Vascular Access Implants and Access Implant Systems

Abstract

The present invention relates to a vascular access implant (1) for connecting an intracorporeal blood circulation (4) to an extracorporeal blood circulation (8), in particular for fluid connection to an extracorporeal blood treatment machine (10), the vascular access implant (1) comprising an arterial fluid line (12) adapted to be permanently connected to an artery (14) of a patient (6), comprising a venous fluid line (32) adapted to be permanently connected to a vein (34) of the patient (6), comprising a controllable valve (42) between the arterial fluid line (12) and the venous fluid line (32) for controlling the arterial fluid line. The invention relates to a vascular access implant system, wherein the arterial fluid line (12) is connected to the arterial fluid line (12) and is connected to the venous fluid line (32) and is connected to the arterial fluid line (1 ...

Description

Technical Field

[0001] The present invention relates to a vascular access implant for connecting / coupling / accessing / connecting an in vivo blood circulation to an extracorporeal blood circulation, in particular for (fluid) connection to an extracorporeal blood treatment machine such as a dialysis machine, comprising an arterial fluid line / blood line adapted for permanent (fluid) connection to an artery of a patient for drawing blood therefrom, comprising a venous fluid line / blood line adapted for permanent (fluid) connection to a vein of a patient for supplying blood thereto, and comprising a controllable arteriovenous connection between the arterial fluid line and the venous fluid line, in particular by means of a controllable valve for controlling the fluid flow between the arterial fluid line and the venous fluid line. Furthermore, the present invention relates to a vascular access implant system according to the preamble of the independent claim. Background Art

[0002] For example, to connect the blood circulation inside the body to the extracorporeal blood circulation, an arteriovenous fistula is created as an abnormal connection between an artery and a vein in the patient. This connection, also called a shunt, enables a higher blood flow through the extracorporeal blood circulation during blood treatment.

[0003] Here, blood from the artery is drained into the extracorporeal blood circuit or the first connection of the extracorporeal blood circuit, then treated and thereafter returned to the patient, in particular from a dialysis machine. A sufficient blood flow in the extracorporeal circuit is a necessary condition for optimal removal of toxins contained in the blood. Depending on the extracorporeal method, very different flow rates are required. They range from about 100 ml / min for the treatment of patients in intensive care units to 6000 ml / min for patients on a heart-lung machine. In hemodialysis, for example, connections of up to 400 ml / min are usually sufficient.

[0004] Patients with chronic renal failure usually receive surgically created arteriovenous fistulas in their arms. Such arteriovenous fistulas are used as vascular access during blood treatment. The walls of the veins are very thin and the blood flow is too little. However, the veins can have a diameter suitable for frequent punctures. On the other hand, arteries are too small in volume and are very unsuitable for punctures, but have sufficient blood flow. Shunts are arterialized veins and are suitable vessels that can be used to treat patients several times a week and puncture with dialysis cannulas due to the increased wall thickness for frequent (venous) punctures.

[0005] Alternatively, a multi-lumen catheter can be placed in the superior or inferior vena cava. If there are several lumens, they are located in a catheter that encompasses all of them. Since there is only one vascular access, blood must be drawn and returned intermittently, i.e. alternately. This requires a dedicated instrument-based device for the dialysis machine. When drawing blood, in particular the venous line must be automatically squeezed to prevent blood from flowing back. Here, a dedicated control mechanism regulates the inflow and outflow phases.

[0006] For example, according to WO 2009 / 033177 A1, a system is known that can be used as a catheter system for dialysis. An implant is implanted in the body under the patient's skin and connected to a blood vessel, such as a vein. The implant has a single closable opening through which a catheter can be inserted and removed. The arterial flow of blood is sucked through this opening by suction pressure or negative pressure, transported to the extracorporeal circulation, processed, and then returned to the body's blood circulation by a flexible hose, which also protrudes into the implant through the opening and is surrounded by the sucked arterial blood. The flexible hose has a longer size so as to extend deeply into the vein. Therefore, arterial blood is taken out at a single blood vessel at an upstream point, processed and reintroduced downstream of the blood vessel.

[0007] WO 03 / 000314 A2 discloses a fistula between an artery and a vein of a patient, which can be regulated and opened (open state) or closed (closed state) by means of a controllable valve. A control unit controls the mechanical valve. No intermediate stages between the open state and the closed state are provided.

[0008] US 2004 / 0133173 A1 discloses an implantable access for connecting an intracorporeal blood circulation to an extracorporeal blood circulation, here for hemodialysis, comprising a rigid structure also having arterial and venous access. Both the arterial and venous accesses have openings in the housing, which openings can be mechanically closed.

[0009] US 6,582,409 B1 discloses an implantable arteriovenous fistula having connections to an artery and a vein and suitable for hemodialysis. This implantable arteriovenous fistula has a specially defined needle entry area in a frame that is completely contained in the body. Blood can be taken from the artery and returned to the vein through special needles that pierce the patient's skin and further into this needle entry area. Thus, a connection to the extracorporeal blood circulation is established.

