Patent Grant
10758144
The present invention relates to cardiac signal sensing devices. More specifically, the invention relates to flexible electrodes and methods for making flexible electrodes for use in a cardiac mapping catheter.
Cardiac arrhythmias may lead to heart disease and death. Arrhythmias may be treated by medication, implantable devices, or by the ablation of specific heart tissue found to be causing arrhythmia. Ablation may be performed by a number of techniques, including the local application of energy, for example, radio frequency energy, or by the application of cryogenic temperatures to the site of the problem tissue.
The specific heart tissue responsible for arrhythmia in a patient may be identified by moving a mapping catheter having one or more electrodes around the interior of the heart and measuring cardiac signals to sense changes in the electrical fields. A map of the electrical conductivity of the heart may be formed from the measurements to identify abnormalities which may be candidates for ablation. Some mapping catheters are designed such that the electrodes may physically contact the heart wall, including flexible designs that are inserted in a compact form and later deployed into a basket-like array. Such an array is deployed after entrance into the heart, and undeployed upon completion of the mapping and prior to removal from the heart.
A mapping catheter having multiple electrodes which must be deployed and undeployed within the heart may benefit from an improved electrode structure.
Example 1 is an electrode for cardiac signal sensing, the electrode including a conductive layer, an intermediate layer, an iridium-containing layer, an iridium oxide layer, and an insulating polymer layer. The conductive layer is formed on a portion of a flexible polymer substrate. The intermediate metal layer has a first portion and a second portion, and is formed on the conductive layer. The iridium-containing layer has a first portion and a second portion, and formed on the first portion of the intermediate metal layer. The iridium-containing layer includes at least 50 wt. % iridium. The iridium oxide layer is formed on the first portion of the iridium-containing layer. The insulating polymer layer is formed on the second portion of the intermediate metal layer and the second portion of the iridium-containing layer. The iridium-containing layer is not formed on the second portion of the intermediate metal layer; and the iridium oxide layer is not formed on the second portion of the iridium-containing layer.
In Example 2, the electrode of Example 1, wherein the iridium-containing layer consists of between 50 wt. % and 99 wt. % iridium, and the balance is platinum.
In Example 3, the electrode of Example 1, wherein the iridium-containing layer includes at least 99 wt. % iridium.
In Example 4, the electrode of any of Examples 1-3, wherein the insulating polymer layer is a parylene polymer.
In Example 5, the electrode of Example 4, wherein the parylene polymer is selected from the group consisting of poly(p-xylylene), poly(monochloro-p-xylylene), and poly(dichloro-p-xylylene).
In Example 6, the electrode of Example 5, wherein the parylene polymer is poly(monochloro-p-xylylene).
In Example 7, the electrode of any of Examples 1-6, wherein the intermediate metal layer includes gold.
Example 8 is a cardiac mapping catheter including an elongate catheter body and a plurality of splines projecting from an end of the catheter body. The splines are flexibly deployable between a radially retracted position and radially extended position. Each of the splines includes a flexible polymer substrate and a plurality of electrodes formed on the flexible polymer substrate, wherein each of the electrodes is according to any of claims 1-7.
Example 9 is a method for making an electrode for cardiac signal sensing, the electrode formed on a flexible polymer substrate having a conductive layer and an intermediate metal layer disposed on the conductive layer. The method includes depositing an iridium-containing layer onto a portion of the intermediate metal layer, depositing an insulating polymer layer, removing the insulating polymer layer from a portion of the iridium-containing layer to form a exposed surface, and electrochemically oxidizing at least a portion of the iridium-containing layer at the exposed surface to form an iridium oxide layer on the iridium-containing layer. The iridium-containing layer includes at least 50 wt. % iridium. The insulating polymer layer is deposited on the flexible polymer substrate, the conductive layer, the intermediate layer, and the iridium-containing layer.
In Example 10, the method of Example 9, wherein removing the insulating polymer layer includes laser ablating the insulating polymer layer from the portion of the iridium-containing layer.
