WO2019229220A1 - Intravasale blutpumpe und verfahren zur herstellung von elektrischen leiterbahnen - Google Patents

Intravasale blutpumpe und verfahren zur herstellung von elektrischen leiterbahnen Download PDF

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Publication number
WO2019229220A1
WO2019229220A1 PCT/EP2019/064154 EP2019064154W WO2019229220A1 WO 2019229220 A1 WO2019229220 A1 WO 2019229220A1 EP 2019064154 W EP2019064154 W EP 2019064154W WO 2019229220 A1 WO2019229220 A1 WO 2019229220A1
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WIPO (PCT)
Prior art keywords
blood pump
electrical
region
conductor tracks
sensors
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Ceased
Application number
PCT/EP2019/064154
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German (de)
English (en)
French (fr)
Inventor
Julian Kassel
Thomas Alexander SCHLEBUSCH
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Kardion GmbH
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Kardion GmbH
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Filing date
Publication date
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Priority to US17/057,044 priority Critical patent/US12194287B2/en
Priority to JP2021517523A priority patent/JP7359462B2/ja
Publication of WO2019229220A1 publication Critical patent/WO2019229220A1/de
Anticipated expiration legal-status Critical
Priority to US19/018,309 priority patent/US20250144397A1/en
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A61M60/816—Sensors arranged on or in the housing, e.g. ultrasonic flow sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the present invention relates to an intravascular blood pump, which can be used in particular as a cardiac assist system. Furthermore, the invention relates to a method for producing electrical interconnects in such a blood pump.
  • LVAD Left Heart Support Systems
  • balloon pumps are known.
  • rotary blood pumps have already been developed which, in particular, can also be introduced in a minimally invasive manner into, for example, the left ventricle and the aorta. In a corresponding way, for example, a support of the right side of the heart is possible.
  • Such systems make high demands on the size.
  • the invention provides an intravascular blood pump, which is based in particular on the rotation pump principle, which can be used in particular as a cardiac support system.
  • the blood pump comprises a tip, a first region with at least one blood passage opening, a flow cannula, a second region with at least one blood passage opening, a motor-operated pump device and a cable for the electrical supply and control of the system.
  • the blood pump is characterized in that at least one electrical strip conductor is provided by a surface coating structure at least in the area of the flow cannula. By the electrical conductor (s) electrical connections and / or sensors can be realized.
  • At least one electronic component can be arranged, in particular one or more active electronic components, for whose electrical connection the at least one electrical conductor serves.
  • electrical conductor tracks of thickness of the electrical connection lines can be reduced in a particularly advantageous manner to a minimum.
  • the requirements for the small size of such systems are taken into account.
  • Such surface coating structures make it possible, in particular, to bridge the region of the flow cannula.
  • other areas of the blood pump can also be bridged, For example, the areas of the blood passage openings and the pumping device or parts thereof.
  • Electronic components in the tip of the system can thus be electrically connected to more remote areas of the system, in particular to the cable, so that, for example, an energy transfer and / or data transfer from or to external control devices and / or evaluation devices is possible .
  • the invention allows a very advantageous electrical contacting of electronic components in the tip or at another position, wherein the electrical contacting or connection to the cable by the electrical surface functionalization very thin and space-saving and thereby very strong, stable and reliable can be executed.
  • the assembly process required for this can be realized in a cost-effective manner.
  • the electronic components in the region of the tip can be, in particular, sensors, for example pressure sensors, flow measuring sensors, temperature sensors or the like.
  • sensors for example pressure sensors, flow measuring sensors, temperature sensors or the like.
  • optical sensors, acceleration or gyroscope sensors and acoustic sensors (microphones) are also possible.
  • sensors or other electronic components and electrode surfaces which are suitable for medical monitoring of the patient and / or the function of the intravascular blood pump and / or for controlling the blood pump.
