His beam lead delivery catheters, systems, and methods

Abstract

The invention discloses a His beam lead delivery catheter, system and method. A catheter for delivering a medical electrical lead from the right atrium of a heart to a His bundle. The catheter includes a straight portion and a hook protruding from a distal end of the straight portion. The hook portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from a distal end of the first curved portion. The second curved portion is curved away from the plane. A third curved portion extends from a distal end of the second curved portion. The third curved portion is curved toward the plane. The catheter forms a lumen extending from a proximal end of the straight portion to an opening at a distal end of the third curved portion.

Description

[0001] This application is a divisional application of application No. 201980037158.7, application date April 2, 2019, and invention name “His bundle lead delivery catheter, system and method”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 651,571, filed on April 2, 2018, entitled BUNDLE OF HIS LEAD DELIVERY CATHETER, SYSTEM AND METHOD, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates to medical electrical lead delivery catheters, systems and methods. In particular, the present disclosure relates to catheters, systems and methods for delivering a medical electrical lead from the right atrium to the bundle of His. Background Art

[0005] Cardiac rhythm management systems can be used to electrically stimulate a patient's heart to treat a variety of cardiac arrhythmias. Stimulating the His bundle can prevent asynchrony that may be associated with right ventricular apical pacing, which can lead to asynchronous delayed activation of the heart and compromised hemodynamics. Normal His-Purkinje activation of the myocardium can result in rapid, continuous, synchronized multi-site depolarization and efficient ventricular contraction of cardiomyocytes in patients with intact His-Purkinje function. There is a continuing need for improved medical electrical lead delivery catheters, systems, and methods for targeting the His bundle. Summary of the invention

[0006] Example 1 is a catheter for delivering a medical electrical lead from the right atrium of the heart to the His bundle. The catheter includes a straight portion and a hook-shaped portion protruding from the distal end of the straight portion. The hook-shaped portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from the distal end of the first curved portion. The second curved portion bends away from the plane. The third curved portion extends from the distal end of the second curved portion. The third curved portion bends toward the plane. The catheter forms an inner cavity extending from the proximal end of the straight portion to an opening at the distal end of the third curved portion.

[0007] Example 2 is the catheter of Example 1, wherein the first curved portion and the second curved portion define a compound curve when projected onto the plane, and the third curved portion has a curvature opposite to the compound curve when projected onto the plane.

[0008] Example 3 is the catheter of Example 1 or Example 2, wherein the catheter is configured to be introduced into the heart through a blood vessel, extend downward along the side wall of the superior vena cava, and cross the right atrium so that the opening at the distal end of the hook is set perpendicular to the portion of the atrioventricular septum adjacent to the bundle of His.

[0009] Example 4 is the catheter of Example 3, wherein the first curved portion includes a bottom portion of the hook.

[0010] Example 5 is the catheter of Example 3 or Example 4, wherein the first curved portion extends from a distal end of the straight portion.

[0011] Example 6 is the catheter of any one of Examples 3 to 5, wherein a length of the first curved portion is greater than a length of the second curved portion.

[0012] Example 7 is the catheter of Example 1 or Example 2, wherein the catheter is configured to be introduced into the heart through a blood vessel, extend downward along the right side wall of the right atrium toward the floor of the right atrium, and extend the anteromedial side away from the floor of the right atrium so that the opening at the distal end of the third curved portion is set perpendicular to the portion of the atrioventricular septum adjacent to the His bundle.

[0013] Example 8 is the catheter of Example 7, wherein the second curved portion includes a bottom portion of the hook.

[0014] Example 9 is the catheter of Example 7 or Example 8, further comprising a fourth curved portion extending from a distal end of the straight portion, the first curved portion extending from a distal end of the fourth curved portion, the fourth curved portion being coplanar with the first curved portion and having a curvature opposite to that of the first curved portion when projected onto a plane.

[0015] Example 10 is the catheter of any of Examples 7 to 9, wherein a length of the second curved portion is greater than a length of the first curved portion.

[0016] Example 11 is the catheter of Example 1, wherein the first curved portion, the second curved portion, and the third curved portion define a compound curve when projected onto a plane, the third curved portion extending toward the first curved portion and crossing the plane.

[0017] Example 12 is the catheter of any one of Examples 1 to 11, wherein the radius of curvature of the first curved portion and the second curved portion is greater than 17 millimeters.

[0018] Example 13 is the catheter of any of Examples 1 to 12, wherein the radius of curvature of the hook is greater than 17 mm.

[0019] Example 14 is a system for delivering a medical electrical lead from the right atrium of a heart to the bundle of His. The system comprises a catheter according to any one of Examples 1 to 13 and a medical electrical lead configured to pass through an inner cavity.

[0020] Example 15 is the system of Example 14, wherein the medical electrical lead includes an active fixation element.

[0021] Example 16 is a catheter for delivering a medical electrical lead from the right atrium of the heart to the His bundle. The catheter includes a straight portion and a hook-shaped portion protruding from the distal end of the straight portion. The hook-shaped portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from the distal end of the first curved portion. The second curved portion is bent away from the plane. The radius of curvature of the second curved portion is greater than 17 mm. The third curved portion extends from the distal end of the second curved portion. The third curved portion is bent toward the plane. The catheter forms an inner cavity extending from the proximal end of the straight portion to an opening at the distal end of the third curved portion.

