Classifications

• • 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
  • A61M60/80—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
  • A61M60/859—Connections therefor
• • 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
  • A61M60/139—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 inside the aorta, e.g. intra-aortic balloon 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
  • A61M60/10—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
  • A61M60/148—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 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• • 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
  • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• • 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
• • 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
  • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed 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
  • A61M60/80—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
  • 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
  • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body

Definitions

• Conduction device for directing blood flow for a cardiac assist system, and manufacturing and assembly procedures
• the invention is based on a device or a method according to the preamble of the independent claims.
• Cardiac support systems can be distinguished for their position on the heart and their access to the bloodstream.
• Long-term support systems may be positioned at the apex of the heart (transapical) and bypass the left ventricle by pumping blood from the apex directly into the aorta via a tube.
• the cardiac support system may be a ventricular assist system as a bridging measure, to bridge to a transplantation (Bridge to Decision, Bridge to Transplant).
• the natural aortic valve can be used to create a connection between the pump inlet and outlet.
• the aorta can be used as an access path (transaortic) in a minimally invasive operation and a sternotomy can be avoided.
• the object of the invention is to specify an improved line device for a cardiac assist system, in particular with permanent connection security and suitable flexibility, and a method for the production and assembly thereof.
• a lead device for conducting a blood flow for a cardiac assist system a method for producing a lead device and a method for mounting a cardiac assist system according to the main claims are presented.
• Advantageous refinements and improvements of the device specified in the independent claim are possible due to the measures listed in the dependent claims.
• a lead device for directing blood flow to a cardiac assist system such as a left ventricular heart support system
• the conduit device may be used as a flow channel in which blood flow from the pump inlet in a left ventricle may be directed to the pump outlet within an aorta.
• a head unit of the cardiac assistance system can be connected to the lead device at one end, and another component of the cardiac support system, for example an impeller housing, can be connected to another end.
• the connection can be realized by means of a positive connection. Additionally or alternatively, the connection can also be realized non-positively.
• the conduit device may be shaped to allow trans-femoral operation (access via the groin) for implanting the cardiac assist system. This can be achieved in particular by the ratio of flexibility and rigidity of the line device.
• a lead device for directing a blood flow for a cardiac assist system has a base body, wherein the main body at a first end, upstream, a proximal (first) connecting portion for connecting the lead device to a head unit of the cardiac assist system and at a second end, downstream, a distal (second ) Comprises connecting portion for connecting the line device to an outlet unit of the cardiac assistance system.
• the connection sections are positive and additionally or alternatively formed positively frictionally connected.
• the base body has a structural section between the connecting sections with at least one stiffness recess, wherein the at least one stiffness recess is designed to change the rigidity of the basic body.
• the conduit device may be formed of a biocompatible material and may be understood as a flow channel for flexibly connecting components of a cardiac assist system for directing a blood flow between the ventricle and the blood vessel.
• the conduit device may be used as a suction tube of the cardiac assist system to induce blood flow and to pass it to an outlet portion of the cardiac support system.
• the cardiac assist system may be understood as a left ventricular assist device (LVAD) or another ventricular assist device (VAD).
• the main body of the conduit device can be formed, for example, as a hollow cylinder and have a substantially tube geometry.
• the proximal connection section at a first end of the main body can be understood as a first connection section and, for example, in the implanted state of the cardiac support system, can be arranged as a left ventricular support system in the left ventricle.
• the distal attachment section at a second end of the base body can be understood as a second attachment section and can be arranged in the implanted state of the left ventricular support system, for example in the aorta.
• a head unit of the heart support system for example a sensor module, can be connected to the proximal connection section.
• the structural section may, for example, be a main body section with a predefined sectional contour for changing the rigidity of the duct device, for example in order to enable the use of the duct device in a transfemoral operation.
• the rigidity can be determined by means of the shaping of the sectional contour of the Structure portion, in particular a number and shape of the at least one stiffness recess can be changed.
• the at least one stiffness recess may, for example, have a helical shape or a wave shape.
• the inlet section can be realized for example by a multi-part window in the main body.
• the inlet portion may be formed to allow introduction of the blood flow into the body of the conduit.
