Adjustable implantable restriction

Abstract

The present application relates to an adjustable implantable restriction (100) for controlling the outflow rate in an implantable drainage tube for cerebral water drainage. Although a valve which has proven to be feasible exists, the present application sets itself the task of improving the valve. This task is solved in that at least one effective length (405) of at least one channel (404) is configured adjustably.

Description

TECHNICAL FIELD

[0001] The present invention relates to an adjustable implantable restriction for controlling the outflow rate in an implantable drainage for brain water drainage, in particular a hydrocephalus valve, for the outflow of liquid from the ventricular system of a patient, comprising at least one housing with a housing interior, at least one first passage for entry and / or exit, wherein at least one body, which is arranged in the housing interior, wherein the body is configured to be movable at least in one direction and has at least one adjustment unit. BACKGROUND

[0002] Hydrocephalus patients have the following medical problem:

[0003] The brain is surrounded in the skull by a special liquid, liquor, sometimes also called cerebrospinal fluid. This liquor is continuously produced and absorbed to the same extent. In the disease of hydrocephalus, also called brain edema, this balance is disturbed. Since the skull is a closed container, an enlargement occurs when more liquor is produced than is absorbed. Due to the enlargement, the cranial sutures cannot grow together in the case of infants, and the intracranial pressure rises in the case of adults. Thus, there is adult and infantile hydrocephalus.

[0004] Hydrocephalus can be divided in its form into internal hydrocephalus, external hydrocephalus, internal and external hydrocephalus, normal pressure hydrocephalus and vacuolar hydrocephalus.

[0005] The treatment of hydrocephalus was initially carried out by simple drainage of the liquor. This was carried out by a simple hose connection between the skull and the large venous vessels, or a corresponding connection of the skull to the abdomen via a hose. However, it was soon recognized that the pressure in the skull must have a certain physiological value if no further complications should occur.

[0006] The modern therapy of hydrocephalus uses an implantable drainage, an artificial connection between the ventricles in the head and a drainage chamber, nowadays mainly the abdomen, to set a certain physiological value.

[0007] Various drainages are known with which the pressure in the skull of a patient can be treated. The drainages should open and release the outflow of liquor, also called cerebrospinal fluid, at a certain critical pressure, thus preventing the formation of overpressure in the skull. Usually, these drainages for protection against overpressure of cerebrospinal fluid are called so-called shunts or ableitungen.

[0008] The core of implantable shunts is a valve that controls the shunt when implanted. This valve is called a hydrocephalus valve. Hydrocephalus valves are implanted subcutaneously on a regular basis. The shunts are usually implanted subcutaneously in the head region.

[0009] According to Miethke, a possible definition of a concept shunt is: any artificial hydraulic connection between a first body portion containing cerebrospinal fluid and a second body portion that can absorb cerebrospinal fluid, see Kombogiorgas, D. (2016) "The Cerebrospinal Fluid Shunts" (1st edition), Nova Science Publishers, Incorporated, pages 130 / 131. Other sources on the topic of hydrocephalus are the book "Normal Pressure Hydrocephalus", Fritsch et al. 2014 Fritsch (2014) and the standards EN ISO 7197 and EN ISO 1463.

[0010] Furthermore, all sources contain professional concepts and definitions on the topic of hydrocephalus. In addition, they also contain known working principles and their grouping.

[0011] Miethke proposes a double grouping in Kombogiorgas (2016), see table 1. In a first subgroup, he groups the valves according to their working principle into differential pressure valves and hydrostatic valves. In a second subgroup, he groups the valves according to their clinical function into fixed valves, i.e. non-adjustable valve types and adjustable valve types.

[0012] Table 1: Working principles of shunts, Kombogiorgas (2016), page 117

[0013]

[0014] According to Miethke, valves of the group of hydrostatic valve principles should be defined as valves or valve components whose design purpose is to prevent overdrainage (Kombogiorgas (2016), page 67). Here, the purpose of the valves of this group is to compensate the force of the hydrostatic pressure acting in the direction of valve opening (so-called balancing).

[0015] Valves with a hydrostatic working principle can be divided into three valve types. Their names are anti-siphon devices, flow control devices and gravity control devices. All three valve types mean differential pressure. This is calculated from the difference between the pressure downstream of the valve minus the pressure upstream of the valve (Ap = p 阀下游 -p 阀 upstream). The differential pressure through which the volume flow is released by the valve defines the opening pressure of the valve.

[0016] Anti-siphon devices match their opening pressure to the level of the suction force acting in the valve. Gravity-controlled devices match their opening pressure to their inclination in the earth's gravitational field. In contrast, flow-controlled devices match the volume flow through them to the pressure difference.

[0017] Valves of similar denomination in the prior art that match a volume flow are flow-dependent, flow-regulating or flow-reducing valves or devices. Here, the concept "flow" shall generally be equivalent to the concept volume flow, volume per time.

[0018] Each hydrocephalus valve is characterized by a characteristic curve. Dr. med. Alfred Aschoff describes the characteristic curve of an in-vitro test of a hydrocephalus valve, 1994, page 32. He discusses it therein because shunt valves are flow controllers with a preferred direction of flow. According to Aschoff, they are distinguished by three features, namely firstly by a unidirectional action, secondly by an opening and closing characteristic, and thirdly by a specific pressure-flow characteristic curve. The pressure-flow characteristic curve is generally more nonlinear. According to Aschoff, its curve depends on the hydrocephalus valve itself, so that a hydrocephalus valve can only be described by specifying the complete characteristic curve.

[0019] Non-regulating hydrocephalus valves are proven by one valve characteristic curve, whereas regulating hydrocephalus valves are proven by multiple valve characteristic curves.

[0020] In the case of a non-regulating hydrocephalus valve, it is clear that the valves of the group of hydrostatic valve principles show a certain volume flow, throughflow, depending on the solution pressure. If the relevant volume flow is recorded in a diagram for each solution pressure, a valve characteristic curve results.

[0021] In the case of a regulating hydrocephalus valve, each setting configures the valve.

[0022] For each configuration, another valve characteristic curve results. Practice shows that the different valve characteristic curves of a valve are similar.

[0023] In the following, some important hydrocephalus valves are described:

[0024] US 8 870 809 B2 (Christoph Miethke GmbH & Co KG) teaches an implantable hydrocephalus system for treating a hydrocephalus patient with a drug. It is suggested to introduce the drug into the patient's brain ventricle by a liquid or fluid or its aid. For this purpose, the drug should be delivered into the cavity, the chamber of the hydrocephalus system, so that they can be hydraulically pressed from there into the brain ventricle by a ventricular catheter. According to the teaching, a system is required for this, which in one state absorbs the drug liquid and in another state brings them in the direction of the brain ventricle. The system is therefore a prerequisite for a valve and thus comprises a valve arrangement with a valve flap in a housing with an inlet and an outlet. The valve arrangement in the valve opens or closes the inlet of the hydrocephalus system depending on the drug liquid pressure in the chamber.

