System for providing stimulation to a patient

Abstract

The present disclosure relates to a system (100) for providing stimulation to a patient, in particular to a left bundle branch region of a heart (701) of a patient, the system comprising: a stimulation pulse generator (10, 610); at least one electrode (30, 620, 800) having a distal end (31) for engagement with the patient and a proximal end for engagement with the generator (10, 610), the electrode (30, 620, 800) being configured to be implanted at least partially in a septum (713) of a heart (701) of the patient and to provide stimulation to the patient, wherein the distal end (31) comprises a fixation portion configured to facilitate implantation in the septum (713); a sheath (50) having a three-dimensional opening for guiding the at least one electrode (30, 620, 800) for implantation of the electrode (30, 620, 800); wherein the generator (10, 610), the electrode (30, 620, 800) and the sheath (50) are adapted to be used in combination with each other.

Description

Technical Field

[0001] This invention relates to systems, methods, and computer programs for delivering stimulation to a patient. More specifically, this invention relates to systems and methods for delivering targeted electrical stimulation to the left bundle branch region of the heart to enhance cardiac function and treat various cardiac conditions. Background Technology

[0002] Cardiac rhythm management devices, such as pacemakers and implantable cardioverter defibrillators (ICDs), have been developed to deliver electrical stimulation to the heart, thereby treating arrhythmias and improving cardiac function. Traditional pacing systems typically stimulate the heart at the right atrium and / or right ventricle to induce contraction. However, this can lead to non-physiological activation patterns, potentially causing or exacerbating heart failure due to asynchronous ventricular contraction.

[0003] Cardiac resynchronization therapy (CRT) has become a valuable tool for patients with heart failure and ventricular asynchrony, typically involving stimulation of both the left and right ventricles to resynchronize cardiac contractions. Traditionally, CRT is performed using an epicardial lead placed on the surface of the heart or indirectly stimulating the left ventricle via a transvenous lead positioned within the coronary sinus.

[0004] Recent advances have focused on more physiological pacing techniques, such as direct left bundle branch area pacing (LBBAP), to mimic the heart's natural conduction pathway. Pacing the left bundle branch area shows promise in providing more synchronized activation of the ventricles and improving cardiac function; however, existing systems and methods still face various challenges. In particular, current technology lacks a medically approved system that covers all the necessary components to smoothly perform the implantation and stimulation of the left bundle branch area. Summary of the Invention

[0005] This invention attempts to address these problems by introducing improvements to known systems and methods.

[0006] The foregoing and other objectives, which will become apparent from the following description, are addressed by the subject matter of the independent claims. Further embodiments are the subject matter of the dependent claims.

[0007] A first aspect of this disclosure relates to a system for providing stimulation to a patient, particularly to the left bundle branch region of a patient's heart, the system comprising: a stimulation pulse generator; at least one electrode (abbreviated as electrode lead) having a distal end for engagement with a patient and a proximal end for engagement with the generator, the electrode being configured to be at least partially implanted in the septum of the patient's heart and to provide stimulation to the patient, wherein the distal end includes a fixation portion configured to facilitate implantation in the septum; a sheath having a three-dimensional opening for guiding the at least one electrode to implantation; wherein the generator, the electrode, and the sheath are adapted for use in combination with each other. The at least one electrode is an epicardial lead or a transvenous lead. In one embodiment, the system comprises a single electrode.

[0008] The advantage of this system is that it provides a set of combined components—generator, electrodes, and sheath—that can be easily implanted and used for stimulation. Furthermore, because these components are suitable for use in combination with each other, they are permitted for medical approval. This thus offers advantages over known individual components, which require off-label usage. The system also has the further advantage of enhancing cardiac function and treating various cardiac conditions. The system can be a conduction-pacing system.

[0009] In another embodiment of the system, the generator may include at least one predefined parameter configured to indicate the location of the electrode, preferably the location of the distal end of the electrode when implanted in the septum of the heart.

