Delivery system for placing leadless pacemaker devices inside the human body

Abstract

The present invention relates to a delivery system for placing a leadless pacemaker device inside the human body, comprising: a catheter device (4) for insertion into the human body, the catheter device (4) having a lumen (3) and a distal end region (8) to be inserted into the human body, the lumen (3) being configured to receive a leadless pacemaker device (2) within the distal end region (8) of the catheter device (4); and a first mapping electrode (10) and a second mapping electrode (11) positioned in the distal end region (8) of the catheter device (8), the first mapping electrode (10) and the second mapping electrode (11) for sensing a mapping signal between the first mapping electrode (10) and the second mapping electrode (11) in mapping mode, and the first The present invention relates to a delivery system in which a mapping electrode (10) is positioned on a mapping extension (9) that protrudes from the side wall (14) of the distal end region (8) of the catheter device (4) toward the central axis (A) of the catheter device (4), the central axis (A) extends in the longitudinal extension direction (L) of the catheter device (4), the mapping extension (9) is movable between a non-mapping position and a mapping position relative to the side wall (14) of the distal end region (8) of the catheter device (4), the angle (α) between the mapping extension (9) and a virtual plane (P) extending perpendicular to the central axis (A) is greater than 5° in the non-mapping position and within the range of 0° to 5° in the mapping position, and a second mapping electrode (11) is positioned outside the side wall (14) of the distal end region (8) of the catheter device (4).

Description

[Technical Field]

[0001] The present invention relates to a delivery system for placing a leadless pacemaker device in the human body using a preamble according to claim 1, a pacemaker placement comprising such a delivery system using a preamble according to claim 12, and a method for mapping tissue regions to identify a suitable implantation site for a leadless pacemaker device using a preamble according to claim 15.

[0002] In recent years, leadless pacemakers have gained increasing attention. Leadless pacemakers avoid leads in that the pacemaker device itself is implanted inside the heart, in contrast to pacemakers that are implanted subcutaneously using leads that extend transvenously into the heart. Pacemakers typically have a capsule shape and are intended to be implanted in cardiac tissue, particularly the wall of the right ventricle. Such leadless pacemakers offer the inherent advantage of not using leads, thereby eliminating patient risks associated with leads that access the heart transvenously, such as pneumothorax, lead dislodgement, lead endocarditis, and venous thrombosis.

[0003] Leadless spacer implantation procedures are gradually becoming more routine as leadless systems begin to encroach on a portion of the traditional pocket-based implantable pacemaker (IPG) market and more physicians and centers are becoming familiar with leadless pacing technology. While leadless systems are larger in mass and volume than leaded tips, their mechanical fixation footprint is substantially larger than that of traditional pocket-based leaded IPG systems because they still require secure / robust fixation within the patient's heart. This footprint results in more insertion points into the patient's anatomical structure, and tends to have a greater overall ability to cause scarring and / or pericardial exudation, which are affected by problematic perforation. Therefore, minimizing the amount of physical trauma inflicted on the patient's anatomical structure is crucial as part of the process of finding a reliable fixation site where the implant tip electrode can effectively access bioelectrical engagement with the patient's cardiac conduction system.

[0004] Commercially available leadless pacemaker systems for improving baseline implantation procedures currently lack solutions that minimize (or completely avoid) the number of repositioning instances performed as part of the placement of leadless devices. At best, a physician's experience with this technique can assist the process, but this familiarity and proficiency still does not truly correct undesirable aspects associated with the implantation procedure.

[0005] U.S. Patent Application Publication No. 2020 / 0338356 describes a mapping catheter system for use with a leadless pacemaker focused on His bundle stimulation.

[0006] U.S. Patent No. 10,874,850 describes another device for delivering an implantable medical device, the delivery device comprising a first electrode inside the delivery bay and a second electrode outside the delivery bay for measuring the impedance between the inside and outside of the delivery bay.

[0007] The object of the present invention is to provide a delivery system that enables clinicians to identify a suitable implantation site for a leadless pacemaker device without requiring them to initially scar or perforate an excessive amount of heart or other tissue.

[0008] This objective is achieved by a delivery system for placing a leadless pacemaker device inside the human body, having the elements of claim 1. Such a delivery system includes the insertion of a delivery catheter 4 into the human body. The catheter device has a lumen and a distal end region that is inserted into the human body. In this regard, the lumen is configured to receive the leadless pacemaker device in the distal end region of the catheter device.

[0009] The delivery system further comprises a first mapping electrode and a second mapping electrode positioned in the distal end region of the catheter device. In mapping mode, the first and second mapping electrodes help to sense the mapping signal between the first and second mapping electrodes.

[0010] The first mapping electrode is positioned on the mapping extension. This mapping extension protrudes from the side wall of the distal end region of the catheter device toward the central axis of the catheter device. The central axis extends in the longitudinal direction of the catheter device. Typically, the side wall extends parallel to the longitudinal axis.

[0011] The mapping extension is movable between a non-mapping position and a mapping position relative to the side wall of the distal end region of the catheter device. The angle between the mapping extension and a virtual plane extending perpendicular to the central axis is greater than 5° in the non-mapping position. The virtual plane intersects the side wall of the delivery catheter at the point where the mapping extension is connected to the side wall. In one embodiment, the angle is in the range of 5° to 90°, particularly 10° to 85°, particularly 15° to 80°, particularly 20° to 70°, particularly 25° to 60°, particularly 30° to 50°, and particularly 35° to 40°. In the mapping position, the angle between the mapping extension and the virtual plane is in the range of 0° to 5°, particularly 1° to 4°, and particularly 2° to 3°. That is, in the mapping position, the mapping extension is positioned essentially perpendicular to the side wall of the distal end region of the catheter device, if the side wall extends essentially parallel to the longitudinal axis (and therefore perpendicular to the virtual plane).

[0012] The second electrode is positioned on the outside of the side wall of the distal end region of the catheter device.

[0013] In contrast to conventional solutions, the fixation device for leadless pacemaker devices does not need to be deployed to map the tissue and find the appropriate implantation site. Rather, the leadless pacemaker, once received within the lumen of the distal end region of the catheter device, can be maintained in its delivery position while performing tissue mapping to find the appropriate implantation site.

[0014] Furthermore, in contrast to other conventional solutions, the mapping signals correlate far better with subsequent sensing and stimulating signals, respectively, detected or applied by the leadless pacemaker device implanted by the delivery system. This is because the first mapping electrode contacts the tissue at the site where the implant's sensing and pacing tip electrode ultimately contacts the patient's tissue, whereas conventional methods require the implant to be extended from the catheter or to acquire mapping data at a location where it is ensured to be physically offset from where the implant's sensing and pacing tip electrode ultimately contacts the patient's tissue. Moreover, only the first mapping electrode is positioned on the mapping extension, while the second mapping electrode is positioned outside the distal end region of the catheter device. Thus, the first and second mapping electrodes are spaced apart, as are the tip and return electrodes of the implant delivered by the delivery system. Therefore, the physical distance between the two mapping electrodes coincides with the separation of the tip and return electrodes on the delivered implant. As a result, the catheter device can acquire signaling that better matches what becomes observable after the implant is placed in the myocardium, realizing the same sensing vector. Conventional solutions using two mapping electrodes on a mapping extension do not adequately account for the sensing vector applied by the implanted leadless pacemaker device. Rather, some conventional solutions utilize two ring electrodes on a delivery catheter for mapping purposes, but do not adequately reflect the effective impedance and current density realized between the electrodes of the leadless pacemaker implanted by such a catheter device.In contrast, when the relative sizes of the first and second mapping electrodes align with the sizes of the tip and ring electrodes found on the implant delivered by the delivery system, the effective impedance between the mapping electrodes and the achievable current density at the first mapping electrode / tissue interface better mimics the implant to collect signaling consistent with what the implant senses, and better mimics the localization of the stimulated output delivered by the implant.