  • sensors can be realized by means of the conductor tracks themselves, for example strain sensors and / or break sensors and / or temperature sensors. In this way, sensors can be integrated in the surface structure in a very advantageous manner. Furthermore, exposed electrodes for recording electrical excitation signals or for performing an electrical impedance measurement are also possible. Such sensors can be realized by sensor areas within the surface coating structure, which Meander-shaped interconnects include. Furthermore, the conductor tracks in the sensor area or regions can be made of a different material than the conductor tracks outside the sensor areas. For example, the printed conductors can be formed in a sensor region of platinum, whereby the sensor region can be used as a temperature sensor.
  • the use of such sensor areas is also possible as electrical sensors, so that the sensors serve, for example, for the dielectric characterization of the surrounding blood.
  • the coupling can take place conductively or capacitively, comparable to an impedance spectroscopy.
  • the integration of a thin surface wave sensor, for example, as a thin ceramic disc for determining, for example, the blood viscosity possible.
  • the flow cannula of the intravascular blood pump has one or more coatable materials.
  • a hose guide made of coatable material can be provided.
  • the surface coating structure for realizing the electrical conductor tracks is applied to the one or more coatable materials.
  • the flow cannula it is expedient for the flow cannula to be flexible.
  • the hose guide can be equipped with a flexible skeleton structure, for example a spiral structure.
  • Other options include zigzag or wave structures.
  • the flexible structure (eg the spiral structure) is expediently designed such that a continuous web structure is present on which the electrical conductor tracks are guided. With particular advantage, such flexible structures of the coatable material are at least partially formed.
  • coating materials for example, metallic materials are suitable, for example titanium and / or stainless steel. Particularly preferred are nickel-titanium alloys (NiTiNol), which are already used in medical technology because of their particularly advantageous properties. In addition to their advantages in terms of their deformation properties, nickel-titanium alloys also have the advantage of being directly coated can.
  • suitable coatable materials are, for example, glass and / or ceramic.
  • the surface coating structure may preferably have a multilayer structure, for example a two-layer structure, wherein the lower layer can be used for metallization of another conductor layer in the intermediate space between two conductor structures, so that a plurality of conductor layer layers are, as it were, interleaved with one another.
  • the total conductor width can be reduced.
  • the layer thickness of the entire conductor structure is reduced.
  • electrical contact pads are provided for electrical contacting of the conductor tracks.
  • the contact pads may, for example, be provided at the end of the flow cannula, opposite the tip of the system.
  • the invention further includes a method for producing electrical interconnects at least in the region of a flow cannula of an intravascular blood pump, reference being made to the above description with regard to this blood pump.
  • the electrical conductor tracks are produced by a surface coating, in particular by surface lithographic methods.
  • optical lithographic methods eg UV lithography
  • planar 2D wafer processes may be applied to cylindrical bodies so that conventional lithographic processes may in principle be used by adjustments of exposure devices.
  • Photolithographic methods in particular three-dimensional UV photolithographic methods, are particularly suitable.
  • To produce the surface structuring in particular a magneton sputtering and optionally wet-chemical etching methods can be used.
  • an insulating base coat may first be applied to the coatable material.
  • this may be an oxide layer applied by sputtering or a polyimide.
  • a photoresist is applied and patterned according to the applied conductor tracks.
  • a lithography mask for example made of chromium-coated quartz substrate, before the photoresist is exposed and developed.
  • the metallic conductor track structure is applied by sputtering.
  • gold is preferably used as the material for the conductor tracks.
  • the photoresist is removed.
  • an electrically insulating and preferably biocompatible surface is applied. Again, this can be done by sputtering, for example, oxide or by applying polyimide or parylene or else.
  • the layer thickness of the resulting sputtered surfaces is preferably in the range of a few hundred nanometers.
  • the following described variant of the method can provide a printed conductor structure with an increased layer thickness (for example a few micrometers).
  • a complete conductive surface coating is produced in principle. This is windowed by a structured photoresist and the exposed windows are then thinned galvanically.
  • an insulating base layer is applied, for example an oxide layer by sputtering or a base layer of polyimide.
  • an initial metallic conductor layer eg gold
  • a photoresist is applied to the initial conductor layer and patterned according to the conductor tracks to be applied.