[0025] DE 38 35 788 A1 according to EP 1 523 635 B1 paragraph

[0003] (Aesculap AG) teaches a fast switching ball valve. Phenomenologically, this is a kind of actuating mechanism, which moves a ball to release or close a passage opening. In the closed state of the valve, the ball is pressed against the passage opening by the pressure of the gas flow. In order to release the passage sequence, the actuating mechanism pushes the ball laterally away from the passage opening. In the closed state of the valve, the ball is pressed against the passage opening by the pressure present, for example gas flow, in order to release the passage opening the actuating mechanism moves the ball away from the passage opening. For this purpose, a manipulation element of the actuating mechanism exerts a lateral impact on the ball, which then releases from the passage opening or from the valve seat of the passage opening. Here, a pulse-driven electromagnet is used as an actuating mechanism for moving the ball, which after actuation by a spring force returns to the original position again.

[0026] EP 1 523 635 B1 (Aesculap AG) suggests a valve with a compact shape memory alloy drive. The suggestion provides a solution to provide a valve that enables a manipulation stroke in the millimeter range. According to this principle, the suggestion combines a base body with a passage opening for closing and releasing a passage opening with two linear elements, in particular SMA wires (shape memory alloy) consisting of shape memory alloy, as an actuating mechanism. They shorten each other depending on the temperature change. Here, the SMA wires are connected to the valve body in such a way that in the case of a shortening on one side of one element it can be moved from a stable position on the passage opening to a stable position next to the passage opening and in the case of a shortening on one side of the other element it can be moved back again to the stable position on the passage opening. In a particularly advantageous design variant, a valve with a binary opening characteristic is created. Phenomenologically, the function of the switch is caused by the position manipulation of the main body in front of the passage opening.

[0027] US 2015 0182 734 Al (Christoph Miethke GmbH & Co. KG) discloses an adjustable hydrocephalus valve, a programmable gravity assistant, for pressure regulation in the skull of a hydrocephalus patient. By a diaphragm, a loose brake is released to release the rotor, so that it can rotate freely around an axis. The reset of the diaphragm reports to the user by an acoustic signal (click) the release or blocking of the brake. Due to a magnet built in, the rotor can be rotated around its axis by a likewise magnetic tool. The rotation serves to adjust the valve characteristics. The valve has proven to be feasible.

[0028] The above implantable hydrocephalus valves have the following general features: a housing comprising an inlet, an outlet and at least one actuating mechanism, wherein the actuating mechanism opens or closes the inlet or outlet through the body depending on the solution pressure.

[0029] These valves have proven to be feasible.

[0030] As early as 1985, US 4676772 A (Cordis-Cooperation) teaches a system for pressure control of cerebrospinal fluid. It comprises an implantable pressure relief valve for a fluid, which has a housing and an adjustment unit for adjusting the opening pressure of the pressure relief valve. Here, a diaphragm deflects depending on the pressure present at the pressure relief valve, so that a passage between a sealing ring and a ball embedded in the diaphragm is opened. For this purpose, the ball is supported in a pot, which is sheared on its outer surface with a thread. By means of the thread, the pot can be screwed into or out of the cover, so that the pressure between the ball and the sealing ring can be adjusted. The position of the pot, i.e. the number of screw threads screwed in, can be shown in the display device by means of a magnetic bridge in the pressure relief valve.

[0031] In summary, US 4676772 A teaches a setting of the valve opening pressure, but not the setting of a defined volume flow in an unfavorable manner. Furthermore, the described technology has the disadvantage that the setting of the valve opening pressure by screwing in the pot can lead to a plastic deformation of the diaphragm. This occurs when a force is exerted on the diaphragm by screwing the pot too strongly onto the ball, which is the elastic limit of the diaphragm here. An exact adjustment of the valve opening pressure is a prerequisite for an exact positioning of the pot in the cover. The pot is twisted in the cover by means of a magnetic bridge, which corresponds to the hand movement of the user. However, the user does not receive any feedback about the friction or relative position between the pot and the cover. Therefore, due to an over- or under-tightening by the user, the pot is not positioned exactly in the cover, so that the valve opening pressure cannot be adjusted exactly.

[0032] The so-called Orbis-Sigma valve is presented by Sainte-Rose, Hooven and Hirsch in: A new approach in the treatment of hydrocephalus, Neurosrg, 1987, 66(2), 213-26. The Orbis-Sigma valve comprises a sapphire diaphragm with a drilled hole and a pin or spike piercing the drilled hole. Here, the pin has an undercut in its cross section in the direction of its end facing the diaphragm. The diaphragm is supported along its circumference in a housing in a flow channel. The pin is supported at its end facing away from the diaphragm in the same housing and the same flow channel. If a pressure difference exists above the diaphragm, this is avoided by its expansion with the pressure gradient. Then, the size of the passage is defined by the shape of the undercut thickness and the vault in the pin. Its size varies with the course of the undercut. Thus, the Orbis-Sigma valve continuously adjusts the size of the passage in interaction with the course of the undercut existing a pressure difference above the diaphragm.

[0033] A disadvantage of the Orbis-Sigma valve is its dependency on the pressure difference. Furthermore, it cannot be assumed that the course of the undercut is constant for all patients. Rather, it has to be coordinated to the respective severity of the hydrocephalus of the patient.

[0034] In EP 0873761 B1 (DePuy) a device for limiting the flow of a fluid is described. The device shows the principle of a so-called Siphon . In 1998, it teaches a technique to limit the flow of a fluid from a first region of a patient to a second region. For this, the device comprises an inlet for receiving the fluid of the first region and an outlet for guiding the fluid to the second region. Furthermore, the device comprises a primary flow path and a secondary flow path, both in fluid communication with the inlet and the outlet. A detector in the device can detect the flow rate, the volume flow of the fluid, so that it can decide depending on its intensity whether to guide it along the primary or the secondary flow path. Here, the detector makes the decision by comparing the current flow rate with a threshold value. When the flow rate of the fluid is smaller than a predetermined threshold value, the detector guides the fluid along the primary flow path from the inlet to the outlet. In contrast, if the flow rate is greater than the predetermined threshold value, the detector guides the fluid along the secondary flow path from the inlet to the outlet. Here, the detector consists of four components, a ball seat, a ball, a leaf spring and a coil spring. The leaf spring presses the ball out of the ball seat, while the coil spring presses the ball into the ball seat. Thus, the difference between the two spring strengths defines the threshold value of the detector.

