Integrated conductor coil electrode

Abstract

An implantable medical lead includes a lead body extending from a proximal end to a distal end. The lead body includes an inner insulating layer and an outer insulating layer. The lead also includes a sleeve mechanically supported by the lead body at the distal end of the lead body. The lead also includes a non-insulated conductor coil. The non-insulated conductor coil includes: a first portion having a first inner diameter; and a second portion having a second inner diameter and extending distally from the outer insulating layer. The first portion is positioned between the inner insulating layer and the outer insulating layer. The second inner diameter is larger than the first inner diameter. An outer surface of the second portion is exposed.

Description

[0001] This application claims the benefit of U.S. patent application serial number 17 / 938,661, filed on October 6, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates generally to implantable medical devices and, more particularly, to implantable medical leads. Background Art

[0003] Some types of implantable medical devices, such as pacemakers or implantable cardioverter-defibrillators, provide electrotherapy to a patient's heart via electrodes. Electrotherapy can be delivered to the heart for pacing, cardioversion, or defibrillation. An implantable medical device may include an electronic circuit system for delivering electrotherapy, wherein the electronic circuit system is encapsulated by a housing, such as a metal, e.g., titanium housing.

[0004] In some examples, an implantable medical device can provide electrotherapy via an implantable medical lead including one or more electrodes. The implantable medical lead can be adapted to treat a variety of cardiac dysfunctions. The implantable medical lead can be navigated within the patient's vasculature to reach one or more target locations for sensing and / or therapy delivery. The electrodes supported by the implantable medical lead can establish electrical communication with cardiac tissue to sense cardiac signals generated by the heart and / or deliver cardiac pacing to the patient. Summary of the invention

[0005] In some examples, an implantable medical lead includes: a lead body extending from a proximal end to a distal end, the lead body comprising: an inner insulation layer defining an inner insulation layer lumen; and an outer insulation layer; a sleeve mechanically supported by the lead body at the distal end of the lead body; and an uninsulated conductor coil electrically connected to an implantable medical device, the uninsulated conductor coil comprising: a first portion having a first inner diameter, wherein the first portion is positioned between the inner insulation layer and the outer insulation layer; and a second portion extending distally from the outer insulation layer, the second portion having a second inner diameter sized to receive the sleeve, wherein the second inner diameter is larger than the first inner diameter, and wherein an outer surface of the second portion is exposed.

[0006] In some examples, a system includes: an implantable medical device; an implantable medical lead, the implantable medical lead comprising: a lead body, the lead body extending from a proximal end to a distal end, the lead body comprising: an inner insulation layer, the inner insulation layer defining an inner insulation layer lumen; and an outer insulation layer; a sleeve, the sleeve being mechanically supported by the lead body at the distal end of the lead body; and an uninsulated conductor coil, the uninsulated conductor coil being electrically connected to the implantable medical device, the uninsulated conductor coil comprising: a first portion, the first portion having a first inner diameter, wherein the first portion is positioned between the inner insulation layer and the outer insulation layer; and a second portion, the second portion extending distally from the outer insulation layer, the second portion having a second inner diameter, the second inner diameter being sized to receive the sleeve.

[0007] In some examples, a method of manufacturing an implantable medical lead includes: forming a sleeve of the implantable medical lead, wherein the sleeve includes a distal electrode; electrically connecting an inner conductor coil to the distal electrode; forming an inner insulating layer, the inner insulating layer covering the inner coil; forming an uninsulated conductor coil, the uninsulated conductor coil defining a coil lumen, wherein the uninsulated conductor coil includes: a first portion having a first inner diameter; and a second portion having a second inner diameter, the second inner diameter being sized to receive the sleeve, wherein the second inner diameter is larger than the first inner diameter; positioning at least a portion of the inner insulating layer within the coil lumen; connecting the second portion to the sleeve; and forming an outer insulating layer, the outer insulating layer covering the first portion of the uninsulated conductor coil but not covering the second portion of the uninsulated conductor coil, so that the second portion remains exposed.

[0008] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a conceptual diagram illustrating an example implantable medical system in accordance with the techniques of this disclosure.

[0010] Figure 2 is a conceptual diagram illustrating a distal portion of an example implantable medical lead in accordance with the presently disclosed techniques.

[0011] Figure 3A and Figure 3B is a conceptual diagram of an example implantable medical lead with a balloon in accordance with the presently disclosed technology.

