Implantable lead

Abstract

An implantable lead is described that includes a header coupler, a helical shaft, and a fixation helix. The header coupler extends from a proximal end to a distal end and defines a central lumen from the proximal end to the distal end. The header coupler includes a base section and a distal tube section extending from the base section to the distal end. The helical shaft includes a proximal handle that extends into the central lumen of the header coupler through a distal opening of the distal tube section. The fixation helix is mounted to a distal section of the helical shaft and is configured to penetrate tissue of a patient. A surface of the header coupler directly engages and fixedly secures to a surface of the helical shaft forming a sealed joint that seals the central lumen of the header coupler and prevents fluid migration into the central lumen of the lead.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 728,839 entitled “IMPLANTABLE LEAD”, filed on December 6, 2024, the subject of which is incorporated herein by reference in its entirety. Technical Field

[0003] The embodiments of this disclosure generally relate to implantable leads, and more specifically to implantable leads for medical devices within a patient. Background Technology

[0004] Some implantable medical devices are used to monitor a patient's cardiac activity and / or deliver electrical therapy to cardiac tissue, among other things. Some pacemakers and implantable cardioverter-defibrillators (ICDs) use insulated leads, implantable cardiac leads, or simply leads, to monitor the heart and provide stimulation therapy by delivering electrical pacing pulses and / or electric shocks. Some leads pierce the myocardial tissue of the heart to deliver stimulation therapy directly into the tissue. Some leads include a central lumen (e.g., a channel) that allows delivery of another tool through the lead body. This other tool can be a stylet, used to manipulate the lead during implantation and / or to remove the lead during retrieval (e.g., lead removal). For example, a locking stylet can be inserted from the proximal end of the lead through the central lumen. The stylet can provide structural support and maneuverability to the lead during implantation and / or removal. During removal, the stylet can be inserted through the central lumen to obtain traction on the inner coil within the lead.

[0005] It is desirable to keep the central lumen of the lead open and unobstructed to allow the core and other tools to be fully inserted into the lead. For example, if the core cannot reach a threshold proximity to the distal end of the lead, multiple sections of the lead may be damaged when the core applies traction on the lead. For instance, a portion of the lead furthest from the core may stretch and break (e.g., fracture), which could substantially impede and complicate the removal procedure.

[0006] The central lumen of the lead may become blocked due to the presence of organic tissue from the patient penetrating it. For example, blood may seep into the central lumen while the lead is inside the patient. Blood in the central lumen may coagulate and harden over time, which may limit or prevent the needle and other instruments from reaching the desired distance within the lead. Therefore, lead removal procedures may experience one or more undesirable effects, such as limited traction and / or an increased risk of lead damage (e.g., breakage).

[0007] An implantable lead is needed that is designed to seal the central lumen to prevent blood and other patient tissue from flowing into it, thereby keeping the central lumen open and unobstructed to accommodate the core needle and other instruments. Summary of the Invention

[0008] According to embodiments described herein, an implantable lead is provided, comprising a header coupling, a helix shaft, and a fixation helix. The header coupling extends from a proximal end to a distal end of the header coupling. The header coupling defines a central lumen extending from the proximal end to the distal end. The header coupling includes a base segment and a distal cannula segment extending from the base segment to the distal end. The helix shaft includes a proximal shank that extends through a distal opening in the distal cannula segment into the central lumen of the header coupling. The fixation helix is ​​mounted to the distal segment of the helix shaft and configured to penetrate the patient's tissue. The surface of the header coupling directly engages and securely fastens to the surface of the helix shaft, forming a sealing joint that seals the central lumen of the header coupling and prevents fluid migration into the central lumen of the lead.

[0009] According to embodiments described herein, an implantable lead is provided, comprising a head connector, a helical shaft, and a fixing helix. The head connector extends from a proximal end to a distal end of the head connector. The head connector defines a central lumen extending from the proximal end to the distal end. The head connector includes a base segment and a distal cannula segment extending from the base segment to the distal end. The helical shaft includes a proximal shank that extends through a distal opening of the distal cannula segment into the central lumen of the head connector. The fixing helix is ​​mounted to the distal segment of the helical shaft and configured to penetrate the patient's tissue. The distal cannula segment of the head connector is crimped onto the proximal shank of the helical shaft, forming a crimp connector that seals the central lumen of the head connector and prevents fluid migration through the distal end and into the central lumen of the lead.

[0010] According to embodiments herein, a method for assembling the distal segment of an implantable lead is provided. The method includes obtaining a head connector extending from a proximal end of the head connector to a distal end. The head connector defines a central lumen extending from the proximal end to the distal end. The head connector includes a base segment and a distal cannula segment extending from the base segment to the distal end. The method includes loading a proximal shank of a helical shaft through a distal opening of the distal cannula segment into the central lumen of the head connector. The method includes attaching a retaining helix to the distal segment of the helical shaft. The retaining helix penetrates the patient's tissue. The method includes forming a sealing joint between a surface of the head connector and a surface of the helical shaft to seal the central lumen of the head connector and prevent fluid migration into the central lumen of the lead. The surface of the head connector directly engages at the sealing joint and is securely fastened to the surface of the helical shaft.

[0011] According to embodiments described herein, an implantable lead is provided, comprising a head connector, a helical shaft, and a fixing helix. The head connector extends from a proximal end to a distal end of the head connector. The head connector defines a central lumen extending from the proximal end to the distal end. The helical shaft includes a proximal shank extending into the central lumen of the head connector. The fixing helix is ​​mounted to the distal segment of the helical shaft and configured to penetrate the patient's tissue. A surface of the head connector directly engages and is securely fastened to a surface of the helical shaft, forming a sealing joint that seals the central lumen of the head connector and prevents fluid migration through the distal end and into the central lumen of the lead. The sealing joint is one of: (i) a press-fit mating interface between the inner surface of the head connector defining the central lumen and the outer surface of the helical shaft, or (ii) a welded joint between the surface of the head connector and the surface of the helical shaft. Attached Figure Description

[0012] Figure 1 A schematic cross-sectional view of the heart is shown relative to an implantable system including an IMD and implantable leads.

[0013] Figure 2 This is another schematic cross-sectional view of the heart, showing the location of His bundle (e.g., His bundle) within the heart.

[0014] Figure 3 An implantable lead according to an embodiment is shown.

[0015] Figure 4 This is a front view of the head connector of the implantable lead according to an embodiment.

[0016] Figure 5 yes Figure 4 Cross-sectional view of the head connector.

[0017] Figure 6 This is a partial cross-sectional view of the head accessory of the implantable lead according to an embodiment.

[0018] Figure 7 This is a partial cross-sectional view of the distal segment of the implanted lead according to an embodiment.

[0019] Figure 8 According to the second embodiment Figure 6 and Figure 7 A close-up partial cross-sectional view of the head accessory shown.

[0020] Figure 9 This is a close-up partial cross-sectional view of the head accessory according to the third embodiment.

[0021] Figure 10 This is a close-up partial cross-sectional view of the head accessory according to the fourth embodiment.

[0022] Figure 11 This is a flowchart of a method for assembling the distal segment of an implantable lead according to an embodiment. Detailed Implementation

[0023] It will be readily understood that, in addition to the exemplary embodiments described herein, the components of the embodiments generally described and illustrated in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following more detailed description of the exemplary embodiments illustrated in the drawings is not intended to limit the scope of the claimed embodiments, but is merely representative of exemplary embodiments.

[0024] Throughout this specification, references to "an embodiment" or "an embodiment" (etc.) mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, phrases such as "in one embodiment" or "in an embodiment" appearing in various places throughout this specification do not necessarily refer to the same embodiment.

[0025] Furthermore, the described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Numerous specific details are provided in the following description to give a thorough understanding of the embodiments. However, those skilled in the art will recognize that various embodiments can be practiced without one or more specific details or using other methods, components, materials, etc. In other instances, well-known structures, materials, or operations have not been shown or described in detail to avoid confusion. The following description is intended only as an example and simply illustrates certain exemplary embodiments.

