FLEXIBLE CATHETER WITH A DRIVE SHAFT

Abstract

A flexible catheter with a drive shaft, and associated devices and systems. In some examples, the disclosure describes a flexible catheter with a drive shaft, with a sleeve surrounding the drive shaft and with a sheath surrounding the drive shaft and the sleeve, wherein the drive shaft, the sleeve and the sheath are pliable, wherein the drive shaft at a proximal end of the drive shaft comprises a coupling element for connecting the drive shaft to a drive motor, wherein the drive shaft at least regionally consist of a alloy which contains at least 10% by weight of chromium, nickel and cobalt in each case.

Claims

1-68. (canceled)

69. A flexible catheter comprising: a drive shaft; a sleeve surrounding the drive shaft; and a sheath surrounding the drive shaft and the sleeve, wherein the drive shaft, the sleeve and the sheath are pliable, wherein the drive shaft at a proximal end of the drive shaft comprises a coupler configured to connect the drive shaft to a drive motor; a pump rotor coupled to the drive shaft and configured to produce a flow when the pump rotor is rotated in a given direction; and a thrust bearing configured to counteract an axial displacement of the drive shaft resulting from the pump rotor being rotated in the given direction.

70. The flexible catheter of claim 69, wherein the pump rotor is configured to produce a flow in a proximal direction when the pump rotor is rotated in the given direction, and the thrust bearing is arranged proximal to the pump rotor to counteract an axial displacement of the drive shaft in a distal direction.

71. The flexible catheter of claim 70, wherein the thrust bearing comprises at least a first bearing element and a second bearing element, wherein the first bearing element is connected to the drive shaft in a rotationally-fixed manner and the second bearing element is connected to the sleeve or to the sheath.

72. The flexible catheter of claim 71, wherein the first bearing element and the second bearing element comprise sliding surfaces that face one another, and that are configured to contact one another to counteract an axial displacement of the drive shaft in a distal direction.

73. The flexible catheter of claim 72, wherein at least the sliding surface of the first bearing element comprises a profiling.

74. The flexible catheter of claim 73, wherein the profiling comprises a plurality of prominences.

75. The flexible catheter of claim 74, wherein each prominence of the plurality of prominences has a height of between 0.03 and 0.1 mm.

76. The flexible catheter of claim 74, wherein each prominence of the plurality of prominences is shaped as a rib extending radially relative to a longitudinal axis of the drive shaft.

77. The flexible catheter of claim 76, wherein each rib has a width of between 0.08 mm and 0.5 mm measured in a tangential direction relative to the longitudinal axis of the drive shaft.

78. The flexible catheter of claim 73, wherein the profiling comprises a plurality of recesses.

79. The flexible catheter of claim 78, wherein each recess of the plurality of recesses has a depth of between 0.03 and 0.1 mm.

80. The flexible catheter of claim 78, wherein each recess of the plurality of recesses is shaped as a groove extending radially relative to a longitudinal axis of the drive shaft.

81. The flexible catheter of claim 80, wherein each groove has a width of between 0.08 mm and 0.5 mm measured in a tangential direction relative to the longitudinal axis of the drive shaft.

82. The flexible catheter of claim 69, wherein the pump rotor is configured to produce a flow in a distal direction when the pump rotor is rotated in the given direction, and the thrust bearing is arranged distal to the pump rotor to counteract an axial displacement of the drive shaft in a proximal direction.

83. The flexible catheter of claim 82, wherein the thrust bearing comprises at least a first bearing element and a second bearing element, wherein the first bearing element is connected to the drive shaft in a rotationally-fixed manner and the second bearing element is connected to the sleeve or to the sheath.

84. The flexible catheter of claim 83, wherein the first bearing element and the second bearing element comprise sliding surfaces that face one another, and that are configured to contact one another to counteract an axial displacement of the drive shaft in a proximal direction.

85. The flexible catheter of claim 84, wherein at least the sliding surface of the first bearing element comprises a profiling.

86. The flexible catheter of claim 85, wherein the profiling comprises a plurality of prominences.

87. The flexible catheter of claim 86, wherein each prominence of the plurality of prominences has a height of between 0.03 and 0.1 mm.

