Line device for conducting a blood flow for a heart support system, and production and assembly method
The invention relates to a line device ( 105 ) for conducting a blood flow for a heart support system. The line device ( 105 ) has a main part ( 205 ), and the main part ( 205 ) has a first attachment section ( 210 ) at a first end for attaching the line device ( 105 ) to a head unit of the heart support system and a second attachment section ( 215 ) at a second end for attaching the line device ( 105 ) to an outlet unit of the heart support system ( 100 ). The attachment sections ( 210, 215 ) are shaped so as to be connectable in a form-fitting and/or force-fitting manner. The main part ( 205 ) has a structured section ( 220 ) with at least one stiffening recess ( 225 ) between the attachment sections ( 210, 215 ), the at least one stiffening recess ( 225 ) being shaped so as to change the stiffness of the main part ( 205 ).
1 . A line device for conducting a blood flow for a cardiac support system, comprising:
a main body, wherein the main body comprises:
a first attachment section at a first end configured to attach the line device to a head unit of the cardiac support system;
a second attachment section at a second end;
a structural section comprising a sidewall, the sidewall comprising:
a flexible section proximal to the first attachment section, the flexible section having a plurality of stiffening recesses between the first attachment section and the second attachment section; and
a rigid section proximal to the flexible section, wherein the rigid section is free of stiffening recesses; and
a lead-out opening extending from an outer surface of the structural section to a lumen of the line device, such that a guidewire can be advanced into the lumen through the first attachment section and out of the lumen through the lead-out opening, wherein the lead-out opening is an elongate opening configured to receive the guidewire, wherein the lead-out opening is at least partially disposed within the rigid section of the sidewall proximal to the flexible section;
wherein the second attachment section is coupled to an outlet unit, the outlet unit comprising an outlet opening, and
wherein each individual stiffening recess of the plurality of stiffening recesses comprises a helical slot extending around the structural section from a first end of the helical slot to a second end of the helical slot, such that the plurality of stiffening recesses are discontinuous.
2 . The line device according to claim 1 , wherein the first attachment section is configured to attach the line device to the head unit of the cardiac support system in a form-locking and/or force-locking manner.
3 . The line device according to claim 1 , wherein the second attachment section comprises at least one connection element configured to establish a force-locking connection.
4 . The line device according to claim 1 , wherein the main body comprises an inlet section between the structural section and the first attachment section, wherein the inlet section is configured to allow initiation of the blood flow.
5 . The line device according to claim 4 , wherein the main body comprises a bending point disposed between the inlet section and the second attachment section, wherein the line device comprises a first longitudinal axis proximal to the bending point and a second longitudinal axis at an angle to the first longitudinal axis distal to the bending point.
6 . The line device according to claim 4 , wherein the inlet section comprises at least one inlet opening through the main body.
7 . The line device according to claim 1 , wherein at least one portion of the main body is made of a shape memory material.
8 . The line device according to claim 7 , wherein the shape memory material is nitinol.
9 . The line device according to claim 1 , further comprising a cable groove configured to guide a cable along the main body.
10 . The line device according to claim 1 , wherein the structural section extends over at least half of the main body.
11 . The line device according to claim 1 , wherein the plurality of stiffening recesses comprises a plurality of slotted holes.
12 . The line device according to claim 1 , further comprising a sealing layer, wherein the sealing layer is disposed on or in the structural section, wherein the sealing layer is configured to seal at least one stiffening recess in a fluid-tight manner.
13 . The line device according to claim 1 , wherein an inner diameter of the main body changes between the first attachment section and the second attachment section.
14 . The line device according to claim 1 , wherein the main body comprises a side opening configured to receive a guide wire.
15 . The line device according to claim 1 , wherein the second attachment section comprises a plurality of recesses.
