WO2011072128A1 - Ensemble réseau d'électrodes implantable avec des électrodes qui sont intégrées avec les circuits intégrés spécifiques qui fournissent du courant aux électrodes/puisent du courant des électrodes - Google Patents

Ensemble réseau d'électrodes implantable avec des électrodes qui sont intégrées avec les circuits intégrés spécifiques qui fournissent du courant aux électrodes/puisent du courant des électrodes Download PDF

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Publication number
WO2011072128A1
WO2011072128A1 PCT/US2010/059691 US2010059691W WO2011072128A1 WO 2011072128 A1 WO2011072128 A1 WO 2011072128A1 US 2010059691 W US2010059691 W US 2010059691W WO 2011072128 A1 WO2011072128 A1 WO 2011072128A1
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WO
WIPO (PCT)
Prior art keywords
array
substrate
electrode
package
conductors
Prior art date
Application number
PCT/US2010/059691
Other languages
English (en)
Inventor
John Janik
Robert Brindley
James Bernard Dunlop, Jr.
Leland Joseph Spangler
Edward Chia-Ning Tang
Original Assignee
Stryker Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stryker Corporation filed Critical Stryker Corporation
Priority to EP10795862.1A priority Critical patent/EP2512585B1/fr
Publication of WO2011072128A1 publication Critical patent/WO2011072128A1/fr
Priority to US13/491,777 priority patent/US10046158B2/en
Priority to US16/036,270 priority patent/US10342971B2/en
Priority to US16/460,601 priority patent/US20190321627A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0553—Paddle shaped electrodes, e.g. for laminotomy
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L23/00—Details of semiconductor or other solid state devices
    • H01L23/28—Encapsulations, e.g. encapsulating layers, coatings, e.g. for protection
    • H01L23/31—Encapsulations, e.g. encapsulating layers, coatings, e.g. for protection characterised by the arrangement or shape
    • H01L23/3107—Encapsulations, e.g. encapsulating layers, coatings, e.g. for protection characterised by the arrangement or shape the device being completely enclosed
    • H01L23/3121—Encapsulations, e.g. encapsulating layers, coatings, e.g. for protection characterised by the arrangement or shape the device being completely enclosed a substrate forming part of the encapsulation
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L23/00—Details of semiconductor or other solid state devices
    • H01L23/52—Arrangements for conducting electric current within the device in operation from one component to another, i.e. interconnections, e.g. wires, lead frames
    • H01L23/538—Arrangements for conducting electric current within the device in operation from one component to another, i.e. interconnections, e.g. wires, lead frames the interconnection structure between a plurality of semiconductor chips being formed on, or in, insulating substrates
    • H01L23/5387—Flexible insulating substrates
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L2924/00—Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
    • H01L2924/0001—Technical content checked by a classifier
    • H01L2924/0002—Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00

Definitions

  • This invention relates generally to an implantable electrode array assembly and, more particularly, to an implantable electrode array with a number of individually activated electrodes wherein each electrode is integral with the semiconductor chip that sources current to/sinks current from the electrode.
  • the current is driven between the electrodes of an electrode array implanted in the patient.
  • the electrode array includes a non-conductive carrier on which typically two or more electrodes are disposed.
  • current is driven from at least one of the electrodes, through the adjacent tissue, to at least one of the other electrodes.
  • the current flow through the tissue influences the tissue to accomplish a desired therapeutic result.
  • an electrode array positioned adjacent the heart may flow currents to stimulate the appropriate contraction and expansion of the heart muscles .
  • the current driven between the electrodes of an array placed on top of the dura in the vertebral column reduces the extent to which chronic pain signals are perceived by the brain.
  • the array may be placed in a location where the current flow stimulates a feeling of satiation as part of an appetite suppression/weight management therapy.
  • the current is flowed to tissue or nerves associated with the bladder or the anal sphincter to assist in control of incontinence. Electrodes may be implanted in a paralysis victim to provide muscle control and/or a sense of feeling.
  • this array can be operated so that there are two or more current flows occurring
  • the practitioner can initially drive current between different combinations of electrodes. Current therefore flows through different sections of tissue. This allows the practitioner to determine between which electrodes, through which tissue, the current flow offers the greatest benefit and/or tolerable side effects. Once the optimal current flow path between the electrodes is determined, the array and its associated power supply are set to operate in this state.
  • the above-described array makes it possible to flow current through more sections of tissue and to selectively focus/diffuse the current flow.
  • use of the above-described array increases the likelihood that the current flow can be set to provide desired therapeutic effects, with tolerable side effects.
  • Still another advantage of the above-described array is that the carrier is formed from superelastic material.
  • a superelastic material is one that, after being subjected to appreciable bending or folding, returns to its initial state.
  • the assembly is then folded or rolled into a form that has a side-to-side width appreciably less than its width in the unfolded/unrolled state.
  • a benefit of an electrode array assembly of this design is that it can be folded into a sheath. The sheath-encased electrode array assembly can then be inserted through an access cannula using a minimally invasive procedure into the patient.
  • the sheath and assembly are steered to over the tissue against which the electrodes integral with the assembly are deployed.
  • the sheath is opened up or removed.
  • the opening/removal of the sheath causes the carrier to unfold.
  • the electrodes deploy over the target tissue.
  • a single bus, or a bus is connected to each of the control modules. Instructions transmitted over the bus inform each control module if it should, serve as a current source, be turned off, or serve as a current sink. Since there are relatively few bus conductors, these conductors can be relatively large in size. This reduces the fragility of these conductors. Further the conductors that extend from each control module to the associated electrode are relatively short and length Also, the electrode array of this invention is further constructed so that the conductors that extend to the electrodes are oriented on axes
  • the electrode array assembly is exposed to relatively minimal stress along the axes perpendicular to these
  • This invention is related to a new and useful electrode array designed for implantation into a living being.
  • the electrode array of this invention includes at least one or more electrode ASIC packages (EAPs) .
  • EAP electrode ASIC packages
  • Each EAP consists of an integrated circuit that includes components for sourcing and/or sinking current.
  • the circuit is
  • Electrodes contained in a package. Disposed over an outer surface of the package are one or more conductors. These conductors function as the electrodes of the EAP.
  • the EAPs are disposed on an array substrate. Also disposed on the array substrate, often between the body of the substrate and the EAPs are one or more conductors. These conductors
  • each EAP includes a package substrate.
  • the package substrates are more rigid than the array substrate.
  • the EAP is constructed so that the on package electrode (electrodes) and the package substrate are located over opposed faces of the integrated circuit. Conductors internal to the package substrate extend to bond pads on the integrated circuit. Often, at least one of these conductors is used to establish an electrical connection between the integrated circuit and the overlying electrode.
  • the electrode array of this invention often includes a frame.
  • the frame is formed out of material that provides the array with at a minimum, some structural rigidity.
  • the frame is formed out of material that is flexible.
  • the frame is formed out of superelastic material.
  • the frame is disposed over the substrate.
  • the frame typically has structural components that at least partially surround the EAPs .