• connection sections may have at least one connection element for positive connection.
• the connecting element may be, for example, a recess or an elevation, for example a nub, or a threaded element.
• the connecting element as a recess or as a knob may for example be round, oval, triangular, polygonal or star-shaped.
• Each of the connection sections can also have a plurality of connection elements, wherein the connection elements can also be formed differently.
• the correspondingly formed engaging or engaging connection partner of the connection element can be realized for connecting the line device to the head unit and additionally or alternatively the outlet unit of the cardiac support system.
• the base body may have an inlet section between the structural section and the proximal or first attachment section, wherein the inlet section is shaped to allow the blood flow to be introduced.
• the inlet section is shaped to allow the blood flow to be introduced.
• At least one partial section of the main body may be formed from a shape memory material.
• the shape memory material may be a biocompatible one Shape memory polymer, or a biocompatible shape memory alloy such as nitinol.
• the entire base body can also be manufactured from the shape memory material.
• nitinol as a shape memory material is advantageous because the nitinol material is a proven material in medicine, especially in the field of cardiovascular medicine, for example, for flap valve prostheses, stents and vascular prostheses, and also because of its biocompatibility and shape memory property to realize complex structures in a small space.
• the conduit device may according to one embodiment also have a cable groove.
• the cable groove may be formed to guide a cable along the body.
• the cable groove may be helically formed around the structural portion circumferentially.
• the cable may, for example, be a cable for signal transmission and additionally or alternatively for energy transmission.
• the cable received by the cable groove may be configured to derive sensor data from the head unit at a pump tip within the heart valve and transmit it to a controller.
• the cable groove can advantageously help to prevent breaking of the cable during operational movements of the cardiac assistance system.
• the structural portion of the conduit device may, according to an embodiment, extend over at least half of the base body. This is with regard to an implantation, in particular in a transfemoral to gang, the line device advantageous to allow the formation of the structural portion a predefined ratio of flexibility and rigidity of the line device.
• the flexibility of the line device may be advantageous, for example, when pushing through an aortic arch, and the stiffness may advantageously cause kinking the conduction device when pushing through a blood vessel are avoided.
• the structural portion may have, as the at least one stiffness recess, a plurality of oblong holes.
• the longitudinal holes may be evenly spaced and formed obliquely across the longitudinal axis of the structural section.
• the plurality of oblong holes can also be formed in a screw shape around the structural section. The use of a plurality of elongated holes as the at least one stiffness recess is advantageous in order to adjust the flexibility of the line device, for example, by the spacing of the individual elongated holes.
• the conduit device may have a sealing layer.
• the sealing layer may be arranged on the structural section and shaped to close the at least one stiffness recess in a fluid-tight manner.
• the fluid-tight closing of the at least one stiffness recess by means of the sealing layer is advantageous for the guidance of the blood flow in order to conduct the blood flow to the outlet unit without loss.
• the sealing portion can be realized for example by means of a potting or encapsulation of the structural portion with a flexible plastic, such as polyurethane or silicone.
• the base body may also have a bending point according to an embodiment, wherein the bending point between the inlet portion and the dis tal connecting portion is arranged.
• the base body may have a first longitudinal axis between the distal connection section and the bending point, and the base body may have a second longitudinal axis oblique to the first longitudinal axis between the bending point and the proximal connection section, the base element being in a region of the Bending rack is formed arcuate.
• the flexure may be shaped to arcuately shape the body of the human anatomy to position the inlet portion in the body Center of a ventricle to allow advantageously to avoid aspiration of the inlet unit to a ventricular wall.
• an inner diameter of the base body may vary from the proximal attachment portion to the distal attachment portion.
• a cross section of the inner diameter can taper in the direction of the distal attachment section. The change in the inner diameter of the base body can advantageously improve the flow properties of the introduced blood stream.
• the inlet section may have at least one inlet opening cut into the main body.
• the inlet opening can, for example, be rectangular or shaped as a rectangle with a circular arc in the direction of the structural section.
• the inlet section can also have a plurality of inlet openings, for example three inlet openings.
• the inlet openings can, for example, be uniformly spaced, wherein between two adjacent inlet openings, for example, a narrow web can connect the proximal connection section to the structural section.