[0035] Thus, the device for limiting the flow of liquid digitally regulates its flow resistance between two states (high flow resistance and low flow resistance). It thus has the disadvantage that the strength of the flow resistance is subjected to adjustability between the two states, but unfortunately, the size of the volume flow cannot be kept constant. Not only the size of the passage of the primary flow path, but also the size of the passage of the secondary flow path, is pre-set by the design of the device on the factory side. Therefore, experts have developed techniques derived in further developments of the prior art, which improve the size specifications of the flow paths on the factory side.

[0036] US 2014 / 0276348 Al (Depuy-Synthes Products, Inc.) teaches from 2013 an overpressure protection device based on the so-called "Siphon " principle. It comprises a housing with an inlet and an outlet and a first flow path within the housing. The first flow path connects the inlet with the outlet. Additionally, the housing comprises a second flow path, which also connects the inlet and the outlet. Both flow paths have a flow resistance or flow resistance, respectively. In contrast, the flow resistance of the second flow path is greater than the flow resistance of the first flow path. Within the first flow path, a valve with a valve seat and a first valve ball and a second valve ball are provided. The first valve ball is movable between a closed position, in which the first valve ball is in contact with the valve seat, and an open position, in which the first valve ball is spaced apart from the valve seat. Here, the first valve ball is arranged between the second valve ball and the valve seat, and the second valve ball is movably arranged between the closed position and the open position.

[0037] Advantageously, the valve opening pressure, the gravitational force of the two balls relative to the lying surface of the first ball in the valve seat is matched by the position of the two balls in the gravitational field of the earth. The greater the angle between the perpendicular and the vertical axis of the valve, the lower the gravitational force of the two balls relative to the lying surface of the first ball in the valve seat. Thus, as the valve transitions from the vertical position to the horizontal position, the valve opening pressure decreases.

[0038] However, matching the valve opening pressure to the orientation of the valve in the gravitational field of the earth does not correspond to the matching of the valve opening gap.

[0039] The overpressure protection device also has the disadvantage that the flow resistance of the second flow path is pre-set by its structure on the factory side. Parameters of the flow resistance, such as, for example, the number of threads and their thread height, are not adjustable after implantation.

[0040] EP 1331019 A2 also teaches a flow control device (Codman). According to the distinction according to Miethke, the device, which is called an antisiphon shunt in the publication itself, teaches a self-regulating flow control valve, but not an adjustable valve. The antisiphon shunt for regulating the volume flow in a patient comprises a housing defining a fluid chamber and an inlet opening and an outlet opening. The inlet opening serves for delivering fluid into the fluid chamber, its outlet opening releases. Additionally, the antisiphon shunt comprises a valve mechanism for regulating the fluid flow through the fluid chamber due to a pressure gradient existing above the fluid chamber. To this end, the valve mechanism in the fluid chamber has a barrier with an opening through which fluid can pass. Furthermore, the antisiphon shunt comprises a pressure sensor for detecting the external pressure surrounding the fluid chamber, and a pre-tensioning element, for example a spring. It is in operative connection with the pressure sensor and is intended to exert a first force on a first surface of the ball. Thereby, the ball is pressed against the opening, thereby continuously preventing fluid from passing through the barrier through the fluid chamber. A balancing force acts on a second surface of the ball in the opposite direction of the first force. Here, not only the first surface but also the second surface is approximately the same size.

[0041] Thus, the document teaches a skilled expert a technique in order to close the opening in the barrier with the help of the ball against an opening pressure. Here, the closure remains until an opening pressure is reached which exceeds the difference between the first force minus the balancing force divided by the cross-sectional area of the opening.

[0042] In a further embodiment, the document teaches a second technique to move one end of the pre-tensioning element, the spring, so that its pre-tensioning force changes. To this end, the document suggests connecting the abdominal cavity, also called the peritoneal cavity, with the fluid chamber by means of a first channel. This can be a hose, for example. The suggestion also includes a reference chamber which is also connected with the abdominal cavity by means of a second channel. The fluid chamber and the reference chamber are connected with each other by means of a diaphragm which is connected with one end of the pre-tensioning element, the spring. As soon as the diaphragm is deflected, the pre-tensioning force of the pre-tensioning element changes through the connection. Here, the deflection follows a pressure difference between the abdominal cavity and the reference chamber. Thus, the antisiphon shunt adjusts its opening pressure independently by matching the stiffness of the pre-tensioning element.

[0043] Unfortunately, the document also does not teach a method for adjusting the gap between the passage, for example the barrier and the ball.

[0044] Therefore, for the prior art, the disadvantage means that the ventricle size and its state are neglected. Thus, the prior art neglects the importance of the shunt volume for the solution of different patients. In physiology, the compliance, the so-called compliance, describes the extensibility of a body structure. In the field of application of hydrocephalus, this corresponds to the compliance of the ventricle. Since the ventricle not only depends on the patient in its geometry but also in its state, its compliance is also different. The compliance of the ventricle is directly proportional to its volume change and inversely proportional to its pressure change. If the compliance depends on the patient, the pressure response changes depending on it at the same shunt volume. The shunts described in the prior art drain the shunt volume in their function as a valve, i.e. they have the disadvantage of a different pressure response depending on the patient.

[0045] US 2014 0336 560 (Hakim Carlos) teaches a programmable shunt with a magnetic rotor. The rotor is connected with a cam disc. A tongue of a curved link is placed on the cam disc, so that the rotation of the rotor follows the movement of the tongue along a curved track. Since the curved track has a slope, the tongue is raised or lowered by rotation. From the corresponding height of the tongue, a lever is pre-tensioned that presses the ball into its valve seat. From the change in pre-tension, the adjustment follows. SUMMARY

[0046] The task is to further improve the treatment of hydrocephalus, which

[0047] As an upcoming prior art, WO 2018 / 184717 A2 (Christoph Miethke GmbH) is taken as a starting point. It teaches a valve with controllable outflow control with a solution.

[0048] To this end, it comprises a housing with an inlet, a passage and an outlet. The passage has a circular contour. A body is supported in the passage. It is a circular body. Since the body diameter is smaller than the passage diameter, a gap is configured between them.

[0049] Despite the existence of this proven valve, the invention takes on the task of improving the valve. Here, the invention starts from the knowledge of the patients' reactions to the solution outflow in different health conditions. In part, the well-being is severely impaired. This knowledge output claims to overcome the above-mentioned disadvantages to further improve the control of the fluid flow from a body part to another body part.