  • a shell formed from flexible, electrically insulating material is disposed around the partially assembly array. More particularly, the insulating material forming the shell is disposed around the underside and sides over the substrate, over the frame and between the EAPs and the frame. The insulting material forming the shell thus holds the components forming the electrode array assembly together. This insulating material also functions as an insulating layer between the EAPs and the frame.
  • the array also includes a transfer package.
  • the transfer package includes components that function as the interface between the external conductors over which power and instructions are supplied to the array and the on-substrate bus.
  • transfer package may be attached to the array using the same means and at the same time the EAPs are secured to the array .
  • the EAPs of the array of this invention are constructed so that the conductors that extend from the components internal to the integrated circuit to the
  • Still another feature of the electrode array of this invention is that while the structure components of the frame may need to extend around the EAPs, there is no requirement that these components be in a precise distance from each other. This serves to reduce the cost associated with both providing the frame and bonding the frame to the rest of the array.
  • Figure 1 is a perspective view of an electrode array constructed in accordance with this invention.
  • Figure 2 is an exploded view of the electrode array of Figure 1 ;
  • Figure 3 is a cross sectional view of the
  • Figure 4 is a plan view of the top of the
  • Figure 5 is a plan view of a section of the upwardly directed surface of the bottom layer of the array substrate ;
  • Figure 6 is a plan view of a section of the upwardly directed surface of the middle layer of the array substrate ;
  • Figure 7 is a diagrammatic illustrate of the conductors forming the on-substrate bus
  • Figure 8 is a plan view of the array frame;
  • Figure 9 is a cross sectional view of a portion of an electrode ASIC package (EAP) of this invention as the EAP is embedded in the array;
  • EAP electrode ASIC package
  • Figure 10 is a block diagram of the electrical components integral with the electrode ASIC package
  • Figure 11 is a cross sectional view of the
  • Figure 12 is an exposed side and partial cross sectional view of the transfer package
  • Figure 13 is an exploded view of an alternative electrode array of this invention.
  • Figure 14 is a cross sectional view of a portion of the alternative electrode array of Figure 13;
  • Figure 15 is a plan view of the unfolded flexible sheet of the electrode array of Figure 13 that forms the substrate, the hinge and superstrate;
  • Figure 16 is a cross sectional view of the sheet of Figure 15 taken along line 16-16;
  • Figure 17 is a cross sectional view of the sheet of Figure 16 taken along line 17-17.
  • FIGs 1, 2 and 3 illustrate the basic features of an electrode array 40 constructed in accordance with this invention.
  • Array 40 includes a number of spaced apart electrodes 42.
  • the electrodes 42 are arranged in a row by column pattern.
  • there are at least 10 electrodes 42 in many versions of the invention there are 20 or more electrodes and, often, 40 or more electrodes.
  • Each electrode 42 is part of an electrode ASIC package 44, (EAP) .
  • EAP 44 in addition to having an electrode 42, includes components, seen in Figure 10, that source or sink current to the electrode. These components may also monitor the voltage present at the associated electrode 42.
  • the EAPs 44 are disposed on a non-conductive substrate 46.
  • a multi-conductor bus 48 ( Figure 7) internal to the substrate 46 supplies power and operating
  • a frame 50 like EAPs 44, is disposed on the substrate.
  • Frame 50 is formed of material that provides some rigidity to the array 40. Typically the material from which the frame 50 is formed has some flexibility though less than that of the substrate 46.
  • Frame 50 includes structural components that at least partially surround the EAPs 44.
  • a transfer package 51 is mounted to one end of the array 40.
  • the transfer package 51 is shown at the right end of the array 40, arbitrarily, the "proximal" end of the array 40.
  • the left end of the array is the “distal” end of the array.
  • Transfer package 51 contains the components that function as an interface that extends between the conductors 52 external to the array 40 and the conductors forming bus 48.
  • Conductors 52 shown as a single cable in the Figures, extend to an implantable device controller.
  • the implantable device controller which is not illustrated, is the implantable unit that provides the power for the current sources and sinks internal to the EAPs 44 as well as the instructions that indicated to which electrodes 42 the current should be source or sunk.
  • the specific structure of the implantable device controller is not part of this invention.
  • Electrode array 40 of this invention also includes a shell 56 formed from, flexible, biocompatable electrically insulating material such as liquid crystal polymer or parylene. Shell 56 extends over the exposed surfaces of substrate 46, frame 50 and transfer package 51.
  • shell 56 material forming shell 56 is also disposed between the EAPs 44 and the frame 50. Shell 56 does not extend over the whole of the EAPs 44. Instead, the top portions of the EAPs 44, the portions on which the electrodes 42 are
  • electrode array 40 when electrode array 40 is disposed against tissue through which current is to be flowed, the electrodes 42 are in contact with the tissue.
  • Substrate 46 is now described initially with respect to
  • Figures 3 and 4 is a laminate structure.
  • substrate 46 is formed from three layers of electrically insulating material so as to have a bottom layer 62, a middle layer 64 and an upper layer 66.
  • Layers 62, 64 and 66 may be formed from material such as liquid crystal polymer or parylene. This material, in addition to being electrically insulating, is flexible.
  • Each layer 62, 64 and 66 has a thickness of 100 microns or less, often 50 microns or less and, in many preferred versions of the invention, 25 microns or less.
  • each layer 62, 64, or 66 has a thickness of between 10 and 15 microns.
  • layers 62, 64 and 66 are shaped so as to provide the illustrated substrate 46 with a center section 68 that has a generally rectangular shape.
  • a head 70 extends forward from the front end, the distal end, of the substrate center section 68.
  • Substrate head 70 is shaped to have two tapered sides (not identified) that, as they extend forward of the center section, taper inwardly toward each other.
  • the head 70 also has a curved front edge, (not identified) that extends between the distal most ends of the sides. Thus, the most distal end of the
  • substrate head 70 has a convex profile.
  • a tail 74 extends away from the proximal end of the substrate center section 68, the end opposite the distal end.
  • Tail 74 is generally in the shape of truncated triangle. As the sides of the tail 74 extend away from the proximal end of the substrate center section 68, the sides taper inwardly toward each other. In the illustrated version of the invention, the sides of the tail are
  • Array substrate 46 is further formed to have a number of slots 78 that extend through layers 62, 64, and 66.
  • Each slot 78 is I-shaped. Slots 78 are formed so that the long center sections of the slots are parallel to the longitudinal axis of the substrate, the axis that extends between the opposed distal and proximal ends.
  • the slots 78 are further arranged in pairs such that two slots 78 that are laterally spaced apart from each other are formed in a number of different longitudinally spaced apart portions of the substrate center section 68. In the illustrated version of the invention, the slots 78 are arranged so that each pair of slots is symmetrically positioned relative to the substrate longitudinal axis.
  • Each slot 80 extend through the substrate head 70.
  • Each slot 80 is generally in the shape of an inverted T wherein the horizontal section of each slot 80 is located slightly forward of and is parallel with the most distal horizontal portion of on the most distally located slots 78.
