Devices, systems, and methods for lead delivery

Abstract

Devices, systems, and methods are provided for delivering a lead or other secondary / device into a patient's heart that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinear shape in a relaxed state including a proximal section and a curved distal section extending distally from the proximal section to the distal end and lying with a first plane, a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve within a second plane that is non-parallel to the first plane.

Description

DEVICES, SYSTEMS, AND METHODS FOR LEAD DELIVERY RELATED APPLICATION DATA

[0001] The present application claims benefit and priority to co-pending U.S. provisional applications Serial Nos. 63 / 620,057 and 63 / 620,064, both filed January 11, 2024, the entire disclosures of which are expressly incorporated by reference herein. The present application is also related to U.S. application Serial No. 16 / 458,034, filed June 29, 2019, the entire disclosure of which is expressly incorporated by reference herein. TECHNICAL FIELD

[0002] The present application relates generally to medical devices, systems, and methods for delivering devices into a patient’s body, e.g., into a patient’s heart, and, more particularly, to sheaths, catheters, and other tubular devices for accessing a patient’s heart and delivering leads for placement against the heart wall, e.g., in the Left Bundle Branch (LBB) or adjacent the His bundle or fast conduction system of the heart, and to systems and methods including such tubular devices. BACKGROUND

[0003] The current standard of care / state of the art for delivery of screw-based implantable cardiac pacing leads (whether retractable or fixed) to site specific locations is through families of pre-shaped curves. These devices are simple and with some understanding of the patient’s anatomy can result in reduced need to exchange for another device of a more advantageous shape for the particular patient and / or anatomy. Such an exchange is highly undesirable as it adds device cost and procedure time and some additional risk to the patient.

[0004] A few products exist that attempt to add features to modulate the shape of the system to reduce and / or eliminate the need for such exchange. These products have generally been unsuccessful in the market both because of poor performance as well as for additional expense. Therefore, a device that can eliminate the risk and cost of exchange in a simple low cost way would be useful.

[0005] Particularly, for example, in Left Bundle Branch (LBB) lead delivery, the target spot where the ideal conduction system access covers a large range of the right ventricular septum, the best electrical location may be more inferior or apical or more superior and / or basal. The specific patient anatomy as seen under fluoroscopy may givesome indication of the preferred shape; however, ideal implantations sites from an electrical / conduction system perspective are variable and not widely conserved among patients. While some degree of sweeping inferiorly or superiorly and / or basally and apically can be finessed in state of the art systems by a combination of advancement and retraction and to a less extent torquing of the shaft, this ultimately covers a small percentage of ideal target sites in any given patient as well as being fully inadequate to cover ideal target sites amongst all patients whether the heart is large or small, dilated or normal, twisted, etc.

[0006] Therefore, improved devices and methods for delivering leads would be useful. SUMMARY

[0007] The present application relates generally to medical devices. For example, devices, systems, and methods are provided for delivering devices into a patient’s body, e.g., into a patient’s heart. More particularly, the present application relates to sheaths, catheters, and other tubular devices for accessing a patient’s heart and delivering leads for placement against the heart wall, e.g., in the Left Bundle Branch (LBB) or adjacent the His bundle or fast conduction system of the heart, and to systems and methods including such tubular devices.

[0008] In one example, a pre-shaped catheter or delivery device is provided including a primary or proximal curve and a secondary or distal curve. In a particular example for LBB lead implantation, the primary curve is configured to provide a general vector into the left ventricle of a patient’s heart and the secondary curve redirects back to the septum (e.g., orthogonally or otherwise out-of-plane with the primary curve).

[0009] In one example, the natural / unmodified primary curve generally locates the exit point of the delivery device inferiorly (e.g., in the direction of the descending inferior vena cava), and likely more inferior than is likely to be desired. Position in the basal / apical axis is then at least partially controlled through advancement and retraction of the delivery device. Thus, the only remaining axis needed for finding and delivering the lead to the ideal spot is “sweeping” inferior to superior (in conjunction with aforementioned apical / basal manipulation). This is accomplished by incorporation of an actuator that is configured to modulate the primary curve.

[0010] In one specific example where a pull actuator is used, a pull wire is located within a lumen extending primarily along an inside edge of the primary curve and then attached between the primary and secondary curves. Thus, actuation of the pull actuator causes the sweeping motion to occur as the primary curve radius is decreased. In another example, the pull wire lumen may include non-straight, e.g., partially helical, pathways so that, while actuation still primarily modulates the primary curve, it may also modulate the planar offset between the primary and secondary curves. This planar offset (which redirects the tip of the delivery device towards the septum for ideally orthogonal approach) may be useful as the septum, especially in heart failure patients with LV dilation, may become more convex; thus, as the device is swept superiorly, the ideal offset angle becomes more inferior. The helical incorporation may accomplish this action automatically, since, as the tip sweeps superiorly, it modulates the planar offset more inferiorly.

[0011] Optionally, in any of the examples described herein, the pull wire may be provided within a pull wire lumen that is braid-embedded along at least the deflectable or steerable distal portion. In addition or alternatively, the pull wire lumen may be located fully inside or outside reinforcement members, e.g., of a braid reinforcement layer of the device, along at least a portion of the delivery device. For example, the pull wire lumen may transition into a neutral position within the device proximal to the deflectable distal portion.

[0012] In accordance with one example, a device is provided for delivering a lead or other secondary device into a patient’s heart that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient’s body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinear shape in a relaxed state including a proximal section and a curved distal section extending distally from the proximal section to the distal end and lying with a first plane; a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve within a second plane that is non-parallel to the first plane.

