Stimulation system with integrated lead component attached to skull mount package

文档序号：689189 发布日期：2021-04-30 浏览：9次中文

阅读说明：本技术 具有连接到颅骨安装包的整体式引线部件的刺激系统 (Stimulation system with integrated lead component attached to skull mount package ) 是由 S.萨贝桑 B.卢 A.卡里彻拉于 2019-09-13 设计创作，主要内容包括：一种刺激系统可以包括一个或更多个刺激部件,每个刺激部件可以包括一个或更多个电极和一个或更多个引线。每个引线可以在引线的第一端连接到所述一个或更多个电极中的电极,并且可以在引线的第二端连接到一个或更多个接合焊盘中的接合焊盘。刺激系统还可以包括圆柱形基底。每个刺激部件可以被固定到圆柱形基底的表面。刺激系统还可以包括颅骨安装包,该颅骨安装包包括识别刺激参数的电子部件。接合焊盘可以电连接到电子部件。颅骨安装包还可以包括一个或更多个接合焊盘。每个引线可以直接电连接且物理连接到所述一个或更多个接合焊盘中的接合焊盘。(A stimulation system may include one or more stimulation components, each of which may include one or more electrodes and one or more leads. Each lead may be connected to an electrode of the one or more electrodes at a first end of the lead and may be connected to a bond pad of the one or more bond pads at a second end of the lead. The stimulation system may also include a cylindrical substrate. Each stimulation component may be secured to a surface of the cylindrical substrate. The stimulation system may also include a skull mount package that includes electronic components that identify the stimulation parameters. The bonding pad may be electrically connected to the electronic component. The skull mount package can also include one or more bond pads. Each wire may be directly electrically and physically connected to a bond pad of the one or more bond pads.)

1. A stimulation system, comprising:

one or more stimulation components, wherein each of the one or more stimulation components comprises:

one or more electrodes; and

one or more leads, wherein each lead of the one or more leads is connected to an electrode of the one or more electrodes at a first end of the lead and to a bond pad of one or more bond pads at a second end of the lead,

a cylindrical substrate, wherein each of the one or more stimulation components is secured to a surface of the cylindrical substrate; and

a skull mount kit comprising:

an electronic component that identifies a stimulation parameter, wherein the one or more bond pads are electrically connected to the electronic component; and

one or more bond pads, wherein each of the one or more wires is directly electrically and physically connected to a bond pad of the one or more bond pads.

2. The stimulation system of claim 1, wherein each of the one or more stimulation components further comprises an insulating substrate, and wherein each of the one or more electrodes is disposed on the insulating substrate.

3. The stimulation system of claim 1, wherein each of the one or more stimulation components is wound onto an outer surface of the cylindrical substrate.

4. The stimulation system of claim 1, wherein the cylindrical base forms a hollow cylinder to which the one or more stimulation components are secured.

5. The stimulation system of claim 1, wherein the cylindrical substrate comprises a thermoplastic material or a thermoset material.

6. The stimulation system of claim 1, further comprising:

a fluoropolymer coating at least partially surrounding the one or more stimulation components being secured.

7. The stimulation system of claim 1, wherein the one or more stimulation components comprise a plurality of stimulation components, and wherein the plurality of stimulation components are secured to the surface of the cylindrical substrate such that the one or more stimulation components do not overlap one another.

8. A stimulation system according to claim 1, wherein:

the one or more electrodes comprise at least 32 electrodes; and

a diameter of the stimulation system across a longitudinal portion that includes at least one of the one or more stimulation components is less than 10 mm.

9. A stimulation system according to claim 1, wherein:

the one or more electrodes comprise less than 9 electrodes; and

a diameter of the stimulation system across a longitudinal portion that includes at least one of the one or more stimulation components is less than 2 mm.

10. The stimulation system of claim 1, wherein the one or more stimulation components include a first set of stimulation components and a second set of stimulation components, wherein spacing between electrodes and/or dimensions of electrodes within the first set of stimulation components is different than spacing between electrodes and/or dimensions of electrodes within the second set of stimulation components.

11. A method of manufacturing a lead assembly, comprising:

providing a set of electrodes and a set of electrical traces on a substrate, wherein each electrode of the set of electrodes is connected to an electrical trace of the set of electrical traces;

inserting a mandrel through the catheter;

wrapping the substrate around the conduit such that the substrate is in a helical shape;

inserting the base-wrapped catheter and mandrel into a heat shrink tube;

heating the heat shrinkable tube after insertion;

removing the heat shrink tubing from the base-wrapped catheter; and

removing the mandrel from the substrate-wrapped catheter.

12. The method of claim 11, wherein the conduit comprises a thermoset material.

13. The method of claim 11, wherein the conduit comprises a thermoplastic material.

14. The method of claim 11, further comprising heating the substrate-wrapped catheter and mandrel prior to inserting the substrate-wrapped catheter and mandrel into the heat shrink tubing.

15. The method of claim 11, wherein the mandrel comprises a metal mandrel coated with a fluoropolymer.

16. The method of claim 11, wherein the substrate comprises a thin film material.

17. The method of claim 11, wherein a first portion of the substrate is wrapped around the conduit and a second portion of the substrate remains unwrapped.

18. The method of claim 17, further comprising providing a set of bond pads on the second portion, wherein each trace of the set of electrical traces is connected to a bond pad of the set of bond pads.

19. A method of implanting an implantable device, the method comprising:

implanting a lead assembly into a brain of a human, wherein the lead assembly comprises:

one or more electrodes; and

mounting a neurostimulator to a person's skull; and

engaging the lead assembly with the neural stimulator.