• an additional component for introducing the blood flow can be dispensed with, which is advantageous with regard to a compact design.
• the distal attachment portion may include a delivery opening for performing a guide wire for positioning the cardiac assist system.
• the guidewire may be inserted at the proximal attachment portion and executed through the deployment opening. This is advantageous to enable positioning of the conduit device along the guidewire and also Prevent damage to the guidewire or pump components.
• the cardiac assistance system may include a head unit, an outlet unit and an embodiment of the above-mentioned conduit device.
• the conduit device may be arranged between the head unit and the outlet unit and connected to the head unit and the outlet unit.
• the method comprises the following steps:
• a base body Forming a base body from a semifinished product from a shape memory material, wherein the base body at a first end has a proximal connection section for connecting the line device to a head unit of the cardiac support system and at a second end a distal connection section for connecting the line device to an output module wherein the base body between the connecting portions has a structural portion with at least one stiffness recess, wherein the at least one stiffness recess is formed to the stiffness of the base body to change;
• an embodiment of the above-mentioned piping device can be advantageously produced.
• a method of mounting an embodiment of the above-mentioned Flerzunterstützungssystems comprises the following step: producing a positive and / or non-positive connection of the head unit and the outlet unit with the line device in order to mount the heart support system.
• Fig. 1 is a perspective view of a cardiac assist system with a conduit device for conducting a blood flow
• Fig. 2 is a side view of a conduit device for directing a blood stream for a Flerzunterstützungssystem
• FIG. 3 shows a side view of a further line device for conducting a bloodstream
• FIG. 6 is a fragmentary perspective view of a distal attachment portion of a conduit device connected to the rotor housing
• FIG. 7 shows a schematic representation of a connecting element
• FIG. 8 is a fragmentary perspective view of a proximal attachment portion of a conduit device
• FIG. 9 is a fragmentary perspective view of a distal attachment portion of a conduit device
• FIG. 10 is a perspective view of a bending point of a line device
• FIG. 11 is a schematic side view of a line device
• Fig. 12 is a perspective view, partly in section, of a portion of a lens support system
• Fig. 13 is a perspective view of a conduit device
• FIG. 14 is a perspective view of a part of a Flerzunterstüt- sation system
• FIG. 15 is a perspective view of a structural portion of a conduit device
• FIG. 16 is a perspective view of a conduit device
• FIG. 17 is a perspective view of a conduit device
• FIG. 18 is a schematic representation of a part of a conduit device
• FIG. 19 shows a partial enlargement of the line device according to FIG. 18
• FIG. Fig. 20 is a flowchart of a manufacturing method
• Fig. 21 is a flowchart of a mounting method.
• FIG. 1 shows a cardiac assist system 100 with a tube-like delivery device 105 for conducting a blood flow according to an exemplary embodiment. Shown is a view of the heart support system 100 as a whole system, which is exemplified here as a left ventricular support system.
• the cardiac assistance system 100 comprises a head unit 110, an outlet unit 15 and the conduit device 105.
• the conduit device 105 is arranged between the head unit 110 and the outlet unit 15 and is connected to the head unit 110 and the outlet unit 15.
• the conduit device 105 may also be referred to as a suction tube, which in the implanted state of the cardiac assist system 100 connects a pump inlet within a heart chamber to an outlet within the aorta.
• the cardiac assist system 100 has a cylindrical, elongated configuration with a substantially constant outer diameter and rounded, tapered ends for easy placement by means of a catheter in a blood vessel, such as the aorta.
• the cardiac support system 100 is bent in the direction of the head unit 110, wherein the bend with respect to a longitudinal axis of the cardiac support system 100 is formed, for example, as an obtuse angle.
• 2 shows a schematic representation of a line device 105 for conducting a blood flow for a cardiac assist system according to an exemplary embodiment in a side view.
• the conduit device 105 may also be referred to as a laser-cut aspiration tube.
• the line device 105 has a main body 205.
• the main body 205 is formed by way of example tubular.
• the main body 205 has at a first end a proximal connection section 210 for connecting the line device 105 to a head unit of the cardiac assist system and at a second end a distal connection section 215 for connecting the line device 105 to an outlet unit of the cardiac support system.
