Delivery device for bundle branch cardiac therapy

Abstract

A catheter (18A) is configured to deliver a lead (18) or other secondary device into a patient's heart (12). The catheter (18A) is configured to deliver the secondary device via a right ventricle (28) near a portion of a left bundle branch (8a) of the patient. The catheter (18A) comprises an elongate tubular member (14). The elongate tubular member (14) comprises: a proximal end (15a); a distal end (15b) sized for introduction into the body of a patient; and a lumen (14A) extending between the proximal end (15a) and the distal end (15b). The elongate tubular member (14) is preformed. The elongate tubular member (14) further includes a distal portion (150b) adjacent to the distal end (15b) and a proximal portion (99) adjacent to the proximal end (15a). The distal portion (150b) defines a curvilinear shape in a relaxed state. The curved shape comprises a curved second region (200) located in a first plane (17) and a curved fourth region (400) located in a second plane (19).

Description

Technical Field

[0001] The present disclosure relates to delivery devices and methods for implanting implantable medical devices. Specifically, the present disclosure relates to delivery devices (such as catheters) for delivering implantable medical devices, systems, and methods for cardiac therapies, including single-chamber or multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing), atrioventricular synchronized pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapies. Background Art

[0002] Implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillators, deliver therapeutic stimulation to the patient's heart, thereby improving the lives of millions of heart disease patients. Figure 1 As illustrated, conventional pacing techniques involve pacing one or more of the four chambers of a patient's heart 12, including the left atrium (LA) 33, right atrium (RA) 26, left ventricle (LV) 32, and right ventricle (RV) 28. A common conventional therapeutic pacing technique for treating a slow heart rate, known as bradycardia, involves delivering electrical pulses to the patient's right ventricular tissue. In response to the electrical pulses, both the right and left ventricles contract. However, because the pulses travel from the right ventricle through the left ventricle, the heartbeat process can be significantly delayed. The electrical pulses travel through muscle cells called myocytes. Conduction between myocytes can be very slow. The delayed electrical pulses can cause the left ventricle to lose synchronization with the right ventricle.

[0003] Over time, the left ventricle can become very inefficient at pumping blood to the body. For some patients, heart failure can develop to the point where the heart is too weak to pump blood to the body. Heart failure can be a devastating diagnosis because, for example, fifty percent of people with heart failure have a life expectancy of five years or less. Another possible cause of heart failure is due to atrial fibrillation, which is an irregular and often very rapid heart rhythm, or arrhythmia. During atrial fibrillation, the heart's atria may beat out of sync with the heart's ventricles due to the arrhythmia of the atria, which can lead to blood clots in the heart and increase the risk of, for example, stroke or heart failure.

[0004] To avoid the potential development of heart failure, some physicians have considered alternative pacing methods involving the heart's conduction system. Pacing the heart's conduction system can conduct electrical impulses quickly (e.g., similar to a car traveling on a highway), while pacing the heart muscle or myocardial tissue can conduct electrical impulses more slowly (e.g., similar to a car traveling on a muddy road).

[0005] The cardiac conduction system includes the sinoatrial node 1, the atrial nodal bundles 2, 4, and 5 (i.e., the anterior nodal bundle 2, the middle nodal bundle 4, and the posterior nodal bundle 5), the atrioventricular node 3, the His bundle 13A (also called the atrioventricular bundle or the His bundle), the left bundle branch 8a, and the right bundle branch 8b. Figure 1 The aortic arch 6 and Buckman's bundle 7 are also shown. Figure 1 The sinoatrial node 1, located at the junction of the superior vena cava and the right atrium, is considered the heart's natural pacemaker because it continuously and repeatedly emits electrical impulses. The electrical impulses travel through the muscle of the right atrium 26 to the left atrium 33 to cause synchronous contraction of the atria. The electrical impulses are also delivered to the atrioventricular node 3 (the only connection between the atria and ventricles) through the interatrial nodal bundle. Conduction through the atrioventricular node or atrioventricular node tissue takes longer than through atrial tissue, which results in a delay between atrial contraction and the start of ventricular contraction. Atrioventricular delay is a delay between atrial contraction and ventricular contraction that allows the atria to empty blood into the ventricles. Then, as the ventricles contract, the valves between the atria and ventricles close, accompanied by ventricular contraction caused by branches of the bundle of His. The bundle of His (bundle of His or His bundle) 13A is located in the membranous atrioventricular septum, near the tricuspid annulus. The His bundle 13A divides into left and right bundle branches 8a, 8b and is formed by specialized fibers called "Purkinje fibers" 9. The Purkinje fibers 9 can be described as being capable of rapidly conducting action potentials along the ventricular septum (VS), rapidly propagating the depolarization wave front through the remaining ventricular myocardium, and producing coordinated contraction of the ventricular myocardium.

[0006] Patients with conduction system abnormalities (such as AV node poor conduction or SA node dysfunction) may receive an IMD (such as a pacemaker) to restore a more normal heart rhythm and AV synchronization. Some types of IMDs, such as pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices provide therapeutic electrical stimulation to the patient's heart via electrodes positioned in or adjacent to the heart on one or more implantable endocardial, epicardial, or coronary venous leads. Therapeutic electrical stimulation can be delivered to the heart in the form of pulses or shocks for pacing, cardioversion, or defibrillation. In some cases, an IMD can sense intrinsic depolarization of the heart and, based on the sensing, control the delivery of therapeutic stimulation to the heart.

[0007] In addition to cardiac pacing, arrhythmias can be treated by, for example, delivering electric shock therapy for cardioversion or defibrillation of the heart from an ICD, which can sense the patient's heart rhythm and classify the heart rhythm according to an arrhythmia detection scheme to detect the onset of tachycardia or fibrillation. The detected arrhythmias may include ventricular tachycardia (VT), rapid ventricular tachycardia (FVT), ventricular fibrillation (VF), atrial tachycardia (AT) and atrial fibrillation (AT). Anti-tachycardia pacing (ATP) is a painless therapy that can be used to treat ventricular tachycardia (VT) to essentially terminate many monomorphic rapid rhythms. Although ATP is painless, ATP may not be able to deliver effective therapy for all types of VT. For example, ATP may not be effective for polymorphic VT with variable morphology. Polymorphic VT and ventricular fibrillation (VF) may be more fatal and may require rapid treatment by electric shock. Summary of the Invention

[0008] The technology disclosed herein generally relates to a catheter that guides an implantable medical device or lead for delivery of the device or lead to the correct location in the ventricular septum at or near the left bundle branch (LBB) and in an orientation for delivering pacing at or near the LBB.

[0009] It may be difficult to implant a lead close enough to the LBB to effectively pace the LBB, or the implanted LBB lead may shift over time, for example due to natural movement or due to injury, and thus left ventricular septal pacing may occur. This is also true for right bundle branch (RBB) pacing that is transferred to right ventricular septal pacing. On the one hand, for patients whose cardiac conduction system is functioning normally, septal pacing may not be desired in some cases. On the other hand, for patients whose cardiac conduction system is not functioning normally, septal pacing may be desired in some cases (such as, for example, when the patient experiences LBB block or RBB block that cannot be corrected or bypassed). In other cases of patients whose cardiac conduction system is not functioning normally (such as, for example, when LBB block or RBB block can be corrected or bypassed), cardiac conduction system pacing is still desired. The pacing mode can be selected based on the needs of the individual patient.

[0010] Additionally, without the need to manipulate the catheter to ensure proper lead placement, it can be difficult to quickly and efficiently implant a lead. Consequently, steerable and maneuverable catheters can be more difficult to use and require a higher level of skill from the medical professional using the catheter to implant the medical device. Additionally, without a force acting on the catheter to push it back from the desired placement position, it can be difficult to push the lead out of the catheter, further complicating correct lead placement. The stiffness and curved structure of the catheter can help offset such difficulties.

[0011] Specifically, this document describes exemplary devices and methods related to a catheter or other delivery device configured to deliver a lead or other secondary device into a patient's heart. More specifically, the catheter is designed to deliver a lead at or near the LBB for cardiac conduction system pacing. Such cardiac conduction system pacing may include, for example, LBB pacing or left bundle branch area (LBBA) pacing. The catheter design includes a pre-shaped distal portion that is curved in a relaxed state. The distal portion facilitates easier and more efficient LBB placement without having to manipulate the catheter to ensure correct placement.

[0012] An exemplary catheter can be configured to deliver a lead or other secondary device into a patient's heart via the right ventricle and adjacent to a portion of the patient's left bundle branch. The catheter can include an elongated tubular member comprising a proximal end, a distal end, and a lumen, the distal end sized for introduction into the patient's body, the lumen extending between the proximal and distal ends. The elongated tubular member can be pre-shaped. The elongated tubular member can include a distal portion adjacent to the distal end and a proximal portion adjacent to the proximal end. The distal portion can define a curved shape in a relaxed state. The proximal portion can define a substantially straight or straight shape in a relaxed state.

[0013] The distal portion may further include a curved second region defining a second radius and a second angle within the first plane. The distal portion may further include a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle within a second plane different from the first plane. The first and second planes may intersect at a plane intersection angle between approximately 50 degrees and approximately 110 degrees. The second radius may be approximately 25 mm to approximately 115 mm. The fourth radius may be approximately 10 mm to approximately 35 mm. The second radius may be greater than the fourth radius.

[0014] In some embodiments, the distal portion may further include a first region distal to the proximal portion and defining a first length within a first plane. The distal portion may further include a third region distal to the curved second region and defining a third length within the first plane. The distal portion may further include a curved sixth region proximal to the first region and defining a sixth radius and a sixth angle within the first plane. The distal portion may further include a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length within the first plane. The sixth radius may be approximately 40 mm to approximately 80 mm. The second radius and the sixth radius may each be greater than the fourth radius.

[0015] In some embodiments, the distal portion may further include a fifth region distal to the curved fourth region and proximal to the distal end and defining a fifth length located within the second plane. The proximal portion may be stiffer than the distal portion. The first region and the curved second region may be stiffer than the third region, the curved fourth region, and the fifth region. Stiffness can be measured in various ways, including, for example, a three-point bend test. Standard ISO 180 and ASTM D790 three-point bend tests can be used to determine flexural stress and strain, flexural modulus, flexural strength, and flexural stress at break and 5% strain for rigid and semi-rigid plastics and other materials.