[0010] EP 1 622 657 B1 discloses a dialysis valve comprising a tube, the tube being fluidically connected between a vein and an artery and also having a pneumatically actuatable bellows. The bellows defines an inner chamber, the tube being arranged in the chamber so that as the length of the bellows changes, a portion of the tube also changes its diameter accordingly. This allows the flow between the artery and the vein to be controlled according to the adjustable diameter of the tube, and the tube acts as an adjustable throttle valve.

[0011] However, all of these prior art systems have the disadvantage that the patient must be punctured with a needle to access the blood circulation, which is painful for the patient and weakens the organ and damages the blood vessels, or that the blood is taken from and delivered to only one vessel, which has a negative impact on the heart. There are also disadvantages in terms of the risk of infection. There is also the risk of widening of the blood vessels due to relaxation of the blood vessel muscles, known as vasodilation. Due to the greater resistance and the accompanying increased demand on the performance of the heart, the usual systems can lead to heart diseases due to vasodilation. There is also always the danger that the needle will come loose and cause an undesired loss of blood to the environment. Summary of the invention

[0012] The object of the present invention is therefore to avoid or at least reduce the disadvantages of the prior art and, in particular, to provide a vascular access implant which allows a painless and safe connection / coupling of an intracorporeal blood circulation to an extracorporeal blood circulation, which increases the safety and sterility of the connection and reduces the associated infection risks, is functionally self-sufficient, and avoids harmful side effects of dialysis treatment on the body.

[0013] This object is achieved according to the invention with respect to a vascular access implant as defined by the features of claim 1 and with respect to a vascular access implant system as defined by the features of claim 14 .

[0014] According to the invention, the vascular access implant is therefore adapted to be connectable via a mechanically formed arterial (coupling) port and a mechanically formed venous (coupling) port to an extracorporeal blood circulation for, in particular, blood treatment in a detachable, painless and safely connectable, i.e., attachable and detachable manner.

[0015] The two ports are designed to protrude in particular from the patient's skin for detachable coupling, thereby achieving a simple and safe connection. Thus, the vascular access implant essentially has a first circuit / structural part, which is implanted in the body, is separated from the environment by the skin and establishes a connection from the artery and vein to the first circuit / structural part of the access implant. In addition, the vascular access implant has a second structural part, which protrudes from the body through the skin and forms a mechanical / mechanically formed (coupling) port, to which the extracorporeal blood circulation can be coupled and decoupled. The first structural part and the second structural part of the vascular access implant are connected (mechanically and fluidically). Thus, a defined interface, in particular for blood treatment, is provided, which can be connected painlessly, provides the patient with a pleasant wearing comfort and ensures a safe and sterile connection.

[0016] According to the invention, the vascular access implant thus has an arterial port, which is fixedly fluidically connected to the arterial fluid line and is suitable for being able to couple to and decouple from a first (external) hose of the extracorporeal blood circulation as an arterial access. Furthermore, the vascular access implant has a venous port, which is fixedly fluidically connected to the venous fluid line and is suitable for being able to couple to and decouple from a second (external) hose of the extracorporeal blood circulation as a venous access. The vascular access implant is specifically designed to be completely incorporated into the patient's body, with only the arterial port / port socket and the venous port / port socket being easily, safely and quickly connectable from the outside and preferably protruding from the body through the patient's skin.

[0017] In terms of design, the above basic idea is essentially achieved by the fact that the vascular access implant has an arterial port and a venous port, each of which is connected to the arterial or venous fluid line by a line. The other end of the line (the end of the line facing away from the arterial or venous fluid line) each has a separate or common adapter or adapter structure for coupling, which is shaped so that the adapter in particular protrudes through the skin and can be easily accessed from outside the body or outside the body. For example, a needle can be inserted from the outside into a defined needle insertion structure of the adapter in order to establish a fluid connection through the needle, or the adapter can be connected and disconnected in a needle-free manner, for example by a Luer connection.

[0018] In this context, the term "connectable" or "attachable and detachable" means that one end of a (first) fluid channel is directly connected to the other end of a different (second) fluid channel, and that these channels are fixed to each other and permanently fixed in said position until a user or control command performs the desired decoupling process, so that a safe and detachable fluid connection is created between the two fluid channels.

[0019] Advantageous embodiments are claimed in the dependent claims and are explained below.

[0020] Preferably, the arterial port may have an arterial connection lock / arterial coupling that is securely connected to the first hose by a positive fit and / or a friction fit, and / or the venous port may have a venous connection lock that is securely connected to the second hose by a positive fit and / or a friction fit. In each case, the connection lock ensures that the line or hose is securely, correctly and securely connected to the corresponding port in a fluidic manner. It can be said that the connection lock securely connects the hose to the corresponding port. By the form fit and / or press fit connection, the hose can also be easily and quickly detached from the port by releasing the form fit or press fit.

[0021] According to one embodiment, the arterial connection lock (arterial coupling) and / or the venous connection lock (venous coupling) can be connected to the corresponding hose in a press-fit manner via a displaceable undercut / displaceable undercut structure such as a hose coupling / quick-release coupling or a Luer lock connection, or can be connected to the corresponding hose in a form-fit manner via a magnetic or magnetizable structure such as a magnetic coupling or a hysteresis coupling. The undercut and / or magnetizable structure provide the advantages of a detachable, painless and safe connection.

