for Industry and Food and Drug Administration Staff," issued on June 27, 2019, by the United States Department of Health and Human Services, the U.S. Food and Drug Administration, and the Center for Medical Devices and Radiological Health. SPPA This is the intensity value. However, alternatively, at least one forward ultrasonic sensor can be adapted to provide a higher overall acoustic output level.

[0031] Alternatively, at least one forward-facing ultrasonic sensor may be adapted to emit forward-facing ultrasound at frequencies below 1 MHz or above 20 MHz. However, advantageously, at least one forward-facing ultrasonic sensor may be adapted to emit forward-facing ultrasound at frequencies above 18 kHz and below 100 MHz, particularly below 50 MHz.

[0032] Advantageously, the catheter includes at least five ports, particularly advantageously at least ten ports, and most advantageously at least fifteen ports, located in the distal region of the tubular body, and each of the at least five ports, at least ten ports, or at least fifteen ports connects the drainage lumen in the distal region of the tubular body to the outside of the tubular body and the outside of the catheter in order to drain fluid from the ventricles into the drainage lumen. Thus, each of the at least five ports, at least ten ports, or at least fifteen ports allows fluid to flow from the ventricles into the drainage lumen through each of the at least five ports, at least ten ports, or at least fifteen ports. This has the advantage of allowing for very efficient drainage of fluid, particularly cerebrospinal fluid, from the ventricles into the drainage lumen.

[0033] Advantageously, at least five ports, at least ten ports, or at least fifteen ports are each located in a port region within the distal region of the tubular body. Particularly advantageously, the port regions extend along the tubular body over a length of approximately 1 cm to approximately 2 cm, particularly over a length of approximately 1.5 cm to approximately 2.0 cm. However, the port regions may extend over a length of less than approximately 1 cm or over a length of more than approximately 2 cm. Advantageously, the catheter includes fewer than 500 ports located in the distal region of the tubular body, and fewer than 500 ports connect the drainage lumen in the distal region of the tubular body to the outside of the tubular body and the outside of the catheter in order to drain fluid from the ventricles into the drainage lumen. However, alternatively, the catheter includes more than 500 ports located in the distal region of the tubular body, and these more than 500 ports connect the drainage lumen in the distal region of the tubular body to the outside of the tubular body and the outside of the catheter in order to drain fluid from the ventricle into the drainage lumen.

[0034] Advantageously, at least five ports, at least ten ports, or at least fifteen ports are each positioned laterally on the side wall of the tubular body. This has the advantage of allowing efficient drainage of fluid, particularly cerebrospinal fluid, from the ventricles into the drainage lumen, while also allowing the distal region of the tubular body, each housing at least five ports, at least ten ports, or at least fifteen ports, to be designed to provide high stability and durability.

[0035] Alternatively, one or more of at least five ports, at least ten ports, or at least fifteen ports may be located at the distal end of the tubular body facing the longitudinal axis of the distal region of the tubular body, rather than being located laterally on the side walls of the tubular body.

[0036] Preferably, at least five ports, at least ten ports, or at least fifteen ports are distributed so as to face all directions along the circumference of the tubular body, particularly along the circumference of the tubular body. Thus, advantageously, openings in the side walls of the tubular body are provided in all 360 degrees along the circumference of the tubular body by at least one of each of the at least five ports, at least ten ports, or at least fifteen ports. This has the advantage of allowing optimal drainage of fluid, particularly cerebrospinal fluid, from the ventricles into the drainage lumen, regardless of the orientation in which the catheter is inserted into the ventricles.

[0037] However, alternatively, at least five ports, at least ten ports, or at least fifteen ports can each be distributed differently in the distal region of the tubular body.

[0038] Preferably, at least one port, at least five, at least ten, or at least fifteen ports are each located proximal to at least one anterior ultrasound sensor. This has the advantage that at least one anterior ultrasound sensor can be positioned at the distal end of the tubular body without leaving space for at least one port, at least five, at least ten, or at least fifteen ports. As a result, there is increased freedom in selecting the shape and size of the at least one anterior ultrasound sensor. Thus, it becomes easier to select the optimal at least one anterior ultrasound sensor for acquiring sonograms, and therefore ultrasound images and / or acoustic representations, of interfaces located anterior to the distal end of the tubular body, such as the interface between brain tissue and cerebrospinal fluid in the ventricles.

[0039] Alternatively, one or more of each of at least one port, at least five, at least ten, or at least fifteen ports shall not be located proximal to at least one forward ultrasonic sensor.

[0040] Preferably, the catheter further includes at least one lateral ultrasound sensor, in particular at least one lateral ultrasound transducer, which emits lateral ultrasound and detects the lateral ultrasound reflected back to at least one lateral ultrasound sensor, in particular to obtain a sonogram, wherein the at least one lateral ultrasound sensor is positioned laterally in the distal region of the tubular body. Thus, in one example, the at least one lateral ultrasound sensor is positioned laterally on the tubular body in the distal region of the tubular body, and therefore outside the tubular body. In another example, the at least one lateral ultrasound sensor is positioned laterally on the inside of the tubular body in the distal region of the tubular body. For example, the at least one lateral ultrasound sensor is positioned laterally 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 ultrasound sensor is positioned behind the side wall of the tubular body in the distal region of the tubular body. In either of the latter two examples, the at least one lateral ultrasound sensor is advantageously mounted on a support structure.

[0041] Regardless of how at least one lateral ultrasound sensor is positioned laterally in the distal region of the tubular body, at least one lateral ultrasound sensor that emits lateral ultrasound and detects lateral ultrasound reflected back to at least one lateral ultrasound sensor, particularly for acquiring a sonogram, has the advantage of being able to acquire a sonogram, and therefore an ultrasound image, of the area around the distal region of the tubular body of the catheter, and / or an acoustic signal, and therefore an acoustic representation, of the area around the distal region of the tubular body of the catheter. Thus, the navigation of the catheter can be improved while it is being moved through the brain to the ventricles. Furthermore, visualization of the ventricles using at least one lateral ultrasound sensor provides important information, such as the size of the ventricles. This information helps to quickly adapt the drainage volume, which is often based only on information from intracranial pressure or external visualizations such as computed tomography (CT) or magnetic resonance imaging (MRI). Furthermore, this information helps identify the cause of catheter failure (empty drained ventricle, clogged catheter, or catheter displacement), as it allows for visualization of empty drained ventricles and catheter displacement. Additionally, monitoring the proper positioning of the catheter within the ventricle during cerebrospinal fluid drainage after the catheter has been positioned within the ventricle can also be improved. Thus, more reliable and safer use of catheters for fluid drainage, particularly cerebrospinal fluid, becomes possible.

[0042] Advantageously, at least one lateral ultrasound sensor is positioned to emit lateral ultrasound substantially away from the tubular body in the direction in which the distal end of the tubular body is facing. Thus, the distal end of the tubular body is oriented along the longitudinal axis of the distal region of the tubular body and, starting from the distal end of the tubular body, faces away from the tubular body. Therefore, emitting lateral ultrasound essentially away from the tubular body in the direction in which the distal end of the tubular body is facing preferably means that the lateral ultrasound is emitted in a direction inclined at an angle of less than 90°, particularly preferably less than 50°, with respect to the direction in which the distal end of the tubular body is facing. Thus, the lateral ultrasound can further be emitted in a direction parallel to the direction in which the distal end of the tubular body is facing, and therefore along the tubular body toward the distal end of the tubular body, and beyond the distal end of the tubular body.