  • Conductors that form bus 48 are disposed between the substrate layers 62, 64 and 66. Specifically a set of longitudinally extending conductors 86 are formed on the face of the substrate bottom layer 62, seen in Figure 5, against which middle layer 64 is disposed. In Figure 5 each set of conductors 86 is shown to have just two
  • each set of conductors 86 includes 16 or less conductors and in some preferred versions of the invention, each set of conductor consists of 8 or less conductors.
  • Each conductor 86 is formed from gold has a side-to-side width of 100 microns or less and often 50 microns or less.
  • Each conductor 86 has a thickness of 25 microns or less and more preferably 10 microns or less.
  • Conductors 86 are arranged so that one set of conductors is centered on the longitudinal axis of the substrate. The other two sets of conductors 86 are located between the outer edges of the layer 62 and the portions of the adjacent slots 78 formed in the layers.
  • the center set of conductors 86 extends proximally forward from a location over the tail-defining portion of the substrate layer 62. More particularly, the center conductors 86 terminate in an area over which transfer package 51 is disposed.
  • the outer two sets of conductors 86 extend forward from a location distally forward of the proximal end terminus of the center- located set of conductors 86.
  • Bus 48 includes a second set of conductors, conductors 88, seen best in Figure 6.
  • Conductors 88 are disposed on the surface of substrate middle layer 64 that is located between the middle layer 64 and the upper layer 66.
  • Bus conductors 88 are formed from the same material and have the same width and thickness dimensions as bus
  • Bus conductors 86 are disposed over
  • Bus conductors 88 are arranged so as to be in plural sets of conductors that are longitudinally spaced apart from each other along the length of the substrate 46. Each set of bus of
  • conductors 88 contains the same number of conductors that are contained in the sets of conductors 86.
  • Sets of bus conductors 88 extend over the portions of substrate middle layer 64 located between the rows of slots 78 formed in the layer.
  • Each bus conductor 88 extends over the underlying three sets of conductors 86; the two outer sets of conductors 86 and the center-located set of conductors 86.
  • the most proximally located set of conductors 88 extends over the portion of the layer 64 immediately proximal to the proximal most row of slots 86.
  • branch conductors 90 are disposed on the same surface of the substrate middle layer 64 on which bus conductors 88 are disposed.
  • Each set of branch conductors 90 includes the same number of conductors as there are in the sets of bus conductors 86 and 88.
  • Branch conductors 90 have the same widths and thicknesses of the bus conductors 86 and 88.
  • Branch conductors 90 are disposed on sections of the substrate middle layer 64 in which slots 78 are formed. More particularly, in each of these sections of substrate middle layer 64 there are three parallel, laterally spaced apart sets of branch conductors 90. On each section of the substrate middle layer 64, a first set of branch
  • conductors 90 is located between the slots 78.
  • branch conductors 90 are located between each slot 78 and the adjacent side edge of the substrate middle layer.
  • branch conductors 90 are parallel to the coplanar bus conductors 88.
  • conductors 88 and 90 may not have this relationship and/or conductors 90 may not be linear.
  • Figure 7 illustrates the structure of bus 48 and the relationship of branch conductors 90 to the bus.
  • the perimeters of the array substrate 46 and slots 78 are shown in phantom.
  • Conductors 86, 88 and 90 are shown as solid lines.
  • FIG 7 the two conductors 86 of the center-located set of conductors 86 are shown having proximal end terminuses that are longitudinally spaced apart from each other. This may be the case when the transfer package 51 is provided with bond pads 237 ( Figure 11) that have a like longitudinal spacing. Vias 91, represented as solid dots in Figure 7, extend through both the substrate middle and top layers 64 and 66, respectively, connect each of the transfer package bond pads 237 to a specific center-located conductor 86.
  • Each bus conductor 88 connects one of the center located conductors 86 to the two corresponding outer-located conductors 86, (one conductor 86 on each side of the
  • Each center located conductor 86 is connected to the complementary outer-located
  • bus conductors 86 by a plurality of longitudinally spaced apart bus conductors 88. This arrangement facilitates
  • Each branch conductor 90 is connected to a
  • a via 94 extends from each of the each branch conductor 90 through the overlying substrate top layer 66. Each via 94 connects the branch conductor 90 to a bond pad 154 ( Figure 9) integral with the overlying EAP 44.
  • Frame 50 provides structural support to the rest of the electrode array 40. In most versions of the
  • frame 50 is provided with material that, in addition to providing structural strength to array 50, is flexible, though less flexible than substrate 46 and
  • frame 50 is formed out of material that, in addition to being flexible, is super elastic.
  • a “super elastic” material is understood to be a material that, in addition to being deformable, after the force holding the material in the deformed shape is removed, returns to its original shape.
  • One such material having the property of being super elastic is a nickel titanium alloy known as Nitinol.
  • frame 50 is formed out a piece of Nitinol having a thickness that is typically 100 microns or less and often in the range of 30 to 70 microns.
  • frame 50 is formed from a single piece of Nitinol and is shaped to have a proximal located tail 96.
  • Frame 50 also has a head 128 that is spaced forward of tail 96.
  • Frame tail 96 includes two beams 97 and 108 that extend perpendicular to the longitudinal axis of the
  • Beam 97 the more proximal of the two beams, is the shorter of the two beams.
  • Beam 108 in addition to being located forward of beam 97, is longer in length than beam 97. Both beams 97 and 108 are centered on the
  • beams 98, 99, 101 and 102 extend between beams 97 and 98.
  • Beams 99 and 101 are perpendicular to beams 97 and extend along axes parallel to the longitudinal axis of frame 50.
  • Beams 98 and 102 taper outwardly from beam 97 so as to extend to the outer ends of beams 108.
  • beam 98 extends from a proximal terminus that is distally forward of the location from which beam 107
  • Frame tail 96 occupies a surface that is substantially identical to that of substrate tail 74.
  • Bridges 112, 114 and 116 extend distally forward from beam 108. Bridge 114 is centered along the
  • Bridges 112 and 116 are spaced apart symmetrically relative to bridge 114.
  • a number of three-sided tabs 118 extend outwardly from bridges 112, 114 and 116.
  • Frame 50 is shaped so that tabs 118 have major axes that are parallel to the longitudinal axis of the frame.
  • Tabs 118 are arranged in pairs; where a tab 118 extends outwardly from one side of a bridge 112, 114 or 116, a laterally aligned tab 118 extends outwardly from the opposed side of the same bridge.
  • the tabs 118 are further so that where the tabs extend outwardly from one bridge 112, 114 and 116 tabs also extend outwardly from the laterally adjacent sections of the other two bridges.
  • Frame 50 is therefore constructed so that the tabs 50 are arranged in rows wherein, in the illustrated version of the invention, there are six tabs in each row.
  • the rows of tabs 118 are longitudinally spaced apart from each other.
  • frame is shaped so that the tabs 118 have a length, distance along the axis parallel to the longitudinal axis of the frame 50, of between approximately 0.5 and 4.0 mm.
