LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, HEART SUPPORT SYSTEM, AND METHOD FOR PRODUCING A LINE DEVICE

Abstract

The invention relates to a line device (105) for conducting a blood flow for a heart support system. The heart support system has a head unit and an outlet unit. The line device (105) has a main part (205). The main part (205) has, at a first end, a first attachment section (210) for attaching the line device (105) to the head unit and, at a second end, a second attachment section (215) for attaching the line device (105) to the outlet unit. Furthermore, the main part (205) has a mesh section (220) between the attachment sections (210, 215), wherein the mesh section (220) has a mesh structure (230) formed from at least one mesh wire (225). In addition, the main part (205) has an inlet section (235), arranged in the first attachment section (210), for introducing the blood flow into the main part (205).

Claims

1. A heart support system comprising: a head unit; an outlet unit; and a line device arranged between the head unit and the outlet unit and configured to conduct a blood flow for the heart support system, wherein the line device comprises: a main part comprising: a first attachment section at a first end configured to attach the line device to the head unit; a second attachment section at a second end configured to attach the line device to the outlet unit; a mesh section between the first attachment sections and the second attachment section, wherein the mesh section comprises a mesh structure formed from at least one mesh wire, and wherein the mesh section is bent at an obtuse angle at a bending point; and an inlet section arranged in the first attachment section and configured to introduce the blood flow into the main part.

2-15. (canceled)

16. The heart support system according to claim 1, wherein at least one of the first attachment section and the second attachment section comprises at least one eyelet configured to thread an end of the at least one mesh wire so as to connect the mesh section to the at least one of the first attachment section and the second attachment section.

17. The heart support system according to claim 1, wherein the first attachment section and/or the second attachment section comprises at least one merlon, wherein the at least one merlon is arranged on a side of the first attachment section and/or the second attachment section facing the mesh section.

18. The heart support system according to claim 17, wherein at least one of the first attachment section and the second attachment section comprises at least one eyelet configured to thread an end of the at least one mesh wire so as to connect the mesh section to the at least one of the first attachment section and the second attachment section, wherein the at least one eyelet is formed in the at least one merlon.

19. The heart support system according to claim 1, wherein the mesh structure is formed as a diamond lattice.

20. The heart support system according to claim 1, wherein the mesh section is configured to receive and/or guide a cable element of the heart support system.

21. The heart support system according to claim 20, wherein the head unit comprises a sensor connected to the cable element.

22. The heart support system according to claim 20, wherein the mesh structure is formed from the at least one mesh wire and the cable element.

23. The heart support system according to claim 1, wherein at least the mesh section is formed of a shape memory material.

24. The heart support system according to claim 1, wherein the mesh section extends over at least half of the main part so as to adjust the stiffness of the main part.

25. The heart support system according to claim 1, wherein the line device further comprises a sealing layer arranged on or in the mesh section, wherein the sealing layer is configured to seal the mesh section in a fluid-tight manner.

26. The heart support system according to claim 1, wherein an inner diameter of the main part changes between the first attachment section and the second attachment section.

27. The heart support system according to claim 1, wherein the inlet section comprises at least one inlet opening cut in the first attachment section.

28. A heart support system comprising: a head unit; an outlet unit; and a line device arranged between the head unit and the outlet unit and configured to conduct a blood flow for the heart support system, wherein the line device comprises: a main part comprising: a first attachment section at a first end configured to attach the line device to the head unit; a second attachment section at a second end configured to attach the line device to the outlet unit; a mesh section between the first attachment section and the second attachment section, wherein the mesh section comprises a mesh structure formed from at least one mesh wire, and wherein the mesh section extends over at least half of the main part so as to adjust the stiffness of the main part; and an inlet section arranged in the first attachment section and configured to introduce the blood flow into the main part.

29. The heart support system according to claim 28, wherein at least one of the first attachment section and the second attachment section comprises at least one eyelet configured to thread an end of the at least one mesh wire so as to connect the mesh section to the at least one of the first attachment section and the second attachment section.

30. The heart support system according to claim 28, wherein the first attachment section and/or the second attachment section comprises at least one merlon, wherein the at least one merlon is arranged on a side of the first attachment section and/or the second attachment section facing the mesh section.

