Catheter System

Abstract

Catheter system for inserting and positioning a double-lumen catheter in a blood vessel, including a double-lumen catheter having a distal catheter tip, with a first lumen and a second lumen, a first mandrin which extends through the first lumen and a second mandrin which extends through the second lumen, both mandrins of the catheter being radio-opaque. The distal end of the second mandrin is arranged at a distance (X) in the proximal direction from the distal catheter tip, the distance between the distal catheter tip and the distal end of the second mandrin corresponding in particular to a functional catheter tip length.

Claims

1. Catheter system for inserting and positioning a double-lumen catheter in a blood vessel, comprising a double-lumen catheter having a distal catheter tip, with a first lumen and a second lumen, a first mandrin which extends through the first lumen and a second mandrin which extends through the second lumen, the second lumen having a distal opening and, in the proximal direction, at least one lateral opening, characterized in that both mandrins of the catheter are radio-opaque, the catheter being designed for insertion into the blood vessel such that the distal end of the second mandrin is arranged behind, in the proximal direction, or at a proximal end of the most proximal lateral opening and at a distance (X) in the proximal direction from the distal catheter tip, the distance (X) between the distal catheter tip and the distal end of the second mandrin representing a functional catheter tip portion.

2. Catheter system according to claim 1, wherein the distance between the distal catheter tip and the distal end of the second mandrin is between 15 and 50 mm.

3. Catheter system according to claim 1, wherein the distal end of the second mandrin is located within the second lumen.

4. (canceled)

5. Catheter system according to claim 1, wherein the first mandrin projects beyond the catheter tip in the distal direction for insertion of the catheter.

6. Catheter system according to claim 1, wherein at least one of the first mandrin and/or the second mandrin have a BaSO4 content between 15-30 wt. %.

7. Catheter system according to claim 1, wherein the first lumen comprises a distal opening, and wherein the region of the catheter surrounding the opening comprises the catheter tip.

8. Catheter system according to claim 1, wherein the catheter has a central wall that separates the first lumen from the second lumen, and wherein the distal end of the central wall represents the catheter tip.

9. Catheter system according to claim 1, wherein the catheter is designed as a dialysis catheter, wherein the first lumen is the venous lumen, and wherein the second lumen is the arterial lumen.

10. Catheter system according to claim 1, wherein the catheter is designed for long-term implantation.

11. A method for inserting and positioning a double-lumen catheter in a blood vessel, comprising the steps of: a. using a double-lumen catheter having a distal catheter tip, with a first lumen and a second lumen, a first radio-opaque mandrin which extends through the first lumen and a second radio-opaque mandrin which extends through the second lumen, the second lumen having a distal opening and, in the proximal direction, at least one lateral opening, and b. inserting the catheter into the blood vessel such that the distal end of the second mandrin is arranged behind, in the proximal direction, or at a proximal end of the most proximal lateral opening and at a distance in the proximal direction from the distal catheter tip, wherein the distance between the distal catheter tip and the distal end of the second mandrin represents a functional catheter tip portion.

Description

[0020] Further details and advantageous embodiments of the invention can be found in the following description, on the basis of which the embodiment of the invention shown in the figures is described and explained in more detail. In the drawings:

[0021] FIG. 1 is a schematic longitudinal sectional view of the distal end region of a catheter system according to one embodiment.

[0022] FIG. 1 shows overall the distal end region 12 of a catheter system 10, firstly comprising a catheter 14 designed as a dialysis catheter, which is designed for insertion into a blood vessel.

[0023] The proximal region of the catheter system 10 is not shown. The proximal region (not shown) of the catheter 14 is designed for connection to a dialyzer via a blood tube system, in order to purify withdrawn blood and supply purified blood to a patient. The proximal end region of the catheter 10 can in particular be designed as in one of the embodiments disclosed in DE 10 2017 118 820.7, the disclosure of which is fully incorporated into the present application by reference.

