Out-of-Plane Deflectable Catheter

Abstract

An example catheter includes a handle assembly having a control member, an elongated body, a pull wire, and at least one radiopaque marker. The elongated body defines a lumen configured to receive a medical electrical lead comprising at least one electrode array. The elongated body includes a proximal portion and a distal portion, the proximal portion being coupled to the handle assembly, the distal portion including an articulation segment and a preformed curved segment. The at least one radiopaque marker is positioned on the distal portion. The pull wire extends from the control member and is anchored to the elongated body distal to the articulation segment, such that actuation of the control member causes the articulation segment to be controllably bend along a first curve in a first geometric plane. The preformed curved segment defines a second curve in a second geometric plane different from the first geometric plane.

Description

Technical Field

[0001] The present disclosure relates to medical devices including an elongated member that can be introduced into a patient's body. Background Art

[0002] Specialized groups of heart cells that form the heart's conduction system control the frequency, conduction pathways, and rate at which action potentials propagate through the heart, which causes the heart to beat in an efficient manner. This specialized conduction system includes the sinoatrial node (SA node), the atrial fasciculus, the atrioventricular node (AV node), the His bundle, and the left and right bundle branches.

[0003] The SA node, located at the junction of the superior vena cava and the right atrium, normally acts as a natural pacemaker that generates action potentials that are conducted through the rest of the heart. When the normal conduction pathway is intact, the action potential generated in the SA node is conducted through the atria and through the interatrial nodal bundle to the AV node. Conduction through the AV node tissue takes longer than through the atrial tissue, resulting in a delay between atrial contraction and the start of ventricular contraction.

[0004] The AV node located in the central fiber body conducts the action potential to the His bundle located above the tricuspid annulus at the top of the ventricular myocardial septum. The His bundle splits into left and right bundle branches, which conduct the action potential to special fibers called "Purkinje fibers". The bundle branches rapidly conduct the action potential along the ventricular septum, where the high-conduction velocity Purkinje fibers activate the contractile myocardium, producing the choreographed natural physiological ventricular activation.

[0005] Conduction abnormalities may cause conduction to slow or be interrupted anywhere along this pathway. For example, the SA node may not generate an action potential fast enough, resulting in a heart rate that is too slow, or bradycardia. AV block may prevent the action potential from being conducted from the atria to the ventricles. Left or right bundle branch block or other conduction abnormalities in the Purkinje fibers or ventricular myocardium may cause the left and right ventricles to contract out of sync. These and other conduction abnormalities can be treated with an external or implanted pacemaker.

[0006] Pacemakers are typically connected to the heart via one or more implantable medical electrical leads, each of which carries one or more electrodes for stimulating the heart and for sensing intrinsic electrical signals associated with the conducted action potential. The electrodes are typically placed on the endocardial surface using a transvenous approach. For example, a right ventricular lead can be advanced into the right ventricle and placed so that the electrode is positioned at or near the right ventricular apex. Low capture thresholds and stable lead positioning have made the right ventricular apex a preferred ventricular stimulation site.

[0007] However, ventricular pacing at the right ventricular apical location does not produce physiological ventricular activation. Both experimental and ambiguous clinical studies have shown that septal pacing can improve various cardiac function parameters compared with apical pacing. Direct myocardial stimulation, as occurs with apical pacing, may result in ventricular myocardial remodeling, including myofiber disorganization and localized hypertrophy distal to the electrodes.

[0008] The most normal physiological way to pace the ventricles when normal AV node conduction fails may be to deliver electrical stimulation pulses directly to the His bundle. Depolarization of the His bundle tissue can normally be conducted through the ventricular conduction pathway, along the left and right bundle branches and reach the rest of the ventricular myocardium. The resulting ventricular contraction, which is faster and results in a narrow QRS complex, and more energetic normal contraction, can produce better coordinated ventricular contractions to achieve efficient cardiac pumping action.

[0009] A medical catheter may be advanced into the patient's vasculature to provide a lumen through which a medical device or therapeutic agent, such as a medical electrical lead, may be introduced to a treatment site. The medical catheter may be advanced to the treatment site by a clinician applying an axial force to a portion of the catheter that is external to the patient's body. Some medical electrical leads may be configured for endocardial introduction into different chambers of a patient's heart, such as the right atrium or right ventricle, using such catheters. Summary of the invention

[0010] In general, the present disclosure relates to: a catheter configured to facilitate identification of a target location for implanting a medical electrical lead and to facilitate implantation of the medical electrical lead at the target location; and a method for using the catheter to identify the target location and implant the medical electrical lead at the target location. As an example, the catheter can facilitate delivery of a medical electrical lead to a target location close to the His bundle for His bundle pacing. The catheter can include a distal portion of at least one electrode array that can be deflected in three dimensions, for example, so that there are curves in two different geometric planes, one or more radiopaque markers are present on each of the geometric planes, and / or in some instances, there is at least one electrode array for mapping the His bundle. At least one radiopaque marker and / or the at least one electrode array can be used to determine a target implant location, such as a target stimulation location. Once the target location is determined, the medical electrical lead can be advanced through the lumen of the catheter to the target location.

[0011] In some instances, a catheter may include a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to accommodate a medical electrical lead comprising at least one electrode, wherein the elongated body includes: a proximal portion connected to the handle assembly and extending along a longitudinal axis; and a distal portion, which may include an articulation segment; and a preformed curve segment located distal to the articulation segment; a pull wire extending from the control member and anchored to the elongated body located distal to the articulation segment; and at least one radiopaque marker, wherein the pull wire is configured to controllably bend the articulation segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane, wherein the at least one radiopaque marker is positioned on the second curve.

[0012] In some examples, a delivery catheter may include: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to receive the medical electrical lead, wherein the elongated body includes: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion, the distal portion may include an articulated segment; and a preformed curved segment, the preformed curved segment being located distal to the articulated segment; a pull wire extending from the control member and anchored to the elongated body located distal to the articulated segment; at least one electrical an electrode array, wherein at least one electrode array is configured to sense electrical signals indicative of a His bundle of a patient's heart; a first radiopaque marker, wherein the first radiopaque marker is located on the articulated segment; and a second radiopaque marker, wherein the second radiopaque marker is located distal to the articulated segment; wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines the second curve in a second geometric plane different from the first geometric plane, and wherein the first geometric plane is offset relative to the second geometric plane in a range of about 40 degrees to about 50 degrees.

[0013] In some examples, a kit may include a catheter, which may include: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, wherein the elongated body includes: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion, which may include an articulated segment; and a preformed curved segment located distal to the articulated segment; a pull wire extending from the control member and anchored to a lumen located distal to the articulated segment. side of the slender body; and at least one radiopaque marker, wherein the at least one radiopaque marker is positioned on the distal portion, wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane; and an implantable element, the implantable element being used for at least one of therapy delivery or sensing, the implantable element being sized for delivery through the lumen and out of the distal end of the slender body.