[0043] The fact that at least one lateral ultrasound sensor is positioned to emit lateral ultrasound substantially away from the tubular body in the direction the distal end of the tubular body is facing has the advantage of being able to acquire a sonogram, and therefore an ultrasound image and / or acoustic representation, of the portion of the catheter that is in contact with the distal region of the tubular body. Thus, the navigation of the catheter can be further improved while it is being moved through the brain to the ventricles. Furthermore, monitoring of the proper positioning of the catheter within the ventricles during cerebrospinal fluid drainage after the catheter has been positioned within the ventricles is improved. Thus, the catheter can be used with greater reliability and safety for the drainage of fluids, especially cerebrospinal fluid. These advantages are particularly evident when each of the at least one lateral ultrasound sensor is positioned to emit lateral ultrasound essentially away from the tubular body in the direction the distal end of the tubular body is facing.

[0044] However, alternatively, at least one lateral ultrasonic sensor is not positioned to emit lateral ultrasonic waves away from the tubular body in the direction in which the distal end of the tubular body is facing.

[0045] Advantageously, at least one of the lateral ultrasonic sensors is a piezoelectric ultrasonic transducer. Thus, advantageously, each of the at least one lateral ultrasonic sensors includes a piezoelectric element, in particular a piezoelectric layer.

[0046] This has the advantage that at least one lateral ultrasonic sensor can be designed to be particularly small and therefore suitable for lateral placement in the distal region of a tubular body. In one modification, at least one lateral ultrasonic sensor is a capacitive ultrasonic transducer. In yet another example, at least one lateral ultrasonic sensor is neither a piezoelectric ultrasonic transducer nor a capacitive ultrasonic transducer. At least one lateral ultrasonic sensor can also be a sensor separate from the transducer. For example, at least one lateral ultrasonic sensor may include a transmitter that emits forward ultrasonic waves and a receiver that detects the forward ultrasonic waves reflected and returning to the receiver, and therefore to the lateral ultrasonic sensor, in particular to obtain a sonogram, and the receiver is a separate unit from the transmitter. Thus, the receiver unit and the transmitter unit can be placed in exactly the same at least one lateral ultrasonic sensor.

[0047] Preferably, at least one lateral ultrasound sensor is adapted to emit lateral ultrasound at a frequency in the range of 1 MHz to 20 MHz, particularly preferably 5 MHz to 12 MHz. This has the advantage of being able to detect and visualize the interface between brain tissue and cerebrospinal fluid in the ultrasound image at a distance of 4 cm to 10 cm from each of the lateral ultrasound sensors of at least one lateral ultrasound sensor. This has the advantage of facilitating catheter navigation as it is moved through the brain into the ventricles.

[0048] Preferably, at least one lateral ultrasonic sensor is adapted to emit lateral ultrasound at a peak dilution pressure in the range of 0 MPa to 7 MPa. This has the advantage that it can avoid brain damage during catheter use caused by the pressure induced by the forward ultrasound. However, as an alternative, at least one lateral ultrasonic sensor is adapted to emit lateral ultrasound at a peak dilution pressure exceeding 7 MPa.

[0049] Advantageously, at least one lateral ultrasonic sensor is adapted to emit lateral ultrasound in a pulse mode of 1 to 100 cycles per pulse. Thereby, advantageously, at least one lateral ultrasonic sensor is adapted to emit lateral ultrasound at a pulse repetition frequency in the range of 100 Hz to 20 kHz. However, more than 100 cycles per pulse may be employed, and the pulse repetition frequency may be selected to be less than 100 kHz or greater than 20 kHz.

[0050] Advantageously, at least one forward ultrasonic sensor and at least one lateral ultrasonic sensor together provide an acoustic output level I 2 below, preferably I SPTA.3 below 190 W / cm 2 where I SPPA.3 is the global maximum attenuation corrected I SPTA.3 intensity value, and I SPTA is the mechanical index (or attenuation corrected I SPPA.3 shown in Table 3 of "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" and "Guidance for Industry and Food and Drug Administration Staff" issued by the U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Devices and Radiological Health on June 27, 2019. SPPAThis is the intensity value. However, alternatively, at least one forward ultrasonic sensor and at least one lateral ultrasonic sensor are adapted to provide a higher acoustic output level as a whole.

[0051] Alternatively, at least one lateral ultrasonic sensor may be adapted to emit lateral ultrasonic waves at frequencies below 1 MHz or above 20 MHz. However, advantageously, at least one lateral ultrasonic sensor may be adapted to emit lateral ultrasonic waves at frequencies above 18 kHz and below 100 MHz, particularly below 50 MHz.

[0052] Advantageously, the catheter includes at least three lateral ultrasound sensors, preferably at least 15 lateral ultrasound sensors, particularly preferably at least 35 lateral ultrasound sensors, and most preferably at least 60 lateral ultrasound sensors, which emit lateral ultrasound and detect the reflected lateral ultrasound that returns to each of the at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, in particular to acquire a sonogram, and in particular to detect the reflected lateral ultrasound that returns to each of the at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, each of which is positioned laterally in the distal region of the tubular body. This has the advantage of allowing for the acquisition of a more complete ultrasound image around the distal region of the tubular body of the catheter. Therefore, catheter navigation is further improved while the catheter is being moved through the brain to the ventricles. Furthermore, monitoring of the proper positioning of the catheter within the ventricles during cerebrospinal fluid drainage after the catheter has been positioned within the ventricles is further improved. In addition, the size of the ventricles can be measured while the catheter is being moved through the brain to the ventricles, and once the catheter is positioned within the ventricles, it can be monitored along with the measurement. Thus, the catheter can be used with even greater reliability and safety for the drainage of fluids, especially cerebrospinal fluid.

[0053] Advantageously, the catheter includes fewer than 500 lateral ultrasound sensors, which emit lateral ultrasound and detect the reflected lateral ultrasound returning to fewer than 500 lateral ultrasound sensors, in particular to acquire a sonogram, and in particular to detect the reflected lateral ultrasound returning to each of the fewer than 500 lateral ultrasound sensors, and the fewer than 500 lateral ultrasound sensors are arranged laterally in the distal region of the tubular body. Alternatively, the catheter includes 500 or more lateral ultrasound sensors, which emit lateral ultrasound and detect the reflected lateral ultrasound returning to 500 or more lateral ultrasound sensors, in particular to acquire a sonogram, and in particular to detect the reflected lateral ultrasound returning to each of the 500 or more lateral ultrasound sensors, and the 500 or more lateral ultrasound sensors are arranged laterally in the distal region of the tubular body.

[0054] In a preferred modification, at least three lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors are each 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 tubular body over a length of about 0.5 cm to about 3 cm, particularly over a length of about 1 cm to about 2 cm. However, in one modification, the lateral ultrasonic sensor area extends along the tubular body over a length of less than about 0.5 cm or over a length of more than about 3 cm. Advantageously, each of the at least three lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors is each a lateral ultrasonic transducer. This has the advantage that each of the lateral ultrasonic sensors in a configuration of at least three, at least fifteen, at least thirty-five, or at least sixty lateral ultrasonic sensors can be designed to be particularly compact and therefore suitable for lateral placement in the distal region of the tubular body.

[0055] Alternatively, each of the at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors may not all be lateral ultrasonic transducers, or even none of them may be lateral ultrasonic transducers. For example, one, two or more, or even all of each of the at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors may include a transmitter that emits forward ultrasonic waves and a receiver that detects forward ultrasonic waves reflected back to the receiver, and thus to the lateral ultrasonic sensor, in particular to obtain a sonogram, wherein the receiver is a separate unit from the transmitter. Thus, the receiver unit and the transmitter unit may be arranged in exactly the same way for each of the at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors.

