Patent Application
20130190754
Not applicable.
a. Field of the Invention
The present invention pertains generally to an electrophysiological device and method for providing energy to biological tissue and, more particularly, to an ablation apparatus that includes a bipolar electrode that uses a flexible polymer electrode. The present invention is also directed to an electrophysiological device that can be used for drug delivery to a target tissue.
b. Background Art
In a normal heart, contraction and relaxation of the heart muscle (myocardium) takes place in an organized fashion as electrochemical signals pass sequentially through the myocardium from the sinoatrial (SA) node located in the right atrium to the atrial ventricular (AV) node and then along a well defined route which includes the His-Purkinje system into the left and right ventricles. Sometimes abnormal rhythms occur in the atrium, a condition known as atrial arrhythmia. Three of the most common arrhythmia are: (1) ectopic atrial tachycardia, (2) atrial fibrillation, and (3) atrial flutter. Arrhythmia can result in significant patient discomfort and even death because of a number of associated problems, including: (1) an irregular heart rate, which causes a patient discomfort and anxiety; (2) loss of synchronous atrioventricular contractions which compromises cardiac hemodynamics resulting in varying levels of congestive heart failure; and (3) blood flow stasis, which increases the vulnerability to thromboembolism. It is sometimes difficult to isolate a specific pathological cause for the arrhythmia, although it is believed that the principal mechanism is one or a multitude of stray circuits within the left and/or right atrium. These circuits or stray electrical signals are believed to interfere with the normal electrochemical signals passing from the SA node to the AV node and into the ventricles. Efforts to alleviate these problems in the past have included administering various drugs. In some circumstances, drug therapy is ineffective and frequently is plagued with side effects, such as dizziness, nausea, vision problems, and other difficulties.
For example, an increasingly common medical procedure for the treatment of certain types of cardiac arrhythmia and atrial arrhythmia involves ablation of heart tissue to cut off the path for stray or improper electrical signals. Such procedures may be performed by catheters that incorporate ablation electrodes. Typically, the catheter is inserted in an artery or vein in the leg, neck, or arm of the patient and threaded, sometimes with the aid of a guidewire or introducer, through the vessels until a distal tip of the catheter reaches the desired location for the ablation procedure in the heart. During the ablation procedure, the electrode of the ablation catheter is placed in contact with the target tissue and therapeutic substance is applied to the tissue via the electrode. Therapeutic substance may be a chemical substance; energy, such as thermal energy (heating or cooling); electrical energy, such as radiofrequency (RF) current; electromagnetic energy, such as light; and acoustic energy, such as ultrasound. Upon delivery of sufficient therapeutic substance to the tissue, the ablation procedure kills and/or irreversibly modifies the target tissue, and produces lesions. The lesion partially or completely blocks the stray electrical signals to lessen or eliminate arrhythmia.
Efficacious delivery of therapeutic substance from the electrode to the target tissue requires that the electrode to be in optimal contact with the target tissue. Ensuring optimal contact between the electrode and the tissue is not readily achieved using rigid electrodes, such as metal electrodes. Several factors that may contribute to suboptimal contact include: (i) the remote manipulation of the catheter from the electrode, typically over four feet away; (ii) the constant movement of the heart wall; (iii) the variable compliance of the heart wall, and (iv) the highly contoured nature of the heart wall. Flexible polymer electrodes are designed to provide superior conformance with tissue than metal electrodes.
In a first aspect, the invention is directed to a bipolar electrode system for ablation therapy, comprising a pressure-sensitive conducting composite layer and at least a pair of electrodes in electrical conductive contact or communication with the pressure-sensitive conducting composite layer. The bipolar electrode system may include a catheter base that is coupled to the conductive element and/or the pressure-sensitive conductive composite. An energy source may be coupled to the pair of electrodes, such that energy (e.g., ablation energy) is delivered via the pressure-sensitive conductive composition when sufficient pressure is applied to transform the pressure-sensitive conductive composite to an electrical conductor. An electrically insulative flexible layer, which may include a passageway for a fill material, may be found adjacent to the pressure-sensitive conductive layer. Sensors may also be located in the electrically insulative flexible layer for monitoring temperature, such as at an outlet coupled to a passageway for a fill material, or elsewhere. In those cases where an outlet is present, the outlet may permit flowable filler material to flow from the passageway. Additionally, a heat sink may be thermally coupled to the pressure-sensitive conductive composite member and/or to the electrically insulative flexible layer. In those electrodes where a passageway is found in the insulative flexible layer, there may also be found a wall such that flowable fill material circulates in the insulative flexible layer. The electrically insulative flexible layer itself may be permeable or non-permeable. In those bipolar electrode systems that include a passageway for a filler material and where the filler material cools the electrode during ablation, the passageway can be a loop such that a cooling fluid travels from a proximal end of the electrode through a distal end of the electrode and returns to the proximal end of the electrode via the passageway.
