System for providing stimulation to patient

Abstract

To provide a system, method, and computer program for providing stimulation to a patient.SOLUTION: The present disclosure relates to a system (100) for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient, the system comprising: a stimulation pulse generator (10); at least one electrode (30) having a distal end for being engaged with the patient and a proximal end for being engaged with the generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end comprises a fixing portion configured to facilitate implanting in the septum; and a sheath (50) having a three-dimensional opening for guiding the at least one electrode for implanting of the electrode. The generator, the electrode and the sheath are adapted for use in combination with each other.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to systems, methods, and computer programs for delivering stimulation to a patient. More particularly, the present 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 disorders.

[0002] Background technology To treat arrhythmias and improve cardiac function, cardiac rhythm management devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), have been developed to deliver electrical stimulation to the heart. Conventional pacing systems typically stimulate the heart at the right atrium and / or right ventricle to induce contractions. However, this can result in nonphysiological activation patterns, potentially causing or worsening heart failure due to dyssynchronous ventricular contractions.

[0003] Cardiac resynchronization therapy (CRT) has emerged as a valuable tool for heart failure patients with ventricular dyssynchrony, which typically involves stimulating both the left and right ventricles to resynchronize cardiac contractions. Traditionally, CRT is accomplished using epicardial leads placed on the surface of the heart or with transvenous leads placed within the coronary sinus to indirectly stimulate the left ventricle.

[0004] Recent advances have focused on more physiological pacing techniques, such as direct left bundle branch area pacing, to mimic the heart's natural conduction pathways. While left bundle branch area pacing holds promise for providing more synchronized activation of the ventricles and improving cardiac function, existing systems and methods still face various challenges. Specifically, the prior art lacks a medically approved system that covers all the necessary components for smooth implantation and stimulation of the left bundle branch area.

[0005] The present invention seeks to address these problems by introducing improvements to known systems and methods.

[0006] Summary of the Invention These and other objects that will become apparent from the following description are solved by the subject matter of the independent claims. Preferred embodiments are the subject matter of the dependent claims.

[0007] A first aspect of the present disclosure relates to a system for providing stimulation to a patient, particularly to providing stimulation to a left bundle bifurcation region of a patient's heart, the system comprising: a stimulation pulse generator; at least one electrode having a distal end for engaging the patient and a proximal end for engaging the generator, the electrode configured to be at least partially implanted in a septum of the patient's heart to provide stimulation to the patient, the distal end including a fixation portion configured to facilitate implantation into the septum; and a sheath having a three-dimensional opening for guiding the at least one electrode for implantation, the generator, electrode, and sheath adapted for use in combination with each other.

[0008] The system has the advantage of providing a combination set of components, namely, a generator, electrodes, and sheath, that can be easily used for implantation and stimulation. Furthermore, because these components are adapted for use in combination with each other, they can be medically approved. This therefore provides an advantage over known individual components that require off-label use. The system has the additional advantage of enhancing cardiac function and treating various cardiac disorders. The system may be a conduction system pacing system.

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

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

[0011] In a further embodiment of the system, the fixation portion may include a helical structure having a length of 0.1 to 5 mm, preferably 0.5 to 4 mm, preferably 1 to 3 mm, and most preferably 1.5 to 1.8 mm, wherein the helical structure is configured to allow the distal end of the electrode to be screwed into the septum, and wherein the helical structure is preferably a separate piece from the electrode such that the helical structure may be at least partially removably attached to the electrode.

[0012] In a further embodiment of the system, the fixation portion may include a first pole and the electrode includes a second pole spaced proximal to the distal end, preferably 1 to 10 mm, preferably 2 to 9 mm, preferably 3 to 8 mm, preferably 4 to 7 mm, preferably 5 to 6 mm from the distal end, the first and second poles being configured to provide stimulation to the patient, the electrode is preferably a bipolar electrode, and the second pole preferably has the shape of a ring, preferably having a length along the length 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.