[0050] Until today, all modern shunt systems are at risk of clogging. This clogging, so-called occlusion, requires a complex cleaning of the clogged shunt, shunt system or one of its components. Alternatively, one of the shunts or its components, such as a catheter, a hydrocephalus valve or an implanted restriction, should be removed. Cleaning and removal are a prerequisite for unnecessary surgery, which can be a source of infection. Unnecessary surgery hinders the supply capacity and is expensive.

[0051] The present invention proposes a solution to further improve the risk of clogging of shunts or hydrocephalus valves, in particular implantable restrictions.

[0052] The improvement is achieved with the features described in the present disclosure. Preferred embodiments are described in other parts of the present disclosure.

[0053] [A1] In the case of an adjustable implantable restriction for controlling the outflow speed in an implantable drainage tube for cerebral water drainage, the task is solved by the at least one effective length of the at least one channel being configured to be adjustable.

[0054] With the adjustable implantable restriction according to the invention, or in other words, the hydrocephalus valve, the patient's well-being can surprisingly be increased. In general, if the patient subjectively concludes that the shunt or hydrocephalus valve, in particular the implantable restriction, implanted in him can be occluded, i.e. clogged, the patient becomes insecure. Conversely, if the patient subjectively recognizes a reduced likelihood of restriction blockage, the patient generally gains confidence in the implantable restriction.

[0055] The prior art solutions are complex because they have a large number of components and a large number of small parts. In contrast to this, the restriction according to the invention proposes to minimize the number of small parts. By this also the number of joints is minimized. The adjustable implantable restriction according to the invention can be understood.

[0056] Since the effective length of the at least one channel is adjustable, the function can be simply implemented and confidence in the restriction is increased.

[0057] Advantageously, adjusting the effective length enables a relatively precise adjustment. This corresponds to its phenomenology from the potentiometer, so that as an advantage a large number of adjustment states is generated. Phenomenologically, the possibility of setting many states according to their effect can be understood as switching between parallel channels.

[0058] The ventricular system of each person varies in its size compared to others. The first patient has a small volume ventricular system, the so-called slit ventricle, while the second patient has a wider ventricular system. Since the implantable restriction according to the application has a plurality of adjustment states, it can be used for very different ventricular system sizes. It can be used for different patient groups since its adjustability creates variability.

[0059] If the effective length of the channel can be changed and the condition is true that only the effective length of the solution, i.e. the cerebrospinal fluid, flows through, the frictional resistance changes proportionally to the increase of the effective length or the decrease of the effective length. In turn, the outflow velocity decreases when the effective length increases and it increases when the effective length decreases.

[0060] In summary, the application thus enables an individual adjustment with respect to the patient and the outflow.

[0061] Surprisingly, the solution suggests that the adjustment of the effective length further increases the reliability of the valve against blockages. Since the length is adjustable, the cross section of the channel can remain constant. Advantageously, it can be designed such that it is significantly larger than the statistical quantity, for example the average size of deposits. By this size selection it is possible to prevent deposits or to flush away flaked-off deposits. Thus, the solution suggests maintaining the possible principle for avoiding blockages: "length before cross section constriction".

[0062] [A2] In a preferred embodiment, the restriction has at least one inlet and outlet, wherein the inlet and outlet or the inlet or the outlet each have at least one coupling site for the implantable hose system. Advantageously, the coupling site is configured as a so-called tulip. The tulip is a one-piece rotating tube section which comprises three sections. The first section is shaped as a cone or a funnel. The second and third sections are shaped as cylinders. The radius of the second section (middle piece) is smaller than the radius of the other two sections, whereby the second section configures a tapering in the course of the tulip. The hose, in particular a medical catheter, can be connected advantageously sealingly by a knotted cord, i.e. a so-called ligature in the second section.

[0063] [A3] In a preferred embodiment, the restriction comprises a housing, wherein at least one movable component is arranged in the housing which is configured to be movable from the outside of the housing.

[0064] The movable component, the inner component, serves as a switching or adjustment unit. Here, the movement of the component is more advantageously in correspondence with the switching or adjustment. The correspondence can be direct or interpreted. The advantage thereof lies in particular in the case that the same pressure conditions are maintained between the inlet and the outlet of the restriction, which makes the flow variable.

[0065] [A4] If in the implantable restriction a setting disk with at least one bore is provided to adjust the effective length of the passage, so that by the position of the setting disk a connection of the inlet and the outlet can be established or closed, it is surprising that the risk of clogging or blocking is further reduced.

[0066] The setting of the setting disk advantageously describes a stronger separation of the so-called solution space from the so-called setting space.

[0067] The solution space can be understood as the space that joins all subspaces to one another, through which the solution flows along its passage through the hydrocephalus valve. In contrast, the setting space can be understood as the space that joins all subspaces, which is part of the kinematic chain for a state change, in particular the adjustment or regulation of the valve properties.

[0068] Clogging is usually caused by the so-called cerebrospinal fluid flowing through the mechanism or part of the shunt, the hydrocephalus valve or the implantable restriction. Cerebrospinal fluid is a protein. It has a strong adhesive force. From this strength, the increased likelihood of adhesion, accumulation, bonding, clamping, i.e. clogging or blocking the mechanism.

[0069] If the hydrocephalus valve according to the invention comprises at least one setting disk, for example in the form of a perforated disk, the cerebrospinal fluid only travels through this disk in order to flow out through the passage. The passage itself has no mechanical link, so the likelihood of clogging or blocking the passage is reduced.

[0070] Advantageously, the implantable restriction is easily adjusted by rotating, twisting the setting or perforated disk. This is also easy to understand. Thus, the patient has the opportunity to understand the working principle of the restriction. In the understanding, the opportunity to recognize the functional reliability of the same restriction increases, so that the trust of the patient in the lasting effect of the restriction generally increases.

[0071] The restriction according to the invention also increases the opportunity to omit a surgical cleaning or removal in the case of an occlusion. If there is a blockage in the passage, it can be circumvented by adjustment. For this purpose, the setting disk can advantageously be positioned so that it is located behind the occlusion, i.e. the solution flows into the passage behind it. Even in unfavorable situations, the likelihood of solution outflow is increased. The risk of clogging, i.e. occlusion, of the restriction is further reduced for hospitals or doctors at a distance.

[0072] [A5] Advantageously, the bore in the setting disk is arranged on the circular radius of the disk outside the center. By a small angle twist, a significant adjustment can thus advantageously be made, since the circular radius corresponds to the gear ratio.

[0073] [A6] Since the setting disk contains at least one magnet, it can thus be twisted by a second magnet.

[0074] [A7] In a preferred embodiment, at least one spring presses the adjustment disc against the passage. This has the advantage that the adjustable implantable restriction prevents undesired loosening. If the spring force is designed to be strong, it is very difficult to adjust the restriction.