[0014] In some examples, a method can include advancing a catheter toward a target location in a patient, wherein the catheter includes: at least one electrode array configured to detect electrical signals indicative of a His bundle of the patient's heart; a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen configured to receive a medical electrical lead, wherein the elongated body includes: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion, the distal portion can include an articulated segment; and a preformed curved segment located at the articulated segment. a distal portion of the articulated segment; a pull wire extending from the control member and anchored to the slender body located distal to the articulated segment; and at least one radiopaque marker positioned on the distal portion, wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane, thereby identifying the target location based on detection of the electrical signal by the at least one electrode array; and advancing a medical electrical lead through the lumen and out of the distal end of the slender body to the target location.

[0015] In some instances, a method may include forming an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to accommodate a medical electrical lead comprising at least one electrode, wherein the elongated body comprises: a proximal portion connected to the handle assembly and extending along a longitudinal axis; and a distal portion, which may include an articulation segment; and a preformed curve segment located distal to the articulation segment, the preformed curve segment anchoring a distal end of a pull wire to the elongated body, wherein the pull wire extends from a control member of the handle assembly to the distal end, wherein the pull wire is configured to controllably bend the articulation segment along a first curve in a first geometric plane by actuating the control member; positioning at least one radiopaque marker on the distal portion, wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane.

[0016] The details of one or more illustrative embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1A is a conceptual diagram showing the right side of the heart where the distal portion of an example catheter is positioned.

[0018] Figure 1B yes Figure 1A An enlarged view of the distal end of the catheter is shown in FIG.

[0019] Figure 2A –2C is a conceptual diagram illustrating an example catheter including an elongated body and a handle assembly.

[0020] Figure 3 is a conceptual diagram illustrating a cross-sectional view of an example catheter having an articulated section including a relatively flexible section and a relatively rigid section.

[0021] Figure 4A and 4B is a conceptual diagram illustrating a cross-sectional view of an example catheter including a single electrode and first and second electrodes, respectively.

[0022] Figure 5 is a flow chart illustrating an example method for manufacturing an example catheter.

[0023] Figure 6 is a flow chart illustrating an example method for delivering a medical electrical lead to a target location using an example catheter. DETAILED DESCRIPTION

[0024] In general, the present disclosure describes example systems, devices, and techniques for implanting a medical device at a target location in a patient's body. In general, the patient can be a human patient. However, in other instances, the patient can be a non-human patient. The target location can generally include any part of the patient's body where stimulation, sensing, or drug delivery is desired. In some instances, the target location includes the His bundle, coronary veins, or tissue suitable for pacing that is not dead, damaged, or otherwise not functioning within general anatomical specifications. His bundle pacing may better simulate natural heart rhythms than pacing at other parts of the heart. However, implantation of medical electrical leads at the His bundle may be difficult.

[0025] Example systems can include catheters having features that control the orientation of a distal portion of the catheter. For example, the catheter can include an articulated segment and a preformed curved segment for achieving deflection in three dimensions along two different geometric planes. In some instances, the curve of the articulated segment can be controlled, for example, by a control member connected to one or more pull wires. In some instances, the curve of the preformed curved segment can be located in a first plane offset from a second plane of the curve of the articulated segment, so that the position of the distal tip of the catheter can be controlled in three-dimensional space.

[0026] The catheter can also include features that facilitate identification of target positioning and facilitate tracking of the distal portion of the catheter relative to the target positioning. For example, the catheter can include fluoroscopic visualization or other visualization of the catheter when the catheter is delivered to the target tissue site, for example, at least one radiopaque marker for manipulating and / or oriented to the catheter. In some instances, the catheter can include at least one electrode array for sensing waveforms, such as ECG. Target positioning such as the His bundle can be determined based on visualization of the catheter using at least one radiopaque marker, detection of the characteristics of the waveform based on the use of at least one electrode array, or both. In this way, compared with other medical electrical lead implant systems, the example system can make the His bundle medical electrical lead implant easier and more predictable, reduce the duration of the His bundle medical electrical lead implantation procedure, reduce the consumption of hospital resources and / or reduce the patient's exposure to radiation.

[0027] In the present disclosure, exemplary systems, devices, and techniques will be described with reference to delivering medical electrical leads to locations close to the His bundle in the heart. However, it will be understood that the exemplary systems, devices, and techniques of the present disclosure are not limited to delivering medical electrical leads to the His bundle. For example, the exemplary systems, devices, and techniques described herein can be used to deliver medical electrical leads to coronary veins, epicardial tissue, or other locations. In addition, the exemplary systems, devices, and techniques described herein can be used to deliver medical electrical leads for neurostimulation therapy (e.g., spinal cord stimulation), deep brain stimulation, stimulation of one or more muscles, muscle groups, or organs, and stimulation of the patient's tissue in general. Further, in some instances, the exemplary systems, devices, and techniques described herein can be used for delivery catheters for dispensing drugs or other beneficial agents from implanted or external drug delivery devices. In short, the exemplary systems, devices, and techniques described herein can be used for application in delivering various medical electrical leads or catheters for delivering therapy to a patient or for patient sensing.

[0028] Figure 1A 2 is a conceptual diagram showing the right side of the heart 14 where the distal portion 22 of the example catheter 20 is positioned. Figure 1A 1, the heart 14 has been stripped back to reveal a portion of the intrinsic conduction system of the heart 14 and the anterior lateral walls of the chambers of the right atrium (RA) 10 and the right ventricle (RV) 6. The associated elements of the intrinsic conduction system of the heart 14 may include the sinoatrial (SA) node 1, the atrioventricular (AV) node 2, the bundle of His 3, the right bundle branch 4, and the Purkinje fibers 5. The SA node 1 is shown near the superior vena cava (SVC) 12 in the RA 10. An electrical impulse that begins at the SA node 1 travels rapidly through the tissue of the RA 10 and the tissue of the left atrium (not shown) to the AV node 2. At the AV node 2, the impulse slows to create a delay before passing through the bundle of His 3, which branches into the right bundle branch 4 and the left bundle branch (not shown) in the interventricular septum 7 and then branches into the Purkinje fibers 5 near the RV apex 16. The flow of electrical impulses creates an orderly sequence of contractions and relaxations of the atria and ventricles to effectively pump blood through the heart 14.

[0029] Due to disease, injury, or natural defects, the intrinsic conduction system of the heart 14 may no longer function within general anatomical norms. Therefore, a pacemaker system can be implanted into the patient such that electrodes carried by implantable medical electrical leads are placed in the atrial appendages 15. The electrodes stimulate the RA 10 downstream of the SA node 1, and the stimulation pulses travel to the AV node 2, the bundle of His 3, and the Purkinje fibers 5 to restore physiological contraction of the heart. However, if the patient's AV node 2 is defective, pacing in the atrial appendages 15 will be ineffective because the pacing site is located upstream of the AV node 2, such as atrioventricular block. This patient can be implanted with a pacemaker system such that the medical electrical lead is placed in the RV apex 16. The RV apex 16 has been an accepted site for pacing because it is relatively easy to engage a medical electrical lead at this site, and pacing from this site has been shown to be safe and effective. Due to the questions raised by recent studies investigating the long-term effects of pacing from the RV apex 16, as previously described, there has been great interest in more physiologically correct pacing.