20. The method of claim 19, wherein:

the lead assembly includes a cord extending with the one or more leads;

a lumen extends through the tether;

implanting the lead assembly includes:

inserting a rigid probe through the lumen;

moving a distal end of the lead assembly to a target location while inserting the rigid probe through the lumen; and

removing the rigid probe from the lumen.

Technical Field

Embodiments relate to implantable stimulation devices. In particular, the system includes an implantable lead assembly that extends integrally to a lead component that is connected to one or more bond pads of a skull mount package that includes a stimulation circuit.

Background

Medical implant devices are becoming more frequently used. Some medical implant devices include leads that deliver stimulation. For example, deep brain stimulation involves implanting lead assemblies within specific portions of the brain. The lead assembly may include a coated wire to which one or more electrodes are attached. The lead assembly may include a conductive material and may take the form of an insulated wire. A connector may connect one end of the lead assembly to a flexible extension, which may be connected (via another connector) to the nerve stimulator. The neurostimulator may include circuitry that determines characteristics of the stimulation to be delivered by the electrode(s).

Neurostimulators are often implanted near the clavicle. The neurostimulator may receive wireless signals from the non-implanted controller device. For example, the wireless signal may correspond to an instruction to transition to a powered on or powered off state and/or to an instruction to use a particular stimulation setting.

Thus, deep brain stimulation devices often include extensions of considerable size and multiple connectors. Each connector may electrically couple the connection members and may include, for example, a screw, a snap-lock mechanism, a welded interface, or an adhesive interface. However, each connection may break or break, which may cause the device to malfunction. In addition, the extension may cause undesirable biological reactions, such as subcutaneous bleeding. Accordingly, it is desirable to develop a neuromodulation device that maintains a connection between the stimulation electrodes and the circuitry but reduces the risk of adverse events and device failure.

Disclosure of Invention

In some embodiments, a stimulation system is provided. The stimulation system may include one or more stimulation components. Each of the one or more stimulation components may include one or more electrodes and one or more leads. Each of the one or more leads may be connected to an electrode of the one or more electrodes at a first end of the lead and may be connected to a bond pad of the one or more bond pads at a second end of the lead. The stimulation system may also include a cylindrical substrate. Each of the one or more stimulation components may be secured to a surface of the cylindrical substrate. The stimulation system may also include a skull mount package that includes electronic components that identify the stimulation parameters. The one or more bond pads may be electrically connected to an electronic component. The skull mount package can also include one or more bond pads. Each of the one or more leads may be directly electrically and physically connected to a bond pad of the one or more bond pads.

In some embodiments, a method of manufacturing a lead assembly is provided. A set of electrodes and a set of electrical traces are disposed on a substrate. Each of the set of electrodes may be connected to an electrical trace of the set of electrical traces. The mandrel may be inserted through the catheter. The substrate may be wrapped around the conduit such that the substrate assumes a helical shape. The base-wrapped catheter and mandrel may be inserted into a heat shrink tube. After insertion, the heat shrink tubing may be heated. The heat shrink tubing may be removed from the base-wrapped catheter. The mandrel may be removed from the catheter wrapped by the substrate.

In some embodiments, a method of implanting an implantable device is provided. The lead assembly may be inserted into a human brain. The lead assembly may include one or more electrodes and one or more leads. Each of the one or more leads may be connected to an electrode of the one or more electrodes at a first end of the lead and may be connected to a bond pad of the one or more bond pads at a second end of the lead. The nerve stimulator may be mounted to a human skull. The lead assembly may be engaged with a nerve stimulator.

Drawings

Illustrative embodiments of the invention are described in detail below with reference to the following drawings:

fig. 1A-1B illustrate various views of a deep brain stimulation system including a neurostimulator implanted near the clavicle, according to embodiments of the present invention.

Fig. 2A-2B illustrate various views of a deep brain stimulation system including a neurostimulator implanted under the scalp, according to embodiments of the present invention.

FIG. 3 illustrates a coiled lead assembly according to an embodiment of the invention.

FIG. 4 illustrates an unsprung lead assembly in accordance with an embodiment of the present invention.

Fig. 5A shows electrodes arranged in a helical configuration and included within a deep brain stimulation system, according to an embodiment of the present invention.

Fig. 5B shows a lead arranged in a helical configuration and included within a deep brain stimulation system, according to an embodiment of the present invention.

Fig. 5C shows a bond pad included within a deep brain stimulation system, according to an embodiment of the present invention.

Fig. 6A-6F illustrate stages in the manufacture of a lead assembly according to an embodiment of the invention.

Fig. 7 illustrates a cross-sectional perspective view of a lead assembly according to an embodiment of the present invention.

Fig. 8A-8F illustrate stages in the manufacture of a lead assembly according to an embodiment of the invention.

Fig. 9 illustrates a cross-sectional perspective view of a lead assembly according to an embodiment of the present invention.

Fig. 10A-10E illustrate various views of a lead assembly according to embodiments of the invention.

Fig. 11A-11F illustrate stages in the manufacture of a lead assembly according to an embodiment of the invention.

Fig. 12 illustrates a cross-sectional perspective view of a lead assembly according to an embodiment of the present invention.

Detailed Description

In some embodiments, a deep brain stimulation system is provided that includes a set of electrodes, a set of traces, and a neurostimulator. In some cases, deep brain stimulation systems include an integral thin film lead assembly (e.g., a cable) manufactured using the same layer of base material (e.g., an insulating material or a dielectric material, such as a polymer material). The base material and/or the integrated film lead assembly itself can have a thickness of, for example, less than about 100 μm. The integrated thin film lead assembly may include a set of electrodes disposed on a first portion of a base material and a set of conductive traces extending across a second portion of the base material. Each trace may be connected to one of the set of electrodes. The integral nature of the thin film lead assembly may facilitate stable physical and electrical connections between components of the deep brain stimulation system, as described in further detail in U.S. application No. (attorney docket No. 104167-.