[0022] Example 17 is the catheter of Example 16, wherein the first curved portion and the second curved portion define a compound curve when projected onto the plane, and the third curved portion has a curvature opposite to the compound curve when projected onto the plane.

[0023] Example 18 is the catheter of Example 16 or Example 17, wherein the catheter is configured to be introduced into the heart transvascularly, extend downward along the side wall of the superior vena cava, and cross the right atrium so that the opening at the distal end of the hook is set perpendicular to the portion of the atrioventricular septum adjacent to the bundle of His.

[0024] Example 19 is the catheter of Example 18, wherein the first curved portion includes a bottom portion of the hook.

[0025] Example 20 is the catheter of Example 18 or Example 19, wherein the first curved portion extends from a distal end of the straight portion.

[0026] Example 21 is the catheter of any of Examples 18 to 20, wherein a length of the first curved portion is greater than a length of the second curved portion.

[0027] Example 22 is the catheter of Example 16 or 17, wherein the catheter is configured to be introduced into the heart through a blood vessel, extend downward along the right side wall of the right atrium toward the bottom surface of the right atrium, and extend the anteromedial side away from the bottom surface of the right atrium so that the opening at the distal end of the hook is set perpendicular to the portion of the atrioventricular septum adjacent to the His bundle.

[0028] Example 23 is the catheter of Example 22, wherein the second curved portion includes a bottom portion of the hook.

[0029] Example 24 is the catheter of Example 22 or Example 23, further comprising a fourth curved portion extending from a distal end of the straight portion, the first curved portion extending from the distal end of the fourth curved portion, the fourth curved portion being coplanar with the first curved portion and having a curvature opposite to that of the first curved portion when projected onto a plane.

[0030] Example 25 is the catheter of any of Examples 22 to 24, wherein a length of the second curved portion is greater than a length of the first curved portion.

[0031] Example 26 is the catheter of Example 16, wherein the first curved portion, the second curved portion, and the third curved portion define a compound curve when projected onto a plane, the third curved portion extending toward the first curved portion and crossing the plane.

[0032] Example 27 is the catheter of any of Examples 16 to 26, wherein the radius of curvature of the hook is greater than 17 mm.

[0033] Example 28 is a system for delivering a medical electrical lead from the right atrium of the heart to the His bundle. The system includes a catheter and a medical electrical lead. The catheter includes a straight portion and a hook-shaped portion protruding from the distal end of the straight portion. The hook-shaped portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from the distal end of the first curved portion. The second curved portion is bent away from the plane. The radius of curvature of the second curved portion is greater than 17 mm. The third curved portion extends from the distal end of the second curved portion. The third curved portion is bent toward the plane. The catheter forms an inner cavity extending from the proximal end of the straight portion to an opening at the distal end of the third curved portion. The medical electrical lead is configured to pass through the inner cavity.

[0034] Example 29 is the system of Example 28, wherein the medical electrical lead includes an active fixation element.

[0035] Example 30 is Example 28 or the system of Example 28, wherein the first curved portion and the second curved portion define a compound curve when projected onto the plane, and the third curved portion has a curvature opposite to the compound curve when projected onto the plane.

[0036] Example 31 is a system of any one of Examples 28 to 30, further comprising a fourth curved portion extending from a distal end of the straight portion, the first curved portion extending from a distal end of the fourth curved portion, the fourth curved portion being coplanar with the first curved portion and having a curvature opposite to that of the first curved portion when projected onto a plane.

[0037] Example 32 is the system of Example 28, wherein the first curved portion, the second curved portion, and the third curved portion define a compound curve when projected onto a plane, the third curved portion extending toward the first curved portion and across the plane.

[0038] Example 33 is a method for implanting a medical electrical lead to stimulate the His bundle. The method includes: introducing a catheter transvascularly through the superior vena cava and into the right atrium of the heart, the hook of the catheter being configured so that the opening at the distal end of the hook is oriented to face the surface of the atrioventricular septum adjacent to the His bundle; extending a fixation element on the distal end of the medical electrical lead from the opening at the distal end of the hook; locating tissue of a target site along the atrioventricular septum; deploying the fixation element in the tissue of the target site to implant the medical electrical lead in contact with the His bundle; and removing the catheter from over the medical electrical lead.

[0039] Example 34 is the method of Example 33, wherein introducing the catheter into the heart through a blood vessel includes: positioning the hook portion in the heart so that the hook portion extends downward along the side wall of the superior vena cava and crosses the right atrium so that the opening at the distal end of the hook portion is positioned perpendicular to the portion of the atrioventricular septum adjacent to the bundle of His.

[0040] Example 35 is the method of Example 33, wherein introducing the catheter into the heart through a blood vessel includes: setting the hook portion in the heart so that the hook portion extends downward along the right side wall of the right atrium toward the bottom surface of the right atrium, and extends the anterior and inner side away from the bottom surface of the right atrium, so that the opening at the distal end of the hook portion is set to be perpendicular to the portion of the atrioventricular septum adjacent to the His bundle.

[0041] Although multiple examples are disclosed, other examples according to the present disclosure will become apparent to those skilled in the art from the following detailed description which shows and describes illustrative embodiments.Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 is a schematic diagram of a His bundle stimulation system according to some embodiments of the present disclosure.

[0043] Figure 2 is a schematic diagram of a catheter for delivering a medical electrical lead from within the right atrium to the bundle of His according to some embodiments of the present disclosure.