[0022] According to an independently claimable aspect of the invention, the vascular access implant may comprise an autonomous energy supplier / autonomous energy supply means for providing energy to components of the vascular access implant. In order to operate in an autarkic manner, the vascular access implant requires electrical energy for its components, in particular for its electromechanical and electrotechnical components, such as sensors. This energy is provided by the autonomous energy supplier.

[0023] According to a further preferred, possibly independently claimed embodiment, it is provided that the autonomous energy supplier of the vascular access implant has an energy harvester / nanoscale generator, which converts energy into electrical energy by means of the patient's body temperature and / or the patient's movements and / or the pulsation of the blood vessels or the controllable arteriovenous connection. The required electrical energy can be "obtained" by the access implant via the energy harvester, which uses body temperature or movements or pulsations as energy sources. The energy harvester performs, in particular, the conversion of mechanical energy into electrical energy by means of the piezoelectric effect, and / or by means of a thermoelectric generator or a thermoelectric crystal, generating electrical energy from a temperature difference by means of the thermoelectric effect.

[0024] In particular, the autonomous energy supply may comprise an energy storage device, in particular a battery such as a lithium-ion battery, for storing electrical energy in the autonomous energy supply of the vascular access implant. The battery ensures that the access implant is supplied with the required electrical energy for its components for a certain period of time in order to function in a self-sufficient manner and to reliably perform its functions.

[0025] According to another embodiment, electrical energy can be supplied to the autonomous energy supplier by wireless / contactless energy transmission, in particular by inductive energy transmission. Preferably, the energy storage device of the autonomous energy supplier can be recharged by contactless energy transmission. To this end, the autonomous energy supplier of the access implant preferably has an antenna of a (coupling) coil so as to be charged by inductive coupling with the magnetic flux in the near field. Thus, the access implant can be kept at a suitable transmitter with a power source (including a transmitting coil) located at a distance of several centimeters, and the transmitter supplies energy to the access implant in a contactless manner.

[0026] It may be useful if the state of charge of the energy storage device is indicated visually and can be read out, in particular by a subcutaneous light source such as an LED or by wireless transmission. The access implant preferably has a light source / lamp, in particular an LED or LCD display, which is placed directly under the patient's skin so that the light transmittance of the skin is sufficient to display information such as the charge state, coupling state or treatment progress through the skin.

[0027] In a preferred embodiment that can be claimed independently, the arterial port and / or the venous port and / or the controllable arteriovenous connection can have a disinfection unit / sterilization unit, in particular a self-disinfecting unit, as a component of the vascular access implant, which has a biocidal or antimicrobial effect and kills bacteria and germs or at least inhibits their growth. The disinfection unit integrated in the vascular access implant serves to ensure the sterility of the arterial port and / or the venous port and / or the controllable arteriovenous connection, so that the access implant can autonomously fulfil its requirements with regard to sterility. The risk of infection is reduced.

[0028] Preferably, the disinfection unit / sterilization unit is suitable for (actively) emitting UV light or plasma to the arterial port and / or the venous port and / or the arteriovenous connection, and / or the disinfection unit may have a (passive) antibacterial coating and / or the disinfection unit may have a light-activated self-disinfecting material. If the disinfection unit is designed as a UV lamp emitting UV light, it can, for example, kill bacteria and germs by short-wave radiation before being connected to the extracorporeal blood circulation, thereby actively disinfecting the arterial or venous port and the arteriovenous connection. If the arterial and / or venous port is coated or equipped with an antibacterial coating acting as a disinfection unit, passive disinfection can provide a longer period of time, in particular permanently. Alternatively or additionally, the disinfection unit may have a refillable container inside the access implant, in which a disinfectant / sterilizer that can be supplied to the arterial and / or venous port is stored.

[0029] In another embodiment that can be independently claimed, the vascular access implant can have an identification element and / or a transponder / transmitter, in particular an RFID chip, as means for contactless identification of the access implant by a suitable reader. A unique identification can ensure that the intracorporeal blood circulation is indeed connected to the correct extracorporeal blood circulation. Patient data can also be sent in a contactless manner to a blood treatment machine in order to (automatically) set up a therapy according to the blood treatment.

[0030] Furthermore, the vascular access implant may preferably have a communication unit, which may be claimed independently, as a component suitable for receiving and sending data in a contactless manner. The communication unit can be used, for example, to establish a data connection between an extracorporeal blood treatment machine or a physician's computer for inputting updated data and the access implant. For example, after a therapy with a dialysis machine, current data can be stored in the access implant and a history can be stored in the access implant itself. During the next therapy, these values ​​are then available to the blood treatment machine, which evaluates these values ​​and commissions or adjusts the therapy accordingly.

[0031] According to an independently claimable aspect of the invention, the vascular access implant may comprise a port misalignment detection / port misalignment detection device as a component of the access implant at the arterial port and / or the venous port, which is adapted to detect, in particular by means of a Hall sensor and / or a reed sensor / reed relay, whether the arterial port or the venous port is correctly connected, or whether the first or second hose is correctly connected to the arterial port or venous port, respectively. The port misalignment detection serves as a safety and monitoring device of the access implant, which may detect an accidental loosening of the hose or an incorrectly connected blood flow, for example, sending a corresponding control or alarm signal. This makes the connection safer.