88. The flexible catheter of claim 86, wherein each prominence of the plurality of prominences is shaped as a rib extending radially relative to a longitudinal axis of the drive shaft.

89. The flexible catheter of claim 88, wherein each rib has a width of between 0.08 mm and 0.5 mm measured in a tangential direction relative to the longitudinal axis of the drive shaft.

90. The flexible catheter of claim 85, wherein the profiling comprises a plurality of recesses.

91. The flexible catheter of claim 90, wherein each recess of the plurality of recesses has a depth of between 0.03 and 0.1 mm.

92. The flexible catheter of claim 90, wherein each recess of the plurality of recesses is shaped as a groove extending radially relative to a longitudinal axis of the drive shaft.

93. The flexible catheter of claim 92, wherein each groove has a width of between 0.08 mm and 0.5 mm measured in a tangential direction relative to the longitudinal axis of the drive shaft.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0051] The mentioned aspects of the present invention are hereinafter explained in more detail by way of a special embodiment example of a catheter of the type suggested here and of a blood pump arrangement of the type suggested here, which are represented schematically in FIGS. 1 to 16. There are shown in:

[0052] FIG. 1 a catheter of the type suggested here, in a lateral view,

[0053] FIG. 2 a blood pump arrangement with the catheter shown in FIG. 1, in an implanted condition,

[0054] FIG. 3 axial sections of parts of the drive shaft of the catheter of FIG. 1, in a lateral view,

[0055] FIG. 4 a cross section through the drive shaft which is represented in FIG. 3, at the location which is characterized there at AA,

[0056] FIG. 5 a distal end-piece of the drive shaft which is stiffened with a reinforcement material, in a lateral view,

[0057] FIG. 6 a longitudinal section through the end-piece which is shown in FIG. 5, at the location which is characterized there at AA,

[0058] FIG. 7 a sleeve of the catheter which is shown in FIG. 1, in a lateral view,

[0059] FIG. 8 a cross section through a part-region of the sleeve shown in FIG. 7 said part region being characterized there at A,

[0060] FIG. 9 a longitudinal section through the catheter which is shown in FIG. 1, in the axial part-section which is characterized there at Y,

[0061] FIG. 10 the distal end-piece which is represented in FIGS. 5 and 6, with a pump rotor which is fastened on this in a rotationally fixed manner,

[0062] FIG. 11 a longitudinal section through the catheter which is show in FIG. 1, in the axial part-section which is characterized there at Z,

[0063] FIG. 12 a longitudinal section through a coupling module of the catheter which is shown in FIG. 1, and

[0064] FIG. 13 an embodiment example of a bearing element of a thrust bearing shown in FIG. 9, in a perspective representation,

[0065] FIG. 14 a further embodiment example of the bearing element which is shown in FIG. 13, likewise in a perspective representation,

[0066] FIG. 15 readings of yield point, tensile strength and elongation at break, for different values of the work-hardening degree for the material 35NLT®, and

[0067] FIG. 16 diagrammatic representation of the readings of tensile strength and elongation at break, which are specified in FIG. 15, as functions of the work-hardening degree for the material 35NLT®.

[0068] Recurring features or features which correspond to one another are characterized by the same reference numerals in the figures.

DETAILED DESCRIPTION

[0069] A special embodiment of a flexible catheter 1 of the type suggested here is represented schematically in FIG. 1. The catheter 1 comprises a pliable drive shaft 2, of which in this figure a proximal end-piece 3 is to be seen, said end-piece projecting out of a proximal coupling module 4 (cantilever), and at its proximal end the drive shaft 2 comprises a coupling element 5 for the connection of the drive shaft 2 to a drive motor, cf. FIG. 2. The catheter 1 moreover comprises a pliable sleeve 6 (not shown here, but see FIGS. 7 to 9) which surrounds the drive shaft 2 and radially mounts it, and a pliable sheath 7 surrounding the drive shaft 1 and the sleeve 6. Thus whereas the coupling module 4 and the proximal end-piece 3 of the drive shaft 2 are arranged at a proximal end 8 of the catheter 1, the catheter 1 at a distal end 9 of the catheter 1 comprises a pump head 10 with a pump casing 11, with a terminating housing 13 which is arranged distally to the pump casing 11 and is for drive shaft 2, and a downstream tubing 12 which is proximally adjacent the pump casing 11 (elements running within the downstream tubing 12 are represented dashed in FIG. 1). A support element 14 in the form of a so-called pigtail tip is arranged distally on the terminating housing 13. The catheter 1 moreover comprises a lock 15. The function of the lock is to radially compress the pump head 10 when this is pulled into the lock 15. The pump head 10 in this compressed condition for example can be subsequently led through an introduction lock (not represented in the figures) and be implanted through this. The introduction lock for example can be fixed at a puncture location on or in the body of a patient, in order in this manner to likewise support the catheter 1 at this location. The document EP2399639 A1 is referred to in this context.