[0015] In contrast to conventional solutions, the specific placement of the first and second mapping electrodes allows for not only recording intracardiac electrograms (IEGM) but also measuring the impedance between the two mapping electrodes and / or performing a pacing capture threshold test using the delivery system's mapping electrodes before implanting a leadless pacemaker. Sensing electrical cardiac signals (such as P waves, R waves, or IEGM), measuring the impedance between the first and second mapping electrodes, and determining how effective the pacing output is (pacing capture threshold test) is a typical mapping task performed in the process of mapping tissue to identify a suitable implantation site. Because the size and spacing of the catheter-based mapping electrodes (i.e., the first and second mapping electrodes) match those found on the implant being delivered, the delivery system ensures access to data commensurate with what the implant can collect before the mechanical engagement between the implant's fixation mechanism and the patient's cardiac tissue is performed.

[0016] The present invention is particularly advantageous for the implantation of leadless pacemakers suitable for conduction system pacing. Conduction system pacing (CSP) is a therapeutic approach that involves placing a leadless pacemaker along different regions of the cardiac conduction system to overcome the site and delay of atrioventricular (AV) conduction disease, thereby providing a pacing solution that results in more synchronized biventricular activation. Leadless pacemaker placement for CSP can target either the bundle of His, known as bundle of His pacing (HBP), or the region of the left bundle branch (LBB), known as LBB pacing (LBBP), or the region of the right bundle branch (RBB). CSP may be used to achieve cardiac resynchronization in heart failure patients with reduced ejection fraction and interventricular dyssynchrony. The use of a delivery system or method according to the present invention facilitates the placement of a leadless pacemaker in the bundle of His, LBB, and / or RBB. Mapping signals emanating by the delivery catheter allow for more reliable identification of the conduction system within the region of the implantation site. The leadless pacemaker can be precisely positioned in the intended portion of the conduction system.

[0017] The delivery system allows for a reduction in the number of holes punctured into the patient's tissue (such as the patient's myocardium) as part of the leadless pacemaker implantation procedure. Ideally, the delivery system completely avoids creating such holes in the patient's tissue. Furthermore, the delivery system opens up the possibility of shortening the implantation procedure duration because fewer retry steps are required to position the leadless pacemaker correctly at the implantation site.

[0018] The mapping extension is positioned at an angle to a virtual plane in its non-mapping position (this position is typically achieved by a spring load that pushes the mapping extension into its non-mapping position), and it needs to be pressed against the tissue so that it is moved to a mapping position that is essentially perpendicular to the central axis and typically perpendicular to the side wall of the distal end region of the catheter device, so that the mapping extension makes firm contact with the tissue being mapped against which the catheter device is pressed.

[0019] Typically, the mapping extension is biased to a non-mapping position. Therefore, unless there is close contact between the catheter device and the tissue being mapped, the mapping extension will assume its non-mapping position. When the catheter device is pressed against the tissue being mapped, the mapping extension is moved to its mapping position, which applies slight pressure to the tissue due to this pre-tension. This pre-tension further applies close but non-traumatic contact between the mapping extension (and thus the first mapping electrode) and the tissue being mapped. Thus, a pre-tensioned mapping extension is a reliable means of ensuring that the first mapping electrode makes close and reliable physical contact with the patient's heart wall at the mapping position of the mapping extension, if the tissue being mapped forms part of the patient's heart wall.

[0020] With the distal end of the catheter device (i.e., the catheter tip) pressed against the tissue, the catheter device itself can be used to obtain insights into the quality of the implantation site by acting as a vehicle for performing sensing, impedance, and pacing capture threshold testing routines, in one embodiment, without requiring the implant to be fixed in the tissue. The catheter device itself may assist in performing such an assessment of the implantation site as a standalone function in which an implantable display (e.g., LCD) reports the status of the implantation site, or there may be a link (e.g., via cable) to a programmer device in which the catheter performs follow-up testing procedures according to GUI-based instructions from the clinician using a programmer device. The latter embodiment can be readily installed as part of a core programmer device application used during follow-up, and may even be facilitated by an guided workflow procedure. Ultimately, the user is given the possibility of determining whether a site in the heart is promising for implantation of a leadless pacemaker, and the possibility of reducing the number of damaged sites in the heart before finally placing a leadless pacemaker.

[0021] In one embodiment, the delivery system is configured to sense a mapping signal between a first mapping electrode and a second mapping electrode. In one embodiment, this mapping signal is at least one of a sensing signal, an impedance signal, and a pacing capture threshold signal. As already outlined above, these mapping signals can be acquired by the delivery system without deploying a leadless pacemaker device that is received in the lumen of the distal end region of the catheter device of the delivery system.

[0022] For example, the delivery system can be used to perform the same follow-up tests (sensing, impedance, and pacing capture thresholds) that are standard with implantable pacemaker devices (leadless or pocket-based), but such tests can be performed before the mechanical fixation of the implant interfacing with the patient's cardiac tissue (i.e., while the implant is still within the "protector cup" of the delivery system in the distal end region of the implantable catheter). A key aspect here is that the tests are performed while the implant fixation is present within the implantable catheter. In one embodiment, the follow-up test is performed by the catheter itself (or by a programmer interfacing with the catheter). In another embodiment, other specific elements introduced as part of the catheter design work in conjunction with the implant to help the implant perform the pre-implantation follow-up test.

[0023] To provide background, follow-up studies common to implantable pacemaker devices, both in the past and present (and therefore the follow-up studies that constitute the performance of this delivery system), electrically evaluate the implant's ability to engage with the patient's cardiac conduction system and the myocardial depolarization potential. They can be performed in any order, as one run does not affect another, and some clinicians may even choose to skip one of the three main tests that make up the suite. Follow-up studies, in no particular order, include at least one of the following: 1.) sensing tests, 2.) impedance tests, and 3.) pacing capture threshold tests.

[0024] Sensing tests are performed by momentarily reducing the pacing rate of the treatment administered to the patient, expecting the patient's intrinsic rhythm to become dominant. During this intrinsic output from the heart itself, the amplitudes of the P-wave (atrial contraction) and R-wave (ventricular contraction) can be evaluated and quantified to provide clinician guidance on the implant's ability to measure the critical inputs necessary for marker generation to ensure proper pacemaker timer and rate management operation. Interestingly, in implantation scenarios, the implant itself is nominally in a non-pacing state, and therefore, within such use cases, reducing the pacing rate of the treatment is usually not necessary to pre-form a sensing test, as no treatment that may require throttling is being administered.

