Implantable Pressure Sensor Probe and Catheter for Implanting a Pressure Sensor Probe

Abstract

The disclosure relates to an implantable pressure sensor probe for measuring a pressure in the left atrium of a human heart, wherein a distal portion of the pressure sensor probe has a pressure sensor for detecting the pressure. A catheter is also described.

Claims

1. A method for implanting a pressure sensor into a left atrium of a human heart, comprising the steps of inserting the pressure sensor transvenously through a coronary sinus of the heart into the left atrium.

2. The method according to claim 1, further comprising the steps of: providing an implantable pressure sensor probe comprising the pressure sensor, wherein the pressure sensor is arranged in a distal portion of the pressure sensor probe; puncturing a shared wall of the coronary sinus and the left atrium to create an opening in the shared wall; and transvenously implanting the pressure sensor probe into the coronary sinus in such a way that the distal portion with the pressure sensor projects through the opening into the left atrium.

3. The method according to claim 2, wherein the pressure sensor probe is inserted into the coronary sinus via a suitable venous access through the subclavian vein.

4. The method according to claim 1, further comprising the steps of: probing the coronary sinus with a suitable implantation tool using combinations of inner and outer catheters with a guide wire and a dilator, wherein the inner catheter is bent at the distal end for puncturing the vessel wall in a left sulcus atrioventricularis, so that the opening of the distal end of the inner catheter points towards the left atrium.

5. The method according to claim 4, wherein an orientation of the tip of the inner catheter is assessed under fluoroscopy using with one or more markers that are detectable by X-rays arranged at the tip of the inner catheter, preferably a cranial marker, a caudal marker and a posterior marker are applied to the inner catheter

6. The method according to claim 1, further comprising the steps of: puncturing a shared wall between the coronary sinus and the left atrium using a puncture wire; inserting a dilator and finally an internal catheter; removing the puncture wire and the dilator; pushing the pressure sensor probe through the implantation tool so that the distal portion of the pressure sensor probe with the pressure sensor protruding into the left atrium; and removing the internal catheter.

7. The method according to claim 2, wherein a puncture needle in a needle catheter is used to create the opening, wherein the puncture needle in the needle catheter is guided wo through the splinting guide lumen of a guide catheter to the posterior wall of the left atrium.

8. The method according to claim 7, further comprising the following steps: puncturing, using the puncture needle, a posterior wall; inserting the needle catheter into the left atrium; withdrawing the puncture needle completely; inserting the pressure sensor, arranged on the distal portion of the pressure sensor probe, into the left atrium via the needle catheter; and withdrawing the needle catheter after the fixation of the pressure sensor.

9. The method according to claim 1, wherein the distal portion of the pressure sensor probe has an anchoring portion for anchoring the distal portion in tissue.

10. The method according to claim 9, wherein the anchoring portion comprises at least one element selected from the following group: barb, umbrella, plate, loop and flange.

11. The method according to claim 1, wherein a catheter for implanting a pressure sensor probe into the left atrium (LA) of a human heart is used, wherein the catheter comprises a catheter body in which a guide lumen for the pressure sensor probe is formed, wherein a distal portion of the catheter body comprises: a lateral exit opening for leading a distal portion of the pressure sensor probe out of the guide lumen; and a marker detectable by X-rays to determine a position of the exit opening.

12. The method according to claim 11, further comprising the steps of: arranging a balloon on the distal portion of the catheter body.

13. The method according to claim 11, wherein the marker comprises a heavy metal.

14. The method according to one of claim 11, wherein the marker is T-shaped.

15. The method according to claim 1, further comprising the steps of: providing an implantable pressure sensor probe comprising the pressure sensor, wherein the pressure sensor is arranged in a distal portion of the pressure sensor probe; providing a balloon catheter having a guide lumen with a lateral exit opening for the pressure sensor probe; advancing the balloon catheter into the coronary sinus with the balloon deflated; wedging the balloon catheter into the coronary sinus from an inside and fixing an exit point relative to a shared wall between the coronary sinus and the left atrium in a position suitable for puncture; puncturing the shared wall through the exit opening; pushing the pressure sensor probe through the guide lumen so that the distal portion of the pressure sensor probe with the pressure sensor protruding into the left atrium; and deflating the balloon.