[0070] This catheter as part of a blood pump arrangement 16 is represented in an implanted condition in a greatly schematic manner in FIG. 2. What is shown is the use or application of the catheter 1 and the blood pump arrangement 16, with which the drive shaft 2 of the catheter 1 is connected via the coupling element 5 to a corresponding coupling element 17 of a drive motor 18 of the blood pump arrangement 1, in a rotationally fixed manner (but axially displaceable manner, see description concerning FIG. 12). The drive motor 18 is designed to produce high rotation speeds in a region between 10,000 and 40,000 revolutions per minute.

[0071] As is shown in FIG. 10, a functional element which is designed as a pump rotor 20 is connected in a rotationally fixed manner to a distal end-piece 19 of the drive shaft 2. The pump rotor 20 is arranged within the pump casing 11 which in this embodiment example is designed such that it can be brought from a radially expanded condition into a radially compressed condition. This for example can be effected with the help of a lock 15 or the introduction lock mentioned above, preferably by way of the pump casing 11, whilst being subjected to a (tensile) force acting towards the proximal end 8 of the catheter, being at least partly pulled into the respective lock and thereby being compressed along a radial direction running transversely to the longitudinal direction. The pump casing 11 can accordingly be brought from the compressed into the expanded condition by way of a reverse force. The document EP2399639 A1 is also referred to here.

[0072] With the application of the pump arrangement 2 which is represented in FIG. 2, the catheter 1 with its distal end 9 in front, is inserted through a puncture location 21 into the body of a patient in its femoral artery 22 and is pushed along this via the aortic arch 23 into the left ventricle 24 of the heart 25. The pump casing 11 is thus positioned in the left ventricle 24 such that it is supported by the support element 14 on an inner wall 26 of the left ventricle 24, and the downstream tubing 12 runs through the aortic valves 27 into the aorta 28. The blood which is driven by the pump rotor 20 and which flows out of the pump casing is thus led through the downstream tubing 12 into the aorta 28. The proximal end 8 of the catheter 1, the proximal end-piece 3 of the drive shaft 2 as well as the drive motor 18 are arranged outside the body.

[0073] In this embodiment example, an (axial) total length of the catheter and an (axial) total length of the drive shaft 2 are in each case about 150 cm (corresponding to an implantable length of about 140 cm), an (axial) total length of the distal end 9 of the catheter (including pump head 12 and support element 14) is about 13.5 cm, in order to permit this application. The flexibility or the pliability of the catheter 1, thus in particular of the drive shaft 6, the sleeve 6 and the sheath 7 are so large that the catheter 1 can be implanted and operated, as has been described above. For this, these components must be able to be elastically curved by 180° at least within the distal end 9 of the catheter, with the typically radius of curvature R of the aortic arch 23 of about 30 mm, as is shown in FIG. 2, without plastic deformation, in particular of the drive shaft 2 thereby occurring.

[0074] As is shown in FIGS. 4 and 6, the drive shaft 2 is designed as a hollow shaft and comprises a cavity 29 extending axially within the drive shaft 2, in order to achieve a high pliability of this drive shaft 2. The cavity 29 extends along the total length of the drive shaft 2. This cavity 29 however is completely filled out with a reinforcement material 30, a co-called core, at least within the roughly 4.5 cm long distal end-piece 19 of the drive shaft, see FIGS. 6, 9 and 10 and the associated description further below, in order here to achieve an adequate stiffness and oscillation stability of the drive shaft 2 or of the distal end-piece 19 of the drive shaft.