• the connection sections 210 and 215 are positively and / or non-positively connectable.
• the base body 105 between the connection sections 210, 215 has a structural section 220 with at least one stiffness recess 225, wherein the at least one stiffness recess 225 is formed to change the rigidity of the main body 205.
• the main body 205 has an inlet section 230 between the structural section 220 and the proximal attachment section 205, wherein the inlet section 230 is shaped to allow introduction of the blood flow.
• the structural section 220 extends, as shown here, according to embodiments over at least half of the main body 205.
• the structural section 220 according to the embodiment illustrated here as a stiffness recess 225 has a plurality of elongated holes.
• the stiffening recesses 225 extend, for example, over the entire structural section 220 and are arranged in a helical circumferential manner.
• the inlet section 230 has at least one inlet opening 235 cut into the main body 205.
• the inlet opening 235 is realized by way of example as a multi-part window.
• the Inlet section 230 comprises according to the exemplary embodiment shown here three rectangular shaped inlet openings 235, which are rounded in the direction of the structural portion 220 in the form of a circular arc.
• FIG. 3 shows a schematic representation of a line device 105 for conducting a blood flow for a lens support system according to an exemplary embodiment.
• the line device 105 shown corresponds or resembles the line device from the above-described FIG. 2 with the exception of the distance between the plurality of elongated holes as a stiffness recess 225.
• the structural section 220 shown here has a finer sectional contour than the coarser section shown in FIG Cut contour on. Adjacent oblong holes are correspondingly smaller in the present FIG. 3.
• the ratio of flexibility and rigidity of the line device 105 can be adjusted by the example of a laser-cut structure.
• the support system also called a pump
• the support system also called a pump
• the support system must on the one hand be flexible enough to be pushed through the aortic arch can, and on the other hand requires some rigidity to be pushed in the axial direction by an applied force through the narrow blood vessels, without kinking.
• a further difference from the already described exemplary embodiment of the line device 105 is the shape of the inlet section 230.
• the inlet section 230 also has three inlet openings 235 in FIG. 3.
• the inlet openings 235 are rectangular in shape, with the sides of each inlet opening 235 lying opposite the longitudinal axis of the line device 105 being longer than the sides opposite to the longitudinal axis.
• the proximal attachment portion 210 and the distal attachment portion 215 correspond to the embodiment described in the preceding FIG. 2.
• 4 shows a schematic representation of a distal connection section 215 of a line device according to one exemplary embodiment.
• the conduit device corresponds or resembles the conduit device of one of the figures described above.
• the distal connection section 215 has at least one connection element 405 for positive connection.
• the connecting element 405 is shown here by way of example as a rectangular recess. Alternatively, the connecting element 405 can also be realized as a collection, as the connecting element shown in the following FIG. 5.
• the proximal connection section optionally has a corresponding or similar connection element 405, such as the connection element 405 shown here for the positive connection.
• the connecting element 405 is embodied, for example, with the aid of a laser cutting contour in order to realize the bond permanently and reliably via a key-lock principle.
• such a laser-cut distal connection section 215 is shown according to the key-lock principle.
• the connecting element 405, which is rectangular in this case, can also have a different geometric shape, for example, the connecting element 405 can be realized as a circle, as an oval, as a triangle, as a polygon or as a star. If the connecting element 405 has an elevation, the elevation may have a flattening, as described with reference to FIG. 7.
• FIG. 5 shows a schematic representation of an impeller housing 502 of a cardiac assist system.
• the impeller shell 502 may correspond to or be part of the outlet assembly of the cardiac assist system described in FIG. 1.
• a rectangular connecting element 505 is shown as a knob on the impeller housing 505.
• the connecting element shown here has a flattened side in order to facilitate the assembly process, that is, the positive connection of the impeller housing 505 with the conduit device.
• the connecting element for positively connecting one of Connecting portions may be formed like the connecting element 505 shown here and realized on one of the connecting portions.