In another aspect, the present invention is direct to a bipolar electrode for ablation therapy that comprises a pressure-sensitive conducting composite layer, an electrically insulative flexible tube adjacent the pressure-sensitive conducting composite layer, at least a pair of electrodes in electrical conductive contact or communication with the pressure-sensitive conducting composite layer, and a passageway for a filler material in the electrically insulative flexible tube.
In yet another aspect, the invention is directed to methods of treating a target tissue. A bipolar electrode system having a pair of electrodes for conducting RF energy and a layer of pressure-sensitive conductive composite that is in electrical contact or communication with at least a portion of the pair of electrodes are coupled to an RF energy supply; the bipolar electrode system is operatively contacted with a target tissue of a subject; pressure is exerted upon the target tissue through the electrode such that the pressure-sensitive conductive composite becomes conductive, delivering energy to the target tissue. The method can include communicating with a heat sink thermally coupled to the bipolar electrode system.
In another aspect, the invention is directed to a bipolar electrode for ablation therapy that includes a catheter having a proximal end and a distal end, at least a pair of electrodes for conducting energy, and a layer of quantum tunneling composite that is in electrical communication with the pair of electrodes, where the layer is located at least in part at a distal end of the catheter. The bipolar electrode can also include an electrically insulative flexible tube thermally adjacent to the pressure-sensitive conducting composite layer. The electrode can also include at least one sensor to measure the temperature of the electrically insulative flexible tube, and/or a heat sink that is coupled to at least the quantum tunneling composite layer or the electrically insulative flexible tube.
In yet another aspect, the invention is directed to a bipolar electrode assembly for conducting ablative energy, where the assembly comprises a pair of electrodes for conducting the ablative energy, a quantum tunneling composite member, and an energy source coupled to the quantum tunneling composite member, wherein the pair of electrodes is disposed relative to the quantum tunneling composite member such that pressure that is applied to the pair of electrodes is transferred to the quantum tunneling composite member and causes the quantum tunneling composite member to become electrically conductive such that it conducts electrical energy to the electrode. The electrode assembly can also include a conductor that is in electrical contact or communication with the quantum tunneling composite member, where the conductor is configured to conduct electrical energy sufficient to cause ablation. The electrode may be located on a distal end of the electrode assembly, and the quantum tunneling composite member may be disposed in physical contact or communication with the electrode along the longitudinal axis of the electrode assembly. The electrode assembly can also include at least one pressure transfer member disposed between the quantum tunneling composite member and the electrode, such that pressure applied to the electrode is transferred through at least one pressure transfer member to the quantum tunneling composite member. A processor that can sense the degree of contact between the electrode and the surface of a tissue to be ablated can also be included in the assembly. A processor that monitors for a change in impedance of the quantum tunneling composite member can also be included with the electrode assembly, where the processor is coupled to a generator to control the energy being generated based on a change in impedance of the quantum tunneling composite member.
In another aspect, the invention is directed to a method of delivering a compound to a target tissue, where a bipolar electrode system that has a pair of electrodes for conducting DC and RF energy and a layer of pressure-sensitive conductive composite that is in electrical contact or communication with at least a portion of the pair of electrodes is coupled to a DC energy supply to the pair of electrodes and with a circulating a flowable filler material that includes the compound to be delivered to the target tissue. The system is operatively contacted to the bipolar electrode system with a target tissue of a subject; the DC energy supply is engaged, and then an effective amount of pressure is exerted upon the target tissue through the electrode such that the pressure-sensitive conductive composite becomes conductive and delivers DC energy to the target tissue. The method can also include coupling an RF energy supply to the pair of electrodes. The method can also include the steps of, after delivering DC energy to the target tissue, disengaging the DC energy supply, engaging a RF energy supply coupled to the pair of electrodes, and exerting an effective amount of pressure upon the target tissue through the electrode such that the pressure-sensitive conductive composite becomes conductive and delivers RF energy to the target tissue. Compounds that can be delivered include those that are electrophoretic and photosensitive, for example.
Pressure-sensitive conductive composite (PSCC) electrodes are disclosed, along with methods for using an electrode for tissue ablation and targeted drug delivery.