[0013] In a further embodiment of the system, the sheath may have an inner surface facing the opening, the inner surface configured to facilitate guidance of the electrode.

[0014] In a further embodiment of the system, the stimulation may be configured to provide left bundle branch area pacing, and the system is preferably a conduction system pacing system.

[0015] In further embodiments of the system, the generator may be one or more of an implantable pulse generator IPG, an implantable cardioverter-defibrillator ICD, a generator for cardiac resynchronization therapy with a defibrillator CRT-D, a generator for cardiac resynchronization therapy with a pacemaker CRT-P.

[0016] In a further embodiment of the system, the generator may include a recess for engaging a proximal end of the electrode, the recess including first and second poles for providing stimulation to the electrode when the electrode engages the recess, the generator preferably including a second recess for engaging a further electrode, the second recess including a terminal, preferably an IS-1 terminal, the further electrode preferably being an electrode configured to be implanted to provide stimulation to the left bundle branch region of the patient's heart or to not provide stimulation to the left bundle branch region of the patient's heart.

[0017] In a further embodiment of the system, the generator may include a programming interface including a switch configured to indicate whether the electrode is implanted in the left bundle bifurcation region of the patient's heart, the switch being configured to activate when the electrode is implanted in the left bundle bifurcation region of the patient's heart.

[0018] In a further embodiment of the system, upon activation of the switch, information that the electrode is implanted in the left bundle bifurcation region of the patient's heart is configured to be indicated to a human, such as a patient, and preferably the bradycardia parameter screen and / or follow-up screen is configured to display this information, and this information is preferably configured to be available on a programmer printout, and this information is preferably configured to be uploaded to the remote monitoring system HMSC.

[0019] In a further embodiment of the system, a switch, when activated, allows a person, such as a patient, to enter left bundle branch LBB, myocardium only and / or bundle branch block BBB, and corrected capture thresholds separately or in combination for substantially manual LV threshold testing.

[0020] In a further embodiment of the system, providing stimulation to the patient depends on the information.

[0021] In a further embodiment of the system, the opening in the sheath includes a stylet and / or the sheath includes a stylet, and the sheath is preferably a catheter.

[0022] In a further embodiment of the system, the sheath includes a first deformation in a first plane and a second deformation in a second plane, the second plane being different from the first plane, and the sheath is preferably configured to be cut to facilitate removal of the sheath after implanting the electrode, preferably a tool can be used to cut the sheath.

[0023] A second aspect of the present disclosure relates to a method of providing stimulation to a patient, particularly to the left bundle bifurcation region of a patient's heart, comprising using the system described in this disclosure.

[0024] A third aspect of the present disclosure relates to a method for providing stimulation to a patient, particularly to a left bundle bifurcation region of a patient's heart, the method including providing a stimulation pulse generator; providing at least one electrode having a distal end for engaging the patient and a proximal end for engaging the generator, the electrode configured to be at least partially implanted in a septum of the patient's heart and to provide stimulation to the patient, the distal end including an anchoring portion configured to facilitate implantation into the septum; and providing a sheath having a three-dimensional opening for guiding the at least one electrode for implantation, the generator, electrode, and sheath adapted for use in combination with each other.

[0025] A fourth aspect of the present disclosure relates to a method for implanting an electrode, preferably an electrode of the system described in the present disclosure, the method including positioning 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 engaging a patient and a proximal end for engaging a generator, the electrode being at least partially implanted in the septum of the patient's heart and configured to deliver stimulation to the patient; implanting the electrode by at least partially fixating the electrode in the septum, preferably in the left bundle bifurcation region of the user's heart; optionally removing the sheath; and optionally cutting the sheath.

[0026] A fifth aspect of the present disclosure relates to a computer program comprising instructions that, when the program is executed by a computer, cause the computer to perform any one of the methods described herein.

[0027] Any of the features and / or advantages of the embodiments described herein may be combined with one another as would be understood by one skilled in the art.