[0075] [A8] Due to the borehole configuration in the adjustment disc, which at least one space on the first side of the adjustment disc with the passage configuration on the second side of the adjustment disc, a fluid bridge is created. Through this fluid bridge solution can flow through the passage, in particular. Due to the diameter of the borehole being greater than the average geometric particle size, in particular the particle diameter of the particles in the solution, the borehole has the advantage of avoiding the risk of occlusion. This risk is further minimized because a slight twisting of the borehole leads to a shear, break or fragmentation of the soiled, partially occluded or occluded hole edge. Pushing away or breaking can advantageously be flushed out by the flowing solution through the borehole and the passage.

[0076] [A9] In a preferred embodiment, the housing wall of the restriction is elastic. Thereby, it can advantageously be pressed in and used as a switch button or switch.

[0077] [A10] Since the adjustment disc is embodied to be movable relative to the spring force, the adjustment disc can be lifted from the seat.

[0078] [A11] In a particularly preferred embodiment, the restriction has at least two states, a passage state and an adjustment state. In the passage state, the adjustment disc does not contact the passage boundary. In contrast, in the adjustment state, the adjustment disc lies on the passage boundary. The advantages of the at least two states prove the reasonability of the dual-purpose use. The passage state can be used for cleaning, flushing or testing the restriction. The adjustment state can be used to adjust the desired outflow resistance. Since the states are independent of each other, they increase the reliability of the restriction.

[0079] [A12] Since the passage is partially or completely closed in the adjustment state, it is ensured that the solution can only flow at the specified point, namely the passage, in particular the borehole or the slit.

[0080] [A13] In a preferred embodiment, in the passage state, the passage is open along its length. The advantage is that the passage can thereby be cleaned as a whole, in particular flushed. In a preferred embodiment, a cleaning or flushing liquid can be introduced for this purpose. Alternatively, a pump can be generated from the repeated movement of the embossing to use the CSF or a flushing liquid as a flushing agent when the passage is open.

[0081] [A14] Since the first state, in particular the through state, is configured to be switchable to the second state, in particular the regulating state, by a pressure on the housing, a switching function is created. The advantage of this result is also increased by the fact that the switching function integrates a threshold and advantageously makes use of its integration. Since the housing integrates a switch with a threshold function, the throttle according to the application ensures that it is only switched from a pressure of a predetermined height. The threshold can advantageously be designed according to a standard according to its minimum height, which thus reduces the risk of an undesired switching of the throttle.

[0082] [A15] It is particularly advantageous if the embodiment is designed in such a way that the lifting of the adjustment disc of one type is designed in such a way that the frictional resistance between the adjustment disc on the one hand and the housing and the channel on the other hand only acts in the centre of rotation. This type of embodiment has the advantage that the lever arm only compensates the rotation between the adjustment disc on the one hand and the housing and the channel on the other hand from zero up to a maximum of 2 mm. This embodiment therefore has the advantage that the braking torque is reduced to a minimum due to the frictional resistance.

[0083] [A16] In a preferred embodiment, the adjustment disc is arranged to be rotatable by 360° in both directions. This arrangement has the advantage that the opening and closing directions can be designed in a simple and comprehensible manner. If the hole runs along the adjustment disc through the channel in a preferred embodiment, the adjustment, the rotation of the adjustment disc in one direction corresponds to a shortening of the effective length of the channel. In contrast, a rotation in the opposite direction corresponds to an elongation of the effective length. The bidirectional twisting thus creates an advantageous prerequisite for the regulation of the outflow resistance.

[0084] [A17] If the adjustment disc interrupts the connection between the inlet and the outlet in at least one position, the outflow of the solution is interrupted therein. Advantageously, the adjustable effective length thus integrates a switching function into the implantable throttle.

[0085] [A18] Advantageously, the sealing surface between the disc and the channel is composed of an implantable plastic with a hardness of preferably 50 Shore to 80 Shore.

[0086] TPE composite materials are in the range of 50 Shore to 90 Shore. Some of them offer the advantage that they are approved according to the guidelines for the hygienic assessment of organic materials. In particular, they are also approved for cold drinking water or tempering drinking water. Since the solution has similar properties to water, the plastic between 50 Shore and 80 Shore has an advantage in the normative hygienic assessment for patient safety.

[0087] [A19] Since the channel guide extends radially, it creates the prerequisite for a simple guidance, namely the positioning of at least one flow inlet above the channel. The advantages of the simple guidance are embodied in a preferred embodiment. If the rotating body, in particular the perforated disc, is arranged relative to the open channel side, the holes can be guided simply, easily and precisely along the channel side. This embodiment can be particularly well understood by the patient due to its simplicity. The production of the channel is simple and inexpensive.

[0088] [A20] If the channel cross section is 0.02 mm 2 to 0.04 mm 2 in the case of a radial arrangement and a length of 30 mm to 40 mm, the design of the channel cross section corresponds to the pressure conditions of a patient with hydrocephalus.

[0089] [A21] A rectangular channel cross section is rectangularly easy to design and manufacture, and is therefore inexpensive. BRIEF DESCRIPTION OF DRAWINGS

[0090] The preferred embodiments of the invention are illustrated schematically in accordance with the drawings. The figures of the drawings show in detail:

[0091] Figure 1 a preferred first embodiment of the invention in a schematic three-dimensional view,

[0092] Figure 2 a preferred second embodiment in a view from above,

[0093] Figure 3 a preferred embodiment of the invention in a view from the outside,

[0094] Figure 4 a preferred embodiment with a diagrammatic representation of a fluid path,

[0095] Figure 5 a preferred embodiment of the throttle of the invention in a perspective side view with a loose membrane cover,

[0096] Figure 6 a preferred embodiment in a side view in two positions of use,

[0097] Figure 7 a preferred embodiment of a passage as a channel labyrinth,

[0098] Figure 8 a preferred embodiment of the invention in a side view,

[0099] Figure 9 a preferred embodiment of the invention with a passage in the form of a labyrinth, or with a channel as a labyrinth, or a labyrinth,

[0100] Figure 10 Preferred embodiments are shown with respect to different extension directions of the channel geometry,

[0101] Figure 11 Preferred embodiments are shown with respect to different designs of the labyrinth,

[0102] Figure 12 Preferred embodiments are shown for separating the solution space and the adjustment space. DETAILED DESCRIPTION

[0103] Figure 1 A hydrocephalus valve 100 according to the application is shown in its structure in a schematic view from above. In this preferred structure, the hydrocephalus valve 100 comprises five components: a housing 200, a passage 300, with a channel 404 or inner part (not shown), an adjustment unit (not shown) and a spring element (not shown).