[0010] In another embodiment of the system, the generator may include stimulation and / or diagnostic functions configured to depend on the location of the distal end of the electrode.

[0011] In a further embodiment of the system, the generator may include stimulation synchronized with a sensed atrial signal from the patient's heart, the atrial signal being detected, for example, by a measuring rod of an electrode. The received atrial signal may be transmitted to the generator and processed there for the generation of stimulation pulses, which stimulate, for example, in synchronization with the sensed atrial signal.

[0012] In another embodiment of the system, the fixing portion may include a helical structure, for example, fixedly or detachably attached to the distal end of the electrode, having a length of 0.1 mm to 5 mm, preferably 0.5 mm to 4 mm, more preferably 1 mm to 3 mm, most preferably 1.5 mm to 1.8 mm, and further preferably 1.5 mm to 3 mm. The helical structure is configured to allow the distal end of the electrode to be screwed into the diaphragm, wherein the helical structure is preferably a separate element from the electrode, such that the helical structure can be at least partially detachably attached to the electrode. In one embodiment of the system, the distal end of at least one electrode may be configured to be screwed into the diaphragm to a depth of at least 5 mm. Alternatively, the helical structure may be screwed into or out of the distal portion of the electrode.

[0013] In another embodiment of the system, the fixing portion may include a first pole, and the electrode includes a second pole proximal to the distal end, wherein the first pole and / or the second pole is preferably spaced 1 mm to 10 mm, preferably 2 mm to 9 mm, preferably 3 mm to 8 mm, preferably 4 mm to 7 mm, preferably 5 mm to 6 mm from the distal end, the first pole and the second pole are configured to provide stimulation to the patient, wherein the electrode is preferably a bipolar electrode, and wherein the second pole is preferably ring-shaped, preferably having a length along the longitudinal direction of the electrode of at least 0.5 mm, preferably at least 1 mm, preferably at least 1.5 mm, preferably at least 2 mm and / or at most 5 mm, preferably at most 4 mm, preferably at most 3 mm, preferably at most 2 mm. In one embodiment, the first electrode may have a ring shape. Alternatively, a helical structure of the fixing portion may form the first electrode. The second pole may be a ring pole, which is received proximally at a predetermined distance from the first pole. Alternatively, the second pole is an electric shock coil.

[0014] In another embodiment of the system, the sheath may have a substantially elongated tubular shape and an open-facing inner surface, wherein the inner surface and / or its cavity is configured to facilitate guiding the electrode, wherein in one embodiment, the inner surface is configured to guide the electrode with low friction.

[0015] In a further embodiment of the system, the stimulation can be configured to provide left bundle branch area pacing (LBBAP), wherein the system is preferably a conduction system pacing system.

[0016] In another embodiment of the system, the generator may be one or more of an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy generator (CRT-D) utilizing a defibrillator, and a cardiac resynchronization therapy generator (CRT-P) utilizing a pacemaker. In one embodiment, the generator may be configured to provide stimulation to the patient according to DX technology and / or VDD mode, for example based on sensed atrial signals. In one embodiment, the generator includes increased atrial sensitivity that can be used for so-called DX technology, processing such detected signals and managing AF once detected by appropriate stimulation. DX technology allows detection of atrial fibrillation (AF) from sensed atrial signals from the patient's heart. VDD mode uses sensed signals from the patient's atria and ventricles for pacing. VDD mode is a physiological atrial and ventricular synchronized ventricular pacing mode, wherein, in one embodiment, a single lead with a floating dipole consisting of, for example, two ring poles for detecting atrial signals may be used.

[0017] In another embodiment of the system, the generator may include a recess for proximal engagement with an electrode, the recess including a first pole and a second pole for transmitting a stimulation signal to the electrode when the electrode engages with the recess. In one embodiment, the generator may include a first recess and a second recess, wherein the first recess is configured to engage with a first branch or a first electrode, and the second recess is configured to engage with a second branch or a second electrode. The second recess includes a terminal, preferably an IS-1 terminal, wherein the second electrode is preferably an electrode configured to be implanted to provide stimulation to or not to the left bundle branch region of the patient's heart. Alternatively, if the corresponding pole of the second branch is an electric shock pole, the second recess includes a DF4 terminal. The first and second branches may be connected by a switching device located distal to their proximal ends.