31. The heart support system according to claim 30, wherein at least one of the first attachment section and the second attachment section comprises at least one eyelet configured to thread an end of the at least one mesh wire so as to connect the mesh section to the at least one of the first attachment section and the second attachment section, wherein the at least one eyelet is formed in the at least one merlon.

32. The heart support system according to claim 28, wherein the mesh structure is formed as a diamond lattice.

33. The heart support system according to claim 28, wherein the mesh section is configured to receive and/or guide a cable element of the heart support system.

34. The heart support system according to claim 33, wherein the head unit comprises a sensor connected to the cable element.

35. The heart support system according to claim 33, wherein the mesh structure is formed from the at least one mesh wire and the cable element.

36. The heart support system according to claim 28, wherein at least the mesh section is formed of a shape memory material.

37. The heart support system according to claim 28, wherein the line device further comprises a sealing layer arranged on or in the mesh section, wherein the sealing layer is configured to seal the mesh section in a fluid-tight manner.

38. The heart support system according to claim 28, wherein an inner diameter of the main part changes between the first attachment section and the second attachment section.

39. The heart support system according to claim 28, wherein the inlet section comprises at least one inlet opening cut in the first attachment section.

40. A method for producing a line device for conducting a blood flow for a heart support system, wherein the method comprises: forming a main part of the line device from a semi-finished product made of a shape memory material, wherein the main part comprises: a first attachment section at a first end configured to attach the line device to a head unit of the heart support system; a second attachment section at a second end configured to attach the line device to an outlet unit of the heart support system; a mesh section between the first attachment section and the second attachment section, wherein the mesh section comprises a mesh structure formed from at least one mesh wire; and an inlet section arranged in the first attachment section and configured to introduce the blood flow into the main part; and heat treating the formed main part in order to emboss a predefined shape into the main part, wherein the predefined shape comprises a bend in the mesh section at an obtuse angle at a bending point.

Description

[0024] Exemplary embodiments of the approach presented here are shown in the drawings and explained in more detail in the following description. They show:¶

[0025] FIG. 1 a schematic illustration of a heart support system with a line device for conducting a blood flow according to an exemplary embodiment;

[0026] FIG. 2 a schematic illustration of a line device for conducting a blood flow for a heart support system according to an exemplary embodiment;

[0027] FIG. 3 a schematic illustration of a part of a line device according to an exemplary embodiment;

[0028] FIG. 4 a schematic illustration of an attachment section of a line device according to an exemplary embodiment;

[0029] FIG. 5 a schematic illustration of a part of an attachment section of a line device according to an exemplary embodiment;

[0030] FIG. 6 a schematic illustration of an attachment section of a line device according to an exemplary embodiment;

[0031] FIG. 7 a schematic illustration of a part of an attachment section of a line device according to an exemplary embodiment;

[0032] FIG. 8 a schematic illustration of a line device according to an exemplary embodiment;

[0033] FIG. 9 a schematic illustration of a line device according to an exemplary embodiment;

[0034] FIG. 10 a schematic illustration of a part of a line device according to an exemplary embodiment;

[0035] FIG. 11 a schematic illustration of a part of a line device according to an exemplary embodiment;

[0036] FIG. 12 a schematic illustration of a part of a line device according to an exemplary embodiment; and

[0037] FIG. 13 a flow diagram of a method for producing a line device for conducting a blood flow for a heart support system according to an exemplary embodiment.

[0038] In the following description of favorable exemplary embodiments of the present invention, the same or similar reference signs are used for the elements which are shown in the various figures and have a similar effect, wherein a repeated description of these elements is omitted.

[0039] FIG. 1 shows a schematic illustration of a heart support system 100 with a line device 105 for conducting a blood flow according to an exemplary embodiment. Shown is a side view of the heart support system 100 as a whole system, which is designed here, by way of example, as a left ventricular support system 100. The heart support system 100 comprises a head unit 110, an outlet unit 115, and the line device 105. The line device 105 is arranged between the head unit 110 and the outlet unit 115 and is connected to the head unit 110 and the outlet unit 115. The line device 105 can also be referred to as a suction tube, which connects a pump inlet within a heart chamber to an outlet within the aorta in the implanted state of the heart support system 100.