The integrated film lead assembly can include one or more spiral shaped members. For example, the spiral portion may extend across part or all of the monolithic thin film lead assembly at a pitch from 200 μm to 1600 μm. The pitch may be, but need not be, uniform across the length of the film lead assembly. The spiral portion may include, may consist of, and/or may support a set of electrodes and/or a set of traces. In some cases, the set of electrodes and/or the set of traces are arranged to collectively form a spiral. The base material may be a support structure shaped as a hollow or solid cylinder. The support structure may be formed of a dielectric material, such as a polymer, having suitable dielectric, pliant and biocompatible properties. Polyurethanes, polycarbonates, silicones, polyethylenes, fluoropolymers, and/or other medical polymers, copolymers, and combinations or mixtures may be used. The conductive material used for the traces may be any suitable conductor, such as stainless steel, silver, copper, or other conductive material, which may have a separate coating or jacket for corrosion resistance, insulation, and/or protection reasons.

The spiral shape may be wound around a cylindrical base material. Each trace may extend between and/or electrically connect the electrode and the neurostimulator. In some cases, one end of the trace is electrically and/or physically connected to a bond pad that is part of or connected to the neurostimulator.

In some cases, the neurostimulator is configured to be implanted under the scalp, rather than near the clavicle. For example, the neurostimulator may be positioned between the skull and the scalp in the space under the scalp or the space under the aponeurosis. This positioning may reduce the overall size of the deep brain stimulation system, as the device does not have to extend outside the scalp. Furthermore, the extension may then be shortened, which may reduce the likelihood that subcutaneous bleeding will occur. It may also reduce the number of incisions formed during the implantation procedure, thereby also reducing the risk of infection and other incision-related complications.

Fig. 1A-1B illustrate various views of a deep brain stimulation system including a neurostimulator implanted near the clavicle, according to embodiments of the present invention. A deep brain stimulation system may include a lead assembly 105, the lead assembly 105 including an electrode and being implanted into the brain such that a portion of the lead assembly 105 including the electrode is located at a target location. The lead assembly 105 may also include a flexible extension 110 extending from the electrode portion. At least a portion of the extension 110 may extend under the skin and connect to a neurostimulator 120 implanted near the clavicle.

Fig. 2A-2B illustrate various views of a deep brain stimulation system including a neurostimulator implanted under the scalp, according to embodiments of the present invention. The deep brain stimulation system may include a lead assembly 205, the lead assembly 205 including an electrode and being implanted into the brain such that a portion of the lead assembly 205 including the electrode is located at a target location. The lead assembly 205 may include an extension 210 portion. At least a portion of the extension 210 may extend under the skin and connect to the neurostimulator 220. The lead assembly 205 may be configured such that the electrode portion and the extension 210 portion are integral.

In this case, the neurostimulator 220 is implanted under the scalp. For example, the nerve stimulator 220 may be attached to the surface of the skull using adhesives, orthopedic fixation devices, screws, and the like. In some cases, the entire surface (e.g., the entire bottom surface) of the neurostimulator 220 may be attached to the skull (e.g., by applying an adhesive to the entire surface). In some cases, the attachment is made at one or more contact points of the neurostimulator 220. For example, the neurostimulator 220 may be configured to include one or more holes through which one or more screws or pins may be inserted.

In some cases, multiple lead assemblies 205 are implanted (e.g., in each hemisphere). Each of the plurality of lead assemblies 205 may be connected to a single neurostimulator 220.

Neurostimulator 220 may include, for example, a housing, a power source, an antenna, and an electronics module (e.g., a computing system). The housing may be composed of a biocompatible material such as a bioceramic or bioglass for radio frequency transparency, or a metal such as titanium. A power source may be within the housing and connected (e.g., electrically connected) to the electronic module to provide power to and operate components of the electronic module. The antenna may be connected (e.g., electrically connected) to the electronic module for wireless communication with an external device via, for example, Radio Frequency (RF) telemetry.

The neurostimulator 220 may include one or more bond pads electrically connected to the electronic module. The lead assembly 210 may be attached to the one or more bond pads (e.g., via a soldering process) to electrically connect the electronic module to electrodes in the lead assembly 210. The electronic module may then apply a signal or current to the conductive traces of the connected lead assemblies 210. The electronic module may include discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing functions attributed to the neuromodulation device or system, such as applying or delivering neural stimulation to a patient. In various embodiments, an electronic module may include: software and/or electronic circuit components, such as a pulse generator, that generate signals to deliver voltage, current, optical or ultrasound stimulation to neural structures via the electrodes; a controller that determines or senses electrical activity and physiological responses via the electrodes and sensors, controls stimulation parameters of the pulse generator (e.g., controls stimulation parameters based on feedback from the physiological responses), and/or causes delivery of stimulation via the pulse generator and the electrodes; and a memory having program instructions executable by the pulse generator and the controller to perform one or more processes for applying or delivering the neural stimulation.

In various embodiments, the lead assembly 210 is a unitary structure that includes a cable or lead body. In some embodiments, lead assembly 110 further includes one or more electrode assemblies having one or more electrodes, optionally including one or more sensors. In some embodiments, the lead assembly 210 further includes a conductive connector (e.g., comprising copper, silver, or gold). In some embodiments, the connector is a bonding material that bonds the conductor material of the cable (e.g., at a bond pad) to an electronic module of the implantable neural stimulator 220. The bonding material may be a conductive epoxy or a metal solder or a weld, such as platinum. In further embodiments, the connectors are conductive wires or traces (in addition to or instead of bond pads). In alternative embodiments, the neurostimulator 220 and the cable are designed to connect to each other via a mechanical connector, such as a pin and sleeve connector, a snap and lock connector, a flexible printed circuit connector, or other mechanisms known to those of ordinary skill in the art.

