Patent Grant
10314649
Electrical ablation therapy has been used in medicine for the treatment of undesirable tissue, such as, for example, diseased tissue, cancer, malignant and benign tumors, masses, lesions, and other abnormal tissue growths. Apparatuses, systems, and methods for conventional ablation therapies may include electrical ablation therapies, such as, for example, high temperature thermal therapies including, focused ultrasound ablation, radiofrequency (RF) ablation, and interstitial laser coagulation, chemical therapies in which chemical agents are injected into the undesirable tissue to cause ablation, surgical excision, cryotherapy, radiation, photodynamic therapy, Moh's micrographic surgery, topical treatments with 5-fluorouracil, and laser ablation.
Drawbacks of conventional electrical ablation therapies include risk of permanent damage to healthy tissue surrounding undesirable tissue due to exposure to thermal energy and/or lack of controlled energy generated by an electrical ablation device. As such, when undesirable tissue occurs or originates at or near critical structures and surgical resection presents an increased risk of morbidity associated with damage to that critical structure, conventional electrical ablation therapies may be an unsatisfactory alternative. At times, the ability to apply controlled energy to ablate cells within a target zone may be affected by one or more characteristics of the target zone and/or available application positions provided by ablative electrodes. Solutions to address the above issues are often invasive and conflict with optimal surgical outcomes. Accordingly, minimally invasive electrical ablation therapy capable of accurately targeting ablative electrodes to a target site and delivering controlled energy to ablate cells within a target zone while retaining necessary infrastructure of the surrounding tissue is desirable.
In one general aspect, the various embodiments are directed to an electrical ablation device. One embodiment of the electrical ablation device includes an elongate member having therealong disposed a first electrode extending along an axis. The first electrode has a proximal end configured to couple to an energy source and a surface configured to couple to a tissue treatment region and delivery ablative energy. A first expandable portion extends along the axis and defines a first perimeter of the first electrode and has an associated first diameter with respect to the axis. The first expandable portion includes a first framework comprising at least one first framework member. The first framework is selectively expandable to transition the first expandable portion from a contracted state to an expanded state. The first framework is selectively contractible to transition the first expandable portion from the expanded state to the contracted state. When the first framework is expanded, the first diameter is expanded and the first expandable portion is transitioned from the contracted state to the expanded state. When the first framework is contracted, the first diameter is contracted and the first expandable portion is transitioned from the expanded state to the contracted state.
In another general aspect, a method of treating tissue using the electrical ablation devices described herein includes delivering the first electrode to a tissue treatment region that includes a biological lumen and expanding the first electrode. The first electrode is contacted to a wall of the lumen proximal to tissue to be treated. Tissue is treated by applying one or more sequences of electrical pulse to the first electrode to induce cell death in the tissue by irreversible electroporation.
The various embodiments of electrical ablation devices, systems, and methods thereof described herein may be better understood by considering the following description in conjunction with the accompanying drawings.
The present disclosure relates generally to the field of electrosurgery. In particular, the present disclosure relates to, although not exclusively, electrosurgical devices. More particularly, the present disclosure relates to, although not exclusively, electrical ablation systems, devices, and methods.
This disclosure describes various elements, features, aspects, and advantages of various embodiments of electrical ablation systems, devices, and methods thereof. It is to be understood that certain descriptions of the various embodiments have been simplified to illustrate only those elements, features and aspects that are relevant to a more clear understanding of the disclosed embodiments, while eliminating, for purposes of brevity or clarity, other elements, features and aspects. Any references to “various embodiments,” “certain embodiments,” “some embodiments,” “one embodiment,” or “an embodiment” generally means that a particular element, feature and/or aspect described in the embodiment is included in at least one embodiment. The phrases “in various embodiments,” “in certain embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment” may not refer to the same embodiment. Furthermore, the phrases “in one such embodiment” or “in certain such embodiments,” while generally referring to and elaborating upon a preceding embodiment, is not intended to suggest that the elements, features, and aspects of the embodiment introduced by the phrase are limited to the preceding embodiment; rather, the phrase is provided to assist the reader in understanding the various elements, features, and aspects disclosed herein and it is to be understood that those having ordinary skill in the art will recognize that such elements, features, and aspects presented in the introduced embodiment may be applied in combination with other various combinations and sub-combinations of the elements, features, and aspects presented in the disclosed embodiments. It is to be appreciated that persons having ordinary skill in the art, upon considering the descriptions herein, will recognize that various combinations or sub-combinations of the various embodiments and other elements, features, and aspects may be desirable in particular implementations or applications. However, because such other elements, features, and aspects may be readily ascertained by persons having ordinary skill in the art upon considering the description herein, and are not necessary for a complete understanding of the disclosed embodiments, a description of such elements, features, and aspects may not be provided. As such, it is to be understood that the description set forth herein is merely exemplary and illustrative of the disclosed embodiments and is not intended to limit the scope of the invention as defined solely by the claims.
All numerical quantities stated herein are approximate unless stated otherwise, meaning that the term “about” may be inferred when not expressly stated. The numerical quantities disclosed herein are to be understood as not being strictly limited to the exact numerical values recited. Instead, unless stated otherwise, each numerical value is intended to mean both the recited value and a functionally equivalent range surrounding that value. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding the approximations of numerical quantities stated herein, the numerical quantities described in specific examples of actual measured values are reported as precisely as possible.
All numerical ranges stated herein include all sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between and including the recited minimum value of 1 and the recited maximum value of 10. Any maximum numerical limitation recited herein is intended to include all lower numerical limitations. Any minimum numerical limitation recited herein is intended to include all higher numerical limitations. Additionally, in some illustrative embodiments, a parameter, measurement, diversion, or range may be given. It is to be understood that any such parameter, measurement, diversion, or range is provided as an illustrative example or instance of an embodiment and is not intended to limit that or other embodiments.
As generally used herein, the terms “proximal” and “distal” generally refer to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” generally refers to the portion of the instrument closest to the clinician. The term “distal” generally refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
As generally used herein, the term “ablation” generally refers to removal of cells either directly or indirectly by supply of energy within an electric field and may include removal by loss of cell function, cell lysis, necrosis, apoptosis, and/or irreversible electroporation. “Ablation” may similarly refer to creation of a lesion by ablation. Additionally, the terms “undesirable tissue,” “target cells,” “diseased tissue,” “diseased cells,” “tumor,” “cell mass” and the like are generally used throughout to refer to cells removed or to be removed, in whole or in part, by ablation and are not intended to limit application of the systems, devices, or methods described herein. For example, such terms include ablation of both diseased cells and certain surrounding cells, despite no definite indication that such surrounding cells are diseased. The terms similarly include ablation of cells located around a biological lumen such as a vascular, ductal, or tract area, for example, to create a margin for a surgeon to resect additional cells by ablation or other method.
According to certain embodiments, an ablation system generally comprises first and second electrodes coupled to an energy source operative to generate an electric field between the first and second electrodes when such electrodes are contacted to tissue and energized. An electrical current supplied to the electric field is conducted between the first and second electrode through the tissue. Without wishing to be bound to any particular theory, it is believed the electrical current propagates through conductive tissue at least partially via electron and/or electrolytic carriers. Electrical ablation devices may generally comprise one or more electrodes configured to be positioned at or near undesirable tissue (e.g., target cells, target site, treatment site, diseased tissue, diseased cells, tumor, cell mass) in a tissue treatment region (e.g., a target region). In general, the electrodes may comprise an electrically conductive portion (e.g., medical grade stainless steel, gold plated, etc.) and may be configured to electrically couple to an energy source. Once positioned at or near undesirable tissue, an energizing potential may be applied to the electrodes to create an electric field to which the undesirable tissue is exposed. The energizing potential (and the resulting electric field) may be characterized by various parameters, such as, for example, frequency, amplitude, pulse width (duration of a pulse or pulse length), and/or polarity. Depending on the desired application, for example, the diagnostic or therapeutic treatment to be rendered, a particular electrode may be configured either as an anode or a cathode, or a plurality of electrodes may be configured with at least one electrode configured as an anode and at least one other electrode configured as a cathode. Regardless of the initial polarity configuration, the polarity of the electrodes may be reversed by reversing the polarity of the output of the energy source. In some embodiments, an exogenous electrolyte may be applied to tissue prior to ablation to increase conductivity. In certain embodiments, application of an exogenous electrolyte may increase or decrease an effective area or density of an electric field.