In Example 11, the method of any of Examples 9-10, wherein depositing the insulating polymer layer includes depositing a parylene polymer by vapor deposition.
In Example 12, the method of any of Examples 9-11, wherein depositing the iridium-containing layer includes applying a first mechanical mask to the substrate, depositing the iridium-containing layer by sputter deposition, and removing the first mechanical mask. The first mechanical mask includes a first opening aligned with the intermediate metal layer to define the portion of the intermediate metal layer.
In Example 13, the method of any of Examples 9-12, wherein removing the insulating polymer layer includes applying a second mechanical mask to the substrate, laser ablating the insulating polymer layer from the portion of the iridium-containing layer; and removing the second mechanical mask. The second mechanical mask includes a second opening aligned with the portion of the iridium-containing layer, wherein the second opening is smaller than the first opening.
In Example 14, the method of any of Examples 9-12, wherein removing the insulating polymer layer includes applying a second mechanical mask to the substrate, laser ablating the insulating polymer layer from the portion of the iridium-containing layer; and removing the second mechanical mask. The second mechanical mask includes a second opening aligned with the portion of the iridium-containing layer, wherein the second opening is about the same size as the first opening.
In Example 15, the method of any of Examples 9-14, wherein electrochemically oxidizing includes immersing the substrate in an electrolytic solution, cycling the iridium-containing layer between positive and negative voltages until a desired thickness of iridium oxide is formed on the surface of the portion of iridium-containing layer, and removing the substrate from the electrolytic solution.
Example 16 is an electrode for cardiac signal sensing, the electrode including a conductive layer, an intermediate layer, an iridium-containing layer, an iridium oxide layer, and an insulating polymer layer. The conductive layer is formed on a portion of a flexible polymer substrate. The intermediate metal layer has a first portion and a second portion, and is formed on the conductive layer. The iridium-containing layer has a first portion and a second portion, and formed on the first portion of the intermediate metal layer. The iridium-containing layer includes at least 50 wt. % iridium. The iridium oxide layer is formed on the first portion of the iridium-containing layer. The insulating polymer layer is formed on the second portion of the intermediate metal layer and the second portion of the iridium-containing layer. The iridium-containing layer is not formed on the second portion of the intermediate metal layer, and the iridium oxide layer is not formed on the second portion of the iridium-containing layer.
In Example 17, the electrode of Example 16, wherein the iridium-containing layer consists of between 50 wt. % and 99 wt. % iridium, and the balance is platinum.
In Example 18, the electrode of Example 16, wherein the iridium-containing layer includes at least 99 wt. % iridium.
In Example 19, the electrode of any of Examples 16-18, wherein the intermediate metal layer includes gold.
In Example 20, the electrode of any of Examples 16-19, wherein the conductive layer includes copper.
In Example 21, the electrode of any of Examples 16-20, wherein the insulating polymer layer is a parylene polymer.
In Example 22, the electrode of Example 21, wherein the parylene polymer is selected from the group consisting of poly(p-xylylene), poly(monochloro-p-xylylene), and poly(dichloro-p-xylylene).
In Example 23, the electrode of Example 22, wherein the parylene polymer is poly(monochloro-p-xylylene).
Example 24 is a method for making an electrode for cardiac signal sensing, the electrode formed on a flexible polymer substrate having a conductive layer and an intermediate metal layer disposed on the conductive layer. The method includes depositing an iridium-containing layer onto a portion of the intermediate metal layer, depositing an insulating polymer layer, removing the insulating polymer layer from a portion of the iridium-containing layer to form a exposed surface, and electrochemically oxidizing at least a portion of the iridium-containing layer at the exposed surface to form an iridium oxide layer on the iridium-containing layer. The iridium-containing layer includes at least 50 wt. % iridium. The insulating polymer layer is deposited on the flexible polymer substrate, the conductive layer, the intermediate layer, and the iridium-containing layer.