[0028] Whether described as method steps, computer programs, and / or means, the functions described herein may be implemented in hardware, software, firmware, and / or combinations thereof. If implemented in software / firmware, the functions may be stored on or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media includes both computer storage media and communication media, including any medium that facilitates transfer of a computer program from one place to another. Storage media may be any available medium that can be accessed by a general-purpose or special-purpose computer. By way of example, and not limitation, such computer-readable storage media may include RAM, ROM, EEPROM, FPGA, CD / DVD or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code means in the form of instructions or data structures and that can be accessed by a general-purpose or special-purpose computer or a general-purpose or special-purpose processor. Any means for controlling, etc., described herein may also be implemented in hardware, software, firmware, and / or combinations thereof, e.g., by one or more general-purpose or special-purpose computers and / or general-purpose or special-purpose processors.

[0029] Preferred embodiments will now be described, by way of example only, with reference to the accompanying drawings in which: [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 1 illustrates a system according to a first embodiment. [Figure 2] FIG. [Figure 3] FIG. [Figure 4] FIG. 1 shows a sheath and electrodes. [Figure 5] FIG. 1 illustrates a method according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0031] Subsequently, presently preferred embodiments will be outlined, primarily with reference to the above figures. It should be noted that further embodiments are certainly possible, and the following description is provided by way of example only, and not by way of limitation.

[0032] 1-4 illustrate a system 100 according to a first embodiment for providing stimulation to a patient, particularly to the left bundle bifurcation region of the patient's heart, the system 100 comprising a stimulation pulse generator 10, at least one electrode 30 having a distal end 31 for engaging with the patient and a proximal end 38 for engaging with the generator 10, the electrode 30 configured to be at least partially implanted in the septum of the patient's heart to provide stimulation to the patient, the distal end 31 including a fixation portion configured to facilitate implantation in the septum, and a sheath 50 having a three-dimensional opening for guiding the at least one electrode 30 for implantation, the generator 10, the electrode 30, and the sheath 50 adapted for use in combination with one another.

[0033] The sheath 50 may include an elongate shaft and / or may have a helical curve. The sheath 50 may have a local radius of the helical curve that increases along the sheath shaft from distal to proximal.

[0034] 5 shows a method 1000 according to a fourth aspect of the present disclosure for implanting an electrode, preferably an electrode of a system described in the present disclosure. The method includes positioning a sheath 200 at least partially in the septum of a user's heart, guiding 300 at least one electrode at least partially through the sheath, the electrode preferably having a distal end for engaging a patient and a proximal end for engaging a generator, the electrode being at least partially implanted in the septum of the patient's heart and configured to deliver stimulation to the patient, implanting 400 the electrode by at least partially anchoring the electrode in the septum, preferably in the left bundle bifurcation region of the user's heart, and optionally removing the sheath and optionally cutting the sheath.

[0035] It should be noted that, as will be understood by those skilled in the art, the above examples / embodiments may be combined with further aspects described herein, and details of the examples may be omitted.

[0036] Many modifications and variations of the described examples and embodiments will be apparent to those skilled in the art in light of the above teachings. The disclosed examples and embodiments are presented for illustrative purposes only. Other alternative embodiments may incorporate some or all of the features disclosed herein. It is therefore intended to cover all such modifications and alternative embodiments that may fall within the true scope of the present invention. [Explanation of symbols]

[0037] 10 Generator 11 Recess 12 First pole of the generator 13 Second Pole of the Generator 15 Second recess, IS-1 terminal 30 electrodes 31 Distal end, spiral structure 35 The Second Pole 38 Proximal end 50 sheath 100 systems 1000 ways 200 Method Steps 300 method steps 400 method steps

Claims

1. 1. A system (100) for delivering stimulation to a patient, particularly to the left bundle bifurcation region of the patient's heart, the system comprising: A stimulation pulse generator (10); at least one electrode (30) having a distal end for engaging the patient and a proximal end for engaging the generator, the electrode configured to be at least partially implanted in the septum of the patient's heart to provide stimulation to the patient, the distal end including a fixation portion configured to facilitate implantation in the septum; a sheath (50) having a three-dimensional opening for guiding said at least one electrode for implantation; Equipped with the generator, the electrode, and the sheath are adapted for use in combination with one another; system.