[0025] Impedance testing evaluates how much load the electrical path between the implant's stimulating cathode and return anode places on the device's pacing output. If this load is too low, it can shorten the product lifespan in problematic ways.

[0026] The pacing capture threshold test determines which pacing voltage and pulse width are sufficient to ensure that the stimulation from the implant successfully generates contractions in the cardiac chamber where the pacemaker is present. Particularly in the case of leadless pacemakers, it is necessary to reduce this output to the lowest amplitude, but it is a safe setting possible to avoid energy waste and shortening of the product life.

[0027] In one embodiment, the mapping extension is made of the same material as the sidewall of the distal end region of the catheter device. A suitable material is a biocompatible polymer. In one embodiment, the mapping extension is made of a shape memory material such as nitinol. Then it is particularly easy to manufacture the mapping extension by applying a pre-tension in a desired direction.

[0028] In one embodiment, the mapping extension comprises: i) an insulating element surrounding all but exactly the tip of the mapping extension; and ii) a conductive electrical connection extending from the exposed tip to the tip electrode of the catheter device and / or an implant received within the catheter device. Thus, the mapping extension may be designed similarly to a wire having insulation over most of its length except for the exposed distal tip.

[0029] In one embodiment, the first mapping electrode is the only electrode present on the mapping extension. A second electrode on the mapping extension is not necessary because a second mapping electrode that functions as a return electrode (counter electrode) is located outside the sidewall within the distal end region of the catheter device. That is, the second mapping electrode is positioned proximally from the distal end of the catheter device. The position of the second mapping electrode coincides with the position of the leadless pacemaker device located within the lumen of the catheter device in a state delivered to the intended implantation site.

[0030] In one embodiment, the first mapping electrode is sized to match the tip electrode of a leadless cardiac pacemaker implanted by a delivery system.

[0031] In one embodiment, the second mapping electrode (which functions as a return electrode for the first mapping electrode) is designed as a ring electrode sized to match the size of the return electrode of an implantable leadless pacemaker implanted by the delivery system. The electrical signal sensed or applied between the first and second mapping electrodes then closely matches the corresponding signal between the tip electrode and the return electrode of the implantable leadless pacemaker implanted by the delivery system.

[0032] In one embodiment, the catheter device is configured to perform the described mapping test independently of other elements of the delivery system or other additional devices, i.e., in the form of standalone catheter behavior.

[0033] In another embodiment, the catheter device functions as a conduit and administrator for performing such mapping tests, directed by a separate programming device operably coupled to the catheter device. Such a programming device may form part of the delivery system or may be implemented separately from the delivery system.

[0034] In one embodiment, the central axes of the first mapping electrode and the catheter device intersect at least at the mapping position of the mapping extension. Thus, at least at the mapping position, the first mapping electrode is located in the region of the central axis, i.e., the same region where the tip electrode of the leadless pacemaker implanted by the delivery system is located when the implantable leadless pacemaker is accepted into the lumen of the distal end region of the catheter device. In other words, the position of the first mapping electrode at that mapping position closely coincides with (or is even identical to) the position of the tip electrode of the implantable leadless pacemaker implanted by the delivery system after implantation. As a result, the values ​​of the mapping signals measured between the first and second mapping electrodes (resulting from sensing events, impedance measurements, and / or pacing capture threshold measurements) closely coincide with (or is optimally identical to) the values ​​of the signals resulting from sensing events, impedance measurements, and / or pacing capture threshold measurements performed by the implantable leadless pacemaker after implantation. In other words, the physiological conditions under which the mapping signals and post-implantation signals are obtained are closely similar to, or even identical to, each other.

[0035] In one embodiment, the mapping extension is inclined with respect to the longitudinal extension direction of the catheter device in the non-mapping position and protrudes from the distal end of the catheter device. At the same time, the mapping extension is coplanar with the distal end of the catheter device in the mapping position. Therefore, the mapping extension is movable in the distal region of the distal end of the catheter device (i.e., distally anterior to the distal end of the catheter device).

[0036] In one embodiment, the distance between the first mapping electrode and the second mapping electrode at the mapping position of the mapping extension is equal to the distance between the tip electrode and the return electrode of a leadless pacemaker delivered by the delivery system. The first and second mapping electrodes are then spaced apart from each other, like the tip electrode and return electrode of an implantable leadless pacemaker implanted by the delivery system. This allows for a particularly high correlation between the mapping signal values ​​between the first and second mapping electrodes and the signal values ​​between the tip electrode and return electrode of the implanted leadless pacemaker. Particularly suitable distances are in the range of 0.5 cm to 4.5 cm, especially 1.0 cm to 3.5 cm, especially 1.5 cm to 3.0 cm, and especially 2.0 cm to 2.5 cm.

[0037] In one embodiment, the first and second mapping electrodes are sized and separated to mimic the size and separation between the tip electrode and return electrode of an implantable leadless pacemaker delivered by a delivery system. Such an arrangement particularly enhances the relevance and significance of the impedance and other mapping signals measured between the first and second mapping electrodes with respect to the physiological conditions between the tip electrode and return electrode of the implantable leadless pacemaker in its implanted state.

[0038] In one embodiment, a first electrode lead for electrically contacting a first mapping electrode and / or a second electrode lead for electrically contacting a second mapping electrode are guided within the side wall of the catheter device.

[0039] In one embodiment, a first mapping electrode is electrically connected to a first contact electrode. In this connection, the first contact electrode helps to electrically connect to the tip electrode of a leadless pacemaker device received within the distal end region of a catheter device.

[0040] In one embodiment, the first contact electrode is positioned on a contact extension (a separate structural element from the mapping extension) that protrudes from the side wall of the distal end region of the catheter device toward (at least to) the central axis of the catheter device, similar to the mapping extension. The contact extension can then contact the tip electrode of a leadless space maker, which is implanted in a particularly appropriate manner, as the tip electrode is also typically located in the region of the central axis of the catheter device.

[0041] In one embodiment, the contact extension includes a shape memory material such as nitinol. It is then particularly easy to manufacture the contact extension by applying pre-tension in a desired direction.

[0042] In one embodiment, the contact extension comprises i) an insulating element surrounding the entire contact extension except for the very tip, and ii) a conductive electrical connection extending from the exposed tip back to the catheter device or mapping extension, respectively. Thus, the contact extension may be designed similarly to a wire, having insulation for most of its length except for the exposed distal tip.

[0043] In one embodiment, the mapping extension and the contact extension are from a set of cantilevered finger-shaped extensions. This arrangement allows for a simple method of both manufacturing and using the catheter device. One of the finger-shaped extensions (i.e., the contact extension) makes electrical contact with the tip electrode of the leadless pacemaker implanted by the catheter device. The other of the finger-shaped extensions (i.e., the mapping extension) makes contact with the intended implantation site in the patient's tissue. The mapping extension and the contact extension then form direct electrical contact between the tip electrode and the tissue at the intended implantation site without damaging the tissue.

[0044] In one embodiment, a second mapping electrode is electrically connected to a second contact electrode. In this connection, the second contact electrode is configured to electrically connect to a return electrode (counter electrode) of a leadless pacemaker device that is received in the lumen within the distal end region of the catheter device.

