Implantation Catheter

Abstract

The disclosure relates to an implantation catheter for implanting a vascular implant into a vessel of a human or animal, comprising a catheter shaft having a proximal end and a distal end, a vascular implant carried by the catheter shaft, and a pressure sensor for sensing a vascular pressure at the distal end. The implantation catheter comprises an inflatable balloon arranged circumferentially around an outside of the catheter shaft in a distal end section of the catheter shaft. Also, a method for implanting a vascular implant into a vessel of a human or an animal is provided.

Claims

1. An implantation catheter for implanting a vascular implant into a vessel of a human or animal, comprising: a catheter shaft having a proximal end and a distal end, a vascular implant carried by the catheter shaft, and a pressure sensor for sensing a vascular pressure at the distal end, wherein the implantation catheter comprises an inflatable balloon arranged circumferentially around an outside of the catheter shaft in a distal end section of the catheter shaft, and the vascular implant is a sensory implant.

2. The implantation catheter according to claim 1, wherein the distal end section extends from the distal end towards the proximal end over up to 10% of the total length of the catheter shaft.

3. The implantation catheter according to claim 1, wherein a distal end of the balloon flushes with the distal end of the catheter shaft.

4. The implantation catheter according to claim 1, wherein the pressure sensor is an electronic pressure sensor.

5. The implantation catheter according to claim 4, wherein the implantation catheter comprises a handle, wherein the handle comprises an evaluation electronics for reading the pressure sensor out.

6. The implantation catheter according to claim 4, wherein the evaluation electronics comprises a wireless communication module for transferring pressure data sensed by the pressure sensor to an external evaluation unit.

7. The implantation catheter according to claim 1, wherein the pressure sensor comprises a measuring lumen having a distal opening at the distal end of the catheter shaft, wherein the measuring lumen is designed and arranged to be filled with a liquid through which a vascular pressure outside the distal opening of the measuring lumen can be transferred to a pressure measuring device connected to a proximal opening of the measuring lumen.

8. The implantation catheter according to claim 1, wherein the vascular implant is or comprises at least one of a pressure sensor, a temperature sensor and a flow sensor.

9. The implantation catheter according to claim 1, wherein the vascular implant comprises a data transfer unit for transferring sensed data to an external evaluation unit.

10. The implantation catheter according to claim 1, wherein the vascular implant is arranged on an outside of the catheter shaft.

11. The implantation catheter according to claim 1, wherein the vascular implant is arranged inside the catheter shaft.

12. An implantation catheter arrangement comprising an implantation catheter according to claim 1 and an evaluation unit, wherein the evaluation unit is operatively coupled with a data transfer unit of the vascular implant and with the pressure sensor of the implantation catheter, wherein the evaluation unit is designed and arranged to receive data from the pressure sensor and from the vascular implant, wherein the evaluation unit has a display for displaying the data received from the pressure sensor and from the vascular implant at the same time.

13. A method for implanting a vascular implant into a vessel of a human or an animal, particularly into the pulmonary artery, with an implantation catheter according to claim 1, the implantation catheter comprising a catheter shaft having a proximal end and a distal end, a vascular implant carried by the catheter shaft, a pressure sensor for sensing a vascular pressure at the distal end, and an inflatable balloon arranged circumferentially around an outside of the catheter shaft in a distal end section of the catheter shaft, the method comprising the following steps: a) inflating the balloon, b) advancing the catheter to an intended implantation site within the pulmonary artery, c) keeping the balloon in its inflated stated and measuring the pulmonary wedge pressure to obtain a first value of the pulmonary wedge pressure, and/or deflating the balloon and measuring the pulmonary arterial pressure to obtain a first value of the pulmonary arterial pressure, d) releasing the vascular implant from the implantation catheter and implanting the vascular implant at the intended implantation site, and e) inflating the balloon or keeping the balloon in its inflated stated and measuring the pulmonary wedge pressure to obtain a second value of the pulmonary wedge pressure, and/or keeping the balloon in its deflated stated or deflating the balloon and measuring the pulmonary arterial pressure to obtain a second value of the pulmonary arterial pressure.

14. The method according to claim 13, wherein the balloon is deflated prior to releasing the vascular implant from the implantation catheter.

15. The method according to claim 13, wherein the method is carried out without using another catheter for measuring the pulmonary wedge pressure or the pulmonary arterial pressure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Further details will be explained in the following with respect to exemplary embodiments and accompanying Figures. In the Figures:

[0050] FIG. 1 shows a longitudinal section through an implantation catheter known from prior art;

[0051] FIGS. 2A-B show schematic sketches of a first embodiment of an implantation catheter comprising an inflatable balloon;

[0052] FIGS. 3A-B show schematic sketches of a second embodiment of an implantation catheter comprising an inflatable balloon; and

[0053] FIG. 4 shows a schematic sketch of a third embodiment of an implantation catheter comprising an inflatable balloon.

DETAILED DESCRIPTION

[0054] FIG. 1 shows a longitudinal section of an implantation catheter 1 according to prior art. This implantation catheter 1 comprises an outer catheter and an inner catheter 3. The inner catheter 3 comprises a pushing element 4 at its distal end. This pushing element 4 serves for pushing an implant 5 out of the implantation catheter 1 once the desired implantation site has been reached. For securing the implant 5 within the implantation catheter 1, a proximal fixation loop 6 is provided that can be moved by pulling two fixation wires 7.