In certain embodiments, a suitable energy source may comprise an electrical waveform generator. The energy source generates an electric field having a suitable characteristic waveform output in terms of frequency, amplitude, pulse width, and polarity. Electrodes may be energized with DC voltages and conduct currents at various frequencies, amplitudes, pulse widths, and polarities. The electrodes may also be energized with time-varying voltages and currents at amplitudes and frequencies suitable for rendering the desired therapy. A suitable energy source may comprise an electrical waveform generator adapted to deliver DC and/or time-varying energizing potentials characterized by frequency, amplitude, pulse width, and/or polarity to the electrodes. The electric current flows between the electrodes and through the tissue proportionally to the potential (e.g., voltage) applied to the electrodes. In various embodiments, supplied electric current is provided by the energy source and comprises a pulse sequence applied to tissue. For example, an energy source may supply various waveforms in one or more pulse sequences tailored to the desired application. Commonly owned U.S. patent application Ser. No. 13/036,908, filed Feb. 28, 2011, titled “ELECTRICAL ABLATION DEVICES AND METHODS,” and U.S. patent application Ser. No. 13/352,495, filed Jan. 18, 2012, titled “ELECTRICAL ABLATION DEVICES AND METHODS,” disclose many such waveforms, pulse sequences, and methods of application thereof for electrical ablation treatment, the contents of which are herein incorporated by reference.
In one embodiment, the energy source may be configured to produce RF waveforms at predetermined frequencies, amplitudes, pulse widths, and/or polarities suitable for thermal heating and/or electrical ablation of cells in the tissue treatment region. One example of a suitable RF energy source may be a commercially available conventional, bipolar/monopolar electrosurgical RF generator, such as Model Number ICC 350, available from Erbe, GmbH. In one embodiment, the energy source may comprise a microwave energy source configured to produce microwave waveforms at predetermined frequencies, amplitudes, pulse widths, and/or polarities suitable for thermal heating and/or electrical ablation of cells in the tissue treatment region. The microwave power source, such as MicroThermx, available from Boston Scientific Corp., may be coupled to a microwave antenna providing microwave energy in the frequency range from 915 MHz to 2.45 GHz.
In one embodiment, the energy source may be configured to produce destabilizing electrical potentials (e.g., fields) suitable to induce thermal heating and/or irreversible electroporation. The destabilizing electrical potentials may be in the form of bipolar/monopolar monophasic electric pulses suitable for inducing thermal heating and/or irreversible electroporation. A commercially available energy source suitable for generating thermal heating and/or irreversible electroporation electric field pulses in bipolar or monopolar mode is a pulsed DC generator such as Model Number ECM 830, available from BTX Molecular Delivery Systems Boston, Mass. In bipolar mode, the first electrode may be electrically coupled to a first polarity and the second electrode may be electrically coupled to a second (e.g., opposite) polarity of the energy source. Bipolar/monopolar monophasic electric pulses may be generated at a variety of frequencies, amplitudes, pulse widths, and/or polarities. Unlike RF ablation systems, which may require high power and energy levels delivered into the tissue to heat and thermally destroy the tissue, irreversible electroporation may require very little energy applied to the tissue to heat and kill the cells of the undesirable tissue using electric field potentials rather than heat. Accordingly, irreversible electroporation systems may avoid the detrimental thermal effects caused by RF ablation systems.
Various embodiments of the electrical ablation systems, devices, and methods described herein utilize electroporation or electropermeabilization techniques to apply external electric fields (electric potentials) to cell membranes to significantly increase permeability of the plasma membrane of the cell. Irreversible electroporation (IRE) is the process of killing cells by increasing the electrical potential across the cell membrane for a long period of time. IRE provides an effective method for destroying cells while avoiding some of the negative complications of heat-inducing therapies. Namely, IRE kills cells without raising the temperature of the surrounding tissue to a level at which permanent damage may occur to the support structure or regional vasculature. Large destabilizing IRE electric potentials may be in the range of about several hundred to about several thousand volts applied in the tissue to increase the local electric field. The increase in the electric field will increase the membrane potential over a distance of about several millimeters, for example, for a relatively long period of time. The destabilizing electric potential forms pores in the cell membrane when the potential across the cell membrane reaches a critical level causing the cell to die by processes known as apoptosis and/or necrosis.
Application of IRE pulses to cells may be an effective way for ablating large volumes of undesirable tissue with no or minimal detrimental thermal effects to the surrounding healthy tissue. As such, in some embodiments, IRE may be utilized in conjunction with the various electrodes and/or other electrical ablation devices disclosed herein to perform one or more minimally invasive surgical procedures or treatments. Without wishing to be bound to any particular theory, it is believed that IRE destroys cells with no or minimal heat, and thus, may not destroy the cellular support structure or regional vasculature. A destabilizing irreversible electroporation pulse, suitable to cause cell death without inducing a significant amount of thermal damage to the surrounding healthy tissue, may have amplitude in the range of several hundred to several thousand volts and may be generally applied across biological membranes over a distance of several millimeters, for example, for a relatively long duration of 1 μs to 100 ms. Thus, the undesirable tissue may be ablated in-vivo through the delivery of destabilizing electric fields by quickly causing cell necrosis.
In certain embodiments, the energy source may comprise a wireless transmitter to deliver energy to the electrodes using wireless energy transfer techniques via one or more remotely positioned antennas. Those skilled in the art will appreciate that wireless energy transfer or wireless power transmission refers to the process of transmitting electrical energy from an energy source to an electrical load without interconnecting wires. In one embodiment, the energy source may be coupled to first and second electrodes by a wired or a wireless connection. In a wired connection, the energy source may be coupled to the electrodes by way of the electrical conductors. In a wireless connection, the electrical conductors may be replaced with a first antenna coupled the energy source and a second antenna coupled to the electrodes, wherein the second antenna may be remotely located from the first antenna. In one embodiment, the energy source may comprise a wireless transmitter to deliver energy to the electrodes using wireless energy transfer techniques via one or more remotely positioned antennas. As previously discussed, wireless energy transfer or wireless power transmission is the process of transmitting electrical energy from the energy source to an electrical load, e.g., the abnormal cells in the tissue treatment region, without using the interconnecting electrical conductors. An electrical transformer is the simplest example of wireless energy transfer. The primary and secondary circuits of a transformer may not be directly connected and the transfer of energy may take place by electromagnetic coupling through a process known as mutual induction. Power also may be transferred wirelessly using RF energy.
As will be appreciated, the electrical ablation devices, systems, and methods may comprise portions that may be inserted into the tissue treatment region percutaneously (e.g., where access to inner organs or other tissue is done via needle-puncture of the skin). Other portions of the electrical ablation devices may be introduced into the tissue treatment region endoscopically (e.g., laparoscopically and/or thoracoscopically) through trocars or channels of the endoscope, through small incisions, or transcutaneously (e.g., where electric pulses are delivered to the tissue treatment region through the skin).
