Surgical instrument for pulsed field ablation
Surgical instruments employing PFA technology with strategically arranged electrodes and endocardial reference electrodes address the limitations of traditional ablation methods by enabling safe and effective ablation through thick myocardial tissues, minimizing thermal damage and achieving deeper lesions.
Patent Information
- Application Number
- PCT/US2024/057433
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-11-28
- Filing Date
- 2024-11-26
- Publication Date
- 2025-06-05
AI Technical Summary
Current surgical ablation techniques, such as those using radiofrequency or cryogenic energy, are ineffective and risky for ablating through thick tissue regions like the left atrial isthmus, due to the risk of thermal damage to cardiac structures.
The development of surgical instruments capable of delivering pulsed field ablation (PFA) therapy, utilizing a surgical clamp or pen with strategically arranged PFA electrodes and a reference electrode for endocardial access, allowing for the creation of transmural lesions in thick tissues like myocardium without causing collateral thermal damage.
PFA technology enables safe and effective ablation through thick tissue regions, minimizing risk to cardiac structures and achieving deeper lesions compared to traditional methods, while also allowing for precise control of energy delivery.
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Figure US2024057433_05062025_PF_FP_ABST
Abstract
Description
SURGICAL INSTRUMENT FOR PULSED FIELD ABLATIONFIELD
[0001] This application relates generally to surgical instruments and pulsed field ablation.BACKGROUND
[0002] Pulsed field ablation (PF A) involves application of pulsed electric fields, which may reversibly or irreversibly destabilize cell membranes through electro-permeabilization, but generally do not affect the structural integrity of tissue components. The nature of PFA allows for very brief periods of therapeutic energy delivery, e.g., milliseconds to microseconds in duration. In many cases, PFA does not cause collateral damage to non-targeted tissue as frequently or severely as thermal ablation.SUMMARY
[0003] Disclosed herein are, among other things, various examples, aspects, features, and embodiments of surgical instruments used with epicardial access to the heart and capable of delivering PFA treatment thereto. One example provides a surgical clamp having a plurality of PFA electrodes suitably distributed over the jaws of the clamp. Another example uses both endocardial and epicardial access to place PFA electrodes in a suitable position to create transmural lesions in a relatively thick target tissue, such as the myocardium. For example, a surgical ablation pen having an array of PFA electrodes along a distal portion thereof is employed for epicardial access, and a catheter including at least one reference electrode is employed for endocardial access. By properly selecting a spatial arrangement of the PFA electrodes and / or an electrode vectoring scheme for the disclosed surgical instruments, a variety of pulsed electric field configurations unattainable with only endocardial access can beneficially be produced.
[0004] According to one example, a surgical ablation device includes: a rod having a lumen between first and second ends thereof; a handle attached to the first end of the rod, the handle including a body and a trigger movable with respect to the body; and a clamping device attached to the second end of the rod and including a first jaw and a second jaw movable with respect tothe first jaw. The clamping device includes a plurality of electrodes, each of the electrodes being individually electrically connected via electrical wiring disposed along the lumen to an electrical cable connected to the handle. The trigger is mechanically coupled through the lumen to the clamping device and configured to cause movement of the second jaw with respect to the first jaw in response to movement of the trigger with respect to the body.
[0005] According to another example, a medical system includes a surgical ablation device including an array of electrodes configured to be placed on an epicardial side of a heart and a catheter including one or more reference electrodes configured to be placed on an endocardial side of the heart. The medical system also includes a signal generator configured to apply voltage pulses between the reference electrode(s) and a selectable set of the electrodes of the array to produce pulsed electric fields in a tissue of the heart between the reference electrode(s) and the selectable set of the electrodes of the array.BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a block diagram illustrating a medical system according to some examples.
[0007] FIG. 2 is a diagram illustrating a surgical ablation clamp that can be used in the medical system of FIG. 1 according to one example.
[0008] FIG. 3 is a block diagram illustrating an electrode array implemented in the surgical ablation clamp of FIG. 2 according to some examples.
[0009] FIGS. 4-6 illustrate vectoring configurations of the electrode array of FIG. 3 according to some examples.
[0010] FIGS. 7-14 are block diagrams illustrating electrode arrays implemented in the surgical ablation clamp of FIG. 2 according to various additional examples.