[0045] This is particularly suitable when the first mapping electrode is in electrical contact with the tip electrode of the implanted leadless pacemaker, and the second mapping electrode is in electrical contact with the return electrode of the same implanted leadless pacemaker. Mapping can then be performed by dealing only with the implanted leadless pacemaker, without requiring any electrical circuitry within the catheter device (except for the electrical connections to the first mapping electrode, the second mapping electrode, and the respective electrodes of the implanted leadless pacemaker).

[0046] In other words, follow-up tests can be performed using the implanted leadless pacemaker (i.e., the implant) itself, via a standard command and interface from the GUI of a programmer device (eliminating the need for such features to be replicated within the catheter or pipelined to the programmer device via a catheter-compatible conduit). The electrode connection made possible by the catheter effectively extends the implant electrode to the surface of the catheter, thereby allowing follow-up routines to be performed without the need to extend the implant fixation device.

[0047] In one embodiment, the second contact electrode includes one or more conductive protrusions or bumps projecting from the side wall of the distal end region of the catheter device toward the lumen of the catheter device. These protrusions / bumps help establish an electrical connection to the ring electrode of the implanted leadless pacemaker device. This ring electrode acts as a return electrode for the tip electrode of the leadless pacemaker device and is positioned proximal to the stimulating electrode or tip electrode of the leadless pacemaker device. In one embodiment, the electrical connection between the protrusions / bumps and the ring electrode is realized via a wired connection bridge. The ring electrode positions the implant's return electrode in direct contact with the patient's blood. It is worth noting that this direct contact with the patient's blood is established at a position / location along the catheter that maintains the separation of the tip electrode / return electrode as seen in the implant itself. Thus, in one embodiment, these bumps / protrusions are not a direct electrical feedthrough, but rather a feedthrough that "jogs" the position of the implant's return electrode to a position that appropriately mimics the position of the return electrode of the implanted / deployed leadless pacemaker device.

[0048] In one embodiment, the raised portion is circumferentially positioned around the inner circumference of the lumen within the distal end region of the catheter device. The raised portion then defines the position of the leadless pacemaker device to be implanted in the delivery system, as the return electrode of the leadless pacemaker device must coincide with the raised portion to establish an electrical contact.

[0049] In one embodiment, the second mapping electrode and the second contact electrode are spaced apart from each other along the longitudinal extension direction. Such spacing compensates for the offset between the tip electrode of a leadless pacemaker positioned in the lumen of the distal end region of the catheter device and the distal end of the catheter device where the first mapping electrode is located at the mapping position of the mapping extension. Due to the spacing between the second mapping electrode and the second contact electrode, the first mapping electrode and the second mapping electrode can be spaced apart from each other by the same distance, like the tip electrode and return electrode of a leadless pacemaker received in the lumen of the catheter device.

[0050] In the aspects described in the independent claims, the present invention relates to a delivery system which can be described as follows:

[0051] A delivery system for placing a leadless pacemaker device inside the human body, A delivery catheter 4 for insertion into the human body, wherein the catheter device has a lumen and a distal end region for insertion into the human body, and the lumen is configured to receive a leadless pacemaker device within the distal end region of the catheter device, In mapping mode, the system includes a first mapping electrode and a second mapping electrode positioned in the distal end region of the delivery catheter 4, which sense the mapping signal between the first mapping electrode and the second mapping electrode. A delivery system in which a first mapping electrode and a second mapping electrode are positioned outside the side wall of the distal end region of a catheter device, with the first mapping electrode positioned distal to the second mapping electrode.

[0052] In one embodiment, the first mapping electrode is positioned at the distal end (directly at the distal end) of the distal end region of the catheter device (i.e., on the distal-distal end of the protector cup that helps to accommodate the leadless pacemaker device implanted by the delivery system).

[0053] In one embodiment, the first mapping electrode is disposed in a single region outside the sidewall of the catheter device that occupies less than 20°, particularly less than 15°, particularly less than 10°, particularly less than 5° around the sidewall, and the second mapping electrode is formed as a ring electrode around the entire circumference of the sidewall of the catheter device.

[0054] In one embodiment, the first mapping electrode is 0.5 mm 2 ~5 mm 2 , particularly 1 mm 2 ~4.5 mm 2 , particularly 1.5 mm 2 ~4 mm 2 , particularly 2 mm 2 ~3.5 mm 2 , particularly 2.5 mm 2 ~3 mm 2 and is disposed in a single region outside the sidewall of the catheter device that occupies a region in the range of, and the second mapping electrode is formed as a ring electrode around the entire circumference of the sidewall of the catheter device.

[0055] In one aspect, the present invention relates to a pacemaker arrangement comprising one of the delivery systems according to the foregoing description, and a leadless pacemaker device received within the lumen of the distal end region of the catheter device. This leadless pacemaker device is intended to be implanted using the delivery system.

[0056] In one embodiment, the tip electrode of the leadless pacemaker device is electrically connected to the first mapping electrode by a first contact electrode.

[0057] In one embodiment, the return electrode of the leadless pacemaker device makes electrical contact with the second mapping electrode via a second contact electrode. In one embodiment, the return electrode is designed as a ring electrode particularly in the proximal region of the leadless pacemaker device.

[0058] In one embodiment, the present invention relates to a method for mapping tissue regions to identify suitable implantation sites for a leadless space maker device. This method includes the steps described below.

[0059] First, the catheter device of the delivery system is introduced into the body of a human or animal, at least partially. In one embodiment, the delivery system is one of the delivery systems described above. The catheter device has a lumen and a distal end region. The leadless pacemaker device is received in the lumen of the distal end region of the catheter device. The catheter device further comprises a mapping extension that protrudes from the side wall of the distal end region of the catheter device toward the central axis of the catheter device. The central axis extends in the longitudinal direction of the catheter device. The mapping extension is movable relative to the side wall of the distal end region of the catheter device. A first mapping electrode is positioned on the mapping extension. The catheter device further comprises a second mapping electrode positioned outside the side wall of the catheter device within the distal end region of the catheter device.

[0060] In another method step, the distal end region of the catheter device is advanced to the tissue site where the leadless pacemaker device is intended to be implanted.

[0061] In a further method step, the distal end region of the catheter device is pressed against the intended implantation tissue site. This moves the mapping extension from a non-mapping position to a mapping position. The angle between the mapping extension and a virtual plane extending perpendicular to the central axis is greater than 5° in the non-mapping position. The virtual plane intersects the side wall of the delivery catheter at the point where the mapping extension is connected to the side wall. In one embodiment, the angle is in the range of 5° to 90°, particularly 10° to 85°, particularly 15° to 80°, particularly 20° to 70°, particularly 25° to 60°, particularly 30° to 50°, and particularly 35° to 40°.

[0062] At the mapping position, the angle between the mapping extension and the virtual plane is in the range of 0° to 5°, particularly 1° to 4°, and especially 2° to 3°. That is, at the mapping position, the mapping extension is positioned essentially perpendicular to the side wall of the distal end region of the catheter device, if the side wall extends essentially parallel to the longitudinal axis (and therefore perpendicular to the virtual plane).