FIG. 3 illustrates a coiled lead assembly according to an embodiment of the invention. Fig. 4 illustrates an extended lead assembly according to an embodiment of the present invention. The lead assembly may be monolithic such that a single substrate (e.g., configured in a different shape) extends across the entire lead assembly. The lead assembly may include a cable having a proximal end 310 and a distal end 315. As used herein, the term "proximal" refers to a first end of the body, while the term "distal" refers to a second end opposite the first end. For example, the proximal end may be the end of the body closest to the user and the distal end may be the end of the body furthest from the user.

The cable may include a support structure and one or more conductive traces formed on a portion of the support structure. As used herein, the term "formed on … …" refers to a structure or feature formed on a surface of another structure or feature, a structure or feature formed within another structure or feature, or a structure or feature formed both on and within another structure or feature. In addition, the cable includes a set of electrodes 320 at the distal end 315 (e.g., formed at the distal end 315, disposed at the distal end 315, attached to the distal end 315). Each electrode 320 and trace may comprise a conductive material.

At the proximal end 310, each conductive trace may terminate at a conductive bond pad 325. In some cases, the distal portion of the lead assembly (including the electrodes 320) is rigid, while the intermediate portion extending from the distal portion to the bond pad (and including the trace) is flexible. The bond pads 325 may include a bonding material, which may be, for example, a conductive epoxy or a metal solder or a solder joint, such as platinum. It will be appreciated that alternative connectors (e.g., to be used in place of bond pad 325, to be used in addition to bond pad 325) are contemplated. For example, mechanical connectors (e.g., pin and sleeve connectors, snap and lock connectors, flexible printed circuit connectors) may be used.

In some embodiments, the support structure extends from a proximal end 310 to a distal end 315. In some embodiments, the support structure may be formed from one layerOr more layers of dielectric material (i.e., insulators). The dielectric material may be selected from the group of non-conductive materials consisting of organic or inorganic polymers, ceramics, glass-ceramics, polyimide-epoxy, epoxy-fiberglass, and the like. In certain embodiments, the dielectric material is a polymer of imide monomers (i.e., polyimide), such asLiquid Crystal Polymer (LCP), parylene, Polyetheretherketone (PEEK), or a combination thereof. In further embodiments, the support structure may be made of one or more layers of dielectric material formed on the substrate. The substrate may be made of any type of metallic or non-metallic material.

The support structure may comprise one or more layers of dielectric material, optionally a substrate, having a thickness (t) from the proximal end 310 to the distal end 315. In some embodiments, the thickness (t) is from 10 μm to 150 μm, for example about 50 μm or about 60 μm. As used herein, the terms "substantially," "approximately," and "about" are defined as being about what is, but not necessarily all what is (and including what is), what is meant, as understood by one of ordinary skill in the art. In any disclosed embodiment, the terms "substantially", "approximately" or "about" may be replaced by "within a percentage of" the indicated content ", wherein the percentage includes 0.1%, 1%, 5% and 10%. In some embodiments, the support structure 220 has a length (l) of 5cm to 150cm, or 50cm to 100cm (e.g., about 75cm) (see, e.g., fig. 2A). In some embodiments, the support structure has a width (w) from the first side to the second side. In some embodiments, the width (w) is from 25 μm to 5mm, for example about 400 μm or about 1000 μm.

In some implementations, the one or more conductive traces are a plurality of traces, e.g., two or more conductive traces or from two to twenty-four conductive traces. The plurality of conductive traces is comprised of one or more layers of conductive material. The conductive material may include pure metals, metal alloys, combinations of metals and dielectrics, and the like. For example, the conductive material may be copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), or the like. In some embodiments, the conductive material also has a thermal expansion characteristic or Coefficient of Thermal Expansion (CTE) that is approximately equal to the CTE of the support structure. Matching the CTE of components in contact with each other may be desirable because it eliminates the development of thermal stresses that may occur during manufacture and operation of the cable, and thus eliminates a known cause of mechanical failure in the components.

One or more conductive traces can be deposited onto the surface of the support structure by using thin film deposition techniques well known to those skilled in the art, such as by sputter deposition, chemical vapor deposition, metal organic chemical vapor deposition, electroplating, electroless plating, and the like. In some embodiments, the thickness of one or more conductive traces depends on the particular impedance desired for the conductor in order to ensure excellent signal integrity (e.g., electrical signal integrity for stimulation or recording). For example, if a conductor with a relatively high impedance is desired, a small thickness of conductive material should be deposited onto the support structure. However, if a signal plane with relatively low impedance is desired, a greater thickness of conductive material should be deposited onto the support structure. In some embodiments, each of the one or more conductive traces has a thickness (d). In some embodiments, the thickness (d) is from 0.5 μm to 100 μm or from 25 μm to 50 μm, for example about 25 μm or about 40 μm. In some embodiments, each of the one or more conductive traces has a length (m) of about 5cm to 200cm, or 50cm to 150cm (e.g., about 80 cm). In some embodiments, each of the one or more conductive traces extends from the proximal end 310 to the distal end 315. In some embodiments, each of the one or more conductive traces has a width (y) from 2.0 μm to 500 μm (e.g., about 30 μm or about 50 μm).