[0075] The drive shaft 2 comprises a multitude of coaxial windings 31, 32 which run spirally around the cavity 29 of the drive shaft 2, in order to convert torsion and bending stresses into axial tensile and compressive stresses. The windings 31, 32 are arranged in two coaxial layers 33, 34 which is to say plies, of the drive shaft 2, wherein the windings 31 are arranged co-radially (with the same winding radius) within the inner layer 33, and the windings 32 are arranged co-radially within the outer layer. The windings 31 of the inner layer 33 have an opposite winding direction compared to the windings of the outer layer 34, so that tensile and compressive stresses can be compensated between the layers, In the shown example, the drive shaft in the inner layer 33 comprises four wires 35 which are wound coaxially and co-radially around the cavity 29, and in the outer layer 34 five wires which are wound coaxially and co-radially around the cavity, wherein axially adjacent windings 31 of the inner layer mutually contact, but axially adjacent windings (winding packet of five wires in each case) 32 of the outer layer however do not mutually contact (in each case given an alignment of the drive shaft which is free of curvature), but have an axial distance of about 0.03 mm. An outer diameter d.sub.a of the drive shaft in the present example is about 0.88 mm and an inner diameter di about 0.28 mm. The wires have a circularly round cross section with a diameter of about 0.15 mm. In the present example, the peripheral direction of the windings 36 of the outer layer 34 is counter to the designated rotation direction of the drive shaft 2 for the (proximal) delivery of blood.

[0076] Here, this rotation direction corresponds to the clockwise direction (defined for a viewing direction from the proximal to the distal end of the drive shaft). The torque to be transmitted in this case leads to the outer layer tending to contract and shorten. Since the inner layer 33 has an opposite tendency due to its opposite winding direction, these tendencies advantageous largely cancel each out. Basically, this mutual compensation can also be achieved in the reverse case, when specifically, the winding direction of the outer layer corresponds to the rotation direction and the winding direction of the inner layer is opposite to the rotation direction of the drive shaft.

[0077] The wires 35, 36 of the drive shaft 2 consist completely of an alloy, which as alloy components contain about 35% by weight of nickel, about 35% by weight of cobalt, about 20% by weight of chromium and about 10% by weight of molybdenum. These alloy components of the alloy can in each case also be greater or smaller by up to 3% by weight, or greater or smaller in each case by up to 2% by weight. With regard to the alloy, in this example it is particularly the case of 35NLT®, but it could just as easily be the case of MP35N®. The weight component of iron in the wires is thus less than 1% by weight and the weight component of titanium is less than 0.1% by weight. The alloy and the windings 31, 32 of the drive shaft are manufactured or formed amid the application of high cold-forming and work-hardening. In this example, a non-rusting, austenitic steel according to the material number DIN 1.4310 (X10CrNi18-8) is selected as a reinforcement material 30 for stiffening the drive shaft 2. Alternatively, any other material which fulfils the demands specified further above in this context could also be selected as a reinforcing material.

[0078] The sleeve 6 is represented in FIGS. 7 and 8. which in the shown example is designed as a bearing coil with a multitude of windings 37, wherein the windings 37 of the bearing coil run around the drive shaft 2 in the axial direction in the manner of a spiral. In the present example, the bearing coil is given by a wound-on flat tape 38. The flat tape 38 has a width B (measured axially) which is larger than the thickness D (measured radially) by a factor of about 6. In the present example, the width B of the windings 37 is 0.6 mm and the thickness D of the windings 37 is 0.1 mm. The windings 37 are moreover angled which is to say tilted as little as possible relative to the longitudinal axis L of the bearing coil (in the straight condition without a curvature of the bearing coil), where possible by less than 5°, so that an inner surface 39 of the sleeve 6 which is formed by the windings 37 is as cylindrical as possible or forms as cylindrical as possible part-surfaces. Moreover, the lateral edges 54 of the flat tape are preferably as rounded as possible, with a radius of curvature r.sub.k of about 0.04 mm. The radius of curvature r.sub.k of the edges 54 is preferably more than 0.04 mm. Moreover, an inner diameter D.sub.1 of the sleeve 6 is about 1 mm and an outer diameter D.sub.A of the sleeve about 1.2 mm and has a gradient/pitch of about 0.7. The sleeve 6 or the flat tape 38 in this example consists of the same alloy as the wires 35, 36 of the drive shaft 2, thus here of 35NLT®, but could however also be manufactured of another one of the materials which are mentioned for this.

