Lead introducer and system including lead introducer

Abstract

A lead introducer includes a divisible sheath configured to be divided along the length of the divisible sheath, a divisible hub configured to be coupled to the proximal end region of the divisible sheath and divided into a first and a second portion, and a needle defining a channel extending along the length of the needle for the delivery of a lead through the needle, the needle not coupled to the divisible hub and the divisible sheath, and a non-cylindrical locking fixture attached to or part of the proximal end region of the needle, wherein the divisible hub includes a cavity having a shape complementary to the non-cylindrical locking fixture of the needle to hold the needle within the divisible hub and restrict the rotation of the needle relative to the divisible hub. Another lead introducer includes a divisible hub and a divisible needle attached to the divisible hub.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 542,064 filed on October 2, 2023, which is incorporated herein by reference in its entirety.

[0002] The present invention relates to the field of implantable stimulation systems and methods of making and using the systems. The present invention also relates to lead introducers for facilitating the insertion of implantable stimulation leads into a patient, as well as methods of making and using the lead introducers and stimulation leads. BACKGROUND ART

[0003] Implantable electrical stimulation systems have proven to have therapeutic effects for various diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic method for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used in the treatment of chronic pain syndromes and incontinence, and several other applications are under investigation. Functional electrical stimulation systems have been applied to restore some functionality of paralyzed limbs in patients with spinal cord injuries.

[0004] Stimulators have been developed to provide therapies for various treatments. A stimulator can include a control module (with a pulse generator), one or more leads, and a stimulator electrode array on each lead. The stimulator electrodes are in contact with or near the nerve, muscle, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. PRIOR ART DOCUMENTS PATENT DOCUMENTS

[0005] PATENT DOCUMENT 1 U.S. Patent No. 6,181,969 Specification PATENT DOCUMENT 2 U.S. Patent No. 6,295,944 [Patent Document 3] U.S. Patent No. 6,391,985 [Patent Document 4] U.S. Patent No. 6,516,227 [Patent Document 5] U.S. Patent No. 6,609,029 [Patent Document 6] U.S. Patent No. 6,609,032 [Patent Document 7] U.S. Patent No. 6,741,892 [Patent Document 8] U.S. Patent No. 7,244,150 [Patent Document 9] U.S. Patent No. 7,450,997 [Patent Document 10] U.S. Patent No. 7,672,734 [Patent Document 11] Strength Patent No. 7,761,165 [Patent Document 12] U.S. Patent No. 7,783,359 [Patent Document 13] U.S. Patent No. 7,792,590 [Patent Document 14] U.S. Patent No. 7,809,446 [Patent Document 15] U.S. Patent No. 7,949,395 [Patent Document 16] U.S. Patent No. 7,974,706 [Patent Document 17] U.S. Patent No. 8,831,742 [Patent Document 18] U.S. Patent No. 8,688,235 [Patent Document 19] U.S. Patent No. 6,175,710 [Patent Document 20] U.S. Patent No. 6,224,450 [Patent Document 21] U.S. Patent No. 6,271,094 Patent Document 22 U.S. Patent No. 6,364,278 Specification Patent Document 23 U.S. Patent Application Publication No. 2007 / 015003 Specification Patent Document 24 U.S. Patent Application Publication No. 2009 / 0187222 Specification Patent Document 25 U.S. Patent Application Publication No. 2009 / 0276021 Specification Patent Document 26 U.S. Patent Application Publication No. 2010 / 0076535 Specification Patent Document 27 U.S. Patent Application Publication No. 2010 / 0268298 Specification Patent Document 28 U.S. Patent Application Publication No. 2011 / 0004267 Specification Patent Document 29 U.S. Patent Application Publication No. 2011 / 0078900 Specification Patent Document 30 U.S. Patent Application Publication No. 2011 / 0130817 Specification Patent Document 31 U.S. Patent Application Publication No. 2011 / 0130818 Specification Patent Document 32 U.S. Patent Application Publication No. 2011 / 0238129 Specification Patent Document 33 U.S. Patent Application Publication No. 2011 / 0313500 Specification Patent Document 34 U.S. Patent Application Publication No. 2012 / 0016378 Specification Patent Document 35 U.S. Patent Application Publication No. 2012 / 0046710 Specification Patent Document 36 U.S. Patent Application Publication No. 2012 / 0071949 Specification Patent Document 37 U.S. Patent Application Publication No. 2012 / 0165911 Specification Patent Document 38 U.S. Patent Application Publication No. 2012 / 0197375 Specification [Patent Document 39] U.S. Patent Application Publication No. 2012 / 0203316 [Patent Document 40] U.S. Patent Application Publication No. 2012 / 0203320 Specification [Patent Document 41] U.S. Patent Application Publication No. 2012 / 0203321 [Patent Document 42] U.S. Patent Application Publication No. 2012 / 0316615 [Patent Document 43] U.S. Patent Application Publication No. 2013 / 0105071 [Patent Document 44] U.S. Patent Application Publication No. 2011 / 0005069 [Patent Document 45] U.S. Patent No. 8,224,450 [Patent Document 46] U.S. Patent Application Publication No. 2011 / 0130803 [Patent Document 47] U.S. Patent Application Publication No. 2011 / 0130816 [Patent Document 48] U.S. Patent Application Publication No. 2013 / 0197602 [Patent Document 49] U.S. Patent Application Publication No. 2013 / 0261684 [Patent Document 50] U.S. Patent Application Publication No. 2013 / 0325091 [Patent Document 51] U.S. Patent Application Publication No. 2013 / 0317587 [Patent Document 52] U.S. Patent Application Publication No. 2014 / 0039587 [Patent Document 53] U.S. Patent Application Publication No. 2014 / 0353001 [Patent Document 54] U.S. Patent Application Publication No. 2014 / 0358209 [Patent Document 55] U.S. Patent Application Publication No. 2014 / 0358210 [Patent Document 56] U.S. Patent Application Publication No. 2015 / 0018915 [Patent Document 57] U.S. Patent Application Publication No. 2015 / 0021817 [Patent Document 58] U.S. Patent Application Publication No. 2015 / 0045864 [Patent Document 59] U.S. Patent Application Publication No. 2015 / 0066120 [Patent Document 60] U.S. Patent Application Publication No. 2013 / 0197424 [Patent Document 61] U.S. Patent Application Publication No. 2015 / 0151113 [Patent Document 62] U.S. Patent Application Publication No. 2014 / 0358207 [Patent Document 63] U.S. Patent No. 8,483,237 [Patent Document 64] U.S. Patent Application Publication No. 2014 / 0296953 [Patent Document 65] U.S. Patent Application Publication No. 2014 / 0343647 [Patent 66] U.S. Patent No. 10,226,616 [Patent Document 67] U.S. Patent No. 11,529,510 [Patent Document 68] U.S. Patent Application Publication No. 2011 / 0224680 [Patent Document 69] U.S. Patent Application Publication No. 2014 / 0039586 [Patent Document 70] U.S. Patent Application Publication No. 2014 / 0276927 [Patent Document 71] U.S. Patent Application Publication No. 2015 / 0073431 [Patent Document 72] U.S. Patent Application Publication No. 2015 / 0073432 [Patent Document 73] U.S. Patent Application Publication No. 2016 / 0317800 [Patent Document 74] U.S. Patent Application Publication No. 2018 / 0333173 [Patent Document 75] U.S. Patent No. 6,437,193 [Overview of the project] [Means for solving the problem]

