Implantable medical device for multi-chamber pacing

Abstract

Systems, devices, and methods can be used to deliver and provide cardiac pacing therapy to a patient. A lead or a small lead carrying one or more left ventricular electrodes can be positioned in or near the interventricular septum to sense left ventricular signals of the patient's heart and to pace the patient's heart. In one example, a small lead containing one or more left ventricular electrodes can extend from a leadless implantable medical device located in the right atrium in the coronary sinus.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 940,711, filed November 26, 2019, entitled "Implantable Medical Devices For Multi-Chamber Pacing," which is incorporated herein by reference in its entirety.

[0002] This technology generally relates to implantable medical devices, and more specifically to leadless implantable medical devices and related applications. Summary of the Invention

[0003] In an illustrative implantable medical device, the device includes a plurality of electrodes. The plurality of electrodes may include: a right atrial electrode, which is positioned within the right atrium to deliver cardiac therapy to or sense electrical activity in the right atrium of a patient's heart; and at least one left ventricular electrode, which is positioned near the left ventricle of the patient's heart. The device may further include a housing extending from a proximal region to a distal region, and the right atrial electrode may be coupled to the proximal region in a leadless manner. The device may further include a small lead extending from the proximal region to the distal region, wherein the proximal region is coupled to the distal region of the housing, and the at least one ventricular electrode is coupled to the distal region of the small lead. Further, the small lead may be configured to extend through the coronary sinus ostium and into the coronary sinus or coronary vein of the patient's heart to position the at least one left ventricular electrode near the left ventricle of the patient's heart. The device may further include: a therapy delivery circuit located within the housing and operatively coupled to the plurality of electrodes to deliver cardiac therapy to the patient's heart; and a sensing circuit located within the housing and operatively coupled to the plurality of electrodes to sense the electrical activity of the patient's heart. The device may further include a controller located within the housing and including a processing circuitry system operatively coupled to the therapy delivery circuit and the sensing circuit. The controller may be configured to use the processing circuitry system and one or more of the plurality of electrodes to monitor electrical activity; and to use the processing circuitry system and one or more of the plurality of electrodes to deliver pacing therapy.

[0004] In one illustrative method, the method may include implanting a right atrial electrode in the right atrial endocardium or right atrial myocardium of a patient's heart, the right atrial electrode being coupled in a leadless manner to a proximal region of an implantable housing. The method may further include implanting at least one left ventricular electrode through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein, wherein the at least one left ventricular electrode is coupled to a distal region of a small lead, and the proximal region of the small lead is coupled to a distal region of the implantable housing. A processing circuitry system may be located, positioned, or disposed within the housing and operatively coupled to the right atrial electrode and the at least one left ventricular electrode. The method may further include: using the processing circuitry system and one or more of the right atrial electrode and the at least one left ventricular electrode to monitor electrical activity; and using the processing circuitry system and one or more of the right atrial electrode and the at least one left ventricular electrode to deliver pacing therapy.

[0005] In one illustrative method, the method may include: delivering a delivery catheter and a penetrating element located, positioned, or disposed within the delivery catheter to the right ventricular endocardium of the interventricular septum wall of a patient's heart; using the penetrating element to puncture the right ventricular endocardium to form an opening through the right ventricular endocardium and into the interventricular septum wall; and retracting the penetrating element. The method may further include: advancing a distal portion of a guiding element through the delivery catheter and the opening into the interventricular septum wall to extend along the left ventricular endocardial wall; and delivering a distal portion of an implantable medical lead over the guiding element to the left ventricular myocardium to extend along the left ventricular endocardial wall to position at least one left ventricular electrode on the distal portion within the left ventricular myocardium.

[0006] In an illustrative system for delivering an implantable medical lead into the interventricular septal wall and located at the left ventricular myocardial attachment, the system may include a delivery catheter extending from a proximal region to a distal region, wherein the distal region is locating as the right ventricular endocardium of the interventricular septal wall adjacent to the patient's heart. The system may further include: a penetrating element that may be located, positioned, or disposed within the delivery catheter to form an opening through the right ventricular endocardium and into the interventricular septal wall; and a guiding element that extends from the proximal region to the distal region. The guiding element may be located, positioned, or disposed within the delivery catheter to enter the interventricular septal wall through the opening and extend along the left ventricular endocardial wall.

[0007] The above overview is not intended to describe every embodiment or every implementation of this disclosure. A more complete understanding will become apparent and understood by taking into account the accompanying drawings, the following detailed description, and the appended claims. In other words, these and various other features and advantages will become apparent upon reading the following detailed description. Attached Figure Description

[0008] Figure 1 This is a conceptual diagram of an example of a leadless implantable medical device (LIMD) located in the right atrium (RA) of a patient's heart, containing a small lead located in the RA of the patient's heart.

[0009] Figure 2-3 depicts an example of a LIMD containing deployable small leads.

[0010] Figure 4 This is a conceptual diagram of a LIMD located in the RA of a patient's heart, containing a small lead that extends through the orifice of the coronary sinus (CS) of the patient's heart.

[0011] Figures 5A-5D This is a conceptual diagram illustrating an example of an implantable medical device (IMD) comprising an implantable medical lead or small lead that extends through the endocardium of the right ventricle into the interventricular septum.

[0012] Figure 6-7 This is a conceptual diagram illustrating an example of an implantable medical device (IMD) that includes an implantable medical lead or small lead extending through the endocardium of a renal vascular endocardium.

[0013] Figure 8 This is a conceptual diagram illustrating an example of a "screw-like" structure that can be used to support one or more electrodes and fix them in myocardial tissue.

[0014] Figure 9 It can be enclosed in, for example Figure 1-8 A block diagram of an illustrative circuit system within the housing of the device and system to provide the functions and therapies described herein.

[0015] Figure 10 The ventricular septal lead and delivery system, in which all components are positioned together with the delivery catheter, are depicted.

[0016] Figure 11 Depicting Figure 10 The delivery catheter portion retracts, thereby releasing the fixed toothed ventricular septal lead and delivery system of the outer lead body.

[0017] Figure 12 Depicting Figure 10-11 The delivery catheter and penetrator elements have both been removed from the ventricular septum lead and delivery system.

[0018] Figure 13 Depicting Figure 10-11 The ventricular septal lead and delivery system are located within the inner lead body, which extends from the outer lead body.

[0019] Figure 14 An illustrative quadrupole lead is depicted. Detailed Implementation

[0020] This disclosure relates to leadless implantable medical devices (LIMDs). Examples of LIMDs with small leads that can be used are described in U.S. Patent No. 10,463,853, granted November 5, 2019, which is incorporated herein by reference in its entirety.

[0021] This disclosure also relates to the Koch region. An example of the use of the Koch region is described in U.S. Patent Application Publication No. 2019 / 0290905, published September 26, 2019, which is incorporated herein by reference in its entirety.

[0022] In general, any suitable type of IMD (or LIMD) can be used, including leads or small leads. Non-limiting examples of suitable IMDs include implantable transvenous pacemakers, transvenous cardiac resynchronization therapy (CRT) devices, transvenous CRT pacemakers (CRT-P), transvenous CRT defibrillators (CRT-D), implantable transvenous cardioverter defibrillators (ICDs), subcutaneous ICDs (S-ICDs), and subcutaneous medical devices.

[0023] Figure 1 The image depicts an example of a LIMD 10 located in the right atrium (RA) of a patient's heart 2, comprising a small lead 20 located in the RA of the patient's heart 2. The LIMD 10 may comprise a housing 11 extending from a distal end region 12 to a proximal end region 14. The small lead 20 may be physically and operatively coupled to the proximal end region 14 of the housing 11 of the LIMD 10.

[0024] The LIMD 10 can be used to sense the electrical activity of a patient's heart or to deliver cardiac therapy to the patient's heart. Typically, a first electrode 21, operatively and physically coupled to a small lead 20, can be implanted in the endocardium or myocardium of a patient with renal angina (RA). Furthermore, a second electrode 31 can be operatively and physically coupled to a fixation element 30 extending from the distal end region 12 of the LIMD 10 and can be implanted in the left ventricular (LV) myocardium. More specifically, the second electrode 31 can be coupled to the distal end region 12 of the implantable housing 11 of the LIMD 10, such as by being positioned on a fixation element 30 (e.g., a helical or screw-like structure) extending away from the housing 11 of the LIMD 10 for fixation. The first electrode 21 can be coupled to a small lead 20 extending from the proximal end region 14 of the housing 11 of the LIMD 10. The LIMD 10 can be described as a ventricular LIMD implanted in the atrium for ventricular pacing, which also includes a small lead or "pigtail" for atrial pacing.