In Example 25, the method of Example 24, wherein removing the insulating polymer layer includes laser ablating the insulating polymer layer from the portion of the iridium-containing layer.
In Example 26, the method of any of Examples 24-25, wherein depositing the insulating polymer layer includes depositing a parylene polymer by vapor deposition.
In Example 27, the method of Example 26, wherein the parylene polymer is poly(monochloro-p-xylylene).
In Example 28, the method of any of Examples 24-27, wherein the intermediate metal layer includes gold.
In Example 29, the method of any of Examples 24-28, wherein depositing the iridium-containing layer includes applying a first mechanical mask to the substrate, depositing the iridium-containing layer by sputter deposition, and removing the first mechanical mask. The first mechanical mask includes a first opening aligned with the intermediate metal layer to define the portion of the intermediate metal layer.
In Example 30, the method of any of Examples 24-29, wherein removing the insulating polymer layer includes applying a second mechanical mask to the substrate, laser ablating the insulating polymer layer from the portion of the iridium-containing layer; and removing the second mechanical mask. The second mechanical mask includes a second opening aligned with the portion of the iridium-containing layer, wherein the second opening is smaller than the first opening.
In Example 31, the method of any of Examples 24-29, wherein removing the insulating polymer layer includes applying a second mechanical mask to the substrate, laser ablating the insulating polymer layer from the portion of the iridium-containing layer; and removing the second mechanical mask. The second mechanical mask includes a second opening aligned with the portion of the iridium-containing layer, wherein the second opening is about the same size as the first opening.
In Example 32, the method of any of Examples 24-31, wherein electrochemically oxidizing includes immersing the substrate in an electrolytic solution, cycling the iridium-containing layer between positive and negative voltages until a desired thickness of iridium oxide is formed on the surface of the portion of iridium-containing layer, and removing the substrate from the electrolytic solution.
Example 33 is a cardiac mapping catheter including an elongate catheter body and a plurality of splines projecting from an end of the catheter body. The splines are flexibly deployable between a radially retracted position and radially extended position. Each of the splines includes a flexible polymer substrate and a plurality of electrodes formed on the flexible polymer substrate. Each of the electrodes includes a conductive layer, an intermediate layer, an iridium-containing layer, an iridium oxide layer, and an insulating polymer layer. The conductive layer is formed on a portion of a flexible polymer substrate. The intermediate metal layer has a first portion and a second portion, and is formed on the conductive layer. The iridium-containing layer has a first portion and a second portion, and formed on the first portion of the intermediate metal layer. The iridium-containing layer includes at least 50 wt. % iridium. The iridium oxide layer is formed on the first portion of the iridium-containing layer. The insulating polymer layer is formed on the second portion of the intermediate metal layer and the second portion of the iridium-containing layer. The iridium-containing layer is not formed on the second portion of the intermediate metal layer. The iridium oxide layer is not formed on the second portion of the iridium-containing layer.
In Example 34, the catheter of Example 33, wherein the iridium-containing layer includes at least 99 wt. % iridium.
In Example 35, the catheter of any of Examples 33-34, wherein the insulating polymer layer includes poly(monochloro-p-xylylene).
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description and drawings, which show and describe illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
A more complete understanding of the present invention is available by reference to the following detailed description of numerous aspects and embodiments of the invention. The detailed description of the invention which follows is intended to illustrate but not limit the invention.
Electrodes embodying the present invention may be employed in cardiac mapping catheters as described in “CARDIAC MAPPING CATHETER” (U.S. Pat. No. 8,447,377, issued May 21, 2013), hereby incorporated by reference in its entirety. Such catheters typically have several flexible splines, each spline including a plurality of electrodes. Electrode embodiments of the present invention are able to flex while also maintaining low impedance and biocompatibility.