• FIG. 6 shows a schematic representation of a distal connection section 215 of a line device connected to the impeller housing 502 according to one exemplary embodiment. Shown are the distal connection section 215, as described with reference to the above FIG. 4, and the wheel housing, as described with reference to FIG. 5, in the connected, ie mounted state.
• an assembled positive connection point between the conduit device in the form of the distal connection section 215 and the adjacent component, the impeller housing 502, is shown here.
• the connecting element 505 here has a protruding shape with a flattened side for facilitating the positive connection when the connecting element 405 is picked up.
• the distal attachment portion 215 is formed as part of the conduit device, exemplified as a nitinol tube.
• FIG. 7 shows a schematic illustration of a connecting element 505 according to an exemplary embodiment. Shown is a cross section of the connecting element 505, which here has a flattening.
• the connecting element 505 shown corresponds or resembles the connecting element, as was described with reference to the preceding FIGS. 5 and 6.
• FIG. 8 shows a schematic representation of a proximal connection section 210 of a line device according to one exemplary embodiment.
• the conduit device corresponds or resembles the conduit device of one of the figures described above. Shown is a laser cut at the proximal end of the line device as a proximal connection section 210.
• the shaping of the proximal connection section 210 shown here permits widening and thus a non-positive interference fit.
• the head unit of the Flerzunter- support system is frictionally with the proximal connection portion 210 connected.
• the proximal connection section 210 has labyrinth recesses 805 in order to allow widening of the proximal connection section 210 and to be able to produce a frictional connection with a corresponding counterpart.
• the labyrinth recesses 805 are realized circumferentially on the connection section.
• each labyrinth recess 805 has a slit-shaped opening which widens in a circular manner, the slit-shaped openings of two adjacent labyrinth recesses 805 facing one another in each case.
• FIG. 9 shows a schematic illustration of a distal connection section 215 of a line device according to one exemplary embodiment.
• the conduit device corresponds or resembles the conduit device of one of the figures described above.
• the distal attachment portion 215 here has a delivery opening 905 for performing a guide wire for positioning the cardiac assist system.
• the delivery opening 905 has an elongated shape by way of example. Due to the elongated shape of the discharge opening 905, the guide wire can be made at a shallow angle and forwarded.
• the guidewire, also called guide-wire is inserted through an opening in the proximal tip of the pump, that is, the cardiac assist system, and passed through the delivery port 905. This allows the cardiac assist system to be positioned along the guidewire without the guidewire touching or damaging the impeller.
• FIG. 10 shows a schematic representation of a bending point 1005 of a line device 105 according to an exemplary embodiment.
• the line device 105 corresponds or resembles the line device of one of the figures described above.
• the main body 205 has the bending point 1005, wherein the bending point 1005 is arranged between the inlet portion 230 and the distal connection portion 215.
• the flexure 1005 is exemplified herein to be useful in implanting the cardiac assistive device. system with the conduit device 105 to allow positioning of the inlet section 230 in the center of the heart chamber.
• the line device 105 is bent by the bending point 1005 along a first longitudinal axis at an obtuse angle.
• the conduit device has correspondingly a first longitudinal axis, and after the bending point 1005 a second longitudinal axis extends obliquely to the first longitudinal axis in order to form the main body 205 in an arcuate manner in the direction of the inlet section 230.
• the main body 205 has a first longitudinal axis between the distal connection section 215 and the bending point 1005. Between the bending point 1005 and the proximal connection portion 210, the base body 205 has a second longitudinal axis oblique to the first longitudinal axis. The second longitudinal axis is at an obtuse angle to the first longitudinal axis.
• the main body 205 is arc-shaped in the region of the bending point 1005.
• At least one subsection of the base body 205 is formed from a shape memory material.
• the entire main body 205 is made of a material, for example Nitinol. Because of the shape memory properties of the nitinol, after laser cutting the nitinol tube body 205, an anatomical curve shape can be applied to position the inlet section 230 in the center of the heart chamber to prevent the tube opening the conduit device 105, that is, the inlet portion 230, sucks on a Herzhunt- wall.
• the nitinol material is a proven material in medicine, in particular in the field of cardiovascular medicine, for example for heart valve prostheses, stents and vascular prostheses.
• Nitinol combines the advantages of biocompatibility and the shape memory property, which makes it possible to realize even complex structures in a small space.