[0030] One site for more physiologically correct pacing is the His bundle 3. As described above, the His bundle 3 forms part of the intrinsic conduction system of the heart 14, and any pace applied from the His bundle 3 will be conducted through the His bundle 3 to the Purkinje fibers 5, and throughout the RV 6 and left ventricle (not shown). However, determining the location of the His bundle 3 and attaching a medical electrical lead proximal to the His bundle 3 can be difficult.

[0031] For example, one preferred location where the His bundle 3 may be paced is on the atrial aspect of the tricuspid annulus, near the anterior attachment of the septal leaflet of valve 13. This location is accessible from RA10 and may be difficult to reach using a distal port catheter. Further, once this location is reached, it may be challenging to maintain the distal port catheter in position because the medical electrical leads are secured to the His bundle 3 or tissue proximal to the His bundle 3. Additionally, locating the His bundle 3 may be difficult in at least some hearts because the His bundle 3 may not be reliably located using imaging techniques in some patients.

[0032] like Figure 1A , the distal portion 22 of the catheter 20 is positioned together in the heart 14. The length of the catheter 20 can vary, but can be between about 30 centimeters and 100 centimeters, with an outer diameter of less than about 14 French, or about 4.667 millimeters. In some examples, the catheter 20 can be inserted into the heart 14 using a transvenous approach through the SVC 12 into the RA 10, and the distal portion 22 can be positioned near the junction between the SVC 12 and the RA 10 so that the distal end 25 of the catheter is guided into contact with endocardial tissue proximal to the His bundle 3. In other examples, the catheter 20 can be guided through the tricuspid valve 13 to the RV6 and guided into contact with endocardial tissue distal to the His bundle 3.

[0033] In some examples, the catheter 20 is a steerable catheter. In some examples, the catheter 20 is a steerable catheter and includes a lumen for receiving a guide wire to assist in advancing the catheter 20 at least a portion of a distance to a target location within the heart 14. In some examples, the catheter 20 includes features that allow it to effectively transfer forces applied to the proximal end of the catheter 20 to the movement of the distal end 25 of the catheter 20, such as through a handle assembly (not shown). For example, the distal portion 22 can include multiple curves proximal to the distal end 25 to facilitate guiding the distal end 25 to a target location, such as tissue proximal to the His bundle 3. In some examples, the multiple curves can be formed by articulated segments that are adjustable, for example, by pull wires that can be manipulated by control members at the handle assembly, preformed curve segments, or other features configured to shape the length of the distal portion 22.

[0034] Catheter 20 may be flexible to facilitate advancement of catheter 20 through the circulatory system, including SVC 12. For example, catheter 20 may include a flexible biocompatible material, such as silicone or polyurethane. Upon advancement into RA 10, catheter 20 may begin to resume its preformed curved segment.

[0035] Figure 1B yes Figure 1A 2 is an enlarged view of a portion of a schematic diagram of a catheter 20. A medical electrical lead 29 having a distal spiral 30 extends out of the distal end 25 of the catheter 20. For example, the catheter 20 may include a delivery catheter for delivering the medical electrical lead 29. The medical electrical lead 29 is configured to provide physiological pacing. For example, the medical electrical lead 29 can pace the heart 14 by delivering electrical pulses to the His bundle 3. The distal spiral 30 can be configured to anchor the medical electrical lead 29 to tissue near the His bundle 3. For example, during delivery of the medical electrical lead 29, a clinician can control the distal spiral 30, for example, through a lead body of the medical electrical lead 29 that can be controlled at or near the handle assembly of the catheter 20, to knob the distal spiral 30 into tissue near the His bundle 3. Although shown as the distal spiral 30, in some examples, the catheter 20 may include additional or alternative fixation elements, including but not limited to one or more tines or one or more barbs. In some instances, as the operator manipulates distal end 25 to the appropriate orientation and advances medical electrical lead 29 distally through the lumen of catheter 20 and out of distal end 25, wall 212 of SVC 12 (eg, Figure 1A) can provide support for the distal portion 22. The wall 212 of the SVC 12 can provide more stable support for the distal portion 20 than the heart wall, for example, without moving like the wall of the atrium 10 each time the heart 14 beats. In some examples, the distal portion 22 can be rigid enough to enable the medical electrical lead 29 to be advanced out of the distal end 25 and anchored to tissue proximal to the His bundle 3 without support from the wall 212 or other portions of the heart 14 opposite the His bundle 3. In this way, during positioning of the catheter 20 and delivery of the medical electrical lead 29, the distal portion 22 may not contact the atrial or ventricular walls of the heart 14 to reduce movement induced by the beating of the heart 14, which may otherwise hinder accurate placement of the medical electrical lead 29.

[0036] Certain shapes of the articulated segments and / or preformed curved segments of distal portion 22 may cooperate with the anatomy of heart 14 to assist a clinician in positioning catheter 20 and delivering medical electrical lead 29 to tissue proximate the bundle of His 3 . Figure 2A 2C is a conceptual diagram showing an example catheter 400 including a handle assembly 410 and an elongated body 420. The catheter 400 can be used in the same manner as described above. Figure 1A and 1B The catheters 20 discussed are the same or substantially similar.

[0037] The elongated body 420 extends from a proximal end 423 to a distal end 425. The elongated body 420 may include any suitable length for reaching a target location of the heart from an entry site such as a femoral entry site or a radial entry site. In some instances, the elongated body may range between about 30 centimeters (cm) and about 100 cm. The elongated body 420 may define a lumen 421 extending longitudinally within the elongated body 420. The lumen 421 may be configured to receive a medical electrical lead comprising at least one electrode array. For example, the lumen 421 may be sized to pass a medical electrical lead through the entire length of the lumen 421. In some instances, the elongated body 420 may include a plurality of lumens, each extending along the longitudinal axis 402 and / or parallel to the longitudinal axis.

[0038] The elongated body 420 may include a proximal portion 424 and a distal portion 422. The elongated body 420 has flexibility that allows the proximal portion 424 and / or the distal portion 422 to deflect when the elongated body 420 is manipulated within the vascular system of the patient. The proximal portion 424 may be coupled to a handle assembly 410 having a control member 416. The proximal portion 424 extends along the longitudinal axis 402. In some instances, the proximal portion 424 may include a stabilizing sheath that surrounds the proximal portion 424 and is configured to transmit a force, such as a torque, at the handle assembly 410 to the distal portion 422. In some instances, the control member 416 may include one or more controls 418 coupled to a pull wire 438. The one or more controls 418 may be manipulated to control the length of the pull wire 438 extending through the elongated body 420. In some instances, the handle assembly 410 may include a hub 412. The hub 412 can be configured to provide access to the lumen of the elongated body 420. In some examples, the handle assembly 410 can include an adjustable handle 414. The adjustable handle 414 can be configured to manipulate (e.g., rotate) the deflection of the distal portion 422. In some examples, the handle assembly 410 can include a flush assembly configured to be coupled to a syringe to, for example, purge air from the lumen of the catheter 400.