  • the exposed metallic conductor tracks or the exposed windows are subsequently electrolytically thickened wet-chemically, so that the desired conductivity can be produced in the exposed metal structures.
  • the photoresist is removed.
  • the surface is etched, so that the electrical interconnect structures are released.
  • an electrically insulating and preferably biocompatible surface is applied, for example by sputtering of oxide or by applying polyimide or parylene or other materials.
  • the process preferably also includes the structuring of the tube material, in which a web structure is produced on which the conductor tracks are guided (for example helical structure). This structuring can take place before or after the production of the printed conductors. Finally, the windows of the web structure are sealed, for example, with silicone or polyurethane.
  • FIG. 1 is a sectional view of a human heart and lungs with introduced intravascular blood pump.
  • Fig. 2 components of an intravascular blood pump (LVAD system); 3 is an isometric view of a flexible tube guide of the flow cannula of an intravascular blood pump;
  • FIG. 4 shows a detail view of the hose guide of a flow cannula with a surface coating structure according to the invention for
  • FIG. 5 shows a detailed view of the hose guide of a flow cannula with a surface coating structure according to the invention with the formation of sensor regions through the conductor tracks;
  • FIG. 6 is a detailed view of the hose guide of a flow cannula with surface coating structure according to the invention, showing electrical contact pads;
  • FIG. 7 shows a detailed view of a cross section through a flow cannula with a surface coating structure according to the invention
  • FIG. 8 shows a further detailed view of a cross section through a flow cannula with a surface coating structure according to the invention with a two-layer structure
  • FIG. 10 shows a further detailed view of a cross section through a surface coating structure with a multilayer construction and shielding.
  • 1 shows a human heart 10 and the surrounding lungs 20, wherein an intravascular blood pump 100 is introduced into the left ventricle 11.
  • an intravascular blood pump 100 By pumping the blood pump 100, the pumping function of the heart 10 supported by oxygen-rich blood, which passes from the pulmonary vein 12 into the left ventricle 1 1, is transferred into the aorta 13.
  • the intravascular blood pump may be for continuous pumping or, for example, the pump is based on a pulsatile-type system in which the pump speed is modulated.
  • Fig. 2 shows schematically the components of an intravascular blood pump 100, which is equipped according to the invention with ahenbe Anlagenungs- structure for the formation of electrical traces.
  • the blood pump 100 includes a tip 1 10, wherein within the tip 1 10 in one area one or more electronic components 1 12 may be provided, in particular sensors.
  • the tip is completed by a sliding cap 1 1 1.
  • a first region 120 inlet cage
  • blood passage openings 121 connects.
  • blood can be sucked from the left ventricle into the blood pump through the blood passage openings 121.
  • a flow cannula 130 and a second region 140 (impeller cage) with further blood passage openings 141 is followed by a flow cannula 130 and a second region 140 (impeller cage) with further blood passage openings 141.
  • an area 150 for a motor-driven pumping device is followed by an area 150 for a motor-driven pumping device.
  • an impeller impeller
  • the pump device 150 is adjoined by a back end 160, via which the electrical connection takes place.
  • a supply cable 170 is provided for the electrical supply and the control.
  • the motor-operated pump device is preferably a rotary pump (flow machine), it also being possible for any reversal of the conveying direction to be provided.
  • sensors or sensor regions for example, fracture sensors or strain sensors or temperature sensors
  • the optionally existing electronic components 1 12 of the tip 1 10 are electrically connected to the supply cable 170.
  • the length of the flow cannula 130 can be bridged, but also the regions 120 and 140 as well as the region with the motor-operated pump device 150.
  • Various components can be combined and realized as one component.
  • the first region 120 may be combined with the flow cannula 130 as a component, which may then be equipped in a very advantageous manner with the surface coating structure according to the invention for the formation of conductor tracks.
  • FIG. 3 shows a combined embodiment of the first region with blood passage openings 221, to which the flow cannula 230 directly adjoins.