[0032] In particular, the controllable arteriovenous connection, in particular by means of a proportional valve, can continuously control or discretely adjust the flow cross section and / or the flow and / or the fluid resistance / flow resistance of the fluid connection between the arterial fluid line and the venous fluid line according to another aspect of the invention that can be independently claimed. Preferably, the controllable arteriovenous connection further comprises a non-return valve, which prevents an undesired backflow from the venous fluid line to the arterial fluid line. The controllable arteriovenous connection or the controllable proportional valve allows accurate adjustment of pressure and flow in order to optimally support blood treatment in particular. The arteriovenous connection of the access implant can be discretely controlled here, for example in order to achieve two states, namely an open state in which the arteriovenous connection is completely open and the fluid connection is established, and a closed state in which the arteriovenous connection is completely closed, or it can also present several discrete states in order to also present intermediate states between the open state and the closed state. Alternatively, it is possible that the arteriovenous connection can be continuously adjusted, for example by means of a proportional valve, in order to be able to react to hemodynamic changes. The blood flow in the arteriovenous connection can be adjusted individually, in particular by throttling to prevent clotting, while relieving the heart. In particular, the controllable arteriovenous connection is closed if the patient is not connected to an extracorporeal blood circulation.The controllable arteriovenous connection avoids side effects during blood treatment, such as cardiac hypertrophy or steal syndrome.

[0033] Preferably, and if necessary, independently claimable, the vascular access implant may have a flow sensor and / or a pressure sensor, which measures the flow or pressure in the controllable arteriovenous connection and / or at the arterial port and / or at the venous port. The flow or pressure is used in particular for controlling the arteriovenous connection and serves as a basis for this. The flow sensor measures the amount and the sign of the blood flow (possible recirculation) and serves as an important parameter for the treatment. The pressure sensor measures the pressure, in particular the pressure of the arteriovenous connection, and in particular serves together with the measured flow as a further parameter for the control.

[0034] According to another preferred and, if necessary, independently claimable embodiment, the vascular access implant may have a central control unit, by means of which components of the vascular access implant are controlled. For example, the central control unit receives data from components such as sensors, processes them and sends the data to components such as a communication unit. By means of the central control unit, the access implant may be automatically controlled.

[0035] Advantageously, a controllable valve, in particular an electromechanical valve, is provided between the arterial fluid circuit and the arterial port, and / or a non-return valve is provided between the venous fluid circuit and the venous port. In the event that the connection to the extracorporeal blood circulation is interrupted at the arterial port, the controllable valve can be quickly closed and prevents an undesired loss of blood to the environment. On the other hand, the non-return valve on the venous port provides a safety element that prevents blood from flowing out of the venous port. Since the venous port is only supplied with blood and not discharged during blood treatment, a non-return valve for closing the venous port is sufficient. In particular, the active control valve of the arterial port is controlled by the central control unit.

[0036] Advantageously, both the arterial port and the venous port are designed in a single, preferably one-piece adapter, in particular in the form of a double connector, which can only be coupled to a corresponding mating adapter. This prevents a situation where a port (e.g. the arterial port) is connected to a hose while another port (e.g. the venous port) is disconnected from the hose. With a single adapter, it is only possible to couple to both the arterial and venous ports simultaneously.

[0037] According to a preferred embodiment which may be claimed independently, the vascular access implant may have a housing which completely encloses / encloses / surrounds all components of the access implant, in particular the electronic components, except for the arterial and venous fluid lines and the arteriovenous ports, to form a sterile barrier between the components and the body, wherein the housing has a biocompatible material on the outside. The housing allows the integration of various even non-biocompatible components into the access implant, which is particularly important for electrical components. Alternatively, the vascular access implant may have a (relatively) rigid biocompatible connection structure which rigidly connects the biocompatible components of the vascular access implant to each other.

[0038] In particular, the arterial and / or venous ports have sealing rings. This ensures a lossless blood connection.

[0039] According to an independently claimable aspect of the invention, the access implant allows adjustment of the distance between the arterial fluid line and the venous fluid line. This ensures that the access implant can be used for different anatomies, since the distance between the artery and the vein is usually different for each patient. The adjustable distance between the artery and the vein can be achieved, for example, by an arteriovenous connection whose length is adjustable.

[0040] The present invention also relates to a vascular access implant system having a vascular access implant and an extracorporeal blood circulation. Here, the vascular access implant according to the present invention is inserted into the vascular access implant system, thereby providing an arterial fitting adapter at one hose end of a first hose of the extracorporeal blood circulation, which can be coupled to the arterial adapter of the vascular access implant system in a form of shape fit and / or press fit, and / or providing a venous fitting adapter at one hose end of a second hose of the extracorporeal blood circulation, which can be coupled to the venous adapter of the venous port in a form of shape fit and / or press fit. Similar to a plug-and-socket connection / plug connection, the adapter and the fitting adapter form a coordinated system for accessing the implant system. The adapter is fitted on a corresponding fitting adapter to establish a fluid connection between the adapter and the fitting adapter. The adapter and the fitting adapter can be designed in different ways. For example, they can be designed as complementary quick-connect components or Luer lock connections. The adapter system and the fitting adapter of the access implant system form a defined interface and ensure a safe connection between the in vivo blood circulation and the extracorporeal blood circulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The invention is explained in more detail below using preferred embodiments with the aid of the accompanying drawings, in which:

[0042] Figure 1is a schematic top view of a vascular access implant according to the invention according to a preferred embodiment of an access implant system according to the invention,

[0043] Figure 2 It is placed in the patient's arm Figure 1 A schematic top view of a vascular access implant of

[0044] Figure 3 Is from Figure 1 Schematic diagram of a vascular access implant and access implant system. DETAILED DESCRIPTION

[0045] Figures 1 to 3 A vascular access implant 1 according to the invention and an access implant system 2 according to the invention according to a preferred embodiment are shown, comprising various components.