[0063] In a further method step, the mapping signal is collected by measurements performed across a first mapping electrode and a second mapping electrode. The collected signaling (which in one embodiment includes one or more of a sensing input, an impedance input, and / or a pacing capture threshold) indicates the suitability of the intended tissue site for implantation of the leadless pacemaker device.

[0064] As mentioned above, particularly suitable mapping signals are the sensing test signal (i.e., an electrical signal indicating intrinsic cardiac activity), the impedance test signal, and / or the pacing capture threshold test signal (i.e., an electrical signal indicating the cardiac response to a pacing pulse).

[0065] As already described with respect to delivery systems, the described method for mapping the tissue regions that utilize such delivery systems is the specific physiological and non-traumatic potential for identifying suitable implantation sites for leadless pacemakers. The physiological response of the tissue at the intended implantation site to stimulation indicates the electrical sensitivity of the site's tissue for subsequent stimulation by the pacing signal of the implanted leadless pacemaker. Intended implantation sites are typically found within the heart of a human or animal patient, for example, in the myocardium or bundle of His region of the right ventricle.

[0066] In an embodiment described in an independent claim, the present invention relates to another method for mapping tissue regions to identify a suitable implantation site for a leadless space maker device. This method can be described as follows:

[0067] A method for mapping tissue regions to identify suitable implantation sites for leadless space maker devices, a) A step of introducing a delivery system catheter device, in particular a delivery system catheter device as described above, into at least partially the body of a human or animal, wherein the catheter device has a lumen and a distal end region, a leadless pacemaker device is received in the lumen within the distal end region of the catheter device, a first mapping electrode and a second mapping electrode are positioned in the distal end region of the delivery catheter 4, and in mapping mode, a mapping signal is sensed between the first mapping electrode and the second mapping electrode, the first mapping electrode and the second mapping electrode are positioned outside the side wall of the catheter device in the distal end region of the catheter device, and the first mapping electrode is positioned distal to the second mapping electrode, b) The step of advancing the distal end region of the catheter device to the tissue site where the leadless pacemaker device is intended to be implanted, c) The step of pressing the distal end of the catheter device against the intended implantation site, d) A method comprising the step of sensing a mapping signal between a first mapping electrode and a second mapping electrode, wherein the sensed signal indicates suitability for a tissue site intended for implantation of a leadless spacemaker device.

[0068] All embodiments of the delivery system can be combined in any desired manner and can be used individually or in any combination to transition to each other delivery system, pacemaker placement, and method of mapping tissue regions. Similarly, all embodiments of the pacemaker placement can be combined in any desired manner and can be used individually or in any combination to transition to the described delivery system and method of mapping tissue regions. Finally, all embodiments of the method of mapping tissue regions can be combined in any desired manner and can be used individually or in any combination to transition to each other method, the described delivery system, and pacemaker placement.

[0069] Further details of aspects of the present invention are described below with reference to exemplary embodiments and accompanying drawings. [Brief explanation of the drawing]

[0070] [Figure 1A] A first embodiment of pacemaker placement in a first operating state is shown. [Figure 1B] Figure 1A shows the pacemaker placement in the second operating state. [Figure 1C] Figure 1A shows the pacemaker placement in the third operating state. [Figure 1D] An enlarged view of Figure 1B is shown to illustrate the wiring for pacemaker placement. [Figure 2A] A second embodiment of pacemaker placement in the first operating state is shown. [Figure 2B] Figure 2A shows the pacemaker configuration in the second operating state. [Figure 2C] Figure 2A shows the pacemaker placement in the third operating state. [Figure 2D] An enlarged view of Figure 2B is shown to illustrate the wiring for pacemaker placement. [Figure 2E] A third embodiment of pacemaker placement is shown. [Figure 3A]Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 3B] Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 3C] Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 3D] Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 3E] Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 3F] Figure 2A shows a series of steps performed to insert an implantable cardiac pacemaker into the pacemaker placement catheter device. [Figure 4] A fourth embodiment of pacemaker placement is shown.

[0071] Figure 1A shows a partial cross-sectional view of pacemaker arrangement 1, which includes a pacemaker 2 positioned within the lumen 3 of a delivery catheter 4 that functions as a catheter device. A traction wire 5 is guided through a guide element 6 of the delivery system to pull the leadless pacemaker 2 through an opening at the distal end 7 of the delivery catheter 4 into the lumen 3 within the distal end region 8 of the delivery catheter 4.

[0072] In the distal end region 7 of the delivery catheter 4, the delivery catheter 4 includes a mapping extension 9 in which a first mapping electrode 10 is positioned in the distal region of the mapping extension 9. The delivery catheter 4 further includes a second mapping electrode 11, also located in the distal end region 8 of the delivery catheter 4, but proximal to the distal end 7. The first mapping electrode 10 is electrically connected to a first mapping electrode lead 12. Similarly, the second mapping electrode 11 is electrically connected to a second mapping electrode lead 13. The first mapping electrode lead 12 and the second mapping electrode 13 are guided through the side wall 14 of the delivery catheter 4. The second mapping electrode 11 is positioned on the outer surface of the side wall 14.

[0073] Figure 1B shows pacemaker configuration 1 of Figure 1A in a different operating state. In this figure and all subsequent figures, similar elements are referred to by the same reference numerals.

[0074] In this second operating state, the leadless pacemaker 2 is received in the lumen 3 of the delivery catheter 4 in a delivery state such that its fixation device 15 (or fixation mechanism) is not exposed (i.e., the fixation device does not extend from the distal end 7 of the delivery catheter 4). In this delivery state, the catheter placement 1 can be guided through a human or animal patient to the intended implantation site of the leadless pacemaker 2 without risking traumatic interaction with the patient's physiological functions due to the exposed sharp fixation device 15. In this operating state, the mapping extension 9 protrudes from the side wall 14 of the delivery catheter 4 at an angle α of approximately 20° between the mapping extension 9 and a virtual plane P that extends perpendicular to the central axis A extending in the longitudinal extension direction L of the delivery catheter 4 by approximately 20°. The virtual plane P intersects the side wall 14 of the delivery catheter 4 at the point where the mapping extension 9 connects to the side wall 14. The first mapping electrode 10 intersects the central axis A.

[0075] In summary, the leadless pacemaker 2 is equipped with a mechanical fixation device 15 that, while loading the leadless pacemaker 2 into the delivery catheter 4, is located outside the delivery catheter 4 in the operating state shown in Figure 1A, but is securely positioned inside the lumen 3 of the distal end region 8 of the delivery catheter 4 in the operating state shown in Figure 1B.

[0076] Figure 1C shows another operating state of pacemaker placement, namely the mapping state. In this mapping state, the delivery catheter 4 is pressed against the tissue 16 at the intended implantation site 17. In doing so, the mapping extension 9 is parallel to the virtual plane P such that angle α is approximately 0°. At the same time, the mapping extension forms an angle β of approximately 90° with the central axis A. As a result, the first mapping electrode 10 makes firm contact with the implantation site 17, i.e., without damaging the tissue 16 at the implantation site 17. The implantation site 17 accessed by the mapping extension 9 is nominally the same location where the tip electrode 18 of the implant will ultimately engage with the patient's physiological function after the device has been fixed in the myocardium. The mechanical fixation device 15 of the leadless pacemaker 2 remains within the lumen 3 of the delivery catheter 4 and therefore does not damage the tissue 16 around the implantation site 17 either.