  • the flow cannula 230 is realized as a flexible inlet hose or as a flexible hose guide.
  • the flexible flow cannula 230 is realized in this example by a helical structure formed by circumferential fenestrated ridges 300.
  • a laser-structured tube of NiTiNol material may be provided as a coatable material for this purpose.
  • a slot-shaped opening is provided, which is provided for the passage of a guide wire in a conventional manner during the Implantati- onsreaes.
  • the skeleton or web structures 300 of the NiTi-Nol material are electrically functionalized by surface coating to form the printed conductors, wherein the printed conductors can serve in particular for the electrical connection of electronic components and / or for the formation of sensors.
  • the spiral structure of the NiTiNol tube can be produced by laser structuring.
  • the cut-out windows of the laser-structured form can be closed by flexible materials, for example by silicone or polyurethane.
  • the flexibility of the hose guide can also be achieved by other structures, for example by zigzag or wave pattern.
  • the surface coating structure as such may be as described above Procedures are applied. In this context, reference is also made to an article by Bechtold et al.
  • FIG. 4 shows a detailed view of the resulting exemplary printed conductor structures on the flow cannula 230.
  • the webs 300 of the laser-structured spiral structure (see FIG. 3), which as it were form the framework of the flexible flow cannula 230, leave windows 301 exposed.
  • the windows 301 are preferably flexibly closed, for example by silicone or polyurethane.
  • the webs 300 together with the closed windows 301 form the hose guide of the flow cannula 230.
  • electrical conductor tracks 302, 303 are applied to the webs 300 by lithography and coating technology.
  • a lithography mask is applied for each layer, which contains the corresponding coating structures (electrical strip conductor structures).
  • the lithographic mask may, for example, be a chromium-coated quartz substrate.
  • Non-conductors such as photoresist or polyimide can be applied by dipping, for example, by immersion, nonconductors such as Parylene C can be deposited, for example in a vacuum.
  • Initial metallic layers are applied in particular by sputtering, thicker layers by electroplating.
  • two approaches can be used in particular: According to method 1, the tube material (for example NiTiNol) is first provided with the electrical surface coating to form the conductor tracks.
  • the flexible structure is produced, for example, by laser cutting (laser structuring), wherein the coating structure and the laser cutting contour are geometrically matched to one another.
  • the windows of the flexible structure are closed, for example by immersion or extrusion coating.
  • process 2 first the pipe material is structured. Subsequently, the surface functionalization for the formation of the printed conductors is produced with the lithographic processes. Finally, the windows of the flexible structure are closed as in method 1.
  • Method 1 has the advantage that the lithography process is simplified.
  • Method 2 has the advantage that mold impressions into the NiTiNol material are possible directly after the structuring of the pipe material, for example "storing in” of bends or cross-sectional changes to the cross section of the starting material (eg widening of the cross section). Because of the process temperatures required for shaping, it is generally advantageous to carry out this step before the lithographic surface coating.
  • the flow cannula 230 is provided with strip conductors 302, 303, which are formed by surface structuring of the bars 300 of the flow cannula 230 (right-hand side of the illustration). Furthermore, meander-shaped conductor tracks are provided which form the sensor areas 304 (left) and the additional sensor area 305 (right). Here, between individual sensor regions 304 straight sections of the conductor tracks may be provided, or the sensor region 305 is formed by a continuous meander-shaped conductor track.
  • the supply and discharge lines 306, 307 of the sensor regions 304 may be made of a different material than the sensor regions themselves be made. A plurality of sensor regions can be implemented via separate supply lines or also, for example, with a common return channel line 308.
  • a temperature sensor it can be provided, for example, to carry out the conductor tracks of the sensor regions 304 or 305 made of platinum, since platinum has a very linear resistance-temperature relationship.
  • the inlet and outlet tracks 306, 307, 308 expediently have the lowest possible resistance in order to exert little influence on the sensor signal.
  • the printed conductor structures can also be used, for example, as strain or fracture sensors. Furthermore, the use is possible, for example, as capacitive sensors, electrode surfaces or contact pads for other sensors.