As shown in fig. 3, according to an aspect of the present disclosure, the lead assembly may be formed in a predetermined shape. In particular, the lead assembly may be formed in a predetermined shape from a prefabricated wafer or panel of dielectric material or alternatively from a substrate. For example, the lead assemblies can be laser cut in a serpentine shape from a pre-fabricated wafer or panel. The serpentine shape may include characteristics designed to maximize the length of the lead assembly that can be fabricated from a single wafer or panel. Conventionally, the wafer or panel has a diameter, length and/or width of less than 10 cm. In some embodiments, the characteristics of the serpentine shape include a predetermined number of turns and a predetermined pitch (p) between each turn to maximize the overall length obtainable by the lead assembly. In certain embodiments, the coiled shape has 2 or more turns, for example from 2 to 25 turns, and the pitch (p) between each turn is from 10 μm to 1cm or from 250 μm to 2mm, for example about 350 μm. Thus, the serpentine shape may maximize the length of the lead assembly that may be fabricated from a single wafer or panel. For example, a single wafer or panel having a finite diameter, length, and/or width of less than 10cm may be used to fabricate lead assemblies having lengths of 5cm to 150cm, 10cm to 100cm, or 25cm to 75cm (e.g., about 15cm) using a serpentine shape.

The lead assembly may also include an electrode assembly at the distal end 315. The electrode assembly can include a support structure and a set of microelectronic structures disposed on the support structure. The microelectronic structure may include electrodes 320, wiring layers, and optional contact(s). In various embodiments, the support structure of the lead assembly and the support structure of the electrode assembly are the same structure (i.e., the support structure is continuous from the proximal end 310 to the distal end 315), which thus creates an integral cable. In some embodiments, a support structure for an electrode assembly comprising one or more layers of dielectric material (optionally including a substrate) has a thickness (r) of from 10 μm to 150 μm, from 15 μm to 70 μm, from 30 μm to 60 μm, or from 40 μm to 60 μm. In some embodiments, the support structure has a width (v) of from 25 μm to 10mm, for example about 50 μm or about 5000 μm.

The routing layer may be continuously formed from one or more conductive traces and may be composed of various metals or alloys thereof, such as copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloys thereof. The wiring layer may have a thickness (x) from 0.5 μm to 100 μm, from 0.5 μm to 15 μm, from 0.5 μm to 10 μm, or from 0.5 μm to 5 μm. In some embodiments, the top surface of the wiring layer is coplanar with the top surface of the support structure. In further embodiments, the wiring layer is embedded within the support structure. In yet further embodiments, the wiring layer is formed on a top surface of the support structure, and the top surface of the wiring layer is raised above the top surface of the support structure.

In some embodiments, each of a set of electrodes 320 is formed on the support structure and in electrical contact with the wiring layer. For example, each electrode 320 may be composed of a conductive material such as copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloy thereof. Each electrode 320 may have a thickness (z) from 0.1 μm to 50 μm, from 0.3 μm to 30 μm, from 0.5 μm to 20 μm, or from 1 μm to 15 μm. A set of electrodes 320 may be formed directly on the support structure or indirectly on the support structure. In some embodiments, a set of contacts is formed on the support structure and provides electrical contact between a set of electrodes 320 and the wiring layer. For example, the contacts may be composed of a conductive material such as copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloy thereof.

Fig. 5A shows electrodes arranged in a helical configuration and included within a deep brain stimulation system, according to an embodiment of the present invention. Fig. 5B shows a lead arranged in a helical configuration and included within a deep brain stimulation system, according to an embodiment of the present invention. As shown, the spiral base 505 is configured in a spiral shape around the support structure 510. A set of electrodes 515 and a set of traces 520 may be formed on the spiral substrate 505. The substrate 505 is wound such that it forms a spiral shape. As used herein, the phrase "helical" refers to a device made from a plurality of helices, which are a type of smooth spatial curve, i.e., a curve in three-dimensional space. The spiral may be wound in a clockwise or counterclockwise direction. The helix has the following characteristics: the tangent at any point is at a constant angle to a fixed line called the axis. It will be appreciated that the common set of electrodes 515 and the set of traces 520 (and/or each individual trace 520) may also be spiral-shaped.

The substrate 505 may extend along a portion of the lead assembly and/or may be helically positioned along a portion of the lead assembly. The portion may comprise substantially the entire length of the one or more conductive traces and/or the set of electrodes. Alternatively, the helical portion may be a portion of the cable that extends between the proximal and distal ends but does not include a connection portion (e.g., that includes a bond pad and/or one or more other connectors). In certain embodiments, the helical portion of the cable includes one or more features including a radius, a helix angle, a pitch (the elevation of the helix for one turn), a helix length, and/or a total elevation of the helix. The radius may be from 200 μm to 900 μm, from 250 μm to 700 μm or from 400 μm to 650 μm, for example about 580 μm. The helix angle may be from 10 ° to 85 °, from 40 ° to 65 °, or from 42 ° to 60 °, for example about 55 °. The pitch may be from 100 μm to 2mm, from 200 μm to 400 μm or from 600 μm to 1600 μm, for example about 720 μm. The helical length may be from 5cm to 150cm or from 50cm to 100cm, for example about 75cm, from the proximal end to the distal end. The total elevation may be from 5cm to 125cm or from 25cm to 75cm, e.g. about 50cm, from the proximal end to the distal end.