[0056] Preferably, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors are each distributed around the circumference of the tubular body, emitting lateral ultrasound in all directions, particularly in all 360 degrees around the circumference of the tubular body, away from the tubular body. This has the advantage of allowing for a more complete ultrasound image of the area surrounding the distal region of the tubular body of the catheter. Thus, the navigation of the catheter is further improved while it is being moved through the brain to the ventricles. Furthermore, monitoring the proper positioning of the catheter within the ventricles during cerebrospinal fluid drainage after the catheter has been positioned within the ventricles is also further improved. Thus, the catheter can be used more reliably and safely for the drainage of fluids, particularly cerebrospinal fluid. This is advantageous because at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors are each positioned to emit lateral ultrasound away from the tubular body in the direction in which the distal end of the tubular body is facing. This has the advantage of being able to generate a cone of lateral ultrasound opening toward the distal end of the tubular body, emitted by at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors, respectively. This has the advantage of being able to generate an ultrasound field for obtaining a panoramic view of the ventricular system around the end of the tubular body and for estimating the size of the ventricular system.

[0057] In certain preferred modifications, at least three of each of at least three lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors provide a tubular shape covering the circumference of the tubular body so as to emit lateral ultrasonic waves in all directions, particularly away from the tubular body, in all 360 degrees around the circumference of the tubular body. In this modification, the aforementioned advantages of lateral ultrasonic sensors distributed around the circumference of the tubular body to emit lateral ultrasonic waves in all directions, particularly away from the tubular body, in all 360 degrees around the circumference of the tubular body, can be achieved in a particularly easy and simple manner.

[0058] However, alternatively, at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors may be arranged differently in the distal region of the tubular body.

[0059] If any of the at least one forward ultrasonic sensor, and possibly at least one side ultrasonic sensor, possibly at least three side ultrasonic sensors, possibly at least fifteen side ultrasonic sensors, possibly at least thirty-five side ultrasonic sensors, and possibly at least sixty side ultrasonic sensors each is a piezoelectric transducer, then each of the at least one forward ultrasonic sensor, and possibly at least one side ultrasonic sensor, possibly at least three side ultrasonic sensors, possibly at least fifteen side ultrasonic sensors, possibly at least thirty-five side ultrasonic sensors, and possibly at least sixty side ultrasonic sensors each advantageously includes a piezoelectric element, in particular a piezoelectric layer. Examples of piezoelectric ultrasonic transducers containing such piezoelectric elements are described in the publication "Piezoelectric single crystal for ultrasonic transducers in biomedical application" by Qifa Zhou et al., in the Journal of Materials Science, Vol. 66, October 2014, pp. 87-111.

[0060] If any of the at least one forward ultrasonic sensor, and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, and possibly at least sixty lateral ultrasonic sensors, is a piezoelectric transducer, then each ultrasonic sensor of the at least one forward ultrasonic sensor, and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, and possibly at least sixty lateral ultrasonic sensors, advantageously includes one or more acoustic impedance matching layers. The purpose of one or more acoustic impedance matching layers is to minimize transmission losses resulting from acoustic impedance mismatch between the surface of the piezoelectric ultrasonic transducer and the tissue and / or liquid on which the piezoelectric ultrasonic transducer operates. Advantageously, the piezoelectric element is coated with one or more acoustic impedance matching layers. As a result, one or more acoustic impedance matching layers are advantageously coated on the front surface of the piezoelectric element, from which ultrasonic waves are emitted. One or more acoustic impedance matching layers can be formed from polymers such as epoxy resin, polyurethane, polystyrene, or parylene, and may further contain fillers such as silver particles. Thereafter, the silver particles may have an average diameter of, for example, 2 μm to 3 μm.

[0061] One or more acoustic impedance matching layers have the advantage that they provide better energy transfer and thus enable more efficient emittance of ultrasound. Parylene, a polymer whose backbone consists of para-benzenediyl rings-C6H4- linked by 1,2-ethanediyl crosslinks-CH2-CH2-, further has the advantage of simultaneously acting as a protective layer for each piezoelectric ultrasonic transducer.

[0062] Regardless of whether each piezoelectric ultrasonic transducer includes one or more acoustic impedance matching layers, each piezoelectric ultrasonic transducer advantageously includes an acoustic absorption backing layer. This has the advantage that the acoustic absorption backing layer can absorb the ultrasonic waves radiated from the back of the piezoelectric element. This prevents undesirable effects caused by the emission of ultrasonic waves from the back of each piezoelectric ultrasonic transducer, which would degrade the quality of the ultrasonic image obtainable with each piezoelectric ultrasonic transducer. Advantageously, the acoustic absorption backing layer is coated on the back of the piezoelectric element. In one example, the acoustic absorption backing layer is formed from an adhesive epoxy resin containing tungsten and silver particles. Such acoustic absorption backing layers and methods for applying them to piezoelectric elements are described, for example, in U.S. Patent No. 6,124,664 of Scimet Life Systems Inc. In another example, the acoustic absorbing backing layer comprises a composite material of tungsten powder, cerium oxide powder in an amount of 1.0% to 4.5% by weight relative to the tungsten, and epoxy in a weight ratio of 4:1 to 50:1 relative to the powder. Examples of such acoustic absorbing backing layers are described in U.S. Patent No. 4,800,316 of Shanghai Lamp Factory Ltd.

[0063] However, at least one forward ultrasonic sensor, as well as possible at least one lateral ultrasonic sensor, possible at least three lateral ultrasonic sensors, possible at least fifteen lateral ultrasonic sensors, possible at least thirty-five lateral ultrasonic sensors, and possible at least sixty lateral ultrasonic sensors, can each be configured in a similarly different manner.

[0064] Advantageously, at least one forward ultrasound sensor is capable of operating in A mode. If the catheter includes two or more forward ultrasound sensors, the forward ultrasound sensors are advantageously capable of operating in either A mode or B mode. In one variation, at least one forward ultrasound sensor is capable of operating in another mode, such as Doppler mode or harmonic mode.

[0065] Advantageously, at least one possible lateral ultrasonic sensor, at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, and at least sixty possible lateral ultrasonic sensors can each operate in either mode A or mode B. In one modification, at least one possible lateral ultrasonic sensor, at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, and at least sixty possible lateral ultrasonic sensors can each operate in another mode, such as Doppler mode or harmonic mode.

[0066] Mode A, also known as amplitude mode, is a mode that scans lines passing through the body, plotting echoes on the screen as a function of depth. Mode B, also known as luminance mode, is a mode in which a linear array of transducers simultaneously scans a plane passing through the body, which can be seen as a two-dimensional image on the screen. This mode is also known as 2D mode. In harmonic mode, the transducer emits fundamental ultrasonic pulses into the body, and a narrow beam at the center of the harmonics is reflected back after passing through the body tissues. When harmonic mode is turned on, only this narrow beam of the pulse is detected. The fundamental ultrasonic pulse and scattered pulses are removed. Therefore, this mode improves lateral resolution and contrast resolution.

[0067] Preferably, at least one port, at least five ports, at least ten ports, or at least fifteen ports are positioned distally to at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors, respectively. This has the advantage of enabling efficient drainage of fluid, particularly cerebrospinal fluid, from the ventricles to the drainage lumen without having to advance the catheter tip too far into the ventricles, while simultaneously allowing for optimal ultrasound imaging from surrounding areas of the distal region having at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors, respectively.

[0068] This advantage is particularly evident when each of the at least one port, at least five ports, at least ten ports, or at least fifteen ports is located distal to each of the at least one lateral ultrasonic sensor, at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors.