[0040] The heart support system 100 has a cylindrical, elongated structure with a substantially constant outer diameter and rounded, tapered ends for easy positioning by means of a catheter in a blood vessel, e.g., the aorta.

[0041] FIG. 2 shows a schematic illustration of a line device 105 for conducting a blood flow for a heart support system according to an exemplary embodiment in a side view. The line device 105 can also be referred to as a braided suction tube. The line device 105 has a main part 205. The main part 205 is formed in a tubular shape, for example. The main part 205 has, at a first end, a first attachment section 210 for attaching the line device 105 to a head unit of the heart support system and, at a second end, a second attachment section 215 for attaching the line device 105 to an outlet unit of the heart support system. In addition, the main part 105 has a mesh section 220 between the attachment sections 210, 215. The mesh section 220 has a mesh structure 230 formed from at least one mesh wire 225, wherein the main part 205 has an inlet section 235, arranged in the first attachment section 210, for introducing the blood flow into the main part 205. The line device 105 shown here can, for example, be similar or correspond to the line device shown in FIG. 1. The line device 105 is formed to be connectable to adjacent components of the heart support system as shown in FIG. 1. At the first attachment section 210, the line device 105 is formed to be connectable to a head unit of the heart support system and at the second attachment section 215, it is formed to be connectable to an outlet unit of the heart support system.

[0042] According to the exemplary embodiment shown here, the inlet section 235 has at least one inlet opening 240 cut in the first attachment section 210. Here, the inlet opening 240 is realized by way of example as a multi-part window. For the inflow of the blood, the inlet section 235 has three rectangularly formed inlet openings 240, which are rounded in the direction of the mesh section 220 in the form of a circular arc.

[0043] According to the exemplary embodiment shown here, the mesh structure 230 is formed as a diamond lattice. For this purpose, the at least one mesh wire 225 is braided as a lattice and has a plurality of diamond meshes that form the mesh structure 230.

[0044] The line device 105 is shown here with a braided flow channel as mesh section 220. According to one exemplary embodiment, at least the mesh section 220 is formed from a shape memory material. By way of example, the line device shown here is completely formed from Nitinol. By using Nitinol, the line device 105 is suitable not only for short-term use but also for a service life of over 10 years. In medicine, in particular in the field of cardiovascular medicine, Nitinol material is a proven material for heart valve prostheses, stents, and vascular prostheses, for example. Nitinol combines the advantages of biocompatibility and of the shape memory property that allows even complex structures to be realized in a small installation space as in the mesh section 220 shown here.

[0045] The mesh section 220 can be braided to the attachment points 210, 215. For this purpose, the attachment points 210, 215 have, for example, as shown here, a fastening element for threading a section of the mesh wire 225. Additionally or alternatively, the mesh section 220 can, for example, also be glued or soldered to the attachment points 210, 215.

[0046] According to the exemplary embodiment shown here, the mesh section 220 extends over at least half of the line device 105 in order to adjust the stiffness of the line device. The line device 105 is formed to allow transfemoral surgery (access via the groin). On the one hand, the line device 105 is thus formed flexibly enough to be able to be pushed through the aortic arch and has, on the other hand, a stiffness in order to be able to be pushed through the blood vessels in the axial direction without kinking. The requirements for flexibility and stiffness of the line device 105 in this regard are adjusted by means of the forming of the mesh section 220. The design of the braided structure adapts the ratio of flexibility and stiffness. Variables in this respect are the number of wire paths of the at least one mesh wire 225, a stiffness and a material thickness of the at least one mesh wire 225, as well as the mesh pattern of the mesh structure 230. The higher the number of wire paths of the at least one mesh wire 225 is, the stiffer is the mesh structure 230. The mesh wire 225 comprises, for example, 12 to 24 wire paths. The larger the wire diameter of the mesh wire 225 is, the stiffer is the mesh structure 230. For example, the wire diameter is between 0.1 millimeters and 0.3 millimeters. In addition, material properties of the mesh wire 225 are important: The higher the modulus of elasticity of the mesh wire 225 is, the stiffer is the mesh structure 230. The mesh wire 225 has an elasticity between 74 GPa and 83 GPa, for example. The mesh type of the mesh structure 230 is also important: the closer the meshes are in the mesh, the stiffer is the mesh.