[0079] The drive shaft 2 and the sleeve 6 could also consist of materials other than the alloys mentioned here. The drive shaft 2 is preferably manufactured from the same material as the sleeve 6. Moreover, a surface of the drive shaft 2 can have a roughness RZ of about 0.6, by which means surprisingly a particularly good wear resistance is achieved. Surprisingly good wear characteristics and thus a high operational reliability can be achieved by way of these measures which are quite simple to implement.

[0080] A longitudinal section through the axial section of the catheter 1 which is indicated at Y in FIG. 1 is represented schematically in FIG. 9. In this section, the catheter 1 comprises bearing elements 40, 41, 42 which are arranged proximally to the pump rotor 20, for the radial and axial mounting of the drive shaft 2.

[0081] The arrangement and design of these bearing elements 40, 41, 42 is matched to the pump rotor 20 of the catheter 1 which is shown in FIG. 10. This pump rotor 20 has a blading 43, whose configuration, design and pitch angle are configured for delivering the blood proximally (proximal delivery direction, i.e., in the direction of the proximal end of the catheter). The bearing elements 40 and 41 form a thrust bearing 44 which is arranged proximally to the pump rotor 20 (The bearing element 41 is a first thrust bearing element of the thrust bearing 44, and the bearing element 40 is a second thrust bearing element of the thrust bearing 44). The thrust bearing 44 on account of the design and arrangement of these (thrust) bearing elements 40, 41, is designed to counteract a distally directed axial displacement of the drive shaft 2 (caused by the proximal delivering effect of the pump rotor 20). Axial bearing forces acting mainly act upon the drive shaft 2 as tension forces on operation of the blood pump arrangement in this manner.

[0082] The (first) bearing element 41 is preferably designed in an annular manner and is connected to the drive shaft 2 in a rotationally fixed manner, for example by way of crimping. The (second) bearing element 40, just as the bearing element 42, in contrast is fixedly connected to the sleeve 6 and to the sheath 7. The bearing elements 40, 41 have annular sliding surfaces 45 and 46 respectively which face one another and which block an axial displacement of the drive shaft 2 in the distal direction in the case of a mutual contacting, The sliding surface 46 of the (first) bearing element 41 has a profiling, see FIGS. 13 and 14 and the associated description below, by which means the formation of a stable lubricant film between the two sliding surfaces 45, 46 is encouraged, and basically a design of the thrust bearing 44 as a hydrodynamic sliding bearing is rendered possible. The lubricant film which is to say the hydrodynamic bearing in this example is formed with the lubricant which is described further below. The bearing element 40, as also the bearing element 42, is moreover designed as a radial bearing element in each case with a sliding surface which faces the drive shaft 2, is designed in a cylindrical manner and is arranged coaxially to the rotation axis of the drive shaft 2.

[0083] Moreover, as is to be recognized in FIG. 9, the drive shaft 2 is reinforced by the reinforcement material 30, in the axial sections, in which it distally exits from the sleeve 6 which is to say is mounted by the bearing elements 40, 41, 42.

[0084] A longitudinal section through the axial section of the catheter 1 which is characterized by the reference numeral Z in FIG. 1 is schematically represented in FIG. 11, and this in particular includes the terminating housing 13 which is adjacent the pump casing 11. The terminating housing 13 is designed in a tubular manner and comprises a distal bearing channel 47 and a bearing element 47 which is arranged therein, for the radial mounting of the distal end-piece 19 of the drive shaft 2. The cavity 47 in particular is dimensioned sufficiently large, in order to permit axial compensation movements of the drive shaft 2.