[0012] Figure 4 is a flow chart of an example technique for manufacturing an example implantable medical lead in accordance with the presently disclosed techniques. DETAILED DESCRIPTION

[0013] A medical system may be temporarily implanted in a patient and then removed. For example, a temporary medical system may be configured to assist in cardiac pacing for up to 7 days and then removed. Such a system may include a temporary implantable medical device (IMD) and a temporary implantable medical lead.

[0014] Generally speaking, an IMD may include components that can connect electrodes of an implantable medical lead to the circuitry of the IMD. For example, the electrodes may be connected to electrical conductors within the lead body, which in turn may be connected to the therapy circuitry and / or sensing circuitry of the IMD. However, for temporary medical leads, conventional manufacturing techniques for long-term implanted leads may not be cost-effective. For example, the electrodes may be formed of more expensive materials (e.g., solid metal tubes) that require extensive processing. Additionally, the electrodes may need to be connected to the electrical conductors, thereby increasing manufacturing costs.

[0015] According to the technology of the present disclosure, an implantable medical lead may include a non-insulated conductor coil electrically connected to an IMD. The non-insulated conductor coil, which may be formed of a conductive material such as multiphase nickel (e.g., MP35N), may be connected to the circuit system of the IMD. Additionally, a portion of the non-insulated conductor coil may be exposed to the patient's tissue so that the exposed portion of the non-insulated conductor coil may operate as an electrode. In this way, the electrical conductors and electrodes of the lead may be integrated into a single component. Therefore, the technology of the present disclosure may eliminate the costs associated with the use of more expensive materials, metal ring components, bonding processes, and the like.

[0016] Although this article is primarily described with respect to cardiac electrotherapy, the IMD and implantable medical leads as described herein can be configured to deliver electrotherapy other than cardiac electrotherapy. In addition, although this article is primarily described as implantable medical leads (e.g., cardiac leads), these techniques can also be applied to another type of device, such as a catheter.

[0017] Figure 1 1 is a conceptual diagram illustrating an example implantable medical system 100 (“system” 100 ) configured to deliver therapy (e.g., pacing) to a heart 102 of a patient 104 . System 100 includes an implantable medical lead 106 (“lead 106 ”) extending from an implantable medical device 108 (“medical device 108 ”) through the vasculature of patient 104 . Lead 106 includes a lead body 110 having a distal portion 112 of lead body 110 (“lead body distal portion 112 ”) that is typically positioned at a target site 114 in the body of patient 104 . In an example, as shown in FIG. Figure 1, the target site 114 may be an area in the right ventricle apex of the heart 102. In an example, the lead 106 may be oriented so that the lead body distal portion 112 is positioned at another portion of the heart 102. For example, the lead 106 may be oriented so that the lead body distal portion 112 is generally positioned at the target site 116 in the atrioventricular septal wall. The system 100 may include additional leads coupled to the medical device 108 and extending into the heart 102.

[0018] Lead body distal portion 112 may include distal end 120 ("lead body distal end 120"). In some examples, lead body distal portion 112 may mechanically support fixation member 122 that is configured to extend distally beyond lead body distal end 120. Fixation member 122 may be configured to penetrate tissue of patient 104 at or near a target site (such as target sites 114, 116). Fixation member 122 may have various shapes, such as a spiral, teeth, screw, loop, etc.

[0019] In some examples, the fixing member 122 may mechanically support a distal electrode (not shown) that is configured to electrically communicate with tissue when the fixing member 122 positions the distal electrode near the target site 114, 116. In some examples, the fixing member or a portion thereof may operate as a distal electrode. In some examples, the distal electrode may be configured to provide pacing to the heart 102. The distal electrode may be electrically connected to one or more conductors extending through the lead body 110. The circuit system 124 is configured to deliver therapy signals to the distal electrode and / or sense cardiac signals from the distal electrode using the conductor. The fixing member 122 may be configured to position the distal electrode so that the distal electrode conducts an electrical signal to the target tissue of the heart 102, thereby depolarizing the myocardium of, for example, the ventricle, and thereby contracting at regular intervals.