[0016] An exemplary method may include advancing a catheter (e.g., such as described herein) through the right ventricle toward a selected position adjacent to a portion of a patient's left bundle branch. The catheter may include a preformed, elongated tubular member extending from a proximal end to a distal end and defining a lumen extending between the proximal and distal ends. The elongated tubular member may include a proximal portion adjacent to the proximal end and a distal portion adjacent to the distal end. The distal portion may define a curved shape in a relaxed state. The proximal portion may define a substantially straight or straight shape in a relaxed state. The distal portion may further include a curved second region defining a second radius and a second angle located within a first plane. The distal portion may further include a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle located within a second plane different from the first plane. The first and second planes may intersect at a plane intersection angle between about 50 degrees and about 110 degrees. The second radius may be about 25 mm to about 115 mm. The fourth radius may be between about 10 mm and about 35 mm. The second radius may be greater than the fourth radius. The method may also include advancing the medical device through the lumen and extending from the distal end of the elongated body to a selected location for at least one of therapy delivery or sensing. The curved shape and stiffness of the catheter may facilitate advancement of the medical lead without relative movement of the catheter during advancement of the medical lead.

[0017] The above summary is not intended to describe each embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic diagram of a patient's heart and conduction system.

[0019] Figure 2 is a conceptual illustration of an illustrative catheter configured to deliver a lead through the right ventricle near a portion of the left bundle branch.

[0020] Figure 3Ais a conceptual diagram illustrating an exemplary therapy system configured to provide cardiac conduction system pacing therapy to the left bundle branch using a single lead placed in the right ventricle.

[0021] Figure 3B yes Figure 3A A close up view of the leads in a patient's heart.

[0022] Figure 4A is a perspective view of multiple identical catheters.

[0023] Figure 4B yes Figure 4A Another perspective view of a single catheter.

[0024] Figure 4C yes Figures 4A to 4B Partial front view of the catheter.

[0025] Figure 5 yes Figures 4A to 4C A partial perspective view of the catheter.

[0026] Figure 6A Figure 4 to Figure 5 Another partial perspective view of the catheter.

[0027] Figure 6B During the implantation of the device in the heart Figure 6A Conceptual diagram of the catheter.

[0028] Figure 7A 4 to 6 is another partial front view of the catheter.

[0029] Figure 7B Figure 4 to Figure 7A Another partial perspective view of the catheter.

[0030] Figure 8A is a partial perspective view of another catheter.

[0031] Figure 8B During device implantation Figure 8A Conceptual diagram of the catheter.

[0032] Figure 9A is another partial front view of the catheter of Figure 8.

[0033] Figure 9B Figure 8 to Figure 9A Another partial perspective view of the catheter.

[0034] Figure 10 is a block diagram of an illustrative method of implanting a medical lead using one of the catheters of Figures 4-9. DETAILED DESCRIPTION

[0035] In the following detailed description of exemplary embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments that may be practiced. It should be understood that other embodiments may be utilized and structural changes may be made without departing from (e.g., still falling within) the scope of the present disclosure as presented here.

[0036] Described herein are delivery devices and methods for delivering medical devices at or near the LBB from the right ventricle. Single-, dual-, and / or triple-chamber medical devices are available that can be delivered to a patient using the delivery devices and methods. The medical devices may include: a transvenous atrial lead carrying an electrode that can be placed in the right atrium; a transvenous ventricular lead carrying an electrode that can be placed in the right ventricle via the right atrium; a coronary sinus lead that can be placed in the left ventricle via the coronary sinus; and a ventricular-to-atrial (VfA) lead that can be placed in the right atrial septum between the right atrium and the left ventricle to pace the left ventricle. Such devices can be implanted using the delivery devices and methods of the present application.

[0037] Should refer to Figures 1 to 10 Describe exemplary systems, devices and methods. It will be apparent to those skilled in the art that an element or process from one embodiment may be used in combination with an element or process of other embodiments, and the possible embodiments of such systems, devices and methods using the feature combinations set forth herein are not limited to the specific embodiments shown in the figures and / or described herein. Further, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be appreciated that the timing of the processes herein and the size and shape of the various elements may be modified and still fall within the scope of the present disclosure, but certain timings, one or more shapes and / or sizes or element types may be superior to other timings, one or more shapes and / or sizes or element types.

[0038] Figure 1 A schematic diagram of a heart 12 is depicted, and Figures 2 to 3B A conceptual diagram illustrating an exemplary delivery system 70 including a catheter 18A that can be used to deliver a medical device or therapy system 71 to a patient's heart 12 is depicted. The patient is typically, but not necessarily, a human. In one or more embodiments, the therapy system 70 can include a catheter 18A as discussed herein. The catheter 18A is intended to allow a medical device (such as a guide wire) to pass through an inner lumen or channel of the catheter so that a user can deliver the device through the lumen of the catheter 18A to a target site within the patient's body.

[0039] The catheter 18A may include various components as further discussed herein, including an inline hub that may further include an integrated valve, flushing ports, etc. Radiopaque markers may be placed on or coupled to the catheter 18A to facilitate fluoroscopic or ultrasound visualization of the catheter once the catheter 18A is introduced into the patient's body. The radiopaque markers may be placed at the distal end of the catheter 18A, as discussed herein.

[0040] Hub 13 can be composed of two or more separable parts, or can be a single part. The elongated tubular member 14 of catheter 18A can be coupled to hub 13 (e.g., via an interference fit, using an adhesive, welding, etc.). An integrated valve or sealing member (not shown) can be designed to seal around a medical device or guidewire as it passes through catheter 18A, and can advantageously reduce or prevent leakage of bodily fluids outside of catheter 18A.

[0041] Flush port or other built-in port 13B (such as Figure 4A The hub 13 (as illustrated) may include a pierceable or otherwise openable opening into the hub and elongated tubular member 14 so that a syringe or other device can be connected to the port (e.g., using a Luer lock, a needle, etc.). This can advantageously allow for the introduction or removal of contents from the catheter 18A or the patient's body. Additional external engagement members may be coupled to the hub 13, as described in U.S. Patent Application Publication No. 2012 / 0029480A1, entitled "Catheter Apparatus," published on February 2, 2012, which is incorporated by reference in its entirety.

[0042] The hub 13 may include a handle or itself serve as a handle for the user to grasp during operation of the catheter 18A. For example, the hub 13 may be configured to have a tapered profile with a central fin to make the hub easier to grasp. The hub 13 may also advantageously provide a more comfortable hand position during operation. In addition, the hub 13 may include hub orientation markings (not shown). The hub orientation markings may indicate to the user the correct orientation to position or maintain the hub or to position or maintain the device so that the alignment direction, orientation or position of the distal end can be correctly, more easily and effectively achieved. The hub orientation markings may take the form of printed, colored or visible markings, or may take the form of tactile, material or physically discernible markings. The orientation markings may be placed on the hub 13, near the hub or anywhere adjacent to the hub.

[0043] The size of the conduit 18A and the elongated tubular member 14 can be set to specifically accommodate passage of a device or system having an outer diameter in the range of about 0.01 inches to about 0.10 inches. In an alternative embodiment, the size of the elongated tubular member 14 can be set to accommodate passage of a device or system sized to be between about 1 French (Fr) and 20 Fr. Thus, the size of the inner diameter of the elongated tubular member 14 can be set to accommodate a range of devices that can pass through the conduit 18A. In some embodiments, for example, the inner diameter of the conduit body can be between about 3 Fr and 7 Fr. In one embodiment, the inner diameter can be from about 5 Fr to about 6 Fr.

[0044] An example of a catheter (e.g., designed to deliver a His bundle pacing lead) may include a C315 delivery catheter. The C315 delivery catheter is described in the Medtronic Model C315 Delivery Catheter Instructions for Use (2016), which is incorporated herein by reference in its entirety. An example of a deflectable delivery catheter (e.g., designed to deliver a His bundle pacing lead) may be the SELECTSITE TM C304 Delivery Catheter. SELECTSITE TM C304 Delivery Catheter Description See Medtronic Model SELECTSITE TM C304 Delivery Catheter Manual (2018) and Instructions for Use (2010), both of which are incorporated herein by reference in their entirety. An example of a delivery catheter apparatus can be found in U.S. Patent Application Publication No. 2015 / 0065872A1, entitled "Delivery Catheter Apparatus and Methods," published on March 5, 2015.

[0045] The therapy system 71 may include an IMD 16 coupled to a cardiac conduction pacing therapy lead 18 (e.g., a left bundle branch pacing lead) and a programmer 24. The IMD 16 may be, for example, an implantable pacemaker, cardioverter, and / or defibrillator that provides electrical pulses to the heart 12 via electrodes coupled to the cardiac conduction pacing therapy lead 18. Additional non-limiting examples of the IMD 16 include a pacemaker having one or more medical leads, a cardiac resynchronization therapy (CRT) device, an implantable cardioverter-defibrillator (ICD), an intracardiac device, and the like. The IMD 16 may also include a housing 60 and may include one or more housing electrodes, such as housing electrode 58, that may be integrally formed with or otherwise connected to an outer surface of the hermetically sealed housing 60 of the IMD 16. The cardiac conduction pacing therapy lead 18 may be electrically coupled to a stimulation generator, a sensing module, or other modules of the IMD 16 via a connector block 34.

[0046] Cardiac pacing therapy leads 18 may be extended into the patient's heart 12 to sense the electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. Figure 3A In the example shown, the cardiac conduction system pacing therapy lead 18 extends through one or more veins and the vena cava, the right atrium, through the tricuspid valve, and into the right ventricle 28 of the heart 12 to pace the cardiac conduction system (e.g., within the ventricular septal wall, near and / or in direct contact with the left bundle branch 8a, near and / or in direct contact with the right bundle branch 8b, near and / or in direct contact with the His bundle 13A, etc.). The cardiac conduction system pacing therapy lead 18 can be positioned to position electrodes 48, 50 (respectively) near, adjacent to, on, within, or around the RBB, LBB for sensing electrocardiographic signals and pacing the cardiac conduction system. The cardiac conduction system pacing therapy lead 18 is shown with a ring electrode 48 and a helical tip electrode 50, which can be selected from a variety of bipolar pacing electrode pairs for pacing the RBB and LBB (respectively) and for sensing the RBB electrocardiogram signal and the LBB electrocardiogram signal (respectively). In an alternative embodiment, the cardiac conduction system pacing therapy lead 18 is also used to pace the RA (at Figure 3A In another alternative embodiment, the cardiac conduction pacing therapy lead 18 may also include an elongated electrode 66 ( Figure 3A ), the elongated electrode may take the form of a coil. IMD 16 may deliver a defibrillation shock to heart 12 via elongated electrode 66 and housing electrode 58.

[0047] An example of a cardiac conduction system pacing therapy lead (e.g., an LBB lead) may be a SELECTSECURE TM 3830 (Medtronic, Inc.) SELECTSECURE TM For a description of the 3830, see Medtronic model SELECTSECURE TM 3830 Manual (2013), which is incorporated herein by reference in its entirety. SELECTSECURE TM 3830 includes two conductors without a lumen.

[0048] As used herein, cardiac conduction system pacing therapy refers to any technology configured to deliver pacing therapy (e.g., pacing pulses, electrical stimulation, etc.) to the cardiac conduction system, which includes, for example, the His bundle 13A, the left bundle branch 8a, the right bundle branch 8b, etc., to initiate activation.