[0018] In one embodiment, the electrode includes a first pole and a second pole, and additionally includes a third pole and a fourth pole (if applicable), wherein the third pole and the fourth pole are located proximal to the second pole, and each of the third pole and the fourth pole (if applicable) is a ring pole contained at a predetermined distance from each other. If applicable, the third and fourth poles may form a dipole. In one embodiment, the third and fourth poles (if applicable) are configured as floating poles to sense atrial signals from the patient's heart. Thus, if the electrodes are properly anchored at their distal ends within the patient's cardiac tissue, they are located in the atria of the heart, for example, in the right atrium. The first pole may be a helical structure forming a fixed portion and simultaneously operating as a stimulating pole. The second pole may be located 1 mm to 10 mm proximal to the first pole, preferably 2 mm to 10 mm, preferably 3 mm to 10 mm, and may be formed as a shock coil.

[0019] In one embodiment, the generator may include an additional recess or a left ventricular electrode (CS electrode, unipolar to quadrupole) that can provide electrical stimulation of cardiac tissue synchronized with sensed atrial signals.

[0020] In another embodiment of the system, the generator (e.g., its processor) may include a programming interface comprising a switch configured to indicate whether an electrode has been implanted in the left bundle branch region of the patient's heart, wherein the switch is configured to be activated when the electrode is implanted in the left bundle branch region of the patient's heart. An algorithm provided by the generator's processor can implement the generator's functionality, wherein the algorithm operates differently based on a value representing the activation state of the switch and results in different states of the functionality.

[0021] In another embodiment of the system, when the switch is activated, information that the electrode is implanted in the left bundle branch region of the patient's heart is configured to be indicated to a person (such as the patient), wherein preferably a slow parameter screen and / or a follow-up screen is configured to display the information, wherein the information is preferably configured to be available on the programmer printout, and wherein the information is preferably configured to be uploaded to the remote monitoring system HMSC.

[0022] In another embodiment of the system, when the switch is activated, individuals such as patients may individually or in combination input the left bundle branch block (LBB), myocardial and / or bundle branch block (BBB) ​​correction capture thresholds for essentially manual LV threshold testing.

[0023] In another embodiment of the system, the stimulation provided to the patient depends on this information.

[0024] In another embodiment of the system, the opening of the sheath includes a core needle and / or the sheath includes a core needle, wherein the sheath is preferably a catheter. The core needle can support electrode implantation.

[0025] In another embodiment of the system, the sheath includes a first deformation in a first plane and a second deformation in a second plane, which is different from the first plane.

[0026] The sheath described above and below is an improved sheath, particularly in terms of the stability of its shape, which provides maximum support for the positioning and anchoring of the electrodes in the septum of the human heart.

[0027] According to one embodiment of the sheath, the sheath is configured for implanting an electrode into the septum of a human heart. The sheath includes an elongated sheath shaft defining an inner lumen (i.e., a three-dimensional opening) for guiding at least one electrode. The sheath shaft has a flexible distal portion, which is pre-shaped in a manner that depicts a helical curve. This means that the sheath shaft, including the opening therein, describes a helical curve.

[0028] A helical curve is defined as at least a portion of a three-dimensional curve that continuously winds around a helical axis, thus also having a component in the longitudinal direction of the helical axis. Therefore, it is, for example, a three-dimensional spiral that winds out of a plane like a snail shell. A helical curve can be, for example, a portion of a three-dimensional spiral whose radius varies (and, for example, increases continuously along the helical axis).

[0029] The helical bending configuration of the distal portion of the sheath shaft prevents discontinuities due to kink sensitivity. In addition, it facilitates the stable positioning of the sheath shaft (in one section) within the cardiac vein and simultaneously shapes it within the cardiac chamber (in another, more distal section), enabling it to support electrode implantation in the diaphragm.