[0020] The system 100 may include a balloon 128 located at the lead body distal portion 112. The balloon 128 may define an internal volume that is configured to receive an inflation medium (e.g., air, saline, or another medium), which in turn causes the balloon 128 to inflate. In an example, the lead body 110 defines an inflation lumen (not shown) that is fluidly coupled to the internal volume and configured such that a clinician can deliver an inflation medium to the internal volume defined by the balloon 128. The inflation lumen may extend from the lead body distal portion 112 to a proximal portion 132 of the lead body 110 ("lead body proximal portion 132"). An outer surface of the lead body proximal portion 132 at or near a proximal end 134 of the lead body 110 ("lead body proximal end 134") may define an opening to the inflation lumen.

[0021] The balloon 128 in the inflated configuration can substantially surround a portion of the fixation member 122 to at least maintain radial displacement between the fixation member 122 and anatomical structures within the patient 104 during passage of the lead body distal portion 112. The system 100 can be configured to accommodate other pathways or techniques to reach a target site within the patient 104 with the balloon 128 in the inflated configuration. For example, the system 100 can be configured such that the balloon 128 in the inflated configuration is adapted to pass through the innominate vein, the inferior vena cava (IVC), and / or another venous pathway to the cavity of the heart 102.

[0022] Lead 106 may include a proximal electrode (e.g., an electrode proximal to a distal electrode positioned at or near lead body distal portion 112). In examples where the proximal electrode is a discrete electrode (e.g., a separate component such as a ring electrode), the proximal electrode may need to be electrically connected to a conductor. However, conventional techniques for manufacturing and connecting discrete electrodes and conductors may not be cost-effective for temporary medical leads (e.g., due to the type of material, additional processing steps, etc.).

[0023] According to the techniques of the present disclosure, lead 106 may include an uninsulated conductor coil electrically connected to IMD 108. The uninsulated conductor coil may be electrically connected to circuit system 124. Additionally, a portion of the uninsulated conductor coil may be exposed to the tissue of patient 104 so that the uninsulated conductor coil may operate as an electrode. In this manner, the conductor and electrode of the lead may be integrated into a single component (i.e., the uninsulated conductor coil). Thus, the techniques of the present disclosure may eliminate costs associated with the use of more expensive materials, metal ring components, bonding processes, etc.

[0024] As used herein, a conductor coil is distinguished from a conductor cable in that a conductor coil is a structure formed or arranged in a spiral shape and defining a lumen, whereas a conductor cable comprises a plurality of wires twisted around a central core. A conductor coil may be relatively rigid and capable of maintaining a coil shape without assistance. Conversely, a conductor cable may be relatively flexible and require, for example, an insulating layer to at least partially surround the conductor cable to prevent the conductor cable from unfolding.

[0025] Figure 2 212 is a conceptual diagram of an example configuration of the distal portion 212 of the lead 206. Except for any differences described herein, the lead 206 can be substantially similar to Figure 1 The lead wire 206. Figure 2 As shown, the lead 206 includes a lead body 210, a sleeve 240, a balloon 228 mechanically supported by the sleeve 240, and an uninsulated conductor coil 242 ("coil 242").

[0026] The lead body 210 may include an inner insulating layer 244 and an outer insulating layer 248. The inner insulating layer 244 and the outer insulating layer 248 may be formed of a material that resists charge conduction. Additionally, the inner insulating layer 244 and the outer insulating layer 248 may be configured to seal the lead body 210 to prevent fluid from penetrating into the lead body 210. In some examples, the inner insulating layer 244 and the outer insulating layer 248 may be tubular.

[0027] Coil 242 can be electrically connected to IMD 108, for example, via a proximal connector of the lead. Coil 242 can be uninsulated along the entire length of coil 242 (e.g., from the proximal end of coil 242 to the distal end of coil 242). Coil 242 can be formed of any conductive material, such as, but not limited to, MP35N, stainless steel (e.g., 108), etc. The coil 242 may include a first portion 250 positioned between the inner insulating layer 244 and the outer insulating layer 248. The first portion 250 may have a first inner diameter that is sized to enable the inner insulating layer 244 (and any components positioned within the inner insulating layer lumen 246) to be positioned within the first portion 250 of the coil 242. For example, the first inner diameter may be slightly larger than the outer diameter of the inner insulating layer 244. The first portion 250 may have a first winding pitch (e.g., coil pitch, coil span, etc.). As used herein, winding pitch refers to the distance between two adjacent windings of a coil (such as the coil 242).