[0025] The LIMD 10 can be used in any suitable manner. In some embodiments, the method of using the LIMD 10 may include implanting a first or right atrial electrode 21 onto the right atrial endocardium or in the right atrial myocardium of a patient's heart 2. This can be described as a small lead 20 extending from a distal end or first portion to a proximal end or second portion. The first or right atrial electrode 21 may be coupled to the distal end or first portion of the small lead 20. The proximal end or second portion of the small lead 20 may be coupled to the proximal end region 14 of the housing 11 of the LIMD 10. A processing circuitry system 19 may be housed in the housing 11 and operatively coupled to the electrodes 21, 31.

[0026] An illustrative method may involve implanting a left ventricular electrode through or near the Koch's triangle of the right atrium, such as in the coronary sinus (CS) ostium, through the right atrial endocardium, through the central fibrous body, and into the basal, septal, or baso-septal region of the left ventricular myocardium of the patient's heart. The left ventricular electrode may be coupled in a leadless manner to a distal portion of the implantable housing. A processing circuitry system may be operatively coupled to the left ventricular electrode. The method may further include using the processing circuitry system and at least one of the right atrial and left ventricular electrodes to monitor electrical activity. Further, the method may include using the processing circuitry system and at least one of the right atrial and left ventricular electrodes to deliver pacing therapy.

[0027] In another embodiment, it can be utilized in different configurations or methods with Figure 1This is similar to the LIMD 10. For example, the LIMD may include a right atrial electrode for implantation on the right atrial endocardium or in the right atrial myocardium of a patient's heart, and said right atrial electrode may be coupled in a leadless manner to a distal region or distal portion of the implantable housing of the LIMD. Further, a left ventricular electrode may be implanted through or near the Koch's triangle of the right atrium, such as in the CS orifice, through the right atrial endocardium and through the central fibrous body into the basal, septal, or baso-septal region of the left ventricular myocardium of the patient's heart. The left ventricular electrode may be coupled to a distal region or first portion of a small lead. A proximal region or second portion of the small lead may be coupled to a proximal region or proximal portion of the implantable housing of the LIMD. A processing circuitry system located in the housing may be operatively coupled to both the right ventricular electrode and the left ventricular electrode. The LIMD may use the processing circuitry system and at least one of the right atrial electrode and the left ventricular electrode to monitor electrical activity. Furthermore, LIMD can use a processing circuit system and at least one of a right atrial electrode and a left ventricular electrode to deliver pacing therapy.

[0028] Illustrative LIMD 40 containing deployable small leads Figure 2A-2B The LIMD 40 may include one or more fixing elements (but not shown), a deployable lead 45, a first electrode 50, and a second electrode 52 coupled to the lead 45. The lead 45 extends from the proximal end region 54 to the distal end region 56, and the second electrode is located near (or within) the distal end region 56.

[0029] LIMD 40 may include a main body portion 41 and a sheath portion 42 movable relative to the main body portion 41. The sheath portion 42 may define an opening or aperture where the main body portion 41 is located. LIMD 40 may define, for example... Figure 2A The collapsed configuration or positioning shown and such Figure 2B The unfolded configuration is shown. When in the retracted configuration, the main body portion 41 can be substantially entirely contained within the opening of the sheath portion 42, such that, for example, the deployable lead 45 is also in the retracted configuration, in which case the lead 45 does not extend beyond or outside the sheath portion 42. More specifically, when in the retracted configuration, the lead 45 can reside within a recess or groove 49. The lead 45 may comprise an elastic material (e.g., formed of an elastic material) such that, for example, when the sheath portion 42 retracts 48 away from the distal end region 44 of the exposed main body portion 41, the lead 45 can be moved 47 at least partially radially away from (e.g., pivoted or partially rotated away from) the main body portion 41 to position the distal end region 56 of the lead 45 and thus the second electrode 52 away from the main body portion 41.

[0030] although Figure 2A-2BNot shown, but one or more fixation elements may be positioned on the distal end region 44 of the body portion 41 of the LIMD 40 and extend distally from said body portion 41. The one or more fixation elements may be electrically active or electrically passive. A first electrode 50 may be positioned on the distal end region 44 of the body portion 41 of the LIMD 40 to engage the endocardial wall of the patient's heart. In deployed positioning, a second electrode 52 may be coupled to a small lead 45 that extends at least partially radially away from the body portion 41. As described herein, the body portion 41 may define or include a recess 49 for at least partially receiving the small lead 45 in retracted positioning. In other words, it can be described that the body portion 41 may be delivered in the form of a "cup" (e.g., defined by a sheath portion 42) and may be extended to deploy the body portion 41 for implantation. In some embodiments, the endocardial wall is the right atrial endocardial wall. Additionally, as... Figure 2B As seen in the diagram, the small lead 45 can be described as having a defined shape with two segments or sections. The first segment, closest to the proximal end region 54, may extend tangentially and in a straight line away from the exterior (e.g., circumference) of the main body portion 41. Subsequently, the second segment, closer to the distal end region 56, may bend or fold away from the tangential line defined by the first segment toward a path that is somewhat parallel or partially parallel to the exterior (e.g., circumference) of the main body portion 41.

[0031] The illustrative LIMD 60 includes deployable lead 65. Figures 3A-3B As depicted in the diagram. The LIMD 60 may include one or more fixing elements 69 (e.g., curved teeth), a deployable lead 65, a first electrode 70, and a second electrode 72 coupled to the lead 65. The lead 65 extends from a proximal end region 74 to a distal end region 76, and the second electrode 72 is located near (or within) the distal end region 76.

[0032] LIMD 60 may include a main body portion 61 and a sheath portion 62 movable relative to the main body portion 61. The sheath portion 62 may define an opening or aperture in which the main body portion 61 is located. LIMD 60 may define a retracted configuration or positioning where the main body portion 61 is substantially entirely within the opening of the sheath portion 62, such that, for example, a deployable lead 65 is also in a retracted configuration or positioning, in which case the lead 65 does not extend beyond or outside the sheath portion 62. LIMD 60 may be further defined as follows: Figures 3A-3BThe unfolded configuration is shown. More specifically, when in the retracted configuration, the small lead 65 can reside within a recess or groove. The small lead 65 may comprise an elastic material (e.g., formed of an elastic material) such that, for example, when the sheath portion 62 is retracted 68 to expose the distal end region 64 of the body portion 61, the small lead 65 can be moved 67 (e.g., pivoted or partially rotated) at least partially radially away from the body portion 61 to position the distal end region 76 of the small lead 65 and thus the second electrode 72 away from the body portion 61.

[0033] One or more fixation elements 69 may be positioned on and extend distally from the body portion 61 of the LIMD 60 in a distal end region 64. The one or more fixation elements 69 may be electrically active or electrically passive. A first electrode 70 may be positioned on the distal end region 64 of the body portion 61 of the LIMD 40 to engage the endocardial wall of a patient's heart. In the deployed position as shown, a second electrode 72 may be coupled to a small lead 65 extending at least partially radially away from the body portion 61. As described herein, the body portion 61 may define or include a recess for at least partially receiving the small lead 65 in the retracted position. In other words, the body portion 61 may be delivered in the form of a "cup" (e.g., defined by a sheath portion 62) and may be extended to deploy the body portion 61 for implantation. In some embodiments, the endocardial wall is the right atrial endocardial wall.

[0034] The illustrative LIMD 63 includes deployable lead 65. Figure 3C The figure depicts LIMD 63 as substantially similar to LIMD 60, except for the movement of the lead 65. As shown, the lead 65 of LIMD 63 swings or rotates away from the body portion 61 in a direction opposite to that of the lead 65 in LIMD 60, to facilitate, for example, re-inserting the body portion 61 into the sheath portion 62. More specifically, when the body portion 61 moves relative to the sheath portion 62 of LIMD 63 to position the body portion 61 within an opening or aperture of the sheath portion 62, the sheath portion 62 can contact the lead 65 and “fold down” the lead (i.e., the body portion 61 is retracted into the sheath portion 62). In other words, LIMD 63 allows the body portion 61 to retract “easily” into the sheath portion 62.