[0011] FIG. 15 is a block diagram illustrating a transverse cross-sectional view of the surgical ablation clamp according to yet another example.
[0012] FIG. 16 is a diagram illustrating a surgical ablation pen that can be used in the medical system of FIG. 1 according to another example.
[0013] FIGS. 17-19 are block diagrams illustrating reference electrode configurations with which the surgical ablation pen of FIG. 16 can be used according to some examples.
[0014] FIG. 20 is a flowchart illustrating a method of delivering PFA treatment to a patient according to some examples.DETAILED DESCRIPTION
[0015] The PFA technology provides a capability for ablating through thicker tissue, e.g., in myocardium, with the use of vectoring. Vectoring involves strategically selecting PFA electrodes and their polarization, e.g., for creating deep lesions or targeting thicker tissue containing cardiac veins and / or cardiac arteries. For example, the left atrial isthmus, from the left inferior pulmonary vein down to the mitral valve annulus, is a lesion required for a Cox- Maze lesion set. The left isthmus region is relatively thick and contains a coronary vein and a coronary artery. The use of radiofrequency (RF) or cryogenic energy is not typically effective for ablating through this region and involves a relatively high risk of thermal damage to the cardiac vein or artery and / or to the mitral valve annulus. In contrast, the use of PFA can be safe in this region and, along with vectoring, can be sufficiently effective in ablating through this thick area of tissue.
[0016] In various examples, the use of a PFA reference electrode can be vectored from the endocardial side to the epicardial side. In some examples, the PFA reference electrode is placed on the endocardial side via an electrophysiology (EP) type catheter in the femoral vein or surgical ablation pen via a purse-string method. This reference electrode is lined up with the PFA electrode(s) positioned on the corresponding epicardial side and is used to deliver PFA vectoring polarization from one side to the other. The energy delivered in this manner ablates the corresponding region and produces irreversible electroporation.
[0017] In various examples, PFA is applicable in both surgical and catheter ablation. Surgical ablation can be performed, e.g., in an open chest, or with the use of minimally invasive techniques. Vectoring of the electrode polarity in surgical ablation has certain advantages in terms of obtaining greater lesion depths and widening or narrowing the area for electrical field transfer. Accordingly, various embodiments disclosed herein are directed at providing surgicalinstruments having a PFA capability. In some examples, a surgical instrument incorporates a plurality of PFA electrodes, e.g., in the form of a metallic, nine-electrode array. In various examples, the PFA electrodes comprise gold, tantalum, platinum, and / or iridium. In addition to delivering PFA energy during cardiac surgery, the PFA electrodes can also be used, e.g., for applying pacing signals and / or sensing live EGM signals on a beating heart.
[0018] FIG. 1 is a block diagram illustrating a medical system 100 according to some examples. The medical system 100 is configured to be used with one or more ablation devices 110, such as catheters and surgical instruments having PFA capabilities. In the example shown, the medical system 100 includes one ablation device 110. In other examples, the medical system 100 may include two or more ablation devices 110. The medical system 100 also includes a medical apparatus 120, an optional pacing device 130, and an optional tracking and navigation system 140.
[0019] The medical apparatus 120 includes a signal generator 122, an electronic controller 123, and an optional cardiac stimulator 128. The electronic controller 123 includes a processor 124 and a memory 126. In the example shown, the medical apparatus 120 is coupled to the ablation device 110, the pacing device 130, and the tracking and navigation system 140 as indicated in FIG. 1.
[0020] The signal generator 122 is configured to generate electrical waveforms suitable for ablating a target tissue, such as, for example, the left isthmus region of the heart. The signal generator 122 is appropriately electrically connected to the ablation device 110 for delivery of energy to the target tissue. The processor 124 is connected to the memory 126 to read data therefrom and to write data thereto. The processor 124 is also configured to receive digital signals originating from the cardiac stimulator 128 and / or the pacing device 130. In various examples, the processor 124 performs algorithmic processing of pertinent data to determine one or more parameters for the waveforms to be generated by the signal generator 122. The memory 126 stores instructions that, when executed by the processor 124, cause the signal generator 122 to execute various modules, processes, and functions, such as PFA waveform generation operations in accordance with the determined parameters, cardiac pacing synchronization, and electrode tracking and visualization.