[0026] The methods described herein can take the structure or aspects of various embodiments discussed herein (e.g., systems and / or implanted leads and / or IMDs). In various embodiments, certain operations may be omitted or added, certain operations may be combined, certain operations may be performed simultaneously, certain operations may be performed concurrently, certain operations may be divided into multiple operations, certain operations may be performed in different orders, or certain operations or a series of operations may be re-executed iteratively. It should be noted that other methods may be used according to the embodiments described herein. Furthermore, where indicated, the methods may be implemented wholly or partially by one or more processors of one or more IMDs, devices, or systems. While the operation of some methods may be described as being performed by one or more processors of a device(s), additionally, some or all of these operations may be performed by one or more processors of another device(s) described herein.

[0027] Embodiments may be implemented in conjunction with one or more implantable medical devices (IMDs). Non-limiting examples of IMDs include neurostimulatory therapy devices such as cardiac monitoring devices, pacemakers, cardioversion devices, rhythm management devices, defibrillators, neurostimulators, etc. For example, an IMD may include one or more structural and / or functional aspects of the devices described in U.S. Patent 9,333,351, "Neurostimulation Method and System to Treat Apnea," and U.S. Patent 9,044,610, "System and Methods for Providing a Distributed Virtual Stimulation Cathode for Use With An Implantable Neurostimulation System," which are incorporated herein by reference.

[0028] All references cited in this document, including publications, patent applications and patents, are incorporated herein by reference to the extent that each reference is individually and specifically indicated by reference and is also presented in its entirety in this document.

[0029] The embodiments described herein depict an implantable lead designed to have an integrated blood seal. More specifically, the implantable lead described herein includes a distal portion designed to prevent blood and other organic fluids from entering the central lumen of the implantable lead. The distal portion of the lead partially includes a head connector (e.g., a head connector member) and a helical shaft. The head connector defines a central lumen representing a distal segment of the central lumen of the implantable lead. At least a portion of the helical shaft extends into the central lumen of the head connector. The helical shaft is mounted to a retaining helix designed to penetrate the patient's tissue to secure the distal end of the lead to the patient. The integrated blood seal is defined by a sealing joint between the surface of the head connector and the surface of the helical shaft. In various embodiments, the sealing joint is formed by direct contact (e.g., engagement) between the respective surfaces of the two components. The sealing joint securely fastens the head connector to the helical shaft. For example, once the sealing joint is formed, the head connector is rigidly fixed to the helical shaft. The head connector may not be able to rotate or translate relative to the helical shaft.

[0030] In the first embodiment, the sealing joint is a crimp joint. For example, the distal section of the head connector can be circumferentially crimped onto the shank of the auger to achieve a sealing joint. The crimping operation can cause the distal section to have an annular indentation (e.g., deformation) along its outer surface. The annular indentation can be attributed to the crimping tool.

[0031] In a second embodiment, the sealing joint is a welded joint, such that the head connector is welded to the helical shaft. For example, the distal end of the head connector may be welded to the proximal side of the intermediate flange of the helical shaft. In another example, the distal end of the head connector may be welded to the outer surface of the helical shaft (e.g., the cylindrical outer surface of the helical shaft shank). In yet another example, the proximal end of the head connector may be welded to the outer surface of the helical shaft to form a sealing joint.

[0032] In the third embodiment, the sealing joint is defined by a press-fit interface between the inner surface of the head connector and the outer surface of the helical shaft. For example, the shank of the helical shaft may taper gradually in the proximal direction along the mating section of the proximal shank. When the shank of the helical shaft is inserted into the central cavity of the head connector through the distal opening of the head connector, the tapered mating section forms a press-fit interface with the inner surface of the head connector.

[0033] Typically, the implantable leads described herein have a head connector permanently engaged with a helical shaft that seals the central (e.g., internal) cavity of the implantable lead to prevent any blood intrusion. The technical effect of the implantable leads described herein is that the central lumen of the implantable lead will remain accessible and unobstructed throughout its implantation lifespan. As an example, the central lumen can remain free of the patient's clotted blood and other organic fluids. With the central lumen open, a physician or other operator can efficiently and effectively remove the implantable lead from the patient as desired or necessary. For example, a locking pin can reach a desired depth or distance within the central lumen to allow the locking pin to apply sufficient tensile load (e.g., traction) on the inner coil of the implantable lead to remove the lead without breakage. In another example, a torque-driven pin can reach a desired depth or distance within the central lumen to allow a torque-driven probe to apply sufficient torque to the fixation elements and / or head connector of the implantable lead to facilitate reverse rotation for removal of the implantable lead.

[0034] In example applications, the implantable leads described herein may be cardiac leads implanted into a patient's cardiac tissue. The implantable leads may be designed to directly deliver electrical stimulation therapy to the cardiac tissue. In example applications, the implantable leads may be used to deliver electrical stimulation in the form of conduction system pacing (CSP). CSP is a cardiac pacing technique involving the implantation of a pacing or defibrillation lead into the interventricular septum between the left and right ventricles to reach the left ventricular bundle branch (LBB) of the His bundle in the heart. The systems and / or IMDs described herein may optionally use more than one of the implantable leads described herein.

[0035] Figure 1 A schematic cross-sectional view of heart 10 relative to implantable system 50 is shown. Heart 10 includes right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV. During normal operation of heart 10, deoxygenated blood from the body returns to right atrium RA via superior vena cava 12 and inferior vena cava 14. Right atrium RA pumps blood to right ventricle RV via atrioventricular valve or tricuspid valve 16, and right ventricle RV then pumps blood to lungs via pulmonary valve 18 and pulmonary artery 20 for reoxygenation and carbon dioxide removal. Neooxygenated blood from lungs is delivered to left atrium LA, which pumps blood to left ventricle LV via mitral valve 22. Left ventricle LV pumps blood throughout the body via aortic valve 24 and aorta 26.

[0036] Figure 2This is another schematic cross-sectional view of the heart 10, showing the location of His bundle 30 (also known as the His bundle) within the heart 10. The His bundle 30 consists of rapidly conducting muscle fibers that begin at the atrioventricular node in the right atrium and propagate to the interventricular septum 32 (also known as the diaphragmatic wall) between the left and right ventricles. The His bundle 30 branches into a right branch and a pair of left branches within the interventricular septum 32. The His bundle 30 serves as the initial path for electrical impulses to travel from the atria to the ventricles. For example, the His bundle 30 transmits electrical signals from the atrioventricular (AV) node to the right and left bundle branches. The right branch travels along the right side of the interventricular septum 32 and supplies excitation to the right ventricle as part of the heart's conduction system. The left bundle branch (LBB) travels along the left side of the interventricular septum 32 and supplies excitation (e.g., electrical impulses) to the Purkinje fibers and the left ventricle. The LBB facilitates synchronized contraction of the left ventricle. The fibers in the branches terminate in a broad network of Purkinje fibers, which distribute the excitation pulses to the cell layer beneath the endocardium.

[0037] Return to Figure 1 The implantable system 50 includes an IMD 52, which is operatively coupled to the implantable lead 54 via a lead adapter 56. The lead adapter 56 is configured to receive a lead connector (not shown) of the implantable lead 54. Although in Figure 1 In this embodiment, implantable system 50 includes only one implantable lead, but in other embodiments, implantable system 50 may include multiple leads, i.e., at least two implantable leads. In one embodiment, implantable lead 54 is a so-called implantable cardiac lead designed to penetrate the cardiac tissue of heart 10. In an example, implantable lead 54 may be positioned and advanced to penetrate the endocardium of septal wall 32 to reach the LBB of His bundle 30. Implantable lead 54 may be a transvenous lead, which enters the vascular system through one of several possible vascular access locations. For example, implantable lead 54 may extend through superior vena cava 12 to the right atrium RA.

[0038] The IMD 52 may be a pulse generator device. In one embodiment, the IMD 52 may be a cardiac pacemaker. However, in other embodiments, the IMD 52 may be an intracardiac defibrillator (ICD), a cardiac resynchronization therapy defibrillator (CRT-D), or the implantable system 50 may include an ICD coupled to a pacemaker, etc. The IMD 52 may be a dual-chamber stimulation device capable of treating both rapid and slow arrhythmias using stimulation therapy (including cardioversion, defibrillation, and pacing stimulation), and capable of detecting heart failure, assessing its severity, tracking its progression, and controlling the delivery of treatment and responding to warnings thereto. The IMD 52 may be controlled to sense atrial and ventricular waveforms of interest, distinguish between two or more ventricular waveforms of interest, deliver stimulation pulses or shocks, and suppress the application of stimulation pulses to the heart based on the distinction between waveforms of interest. The IMD 52 may provide pacing stimulation to the LBB via an implantable lead 54.