[0013] In accordance with another example, a device is provided for delivering a lead or other secondary device into a patient’s heart that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient’s body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinearshape in a relaxed state including a curved proximal section and a curved distal section extending distally from the proximal section to the distal end, the distal section lying with a first plane and the proximal section lying with a second plane that is non- parallel to the first plane; a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve further. The steering element may be slidably received within a secondary lumen, which may extend along the proximal section along one along one side of the proximal section that lies with the second plane, or may extend helically along the proximal section.

[0014] In accordance with still another example, a system is provided for delivering a lead or other secondary device into a patient’s heart that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient’s body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinear shape in a relaxed state including a proximal section and a curved distal section extending distally from the proximal section to the distal end and lying with a first plane; a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve within a second plane that is non-parallel to the first plane. The system also includes a lead comprising a distal portion sized for introduction through the lumen of the delivery device and a fixation element on the distal portion for securing the distal portion to a wall of the patient’s heart.

[0015] In accordance with yet another example, a method is provided for delivering a lead or other secondary device into a patient’s heart that includes introducing a distal end of a tubular member into a right atrium of the patient’s heart; deploying a distal portion in a curvilinear shape state including a proximal section and a curved distal section extending from the proximal section to the distal end and lying within a first plane; and actuating an actuator to cause the proximal section to curve within a second plane that is non-parallel to the first plane, thereby sweeping the distal end within the right atrium. Once the distal end is placed against a wall of the right atrium at a target location, a distal end of an implantable device may be introduced through a lumen of the tubular member, and the distal end of the implantable device may be secured to the wall at the target location, whereupon the tubular member may be removed while leaving the implantable device..

[0016] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0018] FIG. 1 is a perspective view of a delivery catheter or device including a distal portion including a curved proximal section and a curved distal section, with a pull wire extending along the proximal section.

[0019] FIGS. 1A-1C show optional features that may be provided on an actuator for actuating a pull wire of a delivery device, such as the device shown in FIG. 1.

[0020] FIGS. 2A and 2B show the distal portion of the delivery device of FIG. 1 showing movement of the proximal curved section (in phantom), when the pull wire is actuated, to modulate the curve of the proximal section and sweep the distal curved section and distal tip of the delivery device.

[0021] FIG. 3 is a cross-sectional view of a heart showing the distal portion of the delivery device of FIG. 1 positioned with the right atrium, and sweeping the distal tip by modulating the curve of the proximal section.

[0022] FIG. 4 shows a distal portion of another example of a delivery catheter or device including a pull wire within a pull wire lumen that extends helically along a proximal section of the distal portion.

[0023] FIG. 4A is a detail showing attachment of the pull wire of the delivery device of FIG. 4, e.g., at a transition between the proximal and distal sections of the distal portion.

[0024] FIGS. 5A and 5B show exemplary anchoring rings that may be provided at a transition between proximal and distal sections of a steerable distal portion to which a pull wire may be attached.

[0025] FIGS. 6A-6H shown examples of a distal end that may be provided on a pull wire to provide an integral anchor for securing the distal end within a distal portion of a delivery device.

[0026] FIGS. 7A-7C shown an optional tip reducing mechanism that may be provided on a distal tip of a delivery device.

[0027] FIGS. 8A and 8B are perspective and side views, respectively, of an exemplary handle or hub and actuator that may be included on any of the delivery devices herein.

[0028] FIGS. 9A and 9B are perspective and side views, respectively, of another exemplary handle or hub and actuator that may be included on any of the delivery devices herein.

[0029] FIGS. 10A and 10B are perspective and side views, respectively, of still another exemplary handle or hub and actuator that may be included on any of the delivery devices herein.

[0030] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0031] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0032] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0033] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smallerrange between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0034] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0035] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0036] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0037] Turning to the drawings, FIG. 1 shows an example of a delivery device or catheter 10 for delivering a lead, implant, or other secondary device (not shown) into a patient’s body, e.g., into a patient’s heart 90 as shown in FIG. 3. Generally, the device 10 includes an elongate tubular body or shaft 11 including a proximal end 12 carrying a handle or hub 30, a distal end 14 sized for introduction into a body lumen and terminating in a distal tip 15, and a primary lumen 16a extending between the proximal and distal ends 12, 14, e.g., generally along a longitudinal axis 18 to an outlet 19 in the distal tip 15. The primary lumen 16a may be sized for receiving a cardiac lead, pacing device, or othersecondary device (not shown), e.g., intended for implantation within the heart 90, as described further elsewhere herein.

[0038] A port 32 may be provided on the handle or hub 30, which may communicate with the primary lumen 16a, e.g., to allow insertion of a secondary device into the primary lumen 16a. In addition, one or more valves or seals, e.g., a hemostatic valve (not shown) may be provided adjacent the port 32 or otherwise within the handle or hub 30, which may provide a substantially fluid-tight seal, while accommodating insertion of one or more devices, e.g., a pacing lead, into the lumen 16a. Optionally, a side port (not shown) may be provided on the handle or hub 30, e.g., for delivering fluid into and / or aspirating fluid from the primary lumen 161, e.g., around a device inserted into the primary lumen 16a.

[0039] Optionally, the device 10 may include one or more additional lumens (not shown), which may be disposed adjacent the primary lumen 16a, e.g., side-by-side and / or concentrically around the primary lumen 16a at one or more locations along the length of the tubular body 11. For example, as shown in FIG. 1, a secondary or pull wire lumen 16b may be provided that extends from the proximal end 12 at least partially towards the distal end 14, e.g., to receive a pull wire or other steering member 40, which may be actuated to modulate the shape of the tubular body 11, as described further elsewhere herein.