[0049] An exemplary IMD may be described as delivering one or both of conventional pacing therapy and cardiac conduction system pacing therapy. Conventional or traditional pacing therapy may be described as delivering pacing pulses to myocardial tissue that is not part of the cardiac conduction system of the patient's heart, such that, for example, the pacing pulse triggers electrical activation that propagates primarily from one myocardial cell to another myocardial cell (also referred to as "cell to cell"), as opposed to propagating within the cardiac conduction system before the myocardial tissue. For example, conventional pacing therapy may deliver pacing pulses directly to muscular heart tissue (e.g., myocardial tissue) that is to be depolarized to provide cardiac contraction. For example, conventional left ventricular pacing therapy may utilize an implanted left ventricular coronary sinus lead to extend through one or more veins, the vena cava, the right atrium 26, and into the coronary sinus to a region adjacent to the free wall of the left ventricle 32 of the heart 12 to deliver pacing pulses to the myocardial tissue of the free wall of the left ventricle 32.

[0050] Exemplary cardiac conduction system pacing therapies may be described, for example, in U.S. Patent Application Publication No. 2019 / 0111270A1, entitled “His Bundle and Bundle Branch Pacing Adjustment,” published on April 18, 2019. Exemplary left ventricular septal pacing may be described, for example, in U.S. Patent Application Serial No. 16 / 521,000, entitled “AV Synchronous Septal Pacing,” filed on July 24, 2019.

[0051] Cardiac conduction system pacing may include at least one of His bundle pacing, LBB pacing, and RBB pacing. Bundle branch pacing can bypass pathological areas and can have a low and stable pacing threshold. In some embodiments, only one of the left bundle branch or the right bundle branch can be paced using one or more pacing leads. In another embodiment, both bundle branches can be paced simultaneously (e.g., dual bundle branch pacing), which can simulate the inherent activation propagation through the His-Purkinje conduction system, for example, the activation of the pacemaker propagates to both ventricles via both bundle branches for synchronous contraction. On the other hand, His bundle pacing typically paces the His bundle located proximal to the bundle branch. In some embodiments, the IMD 16 can be connected to one, two, or more electrodes located in one or more bundle branches configured for bundle branch pacing. In some embodiments, the IMD 16 can be an intracardiac pacemaker configured to pace one or more portions of the cardiac conduction system (such as one or both bundle branches).

[0052] Figures 3A to 3BA patient's heart 12 is shown implanted with a cardiac conduction system pacing lead 18 for delivering bundle branch pacing according to one example of a therapy system 71. The cardiac conduction system therapy lead 18 is positioned (located) through the tricuspid valve into the RV 28 and implanted in the interventricular septum, for example, about 1 cm to 2 cm distal to the apex of the RA (e.g., Figures 3A to 3B exemplified). Figure 3B yes Figure 3A 1 is a close-up view of a cardiac conduction system therapy lead 18 in a patient's heart 12. In some embodiments, the cardiac conduction system therapy lead 18 may be the only lead implanted in the heart 12. In other embodiments, leads may be present in addition to the cardiac conduction system therapy lead 18 implanted in the heart 12, such as one or more leads implanted via the coronary sinus in the right atrium, right ventricular apex, and left ventricle.

[0053] Figures 3A to 3B The illustrated configuration of therapy system 71 is merely one example. In other examples, the therapy system may include epicardial leads and / or patch electrodes in place of or in addition to cardiac conduction system therapy leads 18, or other configurations shown or described herein or incorporated by reference. Further, IMD 16 need not be implanted in a patient. Thus, it should be understood that the exemplary therapy systems described herein may include any suitable number of leads coupled to IMD 16, and each of these leads may extend to any location within or proximate to heart 12. For example, an exemplary therapy system may include, for example, Figures 3A to 3B A single transvenous lead positioned as illustrated in , or two or more transvenous leads located in respective lumens.

[0054] The exemplary devices and methods described herein may provide an efficient way to implant a lead within a patient near a portion of the LBB using a pre-shaped, curved, multi-plane catheter as illustrated in FIG. 4-9 .

[0055] In at least one embodiment, and as Figures 4A to 4C and Figure 6A As illustrated, catheter 18A can be configured to deliver a lead or other secondary device, such as a cardiac conduction system pacing lead 18, into a patient's heart via the right ventricle and adjacent a portion of the patient's left bundle branch. Catheter 18A can include an elongated tubular member (also referred to as a catheter body) 14 including a proximal end 15a and a distal end 15b. Elongated tubular member 14 can be sized for introduction into a patient's body. Catheter 18A can further include a lumen 14A extending between proximal end 15a and distal end 15b. Lumen 14A can be configured to accommodate a medical device, such as a cardiac conduction system pacing lead 18 ( Figures 3A to 3BDuring implantation of the medical device into a patient, the medical device will be constrained by the structure of lumen 14A of catheter 18A.

[0056] The elongated tubular member 14 can be pre-shaped. For example, the elongated tubular member 14 can be configured to maintain a certain form or shape when in a relaxed state or in a flexed state. In one or more embodiments, the catheter 18A can be pre-shaped to maintain its shape when in a relaxed state. Thus, a pre-shaped catheter can be designed to require less operator manipulation than a steerable, non-pre-shaped catheter because the pre-shaped shape will allow the distal end 15b of the catheter 18A to be closer to the desired position without the need for manipulation or manual placement of the distal end 15b.

[0057] The catheter 18A may further include a distal portion 150b ( Figure 4B 、 Figure 6A and Figure 8A ). The distal portion 150b may include any and all of the regions 100 to 700 as further described herein. The catheter 18A may further include a proximal portion 99 adjacent the proximal end 15a. As discussed herein, the distal portion 150b may define a curved and multi-planar shape in a relaxed state. The proximal portion 99 may define a substantially straight or straight shape in a relaxed state. Additionally, the catheter 18A may include a hub 13 located at the proximal end 15a. Similar to the Medtronic delivery catheter C315, the hub 13 may include integrated valves, flushing ports, etc.

[0058] The size of the catheter 18A can be set so that in its pre-formed shape, the distal end 15b will be positioned substantially perpendicular to the ventricular septum in the RV and adjacent to the LBB to successfully implant the LBB lead (e.g., cardiac conduction system pacing lead 18). This may be correct for a variety of patients with various anatomical structures (e.g., pacemaker-indicated patients, ICD-indicated patients, CRT-indicated patients, heart failure class III and IV patient anatomical structures, etc.). A study of approximately 80 CT scans and 22 different model cardiac anatomical structures showed that most cardiac configurations can be maintained with two different sized catheters 18A, which depends at least in part on the access points and curvatures described herein. In alternative embodiments, based on the range of various regions as further described herein, more or less than two sizes of catheters 18A may be used. The catheter 18A may include a range of radius and bend angle values ​​for different sections, segments, or regions of the catheter 18A. The range of radius and bend angle may differ between larger and smaller catheter embodiments.

[0059] For cardiac anatomies with larger RAs, for example, in a sample set of patient populations, the RA volume was between about 55 milliliters (ml) and about 316 ml. The average volume was about 165 ml. The RA minor axis diameter was between about 2.5 centimeters (cm) and about 7.5 cm. The RA major axis diameter was between about 5 cm and about 10 cm. For patients with larger RAs, a larger catheter 18A as described herein may be preferred. In alternative embodiments, for patients with larger RAs, a smaller catheter 18A as described herein may still be preferred.

[0060] For cardiac anatomy with a relatively normal-sized RA, for example, in a sample set of patient populations, the RA volume ranged from about 40 ml to about 140 ml. The average volume was about 97 ml. The RA minor axis diameter ranged from about 3.5 cm to about 4.5 cm. The RA major axis diameter ranged from about 5 cm to about 7.5 cm. For patients with a more typical-sized RA, a smaller catheter 18A as described herein may be preferred. In alternative embodiments, a larger catheter 18A as described herein may still be preferred for patients with a more typical-sized RA.

[0061] The catheter 18A can be configured to be introduced from the right or left side of the patient 21. In one or more embodiments, the catheter 18A can be configured to be implanted from at least one of the patient's left cephalic vein, axillary vein, and left subclavian vein through the right atrium into the right ventricle of the patient's heart, as shown in FIG. Figure 6B Such access points are collectively referred to herein as left access points. Figure 6B and Figure 8B Certain embodiments are shown (as discussed below), but any embodiment of the catheter 18A can be implanted through the vasculature as illustrated (e.g., with or without additional curves, as discussed further herein). In one embodiment, for smaller cardiac anatomies, the catheter 18A can include a range of radius and bend angle values ​​for different sections, segments, or regions of the catheter 18A. In another embodiment, for larger cardiac anatomies, the catheter 18A can include a range of radius and bend angle values ​​for different sections, segments, or regions of the catheter 18A.

[0062] In one or more embodiments, catheter 18A can be configured to be implanted into the right ventricle of the patient's heart 12 from at least one of the patient's right cephalic vein, right subclavian vein, and axillary vein through the right atrium. Figure 8B Such access points may be collectively referred to herein as right access points. Figure 6B and Figure 8BCertain embodiments are shown, but any embodiment of the catheter 18A can be implanted through the vasculature as illustrated (e.g., with or without additional curves, as discussed further herein). In one embodiment, for smaller cardiac anatomies, the catheter 18A can include a range of radius and bend angle values ​​for different sections, segments, or regions of the catheter 18A. In another embodiment, for larger cardiac anatomies, the catheter 18A can include a range of radius and bend angle values ​​for different sections, segments, or regions of the catheter 18A.

[0063] like Figure 7A and / or Figure 7B As illustrated, the distal portion can include one or more of a first region 100, a curved second region 200, a third region 300, a curved fourth region 400, and an optional fifth region 500. These regions 100 to 500 can advantageously provide more effective and accurate positioning of the distal end 15b of the catheter 18A near a portion of the LBB, at least because the user may not need to manipulate or operate the catheter much or at all. These regions 100 to 500 can advantageously be used in the catheter 18A when the catheter 18A is advanced from the left or right side of the patient. The radius and angle of each region 100 to 400 discussed herein can be the same for both the left and right pathways of the catheter 18A.

[0064] For example, facing the patient and introducing the catheter 18A from the left side of the pathway, if the curved second region 200 is curved counterclockwise relative to the center of an imaginary circle, then from the right side of the pathway, the curved second region 200 is also curved counterclockwise relative to the same center of the same imaginary circle. In addition, for example, regions 100 to 400 can be positioned so that they are concave toward the heart, and can be positioned so that they are roughly curved around the right ventricle of the heart. The magnitude of the length of each region 100 to 500 can also be the same for both the left and right sides of the pathway. For both the left and right sides of the pathway, the distal end 15b of the catheter 18A is positioned near the LBB. This is a result of, for example, the difference in the left and right initial access points and any additional regions other than regions 100 to 400.