[0039] Although not shown, the IMD 52 can communicate wirelessly with external devices, such as programmer devices. These external devices can be used by doctors or other technicians to select and / or modify treatment parameters to be implemented by the IMD 52, or to transmit information bidirectionally between the IMD 52 and a remote monitoring system (not shown).

[0040] Figure 3 An implantable lead 100 according to an embodiment is illustrated. The implantable lead 100 may be... Figure 1 The implantable lead 54 is shown. The implantable lead 100 extends from a proximal end 102 to a distal end 104. The implantable lead 100 includes a retaining spiral 106 at the distal end 104. In an embodiment, the implantable lead 100 includes a terminal connection segment 108 at the proximal end 102. The implantable lead 100 includes a lead body 110 extending from the terminal connection segment 108 to an electrode at or near the distal end 104. The implantable lead 100 may have a distal segment 130 at the distal end 104.

[0041] The distal segment 130 includes a retaining screw 106 protruding beyond the distal end 114 of the outer sheath or cannula 132 of the implantable lead 100. The retaining screw 106 may be a corkscrew designed to be screwed into cardiac tissue. The retaining screw 106 may be made of a metallic material. A rotational torque applied to the implantable lead 100 can drive the retaining screw 106 into cardiac tissue (such as the septal wall 32) to engage and coil the implantable lead 100 into the tissue. The retaining screw 106 can anchor the distal end 104 of the implantable lead 100 to the tissue. In the embodiments described herein, the retaining screw 106 is fixed in place relative to the lead body 110 and the outer sheath 132. For example, the retaining screw 106 permanently protrudes beyond the distal end 114 of the outer sheath 132.

[0042] This contrasts with some known implantable leads that have selectively extendable fixation spirals. Selectively extendable fixation spirals can be fully nested within the lumen of the lead body in the retracted state and can protrude beyond the distal end of the lead body in the extended state. A disadvantage of these known leads is the potential for leakage paths, allowing blood and other organic fluids from the patient to penetrate the central lumen of the lead. For example, the fixation spiral must have some clearance within the surrounding components to allow movement of the fixation spiral relative to the surrounding components. These clearances allow leakage paths into the central lumen, particularly when the fixation spiral is in the extended state and there is an axial gap in the distal region of the lead. The implantable lead 100 according to the embodiments described herein has an integrated blood seal that prevents blood and other organic fluids from penetrating the central lumen. For example, the fixation spiral 106 may not be relative to other parts of the lead (e.g., Figure 4 The head connector 200 shown translates in the distal and proximal directions.

[0043] Terminal connection section 108 is designed to be accommodated in IMD 52 (e.g. Figure 1 In a socket or lead adapter 56 (as shown) (such as a pulse generator device). Terminal connection section 108 may have an IS1 / DF1 configuration, an IS4 / DF4 configuration, or another configuration. Terminal connection section 108 may include conductive contacts 122 and electrically insulating portions 124 alternating with the conductive contacts 122. Conductive contacts 122 may be ring contacts, pin contacts, and / or the like.

[0044] The implantable lead 100 includes multiple electrodes for delivering electrical stimulation to a patient's cardiac tissue. For example, the implantable lead 100 may include a defibrillation (e.g., shock) coil 116, a tip electrode 118, and one or more loop electrodes 120. Electrodes 116, 118, and 120 may be spaced apart along the length of the implantable lead 100. In one embodiment, a retaining spiral 106 may be (e.g., representing) a tip electrode 118. One or more loop electrodes 120 may be arranged between the defibrillation coil 116 and the tip electrode 118. In the illustrated example, the implantable lead 100 has two loop electrodes 120, but in other example embodiments, it may have only one or more loop electrodes 120. In one embodiment, the implantable lead 100 includes at least one loop electrode 120, a tip electrode 118, and a defibrillation coil 116. In another embodiment, the implantable lead 100 includes a tip electrode 118 and at least one loop electrode 120, but does not include a defibrillation coil 116.

[0045] The implantable lead 100 includes an electrical conductor extending from electrodes 116, 118, 120 through lead body 110 to a corresponding conductive contact 122 of terminal connection section 108. The electrical conductor may be a helical coil, a multifilament conductor, and / or the like. Pacing pulses from the IMD 52 can be delivered via one or more electrical conductors to at least one of the loop and tip electrodes 118, 120 to pace cardiac tissue. Defibrillation shocks from the IMD 52 can be delivered via one or more electrical conductors to defibrillation coil 116 to shock cardiac tissue.

[0046] Figure 4 This is a front view of the implantable lead connector 200 according to an embodiment. The lead connector 200 may be... Figure 3 This is a portion of the implantable lead 100 shown. For example, a head connector 200 may be positioned in the distal segment 130 of the implantable lead 100. In one embodiment, the head connector 200 has an integral, one-piece (e.g., monolithic) body 202. The body 202 extends continuously from a proximal end 204 of the head connector 200 to a distal end 206 of the head connector 200. The head connector 200 has a tubular shape and defines a central lumen 208 therethrough. The central lumen 208 may extend from the proximal end 204 to the distal end 206 and may open at both ends 204, 206. The central lumen 208 is designed to receive at least a portion of a helical shaft inserted into the central lumen 208 through a distal opening 210 of the head connector 200 (e.g., at the distal end 206).

[0047] Figure 5 yes Figure 4 A cross-sectional view of the head connector 200. The cross-section is along... Figure 4The wire 5-5 is cut and bisectes the head connector 200. In various embodiments, the head connector 200 is fitted to a helical shaft to form a sealing joint that seals the central lumen of the implantable lead 100 from blood and other organic fluids. The helical shaft can be mounted to a fixed helix, for example... Figure 3 The fixed spiral 106 shown.

[0048] Reference Figure 4 and Figure 5 In this embodiment, the head connector 200 includes a base section 212, a distal tube section 214, and a proximal tube section 216. The base section 212 is arranged along the length of the head connector 200 between the distal tube section 214 and the proximal tube section 216. The distal tube section 214 extends from the base section 212 to a distal end 206. The proximal tube section 216 extends from the base section 212 to a proximal end 204. A central lumen 208 extends continuously through all three sections 212, 214, and 216. The central lumen 208 is defined by an inner surface 222 of the head connector 200. The inner surface 222 may have a cylindrical shape. In this embodiment, the three sections 212, 214, and 216 are different parts of a single body 202, and therefore the sections 212, 214, and 216 are seamlessly connected. In another embodiment, the head connector 200 may be defined by two or three components joined together during the assembly process, rather than as part of a single body. For example, the distal tube section 214 and / or the proximal tube section 216 may be screwed into the base section 212 via helical threads, or chemically bonded with an adhesive, etc. In an embodiment, the base 212 includes a base flange 218. The base flange 218 is an annular flange with a diameter larger than that of the distal tube section 214 and the proximal tube section 216.

[0049] In an example embodiment, the distal tube section 214 is designed to be crimped onto a helical shaft that extends through a distal opening 210 into a central cavity 208. For example, the distal tube section 214 has an elongated length to accommodate a crimping tool applied along the distal tube section 214 to the outer surface 224 of the head connector 200. The crimping tool may be a circumferential crimping tool that presses the distal tube section 214 radially inward around and radially inward to compress the distal tube section 214 into permanent (e.g., continuous) mechanical contact with a portion of the helical shaft located within the central cavity 208. In the example, the length of the distal tube section 214 may be at least 30% of the axial length of the head connector 200 (from proximal end 204 to distal end 206). In the illustrated example, the length of the distal tube section 214 is at least half the length of the head connector 200.