[0044] Figure 3 According to some embodiments of the present disclosure Figure 2 Side view of a catheter used to deliver a medical electrical lead from within the right atrium to the bundle of His.

[0045] Figure 4 According to some embodiments of the present disclosure Figure 3 Bottom view of the catheter shown.

[0046] Figure 5 According to some embodiments of the present disclosure Figure 3 and Figure 4 Another side view of the catheter is shown.

[0047] Figure 6 is a schematic diagram of another catheter for delivering a medical electrical lead from within the right atrium to the bundle of His according to some embodiments of the present disclosure.

[0048] Figure 7 According to some embodiments of the present disclosure Figure 6 Side view of a catheter used to deliver a medical electrical lead from within the right atrium to the bundle of His.

[0049] Figure 8 According to some embodiments of the present disclosure Figure 7 Bottom view of the catheter shown.

[0050] Fig. 9 According to some embodiments of the present disclosure Figure 7 and Figure 8 Another side view of the catheter is shown.

[0051] Fig.10 is a side view of another catheter for delivering a medical electrical lead from within the right atrium to the bundle of His according to some embodiments of the present disclosure.

[0052] Fig.11 According to some embodiments of the present disclosure Fig.10 Bottom view of the catheter shown.

[0053] Fig.12 According to some embodiments of the present disclosure Fig.10 and Fig.11 Another side view of the catheter is shown.

[0054] Although the present disclosure may be subjected to various modifications and alternative forms, specific embodiments have been shown in the drawings by way of example and are described in detail below. However, it is not intended to limit the present disclosure to the specific embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents and alternatives falling within the scope of the present disclosure defined by the appended claims. DETAILED DESCRIPTION

[0055] The output of the heart depends on the synchronization of contractions within and between the heart chambers. Normally, each cardiac cycle is initiated by the depolarization of cells in the sinoatrial node, which begins to contract the myocardial cells of the atria. The electrical impulse continues to the atrioventricular node, which delays the propagation of the signal to allow the atria to contract before the ventricles. The distal portion of the atrioventricular node contains the His bundle. The His bundle propagates the depolarization signal to the left and right branches in the ventricular septum. The left and right branches propagate the depolarization signal to the Purkinje fibers of the left and right ventricles, respectively.

[0056] Various conditions can interfere with the normal electrical conduction system of the heart, which can cause arrhythmias and may impair the heart's output. For example, conduction block along the atrioventricular node can cause the atrial and ventricular contractions to lose rhythm. Conventional pacing therapy attempts to bypass the conduction system between the atria and ventricles by implanting a lead at the tip of the right ventricle, where, ideally, each pulse delivered to the myocardial tissue is propagated as a depolarization wave. However, direct stimulation of the working myocardium (e.g., at the tip of the right ventricle) results in slower propagation than direct stimulation of the dedicated conduction system fibers (the His bundle system). For these and other reasons, it may be difficult to replicate the synchronous contraction of the natural conduction system by pacing only at the tip of the right ventricle or other working myocardial sites.

[0057] The present disclosure relates, among other things, to direct stimulation by targeting the His bundle using the specialized conduction system of the heart. In particular, the present disclosure relates to securing one or more electrodes so as to be in contact with or in proximity to the nerve fibers of the His bundle. The His bundle can be accessed from multiple areas. One area is along the atrioventricular septum in the right atrium at the tip of Koch's triangle. Koch's triangle is a roughly triangular shape on the right atrial septal wall defined by the base of the septal leaflet of the tricuspid valve, the anteromedial edge of the coronary sinus ostium, and the tendon of Todaro. A His capture can be obtained by properly securing a pacing lead at the tip of Koch's triangle.

[0058] A delivery catheter in accordance with an embodiment of the present disclosure is shaped to facilitate placement of a medical electrical lead in the right atrium at the atrioventricular septum just above the septal leaflets of the tricuspid valve and superior thereto.

[0059] Figure 1 is a schematic diagram of a His bundle stimulation system according to some embodiments of the present disclosure. Figure 1 A stimulation system 10 is shown, which includes an implantable pulse generator 12 and a lead 14. The lead 14 is implanted in a heart 16. The implantable pulse generator 12 may include circuitry for sensing bioelectrical signals and / or delivering electrical stimulation via the lead 14. The implantable pulse generator 12 may include a lead interface 18 (e.g., a header). The lead 14 may include a proximal end 20, a distal end 22, and a fixation element 24 disposed at the distal end 22.

[0060] The lead 14 may also include one or more electrical contacts (not shown) at the proximal end 20, one or more electrical elements (e.g., ring electrodes) at the distal end 22, and an inner lumen 73 ( Figure 3 ), and lumen 73 extends from the electrical contacts to the electrical components within lead 14. Lead interface 18 can connect pulse generator 12 to the electrical contacts at proximal end 20 of lead 14 to electrically connect pulse generator 12 to the electrical components.

[0061] like Figure 1 As shown, the lead 14 is implanted in the right atrium 26 at the atrioventricular septum 28 just above the septal leaflet 30 of the tricuspid valve 32 for direct stimulation of the His bundle 34. The lead 14 operates to transmit electrical signals between the His bundle 34 and the implantable pulse generator 12. In some embodiments, the lead 14 may enter the vascular system through a vascular access site (not shown) formed in the wall of the left subclavian vein (not shown), extend through the left brachiocephalic vein (not shown) and the superior vena cava 36, ​​and reach the right atrium 26. Other suitable vascular access sites may be used in various other embodiments.