[0035] LIMDs 40, 60, and 63 can be used in any suitable manner. In some embodiments, the method of using LIMDs 40, 60, and 63 may include attaching one or more of their fixation elements 69 to the endocardial wall of a patient's heart. The fixation elements 69 may be coupled to a distal end region or distal portion 44, 64 of the body portions 41, 61. A processing circuitry system 19 may be disposed in the body portions 41, 61. The method of using LIMDs 40, 60, and 63 may also include implanting first electrodes 50, 70 to engage the endocardial wall of the patient's heart upon attachment of the fixation elements. The first electrodes 50, 70 may be coupled to a distal end region or distal portion 44, 64 of the body portions 41, 61 in a leadless manner. The processing circuitry system 19 may be operatively coupled to each of the first and second electrodes 50, 52, 70, 72.

[0036] The method using LIMDs 40, 60, and 63 may further include implanting second electrodes 52 and 72 to engage the endocardial wall of the patient's heart when the LIMDs 40, 60, and 63 are in the deployed configuration. More specifically, it can be described that the second electrodes 52 and 72 are coupled to the distal end regions or first portions 56 and 76 of the small leads 45 and 65, and the proximal end regions or second portions 54 and 74 of the small lead bodies 45 and 65 may be coupled to the distal end regions 44 and 64 of the main body portions 41 and 61. As described herein, the small leads 45 and 65 may extend at least partially radially away from the main body portions 41 and 61 in the deployed configuration / position, for example, to engage cardiac tissue with the second electrodes 52 and 72.

[0037] The methods using LIMD 40, 60, 63 may further include using the processing circuit system 19 and at least one of the first electrodes 50, 70 and the second electrodes 52, 72 to monitor electrical activity. Furthermore, the methods using LIMD 40, 60, 63 may further include using the processing circuit system 19 and at least one of the first electrodes 50, 70 and the second electrodes 52, 72 to deliver pacing therapy.

[0038] Despite Figure 2A-2B The mounting elements on the LIMD 40 are not depicted, and the following are also depicted. Figures 3A-3C The LIMD 60 has pointed teeth 69, but it should be understood that any suitable fastening element can be used. In some embodiments, the fastening element may comprise one or more helical or screw-like structures. In some embodiments, the fastening element may comprise one or more adhesives (which may be used in conjunction with other fastening elements such as helical structures).

[0039] A conceptual diagram of LIMD 80, located in the right atrium of the patient's heart, containing a small lead 85 extending through the ostium of the coronary sinus (CS) of the patient's heart. Figure 4 The LIMD 80 may include a housing 81 extending from a proximal region 82 to a distal region 84. The LIMD 80 may include multiple electrodes. These electrodes may include one or more right atrial electrodes and one or more left ventricular electrodes, the right atrial electrodes being configured to sense and / or pace right atrial tissue, and the left ventricular electrodes being configured to sense and / or pace left ventricular tissue. For example, as shown, the LIMD 80 includes a right atrial electrode 90 positioned on the proximal region 82 of the implantable housing 81 of the LIMD 80. The right atrial electrode 90 may be implanted in the right atrial endocardium or right atrial myocardium of a patient's heart. In some embodiments, the right atrial electrode 90 may be positioned near the right atrial appendage (e.g., in contact with the right atrial appendage, adjacent to the right atrial appendage, partially located within the right atrial appendage, located within the right atrial appendage, etc.).

[0040] Figure 4 The LIMD 80 also includes a pair of left ventricular electrodes 92 coupled to a small lead 85 extending distally from the housing 81. The small lead 85 can be described as extending from a proximal region 86 to a distal region 87. The proximal region 86 is coupled to a distal end region 84 of the housing 81. The electrodes 92 are positioned on or near the distal region 87 of the small lead 85. Upon implantation, the small lead 85 can extend through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein to position the left ventricular electrodes 92 near the left ventricle of the patient's heart. Thus, in some embodiments, the left ventricular electrodes 92 can be implanted in the coronary sinus or coronary vein, and in other embodiments, the left ventricular electrodes can be implanted in the left ventricular myocardium of the patient's heart, for example, using a helical or screw-like structure. Figure 4 In the illustrated embodiment, it can be described that a plurality of left ventricular electrodes 92 are coupled to a small lead 85, for example, comprising an anode and a cathode. In some embodiments, the plurality of left ventricular electrodes 92 can be used for field steering, for example, to avoid capturing the left atrium (LA) of the patient's heart.

[0041] The LIMD 80 can be described as being implanted in the atrium to sense or pace the atrium. A small lead 85 can be advanced a relatively long distance along the coronary sinus, anterior interventricular vein (AIV), or great cardiac vein (GCV) or lateral vein to pace the left ventricle, or it can be advanced a shorter distance into the coronary sinus and then "downward" anchored into the left ventricular myocardium to pace the left ventricle. In some embodiments, the small lead described herein can be a quadrupole small lead containing four electrodes. Furthermore, any of the small leads described herein can also use active anchorage, which allows adjustment of electrode depth, e.g., the depth of electrode insertion into the left ventricular myocardium.

[0042] Figure 4 The LIMD 80 can be used in any suitable manner. In some embodiments, the method of using the LIMD 80 may include implanting a right atrial electrode 90 onto the right atrial endocardium or in the right atrial myocardium of a patient's heart. The right atrial electrode 90 may be coupled in a leadless manner to a proximal end region or portion 82 of the implantable housing 81. The processing circuitry system 19 may be housed in the housing 81 and operatively coupled to the right atrial electrode 90.

[0043] The method of using LIMD 80 may also include implantation of a left ventricular electrode 92 through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein. The left ventricular electrode 92 may be coupled to a distal region or first portion 87 of a small lead 85. A proximal region or second portion 86 of the small lead 85 may be coupled to a distal end region 84 of an implantable housing 81. The processing circuitry system 19 may also be operatively coupled to the left ventricular electrode 92.

[0044] The method using LIMD 80 may further include monitoring electrical activity using the processing circuitry system 19 and at least one of the right atrial electrode 90 and the left ventricular electrode 92, and may include delivering pacing therapy using the processing circuitry system 19 and at least one of the right atrial electrode 90 and the left ventricular electrode 92. In some embodiments, implanting the left ventricular electrode 92 may include implanting the left ventricular electrode 92 from the coronary sinus into the left ventricular myocardium near a posterior vein in the patient's heart. In some embodiments, implanting the left ventricular electrode 92 may include implanting the left ventricular electrode 92 into the anterior interventricular vein (AIV). In some embodiments, implanting the left ventricular electrode 92 may include implanting the left ventricular electrode 92 into a lateral vein in the patient's heart. Further, in some embodiments, delivering pacing therapy may include utilizing field steering to prevent the left ventricular electrode 92 from capturing the left atrium.

[0045] A conceptual diagram illustrating an example of an implantable medical device (IMD) 100 comprising an implantable medical lead or small lead 150 extending through the endocardium of the right ventricle (RV) is shown in [the diagram]. Figures 5A-5DThe description is as follows. Although a lead is described herein, a small lead extending from the implantable shell of the LIMD within the heart may also be used. In other words, lead 150 may be a lead extending from an IMD located or positioned outside the heart or a small lead extending from a LIMD located or positioned inside the heart.

[0046] Lead 150 can extend from a proximal portion coupled to the control portion (e.g., housing, battery, controller, processing circuitry, etc.) of IMD 100 to a distal portion 154 located in or near the left ventricular myocardium along the left ventricular endocardial wall 8, for example, towards the apex of the patient's heart. The distal portion 154 may be located near the left bundle branch (LBB) of the patient's heart. Although any suitable delivery system can be used to deliver lead 150, the delivery system and the implantation method using such a delivery system are related to... Figures 5A-5D The delivery system is shown and described. Typically, it can be described as puncturing the right ventricular endocardium 6 to allow the lead 150 to be simply pushed into the septal myocardium 7 or the interventricular septal wall and tunneled upward or downward through the septum. The lead 150 can tunnel through the septal myocardium 7 into the basal septum, mid septum, or even the apical septal region.

[0047] Lead 150 can be a multi-pole lead, as described in this article. Figure 14 The quadrupole lead 590 is described. More specifically, the distal portion 154 of the lead 150 may have a quadrupole configuration, which may be the same as or similar to ATTAIN STABILITY™, ATTAIN STABILITYQUAD™, or ATTAIN PERFORMA™ leads available from Medtronic plc of Dublin, Ireland. The lead that can be fixed and positioned on the distal portion may be optionally electrically active or electrically passive and may be mechanically active or adjustable with a side helix or hook. Another exemplary lead that may be employed is described in U.S. Patent No. 9,901,732 to Sommer et al., issued February 27, 2018, which is incorporated herein by reference in its entirety, in which electrodes are bridging in a diagonal configuration to increase the chance of capturing cardiac tissue.