[0028] The coil 242 may also include a plurality of layers extending distally from the outer insulating layer 248 (e.g., along the Figure 2 The second portion 252 extends in the direction indicated by the arrow "D" shown in the figure. Figure 2 As shown, there may be a gap between the outer insulating layer 248 and the sleeve 240, so that the coil 242 may extend distally beyond the distal end of the outer insulating layer 248. In some examples, the coil 242 may be bonded to the inner insulating layer 244 and the outer insulating layer 248 with an adhesive 254. The adhesive 254 may be electrically insulating and seal the gap between the outer insulating layer 248 and the sleeve 240 (e.g., to prevent fluid from penetrating into the lead body 210).

[0029] The second portion 252 may have a second inner diameter that is sized to at least partially receive a sleeve 240 that is mechanically supported by the lead body 210 (e.g., at the distal end of the lead body 210). The second inner diameter may be greater than the first inner diameter. For example, the first inner diameter of the first portion 250 may flare outwardly so that the second inner diameter of the second portion 252 is greater than the first inner diameter. Additionally, in some examples, the second portion 252 may have a second winding pitch that is different from the first winding pitch.

[0030] The outer surface of second portion 252 may be exposed (e.g., exposed to the patient's tissue). Thus, outer insulating layer 248 may insulate (e.g., cover, surround, encapsulate, etc.) first portion 250 of coil 242, but not insulate second portion 252. In some examples, the outer surface of second portion 252 may be at least partially coated with a conductive material having gold, platinum, etc. For example, the outer surface of second portion 252 may be electroplated. Since coil 242 may be electrically connected to circuitry 224 of IMD 208, second portion 252 may operate as an electrode (e.g., a proximal electrode of lead 206) by providing stimulation (e.g., of heart 104) and sensing electrical signals.

[0031] In some examples, the second winding pitch of the second portion 252 can be smaller than the first winding pitch of the first portion 250, such that, for example, a larger surface area of ​​the second portion 252 is exposed to the tissue of the patient 104, which may increase the transmission of electrical energy to the tissue and, in turn, improve the patient's treatment outcome. Conversely, the first winding pitch of the first portion 250 can be larger than the second winding pitch of the second portion 252, such that the first portion 250 is more flexible, which may facilitate navigation of the lead 206 during an implantation procedure.

[0032] The coil 242 may define a coil lumen 255. For example, a first portion 250 having a first inner diameter may define a first portion of the coil lumen 255, and a second portion 252 having a second inner diameter may define a second portion of the coil lumen 255. At least a portion of the inner insulation layer 244 may be positioned within the coil lumen 255.

[0033] In some examples, lead 206 may also include an inner conductor coil 256 ("inner coil 256"). Inner conductor coil 256 may be electrically connected to the distal electrode and IMD 208. Inner coil 256 may be at least partially non-insulated along the length of inner coil 256 (e.g., from the proximal end of inner coil 256 to the distal end of coil interior 256). Inner coil 256 may be formed of any conductive material, such as but not limited to MP35N, stainless steel, etc. Inner coil 256 may be positioned within inner insulating layer lumen 246. Inner coil 256 may be electrically connected to an electrode mechanically supported by lead 206. For example, inner coil 256 may be electrically connected to a distal electrode (e.g., fixation mechanism 122) mechanically supported by sleeve 240. Inner coil 256 may define an inner lumen that may accommodate a stylet, guidewire, etc.

[0034] FIG. 3A to FIG. 3B is a conceptual diagram of an example lead 306. Except for any differences described herein, the lead 306 can be substantially similar to Figure 1 Lead 106 and / or Figure 2For example, the lead 306 may include a coil 342 having an exposed second portion 352. The second portion 352 of the coil 342 may be used as an electrode of the lead 306, such as a proximal electrode. Additionally, the lead 306 may include a balloon 328 located at the distal portion 312 of the lead body. Figure 3A In the example of , the system 300 may be in a configuration that can be used to deliver the lead body 310 to the vasculature or other area in the patient 104 en route to position the lead body distal portion 312 near a target site (such as target sites 114, 116). Figure 3A As shown, the inflation lumen 350 can extend to the balloon 328 such that the balloon 328 and the inflation lumen 350 are in fluid communication.