The articulation control 24 may control bending of the distal end 22 of the lead body 14 by way of one or more articulation control elements, for example wires (not shown) extending from the articulation control 24 to the distal end 22 by way of one or more lumens (not shown) extending through the lead body 14 from the proximal end 20 to the distal end 22. Bending the distal end 22 provides for flexibility in maneuvering the electrode array 16 within a patient's heart.
The deployment control 26 may control deployment of the electrode array 16 by way of a deployment control element 28 (shown in
In use, the cardiac mapping catheter 10 may be inserted into a patient's vasculature with the electrode array 16 in the undeployed, radially retracted position shown in
As shown in
In some embodiments, the conductive layer 40 may be made of a non-biocompatible material, such as copper or a copper alloy. The conductive layer 40 may have a suitable thickness. For example, the conductive layer 40 may have a thickness of as little as about 2 microns, about 4 microns, about 6 microns, or about 7 microns, or as great as about 9 microns, about 10 microns, about 12 microns, or about 14 microns, or have thickness within any range defined between any pair of the foregoing values. In exemplary embodiments, the conductive layer 40 may have a thickness from about 2 microns to about 14 microns, from about 4 microns to about 12 microns, from about 6 microns to about 10 microns, or from about 7 microns to about 9 microns. In some examples, the conductive layer 40 may have a thickness of about 8 microns.
In some embodiments, the intermediate metal layer 42 may be made of gold or a gold alloy and may have a suitable thickness. For example, in some embodiments, the intermediate metal layer 42 may have a thickness of as little as about 0.1 microns, about 0.5 microns, or about 1 micron, or as great as about 2 microns, about 3 microns, or about 4 microns, or have thickness within any range defined between any pair of the foregoing values. In exemplary embodiments, the intermediate metal layer 42 may have a thickness from about 0.1 microns to about 4 microns, from about 0.5 microns to about 3 microns, or from about 1 micron to about 2 microns. In some examples, the intermediate metal layer 42 may have a thickness of about 1.5 microns. The intermediate metal layer 42 may provide oxidation protection of the underlying conductive layer 40, and provide an additional barrier between the conductive layer and body tissues.
In some embodiments, the iridium-containing layer 44 may be formed primarily of iridium. For example, iridium may be present in the iridium-containing layer 44 in an amount as little as about 50 wt. %, about 60 wt. %, or about 70 wt. %, or as great as about 80 wt. %, about 90 wt. %, or about 100 wt. %, or may be present within any range defined between any pair of the foregoing values. In exemplary embodiments, iridium may be present in the iridium-containing layer 44 in an amount from about 50 wt. % to about 100 wt. %, from about 60 wt. % to about 90 wt. %, or from about 70 wt. % to about 80 wt. %. In some examples, iridium-containing layer 44 may include at least 99 wt. % iridium. In some embodiments, the iridium-containing layer 44 may be formed primarily of iridium and platinum may make up the balance. For example iridium may be present in the iridium-containing layer 44 in an amount as little as about 50 wt. %, about 60 wt. %, or about 70 wt. %, or as great as about 80 wt. %, about 90 wt. %, or about 99 wt. %, or may be present within any range defined between any pair of the foregoing values, and the balance platinum. In exemplary embodiments, iridium may be present in the iridium-containing layer 44 in an amount from about 50 wt. % to about 100 wt. %, from about 60 wt. % to about 90 wt. %, or from about 70 wt. % to about 80 wt. %, and the balance platinum.
In some embodiments, the insulating polymer layer 48 may be a biocompatible polymer, such as a biocompatible parylene polymer. In some embodiments, the parylene polymer may be one of poly(p-xylylene) also known as parylene N, poly(monochloro-p-xylylene) also known as parylene C, or poly(dichloro-p-xylylene) also known as parylene D. In exemplary embodiments, the parylene polymer may be poly(monochloro-p-xylylene).
As shown in
The flexible polymer substrate 34 may be made of a polyimide polymer. The electrical trace 50 and the electrical interconnect 52 may be made of copper or a copper alloy. The backside insulating layer 54 may also be made of a polyimide polymer and may itself be biocompatible, or may be covered with an additional biocompatible layer (not shown).