[0065] For most heart sizes, including the first region 100 can advantageously provide a better anatomical fit, allowing for more efficient and accurate placement of the distal end 15b near the LBB. Including the first region 100 can provide stiffness or hardness, which can advantageously provide optimal rigidity and structure during implantation. Including the first region 100 of the catheter 18A can allow the catheter 18A to move smoothly along the vessel as it is advanced into the right atrium. Additionally, the gradual transition from the substantially straight proximal section 99 to the curved second region 200, as well as the combination of the first region 100 and the curved second region 200, allows for optimized geometry for ease of implantation or improved implantation efficiency, facilitates manufacturing, and allows for a separate first region 100 having a different stiffness (or other variables, such as length or material) than the immediately surrounding regions at the proximal and distal ends of the first region 100. The inclusion of the first region 100, the gradual transition, and the stiffness can be optimized for implantation of the catheter 18A into a patient.

[0066] The first region 100 may be defined as being located on the first plane 17 ( Figure 5 a first radius R1 (not shown) and a first angle A1 ( Figure 7A ). R1 ​​can be defined as the radius of an imaginary circle extending through the first region 100. A1 can be defined as the angle within the same imaginary circle containing the first region 100. The first region 100 can have a first length L1 (not shown) based on R1 and A1. The first plane 17 can be positioned substantially or approximately parallel to the coronal plane, which bisects the human body into an abdominal (anterior) section and a dorsal (posterior) section. The first plane 17 can be positioned so that it is substantially parallel to the coronal plane and can bisect the left access point (e.g., for an embodiment introduced from the left), and / or can bisect the right access point (e.g., for an embodiment introduced from the right). The first region 100 can be curved along the first plane 17 in a direction concave toward the heart. For example, the first region 100 can be curved in a direction around the heart. The first region 100 can have a compound or constant curvature, such that R1 can be a compound radius or a constant radius (e.g., constant or nearly constant) falling within the described radius range. In one embodiment, the first region 100 has a substantially constant curvature.

[0067] In one embodiment, the first radius R1 can be between about 50 millimeters (mm) and about 150 mm. A larger-sized catheter 18A introduced from the left or right side of the patient can include an R1 between about 80 mm and about 120 mm. A smaller-sized catheter 18A introduced from the left or right side of the patient can include an R1 between about 80 mm and about 120 mm. In at least one embodiment, R1 can be about 100 mm. In other embodiments for any size and any introduction side, R1 can be between about 75 mm and about 130 mm, between about 95 mm and about 110 mm, etc.

[0068] In some embodiments, the first region 100 is curved, and for the catheter 18A introduced from the left or right side of the patient, the first angle A1 may be between about 1 degree and about 60 degrees. In some embodiments, the first region 100 may be considered to be straight (or substantially straight) within manufacturing tolerances, without expected curvature or radius. The first region 100 allows for variability in the curvature of the catheter 18A. The catheter 18A may be optimized based on patient needs and expectations. In at least one embodiment, A1 may be about 30 degrees. In other embodiments, A1 may be between about 5 degrees and about 60 degrees, between about 10 degrees and about 50 degrees, between about 20 degrees and about 40 degrees, etc.

[0069] In one or more embodiments, the distal portion 150b further includes a curved second region 200. The curved second region 200 can be distal to the first region 100, such that the curved second region 200 is closer to the distal end 15b than the first region 100 and / or the proximal portion 99. In embodiments having a first region 100, the curved second region 200 can be operably coupled to the first region 100. For example, the curved second region 200 can be positioned adjacent to the first region 100 within manufacturing tolerances. In embodiments without the first region 100, the curved second region 200 can be operably coupled to the proximal portion 99 and can be positioned adjacent to the proximal portion 99 within manufacturing tolerances. The curved second region 200 can define a second radius R2 (not shown) and a second angle A2 that lie within the first plane 17. R2 can be defined as the radius of an imaginary circle extending through the curved second region 200. A2 can be defined as an angle within the same imaginary circle that contains the curved second region 200. The curved second region 200 may have a compound or constant curvature, such that R2 may be a compound radius or a substantially constant (e.g., constant or nearly constant) radius falling within the described radius range. In one embodiment, the curved second region 200 has a substantially constant curvature.

[0070] For most heart sizes, including the curved second region 200 can advantageously provide a better anatomical fit, allowing for more efficient and accurate placement of the distal end 15b near the LBB. The curved second region 200 can be sized to ensure that the catheter 18A can reach the target location, and can further be sized to ensure that the catheter 18A actually reaches the target location. The unique R2 and A2 selected and used can be optimized for a specific patient or patient type. The curved second region 200 of the catheter 18A allows the catheter 18A to move smoothly along the blood vessels when it is advanced into the right atrium. Additionally, the gradual transition from the substantially straight proximal section 99 and / or first region 100 to the curved fourth region 400 and / or third region 300 allows for optimized geometry for ease of implantation or improved implantation efficiency, facilitates manufacturing, and allows for a separate curved second region 200 that can have a different stiffness (or other variables, such as length or material) than the immediately surrounding regions at the proximal and distal ends of the curved second region 200. The second region 200 including the curve, gradual transition, and stiffness may be optimized for implantation of the catheter 18A within a patient.

[0071] R1, A1, R2, and A2 may be oriented such that the first region 100 and the curved second region 200 are curved in the same direction in space along the first plane 17 (e.g., A1 and A2 are both positive angles in a common xy plane). 7A to 7B , wherein the first region 100 and the curved second region 200 have the same curvature direction. Therefore, the curved second region 200 may be curved in a direction concave toward the heart along the first plane 17. For example, the curved second region 200 may be curved from the left side of the patient toward the right side of the patient, and may further be curved from the head of the patient toward the feet of the patient.

[0072] The curved second region 200 may have a second length L2 (not shown) based on R2 and A2. In some examples, L2 may be greater than L1. The second radius R2 may be between about 20 millimeters (mm) and about 120 mm. Larger-sized catheters 18A for larger heart volumes, introduced from the left or right side of the patient, may include an R2 between about 40 mm and about 111 mm. In at least one embodiment of a larger-sized catheter 18A, R2 may be about 68.5 mm. In other embodiments of a larger-sized catheter 18A, R2 may be between about 40 mm and about 111 mm, between about 50 mm and about 90 mm, and the like.

[0073] A smaller sized catheter 18A introduced from either the left or right side of the patient may include an R2 between about 25 mm and about 85 mm. In at least one other embodiment of the smaller sized catheter 18A, R2 may be about 52 mm. In other embodiments of the smaller sized catheter 18A, R2 may be between about 25 mm and about 85 mm, between about 35 mm and about 70 mm, etc.

[0074] For a catheter 18A introduced from either the left or right side of the patient, the second angle A2 may be between about 80 degrees and about 230 degrees. Larger catheters 18A introduced from either the left or right side of the patient may include an A2 between about 90 degrees and about 180 degrees. In at least one other embodiment of a larger-sized catheter 18A, A2 may be about 129 degrees. In other embodiments of larger-sized catheters 18A, A2 may be between about 95 degrees and about 167 degrees, between about 100 degrees and about 158 ​​degrees, etc.

[0075] A smaller sized catheter 18A introduced from either the left or right side of the patient may include an A2 between about 95 degrees and about 225 degrees. In at least one embodiment of a smaller sized catheter 18A, A2 may be about 136 degrees. In other embodiments for a smaller sized catheter 18A, A2 may be between about 105 degrees and about 205 degrees, between about 110 degrees and about 200 degrees, etc.

[0076] In one or more embodiments, the distal portion 150b further includes a third region 300. For most heart sizes, including the third region 300 can advantageously provide a better anatomical fit, allowing for more efficient and accurate placement of the distal end 15b near the LBB. Including the third region 300 can provide stiffness or hardness, which can advantageously provide optimal rigidity and structure during implantation. Including the third region 300 of the catheter 18A can allow the catheter 18A to move smoothly along the blood vessel as it is advanced into the right atrium. Additionally, the gradual transition from the curved second region 200 to the curved fourth region 400 allows for optimized geometry for ease of implantation or improved implantation efficiency, facilitates manufacturing, and allows for a separate third region 300 that can have a different stiffness (or other variables, such as length or material) than the immediately surrounding regions at the proximal and distal ends of the third region 300. Including the third region 300, the gradual transition, and the stiffness can be optimized for implanting the catheter 18A into a patient.

[0077] In embodiments having a third region 300, the third region 300 may be distal to the curved second region 200, such that the third region is closer to the distal end 15b than the curved second region 200. The third region 300 may be substantially straight, straight, or curved. The third region 300 may define a third length L3 located within the first plane 17. L3 may be greater than L2. The third region 300 may be operatively coupled to the curved second region 200 such that the third region extends distally from the curved second region 200 along the first plane 17. In some embodiments, the third region 300 may be considered straight (or substantially straight) within manufacturing tolerances, without an expected curvature or radius.

[0078] In an alternative embodiment in which the third region 300 is curved, the third region 300 may define a third angle A3 and a third radius R3 located within the first plane 17. R3 may be defined as the radius of an imaginary circle extending through the third region 300. A3 may be defined as an angle within the same imaginary circle containing the third region 300. The third angle A3 may be between about 1 degree and about 10 degrees. In such alternative embodiments, the third region 300 may have a compound or constant curvature, such that the radius R3 may be a compound radius or a constant radius (e.g., constant or nearly constant). In an alternative embodiment, the third region 300 has a substantially constant curvature.

[0079] For the catheter 18A introduced from the left or right side of the patient, the third length L3 may be between about 1 mm and about 10 mm. A larger-sized catheter 18A introduced from the left or right side of the patient may include an L3 between about 2 mm and about 8 mm. A smaller-sized catheter 18A introduced from the left or right side of the patient may include an L3 between about 2 mm and about 8 mm. In at least one embodiment, L3 may be about 5 mm. In other embodiments, L3 may be between about 3 mm and about 9 mm, between about 4 mm and about 7 mm, between about 5 mm and about 6 mm, etc.

[0080] The curved fourth region 400 (eg Figure 7B and Figure 8B The curved fourth region 400 (as illustrated) may be distal to the third region 300 and / or the curved second region 200, such that the curved fourth region is closer to the distal end 15b than the third region 300 and / or the curved second region 200. The curved fourth region 400 may define a fourth radius R4 (not shown) and a fourth angle A4 located in a second plane 19 different from the first plane 17. The curved fourth region 400 may curve along the second plane 19 in a direction generally from the abdominal (anterior) section toward the dorsal (posterior) section.