  • each row of tabs 50 is spaced approximately 0.5 to 4.0 mm away from the row of laterally adjacent tabs. It should be further understood that frame 50 is further shaped so that each tab 118 that extends outwardly from center located
  • bridge 114 is spaced away from the adjacent tab that extends outwardly from the adjacent bridge 112 or 116. This
  • each tab 118 is shaped to have a center located rectangular opening 120.
  • the major axes of the tab openings 120 are, centered on the major axes of the tabs 118.
  • the outermost tabs 118, the tabs that extend outwardly from the outer side edges of bridges 112 and 116 have tapered front and rear sections, the sections perpendicular to the longitudinal axis of the frame. These sections (not identified) are tapered so that that length of the tab 118 decreases slightly as the tab extends away from the bridge 112 or 116 with which the tab is integral.
  • the outer corners of the tabs (corners not identified) are rounded.
  • a number of rectangularly shaped beams 124 also part of frame 50, connect bridges 112, 114 and 116 together.
  • the frame 50 is shaped so that where a beam 124 extends between bridge 112 and bridge 114 a laterally adjacent beam 124 extends between bridge 114 and bridge 116.
  • the beams 124 are arranged so that a pair of laterally adjacent beams is located immediately in front of and rearward of all but the most proximal row of tabs 118.
  • a pair of beams 124 are located immediately forward of the most proximal row of tabs 118.
  • Each beam 124 has a width, the distance parallel to the longitudinal axis of the frame 50, that is typically 2.0 mm or less and often 0.5 mm or less.
  • frame 50 is further formed so that as the frame extends distally from tail 96, the widths of the bridges 112, 114 and 116 decrease.
  • the width of each bridge 112, 114 and 116 decrease.
  • each bridge 112, 114 and 116, between the second and third most proximal rows of tabs is approximately 0.80 mm.
  • the width of each bridge 112, 114 and 116 immediately rearward of the distal most row of tabs 118 is approximately 0.32 mm.
  • the tabs 118 that extend outwardly from bridge 114 are spaced away from the adjacent tabs 118 integral with bridges 112 and 116.
  • the tabs 118 are spaced longitudinally away from the adjacent inter bridge beams 124.
  • I-shaped slots 119 around the tabs 118 there are I-shaped slots 119 around the tabs 118.
  • Frame 50 is further shaped so as to have openings in adjacent tail beam 108 that form slots 119 around the proximal most tabs 118.
  • center bridge 114 The distal end of center bridge 114 is
  • the frame 50 of electrode array 40 is further formed to have two
  • Head 128 is located forward from a small neck 132 that forms the distal end of center-located bridge 114. Thus, neck 132 is located forward of the two distal most tabs 118 that extend outwardly from bridge 114. Each of the two distal most beams 124 extend from neck 132. Head 128 is located forward of the two distal most beams 124. Head 128 has a proximal edge that extends laterally beyond neck 132 on either side of the neck. The head 128 has two parallel side edges. At the most distal end, head 72 has an outwardly curved distally-directed front edge (not identified) .
  • Each shoulder 130 extends forward from a small land 134 located forward of the associated outer bridge 112 or 116.
  • Each land 134 is integral with and extends distally forward from the outer tab 118 integral with the bridge 112 or 114 with which the tab is integral.
  • Lands 134 serve as the terminuses for the beams 124 that extend from neck 132.
  • Each shoulder 130 is spaced forward and away from the adjacent beam 124. Shoulders 130 are also spaced laterally away from the adjacent side edges of the head 128.
  • the shoulder 130 on the left side of Figure 8 is spaced from the adjacent head side edge along a line that is collinear with the line along which the tabs 118
  • shoulder 130 on the right side of Figure 8 is spaced from the adjacent head side edge along a line collinear with the line along which the tabs associated with bridge 114 are spaced from the adjacent tabs 118 associated with
  • Each shoulder 130 is approximately in the shape of a right angle triangle wherein the 90° corner is located adjacent the bottom of the adjacent side of edge of the head 128.
  • the hypotenuse edge of the shoulder 130 is the outer edge of the shoulder.
  • Each shoulder 130 is, however, further shaped to have a rounded distal end (not
  • a beam 136 connects the hypotenuse of each
  • each beam 130 extends from an outer extension of the associated shoulder forward and inwardly.
  • each beam 136 is spaced forward from the distal end of the associated shoulder 80 and curves inwardly over the adjacent side of the front edge of
  • each beam 136 is connected to a small nose 138 that extends forward from the most forward edge of head 72.
  • a small void space (not
  • substrate 46 and frame 50 are constructed so that when the frame 50 is disposed over the substrate, frame slots 119 are in registration with
  • shoulders 130 are in registration over substrate slots 80.
  • frame 50 may be shaped so as to be non planar.
  • the frame may be shaped so as to have a radius of curvature that is
  • array bridge 114 would thus appear to be above (or below) bridges 112 and 116.
  • Frame 50 would be so curved if it is desirable to provide the array itself with such a curvature. This would facilitate
  • the EAP 44 includes an
  • ASIC application specific integrated circuit
  • the illustrated ASIC 152 is a six sided polyhedron wherein the surfaces are all rectangular.
  • the bottom surface of the ASIC 152 is provided with a number of gold bond pads 154 (only two shown in Figure 9) .
  • Insulating material 156 such as silicone is disposed over the top and side surfaces of the ASIC 152. Insulating material 156 typically has a thickness of 50 microns or less.
  • frame 158 formed of gold or other conductive material is disposed around the outer surface of the insulating
  • the frame 158 is disposed around the sections of insulating material that are disposed around the four side surfaces of the ASIC 152.
  • conductive frame 158 has a thickness of at least 5 microns.
  • a very thin layer of titanium 160 is disposed over the section of insulating layer 156 disposed over the top of the ASIC 152. Titanium layer 160 has a thickness that is typically 5 microns or less. The titanium layer 160 extends above the exposed rectangular face of frame 158 that
  • a cap 168 formed of gold or other conductive material is disposed over both titanium layer 160 and the adjacent face of frame 158.
  • Cap 168 has a thickness of at least 10 microns.
  • a gold-tin solder layer 162 disposed between the face of the frame 158 and the overlying portion of the cap 168. Solder layer 162 establishes a conductive bond between frame 158 and cap 168. Titanium layer 160 is added to the under construction EAP 44 prior to the
  • the titanium layer 160 prevents the run off of the solder forming layer 162 over the top of the ASIC 152.
  • the electrode 42 of the EAP 44 is disposed over the exposed face of the cap 168.
  • the electrode 42 comprises a layer of iridium oxide plated over the exposed face of cap 168.
  • the plating forming the electrode 42 has a thickness of at least 1 micron .
  • the components are constructed so that there will be a gap of at least 1 micron between the faces of the array frame 50 that define the tab openings 120 and the adjacent faces of the EAP conductive frame 158.
  • the EAP 44 also includes a substrate 170 formed from a low temperature co-fired ceramic or other
  • substrates 170 are referred to as "package
  • Each package substrate 170 is disposed under the face of the ASIC 152 opposite the face over which the
  • each package substrate 170 has a thickness of that is typically at least 10 microns or more and often 20 microns or more.