[0039] As described above, the distal portion 422 includes an articulated segment 426 and a preformed curved segment 430 located distal to the articulated segment 426. In some examples, the shape of the distal portion 422 can be controllable. For example, the pull wire 438 can be configured to controllably bend the articulated segment 426 along a first curve 429 in a first geometric plane P1, for example, by actuating the control member 416. The first geometric plane is shown in FIG. Figure 2A and 2B in the page plane, and as Figure 2C 429 . In some examples, the amount of actuation of the control member 416 can control the degree of curvature of the articulated segment 426. For example, the range of the degree of curvature of the articulated segment 426 can be controlled between about 0 degrees and about 240 degrees, such as between about 45 degrees and about 180 degrees or between about 85 degrees and about 100 degrees. In some examples, the range of the length of the articulated segment 426 defining the first curve 429 can be between about 5 cm and about 20 cm, such as about 12 cm to about 15 cm. In some examples, when articulated, the radius 434 of the first curve 429 can range between about 5 mm and about 60 mm, such as between about 10 mm and about 30 mm or between about 15 mm and about 20 mm. By controlling the degree of curvature, the articulated segment 426 can enable the first curve 429 to be adjusted to accommodate changes in the position of the His bundle 3 or differences in the size of the heart that is expanded compared to an average-sized heart.

[0040] The pull wire 438 can enable control of the degree of curvature of the articulation section 426 from the handle assembly 410. For example, the proximal end 437 of the pull wire 438 can be coupled to the control member 416. The pull wire 438 can extend from the control member 416 to the distal end 439 of the pull wire 438, which is anchored to the elongated body 420 located distal to the articulation section 426. For example, the distal end 439 can be anchored to the elongated body 420 using a drawstring 440. The drawstring 440 can include any suitable structure configured to anchor the distal end 439 of the pull wire 438 to the elongated body 420 located distal to the articulation section 426. In some examples, the drawstring 440 can include a radiopaque marker, gold, platinum iridium, other precious metals or alloys thereof, stainless steel, other materials configured to withstand the deflection force from the actuation pull wire 438 that can include sputtered precious metals, or a combination thereof. In some instances, the pull wire 438 comprises a single pull wire. In other instances, the pull wire 438 may comprise a plurality of pull wires. In instances where the pull wire 438 comprises a plurality of pull wires, each of the plurality of pull wires may be configured to control the deflection of the distal portion 422 in one or more directions. The pull wire 438 may comprise any suitable material and construction. In some instances, the diameter of the pull wire 438 may be approximately 0.009 inches (0.23 mm) and may be formed by medical grade 304 stainless steel. In some instances, the pull wire 438 may comprise a coating, such as a fluoropolymer, such as polytetrafluoroethylene (PTFE). By anchoring the distal end 439 of the pull wire 438, the control member 416 is actuated in the proximal direction, such as to shorten the length of the pull wire 438 extending through the elongated body, which may cause the articulated segment 426 to be controlled to bend in the first geometric plane P1. Actuating the control member 416 in a distal direction, for example to extend the length of the pull wire 438, may cause the articulating segment 426 to controllably return to a resting state, for example, an unflexed or less-flexed configuration.

[0041] In some examples, the shape of the distal portion 422 can be pre-formed. For example, the pre-formed curve segment 430 defines the second curve 431 in the second geometric plane P2. The second geometric plane P2 is shown in the plane as at least partially in Figure 2A and 2B Outside the page and as Figure 2C The second geometric plane P2 can be different from the first geometric plane P1. For example, the first geometric plane P1 and the second geometric plane P2 can be offset by an offset angle 427. In some examples, the offset angle 427, for example, the angle of the first geometric plane P1 relative to the second geometric plane P2, ranges from about 10 degrees to about 80 degrees, such as about 30 degrees to about 60 degrees or about 40 degrees to about 50 degrees.

[0042] In some instances, the preformed curve segment 430 may be flexible enough to deform into a substantially straight configuration when passing through the patient's vascular system. When positioned in the patient's heart, the elastic force of the preformed curve segment 430 may be sufficient to restore the preformed shape of the second curve 431. In some instances, the second curve 431 of the preformed curve segment 430 may be formed by, for example, heat setting. In some instances, the degree of curvature of the preformed curve segment 430 may range between about 10 degrees to about 180 degrees, such as between about 30 degrees and about 140 degrees or between about 43.5 degrees and about 124.1 degrees. In some instances, the length of the preformed curve segment 430 defining the second curve 431 ranges between about 6 mm and about 10 cm, such as between about 1 cm and about 5 cm or between about 1 cm and about 2 cm. In some instances, the radius of the second curve 431 ranges between about 1 mm and about 20 mm, such as between about 2 mm and about 10 mm. The degree of curvature of the preformed curved segment 430 may enable the distal end 425 to be oriented substantially perpendicular to tissue proximate the His bundle 3 .

[0043] In some examples, the distal portion 422 can include one or more substantially straight portions. For example, the elongated body 420 can include a substantially straight portion 428 located distal to the articulated segment 426 and proximal to the preformed curved segment 430, and / or a substantially straight portion 432 located distal to the preformed curved segment 430 and including the distal end 425. In some examples, the length of the substantially straight portions 428 and / or 432 can range between about 1 mm and about 15 mm, such as between about 0.5 mm and about 9 mm.

[0044] The distal portion 422 can include at least one radiopaque marker, such as at least one of radiopaque markers 442A, 442B, 442C, and / or 442D (collectively, radiopaque markers 442). The radiopaque markers 442 can include a gold foil with an adhesive backing that is sandwiched between layers of the distal portion 422, as described below with reference to Figure 3Any layer of the distal portion discussed. In some instances, the distal portion 422 can include a first radiopaque marker located on the articulation segment 426, such as radiopaque markers 442A and / or 442B, and a second radiopaque marker located distal to the articulation segment 426, such as radiopaque markers 442C and / or 442D. In some instances, the second radiopaque marker, such as radiopaque marker 442D, can be located at least one of on or distal to a preformed curved segment. By positioning the radiopaque marker 442 on the articulation segment 426 and distal to the articulation segment 426, such as located at least one of on or distal to a preformed curved segment, the three-dimensional position of the distal portion 422 can be determined, such as can be observed by a clinician through fluoroscopy.

[0045] The articulated segment 426 and the preformed curved segment 430 may comprise any suitable material and construction for achieving flexibility, pushability, and torque transmission that facilitates maneuverability of the catheter 400 to a target location within the patient's heart. For example, the articulated segment 426 and the preformed curved segment 430 may comprise one or more coaxial layers of polyether block amide, polyurethane, or silicone rubber, or a composite thereof.

[0046] Figure 3 5 is a conceptual diagram showing a cross-sectional view of an example catheter 500 having an articulated section 526 including a relatively soft section 541 and a relatively hard section 542. The catheter 500, for example, the articulated section 526 may be similar to the catheter 500 described above with reference to FIG. Figure 2A –2C The catheter 400 described is the same or substantially similar, for example, the articulation segment 426. In some examples, the articulation segment 526 can be defined by a composite sidewall 500 that is configured to bend along one or more curves along one or more geometric planes in response to an actuation pullwire 538. For example, the composite sidewall 500 can include a relatively flexible segment 541 extending longitudinally along a first length of the articulation segment 526 and a relatively rigid segment 542 extending longitudinally along a second length of the articulation segment 526. In some examples, the relatively flexible segment 541 and the relatively rigid segment 542 can extend along substantially the same length (e.g., the same or nearly the same as limited by catheter manufacturing capabilities) of the articulation segment 526, such that the first length and the second length are substantially similar. In other instances, the relatively soft segment 541 and the relatively stiff segment 542 may extend different lengths along the distal portion 422 such that at least a portion of a first length of the relatively soft segment 541 and at least a portion of a second length of the relatively stiff segment 542 overlap along at least a portion of the articulation segment 526.