• the main body 205 of the conduit device 105 is formed in the embodiment shown here from an elastic material, Nitinol.
• a semifinished product for the processing of the base body 205 a tube geometry offers.
• the Semifinished product may have a wall thickness of, for example, 0.25 to 0.5 millimeters.
• the contour of the main body 205 shown here is realized by methods for removing material, for example laser cutting, by removing the tube volume in some places. Alternatively, punching and eroding or machining are possible. In this way, z. For example, a spiral or wave form can be introduced into the tube of the basic body 205.
• the spacing of the individual sections of the structural section 220 can also be varied.
• the distance between the individual cuts can be, for example, 0.5 millimeters.
• the size of the Stei ftechniksaussparung 225 and the distance of the stiffness recesses 225 changes the flexibility and rigidity of the conduit device 105. The greater the stiffness recess 225 and the smaller the distance of the cuts, the more flexible the tube of the conduit device 105.
• the laser cut contour can, for example in the frame a heat treatment (eg with a temperature T of at least 500 degrees Celsius) are brought into a certain shape, for. B. with a kink of the main body 205 in the form of the bending point, or with different diameters, as described with reference to the following Fig. 1 1.
• the embossing process of the shape of the main body 205 describes a plastic deformation, without material failure occurs.
• FIG. 1 1 shows a schematic representation of a line device 105 according to one exemplary embodiment.
• the line device 105 corresponds or resembles the line device of one of the above-described figures. Shown is a change in an inner diameter of the main body of the line device 105, which is illustrated by means of exemplary dimensions of the line device 105.
• the main body of the line device has a length of 62 millimeters shown by the mark 1 105.
• an inner diameter of the basic body changes from the proximal connection section to the distal connection section.
• the cross-section of the proximal attachment section has a diameter of 6 millimeters, such as shown by the mark 1 1 10.
• the mark 1 15 shows a length of 35 millimeters of a section of the main body with the proximal connection section, with a continuous inner diameter of 6 millimeters.
• the inside diameter of the conduit 105 tapers from 6 millimeters to 5.49 millimeters, as shown by mark 1125.
• the inner diameter remains constant at 5.49 millimeters over the remaining length of 22 millimeters shown in FIG. 1 of the basic body of the conduit device 105 shown here.
• the change in the inner diameter of the body shown here can improve the flow characteristics of the blood stream.
• the line device 105 can be impressed in the axial direction of different diameters, as shown here.
• the inner diameter can be greater, in particular, in the region with the proximal connection section shown by way of example by the marking 11 1 15 than in the region with the distal connection section shown by the marking 1 130.
• a larger installation space may be available than in the area shown by the mark 1 130, for example, when the area 1 130 is being implanted during implantation of the cardiac support system for insertion of the cardiac support system into a catheter of FIG another component, example, a sleeve is enclosed, as shown in the following Fig. 12.
• FIG. 12 shows a schematic representation of part of a cardiac support system 100 according to one exemplary embodiment.
• the cardiac support system 100 is similar or similar to the cardiac assist system of FIG. 1. Shown is a longitudinal section of the part of the cardiac assist system 100 in the mounted state of the cardiac assistance system 100, which comprises the head unit 110, and the conduit device 105.
• the heart support system 100 has a sleeve 1205.
• the sleeve 1205 encloses a part of the cardiac assistance system opposite the head unit 110, wherein the sleeve 1205 of the conduit device 105 is approximately one Half of the structural portion 220 and the distal connection section encloses.
• the sleeve 1205 is shown only schematically here in order to illustrate an insertion situation of the cardiac assist system with conduit device 105 with regard to the shape of the conduit device 105. Due to the arrangement of the sleeve 1205, the region of the line device 105, which is not enclosed by the sleeve 1205, has a larger usable installation space than the area enclosed by the sleeve 1205.
• FIG. 13 shows a schematic representation of a line device 105 according to one exemplary embodiment.
• the line device 105 corresponds or resembles the line device from one of the above-described figures. Shown is a plan view of the line device 105.
• the line device has a sealing layer 1305 according to the exemplary embodiment shown here.