[0081] For smaller or larger sized catheters 18A introduced from the left or right side of the patient, the plane intersection angle C ( Figure 5 10 degrees. In at least one embodiment, C may be about 73.5 degrees. In other embodiments, C may be between about 50 and about 110 degrees, between about 60 and about 100 degrees, between about 70 and about 80 degrees, etc. The first plane 17 may be positioned substantially or approximately parallel to the coronal plane, which divides the human body into an abdominal (front) section and a back (back) section. The first plane 17 may be positioned so that it is substantially parallel to the coronal plane and divides the left access point into two. The intersection angle C may extend from the first plane 17 toward the back (back) section of the body. The plane intersection angle C is such that when moving distally along the body of the catheter 18A, the catheter 18A and the curved fourth region 400 protrude in space generally toward the rear portion and in a direction toward the upper portion of the body.

[0082] For most heart sizes, whether for left- or right-sided access, intersection angle C can advantageously provide a better anatomical fit, allowing for more efficient and accurate placement of distal end 15b near the LBB. Intersection angle C can allow catheter 18A to smoothly navigate along the vessels as catheter 18A is advanced into the right atrium and through the right atrium into the right ventricle. Additionally, the gradual transition from first plane 17 to second plane 19 allows for optimized geometry for ease of implantation or improved implantation efficiency. Including intersection angle C, the gradual transition can be optimized for implanting catheter 18A into a patient so that distal end 15b is positioned near the LBB.

[0083] R4, A4, R2, and A2 may be oriented such that if the plane intersection angle C is assumed to be 0 degrees, the curved fourth region 400 and the curved second region 200 are curved in the same direction, and both regions are curved in space along the first plane 17 (e.g., A4 and A2 are both positive angles in the common xy plane). 7A to 7B , where if the curved fourth region 400 and the curved second region 200 are both in the first plane 17 , they have the same direction of curvature.

[0084] R4 can be defined as the radius of an imaginary circle extending through the curved fourth region 400. A4 can be defined as an angle within the same imaginary circle containing the curved fourth region 400. The curved fourth region 400 may have a fourth length L4 (not shown) based on R4 and A4. In some embodiments, R4 may be less than R2. L4 may be greater than L1, L3, and / or L5 (discussed further herein). L4 may be less than L1. L4 may be less than L2. The curved fourth region 400 may have a compound or constant curvature, such that R4 may be a compound radius or a constant radius (e.g., constant or nearly constant) falling within the described radius range. In one embodiment, the curved fourth region 400 has a substantially constant curvature.

[0085] For the catheter 18A introduced from the left or right side of the patient, the fourth radius R4 may be between about 5 mm and about 50 mm. A larger-sized catheter 18A introduced from the left or right side of the patient may include an R4 between about 10 mm and about 31 mm. A smaller-sized catheter 18A introduced from the left or right side of the patient may include an R4 between about 10 mm and about 31 mm. In at least one embodiment, R4 may be about 17.5 mm. In other embodiments introduced from the left or right side of the patient, R4 may be between about 11 mm and about 29 mm, between about 12 mm and about 28 mm, etc.

[0086] For the catheter 18A introduced from the left or right side of the patient, the fourth angle A4 may be between about 45 degrees and about 200 degrees. The larger size catheter 18A introduced from the left or right side of the patient may include an A4 between about 55 degrees and about 175 degrees. The smaller size catheter 18A introduced from the left or right side of the patient may include an A4 between about 55 degrees and about 175 degrees. In at least one embodiment, A4 may be about 105 degrees. In other embodiments of any size catheter 18A introduced from the left or right side, A4 may be between about 70 degrees and about 140 degrees, between about 95 degrees and about 115 degrees, between about 66 degrees and about 155 degrees, etc.

[0087] For catheter 18A introduced from either the left or right side of the patient, first region 100, curved second region 200, and third region 300 can all lie substantially within first plane 17, and curved fourth region 400 can lie within second plane 19. First and second planes 17, 19 can position first region 100, curved second region 200, third region 300, and curved fourth region 400 within the RV of the patient's heart, and distal end 15b can be positioned to contact the RV septum at an angle substantially perpendicular to the septal wall (e.g., perpendicular or nearly perpendicular). Planes 17, 19 can also position distal end 15b near the left bundle branch within the septal wall to aid in guiding the conduction system pacing lead to the target treatment site. This allows the user to more easily and efficiently advance the LBB pacing lead for implantation near a portion of the LBB, at least because the user may not need to manipulate or steer the catheter much, or at all.

[0088] For smaller or larger catheters 18A introduced from either the left or right side of the patient, the proximal portion 99 can be stiffer than the distal portion 150b. The stiffness of the device is at least a factor of the materials used in the device. The first region 100 and the curved second region 200 can each be stiffer than the third region 300 and the curved fourth region 400. Various possible materials and stiffness values ​​are discussed further herein.

[0089] Stiffness transitions or differences in stiffness between various regions (such as those described herein) can minimize kinking of the elongated tubular member 14 of the catheter 18A. Additionally, stiffness transitions can provide consistent torque, propulsion efficiency (the ratio of applied force to the resulting movement or propulsion of the catheter 18A), and other handling variables. The various stiffnesses of the regions of the catheter 18A can additionally and advantageously provide physicians with a better device that is easier or more efficient to use or manipulate. Stiffer segments can advantageously provide greater rigidity and support, which can advantageously prevent the catheter 18A from moving in a direction opposite to the force exerted by the catheter 18A on the cardiac tissue. For example, the distal end 15b can contact the ventricular septum, and when a lead or other device is advanced through the catheter 18A and contacts the same cardiac tissue, the catheter 18A can be pushed away from the cardiac tissue due to the forces acting on the catheter 18A, the lead or other device, and the cardiac tissue. The stiffness of the region can reduce or prevent this pushback. The less rigid region can advantageously protect the device and ensure that the device safely contacts the tissue or blood vessel.

[0090] In one or more embodiments, for smaller or larger sized catheters 18A introduced from the left or right side of the patient, the distal portion 150b further includes an optional fifth region 500. The fifth region 500 may be advantageously used or omitted from embodiments to provide an optimized shape, stiffness, or composition for delivering the distal end 15b near the LBB. In any embodiment, the fifth region 500 may advantageously be straight, substantially straight, or curved to provide an optimized shape, stiffness, or composition for delivering the distal end 15b near the LBB.

[0091] In embodiments including a fifth region 500, the fifth region 500 may be distal to the curved fourth region 400, such that the fifth region is closer to the distal end 15b than the curved fourth region 400. The fifth region 500 may be proximal to the distal end 15b. The fifth region 500 may define a fifth length L5 located within the second plane 19. The fifth region 500 may be operably coupled to the curved fourth region 400 such that the fifth region extends distally from the curved fourth region 400 along the second plane 19. In some embodiments, the fifth region 500 may be curved and may have a fifth angle A5 (not shown) that may be from about 1 degree to about 10 degrees and a fifth radius R5 (not shown). A5 may be defined as an angle within the same imaginary circle that contains the fifth region 500. In embodiments where the fifth region is straight, curved, or substantially straight, L5 may be less than each of L1 to L4. L5 may be greater than L3.

[0092] In embodiments including the fifth region 500, the fifth length L5 may be between about 0.1 mm and about 10 mm for catheters 18A introduced from either the left or right side of the patient. Larger catheters 18A introduced from either the left or right side of the patient may include an L5 between about 0.5 mm and about 5 mm. Smaller catheters 18A introduced from either the left or right side of the patient may include an L5 between about 0.1 mm and about 5 mm. In at least one embodiment, L5 may be about 2 mm. In other embodiments, L5 may be between about 1 mm and about 4 mm, between about 2 mm and about 3 mm, etc.

[0093] As discussed herein, the catheter 18A for introduction from the left or right side of the patient may include at least a curved second region 200 and a curved fourth region 400, and may alternatively further include a first region 100, a third region 300, and / or a fifth region 500. Additionally, as further discussed herein, in further embodiments, the catheter 18A for introduction from the right side of the patient may further include one or more of a curved sixth region 600 and a substantially straight region 700, as shown. Figure 8A and Figures 9A to 9BA catheter 18A for introduction from the right side of a patient may include the previously described regions 100 to 500 as discussed herein, and may additionally include a curved sixth region 600 and a substantially straight region 700 .

[0094] The curved sixth region 600 and the substantially straight region 700 may advantageously allow for easier or more efficient introduction of the catheter 18A from the right side of the patient, or may advantageously provide for more accurate placement of the distal end 15b near the LBB for the catheter 18A introduced from the right side of the patient. Additionally, the curved sixth region 600 and the substantially straight region 700 may advantageously provide for optimal stiffness, composition, and material or other mechanical properties, which advantageously provide for optimal stiffness during introduction of the catheter 18A and advantageously provide for more accurate placement of the distal end 15b near the LBB.

[0095] For most heart sizes, the inclusion of the curved sixth region 600 and the substantially straight region 700 advantageously provides a better anatomical fit, allowing for more efficient and accurate placement of the distal end 15b near the LBB. The inclusion of the curved sixth region 600 and the substantially straight region 700 of catheter 18A allows catheter 18A to navigate the tortuous paths of a patient's vasculature to reach the target location. For example, the curved sixth region 600 and the substantially straight region 700 of catheter 18A allow catheter 18A to be implanted through a patient's right cephalic vein, right subclavian vein, or axillary vein, and further allows catheter 18A to be implanted through the right atrium and into the right ventricle of the patient's heart. This can make implantation easier and more efficient for the user. The inclusion of the curved sixth region 600 and the substantially straight region 700 provides stiffness or rigidity, which advantageously provides optimal rigidity and structure during implantation. The inclusion of the curved sixth region 600 and the substantially straight region 700 of catheter 18A allows catheter 18A to move smoothly along the vasculature as it is advanced into the right atrium. Additionally, the gradual transition from the substantially straight proximal section 99 to the curved sixth region 600 and substantially straight region 700 allows for optimization of the geometry for ease of implantation or improved implantation efficiency, ease of manufacturing, and also allows for a separate curved sixth region 600 and substantially straight region 700 that can have a different stiffness (or other variables, such as length or material) than the immediately surrounding regions on the proximal and distal ends of the curved sixth region 600 and substantially straight region 700. Including the curved sixth region 600 and substantially straight region 700, the gradual transition, and stiffness can be optimized for implanting the catheter 18A into a patient. As discussed herein, omitting the curved sixth region 600 and substantially straight region 700 from the catheter 18A may be more advantageous for left-side access points.