[0077] Furthermore, in this mapping state, the first mapping electrode 10 intersects the central axis A. In addition, the tip electrode 18 of the implantable pacemaker 2 intersects the central axis A. Therefore, when the implantable pacemaker 2 is implanted, the tip electrode 18 is positioned in the same location as the first mapping electrode 10, which non-invasively maps the sensitivity of the tissue 16 at the implantation site 17 to be electrically stimulated by the pacing pulse. The first distance D1 between the first mapping electrode 10 (when the mapping extension 9 is in its mapping position) and the second mapping electrode 11 is equal to the second distance D2 between the tip electrode 18 of the leadless pacemaker 2 and the return electrode 19 of the leadless pacemaker 2. This return electrode 19 is designed as a ring electrode at the proximal end of the leadless pacemaker 2.

[0078] Matching this distance or separation, particularly with the effective electrode size of the implanted pacemaker 2, means that the delivery catheter 4 can mimic the electrical engagement of the implanted pacemaker 2 with the patient's conduction system and / or stimulable tissue without the need to deploy the mechanical fixation device 15 of the implanted pacemaker 2. This helps to find a viable electrical interface with the patient's conduction system without first physically puncturing the patient's anatomical structures.

[0079] In the mapping configuration shown in Figure 1C, the mapping extension 9 is essentially flush with the distal end 7 of the delivery catheter 4. It does not essentially protrude from the distal end 7 along the central axis A.

[0080] Figure 1D shows an enlarged view of Figure 1B to illustrate the wiring of pacemaker configuration 1. It can be clearly seen that the first mapping electrode lead 12 extends along the entire length of the side wall 14 of the delivery catheter 4 and along the mapping extension 9, ultimately making electrical contact with the first mapping electrode 10. Thus, the first electrode lead 12 electrically connects the first mapping electrode 10 to the corresponding first mapping electrode port.

[0081] Similarly, the second mapping electrode lead 13 is guided inside the side wall 14 of the delivery catheter 4 to the second mapping electrode 11. The second electrode lead 13 electrically connects the second mapping electrode 11 to the corresponding second mapping electrode port.

[0082] The first mapping electrode lead 12 and the second mapping electrode lead 13 are electrically insulated from each other. It is immediately clear that the first electrode lead 12 is not in contact with the second mapping electrode 11, and the second electrode lead 13 is not in contact with the first mapping electrode 10.

[0083] In this embodiment, neither the tip electrode 18 nor the return electrode 19 of the implantable pacemaker 2 (see Figure 1C for further details of these elements) are in electrical contact with the first mapping electrode 10 or the second mapping electrode 11. Rather, the pacemaker arrangement 1 shown in Figures 1B and 1D is an embodiment in which mapping is performed by a catheter device 4 rather than the implantable pacemaker 2.

[0084] Figure 2A shows a second embodiment of pacemaker configuration 1 in a first operating state in which the leadless pacemaker 2 is retracted into the lumen 3 of the delivery catheter 4 by a traction wire 5. The leadless pacemaker 2 includes mechanical fixation devices 15 in their deployed state. The delivery catheter 4 includes a mapping extension 9 extending from the side wall 14 of the delivery catheter 4 toward the central axis A toward the distal end 7. The mapping extension 9 includes a first mapping electrode 10, which is an electrical contact with a contact electrode 20. The contact electrode 20 is located on a contact extension 21, which also extends from the side wall 14 toward the central axis A. The mapping extension 9 and the contact extension 21 form a cantilevered set of finger-like extensions. Proximal to the distal end region 8 of the delivery catheter 4, a protrusion 22 is located, projecting from the side wall 14 into the lumen 3 of the delivery catheter 4. The protrusion 22 is conductive and makes electrical contact with a second mapping electrode 11.

[0085] As shown in Figure 2B, when the leadless pacemaker 2 reaches its intended position within the lumen 3 of the distal end region 8 of the delivery catheter 4 (this nominally requires that the implant be drawn into the distal tip of the catheter to the extent that it can first pass the entire length of the implant body proximal to the contact extension 21, so that the contact extension can return to its natural bent position as shown in Figure 2A, and then the implant is advanced distally within the catheter to achieve the intended configuration in Figure 2B; see Figures 3A to 3F for further details), the first contact electrode 20 establishes an electrical contact with the tip electrode 18 of the leadless pacemaker 2. Due to the pre-tension of the proximal contact extension 21 of the delivery catheter 4, the contact element 21 firmly presses against the tip electrode 18 of the leadless pacemaker 2 with its contact electrode 20. As a result, a direct electrical contact exists between the tip electrode 18 and the first mapping electrode 10.

[0086] The mapping extension 9 protrudes from the side wall 14 of the delivery catheter 4 toward the central axis A at an angle α of approximately 20° between the mapping extension 9 and the virtual plane P. The raised portion 22 makes electrical contact with the return electrode 19 of the leadless pacemaker 2. As a result, a direct electrical contact also exists between the return electrode 19 and the second mapping electrode 11.

[0087] Figure 2C shows the pacemaker placement 1 in Figures 2A and 2B when it is in the mapping position, i.e., pressed against the tissue 16 at the intended implantation site 17. Refer to this in relation to the description given with respect to Figure 1C, except that in Figure 1C the mapping can be performed only by the delivery catheter 4 itself, whereas in Figure 2C the mapping can be performed by the leadless pacemaker 2 in combination with the delivery catheter 4.

[0088] Similar to the embodiment shown in Figure 1C, the distance D1 between the first mapping electrode 10 and the second mapping electrode 11 corresponds to (is equal to) the second distance D2 between the tip electrode 18 and the return electrode 19 of the leadless pacemaker 2. Since the first mapping electrode 10 and the second mapping electrode 11 are in direct electrical contact with the tip electrode 18 or the return electrode 19, respectively, all electrical tests regarding the suitability of the implantation site 17 for the subsequent implantation of the leadless pacemaker 2 can be performed directly using the leadless pacemaker 2 (distinguishing from the capability provided by the embodiment in Figure 1). Thus, an external programmer to deal with the delivery catheter 4 is no longer necessary in this embodiment. Rather, the leadless pacemaker 2 can deal directly and directly provide and receive the electrical signals necessary for the tests to be performed.

[0089] The mapping extension 9 abuts the tissue 16 almost parallel to it. Therefore, since the mapping extension 9 is parallel to the virtual plane P, the angle α is approximately 0°. As a result, the mapping extension forms an angle β of approximately 90° with the central axis A.

[0090] Figure 2D shows an enlarged view of Figure 2B to illustrate the wiring for pacemaker placement 1.