[0069] If at least five ports, at least ten ports, or at least fifteen ports are each located in the aforementioned port regions within the distal region of the tubular body, the port regions are advantageously located distal to each of the at least one lateral ultrasonic sensor, at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors. If at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors are each present, and at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors are each located in the aforementioned lateral ultrasonic sensor regions, the port regions are advantageously located distal to the lateral ultrasonic sensor regions. Thus, the port regions and the lateral ultrasonic sensor regions are advantageously separated from each other and therefore do not overlap in any way. However, in one modification, the port regions and the lateral ultrasonic sensor regions overlap at least partially.

[0070] However, in one modified example, at least one port, at least five ports, at least ten ports, or at least fifteen ports are not located distal to at least one lateral ultrasonic sensor, at least three lateral ultrasonic sensors, at least fifteen lateral ultrasonic sensors, at least thirty-five lateral ultrasonic sensors, or at least sixty lateral ultrasonic sensors, respectively.

[0071] As an alternative to all these modifications, which include at least one lateral ultrasound sensor, the catheter does not include at least one lateral ultrasound sensor. Advantageously, the tubular body is formed from a flexible material. This flexible material can be a synthetic material such as polyimide or polyurethane. This has the advantage of reducing damage to the brain after catheter insertion into the ventricles.

[0072] However, alternatively, the tubular body is not formed from a flexible material, but from a rigid material. Regardless of whether the tubular body is formed from a flexible material, the tubular body is preferably coated with an antimicrobial coating. This has the advantage of reducing the risk of infection caused by catheter use. For example, antimicrobial coatings that include clindamycin-rifampin combination, minocycline-rifampin combination, or silver coating can be used. Examples of such coatings are described in the publication "Clinical review: Efficacy of antimicrobial-impregnated catheters in external ventricular drainage - a systematic review and meta-analysis" by Xiang Wang et al., Critical Care, Vol. 17, p. 234 (2013).

[0073] However, as an alternative, the tubular body is not coated with an antibacterial coating. Advantageously, the catheter has a length ranging from 20 cm to 30 cm. This has the advantage of being long enough to reach the ventricles without being too long and bulky.

[0074] However, alternatively, the catheter may have a length of less than 20 cm or more than 30 cm. Preferably, the tubular body has an outer diameter in the range of 2 mm to 10 mm, particularly preferably in the range of 2 mm to 4 mm. This has the advantage that the internal drainage lumen extending along the tubular body for fluid drainage can be designed to have a sufficiently large diameter for effective fluid drainage, while maintaining a sufficiently small outer diameter so that the catheter does not cause unnecessary damage to the brain.

[0075] However, alternatively, the tubular body may have an outer diameter of less than 2 mm or more than 10 mm. Preferably, the drainage lumen provides an inner diameter in the range of 1 mm to 8 mm, particularly advantageously 1 mm to 2 mm. This has the advantage that the internal drainage lumen extending along the tubular body for liquid drainage is large enough for effective liquid drainage. Thereafter, the inner diameter of the drainage lumen is advantageously smaller than the outer diameter of the tubular body. Particularly advantageously, the inner diameter of the drainage lumen is at least 0.5 mm smaller, and more advantageously at least 1.0 mm smaller, than the outer diameter of the tubular body. This has the advantage that the tubular body can be configured to have sufficient stability. Nevertheless, the outer diameter of the tubular body is preferably smaller than the inner diameter of the drainage lumen plus 5.0 mm.

[0076] Advantageously, the catheter includes an intracranial pressure sensor that measures intracranial pressure when the catheter is inserted into the ventricle. This has the advantage of allowing the intracranial pressure to be determined during the use of the catheter.

[0077] In an advantageous modification, one of at least one anterior ultrasound sensor, or one of possibly at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors, is simultaneously an intracranial pressure sensor. This has the advantage of allowing the catheter to be configured more compactly. However, in another advantageous modification, the intracranial pressure sensor is one of at least one anterior ultrasound sensor, or one of possibly at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors, is a different sensor. This has the advantage that intracranial pressure can be independently determined from at least one anterior ultrasound sensor, or possibly at least one lateral ultrasound sensor, possibly at least three lateral ultrasound sensors, possibly at least fifteen lateral ultrasound sensors, possibly at least thirty-five lateral ultrasound sensors, or possibly at least sixty lateral ultrasound sensors.

[0078] In these alternative forms of modification, the catheter does not have an intracranial pressure sensor that measures intracranial pressure when the catheter is inserted into the ventricle. Advantageously, the catheter includes wiring that connects at least one forward ultrasound sensor to a connector that connects to a control unit that controls at least one forward ultrasound sensor, the connector being located in the proximal region of the catheter. This has the advantage that the catheter can be separated from the control unit for maintenance purposes and connected to a control unit that controls at least one forward ultrasound sensor when using a catheter that is placed in the ventricular system for drainage of fluid from the ventricles, particularly cerebrospinal fluid, in the human ventricular system.

[0079] However, alternatively, the catheter does not have such connectors. In such cases, the catheter advantageously includes wiring that connects at least one forward ultrasound sensor to a control unit that controls at least one forward ultrasound sensor, and the connector is located in the proximal region of the catheter.

[0080] The catheter further includes at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, which emit lateral ultrasound and detect the reflected lateral ultrasound that returns to each of the at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, in particular to acquire a sonogram, wherein at least one lateral ultrasound sensor is located in the distal region of the tubular body. When positioned laterally, the catheter advantageously includes wiring that connects to connectors connected to control units that control at least one lateral ultrasound sensor, at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, respectively, the connectors being located in the proximal region of the catheter. This has the advantage that the catheter can be separated from the control unit for maintenance purposes and connected to control units that control at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, respectively, when the catheter is placed in the ventricular system for drainage of fluid from the ventricles, particularly cerebrospinal fluid, in the human ventricular system.

[0081] The catheter also includes the aforementioned wiring connecting at least one forward ultrasound sensor to a connector connected to a control unit that controls at least one forward ultrasound sensor, and if the connector is advantageously located in the proximal region of the catheter, the connector connected to a control unit that controls at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors is simultaneously a connector connected to a control unit that controls at least one forward ultrasound sensor. However, in one modification, these are two separate connectors.

[0082] Furthermore, if the catheter also includes the aforementioned wiring connecting at least one forward ultrasound sensor to a connector connected to a control unit that controls at least one forward ultrasound sensor, then the control units that control at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least fifteen lateral ultrasound sensors, at least thirty-five lateral ultrasound sensors, or at least sixty lateral ultrasound sensors are simultaneously the same control unit that controls at least one forward ultrasound sensor. However, in one modification, these are two separate control units.

[0083] However, as an alternative to these modifications, the catheter does not have such connectors. In such cases, the catheter advantageously includes wiring that connects at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, respectively, to control units that control at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, and the connectors are located in the proximal region of the catheter.

[0084] In a preferred modification, the catheter includes wiring that connects to connectors that control at least one forward ultrasound sensor and at least one lateral ultrasound sensor, at least three lateral ultrasound sensors, at least 15 lateral ultrasound sensors, at least 35 lateral ultrasound sensors, or at least 60 lateral ultrasound sensors, respectively, and the connectors are located in the proximal region of the catheter.