[0048] Guiding elements 130, such as guidewires, steerable needles or wires, or needle-guidewire hybrids as part of the ATTAIN family, can be used to guide lead 150 into septum 7. In the case of multiple electrodes and different septa, a single lead 150 can be used to pace multiple locations below the atrium and septum 7. An example of a lead element that can be used is described in U.S. Patent No. 7,881,806 to Sommer et al., issued February 1, 2011, which is incorporated herein by reference in its entirety.

[0049] The IMD 100, including the lead 150, can be used in any suitable manner. In some embodiments, the method of delivery and use of the IMD 100 may include delivering a delivery catheter 110 and a penetrating element 120 disposed in the delivery catheter 110 to a location such as... Figure 5A The image shows the right ventricular endocardium 6 of the interventricular septum wall of a patient's heart. A delivery catheter 110 can be configured to position its distal end 115 to the target implantation site 101 such that the distal end 115 is positioned adjacent to the right ventricular endocardium 6 (e.g., substantially flush with or in contact with the right ventricular endocardium). For example, in one embodiment, the delivery catheter 110 extends from a proximal portion to a distal portion 114, and the distal portion 114 defines a curvature for positioning the distal end 115 of the catheter 110 substantially flush with the right ventricular endocardium 6.

[0050] The method may include using a penetrating element 120 to puncture the right ventricular endocardium 6 to form an opening through the right ventricular endocardium 6 and into the interventricular septal wall 7, such as... Figure 5B As shown. The penetrating element 120 can then be retracted via the delivery catheter 110. Subsequently, the distal portion of the guiding element 130 can be advanced through the delivery catheter 110 and its opening into the interventricular septal wall 7 to extend along the left ventricular endocardial wall 8. The guiding element 130 can extend from a proximal region to a distal region 134, and the distal region 134 can be configured to be positioned within the interventricular septal wall 7 to extend along the left ventricular endocardial wall 8. In at least one embodiment, the distal region 134 may define or include a distal curvature portion that bends upon exiting the delivery catheter 110 into the interventricular septal wall 7 so that at least one region of the distal portion 154 of the implantable medical lead 150 is delivered substantially parallel to the interventricular septal wall 7 into the left ventricular myocardium.

[0051] Additionally, the distal portion of the implantable medical lead 150 of the device 100 can be advanced or delivered over the guiding element 130 to the left ventricular myocardium to extend along the left ventricular endocardial wall 8 to position one or more left ventricular electrodes 162 on the distal portion within the left ventricular myocardium. In one or more embodiments, the guiding element 130 does not extend beyond the tip of the lead 150 and instead may be maintained at a selected distance (e.g., about 1 cm) away from the tip to allow the tip to flex during blunt dissection / tunneling of the lead 150. Further, examples of the guiding element 130 may include a steerable needle, a shaping needle, etc. In some embodiments, one or more left ventricular electrodes 162 may be positioned near the left bundle branch (LBB) of the patient's cardiac conduction system.

[0052] In some embodiments, the right ventricular electrode 160 on the lead 150 can be positioned / implanted near the right ventricular endocardium 6. The right ventricular electrode 160 can be positioned proximal to the left ventricular electrode on the distal portion 154 of the implantable medical lead 150.

[0053] Additionally, the method using IMD 100 may include monitoring the electrical activity of at least one of the right ventricular electrode 160 and the left ventricular electrode 162, and using at least one of the right ventricular electrode 160 and the left ventricular electrode 162 to deliver pacing therapy. In some embodiments, delivering pacing therapy may include delivering pacing pulses to the left ventricular electrode 162, which is configured to pace the left bundle branch of the patient's heart's conduction system. In some embodiments, the implantable medical lead 150 may include a plurality of left ventricular electrodes, a plurality of right ventricular electrodes, or both.

[0054] Figure 6-7 This is a conceptual diagram illustrating one example of an implantable medical device (IMD) 200 comprising an implantable medical lead or small lead 250 extending through the endocardium of the right atrium. Although the lead 250 is described herein, a small lead extending from an implantable housing within the heart may also be used. The distal portion 254 of the lead 250 may be positioned within the left ventricular myocardium along the left ventricular endocardial wall, for example, extending toward the apex of the patient's heart. The distal portion 254 may be located near the left bundle branch (LBB) of the patient's heart 2. The lead 250 may be delivered using any suitable delivery system and method. In at least one embodiment, the reference herein to Figure 5 and Figure 10-14 The delivery system described. For example, the delivery system can be configured to puncture the right atrial endocardium and central fibrous body (CFB) to allow the lead 250 to be easily pushed into the septal myocardium or interventricular septal wall, and as described above. Figure 7 Trajectory 270 in the diagram shows tunneling upwards or downwards through the septum. Lead 250 can tunnel into the basal septum, mid-septum, or even the apical septum region.

[0055] Multi-pole leads can be used, such as those described in this article. Figure 14The quadrupole lead 590 is described. The distal portion 254 of the lead 250 may have a quadrupole configuration, which may be the same as or similar to the ATTAINSTABILITY™, ATTAIN STABILITY QUAD™, or ATTAIN PERFORMA™ leads available from Medtronic, Dublin, Ireland. The lead that can be fixed and positioned on the distal portion may be selectively electroactive or electropassive and may be mechanically active or adjustable with a side helix or hook. Another exemplary lead that may be employed is described in U.S. Patent No. 9,901,732 to Sommer et al., issued February 27, 2018, which is incorporated herein by reference in its entirety, in which the electrodes are bridging in a diagonal configuration to increase the chance of capturing cardiac tissue.

[0056] The guiding element can be a guidewire, a steerable needle, a wire, or a needle-guidewire hybrid as part of the ATTAIN family, which can be used to guide the lead into the septum. In the case of multiple electrodes and different septa, a single lead can be used to pace multiple locations below the atrium and septum. An example of a lead element that can be used is described in U.S. Patent No. 7,881,806 to Sommer et al., issued February 1, 2011, which is incorporated herein by reference in its entirety.

[0057] The IMD 200 can be used in any suitable manner. In some embodiments, the method of implanting and using the IMD 200 may include delivering a delivery catheter and a penetrating element disposed within the delivery catheter to the right atrial endocardium located in or near the Koch's triangle of the patient's heart, such as in the coronary sinus ostium. The method of implanting and using the IMD 200 may also include using the penetrating element to puncture the right atrial endocardium and central fibrous body to form an opening through the right ventricular endocardium and central fibrous body and into the interventricular septal wall. The penetrating element may then be retracted. Subsequently, a distal portion of the guiding element may be advanced through the delivery catheter and the opening and into the interventricular septal wall to extend along the left ventricular endocardial wall.

[0058] Additionally, the method of implanting and using the IMD 200 may include delivering the distal portion 254 of the implantable medical lead 250 over the guiding element to the left ventricular myocardium to extend along the left ventricular endocardial wall to position one or more left ventricular electrodes 262 on the distal portion 254 within the left ventricular myocardium. In some embodiments, the left ventricular electrodes 262 may be positioned near the left bundle branch of the patient's cardiac conduction system. In some embodiments, the method of implanting and using the IMD 200 may further include implanting one or more right atrial electrodes 260 near the right atrial endocardium. The right atrial electrodes 260 may be positioned proximally along the lead 250 to the left ventricular electrode 262 located on the distal portion 254 of the implantable medical lead 250.

[0059] In some embodiments, the method using IMD 100 may further include monitoring the electrical activity of at least one of the right atrial electrode 260 and the left ventricular electrode 262, and delivering pacing therapy using at least one of the right atrial electrode 260 and the left ventricular electrode 262. In some embodiments, delivering pacing therapy may include delivering pacing pulses to the left ventricular electrode 262, which is configured to pace the left bundle branch of the conduction system of the patient's heart. Further, in some embodiments, the implantable medical lead may include multiple left ventricular electrodes, multiple right atrial electrodes, or both.

[0060] A conceptual diagram illustrating an example of a "screw-like" structure that can be used to support one or more electrodes and anchor them in myocardial tissue. Figure 8 The image is depicted in the figure. In some embodiments, an IMD or LIMD may comprise an elongated member 300 extending between a proximal portion and a distal portion 304. A first electrode 320 may be disposed on the distal portion 304 of the elongated member. A second electrode 322 may be disposed proximal to the first electrode 320 on the distal portion 304 of the elongated member 300. A first threaded ball region 312 may be disposed on the distal portion 304 of the elongated member 300 between the first electrode 320 and the second electrode 322. A second threaded ball region 314 may be disposed on the distal portion 304 of the elongated member 300 between the first threaded ball region 312 and the second electrode 322. In some embodiments, the threaded ball regions 312 and 314 may have similar thread patterns or spacing.