[0040] The tubular body 11 may be constructed from one or more layers, e.g., an inner liner surrounding the primary lumen 16a, a reinforcing layer surrounding the inner liner, and an outer layer (not shown). Optionally, one or more coatings (also not shown) may be applied to the inner surface of the inner liner. In one example, a hydrophilic coating, such as Polyvinylpyrrolidone, may be sprayed or otherwise applied onto the surface of the inner liner during fabrication to provide a lubricious inner surface for the lumen 16a of the tubular body 11. The layers of the tubular body 11 may be attached to one another, e.g., by laminating, adhering, adhesive bonding, ultrasonic welding, reflowing or other heating, and the like. Exemplary materials and methods for making the tubular body 11 are disclosed in co-pending applications Serial Nos. 11 / 340,904, filed January 26, 2006, 11 / 670,958, filed February 2, 2007, 12 / 254,818, filed October 20, 2008, and 12 / 551,540, filed August 31, 2009, the entire disclosures of which are expressly incorporated by reference herein.

[0041] The reinforcing layer and / or the material of the outer layer and / or the composite construction of the tubular body 11 may provide desired mechanical propertiesfor the device 10, e.g., to allow the distal end 14 to be advanced, twisted, and / or otherwise manipulated from the proximal end 12, e.g., to rotate the distal end 14 within a patient’s body. Thus, the distal end 14 of the device 10 may be manipulated within a patient’s body from the proximal end 12 without substantial risk of buckling and / or kinking. Optionally, the outer layer at or adjacent the distal end 14 may be substantially flexible or semi-rigid, e.g., to allow the distal portion 22 to bend easily or otherwise be advanced through tortuous anatomy and / or provide a substantially atraumatic distal tip 15.

[0042] In one example, the construction may vary along the length of the device 10 to provide desired properties, e.g., between or within proximal and distal portions 20, 22. For example, the proximal portion 20 of the device 10 adjacent and extending distally from the proximal end 12 may be substantially rigid or semi-rigid, e.g., providing sufficient column strength and / or torque to allow the distal end 14 of the device 10 to be pushed or otherwise manipulated from the proximal end 12, while the distal portion 22 may be relatively or substantially flexible.

[0043] Optionally, the location of the secondary lumen 16b may vary along the length of the tubular body 11, e.g., relative to wires or other reinforcement members of the reinforcement layer. For example, at least partially along the distal portion 22, the secondary lumen 16b may be braid-embedded, e.g., provide in a “tri-axial” position as disclosed in U.S. Patent Nos. 9,427,551, 10,065,015, 10,124,145, and 10,195,395, the entire disclosures of which are expressly incorporated by reference herein. Providing the secondary lumen 16b within a braid-embedded configuration along at least the deflectable section of the distal portion 22 may allow bending forces to be applied to the deflectable section while minimizing risk of the pull wire 40 tearing through the wall of the distal portion 22. The secondary lumen 16b may be directed to a neutral position proximal to the distal portion 22, e.g., to prevent proximal tension on the pull wire 40 from causing the tubular body 11 proximal to the distal portion 22 from bending, e.g., as described in the patents incorporated by reference herein.

[0044] As described further below, the distal portion 22 may have a curvilinear shape configured for introduction and / or manipulation within a patient’s body, e.g., within a right atrium within a patient’s heart and / or other body lumen. For example, as shown in FIG. 1, the distal portion 22 may include multiple curved sections, e.g., a first or proximal section 24 (sometimes referred to as a primary curve) and a second or distal curved section 26 (sometimes referred to as a secondary curve), which may be biased to a predeterminedcurvilinear shape in a relaxed state. The distal portion 22 may be constructed, however, as a single continuous tubular structure, e.g., with a substantially uniform outer diameter or cross-section, although the construction and / or mechanical properties may be variable along the length of the distal portion 22. For example, the proximal and distal sections 24, 26 may have substantially uniform constructions and / or mechanical properties along their respective lengths, with the proximal section 24 being different than the distal section 26.

[0045] In addition, the distal portion 22 may be deflected or deflectable to other shapes to change the curvilinear shape, e.g., to sweep or otherwise manipulate the distal end 14 of the tubular body 11, as described further below. For example, as shown in FIG. 1, the secondary or pull wire lumen 16b may extend at least partially through the tubular body 11, e.g., at least partially through the proximal portion 20 into the distal portion 22, e.g., terminating at a transition between the proximal section 24 and the distal section 26. In the example shown, the secondary lumen 16b extends adjacent the primary lumen 16a substantially parallel to the longitudinal axis 18 along at least the proximal section 24. The secondary lumen 16b may also extend proximally from the distal portion 22, e.g., such that the secondary lumen 16b extends to the proximal portion 20.

[0046] Optionally, a compression-resistant member (not shown) may be provided within the secondary lumen 16b proximal to the distal portion 22, e.g., to prevent bending forces generated by the pull wire 40 from causing the tubular body 11 to bend or deflect proximal to the distal portion 22,similar to those disclosed in U.S. Patent No. 10,195,395. In addition or alternatively, the secondary lumen may transition to a neutral position proximal to the distal portion 22 and / or may be otherwise constructed such bending forces generated by the pull wire 40 from being applied proximal to the distal portion 22.