[0006] One embodiment is a lead introducer comprising a composite needle / sheath having a divisible sheath having a length and a proximal end region, the divisible sheath configured to be divided into a first part and a second part along the length of the divisible sheath; a divisible hub configured to be coupled to the proximal end region of the divisible sheath and to be divided into a first part and a second part; and a needle having a length and a proximal end region, the needle defining a channel extending along the length of the needle for the delivery of a lead through the needle, wherein the needle is configured to extend through the divisible hub and the divisible sheath, the needle is not coupled to the divisible hub and the divisible sheath, and a non-cylindrical locking fixture is attached to or part of the proximal end region of the needle, and the divisible hub includes a cavity having a shape complementary to the non-cylindrical locking fixture of the needle to hold the needle within the divisible hub and restrict the rotation of the needle relative to the divisible hub.

[0007] In at least some embodiments, the non-cylindrical locking fixture includes at least one wing. In at least some embodiments, the composite needle / sheath further includes a divisible lure configured to be inserted into the divisible hub to lock the non-cylindrical locking fixture of the needle into the cavity of the divisible hub, the divisible lure configured to be divided into a first part and a second part. In at least some embodiments, the needle is not joined to the divisible lure. In at least some embodiments, the divisible hub and the divisible lure include complementary positioning features that facilitate simultaneous separation of the divisible hub and the divisible lure.

[0008] Another embodiment is a lead introducer comprising a composite needle / sheath, the divisible sheath having a length and a proximal end region, the divisible sheath configured to be divided into a first part and a second part along the length of the divisible sheath; a divisible hub coupled to the proximal end region of the divisible sheath and configured to be divided into a first part and a second part; and a needle having a length and a proximal end region, the needle defining a channel extending along the length of the needle for the delivery of a lead through the needle, wherein the needle is configured to extend through the divisible hub and the divisible sheath, the needle is not joined to the divisible hub and the divisible sheath, and a divisible lure is configured to be inserted into the divisible hub and adhesively joined to the needle, the divisible lure is configured to be divided into a first part and a second part to break the adhesive bond between at least one of the first or second part of the divisible lure and the needle.

[0009] In at least some embodiments, the divisible hub and divisible lure include complementary positioning features that facilitate simultaneous divisibility of the divisible hub and divisible lure. In at least some embodiments, the divisible hub includes a body and at least two tabs extending from the body, and the divisible hub is configured to be divided together with the divisible sheath and divisible lure using at least two tabs.

[0010] In at least some embodiments of the lead introducers described above, the needle defines a slot along the length of the needle that is configured to laterally release the lead from the channel of the needle. In at least some embodiments of the lead introducers described above, the first portion of the divisible sheath is permanently attached to the first portion of the hub such that the first portion of the divisible sheath remains attached to the first portion of the hub when the hub is divided into first and second portions.

[0011] A further embodiment is a lead introducer comprising a divisible hub configured to be divided into a first part and a second part, and a divisible needle coupled to the divisible hub having a length and a proximal end region, the divisible needle defining a channel extending along the length of the divisible needle for the delivery of a lead through the divisible needle, wherein the divisible needle includes at least one splice and is configured to be divided into a first part and a second part together with the divisible hub along at least one splice.

[0012] In at least some embodiments, the divisible needle is perforated, etched, punched, cut, or grooved along at least one seam to facilitate the division of the divisible needle. In at least some embodiments, the divisible needle comprises two parts which are tacked or spot-welded along at least one seam for temporary connection of the two parts. In at least some embodiments, the lead introducer further includes a fluid-resistant coating or liner disposed over at least a portion of the inner or outer surface of the divisible needle. In at least some embodiments, the fluid-resistant coating or liner is disposed over at least a portion of at least one seam of the divisible needle.

[0013] In at least some embodiments of any of the lead introducers described above, the divisible hub includes a body and at least two tabs extending from the body, and the divisible hub is configured to be divided together with the divisible sheath using at least two tabs. In at least some embodiments of any of the lead introducers described above, the lead introducer further includes a stylet configured to be inserted into the channel of a needle. In at least some embodiments of any of the lead introducers described above, the divisible hub includes at least one slit or vulnerable area for dividing the divisible hub into first and second parts.

[0014] Another embodiment is an insertion kit comprising one of the lead introduction devices described above, and a lead configured to be implanted in a patient, the lead having a lead body with a distal end portion and a proximal end portion, a plurality of electrodes positioned at the distal end portion of the lead body, a plurality of terminals positioned at the proximal end portion of the lead body, and a plurality of conductive wires electrically connecting the electrodes to the terminals, wherein the lead is insertable through a channel in the needle.

[0015] Non-limiting and non-exclusive embodiments of the present invention will be described with reference to the following drawings. In these drawings, unless otherwise specified, similar reference numerals throughout the various drawings refer to similar parts.

[0016] For a clearer understanding of the present invention, please refer to the following "Modes for Carrying Out the Invention," which should be read in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0017] [Figure 1] This is a schematic diagram of another embodiment of an electrical stimulation system, including a transdermal lead body coupled to a control module. [Figure 2A] This is a schematic diagram of one embodiment of a plurality of connector assemblies arranged in the control module of Figure 1 and configured to receive the proximal portion of the lead body of Figure 1. [Figure 2B]Figure 1 shows the proximal portion of the lead body, a lead extension configured to connect the lead body to a control module, and a schematic diagram of one embodiment of the control module shown in Figure 1. [Figure 3A] This is a schematic perspective view of one embodiment of a two-component lead introducer, which includes a composite needle / sheath and a stylet, and is configured to facilitate the implantation of leads for an electrical stimulation system into a patient. [Figure 3B] Figure 3A is a schematic perspective view of the lead introduction device with the stylet inserted into the composite needle / sheath. [Figure 3C] Figure 3A is a schematic perspective view of the distal portion of the composite needle / sheath of the lead introduction device. [Figure 3D] Figure 3A is a schematic perspective view of the proximal portion of the composite needle / sheath of the lead introduction device. [Figure 4A] Figure 3A is a schematic perspective view of the proximal portion of the composite needle / sheath of the lead introducer, with the needle partially withdrawn from the detachable hub. [Figure 4B] Figure 3A is a schematic perspective view of the proximal portion of the composite needle / sheath of the lead introducer, with the needle inserted into the divisible hub. [Figure 4C] Figure 3A is a schematic perspective view of the proximal portion of the composite needle / sheath of the lead guide, in which the needle and detachable lure are inserted into the detachable hub. [Figure 4D] Figure 3A is a schematic end view of the detachable hub of the composite needle / sheath of the lead introduction device. [Figure 4E] Figure 3A is a schematic perspective view of the detachable lure of the composite needle / sheath of the lead introduction device. [Figure 5A] This is a schematic perspective view of one embodiment of a two-component lead introducer, which includes a divisible needle and a stylet, and is configured to facilitate the implantation of leads for an electrical stimulation system into a patient. [Figure 5B] Figure 5A is a schematic perspective view of the lead introduction device with the stylet inserted into the detachable needle. [Figure 5C]Figure 5A is a schematic perspective view of the distal portion of the divisible needle of the lead introducer, where the fluid-resistant coating or liner on the divisible needle is semi-transparent. [Figure 5D] Figure 5A is a schematic perspective view of the distal portion of the divisible needle in the lead introducer, in which a fluid-resistant coating or liner and stylet are inserted into the divisible needle. [Figure 6] This is a schematic diagram of one embodiment of a component of a stimulation system, including an electronic subassembly arranged within a control module according to the present invention. [Modes for carrying out the invention]