[0091] It is clear that the first mapping electrode lead 12 extends only from the contact electrode 20 inside the contact extension 21 and extends to the inside of a small portion of the side wall 14 of the delivery catheter 4, and to the first mapping electrode 10 inside the mapping extension 9. In contrast to the embodiments shown in Figures 1B and 1D, the first mapping electrode lead does not extend along the entire length of the side wall 14 of the delivery catheter 4. Thus, in this embodiment, the first electrode lead 12 electrically connects the first mapping electrode 10 to the tip electrode 18 of the leadless pacemaker 2.

[0092] The second mapping electrode lead 13 is guided inside the side wall 14 of the delivery catheter 4 between a raised portion 22 that electrically contacts the return electrode 19 of the leadless pacemaker 2, up to the second mapping electrode 11. The second electrode lead 13 electrically connects the second mapping electrode 11 to the return electrode 19 of the leadless pacemaker 2.

[0093] The first mapping electrode lead 12 and the second mapping electrode lead 13 are electrically insulated from each other. It is immediately clear that the first electrode lead 12 is not in contact with the second mapping electrode 11, and the second electrode lead 13 is not in contact with the first mapping electrode 10.

[0094] In this embodiment, the tip electrode 18 and return electrode 19 of the leadless pacemaker 2 are in electrical contact with the first mapping electrode 10 or the second mapping electrode 11, respectively. As a result, the pacemaker configuration 1 shown in Figures 2B and 2D is an embodiment in which mapping is performed by the implanted pacemaker 2 rather than by a catheter device 4, which nominally serves only to extend the tip electrode 18 and return electrode 19 of the leadless pacemaker 2 to their intended sites of action.

[0095] Figure 2E shows a third embodiment of leadless space maker arrangement 1, representing a combination of the embodiments shown in Figures 1A to 1D on the one hand and Figures 2A to 2D on the other.

[0096] It is clear that the first mapping electrode lead 12 extends inside the entire length of the side wall 14 of the delivery catheter 4 and inside the mapping extension 9, ultimately making electrical contact with the first mapping electrode 10. The first mapping electrode lead 12 also extends from the contact electrode 20 inside the contact extension 21, inside a small portion of the side wall 14 of the delivery catheter 4, and inside the mapping extension 9, to the first mapping electrode 10. Thus, in this embodiment, the first electrode lead 12 electrically connects the first mapping electrode 10 to the corresponding first mapping electrode port and the tip electrode 18 of the leadless pacemaker 2. Appropriate electrode isolation for selecting either electrical path is not shown for simplification.

[0097] The second mapping electrode lead 13 is guided inside the side wall 14 of the delivery catheter 4 from the second mapping electrode port to the second mapping electrode 11. The second mapping electrode lead 13 is further guided inside the side wall 14 of the delivery catheter 4 to the second mapping electrode 11, between the raised portion 22 which makes electrical contact with the return electrode 19 of the leadless pacemaker 2. The second electrode lead 13 electrically connects the second mapping electrode 11 to the second mapping electrode port and the return electrode 19 of the leadless pacemaker 2. Again, appropriate electrode isolation for selecting any electrical path is not shown for simplification.

[0098] In this embodiment, the user can decide whether mapping is performed i) by a leadless pacemaker 2 (which is a return electrode 19 electrically connected via its tip electrode 18 and to the first mapping electrode 10 or the second mapping electrode 11, respectively), or ii) by a delivery catheter 4, i.e., via the first and second mapping electrode ports connected to the delivery catheter 4.

[0099] Therefore, the pacemaker configuration 1 shown in Figure 2E is an embodiment in which mapping can be performed by an implantable pacemaker 2 or a catheter device 4.

[0100] For completeness, in this embodiment as well, the first mapping electrode lead 12 and the second mapping electrode lead 13 are electrically insulated from each other. It is immediately apparent that the first electrode lead 12 is not in contact with the second mapping electrode 11, and the second electrode lead 13 is not in contact with the first mapping electrode 10.

[0101] Figures 3A to 3F show a series of method steps performed to load the leadless pacemaker 2 of the embodiment shown in Figures 2A to 2D into the delivery catheter 4. The arrows shown at the top of each of Figures 3A to 3F indicate the direction of movement performed in each method step. Downward arrows indicate proximal movement of the delivery catheter 4, and upward arrows indicate distal movement of the delivery catheter 4.

[0102] In Figure 3A, the leadless pacemaker 2 is pulled into the lumen of the catheter device 4 by the loading device 24. The mapping extension 9 is bent distally, and the contact extension 21 is bent proximal. As seen in Figure 3B, the leadless pacemaker 2 is further pulled proximal to the delivery catheter 4. In the state shown in Figure 3B, the leadless pacemaker 2 is still in contact with the mapping extension 9. As the leadless pacemaker 2 is further pulled proximal to the delivery catheter 4, it loses contact with the mapping extension 9 (see Figure 3C). As shown in Figure 3D, the leadless pacemaker 2 is further drawn into the lumen of the delivery catheter 4 until it loses contact with the contact extension 21 (see Figure 3D). Therefore, the distal region of the delivery catheter 4 needs to be longer than the leadless pacemaker 2 (in both cases, this is considered along the longitudinal extension direction of the delivery catheter 4).

[0103] Subsequently, as shown in Figure 3E, the leadless pacemaker 2 is pushed distally by the loading device 24. This distal movement continues until the leadless pacemaker 2 is in close contact with the contact extension 21, as shown in Figure 3F. Here, the contact electrode 20 located on the contact extension 21 firmly contacts the tip electrode 18 of the leadless pacemaker 2, establishing an electrical contact between the first mapping electrode 10 located on the mapping extension 9 and the tip electrode 18 of the leadless pacemaker 2. The state shown in Figure 3F corresponds to the state of pacemaker configuration 1 shown in Figure 2B.

[0104] Figure 4 shows another embodiment of pacemaker configuration 1. This pacemaker configuration 1 is similar to the pacemaker configurations shown in Figures 2A to 2C. Therefore, refer to the above-mentioned description with respect to Figures 2A to 2C as well. Pacemaker configuration 1 in Figure 4 also includes a contact extension 21 for direct contact with the tip electrode 18 of the leadless pacemaker 2 received in the lumen 3 of the delivery catheter 4. However, in contrast to the embodiments shown in Figures 2A to 2C, the first mapping electrode 10 is positioned directly on the outside of the side wall 14 of the delivery catheter 4, rather than on the mapping extension.

[0105] While this configuration facilitates the loading of the delivery catheter 4 compared to the embodiment in Figure 2, it introduces an offset between the tissue examination sites 23 (i.e., the sites from which mapping data can be collected) and the location where the tip electrode 18 of the leadless pacemaker 2 ultimately contacts the patient's tissue 17 during implantation. Therefore, the results of testing the tissue 16's suitability for implantation of the leadless pacemaker 2, as supported by the embodiment found in Figure 4, do not accurately reflect, but rather approximate, the tissue's suitability at the implantation site 17.