As used herein, “pressure-sensitive polymer,” “pressure-sensitive composite” and “PSCC” generally mean a pressure-sensitive conductive composite that has unique electrical properties wherein the electrical resistance of the PSCC varies inversely in proportion to the pressure that is applied to the PSCC. Useful PSCCs commonly have a high electrical resistance when quiescent (not under pressure), and become conductive under pressure, where the electrical resistance may fall, for example, to less than one ohm. When quiescent, the PSCC material can have a resistance that is greater than 100,000 ohms to greater than 1M ohms, and as a non-conductor (e.g., having a resistance greater than 10M ohms).
The present invention can use various pressure-sensitive conductive composite materials. For example, U.S. Pat. No. 6,999,821 discloses conductor-filled polymers that can include presently available materials approved for implantation in a human body such as silicone rubber with embedded metallic, carbon or graphite particles or powder. For example, silver-filled silicone rubbers, such as NuSil R2637 (NuSil; Carpinteria, Calif.) and similar products from Specialty Silicone Products (Ballston Spa, NY) can be used. Other insulating or weakly conductive materials (e.g., non-conductive elastomers) can be embedded with conductive materials, conductive alloys and/or reduced metal oxides (e.g., using one or more of gold, silver, platinum, iridium, titanium, tantalum, zirconium, vanadium, niobium, hafnium, aluminum, silicone, tin, chromium, molybdenum, tungsten, lead, manganese, beryllium, iron, cobalt, nickel, palladium, osmium, rhenium, technetium, rhodium, ruthenium, cadmium, copper, zinc, germanium, arsenic, antimony, bismuth, boron, scandium and metals of the lanthanide and actinide series and, if appropriate, at least one electroconductive agent). The conductive material can comprise a powder, gains, fibers or other shaped forms. The oxides can be mixtures comprising sintered powders of an oxycompound. The alloy can be conventional, such as, for example, titanium boride.
Other examples of PSCCs that can be suitable for use in connection with embodiments of the present invention include quantum tunneling composites (“QTC”), such as those available through Peratech Ltd. (Darlington, UK), and include the QTC pill, the QTC substrate and the QTC cables. QTC materials can have variable resistance values that range from >10 M ohms (in the absence of stress) to <1 ohm when under pressure.
Other examples of PSCC materials that can be used in the present invention include the conductive polymers disclosed in U.S. Pat. Nos. 6,646,540, 6,495,069, and 6,291,568. These materials can have a variable resistance of >1012 ohms before any stress is applied to less than 1 ohm when finger pressure is applied.
As a result of this unique property, PSCC materials have the ability to transform from an effective insulator to a metal-like conductor when deformed by compression, twisting, or stretching. The electrical response of a PSCC can be tuned appropriately to the spectrum of pressures being applied. Its resistance range often varies from greater than 10 M ohms to less than 1 ohms. The transition from insulator to conductor often follows a smooth and repeatable curve, with the resistance dropping monotonically to the pressure applied. Moreover, the effect is reversible once the pressure is removed, restoring electrical resistance. Thus, a PSCC may be transformed from an insulator to a conductor, and back to an insulator, simply by applying the appropriate pressure. PSCCs can conduct large currents (up to 10 Amps) and support large voltages (40 V and higher).
The PSCC can transform from an insulator (that is, conducting little or no current) to an effective conductor simply by applying a small change in pressure to the PSCC. For example, by applying pressure with a hand, or more particularly, with a finger, a surgeon can transform the PSCC from an insulator to a conductor to permit contact sensing.
The PSCC can also be chosen or customized to have a specific pressure sensitivity such that the insulator-conductance transition occurs over a wide or narrow range. For example, highly sensitive PSCCs, which register a sharp change in resistance with a finite amount of applied pressure, may be preferred for soft contact applications such as the atrial wall. Less-sensitive PSCCs, which require more pressure to register the same amount of change in resistance, may be preferred for hard contact applications such as ablation in ventricular walls.
Because a PSCC's resistance drops monotonically as pressure increases, a PSCC electrode is able to deliver energy for ablation gradually, and then increasingly as pressure increases.
In an embodiment of the present invention, the electrode is fabricated with a PSCC that differentiates between a soft and a hard push. Such a device can be used to switch, for example, an ablation electrode in response to a concentrated pressure while ignoring the general background pressure. Alternatively, such a device can “turn on” and deliver electrical energy that is already present within the device.
