The potential for implanting electronic devices into patients with direct interface to the neural system is vast. Systems which may enable paraplegics to regain control of their bladder or limbs, provide vision for the blind, or restore vocal cord function are all under development, and promising initial results have been obtained in some experiments.
A key component of some implantable systems is a needle array to enable interfacing of the electronics with a neuron or directly into brain tissue. For example, U.S. Pat. No. 5,215,088 to Normann et al. discloses a three-dimensional electrode device which can be used as a neural or cortical implant. The device of Normann, also known as the Utah Electrode Array (UEA), can be used to provide a neural interface to electronic equipment for sensing and/or stimulation. Alternative approaches for fabricating similar devices are known, but require a large number of masking steps which also slows down production and increases cost of manufacture.
A general embodiment of the present invention sets forth a method for wafer-scale fabrication of needle arrays. The method can include mechanically modifying the upper surface of a primary wafer to produce a plurality of vertically-extending columns. The next steps involve etching the primary wafer to produce a plurality of needles from the plurality of vertically-extending columns. Tips of the plurality of needles can be coated with an electrically conductive coating. A retainer wafer can be secured to the lower surface of the wafer at based ends of the plurality of needles before separating or singulating the wafer into a plurality of individual needle arrays while leaving the retainer wafer intact. The individual needle arrays can then be encapsulated with an electrically insulative coating so that edges of the arrays are covered by the electrically insulative coating. The tips of the plurality of needles can also be de-encapsulated to expose a desired amount of tip area.
Another general embodiment of the present invention sets forth a structure for processing a needle array, comprising a plurality of columns extending vertically from a substrate and situated on the periphery of the substrate, as well as a plurality of needles circumscribed by the plurality of columns. The plurality of columns defines a well in which the plurality of needles is situated, and wherein the well has a depth sufficient to contain a quantity of material that can submerge the plurality of needles, without the need for an additional container.
There has thus been outlined, rather broadly, the more important features of the invention so that the detailed description thereof that follows may be better understood, and so that the present contribution to the art may be better appreciated. Other features of the present invention will become clearer from the following detailed description of the invention, taken with the accompanying drawings and claims, or may be learned by the practice of the invention.
Additional features and advantages of the invention will be apparent from the detailed description which follows, taken in conjunction with the accompanying drawings, which together illustrate, by way of example, features of the invention; and, wherein:
Reference will now be made to the exemplary embodiments illustrated, and specific language will be used herein to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended.
In describing embodiments of the present invention, the following terminology will be used.
The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a needle” includes reference to one or more of such needles and “etching” includes one or more of such steps.
As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.
Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “50-250 micrometers” should be interpreted to include not only the explicitly recited values of about 50 micrometers and 250 micrometers, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 60, 70, and 80 micrometers, and sub-ranges such as from 50-100 micrometers, from 100-200, and from 100-250 micrometers, etc. This same principle applies to ranges reciting only one numerical value and should apply regardless of the breadth of the range or the characteristics being described.
As used herein, the term “about” means that dimensions, sizes, formulations, parameters, shapes and other quantities and characteristics are not and need not be exact, but may be approximated and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like and other factors known to those of skill. Further, unless otherwise stated, the term “about” shall expressly include “exactly,” consistent with the discussion above regarding ranges and numerical data.
As used herein with respect to an identified property or circumstance, “substantially” refers to a degree of deviation that is sufficiently small so as to not measurably detract from the identified property or circumstance. The exact degree of deviation allowable may in some cases depend on the specific context.
In the present disclosure, the term “preferably” or “preferred” is non-exclusive where it is intended to mean “preferably, but not limited to.” Any steps recited in any method or process claims may be executed in any order and are not limited to the order presented in the claims. Means-plus-function or step-plus-function limitations will only be employed where for a specific claim limitation all of the following conditions are present in that limitation: a) “means for” or “step for” is expressly recited; and b) a corresponding function is expressly recited. The structure, material or acts that support the means-plus function are expressly recited in the description herein. Accordingly, the scope of the invention should be determined solely by the appended claims and their legal equivalents, rather than by the descriptions and examples given herein.
As mentioned above, needle arrays, such as the Utah Electrode Array (UEA) have been the subject of experimental use. Accordingly, fabrication of the UEA to date has been one array at a time. This process is time consuming, and has yielded less consistency in results than desirable, especially for clinical use. The present invention provides methods for fabrication of microelectrode arrays that are more amenable to mass production while providing more consistent array characteristics.