[0047] Composite sidewall 500 includes inner portion 501 and outer portion 502. Inner portion 501 can extend about 360 degrees around inner assembly 519. Inner portion 501 can include a first polymer having a first hardness. In some examples, inner assembly can include multi-lumen tube 520. Multi-lumen tube 520 includes a relatively large lumen 521 and three relatively small lumens 522A, 522B, and 524. Pull wire 538 can extend within lumen 524. Lumens 521, 522A, 522B, and 524 can be fluidly coupled to distal end 425 of catheter 400 and proximal port of handle assembly 410 ( Figure 2A –2C). In other examples, the inner assembly 519 can include a tube having any number of lumens or a single lumen. The outer portion 502 can extend around approximately 180 degrees of the surface 503 of the inner portion 501. The outer portion 502 can include a second different polymer having a second different hardness (e.g., a higher hardness than the first polymer of the inner portion 501). In some examples, the outer portion 502 can extend around a lesser portion of the inner portion 501 (e.g., at least 10 degrees) or a greater portion of the inner portion 501 (e.g., up to 350 degrees). The outer portion 502 can be adhered to the inner portion 501 so that the inner portion 501 forms a relatively soft section 541, and the combination of the inner portion 501 and the outer portion 502 forms a relatively hard section 542. In some examples, the composite sidewall 500 can include a reinforcement structure 518. The reinforcement structure 518 can include, for example, a metal braid or a metal coil, such as stainless steel or nickel titanium alloy.

[0048] In some examples, when the pull wire 538 is actuated, the composite sidewall 500 can cause the articulated segment 526 to bend in a first direction in a first geometric plane toward the relatively soft segment 541, which is more flexible or provides less resistance to bending than the relatively stiff segment 542. In other words, the circumferential orientation of the relatively soft segment 541 and the relatively stiff segment 542 along a longitudinal axis (e.g., longitudinal axis 402) can be configured to controllably bend the articulated segment 526 in a first direction along a first curve 429 in response to actuation of the pull wire 538 by the control member 416. In some examples, the circumferential orientation of the relatively soft segment 541 and the relatively stiff segment 542 can vary along the length of the articulated segment 526, thereby allowing the articulated segment 526 to controllably bend into a complex shape, including, for example, one or more curves with multiple cusps, two or more curves in a single plane, two or more curves in multiple planes, or a combination thereof.

[0049] In some examples, catheter 400 can include at least one electrode adjacent to the distal end. Figure 4A and 4B6 is a conceptual diagram illustrating a cross-sectional view of an example catheter 600A and 600B (collectively referred to as "catheter 600") including an electrode array 650 and a first electrode 650A and a second electrode 650B, respectively. Electrode array 650 may include one or more electrodes. Except for the differences described herein, catheter 600 is similar to the above-referenced catheters. Figure 2A –3 described catheter 400 and / or 500 are the same or substantially similar. In the illustrated example, electrode array 650 (and / or first electrode array 650A and second electrode array 650B) can be formed directly on a component of catheter 600. In other examples, a medical electrical lead (e.g., medical electrical lead 29) can include electrode array 650 (and / or first electrode array 650A and second electrode array 650B) located at or near the distal tip of the medical electrical lead, which can pass through a lumen of catheter 600 (e.g., Figure 3 of the tubular cavity 521) is introduced into the distal end 625.

[0050] exist Figure 4A In the example shown in , the electrode array 650 can be electrically coupled to, for example, a sensing circuit system for sensing an electrocardiogram (ECG) to sense a waveform such as an ECG. For example, the catheter 600 can include at least one conductor 652 that electrically couples the electrode array 650 to an external device (not shown) configured to receive and debug the patient's physiological signals. In some embodiments, the external device can include a user interface that can include a display for displaying physiological signals. In some embodiments, the external device can include a circuit system for processing signals, such as a digital signal processor (DSP), a microprocessor, an application specific integrated circuit (ASIC), or other processor or processing circuit system, for automatically detecting features in the signal.

[0051] The electrode array 650 can be used to determine a target implant location, for example, a target stimulation location near the His bundle 3 ( Figure 1A and 1B ). In some instances, the electrode array 650 may include an electrode array that can be configured to map the focused His bundle. In some instances, an external device or user, such as a physician, can detect the location of the His bundle 3 based on an ECG waveform. For example, when the electrode array 650 is positioned adjacent to the His bundle 3, the ECG waveform may include an atrial P wave, a ventricular QRS signature, and a His spike between the P wave and the QRS signature. In instances where the external device includes a processor capable of detecting features within a physiological signal, the processor is capable of detecting an electrical potential waveform indicative of the His bundle 3. For example, the His bundle 3 has a signature waveform with a frequency of approximately 200 Hz that can be detected by the processor. In this way, translating the catheter 600 along tissue near the His bundle 3 while collecting the ECG can allow the location of the His bundle 3 to be determined.

[0052] In some examples, the electrode array 650 can be positioned within the lumen of the catheter 600, such as proximal to the distal tip 625, to reduce the amplitude of the P wave and / or QRS signature. For example, the electrode array 650 can be positioned at a distance d1 from the distal tip 625. In some examples, the distance d1 can be greater than about 1 mm from the distal end 425, such as in a range between about 1 mm and about 2 mm from the distal end 425. Reducing the detected amplitude of the P wave and / or QRS signature can improve the detection of the waves of the His bundle.

[0053] In some instances, the ECG can be used to distinguish between living tissue suitable for pacing and dead (ischemic) or damaged tissue that is not suitable for pacing. For example, the ECG can include a lower voltage amplitude when the electrode array 650 is adjacent to the central fiber body, dead or damaged tissue than when the electrode array 650 is adjacent to living tissue.

[0054] In some instances, such as Figure 4B As shown in , at least one electrode may include a first electrode array 650A and a second electrode array 650B. The first electrode array 650A and the second electrode array 650B may define a bipolar electrode pair together. In some instances, the first electrode array 650A and the second electrode array 650B may be arranged at substantially the same longitudinal position, such as a certain distance d1 from the distal end 625, wherein the gap with a distance d2 is transverse to the longitudinal axis therebetween. In some instances, the distance d2 may be within a range between about 0.5 mm and about 5 mm. In some instances, the conductors 652A and 652B of the first electrode array 650A and the second electrode array 650B may be coupled to an electrical energy source (not shown) respectively. For example, the electrical energy source may be a part of an external device for signal monitoring or a different external device. The electrical energy source may apply a voltage or current between the first electrode array 650A and the second electrode array 650B. When the first electrode array 650A and the second electrode array 650B are in contact with the tissue or in close proximity to the tissue (e.g., less than about 2 mm), electrical energy from the electrical energy source can travel through the tissue. The current and / or voltage of the electrical energy traveling through the tissue can be measured, for example, by an external device, and can be used to determine the impedance of the tissue. By translating the distal end 625 across the tissue and monitoring the impedance, the positioning of the His bundle 3 can be determined. For example, the tissue containing the His bundle 3 can exhibit a lower impedance compared to the impedance of the adjacent endocardial tissue. In some instances, the impedance of the tissue of the His bundle 3 can be about 50% lower than the impedance of the adjacent endocardial tissue.