  • FIG. 6 shows a preferred electrical contacting of the conductor tracks 302, 303 by electrical contact pads 310, 31 1, 312, 313.
  • This electrical contacting can take place, for example, at the end of the flow cannula 230, that is to say in the direction of the second area 140.
  • the interconnects are also performed on other components of the blood pump, for example, over the range 140, 150 to the electrical connection portion 160.
  • the electrical connection can be made for example by Leitkleben, soldering, bonding or adhesion.
  • the connection can be made directly from, for example, NiTiNol component to NiTiNol component or from NiTiNol component directly to a cable or a thin-film substrate, depending on the configuration of the blood pump.
  • Fig. 7 shows a cross section through the resulting layer structure, which realizes the electrical conductor tracks.
  • 710 represents the underlying NiT-iNol structure or another coatable material as a supporting structure of the flow cannula.
  • 720 represents an insulating base layer, for example of silicon oxide or polyimide.
  • 730 shows the metallic conductor track structures, for example of gold.
  • 740 provides an insulating By repeated repetition of the surface coating (surface lithography), a multi-layer structure, for example a two-layer structure can be realized, as illustrated in Fig. 8.
  • 710, 720, 730 and 740 represent the coatable structure, the insulating base layer, the first layer of the interconnect structures and the insulating termination layer, respectively, comparable to FIG. 7.
  • interconnect 750 is provided, which is arranged in a slightly higher level.
  • the space (empty space) between the printed conductor structures 730 on the lower layer is used for the metallization of the upper layer by arranging the metallic conductor layer in this intermediate space.
  • This staggered arrangement of the printed conductors on different levels avoids the formation of larger elevations or roughnesses of the surface structure in the regions in which metallic printed conductors would overlap one another. This can occur in particular in higher multi-layer structures with six or more layers.
  • this embodiment with offset arrangement compared to a purely coaxial embodiment has the advantage that the resulting layer thickness of the entire conductor structure is reduced.
  • this embodiment is also particularly advantageous since the overall conductor width is reduced. If an offset arrangement of the conductor tracks is not desired or possible, it is alternatively also possible to compensate for any unevenness that may occur as a result of superimposed conductor tracks, for example with a silicone layer or the like.
  • Fig. 9 shows another structure of a multilayer wiring pattern.
  • four narrow interconnects 910 and two wide interconnects 920 are arranged one above the other on the coatable material (not shown in detail).
  • the narrow strip conductors 910 serve, for example, as a communication bus for a pressure and a temperature sensor in the tip of the blood pump.
  • the wide traces 920 have a smaller one Resistance (electrical power) and serve, for example, to connect an ultrasonic element in the tip of the blood pump.
  • a total of seven layers are required for the surface coating.
  • FIG. 10 shows a similar example of a multilayer structure with four narrow interconnects 1010 and two broad interconnects 1020.
  • shielding 1030 which shield the interconnects 1010 and 1020 against each other and to the outside, so that a defined line impedance and less high-frequency radiation is achieved with shielded guidance of the signals.
  • shielding 1030 which shield the interconnects 1010 and 1020 against each other and to the outside, so that a defined line impedance and less high-frequency radiation is achieved with shielded guidance of the signals.
  • the up to 11 layers can be suitably guided in the width and passed, for example, by a vertical through-hole in the uppermost metal layer.

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PCT/EP2019/064154 2018-05-30 2019-05-30 Intravasale blutpumpe und verfahren zur herstellung von elektrischen leiterbahnen Ceased WO2019229220A1 (de)

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US17/057,044 US12194287B2 (en) 2018-05-30 2019-05-30 Method of manufacturing electrical conductor tracks in a region of an intravascular blood pump
JP2021517523A JP7359462B2 (ja) 2018-05-30 2019-05-30 血管内血液ポンプおよび電気導体トラックの作製方法
US19/018,309 US20250144397A1 (en) 2018-05-30 2025-01-13 Method of manufacturing electrical conductor tracks in a region of an intravascular blood pump

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