Because PSCC electrode devices and systems may be used to deliver ablation with a “soft start,” the PSCC electrode devices and systems of the present invention may be used in direct contact with the target tissue, thereby eliminating the physical gap that sometimes exists with other ablation electrodes. Eliminating the gap can reduce the possibility of arcing, and thereby can improve the safety and efficacy of ablation.
In some embodiments, the PSCC electrode device can contain a filler material that can be used, for example, to cool the device and surrounding tissues, or to carry desired compounds. “Filler material” (e.g., as shown as element 12 in
The PSCC bipolar electrode system 120 ablates tissue by delivering ablation energy, depicted in
Having an open system for a flowable filler material 12, shown in
Unlike the first bipolar electrode, as depicted in
The PSCC bipolar electrode system 130 ablates tissue by delivering ablation energy, depicted in
The PSCC electrode 40 having a closed-cooling system for a flowable material 12, as shown in
During electroporation, the bipolar electrodes 26 are energized with direct current 16 to create tissue ablation via cellular necrosis or apoptosis. In other applications, the bipolar electrodes 26 are energized with direct current 16 while the porous distal portion carries electrophoretic agents, such as photosensitive drugs for photodynamic therapy. This electroporation technique therefore provides in situ drug delivery. Such techniques may be used for tissue conditioning as precursor to ablative therapies, such as radiofrequency catheter ablation, ultrasound, and photodynamic therapy. After conditioning the tissue with a drug, the electrodes can be energized in a bipolar setting using RF current.
The present teachings permit the construction of a flexible, pressure-sensitive ablation electrode that can be used in a wide variety of different tissue environments, including for example, tissues having varying degrees of elasticity and contour. The present teachings further permit the construction of a flexible electrode that responds to pressure that is applied to the electrode, for example, pressure that may be applied to the electrode by the myocardium. Such electrodes may be used to respond to pressure that is applied directly to the PSCC component (for example, when the PSCC component is located at the most distal portion of a catheter), or to pressure that is applied indirectly to the PSCC (for example, when an electrode tip is disposed between the PSCC component and the tissue). When used in conjunction with an electrode tip, it is desired that the electrode tip be formed of an electrically conductive material that is relatively stiffer than the PSCC. This will permit the electrode tip to transfer pressure from the electrode tip to the PSCC component. Optionally, one or more additional pressure transfer elements may be used, for example, between the electrode tip at a distal end and the PSCC component located at a more proximal end. In the case where a PSCC component is positioned within a catheter, the PSCC component can be used to respond to pressure that is applied axially to catheter. Of course, the PSCC component could be oriented in order to respond to pressure that is applied transversely to the catheter.
While the embodiments disclosed in the attached figures disclose an electrode that is generally cylindrical in shape, the present invention also contemplates that the electrode may be thrilled into various shapes to better fit the contour of the target tissue. In one embodiment, for example, the electrode can be made long enough to strap around and form a noose around the pulmonary veins in epicardial applications. For example, electrical conductor 16 that is coupled to the energy source may be formed into a desired shape, and then the PSCC layer can be formed over the conductive element in the preferred shape. For example, the electrode may be shaped like a spatula for certain applications, including for example, minimally invasive sub-xyphoid epicardial applications, where the spatula shape will permit directional placement and navigation in the pericardial sac. Because PSCC can be made as a flexible material, it can be used for electrodes having a great variety of shapes, including a spatula.
Generally, flexibility is a very desirable characteristic in a catheter. Some applications, however, may require a less flexible and/or rigid catheters. Thus, as an alternative to the flexible embodiments discussed above, it is contemplated that the same structural design may be used to produce a less flexible (or even rigid or partially rigid) ablation device. For example, the PSCC electrode may use a rigid core, instead of a flexible core. It may be solid conductive core of varying degrees of rigidity, or a non-conductive core coated with a conductive layer such that the combination achieves a desired degree of rigidity. A PSCC substrate layer may then be applied to the core such that when the electrode is pressed against tissue, the PSCC becomes a conductor and electrically couples the conductive core (or layer, as the case may be) to the tissue via the PSCC. In this alternative embodiment, the PSCC may be coated with one or more outer electrically-conductive layers (which may be rigid or flexible). In this further modification, the PSCC layer can be sandwiched between at least two conductive coatings, and thus under pressure, RF energy may be delivered to the tissue via the compressible PSCC layer.