[0085] Regardless of whether the control unit controlling at least one forward ultrasonic sensor and the control units controlling at least one lateral ultrasonic sensor, at least three lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors are the exact same control unit or separate control units, the control units are advantageously adapted to control each ultrasonic sensor or a group of ultrasonic sensors to emit forward and / or lateral ultrasonic waves, respectively. Furthermore, the control units are advantageously adapted to receive signals from reflected forward ultrasonic waves received by at least one forward ultrasonic sensor, particularly for obtaining sonograms, or from reflected lateral ultrasonic waves received by at least one lateral ultrasonic sensor, at least three lateral ultrasonic sensors, at least 15 lateral ultrasonic sensors, at least 35 lateral ultrasonic sensors, or at least 60 lateral ultrasonic sensors, particularly for obtaining sonograms. Furthermore, the control unit is advantageously adapted to compute an ultrasonic image, and therefore a sonogram, based on the received signal, and / or to compute an acoustic signal representing the sonogram based on the received signal. However, in an advantageous modification, the control unit can be connected to a separate computing unit adapted to compute an ultrasonic image, and therefore a sonogram, based on the received signal, and / or to compute an acoustic signal representing the sonogram based on the received signal. Thereafter, the separate computing unit may be a personal computer (PC), a tablet, a smartphone, or any other device including a processor adapted to compute an ultrasonic image, and therefore a sonogram, or an acoustic signal which is an acoustic representation of the sonogram, based on the received signal.

[0086] Advantageously, each wiring of at least one forward ultrasonic sensor and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, or possibly at least sixty lateral ultrasonic sensors includes at least n+1 electrical connections, where n is the total number of sensors, which is the sum of each of the at least one forward ultrasonic sensor and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, or possibly at least sixty lateral ultrasonic sensors.

[0087] Advantageously, the wiring for at least one forward ultrasonic sensor, and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, or possibly at least sixty lateral ultrasonic sensors, is a printed circuit board (PCB), particularly a high-density interconnect PCB (HDI PCB). Therefore, the printed circuit board advantageously includes a flexible substrate. The flexible substrate can be formed from, for example, polyimide, polyester, polyethylene naphthalate, polytetrafluoroethylene (PTFE), or aromatic polyamide. Particularly advantageous, the flexible substrate is formed from a polyimide film, polyester film, polyethylene naphthalate film, polytetrafluoroethoxylen (PTFE) film, or aromatic polyamide 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.

[0088] Printed circuit boards are advantageously terminated with connectors. These connectors can be custom-made or standard connectors for electrical connections to control units.

[0089] However, alternatively, the wiring for at least one forward ultrasonic sensor, and possibly at least one side ultrasonic sensor, possibly at least three side ultrasonic sensors, possibly at least fifteen side ultrasonic sensors, possibly at least thirty-five side ultrasonic sensors, or possibly at least sixty side ultrasonic sensors, is formed from conductors rather than printed circuit boards (PCBs).

[0090] Advantageously, the catheter is magnetic resonance imaging compatible and, in particular, magnetic resonance imaging safe. Therefore, the catheter is advantageously usable in patients in a magnetic resonance imaging (MRI) machine. This is advantageous if the magnetic resonance imaging (MRI) machine employs a magnetic field of up to 3 Tesla. In this magnetic field, the catheter does not heat up, does not move within the patient's brain, and therefore does not cause injury to the patient within the MRI machine. Furthermore, the catheter does not introduce artifacts into the images obtained by the magnetic resonance imaging (MRI) machine. However, in alternative forms, the catheter is not magnetic resonance imaging compatible.

[0091] Regardless of how the wiring is done, the catheter according to the present invention is advantageously used and sold in combination with a control unit that controls at least one forward ultrasonic sensor and possibly at least one lateral ultrasonic sensor, possibly at least three lateral ultrasonic sensors, possibly at least fifteen lateral ultrasonic sensors, possibly at least thirty-five lateral ultrasonic sensors, or possibly at least sixty lateral ultrasonic sensors, respectively. Therefore, the combination of such a control unit with the catheter described above is advantageous.

[0092] The control unit is advantageously adapted to control at least one forward ultrasound sensor and possibly at least one lateral ultrasound sensor, possibly at least three lateral ultrasound sensors, possibly at least fifteen lateral ultrasound sensors, possibly at least thirty-five lateral ultrasound sensors, or possibly at least sixty lateral ultrasound sensors, respectively. Accordingly, the control unit is advantageously adapted to apply an excitation signal with phase information at a preset amplitude to each of the at least one forward ultrasound sensor and possibly at least one lateral ultrasound sensor, possibly at least three lateral ultrasound sensors, possibly at least fifteen lateral ultrasound sensors, possibly at least thirty-five lateral ultrasound sensors, or possibly at least sixty lateral ultrasound sensors, when connected to a catheter. Furthermore, the control unit is advantageously adapted to receive a signal from at least one forward ultrasound sensor that contains information about forward ultrasound that has been reflected back to at least one forward ultrasound sensor and detected by at least one forward ultrasound sensor. Furthermore, the control unit is advantageously adapted to receive signals from each of the following possible lateral ultrasonic sensors: at least one possible lateral ultrasonic sensor, at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, or at least sixty possible lateral ultrasonic sensors, and such signals may be reflected back to each of the following lateral ultrasonic sensors: at least one possible lateral ultrasonic sensor, at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, or at least sixty possible lateral ultrasonic sensors, and include information about the lateral ultrasonic detected by each of the following lateral ultrasonic sensors: at least one possible lateral ultrasonic sensor, at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, or at least sixty possible lateral ultrasonic sensors.

[0093] The control unit is advantageously adapted to operate at least one forward ultrasound sensor in A mode. If the catheter includes two or more forward ultrasound sensors, the control unit is advantageously adapted to operate the forward ultrasound sensors in either A mode or B mode. Thereafter, in an advantageous modification, the control unit is adapted to operate at least one forward ultrasound sensor in B mode to provide an ultrasound image oriented perpendicular to the longitudinal axis of the distal region of the tubular body and focused on a plane located at a distance from the distal tip of the tubular body. Thereafter, the control unit is advantageously adapted to sweep the above distance and acquire ultrasound images at different distances while sweeping the distance.

[0094] In another modification, the control unit is adapted to operate at least one forward ultrasonic sensor in a different mode, such as Doppler mode or harmonic mode. The control unit is advantageously adapted to operate at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, or at least sixty possible lateral ultrasonic sensors, each in either mode A or mode B. Thereafter, in an advantageous modification, the control unit is adapted to operate at least three possible lateral ultrasonic sensors, at least fifteen possible lateral ultrasonic sensors, at least thirty-five possible lateral ultrasonic sensors, or at least sixty possible lateral ultrasonic sensors in mode B to provide an ultrasonic image oriented perpendicular to the longitudinal axis of the distal region of the tubular body and focused on a plane located at a distance from the distal tip of the tubular body. Thereafter, the control unit is advantageously adapted to sweep the distance and acquire ultrasonic images at different distances while sweeping the distance. In another modification, the control unit is adapted to operate each of the possible at least one lateral ultrasonic sensor, possible at least 15 lateral ultrasonic sensors, possible at least 35 lateral ultrasonic sensors, and possible at least 60 lateral ultrasonic sensors in a different mode, such as Doppler mode or harmonic mode.

[0095] Furthermore, the control unit is advantageously adapted to calculate an ultrasonic image, and therefore a sonogram, in real time based on the received signal, and / or to calculate an acoustic signal representing the sonogram in real time based on the received signal.

[0096] If the control unit is adapted to calculate the sonogram in real time, the control unit may, advantageously, include a display for displaying the calculated sonogram. However, in one modification, the control unit may be directly or indirectly connected to a separate display for displaying the calculated sonogram. If the control unit is adapted to calculate an acoustic signal representing the sonogram in real time, the control unit may, advantageously, include an audio output for outputting the calculated acoustic signal. The audio output may be a speaker or headphones, or an output directly or indirectly connected to a speaker or headphones.