[0018] The present invention relates to the field of implantable stimulator systems and to methods for manufacturing and using such systems. The present invention also relates to lead guides for facilitating the insertion of implantable stimulator leads into patients, and to methods for manufacturing and using lead guides and stimulator leads.

[0019] A suitable implantable electrical stimulation system includes, but is not limited to, at least one lead with one or more electrodes positioned along the distal end of the lead, and one or more terminals positioned along the one or more proximal ends of the lead. Examples of electrical stimulation systems with leads are, for example, U.S. Patents No. 6,181,969, 6,295,944, 6,391,985, 6,516,227, 6,609,029, 6,609,032, 6,741,892, 7,244,150, 7,450,997, 7,672,734, and 7,761,165. The documents, specifications No. 7,783,359, No. 7,792,590, No. 7,809,446, No. 7,949,395, No. 7,974,706, No. 8,831,742, No. 8,688,235, No. 6,175,710, No. 6,224,450, No. 6,271,094, No. 6,295,944, No. 6,364,278, and No. 6,391,Specifications No. 985, U.S. Patent Application Publication No. 2007 / 0150036, No. 2009 / 0187222, No. 2009 / 0276021, No. 2010 / 0076535, No. 2010 / 0268298, No. 2011 / 0004267, No. 2011 / 0078900, No. 2011 / 0130817, No. 2011 / 0130 Specification No. 818, Specification No. 2011 / 0238129, Specification No. 2011 / 0313500, Specification No. 2012 / 0016378, Specification No. 2012 / 0046710, No. 2012 / 0071949 Specification, 2012 / 0165911 Specification, 2012 / 0197375 Specification, 2012 / 0203316 Specification, 2012 / 0203320 Specification, No. 2012 / 0203321 specification, 2012 / 0316615 specification, 2013 / 0105071 specification, 2011 / 0005069 specification, 2010 / 0268298 Specification, Specification No. 2011 / 0130817, Specification No. 2011 / 0130818, Specification No. 2011 / 0078900, Specification No. 2011 / 0238129, No. 2011 / 031 These are found in Specification No. 3500, No. 2012 / 0016378, No. 2012 / 0046710, No. 2012 / 0165911, No. 2012 / 0197375, No. 2012 / 0203316, No. 2012 / 0203320, and No. 2012 / 0203321, all of which are incorporated in their entirety by reference. It will be understood that the lead introducers described herein can also be used for embedding other types of leads, including but not limited to optical or electrical / optical leads.

[0020] Figure 1 schematically illustrates one embodiment of an electrical stimulation system 100. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator such as an implantable pulse generator or an in vitro test generator) 102 and at least one lead 103 that can be coupled thereto. The lead 103 includes one or more lead bodies 106, an array of electrodes 133 such as an electrode 134, and an array of terminals (e.g., 210 in Figures 2A and 2B) arranged along one or more lead bodies 106. In at least some embodiments, the lead is equidiameter along the longitudinal length of the lead body 106. Figure 1 shows one lead 103 coupled to the control module 102. Other embodiments may include two, three, four, or five or more leads 103 coupled to the control module 102.

[0021] The lead 103 can be coupled to the control module 102 in any suitable manner. In at least some embodiments, the lead 103 is coupled directly to the control module 102. In at least some other embodiments, the lead 103 is coupled to the control module 102 through one or more intermediate devices. For example, in at least some embodiments, one or more lead extensions 224 (see, for example, Figure 2B) can be placed between the lead 103 and the control module 102 to extend the distance between the lead 103 and the control module 102. In addition to or instead of one or more lead extensions, other intermediate devices can be used, such as splitters or adapters or combinations thereof. If the electrical stimulation system 100 includes multiple elongated devices between the lead 103 and the control module 102, it will be understood that these intermediate devices can be configured in any suitable arrangement.

[0022] In Figure 1, the electrical stimulation system 100 is shown to have a splitter 107 configured and positioned to facilitate coupling of a lead 103 to a control module 102. The splitter 107 includes a splitter connector 108 configured to couple the proximal end of the lead 103 to one or more splitter tails 109a and 109b configured and positioned to couple to the control module 102 (or another splitter, lead extension, or adapter, etc.).

[0023] The control module 102 typically includes a connector housing 112 and a sealed electronics housing 114. An electronics subassembly 110 and an optional power supply 121 are housed within the electronics housing 114. A control module connector 144 is housed within the connector housing 112. The control module connector 144 is configured and positioned to establish an electrical coupling between the lead 103 and the electronics subassembly 110 of the control module 102.

[0024] An electrical stimulation system, or a component of an electrical stimulation system including one or more lead bodies 106 and a control module 102, is typically implanted in a patient. Electrical stimulation systems can be used for a variety of applications, including but not limited to brain stimulation, nerve stimulation, spinal cord stimulation, muscle stimulation, and similar stimulation.

[0025] The electrodes 134 can be formed using any conductive biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, and conductive carbon, as well as combinations thereof. In at least some embodiments, one or more of the electrodes 134 are formed from one or more of platinum, platinum iridium, palladium, palladium rhodium, or titanium. The number of electrodes 134 in each array 133 can vary. For example, there may be 2, 4, 6, 8, 10, 12, 14, 16, or 17 or more electrodes 134. Other numbers of electrodes 134 can be used as long as they are recognized.

[0026] The electrodes of one or more lead bodies 106 are typically arranged in or separated by a non-conductive biocompatible material such as silicone, polyurethane, polyetheretherketone ("PEEK"), epoxy, or a combination thereof. The lead bodies 106 can be formed into a desired shape by any process including, for example, molding (including injection molding) and casting. The non-conductive material typically extends from the distal end of one or more lead bodies 106 to the proximal end of each of the lead bodies 106.

