VASCULAR ACCESS IMPLANT AND ACCESS IMPLANT SYSTEM

Abstract

A vascular access implant and system for connecting an intracorporeal blood circulation to an extracorporeal blood circulation includes an arterial fluid line for connection to a patient's artery and a venous fluid line for connection to a patient's vein. A controllable artery-vein-connection between the arterial fluid line and venous fluid line controls fluid flow between the arterial fluid line and venous fluid line. An arterial port is in fixed fluid connection with the arterial fluid line for coupling to and decoupling from a first hose of the extracorporeal blood circulation. A venous port is in fixed fluid connection with the venous fluid line for coupling to and decoupling from a second hose of the extracorporeal blood circulation.

Claims

1. A vascular access implant for connecting an intracorporeal blood circulation to an extracorporeal blood circulation, the vascular access implant comprising: an arterial fluid line adapted to be permanently connected to an artery of a patient; a venous fluid line adapted to be permanently connected to a vein of the patient; a controllable artery-vein-connection between the arterial fluid line and the venous fluid line that controls a fluid flow between the arterial fluid line and the venous fluid line; an arterial port which is in fixed fluid connection with the arterial fluid line and is adapted, as an arterial access, for coupling to and decoupling from a first hose of the extracorporeal blood circulation; and a venous port which is in fixed fluid connection with the venous fluid line and is adapted, as a venous access, for coupling to and decoupling from a second hose of the extracorporeal blood circulation.

2. The vascular access implant according to claim 1, wherein: the arterial port comprises an arterial connecting lock that firmly connects to the first hose by a positive fit and/or frictional fit, and/or the venous port comprises a venous connecting lock that firmly connects to the second hose by a positive fit and/or frictional fit.

3. The vascular access implant according to claim 2, wherein the arterial connecting lock and/or the venous connecting lock connect to the first hose and/or second hose, respectively, via an undercut structure in a form-fitting manner or via a magnetic or magnetizable structure in a force-fitting manner.

4. The vascular access implant according to claim 1, wherein the vascular access implant comprises an autonomous energy supply that provides energy for components of the vascular access implant.

5. The vascular access implant according to claim 4, wherein the autonomous energy supply comprises an energy harvester that converts energy of a body temperature of the patient and/or of a movement of the patient and/or of a pulsation of a vessel or the controllable artery-vein-connection into electrical energy and supplies it to the autonomous energy supply.

6. The vascular access implant according to claim 4, wherein the autonomous energy supply comprises an energy storage device for storing electrical energy in the autonomous energy supply of the vascular access implant.

7. The vascular access implant according to claim 4, wherein electrical energy can be supplied to the autonomous energy supply by wireless/contact-less energy transmission.

8. The vascular access implant according to claim 7, wherein the autonomous energy supply comprises an antenna of a coupling coil for wireless energy transmission, by which energy is supplied to the autonomous energy supply in a contact-less manner via inductive coupling with a magnetic flow in a near field.

9. The vascular access implant according to claim 1, wherein the arterial port and/or the venous port and/or the controllable artery-vein-connection comprise a disinfection unit as a component of the vascular access implant hich that has an anti-bacterial effect.

10. The vascular access implant according to claim 9, wherein: the disinfection unit emits UV light or a plasma to at least one of the arterial port, the venous port, and the controllable artery-vein-connection; and/or the disinfection unit comprises an anti-bacterial coating or an anti-bacterial material and/or comprises a self-disinfecting material adapted to be activated by light.

11. The vascular access implant according to claim 1, further comprising: an identification element for contact-less identification by means of a reader; and/or a communication unit adapted to receive and send data in a contact-less manner.

12. The vascular access implant according to claim 1, wherein the vascular access implant comprises a port dislocation detection at the arterial port and/or at the venous port that is adapted to detect whether the arterial port and the venous port are correctly coupled.

13. The vascular access implant according to claim 4, wherein the autonomous energy supply supplies energy to at least one of the disinfection unit, the identification element, the communication unit, and the port dislocation detection.