[0047] As shown in FIG. 1, the pull wire 40 may be slidably received through the secondary lumen 16b, including a proximal end 42 coupled to an actuator 34 on the handle or hub 30 and a distal end 46 axially fixed within the distal portion 22, e.g., at a transition between the proximal and distal sections 24, 26. The pull wire 40 may have any desired cross-section, e.g., a circular or rectangular cross-section. A rectangular cross-section may preserve the profile of the pull wire 40, while optimizing pull strength and / or weld strength when attached to the anchor 48. For example, as shown in FIG. 1, an anchor 48 may be embedded, mounted, or otherwise secured to or within the distal portion 22 at the transition, and the distal end 46 of the pull wire 40 may be attached to the anchor 48, e.g., by one or more of bonding with adhesive, fusing, welding, mating connectors, and the like, therebypreventing movement of the distal end 46 while the pull wire 40 remains slidable within the secondary lumen 16b proximal to the distal end 44. In addition or alternatively, the distal end 46 may be attached to other structures at the transition, e.g., one or wires or other reinforcement members within the wall of the tubular body 11, and / or directly embedded in the wall of the tubular body 11.

[0048] Alternatively, other anchors may be provided at the transition for securing the distal end 46 of the pull wire 40. For example, FIG. 5A shows an enclosed ring 248 that may be embedded or otherwise mounted at the transition. Alternatively, FIG. 5B shows an open or “C” shaped ring 248’ that may be embedded or otherwise mounted at the transition. In one example, the open ring 248’ may have an arc length between about ninety and two hundred seventy degrees (90-270º). The distal end 46 of the pull wire 40 may be permanently attached to the ring 248, 248’, e.g., by one or more of bonding with adhesive, fusing, welding, mechanical connectors, and the like. Optionally, if an enclosed ring 248 is provided, the material may be sufficiently soft to allow the ring to be slit, e.g., if the tubular body 11 is slit to facilitate removing the device 10 after delivering a lead or other implantable device through the primary lumen 16a, as described elsewhere herein. Alternatively, if the open ring 248’ is provided, the gap 249’ may be aligned with a desired slit line along the tubular body 11, e.g., to facilitate slitting the tubular body 11.

[0049] Alternatively, one or more anchors may be provided on the distal end of the pull wire, e.g., integrally formed on or attached to the distal end, e.g., to secure the distal end within or otherwise to a distal portion of a delivery device. For example, FIGS. 6A-6H show optional features that may be provided on a distal end of a pull wire, which may axially fix the distal end with or without attaching to a separate anchor. For example, as shown in FIG. 6A, a distal end 46a is shown that includes a plurality of holes or recesses 47a extending through or into the distal end 46a such that material may be received therein to secure the distal end 46a to the tubular body. For example, during manufacturing the distal end 46a may be positioned at the transition between the proximal and distal sections (e.g., at the location of the anchor 48 shown in FIGS. 1-2B) and the material forming the outer layer of the tubular body may be directed into the holes 47a, e.g., melted or otherwise caused to reflow into the holes 47a, and / or adhesive or other additive material may be introduced into the holes 47a and around the distal end 46a to attach the distal end 46a to the surrounding tubular body, while the pull wire proximal to the distal end 46a remains free to slide within the secondary lumen (not shown).

[0050] In addition or alternatively, as shown in FIG. 6B, one or more scallops, grooves, or other features 47b may be formed around or in the distal end 46b (e.g., shown also with holes 47a), which receive material from the tubular body, adhesive, and / or additive material to anchor the distal end 46b relative to the tubular body. In a further alternative, as shown in FIG. 6C, one or more slots or buttons 47c may be formed in the distal end 46c that may receive material in a similar manner during manufacturing.

[0051] Turning to FIG. 6D, in another alternative, a hook 47d may be formed in the distal end 46d such that tubular body material, adhesive, and / or additive material may be received around and within the hook 47d to anchor the distal end 46d. For example, the distal end 46d may be folded or bent back on itself to provide an enlarged structure that may be embedded within the tubular body and provide a substantial anchor to prevent proximal movement of the distal end 46d. Alternatively, as shown in FIGS. 6E or 6F, the distal end 46e, 46f may be split, e.g., by cutting the distal end 46e, 46f into two tails 47e, 47f. In the example shown in FIG. 6E, each tail 47e also includes a plurality of optional recesses or holes 47a. In the example shown in FIG. 6F, the tails 47f may be formed by cutting the distal end 46f and stretching the resulting tails 47f to provide an expanded anchor for securing the distal end 46f. In yet another alternative, as shown in FIG. 6G, the distal end 46g may be flattened or otherwise deformed, e.g., from a cylindrical or other cross-sectional shape to provide an enlarged tip 47g that may be embedded within the material of the tubular body (and / or secured with adhesive or additive material) such that the enlarged tip 47g prevents the distal end 46g of the pull wire 40g from being pulled from the tubular body, e.g., when proximal tension is applied to the pull wire 40g, similar to the other anchors or features described herein.

[0052] Alternatively, FIG. 6H shows an example of a diamond anchor 47h that may be provided on the distal end 46h of a pull wire, e.g., optionally shown including a plurality of holes or recesses therein. The diamond anchor 47h may include a short, truncated distal end, which may have reduced stiffness, while not providing a hard kink point. In addition, the anchor 47h may include a longer, tapered proximal end, which may serve as a guiding edge during slitting, e.g., with the tapered shape deflecting the slitter blade away from a pull ring to which the anchor may be attached.

[0053] Returning to FIG. 1 and with additional reference to FIGS. 2A and 2B, in the example shown, the distal section 26 may curve within a first plane 27 in its relaxed state, e.g., defining a first radius of curvature R1 and arc length L1, as best seen in FIG. 2B. Forexample, the distal section 26 may have a radius of curvature R1 between about eight and fifteen millimeters (8-15 mm), and may curve along an arc length L1 of at least ninety degrees (90º) or between about ninety and one hundred thirty degrees (90-130º).