[0027] Terminals (e.g., 210 in Figures 2A and 2B) are typically positioned along the proximal ends of one or more lead bodies 106 of the electrical stimulation system 100 (and any splitter, lead extension, or adapter, etc.) to achieve electrical coupling to corresponding connector contacts (e.g., 214 in Figure 2A and 240 in Figure 2B). Connector contacts are positioned on connectors (e.g., 144 in Figures 1-2B and 221 in Figure 2B), which are positioned on, for example, a control module 102 (or a lead extension, splitter, or adapter, etc.). Conductive wires or cables (not shown) extend from the terminals to electrodes 134. One or more electrodes 134 are typically electrically coupled to each terminal. In at least some embodiments, each terminal is connected to only one electrode 134.

[0028] The conductive wires ("conductors") may be embedded in the non-conductive material of the lead body 106 or arranged in one or more lumens (not shown) extending along the lead body 106. In some embodiments, there is an individual lumen for each conductor. In other embodiments, two or more conductors extend through the lumens. Furthermore, one or more lumens (not shown) may be present opening at or near the proximal end of the lead body 106, for example, to insert a stylet to facilitate the placement of the lead body 106 into a patient. In addition, one or more lumens (not shown) may be present opening at or near the distal end of the lead body 106, for example, to inject drugs or medications into the implantation site of the lead body 106. In at least one embodiment, these one or more lumens are often or periodically flushed with saline or epidural fluid. In at least some embodiments, one or more lumens can be permanently or removablely sealed at the distal end.

[0029] Figure 2A is a schematic side view of one embodiment of the proximal end of one or more elongated devices 200 configured and arranged to be coupled to one embodiment of a control module connector 144. The one or more elongated devices may include, for example, a lead body 106, one or more intermediate devices (e.g., a splitter 107 in Figure 1, a lead extension 224 in Figure 2B, or an adapter, or a combination thereof), or a combination thereof. Figure 2A shows two elongated devices 200 coupled to a control module 102. These two elongated devices 200 may be two tails, or two different leads, or any other combination of elongated devices, as shown in Figure 1.

[0030] The control module connector 144 has at least one port into which the proximal end of the elongated device 200 can be inserted, as indicated by the directional arrows 212a and 212b. In Figure 2A (and other figures), the connector housing 112 is shown to have two ports 204a and 204b. The connector housing 112 may have any suitable number of ports, including, for example, one, two, three, four, five, six, seven, eight, or nine or more ports.

[0031] The control module connector 144 also includes multiple connector contacts, such as connector contacts 214 located within each of the ports 204a and 204b. When the elongated device 200 is inserted into ports 204a and 204b, the connector contacts 214 can align with multiple terminals 210 located along the proximal end of the elongated device 200 to electrically couple the control module 102 to an electrode (134 in Figure 1) located at the distal end of the lead 103. Examples of connectors within a control module can be found, for example, in U.S. Patent No. 7,244,150 and No. 8,224,450, which are incorporated in their entirety by reference.

[0032] Figure 2B is a schematic side view of another embodiment of the electrical stimulation system 100. The electrical stimulation system 100 includes a lead extension 224 configured and positioned to connect one or more elongated devices 200 (e.g., a lead body 106, a splitter 107, an adapter, or another lead extension, or a combination thereof) to a control module 102. In Figure 2B, the lead extension 224 is shown to connect to a single port 204 defined within the control module connector 144. The lead extension 224 is also shown to connect to a single elongated device 200. In an alternative embodiment, the lead extension 224 is configured and positioned to connect to multiple ports 204 defined within the control module connector 144, or to accept multiple elongated devices 200, or both.

[0033] A lead extension connector 221 is positioned on the lead extension 224. In Figure 2B, the lead extension connector 221 is shown positioned at the distal end 226 of the lead extension 224. The lead extension connector 221 includes a connector housing 228. The connector housing 228 defines at least one port 230 into which the terminals 210 of the elongated device 200 can be inserted, as indicated by the directional arrow 238. The connector housing 228 further includes a plurality of connector contacts, such as connector contacts 240. When the elongated device 200 is inserted into the port 230, the connector contacts 240 positioned in the connector housing 228 can align with the terminals 210 of the elongated device 200 to electrically couple the lead extension 224 to an electrode (134 in Figure 1) positioned along the lead (103 in Figure 1).

[0034] In at least some embodiments, the proximal end of the lead extension 224 is configured and positioned similarly to the proximal end of the lead 103 (or other elongated device 200). The lead extension 224 may include a plurality of conductive wires (not shown) that electrically couple to the connector contacts 240 at the proximal end 248 opposite its distal end 226. In at least some embodiments, the conductive wires arranged in the lead extension 224 can be electrically coupled to a plurality of terminals (not shown) arranged along the proximal end 248 of the lead extension 224. In at least some embodiments, the proximal end 248 of the lead extension 224 is configured and positioned to be inserted into a connector located in another lead extension (or another intermediate device). In other embodiments (as shown in Figure 2B), the proximal end 248 of the lead extension 224 is configured and positioned to be inserted into a control module connector 144.

[0035] Returning to Figure 1, at least a portion of the stimulating electrode takes the form of a segment electrode that extends only partially around the periphery (e.g., circumference) of the lead. The segment electrodes can be provided in an electrode set, each set having electrodes circumferentially distributed around the lead at specific longitudinal positions.

[0036] In at least some embodiments, the operator can use a recording electrode to determine the location of a target nerve cell and then position a stimulating electrode accordingly. In some embodiments, the same electrode can be used for both recording and stimulating. In some embodiments, separate leads can be used, one having a recording electrode for determining the target nerve cell and a second lead having a stimulating electrode that replaces the first lead after the identification of the target nerve cell. In some embodiments, the same lead may contain both a recording electrode and a stimulating electrode, or the electrodes may be used for both recording and stimulating.

[0037] In Figure 1, the electrode 134 is shown to include both a ring electrode 120 and a segment electrode 122. In some embodiments, the electrode 134 is entirely segmented. The segment electrode 122 in Figure 1 is in a set state consisting of three (one of which is not visible in Figure 1), in which case the three segment electrodes of a particular set are electrically isolated from each other and offset circumferentially along leads 1-3. Any appropriate number of segment electrodes, e.g., two, three, four, or five or more segment electrodes, can be formed in a set state. Lead 103 in Figure 1 has 30 segment electrodes 122 (10 sets, each consisting of three electrodes) and two ring electrodes 120, for a total of 32 electrodes 134.