The systems, devices, and methods for electrical ablation therapy may be adapted for use in minimally invasive surgical procedures to access tissue treatment regions in various anatomic locations, such as, for example, the brain, lungs, breast, liver, gall bladder, pancreas, prostate gland, and various internal body or biological lumen (e.g., a natural body orifice) defined by the esophagus, stomach, intestine, colon, arteries, veins, anus, vagina, cervix, fallopian tubes, and the peritoneal cavity. Minimally invasive electrical ablation devices may be introduced to the tissue treatment region though a small opening formed in the patient's body using a trocar or through a natural body orifice such as the mouth, anus, or vagina using translumenal access techniques known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ wherein electrical ablation devices may be initially introduced through a natural body orifice and then advanced to the tissue treatment site by puncturing the walls of internal body lumen. In various embodiments, the electrical ablation system may be adapted to treat undesirable tissue in the brain, lung, breast, liver, gall bladder, pancreas, or prostate gland, using one or more electrodes positioned percutaneously, transcutaneously, translumenally, minimally invasively, and/or through open surgical techniques, or any combination thereof.
In certain embodiments, the systems, devices, and methods may be configured for minimally invasive ablation treatment of cell masses, tumors, growths, or other undesirable tissue. Minimally invasive ablation treatment of undesirable tissue may be characterized by the ability to reduce trauma by accurately targeting undesirable tissue through one or more biological lumens (e.g., a natural body orifice, vascular, duct, or tract area) and applying an electric field to ablate undesirable tissue in a controlled and focused manner while at the same time retaining the cellular infrastructure of the surrounding healthy tissue. According to various embodiments, delivering an electrode to a biological lumen and contacting the lumen wall in a controlled manner provides increased electroablative accuracy which may reduce undesirable lesions, increase probability of desirable circumferential ablation zones, and/or retain necessary infrastructure in surrounding tissue. For example, uniformity and/or density of an electric field over particular regions of the electric field established by various electrodes and/or returns may be more precisely focused or controlled. In certain embodiments, contacting a lumen wall in a controlled manner comprises circumferentially contacting the lumen wall at two or more locations about the circumference of the wall at or near a treatment site, for example, at or along two locations about the circumference of the wall separated by 15°, 30°, 90°, or 180°, for example. Such contact may be continuous, such as contact connecting two points, or discontinuous, such as contact at a first point and at a second point without contact along at least an intervening portion of the lumen wall between the first and second points.
When a tissue treatment region is located at or near a biological lumen, such as a vascular, duct, cavity, orifice, or tract area, for example, minimally invasive electrical ablation devices comprising electrodes may be delivered to the tissue treatment region through an artificial lumen (e.g., channel of endoscope, sheath, sleeve, trocar) and/or through one or more biological lumens, as herein described. In various embodiments, an electrical ablation device (e.g., electrode or an electrode disposed along a probe comprising an elongate member) may be fed through the biological lumen within an endoscope, trocar, sheeth, sleeve, or channel, for example. An electrical ablation device may also be configured to be fed through a biological lumen “naked,” that is, without assistance from the above instruments. For example, an electrode may be configured to be flexibly fed or directed through one or more biological lumens to the treatment region. In some embodiments, electrodes may be provided along a distal portion of an elongate member comprising a probe. The elongate member may thereby be configured to deliver one or more electrodes to a tissue region. Portions of the elongate member proximal to an electrode may respond to signals from a clinician directing one or more of such positions along a length of the elongate member to move. For example, an elongate member may be responsive to signals to bend at the one or more positions along its length during delivery to a tissue region. Once electrical ablation devices (e.g., electrodes) are delivered or located at or near undesirable tissue in the treatment region, electrodes may be deployed to contact lumen tissue and apply ablative treatment. Such bending, therefore, may assist in navigation and/or placement of the electrical ablation device through or within a biological lumen during delivery, deployment, or during or after ablative treatment.
In particular embodiments, electrodes may be configured to expand circumferentially, for example, when deployed or once located at or near undesirable tissue within a tissue region. Expansion may be the result of deployment, an electrical, mechanical, chemical, or thermal signal actuating an expansion, or, in some instances, a contraction. In some embodiments, electrodes may be configured to expand in at least one dimension. For example, electrodes may be configured to expand in diameter. Electrodes may further be configured to expand in length, such as extending a length of the electrode. In some embodiments, an extension in length may be independent of an expansion in diameter. For example, electrodes may expand in length without expanding in diameter or may expand in diameter without expanding in length. In other embodiments, however, an expansion in diameter or length may be concomitant with an increase or decrease in diameter or length. In certain embodiments, electrodes may be configured to expand only in diameter or length. In various embodiments, electrodes expandable in one or more dimensions may be similarly configured to contract in one or more dimensions. Such electrodes may be said to be transitionable between an expanded state and a contracted state. In some embodiments, transitions between one or more expanded states and one or more contracted states may be in response to a signal provided by a clinician. Thus, in some embodiments, a clinician may selectively transition an electrode to a desired expanded and/or contracted state to beneficially fit an electrode to a desired application, such as a procedure and/or biological structure. In certain instances, selecting an expanded state may provide increase contact about a circumference of a lumen thereby creating a more precisely defined electric field and increasing controllability of electric field potentials, for example. In various embodiments, an electrode may comprise an antenna, such as a microwave antenna, wherein undesirable tissue positioned adjacent to or near the antenna may be more fully exposed to ablative energy when the electrode is in an expanded state compared to a contracted state. For example, a diameter, length, and/or surface area of an electrode comprising antenna may be increased in the expanded state such undesirable tissue is fully exposed to ablative energy.
An electrical ablation system 10 incorporating an electrical ablation device 12 according to one embodiment is illustrated in
In
The electrical ablation system 10 illustrated in
In some embodiments, electrodes 21, 22 may deliver electric field pulses to the undesirable tissue. Such electric field pulses may be characterized by various parameters, such as, for example, pulse shape, amplitude, frequency, pulse width, polarity, total number of pulses and duration. In various embodiments, the electric field pulses may be sufficient to induce thermal heating in the undesirable tissue without inducing irreversible electroporation in the undesirable tissue. In certain embodiments, the electric field pulses may be sufficient to induce irreversible electroporation in the undesirable tissue. The effects induced may depend on a variety of conditions, such as, for example, tissue type, cell size, and electrical field pulse parameters. For example, the transmembrane potential of a specific tissue type may primarily depend on the amplitude of the electric field and pulse width.
In one embodiment, the input to the energy source 11 may be connected to a commercial power supply by way of a plug (not shown). The output of the energy source 11 is coupled to electrodes 21, 22, which may be energized using an activation switch (not shown) on the handle 14, or an activation switch mounted on a foot activated pedal (not shown). The energy source 11 may be configured to generate electric pulses at a predetermined frequency, amplitude, pulse width, and/or polarity that are suitable to induce thermal heating in the undesirable tissue in the treatment region or induce irreversible electroporation to ablate substantial volumes of undesirable tissue in the treatment region. The polarity of the DC pulses may be reversed or inverted from positive-to-negative or negative-to-positive a predetermined number of times to induce irreversible electroporation to ablate substantial volumes of undesirable tissue in the treatment region.
In some embodiments, one or more series of electric pulses may be applied to induce IRE. In one embodiment, a timing circuit may be coupled to the output of the energy source 11 to generate electric pulses. The timing circuit may comprise one or more suitable switching elements to produce the electric pulses. For example, the energy source 11 may produce a series of m electric pulses (where m is any positive integer) of sufficient amplitude and duration less than the necrotic threshold to induce thermal heating in the undesirable tissue when the m electric pulses are applied and a series of n electric pulses (where n is any positive integer) of sufficient amplitude and duration to induce irreversible electroporation suitable for tissue ablation when the n electric pulses are applied. In various embodiments, the electric pulses may have a fixed or variable pulse width, amplitude, and/or frequency.