2. 10. The system of claim 1, wherein the generator includes at least one predefined parameter configured to indicate a position of the electrode, preferably the distal end of the electrode, when implanted in the septum of the heart.

3. The system of claim 1 or 2, wherein the generator includes stimulation and / or diagnostic functions configured to depend on the position of the distal end of the electrode.

4. the fixation portion comprises a helical structure having a length of 0.1 to 5 mm, preferably 0.5 to 4 mm, preferably 1 to 3 mm, most preferably 1.5 to 1.8 mm, the helical structure being configured to allow the distal end of the electrode to be screwed into the septum; the helical structure is preferably a separate part from the electrode such that the helical structure can be at least partially removably attached to the electrode; A system according to any one of claims 1 to 3.

5. the fixed portion includes a first pole, and the electrode includes a second pole spaced proximal to the distal end, preferably 1-10 mm, preferably 2-9 mm, preferably 3-8 mm, preferably 4-7 mm, preferably 5-6 mm, from the distal end, the first and second poles being configured to provide stimulation to the patient, the electrode being preferably a bipolar electrode; Preferably, the second pole has the shape of a ring, preferably with 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; A system according to any one of claims 1 to 4.

6. The system of claim 1 , wherein the sheath has an inner surface facing the opening, the inner surface configured to facilitate guidance of the electrode.

7. 7. The system of claim 1, wherein the stimulation is configured to provide left bundle branch area pacing, and the system is preferably a conduction system pacing system.

8. 8. The system of claim 1, wherein the generator is one or more of an implantable pulse generator IPG, an implantable cardioverter defibrillator ICD, a generator for cardiac resynchronization therapy by a cardioverter defibrillator CRT-D, a generator for cardiac resynchronization therapy by a pacemaker CRT-P.

9. the generator includes a recess (11) for engaging the proximal end of the electrode, the recess including a first pole (12) and a second pole (13) for applying the stimulus to the electrode when the electrode engages the recess; the generator preferably includes a second recess (15) for engaging a further electrode, the second recess including a terminal, preferably an IS-1 terminal, the further electrode preferably providing stimulation to the left bundle branch region of the patient's heart; or not applying stimulation to the left bundle branch region of the patient's heart an electrode configured to be implanted in a manner similar to that described above; A system according to any one of claims 1 to 8.

10. the generator includes a programming interface including a switch configured to indicate whether the electrode is implanted in the left bundle bifurcation region of the patient's heart; the switch is configured to activate when the electrode is implanted in the left bundle branch region of the patient's heart. A system according to any one of claims 1 to 9.

11. configured such that, upon activation of the switch, information is provided to a human, such as the patient, that the electrode is implanted in the left bundle bifurcation region of the patient's heart; Preferably, the bradycardia parameter screen and / or the follow-up screen are configured to display this information; This information is preferably arranged to be available on a programmer printout; This information is preferably arranged to be uploaded to the remote monitoring system HMSC, The system of claim 10.

12. 12. The system of claim 10 or 11, wherein the switch, when activated, allows a person, such as the patient, to enter left bundle branch LBB, myocardial only and / or bundle branch block BBB, corrected capture thresholds, separately or in combination, for substantially manual LV threshold testing.

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

14. 14. The system of claim 1, wherein the opening in the sheath includes a stylet and / or the sheath includes a stylet, the sheath being preferably a catheter.

15. the sheath includes a first deformation in a first plane and a second deformation in a second plane, the second plane being different from the first plane; the sheath is preferably configured to be cut to facilitate removal of the sheath after implantation of the electrode, and preferably a tool can be used to cut the sheath; A system according to any one of claims 1 to 14.

Images