[0038] Segment electrodes can be used to direct the stimulating current to one side of a lead or to a portion of another side. When segment electrodes are used in conjunction with an implantable pulse generator that delivers the current stimulus, current steering (i.e., radial positioning around the lead axis) can be achieved, which delivers the stimulus more precisely to a position around the lead axis. Since target structures in deep brain stimulation are typically not symmetrical around the axis of the distal electrode array, segment electrodes can provide better current steering than ring electrodes. Instead, the target can be positioned on one side of a plane extending through the lead axis. The use of segment electrode arrays allows for current steering not only along the length of the lead but also around the lead. This provides highly accurate three-dimensional targeting and delivery of current stimulus to neural target tissue while potentially avoiding stimulation of other tissues.

[0039] Examples of leads having segmented electrodes are U.S. Patent Application Publications 2010 / 0268298, 2011 / 0005069, 2011 / 0078900, 2011 / 0130803, 2011 / 0130816, 2011 / 0130817, 2011 / 0130818, 2011 / 0078900, and 20 Specification No. 11 / 0238129, Specification No. 2011 / 0313500, Specification No. 2012 / 0016378, Specification No. 2012 / 0046710, Specification No. 2012 / 0071949, Specification No. 2012 / 0165911, Specification No. 2012 / 0197375, Specification No. 2012 / 0203316, Specification No. 2012 / 0203320, Specification No. 2012 / 0203321 Specifications, Specification No. 2013 / 0197602, Specification No. 2013 / 0261684, Specification No. 2013 / 0325091, Specification No. 2013 / 0317587, No. 2014 / 00395 Specification No. 87, Specification No. 2014 / 0353001, Specification No. 2014 / 0358209, Specification No. 2014 / 0358210, Specification No. 2015 / 0018915, No. 2015 / 00 This includes U.S. Patent Publication No. 21817, No. 2015 / 0045864, No. 2015 / 0021817, No. 2015 / 0066120, No. 2013 / 0197424, No. 2015 / 0151113, No. 2014 / 0358207, and U.S. Patent No. 8,483,237, all of which are incorporated herein by reference in their entirety. Leads may also include tip electrodes, and examples of leads having tip electrodes include at least some of the references cited herein, as well as U.S. Patent Publication No. 2014 / 0296953 and No. 2014 / 0343647, all of which are incorporated herein by reference in their entirety. Leads having segment electrodes may be directional leads that can use the segment electrodes to provide stimulation in a specific direction.

[0040] Conventional percutaneous implantation techniques often involve inserting a lead guide, such as an epidural needle, into the patient. The lead is then inserted into the lead guide, which is positioned at the target stimulation site. Once the lead is properly positioned, the lead guide is removed from the patient, leaving the lead in place. In many cases, the lead guide is removed by sliding it off the proximal end of the lead. However, this action can sometimes result in lead displacement, preventing the lead from being positioned at the desired stimulation site.

[0041] Other percutaneous implantation techniques utilize lateral release lead introducers that include a multi-piece insertion needle, which allows the lead to be laterally separated from the multi-piece insertion needle instead of sliding the needle away from the end of the lead. Lateral release or lateral release can reduce unintentional movement of the lead when removing the lead introducer. Lateral release or lateral release lead introducers can be particularly useful for implanting leads with multiple tails, such as lead 103 shown in Figure 3, or arrangements of unequal diameters along a lead. Examples of lateral release or release lead introducers can be found, for example, in U.S. Patent Nos. 10,226,616 and 11,529,510, and U.S. Patent Publication Nos. 2011 / 0224680, 2014 / 0039586, 2014 / 0276927, 2015 / 0073431, 2015 / 0073432, 2016 / 0317800, and 2018 / 0333173, all of which are incorporated herein by reference in their entirety.

[0042] At least some of these lateral release lead inserters include an outer needle, an inner needle, a divisible member, and a stylet. The four components of these lateral release lead inserters increase the complexity compared to the conventional lead inserters discussed above, which use only one or more components (e.g., an epidural needle and an optional stylet). In some cases, these early lateral release lead inserters are not rigid enough, which may hinder insertion or prolong the insertion time.

[0043] To reduce the number and complexity of components, Figures 3A to 3D show a two-component lateral release lead introducer 430 having a composite needle / sheath 440 and a stylet 442. The stylet 442 includes a shaft 442a and a handle 442b. The shaft 442a of the stylet 442 is inserted into the composite needle / sheath 440, and this combination is inserted into the patient. After insertion and positioning of the lead introducer 430 at or near the implantation site, the stylet 442 is removed from the composite needle / sheath 440, and the lead is inserted into the composite needle / sheath 440 for delivery and positioning of the lead 103 at the implantation site.

[0044] In at least some embodiments, the composite needle / sheath 440 includes a divisible sheath 446, a divisible hub 444 attached thereto, and a needle 448 that is enclosed within the divisible hub or divisible sheath but is not joined. The composite needle / sheath 440 may include a divisible lure 454 that can be partially inserted into the divisible hub to retain the proximal portion 445 of the needle 448 within the divisible hub 444. Any other suitable mechanism or component can be used to maintain the proximal portion of the needle 448 within the divisible hub 444. In at least some embodiments, the divisible sheath 446 is joined to the divisible hub 444. For example, the divisible hub 444 can be molded onto the divisible sheath 446, or the divisible sheath can be attached to the divisible hub by adhesive.

[0045] The divisible sheath 446 is arranged to be divided into two parts along its longitudinal length for removal of the divisible sheath after lead placement. In at least some embodiments, the divisible sheath 446 includes one or more perforated (or cut, weakened, or thinned, etc.) regions 474 extending along at least a portion of its longitudinal length. In at least some embodiments, the divisible sheath 446 may be pre-divided, perforated, cut, weakened, or thinned only within or adjacent to the hub 444 and may not have any further perforations, etc., along the length of the divisible sheath. The divisible sheath can be manufactured from any suitable material, including but not limited to polymer materials such as high-density polyurethane (HDPE) or polytetrafluoroethylene (PTFE). As an example, a material such as PTFE can be easily and reliably divided in the extrusion direction when extruded without pre-cutting or perforation.

[0046] Figures 3D and 4A–4E show the proximal portion of the divisible sheath 446, the divisible hub 444, and the divisible lure 454. The divisible hub 444 includes a body 462 and at least two separation tabs 464, 466 extending away from there. The two separation tabs 464, 466 are used to separate each of the divisible sheath 446, the divisible hub 444, and the divisible lure 454 into two parts by pulling the two separation tabs away from each other. In some embodiments, the separation step may further include first pressing the two separation tabs 464 and 466 together to initiate the separation of one or both of the divisible hub 444 and the divisible sheath 446, and then pulling the two separation tabs 464 and 466 away from each other to complete the separation.