In some cases, the characteristics of the spiral at a first portion of the lead assembly including the electrode 515 are different than the characteristics of the spiral at a second portion of the lead assembly including the trace 520. In some embodiments, the first portion (which supports electrode 515) has a first helical structure. The first portion may be defined as the last 1cm to 15cm of the cable on the distal end of the cable. In certain embodiments, the first portion comprises a tight spiral (e.g., for tissue penetration as in deep brain stimulation or connection to a device such as a neurostimulator) having features comprising a radius from 200 μm to 900 μm, a helix angle from 10 ° to 85 °, and a pitch from 200 μm to 400 μm. In some implementations, the second portion (which supports the trace 520) has a second spiral structure. In certain embodiments, the second portion comprises a loose spiral having features comprising a radius from 200 μm to 900 μm, a helix angle from 10 ° to 85 °, and a pitch from 600 μm to 1600 μm.

In some cases, of lead assembliesSome or all of the electrode and/or lead may also include a housing disposed over, positioned over, and/or surrounding the electrode and/or lead. The housing may be comprised of a medical grade polymeric material. In some embodiments, the medical grade polymer is thermoset or thermoplastic. For example, the medical grade polymer may be: soft polymers such as silicones; polymer dispersions, such as latex; chemical vapor deposited poly (p-xylylene) polymers such as parylene; or polyurethanes, such asThermoplastic polycarbonate-urethane (PCU) orThermoplastic silicone-polycarbonate-urethane (TSPCU).

As shown in fig. 5C, at the proximal end of the lead assembly, the substrate 505 may flatten such that it no longer takes on a helical shape. Furthermore, in some cases, the support structure 510 is not present at the proximal end or is also flat (non-cylindrical) in shape. Each trace 520 may terminate at a bond pad 525. In some cases, the bond pads 525 and the traces 520 include the same material and/or the same composition. The lead assembly may be configured such that there is a 1:1 ratio, for example, between the traces and bond pads, or multiple traces 520 may be connected to individual bond pads 525.

Fig. 6A-6F illustrate stages in the manufacture of a lead assembly according to embodiments of the invention (e.g., for manufacturing the lead assembly depicted in fig. 4 and 5A-5C). More specifically, fig. 6A-6F illustrate stages during a process for forming a spiral substrate that can support electrical traces and/or electrodes.

As shown in fig. 6A, a coating 605 may be formed on a mandrel 610. The coating 605 may include a material that may facilitate withdrawal of the mandrel 610 towards the end of the process. For example, coating 605 may include heat shrink tubing, fluoropolymer, polytetrafluoroethylene, and/or teflon, which may recover at, for example, 195 ℃. The mandrel 610 may include a rigid material, a metallic material, and/or a fluoropolymer (e.g., polytetrafluoroethylene).

As shown in fig. 6B, the mandrel 610 may be inserted into a thermoplastic catheter 615 (e.g., comprising thermoplastic polyurethane). The thermoplastic conduit 615 may comprise a reflowable material and/or may comprise, for example, a CarboSil tube.

The substrate 620 may then be wrapped around the thermoplastic conduit 615 (fig. 6C). The first portion 620 of the substrate may be wound to include, for example, regular spacing between subsequent windings across the entire mandrel or across each of one or more portions of the mandrel. The substrate may comprise a film material and/or a polymer, such as a Liquid Crystal Polymer (LCP). The wound mandrel may then be thermoformed to define a helical shape. While the first portion 620 of the substrate may be wound into a spiral portion, the second portion 625 may remain planar to support connectors (e.g., bond pads). The first portion 620 and the second portion 625 of the substrate may, but need not, have the same composition and/or thickness.

The wound mandrel may then be inserted into a peelable heat shrink tube (and/or a tube comprising a fluoropolymer) 630. The assembly can then be recovered (e.g., at 195 ℃) to shrink the heat shrink tubing (fig. 6D). The shrunk heat shrink tubing 630 may apply pressure to the wound mandrel to hold the assembly together. During the heating process, the thermoplastic conduit 615 may further reflow, which may be glued into the first portion 620 of the substrate. The reflow may provide a smoother surface to the assembly such that the first portion 620 of the substrate is not elevated relative to the thermoplastic conduit 615.

The assembly may then be cooled (e.g., to room temperature), and heat shrink tubing 630 may be peeled away (fig. 6E). The mandrel 610 and coating 605 may then be removed (fig. 6F). As shown in the cross-section shown in fig. 7, the resulting lead assembly includes a probe lumen 740 passing through a middle portion of the lead assembly. The lead assembly may include a helically wound substrate 722 and a thermoplastic catheter 615 or other support structure. The depicted cross-section shows the substrate 722 as extending completely around the thermoplastic conduit 615. However, it will be appreciated that due to the helical nature of the substrate, for any given cross-section corresponding to a particular location along the length of the wire assembly, the substrate extends only across a portion of the perimeter. The diameter of the lumen 740 may be, for example, at least 10%, at least 25%, at least 33%, or at least 50% of the diameter of the helically wound portion of the lead assembly. The diameter of the lumen 740 may be, for example, less than 90%, less than 75%, less than 66%, or less than 50% of the diameter of the helically wound portion of the lead assembly.

During the implantation procedure, a probe (e.g., a rigid thin object, such as a thin metal object) may be inserted into the probe lumen 740. The probe may provide rigidity to the lead assembly to facilitate implantation of the device at a target site.

Thus, fig. 6A-6F illustrate how a lead assembly including a central lumen can be manufactured using thermoplastic. In the example shown, the thermoplastic conduit is reflowed to substantially bond the spiraled substrate and the underlying material together so that the supporting mandrel can be removed. Another method for manufacturing a lead assembly having a central lumen is to use a thermoset material.

Fig. 8A-8F illustrate stages in the manufacture of a lead assembly according to an embodiment of the present invention using a thermoset material. More specifically, fig. 8A-8F illustrate stages during formation of a spiral substrate that can support electrical traces and/or electrodes.