[0096] In one or more embodiments of catheter 18A introduced from the right side of the patient, and as Figure 8A and Figures 9A to 9B As illustrated, the distal portion 150b further includes a curved sixth region 600, which may be distal to the proximal portion 99 such that the curved sixth region is closer to the distal end 15b than the proximal portion 99. In one or more embodiments, the curved sixth region 600 is operatively coupled to the proximal portion 99 and extends from the proximal portion 99 toward the distal end 15b. The curved sixth region 600 may define a sixth radius R6 (not shown) and a sixth angle A6. R6 may be defined as the radius of an imaginary circle extending through the curved sixth region 600. A6 may be defined as an angle within the same imaginary circle containing the curved sixth region 600. The curved sixth region 600 may be located within the first plane 17 proximal to or proximal to the first region 100. The curved sixth region 600 may have a sixth length L6 (not shown) based on R6 and A6. R6 may be greater than R4. L6 may be greater than L2. In alternative embodiments, L6 may be less than L2 and may be greater than L7 (discussed further herein). For example, the curved sixth region 600 may curve from the patient's right side toward the patient's left side, and may also curve from the patient's head toward the patient's feet. The curved sixth region 600 may have a compound or constant curvature, such that R6 may be a compound radius or a constant radius falling within the described radius range. In one embodiment, the curved sixth region 600 has a substantially constant curvature.

[0097] Additionally, R6, A6, R1, and A1 may be oriented such that the curved sixth region 600 and the first region 100 are curved in different directions in space along the first plane 17 (e.g., one of A6 and A4 is a positive angle in the common xy plane, while the other of A6 and A4 is a negative angle or a positive angle of a different value in the common xy plane). Figures 9A to 9B , where the curved sixth region 600 and the first region 100 have different directions of curvature if both are in the first plane 17. In an alternative embodiment, the curved sixth region 600 and the first region 100 have the same direction of curvature.

[0098] Additionally, R6, A6, R2, and A2 may be oriented such that the curved sixth region 600 and the curved second region 200 are curved in different directions in space along the first plane 17 (e.g., one of A6 and A2 is a positive angle in the common xy plane, while the other of A6 and A2 is a negative angle or a positive angle of a different value in the common xy plane). Figures 9A to 9B, where if the curved sixth region 600 and the curved second region 200 are both in the first plane 17 , they have different directions of curvature such that the combination of the curved regions forms an “S” or serpentine shape.

[0099] The sixth radius R6 may be between about 20 mm and about 100 mm. A larger sized catheter 18A introduced from the right side of the patient may include an R6 between about 40 mm and about 80 mm. A smaller sized catheter 18A introduced from the right side of the patient may include an R6 between about 40 mm and about 80 mm. In at least one embodiment, R6 may be about 70 mm. In other embodiments, R6 may be between about 50 mm and about 75 mm, between about 59 mm and about 68 mm, between about 60 mm and 65 mm, etc.

[0100] The sixth angle A6 may be between about 70 degrees and about 130 degrees. A larger sized catheter 18A introduced from the right side of the patient may include an A6 between about 80 degrees and about 120 degrees. A smaller sized catheter 18A introduced from the right side of the patient may include an A6 between about 80 degrees and about 120 degrees. In at least one embodiment, A6 may be about 100 degrees. In other embodiments, A6 may be between about 85 degrees and about 115 degrees, between about 76 degrees and about 111 degrees, between about 80 degrees and about 100 degrees, between about 85 degrees and about 95 degrees, etc.

[0101] In one or more embodiments, the distal portion 150b of the catheter 18A, introduced from the patient's right side, may further include a substantially straight seventh region 700. In alternative embodiments, the catheter 18A does not include the substantially straight seventh region 700. For most heart sizes, including the substantially straight seventh region 700 can advantageously provide a better anatomical fit, allowing for more efficient and accurate placement of the distal end 15b near the LBB. For example, the substantially straight seventh region 700 can provide anatomical fit with the tortuous vascular path through the patient to the heart. The pre-set curve allows the catheter 18A to follow the curve of the superior vena cava and quickly reach the target location without manual manipulation of the catheter 18A. The inclusion of the substantially straight seventh region 700 can provide stiffness or rigidity, which can advantageously provide optimal rigidity and structure during implantation. The inclusion of the substantially straight seventh region 700 in the catheter 18A can allow the catheter 18A to move smoothly along the vessel as it is advanced into the right atrium. Additionally, the gradual transition from the substantially straight proximal section 99 to the substantially straight seventh region 700 allows for optimization of the geometry for ease of implantation or improved implantation efficiency, ease of manufacturing, and also allows for a separate substantially straight seventh region 700 that can have a different stiffness (or other variables, such as length or material) than the immediately surrounding regions on the proximal and distal ends of the substantially straight seventh region 700. Including the substantially straight seventh region 700, the gradual transition, and stiffness can be optimized for implantation of the catheter 18A into a patient. As discussed herein, omitting the substantially straight seventh region 700 can benefit left-sided access.

[0102] In some embodiments, the substantially straight seventh region 700 may be distal to the curved sixth region 600. The substantially straight seventh region 700 may be proximal to the first region 100 and / or the curved second region 200. The substantially straight seventh region 700 may define a seventh length L7 located within the first plane 17. The substantially straight seventh region 700 may be operatively coupled to the curved sixth region 600 such that the substantially straight seventh region extends distally from the curved sixth region 600 along the first plane 17. L7 may be greater than L1, L3, L4, and / or L5. L7 may be less than L6 and / or L2.

[0103] In an alternative embodiment, the substantially straight seventh region 700 is curved and not completely straight, and the substantially straight seventh region 700 may have a seventh angle A7 (not shown) and a seventh radius R7 (not shown). A7 may be defined as an angle within the same imaginary circle that contains the substantially straight seventh region 700. In such an embodiment, the seventh angle A7 may be between about 1 degree and about 10 degrees.

[0104] The seventh length L7 may be between about 25 mm and about 175 mm. A larger sized catheter 18A introduced from the right side of the patient may include an L7 between about 50 mm and about 150 mm. A smaller sized catheter 18A introduced from the right side of the patient may include an L7 between about 50 mm and about 150 mm. In at least one embodiment, L7 may be about 115 mm. In other embodiments of any size catheter 18A introduced from the right side of the patient, L7 may be between about 60 mm and about 140 mm, between about 75 mm and about 125 mm, between about 82 mm and about 111 mm, between about 91 mm and about 100 mm, etc.

[0105] Without a force acting on the inner wall of catheter 18A to push it back from the desired placement position, it may be difficult to push a lead (e.g., cardiac conduction system pacing lead 18) out of catheter 18A that is introduced on either the left or right side of the patient. This may make it difficult to properly place the lead. The stiffness and curved structure of catheter 18A can help offset such difficulties. For example, the curved structure can provide structural stiffness and torque resistance. In addition, for example, the material used can provide stiffness and torque resistance.

[0106] In one or more embodiments of the catheter 18A comprising larger and smaller sizes introduced from either the left or right side of the patient, the proximal portion 99 is harder than the distal portion 150b. Stiffness can be defined as the ability of a material to resist elastic deformation when a load is applied. In one or more embodiments, the curved sixth region 600, the substantially straight seventh region 700, the first region 100, and the curved second region 200 are each harder than each of the third region 300, the curved fourth region 400, and the fifth region 500. When these relative stiffnesses are achieved, the stiffness of the proximal portion 99 provides greater strength for the large sections of the elongated tubular member 14, so that there is a greater resistance to movement of the catheter 18A during the lead is pushed out of the catheter 18A.

[0107] More specifically, the curved second region 200 can have a greater stiffness than the curved fourth region 400, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, this stiffness can advantageously provide additional flexibility in the curved fourth region 400 to achieve proper orientation adjacent to the septal wall without damaging the septal wall.

[0108] Furthermore, the proximal portion 99 can have a greater stiffness than the distal portion 150b, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, such stiffness can advantageously provide additional flexibility in the distal portion 150b to achieve proper orientation adjacent to the septal wall without damaging the septal wall.

[0109] Furthermore, the curved sixth region 600 can have a greater stiffness than the curved second region 200, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, this stiffness can advantageously provide additional flexibility in the curved second region 200 to achieve proper orientation adjacent to the septal wall without damaging the septal wall. In some embodiments, the curved sixth region 600 and the curved second region 200 can have similar stiffness, or can have the same stiffness, which can advantageously provide greater stability and stiffness and provide back pressure as described herein along a larger section of the catheter 18A.

[0110] Furthermore, the substantially straight seventh region 700 can have a greater stiffness than the curved second region 200, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, this stiffness can advantageously provide additional flexibility in the curved second region to achieve proper orientation adjacent to the septal wall without damaging the septal wall. In some embodiments, the substantially straight seventh region 700 and the curved second region 200 can have similar stiffness, or can have the same stiffness, which can advantageously provide greater stability and stiffness and provide back pressure as described herein along a greater section of the catheter 18A.

[0111] Furthermore, the first region 100 and the curved second region 200 can each have a greater stiffness than each of the third region 300 and the curved fourth region 400, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, this stiffness can advantageously provide additional flexibility in the third region 300 and the curved fourth region 400 to achieve proper orientation adjacent to the septal wall without damaging the septal wall.

[0112] Furthermore, the curved sixth region 600, the substantially straight seventh region 700, the first region 100, and the curved second region 200 can each have a greater stiffness than each of the third region 300 and the curved fourth region 400, which can advantageously provide greater stability and stiffness and provide back pressure on the wall opposite the ventricular septal wall within the right ventricle during implantation. Additionally, such stiffness can advantageously provide flexibility in the third region 300 and the curved fourth region 400 to achieve proper orientation adjacent to the septal wall without damaging the septal wall.

[0113] The catheter 18A can be constructed using one or more materials. For example, the elongated tubular member 14 can be constructed from concentric material layers, including a hydrophilic liner, an intermediate braid, and an outer elastomeric material (e.g., a polyether block amide material). The outer material can also include a nylon material (e.g., nylon-12). The outer material can be a combination of an elastomer and a nylon material. The intermediate braid can include an enhanced braid pattern and a braided wire, such as a braided wire with a diamond shape. The braided wire can be between 0.001 inches and 0.0025 inches. The braid can be a common braid or a Hergless braid and can have 8, 16, or 32 threads. Common braid patterns typically use a single-line two-under-two, over-two pattern. Diamond braid patterns typically use a double-line two-under-two, over-two line pattern. The diamond braid pattern can provide better torque and greater rigidity. The Hergless braid pattern typically uses a one-over-three, one-under-three pattern, which can provide even greater stiffness. The hydrophilic lining can allow a medical device (e.g., cardiac conduction system pacing lead 18) to slide more easily relative to the catheter 18A due to reduced friction. This also results in less force being exerted on the inner wall of the catheter 18A, so when the medical device is pushed out of the catheter 18A, the catheter 18A will not move out of position.

[0114] In one or more embodiments, each of the various regions of the catheter 18A can have a specific hardness (e.g., as measured using a durometer). Hardness can be defined as the ability of a material to resist puncture. In one or more embodiments, the proximal portion 99 can have a Shore D hardness of approximately 70D to approximately 74D. In one or more embodiments, the first region 100 and the curved second region 200 can have a Shore D hardness of approximately 55D to approximately 74D. In one or more embodiments, the third region 300, the curved fourth region 400, and the fifth region 500 can have a Shore D hardness of approximately 30D to approximately 72D. In one or more embodiments, the curved sixth region 600 and the substantially straight seventh region 700 can have a Shore D hardness of approximately 55D to approximately 74D.