[0047] In at least some embodiments, the angle 468 between the two separation tabs 464 and 466 does not exceed 180 degrees, 120 degrees, 90 degrees, 60 degrees, 30 degrees, or 20 degrees. In other embodiments, the separation tabs can be separated by 180 degrees as disclosed in U.S. Patent Application Publications 2011 / 0224680, 2014 / 0039586, 2014 / 0276927, 2015 / 0073431, and 2015 / 0073432, all of which are incorporated herein by reference in their entirety. In yet another embodiment, the detachable tab may extend proximal to the longitudinal axis of the divisible sheath 450 (or at an acute angle not exceeding 89, 80, 75, 60, or 45 degrees), as disclosed in U.S. Patent Application Publication No. 2016 / 0317800, the entire contents of which are incorporated herein by reference.

[0048] In at least some embodiments, the divisible hub 444 and the divisible lure 454 may include one or more slits or vulnerable regions 463a, 463b, 463c, and 463d between the pull tabs 464 and 466. These slits or vulnerable regions 463a, 463b, 463c, and 463d facilitate the separation of the divisible hub 444 and the divisible lure 454 into two parts when the divisible sheath 446 is divided and separated into two regions using the two pull tabs 464, 466 as described above. In at least some embodiments, one or more of the slits or vulnerable regions 463a, 463b, 463c, and 463d are V-shaped with their apex near the center of the divisible hub 444 or the divisible lure 454, for example, as shown in Figures 4D and 4E. In at least some embodiments, the portion of the divisible hub 444 or divisible lure 454 having slits or vulnerable areas 463a, 463b, 463c, and 463d is shorter in length than the length of the other portion of the divisible hub or divisible lure. In the embodiments shown in Figures 3A to 4E, the slits or vulnerable areas 463a and 463b of the divisible hub 444 extend only partially along the length of the divisible hub, with the remainder of the length of this portion of the divisible hub being open. This shortens the length of the divisible hub 444 that is divided to separate the divisible hub into two parts.

[0049] After the lead is inserted and positioned in the desired implantation location, the divisible sheath 446, divisible hub 444, and divisible luer 454 can be simultaneously separated into two parts using two separate tabs 464, 466, respectively. The resulting separated parts of the divisible sheath 446, divisible hub 444, and divisible luer 454 can be withdrawn from around the needle, and in the case of the divisible sheath, from the patient's tissue. These parts, with the needle 448 and lead remaining, can be discarded.

[0050] The needle 448 can be manufactured from any suitable material, including but not limited to stainless steel or other metals. The needle 448 of the composite needle / sheath 440 includes a proximal end portion 445 (Figure 4B) and a distal end portion 447 (Figure 3C). Figure 3C shows the distal end portion 447 of the needle 448 extending from the divisible sheath 446. The distal end portion 447 of the needle 448 may have a beveled surface with a sharp tip suitable for penetrating patient tissue during the insertion of the lead introducer 430 into the patient. At least the sharp tip of the needle 448, and preferably the beveled surface as well, extends distally beyond the distal end of the divisible sheath 446. In other embodiments, the distal end portion 447 of the needle 448 may have a Tuohy tip or a blunt epidural needle tip. For example, an optional bend, such as the bend disclosed in U.S. Patent Application Publication No. 2016 / 0317800, which is incorporated in its entirety by reference herein, can be provided along the distal end portion of the needle 448.

[0051] The needle 448 defines a channel 449 (Figure 4B) extending along the longitudinal length of the needle to receive the stylet 442 and the lead. The needle also defines a slot 450 extending along the longitudinal length of the needle. A detachable sheath 446 covers this slot during insertion of the lead introducer 430 and delivery of the lead. The slot 450 allows for lateral separation of the lead from the needle 448 by passing the lead, which is initially present in the channel 449, through the slot laterally. In at least some embodiments, to facilitate lateral separation, the slot 450 has a width at least equal to the diameter of the lead. In other embodiments, the lead has a diameter larger than the slot 450 of the needle 448. The body of the lead can be formed from a deformable material, and the lead is removable from the channel 449 by applying a lateral force to at least one of the lead or the needle 448 that deforms sufficiently to allow it to pass laterally through the slot 450 in the needle 448. The detachable hub 444 includes a hub lumen 443 that communicates with the channel 449 of the needle 448. The detachable lure 454 includes a lure lumen 476 that communicates with the channel 449 of the needle 448.

[0052] During the assembly of the composite needle / sheath 440, the proximal end portion 445 of the needle 448 is positioned within the divisible hub 444. In at least some embodiments, the needle 448 is not joined to the divisible hub 444. A locking fixture 452 is attached to or forms part of the proximal end portion 445 of the needle 448. The divisible hub 444 defines a cavity 451 complementary to the locking fixture 452. During the assembly of the lead introducer 430, the locking fixture 452 is inserted into the cavity 451 together with the mounted needle 448. In at least some embodiments, a divisible luer 454 is inserted into the divisible hub 444 to lock the locking fixture 452 into the cavity 451 of the divisible hub 444. Other arrangements or components may be used to lock the locking fixture 452 into the cavity 451 of the divisible hub 444. When locked within the divisible hub 444, the locking fixture 452 prevents or inhibits rotation of the needle 448 relative to the divisible hub. When locked within the divisible hub 444, the divisible hub and divisible lure 454 prevent or inhibit parallel or axial movement of the needle 448 relative to the divisible hub. In at least some embodiments, the use of the locking fixture 452 allows for an arrangement in which the needle 448 and the locking fixture 452 are not joined to the divisible hub 444.

[0053] In at least some embodiments, the locking fixture 452 includes one or more feature elements that give the combination of the locking fixture 452 and the proximal end portion 445 of the needle 448 a non-cylindrical cross-section. For example, the locking fixture 452 in the illustrated embodiment includes one or more wings 453 that extend away from the cylindrical portion of the proximal end portion 445 of the needle 448. In other embodiments, the locking fixture 452 may include any other suitable feature elements that can be used to secure the needle 448 within the divisible hub or to give the combination of the locking fixture 452 and the proximal end portion 445 of the needle 448 a non-cylindrical cross-section.

[0054] In at least some embodiments, the proximal end portion 445 of the locking fixture 452 or needle 448 is joined to the divisible hub 444 or divisible lure 454 using glue or other adhesive, but not to the divisible sheath 446. In at least some embodiments, the composite needle / sheath 440 does not include a cavity 451 within the locking fixture 452 or divisible hub 444, but the proximal end portion 445 of the needle is joined to the divisible hub 444 or divisible lure 454 using glue or other adhesive, but not to the divisible sheath 446. In at least some of these embodiments using glue or other adhesive, the proximal end portion 445 of the locking fixture 452 or needle 448 is joined to the divisible lure 454, but not to the divisible sheath 446 or divisible hub 444. In at least some embodiments, when glue or other adhesive is used to join the proximal end portion 445 of the needle 448 or the locking fixture 452 to the divisible hub 444 or divisible lure 454, when the divisible hub or divisible lure is divided into two parts, the joint formed by the glue or other adhesive applied to at least one of these parts is broken, and the needle is detached from one (or, in some embodiments, both) of these parts of the divisible hub or divisible lure.