The method includes mechanically modifying the wafer to produce a plurality of vertically extending columns. Mechanical modification of the wafer can be accomplished using any suitable technique such as, but not limited to, sawing, ablation, or any other suitable material removal technique. The wafer can be sawed or cut using a dicing saw. Alternate techniques for cutting the trenches may include deep reactive ion etching, electro-discharge machining (EDM), and the like. For example,
As can be seen in
The wafer can be etched to reshape the vertically-extending columns under conditions suitable to produce a plurality of substantially uniformly shaped needles from the vertically-extending columns. For example, etching can be performed using a dynamic etch to round the columns and a static etch to form points at the tips of the columns. In dynamic etching, the width of the columns are isotropically thinned. During the dynamic etching process the wafer can be mounted in the Teflon wafer holder, and immersed with columns facing down, into an acid mixture of HF—HNO3. Typically, the HF—HNO3 ratio is about 1:19, although other proportions can be suitable. The wafer holder is rotated clockwise while the magnetic stirrer, rotating counter-clockwise, stirs the acid aggressively. The unique combination of wafer and stir-bar rotation help in achieving uniform etching across the high aspect ratio columns. Stirring the etchant causes an aggressive and continuous flow of the etchant into the dicing kerfs, thereby leading uniformly etched square columns with rounded corners. Suitable etching solutions can include, but are not limited to, mixtures of hydrofluoric acid and nitric acid, TMAH, or any other etchant suitable for controlled etching of the material forming the columns.
Dynamic etching can be performed by placing the wafer into or onto a suitable holder. The wafer can then be exposed to or immersed in an etching solution. The holder can be constructed of a material which is resistant to the etching solution, such as polytetrafluoroethylene (e.g. Teflon®) or other polymers. Conventional vacuum chuck wafer spinners can be particularly useful for this purpose. The wafer can be fully immersed in the etching solution and rotated in one direction. A stirrer stirs the etching solution in an opposite direction to provide aggressive and continuous flow of fresh etching solution into the dicing kerfs. During dynamic etching, the exposed columns are etched into a needle shape.
In static etching, the tips of the electrodes are preferentially sharpened over the needle trunk and the base. During the static etching process the holder is placed in the acid mixture with the columns facing upwards, and neither the acid is stirred nor is the wafer rotated. The static etch preferentially etches and sharpens the tops of the columns, until the final column shape has a sharp tip. The etch rate is greater at the tops of the columns because the activity of the etching solution at the base of microneedle is reduced, and little fluid motion is present to replenish depleted etchant.
Additional processing steps can be performed to deposit electrically conductive material onto the needles to provide a low impedance electrical connection from the needle body to the tissue in which the needle array is inserted. In one aspect, a coating can be deposited on the needle body. The coating may be, for example, one or more metals, designed to adhere to the needle body and provide an Ohmic contact between the metal and the needle body. The coating can help to provide a stable interface when inserted in vivo.
For example, for silicon micro-needles, a metal stack of iridium or platinum over titanium has proven to provide good performance for stimulation and recording. More specifically, in one specific example of this coating scheme, about 50 nanometers of titanium, following by about 240 nanometers of platinum, or about 100 nanometers of iridium were deposited by sputtering. The titanium provides an adhesion layer to the silicon needle body. After conversion to iridium oxide, the iridium layer provides a stable low-impedance electric interface when inserted in vivo. Iridium can be converted to iridium oxide by electrochemical activation. Other coatings can also be used, including for example combinations of titanium and iridium, platinum and iridium, or even direct sputtering in oxygen plasma of iridium oxide directly onto the silicon needle tips.
Other optional aspects can include forming electrical contacts on the back side of the needle array for facilitating electrical connection to other features and/or components which allow the needles to be individually addressable.
Coating of the tips of the needles with electrically conductive material may be facilitated by masking the shafts of the needles. In one aspect of the present invention, the needles are submerged in a resist material so that they are at least partially embedded within the resist material. Thus in one aspect, the needles may be entirely embedded within the resist material. Alternatively, the needles can be embedded to a limited depth of resist material, so that the tips of the needles are exposed at a desired length. The exposed tip length can then be made to constitute the active area of the electrodes by metallizing them, while the length of shaft embedded in the resist material is left unaffected.