As shown in fig. 8A, a coating 805 may be applied to a catheter 810. The catheter 810 may comprise, for example, a thermoset material and/or a silicone catheter. The coating 805 may comprise, for example, a diluted liquid silicone resin. In some cases, coating 805 is applied after the surface of catheter 810 is prepared for adhesion (e.g., by performing plasma activation or oxygen plasma activation). After the coating 805 is applied, the coated catheter may be partially heat cured (e.g., to a thickness of 50-100 μm). This partial curing can cause the surface of the catheter to become tacky.

The mandrel 815 may be inserted into the coated catheter (fig. 8B). The mandrel 815 may include and/or may be, for example, a rigid material, a metallic material, and/or a fluoropolymer (e.g., polytetrafluoroethylene). The mandrel 815 may include a rigid material, a metallic material, and/or a fluoropolymer (e.g., polytetrafluoroethylene) coated with a material such as a fluoropolymer, polytetrafluoroethylene, and/or teflon.

A first portion 820 of the substrate may then be wrapped around the coated catheter 810 (fig. 8C). In some cases, the surface of first portion 820 of the substrate may be prepared for adhesion by, for example, performing plasma activation (e.g., oxygen plasma activation) prior to winding.

The first portion 820 of the substrate may be wound to include, for example, regular spacing between subsequent windings across the entire mandrel or across each of one or more portions of the mandrel. The substrate may comprise a film material and/or a polymer, such as a Liquid Crystal Polymer (LCP). While the first portion 820 of the substrate may be wound into a spiral portion, the second portion 825 may remain planar to support connectors (e.g., bond pads). The first portion 820 and the second portion 825 of the substrate may, but need not, have the same composition and/or thickness.

The wound mandrel may then be inserted into a peelable heat shrink tube (and/or a tube comprising fluoropolymer and/or PEELZ) 830. The assembly can then be recovered (e.g., at 195 ℃) to shrink the heat shrink tubing (fig. 8D). The shrunk heat shrink tubing 830 may apply pressure to the wound mandrel to hold the assembly together. The partially cured coating 805 on the catheter 810 can adhere to the wrapped first portion 820 of the substrate due to covalent bonding under the heat and pressure of the fully curable coating 805.

The assembly may then be cooled (e.g., to room temperature), and heat shrink tube 830 may be peeled away (fig. 8E). The mandrel 815 may then be removed (fig. 8F).

As shown in the cross-section shown in fig. 9, the resulting lead assembly includes a probe lumen 940 through the middle portion of the lead assembly. The lead assembly may include a helically wound substrate 922 and a catheter 910 coated with a coating 905 (e.g., a thermoset coating), which coating 905 may aid in adhering the substrate 922 to the catheter 910. The depicted cross-section shows the base 922 as extending completely around the conduit 910. However, it will be understood that due to the helical nature of the substrate, the substrate may only extend across a portion of the perimeter for any given cross-section corresponding to a particular location along the length of the lead assembly. The diameter of the lumen 940 can be, for example, at least 10%, at least 25%, at least 33%, or at least 50% of the diameter of the helically wound portion of the lead assembly. The diameter of the lumen 940 can be, for example, less than 90%, less than 75%, less than 66%, or less than 50% of the diameter of the helically wound portion of the lead assembly.

Fig. 10A-10E illustrate various views of a lead assembly according to embodiments of the invention. The lead assembly depicted includes one manufactured according to the manufacturing shown in fig. 8A-8F. The lead assembly also includes a proximal segment 1005, the proximal segment 1005 including a plurality of bond pads. The lead assembly also includes a distal segment. The distal segment includes a first distal segment portion 1010 (shown in fig. 10D) and a second distal segment portion 1015 (shown in fig. 10C) and an intermediate segment extending between the proximal segment 1005 and the distal segment and including an intermediate segment portion 1020 (shown in fig. 10E).

Across the distal and intermediate segments, the substrate 1025 is wound into a helical shape. At the proximal section 1005, the base 1025 is in a planar configuration. At the distal end, a set of electrodes 1030 is disposed on a spiral-shaped base 1025. Lumen 1035 extends through the portion of the lead assembly that includes wrapped substrate 1025. Each electrode 1030 may be connected to an electrical trace 1040, the electrical trace 1040 extending from the electrode to a bond pad in a spiral shape along an intermediate segment (along the substrate 1025).

Fig. 11A-11F illustrate stages in the manufacture of a lead assembly according to an embodiment of the present invention using a thermoset material. More specifically, FIGS. 11A-11F illustrate stages during formation of a spiral shaped substrate that can support electrical traces and/or electrodes.

As shown in fig. 11A, a mandrel 1110 may be inserted into a silicone catheter 1112. (it will be appreciated that alternatively, a coating may be applied to the mandrel 1110). The mandrel 1110 may include and/or may include, for example, a rigid material, a metallic material, and/or a fluoropolymer (e.g., polytetrafluoroethylene). The mandrel 1110 may comprise a rigid material, a metallic material, and/or a fluoropolymer (e.g., polytetrafluoroethylene) coated with a material such as a fluoropolymer, polytetrafluoroethylene, and/or teflon. The silicone catheter 1112 can have an inner diameter of less than 0.050, less than 0.030, less than 0.020, and/or about 0.020 inches, for example. The silicone conduit 1112 can have an outer diameter of less than 0.100, less than 0.050, less than 0.040, and/or about 0.037 inches, for example. The mandrel 1110 can have an outer diameter of, for example, greater than 0.005, greater than 0.010, about 0.018, less than 0.020, and/or less than 0.030 inches.