The electrical ablation device 12 may be operated either in bipolar mode, e.g., the electrodes are relatively close to one another, or monopolar mode, e.g., the electrodes are far apart and one electrode typically has a much larger surface area. For example, the electrodes 21, 22 may be employed in a bipolar electrical ablation system in which the first electrode 21 has a positive polarity relative to the other electrode 22. In monopolar mode, a grounding pad, as illustrated in
Returning to
In various embodiments, the elongate member 18 may be flexible along all or a portion of its length. Such flexible portions may be bendable, deformable, or elastic, for example. Flexible portions may also be conditionally flexible or conditionally rigid, for example. In some embodiments, the elongate member 18 comprises flexible portions which may be mechanically bendable such that portions of the elongate member 18 are pivotable in response to a signal or otherwise manipulatable. In some embodiments, the elongate member 18 may be proximally and/or distally advanced relative to the handle 14. A distal advance of the elongate member 18 relative to the distal end of the handle 14, for instance, may coincide with a distal advance of the elongate member 18 relative to the proximal end of the handle 14. In certain embodiments, when advancing the elongate member 18 increases a length of the elongate member 18, distal to the distal end of the handle 14, the increase in length coincides with a decrease in length of the elongate member 18 proximal to the proximal end of the handle 14. In various embodiments, a proximal advance of the elongate member 18 relative to the distal end of the handle 14 coincides with a proximal advance of the elongate member 18 relative to the proximal end of the handle 14. In certain embodiments, when advancing the elongate member 18 decreases a length of the elongate member 18 distal to the distal end of the handle 14, the decrease in length coincides with an increase in length of the elongate member 18 proximal to the proximal end of the handle 14. While the elongate member 18 illustrated in
In some embodiments, one or more portions of the elongate member 18 may be coiled, nested, or otherwise contained within the handle 14 or a distal portion of the elongate member 18. In some such embodiments, a distal advance of the elongate member 18 relative to the distal end of the handle 14 does not coincide with a distal advance of the elongate member 18 relative to the proximal end of the handle 14. In one such embodiment, a proximal advance of the elongate member 18 relative to the distal end of the handle 14 does not coincide with a proximal advance of the elongate member 18 relative to the proximal end of the handle 14. In certain embodiments, when advancing the elongate member 18 increases a length of the elongate member 18 distal to the distal end of the handle 14, the length of the elongate member 18 proximal to the proximal end of the handle 14 remains the same. In one such embodiment, when advancing the elongate member 18 decreases a length of the elongate member 18 distal to the distal end of the handle 14, the length of the elongate member 18 proximal to the proximal end of the handle 14 remains the same.
In certain embodiments, the electrical ablation system 10 comprises a relatively flexible elongate member 18 and may be introduced, directed, and delivered to a tissue treatment region within the sheath 40. The sheath 40 may be a hollow bore, such as a tube, for example. In some embodiments, the sheath 40 is semi-rigid and may be used to accurately deliver the first electrode 21 to a tissue treatment region. The elongate member 18 may be translatable through the hollow bore to alternately withdraw and deploy one or more electrode(s) 21, 22 or a portions thereof. In some embodiments, the elongate member 18 comprises an extendable portion, such as an extendable length. The length may be extendable by, for example, distally extending the elongate member 18 such that the elongate member 18 distally elongates relative to the distal end of the handle 14, thus advancing or deploying the first electrode 21 or a portion thereof. Similarly, an actuator, such as slide assembly 34, may be provided to extend the elongate member 18. For example, the elongate member 18 may advance or deploy the first electrode 21 or a portion thereof by distally feeding an additional length of the elongate member 18. It is to be appreciated that extension of the elongate member 18 is not limited to feeding additional elongate member 18 distally from the handle 14. In some embodiments, a portion of the elongate member 18 may extend by moving a first portion of the elongate member 18 relative to a second portion of the elongate member 18. The first and second portions of the elongate member 18 may flank both sides of a nested portion such that a relative movement between the first and second portions of the elongate member 18 may thereby result from a telescopic extension or retraction of a length of the elongate member 18, increasing or decreasing the overall length of the elongate member 18. The first and second portions of the elongate member 18 may also flank both sides of a folded portion of the elongate member 18 such that a relative movement between the first and second portions of the elongate member 18 may thereby result from a folding or unfolding of the folded portion resulting in an accordion-like extension or retraction of a length of the elongate member 18. Relative movement between first and second portions may be accomplished by any known mechanism, such as pulleys, reciprocating extension members, slide mounts, gears, and/or tracks, for example. In some embodiments, the elongate member 18 may advance or deploy the first electrode 21 by progressive release of a bias within the elongate member 18. In the embodiment illustrated in
As previously described, the elongated member 18 may comprise a distally located tip 28. In certain embodiments, the tip 28 may include an insulator configured to resist conduction of electric current. It is to be appreciated that tips 28 of various dimensions may be provided to suit particular applications. For example, in some embodiments, the length of the tip 28 may be longer than the first electrode 21 while in other embodiments the length of the tip 28 may be shorter than the first electrode 21. Tips 28 of various lengths may beneficially increase stability of the first electrode 21 during ablation or assist delivery of the first electrode 21 by, for example, increasing steerability of the elongate member 18. In various embodiments, a diameter of the tip 28 may be greater than or less than a diameter of the first electrode 21 in a contracted state. In some such embodiments, the tip 28 may comprise multiple diameters. Tips 28 comprising multiple diameters may be configured to assist in delivery, placement, and/or positioning of the first electrode 21. For example, contours provided about the multiple diameters of the tip 28 may be designed to anchor or fitably position the first electrode 21 at or near a treatment site. Such contours may also include one or more surface features configured to grippably engage tissue at or near a treatment site. In various embodiments, the tip 28 comprises a distal end configured to assist in delivery, placement and/or positioning of the first electrode 21. For example, a distal end of the tip 28 may comprise a dull or blunt end, as illustrated in
In various embodiments, the slide assembly 34 is operatively coupled to the sheath 40 such that movement of the slide member 30 in a first direction advances the sheath 40 relative to the distal end of the handle 14 and movement of the slide member 30 in a second direction retracts the sheath relative to the distal end of the handle 14. In some embodiments, the sheath may be retractable relative to the distal end of the handle 14 to expose or deliver the first electrode 21 to a deployed position at or near a treatment site. In some embodiments, the sheath 40 may be advanceable relative to the distal end of the handle 14 to envelope or withdraw the first electrode 21 to a withdrawn position. It will be appreciated that the elongate member 18 may be advanceable by arrangements other than the slide member 30, such as a lever, trigger, actuator, or button, for example, and advancement or retraction may be effectuated manually, electrically, and/or mechanically, for example. In one embodiment, the elongate member 18 may be advanced or retracted by increasing or decreasing a length of the elongate member 18. For example, one or more electrodes 21 or other portions of the elongate member 18 may comprise an adjustable length comprised of an elastic or otherwise extendable or compressible material such that an adjustment of the length effectuates an advancement or retraction of the elongate member 18. In some embodiments, a distal advancement of the elongate member 18 deploys the first electrode 21 to target tissue and a proximal retraction of the elongate member 18 withdraws the first electrode 21 from target tissue. In some embodiments, one or more actuators may be configured to deploy the first electrode 21 to a treatment region, to withdraw the first electrode 21 from a treatment region, to extend or flex the first electrode 21, and/or to transition the expandable portion 20 between contracted and expanded states. In some embodiments, multiple transitions may be actuated by the same or different actuators. For example, an actuation signal to transition between a contracted state and an expanded state may be coupled with an actuation signal to withdraw or deploy the first electrode 21.
In various embodiments, first and second electrodes 21, 22 may be disposed along the distal portion of the elongate member 18 and may be employed to more precisely define a treatment area to, for example, ablate undesirable tissue while reducing muscle contractions in adjoining tissues.