16. The method according to claim 1, further comprising the steps of: measuring, by the pressure sensor, a pressure in the left atrium and generating pressure signals; detecting, by a pectorally implanted unit, the pressure signals from the pressure sensor; and sending, by the pectorally implanted unit, the detected pressure signals to a device located outside the human body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Further advantages and embodiments are described below with reference to the figures, in which:

[0034] FIG. 1 shows an exemplary and schematic flow chart of a method for implanting a pressure sensor into the left atrium of a human heart;

[0035] FIG. 2 shows a distal portion of an implantable pressure sensor probe according to an exemplary embodiment;

[0036] FIG. 3 shows a schematic rear view of a human heart with a pressure sensor probe extending into the coronary sinus;

[0037] FIG. 4 shows a schematic internal view of the left atrium of the heart from FIG. 3, with a distal portion of the pressure sensor probe with a pressure sensor extending through a puncture point into the left atrium;

[0038] FIG. 5 shows a catheter inserted into a coronary sinus for implanting a pressure sensor probe according to an exemplary embodiment; and

[0039] FIG. 6 shows another exemplary embodiment of a catheter, wherein the catheter has an inflatable balloon distally.

DETAILED DESCRIPTION

[0040] FIG. 1 shows a schematic flow chart of a method for implanting a pressure sensor 12 into the left atrium LA of a human heart according to an exemplary embodiment. The pressure sensor 12 is implanted transvenously (for example via the subclavian vein) through the coronary sinus CS of the heart into the left atrium LA. In the following explanation of the method, reference is also made immediately to FIGS. 2 to 6, which show views of the left atrium LA or views of components relevant for implantation, such as a catheter 2 and a pressure sensor probe 1, in greater detail.

[0041] In a first step S1, the method according to FIG. 1 comprises providing an implantable pressure probe 1 which has the pressure sensor 12 to be implanted. For example, a probe similar to the known coronary sinus probes of CRT systems may be additionally equipped with a pressure sensor 12 at its distal end.

[0042] FIG. 2 shows a distal portion of an implantable pressure sensor probe 1 for measuring a pressure in the left atrium LA according to an exemplary embodiment. The pressure sensor 12 is arranged on the distal portion of the pressure sensor probe 1. A cable 13 leads to the pressure sensor 12 and is electrically insulated from the surrounding tissue by an insulation 131. For example, signals indicating a pressure detected by the pressure sensor 12 in the left atrium LA may be supplied to an implanted or extracorporeal receiving device via the cable 13 of the pressure sensor probe 1.

[0043] In the embodiment according to FIG. 2, the distal portion of the pressure sensor probe 1 comprises, in addition to the one pressure sensor 12, an anchoring portion 11 for anchoring the distal portion of the pressure sensor probe 1 in the tissue. The anchoring portion 11, which in this case is in the form of a number of barbs, may anchor the pressure sensor probe 1 in the tissue, for example in the implanted state, in such a way that the position of the pressure sensor 12 in the left atrium LA remains stable.

[0044] In a second step S2 of the exemplary embodiment of the implantation method according to FIG. 1, the shared wall of the coronary sinus CS and the left atrium LA is punctured to create an opening P in that wall. For orientation regarding the heart anatomy, please refer to FIGS. 3 and 4.

[0045] FIG. 3 shows a schematic rear view of a human heart, with the right atrium RA and left atrium LA located above the right ventricle RV and above the left ventricle LV, respectively. The coronary sinus CS together with the atrioventricular sulcus SA are also shown. The coronary sinus CS extends along a posterior wall of the left atrium, which is punctured in the second method step S2.

[0046] FIG. 4 shows a schematic internal view of the left atrium LA of the heart from FIG. 3. The attachment points of the pulmonary veins PV and the mitral valve M between the left atrium LA and the left ventricle LV are visible. The atrial septum AS and the ventricular septum VS are also schematically drawn. In the vicinity of the mitral valve M, the wall of the left atrium LA has the opening (puncture point) P that was created in the second method step S2 from the coronary sinus CS.

[0047] According to an exemplary variant, to create the opening P—similarly to a septal puncture—a puncture needle in a needle catheter is guided through the splinting guide lumen of a guide catheter to the posterior wall of the left atrium LA. Possible embodiments of a catheter 2 that may be used as such a guide catheter are shown in FIGS. 5 and 6 and are explained in more detail below.

[0048] The puncture needle then punctures the posterior wall and the needle catheter is inserted into the left atrium LA. The puncture needle is then withdrawn completely and the pressure sensor 12 arranged on the distal portion of the pressure sensor probe 1 is inserted into the left atrium LA via the horizontal needle catheter. After fixation of the pressure sensor 12, the needle catheter is withdrawn.