[0035] The balloon 328 can be attached to the lead body distal portion 312. The fixation member 322 can extend distally (eg, in a distal direction D) to the lead distal end 320 of the lead body distal portion 312. Figure 3A System 300 is shown with balloon 328 in a deflated configuration. Fixation member 322 can mechanically support distal electrode 323 that is configured to electrically communicate with tissue when positioned proximate a target site (such as target sites 114, 116) within patient 104.

[0036] In some examples, the lead body 310 is positioned within the sheath lumen of the sheath. The sheath can be, for example, an introducer sheath configured to provide access to the jugular vein, innominate vein, and / or subclavian vein. In some examples, the sheath is a delivery catheter. The sheath can include an inner wall defining the sheath lumen, and can also include a sheath opening leading to the sheath lumen. The system 300 can be configured to translate through the sheath lumen to pass through the sheath opening when the balloon 328 is in a contracted configuration.

[0037] In any event, the balloon 328 may be inflated en route to position the lead body distal portion 312 proximate a target site within the patient 104 . Figure 3A The balloon 328 is illustrated in a collapsed configuration and defines a maximum initial dimension D1 (e.g., inner diameter). The system 300 may define a maximum initial dimension D1, for example, to allow the lead body 310 to translate through the sheath lumen and the sheath opening. In an example, the lead body 310 includes a marker 360 (e.g., proximal to the balloon 328) that is configured to indicate that the balloon 328 is distal to the sheath opening so that the balloon 328 is free to expand without being constrained by the sheath lumen 126. The marker 360 may be configured to be visible on an imaging system, such as a fluoroscope, ultrasound, or other system configured to provide an image of the system 300 within the patient 104.

[0038] Figure 3BThe system 300 is illustrated with the balloon 328 in an inflated configuration. The balloon 328 can define an interior volume 362 configured to contain an inflation medium (e.g., air, saline, or another inflation medium) such that the balloon 328 is inflated. Figure 3A The contracted configuration transforms into Figure 3B Inflated configuration depicted. In an example, the internal volume 362 is at least partially defined by an inner surface 364 of the balloon 328 ("balloon inner surface 364") and an outer surface 366 of the lead body distal portion 312 ("distal outer surface 366"). The lead body 610 can define an inflation lumen 350 configured to provide an inflation medium to the internal volume 362. For example, the inflation lumen 350 can extend into the internal volume 362 such that the balloon 328 and the internal volume 362 are in fluid communication.

[0039] In the inflated configuration, the balloon 328 can define a maximum expansion dimension D2 (e.g., inner diameter). The maximum expansion dimension D2 of the inflated configuration is greater than the maximum initial dimension D1 of the deflated configuration. In the inflated configuration, the balloon 328 extends distally to the lead distal end 320, wherein a portion of the fixing member 322 extends distally to the balloon 328. The balloon 328 can substantially form a buffer circumferentially surrounding the fixing member 322. In an example, when the balloon 328 is in an inflated condition, the balloon 328 defines a substantially annular shape surrounding the lead body distal portion 312 and the lead distal end 320. The balloon 328 can be configured so that the lead body distal portion 312 extends at least partially within the hole defined by the substantially annular shape. In an example, the fixing member 322 is configured to extend at least partially through the hole defined by the substantially annular shape.

[0040] Figure 4 is a flow chart of an example technique for manufacturing an example implantable medical lead according to the techniques of the present disclosure. Figure 4 Mainly in Figure 2 206, but it should be understood that Figure 4 The method can be applied to other examples of the system as described herein.

[0041] The method of manufacturing lead 206 may include forming sleeve 240 (400). In some examples, sleeve 240 may include balloon 228 and a distal electrode (such as fixation mechanism 122, which may be helical). In such examples, inner coil 256 may be electrically connected to fixation mechanism 122 (402).

[0042] Inner insulating layer 244 may be formed such that inner insulating layer 244 covers inner coil 256, thereby insulating inner coil 256 (404). In some examples, inner insulating layer 244 may cover inner coil 256 from a proximal end to a distal end of inner coil 256.

[0043] Coil 242 may be formed (406). Coil 242 may be formed to include a first portion 250 having a first inner diameter and a first winding pitch. Coil 242 may also be formed to include a second portion 252 having a second inner diameter and a second winding pitch. During formation of coil 242, the first inner diameter of first portion 250 may increase (e.g., flare outward) such that the second inner diameter of second portion 252 is greater than the first inner diameter. Additionally, in some examples, second portion 252 may have a second winding pitch that is different from the first winding pitch. For example, the second winding pitch may be reduced (e.g., to increase the surface area of ​​second portion 252).