In some embodiments, where the elongate member comprises multiple electrodes, the distance “d” between electrodes may be adjustable. Referring again to
According to the various embodiments of electrical ablation systems, devices, and methods disclosed herein, electrodes 21 may comprise flexible and/or expandable portions. In some instances, such flexible and/or expandable portions may include a framework comprising one or more framework members providing, which may provide structure to the flexible and/or expandable portions. In various embodiments, a framework defines a selectively expandable perimeter and/or diameter of the expandable portion and may include one or more energy delivery surfaces configured to contact tissue and deliver ablative energy. Herein, the generalized shape and periphery surfaces of expandable and/or flexible portions may be generally referred to as a basket. It is to be appreciated that the electrodes in
Framework members may be configured to flex or bend in one or more directions and may comprise flexible materials exhibiting elastic and/or reflexive properties. For example, framework members may comprise materials such as plastics, polymers, alloys, metallics, or other elastics including superelastics. Framework members may similarly comprise rigid or conditionally rigid materials configures to flex or bend about a joint or socket, for example. In some embodiments, a clinician may decrease trauma associated with directing electrodes through tortuous biological lumens by utilizing a flexible electrode 21. Flexible electrodes 21 may beneficially reach undesirable tissues in target regions that may otherwise be considered inoperable. In various embodiments, flexible electrodes 21 may also increase the contact area between tissue contact regions of the flexible electrodes 21 and undesirable tissue. As those having skill in the art will recognize, flexible electrodes 21 may be especially helpful by providing greater control over an application when, for example, undesirable tissue is partially obstructing a biological lumen.
In various embodiments, electrodes 21 may be expandable in any physical dimension, such as, for example, width or height. In some embodiments, for instance, an expansion of an electrode 21 may be described as an increase in a diameter of the electrode 21. As generally used herein, the term “diameter” generally means a straight line distance between two points located along a perimeter of an expandable portion 20 such that the straight line passes through the axis of the expandable portion 20. The perimeter of an expandable portion 20 may comprise a periphery or external surface of the expandable portion 20. For example, in some embodiments, the framework 50 defines a perimeter of the expandable portion 20 and a diameter may be the distance between two tissue contact regions on opposing sides of the framework. It is to be appreciated that diameter is not limited to a specific geometric shape or cross-section and includes helical, circular, triangular, rectangular, pentagonal, hexagonal, or any other suitable shape, be it a regular geometric shape or irregular, for example.
In addition to expandability and/or flexibility, an electrode 21 may also be extendable. That is, a length of the electrode 21 may be extendable by extending a movable portion of the electrode 21 relative to a fixed portion of the electrode 21. For example, in one embodiment of the flexible electrode 21 illustrated in
In various embodiments, an electrical ablation device 12 comprises one or more expandable electrodes 21. Expandable electrodes 21, such as those illustrated in
The degree to which a dimension of an expandable portion 20 may expand may be many multiples of the original value of the dimension. For example, a dimension of an expandable portion 20 in a first state may have a value of 1 and the dimension of the expandable portion 20 in a second state may have a value of 2, 3, 10, 20 or greater, such as 40. In certain embodiments, the degree of expansion is limited only by the length of the expandable portion 20 in the first state. In some embodiments, a variable expansion feature is provided. A variable expansion feature may enable the clinician to adjust the degree to which an electrode 21 expands. For example, a clinician may adjust the degree of expansion to a predetermined diameter before or during a procedure. A variable expansion feature may also be configured to adapt to a procedure or provide feedback to the clinician such that the degree of expansion may be adjusted. For example, the magnitude of an expansion force may be finite and/or nominal after a particular degree of expansion has taken place such that degree of expansion may be limited when external resistance to expansion is at or near a predetermined threshold, for example, when a wall or structure is obstructing a full expansion. Such a variable expansion feature may be further adjustable to tailor to specific applications. For example, an electrode 21 comprising a conductive balloon may be inserted into a lumen and inflated by controllable pressure to substantially conform to the shape of the lumen. Such a complementary shape may increase circumferential contact about the lumen without exerting an invasive force on tissue. Similarly, in various embodiments, framework members 52 retain at least partial flexibility when the expandable portion 20 is in the expanded state. For example, framework members 52 may be flexible inward toward the axis and/or outward of the axis. The elongate member 18 and/or expandable portion 20 may similarly be flexible away from the axis at various angles and directions. In some embodiments, an adaptable feature includes an electrode 21 wherein the length of the expandable portion 20 may be adjustable. For example, in some embodiments, an expandable portion 20 may be withdrawn or received within the sheath 40 such that only the portion of the expandable portion 20 that remains deployed is expanded when the expandable portion 20 is selectively transitioned to the expanded state.
According to various embodiments, electrodes 21 or expandable portions 20 thereof may be selectively transitioned between a contracted state and one or more expanded states.
In some embodiments, transitioning an expandable portion 20 from a contracted state to an expanded state may be driven by an expansion force. Expansion forces may be applied to one or more framework members 52 to effectuate an expansion. Expansion forces may comprise any known force, such as torque, compression, or tension, for example. In one embodiment, for instance, changes in internal pressure drive transitions using an injectable, such as a solid, liquid, or gas, injected into or released from a cavity defined within a framework 50. Increase in interior pressure may expand the framework 50 to an equilibrium pressure in one or more regions of the framework 50 or may drive further expansion by increasing tension about the cavity of the framework 50. Similarly, contraction forces may be applied to one or more framework members 52 to drive a contraction, such as a contraction between an expanded state and a less expanded state. Contraction forces may comprise any known force, such as torque, compression, and tension, for example, to decrease a dimension. For example, in one embodiment, changes in internal pressure drive transitions using an injectable, such as a solid, liquid, or gas, injected into or released from a cavity defined within a framework 50. Decrease in interior pressure, such as a release of an injectable, may contract the framework 50 to an equilibrium pressure in one or more regions of the framework 50 by relieving tension about the cavity or may drive further contraction by releasing additional injectable, thereby allowing external pressure to compress the framework 50 and occupy the cavity.
In various embodiments, electrical ablation devices 12 may employ compression, tension, and/or rotation to transition electrodes 21 or expandable portions 20 between contracted and expanded states. In some embodiments, compression of framework members 52 may decrease a length of the expandable portion 20 while, at the same time, increase a diameter of the expandable portion 20. For example, compressed framework members 52 may strain, bow, or bend outward of the axis to relieve compressive stress. Compression may also drive a repositioning of framework members 52 within the framework 50 to effectuate a transition that increases a diameter of an expandable portion 20 without decreasing a length of the expandable portion 20. For example, one or more framework members 52 or portions thereof may be urged outward of the axis or along the elongate member 18 resulting in repositioning of those or other framework members 52 and an increase in a dimension of the expandable portion 20. In some embodiments, tension of framework members 52 may increase a length of the expandable portion 20 while, at the same time, decreasing a diameter of the expandable portion 20. For example, otherwise bowed or outward extending framework members 52 may be tensioned to strain, stretch, or straighten inward toward the axis as to relieve tension stress. Tension may also drive repositioning of framework members 52 within the framework 50 to effectuate a transition that increases a diameter of the expandable portion 20 without decreasing a length of the expandable portion 20. For example, one or more framework members 52 or portions thereof may be pulled inward toward the axis or along the elongate member 18 resulting in repositioning of those or other framework members 52 and a decrease in a dimension of the expandable portion 20. In some embodiments, a rotation of a first coupler configured to couple manipulations effectuating relative movements between framework members 52 or portions thereof relative to a second coupler may increases or decreases a distance between framework members 52 or portions thereof. For example, a decrease in the distance may compress one or more intervening portions or other framework members 52 while an increase in the distance may tension one or more intervening portions or framework members 52.