  • the substrate 170 is further dimensioned to extend at least 10 microns and often 20 microns or more beyond the outer faces of frame 158. Given the differences in the materials in which the array substrate 46 and the package substrates 170 are formed, it should be appreciated that the package substrates 170 are appreciably more rigid than the array substrate 46.
  • substrate 170 may be formed multiple layers of material.
  • each package substrate is formed so as to define closed-ended bores 172 that extend downwardly from surface of the substrate against which the ASIC 152 is disposed.
  • One end of each of these bores 172 is filled with a conductive adhesive 174 such as a conductive polymer adhesive.
  • conductive plugs 176 below all but one of the adhesive filled bores 172 substrate 170 is formed to have conductive plugs 176.
  • Plugs 176 which may be formed from gold, extend slightly below the face of the substrate 170, for example, approximately 10 microns below the face of the substrate .
  • a conductive trace 180 is embedded in the package substrate 170.
  • Trace 180 may be formed from gold and have a thickness of at least 1 micron and a width of at least 10 microns.
  • One end of trace 180 is located below and
  • the opposed end of the trace 180 terminates at a via 182 that extends through the substrate 170.
  • Via 182 extends to the face of the substrate 170 on which the ASIC 152 is mounted. More particularly, the via 182 is positioned so that when the frame-encased ASIC 152 is disposed over the substrate 170, the base of the ASIC frame 158 is disposed over and in contact with the via 182.
  • each of the ASIC bond pads 154 is disposed over one of the substrate
  • Each ASIC bond pad 154 is therefore in contact with one of adhesive plugs 174 disposed in the bores 172.
  • One of the ASIC bond pads 154 specifically the bond pad through which signals are sourced to and sunk from the electrode 42, is bonded to the adhesive plug in contact with the substrate trace 180.
  • conductive trace 180 and the via 182 integral with the substrate 170 form a conductive path between this ASIC bond pad 154 and the conductive frame 158 that surrounds the ASIC 152.
  • Frame 158, solder layer 162 and cap 168 function as the conductive elements of the EAP 44 over which signals are exchanged between the conductive components of the package substrate 170 and the EAP electrode 42.
  • FIG. 10 The components internal to a semiconductor die forming an ASIC 152 are now described by reference to Figure 10. These components include a current source 186 to which a current sink 188 is connected in series. A conductor 187 internal to the ASIC that extends to the electrode 42 is connected to the junction of the current source 186 and current sink 188. Not shown in Figure 10 are the components outside of the ASIC 152 that establish the conductive path between the conductor 187 and the electrode 42. Power for actuating the current source 186 and current sink 188 come respectively from + Vcc and ⁇ Vcc pins (the bond pads 154 to which these signals are supplied.
  • a state machine 190 also part of ASIC 152, both controls the on/off state of the current source 186 and current sink 188 as well as the level of current these components, respectively, source and sink.
  • Three conductors extend to the state machine 190.
  • a first conductor, conductor 191 serves as the ground conductor. While not illustrated, branches of the conductor 191 extend to the other circuits internal to the ASIC such as the current source 186 and current sink 188.
  • a conductor 192 is the conductor over which clock signals are applied to the state machine 190. Data signals, the actual instructions that regulate the operation of the ASIC and, by extension, the associated electrode 42, are applied to the state
  • An op amp 196 is connected to conductor 184 to monitor the voltage across the electrode 42.
  • Op amp 196 is operated as a non-inverting amplifier; conductor 187 is connected to the non-inverting pin of the amplifier.
  • a resistor 198 is tied between the inverting input of the amplifier 196 and ground.
  • a resistor 202 is tied between the inverting input and the output.
  • the ASIC 152 has two outputs, conductors 208 and 210 from the output of
  • Each of the outputs 208 and 210 is connected to a separate one of the conductors integral with bus 48.
  • Two switches 204 and 206 selectively connect, respectively, conductors 208 and 210 to the output pin of amplifier 196.
  • State machine 190 regulates the open/closed state of the switches 204 and 206. The selective setting of the
  • switches 204 and 206 allows the output signal from amplifier to be selectively applied to either one of the two bus conductors.
  • the implantable device controller To monitor operation of the array 40, it is often desirable for the implantable device controller to simultaneously receive signals from bus 48 indicating the voltage present at at least two electrodes 42.
  • transfer package 51 includes a ceramic base 214.
  • a frame 216 also formed from a ceramic, surrounds the outer perimeter of the base 214. In some versions of the invention, the frame 216 may be slightly stepped back from the outer perimeter of the base 214.
  • Package frame 216 is typically formed with one or more openings through which the off-array wires 52 extend into the package 51.
  • this opening is a through bore 220 in one of the frame-forming panels.
  • this opening is the absence of one of the side panels forming the frame.
  • the opening may consist of a slot that extends from one of the edges of one of the frame-forming panels.
  • Each wire 52 consists of a conductor (not
  • a potting material 230 encapsulates the wires 52 within the frame 216 between the base 214 and the cap 218.
  • a non-conductive polymer such as silicone may function as the potting material 230.
  • Package base 214 is formed to have a number of closed end bores 232.
  • the number of bores 232 corresponds to the number of connections that need to be made from wires 52 to the array bus 48.
  • Each bore 232 extends
  • a plug of conductive adhesive 234 is disposed in each bore 232.
  • a plug of conductive material 236, essential identical to the EAP plugs 176 is located between each adhesive-filed
  • each plug 236, that is the face visible when viewing the exposed surface of the base 214, functions as the bond pad 237 to which one of the substrate vias 91 is bonded.
  • the plugs 236 are shown as extending a slight distance below the exposed surface of the base 214. This may not always be the case.
  • each wire 52 enters the package 51 through one of the openings 220.
  • a seal 221 seated in the opening is
  • Seal 221 may be formed from glass or polymer.
  • the cable containing the plurality of wires 52 enters the package through a single opening 220. Inside the package 51, the individual wires are separated from each other.
  • each wire 52 is positioned so that the exposed conductive tip 228 of the wire is bonded to one of the adhesive plugs 234.
  • the potting material 230 is introduced into the frame 216 above the base to fix the wires in the package 51. Cap 218 is then fitted over the frame
  • Electrode array 40 of this invention is the assembly of this invention is the assembly of the substrate 46.
  • Substrate layers 62, 64, and 66 are each formed with the conductors 86, 88, 90 and vias 91, 92 and 94 formed thereon. Layers 62, 64, and 66 are stacked one on top of another. As a consequence of this assembly process, the vias bond to the underlying conductors by an ultrasonic bonding process so as to establish the conductor-to- conductor connections.
  • the EAPs 44 and transfer package 51 are then bonded to substrate layer 66.
  • a thermal compression process may be used to perform this bonding process.
  • the plugs 176 integral with the EAP package substrates 170 bond to the underlying vias 94.
  • the transfer package substrate plugs 176 bond to vias 91.
  • This bonding sometimes referred to as bump bonding, is what at least temporarily holds the EAPs 44 and the transfer package 51 to the underlying substrate 46.