[0046] The access implant 1 serves as an interface between the intracorporeal blood circulation 4 of the patient 6 and the extracorporeal blood circulation 8, so that blood can be drawn from the patient 6, treated with a blood treatment machine 10 in the form of a dialysis machine, and then fed back to the patient 6. With the extracorporeal blood circulation 8, various blood treatments such as hemodialysis, hemodiafiltration, ultrafiltration or (therapeutic) apheresis can be performed to remove toxins from the blood.

[0047] The access implant 1 has an arterial fluid line 12 extending into an artery 14 of the patient 6 and fluidly connected to the artery 14 (see Figure 3 ), for example, in the form of a flexible arterial silicone line or a line made of a suitable vascular replacement material. Alternatively, the arterial fluid line 12 can also be securely sutured to the artery 14. The arterial fluid line 12 can be used to draw or extract / remove a certain amount of blood from the artery 14 of the patient 6.

[0048] The arterial fluid line 12 delivers the extracted blood to a rigid arterial port 16. This arterial port 16 protrudes through the skin 17 of the patient 6, penetrating the skin barrier, so to speak, so that the arterial port 16 is easily accessible from the outside (outside the body) and can be coupled to and decoupled from the extracorporeal blood circulation 8. The arterial port 16 features an arterial adapter 18 or is designed as an arterial adapter 18, which is adapted to be able to be coupled to and decoupled from an arterial fitting adapter 20 of the extracorporeal blood circulation 8 in a form-fitting and / or magnetic manner (i.e. in a press-fitting manner) (see Figure 3 The arterial adapter 18 is connected to the arterial fluid line 12 in a fluid-tight manner and can, so to speak, form the terminal (blood) outlet of the access implant 1 to the extracorporeal blood circulation 8 .

[0049] The arterial adapter 18 of the in vivo blood circulation 4 and the arterial matching adapter 20 of the extracorporeal blood circulation 8 together form a coordinated system of access implant system 2 and defined interface. The arterial adapter 18 is assembled on the corresponding arterial matching adapter 20 to form a lossless, simple and detachable fluid connection between the adapter 18 and the matching adapter 20. The matching adapter 20 forms the end portion of the first (arterial) hose 22 of the extracorporeal blood circulation 8. Therefore, the adapter 18, which is one end of the (first) fluid channel (of the in vivo blood circulation 4), is directly connected to the matching adapter 20, which is the other end of the (second) fluid channel (of the extracorporeal blood circulation 8), and is fixed against each other and permanently maintained in this position until the user performs the desired decoupling process. This forms a safe and detachable fluid connection between the two blood circulations 4 and 8. The arterial adapter 18 is used as an arterial connection lock 19. The maximum magnetic attraction is usually sufficient to realize the arterial connection lock 19 in a press-fit manner. In particular, the arterial connection lock 19 is designed so that in the event of a strong pull on the mating adapter 20 and thus on the adapter 18, the connection is released in either direction, minimizing the risk of the access implant 1 being torn off with maximum damaging consequences.

[0050] Similar to the arterial side of the access implant 1, the vascular access implant 1 also has a rigid venous port 24 with similar features of a venous adapter 26 on its venous side, which can be connected to a corresponding venous fitting adapter 28 of a second hose 30 of the extracorporeal blood circulation 8 in a press-fit and / or form-fit manner. The venous adapter 26 thus forms a venous connection lock 27. Cleaned or treated blood can be returned to the access implant 1 through the connection to the venous port 24. The blood flows to a venous fluid line 32, which is connected to the venous port 10 and is implemented in the form of a flexible venous silicone line extending into and fluidically connected to a vein 34 of the patient 6. Thus, a fluid connection is established between the second hose 30 and the vein 34 of the patient 6. The arterial port 16 and the venous port 24 form a fluid circuit that connects the in vivo blood circulation 4 of the patient 6 with the extracorporeal blood circulation 4.

[0051] The following explains the functional mode of the vascular access implant 1 according to a preferred embodiment. Thus, instead of puncturing a cannula through the skin 17 of the patient 6 into a blood vessel (artery / vein) of the patient 6 during each treatment of the patient 6, thereby creating a blood collection site that drains blood for extracorporeal blood treatment, and also performing a second puncture to return purified blood to the vein of the patient 6, as is the case with conventional shunts, the access implant 1 provides a fully implantable interface device that is permanently connected to the artery 14 and vein of the patient 34 and provides two separate fluid connections or two separate ports (arterial port 16 and venous port 24) with in-phase extracorporeal blood circulation 8. The extracorporeal blood circulation 8 can be coupled to the access implant 1 in a painless manner (detachably) without restrictions such as the number of attachments and detachments or changes in position, as is the case with cannulation (vascular injury).