As shown in fig. 11B, the catheter-mandrel assembly may be inserted into a thermoplastic catheter 1115 (e.g., comprising thermoplastic polyurethane). The thermoplastic conduit 1115 may comprise a reflowable material and/or may comprise, for example, a CarboSil tube. The thermoplastic conduit 1115 can have an inner diameter of less than 0.10, less than 0.080, less than 0.050, about 0.042, greater than 0.030, and/or greater than 0.040 inches, for example. The thermoplastic conduit 1115 may have an outer diameter of less than 0.100, less than 0.050, about 0.046, greater than 0.030, and/or greater than 0.040 inches, for example.

The first portion 1120 of the substrate can then be wrapped around the thermoplastic conduit 1115 (fig. 11C). The winding may be performed to create, for example, regular intervals between subsequent windings across the entire thermoplastic conduit or across each of one or more portions of the thermoplastic conduit. The substrate may comprise a film material and/or a polymer, such as a Liquid Crystal Polymer (LCP). The wound structure may then be thermoformed (e.g., at 150 ℃) to define a spiral shape. While the first portion 1120 of the substrate may be wound into a spiral portion, the second portion 1125 may remain planar to support connectors (e.g., bond pads). The first portion 1120 and the second portion 1125 of the substrate may, but need not, have the same composition and/or thickness.

The wound structure may then be inserted into a peelable heat shrink tube (and/or a tube comprising fluoropolymer and/or PEELZ) 1130. The assembly can then be recovered (e.g., at 195 ℃) to shrink the heat shrink tubing (fig. 11D). The shrunk heat shrink tubing 630 may apply pressure to the wound mandrel to hold the assembly together. During the heating process, the thermoplastic conduit 1115 may further reflow, which may be bonded into the first portion 1120 of the substrate. The reflow may provide a smoother surface to the assembly such that the first portion 1120 of the substrate is not elevated relative to the thermoplastic conduits 1115.

The assembly may then be cooled (e.g., to room temperature), and the heat shrink tubing 1130 may be peeled away (fig. 11E). The mandrel 1115 may then be removed (fig. 11F). Thus, both thermosetting and thermoforming (e.g., using heat shrink tubing 1130 and thermoplastic conduit 1115, respectively) may stabilize the helical position of the first portion 1120 of the substrate.

As shown in the cross-section shown in fig. 12, the resulting lead assembly includes a probe lumen 1240 through the middle portion of the lead assembly. The lead assembly may include a helically wound substrate 1222, the substrate 1222 being wound around a thermoplastic conduit 1215, the thermoplastic conduit 1215 being adhered to a silicone conduit 1212. The depicted cross-section shows the substrate 1222 as extending completely around the thermoplastic conduit 1215. However, it will be understood that due to the helical nature of the substrate, the substrate may only extend across a portion of the perimeter for any given cross-section corresponding to a particular location along the length of the lead assembly. The diameter of the lumen 1240 can be, for example, at least 10%, at least 25%, at least 33%, or at least 50% of the diameter of the helically wound portion of the lead assembly. The diameter of the lumen 1240 can be, for example, less than 90%, less than 75%, less than 66%, or less than 50% of the diameter of the helically wound portion of the lead assembly.

The various designs and processes disclosed herein may facilitate the creation of a stimulation system having a small outer diameter that may reduce inflammation and damage when the system is implanted or when it is positioned at the implantation site. In some cases, the stimulation system (e.g., and/or the lead body) may have an outer diameter of less than 20mm, less than 10mm, less than 5mm, less than 2mm, less than 1.5mm, less than 1.4mm, and/or about 1.2 mm. In some cases, stimulation systems may be designed to include a large number of electrodes and traces (e.g., about 8, 16, 32, or 64 electrodes and/or more than 4, more than 8, more than 16, or more than 32 electrodes) while still having a small outer diameter (e.g., less than 20mm, less than 10mm, less than 5mm, less than 2mm, less than 1.5mm, less than 1.4mm, and/or about 1.2 mm).

In the above description, specific details are given to provide a thorough understanding of the embodiments. However, it is understood that embodiments may be practiced without these specific details. For example, circuits may be shown in block diagrams in order not to obscure the embodiments in unnecessary detail. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail in order to avoid obscuring the embodiments.

It is noted that the embodiments may be described as a process which is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be rearranged. A process terminates when its operations are completed, but may have additional steps not included in the figure.

While the principles of the disclosure have been described above in connection with specific apparatuses and methods, it is to be clearly understood that this description is made only by way of example and not as a limitation on the scope of the disclosure.

The claims (modification according to treaty clause 19)

1. A stimulation system, comprising:

a plurality of stimulation components, wherein each of the one or more stimulation components comprises:

one or more electrodes; and

a cylindrical substrate, wherein the plurality of stimulation components are secured to a surface of the cylindrical substrate such that the leads of the plurality of stimulation components do not overlap one another across a length of the cylindrical substrate; and

a skull mount kit comprising:

an electronic component that identifies a stimulation parameter, wherein the one or more bond pads are electrically connected to the electronic component; and

one or more bond pads, wherein each of the one or more wires is directly electrically and physically connected to a bond pad of the one or more bond pads.

3. The stimulation system of claim 1, wherein each of the one or more stimulation components is wound onto an outer surface of the cylindrical substrate.

4. The stimulation system of claim 1, wherein the cylindrical base forms a hollow cylinder to which the one or more stimulation components are secured.

5. The stimulation system of claim 1, wherein the cylindrical substrate comprises a thermoplastic material or a thermoset material.

6. The stimulation system of claim 1, further comprising:

a fluoropolymer coating at least partially surrounding the one or more stimulation components being secured.

7. A stimulation system according to claim 1, wherein the substrate comprises a thin film material.