[0047] In the exemplary embodiment shown here, the line device 105 is bent in the direction of the first attachment section 210, wherein the bend is by way of example formed as an obtuse angle with respect to a longitudinal axis of the line device 105. The bending can be realized by heat treating the mesh section 220 made of Nitinol. Due to the shape memory properties of the Nitinol, the line device 105 can be formed by a waveform of the mesh section 220 corresponding to human anatomy in order to allow positioning of the inlet opening of the inlet section 235 in the first attachment section 210 in the middle of the heart chamber.

[0048] FIG. 3 shows a schematic illustration of a part of a line device 105 according to an exemplary embodiment. A section of the mesh section 220 connected to the second attachment section 215 is shown in a side view. The first attachment section can be formed like the second attachment section 215 shown here by way of example. The part of the line device 105 shown here is a detail of a similar or corresponding line device as described with reference to FIG. 2.

[0049] According to this exemplary embodiment, at least one of the attachment sections, in this case by way of example the second attachment section 215, has at least one eyelet 310 for threading an end of the at least one mesh wire 225 in order to connect the mesh section 220 to the corresponding attachment section. In addition, the first attachment section and/or the second attachment section 215 has at least one merlon 305 as an attachment point for the mesh section 220. The merlon 305 is arranged in particular on the side of the attachment section 215 facing the mesh section 220, as shown here. Optionally, the at least one eyelet 310 is formed in the at least one merlon 305, as shown here.

[0050] By way of example, the second attachment section 215 has here a plurality of merlons 305. Each of the merlons 305 has an eyelet 310, through which a section of a mesh wire 225 is guided. In the exemplary embodiment shown here, the structure of the mesh section 220 is formed by way of example from several mesh wires 225. Wire ends of the mesh wires are, for example, integrated into the mesh structure, as indicated by the markings 315 and 320. By means of the mesh wires 225, pump components adjacent through the first and the second attachment section 215, i.e., further components of the heart support system, such as the head unit and the outlet unit, can be connected to the line section 105 permanently and securely. For this purpose, an eyelet 310 into which the mesh wire 225 is threaded is provided for each wire loop of the at least one mesh wire 225. The eyelet 310 can be realized as a bore.

[0051] FIG. 4 shows a schematic illustration of an attachment section of a line device according to an exemplary embodiment. A second attachment section 215 is shown by way of example in a top view. The second attachment section 215 shown here corresponds or is similar to the attachment sections shown in the preceding figures. The at least one mesh wire can be braided into the second attachment section 215. As attachment points for the braiding-in of the mesh wire 225, the second attachment section 215 has a plurality of merlons 305 distributed rotationally evenly on the diameter of the second attachment section 215, i.e., spaced circumferentially evenly. The second attachment section 215 comprises, for example, 6 to 12 merlons 305; 12 merlons 305 are shown here. The eyelets 310 formed in the merlons 305 are realized as bores in the circumferential direction of the cylindrical second attachment section 215 in order to allow tangential threading of the mesh wire 225 in order to not increase the total diameter of the line device 105.

[0052] FIG. 5 shows a schematic illustration of a part of an attachment section 215 of a line device according to an exemplary embodiment. The part shown here is a detail of the second attachment section 215 shown in the preceding FIG. 4. In the detail shown here, each of the merlons 305 has an exposed eyelet 310 as a single attachment point, into which the mesh wire can be tangentially inserted. The eyelets 310 each run transversely with respect to the longitudinal axis of the line device through the merlons 305.

[0053] FIG. 6 shows a schematic illustration of an attachment section 215 of a line device according to an exemplary embodiment. The cross section of a second attachment section 215 is shown in order to illustrate exemplary dimensions of the second attachment section 215. The second attachment section 215 shown corresponds to or is similar to the second attachment section 215 of one of the figures described above. The first attachment section can be formed similarly or correspondingly. The second attachment section 215 has, for example, an inner diameter of 5.5 millimeters indicated by the marking 605 and an outer diameter of 6 millimeters indicated by the marking 610. The merlons 305 have a wall thickness of 0.25 millimeters, which the marking 615 indicates, a width of 0.5 millimeters indicated by the marking 620, and a height of 0.6 millimeters indicated by the marking 625. Each merlon 305 has an eyelet 310 with an inner diameter of 0.15 millimeters, as indicated by the marking 630. The distance from the outer wall of the merlon 305 to the center point of the eyelet 310 is, for example, 0.25 millimeters, as the marking 635 indicates, and the distance from the center point of the eyelet 310 to an upper free end of the merlon 305 is also 0.25 millimeters, as indicated by the marking 340. The bore diameter of each eyelet 310 is somewhat larger than the thickness of the mesh wire in order to allow a wire end to be inserted and the mesh wire to be braided in. The eyelets 310 can be drilled by means of a laser drilling method.