[0030] In one embodiment, the distal portion of the sheath shaft is pre-formed such that the local radius of the helical curve increases continuously along the sheath shaft from its distal end to its proximal end.

[0031] In particular, in one embodiment, the local radius can increase exponentially from the distal end to the proximal end of the sheath shaft. For example, a helical curve can be described in polar coordinates in a top view along the helical axis, the helical curve winding around the helical axis, with the distal end of the sheath shaft located at the origin of the coordinate system. In this case, the helical curve can be parameterized by a polar angle that varies continuously from the origin, wherein the local radius of the helical curve increases exponentially with the polar angle passed through.

[0032] In one embodiment, the local gradient along the helical curve can be variable (relative to the helical axis). The local gradient of the helical curve can increase from the proximal end to the distal end of the distal portion. Therefore, the distal end can be aligned, for example, primarily in the direction of the helical axis of the helical curve. For example, during the implantation of the electrode into the heart chamber, the distal end can be perpendicular to the septum of the heart.

[0033] According to one embodiment, the helical curve winds around a helical axis, thereby covering an angle of up to 340°. For example, in a top view along the helical axis, the helical curve winds around the helical axis, and the helical curve can be described in polar coordinates, where the distal end of the sheath axis is located at the origin of the coordinate system. In this case, a polar angle interval of, for example, from 0 to a maximum of 340° is sufficient to trace the entire helical curve of the distal portion. Visually, this means that the helical curve according to this embodiment describes almost the largest possible complete circle (i.e., at least 20° smaller than a complete circle) in a top view.

[0034] In contrast, according to another embodiment, the coverage angle is in the range of 4 rad to 20 rad. Therefore, this embodiment visually allows the distal portion of the sheath shaft to completely wrap around the helical axis multiple times (up to 3 times).

[0035] By indicating that the distal portion is flexible, it should be expressed as the distal portion being elastically stretchable, wherein the distal portion is pre-shaped such that it adopts a helical bending shape, at least in the unloaded (undeformed) state.

[0036] The sheathed shaft can, for example, be at least partially composed of a relatively flexible plastic material (such as silicone). For instance, such a sheathed shaft can be produced in a so-called reflow process, in which one or more segments made of plastic are initially applied to at least one wire. The at least one wire is then removed, leaving at least one inner lumen intact.

[0037] In one embodiment, the sheath shaft has a stiffness that decreases (not necessarily monotonically) from proximal to distal. In other words, the sheath shaft can become increasingly flexible from proximal to distal. Specifically, the stiffness can decrease monotonically from proximal to distal. Because the stiffness of the sheath shaft decreases from proximal to distal, the sheath shaft can maintain good maneuverability in the proximal portion while having sufficient flexibility in the distal portion to adapt well to the vascular tree.

[0038] The sheath shaft may include, for example, multiple sections with different stiffnesses. Therefore, the different stiffnesses of the individual sections can be achieved, for example, by using tubes made of materials with different hardnesses, thus changing the stiffness.

[0039] According to one embodiment, the sheath shaft may have a soft tip at its distal end. This means that the distal tip is particularly soft (i.e., less rigid) compared to other parts of the sheath shaft, especially compared to other parts of the distal portion. This can be a non-traumatic tip, which prevents damage to blood vessels or other tissues due to its soft configuration.

[0040] In another embodiment, the sheath is configured to be cut, for example, in the longitudinal direction, to facilitate removal of the sheath preferably after electrode implantation, wherein a tool is preferably used to cut the sheath. Alternatively, the cut can be provided without a separate tool.

[0041] In another embodiment, the electrode (e.g., a CRT-D electrode) includes a third electrode and a fourth electrode that together form a dipole.

[0042] A second aspect of this disclosure relates to a method for providing stimulation to a patient, particularly to the left bundle branch region of the patient's heart, comprising: using a system as described in this disclosure.