[0050] In one embodiment, the distal tube segment 214 includes an annular crimp landing region 220. The wall thickness of the distal tube segment 214 along the annular crimp landing region 220 is less than the wall thickness of the distal tube segment 214 outside the annular crimp landing region 220. For example, the distal tube segment 214 is defined by a cylindrical wall 226. The cylindrical wall 226 is thinner along the annular crimp landing region 220 than the region along the distal tube segment 214 proximal and / or distal to the annular crimp landing region 220. The annular crimp landing region 200 extends axially from the proximal shoulder 230 of the distal tube segment 214 to the distal shoulder 232 of the distal tube segment 214. The reduced wall thickness makes the distal tube segment 214 more flexible, thereby allowing the distal tube segment 214 to deform with less force by a crimping tool than would be with a larger wall thickness. In an example embodiment, the distal tube section 214 includes a distal radial lip 228 extending from the distal shoulder 232 to the distal end 206. The distal radial lip 228 has a greater wall thickness than the annular pressing landing region 220. Figure 4 and Figure 5 The head connector 200 is shown before the head connector 200 undergoes a crimping operation. For example, Figure 4 and Figure 5 The head connector 200 is in a pre-pressed state. In this example, the head connector 200 is made of metal. The head connector 200 can be formed by molding processes, etc.

[0051] Figure 6 This is a partial cross-sectional view of the head assembly 300 of the implantable lead according to an embodiment. The head assembly 300 includes... Figure 4 and Figure 5 The head connector 200 is shown. Figure 6 The head accessory 300 includes a head connector 200, a helical shaft sub-accessory 301 including a helical shaft 302, and a fixing helix 106. The head connector 200 is shown in cross-section to allow observation of the interior of the central cavity 208. Other components are not shown in cross-section. The head accessory 300 may be... Figure 3 This is a portion of the implantable lead 100 shown. For example, a head accessory 300 may be positioned in the distal segment 130 of the implantable lead 100.

[0052] A retaining screw 106 is mounted to the distal segment 304 of the screw shaft 302. As described above, the retaining screw 106 is configured to penetrate the patient's tissue. The screw shaft 302 also includes a proximal shank 306 extending into the central lumen 208 of the head connector 200. The proximal shank 306 enters the central lumen 208 through a distal opening 210 of the distal tube segment 214. During assembly, the surface of the head connector 200 directly engages and is securely fastened to the surface of the screw shaft 302, forming a sealing joint 308 that seals the central lumen 208 of the head connector 200 and prevents fluid migration through the distal end 206 and into the central lumen of the lead 100.

[0053] In the illustrated embodiment, the sealing joint 308 is a crimp joint 310. The crimp joint 310 is positioned along the distal tube section 214 of the head connector 200. For example, even if blood or other organic fluids can enter the distal opening 210 of the head connector 200, the crimp joint 310 prevents the blood or other organic fluids from moving beyond the crimp joint 310 in the proximal direction. In the illustrated embodiment, the crimp joint 310 is defined between the inner surface 222 of the head connector 200 (along the distal tube section 214) and the outer surface 312 of the proximal shank 306. The crimp joint 310 is formed by applying a crimping tool (e.g., a crimping die) to the distal tube section 214 and then applying radial force via the crimping tool to press the head connector 200 against the proximal shank 306 of the helical shaft 302. The terms “crimp” and “crimping” as used herein include swaging. The crimp connector 310 is a mechanical seal. In the example, both the helical shaft 302 and the head connector 200 are made of metal. The crimp connector 310 can be a metal-to-metal mechanical joint.

[0054] The crimping operation deforms the distal tube section 214 and the proximal shank 306. For example, the interface between the inner surface 222 and the outer surface 312 in the region of the crimping joint 310 may be irregular or otherwise altered relative to the interface outside the region of the crimping joint 310. The crimping joint 310 is aligned with the annular crimp landing region 220 of the distal tube section 214. For example, a crimping tool may be applied along the annular crimp landing region 220 onto the outer surface 224 of the distal tube section 214. Due to the force applied by the crimping tool onto the outer surface 224, the distal tube section 214 may have an annular indentation 316 along the outer surface 224 after the crimping operation. The annular indentation 316 may be a groove or other groove caused by the compressive force of the crimping tool. In an embodiment, the annular indentation 316 is positioned along the annular crimp landing region 220. The crimping joint 310 locks the auger 302 to the head connector 200. For example, after the crimping operation, the spiral shaft 302 is axially and rotatably fixed in place relative to the head connector 200. Due to the crimping joint 310, the spiral shaft 302 can be inseparable from the head connector 200.

[0055] In the illustrated embodiment, the helical shaft 302 includes an intermediate flange 320 disposed between a proximal shank 306 and a distal segment 304 of the helical shaft 302. The distal end 206 of the head connector 200 may abut the proximal side 321 of the intermediate flange 320. For example, during assembly, the proximal shank 306 may be loaded into the central cavity 208 of the head connector 200 until the proximal side 321 of the intermediate flange 320 abuts against the distal end 206 of the abutting head connector 200, thereby preventing further advancement into the central cavity 208. A crimping operation may be performed when the distal end 206 contacts the proximal side 321. Optionally, after the crimping operation, the distal end 206 may be at least slightly spaced from the proximal side 321. For example, the crimp connector 310 is located near the distal end 206 of the head connector 200, so once the crimp connector 310 is established, it is not necessary to ensure that the distal end 206 remains in contact with the intermediate flange 320 of the auger shaft 302.

[0056] The retaining screw 106 is fastened to the distal section 304 of the helical shaft 302. In the illustrated embodiment, the distal section 304 of the helical shaft 302 includes a distal boss 322. For example, an intermediate flange 320 may be axially arranged between the proximal shank 306 and the distal boss 322. The distal boss 322 may extend from the intermediate flange 320 to the distal end of the helical shaft 302. The proximal section of the retaining screw 106 may surround and mechanically engage the peripheral surface of the distal boss 322 to mount the retaining screw 106 to the helical shaft 302. Alternatively, the mounting may be reinforced by welding the retaining screw 106 to the distal boss 322, by applying an adhesive to bond the retaining screw 106 to the distal boss 322, etc. In another alternative example, the distal boss 322 may include one or more protrusions, such as tabs or helical threads, which are mechanically engaged with the proximal section of the retaining screw 106 to reinforce the connection. In another embodiment, the helical shaft 302 may be omitted. Figure 6 The distal boss 322 is shown. For example, the proximal end of the retaining auger 106 may be welded, glued, or otherwise secured to the distal side of the intermediate flange 320 of the auger shaft 302.

[0057] In an embodiment, the retaining screw 106 is axially fixed in place relative to the head connector 200 via the crimp connector 310 and the mounting of the retaining screw 106 to the screw shaft 302. For example, the head connector 200, the screw shaft 302, and the retaining screw 106 can be fastened together as a unit. In the example, the retaining screw 106 is rotatably fixed to the head connector 200 via the screw shaft 302. As a result, the three components 106, 200, and 302 of the head accessory 300—namely, the retaining screw 106, the head connector 200, and the screw shaft 302—can rotate together without relative rotational movement. Thus, a torque applied to the proximal end of the screw shaft 302 and / or the proximal end 204 of the head connector 200 in a first rotational direction (such as clockwise) can cause the head accessory 300 to rotate relative to the patient in the first rotational direction. The torque can be applied by inserting a core needle (e.g., a locking core needle) through the central lumen of the implantable lead 100. Rotation in the first direction causes the fixing screw 106 to spiral into the patient tissue in the forward direction. Torque applied in the opposite second direction of rotation (such as counterclockwise) causes the head accessory 300 to rotate together in the second direction of rotation, which causes the fixing screw to spiral out of the patient tissue.

[0058] Figure 7 This is a partial cross-sectional view of the distal segment 402 of the implantable lead 400 according to an embodiment. The distal segment 402 includes... Figure 6 The head accessory 300 is shown. The distal segment 402 may be... Figure 3The distal segment 130 of the implantable lead 100 is shown. For example, the implantable lead 400 may be... Figure 3 The implantable lead 100 is shown in the figure. Figure 7 This illustrates an example lead configuration including the head accessory 300. In other embodiments, the head accessory 300 may be part of a different implantable lead.