In various embodiments, framework members 52 comprise memory materials. Memory materials may include reflexive and/or elastic materials configured to return to a memory orientation or arrangement following removal of a deformative stress. For example, in some embodiments, framework members 52 are configured to be deformed by a deformative stress above or below an elastic limit and return to a memory form upon removal of the deformative stress and/or subsequent manipulation, such as a change in temperature. In certain embodiments, memory materials include shape memory materials having one-way and/or two-way memory effect. Memory materials may also include materials that may be deformable and reformable by manipulation. For example, a first counter rotation between two portions of a coil may partially unwind the coil while a second counter rotation, opposite of the first, may rewind the coil. Materials having such properties are known in the art and include polymers such as memory foams, plastics, elastomers, and rubbers as well as metallics and alloys. It is to be appreciated that such materials include superelastics and shape memory materials, such as alloys (e.g., NiTi), ceramics, and polymers including gels, foams, and solids. Notably, when framework members 52 comprise memory materials that are poor conductors, conductive materials may be used to establish an electrical path for ablative energy to be transmitted and delivered to tissues. For example, conductive coatings, wires, sleeves, and/or tissue contact regions may be used to transmit and deliver energy to tissue. In some embodiments, elastic limits of framework members 52 may be increased due to arrangement and/or orientation of framework members 52. For example, framework members 52 may comprise configurations of coils or braids comprising increased elastic limits due to, for example, distributed strains.
In various embodiments, framework members 52 a memory form that may be manipulated or otherwise deformed or retained by a retaining force and upon removal of the retaining force, the material at least partially returns to the memory form. Framework members 52 having a memory form may be arranged within the expandable portion 20 in any suitable manner such that the framework members 52 will return to the memory form following removal of a retaining force or upon manipulation. For example, a framework 50 comprising a conductive coating and including framework members 52 comprising a foam polymer may be configured to expand in at least one dimension upon removal of a retaining force and contract in the at least one dimension upon application of the retaining force. In certain embodiments, the retaining force is provided by a channel (e.g., an artificial channel defined within an endoscope, trocar, or sheath) in which the expandable portion 20 is received. Other retaining structures may also be used to apply a retaining force. For example, hooks, latches, constrictable loops, or other retaining mechanisms may be employed in certain embodiments to retain framework members 52 and/or prevent framework members 52 from transitioning to one or more memory forms.
Framework members 52 may individually or collectively have one or more memory forms and/or retained forms. For example, framework members 52 may deform in response to a retaining force and return to a memory form when the retaining force is removed. Alternately, framework members 52 may comprise a first memory form and a second memory form wherein when one or more framework members 52 are in the first memory form the expandable portion 20 is in an expanded state and wherein when one or more of the framework members 52 are in the second memory form, the expandable portion 20 is in a contracted state. In certain embodiments, the memory form may correspond to the expanded state and thus comprises an increased diameter compared to the retained form or may correspond to the contacted state and thus comprises a decreased diameter compared to the retained form. Of course, in some embodiments, a retaining force may be combined with and or coupled to a second, third, or plurality of additionally forces to effectuate an active transition between contracted and expanded states.
Framework members 52 may be configured to deform or strain to reduce a diameter of the expandable portion 20 when framework members 52 are compressed toward the axis or are otherwise retained. In this way, an electrode 21 may be directed to a tissue treatment region within an artificial channel in a contracted state and be expandable upon deployment at or near the tissue treatment site and/or in response to removal of the retaining force. In one embodiment, a first framework member 52 comprising a bias, such as a spring, foam, or other memory material, is biased outward of the axis, such as radially. When the expandable portion 20 is pushed, pulled, or rotated within a channel having a diameter less than a diameter of the expandable portion 20 in the expanded state, the channel compresses the first framework member 52 toward the axis, retaining it in a retained form. However, when the expandable portion 20 is pushed, pulled, or rotated from the channel, the first framework member 52 is no longer retained by the channel and, therefore, transitions to the memory form upon deployment and extends outward of the axis. In a further embodiment, a second framework member 52 extends proximally toward the channel when the expandable portion 20 is deployed and in the expanded state. The second framework member 52 comprises a proximal lip and a distal compression surface coupled to the outward extending portion of the first framework member 52. When the expandable portion 20 is received within the channel, the proximal lip is progressively drawn into the channel, leveraging the distal compression surface toward the axis, compressing the first framework member 52, and decreasing a diameter of the expandable portion 20.
Still referring to
The expandable portion 20 in the expandable state illustrated in
The framework members 52 illustrated in
In some embodiments, framework members 52 are arranged as a regular or an irregular grouping of looped coils, braids, or folds occupying a portion of the expandable portion. In various embodiments, framework members 52 may comprise a material, orientation, and/or arrangement imparting the framework members 52 with a memory form when loads are within an associated elastic limit. For example, a framework member 52 may comprise a spring (e.g., a bow, compression, torsion, or tension spring) having an associated memory form and associated elastic limit. The spring may increase or decrease in a dimension in response to an application or removal of a load. When springs are coils or helixes wound about the axis, framework members 52 may be at least partially unwound when the expandable portion 20 is in the contracted state and framework members 52 may be rewound when the expandable portion 20 is in the expanded state. Framework members 52 comprising coils or helixes may also comprise a changed diameter upon application or removal of a load when, for example, a load longitudinally strains a spring. In this way, a clinician may, for example, increase a diameter of a framework member 52 by compressing a compression spring or releasing tension applied to a tension spring. Similarly, a clinician may, for example, decrease a diameter of a framework member 52 by releasing a compressive load applied to a compression spring or apply a tension to a tension spring. Thus, framework members 52 may undergo deformative strains, such as linear or torsion, in a retained form and transition to a memory form upon removal or reversal of a load or force.
In various embodiments, framework members 52 may be braided to form one or more baskets along a length of the expandable portion 20. In one embodiment, framework members 52 are braided into a general cylindrical or tube-like arrangement as illustrated in
In additional embodiments, framework members 52 may be arranged in one or more concentric coils (e.g., loops or wrappings) of framework members 52 arranged about the axis. An outer band of the coil may thereby be rotatable relative to an inner band of the coil such that the expandable portion 20 may be transited between contracted and expanded states by relative rotations between the bands. Such framework members 52 may further comprises an associated memory form and an associated retained form such that a relative rotation between bands comprises a retain force and transitions the expandable portion 20 from the expanded state to the contracted state and a release of the retaining force transitions the expandable portion 20 from the contracted state to the expanded state. In other embodiments, however, a relative rotation between bands may transition the expandable portion 20 from the contracted state to the expanded state and a release of a retaining force may transition the expandable portion 20 from the expanded state to the contracted state. It is to be appreciated that multiple coils comprising multiple bands rotatable relative to one another such that various diameters along the length of the expandable portion 20 may be used to adjustable diameters of the expandable portion 20 to meet various applications.
In various embodiments, electrical ablation devices 12 comprise movable portions. Movable portions may comprise framework couplers and/or movable elements including rings, blocks, or collars disposed about or along the elongate member 18. Movable portions may be slidable along a tract, rotatable about threads, or movable along a distance of the elongate member 18, for example. Elongate members 18 and/or expandable portions 20 may further comprise an adjustable distance such that a movable portion does not physically transition along an elongate member 18 but rather moves as a result of a decrease or increase in the relative distance between the movable portion and another movable portion or position along the elongate member 18 or with respect to the axis. For example, an elongate member 18 may comprise an adjustable distance wherein an adjustment in the distance results in a first movable portion moving relative to a second movable portion. In certain embodiments, the distance between movable portions may be adjusted by extending or retracting a folded or nested portion of the adjustable distance, for example. Extending or retracting may be accomplished by, for example, relative rotations, release of a bias, and/or application of counter or relative forces between two portions. In one embodiment, an electric ablation device 12 comprises a movable portion such as a block, ring, coupler, or other element comprising an abutment surface. The element may be configured to be movable along an elongate member 18 and abut a framework member 52. In some embodiments, movement of the element applies a compressive stress to framework members 52 or relieves a compressive strain. In various embodiments, pulleys or gears may also be employed to move movable portions. For example, movable portions may ride along a track defined along the elongate member 18. The track may include gears configured to move a movable portion or adjust a length of the elongate member 18 between movable portions, for example, by nesting a portion of the elongate member 18.