[0055] Once the target location is determined, the medical electrical lead may be advanced through lumen 421 , out distal tip 425 , and attached to tissue proximate the target location, as discussed above.

[0056] Electrodes 650, 650A, and 650B can have any shape. For example, electrode array 650 can take the form of a ring of conductive material or a portion of a ring of conductive material, for example, not including a full 360 degree circumference of the ring, for example, to focus sensing in a specific direction transverse to the longitudinal axis that can produce a silent response. As another example, each of electrode arrays 650A and 650B can be a portion of a ring of conductive material (the portions are each less than half of the ring, but not necessarily the same circumferential extent).

[0057] The catheters described herein may be used to deliver medical electrical leads using any suitable technique. Figure 5 is a flow chart showing an example method for making an example catheter. The catheter can be used in conjunction with the above Figure 1A -4 are identical or substantially similar to the catheters 20, 400, 500, and / or 600 discussed above. Although the catheters 400 and 500 are described with respect to FIG. Figure 5 , but in other instances, Figure 5 The method can be used with other catheters having features for controlling the orientation of a distal portion of the catheter, the features comprising: an articulated segment; a pull wire for controllably bending the articulated segment along a first curve in a first geometric plane; a preformed curve segment that defines a second curve in a second geometric plane; and at least one radiopaque marker.

[0058] Figure 5 The technology shown in includes forming an elongated body 420. As discussed above, the elongated body 420 can extend from a proximal end 423 to a distal end 425 and define a lumen 421 (602) extending longitudinally within the elongated body 420. The lumen 421 can be configured to receive a medical electrical lead including at least one electrode. The elongated body 420 can include a proximal portion 424 and a distal portion 422. The proximal portion 424 can extend along the longitudinal axis 402 and can be configured to be coupled to the handle assembly 410. The distal portion 422 can include an articulation segment 426 and a preformed curved segment 430 located distal to the articulation segment 426.

[0059] The elongated body 420 can be formed by any suitable technique, for example, extruding one or more polymers to form the inner assembly 519 and depositing one or more polymer layers on the elongated tube. Two or more elongated tubes can be molded or otherwise adhered together to define the multi-lumen tube 520 of the inner assembly 519. In some examples, forming the elongated body 420 can include winding or braiding one or more metal wires onto a mandrel (or the inner assembly 519) to form a reinforcement structure (e.g., reinforcement structure 518). In some examples, one or more polymer layers can be deposited on the inner and / or outer surfaces of the reinforcement structure 518. In some examples, the inner assembly 519 can be inserted into the reinforcement structure 518.

[0060] In some examples, forming the elongated body 420 can include forming a proximal portion 424, forming a distal portion 422, and attaching the proximal portion 424 to the distal portion 422. Attaching the proximal portion 424 to the distal portion 422 can include, for example, adhering the proximal portion 424 to the distal portion 422 using a suitable adhesive or welding (e.g., heat welding or ultrasonic welding) the proximal portion 424 to the distal portion 422.

[0061] In some examples, forming the distal portion 422 can include heat setting (e.g., heat forming) at least a portion of the distal portion 422 to form a pre-formed curved segment 430. In some examples, forming the distal portion 422 can include at least forming a relatively soft section 541 extending longitudinally along a first length of the articulation segment 526, and forming a relatively hard section 542 extending longitudinally along a second length of the articulation segment 526 on at least a portion of a surface of the relatively soft section 541. For example, forming the distal portion 422 can include at least forming an inner portion 501 extending longitudinally along a first length of the articulation segment 526 by, for example, extruding or depositing a polymer on the inner assembly 519. As discussed above, the inner portion 501 extends about 360 degrees around the inner assembly 519 and can include a first polymer having a first hardness. Forming the distal portion 422 can also include forming an outer portion 502 extending longitudinally along the second length of the articulating segment on at least a portion of the surface 503 of the inner portion 501, such as by extruding or depositing a polymer onto the inner assembly 519. As discussed above, the outer portion 502 can extend about 180 degrees of the inner portion 501 around the surface 503 and can include a second different polymer having a second different hardness.

[0062] Figure 5The technique shown in also includes anchoring the distal end 439 of the pull wire 438 to the elongated body 420 (604). As discussed above, the pull wire 438 can extend from the control member 416 of the handle assembly 410 to the distal end 439, so that the pull wire 438 can be configured to controllably bend the articulated segment 426 along a first curve in the first geometric plane P1 by actuating the control member 416. In some examples, anchoring the distal end 439 to the elongated body 420 can include adhering or otherwise bonding the distal end 439 to a portion of the elongated body 420, such as a portion of the lumen 524.

[0063] Figure 5 The technique shown in also includes positioning at least one radiopaque marker on the distal portion (606). In some examples, positioning at least one radiopaque marker can include adhering a radiopaque material, such as gold foil, between layers of the distal portion 422, such as between the inner assembly 519 and the inner portion 501.

[0064] The catheters described herein can be assembled using any suitable technique. Figure 6 is a flow chart illustrating an example method for delivering a medical electrical lead to a target location using an example catheter. The catheter may be used in conjunction with the above-described Figure 1A -3 discussed above are identical or substantially similar to the catheters 20, 400, 500, and / or 600. Although the catheters 20, 400, and 500 are described above, Figure 6 , but in other instances, Figure 6 The method can be used to assemble other catheters having features configured to control the orientation of a distal portion of the catheter, the features comprising: an articulation segment; a pull wire, the pull wire being used to controllably bend the articulation segment along a first curve in a first geometric plane; a preformed curve segment, the preformed curve segment defining a second curve in a second geometric plane; and at least one radiopaque marker.

[0065] Figure 6The techniques shown in 612 include advancing the catheter 400 (612) toward a target location (e.g., His bundle 3) in a patient as discussed above. In an example where the catheter 400 includes a first radiopaque marker (e.g., radiopaque marker 442A or 442B) located on the articulating segment 426 and a second radiopaque marker (e.g., radiopaque marker 442C or 442D) located distal to the articulating segment 426, advancing the catheter 400 toward the target location may include imaging the first radiopaque marker and the second radiopaque marker to determine a three-dimensional configuration of the distal portion 422 based on the positions of the first radiopaque marker and the second radiopaque marker. In some examples, after advancing the catheter 400 toward the target location, the techniques may include actuating the control member 416, for example, via one or more controls 418, so that the pull wire 438 controllably bends the articulating segment 426 to the first curve 429.

[0066] Figure 6 The techniques shown in also include identifying a target location (614) based on detecting an electrical signal using at least one electrode 450. For example, as discussed above, the electrode 450 can be electrically coupled to a sensing circuit system, such as for sensing an electrocardiogram (ECG), to enable an external device or user to detect the location of the His bundle 3. In this way, the techniques can include translating the catheter 400 along tissue near the His bundle 3 while collecting the ECG can allow the location of the His bundle 3 to be determined. In some examples, the techniques can include controlling the position of the electrode 450 relative to the distal end 425 to reduce the amplitude of the P wave and / or QRS signature, as discussed above, to improve the detection of the His spike.