14. A vascular access implant system comprising: a vascular access implant according to claim 1, and an extracorporeal blood circulation, the vascular access implant system further comprising at least one of: an arterial mating adapter provided at one hose end of the first hose of the extracorporeal blood circulation, said arterial mating adapter configured for coupling to the arterial port in a form- and/or force-fitting manner; and a venous mating adapter provided at one hose end of the second hose of the extracorporeal blood circulation, said venous mating adapter configured for coupling to the venous port in a form- and/or force-fitting manner.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0040] The invention is explained in more detail below using a preferred embodiment with the help of accompanying Figures wherein:

[0041] FIG. 1 is a schematic top view of a vascular access implant according to the invention of an access implant system according to the invention according to a preferred embodiment;

[0042] FIG. 2 is a schematic top view of the vascular access implant of FIG. 1 placed in an arm of a patient; and

[0043] FIG. 3 is a schematic diagram view of the vascular access implant and the access implant system from FIG. 1.

DETAILED DESCRIPTION

[0044] FIGS. 1 to 3 show a vascular access implant 1 according to the invention and an access implant system 2 of the invention according to a preferred embodiment comprising a variety of components.

[0045] The access implant 1 serves as an interface between an intracorporeal blood circulation 4 of a patient 6 and an extracorporeal blood circulation 8 in order to draw blood from the patient 6, treat it with a blood treatment machine 10 in the form of a dialysis machine and then feed it back to the patient 6. With the extracorporeal blood circulation 8, various blood treatments can be performed, such as hemodialysis, hemodiafiltration, ultrafiltration or (therapeutic) apheresis to remove toxins from the blood.

[0046] The access implant 1 has an arterial fluid line 12 (see FIG. 3), for example in the form of a flexible arterial silicone line or a line made of a suitable vascular replacement material, which protrudes into an artery 14 of the patient 6 and is fluidly connected to it. Alternatively, the arterial fluid line 12 can also be firmly sutured to the artery 14. The arterial fluid line 12 can be used to draw off or withdraw/remove a quantity of blood from the artery 14 of the patient 6.

[0047] The arterial fluid line 12 conveys the extracted blood to a rigid arterial port 16. This arterial port 16 projects through a skin 17 of the patient 6, penetrates the skin barrier, so to speak, so that the arterial port 16 is easily accessible from 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 mating adapter 20 of the extracorporeal blood circulation 8 in a form-fitting and/or magnetic manner (i.e. in a force-fitting manner) (see FIG. 3). The arterial adapter 18 is connected to the arterial fluid line 12 in fluid-tight manner and forms, so to speak, the terminal (blood) outlet of the access implant 1 to the extracorporeal blood circulation 8.

[0048] The arterial adapter 18 of the intracorporeal blood circulation 4 and the arterial mating adapter 20 of the extracorporeal blood circulation 8 together form a coordinated system of the access implant system 2 and a defined interface. The arterial adapter 18 fits on the corresponding arterial mating adapter 20 to create a lossless, simple and detachable fluid connection between the adapter 18 and the mating adapter 20. The mating adapter 20 forms a terminal portion of a first (arterial) hose 22 of the extracorporeal blood circulation 8. The adapter 18 as one end of the (first) fluid channel (of the intracorporeal blood circulation 4) is thus directly connected to the mating adapter 20 as another end of the (second) fluid channel (of the extracorporeal blood circulation 8) and fixed against each other and permanently held in this position until a desired decoupling process is performed by a user. This creates a safe and detachable fluid connection between both blood circulations 4, 8. The arterial adapter 18 functions as an arterial connecting lock 19. A magnetic maximum force of attraction is usually sufficient to realize an arterial connecting lock 19 in a force-fitting manner. In particular, the arterial connecting lock 19 is designed in such a way that in the event of a strong pull on the mating adapter 20 and thus on the adapter 18, no matter in which direction, the connection is released, thus minimizing the risk of the access implant 1 being torn out with greatest damage consequence.

[0049] Analogous to the arterial side of the access implant 1, the vascular access implant 1 also has a rigid venous port 24 on its venous side with analogous features of a venous adapter 26, which can be connected to a corresponding venous mating adapter 28 of a second hose 30 of the extracorporeal blood circulation 8 in a force- and/or form-fitting manner. The venous adapter 26 thus forms a venous connecting lock 27. The cleaned or treated blood can be returned to the access implant 1 via the connection with the venous port 24. The blood flows to a venous fluid line 32 connected to the venous port 10 and realized in the form of a flexible venous silicone line that extends into a vein 34 of the patient 6 and is fluidly connected to it. 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 create a fluid circuit that connects the intracorporeal blood circulation 4 of the patient 6 with the extracorporeal blood circulation 4.