[0115] In one or more embodiments, each of the various regions of the conduit 18A can have a specific stiffness (e.g., as measured using a three-point stiffness test). The stiffness of various materials can be defined based on a tensile modulus measured in megapascals (MPa). The tensile modulus of various materials can be as follows: Nylon-12 can have a stiffness of approximately 1400 MPa. Pebax 74D can have a stiffness of approximately 703 MPa. Pebax 72D can have a stiffness of approximately 510 MPa. Pebax 70D can have a stiffness of approximately 414 MPa. Pebax 63D can have a stiffness of approximately 307 MPa. Pebax 55D can have a stiffness of approximately 170 MPa. Pebax 45D can have a stiffness of approximately 88 MPa. Pebax 40D can have a stiffness of approximately 73 MPa. Pebax 35D can have a stiffness of approximately 19 MPa.

[0116] In one or more embodiments, the proximal portion 99 may have an outer jacket or layer constructed of nylon-12. In one or more embodiments, the first region 100 may have an outer jacket or layer constructed of Pebax 74D. In one or more embodiments, the curved second region 200 may have an outer jacket or layer constructed of Pebax 72D. In one or more embodiments, the third region 300 may have an outer jacket or layer constructed of Pebax 70D. In one or more embodiments, the curved fourth region 400 may have an outer jacket or layer constructed of Pebax 63D. In one or more embodiments, the fifth region 500 may have an outer jacket or layer constructed of Pebax 55D. In one or more embodiments, the curved sixth region 600 may have an outer jacket or layer constructed of Pebax 45D. In one or more embodiments, the substantially straight seventh region 700 may have an outer jacket or layer constructed of Pebax 40D. In alternative embodiments, each of regions 100 - 700 may be constructed using one or more of any of the materials discussed herein, which may result in each of regions 100 - 700 having various stiffnesses.

[0117] In alternative embodiments, materials with lower modulus or higher modulus can be used. The relative stiffness between regions can be maintained, as described herein. Thus, if the modulus is changed, other variables (e.g., the amount of material used or the volume of material) can be changed to maintain the relative stiffness between regions, as described herein.

[0118] Figure 101 is a flow chart of a method 1000 for implanting a medical device using catheter 18A. Although described with respect to cardiac conduction system therapy lead 18 and catheter 18A, method 1000 can be used with any suitable medical device and catheter. Method 1000 may include advancing catheter 18A toward a selected location adjacent to a portion of the cardiac conduction system (e.g., toward the patient's left bundle branch via the right ventricle) 1002. Method 1000 may also include advancing the medical device through lumen 14A and out of distal end 15b of the elongated body to a selected location for at least one of therapy delivery or sensing 1004.

[0119] The catheter 18A used in method 1000 may be the same as or similar to the catheter 18A discussed herein. The catheter 18A may include a preformed elongated tubular member 14. The preformed elongated tubular member 14 may extend from a proximal end 15a to a distal end 15b. The preformed elongated tubular member 14 may define a lumen 14A extending between the proximal end 15a and the distal end 15b. The preformed elongated tubular member 14 may include a proximal portion 99 adjacent to the proximal end 15a. The preformed elongated tubular member may include a distal portion 150b adjacent to the distal end 15b. The distal portion 150b may define a curved shape in a relaxed state. The curved shape and rigidity of the catheter 18A may facilitate advancement of the medical device. Such advancement of the medical device may be performed without relative movement of the catheter 18A during advancement of the medical device.

[0120] Various embodiments have been described. These and other embodiments are within the scope of the following claims. For example, the illustrative methods described herein can be implemented using a single-chamber, dual-chamber, or triple-chamber pacemaker (e.g., CRT-P) or ICD (e.g., CRT-D) device.

[0121] Exemplary Embodiments

[0122] Although the present disclosure is not limited thereto, an understanding of various aspects of the present disclosure will be gained through a discussion of the specific exemplary embodiments provided below. Various modifications to the exemplary embodiments as well as additional embodiments of the present disclosure will become apparent herein.

[0123] Embodiment Ex1: A catheter configured to deliver a lead or other secondary device into a patient's heart via the right ventricle and adjacent to a portion of the patient's left bundle branch, wherein the catheter comprises:

[0124] an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body,

[0125] wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and the distal portion defines a curvilinear shape in a relaxed state,

[0126] The distal portion includes:

[0127] a curved second region defining a second radius and a second angle within the first plane; and

[0128] a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane,

[0129] wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees,

[0130] wherein the second radius is from about 25 mm to about 115 mm,

[0131] wherein the fourth radius is from about 10 mm to about 35 mm, and

[0132] The second radius is greater than the fourth radius.

[0133] Embodiment Ex2: The catheter according to embodiment Ex 1, wherein the distal portion further comprises:

[0134] A first region is proximal to the curved second region and defines a first length that lies within the first plane.

[0135] Embodiment Ex3: The catheter according to any one of Embodiments Ex1 to 2, wherein the distal portion further comprises:

[0136] A third region is distal to the curved second region and defines a third length that lies within the first plane.

[0137] Embodiment Ex4: The catheter according to any one of embodiments Ex1 to 3,

[0138] wherein the second angle is from about 85 degrees to about 230 degrees, and

[0139] The fourth angle is about 55 degrees to about 180 degrees.

[0140] Embodiment Ex5: The catheter according to any one of embodiments Ex2 to 4,

[0141] wherein the proximal portion is harder than the distal portion, and

[0142] The first region and the curved second region are harder than the third region and the curved fourth region.

[0143] Embodiment Ex6: The catheter according to any one of Embodiments Ex1 to 5, wherein the distal portion further comprises:

[0144] A fifth region is distal to the curved fourth region and proximal to the distal end and defines a fifth length within the second plane, wherein the fifth length is less than or equal to approximately 5 mm.

[0145] Embodiment Ex7: The catheter according to any one of embodiments Ex1 to 6, wherein the catheter is configured to be implanted into the right ventricle of the patient's heart from at least one of the patient's left cephalic vein, axillary vein, and left subclavian vein through the right atrium.

[0146] Embodiment Ex8: The catheter of any one of Embodiments Ex3 to 6, wherein the distal portion further comprises:

[0147] a curved sixth region defining a sixth radius and a sixth angle within the first plane proximal to the first region; and

[0148] a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length lying within the first plane,

[0149] wherein the sixth angle is about 80 degrees to about 120 degrees,

[0150] wherein the proximal portion is harder than the distal portion, and

[0151] Wherein the curved sixth region, the substantially straight seventh region, the first region and the curved second region are stiffer than the third region and the curved fourth region.

[0152] Embodiment Ex9: The catheter according to embodiment Ex8, wherein the catheter is configured to be implanted into the right ventricle of the patient's heart from at least one of the patient's right cephalic vein, right subclavian vein, and the axillary vein through the right atrium.

[0153] Embodiment Ex10: The catheter of any one of Embodiments Ex2 to 9, wherein the first region further defines a first radius and a first angle, and wherein the first radius is about 80 mm to about 120 mm, and wherein the first angle is less than or equal to about 60 degrees.

[0154] Embodiment Ex1 1: The catheter of any one of Embodiments Ex3 to 10, wherein the third length is about 1 mm to about 10 mm.

[0155] Embodiment Ex 12: The catheter according to any one of embodiments Ex 7 to 11, wherein the sixth radius is about 40 mm to about 80 mm.

[0156] Embodiment Ex 13: The catheter according to any one of Embodiments Ex 7 to 11, wherein the seventh length is about 50 mm to about 150 mm.

[0157] Embodiment Ex 14: The catheter of any one of Embodiments Ex 2 to 13, wherein the first region defines a first length and the curved second region defines a second length, and wherein the second length is greater than the first length.

[0158] Embodiment Ex 15: The catheter of embodiment Ex 14, wherein the curved fourth region defines a fourth length, and wherein the fourth length is greater than the first length, and wherein the fourth length is less than the second length.

[0159] Embodiment Ex 16: The catheter of any one of Embodiments Ex 7 to 15, wherein the curved sixth region defines a sixth length, and wherein the sixth length is greater than the second length.

[0160] Embodiment Ex 17: The catheter according to any one of Embodiments Ex 1 to 16, wherein the proximal portion is at least partially composed of a material having a Shore hardness of about 70D to about 74D and may additionally or alternatively have a Young's modulus of about 1400 MPa.

[0161] Embodiment Ex18: A catheter according to any one of Embodiments Ex2 to 17, wherein the first region and the curved second region are each at least partially composed of a material having a Shore hardness of about 55D to about 74D and may additionally or alternatively have a Young's modulus of about 703 MPa to about 510 MPa.

[0162] Embodiment Ex19: A catheter according to any one of embodiments Ex6 to 18, wherein the third region, the curved fourth region and the fifth region are each at least partially composed of a material having a Shore hardness of about 30D to about 72D and may additionally or alternatively have a Young's modulus of about 414 MPa to about 170 MPa.

[0163] Embodiment Ex20: A catheter according to any one of embodiments Ex7 to 19, wherein the curved sixth region and the substantially straight seventh region are each at least partially composed of a material having a Shore hardness of about 55D to about 74D and may additionally or alternatively have a Young's modulus of about 88 MPa to about 19 MPa.

[0164] Embodiment Ex21: The catheter of any one of Embodiments Ex1 to 20, wherein when the first plane is oriented substantially parallel to the coronal plane of the body, the region of the fourth curve extends in a direction from the coronal plane toward the dorsal region of the body.

[0165] Example Ex22: A method comprising:

[0166] Advancing a catheter through the right ventricle toward a selected location adjacent to a portion of a left bundle branch of the patient, wherein the catheter comprises:

[0167] a preformed elongated tubular member extending from a proximal end to a distal end and defining a lumen extending therebetween, the elongated tubular member including a proximal portion adjacent the proximal end and a distal portion adjacent the distal end, wherein the distal portion defines a curvilinear shape in a relaxed state, and

[0168] The distal portion includes:

[0169] a curved second region defining a second radius and a second angle within the first plane; and

[0170] a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane,

[0171] wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees,

[0172] wherein the second radius is from about 25 mm to about 115 mm,

[0173] wherein the fourth radius is from about 10 mm to about 35 mm, and

[0174] wherein the second radius is greater than the fourth radius; and

[0175] advancing a medical device through the lumen and out of the distal end of the preformed elongated tubular member to a selected location for at least one of therapy delivery or sensing,

[0176] The curved shape and stiffness of the catheter facilitate advancement of the medical device without relative movement of the catheter during advancement of the medical device.