[0054] The distal section 26 may be sufficiently flexible to allow the distal section 26 to be straightened, e.g., when introduced into a delivery sheath or other device (not shown), yet may be resiliently biased to return towards the curved shape, e.g., by shape- setting the desired curved shape into the distal section material. For example, as shown in FIG. 3, when the distal portion 22 is deployed within a chamber within a patient’s heart 90, e.g., the right atrium 92, from a delivery sheath 8, the distal section 26 may resiliently adopt the curved shape shown, while being sufficiently flexible to allow manipulation of the distal end 14 relative to anatomical structures, such as the septum. Optionally, the reinforcement layer may be omitted along the distal section 26,e.g., if desired to provide additional flexibility.

[0055] With particular reference to FIG. 2A, the proximal section 24 may also have a curved shape in the relaxed state, e.g., having a radius of curvature R2 lying with a second plane 25. For example, the proximal section 24 may have a curved shape defining a radius of curvature R1 between about ten and thirty millimeters (10-30 mm), and may curve along an arc length L2 less than ninety degrees (90º), e.g., between about twenty and one hundred ten degrees (20-110º). In this example, the secondary lumen 16b may extend along an inside edge of the proximal section 24 adjacent the primary lumen 16a (not shown in FIG. 2A), i.e., such that the secondary lumen 16b lies within the second plane 25 adjacent the primary lumen 16a. Thus, when the pull wire 40 is actuated, the proximal tension may apply a bending force to the proximal section 24, causing the proximal section 24 to curve further within the second plane 25, e.g., as shown in phantom in FIG. 2A.

[0056] In the example shown in FIGS. 2A and 2B, the second plane 25 is non- parallel to the first plane 27, e.g., such that the planes 25, 27 are orthogonal to one another. In one particular example, the second plane 25 may be substantially perpendicular to the first plane 26, while intersecting one another at an acute angle. For example, as shown in FIGS. 2A-2B, the proximal section 24 may lie within the second plane 25 (parallel to the surface shown in FIG. 2A), and curve to the right along the arc length L2, whereupon the distal section 24 may curve upwardly out of the second plane 25 within the first plane 27and along the arc length L1 (parallel to the surface shown in FIG. 2B).

[0057] Alternatively, the proximal section 24 may be substantially straight in the relaxed state (not shown), while curving within the second plane 25 when actuated, while the distal section 26 has a curved shape in the relaxed state. Again, the second plane 25 is non-parallel, e.g., orthogonal, to the first plane 27 when the proximal section 24 is actuated to curve within the second plane 25.

[0058] In a further alternative, FIG.4 shows another example of a distal portion 122 that may be provided on a delivery device (with other components, e.g., the proximal portion, handle or hub, etc., not shown, being similar to any of the other devices herein). Similar to the distal portion 22 shown in FIGS. 2A and 2B, the distal portion 122 includes a proximal section 124 and a curved distal section 126, with the distal section 126 lying within a first plane 127 that is non-parallel to a second plane 125 within which the proximal section 124 lies. The proximal section 124 may be curved within a second plane in its relaxed state or, alternatively, may be substantially straight or have a three dimensional curved shape. In this example, a secondary or pull wire lumen 116b extends helically along the proximal section 124.

[0059] As best seen in FIG. 4A, a pull wire 140 is slidably received within the secondary lumen 116b with a distal end 146 of the pull wire 140 coupled to an anchor 148 (and / or otherwise secured) at a transition between the proximal and distal sections 124, 126. Consequently, when the pull wire 140 is pulled or otherwise actuated, e.g., from an actuator on a handle or hub (not shown, but similar to other examples herein), the proximal section 124 may be curved further from the relaxed state. However, due to the helical shape of the secondary lumen 116b, the proximal section 124 may bend out of the second plane 125, e.g., into a more complicated curvilinear shape than a simple, planar curve. Optionally, the pitch and / or other shape of the secondary lumen 116b may be uniform or variable along the length of the proximal section 124 and / or may be oriented clockwise or counterclockwise (e.g., distally down the length of the proximal section 124) around the primary lumen (not shown), depending on the desired curved shape. In addition, the secondary lumen 116b may include one or multiple windings around the primary lumen along the proximal section 124. For example, the secondary lumen 116b shown in FIGS. 4 and 4A has a uniform counterclockwise helical pitch that includes one and a half windings along the length of the proximal section 124.

[0060] Optionally, one or more stiffness segments may be provided in the proximal section 124, if desired. For example, the stiffness segment(s) may configure the proximalsection 124 to be mildly left-handed when subjected to minimal deflection by the pull wire 140 and may be come more significantly left-handed under more extensive deflection. This example may facilitate positioning the distal end 114 in both superior and inferior positions along a target line when the pull wire 140 is actuated.

[0061] Returning to FIG. 1, an exemplary actuator 34 is shown that is movable relative to the handle or hub 30 to pull the proximal end 42 of the pull wire proximally to apply a proximal tension to the pull wire 40 and, consequently, apply a bending moment to the proximal section 24 of the tubular body 11. In the example shown, the actuator 34 is a slider that is movable along the handle or hub 30, e.g., between a first or distal position, e.g., in which no or little tension is applied to the pull wire 40, and a second or proximal position.

[0062] The actuator 34 may be freely movable between the first and second positions or may be biased to a desired position, e.g., to the first position such that the actuator 34 may be activated to curve the proximal section 24 and, when the actuator 34 is released, the proximal section 24 resiliently returns towards its relaxed state.