In various embodiments, framework members 52 may be movable with respect to the elongate member 18. One or more framework members 52 or portions thereof may be configured to slide along or pivot with respect to the elongate member 18. For example, a first portion of a framework member 52 may be fixed or pivotably fixed to the elongate member 18 at a first position and a second portion of the framework member 52 may be fixed or pivotably fixed to the elongate member 18 at a second position.
It is to be appreciated that the proximal and distal orientation is provided to assist in the understanding of the systems, devices, and methods disclosed herein. In certain embodiments orientations and/or arrangements may be reversed such that the goal of transitioning an expandable portion remains that same. For example, the distal coupler 56 may be rotatably movable upon threads, for instance, provided near the distal coupler 56. Such orientational variations do not deviate from this disclosure. Indeed, in one embodiment, the proximal coupler 54 and the distal coupler 56 are rotatable about threads provided about the surface of the elongate member 18. Similarly, in another embodiment, the distal coupler 56 is clickably movable along the elongate member 18. In further embodiments, a series of framework 50 arrangements and/or expandable portions 20 may be disposed along the distal portion of the elongate member 18. Such a series of framework 50 arrangements and/or expandable portions 20 may be configured for a desired application and provide customizable ablation zones within a biological lumen or treatment site.
In certain embodiments, framework members 52 may comprise a coil operatively coupled to the elongate member 18 at a first position. In such an embodiment, relative counter rotation between the first position and a second position at least partially unwinds the coil and corresponds to an increase in a diameter of the expandable portion 20. For example, when the framework member 52 is a right-handed coil or helix a clockwise rotation of a proximal position relative to a distal position transitions the expandable portion 20 between the contracted state and an expanded state while a counterclockwise rotation of the proximal position relative to the distal position transitions the expandable portion 20 from an expanded state to the contracted state. Similarly, when the framework member 52 is a left-handed coil or helix a clockwise rotation of the distal position relative to the proximal position transitions the expandable portion 20 from the contracted state to an expanded state while a counterclockwise rotation of the distal position relative to the proximal position transitions the expandable portion 20 from an expanded state to a more contracted state. In a similar embodiment, the longitudinal distance between the proximal and distal positions is also adjustable. For example, the proximal position may be slidable toward the distal position, thus, reducing the distance between the two. In one embodiment, one or both positions are threadably rotatable about the elongate member 18 such that rotation of the positions increases or decreases the distance between the proximal and distal positions. In other embodiments, one or both positions are clickably or slidably positionable along the elongate member 18. It is to be appreciated that a coil may be rotatable at multiple positions such that various diameters along the length of the expandable portion 20 may be adjustable to meet various applications.
As previously described, one or a multiple of methods may be employed to effectuate a relative movement between a first movable portion comprising a proximal portion of framework members 50, such as a proximal coupler, and a second movable portion comprising a distal portion of framework members 52, such as a distal coupler. For example, in some embodiments, a clinician may engage an interface to signal actuation or a relative movement between the first and second portions. Actuation signals may trigger transitions effectuated by mechanical and/or electrical elements. In certain embodiments, an actuator comprises a manipulator configured to manually extend or retract portions of framework members 52 and/or portions of the elongate member 18. A signal may result in a rotation of a coupler about a threaded track, as in
In the embodiment illustrated in
In some embodiments, a sheath 40 is not provided and an electrode 21 may be delivered to a target region within another delivery device. In some such embodiments, the electrode 21 may be delivered to the target region naked, that is, not within an artificial channel. In these and other embodiments, the electrode 21 may be delivered to a target region by advancing the elongate member 18 through a biological orifice or lumen. Once delivered to the target region, the electrode 21 may be expanded in response to an actuation signal. The electrical ablation device 12 illustrated in
In various embodiments, the elongate member 18 may be flexible along all or a portion of its length. Such flexible portions may be bendable, deformable, or elastic, for example. Flexible portions may also be conditionally flexible or conditionally rigid. In some embodiments, the elongate member 18 comprises flexible portions which may be mechanically bendable such that portions of the elongate member 18 are pivotable in response to a signal or otherwise manipulable. In one embodiment, the elongate member 18 comprises a maneuverable portion configured to maneuver within a biological lumen such as vascular, duct, cavity, orifice, or tract area, for example, and deliver an electrode 21, to a target site. In one embodiment, a cardiac catheter platform comprises one or more electrodes 21 disposed along the distal portion of a flexible and/or maneuverable elongate member 18 configured to deliver the one or more electrodes 21 into chamber, vessel, or a surface of the heart to endocardially ablate spots for treatment for atrial fibrillation, for example. The one or more electrodes 21 may be selectively expandable between contracted and expanded states. In some embodiments, multiple electrodes 21 are disposed along the distal portion of the elongate member 18 and spaced to deliver energy to cardiac tissue within a tightly controlled electric field. In some such embodiments, the distance between electrodes 21 along the distal portion of the elongate member 18 may be adjustable to conform to a particular procedure.
Referring to
In various embodiments, electrical ablation devices 12 include accessory features such as optics, applicators, and sensors. For example, transducers or sensors may be located in the handle 14, or tip 28, or other suitable location to sense, for example, the force required to expand an electrode 21. This feedback information may be useful to determine whether electrodes 21 have been properly positioned within a biological lumen at or near a tissue treatment site. Manual actuation of an expandable portion 20 may similarly provide feedback to a clinician regarding the force required to fully expand the expandable portion 20. In this way, the clinician may decide that full expansion of the expandable portion 20 is either unnecessary or may otherwise result in unnecessary trauma and adjust the degree of expansion accordingly. In certain embodiments, feedback is provided to the clinician to physically sense when an electrode 21 is placed at or near a tissue treatment site. In some embodiments, feedback information provided by the transducers or sensors may be processed and displayed by circuits located either internally or externally to the energy source 11. Sensor readings may be employed, for example, to determine whether an electrode 21 has been properly located at or near a tissue treatment site thereby assuring a suitable margin of error has been achieved in locating the electrode 21. Sensor readings may also be employed, for example, to determine whether pulse parameters need to be adjusted to achieve a desired result, such as, for example, reducing the intensity of muscular contractions in the patient.
In one embodiment, an electrical ablation device 12 includes an accessory feature comprising an electrolyte applicator. An electrolyte applicator may be configured to apply or deliver an exogenous electrolyte at or near a tissue treatment site. An electrolyte applicator may include a delivery portion and a reservoir portion. In some instances, the delivery portion may comprise the reservoir portion. The reservoir portion may be configured to contain electrolyte for delivery. The delivery portion may be configured to deliver electrolyte at or near the tissue treatment site. In some embodiments, the delivery portion comprises a channel adjacent to or within the elongate member 18 or sheath 40. In one embodiment, the delivery portion comprises the tip 28. A clinician may actuate an actuator located on the handle 14, for example, to deliver electrolyte from the delivery portion. In certain embodiments, the delivery portion may be deployable independent of the electrode 21 from a lumen or artificial channel. In some embodiments, the delivery portion, reservoir portion, or the electrolyte applicator may be separate from the electrical ablation system 10. In various embodiments, the delivery portion of an electrolyte applicator may apply an aqueous electrolyte solution to the treatment area prior to or during a treatment to increase conductivity. In other embodiments, however, no solution may be added or a separate or same accessory feature may be configured to apply suction to a treatment area to, for example, remove fluids prior to or during a treatment.