[0062] The fixation element 24 can fix the lead 14 to cardiac tissue, such as a tissue region that can directly stimulate the Hissler beam 34. In some embodiments, the fixation element 24 can be electrically coupled to the implantable pulse generator 12 by, for example, one of the electrical conductors (such as a coil) extending to the proximal end 20 of the lead 14 for docking with the lead interface 18. Thus, the fixation element 24 can mechanically and electrically couple the lead 14 to the tissue and facilitate the transmission of electrical energy from the Hissler beam 34 in the sensing mode and to the Hissler beam 34 in the stimulation mode. In some embodiments, the fixation element 24 is a fixed fixation element, such as a helix fixed to the lead 14. Such a fixation element 24 can be deployed by rotating the lead 14 itself to implant the fixation element 24 into the tissue. In some other embodiments, the fixation element 24 can be an active fixation element, such as a helix or one or more tines. Such an active fixation element may be deployed by rotating a connected coil at the proximal end 20, which transmits torque along the coil to rotate the fixation element 24 and implant the fixation element 24 into the tissue without rotating the lead 14 itself. The use of an active fixation element for the fixation element 24 may allow for more precise placement of the lead 14. The use of an active fixation element for the fixation element 24 may also provide better mapping capabilities because the user does not need to be concerned about accidental entanglement of the helix in the tissue.

[0063] Although placing the lead 14 at various locations may be able to indirectly stimulate the His bundle 34, placing the lead 14 together with one or more electrodes (such as the fixation element 24), in contact with the fibers of the His bundle 34, or in close proximity to the fibers of the His bundle 34 (e.g., within 5 mm), can reliably capture the tissue of the His bundle 34 with a pacing pulse (i.e., causing the cells to depolarize and propagate the activation signal). For example, the fixation element 24 in contact with the His bundle 34 can capture the His bundle 34 above the left ventricular branch 38 and the right ventricular branch 40 of the dedicated conduction system, thereby causing the depolarization wave to travel down the septum 42 along both the left branch 38 and the right branch 40. The depolarization wave can propagate to the working myocardial tissue of the left ventricle 44 and the right ventricle 46, thereby causing the left ventricle 44 and the right ventricle 46 to contract.

[0064] although Figure 1 Only a single lead connected to the implantable pulse generator 12 and implanted for cardiac stimulation is shown, but various other embodiments may have alternative leads and / or one or more additional leads for sensing bioelectric activity and / or stimulating the His bundle 34 or other areas of the heart 16.

[0065] As discussed herein, delivering a lead to a target in the right atrium 26 at the atrioventricular septum 28 just above the septal leaflet 30 of the tricuspid valve 32 can be a difficult process. A small area of ​​tissue providing access to the His bundle 34 must first be located. The target can be located by a catheter having electrodes that sense electrical biomarkers indicating electrical activation of the His bundle during the mapping process. Biomarkers are typically weak and only appear when a signal is sensed by an electrode near the His bundle (e.g., by sensing the biomarker as a near-field signal). In various cases, one or more electrodes of the mapping catheter will need to contact the tissue providing access to the His bundle. Once positioned by the mapping catheter, the lead must be advanced to the small area. The location of the small area may be lost when the mapping catheter is replaced with a lead and / or before the lead is adhered to the small area. In any case, the catheters, systems, and methods disclosed herein can facilitate precise placement and stability of the lead 14 at the target location.

[0066] Figure 2 is a schematic diagram of a catheter for delivering a medical electrical lead from within the right atrium to the His bundle according to some embodiments of the present disclosure. Figure 2 A catheter 50 is shown, which includes a straight portion 52 and a hook 54. The hook 54 may protrude from the straight portion 52. The catheter 50 may be as described above with reference to Figure 1 The lead 14 is introduced into the heart 16 via a blood vessel as described above. Figures 3 to 5As described, the catheter 50 is configured to extend downward along the side wall of the superior vena cava 36 and across the right atrium 26 so that the opening 56 at the distal end 58 of the hook 54 is disposed perpendicular to the portion of the atrioventricular septum 28 adjacent to the bundle of His 34. With such orientation, the lead 14 passing through the catheter 50 can be precisely delivered to the target site for implantation.

[0067] Figure 3 According to some embodiments of the present disclosure Figure 2 A side view of a catheter 50 for delivering a medical electrical lead from within the right atrium to the bundle of His is shown. Figure 3 A catheter 50 is shown, which includes a straight portion 52 and a hook portion 54. The hook portion 54 may include a first curved portion 60, a second curved portion 62, and a third curved portion 64. The hook portion 54 may protrude from a distal end 66 of the straight portion 52. The first curved portion 60 may extend from a distal end 66 of the straight portion 52. The second curved portion 62 may extend from a distal end 68 of the first curved portion 60. The third curved portion 64 may extend from a distal end 70 of the second curved portion 62. In some embodiments, as shown in FIG. Figure 3 As shown, the third curved portion 64 may include an opening 56 at the distal end 58 of the hook 54. The straight portion 52 and the first curved portion 60 may define a plane P1. Figure 4 and Figure 5 As shown, as described below, the second curved portion 62 can bend away from the plane P1. Figure 4 and Figure 5 As shown, the third curved portion 64 can be bent back toward the plane P1. Figure 3 In FIG. 1 , plane P1 is the plane of the page, so the straight portion 52 and the first curved portion 60 are shown in the cross section, while the second curved portion 62 and the third curved portion 64 are outside the plane P1 and are not shown in the cross section.