[0063] Optionally, the actuator 34 may include one more additional features to control and / or limit movement between the first and second positions. For example, as shown in FIG. 1, the actuator 34 may include a vector redirect element 35. FIGS.1A-1C are cross-sectional views of other features that may be included as part of the actuator, which may facilitate “sweeping” the distal end 14 of the device 10 when the actuator is manipulated. For example, FIG.1A shows an example of an active- brake mechanism that may be included within the handle 30a. The actuator may be coupled to a carriage 36a slidable within the handle 30a to which the proximal end of the pull wire (not shown) may be attached such that actuation of the actuator causes the carriage 36a to slide axially within the handle 30a. A brake lock 37a may be provided that prevents axial movement of the carriage 36a until released or until a predetermined threshold is exceeded, e.g., such that the actuator holds the distal section 22 at a shape when the actuator is released at any desired position. Alternative, as shown in FIG.1B, an infinitely variable sliding mechanism may be provided that relies on natural friction, e.g., using an O-ring 38b. In another alternative shown in FIG. 1C, the carriage 36c may include aa ratchet or quantized mechanism, which may be easily operated in both superior sweeping or inferior dropping / relaxing.

[0064] Turning to FIGS. 8A and 8B, another example of a handle or hub 230 is shown that may be provided on the proximal end of a tubular body of any of the delivery devices herein. The hub 230 may include a distal end 230a configured to be attached to the proximal end of a delivery device (not shown), e.g., by one or more of cooperating threads or connectors, interference fit, bonding with adhesive, fusing, sonic welding, and the like. The handle or hub 230 includes an actuator 234 that may be coupled to the proximal end 242 of a pull wire 240, which may then extend through the distal end 230a, e.g., into a secondary lumen of the tubular body attached to the distal end 230a. In the example shown, the actuator 234 includes a slider that is movable axially along a shaft 236 extending from the hub 230, thereby pulling the pull wire 240 proximally.

[0065] Alternatively, in the example shown in FIGS. 9A and 9B, the actuator on the handle or hub 330 includes a lever 334 that is pivotably mounted on the hub 330 such that the lever 234 may be pulled, causing the lever 334 to rotate, thereby pulling the pull wire 340 proximally. In another alternative shown in FIGS. 10A and 10B, the actuator 430 on the handle or hub 430 includes a rotating cylinder mounted on a shaft 436 extending from the hub 430 such that, rotation of the cylinder causes the cylinder to move helically up the shaft 436, thereby pulling the pull wire 440 proximally.

[0066] Turning to FIG. 3, the delivery devices herein, e.g., the device 10 shown in FIG. 1, may be used to introduce and place a lead or other implant (not shown) within a patient’s heart 90. For example, initially, the distal portion 22 of the device 10 may be introduced into the patient’s vasculature, e.g., from a percutaneous or other peripheral access site over a guidewire or other rail (not shown) and / or through a delivery sheath 8, and introduced into the heart 90. For example, as shown, a delivery sheath 8 may be introduced into the patient’s venous system and advanced through the superior vena cava 94 into the right atrium 92.

[0067] The distal portion 22 of the device 10 may then be introduced through a lumen of the delivery sheath 8 and advanced until the distal section 26 and then the proximal section 24 are deployed within the right atrium 92. With the distal portion 22 exposed within the atrium 92, the proximal and distal sections 24, 26 may resiliently attempt to adopt the shapes of their relaxed states. For example, in the orientation shown in FIG. 3, the proximal section 24 may curve slightly within the second plane and the distal section 26 may curve within the first plane out of the second plane, thereby placing thedistal end 14 of the device 10 against a wall of the right atrium 92, e.g., against the right ventricle septum (not shown).

[0068] The actuator (not shown) may be manipulated to cause the proximal section 24 to curve further, e.g., as shown in phantom, thereby causing the distal section 26 and the distal end 14 of the device 10 to sweep along the wall of the right atrium 92, e.g., to direct the distal end 14 along the right ventricle septum. In particular, the device 10 may be constructed such that the sweeping action is generally in the axis from the apex of the heart 90 to the base, such that causing the proximal section 24 to curve further may generally move the distal tip 15 of the device 10 away from the apex and toward the base, further without moving the distal tip 15 of the device 10 off of the septal wall or driving the tip into the septal wall. For example, this action may be accomplished by torquing the device 10, and motion in the anterior posterior plane, e.g., from the anterior wall of the heart 90 to the posterior wall of the heart 90 along the septum can be accomplished by advancing or retracting the device 10. In general, relatively small movement, e.g., adjusting the deflection angle by about ten to thirty degrees (10-30º) and / or moving the device tip 15 by about three to ten millimeters (3-10 mm) with precision may be useful, e.g., to locate and deliver a lead to the position of optimal capture of the conduction system, e.g., at the left bundle branch.

[0069] This motion may be performed alone or along with moving the device 10, e.g., axially and / or rotationally, to position the distal end 14 as desired. Once the distal end 14 is positioned at a desired target location, e.g., adjacent the Left Bundle Branch (LBB) or His bundle (not shown), the lead or other implantable device (not shown) may be introduced through the primary lumen 16a and secured at the target location, similar to conventional lead delivery systems.

[0070] For example, with the distal tip 15 placed against the septum overlying the His bundle or LBB, a lead may be introduced through the primary lumen 16a until a distal thereof exits the outlet 19 and contacts the septum. Optionally, the lead may include one or more fixation elements, e.g., a screw tip (not shown) that may be threaded into the septum to secure the lead.