[0021] In some examples, the ablation device 110 is a surgical instrument configured to receive electrical waveforms from the signal generator 122 and deliver the corresponding energy to the target tissue. Various examples of surgical ablation instruments implementing the ablation device 110 are described in more detail below in reference to FIGS. 2-19. During a medical procedure, the ablation device 110 is manipulated and positioned such that one or more electrodes 112 thereof are near the target tissue. The electronic controller 123 then configures and operates the signal generator 122 to apply selected waveforms to the one or more electrodes 112 which deliver the corresponding energy to the target tissue. In one example, different ones of the electrodes 112 are independently connectable to an external signal generator, with each electrode 112 including a respective insulated electrical lead designed to sustain a voltage of greater than about 500 V without a dielectric breakdown in the insulation. In some examples, the electrical insulation on each of the electrical leads is selected such that an electrical potential difference of about 4 kV across its thickness does not cause a dielectric breakdown therein. In some examples, the electronic controller 123 runs a suitable algorithm to automatically make decisions on vectoring and waveforms given a specific tissue thickness and then operates the signal generator 122 accordingly.
[0022] When present, the pacing device 130 is suitably coupled to a patient (not explicitly shown in FIG. 1) and configured to receive a heart pacing signal from the cardiac stimulator 128 for patient’s cardiac stimulation. In some examples, an indication for the pacing signal is transmitted by the cardiac stimulator 128 to the electronic controller 123. Based on the indication, the processor 124 and the memory 126 are operated by the electronic controller 123 to select, compute, or otherwise identify a pacing pulse waveform. The electronic controller 123 then configures the signal generator 122 to generate that pacing pulse waveform and apply it, via the cardiac stimulator 128, to the pacing device 130 in proper synchronization with the cardiac cycle.
[0023] When present, the tracking and navigation system 140 is typically used for guiding a medical procedure. In the example shown, the tracking and navigation system 140 is coupled to the medical apparatus 120. In some other examples, the tracking and navigation system 140 is integrated into the medical apparatus 120. The tracking and navigation system 140 is designed to help visualize the real-time position and orientation of catheters, ablation devices, and / orauxiliary devices within the patient’s body, e.g., to increase the accuracy of targeted ablation and reacquisition of pacing sites for re-ablation. In various implementations, the tracking and navigation system 140 enables one or both of impedance-based tracking and electromagnetic tracking.
[0024] In one example, the tracking and navigation system 140 operates to determine the position of an electromagnetic (EM) sensor referenced to the tracked device using three or more magnetic sources of a magnetic-field generator 142 as references. The magnetic sources of the magnetic field generator 142 are positioned such that a volume of magnetic fields 144 generated thereby envelopes the tracked portion of the ablation device 110, catheter, or auxiliary device having the corresponding EM sensor. The magnetic fields in that volume are calibrated and can be controlled with the electronic controller 123. Based on the response of the EM sensor to such magnetic fields, position of the tracked portion is accurately determined and tracked in real time. With the tracked location information, a visual representation of the ablation device 100, catheter, or auxiliary device is displayed on an anatomical map, e.g., to provide spatial and anatomic context for visualizing the electrode locations. Such visual representations can be generated, e.g., using the processor 124 or another processing device coupled to or integrated into the medical apparatus 120 or the tracking and navigation system 140.
[0025] In some examples, the ablation device 110 includes an actuation mechanism 116, e.g., a knob, a lever, a handle, or other suitable mechanism for moving, deflecting, steering, reconfiguring, and otherwise manipulating the ablation device 110 or relevant portions thereof within the patient’s anatomy. The actuation mechanism 116 can be controlled by an operator based on a location of the distal portion of the ablation device 110 and the overall objective of the medical procedure. In some examples, the operator controls the actuation mechanism 116 with the aid of the above-mentioned visual representations generated with the tracking and navigation system 140, e.g., based in part on the signals received from one or more sensors 114 of the ablation device 110.