[0068] like Figure 3As further shown, the catheter 50 forms a lumen 72 extending from the proximal end 74 of the straight portion 52 to the opening 56 at the distal end 58 of the hook 54. In some embodiments, the diameter D of the lumen 72 can be as small as 1 French unit (Fr), 2Fr, 3Fr, 4Fr, 5Fr or 6Fr, or as large as 7Fr, 8Fr, 9Fr, 10Fr, 11Fr or 12Fr, or any value between any two of the above values ​​(such as, for example, 1Fr to 12Fr, 2Fr to 11Fr, 3Fr to 10Fr, 4Fr to 9Fr, 5Fr to 8Fr, 6Fr to 7Fr, 6Fr to 9Fr or 7Fr to 9Fr). The portion of the lumen 72 extending through the straight portion 52 defines an axis A. It has been found that when fixation element 24 is an active fixation element as described above, a diameter D of lumen 72 equal to or greater than 6 Fr, such as 6 Fr to 9 Fr, may be required to accommodate lead 14 since such leads tend to have larger diameters.

[0069] like Figure 3 As shown, when the hook 54 is bent around, it defines a bottom 76 of the hook 54. The bottom 76 is the point where the hook 54 contacts the plane P2, which is farthest from the distal end 66 of the straight portion 52, and the plane P2 is perpendicular to both the plane P1 and the axis A. In some embodiments, as shown in FIG. Figure 3 As shown, the first curved portion 60 may include a base 76 of the hook 54 .

[0070] In some embodiments, Figure 3 As shown, the first curved portion 60 and the second curved portion 62 define a composite curve when projected onto the plane P1. Figure 3 As shown, the third curved portion 64 has a curvature opposite to the composite curve of the first curved portion 60 and the second curved portion 62 when projected onto the plane P1.

[0071] In some embodiments, the radius of curvature along the first curved portion 60 and the second curved portion 62 is greater than 17 mm. It has been found that a radius of curvature along the first curved portion 60 or the second curved portion 62 less than 17 mm may hinder the torque applied to the fixation element 24 ( Figure 1 ), especially when the fixation element 24 is an active fixation element as described above. In some embodiments, the radius of curvature along the third curved portion 64 is greater than 10 mm. In some other embodiments, the radius of curvature along the entire hook portion 54 is greater than 17 mm. In some embodiments, the length of the first curved portion 60 is greater than the length of the second curved portion 62.

[0072] Figure 4 According to some embodiments of the present disclosure Figure 3A bottom view of the catheter 50 is shown. Figure 4 As shown, the first curved portion 60 lies in plane P1. The second curved portion 62 bends away from plane P1 as it extends from the distal end 68 of the first curved portion 60. The third curved portion 64 bends back toward plane P1 as it extends from the distal end 70 of the second curved portion 62.

[0073] Figure 5 According to some embodiments of the present disclosure, Figure 3 and Figure 4 Another side view of the catheter 50 is shown. Figure 5 In the figure, the catheter 50 is shown around Figure 3 The axis A in the figure is rotated 90 degrees. Figure 5 As shown, the straight portion 52 and the first curved portion 60 lie in a plane P1 , the second curved portion 62 curves away from the plane P1 , and the third curved portion 64 curves back toward the plane P1 .

[0074] A system for delivering a medical electrical lead from within the right atrium 26 to the His bundle 34 may include a catheter 50 according to any of the above embodiments, and a lead 14 configured to pass through the lumen 72 of the catheter 50. In some embodiments, the lead 14 may include a fixation element 24. In some embodiments, as described above, the fixation element 24 is an active fixation element.

[0075] Taking into account Figures 1 to 5 , a method of implanting a lead 14 to stimulate the His bundle 34 may include introducing a catheter 50 transvascularly through the superior vena cava 36 and into the right atrium 26 of the heart 16, the hook 54 of the catheter 50 being configured such that an opening 56 at a distal end 58 of the hook 54 is disposed perpendicular to a portion of the atrioventricular septum 28 adjacent to the His bundle 34. A fixation element 24 on the distal end 22 of the lead 14 may extend from the opening 56. Tissue of a target site along the atrioventricular septum 28 may be located, and the fixation element 24 may be deployed in the tissue of the target site to implant the lead 14 in contact with the His bundle 34. The catheter 50 may be removed from the lead 14.

[0076] In some embodiments, introducing the catheter 50 transvascularly into the heart 16 may include positioning the hook 54 within the heart 16 so that it extends downward along the side wall of the superior vena cava 36 and across the right atrium 26 so that the opening 56 at the distal end 58 of the hook 54 is positioned perpendicular to the portion of the atrioventricular septum 28 adjacent to the bundle of His 34.