  • the EAPs 44 the four inner columns of EAPs 44, the four EAPs in each row of EAPs located closest to the longitudinal axis of the array, are disposed on the substrate tabs 78.
  • Transfer package 51 is disposed over the substrate tail 74 so as to extend over substrate vias 91.
  • Transfer package plugs 236 function as the bond pads for the package.
  • the package 51 is positioned so that each one of the
  • plugs 236 is in registration over the appropriate one of the substrate vias 91. The same process used to hold the
  • EAPs 44 to the substrate 46 are used to hold the transfer package 51 to the substrate.
  • the same processes used to bond the EAP plugs 176 to substrate vias 94 is used to bond the transfer package plugs 236 to vias 91.
  • a first coat of polymer forming shell 56 is disposed over the partially assembled array. More
  • the initial coating of polymer is applied over the top surface of the substrate of a sufficient depth to extend over the outer exposed
  • Transfer package 51 extends through the opening between frame beams 97, 99, 101 and 108 (opening not identified) .
  • a second coating of liquid crystal polymer is applied to the array.
  • This liquid crystal polymer is applied to cover frame 50 as well as to extend to and bond with the outer perimeter of the first coating of liquid crystal polymer.
  • the liquid crystal polymer of this second coating flows into the gaps between the outer perimeters of EAPs 44 and transfer
  • This second layer of liquid crystal polymer in addition to completing the formation of shell 56, also serves as the structural component of the array that holds the frame 50 to the rest of the array 50. This second coating of polymer also further fixes the EAPs 44 and transfer package 51 to the rest of the array.
  • this second coating of liquid crystal polymer is applied in such a manner that shell 56 does not completely cover the EAPs 44. Instead, the relative heights of the shell 56 and EAPs 44 are such that the EAPs extend approximately 5 microns above the outer surface of the shell 44. This means that each electrode 42 of an EAP 44 is exposed. When the array is disposed against tissue through which currents are to be flowed, the EAP electrodes 42 will be in contact with the tissue.
  • the shell-forming polymer does not completely cover the transfer package 51. Accordingly, as illustrated in Figure 1, the top of the transfer package may extend above shell 56. Owing to its larger height, in comparison to the EAPs 44, the transfer package 51 extends higher above the outer surface of the shell than the EAPs.
  • the frame 50 is positioned over and slightly above the substrate.
  • the EAPs extend through frame openings 120 by approximately 25 microns
  • transfer package 51 extends through opening between frame beams 99 and 101 by approximately 150 microns.
  • the EAP 44 and transfer package 51 extend above the frame 42 approximately 25 microns.
  • Polymer forming shell 56 is flowed around over the exposed faces of the substrate 46 and frame 49 as well as in the void space between the substrate and the frame. A fraction of this polymer flows between the EAPs 44 and the adjacent opening defining faces of the frame. Polymer similarly flows between the transfer package 51 and the adjacent sections of the frame. As a consequence of the polymer curing, the EAPs 44 and transfer package 51 are bonded to the substrate 46.
  • the polymer forming shell 56 is a conformal coating. In both methods of manufacture, this material, when applied, does not bridge the slots 78 and 80 formed in the substrate 48 or the slots 119 formed in the frame 51. Likewise the coating does not bridge between the frame head 128 and shoulders 130. Consequently, upon assembly, electrode array 40, as seen in Figure 1, has a number of I- shaped slots 235 and inverted T-shaped slots 238. Both slots 235 and 238 extend through shell 56. Slots 235 are aligned with substrate slots 78. Slots 238 are aligned with substrate slots 235. Each row of two slots 235 can
  • each row of EAPs 44 thus has four inner EAPs each of which is embedded in one of the array slots and two outer EAPs.
  • Each outer-located EAP 44 is located between the side parameter of array and the outermost tab-embedded EAP.
  • frame 50 functions as a structural lattice that supports the other components of the array. Frame 50 thus holds the rest of the array in a semi-rigid shape. This substantially
  • the array eliminates the possibility that, post-implantation, the array will undergo uncontrolled flexing or folding.
  • the essential elimination of this movement of the array results in a like elimination that, as a result of such movement, the electrodes 42 will so shift position that they will no longer be located where they can flow current through the tissue through which such current flow will have the desired therapeutic effect.
  • the array 40 will have a like shaped curvature .
  • the frame is made from supereleastic material, the frame also allows the array to be folded or rolled so that it can be placed in a relatively small deployment instrument.
  • Such an assembly is disclosed in, the
  • the array of this version of the invention is designed to be folded around three axes, the longitudinal axes of frame bridges 112, 114 and 116.
  • frame beams 108 and 124 are curved, (curve in or out of the plane of Figure 8) .
  • the sections of the substrate 46 between frame bridges 112, 114 and 1124 and below will likewise curve with the bending of the beams 108 and 124.
  • the array tabs 239 are separate from the surrounding components of the array, in particular, the under curvature beams 124. These tabs 239 which include substrate tabs 79 and frame tabs 118 are not therefore bent/folded to the extent the surrounding portions of the array are bent/folded. Since the tabs are subjected to minimal if any flexure during this array folding process, the EAPs 44 seated on the substrate tabs 79 and in the frame tabs 118, are likewise not subjected to such deformation. The essential elimination of this curving, bending of the EAPs 44 likewise substantially reduces the likelihood that the EAPs could be break apart by such curving.
  • the essential elimination of this curving, bending of the EAPs 44 likewise substantially reduces the likelihood that the EAPs could be break apart by such curving.
  • the array 40 can be placed in a delivery device such as a delivery cannula.
  • a delivery device such as a delivery cannula.
  • the array can be disposed in a cannula that has a lumen with a diameter that is less than the width of the array when the array is in the unfolded/unrolled state.
  • the array of this invention upon being folded/rolled can be placed in a relatively narrow delivery device that allows the array to be inserted percutaneously over the target tissue, the tissue through which the current is to be deployed .
  • the superelastic properties of the frame 50 causes the frame and, by extension, the whole of the array 40 to unfold into the shape in which they should be so as to be properly deployed against the tissue through which the current is to be flowed. If the array 40 has a curved shaped, the curvature of the array increases the likelihood that when the array is deployed, each of the electrodes 42 will be disposed against the similarly curved tissue .
  • Array 40 of this invention also includes
  • Electrodes 42 that are rigidly integral with the components that source/sink current to the electrodes and that measure the voltages developed as a consequence of the current flow through the tissue.
  • This array of this invention therefore does not require the presence of flexible miniaturized connections between the electrodes and the components that source/sink current to/from the electrodes. The essential elimination of these conductors results in a like
  • the initial conductive path to/from any ASIC bond pad 154 is through the conductive adhesive plugs 174 internal to the associated package substrate 170.
  • the next segment of the conductive path is either the conductive plug 176 or
  • conductive plugs 176 and the conductive traces 180 are all rigid within the package substrate 170.
  • the ASIC 152 itself is firmly bonded to the package substrate 170.