[0059] The distal segment 402 includes an outer sheath 404 that surrounds a portion of the head connector 200, the helical shaft 302, and the retaining helix 106. The distal portion of the retaining helix 106 protrudes beyond the distal end 406 of the outer sheath 404. The outer sheath 404 may be an electrically insulating and tubular component (such as a sleeve). In one example, the outer sheath 404 is made of silicone. In another example, the outer sheath 404 may be made of a different polymer material. In this embodiment, the outer sheath 404 may extend from the annular electrode 408 of the implantable lead 400 to the distal end 406. For example, the outer sheath 404 may extend from the edge of the exposed portion 410 of the annular electrode 408. The exposed portion 410 may be exposed to the patient's organic tissues and fluids and may serve as an electrode surface for delivering pacing pulses and / or sensing electrical signals.

[0060] In an embodiment, the implantable lead 400 includes an inner sheath 412 and an inner coil 414 within the inner sheath 412. The inner sheath 412 may surround and mechanically engage the outer surface 224 of the head connector 200 along the proximal tubular section 216. The inner sheath 412 may be an electrically insulating and tubular component (such as a sleeve). The inner coil 414 may surround and mechanically and electrically engage a portion of the proximal shank 306 of the helical shaft 302. The inner coil 414 is conductive. The inner coil 414 may be made of a metallic material. The inner coil 414 may be an electrical conductor that extends through the lead body 110 to electrically connect electrodes to corresponding conductive contacts 122 of the terminal connection section 108 (in Figure 3 (As shown in the diagram). For example, the inner coil 414 can be electrically connected to the fixed screw 106, which serves as a tip electrode. The inner coil 414 can be electrically connected to the fixed screw 106 via the screw shaft 302.

[0061] In one embodiment, the distal segment 402 of the implantable lead 400 includes a head canister 416 having a cylindrical shape and defining a cavity 418. The distal tube segment 214 of the head connector 200 is disposed within the cavity 418. The head canister 416 may be made of a metallic material. The proximal end 420 of the head canister 416 may be fastened to the base segment 212 and / or the distal tube segment 214 of the head connector 200. For example, the proximal end 420 may be soldered to the base segment 212 of the head connector 200. An outer sheath 404 may surround the head canister 416.

[0062] In one embodiment, the distal segment 402 includes a cylindrical support member 422 located distal to the helical shaft 302 and surrounded by a fixing helix 106. For example, the cylindrical support member 422 may be arranged adjacent to the distal boss 322 of the helical shaft 302. The fixing helix 106 may coil around the cylindrical support member 422 within the cavity 418 of the head canister 416 and within the outer sheath 404. The cylindrical support member 422 may be optional. In another embodiment, the distal segment 402 may lack the cylindrical support member 422.

[0063] The inner coil 414 and / or inner sheath 412 define a central lumen 424. The central lumen 424 extends at least a majority of the length of the implantable lead 400 from the distal segment 402 toward the proximal end 420 of the implantable lead 400. The central lumen 424 is referred to herein as the lead central lumen 424. The lead central lumen 424 is fluidly connected to and coaxial with the central lumen 208 of the head connector 200. The central lumen 424 provides a channel for the insertion of tools, such as probes, into the implantable lead 400. The tools can be used to assist in manipulating the implantable lead 400 through the patient's transvenous system during implantation and removal. A crimp connector 310 seals the central lumen 208 of the head connector 200, which constructively seals the distal end 406 of the lead central lumen 424 to prevent fluid migration through the distal end 406 and into the central lumen of the lead 100. For example, the inner coil 414 and / or inner sheath 412 may surround and seal to the proximal tubular section 216 of the head connector 200. The central lumen 208 of the head connector 200 serves as an extension of the lead central lumen 424. The crimp connector 310 prevents blood and other organic fluids from entering the lead central lumen 424 through the head connector 200. Due to the crimp connector 310, the lead central lumen 424 remains free of (e.g., completely free of) coagulated blood and other bodily fluids. Locking needles and other tools can access the distal segment 402 of the implantable lead 400 through the lead central lumen 424 without being blocked by blood or other bodily fluids. In summary, the crimp connector 310 prevents migrating fluid from filling the central lumen 424, causing coagulation, thereby blocking the long portion of the central lumen 424 of the implantable lead 400. This results in full access to the central lumen 424, thus providing a benefit at a later time during the extraction of the implanted lead 400, as the extraction lead can be fully inserted from the proximal end 420 and anchored at the distal end 406.

[0064] exist Figure 7 In this embodiment, the outer sheath 404 is described as an integral tubular member (e.g., a sleeve). In another embodiment, the outer sheath may be a combination of multiple components. For example, the outer sheath may be defined by a sleeve and a distal tip member. The distal tip member may extend from the distal end of the sleeve to the distal end 406.

[0065] Figure 8 According to the second embodiment Figure 6 and Figure 7 The image shows a close-up partial cross-sectional view of the head accessory 300. The head accessory 300 includes a head connector 200, a spiral shaft 302, and a retaining spiral 106. A head canister 416 is also shown. The head connector 200 and the head canister 416 are shown in cross-section. Similar to... Figure 6 and Figure 7 In the illustrated embodiment, the head connector 200 is directly engaged and securely fastened to the auger shaft 302 via a sealing joint 308. The sealing joint 308 seals the central cavity 208 of the head connector 200 and prevents fluid migration through the distal end 206 and into the central cavity of the lead 100. In the illustrated embodiment, the sealing joint 308 is a welded joint 500. The welded joint 500 is formed between the distal end 206 of the head connector 200 and the proximal side 321 of the intermediate flange 320 of the auger shaft 302. The welded joint 500 may extend circumferentially along the entire annular surface of the head connector 200. The welded joint 500 seals the distal opening 210 of the distal tube section 214. The welded joint 500 prevents blood and / or other organic fluids from entering the central cavity 208 through the distal opening 210. The welded joint 500 can be formed by spot welding the distal end 206 of the head connector 200 to the intermediate flange 320. The welding process uses high temperature to permanently connect the distal side 502 of the head connector 200 to the proximal side 321 of the intermediate flange 320 of the screw shaft 302 at the weld joint 500.

[0066] Figure 9 This is a close-up partial cross-sectional view of the head accessory 300 according to the third embodiment. Figure 9 The third embodiment shown is similar to Figure 8 The second embodiment shown is because the sealing joint 308 is a welded joint. Figure 9 The weld joint 510 is located within the central cavity 208 of the head connector 200. For example, the weld joint 510 is formed between the outer surface 312 of the proximal shank 306 of the helical shaft 302 and the inner surface 222 of the head connector 200. The weld joint 510 can be located anywhere along the length of the head connector 200. In one example, the weld joint 510 is located at or near the distal end 206 of the head connector 200 (e.g., within 1 mm or 2 mm), such as... Figure 9 As shown. In another example, weld joint 510 can be spaced further away from distal end 206. The function of weld joint 510 is the same as... Figure 8 The welded joint 500 is identical to the one in the middle, and the central inner cavity 208 is sealed to prevent blood and other fluids from penetrating through the central inner cavity 208 (e.g., entering). Figure 7(See the inner cavity 424 of the lead center shown). The weld joint 510 can be formed by spot welding the inner surface 222 of the head connector 200 to the outer surface 312 of the helical shaft 302. The welding process uses high temperature to permanently connect the inner surface 222 to the outer surface 312 at the weld joint 510.

[0067] Figure 10 This is a close-up partial cross-sectional view of the head accessory 300 according to the fourth embodiment. The head accessory 300 includes a head connector 200, a spiral shaft 302, and a fixing spiral 106. The head connector 200 is shown in cross-section. Similar to... Figures 6 to 9 In the illustrated embodiment, the head connector 200 is directly engaged and securely fastened to the auger 302 via a sealing joint 308. The sealing joint 308 seals the central cavity 208 of the head connector 200 and prevents fluid migration through the distal end 206 and into the central cavity of the lead 100. In the illustrated embodiment, the sealing joint 308 is defined by a press-fit interface 520 between the inner surface 222 of the head connector 200 and the outer surface 312 of the auger 302. The proximal shank 306 of the auger 302 tapers proximally along at least a mating section 522 of the proximal shank 306. For example, the proximal end of the mating section 522 of the proximal shank 306 has a smaller diameter than the distal end of the mating section 522. When the proximal shank 306 is inserted into the central cavity 208 through the distal opening 210, the mating section 522 forms a press-fit interface 520 with the inner surface 222 of the head connector 200. The press-fit interface 520 can be defined by direct surface-to-surface contact between the two components. The helical shaft 302 can be loaded into the central cavity 208 with sufficient mechanical force through the distal opening 210 to reliably seal the central cavity 208 to prevent the penetration of blood and other bodily fluids.