[0077] Figure 6 is a schematic diagram of another catheter for delivering a medical electrical lead from within the right atrium to the His bundle according to some embodiments of the present disclosure. Figure 6A catheter 150 is shown, which includes a straight portion 152 and a hook 154. The hook 154 may protrude from the straight portion 152. As described above with reference to Figure 1 As described with respect to lead 14, catheter 150 may be introduced transvascularly into heart 16. Figures 7 to 9 As described, the catheter 150 is configured to extend downwardly along the right side wall of the right atrium 26 toward the bottom surface 155 of the right atrium 26, and to extend the front inner side away from the bottom surface 155, so that the opening 156 at the distal end 158 of the hook 154 is set perpendicular to the part of the atrioventricular septum 28 adjacent to the His bundle 34. Positioned in this way, the lead 14 passing through the catheter 150 can be accurately delivered to the target site for implantation. In some embodiments, the catheter 150 can be configured to contact the bottom surface 155. In some other embodiments, the catheter 150 can be configured to approach but not contact the bottom surface 155.

[0078] Figure 7 According to some embodiments of the present disclosure Figure 6 A side view of a catheter 150 for delivering a medical electrical lead from within the right atrium to the bundle of His is shown. Figure 7 A catheter 150 including a straight portion 152 and a hook portion 154 is shown. The hook portion 154 may include a first curved portion 160, a second curved portion 162, a third curved portion 164, and a fourth curved portion 165. The hook portion 154 may protrude from a distal end 166 of the straight portion 152. The first curved portion 160 may extend from a distal end 167 of the fourth curved portion 165. The second curved portion 162 may extend from a distal end 168 of the first curved portion 160. The third curved portion 164 may extend from a distal end 170 of the second curved portion 162. In some embodiments, as Figure 7 As shown, the third curved portion 164 may include an opening 156 at the distal end 158 of the hook 154. The fourth curved portion 165 may extend from the distal end 166 of the straight portion 152. The straight portion 152, the fourth curved portion 165, and the first curved portion 160 may define a plane P1. Therefore, the fourth curved portion 165 is coplanar with the straight portion 152 and the first curved portion 160. Figure 7 As shown, the fourth curved portion 165 has an opposite curvature to the first curved portion 160 .

[0079] As described below, Figure 8 and Fig. 9 As shown, the second curved portion 162 can be bent away from the plane P1. Figure 8 and 9 As shown, the third curved portion 164 may also bend back toward the plane P1. Figure 7, plane P1 is the plane of the page, so the straight portion 152, the fourth curved portion 165 and the first curved portion 160 are shown in the cross section, while the second curved portion 162 and the third curved portion 169 are outside the plane P1 and are not shown in the cross section.

[0080] like Figure 7 As further shown, the catheter 150 forms a lumen 172 extending from a proximal end 174 of the straight portion 152 to an opening 156 at a distal end 158 of the third curved portion 164. In some embodiments, the diameter D of the lumen 172 can be as small as 1 French unit (Fr), 2Fr, 3Fr, 4Fr, 5Fr or 6Fr, or as large as 7Fr, 8Fr, 9Fr, 10Fr, 11Fr or 12Fr, or any value between any two of the above values ​​(such as, for example, 1Fr to 12Fr, 2Fr to 11Fr, 3Fr to 10Fr, 4Fr to 9Fr, 5Fr to 8Fr, 6Fr to 7Fr, 6Fr to 9Fr or 7Fr to 9Fr). The portion of the lumen 172 extending through the straight portion 152 defines an axis A. It has been found that when fixation element 24 is an active fixation element, a diameter D of lumen 172 equal to or greater than 6 Fr, such as 6 Fr to 9 Fr, may be required to accommodate lead 14, as such leads tend to have larger diameters.

[0081] like Figure 7 As shown, when the hook 154 is bent around, it defines a bottom 176 of the hook 154. The bottom 176 is the point where the hook 154 contacts the plane P2, which is farthest from the distal end 166 of the straight portion 152, and the plane P2 is perpendicular to both the plane P1 and the axis A. In some embodiments, as shown in FIG. Figure 7 As shown, the second curved portion 162 may include a bottom 176 of the hook 154 .

[0082] In some embodiments, Figure 7 As shown, the first curved portion 160 and the second curved portion 162 define a compound curve when projected onto plane P1. In some embodiments, the radius of curvature along the first curved portion 160 and the second curved portion 162 is greater than 17 mm. It has been found that a radius of curvature along the first curved portion 160 and the second curved portion 162 less than 17 mm may hinder the torque to the fixation element 24 ( Figure 1 ), especially when the fixation element 24 is an active fixation element as described above. In some embodiments, the radius of curvature along the third curved portion 164 is greater than 10 mm. In some other embodiments, the radius of curvature along the entire hook portion 154 is greater than 17 mm. In some embodiments, the length of the second curved portion 162 is greater than the length of the first curved portion 160.

[0083] Figure 8 According to some embodiments of the present disclosure Figure 7 A bottom view of the catheter 150 is shown. Figure 8 As shown, the first curved portion 160 is located in plane P1. The second curved portion 162 bends away from plane P1 as it extends from the distal end 168 of the first curved portion 160. The third curved portion 164 bends back toward plane P1 as it extends from the distal end 170 of the second curved portion 162.

[0084] Fig. 9 According to some embodiments of the present disclosure Figures 7 and 8 Another side view of the catheter 150 is shown. Fig. 9 , the catheter 150 is shown around Figure 7 The axis A in the figure is rotated 90 degrees. Fig. 9 As shown, the straight portion 152 , the fourth curved portion 165 , and the first curved portion 160 are located in a plane P1 , the second curved portion 162 curves away from the plane P1 , and the third curved portion 164 curves back toward the plane P1 .