[0061] Figure 9 It can be enclosed within the housing of the illustrative IMD 400 to provide the information described in this article. Figure 1-8 A block diagram of the circuit system describing the function of the cardiac therapy. In other words, the IMD 400 can be used with... Figure 1-8 Any one or more embodiments described herein may be used together. The electronic circuitry of device 400 may include software, firmware, and hardware that collaboratively monitor atrioventricular and ventricular electrocardiographic signals, determine when cardiac therapy is needed, and / or deliver electrical pulses to the patient's heart according to programmed treatment modes and pulse control parameters. The electronic circuitry may include control circuitry 480 (e.g., including processing circuitry), memory 482, therapy delivery circuitry 484, sensing circuitry 486, and / or telemetry circuitry 488. In some instances, device 400 includes one or more sensors 490, such as patient activity sensors, for generating signals related to the patient's physiological function, state, or condition to determine the need for pacing therapy and / or control of the pacing rate.

[0062] Power source 498 can provide power as needed to the circuitry of device 400, which includes each of components 480, 482, 484, 486, 488, and 490. Power source 498 may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. The connections between power source 498 and each of components 480, 482, 484, 486, 488, and 490 can be understood from the overall block diagram, but are not shown for clarity. For example, power source 498 may be coupled to one or more charging circuits included in therapy delivery circuitry 484 to provide the power required to charge holding capacitors included in therapy delivery circuitry 484, which are discharged at appropriate times under the control of control circuitry 480 to deliver pacing pulses, for example, according to a dual-chamber pacing mode, such as DDI(R). The power supply 498 can also be coupled to components of the sensing circuit 486 (such as sensing amplifiers, analog-to-digital converters, switching circuit systems, etc.), sensor 490, telemetry circuit 488, and memory 482 to provide power to various circuits.

[0063] The rechargeable power supply 498 can be recharged using any suitable technology. In some embodiments, the device 400 may include an antenna, an induction coil, or other inductively coupled structures configured to be coupled to another device, such as an external charger or programmer, to receive power in situ. Various examples of charging leadless implantable medical devices are described in U.S. Patent Publication No. 2018 / 0212451 (Schmidt et al.), filed January 26, 2017, entitled “Recharge of Implanted Medical Devices,” which is incorporated herein by reference in its entirety. The device 400 may also be configured to use various techniques to extend the lifespan of the power supply 498, such as a low-power mode.

[0064] Various examples of power supplies and power-related technologies may be used, such as those found in U.S. Patent No. 8,383,269, granted February 26, 2013 (Scott et al.), U.S. Patent No. 8,105,714, granted January 31, 2012 (Schmidt et al.), and U.S. Patent No. 7,635,541, granted December 22, 2009 (Scott et al.), each of which is incorporated herein by reference in its entirety.

[0065] The illustrated functional blocks represent the functions included in device 400 and may include any discrete and / or integrated electronic circuit components that implement analog and / or digital circuitry capable of producing the functions attributed to device 400 herein. Each component may include processing circuitry systems (such as application-specific integrated circuits (ASICs), electronic circuits, processors (shared, dedicated, or grouped), and memories), combinational logic circuits, state machines, or other suitable components or combinations of components that provide the described functions, executing one or more software or firmware programs. The specific form of software, hardware, and / or firmware used to implement the functions disclosed herein will be determined primarily by the specific system architecture employed in the medical device and the specific detection and therapy delivery methods employed by the medical device. Given the disclosure herein, providing software, hardware, and / or firmware to implement the described functions in the context of any modern cardiac medical device system is within the capabilities of those skilled in the art.

[0066] Memory 482 may comprise any volatile, non-volatile, magnetic, or electrically non-transitory computer-readable storage medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other memory device. Furthermore, memory 482 may comprise a non-transitory computer-readable medium storing instructions that, when executed by one or more processing circuits, cause control circuitry 480 and / or other processing circuitry systems to perform single-chamber, dual-chamber, or triple-chamber pacing (e.g., single-chamber or multi-chamber pacing) functions or other sensing and therapy delivery functions of device 400. The non-transitory computer-readable medium storing instructions may comprise any of the media listed above.

[0067] Control circuitry 480 may communicate, for example, via a data bus with therapy delivery circuitry 484 and sensing circuitry 486 to sense cardiac electrical signals and control the delivery of cardiac electrical stimulation therapy in response to sensed cardiac events, such as P and R waves, or the absence of a cardiac event. Electrodes 422, 424, 442 (e.g., left ventricular electrode, right ventricular electrode, right atrial electrode, shell electrode, etc.) may be electrically coupled to therapy delivery circuitry 484 to deliver electrical stimulation pulses to the patient's heart and to sensing circuitry 486 to sense cardiac electrical signals.

[0068] Sensing circuit 486 may include an atrial (A) sensing channel 487 and a ventricular (V) sensing channel 489. For example, electrodes 422, 424 may be coupled to atrial sensing channel 487 to sense atrial signals, such as P waves associated with atrial myocardial depolarization. Further, in some embodiments, sensing circuit 486 may include a switching circuit system for selectively coupling one or more of the available electrodes to the cardiac event detection circuitry included in atrial sensing channel 487. The switching circuit system may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable for selectively coupling components of sensing circuit 486 to selected electrodes. Further, for example, electrodes 424, 442 may be coupled to ventricular sensing channel 489 to sense ventricular signals, such as R waves associated with ventricular myocardial depolarization.

[0069] Each of the atrial sensing channel 487 and the ventricular sensing channel 489 may include a cardiac event detection circuitry for detecting P waves and R waves, respectively, from cardiac electrical signals received from the respective sensing channel. The cardiac event detection circuitry included in each of channels 487 and 489 may be configured to amplify, filter, digitize, and rectify the cardiac electrical signals received from selected electrodes to improve signal quality for detecting cardiac electrical events. The cardiac event detection circuitry within each channel 487 and 489 may include one or more sensing amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), timers, or other analog or digital components. Cardiac event sensing thresholds, such as P wave sensing thresholds and R wave sensing thresholds, may be automatically adjusted by each respective sensing channel 487 and 489 under the control of the control circuitry 480, for example, based on timing intervals and sensing thresholds determined by the control circuitry 480 and stored in memory 482 and / or controlled by the hardware, firmware, and / or software of the control circuitry 480 and / or the sensing circuitry 486.

[0070] When detecting cardiac electrical events based on sensing threshold crossovers, sensing circuit 486 can generate sensed event signals that are passed to control circuit 480. For example, atrial sensing channel 487 can generate a P-wave sensed event signal in response to a P-wave sensed threshold crossover. Ventricular sensing channel 489 can generate an R-wave sensed event signal in response to an R-wave sensed threshold crossover. Control circuit 480 can use the sensed event signals to set a pacing escape interval timer that controls the basic time interval used to schedule cardiac pacing pulses. The sensed event signals can trigger or suppress pacing pulses, depending on the specific programmed pacing mode. For example, a P-wave sensed event signal received from atrial sensing channel 487 can cause control circuit 480 to suppress scheduled atrial pacing pulses and schedule ventricular pacing pulses with a programmed atrioventricular (AV) pacing interval. If an R-wave is sensed before the AV pacing interval ends, the ventricular pacing pulse can be suppressed. If the AV pacing interval is cut off before the control circuit 480 receives the R-wave sensing event signal from the ventricular sensing channel 489, the control circuit 480 can use the therapy delivery circuit 484 to deliver a scheduled ventricular pacing pulse synchronized with the sensed P wave.

[0071] In some instances, device 400 can be configured to deliver various pacing therapies, including bradycardia pacing, cardiac resynchronization therapy, post-shock pacing, and / or tachycardia-related therapies such as ATP. For example, device 40 can be configured to detect non-sinus tachycardia and deliver ATP. Control circuitry 480 can determine cardiac event time intervals, such as the PP interval between consecutive P-wave sensed event signals received from atrial sensing channel 487, the RR interval between consecutive R-wave sensed event signals received from ventricular sensing channel 489, and the PR and / or RP intervals received between P-wave sensed event signals and R-wave sensed event signals. These intervals can be compared to tachycardia detection intervals to detect non-sinus tachycardia. Tachycardia can be detected in a given cardiac chamber based on a threshold number of detected tachycardia detection intervals.