• the sealing layer 1305 is arranged on or in the structural section 220 and shaped to close the at least one stiffness recess in a fluid-tight manner.
• the sealing layer 1305 can be formed by encapsulation or encapsulation of the structural section 220 with a biocompatible plastic.
• the sealing layer 1305 seals the structure section 220 in a fluid-tight manner so that the blood stream in the inlet section 230 can be sucked in and pumped through the line device 105, along the structural section 220, into the outlet unit and thus into the aorta without loss.
• the sealing layer 1305 is formed from a plastic that is still soft enough after curing to withstand the movements of the line device 105 during operation of the cardiac assist system, eg. As polyurethane or silicone. When the heart support system, in particular the conduit device 105, is pushed through the aortic arch during an operation, cracking in the plastic of the sealing layer 1305 is avoided by a suitably selected material of the sealing layer 1305.
• FIG. 14 shows a schematic illustration of a part of a cardiac support system 100 according to one exemplary embodiment.
• the cardiac support system 100 is similar or similar to the cardiac assist system of any of the above-described figures.
• a side view of the portion of the cardiac assist system 100 including the head unit 110 and the conduit 105 is shown.
• the head unit 110 is exemplified here as a sensor module.
• a sensor cable 1405 is guided along the inside of the conduit device 105 from the proximal attachment portion 210 through the inlet portion 230 and through the stiffness recess 225 closest to the inlet portion 230 to the structural portion 220 abutting the outside of Conduction device 105 out.
• the sensor cable 1405 is guided along the longitudinal axis of the line device 105 in a spiral shape around the structure section 220.
• the sensor cable 1405 which allows an electrical data and energy connection from the sensor tip, that is the head unit 110, to the pump in a section of the cardiac assist system arranged downstream of the outlet unit, can be fastened in a fracture-proof manner. For example, by gluing, encapsulation, or potting the sensor cable 1405.
• the regular movement of the line device 105 during operation of the cardiac support system 100, due to the pulse and movements of the patient, is not passed on to the cable in this way.
• the line device corresponds or resembles the line device of one of the figures described above.
• the structural portion 220 is here exemplified nitinol and has a continuous coil 1505 on which the sensor cable 1405 is attached.
• the stiffness recesses of the structural portion 220 are sealed with the sealing layer 1305.
• the sensor cable 1405 is exemplified as a flexible thin film substrate and by the continuous coil 1505 of largely decoupled mechanical stresses to avoid tensile loads and cable breakage.
• the coil 1505 is slightly wider than the sensor cable 1405 executed, z. B. by about 0.5 to 1 millimeter.
• the distances of the stiffness recesses increase on the bending outer side of the structural portion 220, wherein the stiffness recesses are compressed on the bending internal side.
• the continuous coil 1505 is not or only slightly deformed by the bending of the structural section 220, thus providing mechanical protection for the sensor cable 1405.
• FIG. 16 shows a schematic representation of a line device 105 according to one exemplary embodiment.
• the line device 105 corresponds or resembles the line device from one of the above-described figures.
• the line device 105 has a cable groove 1605 according to the embodiment shown here, the cable groove 1605 being designed to feed a cable along the base 205 lead, in particular wherein the cable groove 1605 helically or helically around the structure section 220 is formed circumferentially.
• the cable groove 1605 for example, the sensor cable, as described with reference to the preceding FIGS. 14 and 15, can be accommodated.
• the cable groove 1605 is shaped to at least partially accommodate the sensor cable in order to additionally mechanically protect the sensor cable. Accordingly, here is shown a laser-cut embodiment of the conduit device 105 with integrated cable groove 1605 to provide additional mechanical protection to an integrated cable.
• FIG. 17 shows a schematic representation of a line device 105 according to one exemplary embodiment.
• the conduit device 105 is similar to or similar to the conduit device 105 of FIG. 10 except for the delivery opening 905.
• the delivery opening 905 is disposed in part in the structural portion 220 and elsewhere in the distal attachment portion 215.
• the exit opening 905 for carrying out the guide wire is also cut here as an elongated recess in the main body of the line device 105.