[0044] The second portion 252 may be connected to the sleeve 240 (408). The outer insulating layer 248 may be formed so that the outer insulating layer 248 covers the first portion 250 but does not cover the second portion 252 (410). In this way, the second portion 252 may be exposed and operated as an electrode (such as a proximal electrode). In some examples, the coil 242 may be bonded to the inner insulating layer 244 and the outer insulating layer 248 with an adhesive 254 (412). The adhesive 254 may be electrically insulating and seal the gap between the outer insulating layer 248 and the sleeve 240.

[0045] In some examples, the Figure 4 The order of the steps of the method does not affect the final product.

[0046] Various aspects of the disclosure have been described. These and other aspects are within the scope of the following claims.

[0047] The following examples are a non-limiting list of clauses in accordance with one or more techniques of the present disclosure.

[0048] Embodiment 1. An implantable medical lead, comprising: a lead body extending from a proximal end to a distal end, the lead body comprising: an inner insulating layer defining an inner insulating layer lumen; and an outer insulating layer; a sleeve mechanically supported by the lead body at the distal end of the lead body; and a non-insulated conductor coil electrically connected to an implantable medical device, the non-insulated conductor coil comprising: a first portion having a first inner diameter, wherein the first portion is positioned between the inner insulating layer and the outer insulating layer; and a second portion extending distally from the outer insulating layer, the second portion having a second inner diameter, the second inner diameter being sized to receive the sleeve, wherein the second inner diameter is larger than the first inner diameter, and wherein an outer surface of the second portion is exposed.

[0049] Embodiment 2. The implantable medical lead of Embodiment 1, wherein the uninsulated conductor coil defines a coil lumen, and wherein at least a portion of the inner insulation layer is positioned within the coil lumen.

[0050] Embodiment 3: The implantable medical lead according to embodiment 1, further comprising an inner conductor coil positioned within the lumen of the inner insulating layer.

[0051] Embodiment 4. The implantable medical lead of Embodiment 3, wherein the inner coil is electrically connected to an electrode mechanically supported by the sleeve.

[0052] Embodiment 5. The implantable medical lead of Embodiment 1, wherein the uninsulated conductor coil is bonded to the inner insulating layer and the outer insulating layer with an adhesive, and wherein the adhesive is electrically insulating.

[0053] Embodiment 6. The implantable medical lead according to Embodiment 1, further comprising a balloon mechanically supported by the sleeve.

[0054] Embodiment 7. The implantable medical lead of Embodiment 1, wherein the outer surface of the second portion is coated with a conductive material.

[0055] Embodiment 8. The implantable medical lead of Embodiment 7, wherein the outer surface of the second portion is plated.

[0056] Embodiment 9. A system comprises: an implantable medical device; an implantable medical lead, the implantable medical lead comprising: a lead body, the lead body extending from a proximal end to a distal end, the lead body comprising: an inner insulating layer, the inner insulating layer defining an inner insulating layer lumen; and an outer insulating layer; a sleeve, the sleeve being mechanically supported by the lead body at the distal end of the lead body; and a non-insulated conductor coil, the non-insulated conductor coil being electrically connected to the implantable medical device, the non-insulated conductor coil comprising: a first portion, the first portion having a first inner diameter, wherein the first portion is positioned between the inner insulating layer and the outer insulating layer; and a second portion, the second portion extending distally from the outer insulating layer, the second portion having a second inner diameter, the second inner diameter being sized to receive the sleeve.

[0057] Embodiment 10. The system of Embodiment 9, wherein the uninsulated conductor coil defines a coil lumen, and wherein at least a portion of the inner insulation layer is positioned within the coil lumen.

[0058] Embodiment 11. The system of embodiment 9 further comprising an inner conductor coil positioned within the inner insulation layer lumen.

[0059] Embodiment 12. The system of Embodiment 11, wherein the inner coil is electrically connected to an electrode mechanically supported by the sleeve.

[0060] Embodiment 13. The system of Embodiment 9, wherein the uninsulated conductor coil is bonded to the inner insulation layer and the outer insulation layer with an adhesive, and wherein the adhesive is electrically insulating.