[0072] Therapeutic delivery circuit 484 may include an atrial pacing circuit 483 and a ventricular pacing circuit 485. Each pacing circuit 483 and 485 may include a charging circuit system, one or more charge storage devices such as one or more low-voltage holding capacitors, an output capacitor, and / or a switching circuit system that controls when the holding capacitor is charged and discharged across the output capacitor to deliver pacing pulses to the pacing electrode vector coupled to the respective pacing circuit 483, 485. Electrodes 424, 442 may be coupled to the ventricular pacing circuit 485 in the form of a bipolar cathode and anode pair to deliver ventricular pacing pulses, for example, when the AV or VV pacing interval set by control circuit 480 is cut off, to provide atrial-synchronized ventricular pacing intervals and substantially low ventricular pacing rates.

[0073] Atrial pacing circuit 483 can be coupled to, for example, electrodes 422, 424 to deliver atrial pacing pulses. Control circuit 480 sets the atrial pacing interval according to a programmed lower pacing rate or a temporarily lower rate set according to a pacing rate indicated by a rate responsive sensor. If the atrial pacing interval is cut off before a P-wave sensed event signal is received from atrial sensing channel 487, the atrial pacing circuit can be controlled to deliver atrial pacing pulses. Control circuit 480 initiates the AV pacing interval in response to the delivered atrial pacing pulses to provide synchronized multiventricular pacing (e.g., biventricular or triventricular pacing).

[0074] The therapy delivery circuit 484 can, based on control signals received from the control circuit 480, charge the holding capacitor of the atrial pacing circuit 483 or the ventricular pacing circuit 485 to a programmed pacing voltage amplitude and discharge the capacitor for a programmed pacing pulse width. For example, the pacing timing circuit included in the control circuit 480 may include a programmable digital counter, set by the microprocessor of the control circuit 480, to control the basic pacing time interval associated with various single-chamber or multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing) modes or anti-tachycardia pacing sequences. The microprocessor of the control circuit 480 can also set the amplitude, pulse width, polarity, or other characteristics of the cardiac pacing pulse, which may be based on programmed values ​​stored in memory 482.

[0075] The device 400 may include other sensors 490 for sensing signals from the patient to determine the need for and / or control of the electrical stimulation therapy delivered by the therapy delivery circuitry 484. In some instances, sensors indicating the need for increased cardiac output may include patient activity sensors, such as accelerometers. The increase in the patient's metabolic demand caused by the increased activity indicated by the patient activity sensors may be determined by the control circuitry 480 to determine the pacing rate indicated by the sensors.

[0076] Control parameters used by control circuitry 480 to sense cardiac events and control the delivery of pacing therapy can be programmed into memory 482 via telemetry circuitry 488, which can also be described as a communication interface. Telemetry circuitry 488 includes a transceiver and antenna for communicating with external devices such as programmers or home monitors using radio frequency communication or other communication protocols. Control circuitry 480 can use telemetry circuitry 488 to receive downlink telemetry from external devices and transmit uplink telemetry to external devices. In some cases, telemetry circuitry 488 can be used to transmit and receive communication signals from another medical device implanted in the patient's body.

[0077] Explanatory ventricular septal lead and delivery system 500 Figure 10-14 As described herein, the system can be configured in accordance with the provisions of this document. Figure 4 The illustrative methods and systems described are used in a similar manner. The lead and delivery system 500 may include a delivery catheter 510 extending from a proximal region (not depicted) to a distal region 514. The delivery catheter 510 may define an opening or orifice extending from the proximal end to the distal end 516. Other components of the lead and delivery system 500 may be located or positioned within the opening of the delivery catheter 510 for delivery to target locations, such as the right ventricular endocardium, interventricular septum, etc.

[0078] The delivery catheter 510 can be manipulated by a clinician to position or position the distal end 516 near a target location (e.g., adjacent to the target location, in close contact with the target location, substantially flush with the target location), such as the right ventricular endocardium, right atrial endocardium, and central fibrous body (CFB) of the interventricular septum of a patient's heart. When the delivery catheter 510 is positioned near the target location, it can be retracted, thereby exposing the penetrating element 520 located within the inner lead body 560, which is situated within the outer lead body 550, such as... Figure 11 As shown. In other words, the delivery catheter 510 can move relative to the rest of the system 500. In at least one embodiment, the rest of the system 500 can be held or held, and can be fixed and stationary, when the delivery catheter 510 is pulled proximally away from the target position.

[0079] The external lead body 550 extends from the proximal end region to the distal end region 554 and, among other things, includes a fixation element 555 located near the distal end region 554. The fixation element 555 may be resilient, such that, for example, it can "fold up" within the delivery catheter 510 and can move or "spring up" to, for example, Figure 11The deployment state is shown. In other words, the retaining element 555 can be configured in both a retracted and deployed configuration. The retaining element 555 can be pre-positioned in the deployed configuration and configured to move back to the deployed configuration without the application of external force. Thus, the delivery catheter 510 can provide external force by contacting the retaining element 555 to hold (e.g., "fold down", restrain, etc.) the retaining element 555 in the retracted configuration when the distal end region 554 is within the opening of the delivery catheter 510. More specifically, each retaining element extends from the proximal end 556 attached to the distal end region 554 to the distal end 558, and in the retracted configuration, the distal end 558 can extend and point toward the distal end 516 of the delivery catheter 510. When the distal end 516 of the delivery catheter 510 is adjacent to tissue at the target location and the delivery catheter 510 moves to release the fixation element 555 of the outer lead body 550, the fixation element 555 can pierce the tissue at the target location and "pull" the outer lead body 550 (as well as the inner lead body 560 and the penetrating element 520) into the tissue. Such a fixation element configuration is further described in U.S. Patent Application Publication No. 2019 / 0076646 A1, entitled "Securing an Implantable Medical Device In Position while Reducing Perforations," published March 14, 2019, which is incorporated herein by reference in its entirety. Although... Figure 11-13 Two fixing elements 555 are depicted, but it should be understood that one or more fixing elements may be used with the illustrative systems and methods described herein.

[0080] A distance 501 can be defined between the location where the proximal end 556 of the retaining element 555 is coupled to the outer lead body 550 (e.g., extending from the outer lead body) and the distal penetrating end 524 of the penetrating element 520. The distance 501 can be between about 2 millimeters (mm) and about 15 mm. In one embodiment, the distance 501 can be 4 mm. In one or more embodiments, the distance 501 can be greater than or equal to 2 mm, greater than or equal to 5 mm, greater than or equal to 8 mm, etc., and / or less than or equal to 4 mm, less than or equal to 7 mm, less than or equal to 10 mm, less than or equal to 12 mm, etc.

[0081] In some embodiments, distance 501 may be referred to as the initial penetration distance because, for example, the force applied to the inner lead body 560 and the penetrating element 520 by releasing the retaining element 555 in the unfolded, positioned, and “grasped” tissue may be sufficient to drive the inner lead body 560 and the penetrating element 520 to the target location up to the distal end region 554 of the outer lead body 550. In other words, the retaining element 555 can “drive” the inner lead body 560 and the penetrating element 520 into the tissue across distance 501.

[0082] Furthermore, the relationship between distance 501 and the length and shape of fixation element 555 (i.e., from proximal end 556 to distal end 558) can be defined as providing effective penetration to a specific target location. For example, the length of fixation element 555 may be about 20% or mm smaller than distance 501 to, for example, allow penetration element 530 and inner lead body 560 (e.g., at least distal end 568) to contact and / or penetrate the endocardium before fixation element 555 contacts the endocardium.

[0083] The external lead body 550 may include one or more electrodes within the distal end region 554. In at least one embodiment, when the fixation element 555 is located in the right ventricular endocardium, the fixation element 555 may be used as an electrode for, for example, sensing right ventricular tissue and / or pacing right ventricular tissue.

[0084] The outer lead body 550 is defined to extend from the proximal end region to the distal end region 554 and as follows Figure 11-13 The inner lead body 560 can be located within the opening shown. The inner lead body 560 can also extend from the proximal end region to the distal end region 564 and can define an opening extending from the proximal end region to the distal end region 564, into which a penetrating element 520, a guidewire, or a core needle can be inserted (e.g., located therein). Figure 11 As shown, the penetrating element 520 extends from the proximal end to the distal penetrating end 524 and is located in the opening of the inner lead body 560 that extends distally from the distal end 568 of the inner lead body 560.