An exemplary process flow for masking and metallization of needle tips is shown in
The size of the active area of the electrode has a significant impact on electrode performance, so it may be desired to carefully control the depth of resist and, effectively, the exposed tip length. The resist material may be spin coated onto the wafer using relatively low revolution rates of about 20-500 rpm, and often from 50 or 100-500 revolutions per minute (rpm) as compared to conventional spin rates of 2000-3000 rpm used in semiconductor device fabrication. The spin rate should be sufficiently low to embed the structures in the resist while also providing a sufficiently uniform coverage of resist material across the wafer. In a particular embodiment, the depth of resist is controlled by varying the spinning speed during resist coating. As shown in
Another advantage of the above described techniques is that the upper portions of the high-aspect ratio structures need not be planar. For example, as described in U.S. patent application Ser. No. 11/807,766, incorporated here by reference, a micro-needle array can have micro-needle tips disposed in a non-planar surface, e.g. trough, saddle, cylindrical, or slant arrays. It has been observed that surface tension of the resist material helps the upper surface of the resist material to conform to nearly any curvature of the top of the high-aspect ratio structures. After application, the resist material can be cured, for example by baking. Before curing, the wafer may be optionally placed under vacuum (e.g., pressure less than about 10−2 torr) to encourage bubble elimination from the resist material. In one alternative aspect, the vertically-extending columns at the periphery of the wafer can be configured to define a well of sufficient depth to contain the resist material without the need for an additional container. The resist material can alternatively be removed via laser ablation.
Once the desired needle array device is formed, the needle array may be encapsulated in a non-conductive, non-reactive material to help improve compatibility in vivo. For example, materials can include parylene-C, silicon carbide, and/or silicone. Parylene-C can, for example, be deposited by low-pressure chemical vapor deposition. It will be appreciated that the tips can be left unencapsulated to allow electric contact between the micro-needles and the tissue into which the array is inserted. For example, the tips may be masked prior to the encapsulation. Alternately, the entire needles may be encapsulated, and then the non-conductive, non-reactive material removed from the tip portions.
In order to decrease the impedance of their active areas the electrode tips need to be de-encapsulated. This process can also be carried out on a wafer scale. However, when the needles are encapsulated while part of an intact wafer, once the arrays are cut from the wafer exposed edges are created. For improved biocompatibility, each needle array should be completely covered with the encapsulating layer. Therefore, the arrays can be singulated prior to depositing of the encapsulating layer. Previously this would hinder realization of the benefits of wafer scale fabrication, at least for the steps of encapsulation and de-encapsulation. In view of this limitation, the present invention provides a method in which the wafer is mounted on a second (carrier) wafer, e.g. by using a wafer grip. Then singulation can be done with a thick blade, EDM, or other material removal process to singulate the arrays in the product wafer, while leaving the carrier wafer intact. In this manner, individual arrays remain in position with respect to one another without becoming multiple loose arrays.
One suitable fabrication process is shown in the diagrams of
In order to retain electrical conductivity of the metalized tips it then becomes desirable to remove the protective coating over the tips. Thus, a resist etching approach can be followed similar to that used to deposit the metal on the tips. Alternatively, the protective coating can be deposited everywhere except the tips, e.g. by masking or selective directed deposition.
Individual arrays can be recovered either by removing the carrier wafer or by cutting through the carrier wafer along gaps 76 formed around the array perimeter edges. Individual arrays 78 (shown in
As an illustration of one alternative, the tips of the needles may be de-encapsulated using laser ablation (e.g., using an excimer laser) and shadow masking techniques. For example, a shadow mask can be made by forming holes in a wafer in positions corresponding to the needles. The holes may be etched, for example using an anisotropic etchant (e.g. KOH or TMAH) or by deep reactive ion etching. The array can then be temporarily joined to the shadow mask and the needles can be inserted through the holes. The thickness of the shadow mask is equal to the height of the electrodes minus the desired exposure height of de-encapsulation.
The principles of the present invention can be readily extended to production of arrays having highly irregular backside geometry. For example, wireless communication, power coils and other devices can be integrated onto the backside of the array. However, such features also involve significantly irregular and non-planar geometry which introduces some complications into processing.
The array assemblies can then be release from the holder and the same or similar holder 88 can be removably secured to the back-side of the wafer as shown in
While the forgoing exemplary embodiments are illustrative of the principles of the present invention in one or more particular applications, it will be apparent to those of ordinary skill in the art that numerous modifications in form, usage and details of implementation can be made without the exercise of inventive faculty, and without departing from the principles and concepts of the invention. Accordingly, it is not intended that the invention be limited, except as by the claims set forth below.
This application claims the benefit of U.S. Patent Application No. 61/052,509, filed May 12, 2008 which is incorporated herein by reference. This application is also related to U.S. patent application Ser. No. 11/807,763, filed May 29, 2007 which is incorporated herein by this reference.
Number | Date | Country | |
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61052509 | May 2008 | US |