[0043] A third aspect of this disclosure relates to a method for providing stimulation to a patient, particularly to the left bundle branch region of a patient's heart, comprising: providing a stimulation pulse generator; providing at least one electrode having a distal end for engagement with a patient and a proximal end for engagement with the generator, the electrode being configured to be at least partially implanted in a septum of the patient's heart, and providing stimulation to the patient, wherein the distal end includes a fixation portion configured to facilitate implantation in the septum; providing a sheath having a three-dimensional opening for guiding the at least one electrode for implantation; wherein the generator, electrode, and sheath are adapted for use in combination with each other.

[0044] A fourth aspect of this disclosure relates to a method for implanting an electrode, preferably an electrode of the system as described in this disclosure, the method comprising: placing a sheath at least partially in the septum of a user's heart; guiding at least one electrode at least partially through the sheath, the electrode preferably having a distal end for engagement with a patient and a proximal end for engagement with a generator, the electrode being configured to be at least partially implanted in the septum of the patient's heart and to provide stimulation to the patient; implanting the electrode by optionally removing the sheath, preferably in the left bundle branch region of the user's heart, while securing the electrode at least partially in the septum; and optionally cutting the sheath.

[0045] The fifth aspect of this disclosure relates to a computer program including instructions that, when executed by a computer or processor (e.g., a generator's processor), cause the computer / processor to perform any of the methods described herein. The generator's processor is configured to generate a corresponding stimulation signal as described above, which is transmitted to the patient's body via at least one electrode for stimulation. In one embodiment, the stimulation signal may be generated by the generator's processor for ventricular stimulation based on sensed atrial signals. These signals are determined, for example, by the processor during cycle determination of atrioventricular conduction (so-called fusion pacing).

[0046] As will be understood by those skilled in the art, any features and / or advantages of the aspects described herein may be combined with each other.

[0047] Whether described as method steps, computer programs, and / or apparatuses, the functions described herein can be implemented in hardware, software, firmware, and / or combinations thereof. When implemented in software / firmware, these functions can be stored on a computer-readable medium or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media include both computer storage media and communication media, with communication media including any medium that facilitates the transfer of a computer program from one location to another. Storage media can be any available medium accessible by a general-purpose or special-purpose computer. For example, but not limitingly, such computer-readable storage media can include RAM, ROM, EEPROM, FPGA, CD / DVD or other optical disc storage, disk storage or other magnetic storage devices, or any other medium capable of carrying or storing desired program code units in the form of instructions or data structures and accessible by a general-purpose or special-purpose computer, or a general-purpose or special-purpose processor. Any apparatus for control, etc., as described herein can also be implemented, for example, by means of one or more general-purpose or special-purpose computers and / or general-purpose or special-purpose processors, in hardware, software, firmware, and / or combinations thereof. Attached Figure Description

[0048] In the following description, embodiments of the invention described above are illustrated by way of example only. Refer to the following figures: Figure 1 The system according to the first aspect is shown; Figure 2 The generator is shown; Figure 3 The electrodes housed within the sheath are shown; Figure 4 The sheath and electrodes are shown; Figure 5 A method according to an embodiment is shown. Figure 6 A single-lead CRT system is shown in a side view; and Figure 7 A cross-section of a human heart with implanted electrodes is depicted. Detailed Implementation

[0049] The embodiments will then be outlined primarily with reference to the accompanying drawings. Note that other embodiments are of course possible, and the following explanations are provided by way of example only and not as limitations.

[0050] Figures 1 to 4A system according to a first aspect is shown. System 100 is used to provide stimulation to a patient, particularly to the left bundle branch region of the patient's heart. System 100 includes a stimulation pulse generator 10 and at least one electrode 30, the at least one electrode 30 having a distal end 31 for engagement with a patient and a proximal end 38 for engagement with the generator 10. The electrode 30 is configured to be at least partially implanted in the septum of the patient's heart and to provide stimulation to the patient, wherein the distal end 31 includes a fixation portion configured to facilitate implantation in the septum. The system also includes a sheath 50 having an elongated, generally cylindrical, three-dimensional opening for guiding the at least one electrode 30 for implantation. The generator 10, electrode 30, and sheath 50 are adapted for use in combination with each other.