[0097] However, in a favorable modification, the control unit can be connected to a separate computing unit adapted to compute an ultrasonic image, and therefore a sonogram, in real time based on the received signal, and / or to compute an acoustic signal representing the sonogram in real time based on the received signal. The separate computing unit can be a personal computer (PC), a tablet, a smartphone, or any other device containing a processor adapted to compute an ultrasonic image, and therefore a sonogram, or an acoustic signal which is an acoustic representation of the sonogram, based on the received signal.

[0098] Alternatively, the control unit and catheter can be sold separately. Advantageously, the catheter according to the present invention is used in a configuration comprising a mandolin, particularly a stylet, and a catheter. Thereafter, the mandolin is a guide for the catheter. Advantageously, the mandolin is a rigid wire or stylet inserted into the catheter, giving shape and rigidity to the catheter as it passes through the brain to the ventricles. Thus, advantageously, the configuration comprises a mandolin, particularly a stylet, and a catheter according to the present invention. In an advantageous modification, the configuration further comprises the control unit described above. Thus, the configuration advantageously comprises a mandolin, particularly a stylet, and a combination of the control unit and catheter described above.

[0099] However, alternatively, the control unit and catheter combination can be used without the mandolin. Furthermore, the catheter can be used and sold independently of the mandolin and independently of the control unit.

[0100] Other advantageous embodiments and combinations of features can be derived from the following detailed description and the entirety of the claims. The following are drawings used to illustrate the embodiment. [Brief explanation of the drawing]

[0101] [Figure 1] This is a simplified schematic diagram of a configuration including a stylet, a control unit, and a catheter according to the present invention. [Figure 2] Figure 1 is a simplified schematic diagram of the catheter's cross-section, where the cross-section is positioned along the tubular body of the catheter, within the lateral ultrasound sensor area in the distal region of the tubular body. [Figure 3] A simplified schematic diagram of a cross-section of another catheter according to the present invention, wherein the cross-section is positioned along the tubular body of the catheter at a location within the lateral ultrasonic sensor area in the distal region of the tubular body. [Modes for carrying out the invention]

[0102] In the diagram, the same reference symbol is assigned to the same component. Preferred Embodiment Figure 1 is a simplified schematic diagram of Configuration 1, which includes a combination 3 of a stylet 2, a control unit 4, and a catheter 10 according to the present invention. Thus, Configuration 1 includes a stylet 2 and a catheter 10.

[0103] The catheter 10 is placed for the drainage of fluid from the ventricles of the ventricular system, particularly the ventricles of the human ventricular system, especially cerebrospinal fluid (CSF). More precisely, the catheter 10 is an external ventricular drainage catheter. The catheter 10 includes a tubular body 11, which has an internal drainage lumen 12 extending along the tubular body 11 for fluid drainage. Thus, the tubular body 11 is formed from a flexible material. More precisely, the tubular body 11 is formed from polyimide. In one modification, the tubular body 11 is formed from another material, such as polyurethane. In yet another modification, the tubular body 11 is formed from a rigid material. Regardless of the material from which the tubular body is formed, in the embodiment shown in Figure 1, the tubular body 11 is formed from a tube having a lumen that forms the drainage lumen 12. Thus, the tubular body 11 is coated with an antimicrobial coating 23. In one variation, catheter 10 does not have an antibacterial coating on its tubular body.

[0104] The tubular body 11 includes 16 ports 13.1, 13.2, and 13.3 located in the port region 14 of the distal region 15 of the tubular body 11. These 16 ports 13.1, 13.2, and 13.3 are arranged laterally on the side wall of the tubular body 11. Each of the 16 ports 13.1, 13.2, and 13.3 connects the drainage lumen 12 to the outside of the tubular body 11 and the outside of the catheter 10 in order to drain fluid from the ventricle into the drainage lumen 12. The 16 ports 13.1, 13.2, and 13.3 are distributed around the circumference of the tubular body 11 so as to face in all directions along the circumference of the tubular body 11. Therefore, an opening in the side wall of the tubular body 11 is provided in all 360 degrees around the circumference of the tubular body 11 by at least one of the 16 ports 13.1, 13.2, and 13.3.

[0105] The port region 14 extends along the tubular body 11 over a length of approximately 1 cm to approximately 2 cm. In one modified example, the port region 14 extends along the tubular body 11 over a length of approximately 1.5 cm to approximately 2.0 cm.

[0106] In one variation, the catheter may have more than 16 ports or fewer than 16 ports. In one example, the catheter has only one port. In another example, the catheter has four ports. In yet another example, the catheter has six ports. In yet another example, the catheter has ten ports.

[0107] As shown in Figure 1, the tubular body 11 includes an outlet 18 for draining liquid from the drainage lumen 12 to the outside of the tubular body 11, and the outlet 18 is located in the proximal region 19 of the tubular body 11. Therefore, a liquid recovery volume (not shown here) can be connected to the outlet 18 to drain liquid from the drainage lumen 12.

[0108] The catheter 10 further includes a forward ultrasound sensor 16, which emits forward ultrasound and detects the forward ultrasound that is reflected back to the forward ultrasound sensor 16. This forward ultrasound sensor 16 is positioned to emit forward ultrasound in a direction away from the tubular body 11, from the distal end 17 of the tubular body 11, along the longitudinal axis of the distal region 15 of the tubular body 11. This forward ultrasound sensor 16 is a forward ultrasound transducer and is located at the distal end 17 of the tubular body 11, which is the distal end of the catheter 10. More precisely, the forward ultrasound transducer is a piezoelectric ultrasound transducer and is adapted to emit forward ultrasound at frequencies in the range of 5 MHz to 12 MHz. In one modification, the forward ultrasound sensor 16 is adapted to emit forward ultrasound at other frequencies, such as 20 kHz, 15 MHz, 18 MHz, or 50 MHz. Regardless of frequency, the forward ultrasound sensor 16 can also be another type of sensor, such as a capacitive ultrasound transducer.

[0109] However, in one modification, the catheter includes two or more forward ultrasound sensors that emit forward ultrasound and detect the forward ultrasound that is reflected back to the forward ultrasound sensors. In one example, the catheter includes three forward ultrasound sensors that emit forward ultrasound and detect the forward ultrasound that is reflected back to the three forward ultrasound sensors. These three forward ultrasound sensors are positioned to emit forward ultrasound away from the distal end of the tubular body, in a direction inclined at an angle of 5° with respect to the longitudinal axis of the distal region of the tubular body, and are inclined at least 5° to each other.

[0110] Each forward ultrasonic sensor, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a peak lean pressure of 1 MPa. In one modification, each forward ultrasonic sensor, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a peak lean pressure of 3 MPa. In yet another modification, each forward ultrasonic sensor, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a peak lean pressure of 6 MPa.

[0111] Furthermore, each of the forward ultrasonic sensors, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves in a pulsed manner, with one pulse per cycle. Thus, each of the forward ultrasonic sensors, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a pulse repetition frequency of 100 Hz. In one variation, each of the forward ultrasonic sensors, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a pulse repetition frequency of 1 kHz. In another variation, each of the forward ultrasonic sensors, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a pulse repetition frequency of 10 kHz. In yet another variation, each of the forward ultrasonic sensors, or any of the forward ultrasonic sensors, is adapted to emit forward ultrasonic waves at a pulse repetition frequency of 20 kHz.

[0112] From the emitted forward ultrasound signal and the detected forward ultrasound signal that is reflected back to the forward ultrasound sensor 16, the control unit 4 can calculate an ultrasound image of an interface located in front of the distal tip 17 of the tubular body 11, such as the interface between brain tissue and cerebrospinal fluid within the ventricles. These ultrasound images are sonograms. Furthermore, in addition to acquiring these sonograms, the control unit 4 can also calculate an acoustic signal representing an image of an interface located in front of the distal tip 17 of the tubular body 11, such as the interface between brain tissue and cerebrospinal fluid within the ventricles, from the emitted forward ultrasound signal and the detected forward ultrasound signal that is reflected back to the forward ultrasound sensor 16.