[0054] FIG. 7 shows a schematic illustration of a part of an attachment section of a line device according to an exemplary embodiment. The part shown here is a further detail of the second attachment section 215 shown in FIG. 4, wherein a side view of the detail is shown here. The exemplary shape of the eyelets 310 shown here and the arrangement of the eyelets 310 and merlons 305 allow radial tangential access. The eyelets 310 and the merlons 305 are arranged and dimensioned such that a radial-tangential laser access path is possible when producing the second attachment section 215.

[0055] FIG. 8 shows a schematic illustration of a line device 105 according to an exemplary embodiment. The line device 105 corresponds or is similar to the line device of one of the figures described above. Shown is a change in an inner diameter of the main part of the line device 105, which is illustrated using exemplary dimensions of the line device 105. The main part of the line device 105 has a length of 62 millimeters illustrated by the marking 805. According to the exemplary embodiment shown here, an inner diameter of the main part changes from the first attachment section to the second attachment section. The cross section of the first attachment section has a diameter of 6 millimeters, as indicated by the marking 810. The marking 815 indicates a length of 35 millimeters of a section of the main part with the first attachment section with an inner diameter of 6 millimeters throughout. In the section marked by the marking 820, which has a length of 5 millimeters and adjoins the section of the marking 815, the inner diameter of the line device 105 tapers from 6 millimeters to 5.5 millimeters, as indicated by the marking 825. Over the remaining length, indicated by the marking 830, of 22 millimeters of the main part of the line device 105 shown here, the inner diameter remains constant at 5.49 millimeters. The change in the inner diameter of the main part shown here can improve the flow properties of the blood flow. For this purpose, different diameters in the axial direction can be embossed into the line device 105 as shown here. The inner diameter can in particular be larger in the region with the first attachment section indicated by way of example by the marking 815 than in the region with the second attachment section indicated by the marking 830. In the region corresponding to the marking 815, a larger installation space can, for example, be available than in the region indicated by the marking 830 if the region 830 is, for example, enclosed by a further structural element, for example a sleeve, for inserting the heart support system into a catheter when implanting the heart support system. The braided contour of the mesh section of the line device 105 as a Nitinol element can be formed within the scope of a heat treatment into a predefined shape with, for example, different diameters as shown here. The embossing process in this case describes a plastic deformation without the occurrence of material failure.

[0056] FIG. 9 shows a schematic illustration of a line device 105 according to an exemplary embodiment. A side view of the line device 105 is shown. By means of markings, this figure illustrates exemplary dimensions of the line device 105 as a suction tube. The line device 105 substantially corresponds to the line device described with reference to FIG. 2, with the exception of a sealing layer 905 arranged on the mesh section 220. According to the exemplary embodiment shown here, the line device 105 comprises the sealing layer 905. The sealing layer 905 is arranged on or in the mesh section 220. The sealing layer 905 is formed to seal the mesh section 220 in a fluid-tight manner. By way of example, the sealing layer 905 is shown here as a silicone casting.

[0057] According to the exemplary embodiment shown here, the mesh section 220 furthermore has a bending point 910. The mesh section 220 is in particular bent at an obtuse angle at the bending point, here by way of example by 26 degrees as indicated by the marking 915. The first attachment section 210 has a length of 15.4 millimeters indicated by the marking 920. The section, indicated by the marking 925, of the mesh section 220 with the bending point 910 has a length of 13.6 millimeters, and the remaining section of the main part with a second part of the mesh section 220 and the second attachment section has a length of 33 millimeters as indicated by the marking 930. At the point indicated by the marking 935, the mesh section has a bend of 2 degrees.