As shown in
As shown in
In some embodiments, the iridium-containing layer 44 as deposited may have a suitable thickness. For example, in some embodiments, the iridium-containing layer 44 may have a thickness of as little as about 0.1 microns, about 0.2 microns, or about 0.4 microns, or as great as about 0.6 microns, about 0.8 microns, or about 1 micron, or have thickness within any range defined between any pair of the foregoing values. In exemplary embodiments, the iridium-containing layer 44 may have a thickness from about 0.1 microns to about 1 micron, from about 0.2 microns to about 0.8 microns, or from about 0.4 microns to about 0.6 microns. In some examples, the iridium-containing layer 44 may have a thickness of about 0.5 microns as deposited.
As shown in
Following deposition of the insulating polymer layer 48, the insulating polymer layer 48 over a portion of the iridium-containing layer 44 may be removed. In some embodiments, removing the insulating polymer layer 48 from the portion of the iridium-containing layer 44 may be as shown in
As shown in
As shown in
In some embodiments, the iridium oxide layer 46 may be formed by electrochemically oxidizing the first portion 66 of the iridium-containing layer 44. In some embodiments, the flexible polymer substrate 34 may be immersed in an electrolytic solution such that the first portion 66 of the iridium-containing layer 44 may be exposed to an electrolytic solution. Examples of the electrolytic solution may include a saline solution such as phosphate buffered saline solution. A cathode may also be positioned within the electrolytic solution and a voltage may be applied between the cathode and the electrode 36 to pass an electrical current between the cathode and the electrode 36. Oxygen may be released from the electrolytic solution when the voltage is applied. The released oxygen reacts with the iridium of the iridium-containing layer 44 to form the iridium oxide layer 46. In some embodiments, the voltage may be cycled between positive and negative voltages until a desired thickness of iridium oxide is formed. Once the desired thickness of iridium oxide is formed, the flexible polymer substrate 34 may be removed from the electrolytic solution. Forming the iridium oxide layer 46 in this way may produce improved adhesion of the iridium oxide layer 46 compared to, for example, sputter depositing a layer of iridium oxide directly. In addition, the iridium oxide layer 46 may provide improved electrical performance by reducing impedance of the electrode 36 by at least 25% compared to sputter depositing a layer of iridium oxide directly.
As shown in
The iridium-containing layer 44 may have a high melting point, such as in excess of 2000° C. The iridium-containing layer 44 may also have a partially reflective surface finish that reflects at least a portion of the laser energy from the surface during a laser ablation process. Thus, the iridium-containing layer 44 may be able resist laser damage while the insulating polymer layer 48 exposed by the second opening 84 is removed. This resistance to damage may allow for a more thorough removal of the insulating polymer layer 48 by a lengthier laser ablation process to produce a cleaner surface on the first portion 66 of the iridium-containing layer 44. The cleaner surface on the first portion 66 may allow the iridium oxide layer 46 to form more evenly over the first portion 66 of the iridium-containing layer 44 leading to improved impedance. The cleaner surface may also lead to improved adhesion of the iridium oxide layer 46 to the iridium-containing layer 44, which may enable electrodes 36 to be able to flex with deployment of the electrode array 16, while also maintaining low impedance and biocompatibility.
In the embodiments described above, each of the conductive layer 40, the intermediate metal layer 42, the iridium-containing layer 44, and the iridium oxide layer 46 is formed only on one other material which may lead to overall improved layer-to-layer adhesion by optimizing the deposition process for deposition on a single material. In addition, the electrode 36 may be biocompatible by having only the biocompatible materials exposed, such the insulating polymer layer 48 and the iridium oxide layer 46, and by not having any non-biocompatible materials exposed, such as the conductive layer 40.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.
This application claims priority to Provisional Application No. 62/207,814, filed Aug. 20, 2015, which is herein incorporated by reference in its entirety.
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