[0068] In various alternative embodiments, the head connector 200 may omit the proximal cannula section 216. For example, the head connector 200 may include only the base section 212 and the distal cannula section 214. The base section 212 may define the proximal end of the head connector 200. The inner coil 414 and / or inner sheath 412 of the implantable lead 400 ( Figure 7 (As shown in the diagram) It can be directly fastened and sealed to the base section 212 of the head connector 200. This first alternative head connector design can replace Figures 4 to 10 The head connector 200 shown is shown.

[0069] In a second alternative head connector design, the head connector 200 may omit the distal tube section 214. For example, the head connector 200 may include only the proximal tube section 216 and the base section 212. The base section 212 may define a distal opening leading to the central lumen 208. In a first alternative embodiment, the sealing joint 308 is defined by a press-fit interface between the inner surface 222 of the head connector 200 located at the distal end of the base section 212 and the outer surface 312 of the helical shaft 302. For example, Figure 10 The tapered mating section 522 shown can form a press-fit interface with the inner surface 222 along the base section 212 of the head connector 200. In a second alternative embodiment using a head connector lacking the distal tube section, the sealing joint 308 is similar to... Figure 8 and Figure 9 The weld joint shown is a weld joint. The weld joint may be located along the base section 212 or the proximal tube section 216 between the outer surface 312 of the proximal shank 306 of the auger 302 and the inner surface 222 of the head connector. In a third alternative embodiment using a head connector lacking the distal tube section, the sealing joint 308 is a crimp joint positioned along the proximal tube section 216 of the head connector 200. For example, a crimping tool may radially compress the proximal tube section 216 to permanently engage with the proximal shank 306 of the auger 302 extending through the proximal tube section 216. Generally, various features and examples described herein may be combined unless the combination of the first and second features would impair the function of one feature or render one feature useless.

[0070] Figure 11 This is a flowchart of a method 600 for assembling a distal segment of an implantable lead according to an embodiment. Method 600 can be used to assemble the distal segment 300 and its components, such as... Figures 4 to 10 As shown in the illustration. In different embodiments, the method may include... Figure 11 Different steps not shown in the diagram can be omitted. Figure 11 One or more of the steps shown, and / or may have the same as Figure 11 The different order of steps shown are illustrated. The order of steps may differ from the order presented below. In one example, step 606 may occur before step 604.

[0071] At step 602, a head connector 200 extending from its proximal end 204 to its distal end 206 is obtained. The head connector 200 may have a tubular shape. The head connector 200 defines a central lumen 208 extending from the proximal end 204 to the distal end 206. The head connector 200 includes a base segment 212 and a distal tubular segment 214 extending from the base segment 212 to the distal end 206. The head connector 200 may also include a proximal tubular segment 216 extending from the base segment 212 to the proximal end 204.

[0072] At step 604, the proximal end of the helical shaft fitting 301 is mounted on the distal opening 210 of the distal tube section 214 via the central cavity 208 of the head connector 200.

[0073] At step 608, a sealing joint 308 is formed between the surface of the head connector 200 and the surface of the screw shaft fitting 301 to seal the central cavity 208 of the head connector 200. In one example, the surface of the head connector 200 may be directly engaged at the sealing joint 308 and securely fastened to the surface of the screw shaft fitting 301.

[0074] In a first embodiment, forming a sealing joint 308 includes crimping a distal tube section 214 of the head connector 200 onto a proximal shank 306 of the helical shaft 302, forming a crimped joint 310 that seals the central cavity 208 of the head connector 200 and prevents fluid migration through the distal end 206 and into the central cavity of the lead 100. The distal tube section 214 may include an annular crimp landing region 220. The wall thickness of the distal tube section 214 along the annular crimp landing region 220 is less than the wall thickness of the distal tube section 214 outside the annular crimp landing region 220. Crimping allows the crimped joint 310 to be positioned along the annular crimp landing region 220.

[0075] In the second embodiment, forming the sealing joint 308 includes forming welded joints 500 and 510 by welding the surface of the head connector 200 to the surface of the auger shaft 302. The auger shaft 302 may include an intermediate flange 320 disposed between the proximal shank 306 and the distal segment 304 of the auger shaft 302. The welded joint 500 may be formed by welding the distal end 206 of the head connector 200 to the proximal side 321 of the intermediate flange 320 of the auger shaft 302. The welded joint 510 may be formed by welding the inner surface 222 of the head connector 200 to the outer surface 312 of the proximal shank 306 of the auger shaft 302.

[0076] In a third embodiment, forming the sealing joint 308 includes press-fitting the outer surface 312 of the helical shaft 302 onto the inner surface 222 of the head coupler 200 defining a central cavity 208. In the example, the proximal shank 306 of the helical shaft 302 tapers proximally along at least a mating section 522 of the proximal shank 302. The press-fitting includes inserting the proximal shank 302 through the distal opening 210 of the distal tube section 214 into the central cavity 208 to form a press-fitting interface 520 with the inner surface 222 of the head coupler 200.

[0077] At step 610, at least a portion of the head connector 200 and the helical shaft accessory 301 may be loaded into the cavity 418 of the head can 416. The head can 416 may be made of a metallic material. The head can 416 may have a cylindrical shape. The method may include securing the proximal end 420 of the head can 416 to the base section 212 of the head connector 200.

[0078] At step 612, an outer sheath 404 or insulator is applied to surround the distal portion of the head can 416, the head connector 200, and the helical shaft fitting 301.

[0079] Method 600 may include one or more additional steps. The additional steps may involve connecting the assembled distal segment to other components of the implantable lead (such as an inner coil, inner sheath, ring electrode, and / or the like).

[0080] Furthermore, this disclosure includes examples pursuant to the following terms:

[0081] Clause 1. An implantable lead, comprising:

[0082] A head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end;

[0083] A helical shaft, the helical shaft including a proximal shank extending through a distal opening of the distal tube section into the central cavity of the head connector; and

[0084] A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue.

[0085] The surface of the head connector is directly engaged with and fixedly fastened to the surface of the helical shaft, forming a sealed joint to prevent fluid from migrating into the central cavity of the lead wire.

[0086] Clause 2. The implantable lead according to Clause 1, wherein the sealing connector is a crimped connector and positioned along the distal tube section of the head connector, wherein the surface of the head connector forming the sealing connector is an inner surface defining the central lumen, and the surface of the helical shaft forming the sealing connector is an outer surface of the proximal shank.

[0087] Clause 3. The implantable lead as described in Clause 2, wherein the distal tube segment has an annular indentation along the outer surface of the head connector, the annular indentation being attributable to a crimping tool.

[0088] Clause 4. An implantable lead according to Clause 2 or Clause 3, wherein the distal tube segment includes an annular compression landing region, wherein the wall thickness of the distal tube segment along the annular compression landing region is less than the wall thickness of the distal tube segment outside the annular compression landing region.

[0089] Clause 5. The implantable lead according to any one of Clauses 1 to 4 further includes an outer sheath surrounding the head connector and the helical shaft, wherein a portion of the fixing helix protrudes beyond the distal end of the outer sheath.

[0090] Clause 6. An implantable lead according to any one of Clauses 1 to 5, wherein the retaining spiral is axially fixed in place relative to the head connector via the sealing joint between the head connector and the spiral shaft.

[0091] Clause 7. An implantable lead according to any one of Clauses 1 to 6, wherein the sealing joint is a welded joint.

[0092] Clause 8. An implantable lead according to any one of Clauses 1 to 7, wherein the helical shaft includes an intermediate flange disposed between the proximal shank and the distal segment of the helical shaft, and the distal end of the head connector abuts against the proximal side of the intermediate flange of the helical shaft.