[0177] Embodiment Ex23: A catheter configured to deliver a lead or other secondary device into a patient's heart via the right ventricle and adjacent to a portion of the patient's left bundle branch, wherein the catheter comprises:

[0178] an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body,

[0179] wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and the distal portion defines a curvilinear shape in a relaxed state,

[0180] The distal portion includes:

[0181] a first region distal to the proximal portion and defining a first length lying within the first plane;

[0182] a curved second region distal to the first region and defining a second radius and a second angle within the first plane;

[0183] a third region distal to the curved second region and defining a third length lying within the first plane;

[0184] a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane;

[0185] a curved sixth region proximal to the first region and defining a sixth radius and a sixth angle within the first plane; and

[0186] a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length lying within the first plane;

[0187] wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees,

[0188] wherein the second radius is from about 25 mm to about 115 mm,

[0189] wherein the fourth radius is from about 10 mm to about 35 mm,

[0190] wherein the sixth radius is about 40 mm to about 80 mm, and

[0191] The second radius and the sixth radius are each larger than the fourth radius.

[0192] Embodiment Ex24: A catheter configured to deliver a lead or other secondary device into the patient's heart adjacent to a portion of the patient's left bundle branch via at least one of the patient's left cephalic vein, axillary vein, and left subclavian vein through the right atrium and into the right ventricle of the patient's heart, wherein the catheter comprises:

[0193] an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body,

[0194] wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and the distal portion defines a curvilinear shape in a relaxed state,

[0195] The distal portion includes:

[0196] a first region defining a first radius and a first angle within a first plane;

[0197] a curved second region distal to the first region and defining a second radius and a second angle within the first plane;

[0198] a third region distal to the curved second region and defining a third length lying within the first plane; and

[0199] a curved fourth region distal to the third region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane,

[0200] The first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees.

[0201] Embodiment Ex25: A catheter configured to enter the right ventricle of a patient's heart through the right atrium via at least one of the patient's right cephalic vein, right subclavian vein, and axillary vein, to deliver a lead or other secondary device into the patient's heart adjacent to a portion of the patient's left bundle branch, wherein the catheter comprises:

[0202] an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body,

[0203] wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and the distal portion defines a curvilinear shape in a relaxed state,

[0204] The distal portion includes:

[0205] a first region defining a first radius and a first angle within a first plane;

[0206] a curved second region distal to the first region and defining a second radius and a second angle within the first plane;

[0207] a third region distal to the curved second region and defining a third length lying within the first plane;

[0208] a curved fourth region distal to the third region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane;

[0209] a fifth region distal to the curved fourth region and proximal to the distal end and defining a fifth length lying within the second plane;

[0210] a curved sixth region distal to the proximal portion and defining a sixth radius and a sixth angle within the first plane proximal to the first region; and

[0211] a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length lying within the first plane,

[0212] The first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees.

[0213] The present disclosure has been provided with reference to exemplary embodiments and examples, and is not intended to be construed in a limiting sense. As previously mentioned, those skilled in the art will recognize that various other exemplary applications can utilize the beneficial properties of the apparatus and methods described herein using the techniques described herein. Various modifications of the exemplary embodiments and examples will become apparent after reference to this specification.

[0214] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a non-transitory computer-readable medium that corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0215] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the term "processor," as used herein, may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

[0216] All references and publications cited herein are expressly incorporated by reference in their entirety for all purposes unless in any respect directly inconsistent with this disclosure.

[0217] Unless otherwise specified, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of the present disclosure.

[0218] Unless otherwise indicated, all numerical values ​​expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as modified by the terms "exactly" or "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by one skilled in the art utilizing the teachings disclosed herein or, for example, within typical ranges of experimental error.

[0219] The recitation of numerical ranges by endpoints includes all numbers within the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within the range. As used herein, the term "at most" or "not more than" a number (e.g., at most 50) includes that number (e.g., 50), and the term "not less than" a number (e.g., not less than 5) includes that number (e.g., 5).

[0220] The terms "coupled" or "connected" refer to elements being directly attached to one another (in direct contact with one another) or indirectly attached (with one or more elements between and attaching the two elements). Both terms can be modified by the interchangeable use of "operably" and "operably" to describe a coupling or connection configured to allow the components to interact to perform at least some function (e.g., a mobile user device can be operatively coupled to a cellular network to send data to or receive data from it).

[0221] References to "one embodiment," "an embodiment," "certain embodiments," or "some embodiments," etc., mean that a particular feature, configuration, component, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases in various places throughout are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, configurations, components, or characteristics may be combined in any suitable manner in one or more embodiments.

[0222] As used in this specification and the appended claims, the singular forms "a," "an," and "the" encompass embodiments having plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense, including "and / or," unless the context clearly dictates otherwise.

[0223] As used herein, “having,” “including,” “comprising,” etc. are used in their open-ended sense and generally mean “including, but not limited to.” It should be understood that “consisting essentially of,” “consisting of,” etc. are encompassed by “comprising,” etc.

[0224] The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0225] The phrases "at least one of," "including at least one of," and "one or more of" following a list refer to any one of the items in the list and any combination of two or more items in the list.

Claims

1. A catheter configured to deliver a lead or other secondary device into a patient's heart via the right ventricle and adjacent a portion of the patient's left bundle branch, wherein the catheter comprises: an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body, wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and wherein the distal portion defines a curvilinear shape in a relaxed state, wherein the distal portion comprises: a curved second region defining a second radius and a second angle within the first plane; and a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane, wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees, wherein the second radius is from about 25 mm to about 115 mm, wherein the fourth radius is from about 10 mm to about 35 mm, and The second radius is greater than the fourth radius.

2. The catheter of claim 1 , wherein the distal portion further comprises: A first region is proximal to the curved second region and defines a first length that lies within the first plane.

3. The catheter according to any one of claims 1 to 2, wherein the distal portion further comprises: A third region is distal to the curved second region and defines a third length that lies within the first plane.

4. The catheter according to any one of claims 1 to 3, wherein the second angle is from about 85 degrees to about 230 degrees, and The fourth angle is about 55 degrees to about 180 degrees.

5. The catheter according to any one of claims 3 to 4, wherein the proximal portion is harder than the distal portion, and The first region and the curved second region are harder than the third region and the curved fourth region.

6. The catheter according to any one of claims 1 to 5, wherein the distal portion further comprises: A fifth region is distal to the curved fourth region and proximal to the distal end and defines a fifth length lying within the second plane, wherein the fifth length is less than or equal to approximately 5 mm.

7. The catheter of any one of claims 1 to 6, wherein the catheter is configured to be implanted into the right ventricle of the patient's heart from at least one of the patient's left cephalic vein, axillary vein, and left subclavian vein through the right atrium.

8. The catheter according to any one of claims 3 to 6, wherein the distal portion further comprises: a curved sixth region defining a sixth radius and a sixth angle within the first plane proximal to the first region; and a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length lying within the first plane, wherein the sixth angle is about 80 degrees to about 120 degrees, wherein the proximal portion is harder than the distal portion, and wherein the curved sixth region, the substantially straight seventh region, the first region, and the curved second region are stiffer than the third region and the curved fourth region.

9. The catheter of claim 8, wherein the catheter is configured to be implanted into the right ventricle of the patient's heart from at least one of the patient's right cephalic vein, right subclavian vein, and the axillary vein through the right atrium.

10. The catheter of any one of claims 2 to 9, wherein the first region further defines a first radius and a first angle, and wherein the first radius is about 80 mm to about 120 mm, and wherein the first angle is less than or equal to about 60 degrees.

11. The catheter of any one of claims 3 to 10, wherein the third length is about 1 mm to about 10 mm.

12. The catheter of any one of claims 7 to 11, wherein the sixth radius is about 40 mm to about 80 mm.

13. The catheter of any one of claims 7 to 11, wherein the seventh length is about 50 mm to about 150 mm.

14. The catheter of any one of claims 2 to 13, wherein the first region defines a first length and the curved second region defines a second length, and wherein the second length is greater than the first length.

15. The catheter of any one of claims 1 to 14, wherein the proximal portion is at least partially constructed of a material having a Shore durometer of about 70D to about 74D.

16. The catheter of any one of claims 2 to 15, wherein the first region and the curved second region are each at least partially constructed of a material having a Shore durometer of about 55D to about 74D.

17. The catheter of any one of claims 6 to 16, wherein the third region, the curved fourth region, and the fifth region are each at least partially constructed of a material having a Shore durometer of about 30D to about 72D.

18. The catheter of any one of claims 7 to 17, wherein the curved sixth region and the substantially straight seventh region are each at least partially constructed of a material having a Shore durometer of about 55D to about 74D.

19. The catheter of any one of claims 1 to 18, wherein when the first plane is oriented substantially parallel to a coronal plane of the body, the curved fourth region extends in a direction from the coronal plane toward a dorsal region of the body.

20. A method comprising: Advancing a catheter through the right ventricle toward a selected location adjacent to a portion of a left bundle branch of the patient, wherein the catheter comprises: a preformed elongated tubular member extending from a proximal end to a distal end and defining a lumen extending therebetween, the elongated tubular member including a proximal portion adjacent the proximal end and a distal portion adjacent the distal end, wherein the distal portion defines a curvilinear shape in a relaxed state, and wherein the distal portion comprises: a curved second region defining a second radius and a second angle within the first plane; and a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane, wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees, wherein the second radius is from about 25 mm to about 115 mm, wherein the fourth radius is from about 10 mm to about 35 mm, and wherein the second radius is greater than the fourth radius; and advancing a medical device through the lumen and out of the distal end of the preformed elongated tubular member to a selected location for at least one of therapy delivery or sensing, The curved shape and stiffness of the catheter facilitate advancement of the medical device without relative movement of the catheter during advancement of the medical device.

21. A catheter configured to deliver a lead or other secondary device into a patient's heart via the right ventricle and adjacent a portion of the patient's left bundle branch, wherein the catheter comprises: an elongated tubular member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end sized for introduction into a patient's body, wherein the elongated tubular member is preformed and further comprises a distal portion adjacent the distal end and a proximal portion adjacent the proximal end, and wherein the distal portion defines a curvilinear shape in a relaxed state, wherein the distal portion comprises: a first region distal to the proximal portion and defining a first length lying in a first plane; a curved second region distal to the first region and defining a second radius and a second angle within the first plane; a third region distal to the curved second region and defining a third length lying within the first plane; a curved fourth region distal to the curved second region and defining a fourth radius and a fourth angle lying in a second plane different from the first plane; a curved sixth region proximal to the first region and defining a sixth radius and a sixth angle lying within the first plane; and a substantially straight seventh region distal to the curved sixth region and proximal to the first region and defining a seventh length lying within the first plane; wherein the first plane and the second plane intersect at a plane intersection angle between about 50 degrees and about 110 degrees, wherein the second radius is from about 25 mm to about 115 mm, wherein the fourth radius is from about 10 mm to about 35 mm, wherein the sixth radius is from about 40 mm to about 80 mm, and The second radius and the sixth radius are each greater than the fourth radius.

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