[0061] Example 14. The system of Example 9, wherein the implantable medical lead further comprises a balloon mechanically supported by the sleeve.

[0062] Embodiment 15. The system of Embodiment 9, wherein the outer surface of the second portion is coated with a conductive material.

[0063] Embodiment 16. The system of Embodiment 15, wherein the outer surface of the second portion is electroplated.

[0064] Embodiment 17. A method for manufacturing an implantable medical lead, the method comprising: forming a sleeve of the implantable medical lead, wherein the sleeve includes a distal electrode; electrically connecting an inner conductor coil to the distal electrode; forming an inner insulating layer, the inner insulating layer covering the inner coil; forming a non-insulated conductor coil, the non-insulated conductor coil defining a coil lumen, wherein the non-insulated conductor coil includes: a first portion having a first inner diameter; and a second portion having a second inner diameter, the second inner diameter being sized to receive the sleeve, wherein the second inner diameter is larger than the first inner diameter; positioning at least a portion of the inner insulating layer within the coil lumen; connecting the second portion to the sleeve; and forming an outer insulating layer, the outer insulating layer covering the first portion of the non-insulated conductor coil but not covering the second portion of the non-insulated conductor coil, so that the second portion remains exposed.

[0065] Example 18. A method according to Example 17, wherein the sleeve also includes a balloon.

[0066] Embodiment 19. A method according to Embodiment 17, wherein forming the non-insulated conductor coil comprises: forming the first portion of the non-insulated conductor coil to have a first winding pitch; and forming the second portion of the non-insulated conductor coil to have a second winding pitch, wherein the second winding pitch is smaller than the first winding pitch.

[0067] Embodiment 20. The method of Embodiment 17, further comprising bonding the uninsulated conductor coil to the inner insulation layer and the outer insulation layer with an adhesive, wherein the adhesive is electrically insulating.

Claims

1. An implantable medical lead, comprising: A lead body extending from the proximal end to the distal end, the lead body comprising: an inner insulating layer defining an inner insulating layer lumen; and Outer insulation layer; a sleeve mechanically supported by the lead body at the distal end of the lead body; and An uninsulated conductor coil, the uninsulated conductor coil being electrically connected to an implantable medical device, the uninsulated conductor coil comprising: a first portion having a first inner diameter, wherein the first portion is positioned between the inner insulating layer and the outer insulating layer; and A second portion extends distally from the outer insulation layer, the second portion having a second inner diameter sized to receive the sleeve, wherein the second inner diameter is greater than the first inner diameter, and wherein an outer surface of the second portion is exposed.

2. The implantable medical lead of claim 1, wherein the uninsulated conductor coil defines a coil lumen, and wherein at least a portion of the inner insulation layer is positioned within the coil lumen.

3. The implantable medical lead of claim 1 or 2, further comprising an inner conductor coil positioned within the lumen of the inner insulation layer.

4. The implantable medical lead of claim 3, wherein the inner coil is electrically connected to an electrode mechanically supported by the sleeve.

5. The implantable medical lead of any one of claims 1 to 4, wherein the uninsulated conductor coil is bonded to the inner and outer insulating layers with an adhesive, and wherein the adhesive is electrically insulating.

6. The implantable medical lead of any one of claims 1 to 5, further comprising a balloon mechanically supported by the sleeve.

7. The implantable medical lead according to any one of claims 1 to 6, wherein the outer surface of the second portion is coated with a conductive material.

8. The implantable medical lead of claim 7, wherein the outer surface of the second portion is plated.

9. A system, comprising: Implantable medical devices; An implantable medical lead according to any one of the preceding claims.

10. The system of claim 9, wherein the uninsulated conductor coil defines a coil lumen, and wherein at least a portion of the inner insulation layer is positioned within the coil lumen.

11. The system of claim 9 or 10, further comprising an inner conductor coil positioned within the inner insulation lumen.

12. The system of claim 11, wherein the inner coil is electrically connected to an electrode mechanically supported by the sleeve.

13. The system of any one of claims 9 to 12, wherein the uninsulated conductor coil is bonded to the inner and outer insulation layers with an adhesive, and wherein the adhesive is electrically insulating.

14. The system of any one of claims 9 to 13, further comprising a balloon mechanically supported by the sleeve.

15. The system of any one of claims 9 to 12, wherein the outer surface of the second portion is coated with a conductive material.

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