In certain embodiments, at least one of a temperature sensor and pressure sensor may be located in or proximate the electrical ablation system 10. The temperature sensor and/or pressure sensor may be located within the handle 14, protective sleeve 38, sheath 40, elongate member 18, at the distal end of the elongate member 18, such as the tip 28, or within one or more electrodes 21. In certain embodiments, the temperature sensor and/or pressure sensor may be separate from the electrical ablation system 10. The temperature sensor and pressure sensor may provide feedback to the operator, surgeon, or clinician to apply an electric field pulse to the undesirable tissue. The pressure and/or temperature information may be useful to determine whether the undesirable tissue may be treated having reduced or no detrimental thermal effects to surrounding healthy tissue. According to certain embodiments, the temperature sensor may measure the temperature of the tissue treatment region, undesirable tissue, or the area surrounding one or more electrodes before, during, and/or after treatment such as before and/or after the first and/or second sequences of electrical pulses are delivered to the tissue. According to certain embodiments, the pressure sensor may measure the pressure of the tissue treatment region, the space between the electrodes, and/or the area surrounding one or more electrodes before, during, and/or after treatment, such as before and/or after the first and/or second sequences of electrical pulses are delivered to the tissue.
The electrical ablation system 10 may be employed to ablate undesirable tissue in delicate zones or near critical structures and be deployed through a biological lumen, such as vascular, ducts, or tract areas. The electrical ablation system 10 may be configured to treat a number of lesions and osteopathologies comprising metastatic lesions, tumors, fractures, infected sites, and inflamed sites in a tissue treatment region using electrical energy. The electrical ablation devices 12 may be configured to be positioned within a patient's natural body orifice, e.g., the mouth, anus, and vagina, and/or advanced through internal body lumen or cavities, e.g., the esophagus, stomach, intestines, colon, cervix, and urethra, to reach the tissue treatment region. For example, an elongate member 18 may be configured to be positioned and passed through a small incision or keyhole formed through the patient's skin or abdominal wall using a trocar to reach the tissue treatment region. The tissue treatment region may be located in the patient's brain, lung, breast, liver, gall bladder, pancreas, prostate gland, various internal body lumen defined by the esophagus, stomach, intestine, colon, arteries, veins, anus, vagina, cervix, fallopian tubes, and the peritoneal cavity. The electrical ablation system 10 may be used in conjunction with endoscopic, laparoscopic, thoracoscopic, open surgical procedures via small incisions or keyholes, percutaneous techniques, transcutaneous techniques, and/or external non-invasive techniques, and any combinations thereof.
In one embodiment, the electrical ablation device 12 may be employed in conjunction with an artificial channel (e.g., a flexible endoscope, as well as a rigid endoscope, laparoscope, or thoracoscope, such as the GIF-100 model available from Olympus Corporation). In one embodiment, the endoscope may be introduced to the tissue treatment region trans-anally through the colon, trans-orally through the esophagus and stomach, trans-vaginally through the cervix, transcutaneously, or via an external incision or keyhole formed in the abdomen in conjunction with a trocar. The electrode 21 may thereby be delivered to a tissue treatment region via insertion and guided into or proximate the tissue treatment region using the endoscope. Such delivery may also be accomplished using other various artificial channels. The endoscope or other artificial channel may define one or more channels for receiving additional devices such as a light source and a viewing port. Images within the field of view of the viewing port may be received by an optical device, such as, for example, a camera comprising a charge coupled device (CCD) usually located within the endoscope, and transmitted to a display monitor (not shown) outside the patient. In other embodiments, the endoscope is not utilized, and the electrical ablation device 12 comprises a light source and/or a viewing port, for example. Still additional embodiments employ other techniques to determine proper instrument placement, such as, for example, ultrasound or a computerized tomography (CT) scan.
According to one embodiment, methods of electrically ablating tissue include delivering a first electrode 21 to a tissue treatment region. The first electrode 21 may be configured to couple to the energy source and to a tissue treatment region located within or near a lumen. In one embodiment the first electrode 21 is delivered or directed into a lumen at or near a tissue treatment region through a hollow bore, such as an artificial channel. The first electrode 21 may then be deployed at or near a tissue treatment site. Once deployed, an expandable portion 20 of the first electrode 21 may be expanded in at least one dimension (e.g., diameter or length) and then contacted with the lumen wall. A second electrode 22 may be coupled to the first electrode 21 and the patient such that the second electrode 22 is in conductive communication with the first electrode 21 through the patient and represents a difference in electric potential with respect to the first electrode 21. For example, in some embodiments, the second electrode 22 may be a ground or return pad, a needle electrode, or medical clamp in contact or conductive communication with the patient. In various embodiments, the second electrode 22 may be a separately placed electrode, such as a conductive material, return pad, needle, or clamp, for example, may be located at a near by or adjacent tissue, surface, or lumen. Once delivered to a tissue treatment region, the first electrode 21 may be actuated (e.g., deployed, expanded, and energized) to ablate the undesirable tissue.
In some embodiments, expanding an expandable portion 20 of a first electrode 21 comprises transitioning the expandable portion 20 from a contracted state to an expanded state. Transitioning an electrode 21 from a contracted state to an expanded state may comprise increasing at least one dimension of the electrode 21. In certain embodiments, when the expandable portion 20 transitions from the contracted state to the expanded state, a diameter of the expandable portion 20 proportionally decreases in length. In other embodiments, however, the diameter of the expandable portion 20 does not expand proportionally to a decrease in length.
In some embodiments, the first electrode 21 may be alternately or selectively transitionable between a contracted state and an expanded state. In certain embodiments, a transition from a contracted state to an expanded state comprises a relative movement between two portions of a framework or framework members 52. The relative movement may be rotational or longitudinal. For example, a decrease in the distance between two portions of a framework 50 or framework members 52 may transition an expandable portion 20 from a contracted state to an expanded state. Relative movement may result in one or more framework members 52 extending outward of the axis. Outward extension may be the result of bowing of one or more framework members 52. Framework members 52 extending outward of the axis may similarly prop-up, extend, or otherwise reposition other framework members 52 outward of the axis. Various memory materials and orientations of framework members 52 may be employed to assist in transitioning an expandable portion 20 between contracted and expanded states. For example, framework members 52 may be arranged as springs, coils, braids, multi-member baskets, umbrellas, and injectable cavities and may comprise rigid, jointed, or memory materials, including shape set memory superelastics. For example, framework members 52 may comprise metallics, alloys, rubbers, plastics, polymers, and various conductive materials.
In various embodiments, expanding an electrode comprises expanding a diameter or radius or of the expandable portion many times that of the electrode in a contracted state. Depending on the desired application, electrodes may expand 2, 5, 10, 20, 40 or more times in diameter or radius to expand to a diameter conforming to a diameter of a tissue treatment region comprising a biological lumen, such as, for example, a larynx. In various embodiments, the diameter of the first electrode may by different from the diameter of the second electrode. Similarly, in some embodiments, the first electrode may have a different length than the second electrode. Again, depending on the desired application, such variations are contemplated and are considered within this disclosure. As is to be appreciated, when multiple electrodes are disposed along the distal portion of an elongate member, various spacing between the electrodes may also be desirable. In some such embodiments, the distance from the first electrode to the second electrode may be adjusted from 0.5 cm to 3 cm, such as, for example, 1 cm, 1.5 cm, 2.0 cm, and 3 cm. However, in other applications it may be desirable to greatly increase the distance between first and second electrodes to, for example, customize the size of the electric field to a particular application.
Electrodes 21 may be introduced, delivered, deployed, or expanded according to any of the above methods and then contacted with a lumen wall. Contact with a lumen wall is preferably at least partially circumferential. Electrical current may then be applied in various pulse power outputs, such as monophasic square waves, biphasic square waves, RF modulated high voltage, or nanosecond duration pulses, for example. The applied current and waveform can be customized for the desired application and clinical goal to provide various tissue effects such as cell lysis, apoptosis, or irreversible electroporation.
Although the various embodiments of the devices have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors such as tips, electrodes, and elongate members may be employed. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
| Number | Name | Date | Kind |
|---|---|---|---|
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| Number | Date | Country | |
|---|---|---|---|
| 20140039491 A1 | Feb 2014 | US |