[0113] The forward ultrasound sensor 16 emits forward ultrasound and detects the forward ultrasound that is reflected back to the forward ultrasound sensor 16, thereby enabling real-time visualization and acoustic representation of the anterior interface of the catheter 10, such as the interface between brain tissue and cerebrospinal fluid in the ventricles anterior to the catheter 10. As a result, the forward ultrasound sensor 16 facilitates the navigation of the catheter 10 within the brain and ventricles.

[0114] The 16 ports 13.1, 13.2, and 13.3 are located proximal to the forward ultrasonic sensor 16. Therefore, the port region 14 is located proximal to the forward ultrasonic sensor 16.

[0115] The catheter 10 further includes 36 lateral ultrasound sensors 20.1, 20.2, 20.3, which emit lateral ultrasound and detect the lateral ultrasound that is reflected back to the lateral ultrasound sensors 20.1, 20.2, 20.3. These lateral ultrasound sensors 20.1, 20.2, 20.3 are lateral ultrasound transducers, i.e., lateral piezoelectric ultrasound transducers, and are positioned laterally in the lateral ultrasound sensor area 21 within the distal region 15 of the tubular body 11. As a result, the lateral ultrasound sensor area 21 extends along the tubular body 11 over a length ranging from approximately 0.5 cm to approximately 3 cm. In one modification, the lateral ultrasound sensor area 21 extends along the tubular body over a length ranging from approximately 1 cm to approximately 2 cm. Regardless of the length of the lateral ultrasonic sensor region 21, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 are positioned laterally on the side wall of the tubular body 11 and attached to the support structure 22, as shown in Figures 2 and 3.

[0116] The lateral ultrasound sensors 20.1, 20.2, and 20.3 are distributed around the circumference of the tubular body 11 and emit lateral ultrasound in all directions, particularly away from the tubular body 11, in all 360 degrees around the circumference of the tubular body 11. However, in one modification, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are located over less than 360 degrees of the circumference, or even within only one field of view of the catheter. Furthermore, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are positioned to emit lateral ultrasound away from the tubular body 11 in a direction inclined at a 45° angle with respect to the direction in which the distal tip 17 of the tubular body 11 is facing. Thus, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are positioned to emit lateral ultrasound away from the tubular body 11 in substantially the direction in which the distal tip 17 of the tubular body 11 is facing. As a result, the distal tip 17 of the tubular body 11 is oriented along 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, faces away from the tubular body 11. In one modification, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are positioned differently. In one example, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are positioned to emit lateral ultrasound away from the tubular body 11 in a direction inclined at a 50° angle with respect to the direction in which the distal tip 17 of the tubular body 11 is facing. In another example, the lateral ultrasound sensors 20.1, 20.2, and 20.3 are positioned to emit lateral ultrasound away from the tubular body 11 in a direction inclined at an 85° angle with respect to the direction in which the distal tip 17 of the tubular body 11 is facing.

[0117] The lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at frequencies in the range of 5 MHz to 12 MHz. In one variation, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit forward ultrasonic waves at other frequencies, such as 20 kHz, 15 MHz, 18 MHz, or 50 MHz. Regardless of frequency, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 can also be other types of sensors, such as capacitive ultrasonic transducers.

[0118] Lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a peak lean pressure of 1 MPa. In another modification, lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a peak lean pressure of 3 MPa. In yet another modification, lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a peak lean pressure of 6 MPa. Furthermore, lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves in a pulsed manner with one pulse per cycle. Thus, lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 100 Hz. In one modification, lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 1 kHz. In yet another modification, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 10 kHz. In yet another modification, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 are adapted to emit lateral ultrasonic waves at a pulse repetition frequency of 20 kHz.

[0119] One of the lateral ultrasound sensors 20.1 is also an intracranial pressure sensor that measures intracranial pressure when the catheter is inserted into the ventricle. However, in one variation, the intracranial pressure sensor is a separate sensor from the anterior ultrasound sensor and the lateral ultrasound sensor. In yet another variation, the catheter does not have an intracranial pressure sensor that measures intracranial pressure when the catheter is inserted into the ventricle.

[0120] In one variation, the catheter includes only one lateral ultrasound sensor. In another variation, the catheter includes 15 lateral ultrasound sensors. In yet another variation, the catheter includes 60 lateral ultrasound sensors. In yet another variation, the catheter includes 72 or even more lateral ultrasound sensors.

[0121] Regardless of the number of lateral ultrasonic sensors, the 16 ports 13.1, 13.2, and 13.3 are located distal to the 36 lateral ultrasonic sensors 20.1, 20.2, and 20.3. Therefore, port region 14 is located distal to lateral ultrasonic sensor region 21. As a result, port region 14 and lateral ultrasonic sensor region 21 are separated from each other and therefore do not overlap in any way.

[0122] The catheter 10 has a length of 30 cm. However, in one modification, the catheter is longer than 30 cm. In another modification, the catheter 10 is 25 cm long. In yet another modification, the catheter 10 is 20 cm long. In yet another modification, the catheter 10 is less than 20 cm long. The tubular body 11 has an outer diameter of 4 mm, and the drainage lumen 12 has an inner diameter of 2 mm. However, the outer diameter of the tubular body 11 can be smaller or larger than 4 mm. For 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 lumen 12 can be smaller or larger than 2 mm. For example, the inner diameter of the drainage lumen 12 can be 1 mm, 4 mm, 5 mm, 6 mm, or 8 mm. However, advantageously, the inner diameter of the drainage lumen 12 is at least 0.5 mm, or even at least 1.0 mm, smaller than the outer diameter of the tubular body 11.

[0123] As shown in Figure 1, the catheter 10 includes wiring 24 that connects the forward ultrasound sensor 16 and the lateral ultrasound sensors 20.1, 20.2, and 20.3 to a connector 25 which is connected to a control unit 4 that controls both the forward ultrasound sensor 16 and the lateral ultrasound sensors 20.1, 20.2, and 20.3. The connector 25 is located in the proximal region 19 of the catheter 10.

[0124] The wiring 24 for the forward ultrasonic sensor 16 and the 36 lateral ultrasonic sensors includes at least 38 electrical connections. Thus, the wiring 24 includes n+1 electrical connections, where n is the total number of sensors, which is the sum of the forward ultrasonic sensor 16 and the 36 lateral ultrasonic sensors. The wiring 24 is a high-density interconnect printed circuit board (HDI PCB) including a flexible substrate made of Kapton with a thickness of 125 μm. However, in variations, the wiring 24 can be configured differently. For example, the HDI PCB may include different flexible or rigid substrates. In yet another variation, the wiring may be formed from individual conductors instead of a printed circuit board.

[0125] The control unit 4 is adapted to control the forward ultrasonic sensor 16 and the lateral ultrasonic sensors 20.1, 20.2, and 20.3. Thus, when connected to the catheter 10, the control unit 4 is adapted to apply excitation signals with phase information, at a preset amplitude, to each of the ultrasonic sensors 16 and 20.1, 20.2, and 20.3. Furthermore, the control unit 4 is adapted to receive signals from the forward ultrasonic sensor 16, including information about the forward ultrasonic waves detected by the forward ultrasonic sensor 16, which are reflected back to the forward ultrasonic sensor 16. Thus, the control unit 4 is adapted to operate the forward ultrasonic sensor 16 in A mode. To enable this, the forward ultrasonic sensor 16 is capable of operating in A mode. However, in the aforementioned variant where the catheter includes two or more forward ultrasonic sensors, the control unit is adapted to operate the forward ultrasonic sensor in either A mode or B mode. To enable this, the forward ultrasonic sensor is capable of operating in either A mode or B mode. Accordingly, the control unit 4 is adapted to operate the forward ultrasound sensor in B-mode to provide an ultrasound image that is oriented perpendicular to the longitudinal axis of the distal region 15 of the tubular body 11 and focused on a plane located at a distance from the distal tip 17 of the tubular body 11. Accordingly, the control unit 4 is adapted to sweep the distance and acquire ultrasound images at different distances while sweeping the distance.