[0106] The distance D1 between the first mapping electrode 10 and the second mapping electrode 11 still coincides with the second distance D2 between the tip electrode 18 and the return electrode 19 of the implanted leadless pacemaker 2, although the measurement performed in the embodiment shown in Figure 4 is somewhat less accurate than the measurement performed in the embodiments shown in Figures 1A to 2C. However, as described above, by positioning the first mapping electrode 10 outside the side wall 14 of the delivery catheter 4, its structure is less demanding than when the first mapping electrode 10 is positioned on the mapping extension, as in the embodiments shown in Figures 1A to 2C. Because the contact extension 21 is the only internal finger-like extension of the delivery system 1, the delivery catheter 4 can be repositioned more easily than the delivery catheter in the embodiments shown in Figures 2A to 2C (a process that requires at least the deployment of the distal end of the catheter by the fixation device 15 of the leadless pacemaker 2, and more likely the entire length of the leadless pacemaker 2, and re-storage by the sheath).

[0107] The first mapping electrode 10 is directly connected to the tip electrode 18 of the leadless space maker 2 by a contact electrode 20 on the contact extension 21. This contact extension 21 is generally formed as the contact element 21 in the embodiments shown in Figures 2A to 2C.

[0108] Therefore, the embodiment in Figure 4 is very similar to the embodiments shown in Figures 2A to 2C and shares most of the characteristics of those embodiments. The main difference is that the electrosensitivity of the tissue 16 is not measured directly at the intended implantation site 17, but rather at the tissue examination site 23, which is offset from the target position by the nominal radius of the distal end of the catheter.

Claims

1. A delivery system (1) for placing a leadless pacemaker device (2) inside the human body, A catheter device (4) for insertion into the human body, wherein the catheter device (4) has a lumen (3) and a distal end region (8) that is inserted into the human body, and the lumen (3) is configured to receive a leadless pacemaker device (2) within the distal end region (8) of the catheter device (4), A first mapping electrode (10) and a second mapping electrode (11) are arranged in the distal end region (8) of the catheter device (8), wherein the first mapping electrode (10) and the second mapping electrode (11) are for sensing a mapping signal between the first mapping electrode (10) and the second mapping electrode (11) in mapping mode, The first mapping electrode (10) is positioned on a mapping extension (9) that protrudes from the side wall (14) of the distal end region (8) of the catheter device (4) toward the central axis (A) of the catheter device (4), and the central axis (A) extends in the longitudinal extension direction (L) of the catheter device (4). The mapping extension (9) is movable between a non-mapping position and a mapping position with respect to the side wall (14) of the distal end region (8) of the catheter device (4), and the angle (α) between the mapping extension (9) and a virtual plane (P) extending perpendicular to the central axis (A) is greater than 5° in the non-mapping position and within the range of 0° to 5° in the mapping position. The delivery system (1) is positioned outside the side wall (14) of the distal end region (8) of the catheter device (4).

2. The delivery system according to claim 1, wherein the central axis (A) of the first mapping electrode (10) and the catheter device (4) intersect at least at the mapping position of the mapping extension (9).

3. The delivery system according to claim 1 or 2, wherein the mapping extension (9) protrudes from the distal end (7) of the catheter device (4) in the longitudinal extension direction (L) of the catheter device (4) at the non-mapping position, and is nominally flush with the distal end (7) of the catheter device (4) at the mapping position.

4. The delivery system according to any one of claims 1 to 3, wherein the distance (D1) between the first mapping electrode (10) and the second mapping electrode (11) at the mapping position of the mapping extension (9) is equal to the distance (D2) between the tip electrode (18) and the return electrode (19) of the leadless space maker (2) delivered by the delivery system (1).

5. The delivery system according to any one of claims 1 to 4, wherein at least one of a first electrode lead (12) for electrically contacting the first mapping electrode (10) and a second electrode lead (13) for electrically contacting the second mapping electrode (11) is guided within the side wall (14) of the catheter device (4).

6. The delivery system according to any one of claims 1 to 5, wherein the first mapping electrode (10) is electrically connected to a first contact electrode (20), and the first contact electrode (20) is configured to electrically connect to the tip electrode (18) of a leadless pacemaker device (2) received in the lumen (3) of the distal end region (8) of the catheter device (4).

7. The delivery system according to claim 6, wherein the first contact electrode (20) is positioned on a contact extension (21) that protrudes from the side wall (14) of the distal end region (8) of the catheter device (4) toward the central axis (A) of the catheter device (2).

8. The delivery system according to claim 7, wherein the mapping extension (9) and the contact extension (21) form a set of cantilevered finger-shaped extensions.

9. The delivery system according to any one of claims 1 to 8, wherein the second mapping electrode (11) is electrically connected to a second contact electrode (22), and the second contact electrode (22) is configured to electrically connect to a return electrode (19) of a leadless pacemaker device (2) received in the lumen (3) of the distal end region (8) of the catheter device (4).

10. The delivery system according to claim 9, wherein the second contact electrode (22) includes a protrusion projecting from the side wall (14) of the distal end region (8) of the catheter device (4) toward the lumen (3) of the catheter device (4).

11. The delivery system according to claim 9 or 10, wherein the second mapping electrode (11) and the second contact electrode (22) are spaced apart from each other in the longitudinal extension direction (L).

12. A pacemaker arrangement comprising a delivery system (1) according to any one of claims 1 to 11, and a leadless pacemaker device (2) received in the lumen (3) of the distal end region (8) of the catheter device (4).

13. The pacemaker arrangement according to claim 12, wherein the tip electrode (18) of the leadless pacemaker device (2) is electrically connected to the first mapping electrode (10) via the first contact electrode (20).

14. The pacemaker arrangement according to claim 12 or 13, wherein the return electrode (19) of the leadless pacemaker device (2) is electrically connected to the second mapping electrode (11) via a second contact electrode (22).

15. A method for mapping tissue regions to identify suitable implantation sites for leadless space maker devices, a) A step of introducing a delivery system (1), particularly a catheter device (4) of the delivery system (1) according to any one of claims 1 to 11, into the body of a human or animal, at least partially, wherein the catheter device (4) has a lumen (3) and a distal end region (8), and a leadless pacemaker device (2) is received in the lumen (3) of the distal end region (8) of the catheter device (4), and the catheter device (4) is connected from the side wall (14) of the distal end region (8) of the catheter device (4) to the central axis of the catheter device (4). The procedure includes a mapping extension (9) projecting toward (A), the central axis (A) extending in the longitudinal extension direction (L) of the catheter device (4), the mapping extension (9) being movable relative to the side wall (14) of the distal end region (8) of the catheter device (4), a first mapping electrode (10) positioned on the mapping extension (9), and the catheter device (4) further comprising a second mapping electrode (11) positioned outside the side wall (14) of the distal end region (8) of the catheter device (4), the procedure includes the steps of: b) The step of advancing the distal end region (8) of the catheter device (4) to the tissue site (17) where the leadless pacemaker device (2) is intended to be implanted, c) A step of moving the mapping extension (9) from a non-mapping position to a mapping position by pressing the end (7) of the distal end region (8) of the catheter device (4) against the tissue site (17) where implantation is intended, wherein the angle (α) between the mapping extension (9) and a virtual plane (P) extending perpendicular to the central axis (A) is greater than 5° in the non-mapping position and within the range of 0° to 5° in the mapping position. d) A method comprising the step of collecting a mapping signal between the first mapping electrode (10) and the second mapping electrode (11), wherein the collected signal indicates the suitability of the tissue site (17) where the leadless space maker device (2) is intended to be implanted.

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