[0055] In at least some embodiments, a portion of the divisible lure 454 fits relatively snugly into the divisible hub 444 to lock the locking fixture 452 into the divisible hub. In at least some embodiments, when inserted into the divisible hub 444, the divisible lure 454 forms a friction fit that resists the removal of the divisible lure from the divisible hub. In at least some embodiments, the divisible hub 444 and the divisible lure include any suitable known coupling or locking arrangement for retaining the divisible lure within the divisible hub.

[0056] In at least some embodiments, the divisible lure 454 includes one or more first positioning features 455a that engage with one or more second positioning features 455b of the divisible hub 444. In the illustrated embodiment, the first positioning features 455a of the divisible lure 454 are rails, and the second positioning features 455b of the divisible hub 444 are corresponding notches. In at least some embodiments, the first and second positioning features 455a, 455b facilitate the division of the divisible lure 454, along with the division of the divisible hub 444 using the pull tabs 464, 466, by maintaining a portion of the divisible lure on each portion of the divisible hub. In at least some embodiments, the divisible lure 454 and the locking fixture 452 can be a single unit.

[0057] In at least some embodiments, during operation, the stylet 442 is received into the channel 449 during insertion. The stylet 442 is withdrawn along the channel 449 and the lead is inserted. After the lead is positioned at or near the desired implantation site, the divisible hub 444, the divisible sheath 446, and the divisible luer 454, if present, are separated and then removed. The needle 448 is removed from the patient, and the lead remains implanted through the slot 450.

[0058] Figures 5A to 5D show a lateral release lead introducer 530 having a divisible needle device 540 and a stylet 542. The stylet 542 includes a shaft 542a and a handle 542b. The shaft 542a of the stylet 542 is inserted into the divisible needle device 540, and this combination is inserted into the patient. After insertion and positioning of the lead introducer 530 at or near the implantation site, the stylet 542 is removed from the divisible needle device 540, and the lead is inserted into the divisible needle device 540 for delivery and positioning of the lead to the implantation site.

[0059] The divisible needle device 540 includes a divisible hub 544 and a divisible needle 548. The divisible needle 548 may include a needle shaft 570 which is perforated, etched, punched, cut, or grooved, or is two parts which are tacked or spot-welded along the needle for their temporary connection.

[0060] The divisible needle 548 can be manufactured from any suitable material, including but not limited to stainless steel or other metals. The distal end portion 547 of the divisible needle 548 may have a beveled surface with a pointed tip suitable for penetrating patient tissue during insertion of the lead introducer 530 into the patient. In other embodiments, the distal end portion 547 of the needle 548 may have a Tuohy tip or a blunt epidural needle tip. Along the distal end portion of the divisible needle 548, an optional bend may be provided, such as the bend disclosed in U.S. Patent Application Publication No. 2016 / 0317800, the entire content of which is incorporated herein by reference.

[0061] The divisible hub 544 may be the same as the divisible hub 444 described above, except that it is joined to the divisible needle 548. When the divisible hub 544 is divided into two parts, the divisible needle 548 is also divided into two parts, with each part of the divisible hub attached to the corresponding part of the divisible needle. The divisible hub 544 may include two separation tabs 564, 566 that are the same as or similar to the two separation tabs 464, 466 described above. The divisible hub 544 may include one or more slits or vulnerable areas 563 that are the same as or similar to the slits or vulnerable areas 463a, 463b described above.

[0062] In at least some embodiments, the divisible needle 548 includes a fluid-resistant coating or liner 580 disposed over at least a portion of the inner or outer surface of the needle shaft 570 of the divisible needle. In Figure 5C, the fluid-resistant coating or liner 580 is shown translucently for illustrative purposes of the needle shaft 570. In at least some embodiments, the fluid-resistant coating or liner 580 is disposed over the aforementioned portion of the inner or outer surface of the needle shaft 570 of the divisible needle 548, which includes at least a portion of the seam 571 over which the divisible needle will be divided, for example, over a perforated, cut, grooved, welded area, or similar. In at least some embodiments, the fluid-resistant coating or liner 580 is disposed over a portion of the inner or outer surface of the entrance of at least the aforementioned portion of the divisible needle 548 that will be inserted into the patient (optionally excluding the tip or distal end portion of the divisible needle). The fluid-resistant coating or liner 580 can be applied to the inner surface, the outer surface, or both the outer and inner surfaces.

[0063] Examples of materials for the fluid-resistant coating or liner 580 include, but are not limited to, biocompatible polymers such as silicone, polyurethane, or polyetheretherketone (PEEK), or biocompatible adhesives or glues or combinations thereof, such as biocompatible epoxy. The fluid-resistant coating or liner 580 can be formed on a divisible needle 548 by immersion coating, heat shrinkage, addition of polymer, adhesive, or glue, or by any other suitable method.

[0064] Figure 6 is a schematic diagram of one embodiment of the components of an electrical stimulation system 600, including an electronic subassembly 610 located within a control module. It will be understood that the electrical stimulation system may include more, fewer, or different components and may have a variety of different configurations, including those disclosed in the stimulator references cited herein.

[0065] Some components of the electrical stimulation system (e.g., power supply 612, antenna 618, receiver 602, and processor 604) may be arranged on one or more circuit boards or similar carriers within the sealed housing of the implantable pulse generator, as needed. For example, power supply 612 may include a battery such as a primary battery or a rechargeable battery. Other examples of power supplies include supercapacitors, nuclear batteries or atomic batteries, mechanical resonators, infrared concentrators, thermally driven energy sources, flexurally driven energy sources, bioenergy power supplies, fuel cells, biobatteries, osmotic pumps, and power supplies described in U.S. Patent No. 6,437,193, the entire content of which is incorporated herein by reference.

[0066] Alternatively, power can be supplied by an external power source via inductive coupling through an optional antenna 618 or a secondary antenna. The external power source may reside in a device attached to the user's skin or in a unit permanently or periodically located near the user.

[0067] If the power supply 612 is a rechargeable battery, the battery can be recharged using an optional antenna 618 as needed. For recharging, power can be supplied by inductively coupling the battery through the antenna to a recharging unit 616 located outside the user's body. Examples of such arrangements can be found in the references listed above.

[0068] In one embodiment, an electric current is emitted by electrodes 134 on the lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. Generally, a processor 604 is included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor 604 can control one or more of the pulse timing, frequency, amplitude, width, and waveform as needed. Furthermore, in at least some embodiments, the processor 604 can, as needed, select which electrodes can be used to provide stimulation. In some embodiments, the processor 604 can select which electrode will be the cathode and which electrode will be the anode. In some embodiments, the processor 604 can be used to determine which electrode provides the most advantageous stimulation to the desired tissue.