[0052] The access implant 1 also has a housing 36, which has its exterior designed with a biocompatible material and, due to its structural design, can be permanently and completely implanted in the body of the patient 6. Only the arterial port 16 or arterial adapter 18 and the venous port 24 or venous adapter 26 protrude from the patient's skin 15. The housing 36 encloses the access implant 1, except for the protruding arterial fluid line 12, the protruding arterial port 16, the protruding venous fluid line 32 and the protruding venous port 24.

[0053] In addition, the vascular access implant 1 has a branch 38 starting from the arterial fluid line 12, which is connected to the venous fluid line 32 via a controllable arteriovenous connection 40 so as to short-circuit the artery 14 and the vein 34, which is similar to a bypass. In the arteriovenous connection 40, a controllable electromechanical proportional valve 42 is inserted to continuously control the flow in the arteriovenous connection 40. The proportional valve 42 can be continuously closed from an open position and then reopened again, which also realizes a state between the open position and the closed position. By means of the proportional valve 42, the resistance or flow in the arteriovenous connection 40 can be changed within a few milliseconds in order to react to hemodynamic changes. The blood flow in the arteriovenous connection 40 can therefore be individually adjusted, and clotting can be prevented by throttling and at the same time the burden on the heart can be reduced. If the patient 6 is connected to the blood treatment machine 10 using the extracorporeal blood circulation 8, the controllable arteriovenous connection 40 is opened, and if the patient 6 is not connected to the extracorporeal blood circulation 8, it is closed.

[0054] In order to prevent blood from recirculating in the artery 14 in the arteriovenous connection 40 , a non-return valve 44 is also provided in the arteriovenous connection 40 , which only allows a flow direction from the artery 14 to the vein 34 .

[0055] A controllable electromechanical valve 46 switching between an open state and a closed state is provided in the arterial fluid line 12 before or upstream of the arterial port 8. Alternatively, the controllable valve 46 can also vary the flow rate in a continuous manner. The controllable valve 46 is designed to interrupt the blood flow immediately when the arterial matching adapter 20 is decoupled from the arterial port 16 to prevent uncontrolled discharge to the environment.

[0056] A check valve 48 is also provided in the venous fluid line 32 in front of the venous port 24. This check valve does not necessarily have to be actively operable, since it closes the venous port 24 from the environment in response to pressure when disconnected. The venous port 24 only allows blood to flow into the access implant 1 through the check valve 48. Thus, the check valve 48 securely closes the venous port 24 and ensures that there are no undesired exit points from the patient's 6 blood system.

[0057] In order to be able to act autonomously and independently or to be able to be actuated, the access implant 1 comprises an autonomous energy supply 50 for providing electrical energy to the (electrical) components of the access implant 1. On the one hand, the autonomous energy supply 50 comprises an energy storage device 52 in the form of a rechargeable lithium-ion battery to store electrical energy for a longer period of time, and on the other hand, the autonomous energy supply 50 has a first energy harvester 54 in the form of a thermoelectric generator that converts temperature differences into electrical energy by the thermoelectric effect and feeds it to the energy storage device 52, and a second energy harvester 56 that can convert the movement energy of the patient 6 into electrical energy and feed it to the energy storage device 52. With the two energy harvesters 54, 56, the autonomous energy supply 50 of the access implant 1 can continuously supply electrical energy without having to connect it to an external charging station. In order to be able to charge the energy storage device 52 of the autonomous energy supply 50 independently of the energy harvesters 54, 56, the autonomous energy supply 50 has an antenna coupled to a coil or charging coil 58, so that it can also be charged wirelessly in the near field by inductive energy transfer if necessary. This allows access implant 1 to be held at a distance of several centimeters to a complementary external coupling coil in order to charge energy storage device 52 via charging coil 58 in an inductive and contactless manner.

[0058] Access implant 1 also has an indicator 60 in the form of an LED to indicate the charge state of energy storage device 52. The LED has sufficient brightness to be visually perceived through skin 17 of patient 6. For example, when the energy level is low, the charge state of energy storage device 52 may be displayed in the form of a flashing red LED.

[0059] In order to disinfect the arterial port 16 and the venous port 24 for coupling / connection, the access implant 1 has an antimicrobial disinfection unit 62 in the form of a UV lamp (emitter) as a component of the access implant 1. The disinfection unit 62 can disinfect or sterilize the surfaces of the two ports 16 and 24 by emitting UV light. In addition, the arterial port 16 and the venous port 24 have a material or an antimicrobial coating with an antimicrobial effect to achieve a permanent passive disinfection of the ports 16, 24. The arteriovenous connection 40 can also be irradiated and disinfected with UV light from the disinfection unit 62.

[0060] The data can be transmitted via a communication unit 64 as a further component, in particular via The data can be transmitted to the extracorporeal blood treatment machine 10 via a WLAN connection in order to optimally adjust the therapy. The data can also be transmitted to the access implant via the communication unit 64. The communication unit 64 is therefore designed for wireless communication with other machines or systems.