[0050] The way of function of the vascular access implant 1 according to the preferred embodiment is explained below. So instead of piercing a cannula through the skin 17 of the patient 6 into the vessel (artery/vein) of the patient 6 during each treatment of the patient 6 and thus creating a blood collection site to drain the blood for an extracorporeal blood treatment, and also performing a second puncture to return the purified blood to the vein of the patient 6, as is the case with a commonly used shunt, the access implant 1 provides a fully implantable interface device which is permanently connected to both the artery 14 and the vein of the patient 34 and which provides a defined common port with two separate fluid connections or two separate ports (arterial port 16 and venous port 24) to the extracorporeal blood circulation 8. The extracorporeal blood circulation 8 can be (detachably) coupled to the access implant 1 in painless manner, without having restrictions such as the number of attachments and detachments or a change of location, as is the case with cannula punctures (vascular damage).

[0051] The access implant 1 also has a housing 36 which has its outside designed with biocompatible materials and can be permanently and completely implanted in the body of the patient 6 due to its structural design. Only the arterial port 16 or the arterial adapter 18 and the venous port 24 or the venous adapter 26 protrude from the skin 15 of the patient. The housing 36 encloses, except for the projecting arterial fluid line 12, the projecting arterial port 16, the projecting venous fluid line 32 and the projecting venous port 24, the access implant 1.

[0052] 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 artery-vein-connection 40 in order to short-circuit the artery 14 with the vein 34, similar to a bypass. In the artery-vein-connection 40, a controllable electromechanical proportional valve 42 is interposed to continuously control the flow in the artery-vein-connection 40. The proportional valve 42 can be continuously closed from an open position and then reopened again, which also realizes states between an open position and a closed position. Via the proportional valve 42, a resistance or flow in the artery-vein-connection 40 can be changed within milliseconds in order to react to hemodynamic changes. A blood flow in the artery-vein-connection 40 can thus be individually adapted, and it is possible to prevent a coagulation by having a throttling and at the same time relieve the heart. If the patient 6 is connected to the blood treatment machine 10 using the extracorporeal blood circulation 8, the controllable artery-vein-connection 40 is opened, and if the patient 6 is no longer connected to the extracorporeal blood circulation 8, it is closed.

[0053] In order to prevent a recirculation of blood into the artery 14 in the artery-vein-connection 40, a check valve 44 is also provided in the artery-vein-connection 40, which only permits a flow direction from the artery 14 to the vein 34.

[0054] In front of the arterial port 8 or upstream of it, a controllable electromechanical valve 46 is provided in the arterial fluid line 12, which switches over between an open state and a closed state. Alternatively, the controllable valve 46 can also change a flow in continuous manner. The controllable valve 46 is designed to immediately interrupt the blood flow when the arterial mating adapter 20 is decoupled from the arterial port 16 to prevent uncontrolled discharge into the environment.

[0055] A check valve 48 in the venous fluid line 32 is also provided in front of the venous port 24. This check valve does not necessarily have to be actively operable, as it closes the venous port 24 from the environment depending on the pressure in the event of uncoupling. The venous port 24 only allows blood to flow into the access implant 1 by means of the check valve 48. The check valve 48 thus securely closes the venous port 24 and ensures that there is no unwanted exit point of the blood system of the patient 6.

[0056] In order to be able to act autonomously and independently or to be capable of being actuated, the access implant 1 comprises an autonomous energy supply 50 which provides electrical energy for the (electrotechnical) 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 over 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 which converts temperature differences into electrical energy by means of the thermoelectric effect and feeds it to the energy storage device 52, and a second energy harvester 56 which can convert movement energy of the patient 6 into electrical energy and feeds 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 be continuously supplied with electrical energy without the need 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, if necessary, the autonomous energy supply 50 has an antenna of a coupling coil or charging coil 58 so that it can also be charged wirelessly in the near field if required by means of inductive energy transmission. This allows the access implant 1 to be held to a complementary external coupling coil at a distance of a few centimeters in order to charge the energy storage device 52 via the charging coil 58 in inductive and contact-less manner.