[0093] Clause 9. The implantable lead as described in Clause 8, wherein the sealing joint is a welded joint between the distal end of the head connector and the proximal side of the intermediate flange of the helical shaft.

[0094] Clause 10. An implantable lead according to any one of Clauses 1 to 6 and 8, wherein the sealing joint is defined by a press-fit interface between the inner surface of the head connector defining the central cavity and the outer surface of the helical shaft.

[0095] Clause 11. The implantable lead according to Clause 10, wherein the proximal shank of the helical shaft tapers in the proximal direction along at least a mating section of the proximal shank, and when the proximal shank is inserted into the central cavity through the distal opening, the mating section forms the press-fit interface with the inner surface of the head connector.

[0096] Clause 12. An implantable lead according to any one of Clauses 1 to 11, wherein the head connector has a proximal canal section extending from the base section to the proximal end of the head connector, wherein the implantable lead comprises:

[0097] Inner sheath, the inner sheath surrounding and engaging the outer surface of the proximal tube section; and

[0098] The inner coil within the inner sheath surrounds and engages a portion of the proximal shank of the helical shaft.

[0099] Clause 13. The implantable lead according to any one of Clauses 1 to 12 further includes a head canister having a cylindrical shape and defining a cavity, wherein a proximal end of the head canister is fastened to the base section of the head connector, and a distal tube section of the head connector is disposed within the cavity of the head canister, the head canister being made of a metallic material.

[0100] Clause 14. An implantable lead according to any one of Clauses 1 to 13, wherein the distal segment of the helical shaft includes a distal boss, and the retaining helix surrounds and engages the peripheral surface of the distal boss to mount the retaining helix to the distal segment of the helical shaft.

[0101] Clause 15. An implantable lead, comprising:

[0102] A head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end;

[0103] A helical shaft, the helical shaft including a proximal shank extending through a distal opening of the distal tube section into the central cavity of the head connector; and

[0104] A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue.

[0105] The distal tube section of the head connector is pressed onto the proximal shank of the helical shaft to form a crimped joint that seals the central cavity of the head connector.

[0106] Clause 16. The implantable lead according to Clause 15, wherein the inner surface of the head connector defining the central cavity is directly engaged and securely fastened to the outer surface of the proximal shank via the crimping joint.

[0107] Clause 17. An implantable lead according to Clause 15 or Clause 16, wherein the distal tube segment has an annular indentation along the outer surface of the head connector, the annular indentation being attributable to a crimping tool.

[0108] Clause 18. A method for assembling the distal segment of an implantable lead, the method comprising:

[0109] A head connector is obtained, the head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end;

[0110] The proximal shank of the helical shaft is loaded into the central cavity of the head connector through the distal opening of the distal tube section;

[0111] A fixation spiral is attached to the distal segment of the spiral shaft, the fixation spiral being configured to penetrate the patient's tissue; and

[0112] A sealing joint is formed between the surface of the head connector and the surface of the helical shaft to seal the central cavity of the head connector and prevent fluid from migrating into the central cavity of the lead wire, wherein the surface of the head connector is directly engaged at the sealing joint and securely fastened to the surface of the helical shaft.

[0113] Clause 19. The method according to Clause 18, wherein forming the sealing joint comprises pressing the distal tube section of the head connector onto the proximal shank of the helical shaft to form a crimped joint that seals the central cavity of the head connector.

[0114] Clause 20. The method according to Clause 19, wherein the distal pipe section includes an annular crimp landing region, wherein the wall thickness of the distal pipe section along the annular crimp landing region is less than the wall thickness of the distal pipe section outside the annular crimp landing region, wherein the crimping causes the crimp joint to be positioned along the annular crimp landing region.

[0115] Clause 21. The method according to Clause 18, wherein forming the sealing joint comprises forming a welded joint by welding the surface of the head connector to the surface of the helical shaft.

[0116] Clause 22. The method according to Clause 21, wherein the auger shaft includes an intermediate flange disposed between the proximal shank and the distal section of the auger shaft, and forming the weld joint includes welding the distal end of the head connector to the proximal side of the intermediate flange of the auger shaft.

[0117] Clause 23. The method according to Clause 18, wherein forming the sealing joint includes press-fitting the outer surface of the helical shaft onto the inner surface of the head connector defining the central cavity.

[0118] Clause 24. The method according to Clause 23, wherein the proximal shank of the helical shaft tapers gradually in the proximal direction along at least a mating section of the proximal shank, and the press-fit includes inserting the proximal shank into the central cavity through the distal opening of the distal tube section to form a press-fit interface with the inner surface of the head connector.

[0119] Clause 25. The method according to any one of Clauses 18 to 24 further includes:

[0120] The distal tube section of the head connector, at least a portion of the helical shaft, and a portion of the fixing helix are loaded into the cavity of the head can, the head can being made of metal and having a cylindrical shape; and

[0121] Secure the proximal end of the head canister to the base section of the head connector.

[0122] Clause 26. The method according to any one of Clauses 18 to 25 further includes applying an outer sheath around the head connector and the helical shaft, wherein a portion of the fixing helix protrudes beyond the distal end of the outer sheath.

[0123] Clause 27. The method according to any one of Clauses 18 to 26, wherein the distal section of the helical shaft includes a distal boss, and mounting the fixing helix to the distal section of the helical shaft includes loading the fixing helix onto the distal boss to surround and engage the peripheral surface of the distal boss.

[0124] Clause 28. An implantable lead, comprising:

[0125] A head connector extending from a proximal end of the head connector to a distal end of the head connector, the head connector defining a central cavity extending from the proximal end to the distal end;

[0126] A helical shaft, the helical shaft including a proximal shank extending into the central cavity of the head connector; and

[0127] A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue.

[0128] Wherein, the surface of the head connector is directly engaged and fixedly fastened to the surface of the helical shaft, forming a sealing joint that seals the central cavity of the head connector and prevents fluid migration into the central cavity of the lead wire, wherein the sealing joint is one of: (i) a press-fit interface between the inner surface of the head connector defining the central cavity and the outer surface of the helical shaft, or (ii) a welded joint between the surface of the head connector and the surface of the helical shaft.

[0129] Clause 29. The implantable lead according to Clause 28, wherein the sealing joint is a welded joint, and the welded joint is defined between the distal surface of the head connector and the outer surface of the helical shaft.

[0130] Clause 30. The implantable lead according to Clause 28, wherein the sealing connector is the press-fit interface, and the proximal shank of the helical shaft tapers in the proximal direction along at least a mating section of the proximal shank, wherein when the proximal shank is inserted into the central lumen through the distal opening of the distal tube section, the mating section of the proximal shank forms the press-fit interface with the inner surface of the head connector.

[0131] Throughout this specification, references to "an embodiment" or "an embodiment" (etc.) mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, phrases such as "in one embodiment" or "in an embodiment" appearing in various places throughout this specification do not necessarily refer to the same embodiment.

[0132] The term "defined size" as used herein is not limited to the act of manufacturing, but refers to dimensions such as length, width, and volume. Defining a cavity to accommodate a particular component is not a methodological operation, but rather a characteristic of the cavity. As used herein, the term "about" or "approximately" immediately preceding the stated value indicates that the actual value may be + / - a specified threshold. The specified threshold may be 5%, 10%, etc., of the stated value.

[0133] It should be understood that the above description is intended to be illustrative and not restrictive. For example, the above embodiments (and / or aspects thereof) can be used in combination with each other. Furthermore, many modifications can be made to adapt particular situations or materials to the teachings of the subject matter of the invention without departing from the scope of the subject matter. While the dimensions and types of materials described herein are intended to define parameters of the subject matter, they are by no means limiting, but rather exemplary embodiments. Many other embodiments will be apparent to those skilled in the art upon reading the above description. Therefore, the scope of the subject matter of the invention should be determined by reference to the appended claims and the full scope of their equivalents. In the appended claims, the terms “including” and “in which” are used as concise English equivalents to the corresponding terms “comprising” and “wherein”. Furthermore, in the following claims, the terms “first,” “second,” and “third,” etc., are used merely as designations and are not intended to impose numerical requirements on their objects. Furthermore, the limitations of the following claims are not written in the form of component plus function and are not intended to be interpreted based on 35 U.SC §112(f), unless and until such a claim limitation expressly uses the phrase “means for” followed by a functional statement without further structure.