16 . A cardiac support system, comprising:
a head unit;
an outlet unit; and
a line device disposed between the head unit and the outlet unit, the line device comprising a main body, wherein the main body comprises:
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;
a structural section comprising a sidewall, the sidewall comprising:
a flexible section proximal to the first attachment section, the flexible section having a plurality of stiffening recesses between the first attachment section and the second attachment section; and
a rigid section proximal to the flexible section, wherein the rigid section is free of stiffening recesses; and
a lead-out opening extending from an outer surface of the structural section to a lumen of the line device, such that a guidewire can be advanced into the lumen through the first attachment section and out of the lumen through the lead-out opening, wherein the lead-out opening is an elongate opening configured to receive the guidewire, wherein the lead-out opening is at least partially disposed within the rigid section of the sidewall proximal to the flexible section;
wherein the second attachment section is coupled to the outlet unit, the outlet unit comprising an outlet opening, and
wherein each individual stiffening recess of the plurality of stiffening recesses comprises a helical slot extending around the structural section from a first end of the helical slot to a second end of the helical slot, such that the plurality of stiffening recesses are discontinuous.
17 . The cardiac support system of claim 16 , wherein the first attachment section is configured to attach the line device to the head unit of the cardiac support system in a form-locking and/or force-locking manner.
18 . The cardiac support system of claim 16 , further comprising a cable configured to extend helically around the structural section.
19 . The cardiac support system of claim 18 , wherein the main body further comprises a cable groove configured to guide the cable along the main body, wherein the cable groove extends helically around the main body.
20 . The cardiac support system of claim 16 , wherein the head unit comprises a sensor assembly.
21 . The cardiac support system of claim 20 , further comprising a cable coupled to the sensor assembly and extending along an outer wall of the line device.
22 . A method for producing a line device for conducting a blood flow for a cardiac support system, the method comprising:
forming a main body from a semi-finished product made of a shape memory material, wherein the main body comprises:
a first attachment section at a first end configured to attach the line device to a head unit of the cardiac support system;
a second attachment section at a second end;
a structural section comprising a sidewall, the sidewall comprising:
a flexible section proximal to the first attachment section, the flexible section having a plurality of stiffening recesses between the first attachment section and the second attachment section; and
a rigid section proximal to the flexible section, wherein the rigid section is free of stiffening recesses; and
a lead-out opening extending from an outer surface of the structural section to a lumen of the line device, such that a guidewire can be advanced into the lumen through the first attachment section and out of the lumen through the lead-out opening, wherein the lead-out opening is an elongate opening configured to receive the guidewire, wherein the lead-out opening is at least partially disposed within the rigid section of the sidewall proximal to the flexible section;
wherein the second attachment section is coupled to an outlet unit, the outlet unit comprising an outlet opening, and
wherein each individual stiffening recess of the plurality of stiffening recesses comprises a helical slot extending around the structural section from a first end of the helical slot to a second end of the helical slot, such that the plurality of stiffening recesses are discontinuous; and
heat treating the formed main body so as to emboss a predetermined shape on the main body.
23 . The method according to claim 22 , wherein the first attachment section is configured to attach the line device to a first unit of the cardiac support system in a form-locking and/or force-locking manner.
24 . The method according to claim 22 , further comprising producing a form-locking and/or force-locking connection of the outlet unit to the line device to assemble the cardiac support system.
25 . The line device of claim 1 , wherein the structural section comprises a lateral inlet opening between the first attachment section and the second attachment section, the lateral inlet opening in fluid communication with an interior of the structural section, and the lateral inlet opening integral with the structural section.
26 . The line device of claim 1 , wherein the structural section is curved at a bending point, and wherein the bending point is between a proximal straight portion and a distal straight portion of the structural section.
27 . The line device of claim 1 , wherein the first ends of at least some of the helical slots are aligned along an axis parallel to a longitudinal axis of the structural section.
28 . The line device of claim 27 , wherein at least some of the helical slots are aligned along a second axis parallel to a longitudinal axis of the structural section.
29 . The line device of claim 1 , wherein at least some of the helical slots are arranged in a repeating pattern.
30 . The line device of claim 1 , wherein the second attachment section is joined to the outlet unit in a form-locking or force-locking manner.