[0069] Either processor can be as simple as an electronic device that generates pulses at regular intervals, or the processor can have the ability to receive and interpret instructions from an external programming unit 608 that allow for modification of pulse characteristics. In the illustrated embodiment, the processor 604 is coupled to a receiver 602, which is then coupled to an optional antenna 618. This allows the processor 604 to receive instructions from an external information source that, if necessary, dictate pulse characteristics and electrode selection.

[0070] In some embodiments, the antenna 618 has the function of receiving signals (e.g., RF signals) from the extracorporeal telemetry unit 606 programmed by the programming unit 608. The programming unit 608 may be located outside of or part of the telemetry unit 606. If necessary, the extracorporeal telemetry unit 606 may be a device worn on the user's skin or carried by the user, and may take the form of a pager, cell phone, or remote controller. Alternatively, the telemetry unit 606 may not be worn or carried by the user and may be available only at a home station or clinic. The programming unit 608 may be any unit that can provide information to the telemetry unit 606 for transmission to the electrical stimulation system 600. The programming unit 608 may be part of the telemetry unit 606 or provide signals or information to the telemetry unit 606 via a wireless or wired connection. An example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit 606.

[0071] Signals sent to the processor 604 through the antenna 618 and receiver 602 can be used to modify or otherwise instruct the operation of the electrical stimulation system. For example, these signals can be used to modify the pulses of the electrical stimulation system, such as modifying one or more of the pulse width, pulse frequency, pulse waveform, and pulse amplitude. These signals can instruct the electrical stimulation system 600 to stop operation, start operation, start charging the battery, or stop charging the battery. In other embodiments, the stimulation system does not include the antenna 618 or receiver 602, and the processor 604 operates as programmed.

[0072] Optionally, the electrical stimulation system 600 may include a transmitter (not shown) coupled to the processor 604 and antenna 618 for sending and receiving signals to a telemetry unit 606 or another unit having the capability to receive signals. For example, the electrical stimulation system 600 may transmit signals indicating whether it is functioning properly, when the battery needs charging, or the remaining charge level in the battery. The processor 604 may have the capability to transmit information about pulse characteristics so that a user or clinician can determine various characteristics.

[0073] The above specification, examples, and data provide an explanation of the manufacture and use of the configuration of the present invention. Since many embodiments of the present invention can be made without departing from the spirit and scope of the invention, the present invention also resides in the claims appended below. [Explanation of Symbols]

[0074] 530 Lateral release lead introduction device 540-part divisible needle device 542 Stylet 544 splittable hub 548 divisible needles

Claims

1. A divisible sheath having a length and a proximal end region, wherein the divisible sheath is configured to be divided into a first part and a second part along the length of the divisible sheath, A divisible hub, which is coupled to the proximal end region of the divisible sheath and is configured to be divided into a first portion and a second portion, A needle having a length and a proximal end region, wherein a channel extending along the length of the needle is defined for the delivery of a lead through the needle, and is configured to extend through the divisible hub and the divisible sheath, and is not joined to the divisible hub and the divisible sheath, A non-cylindrical locking fixture attached to or part of the proximal end region of the needle, wherein the divisible hub includes a cavity having a shape complementary to the non-cylindrical locking fixture of the needle in order to hold the needle within the divisible hub and restrict the rotation of the needle relative to the divisible hub, A composite needle / sheath, including a lead introduction device.

2. The lead introduction device according to claim 1, wherein the non-cylindrical locking fixture includes at least one wing.

3. The lead introducer according to claim 1 or 2, wherein the needle defines a slot along the length of the needle, configured to laterally release the lead from the channel of the needle.

4. The lead introducer according to any one of claims 1 to 3, further comprising a stylet configured to be inserted into the channel of the needle.

5. The lead introducer according to any one of claims 1 to 4, wherein the first portion of the divisible sheath is permanently attached to the first portion of the hub such that the first portion of the divisible sheath remains attached to the first portion of the hub when the hub is divided into a first portion and a second portion.

6. The lead introducer according to any one of claims 1 to 5, wherein the divisible hub includes at least one slit or vulnerable region for dividing the divisible hub into a first portion and a second portion.

7. The composite needle / sheath further includes a divisible lure configured to be inserted into the divisible hub to lock the non-cylindrical locking fastener of the needle into the cavity of the divisible hub, The lead introducer according to any one of claims 1 to 6, wherein the divisible lure is configured to be divided into a first part and a second part, and optionally the needle is not joined to the divisible lure.

8. A divisible sheath having a length and a proximal end region, wherein the divisible sheath is configured to be divided into a first part and a second part along the length of the divisible sheath, A divisible hub, which is coupled to the proximal end region of the divisible sheath and is configured to be divided into a first portion and a second portion, A needle having a length and a proximal end region, wherein a channel extending along the length of the needle is defined for the delivery of a lead through the needle, and is configured to extend through the divisible hub and the divisible sheath, and is not joined to the divisible hub and the divisible sheath, A divisible lure configured to be inserted into the divisible hub and adhesively bonded to the needle, wherein the divisible lure is configured to be divided into a first part and a second part, thereby breaking the adhesive bond between at least one of the first part and the second part of the divisible lure and the needle, A composite needle / sheath, including a lead introduction device.

9. The lead introducer according to claim 7 or 8, wherein the divisible hub and the divisible lure include complementary positioning features that facilitate the simultaneous divisibility of the divisible hub and the divisible lure.

10. The divisible hub includes a body and at least two tabs extending from the body, The lead introducer according to any one of claims 1 to 9, wherein the divisible hub is configured to be divided using the at least two tabs together with the divisible sheath and the divisible lure.

11. A divisible hub configured to be divided into a first part and a second part, A divisible needle coupled to the divisible hub and having a length and a proximal end region, wherein a channel extending along the length of the divisible needle is defined for the delivery of a lead through the divisible needle, and includes at least one splice, and is configured to be divided together with the divisible hub along the at least one splice into a first portion and a second portion, Lead introducer including

12. a) The divisible needle is perforated, etched, punched, notched, or grooved along the at least one joint to facilitate the division of the divisible needle, or b) The divisible needle comprises two parts, the two parts being tucked or spot-welded along the at least one joint for temporary connection of the two parts, according to claim 11.

13. The lead introducer according to claim 11 or 12, further comprising a fluid-resistant coating or liner disposed over at least a portion of the inner or outer surface of the divisible needle.

14. The lead introducer according to claim 13, wherein the fluid-resistant coating or liner is arranged over at least a portion of the at least one joint of the divisible needle.

15. The lead introducer according to any one of claims 1 to 14, A lead configured to be implanted in the patient, A lead body having a distal end portion and a proximal end portion. Multiple electrodes arranged at the distal end portion of the lead body, Multiple terminals arranged at the proximal end portion of the lead body, Multiple conductive wires electrically coupling the electrode to the terminal, The lead, including, Includes, An insertion kit in which the lead can be inserted through the channel of the divisible needle.

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