[0024] The catheter 14 has a round contour in cross section with an outer wall 17. Furthermore, the catheter 14 has a central wall 18 which extends along a longitudinal axis and forms a central plane. The central wall 18 separates the inside of the catheter into a first lumen 20, which is designed as an introduction lumen (venous lumen), and a second lumen 22, which is designed as a withdrawal lumen (arterial lumen). Blood can be withdrawn from a patient through the withdrawal lumen 22, purified in the dialyzer, and the blood purified in this way can then be returned to the patient through the introduction lumen 20. At its distal end 24, the withdrawal lumen 22 has a distal opening 26 designed as a withdrawal opening. The introduction lumen 20 has, at its distal end 28, a distal opening 30 designed as an introduction opening.

[0025] As can further be seen from FIG. 1, the introduction lumen 20 has a venous lateral opening 32 spaced apart from the introduction opening 30 in the proximal direction 11. This lateral opening 32 is used to ensure that blood can be introduced even if the introduction opening 30 were to be closed, for example by abutting a blood vessel. Accordingly, as is clear from FIG. 2, an arterial lateral opening 34 spaced apart from the withdrawal opening 26 in the proximal direction 11 is provided on the withdrawal lumen 22, so that blood can be withdrawn even if the withdrawal opening 26 were to be closed, for example by abutting a blood vessel. The introduction opening 28 is therefore located behind the withdrawal opening 26 in the distal direction 13, so that the introduction opening 28 is more distal than the withdrawal opening 26.

[0026] The exact geometry of the distal end region of the catheter 14, shown schematically in FIG. 1, can in particular be designed as in one of the embodiments disclosed in DE 10 2017 118 819.3, the disclosure of which is fully incorporated into the present application by reference.

[0027] A first mandrin 36 is arranged in the introduction lumen 20. This therefore extends through the introduction lumen 20. This is the venous mandrin. The distal end 38 of the first mandrin 36 protrudes in the distal direction 13 beyond the distal end 40 of the catheter 14. The distal end 38 consequently forms the distal end of the catheter system 10.

[0028] A second mandrin 42 is also arranged in the withdrawal lumen 22. The distal end 44 of the second mandrin 42 ends at the proximal end 46 of the arterial lateral opening 34. The distance X between the distal end 44 and the catheter tip 40 represents the functional catheter tip portion 48, which consequently extends from the proximal end 46 of the lateral opening 34 to the catheter tip 40. This distance X can be 20 mm, for example.

[0029] Both mandrins 36 and 42 are radio-opaque. These contain, for example, 24% barium sulfate (BaSO4), so that the mandrins consist of material that is visible in the X-ray contrast and can be recognized by an X-ray device. Thus, when the catheter is inserted into a blood vessel, the position, in particular the distal end 38 of the first mandrin 36, can first be determined in order to thus supply the catheter into the blood vessel in the distal direction 13 to its intended position.

[0030] The intended position can be, for example, at the transition between the superior vena cava (SVC) and the right ventricle (right atrium (RA)). This intended position can in particular be achieved when the distal end 44 of the second mandrin 42 has reached this position. The functional portion 48 of the catheter 14 thus protrudes further from this intended position in the distal direction 13 into the blood vessel, for example the right atrium. The surgeon can thus determine in particular where the proximal end 46 of the most proximal lateral opening 34 in the withdrawal lumen 22 is located. After positioning, the mandrins 36 and 42 are removed. Dialysis can then be carried out, with blood being withdrawn from the blood vessel through the withdrawal lumen 22 and supplied to a dialyzer for purification, and the purified blood being returned to the blood vessel via the introduction lumen 20. The catheter 14 can in particular be a long-term catheter, which can remain in the body in particular for several days, weeks or months or up to a year.

[0031] In contrast with the prior art, an X-ray marker, in particular containing tungsten, on the outside of the catheter in the region of the proximal end 46 of the most proximal lateral opening 34 can be completely dispensed with. Only the catheter 14 remains on the body in contact therewith.