[0057] The access implant 1 also has an indicator 60 in the form of an LED to indicate the state of charge of the energy storage device 52. The LED has sufficient luminosity to be visually perceived through the skin 17 of the patient 6. For example, the state of charge of the energy storage device 52 can be displayed in the form of the red flashing LED when the energy level is low.

[0058] In order to sterilize the arterial port 16 and the venous port 24 for coupling/connecting, the access implant 1 has an anti-bacterial 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 surfaces of both ports 16 and 24 by emitting UV light. In addition, the arterial and venous ports 16, 24 have a material with anti-bacterial effect or an anti-bacterial coating to achieve a long-lasting passive disinfection of the ports 16, 24. The artery-vein-connection 40 can also be irradiated and disinfected with UV light from the disinfection unit 62.

[0059] Data can be transferred to the extracorporeal blood treatment machine 10 by means of a communication unit 64 as a further component, in particular by means of a Bluetooth® or WLAN connection, in order to optimally adjust a therapy. Data can also be transferred to the access implant via the communication unit 64. The communication unit 64 is thus designed for wireless communication with other machines or systems.

[0060] An identification element 66 (as a further component) in the form of an RFID chip or an NFC coil is also connected to the communication unit 64 within the housing 36 of the vascular access implant 1. Using the identification element 66, the patient 6 can be uniquely identified by other machines. 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 adapt and adjust a therapy to the patient 3 accordingly. Since, for example, an NFC coil only has a very short range, data security can be increased since only data in the near field is transmitted. Reading the patient data by an unauthorized person is made more difficult, as the data would have to be tapped in the immediate vicinity. In particular, the data in the access implant 1 can also be encrypted, whereby preferably the communication unit 64 or the central control unit 70 performs the encryption. The blood treatment machine 10, which knows the encryption key, can then correspondingly decrypt the data transmitted in encrypted form. Similarly, the access implant 1 can also decrypt encrypted data from the blood treatment machine 10.

[0061] In order to determine a correct connection status at the arterial and venous port 16, 24, the access implant 1 has a port dislocation detection 68 (as a further component), which can detect by means of the Reed sensor and/or Hall sensor whether the respective mating adapter 20, 28 is correctly connected to the adapter 18, 26. The port dislocation detection 68 measures a magnetic or a changing magnetic flux and determines whether there is a correct coupling to the respective port 16, 24. A correct connection is of enormous importance, as it functions as a safety device and detects the intentional or unintentional loosening of the hose 22, 30 and then interrupts a fluid connection by means of the controllable valves 46 in order to avoid blood loss. In particular, the check valve 48 can also be (electromechanically) closable. If, for example, only the arterial hose 22 comes loose unintentionally, the check valve 48 can be closed, triggering a pressure alarm on the blood treatment machine 10 and stopping a blood pump. Alternatively, the access implant 1 can also close both valves 46, 48 and send a control command or 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 error information associated with the error on the display.

[0062] The vascular access implant 1 also has a central control unit 70, which processes received data/signals and can drive all (electrotechnical) components of the access implant 1. The control unit 70 is thus 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 regarding a current (valve) state, controls the controllable valve 46 and also receives data from the latter on 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 on, for example, a current state of charge, a current maximum charge capacity, an energy production and an energy consumption by the components, controls the indicator 60 and optionally an acoustic signal generator, controls the disinfection unit 62 and, if any, receives error messages, for example if the UV lamp is defective, controls the communication unit 64 and receives data from it, controls the identification element 66, if necessary, and receives data from the port dislocation detection 68. In addition, the control unit 70 stores relevant data such as patient data, therapy data, component data and reference data in its memory.

[0063] The artery-vein-connection 40 has a pressure sensor 72 and a flow sensor 74, which measures the pressure and the flow in the artery-vein-connection 40 and forwards them to the central control unit 70 as data. 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 artery-vein-connection 40, which can be used to avoid side effects of a blood treatment such as cardiac hypertrophy.

[0064] With the access implant 1 according to the invention or the access implant system according to the invention, the patient is provided with a device or system for pain-free coupling with increased safety, reduced risk of infection, improved patency and better therapy conditions with less vasodilation, lower risk of heart disease and lower susceptibility to unwanted blood loss.