  • PASIC 152 are relatively rigid. This rigidity of these connections reduces the likelihood that, when the array 40 is folded, rolled, bent or flexed, the deformations of the array substrate 46 will stress these connections to the point at which the connections may break.
  • each EAP 44 of this invention can be tested prior to its assembly on an array 40. This reduces the likelihood that an assembled array of this invention will contain a faulty EAP 44.
  • Still another feature of this invention is that the material forming shell 56 does more than form an outer cover around the other components of the array 40.
  • the shell-forming material is applied in such a manner that it adheres to many if not all of the exposed surfaces of the interior components of the array.
  • the shell thus functions as a matrix which fixes the other components of the array in their assembled positions. This reduces the likelihood that these components could undergo malfunction-causing
  • the EAPs can be designed to be so shaped. Then, the frame that provides structural rigidity to the rest of the array can be shaped to accommodate both the shape and size of the EAPs 44.
  • FIGS 13 and 14 illustrate an alternative electrode array 240 of this invention.
  • Array 240 includes the EAPs 44 and frame of array 40.
  • Electrode array 240 also includes a flexible sheet 242, seen in Figure 13, that, upon assembly of the array, as seen in Figure 14 has a section that becomes a substrate 246 and a section that becomes a superstrate 248.
  • a flexible strip 250 Formed integrally with and extending proximally from sheet 242 is a flexible strip 250.
  • Strip 250 carries the conductors 252 that connect the array bus to the implantable device controller.
  • Flexible sheet 242 is formed from three layers 256, 258 and 260 of material. Layers 256, 258 and 260, respectively the bottom, middle and upper layers of sheet 242 are formed from the same material and have the same thickness as layers 62, 64 and 66 of substrate 46. Sheet 242 is formed so as to, in the unfolded state, define the substrate 246 and superstrate 248. Between the substrate 246 and
  • sheet 242 is formed to have a hinge 247.
  • hinge 247 is coplanar with substrate 246 and superstrate 248.
  • Layers 256, 258 and 260 are formed to define in the substrate 246 multiple, longitudinally spaced apart rows of slots 262. Slots 262 are analogous to slots 78 of substrate 48. Layers 256, 258 and 260 are also formed so have in the proximal end two slots 264 that are located above the slots 262. Slots 264 are analogous to slots 80 of substrate 48. Layers 256, 258 and 260 are further formed to define in the superstrate section 248 of the sheet 242 multiple rows of I-shaped slots 268. Each row of slots 268 is aligned with a row of slots 262. The number of slots 268 in each row of slots 268 is identical to the number of slots 262 in each row of slots 262. Sheet superstate section 248 is further formed to have plural slots 270 that are laterally aligned with and have the same shape as substrate section slots 264. Flexible sheet 242 is further formed so that when the sheet is curved to bring
  • Sheet layers 256, 258 and 260 are further formed so that the section of sheet 242 that forms superstrate 248 has a number of rectangular windows 272.
  • Windows 272 are arranged in plural, laterally spaced apart rows. The number of rows of windows 272 corresponds to the number of rows of EAPs 44. The number of windows 272 in each row corresponds to the number of EAPs 44 in a row of EAPs.
  • Conductive traces and vias are formed on sheet layers 256 and 258 to perform functions similar to those performed by conductors 86, 88 and 90 of substrate 46.
  • Conductive traces 276 are shown formed on sheet bottom layer 256. Traces 276 are coming in and out of the plane of Figure 16. In the Figure 16 traces 276 appear embedded in the top of substrate layer 256 and the below discussed traces 280 appear embedded in substrate layer 258. This is for ease of illustration. Conductive traces 276 are
  • traces 276 are the bus conductors that extend longitudinally through array 240.
  • Conductive traces 280 are shown formed on sections of sheet middle layer 258. Conductive traces 280 are analogues to branch conductors 90 of the first embodiment of the invention. Not illustrated in Figure 16 are the
  • conductive traces formed on sheet middle layer 256 that are analogues to bus conductors 88. These traces are
  • Vias 278 and 282 extend through substrate-forming section of the sheet 242. Vias 278 extend through sheet middle layer 258 to connect conductive traces 276 to
  • Vias 278 are thus analogues to vias 92.
  • Vias 282 extend from ends of conductive traces 280 through substrate upper layer 282. Vias 282 are the conductive paths between the EAP bond pads to traces 280. Vias 282 are thus analogues to vias 94.
  • proximally extending sections of the bottom, middle and upper layers 258, 260, 262, form strip 250.
  • gold traces are formed on strip-forming section of lower layer 258 so as to form conductors 252.
  • Conductors 252 are integral with the gold traces that form the center located conductive traces 276 on the substrate- forming section of the lower layer 258.
  • vias may extend through the strip-forming sections of the middle and upper layers 260 and 262, respectively. These vias serve as the
  • middle layer 260 and upper layer 262 are simply not present at the free end of the strip. Owing to the absence of these layers of strip-forming material, the ends of the strip
  • conductors 252 are therefore exposed. The exposed ends of these conductors 252 can then be bonded or otherwise
  • Assembly of electrode array 240 of this invention may begin with fabrication and testing of the EAPs 44 and flexible sheet 242.
  • the EAPs 44 are disposed over the substrate 246 portion of the unfolded sheet 242 and bump bonded to vias 282.
  • Liquid crystal polymer or parylene is applied over the ends of the EAP substrates 170 that project beyond the EAP frames 158. This coating at least
  • section 247 is folded so that the sheet superstrate
  • section 248 is disposed over the substrate section 246.
  • the EAPs 44 seat in the sheet windows 272; slots 268 go into registration with slots 262; and slots 270 are placed in registration with slots 264.
  • the surface of the superstrate 248 that faces the substrate 246 is pressed against the frame 50.
  • component-to-component contact serves to temporarily hold the frame to the rest of the partially assembled array 240.
  • a second coating of liquid crystal polymer or parylene is applied to the partially assembled array.
  • the material of this coating is flowed into the gaps between each EAP 44 and the adjacent faces of the frame 50 and superstrate 248.
  • the coating is also flowed over the exposed surfaces of the hinge 247 and superstrate 248.
  • Coating is also applied over the side of the partially- assembled array 240 where the free ends of the substrate 246 and superstrate 248 are present.
  • the layers of coating when cured, collectively form the flexible shell 288 of the array 240.
  • Coating may also be applied over flexible
  • This coating may or may not be applied to the strip at the time the coating is applied to complete the process of assembling the array 240.
  • a coating that, when cured, is flexible may not be applied to strip 250. Instead a tube formed from biocompatible
  • electrically insulating material such as a liquid crystal polymer may be fitted over strip 250.
  • An advantage of array 240 of this invention is that flexible sheet 244 performs plural functions.
  • the sheet serves as both a substrate and superstrate for the array. In these capacities, the sheet provides the array with mechanical strength.
  • the substrate portion of the sheet serves to temporarily hold the frame in position until the coating can be applied to permanently affix the frame in place.