[0051] As described above, the sheath 50 may include an elongated shaft and / or may have a helical bend at its distal portion. The sheath 50 may have a local radius of curvature that increases along the sheath shaft from its distal end to its proximal end.

[0052] Figure 5 A method 1000 according to a fourth aspect of this disclosure is shown for implanting an electrode, preferably an electrode of a system as described in this disclosure. The method includes the steps of: placing a sheath at least partially 200 in the septum of a user's heart; guiding at least one electrode at least partially through the sheath, the electrode preferably having a distal end for engagement with a patient and a proximal end for engagement with a generator, the electrode being configured to be at least partially implanted in the septum of the patient's heart and to provide stimulation to the patient; implanting the electrode 400 by optionally removing the sheath, preferably in the left bundle branch region of the user's heart, while securing the electrode at least partially in the septum; and optionally cutting the sheath.

[0053] exist Figure 6The image shows a single-lead CRT system without a sheath. It includes a CRT-D type stimulation generator 610. An electrode 620 is connected to the generator at a head with two recesses. Electrode 620 includes a distal first pole (terminal pole) 640 with a helical portion for deep implantation and fixation within a diaphragm of the ventricle of the heart. The first pole 640 is also configured to detect electrical signals from the heart and stimulate the left bundle branch region for LBBAP. Electrode 620 also includes a helical shock pole 650 for delivering a defibrillation signal to the patient's heart, wherein the shock pole 650 is located proximal to the first electrode pole 640. Additionally, electrode 620 includes a dipole 660 having two annular poles spaced apart from each other in the longitudinal direction of electrode 620. This dipole 660 is configured to detect intrinsic atrial impulses and is located in the right atrium when properly implanted in the patient's heart. The dipole 660 is located proximal to the shock pole 650. Proximal to dipole 660, electrode 620 includes a switching device 670 that splits electrode 620 into a first electrode branch 680 and a second electrode branch 690. The first electrode branch 680 mechanically and electrically connects the ventricular first electrode 640 and the spiral shock electrode 650 to generator 610, and the second electrode branch 690 mechanically and electrically connects dipole 660 to generator 610.

[0054] Figure 7 A human heart 701 with a quadrupole CRT-D electrode 800 implanted therein is shown. The CRT-D electrode 800 is guided through the superior vena cava 712 and the right atrium 702 into the right ventricle 703. Here, it is anchored deep within the septum 713 that separates the right ventricle 703 and the left ventricle 705 from each other. To properly secure the CRT-D electrode 800, its first electrode 801 is designed as a spiral electrode. It is screwed into the septum 713 such that it almost reaches the left ventricle 705 (but remains within the septum 713).

[0055] The CRT-D electrode 20 also includes a second electrode 802, which is designed as a shock coil. In the implanted state of the CRT-D electrode 800, it is located within the right ventricle 703 and is configured to deliver a shock pulse to the heart 701 in the event of an episode of tachycardia to achieve defibrillation of the heart 701.