[0067] In some examples, the technique may include measuring current and / or voltage to determine the impedance of tissue between a first electrode and a second electrode adjacent to the first electrode (e.g., a bipolar electrode) and spaced a distance from the first electrode (e.g., a bipolar electrode). For example, the technique may include translating the medical electrical lead 29 across the tissue and monitoring the impedance of the tissue to identify an impedance indicative of the His bundle 3.

[0068] Figure 6 The technique shown in the embodiment also includes, after identifying the target location, advancing the medical electrical lead 29 through the lumen 421 and out of the distal end 425 of the elongated body 420 to the target location (616). For example, the technique may include advancing the medical electrical lead 29 out of the distal end 425 of the catheter 400 and controlling the distal helix 30, for example, through the lead body of the medical electrical lead 29 controllable at or near the handle assembly of the catheter 20, to knob the distal helix 30 into tissue proximate to the His bundle 3.

[0069] The following clauses present example topics described in this article.

[0070] Item 1. A catheter comprising: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to accommodate a medical electrical lead comprising at least one electrode, wherein the elongated body comprises: a proximal portion connected to the handle assembly and extending along a longitudinal axis; and a distal portion comprising: an articulating segment; and a preformed curve segment located distal to the articulating segment; a pull wire extending from the control member and anchored to the elongated body located distal to the articulating segment; and at least one radiopaque marker, wherein the pull wire is configured to controllably bend the articulating segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane, wherein the at least one radiopaque marker is positioned on the second curve.

[0071] Clause 2. The catheter of Clause 1, wherein the catheter further comprises at least one electrode array adjacent to the distal end.

[0072] Clause 3. The catheter of Clause 2, wherein the at least one electrode array is positioned greater than about 1 millimeter from the distal end of the elongated body.

[0073] Clause 4. The catheter of Clause 2, wherein the at least one electrode array is positioned about 1 mm to about 2 mm from the distal end of the elongated body.

[0074] Clause 5. A catheter according to any one of clauses 2 to 4, wherein the at least one electrode array comprises a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged at substantially the same longitudinal position, wherein a gap is transverse to the longitudinal axis therebetween.

[0075] Clause 6. The catheter of any one of Clauses 1 to 5, wherein the length of the articulated segment defining the first curve is in the range of about 5 centimeters (cm) to about 20 cm.

[0076] Clause 7. The catheter of any of Clauses 1 to 6, wherein the length of the preformed curve segment defining the second curve is in the range of about 2 cm and about 5 cm.

[0077] Clause 8. The catheter of any one of Clauses 1 to 7, wherein a radius of the first curve is in the range of about 5 mm and about 30 mm.

[0078] Clause 9. The catheter of any one of Clauses 1 to 8, wherein the radius of the second curve is in the range of about 1 mm and about 20 mm.

[0079] Clause 10. The catheter of any one of Clauses 1 to 9, wherein the angle of the first curve is in the range of about 10 degrees and about 240 degrees.

[0080] Clause 11. The catheter of any of Clauses 1 to 10, wherein the angle of the second curve is in the range of about 10 degrees and about 180 degrees.

[0081] Clause 12. The catheter of any one of Clauses 1 to 11, wherein the offset of the first geometric plane relative to the second geometric plane is in a range of about 10 degrees to about 80 degrees.

[0082] Clause 13. A catheter according to any one of clauses 1 to 12, wherein the elongated body includes a substantially straight portion located distal to the preformed curved segment and including the distal end, wherein the length of the substantially straight portion is between about 5 mm and about 9 mm.

[0083] Clause 14. A catheter according to any one of Clauses 1 to 13, wherein the articulated segment is defined by a composite side wall comprising: a relatively soft segment extending longitudinally along a first length of the articulated segment; and a relatively stiff segment extending longitudinally along a second length of the articulated segment.

[0084] Clause 15. A catheter according to Clause 14, wherein the relatively soft segment and the relatively stiff segment are configured along the circumferential orientation of the longitudinal axis so that the articulated segment can be controlled to bend in a first direction along the first curve in response to actuation of the pull wire by the control member.

[0085] Clause 16. A catheter according to any one of clauses 1 to 15, wherein the at least one radiopaque marker comprises: a first radiopaque marker, the first radiopaque marker being located on the articulated segment; and a second radiopaque marker, the second radiopaque marker being located distal to the articulated segment.

[0086] Clause 17. The catheter of Clause 16, wherein the second radiopaque marker is located at least one of on or distal to the preformed curved segment.

[0087] Item 18. A delivery catheter comprising: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to receive the medical electrical lead, wherein the elongated body comprises: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion comprising: an articulating segment; and a preformed curved segment distal to the articulating segment; a pull wire extending from the control member and anchored to the elongated body distal to the articulating segment; at least one electrode An array, wherein at least one electrode array is configured to sense electrical signals indicative of a His bundle of the patient's heart; a first radiopaque marker, wherein the first radiopaque marker is located on the articulated segment; and a second radiopaque marker, wherein the second radiopaque marker is located distal to the articulated segment; wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines the second curve in a second geometric plane different from the first geometric plane, and wherein the first geometric plane is offset relative to the second geometric plane in a range of about 40 degrees to about 50 degrees.

[0088] Clause 19. A kit comprising: a catheter, the catheter comprising: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, wherein the elongated body comprises: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion comprising: an articulated segment; and a preformed curved segment located distal to the articulated segment; a pull wire extending from the control member and anchored to a The elongated body; and at least one radiopaque marker positioned on the distal portion, wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane; and an implantable element for at least one of therapy delivery or sensing, the implantable element being sized for delivery through the lumen and out of the elongated body at the distal end.

[0089] Clause 20. The kit of Clause 19, wherein the catheter further comprises at least one electrode array adjacent to the distal end.

[0090] Clause 21. The kit of Clause 20, wherein the at least one electrode array is positioned greater than about 1 millimeter from the distal end of the elongated body.

[0091] Clause 22. The kit of any one of Clauses 19 to 21, wherein the angle of the first curve is in the range of about 10 degrees and about 240 degrees.

[0092] Clause 23. The kit of any one of Clauses 19 to 22, wherein the angle of the second curve is in the range of about 10 degrees and about 180 degrees.

[0093] Clause 24. The kit of any one of Clauses 19 to 23, wherein the offset of the first geometric plane relative to the second geometric plane is in the range of about 10 degrees to about 80 degrees.

[0094] Clause 25. A kit according to any one of clauses 19 to 24, wherein the articulated section is defined by a composite side wall comprising: a relatively soft section extending longitudinally along a first length of the articulated section; and a relatively stiff section extending longitudinally along the length of the articulated section.

[0095] Clause 26. A kit according to clause 25, wherein the relatively soft segment and the relatively hard segment are configured in a circumferential orientation along the longitudinal axis so that the articulated segment can be controlled to bend in a first direction along the first curve in response to actuation of the pull wire by the control member.