[0061] An identification element 66 in the form of an RFID chip or an NFC coil (as an additional component) is also connected to the communication unit 64 in the housing 36 of the vascular access implant 1. Using the identification element 66, other machines can uniquely identify the patient 6. For example, in addition to the data transmitted via the communication unit 64, an external reader of the blood treatment machine 10 can wirelessly read out the data of the identification element 66 and debug and adjust the therapy for the patient 3 accordingly. For example, since the NFC coil has only a very short range, data security can be improved because only data in the near field is transmitted. It becomes more difficult for unauthorized persons to read patient data because the data must be stolen nearby. In particular, the data in the access implant 1 can also be encrypted, whereby the encryption is preferably performed by the communication unit 64 or the central control unit 70. Then, the blood treatment machine 10, which knows the encryption key, can correspondingly decrypt the data transmitted in encrypted form. Similarly, the access implant 1 can also decrypt encrypted data from the blood treatment machine 10.

[0062] In order to determine the correct connection state at the arterial port 16 and the venous port 24, the access implant 1 has a port misalignment detector 68 (as an additional component), which can detect whether the corresponding matching adapter 20, 28 is correctly connected to the adapter 18, 26 by means of a reed sensor and / or a Hall sensor. The port misalignment detector 68 measures the magnetic flux or the changing magnetic flux and determines whether there is a correct coupling with the corresponding port 16, 24. The correct connection is crucial because it serves as a safety device and detects intentional or accidental loosening of the hose 22, 30, and then interrupts the fluid connection by the controllable valve 46 to avoid blood loss. In particular, the check valve 48 can also be (electromechanically) closable. If, for example, only the arterial hose 22 is accidentally loosened, the check valve 48 can be closed, thereby triggering a pressure alarm on the blood treatment machine 10 and stopping the blood pump. Alternatively, the access implant 1 can also close the two valves 46 , 48 and send a control command or an alarm command via the communication unit 64 to the blood treatment machine 10 , which then stops the blood treatment and displays an alarm signal or an error message associated with the error on a display.

[0063] The vascular access implant 1 also has a central control unit 70, which processes the received data / signals and can drive all (electrotechnical) components of the access implant 1. The control unit 70 is therefore the central node of the access implant 1 for all electrotechnical components. The central control unit 70 controls the proportional valve 42 and receives data from it about the current (valve) state, controls the controllable valve 46 and also receives data from the latter about its state, controls the autonomous energy supply 50 with the energy storage device 52, the two energy harvesters 54, 56 and the charging coil 58 and receives data from it about, for example, the current state of charge, the current maximum charge capacity, the energy generation and the energy consumption of the components, controls the indicator 60 and the optional acoustic signal generator, controls the disinfection unit 62 and receives error information if any (e.g., whether the UV lamp is faulty), controls the communication unit 64 and receives data from it, controls the identification element 66 if necessary and receives data from the port misalignment detector 68. Furthermore, the control unit 70 stores relevant data in its memory, such as patient data, therapy data, component data and reference data.

[0064] The arteriovenous connection 40 has a pressure sensor 72 and a flow sensor 74, which measure the pressure and flow in the arteriovenous connection 40 and forward them as data to the central control unit 70. The data and parameters of the pressure sensor 72 and the flow sensor 74 form the basis for controlling the proportional valve 42 of the controllable arteriovenous connection 40, which can be used to avoid side effects of blood treatment, such as cardiac hypertrophy.

[0065] With the access implant 1 according to the present invention or the access implant system according to the present invention, the patient is provided with a device or system for painless coupling, increased safety, reduced risk of infection, improved patency and better treatment conditions, as well as less vasodilation, reduced risk of heart disease and reduced susceptibility to unwanted blood loss.