[0085] A longitudinal section through the proximal coupling module 4 shown in FIG. 1 is represented schematically in FIG. 12, said coupling module comprising a proximal bearing channel 49 for the proximal end-piece 3 of the drive shaft 2, wherein the proximal end-piece 3 of the drive shaft 2 runs axially through the bearing channel 49 and projects axially out of the proximal coupling module 4. A bearing element 50 for the radial stabilization or mounting of the proximal end-piece 3 of the drive shaft 2 is arranged in the bearing channel 49. The sleeve 6 extends axially through this bearing element 50 up to its proximal end. The bearing element 50 in this embodiment has the function of radially stabilizing and supporting the sleeve 6 from the outside. In an alternative embodiment, the sleeve 60 does not run through the bearing element 50, but ends (coming from the distal side) at the distal end of the bearing element 50. In this case, the bearing element 50 for example is designed as a sliding bearing or as a roller bearing. The proximal end-piece 3 can be stiffened by the reinforcement material 30, just as the distal end-piece 19, in particular in the axial sections, in which the drive shaft exits out of the bearing channel 49 or is mounted by the bearing element 50. The bearing elements 40, 41, 42, 48 and 50 preferably consist of zirconium oxide, preferably in the form stabilized with yttrium, of aluminium oxide, of a ceramic or of the same materials as the wires 35, 36 of the drive shaft 2.

[0086] The coupling housing 4 moreover comprises channels 51 for the feed and discharge of the lubricant, wherein the channels are connected in a fluid-leading manner to the bearing channel 49 as well as to an intermediate space between the sleeve 6 and the drive shaft 2. According to the sixth aspect of the invention, an intermediate space or intermediate gap between the drive shaft and the sleeve is filled with a lubricant which is biocompatible and preferably also physiological. The lubricant is biocompatible and in this example is the case of distilled water, but it could also be a physiological saline solution or glucose solution.

[0087] The coupling element 5 of the drive shaft 2 is designed as rigidly as possible and is connected to the proximal end-piece 3 of the drive shaft 2 in a manner fixed with regard to rotation, traction and compression. The coupling element 5 of the drive shaft as well as the coupling element 17 of the drive motor 18, which in this example is designed as a receiver for the coupling element 5, comprises axial sliding surfaces 52 and 53 respectively, which correspond to one another, for forming a rotationally fixed, but axially displaceable connection. These sliding surfaces run parallel to the longitudinal axis of the respective coupling element 5 and 17 respectively and do not change their shape along the longitudinal axis of the respective coupling element 5 and 17 respectively. With this example, with regard to the coupling element 5 of the drive shaft 2 it is the case of a square end.

[0088] The sheath 7 can consist completely or at least regionally of a plastic, for example of polyurethane, in particular of a carbothane or a urethane. The sheath preferably has a metal reinforcement, which for example can consist of the alloy which is suggested for the drive shaft, thus for example of MP35N®.

[0089] FIGS. 13 and 14 in each case show a schematic perspective representation of an embodiment example of the first bearing element 41 of the thrust bearing 44 which is shown in FIG. 9. The sliding surface 46 of the respective bearing element 41 comprises a profiling 55, so that the two sliding surfaces 45, 46 with an interaction with the lubricant form a hydrodynamic sliding bearing, by which means a wear volume of the sliding surfaces 45, 46 or of the two bearing elements 40, 41 can be significantly reduced. In the embodiments represented here, the profiling 55 of the respective sliding surface 46 comprises several prominences 56 and recesses 57. In the example represented in FIG. 13, there are exactly 12 prominences and 12 recesses, in the example shown in FIG. 14 there are precisely 8 prominences and 8 recesses, wherein the prominences 56 and recesses 57 in each case are arranged uniformly distributed over the sliding surface 46 along a peripheral direction or circumferential direction (indicated in each case by an arrow characterized by U in the figures) of the respective sliding surface 46 and are designed as an alternating sequence of ribs and grooves.

[0090] These ribs and grooves extend in each case from an inner edge 58 of the respective sliding surface 46 which faces the drive shaft 2, up to an outer edge 59 of the respective sliding surface 46 which is away from the drive shaft 2. In the example represented in FIG. 13, the ribs in each case have a height (this corresponds to the depth of the respective laterally adjacent groove) of about 0.06 mm and an average width (measured in the peripheral direction U) of about 0.2 mm. In the example represented FIG. 13, the prominences 55 which are designed as ribs in each case have a maximal height of about 0.1 mm, wherein each prominence has a leading surface 60 and a trailing surface 61, wherein the leading surface 60 advances with respect to the trailing surface 61 given a rotation of the bearing element 41 in the designated rotation direction along the peripheral direction U (in the clockwise direction given a viewing direction to the distal end 9 of the catheter 1).