[0085] A system for delivering a medical electrical lead to the His bundle 34 within the right atrium 26 may include a catheter 150 according to any of the above embodiments and a lead 14 configured to pass through a lumen 172 of the catheter 150. In some embodiments, the lead 14 may include a fixation element 24. In some embodiments, as described above, the fixation element 24 is an active fixation element.

[0086] Taking into account Figure 1 and Figure 6-Figure 9 , a method of implanting a lead 14 to stimulate the His bundle 34 may include transvascularly introducing a catheter 150 through the superior vena cava 36 and into the right atrium 26 of the heart 16, the hook 154 of the catheter 150 being configured such that an opening 156 at a distal end 158 of the hook 154 is disposed perpendicular to a portion of the atrioventricular septum 28 adjacent to the His bundle 34. A fixation element 24 on the distal end 22 of the lead 14 may extend from the opening 56. Tissue of a target site along the atrioventricular septum 28 may be located and the fixation element 24 deployed in the tissue of the target site to implant the lead 14 in contact with the His bundle 34. The catheter 50 may be removed from over the lead 14.

[0087] In some embodiments, transvascularly introducing the catheter 150 into the heart 16 may include positioning the hook 154 within the heart 16 so that it extends downward along the right side wall of the right atrium 26 toward the floor 155 of the right atrium 26 and extends anteromedially away from the floor 155 of the right atrium 26 so that the opening 156 at the distal end 158 of the hook 154 can be positioned perpendicular to the portion of the atrioventricular septum 28 adjacent to the His bundle 34.

[0088] Fig.10 is a side view of another catheter for delivering a medical electrical lead from within the right atrium to the bundle of His, according to some embodiments of the present disclosure. Fig.10 The catheter 250 is shown, which includes a straight portion 252 and a hook portion 254. The hook portion 254 may include a first curved portion 260, a second curved portion 262, and a third curved portion 264. The hook portion 254 may protrude from a distal end 266 of the straight portion 252. The first curved portion 260 may extend from a distal end 266 of the straight portion 252. The second curved portion 262 may extend from a distal end 268 of the first curved portion 260. The third curved portion 264 may extend from a distal end 270 of the second curved portion 262. Fig.10 As shown, the third curved portion 264 may include an opening 256 ( Fig.11 ). The straight portion 252 and the first curved portion 260 can define a plane P1. When the hook portion 254 is bent around, it defines a bottom 276 of the hook portion 254. The bottom 276 is the point where the hook portion 254 contacts the plane P2, which is farthest from the distal end 266 of the straight portion 252. The plane P2 is perpendicular to both the plane P1 and the axis A. In some embodiments, as shown in FIG. Fig.10 As shown, the second curved portion 262 may include a bottom 276 of the hook 254 .

[0089] like Fig.11 and 12 As shown and described below, the second curved portion 262 can be curved away from the plane P1. Fig.11 and 12 As shown, the third curved portion 264 is bent back toward the plane P1 and extends out from the plane P1. Fig.10 , plane P1 is the plane of the page, so straight portion 252 and first curved portion 260 are shown in cross section, while second curved portion 262 and third curved portion 264 are not shown in cross section because they are outside of plane P1, except where third curved portion 264 intersects plane P1 at intersection 278. Fig.10 As shown, the first curved portion 260 and the second curved portion 262 define a composite curve when projected onto the plane P1. Unlike the above-described embodiments, the third curved portion 264 does not have a curvature opposite to the composite curve of the first curved portion 260 and the second curved portion 262, but rather generally curves back toward the first curved portion 260 when projected onto the plane P1, continuing the composite curve.

[0090] like Fig.10As further shown, the catheter 250 forms a lumen 272 extending from a proximal end 274 of the straight portion 252 to an opening 256 at a distal end 258 of the hook 254. In some embodiments, the diameter D of the lumen 272 can be as small as 1 French unit (Fr), 2Fr, 3Fr, 4Fr, 5Fr or 6Fr, or as large as 7Fr, 8Fr, 9Fr, 10Fr, 11Fr or 12Fr, or any value between any two of the above values ​​(such as, for example, 1Fr to 12Fr, 2Fr to 11Fr, 3Fr to 10Fr, 4Fr to 9Fr, 5Fr to 8Fr, 6Fr to 7Fr, 6Fr to 9Fr or 7Fr to 9Fr). The portion of the lumen 272 extending through the straight portion 252 defines an axis A. It has been found that when fixation element 24 is an active fixation element as described above, a diameter D of lumen 272 equal to or greater than 6 Fr, such as 6 Fr to 9 Fr, may be required to accommodate lead 14, as such leads tend to have larger diameters.

[0091] In some embodiments, when projected onto plane P l When the first curved portion 260 and the second curved portion 262 are placed on the implant, the radius of curvature along the first curved portion 260 and the second curved portion 262 is greater than 17 mm. It has been found that a radius of curvature along the first curved portion 260 or the second curved portion 262 less than 17 mm may hinder the torque from being applied to the fixation element 24 ( Figure 1 ), especially when the fixing element 24 is an active fixing element as described above. In some embodiments, the radius of curvature along the third curved portion 264 is greater than 10 mm. In some other embodiments, the radius of curvature along the entire hook portion 254 is greater than 17 mm.

[0092] Fig.11 According to some embodiments of the present disclosure, Fig.10 A bottom view of the catheter 250 is shown. Fig.11 As shown, the first curved portion 260 is located in the plane P1. The second curved portion 262 bends away from the plane P1 as it extends from the distal end 268 of the first curved portion 260. The third curved portion 264 bends back toward the plane P1 and intersects the plane P1 at the intersection 278 as it extends from the distal end 270 of the second curved portion 262 and generally toward the first curved portion 260.