The electrically conductive element may be mounted on an electrically insulative but thermally conductive shaft. The thermally conductive shaft can improve the cooling of the electrode and the electrode-tissue interface temperature during ablation by thermally conducting heat from the interface to the ambient flowing blood in endocardial applications. In addition, the thermally conductive shall can be equipped with thermal sensors that can be used for temperature controlled RF ablation. The thermally conductive shaft may be made of an electrically insulative, thermally conductive material, including, for example, COOLPOLY® thermally conductive, electrically insulative plastic. In an embodiment, the thermally conductive shaft is made of a biocompatible, thermally conductive, electrically insulative material.
The heat sink can comprise a material with high thermal conductivity. The use of a heat sink can be particularly useful for small electrodes typically around 10 mm or less, or for sectioned electrodes that may give rise to hot spots. The heat sink may be made of an electrically insulative, thermally conductive material, including, for example, thermally conductive polyurethane (e.g., polyurethane with thermally conductive ceramic powder embedded therein), diamond, aluminum nitride, boron nitride, silicone, thermal epoxy and thermally conductive, electrically insulative plastics. In an embodiment, the thermally conductive shaft is made of a biocompatible, thermally conductive, electrically insulative material.
The electrically insulative member 20 may provide one or more passageways for carrying filter materials 12 that are flowable (e.g. saline solution) to the distal end of the electrode and/or the electrode-tissue interface 100. The passageways include an inlet to the electrode, and an outlet at the distal end of the electrode. Moreover, one or more thermal sensors may be placed in the passageway, for example, to measure the temperature of the coolant at the inlet and at the outlet. The temperature difference between the inlet and outlet during ablation could be used to monitor the efficacy of the electrode-tissue interface cooling and also to perform temperature-controlled ablation. One or more of the passageways may be alternatively defined as a cooling tube, which may comprise the same material as, or a material different from, the electrically insulative member.
The electrically insulative tube inside the catheter shaft may be thermally insulative or may contain a thermally insulative layer. Such thermal insulation helps minimize the degree to which the flowable filler material is heated to body temperature as the result of thermal conduction through the catheter shaft wall as the fluid travels from the outside fluid source through the catheter shaft and to the electrode. The thermally conductive tube inside the electrode, on the other hand, can cool the electrode and the electrode-tissue interface during ablation by thermally conducting the heat from the interface to the flowing fluid inside the tube catheter.
In an optional embodiment, the electrodes may be combined with a processor that monitors the current that is being delivered by the power source. Thus, a computer processor (not shown) monitors the maximum current being delivered and use this information to help control the ablation process. Because a PSCCs resistance drops monotonically as pressure increases, the amount of current being delivered can be used to assess a degree of contact between the contact surface and target tissue. Using this information, the computer processor (not shown) may decrease or increase the power level of the power source. By way of example only, the computer processor (not shown) may be used to limit the total amount of energy that is delivered to a target tissue. Depending on the nature of the tissue, the power level and the total energy delivered to the electrode and the tissue may be increased or decreased to improve the safety and efficacy of lesion creation.
The PSCC used in the present invention may be chosen to have a specific pressure sensitivity. For example, highly sensitive PSCCs, which register a sharp change in resistance with a finite amount of applied pressure, may be preferred for soft contact applications such as the atrial wall. Less sensitive PSCCs, which require more pressure to register the same amount of change in resistance, may be preferred for hard contact applications such as ablation in ventricular walls.
The RF source to be used with the present invention is preferably within the radio frequency range of 100-1000 kHz, and more preferably with 250 kHz-550 kHz. The electrical energy source (RF and/or direct current source) is preferably capable of delivering up to 150 Watts of electrical power.
It is contemplated that each of the embodiments discussed above may optionally be used in connection with one or more electrically-conductive, outer coverings. Preferably, the outer covering is electrically conductive, such as a flexible wire mesh, a conductive fabric, a conductive polymer layer (which can be porous or nonporous), or a metal coating. The outer covering may be used to not only increase the mechanical integrity, but to enhance the PSCC device's ability to assess the tissue contact (for example, in the when measuring electrical characteristics using a reference electrode connected to the target tissue). In some embodiments, the outer covering may be made using a biocompatible material in order to help make the overall assembly biocompatible. Preferably the outer covering is flexible, though certain applications may prefer a medium to high degree of rigidity.
One of ordinary skill will appreciate that while the PSCC materials may be designed to respond to a variety of stresses, the principles and embodiments herein may be adapted to respond to specific stress forces, for example, axial forces, orthogonal forces, twisting, compressing, stretching, etc., without deviating from the scope of the present invention.
Although multiple embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11968044 | Dec 2007 | US |
| Child | 13555929 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11647279 | Dec 2006 | US |
| Child | 11968044 | US |