[0104] In the preferred structure shown, the housing 200 is divided into a housing cover and a housing bottom, in the intermediate space, the housing interior space 201, the inner part (not shown) is arranged.

[0105] In the housing cover and the housing bottom, respectively, a passage is made, into which, respectively, an inlet 202 and an outlet 203 for liquor are brought. They act together with the housing interior space 201 and the channel 404 as a fluid connection. In the setting of the preferred structure, this allows liquor to pass through the channel 404 from the inlet 202 to the outlet 203, so that it travels through the adjustable restriction 100, the hydrocephalus valve 100.

[0106] In another setting, the passage 300, i.e. in particular the channel 404, is closed, the adjustment unit is acted upon by a perforated disc (not shown). Its torsion acts in the end position (position A) as a closure of the channel 404 and opens it in the end position (position B, C or D). Since the different end positions make the effective length 405 of the channel 404, i.e. the length through which it is effectively flowed through by liquor, adjustable, the implantable restriction 100 can thus be described phenomenologically as a linear potentiometer. The potentiometer advantageously functions by a first movement (rotary movement) releasing the rotatability of the perforated disc (not shown), which is configured with the torsion changing the position of the channel inflow.

[0107] In one preferred embodiment, the channel 404 is radial, in particular shaped as an arc. Its radius r 通道 Corresponding to the radius r 孔 In one alternative embodiment, the channel 404 can have a U-shaped profile or a V-shaped profile in its channel cross section 406.

[0108] Figure 2 A preferred embodiment of the hydrocephalus valve 100 is shown in a sectional view from above. It indicates that this embodiment is profiled as an interaction of several components in the housing 200. Participants are the inlet 202, the inner part (not shown), the regulating unit (not shown) and several outlets 203. Figure 2 An exemplary number of four outlets 203 is shown. The outlets 203 are arranged in the housing inner space 201 along a circle around the rotor axis 705.

[0109] Because the outlets 203 are distributed along a circle, the fluid, e.g. cerebrospinal fluid, becomes passable through the different outlets 203, if the inner part (not shown) opens the outlets 203, i.e. the passages 404, as a result of the rotational adjustment of the regulating unit (not shown).

[0110] The respective outlet lengths: LI, L2, L3 and L4 vary. Figure 2 It is shown that for the preferred embodiment a distinction of the outlet lengths can be made. They are distinguished according to the relation L4>L3>L2>LI.

[0111] In alternative embodiments other relations can be applied, e.g. L4>2-L3>3-L2>4-L1, where L1>inlet length applies. Relations of the inlet length to the outlet lengths can also be used. As the outlet lengths vary, the flow resistance varies.

[0112] Because the regulating unit (not shown) is embodied as a rotor with one or more holes, the fluid 900 travels through the one or more holes into the one or more outlets 203. Thus, this embodiment corresponds phenomenologically to a potentiometer with different regulating stages, each regulating stage corresponding to an outlet 203, or its length L, or the flow resistance.

[0113] Thus, in this embodiment the regulating unit (not shown) is shaped as a symmetrical perforated disc (not shown). The concept of a perforated disc comprises a large number of discs and disc-like sheet materials or bag covers. Preferably, the concept of a perforated disc comprises a symmetrical disc or a polygonal disc with at least one perforated disc passage, i.e. a hole or a bore. According to an alternative understanding, neither the perforated disc nor the perforated disc passage has to be symmetrical, they can also be asymmetrical. According to this alternative understanding, they have a grid, a mesh or a gap profile, where the grid density increases or can vary.

[0114] Figure 3 The preferred embodiment of the invention is shown in a view with a membrane cover. The membrane cover is an embossing 205, which corresponds in a profile section to a staircase with several steps.

[0115] The advantage of the embossed membrane is the "click". If the membrane is deflected from its rest position and is passed over a certain degree of deflection, it breaks through. If the membrane breaks through, it no longer bulges out, but bulges in. The membrane tip continues to turn by 180°. The break-through occurs very quickly, which thus generates a sound that can be heard as a "click".

[0116] Figure 4 The throttle 100 of the invention is shown with a distance 212 of the housing wall 212 to the bolt 804. When pressed onto the embossing 205 to release the brake, the distance is reduced. By pressing, the housing cover 204 is deformed until it rests on the bolt 804 and further guides it against the spring force of the spring element 800, against the spring 802. The embossing 205 is designed in such a way that the successful release, i.e. the loosening of the brake, is signaled by a click, because the upper part of the housing is embodied as a cracking membrane, i.e. a stepped circular membrane (not shown). Figure 4 Furthermore, it is disclosed that, if no pressure is acting on the bolt 804 by the embossing 205, a fluid (not shown) can flow through (arrow) along the throttle 100 of the invention. Here, the solution (not shown) flows through the borehole 721.

[0117] Figure 5 A preferred embodiment of the brake 1000 is disclosed. The brake 1000 comprises a brake face 1001 on the rotor 703 and an inner part brake face 1003 on the inner part 400, a silicone 1002 and a spring element 800.

[0118] In a preferred embodiment, the spring element 800 consists of a spring seat 801, a spring 802, preferably a coil spring 803 and a bolt 804. The spring seat 801 is firmly shaped in the adjustment unit 700. According to Figure 5 the disclosure in, the spring seat is drilled in the rotor 703. In an alternative embodiment, it can be milled, pressed, screwed, clamped or welded.

[0119] By means of the spring element 800, the brake 1000 can be tightened or loosened.

[0120] In a use position, which can be called "brake position" or "rest position", the hydrocephalus 100 is continuously blocked against opening.

[0121] In a preferred embodiment, the brake 1000 is integrated into the adjustable implantable restriction 100 to control the outflow rate in an implantable drainage tube for cerebral water drainage. It frictionally brakes or releases the movement of the adjustment unit 700, in particular the rotor 703. In a preferred embodiment, the restriction 100 has at least one inlet and outlet to which a soft tube system (not shown) implantable via at least one coupling site is connected. Here, the implantable restriction 100 comprises a housing in the interior space of which at least one movable component, the adjustment unit 700, is arranged, which can be moved from the outside of the housing, preferably by a magnet, so that its movement makes the flow volume variable under constant pressure conditions between the inlet and outlet of the restriction 100. Here, the movement of the adjustment unit 700, in particular the movement of the rotor 703, converts the rotational angle specification brought about by the magnet into an adjustment of the effective length of the at least one channel (see Fig. 4, item 405). Alternatively, the adjustment unit 700 can be understood as the rotor 703, the adjustment disc 720 or the perforated disc 720. Figure 1

[0122] In the case of a restriction according to the application for the outflow of fluid from the ventricular system of a patient, the release movement from the brake unit 1000 is converted kinematically. Since it comprises at least one adjustment unit 700, which is movably configured in a first axial movement direction, and the axial movement of the adjustment unit 700 is configured to be inhibited by the brake unit 1000, the release of the brake unit 1000 releases the inhibited adjustment unit 700 and creates a release path flow inlet.