[0085] System 500 can be configured to constrain or limit the penetration element 520 to extend beyond the distal end 568 of the inner lead body 560 by a distance 502. Distance 502 can be defined between the distal end 568 of the inner lead body 560 and the distal penetration end 524 of the penetration element 520 (e.g., a sharp point configured to penetrate the right ventricular endocardium). Distance 502 can be between about 1 millimeter (mm) and about 5 mm. In one embodiment, distance 502 can be 2 mm. In one or more embodiments, distance 502 can be greater than or equal to 1 mm, greater than or equal to 1.5 mm, greater than or equal to 2.5 mm, etc., and / or less than or equal to 5 mm, less than or equal to 4 mm, less than or equal to 3.5 mm, less than or equal to 3 mm, etc.

[0086] The inner lead body 560 may further include one or more electrodes 569, which may be configured to be positioned within the ventricular septum to sense cardiac electrical activity and deliver pacing therapy (e.g., cardiac conduction system pacing therapy, left bundle branch pacing therapy, etc.). Figure 11 Only one of electrodes 569 was exposed.

[0087] Once the outer lead body 550 is secured to a target location, such as the right ventricular endocardial wall, the inner lead body 560 can be moved relative to the outer lead body 550 to implant the distal end region 564 of the inner lead body 560 within the interventricular septum. More specifically, the outer lead body 550 can remain relatively stationary while secured or anchored to tissue at the target location. The penetrating element 520 will be used to penetrate the target location (e.g., the right ventricular endocardium), and therefore, the inner lead body 560 can then follow the opening formed by the penetrating element 520 (e.g., tunnel into the opening). The penetrating element can first be removed from the inner lead body 560 (e.g., retracted proximally). In some embodiments, the inner lead body 560 can then be moved relative to the outer lead body 550 to position the distal end region 564 at a desired location for sensing and / or pacing (e.g., positioned within the interventricular septum near the left ventricular endocardium by puncturing or penetrating the left ventricular endocardium). In other embodiments, a guidewire or mandrel can be inserted through the opening of the inner lead body 560, and then the guidewire or mandrel can be used to position the distal end region 564 of the inner lead body 560 in a desired location. Additionally, the distal end region 564 and distal end 568 of the inner lead body 560 can define a curvature or taper configured to provide tunneling access to tissue and effectively enlarge the opening formed by the penetrating element 520.

[0088] The inner lead body 560 and the outer lead body 550 are in Figure 12As depicted in the figure, the penetrating element 520 and delivery conduit 510 are completely removed. For example, the inner lead body 560 moves distally away from the outer lead body 550 after the outer lead body 550 is secured to the target position. Figure 13 As depicted in the figure, the inner lead body 560 may also include or define a fixing element 561 configured to secure or fix the inner lead body 560 in a desired position. In this embodiment, the fixing element 561 is configured to provide "one-way" fixation. Therefore, the fixing element 561 constrains the inner lead body 560 to move proximally toward (e.g., backward toward) the outer lead body 550 after the inner lead body 560 has moved away from (e.g., distally) the outer lead body 550. Furthermore, as the inner lead body 560 becomes more exposed, more electrodes among the electrodes 569 along the inner lead body 560 become visible.

[0089] in short, Figure 10-13 The lead and delivery system 500 enables mechanical injection into the space within the septum. This can be described as loading the lead into the delivery system, with a perforating element extending distally beyond the lead and covered by a catheter. After positioning the lead at the desired implantation location, the lead can extend beyond the catheter. As the lead extends beyond the catheter, a fixation element (e.g., a nickel-titanium alloy needle) can engage the endocardium. Further, when the fixation element is actuated, it extends the lead beyond the delivery system. Still further, as the lead tip / needle is actuated forward, the lead is injected into the septum and simultaneously secured. The needle can then be retracted, and subsequently, the inner lead assembly can be tunneled to the desired location. In at least one instance, to guide the lead during tunneling, the lead / catheter can be displaced, and a shaped / steerable needle can be used. Further, the inner and outer lead assemblies can then be secured.

[0090] An illustrative quadrupole lead 590 that can be used with the systems and methods described herein Figure 14 As depicted, the lead 590 includes four bipolar electrodes 592 spaced apart along its length. The electrodes 592 may be spaced from about 1 mm to about 5 mm apart. Additionally, the lead 590 includes a plurality of small fixation elements 594 located between each of the electrodes 592. In one embodiment, the fixation element 594 may be a flexible polymer tip that can fold downwards within the delivery catheter and unfold into the muscle fibers upon deployment. Furthermore, when sufficient force is applied, the fixation element 594 will flex and allow for long-term removal (e.g., pulled out of the implantation site, moved proximally away from the implantation site).

[0091] In another embodiment, lead 590 may include... Figure 14The fixing element 594 shown is a helical or spiral-shaped fixing element. The helix allows the lead 590 to be secured and subsequently advances the inner lead body after the outer lead body is secured.

[0092] In another embodiment, similar to the fixation element 561 of the inner lead body 560, the fixation element 594 can be configured to be primarily “unidirectional”. In other words, the fixation element 594 can constrain the lead 590 to move more proximally than distally, to allow implantation but constrain displacement in the proximal direction, for example.

[0093] For all purposes, all references and publications cited herein are expressly incorporated herein by reference in their entirety, unless in any way directly contradict this disclosure.

[0094] Unless otherwise stated, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0095] Unless otherwise stated, all figures used in the specification and claims to indicate the size, quantity, and physical properties of features are to be understood as being modified by the terms “complete” or “about”. Therefore, unless indicated to the contrary, the numerical parameters shown in the foregoing specification and appended claims are approximations that may vary depending on the desired properties sought by those skilled in the art using the teachings disclosed herein or, for example, within typical ranges of experimental error.

[0096] Orientation-related terms, such as “proximal,” “distal,” or “end,” are used to describe the relative positioning of components and do not imply a limitation on the absolute orientation of the contemplated embodiments.

[0097] The terms “coupled” or “connected” refer to components being directly connected to each other (in direct contact) or indirectly connected (having one or more components between two components and connecting them). Both terms can be modified by “operatively” and “operably”, which are used interchangeably to describe a coupling or connection configured to allow components to interact to perform a function.

[0098] The singular forms “a”, “an”, and “the” cover embodiments with plural indicators unless the context clearly indicates otherwise.

[0099] The term "or" is generally used in its inclusive sense, such as meaning "and / or," unless the context clearly indicates otherwise. The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0100] The phrases “at least one,” “including at least one,” and “one or more” that follow a list refer to any item in the list as well as any combination of two or more items in the list.

[0101] Illustrative Examples

[0102] Example 1: An implantable medical device comprising:

[0103] Multiple electrodes, the multiple electrodes comprising:

[0104] A right atrial electrode, which can be positioned within the right atrium to deliver cardiac therapy to the right atrium of a patient's heart or to sense the electrical activity of the right atrium; and

[0105] At least one left ventricular electrode, which can be positioned near the left ventricle of the patient's heart;

[0106] A housing extending from a proximal end region to a distal end region, wherein the right atrial electrode is coupled to the proximal end region in a leadless manner;

[0107] Small leads extending from a proximal region to a distal region, wherein the proximal region is coupled to the distal end region of the housing, and the at least one ventricular electrode is coupled to the distal region of the small leads, wherein the small leads are configured to extend through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein to position the at least one left ventricular electrode near the left ventricle of the patient's heart.

[0108] A therapy delivery circuit, located within the housing and operatively coupled to the plurality of electrodes, for delivering cardiac therapy to the patient's heart;

[0109] A sensing circuit, located within the housing and operatively coupled to the plurality of electrodes, is provided to sense the electrical activity of the patient's heart; and

[0110] A controller, located within the housing and including a processing circuitry operatively coupled to the therapy delivery circuitry and the sensing circuitry, is configured to:

[0111] The processing circuitry system and one or more of the plurality of electrodes are used to monitor electrical activity; and

[0112] The processing circuitry system and one or more of the plurality of electrodes are used to deliver pacing therapy.

[0113] Example 2. The device according to Example 1, wherein the at least one left ventricular electrode can be implanted from the coronary sinus into the left ventricular myocardium near the posterior vein of the patient's heart.

[0114] Example 3. The device according to Example 1, wherein the at least one left ventricular electrode can be implanted into the anterior interventricular vein of the patient's heart.

[0115] Example 4. The device according to Example 1, wherein the at least one left ventricular electrode can be implanted into a lateral vein of the patient's heart.

[0116] Example 5. The device according to any one of Examples 1 to 4, wherein delivery of pacing therapy includes using field steering to avoid the at least one left ventricular electrode capturing the left atrium.