• the outward opening is, for example, chamfered both on the inside of the line device 105 and on the outside of the line device 105 and thus has an inside diameter chamfer 1705 and an outside diameter chamfer 1710.
• FIG. 18 shows a schematic representation of a line device 105 according to one exemplary embodiment.
• the line device 105 shown corresponds or resembles the line device 105 described with reference to FIG. 10, with additional markings for illustrating exemplary dimensions of the line device 105 being shown here.
• the conduit device 105 has an inner diameter of 6.5 millimeters shown by the mark 1805.
• the outer diameter shown in this area by the mark 1810 is 7 millimeters.
• the angle of the bend indicated by the mark 1815 is 26 degrees.
• the marking 1820 shows a length of 15 millimeters of a region of the line device 105 that includes the proximal connection section 210 and the inlet section 230, as well as a region of the structure section 220 with the recess recess closest to the inlet section 230.
• An adjacent bent portion of the structural portion 220 which is inclined with respect to the longitudinal axis of the conduit device 105, has a length of 14 millimeters, as shown by the mark 1825.
• the adjacent portion of the conduit device 105 provided with the mark 1830 includes a remainder of the structural portion 220 and the distal attachment portion 215, the circular mark 1835 showing the portion of the conduit device 105 with the distal attachment portion 215 shown in the following FIG is described.
• FIG. 19 shows a schematic representation of a part of a line device according to an exemplary embodiment. Shown is the one in the 18 marked end section of the line device with the distal connection section 215 with markings for illustrating exemplary dimensions. At the distal attachment portion 215, the conduit device has an inner diameter of 5.5 millimeters shown by the mark 1905. The outer diameter shown in this area by the mark 1910 is 6 millimeters. The mark 1915 shows a portion of the distal attachment portion 215 having a length of 2.40 millimeters.
• FIG. 20 shows a flow diagram of a method 2000 for producing a conduction device for conducting a blood flow for a cardiac assist system according to one exemplary embodiment.
• the method 2000 includes a step 2005 of molding and a step 2010 of heat treatment.
• a base body is formed from a shape memory material semi-finished product.
• the main body has at a first end a proximal or first connection section for connecting the line device to a head unit of the cardiac support system and at a second end a distal connection section for connecting the line device to an outlet unit of the cardiac support system.
• the connection sections are formed in a form-fitting and / or non-positively connectable manner.
• the main body has a structural section with at least one stiffness recess between the connecting sections, wherein the at least one stiffness recess is formed to change the rigidity of the main body.
• the main body optionally has an inlet section between the structural section and the proximal or first attachment section, wherein the inlet section is formed to allow the blood flow to be introduced.
• step 2010 of the heat treatment the main body formed in the step 2005 of molding is heat-treated to emboss the master body with a predetermined shape.
• FIG. 21 shows a flow chart of a method 2100 for mounting a cardiac assist system according to one embodiment. By implementing the method 2100 of mounting, a cardiac assist system similar to or similar to the cardiac assist system of any of the above-described figures may be mounted.
• the method 2100 includes a step 2105 of producing a positive and / or positive connection of the head unit and the outlet unit with the lead device to assemble the cardiac assist system. If an exemplary embodiment comprises a "and / or" link between a first feature and a second feature, then this is to be read such that the exemplary embodiment according to one embodiment includes both the first feature and the second feature and according to another embodiment. either only the first feature or only the second feature.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Cardiology (AREA)
• Hematology (AREA)
• Mechanical Engineering (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Vascular Medicine (AREA)
• Transplantation (AREA)
• External Artificial Organs (AREA)
• Prostheses (AREA)

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• 2018
  • 2018-05-30 DE DE102018208536.6A patent/DE102018208536A1/de not_active Withdrawn
• 2019
  • 2019-05-30 WO PCT/EP2019/064136 patent/WO2019229210A1/de not_active Ceased
  • 2019-05-30 US US17/057,355 patent/US20210268264A1/en active Pending
  • 2019-05-30 CN CN201980046811.6A patent/CN112543658A/zh active Pending
  • 2019-05-30 JP JP2021517522A patent/JP7357383B2/ja active Active
  • 2019-05-30 DE DE112019002711.5T patent/DE112019002711A5/de active Pending

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