[0055] The implantation catheter is guided on a guide wire 8 through the body of the patient towards the intended implantation site. In order to locate the desired implantation site and the correct positioning of the implantation catheter 1, the implant 5 is provided with an antenna 9 and an X-ray opaque marker 10 arranged at the antenna 9.

[0056] For steering the implantation catheter 1 through the body of the human or animal patient, a pull wire 11 is provided that is tightly connected with the pushing element 4 of the inner catheter 3.

[0057] At the desired implantation site, the outer catheter 2 is retracted with respect to the inner catheter 3 so as to release the implant 5 from the implantation catheter 1.

[0058] Below the longitudinal section of FIG. 1, two cross-sectional views (along the dashed lines through the longitudinal section) are provided. The left cross-sectional view shows the relative arrangement of the guidewire 8 and the implant 5 inside the outer catheter 2 in a distal end section of the implantation catheter 1. The right cross-sectional view shows the different lumina that are present in the inner catheter 3 through which the fixation wires 7, the pull wire 11 for steering the implantation catheter 1 and the guidewire 8 are guided. Furthermore, an empty lumen 12 can be seen that is not needed for the functionality of the implantation catheter 1.

[0059] FIG. 2A shows an implantation catheter 20 comprising a catheter shaft 21 with a distal opening 22 at its distal end 23. The catheter shaft 21 is arranged and designed to house an implant in its interior or on its outside.

[0060] In a distal end section 24 of the catheter shaft 21, a balloon 25 is provided that radially extends around an outside of the catheter shaft 21. Due to this balloon 25, the implantation catheter 20 can float with the bloodstream towards a desired site of implantation, e.g., inside the pulmonary artery.

[0061] FIG. 2B shows a cross-sectional view through the implantation catheter 20 of FIG. 2A. Thereby, the same numeral references will be used in this and in the following Figures for the same structural elements.

[0062] The catheter shaft 21 comprises a first lumen 26 and a second lumen 27 for guiding fixation wires for fixing an implant arranged inside the catheter shaft 21. It furthermore comprises a balloon lumen 28 that serves for providing the balloon 25 with an appropriate liquid such as a salt solution for inflating the balloon 25. The catheter shaft 21 furthermore comprises a measuring lumen 29 that has a distal opening and is filled with a liquid. The pressure being present on the distal end 23 of the implantation catheter 20 can then be transferred through the liquid column being present in the measuring lumen 29 to a proximal end of the implantation catheter 20 and a pressure monitoring device being arranged at the proximal end of the implantation catheter 20. Thus, the measuring lumen 29 servestogether with the pressure monitoring device additionally provided at the proximal end of the measuring lumen 29as the pressure sensor of the implantation catheter 20.

[0063] FIG. 3A shows another embodiment of the implantation catheter 20, wherein reference is made to the explanations given with respect to FIGS. 2A and 2B. In the following, only the differences to the embodiment of FIGS. 2A and 2B will be explained.

[0064] In contrast to the implantation catheter 20 depicted in FIG. 2A, the implantation catheter 20 of FIG. 3A has an electronic pressure sensor 30 arranged at the distal end 23 of the implantation catheter 20. This electronic pressure sensor 30 is connected via a connecting line 31 with an evaluation unit being present at a proximal end of the catheter shaft 21, e.g., in a handle of the implantation catheter 20. Then, it is possible to transmit signals sensed by the electronic pressure sensor 30 through the connecting line 31 towards such an evaluation electronics.

[0065] FIG. 3B shows a cross-sectional view through the implantation catheter 20 of FIG. 3A. Once again, a first lumen 26 and a second lumen 27 for guiding fixation wires for fixing an implant being present within the catheter shaft 21 are provided. Furthermore, a balloon lumen 28 is provided through which a salt solution can be fed to the balloon 25 in order to inflate the balloon 25. Likewise, the balloon lumen 28 serves for withdrawing such a salt solution from the balloon 25 in order to deflate the balloon.

[0066] The implantation catheter 20 of FIG. 3B uses a measuring lumen 32 for guiding the connecting line 31 that connects the electronic pressure sensor 30 with an evaluation electronics. Thus, in contrast to the exemplary embodiment depicted in FIGS. 2A and 2B, the measuring lumen 32 is not filled with a liquid like the measuring lumen 29, but rather serves for guiding the connecting line 31.

[0067] FIG. 4 shows a longitudinal section through another embodiment of the implantation catheter 20. It comprises an inner catheter 33 and an outer catheter 34. Both serve as catheter shaft 21. An implant 35 is located distal of the inner catheter 33. The outer catheter 34 serves as protective covering for the implant 35. The balloon 25 is arranged outside the outer catheter 34 circumferentially around the outer catheter 34. Distal of the implant 35, a fixation structure 36 is present inside the outer catheter 34 that serves for fixing the implant 35 inside the catheter shaft 21. Once the implant 35 is to be released from the implantation catheter 20, the fixation structure 36 is retracted. At the same time, the outer catheter 34 is retracted relatively with respect to the inner catheter 33. Then, the implant 35 is released and can be implanted at the desired site of implantation.

[0068] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this disclosure, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.