Claims

1. An implantable lead, comprising: A head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end; A helical shaft, the helical shaft including a proximal shank that extends through a distal opening of the distal tube section into the central cavity of the head connector; as well as A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue. The surface of the head connector is directly engaged with and fixedly fastened to the surface of the helical shaft, forming a sealed joint to prevent fluid from migrating into the central cavity of the lead wire.

2. The implantable lead according to claim 1, wherein, The sealing joint is a crimped joint and is positioned along the distal tube section of the head connector, wherein the surface of the head connector forming the sealing joint is the inner surface defining the central cavity, and the surface of the helical shaft forming the sealing joint is the outer surface of the proximal shank.

3. The implantable lead according to claim 2, wherein, The distal tube section has an annular indentation along the outer surface of the head connector, which can be attributed to the crimping tool.

4. The implantable lead according to claim 2, wherein, The distal pipe section includes an annular pressing land area, wherein the wall thickness of the distal pipe section along the annular pressing land area is less than the wall thickness of the distal pipe section outside the annular pressing land area.

5. The implantable lead according to claim 1, further comprising an outer sheath surrounding the head connector and the spiral shaft, wherein, A portion of the fixing spiral protrudes beyond the distal end of the outer sheath.

6. The implantable lead according to claim 1, wherein, The fixing screw is axially fixed in place relative to the head connector via the sealing joint between the head connector and the screw shaft.

7. The implantable lead according to claim 1, wherein, The sealing joint is a welded joint.

8. The implantable lead according to claim 1, wherein, The helical shaft includes an intermediate flange disposed between the proximal shank and the distal section of the helical shaft, and the distal end of the head connector abuts against the proximal side of the intermediate flange of the helical shaft.

9. The implantable lead according to claim 8, wherein, The sealing joint is a welded joint between the distal end of the head connector and the proximal side of the intermediate flange of the helical shaft.

10. The implantable lead according to claim 1, wherein, The sealing joint is defined by the press-fit interface between the inner surface of the head connector that defines the central cavity and the outer surface of the helical shaft.

11. The implantable lead according to claim 10, wherein, The proximal shank of the helical shaft gradually tapers in the proximal direction along at least a mating section of the proximal shank, and when the proximal shank is inserted into the central cavity through the distal opening, the mating section forms the press-fit interface with the inner surface of the head connector.

12. The implantable lead according to claim 1, wherein, The head connector has a proximal cannula section extending from the base section to the proximal end of the head connector, wherein the implantable lead includes: Inner sheath, the inner sheath surrounding and engaging the outer surface of the proximal tube section; and The inner coil within the inner sheath surrounds and engages a portion of the proximal shank of the helical shaft.

13. The implantable lead of claim 1, further comprising a head canister having a cylindrical shape and defining a cavity, wherein, The proximal end of the head can is fastened to the base section of the head connector, and the distal tube section of the head connector is arranged within the cavity of the head can, the head can being made of a metallic material.

14. The implantable lead according to claim 1, wherein, The distal section of the helical shaft includes a distal boss, and the fixing helix surrounds and engages the peripheral surface of the distal boss to mount the fixing helix to the distal section of the helical shaft.

15. An implantable lead, comprising: A head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end; A helical shaft, the helical shaft including a proximal shank that extends through a distal opening of the distal tube section into the central cavity of the head connector; as well as A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue. The distal tube section of the head connector is pressed onto the proximal shank of the helical shaft to form a crimped joint that seals the central cavity of the head connector.

16. The implantable lead according to claim 15, wherein, The inner surface of the head connector defining the central cavity is directly engaged and securely fastened to the outer surface of the proximal handle via the crimp joint.

17. The implantable lead according to claim 15, wherein, The distal tube section has an annular indentation along the outer surface of the head connector, which can be attributed to the crimping tool.

18. A method for assembling the distal segment of an implantable lead, the method comprising: A head connector is obtained, the head connector extending from a proximal end to a distal end of the head connector, the head connector defining a central lumen extending from the proximal end to the distal end, the head connector including a base section and a distal tube section extending from the base section to the distal end; The proximal shank of the helical shaft is loaded into the central cavity of the head connector through the distal opening of the distal tube section; A fixation spiral is installed on the distal segment of the spiral shaft, the fixation spiral being configured to penetrate the patient's tissue; as well as A sealing joint is formed between the surface of the head connector and the surface of the helical shaft to seal the central cavity of the head connector and prevent fluid from migrating into the central cavity of the lead wire, wherein the surface of the head connector is directly engaged at the sealing joint and securely fastened to the surface of the helical shaft.

19. The method according to claim 18, wherein, Forming the sealing joint includes pressing the distal tube section of the head connector onto the proximal shank of the helical shaft to form a crimped joint that seals the central cavity of the head connector.

20. The method according to claim 19, wherein, The distal pipe section includes an annular crimped landing region, wherein the wall thickness of the distal pipe section along the annular crimped landing region is less than the wall thickness of the distal pipe section outside the annular crimped landing region, wherein the crimping causes the crimped joint to be positioned along the annular crimped landing region.

21. The method according to claim 18, wherein, Forming the sealing joint includes forming a welded joint by welding the surface of the head connector to the surface of the helical shaft.

22. The method according to claim 21, wherein, The helical shaft includes an intermediate flange disposed between the proximal shank and the distal section of the helical shaft, and forming the weld joint includes welding the distal end of the head connector to the proximal side of the intermediate flange of the helical shaft.

23. The method according to claim 18, wherein, Forming the sealing joint includes pressing the outer surface of the helical shaft onto the inner surface of the head connector that defines the central cavity.

24. The method according to claim 23, wherein, The proximal shank of the helical shaft gradually tapers in the proximal direction along at least a mating section of the proximal shank, and the press-fit includes inserting the proximal shank into the central cavity through the distal opening of the distal tube section to form a press-fit interface with the inner surface of the head connector.

25. The method of claim 18, further comprising: The distal tube section of the head connector, at least a portion of the helical shaft, and a portion of the fixing helix are loaded into the cavity of the head can, the head can being made of metal and having a cylindrical shape; and Secure the proximal end of the head canister to the base section of the head connector.

26. The method of claim 18, further comprising applying an outer sheath around the head connector and the helical shaft, wherein, A portion of the fixing spiral protrudes beyond the distal end of the outer sheath.

27. The method according to claim 18, wherein, The distal section of the helical shaft includes a distal boss, and mounting the fixing helix to the distal section of the helical shaft includes loading the fixing helix onto the distal boss to surround and engage the peripheral surface of the distal boss.

28. An implantable lead, comprising: A head connector extending from a proximal end of the head connector to a distal end of the head connector, the head connector defining a central cavity extending from the proximal end to the distal end; A helical shaft, the helical shaft including a proximal shank that extends into the central cavity of the head connector; as well as A fixation spiral is attached to the distal segment of the spiral shaft and configured to penetrate the patient's tissue. Wherein, the surface of the head connector is directly engaged and fixedly fastened to the surface of the helical shaft, forming a sealing joint that seals the central cavity of the head connector and prevents fluid migration into the central cavity of the lead wire, wherein the sealing joint is one of: (i) a press-fit interface between the inner surface of the head connector defining the central cavity and the outer surface of the helical shaft, or (ii) a welded joint between the surface of the head connector and the surface of the helical shaft.

29. The implantable lead according to claim 28, wherein, The sealing joint is a welded joint, and the welded joint is defined between the distal surface of the head connector and the outer surface of the helical shaft.

30. The implantable lead according to claim 28, wherein, The sealing joint is the press-fit interface, and the proximal shank of the spiral shaft gradually tapers in the proximal direction along at least the mating section of the proximal shank. When the proximal shank is inserted into the central cavity through the distal opening of the distal tube section, the mating section and the inner surface of the head connector form the press-fit interface.

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