[0056] The CRT-D electrode 800 also includes a third electrode 803 and a fourth electrode 804 that together form a dipole 806 (i.e., one of the third electrode 803 and the fourth electrode 804 serves as the counter electrode to the corresponding other electrode). Because the third electrode 803 is located proximal to the second electrode 802, and because the fourth electrode 804 is located proximal to the third electrode 803, the dipole 806 is also referred to as the proximal dipole 806. The proximal dipole 806 is used to sense atrial signals in the heart 701 so that ventricular stimulation can be applied via the first electrode 801 and / or the second electrode 802 in response to the sensed atrial signals. For example, the proximal dipole 806 is arranged such that it floats within the atrium 702 after the electrode 800 is implanted. Floating means that the dipole 806 is not (additionally) fixed to the cardiac tissue. Thus, the dipole 806 can float freely within the atrium 702 or rest against the wall of the atrium 702. The distance between the opposing ends of the third electrode 803 and the fourth electrode 804 (forming dipole 806) is in the range of 10 mm to 20 mm, particularly 10 mm to 13 mm. The distance between the distal end of the fourth electrode 204 and the proximal end of the first electrode 201 is, for example, in the range of 100 mm to 200 mm, particularly 100 mm to 140 mm, particularly 100 mm to 125 mm. At its distal end, electrode 800 is connected to a generator (not shown) for processing sensed atrial signals and for generating stimulation signals based on the received atrial signals. In order to... Figure 7 Electrode 800 is implanted at the predetermined location shown, using an appropriate sheath (not shown).

[0057] Note that, as those skilled in the art will understand, the above examples / implementations can be combined with other aspects described herein, and details of the examples may be omitted.

[0058] Figure Labels

[0059] 10 Generator

[0060] 11 recess

[0061] 12 Generator First Pole

[0062] 13 Generator Second Pole

[0063] 15 Second recess, IS-1 terminal

[0064] 30 electrodes

[0065] 31. Distal end, spiral structure

[0066] 35 Second Pole

[0067] 38 Proximal

[0068] 50 Sheath

[0069] 100 System

[0070] 1000 methods

[0071] 200 Methods and Steps

[0072] 300 Methods and Steps

[0073] 400 Methods and Steps

[0074] 610 Generator

[0075] 620 electrode

[0076] 640 First Pole

[0077] 650 electric shock electrode

[0078] 660 Dipole

[0079] 670 Switching Device

[0080] 680 First Electrode Branch

[0081] 690 Second electrode branch

[0082] 701 Human Heart

[0083] 702 Right atrium

[0084] 703 Right ventricle

[0085] 704 Left atrium

[0086] 705 Left ventricle

[0087] 712 Superior vena cava

[0088] 713 Diaphragm

[0089] 800 CRT-D electrode

[0090] 801 First Electrode

[0091] 802 Second Electrode

[0092] 803 Third Electrode

[0093] 804 Fourth Electrode

[0094] 806 Dipole.

Claims

1. A system (100) for providing stimulation to a patient, particularly to the left bundle branch region of the patient's heart (701), said system comprising: Stimulation pulse generator (10, 610); At least one electrode (30, 620, 800) having a distal end (31) for engagement with the patient and a proximal end (38) for engagement with the generator (10, 610), the electrode (30, 620, 800) being configured to be at least partially implanted in a septum (713) of the patient's heart (701) and to provide stimulation to the patient, wherein the distal end (31) includes a fixation portion (31, 640, 801) configured to facilitate implantation in the septum (713); A sheath (50) having a three-dimensional opening for guiding the at least one electrode (30, 620, 800) to be implanted; The generator (10, 610), the electrodes (30, 620, 800) and the sheath (50) are adapted to be used in combination with each other.

2. The system (100) according to claim 1, wherein, The generator includes at least one predefined parameter configured to indicate the position of the electrodes (30, 620, 800) when the electrodes (30, 620, 800) are implanted in the septum (713) of the heart (701), preferably the position of the distal end (31) of the electrodes (30, 620, 800).

3. The system (100) according to any one of claims 1 to 2, wherein, The generator (10, 610) includes stimulation and / or diagnostic functions configured to depend on the position of the distal end (31) of the electrodes (30, 620, 800).

4. The system (100) according to any one of claims 1 to 3, wherein, The fixing portion includes a helical structure having a length of 0.1 mm to 5 mm, preferably 0.5 mm to 4 mm, preferably 1 mm to 3 mm, and most preferably 1.5 mm to 1.8 mm. The helical structure is configured to allow the distal end (31) of the electrode (30, 620, 800) to be screwed into the diaphragm (713). The helical structure is preferably a separate element from the electrode, such that the helical structure can be at least partially removably attached to the electrode.