[0123] The brake 1000 ensures the adjustment by frictional fit. Silicone 1002 is provided between the adjustment unit 700 and the inner component 400 to seal. For this purpose, the coil spring 803 presses the rotor 703 against the housing bottom 205. By this pressing, the rotor brake face 1001 is pressed against the silicone 1002, so that it lies tightly against the inner component brake face 1003. The valve is sealed. In an alternative embodiment, instead of silicone 1002, a biocompatible plastic or rubber can also be used.

[0124] In the Figure 5 , the membrane cover is de-pressurized so that no external force is applied to the bolt by the membrane cover. The force of the coil spring 803 thus enables the free rotation of the kinematically sealed rotor 703, i.e. the perforated disc. Here, the solution (not shown) flows through the boreholes 721.

[0125] Figure 6 The use position of the implantable restriction 100 in two states is shown. In the first state, the rest position, the channel 404 is closed. In the second state, the adjustment position, the channel 404 is open.

[0126] ​If the implantable throttle is at rest, a distance 212 is set between the bolt end 805 and the emboss 205.

[0127] The figure teaches that in the preferred embodiment the adjustment unit 700 is supported in the symmetrical inner part 400. For this purpose, the bolt 804 is formed in one piece by the adjustment unit 700, which is held in a bore of the inner part 400.

[0128] By pressing in the emboss 205, the pressing-in force first overcomes the distance 212 before it is transmitted onto the bolt end 805 against the spring. When the pressing-in force, the external force, is greater than the counterforce of the spring, the adjustment unit 700 is lifted from its seat and releases the passage 404.

[0129] Figure 7 A preferred embodiment of the passage 404 with a U-shaped profile is shown, which runs through an arc of approximately 340°. In alternative embodiments, the sum of the arc can be 30°, 45°, 60°, 90°, 120°, 160°, 180° or 270°. In alternative embodiments, the sum of the arc is greater than 20° and less than 200°, or greater than 30° and less than 180°.

[0130] In this embodiment, the open side length of the passage 404 corresponds to at least one quarter of all the other closed side lengths of the passage 404, since the three sides of its U-shaped profile have the same side length.

[0131] Figure 7 The effective length 405 between the bore 721 and the outlet 203 is shown exemplarily. The effective length 405 can be adjusted such that the adjustment unit 700 can be moved on the at least one magnet 723 by means of the magnetic coupling.

[0132] Figure 8 Two switching states of the housing cover 204 are disclosed. The housing cover 204 can also be understood as a housing wall. The throttle of the invention is characterized in that the adjustment unit is supported in the housing cover 204 or the housing wall, which can be moved by pressing in the emboss 205.

[0133] In the first state, the rest position, the membrane tip, i.e. the emboss tip, points upwards before the pressing in and its breakthrough, and downwards after the pressing in and the breakthrough. The breakthrough produces a click.

[0134] Figure 9 The throttle 100 of the invention with the preferred embodiment of the passage with a passage is disclosed, here it or a part thereof, in particular the passage 404, is completely or partially formed as a labyrinth 401, in particular milled from a plate.

[0135] Figure 10 Alternative embodiments of the different channeling of the passage shape, the labyrinth 401, are shown.

[0136] Three preferred embodiments are introduced in the following. They carry the names "in-in", "out-out" and "in-out" (not shown). These names help the reader to classify the embodiments according to one of their functions. They describe the main function of the valve by containing two words each. The first word describes the position of the labyrinth entry flow 905 and the second word describes the position of the labyrinth exit flow 906.

[0137] For example, the embodiment "in-in" describes a hydrocephalus valve 100 with the main function to allow the solution 901 to enter the labyrinth 401 close to the axis and to hit the fluid bridge 600 in the direction of the center of the hydrocephalus valve, i.e. between the perforated disc 720 and the channel 404, i.e. the axis 705 of the labyrinth 401.

[0138] In contrast, the embodiment "out-out" describes a throttle 100 of the invention, in which the solution 901 enters and leaves the labyrinth 401 close to the axis.

[0139] The embodiment "in-out" reminds of the teaching to introduce the solution 901 close to the axis into the labyrinth 401. Due to the rising of the thread (not shown) of the labyrinth 401, the solution 901 is guided into the screw with increasing radius. Thus, the end of the ramp, i.e. the labyrinth exit (not shown) is located at the outer edge.

[0140] Figure 11 Alternative embodiments of the labyrinth are shown, i.e. the guidance of the channel.

[0141] The concept labyrinth expresses a system of liquid channels, roads or paths. The liquid channels change in their direction.

[0142] Figure 11 The disclosed labyrinth is made as a continuous channel, which follows a shape in its course. In the preferred embodiment, the shape imitates a snail shell (Schneckenhaus). Thus, the hydrocephalus valve is characterized in that the labyrinth 401 follows a screw profile in its course. The screw-shaped labyrinth is shaped with a channel which is longer with respect to its base. The profile of the labyrinth can vary, so that it can be a U-shaped profile or a V-shaped profile along its length. For this preferred embodiment, the hydrocephalus valve can also be implemented in segments, i.e. subdivided into subsegments. Here, each segment, each subsegment has an alternative shape of the channel 404 or the labyrinth 401.

[0143] In the preferred embodiment, the U-shaped profile has dimensions of 0.4 mm height and 0.4 mm depth. Advantageously, thus particles with a maximum diameter of 0.03 mm can travel through the labyrinth.

[0144] If the solution enters the valve 100, i.e. the housing 200, it flows through the housing inlet, the jet and finally along the surface of the perforated disc 401. If partial volumes of the solution reach the holes 401, they are discharged into the labyrinth. Different embodiments can be envisaged, how the liquid passage between the supply channel and the labyrinth can be established.

[0145] The above-mentioned shunt valve of the invention can be combined with other valves. Here, the shunt valve of the invention can be arranged in front of or behind another valve in the flow / drainage direction. In combination with another valve, whose closing body is spring-loaded and opens in response to the solution pressure, the above-mentioned valve can be used to produce a switching effect.

[0146] Alternatively, a special gravity valve, i.e. a switchable gravity valve, is used in the housing. The gravity valve can be closed and opened. For this purpose, an adjustment / switching device is preferably provided, which is in operative connection with the closing part of the gravity valve.