[0058] FIG. 10 shows a schematic illustration of a part of a line device according to an exemplary embodiment. A top view of a detail of the mesh section 220 with a sealing layer 905 is shown. The mesh section 220 is shown as a wire mesh structure, and is, by way of example, cast with a plastic as a sealing layer 905. The sealing layer 905 seals the mesh section 220 in a fluid-tight manner so that the blood flow in the inlet section can be sucked in and pumped through the line device 105, along the mesh section 220, into the outlet unit and thus into the aorta without loss. The sealing layer 905 is formed from a plastic, e.g., polyurethane or silicone, which is still soft enough after curing to withstand the movements of the line device 105 during operation of the heart support system. When the heart support system, in particular the line device 105, is pushed through the aortic arch during surgery, cracks are prevented from forming in the plastic of the sealing layer 905 as a result of a correspondingly selected material of the sealing layer 905.

[0059] FIG. 11 shows a schematic illustration of a part of a line device according to an exemplary embodiment. A detail of a section of a mesh section 220 is shown. The mesh section 220 substantially corresponds to the mesh section 220 shown in the preceding figures. In addition, the mesh section 220 according to the exemplary embodiment shown here is formed to receive a cable element 1105 of the heart support system, and, additionally or alternatively, the mesh section 220 is formed to guide a cable element 1105 of the heart support system. As shown here, the mesh structure 230 is optionally formed from the at least one mesh wire 225 and the cable element 1105. The wire mesh of the mesh structure 230 thus comprises an additionally braided-in cable as a cable element 1105. The cable element 1105 can be designed as a section of a cable that allows an electrical data and energy connection from the head unit, e.g., a sensor tip, to the pump of the heart support system. If the mesh structure 230 is formed from several mesh wires 225, a mesh wire 225 is optionally exchanged for the cable element 1105 and the cable element 1105 is braided in in a break-proof manner. If the mesh section 220 has a sealing layer, the sealing layer is an additional mechanical protection of the cable element 1105.

[0060] Alternatively, as a replacement of a Nitinol wire as a mesh wire 225, the cable element 1105 is already integrated in the weaving process during the production of the mesh structure 230. Used for this purpose is in particular a round cable, which has similar geometric diameters and mechanical properties as the mesh wire 225 and a thermal resistance for the subsequent heat treatment. Alternatively, the cable is furthermore guided along the outer or inner side of the mesh section without being braided in, as shown in FIG. 12.

[0061] FIG. 12 shows a schematic illustration of a part of a line device according to an exemplary embodiment. The illustration is similar or corresponds to the illustration of the detail of the line device described with reference to FIG. 10. In addition, the detail of the mesh section 220 shown here with the sealing layer 905 comprises the cable element 1105. The mesh section 220 is shown by way of example as a wire mesh with an applied and cast flat ribbon cable as a cable element 1105. The cable element 1105 is arranged circumferentially in the shape of a spiral around the longitudinal axis of the mesh section 220, it is glued here and cast or injection-molded with the sealing layer 905, i.e., surrounded by the sealing layer 905. In order to keep the mechanical stresses on the cable element 1105 low, the braided wire slope of the mesh wire is used here by way of example for routing the cable element 1105 in a spiral shape and for fastening the cable element 1105.

[0062] FIG. 13 shows a flow diagram of a method 1300 for producing a line device for conducting a blood flow for a heart support system according to an exemplary embodiment. The heart support system has a head unit and an outlet unit. The method 1300 comprises a step 1301 of forming and a step 1303 of heat treating. In step 1301 of forming, a main part is formed from a semi-finished product made of a shape memory material. The main part has, at a first end, a first attachment section for attaching the line device to the head unit and, at a second end, a second attachment section for attaching the line device to the outlet unit. The main part additionally has a mesh section between the attachment sections. The mesh section has a mesh structure formed from at least one mesh wire. Furthermore, the main part has an inlet section, arranged in the first attachment section, for introducing the blood flow into the main part. In step 1303 of heat treating, the main part formed in step 1301 is heat treated in order to emboss a predefined shape into the main part.

[0063] If an exemplary embodiment includes an “and/or” conjunction between a first feature and a second feature, this should be read to mean that the exemplary embodiment according to one embodiment comprises both the first feature and the second feature and according to another embodiment comprises either only the first feature or only the second feature.