[0091] This leading surface 60 is inclined or beveled with respect to the longitudinal axis of the bearing element 41, in a manner such that the prominence 56 reduces or tapers upwards (i.e., in the direction of the opposite sliding surface 45 of the second bearing element 40, thus in the distal direction in the present example). Basically, thus in any other embodiment examples of profilings of the bearing element 41, a more uniform bow wave formation of the lubricant can be achieved, and by way of this a more stable lubricant film can be formed, with such inclined which is to say beveled leading surfaces 60. On its respective upper side 62, each of the prominences 56 has an average width (measured in the peripheral direction U) of about 0.3 mm, wherein the width of the prominence 56 increases in the radial direction. An average width (measured in the peripheral direction U) of the grooves 57 in this example is about 0.1 mm, wherein the width of the grooves also increases radially outwards. The embodiments which are shown in FIGS. 13 and 14 can be manufactured for example by way of a (cutting) laser.

[0092] “The dependency between the material characteristics yield point, tensile strength, elongation at break and cold work-hardening degree, based on the details of the manufacturer Fort Wayne Metals, is represented with the example of the material 35NLT® in FIGS. 15 and 16. By way of this example, it is shown that different heat-treatment conditions and work-hardening degrees of a material can generally lead to very different material characteristics.

[0093] For example, if the drive shaft 2 and/or the sleeve 6 of the embodiment example shown in FIGS. 1 to 15 consist of 35NLT®, then the work-hardening degree of this material is preferably at about 35 to 70%, particularly preferably at 50% to 60%, so that here a tensile strength of about 2000 to 2200 MPa, for example 2068 MPa is achieved, and an elongation at break of 3.5% is not fallen short of. In the foregoing disclosure, it will be understood that the term “about” should be taken to mean±20% of the stated value, as is known in the art.”

LIST OF REFERENCE NUMERALS

[0094] 1 catheter [0095] 2 drive shaft [0096] 3 proximal end-piece of the drive shaft [0097] 4 coupling module [0098] 5 coupling element of the drive shaft [0099] 6 sleeve [0100] 7 sheath [0101] 8 proximal end of the catheter [0102] 9 distal end of the catheter [0103] 10 pump head [0104] 11 pump casing [0105] 12 downstream tubing [0106] 13 terminating housing [0107] 14 support element [0108] 15 lock [0109] 16 blood pump arrangement [0110] 17 coupling element of the drive motor [0111] 18 drive motor [0112] 19 distal end-piece of the drive shaft [0113] 20 pump rotor [0114] 21 puncture location [0115] 22 femoral artery [0116] 23 aortic arch [0117] 24 left ventricle [0118] 25 heart [0119] 26 inner wall [0120] 27 aortic valve [0121] 28 aorta [0122] 29 cavity [0123] 30 reinforcement material [0124] 31 winding of the drive shaft [0125] 32 winding of the drive shaft [0126] 33 coaxial layer of the drive shaft [0127] 34 coaxial layer of the drive shaft [0128] 35 wire of the drive shaft [0129] 36 wire of the drive shaft [0130] 37 winding of the sleeve [0131] 38 flat tape [0132] 39 inner surface of the sleeve [0133] 40 bearing element [0134] 41 bearing element [0135] 42 bearing element [0136] 43 blading [0137] 44 thrust bearing [0138] 45 sliding surface [0139] 46 sliding surface [0140] 47 bearing channel of the terminating housing [0141] 48 bearing element [0142] 49 bearing channel of the coupling module [0143] 50 bearing element [0144] 51 channel for the lubricant [0145] 52 sliding surface [0146] 53 sliding surface [0147] 54 edge [0148] 55 profiling [0149] 56 prominence [0150] 57 recess [0151] 58 inner edge [0152] 59 outer edge [0153] 60 leading surface [0154] 61 trailing surface