[0026] FIG. 2 is a diagram illustrating a surgical ablation clamp 200 that can be used in the medical system 100 according to one example. The clamp 200 is an example of the ablation device 110 shown in FIG. 1. As such, the clamp 200 has a plurality (illustratively nine) ofelectrodes 112, which are labeled 112i- 1129. In other examples, a different (from nine) number of electrodes can also be used. Each of the electrodes 1121-1129 has a respective individual electrical wire connected thereto to make each of the electrodes individually operable. The individual electrical wires are connected to respective electrical conductors of an electrical cable 240, which runs through a lumen of a cylindrical rod (e.g., a hollow tube) 220 and a clamp handle 230 to a multi-pin connector 250. The multi-pin connector 250 includes nine pins 260i- 26O9 that can be plugged into the corresponding electrical ports of the medical apparatus 120, thereby providing dedicated electrical connections to the electrodes 1121-1129, respectively, and enabling the electrodes to receive individual signal waveforms from the signal generator 122. In various additional embodiments, the clamp 200 may have more or fewer than nine electrodes 112. In such embodiments, the electrical cable 240 and the multi-pin connector 250 are designed accordingly to support an intended number of electrical connections to the electrodes 112.
[0027] A clamping device 210 of the clamp 200 has first and second jaws, which are labeled 202 and 204, respectively. In the example shown, the electrodes 1121-1129 are all located on the same jaw, illustratively, the first jaw 202. In other examples, the clamping device 210 may have other suitable distributions of the electrodes 112 over the first and second jaws 202, 204, e g., as further illustrated in FIGS. 3-14. In one example, the electrodes 112i- 1129 can all be located on the second jaw 204. The jaws 202, 204 are typically covered with a biocompatible material (e.g., a polymer) to enable safe contact of the clamping device 210 with the target tissue.
[0028] The clamp handle 230 has a curved shape and is designed to provide a comfortable and functional grip to the operator. The electrical cable 240 is inserted into a proximal end 232 of the handle 230. The cylindrical rod 220 is attached to a distal end 228 of the handle 230. In some examples, the rod 220 is flexible and is referred to as the “malleable neck.” The handle 230 also has a trigger 234 and a release button (or lever) 236. For example, when the clamping device 210 is clamped onto tissue, the lever 236 locks the jaws (with an audible click). Then, sliding the lever 236 backwards unlocks the jaws 202, 204. In the example shown, the first jaw 202 is fixed with respect to the rod 220, and the second jaw 204 is movable with respect to the first jaw 202. The second jaw 204 can be adjusted using the trigger 234 and the release button 236. In some examples, the trigger 234 is configured to actuate a ratcheting mechanism located inside the handle 230 and mechanically coupled to the second jaw 204 via a suitable lumen ofthe cylindrical rod 220. Each time the trigger 234 is pressed towards the handle 230, e.g., as indicated by an arrow 235, the ratcheting mechanism is actuated to move the second jaw 204 closer to the first jaw 202. By pressing the trigger 234 one or more times, the operator can incrementally move the second jaw 204 by a small distance each time toward the first jaw 202, eventually gripping the target tissue or organ with an appropriate degree of tightness for the intended medical procedure. The ratcheting mechanism enables the operator to tighten the jaws 202, 204 precisely as needed, with little effort. The release button 236 allows the operator to loosen the grip of the clamping device 210 rapidly by resetting the ratcheting mechanism when pressed. In some examples, one or both of the first and second jaws 202, 204 are malleable and can be shaped as needed. In some examples, one or both of the first and second jaws 202, 204 have a fixed shape.
[0029] In some examples, the clamp 200 includes an optional fluid-delivery device 270 for delivering fluid to the jaws 202, 204 of the clamping device 210. The fluid-delivery device 270 can be used, e.g., with an embodiment of the jaws 202, 204 illustrated in FIG. 15. The fluiddelivery device 270 includes a fluid delivery conduit 272 in fluid communication with the jaws 202, 204. In one example, the fluid delivery conduit 272 includes flexible plastic tubing disposed within the clamp handle 230 and further within a lumen of the cylindrical rod 220 and configured to deliver fluids to one or more electrodes 112. In some examples, the fluid delivery conduit 272 enters the clamp handle 230 at the proximal end 232. In the example shown, a fluid injection port 274 located at the end of the fluid delivery conduit 272 is connected to a syringe 276 having a plunger 278. In one example, the barrel of the syringe 278 is filled with a fluid, which can be transferred to or withdrawn from the volume(s) adjacent to the electrodes 112, via the fluid delivery conduit 272, by appropriately moving the plunger 278. In some examples, instead of being connected to the syringe 276, the fluid injection port 274 is connected to a different (e.g., motorized and electronically controllable) fluid injector. In such examples, the electronic controller 123 may control the motorized fluid injector via a suitable control algorithm. The algorithm may be configured, for example, to set the flow rate depending on certain attributes of the PFA procedure. In various examples, the fluid delivered via the fluid delivery conduit 272 is selected from the group consisting of saline, an electrolyte solution, asolution including one or more therapeutic agents (such as genes, RNA, drugs, etc.), and a physiological solution.