5. The system (100) according to any one of claims 1 to 4, wherein, The fixed portion includes a first electrode (31, 640, 801), and the electrodes (30, 620, 800) include a second electrode (35, 650, 802) near the distal end (31), preferably spaced 1 mm to 10 mm, preferably 2 mm to 9 mm, preferably 3 mm to 8 mm, preferably 4 mm to 7 mm, preferably 5 mm to 6 mm from the distal end (31), the first electrode and the second electrode (31, 35, 640, 650, 801, 802) being configured to provide stimulation to the patient, wherein the electrodes (30, 620, 800) are preferably bipolar electrodes, wherein the second electrode (35) preferably has a ring shape, preferably having a length of at least 0.5 mm, preferably at least 1 mm, preferably at least 1.5 mm, preferably at least 2 mm and / or at most 5 mm, preferably at most 4 mm, preferably at most 3 mm, preferably at most 2 mm along the longitudinal direction of the electrodes (30, 620, 800).

6. The system (100) according to any one of claims 1 to 5, wherein, The sheath (50) has an inner surface facing the opening, wherein the inner surface is configured to facilitate the guiding of the electrodes (30, 620, 800).

7. The system (100) according to any one of claims 1 to 6, wherein, The stimulation is configured to provide pacing in the left bundle branch region, wherein the system (100) is preferably a conduction pacing system.

8. The system according to any one of claims 1 to 7, wherein, The generator (10, 610) is one or more of an implantable pulse generator IPG, an implantable cardioverter defibrillator ICD, a generator CRT-D for cardiac resynchronization therapy using a defibrillator, and a generator CRT-P for cardiac resynchronization therapy using a pacemaker.

9. The system according to any one of claims 1 to 8, wherein, The generator includes a recess (11) for proximal engagement with the electrodes (30, 620, 800), the recess (11) including a first pole (12) and a second pole (13) for transmitting the stimulation signal to the electrodes (30, 620, 800) when the electrodes (30, 620, 800) are engaged with the recess, wherein the generator (610) preferably includes a second recess for engagement with another electrode, the second recess including a terminal, preferably an IS-1 terminal, wherein the other electrode is preferably an electrode configured to be implanted to provide stimulation to or not to the left bundle branch region of the patient's heart.

10. The system according to any one of claims 1 to 9, wherein the generator (10, 610) includes a programming interface comprising a switch configured to indicate whether the electrodes (30, 620, 800) are implanted in the left bundle branch region of the patient's heart (701). in, The switch is configured to be activated when the electrodes (30, 620, 800) are implanted in the left bundle branch region of the patient's heart (701).

11. The system according to claim 10, wherein, When the switch is activated, information regarding the implantation of the electrodes (30, 620, 800) in the left bundle branch region of the patient's heart (701) is configured to be indicated to a person, such as the patient, when the switch is activated. Preferably, the overly slow parameter screen and / or follow-up screen are configured to display this information. This information is preferably configured to be available in the programmer's printout. Preferably, this information is configured to be uploaded to the remote monitoring system HMSC.

12. The system according to claim 10 or 11, wherein, When the switch is activated, individuals such as patients are allowed to input left bundle branch block (LBB), myocardial block and / or bundle branch block (BBB) ​​corrected capture thresholds individually or in combination for essentially manual LV threshold testing.

13. The system according to any one of claims 10 to 12, wherein, Providing stimulation to the patient depends on the information provided.

14. The system according to any one of claims 1 to 13, wherein, The opening of the sheath (50) includes a core needle and / or wherein the sheath (50) includes a core needle, wherein the sheath (50) is preferably a catheter.

15. The system according to any one of claims 1 to 14, wherein, The sheath (50) includes a first deformation in a first plane and a second deformation in a second plane, which is different from the first plane, wherein the sheath (50) is configured to be cut to facilitate removal of the sheath, preferably after the electrode is implanted, wherein the sheath can preferably be cut using a tool.

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