[0093] Fig.12 According to some embodiments of the present disclosure, Fig.10 and 11 Another side view of the catheter 250 is shown in FIG. Fig.12 , the catheter 250 is shown around Fig.10 The axis A in the figure is rotated 90 degrees. Fig.12As shown, the straight portion 252 and the first curved portion 260 lie in a plane P1 , the second curved portion 262 curves away from the plane P1 , and the third curved portion 264 curves back through the plane P1 to intersect the plane P1 at an intersection 278 .

[0094] A system for delivering a medical electrical lead to the His bundle 34 within the right atrium 26 may include a catheter 250 according to any of the above embodiments, and a lead 14 configured to pass through a lumen 272 of the catheter 250. In some embodiments, the lead 14 may include a fixation element 24. In some embodiments, as described above, the fixation element 24 is an active fixation element.

[0095] Taking into account Figure 1 and Figure 10-12 , a method of implanting a lead 14 to stimulate the His bundle 34 may include introducing a catheter 250 transvascularly through the superior vena cava 36 and into the right atrium 26 of the heart 16, the hook 254 of the catheter 250 being configured such that when the distal end 258 is in contact with tissue at a target site, an opening 256 at the distal end 258 of the hook 254 is disposed perpendicular to a portion of the atrioventricular septum 28 adjacent to the His bundle 34. A fixation element 24 on the distal end 22 of the lead 14 may extend from the opening 256. Tissue at a target site along the atrioventricular septum 28 may be located. When the fixation element 24 is deployed in tissue at a target site to implant the lead 14 in contact with the His bundle 34, the curvature of the hook 254 combined with the elasticity of the catheter 250 may force the distal end 258 against the tissue and provide a more stable deployment of the fixation element 24. The catheter 250 may be removed from over the lead 14.

[0096] Various modifications and additions may be made to the discussed embodiments without departing from the scope of the present disclosure. For example, although the above-described embodiments relate to specific features, the scope of the present disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Therefore, the scope of the present disclosure is intended to cover all such substitutions, modifications and variations and all equivalent forms thereof that fall within the scope of the claims.

Claims

1. A catheter for delivering a medical electrical lead to the atrioventricular septum of a heart, the catheter comprising: a straight portion having a proximal end and a distal end; and A hook-shaped portion protruding from a distal end of the straight portion, the hook-shaped portion comprising: a first curved portion, the straight portion and the first curved portion defining a plane, the first curved portion having a radius of curvature greater than 17 mm; a second curved portion extending from a distal end of the first curved portion, the second curved portion being curved away from the plane, the curvature radius of the second curved portion being greater than 17 mm; and a third curved portion extending from a distal end of the second curved portion, the third curved portion being curved toward the plane, The catheter forms an inner lumen extending from the proximal end of the straight portion to an opening at the distal end of the third curved portion, the inner lumen having a diameter of 6 Fr to 9 Fr, and The catheter is configured to be introduced into the heart via a blood vessel so that the opening at the distal end of the third portion is disposed perpendicular to a portion of the atrioventricular septum of the heart.

2. The catheter according to claim 1, wherein The first curved portion and the second curved portion define a compound curve when projected onto the plane, and the third curved portion has a curvature opposite to the compound curve when projected onto the plane.

3. The catheter according to claim 1, wherein The catheter is configured to be introduced transvascularly into the heart, extend down the side wall of the superior vena cava, and cross the right atrium so that the opening at the distal end of the hook is disposed perpendicular to a portion of the atrioventricular septum adjacent the bundle of His.

4. The catheter according to claim 3, wherein: The first bent portion includes a bottom portion of the hook.

5. The catheter according to claim 3, wherein: The first curved portion extends from a distal end of the straight portion.

6. The catheter according to claim 1, wherein The length of the first curved portion is greater than the length of the second curved portion.

7. The catheter according to claim 1, wherein: The catheter is configured to be introduced into the heart through a blood vessel, extend downward along the right side wall of the right atrium toward the bottom surface of the right atrium, and extend the anteromedial side away from the bottom surface of the right atrium so that the opening at the distal end of the hook is arranged perpendicular to the portion of the atrioventricular septum adjacent to the His bundle.

8. The catheter according to claim 7, wherein The second curved portion includes a bottom portion of the hook.

9. The catheter according to claim 7 further includes a fourth curved portion extending from a distal end of the straight portion, the first curved portion extending from a distal end of the fourth curved portion, the fourth curved portion being coplanar with the first curved portion and the fourth curved portion having a curvature opposite to that of the first curved portion when projected onto the plane.

10. The catheter according to claim 7, wherein: The length of the second curved portion is greater than the length of the first curved portion.

11. The catheter according to claim 1, wherein The first curved portion, the second curved portion, and the third curved portion define a compound curve when projected onto the plane, the third curved portion extending toward the first curved portion and crossing the plane.

12. The catheter of claim 1, wherein: The radius of curvature of the hook portion is greater than 17 mm.

13. A medical system, comprising: A catheter according to any one of claims 1 to 12; and The medical electrical lead is configured to pass through the lumen.

14. The medical system according to claim 13, wherein: The medical electrical lead includes an active fixation element.

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