[0126] Furthermore, the control unit 4 is adapted to receive signals from the lateral ultrasonic sensors 20.1, 20.2, and 20.3, which are reflected back to each of the sensors and contain information about the lateral ultrasonics detected by each of the sensors. Accordingly, the control unit 4 is adapted to operate the lateral ultrasonic sensors 20.1, 20.2, and 20.3 in A mode and in B mode. Thus, the lateral ultrasonic sensors 20.1, 20.2, and 20.3 are capable of operating in both A mode and B mode. Accordingly, the control unit 4 is adapted to operate the lateral ultrasound sensors 20.1, 20.2, and 20.3 in B-mode to provide an ultrasound image that is oriented perpendicular to the longitudinal axis of the distal region 15 of the tubular body 11 and focused on a plane located at a distance from the distal tip 17 of the tubular body 11. Accordingly, the control unit 4 is adapted to sweep the above distance and acquire ultrasound images at different distances while sweeping the distance.

[0127] The control unit 4 is adapted to calculate an ultrasonic image, and therefore a sonogram, in real time based on the received signal, and is also adapted to calculate an acoustic signal representing the sonogram in real time based on the signals received from the forward ultrasonic sensor 16 and the side ultrasonic sensors 20.1, 20.2, and 20.3. The control unit 4 further includes a display 26 for displaying the calculated sonogram and a speaker 27 for outputting the acoustic signal.

[0128] Figure 2 shows a simplified schematic diagram of the cross-section of the catheter 10 shown in Figure 1. Thereafter, the cross-section is positioned along the tubular body 11 at a location within the lateral ultrasound sensor area 21 in the distal region of the tubular body 11. Thus, Figure 2 shows that the support structure 22 to which the ultrasound sensor 20.1 is attached has a square cross-section and surrounds the drainage lumen 12 which has a circular cross-section and extends along the tubular body 11. Thus, the ultrasound sensor 20.1 is attached to the outer surfaces of the four sides of the support structure 22 and is therefore distributed around the circumference of the tubular body 11, emitting lateral ultrasound in all directions, particularly in the direction away from the tubular body 11, in all 360 degrees around the circumference of the tubular body 11.

[0129] Figure 3 shows a simplified schematic cross-section of another catheter 110 according to the present invention, where the cross-section is positioned along the tubular body 111 at a location within the lateral ultrasonic sensor area 121 in the distal region of the tubular body 111. This catheter 110 is largely identical to the catheter 10 shown in Figure 1. However, in catheter 110, the support structure 122 to which the ultrasonic sensor 120.1 is attached has a triangular cross-section and surrounds the drainage lumen 112, which has a circular cross-section and extends along the tubular body 111.

[0130] The present invention is not limited to the embodiments shown in the figures. Other modifications and variations are readily available to those skilled in the art. In summary, it should be noted that, relating to the technical fields mentioned earlier, catheters implanted in the ventricular system, particularly external ventricular drainage catheters, for the drainage of fluid from the ventricles of the ventricular system, especially human ventricular system, especially cerebrospinal fluid, should be manufactured that can be used reliably and safely for cerebrospinal fluid drainage.

Claims

1. A catheter (10, 110) placed in the ventricular system for draining fluid from the ventricles of the ventricular system, particularly the human ventricular system, especially for draining cerebrospinal fluid, particularly an external ventricular drainage catheter, a) A tubular body (11, 111) having an internal drainage lumen (12, 112) extending along the tubular body (11, 111) for draining the liquid, b) At least one port (13.1, 13.2, 13.3) located in the distal region (14) of the tubular body (11, 111), wherein at least one port (13.1, 13.2, 13.3) connects the drainage lumen (12, 112) to the outside of the tubular body (11, 111) and the outside of the catheter (10, 110) in order to drain the fluid from the ventricle into the drainage lumen (12, 112) and Equipped with, The catheter (10, 110) further includes at least one forward ultrasonic sensor, in particular at least one forward ultrasonic transducer, wherein the at least one forward ultrasonic sensor (16) emits forward ultrasonic waves and detects forward ultrasonic waves that are reflected back to the at least one forward ultrasonic sensor (16), in particular for acquiring a sonogram, and the at least one forward ultrasonic sensor (16) is located at the distal end (17) of the tubular body (11, 111).

2. The catheter (10, 110) according to claim 1, characterized in that the at least one forward ultrasonic sensor (16) is positioned to emit forward ultrasonic waves in a direction away from the tubular body (11, 111) from the distal tip (17) of the tubular body (11, 111) in a direction along the longitudinal axis 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 forward ultrasonic sensor (16) is adapted to emit forward ultrasonic waves at frequencies in the range of 1 MHz to 20 MHz, particularly 5 MHz to 12 MHz, particularly at a center frequency.

4. The catheter includes at least five ports (13.1, 13.2, 13.3), preferably at least ten ports (13.1, 13.2, 13.3), and particularly preferably at least fifteen ports, located in the distal region (15) of the tubular body (11, 111). The catheter (10, 110) according to any one of claims 1 to 3, characterized in that the drainage lumen (12, 112) in the distal region (15) of the tubular body (11, 111) is connected to the outside of the tubular body (11, 111) and the outside of the catheter (10, 110), respectively, in order to drain the fluid from the ventricle into the drainage lumen (12, 112).

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

6. The catheter (10, 110) further comprises at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1), in particular at least one lateral ultrasonic transducer, the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) emits lateral ultrasonic waves and detects lateral ultrasonic waves that are reflected back to the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1), in particular to acquire a sonogram, the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) is arranged laterally in the distal region (15) of the tubular body (11, 111), the catheter (10, 110) according to any one of claims 1 to 5.

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

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 frequencies in the range of 1 MHz to 5 MHz, particularly 5 MHz to 12 MHz.

9. The catheter (10, 110) includes at least three lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), preferably at least 15 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), particularly preferably at least 35 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), most preferably at least 60 lateral ultrasound sensors, the lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1) emit and reflect lateral ultrasound, particularly to acquire sonograms, the at least three lateral ultrasound sensors, the at least 15 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), the at least A catheter (10, 110) according to any one of claims 6 to 8, characterized in that it detects lateral ultrasound returning to 35 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1) or at least 60 lateral ultrasound sensors, wherein at least 3 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), at least 15 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), at least 35 lateral ultrasound sensors (20.1, 20.2, 20.3, 120.1), or at least 60 lateral ultrasound sensors are each arranged laterally in the distal region (15) of the tubular body (11, 111).

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

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

13. The catheter (10,110) according to any one of claims 6 to 12, wherein the catheter (10,110) includes wiring (24) connecting the at least one forward ultrasonic sensor (16) and the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1) to a connector (25) connected to a control unit (4) that controls the at least one forward ultrasonic sensor (16) and the at least one lateral ultrasonic sensor (20.1, 20.2, 20.3, 120.1), and the connector (25) is located in the proximal region (19) of the catheter (10,110).

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

15. A configuration (1) comprising a mandolin, particularly a stylet (2), and a catheter (10, 110) according to any one of claims 1 to 13.

Images