[0066] Reference numerals list

[0067] 1 Vascular access implants

[0068] 2 Vascular Access Implant Systems

[0069] 4 Blood circulation in the body

[0070] 6 Patients

[0071] 8 Extracorporeal blood circulation

[0072] 10 Blood Processing Machine

[0073] 12 Arterial fluid lines

[0074] 14 Patient's artery

[0075] 16 Arterial Port

[0076] 17 Patient's skin

[0077] 18 Arterial Adapter

[0078] 19 Artery Connection Lock

[0079] 20 Artery Fitting Adapter

[0080] 22 First hose

[0081] 24 IV Port

[0082] 26 Venous Adapter

[0083] 27. Venous connection lock

[0084] 28 IV adapter

[0085] 30 Second hose

[0086] 32 Intravenous fluid lines

[0087] 34 Patient's vein

[0088] 36 Housing

[0089] 38 branches

[0090] 40 Arteriovenous connection

[0091] 42 Proportional valve

[0092] 44 Check valve

[0093] 46 Controllable valve

[0094] 48 Check valve

[0095] 50 Autonomous Energy Supply Device

[0096] 52 Energy storage device

[0097] 54 First Energy Harvester

[0098] 56 Second Energy Harvester

[0099] 58 Charging coil

[0100] 60 Indicator

[0101] 62 Disinfection Unit

[0102] 64 Communication Units

[0103] 66 Identification element

[0104] 68-port misalignment detector

[0105] 70 Central Control Unit

[0106] 72 Pressure Sensor

[0107] 74 Flow sensor

Claims

1. A vascular access implant (1) for connecting an intracorporeal blood circulation (4) to an extracorporeal blood circulation (8), comprising an arterial fluid line (12) adapted to be permanently connected to an artery (14) of a patient (6), comprising an intravenous fluid line (32) adapted to be permanently connected to a vein (34) of a patient (6), comprising a controllable arteriovenous connection (40) between the arterial fluid line (12) and the venous fluid line (32), wherein the controllable arteriovenous connection (40) controls the fluid flow between the arterial fluid line (12) and the venous fluid line (32), in an arterial port (16) which is fixedly fluidically connected to the arterial fluid line (12) and is suitable for being coupled to and decoupled from a first hose (22) of the extracorporeal blood circulation (8) as an arterial access, and a venous port (24) which is in fixed fluid connection with the venous fluid line (32) and is suitable for being coupled to and decoupled from a second hose (30) of the extracorporeal blood circulation (8) as a venous access, and Features The arterial port (16) comprises an arterial connection lock (19), which is firmly connected to the first hose (22) in a form-fitting manner through an undercut structure or in a press-fitting manner through a magnetic or magnetizable structure, and / or The venous port (24) comprises a venous connection lock (27) which is securely coupled to the second hose (30) in a form-fitting manner through an undercut structure or in a press-fitting manner through a magnetic or magnetizable structure.

2. The vascular access implant (1) according to claim 1, characterized in that The vascular access implant (1) comprises an autonomous energy supplier (50) which provides energy to components (42; 46; 62; 64; 66; 68; 70; 72; 74) of the vascular access implant (1).

3. The vascular access implant (1) according to claim 2, characterized in that The autonomous energy supplier (50) includes an energy harvester (54; 56), which converts the body temperature of the patient (6) and / or the movement of the patient (6) and / or the pulsation energy of the controllable arteriovenous connection (40) into electrical energy and supplies it to the autonomous energy supplier (50).

4. The vascular access implant (1) according to claim 2, characterized in that The autonomous energy supply (50) comprises energy storage means (52) for storing electrical energy in the autonomous energy supply (50) of the vascular access implant (1).

5. The vascular access implant (1) according to claim 2, characterized in that Electrical energy may be supplied to the autonomous energy supplier (50) via wireless / contactless energy transmission.

6. The vascular access implant (1) according to claim 5, characterized in that The autonomous energy supplier (50) comprises an antenna coupled to a coil (58) for wireless energy transmission, through which energy can be supplied to the autonomous energy supplier (50) in a contactless manner by inductive coupling with a magnetic flow in the near field.

7. The vascular access implant (1) according to claim 1, characterized in that The arterial port (16) and / or the venous port (24) and / or the controllable arteriovenous connection (40) comprises a disinfection unit (62) having an antimicrobial effect as a component of the vascular access implant (1).

8. The vascular access implant (1) according to claim 7, characterized in that The disinfection unit (62) emits UV light or plasma toward the arterial port (16) and / or the venous port (24) and / or the controllable arteriovenous connection (40), and / or the disinfection unit (62) includes an antimicrobial coating or antimicrobial material and / or includes a self-disinfecting material that can be activated by light.

9. The vascular access implant (1) according to claim 1, characterized in that The vascular access implant (1) comprises, as a component of the vascular access implant (1), an identification element (66) for contactless identification by a reader and / or a communication unit (64) as a component of the vascular access implant (1) adapted to receive and send data in a contactless manner.

10. The vascular access implant (1) according to claim 1, characterized in that The vascular access implant (1) comprises a port misalignment detector (68) located at the arterial port (16) and / or the venous port (24) as a component of the vascular access implant (1), which is suitable for detecting that the arterial port (16) and the venous port (24) are correctly coupled.

11. The vascular access implant (1) according to claim 2, characterized in that The autonomous energy supplier (50) supplies a sufficient amount of energy to a disinfection unit (62) and / or an identification element (66) and / or a communication unit (64) and / or a port misalignment detector (68) as components of the vascular access implant (1).

12. The vascular access implant (1) according to claim 1, characterized in that The controllable arteriovenous connection (40) between the arterial fluid line (12) and the venous fluid line (32) controls the fluid flow between the arterial fluid line (12) and the venous fluid line (32) via a controllable valve (42).

13. The vascular access implant (1) according to claim 10, characterized in that The port misalignment detector (68) is adapted to detect that the arterial port (16) and the venous port (24) are correctly coupled via a Hall sensor and / or a reed sensor.

14. A vascular access implant system (2) comprising a vascular access implant and an extracorporeal blood circulation (8), It is characterized in that A vascular access implant (1) as claimed in claim 1 is used, and An arterial adapter (20) is provided at one end of a first hose (22) of the extracorporeal blood circulation (8), wherein the arterial adapter (20) can be coupled to the arterial port (16) as an arterial adapter (18) in a form-fitting and / or press-fitting manner, and / or A venous adapter (28) is provided at one hose end of a second hose (30) of the extracorporeal blood circulation (8), and the venous adapter (28) can be coupled to the venous port (24) as a venous adapter (26) in a form-fitting and / or press-fitting manner.

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