[0147] In an extended embodiment, the shunt of the invention can be electrified. For this purpose, at least one drive is arranged in the shunt valve of the invention, which is able to twist the rotor. Furthermore, at least one transmitting unit and receiving unit and a sensor are to be incorporated. The task of the sensor is to record the so-called intracranial pressure in the patient's head, so that it can be transmitted to an external instrument, if possible, by means of the transmitting unit and receiving unit. Conversely, the drive can receive signals from an external instrument, in order to put the drive into operation.

[0148] The drive is activated by a storable control device, in which for example a desired time curve of the pressure drop in the solution is stored. This curve is compared in the control device by means of an algorithm with the pressure values of a not shown pressure measuring device. The difference between the two values results in a control pulse to the electric drive.

[0149] The adjustable valve combination explained below is able to run the desired pressure curve without additional aids in the case of electronic control together with a not shown pressure measurement. Its combination, also with a conventional shunt valve, is also able to run at least an approximately desired pressure curve on a purely mechanical basis.

[0150] In an embodiment, magnets are arranged in the rotor for adjustment. Furthermore, the magnets are likewise used for a so-called adjustment instrument, so that the implanted valve can be adjusted manually by twisting the adjustment instrument. Instead of an adjustment device, a storable stepper motor can also be used.

[0151] Figure 12 The separation of the solution space and the adjustment space is taught. The leakage current 903 is minimized therein.

[0152] List of reference symbols

[0153] 100 shunt valve, adjustable implantable throttle valve

[0154] 200 housing

[0155] 201 Internal space of the shell

[0156] Entrance 202

[0157] 203 Exports

[0158] 204 housing cover, housing wall

[0159] 205 Embossed

[0160] 212 Distance

[0161] 300 through the department

[0162] 400 Internal Components

[0163] 401 Maze

[0164] 404 error

[0165] 405 Effective Length

[0166] 406 Channel Cross-section

[0167] 600 fluid bridge

[0168] 700 Adjustment Unit

[0169] 703 Rotor

[0170] 705 Rotor shaft

[0171] 720 perforated plate, adjustment plate

[0172] 721 Drilling

[0173] 723 Magnet

[0174] 800 Spring Element

[0175] 801 Spring Seat

[0176] 802 Spring

[0177] 803 Coil Spring

[0178] 804 bolts

[0179] 805 bolt end

[0180] 900 fluid

[0181] 901 solution

[0182] 903 Leakage Current

[0183] 905 Maze Entry Flow

[0184] 906 labyrinth exit flow

[0185] 1000 brake unit

[0186] 1001 brake face

[0187] 1002 silica gel

[0188] 1003 inner component brake face

Claims

1. An implantable restriction (100) for controlling the outflow velocity in an implantable drainage tube for cerebral hydrodrainage, characterized in that, At least one effective length (405) of at least one channel (404) is configured adjustably, wherein for adjusting the effective length (405) of the channel (404) an adjusting disk (720) is provided, wherein the throttle (100) has at least two states, a through state and an adjusting state, wherein the adjusting disk (720) does not touch the border of the channel (404) in the through state and the adjusting disk (720) is placed on the border of the channel (404) in the adjusting state, wherein the throttle (100) comprises a housing (200) and the through state can be switched to the adjusting state by a pressure onto the housing (200).

2. An implantable restriction device according to claim 1, wherein, The throttle (100) has at least one inlet (202) and outlet (203), wherein the inlet (202) and the outlet (203) or the inlet (202) or the outlet (203) respectively have at least one coupling point for an implantable hose system.

3. The implantable restriction device of claim 1, wherein, In the housing (200) at least one movable component (700) is arranged, which is configured to be movable from the outside of the housing (200) so that its movement enables a variable flow under constant pressure conditions between the inlet (202) and the outlet (203) of the throttle (100).

4. The implantable restriction device of claim 1, wherein, For adjusting the effective length (405) of the channel (404) an adjusting disk (720) is provided, which has at least one bore (721) so that an adjustment can be established or closed by means of the connection of the inlet (202) and the outlet (203) depending on the position of the adjusting disk (720).

5. An implantable restriction device according to claim 4, wherein, The bore (721) in the adjusting disk (720) is arranged on the circular radius of the adjusting disk (720) outside the center.

6. The implantable restriction device of claim 4, wherein, The adjusting disk (720) contains at least one magnet (723).

7. Implantable restriction device according to any one of claims 1 to 6, characterized in that There is at least one spring (802) and the spring (802) presses the adjusting disk (720) against the channel (404).

8. An implantable restriction device according to any one of claims 1 to 6, wherein, The bore (721) in the adjusting disk (720) is configured in such a way that it establishes at least one space with the channel (404) on a first side of the adjusting disk (720) and on a second side of the adjusting disk (720).

9. An implantable restriction device according to any one of claims 1 to 6, wherein, The housing wall (204) of the throttle (100) is configured elastically.

10. An implantable restriction device according to any one of claims 1 to 6, wherein, The adjusting disk (720) is embodied so that it can be moved against the spring force.

11. An implantable restriction device according to any one of claims 1 to 6, wherein, In the adjusting state the channel (404) is partially or completely closed.

12. An implantable restriction device according to any one of claims 1 to 6, wherein, In the through state the channel (404) is open along its length.

13. An implantable restriction device according to any one of claims 1 to 6, wherein, When the adjusting disk (720) is lifted, the frictional force between the adjusting disk on the one hand and the housing (200) and the channel (404) on the other hand, which prevents a rotation, only acts on the center of rotation and thus only with a lever arm of zero to 0.5 mm maximum 2 mm resists the rotational movement between the adjusting disk on the one hand and the housing and the channel (404) on the other hand and reduces the braking torque due to the frictional force to a minimum.

14. An implantable restriction device according to any one of claims 1 to 6, wherein, The adjusting disk (720) is arranged so that it can be rotated 360° in both directions.

15. An implantable restriction device according to any one of claims 1 to 6, wherein, The adjustment disc (720) interrupts the connection of the inlet (202) and the outlet (203) in at least one position.

16. An implantable restriction device according to any one of claims 1 to 6, wherein, The sealing surface between the adjustment disc (720) and the channel (404) is realized by an implantable plastic with a hardness of 50 Shore units to 80 Shore units.

17. An implantable restriction device according to any one of claims 1 to 6, wherein, The channel (404) extends radially.

18. An implantable restriction device according to any one of claims 1 to 6, wherein, The channel cross section (406) is 0.02 mm in the case of a radial arrangement and a length of 30 to 40 mm 2 up to 0.04 mm 2 of the face.

19. An implantable restriction device according to any one of claims 1 to 6, wherein, The channel cross section (406) is rectangular designed.

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