[0049] In a second step S2 of the exemplary embodiment of the implantation method according to FIG. 1, the pressure probe 1 is implanted transvenously (for example via the subclavian vein) into the coronary sinus CS, moreover in such a way that the distal portion with the pressure sensor 12 projects through the opening P into the left atrium LA.

[0050] This is illustrated in more detail in FIGS. 3 and 4. FIG. 3 shows a portion of a pressure sensor probe 1 implanted in the coronary sinus CS in the manner described. FIG. 4 shows a distal portion of the pressure sensor probe 1 from FIG. 3 from an internal perspective of the left atrium LA, said distal portion extending, with the pressure sensor 12 arranged on it, through the puncture point P into the left atrium LA.

[0051] In FIG. 4 it is clearly visible that the pressure sensor 12 in this embodiment is located completely in the left atrium LA and may thus directly measure a filling pressure prevailing there. In this case, the pressure sensor 12 projects freely into the cavity of the left atrium LA. This has the advantage that myocardial cells are unable to grow over the pressure sensor.

[0052] In the following, exemplary embodiments of a catheter 2 for implanting a pressure sensor probe 1 into the left atrium LA are explained with reference to FIGS. 5 and 6. The catheter is inserted into a distally tapering coronary sinus CS. An ostium OS of the coronary sinus is shown at the left edge of each image.

[0053] The catheter 2 shown in FIG. 5 comprises a tubular catheter body 20, in which a guide lumen 21 is formed for the pressure sensor probe 1 to be implanted. The guide lumen 21 is large enough to accommodate the pressure sensor probe 1. A distal portion of the catheter body 20 has a lateral exit opening 22 for guiding the distal portion of the pressure sensor probe 1 out of the guide lumen 21. The pressure sensor 12 arranged on the distal portion of the pressure sensor probe 1 may thus be guided through the guide lumen 21 into the coronary sinus CS, then leave the guide lumen 21 through the lateral exit opening 22 and project through the puncture point P into the left atrium LA.

[0054] In addition, a marker 24 is attached to the distal portion of the catheter body 20 and is detectable by X-rays in order to determine a position of the exit opening 22. In particular, the position of the outlet opening 22 in the direction of the left atrium LA may be adjusted under fluoroscopy by selective rotation of the catheter body 20. The marker 24 may, for example, comprise a heavy metal that is impermeable to X-rays and therefore easily recognisable by fluoroscopy.

[0055] In the shown variant, the marker 24 is T-shaped. This makes it easy to read an orientation of the catheter body 22 (and in particular a direction of the exit opening 22) under fluoroscopy. In this case, the marker 24 is in the form of an upright T on the same semicircle of the catheter body 20 as the exit opening 22. If the marker 24 shows an upright T in fluoroscopy, the exit opening 22 is directed ventrally (this corresponds to a correct rotation for access to the left atrium LA). On the other hand, if the T is inverted, the exit opening points dorsally and must be rotated 180°.

[0056] In the present exemplary embodiment, there is only a single marker 24 on the catheter body 20. Additional markers may in principle facilitate orientation.

[0057] The variation of the catheter 2 from FIG. 5 shown in FIG. 6 additionally has a balloon 23 distally, which may be filled and deflated. In other words, the catheter 2 is designed as a balloon catheter. This makes it possible to temporarily wedge the balloon catheter 2 in a suitable position from the inside in the coronary sinus CS during implantation by filling the balloon 23. For example, this allows the exit point 22 of the catheter body 20 to be fixed in a suitable position relative to the wall between the coronary sinus CS and the left atrium LA for puncture. As described above, the catheter body 20 may first be deliberately rotated into the suitable position by means of the marker 24 under fluoroscopy.

[0058] 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 teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate 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 invention, 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.

LIST OF REFERENCE SIGNS

[0059] 1 Pressure sensor probe [0060] 11 Anchoring portion [0061] 12 Pressure sensor [0062] 13 Connecting cable [0063] 131 Insulation [0064] 2 Catheter [0065] 20 Catheter body [0066] 21 Guide lumen [0067] 22 Exit opening [0068] 23 Balloon [0069] 24 Marker [0070] AS Atrial septum [0071] CS Coronary sinus [0072] LA Left atrium [0073] LV Left ventricle [0074] M Mitral valve [0075] OS Ostium of the coronary sinus [0076] P Opening (puncture point) [0077] PV Pulmonary veins [0078] RA Right atrium [0079] RV Right ventricle [0080] SA Atrioventricular sulcus [0081] S1-S3 Method steps [0082] VS Chamber septum