[0096] Clause 27. A kit according to any one of clauses 19 to 26, wherein the at least one radiopaque marker comprises: a first radiopaque marker, the first radiopaque marker being adjacent to the articulation segment; and a second radiopaque marker, the second radiopaque marker being adjacent to the distal end.

[0097] Clause 28. A kit according to any one of clauses 19 to 26, wherein the at least one radiopaque marker comprises: a first radiopaque marker, the first radiopaque marker being adjacent to the articulated segment; and a second radiopaque marker, the second radiopaque marker being adjacent to the pre-formed curved segment.

[0098] Clause 29. A method comprising: advancing a catheter toward a target location in a patient, wherein the catheter comprises: at least one electrode array, the at least one electrode array being configured to detect an electrical signal indicative of a His bundle of the patient's heart; a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to receive the medical electrical lead, wherein the elongated body comprises: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and a distal portion comprising: an articulated segment; and a preformed curved segment located at the articulated segment. a distal portion of the articulated segment; a pull wire extending from the control member and anchored to the slender body located distal to the articulated segment; and at least one radiopaque marker positioned on the distal portion, wherein the pull wire is configured to controllably bend the articulated segment along a first curve in a first geometric plane by actuating the control member, and wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane, thereby identifying the target location based on detection of the electrical signal by the at least one electrode array; and advancing a medical electrical lead through the lumen and out of the distal end of the slender body to the target location.

[0099] Clause 30. The method of Clause 29, wherein the method further comprises, after advancing the catheter toward the target location, actuating the control member to cause the pull wire to controllably bend the articulating section to the first curve.

[0100] Clause 37. A method according to any one of clauses 29 to 36, wherein the at least one radiopaque marker comprises: a first radiopaque marker, the first radiopaque marker being located on the articulated segment; and a second radiopaque marker, the second radiopaque marker being located distal to the articulated segment, and wherein the method further comprises imaging the first radiopaque marker and the second radiopaque marker after advancing the catheter toward the target position to determine a three-dimensional configuration of the distal portion based on the positions of the first radiopaque marker and the second radiopaque marker.

[0101] Clause 38. A method according to any one of clauses 29 to 36, wherein the at least one radiopaque marker comprises: a first radiopaque marker, the first radiopaque marker being adjacent to the articulated segment; and a second radiopaque marker, the second radiopaque marker being adjacent to the preformed curved segment, and advancing the catheter toward the target position comprises imaging the first radiopaque marker and the second radiopaque marker to determine a three-dimensional configuration of the distal portion based on the positions of the first radiopaque marker and the second radiopaque marker.

[0102] Item 33. A method comprising: forming an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally within the elongated body, the lumen being configured to accommodate a medical electrical lead comprising at least one electrode array, wherein the elongated body comprises: a proximal portion connected to the handle assembly and extending along a longitudinal axis; and a distal portion comprising: an articulation segment; and a preformed curve segment located distal to the articulation segment, the preformed curve segment anchoring a distal end of a pull wire to the elongated body, wherein the pull wire extends from a control member of the handle assembly to the distal end, wherein the pull wire is configured to controllably bend the articulation segment along a first curve in a first geometric plane by actuating the control member; positioning at least one radiopaque marker on the distal portion, wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane.

[0103] Item 34. A method according to Item 33, wherein forming the slender body includes: forming the proximal portion; and forming the distal portion by at least: forming an inner portion, the inner portion extending longitudinally along a first length of the articulated segment; and forming an outer portion extending longitudinally along a second length of the articulated segment on at least a portion of a surface of the inner portion; and attaching the proximal portion to the distal portion.

[0104] Clause 35. A method according to clause 33 or 34, wherein forming the distal portion includes controlling the circumferential orientation of the relatively soft segment and the relatively hard segment along the longitudinal axis, wherein the circumferential orientation of the relatively soft segment and the relatively hard segment is configured to cause the articulated segment to be controllably bend along a first direction of the first curve in response to actuating the pull wire through the control member.

[0105] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

1. A catheter, comprising: a handle assembly having a control member; an elongated body extending from a proximal end to a distal end and defining a lumen extending longitudinally therein, the lumen being configured to receive a medical electrical lead including at least one electrode, wherein the elongated body comprises: a proximal portion coupled to the handle assembly and extending along a longitudinal axis; and A distal portion, the distal portion comprising: an articulated section; and a preformed curved segment, the preformed curved segment being located distal to the articulated segment; a pull wire extending from the control member and anchored to the elongated body distal to the articulating section; and At least one radiopaque marker, wherein the pull wire is configured to controllably bend the articulated section along a first curve in a first geometric plane by actuating the control member, and Wherein the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane, wherein the at least one radiopaque marker is positioned on the second curve.

2. The catheter of claim 1, wherein the catheter further comprises at least one electrode array adjacent to the distal end.

3. The catheter of claim 2, wherein the at least one electrode array is positioned greater than 1 mm from the distal end of the elongated body.

4. The catheter of claim 2 or 3, wherein the at least one electrode array is positioned 1 mm to 2 mm from the distal end of the elongated body.

5. The catheter of claim 2 or 3, wherein the at least one electrode array comprises a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged at substantially the same longitudinal position, wherein a gap is transverse to the longitudinal axis therebetween.

6. The catheter according to any one of claims 1 to 3, wherein the length of the articulated segment defining the first curve is in the range of 5 cm to 20 cm.

7. The catheter according to any one of claims 1 to 3, wherein the length of the pre-formed curve segment defining the second curve is in the range of 2 cm and 5 cm.

8. The catheter according to any one of claims 1 to 3, wherein the radius of the first curve is in the range of 5 mm and 30 mm.

9. The catheter according to any one of claims 1 to 3, wherein the radius of the second curve is in the range of 1 mm and 20 mm.

10. The catheter according to any one of claims 1 to 3, wherein an angle of the first curve is within a range of 10 degrees and 240 degrees.

11. The catheter according to any one of claims 1 to 3, wherein an angle of the second curve is within a range of 10 degrees and 180 degrees.

12. The catheter of any one of claims 1 to 3, wherein the offset of the first geometric plane relative to the second geometric plane is in the range of 10 degrees to 80 degrees.

13. The catheter according to any one of claims 1 to 3, wherein the elongated body comprises a substantially straight portion located distal to the preformed curved segment and including the distal end, wherein the length of the substantially straight portion is between 5 mm and 9 mm.

14. The catheter of any one of claims 1 to 3, wherein the articulated section is defined by a composite sidewall comprising: a relatively flexible section extending longitudinally along a first length of the articulated section; as well as A relatively stiff section extends longitudinally along a second length of the hinge section.

15. The catheter of claim 14, wherein the relatively soft segment and the relatively stiff segment are configured along the circumferential orientation of the longitudinal axis to controllably bend the articulated segment in a first direction along the first curve in response to actuation of the pull wire by the control member.

16. The catheter of any one of claims 1 to 3, wherein the at least one radiopaque marker comprises: a first radiopaque marker located on the articulated segment; as well as A second radiopaque marker is located distal to the articulating segment.

17. The catheter of claim 16, wherein the second radiopaque marker is located at least one of on or distal to the preformed curved segment.

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