[0071] Once the lead is secured, the device 10 may be removed, e.g., by slitting the hub 30 and tubular body 11, e.g., using tools and methods known in the art. If the device 10 includes an enclosed ring 248 for securing the distal end 46 of the pull wire 40 within the distal portion 22, e.g., as shown in FIG. 5A, the ring 248 may be sufficiently soft (e.g.,through material selection, level of annealing, etc.) such that the ring 248 may be easily slit or cut, e.g., as a slitter or other cutting tool is directed from the hub 30 distally along the tubular body 11 from the proximal end 12, through the proximal and distal portions 20, 22 to the distal end 14.

[0072] Alternatively, if a partial ring 248’ is provided, e.g., as shown in FIG. 5B, a guide or other indicator may be provided on the hub 30, e.g., such that distal advancement of the slitter or other tool passes through the gap 249’ when the slitter encounters the ring 248’ within the distal portion 22. If the distal end 46 of the pull wire 40 is embedded or otherwise secured directly in the wall of the tubular body11, optionally, the distal end 46 may have a shape to facilitate sitting the tubular body 11 along the transition where the distal end 46 is secured. For example, FIG. 6H shows a diamond-shaped anchor 47h that may include a tapered proximal shape. Thus, if a slitter encounters the anchor 47h, the tapered proximal shape may provide a guiding edge to direct the slitter around the anchor 47h while the tubular body 11 is being slit.

[0073] Optionally, in any of the delivery devices herein, one or more markers may be provided on the tubular body 11, e.g., to identify the proximal and / or distal sections 24, 26 and / or transition between them and / or the distal tip 15. In one example, two or more split distal marker bands may be provided with a known spacing, e.g., about one millimeter (1 mm) between adjacent radiopaque bands, which may be identified to gauge normality to the implantation site. For example, if fluoroscopy or other external imaging is aligned to be in plane with the septum in the area of likely desired implantation, then the two marker bands, when ideally positioned orthogonally, will show a clear separation between them. However any significant angular offset (other than normal to the septum) the marker bands will not be clearly separated and may even overlap.

[0074] Also optionally, any of the delivery devices herein may include a self-closing and / or tapered distal tip 515, e.g., as shown in FIGS. 7A-7C. The tip 515 may provide a rounded, soft surface for the delivery device, which may eliminate the need for a dilator (which adds cost and complexity and additional time). Although some physicians use current delivery systems without dilators, this method is shunned by most physicians as the tips of these devices are widely agreed to be insufficiently atraumatic for such use. To address these concerns, the tip 515 may be formed from a highly elastomeric material such as 25 or 35D PEBAX, urethane, and the like. Optionally, such tips may also take advantageof previously disclosed coated liner elements to ensure that, in spite of the collapsed tip, elements such as leads may still easily pass through the outlet 519 of the tip 515.

[0075] Optionally, any of the delivery devices herein may a tip including conductivity properties such that sensing elements on the lead may be bridged (with resistance much lower than the saline / blood they must otherwise go through when the lead is retracted) to the tip of the lead delivery system such that the lead delivery system tip transfers the electrical signals of the tissue to the lead as if the lead were at the tip. This may be useful as leads used in such cases typically include screws that should not protrude from the delivery device during navigation and should be retracted to a safe distance that is difficult to control.

[0076] For example, conductive elements may be added to the liner of the tubular body adjacent the distal tip, or conductive elements may be added to the greater tip (with or without liner). Alternatively, one or more electrodes may be added, or alternatively the internal braid of the tubular body may be bridged along a partial or full length of the tubular body, which may be may reconnected electrically with the conductive tip or conductive liner. In another alternative, a conductive element may separately be introduced through the device that is electrically conductive, e.g., a wire, temporary pacing wire, stylet, and the like, may be used to probe the voltage at the target implantation depth. Optionally, such voltage sensing elements and / or electrodes may also be used to infer or determine tissue contact.

[0077] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

WE CLAIM:

1. A device for delivering a lead or other secondary device into a patient’s heart, comprising: an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient’s body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinear shape in a relaxed state including a proximal section and a curved distal section extending distally from the proximal section to the distal end and lying with a first plane; a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve within a second plane that is non-parallel to the first plane.

2. The device of claim 1, wherein the proximal section is curved within the second plane in the relaxed state and wherein the activation of the actuator causes the proximal section to curve further within the second plane.

3. The device of claim 2, wherein the proximal section defines a first radius of curvature in the relaxed state and wherein the activation of the actuator causes the proximal section to curve to one or more radii of curvature smaller than the first radius of curvature.

4. The device of claim 2, wherein the second plane is orthogonal to the first plane.

5. The device of claim 2, wherein the second plane is substantially perpendicular to the first plane.

6. The device of claim 1, wherein the distal end terminates at a distal tip configured for placement against a wall of the patient’s heart such that an outlet communicating with the primary lumen is positionable against the wall.

7. The device of claim 1, wherein the steerable element comprises a pull wire slidably received within a secondary lumen that extends proximally from the transition through the proximal section.

8. The device of claim 7, wherein the secondary lumen extends along one side of the proximal section that lies with the second plane.

9. The device of claim 7, wherein the secondary lumen transitions within the tubular member proximal to the proximal section.

10. The device of any preceding claim, wherein the actuator is coupled to the steering element and movable from a first position to a second position, the proximal section defining a smaller radius of curvature within the second plane with the actuator in the second position than in the first position.