[0117] Example 6: A method that includes:

[0118] A right atrial electrode is implanted in the right atrial endocardium or right atrial myocardium of the patient's heart. The right atrial electrode is coupled to the proximal end region of the implantable housing in a leadless manner, wherein the processing circuitry system is housed in the housing and operatively coupled to the right atrial electrode.

[0119] At least one left ventricular electrode is implanted by passing through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein, the at least one left ventricular electrode being coupled to a distal region of a small lead, the proximal region of the small lead being coupled to a distal end region of the implantable housing, wherein the processing circuitry is operatively coupled to the at least one left ventricular electrode.

[0120] The processing circuitry system and one or more of the right atrial electrode and at least one left ventricular electrode are used to monitor electrical activity; and

[0121] The processing circuitry system, along with one or more of the right atrial electrode and at least one left ventricular electrode, is used to deliver pacing therapy.

[0122] Example 7: According to the method of Example 6, implanting the left ventricular electrode includes implanting the left ventricular electrode from the coronary sinus into the left ventricular myocardium, near the posterior vein of the patient's heart.

[0123] Example 8: According to the method of Example 6, implanting the left ventricular electrode includes implanting the left ventricular electrode into the anterior interventricular vein of the patient's heart.

[0124] Example 9: According to the method of Example 6, implanting the left ventricular electrode includes implanting the left ventricular electrode into a lateral vein of the patient's heart.

[0125] Example 10: The method according to any one of Examples 6 to 9, wherein the delivery of pacing therapy includes using field steering to avoid the left ventricular electrode capturing the left atrium.

[0126] Example 11: A method that includes:

[0127] The delivery catheter and the penetrating element placed in the delivery catheter are delivered to the right ventricular endocardium of the interventricular septum wall of the patient's heart;

[0128] The penetrating element is used to puncture the right ventricular endocardium to form an opening through the right ventricular endocardium and into the interventricular septum wall;

[0129] Retract the penetrating element;

[0130] The distal portion of the guiding element passes through the delivery catheter and the opening and enters the interventricular septum wall to extend along the endocardial wall of the left ventricle; and

[0131] A distal portion of an implantable medical lead is delivered over the guiding element to the left ventricular myocardium to extend along the left ventricular endocardial wall to position at least one left ventricular electrode on the distal portion within the left ventricular myocardium.

[0132] Example 12: According to the method of Example 11, wherein the at least one left ventricular electrode is positioned near the left bundle branch of the conduction system of the patient's heart.

[0133] Example 13: The method according to any one of Examples 11 to 12 further includes implanting at least one right ventricular electrode near the endocardium of the right ventricle, the at least one right ventricular electrode being positioned proximal to the at least one left ventricular electrode on the distal portion of the implantable medical lead.

[0134] Example 14: The method described in Example 13 further includes:

[0135] Monitoring the electrical activity of at least one of the at least right ventricular electrodes and at least one of the at least left ventricular electrodes; and

[0136] Pacing therapy is delivered using at least one of the at least one right ventricular electrode and at least one left ventricular electrode.

[0137] Example 15: The method according to Example 14, wherein the delivery of pacing therapy includes using the at least one left ventricular electrode to deliver pacing pulses to the left bundle branch of the conduction system of the patient's heart.

[0138] Example 16: The method according to any one of Examples 13 to 15, wherein the at least one left ventricular electrode comprises a plurality of left ventricular electrodes, and wherein the at least one right ventricular electrode comprises a plurality of right ventricular electrodes.

[0139] Example 17: The method according to any one of Examples 11 to 16, wherein the delivery catheter extends from a proximal portion to a distal portion, the distal portion defining a curvature for positioning the distal end of the catheter substantially flush with the endocardium of the right ventricle.

[0140] Example 18: The method according to any one of Examples 11 to 17, wherein the guiding element extends from a proximal region to a distal region, wherein the distal region includes a distal curvature portion that bends as it exits the delivery catheter into the interventricular septum wall, so as to deliver at least one region of the distal portion of the implantable medical lead substantially parallel to the interventricular septum wall into the left ventricular myocardium.

[0141] Example 19: A system for delivering an implantable medical lead into the interventricular septum wall and near the left ventricular myocardium, the system comprising:

[0142] A delivery catheter extending from a proximal region to a distal region, the distal region being locating as the right ventricular endocardium adjacent to the interventricular septum wall of the patient's heart;

[0143] A penetrating element, which can be disposed in the delivery catheter to form an opening through the right ventricular endocardium and into the interventricular septum wall; and

[0144] A guiding element extending from a proximal region to a distal region, the guiding element being able to be placed in the delivery catheter to enter the interventricular septum wall through the opening and extend along the endocardial wall of the left ventricle.

[0145] Example 20: The system according to Example 19, wherein the system further includes an implantable medical lead comprising at least one left ventricular electrode and capable of being delivered over the guiding element to the left ventricular myocardium to extend along the left ventricular endocardial wall to position the at least one left ventricular electrode in the left ventricular myocardium of the patient's heart.

[0146] Example 21: According to the system of Example 20, wherein the at least one left ventricular electrode is positioned near the left bundle branch of the conduction system of the patient's heart.

[0147] Example 22: The system according to any one of Examples 20 to 21, wherein the implantable medical lead further includes at least one right ventricular electrode that can be positioned near the endocardium of the right ventricle.

[0148] Example 23: The system according to Example 22, wherein the at least one left ventricular electrode comprises a plurality of left ventricular electrodes, and wherein the at least one right ventricular electrode comprises a plurality of right ventricular electrodes.

[0149] Example 24: The system according to any one of Examples 19 to 23, wherein the distal end region of the delivery catheter defines a curvature for positioning the distal end of the catheter substantially flush with the endocardium of the right ventricle.

[0150] Example 25: The system according to any one of Examples 19 to 24, wherein the distal end region of the guiding element includes a distal curvature portion that bends as it exits the delivery catheter into the interventricular septum wall, so as to deliver at least one region of the distal portion of the implantable medical lead substantially parallel to the interventricular septum wall into the left ventricular myocardium.

[0151] Therefore, various embodiments of implantable medical devices for multi-chamber pacing are disclosed. It should be understood that the aspects disclosed herein can be combined in different combinations than those specifically presented in the specification and drawings. It should also be understood that, depending on the example, the actions or events of any process or method described herein can be performed in a different order, and can be added, combined, or excluded entirely (e.g., all described actions and events may not be necessary for performing the technique). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. An implantable medical device comprising: Multiple electrodes, the multiple electrodes comprising: A right atrial electrode, which can be positioned within the right atrium to deliver cardiac therapy to the right atrium of the patient's heart or to sense the electrical activity of the right atrium; and At least one left ventricular electrode, the at least one left ventricular electrode being positioned near the left ventricle of the patient's heart to deliver cardiac therapy to the left ventricle of the patient's heart or to sense the electrical activity of the left ventricle; A housing extending from a proximal end region to a distal end region, wherein the right atrial electrode is coupled to the proximal end region in a leadless manner; Small leads extending from a proximal region to a distal region, wherein the proximal region is coupled to the distal end region of the housing, and the at least one left ventricular electrode is coupled to the distal region of the small leads, wherein the small leads are configured to extend through the coronary sinus ostium of the patient's heart and into the coronary sinus or coronary vein to position the at least one left ventricular electrode near the left ventricle of the patient's heart. A therapy delivery circuit, located within the housing and operatively coupled to the plurality of electrodes, for delivering cardiac therapy to the patient's heart; A sensing circuit, located within the housing and operatively coupled to the plurality of electrodes, is provided to sense the electrical activity of the patient's heart; and A controller, located within the housing and including a processing circuitry operatively coupled to the therapy delivery circuitry and the sensing circuitry, is configured to: The processing circuitry system and one or more of the plurality of electrodes are used to monitor electrical activity; and The processing circuitry system and one or more of the plurality of electrodes are used to deliver pacing therapy.

2. The device of claim 1, wherein the at least one left ventricular electrode can be implanted from the coronary sinus into the left ventricular myocardium near the posterior vein of the patient's heart.

3. The device of claim 1, wherein the at least one left ventricular electrode is implantable into the anterior interventricular vein of the patient's heart.

4. The device of claim 1, wherein the at least one left ventricular electrode is implantable into a lateral vein of the patient's heart.

5. The device according to any one of claims 1 to 4, wherein delivery of pacing therapy includes using field steering to avoid the at least one left ventricular electrode capturing the left atrium.

Images