  • the structural component that carries the conductors 252 that connect the array 240 to the implantable device controller, flexible strip 250 is integral with the sheet. This means that the conductors that are connected to the IDC and at least some of the on-array bus conductors can be formed as a single conductive trace. This eliminates the need to provide the array 240 of this invention with a transfer package.
  • each of the disclosed features be in each version of the invention.
  • the array may be very flexible. This would allow the array to conform to tissue with irregularly shaped features. In these versions of the invention it may
  • a flexible sheet that defines the array substrate and superstrate does not always also have to include the conductor-carrying flexible strips.
  • each EAP 44 should likewise be understood as exemplarily and not limiting. In some versions of the invention; some EAPs may have
  • EAPs 44 on an array is not limited to the row by column pattern in the illustrated embodiments of the invention. Similarly the array itself may not have the elongated shape of the described
  • the array may have a profile that is square, triangular, or even rounded .
  • arrays of this invention may not be designed for percutaneous implantation.
  • the arrays of these versions of the invention may not have the geometric
  • each electrode 42 will be part of EAP 44, this may not always be the case.
  • one, more or even all of the electrodes may simply be stand alone components. Conductors extend from the current sources, current sinks and/or current sinks and/or voltage/current monitoring electrodes to these electrodes. This version of the array may be provided if the size of the electrodes is such that any associated packaging would be too small to accommodate the
  • the package substrates 170 may still be used to provide both rigid support for the individual ASICs 152 and serve as the support for the components that provide the relatively rigid electrical connections to/from the ASICs. Vias similar to the vias of the incorporated by reference US Pat. App .
  • each EAP have only a single electrode.
  • the exposed surface of one or more EAPs may be provided with two or more spaced apart electrodes.
  • internal to the EAP is a switch. This switch can be set to selectively connect one or more and less than all of the on-package electrodes to the active current source and/or current sink in the package.
  • one or more of the EAPs 44 in addition to having plural electrodes 42, has plural current sources, current sinks or amplifiers. Then depending on the instructions received by the EAP, the plural electrodes on the EAP can be simultaneously, sourcing different currents or sinking different currents. Alternatively, one electrode could be sourcing current while an adjacent electrode on the same EAP 44 could be sinking current. Still in another operating configuration of this invention, one electrode on the EAP may be sourcing or sinking current while the second
  • Electrode is employed to monitor the voltage across the adjacent tissue.
  • each electrode 42 functions as the whole of the exposed surface of the conductive material forming each electrode 42.
  • electrically insulating material may cover one or more portions of the electrode-forming conductive layer.
  • This conductive layer instead of being a single electrode thus serves as the component that, in combination with the insulating material forms a plurality of spaced apart electrodes. These spaced apart electrodes, given that they are part of common conductive layer, have a common potential.
  • the electrode ASIC packages of this invention may have physical constructions different from what has been described.
  • the connection from ASIC semiconductor die to the electrode is through a bond pad on surface of the die closest to the electrode.
  • the die is enclosed in a package shell formed from ceramic or other electrically insulating material. Vias on the shell section that abut the package substrate connect the conductors to the complementary bond pads on the die.
  • the electrode is typically formed on the shell section opposite the section disposed against the package substrate. A via in the shell section located between the die and the electrode establishes the electrical connection between the components internal to the
  • An advantage of this version of the invention is that it eliminates the need to provide a conductive frame around the outside of the die to function as the conductive link between the die components and the electrode.
  • the underlying substrate may then include conductors that provide the electrical connections between the individual integrated circuits.
  • the layers of material forming the substrate on which the conductors are formed may serve an additional function than conductor support components.
  • This material may be formed from semi-rigid material such as silicone.
  • the substrate in addition to serving as the support for the conductors services as the semi-rigid frame that provides the array with at least a degree of structural definition .
  • the material forming the substrate can serve as a section of the shell of the array.
  • this material bonds to the sides of the material forming the substrate.
  • the substrate thus becomes the section of the shell disposed under the EAPs 44 and any underlying support frame.
  • the frame there is no requirement that the frame be a single- piece structure.
  • the frame may consist of a plurality of separate structural members that provide the array with more rigidity than is provided by the substrate and/or shell.
  • the frame may consist of a plurality of elongated individual ribs that extend longitudinally through the array. These ribs may not be connected to each other. Accordingly, the ribs would provide the array with
  • superstrate may be practiced with integrated circuits and electrodes other than the integrated EAP package of this invention.
  • electrodes may be formed on or attached to the superstrate forming portion of the flexible sheet.
  • the frame may be omitted.

Abstract

L'invention porte sur un réseau d'électrodes (40) avec un substrat flexible (46, 56) sur lequel sont disposées plusieurs électrodes espacées (42). Les électrodes font partie de boîtiers de réseau d'électrodes (44). Chaque boîtier de réseau d'électrodes (44) comprend au moins une électrode et un circuit intégré (152) avec des composants qui fournissent du courant à, puisent du courant depuis ou contrôlent le signal présent dans l'électrode associée.
PCT/US2010/059691 2009-12-11 2010-12-09 Ensemble réseau d'électrodes implantable avec des électrodes qui sont intégrées avec les circuits intégrés spécifiques qui fournissent du courant aux électrodes/puisent du courant des électrodes WO2011072128A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP10795862.1A EP2512585B1 (fr) 2009-12-11 2010-12-09 Ensemble réseau d'électrodes implantable avec des électrodes qui sont intégrées avec les circuits intégrés spécifiques qui fournissent du courant aux électrodes/puisent du courant des électrodes
US13/491,777 US10046158B2 (en) 2009-12-11 2012-06-08 Implantable electrode array assembly with an array substrate, electrodes and integrated circuits, the integrated circuits being attached to package substrates
US16/036,270 US10342971B2 (en) 2009-12-11 2018-07-16 Implantable electrode array assembly with an array substrate, electrodes and packaged integrated circuits
US16/460,601 US20190321627A1 (en) 2009-12-11 2019-07-02 Method of manufacturing electrode array assembly having integrated circuits

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28582709P 2009-12-11 2009-12-11
US61/285,827 2009-12-11

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/491,777 Continuation US10046158B2 (en) 2009-12-11 2012-06-08 Implantable electrode array assembly with an array substrate, electrodes and integrated circuits, the integrated circuits being attached to package substrates

Publications (1)

Publication Number Publication Date
WO2011072128A1 true WO2011072128A1 (fr) 2011-06-16

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PCT/US2010/059691 WO2011072128A1 (fr) 2009-12-11 2010-12-09 Ensemble réseau d'électrodes implantable avec des électrodes qui sont intégrées avec les circuits intégrés spécifiques qui fournissent du courant aux électrodes/puisent du courant des électrodes

Country Status (3)

Country Link
US (3) US10046158B2 (fr)
EP (1) EP2512585B1 (fr)
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US10046158B2 (en) 2018-08-14
EP2512585A1 (fr) 2012-10-24
US20180339150A1 (en) 2018-11-29
US20190321627A1 (en) 2019-10-24
US20120330393A1 (en) 2012-12-27
EP2512585B1 (fr) 2014-09-10

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