11. The device of claim 10, wherein the actuator is biased to the first position.

12. The device of claim 10, wherein the proximal section is curved within the second plane in the first position.

13. The device of claim 10, wherein the actuator comprises a slider or a lever on a handle or hub carried on the proximal end.

14. The device of any one of claims 1-9, wherein the steering element is braid- embedded within the proximal section.

15. The device of any one of claims 1-9, wherein the steering element transitions to a neutral position proximal to the distal portion to prevent bending forces applied by the steering element from bending the tubular member proximal to the distal portion.

16. The device of any one of claims 1-9, further comprising a self-closing distal tip on the distal end to provide an atraumatic distal tip for the tubular member whileallowing one or more devices to be introduced through the distal tip from the primary lumen.

17. The device of any one of claims 1-9, further comprising an anchor secured within the tubular member at the transition and wherein a distal end of the steering element is attached to the anchor.

18. The device of claim 17, wherein the anchor comprises an enclosed ring embedded in the tubular member at the transition.

19. The device of claim 17, wherein the anchor comprises an open ring embedded in the tubular member at the transition including a gap to facilitate slitting the tubular member.

20. The device of any one of claims 1-9, wherein a distal end of the steering element comprises an anchor for axially fixing the distal end at the transition.

21. A device for delivering a lead or other secondary device into a patient’s heart, comprising: an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient’s body, a primary lumen extending therebetween, and a flexible distal portion defining a curvilinear shape in a relaxed state including a curved proximal section and a curved distal section extending distally from the proximal section to the distal end, the distal section lying with a first plane and the proximal section lying with a second plane that is non- parallel to the first plane; a steering element extending through the tubular member from the proximal end to a transition between the proximal section and the distal section; and an actuator on the proximal end coupled to the steering element activatable to cause the proximal section to curve further.

22. The device of claim 21, wherein the activation of the actuator causes the proximal section to curve further within the second plane.

23. The device of claim 22, wherein the proximal section defines a first radius of curvature in the relaxed state and wherein the activation of the actuator causes the proximal section to curve to one or more radii of curvature smaller than the first radius of curvature.

24. The device of any one of claims 21-23, wherein the steerable element comprises a pull wire slidably received within a secondary lumen that extends proximally from the transition through the proximal section.

25. The device of claim 24, wherein the secondary lumen extends along one side of the proximal section that lies with the second plane.

26. The device of claim 24, wherein the secondary lumen extends helically through the proximal section.

27. The device of any one of claims 21-23, wherein the second plane is orthogonal to the first plane.

28. The device of claim 24, wherein the secondary lumen transitions within the tubular member proximal to the proximal section.

29. The device of any one of claims 21-23, further comprising a self-closing distal tip on the distal end to provide an atraumatic distal tip for the tubular member while allowing one or more devices to be introduced through the distal tip from the primary lumen.

30. The device of any one of claims 21-23, further comprising an anchor secured within the tubular member at the transition and wherein a distal end of the steering element is attached to the anchor.

31. The device of claim 30, wherein the anchor comprises one or more holes, recesses, scallops, or slots in the distal end of the steering element to receive material to secure the distal end to the tubular member.

32. The device of claim 30, wherein the anchor comprises a hook formed on the distal end of the steering element.

33. The device of claim 30, wherein the anchor comprises a split tail formed on the distal end of the steering element.

34. The device of claim 30, wherein the anchor comprises a flattened head formed on the distal end of the steering element.

35. A system for delivering a lead or other secondary device into a patient’s heart, comprising: a delivery device according to any one of claims 1-9 and 21-23; and a lead comprising a distal portion sized for introduction through the lumen of the delivery device and a fixation element on the distal portion for securing the distal portion to a wall of the patient’s heart.

36. The system of claim 35, wherein the lead comprising one or more sensing elements on the distal portion, and wherein the tubular member comprises one or more conductivity elements on the distal end configured to transfer electrical signals from tissue adjacent the distal end to the one or more sensing elements when the distal portion of the lead is positioned within the distal end of the tubular member.

37. The system of claim 36, wherein the one or more conductivity elements comprise conductive elements on a liner of the tubular member within the primary lumen.

38. The system of claim 36, wherein the one or more conductivity elements comprise conductive elements extending through the distal end of the tubular member.

39. The system of claim 36, wherein the one or more conductivity elements comprise one or more electrodes on the distal end.

40. A method for delivering a lead or other secondary device into a patient’s heart, comprising:introducing a distal end of a tubular member into a right atrium of the patient’s heart; deploying a distal portion in a curvilinear shape state including a proximal section and a curved distal section extending from the proximal section to the distal end and lying within a first plane; actuating an actuator to cause the proximal section to curve within a second plane that is non-parallel to the first plane, thereby sweeping the distal end within the right atrium. once the distal end is placed against a wall of the right atrium at a target location: introducing a distal end of an implantable device through a lumen of the tubular member; securing the distal end of the implantable device to the wall at the target location; and removing the tubular member while leaving the implantable device.

41. The method of claim 40, wherein the proximal section has a curved shape within the second plane when the distal portion is deployed within the right atrium.

42. The method of claim 40, wherein the distal end is positioned against a septum of the heart when the distal portion is deployed.

43. The method of claim 42, wherein the actuator is actuated to position the distal tip adjacent the His bundle and wherein the implantable device is introduced and secured adjacent the His bundle.

44. The method of claim 42, wherein the actuator is actuated to position the distal tip adjacent the Left Bundle Branch (LBB) and wherein the implantable device is introduced and secured adjacent the LBB.

45. The method of claim 40, wherein securing the distal end of the implantable device comprises screwing a fixation element on the distal end of the implantable device into the septum.

Images