[0030] FIG. 3 is a block diagram illustrating an electrode array 300 implemented in the clamping device 210 according to one example. In the example shown, the electrode array 300 has fourteen electrodes 112, which are labeled 112i- 11214. All of the electrodes 112i- 112u have the same size. The electrodes 1121-112? are equidistantly distributed along the first jaw 202 of the clamping device 210. That is the distance between any two adjacent electrodes 112 along the edge of the first jaw 202 is the same. The electrodes 1128-11214 are similarly equidistantly distributed along the second jaw 204 of the clamping device 210. The relative position of the electrodes 112 is such that the electrodes 112; and 112;+? are aligned to be next to each other when the gap separating the jaws 202, 204 is closed. For example, the electrodes 112? and 11214 are located at a same first distance from a pivot axis 302 of the second jaw 204. The electrodes 112e and 112B are located at a same second distance from the pivot axis 302, with the second distance being greater than the first distance. The electrodes 112s and 112n are located at a same third distance from the pivot axis 302, with the third distance being greater than the second distance, and so on. With various vectoring configurations, some of which are described in more detail below, electrode array 300 can beneficially be used for ablating thicker tissues in a manner that does not leave “gaps” in the ablation line. Such gaps are typically detrimental as they might lead to reoccurrence of arrythmia or, in some cases, establishment of a different pathway for another arrythmia after the PFA procedure. In general, several vectoring schemes described herein below, e.g., in reference to FIGS. 3-15 and 17-19, are variously illustrated using the depiction of electrical -field lines and / or electrical-current paths. A person of ordinary skill in the pertinent art will readily recognize from the layout of the corresponding figure whether electrical-field lines or electrical-current paths (or both) are depicted therein.
[0031] FIGS. 4-5 illustrate vectoring configurations of the electrode array 300 according to some examples. The relative polarity of the potentials applied to electrode pairs are indicated by the plus (+) and minus (-) signs. In some examples, different electrode pairs are pulsed at different times by appropriately routing different pulses of a sequence of pulses generated by the signal generator 122 to different respective electrode pairs.
[0032] In the configuration of FIG. 4, PFA pulses are applied to adjacent electrodes located on the same jaw. For example, a first PFA pulse is applied between the electrodes 112i and 1122. A second PFA pulse is applied between the electrodes 112 and 112s, and so on until all pairs of adjacent electrodes on the first jaw 202 have been pulsed. A next PFA pulse is then applied between electrodes 112g and 1129. A subsequent PFA pulse is applied between the electrodes 1129 and 112io, and so on until all pairs of adjacent electrodes on the second jaw 204 have been pulsed.
[0033] In the configuration of FIG. 5, PFA pulses are applied to electrodes of the same jaw separated by two other electrodes. For example, a first PFA pulse is applied between the electrodes 112i and 1124. A second PFA pulse is applied between the electrodes 112 and 112s, and so on until electrodes on the first jaw 202 have been pulsed. A next PFA pulse is then applied between the electrodes 112g and 112n. A subsequent PFA pulse is applied between the electrodes 112g and 112B, and so on until electrodes on the second jaw 204 have been pulsed.
[0034] FIG. 6 illustrates yet another vectoring configuration of the electrode array 300 according to an additional example. In the example shown, the corresponding clamping device 210 is clamped on a myocardial tissue 602 to deliver PFA. PFA pulses are applied to electrodes 112b112j located on different jaws 202, 204 of the clamping device 210, thereby creating a wider energy field than that of the vectoring configurations illustrated in FIGS. 4-5. For example, a first PFA pulse is applied between the electrode 112s located on the second jaw 204 and one or more of the electrodes 112i, 1123. 112s, and 112? located on the first jaw 202. A second PFA pulse is applied between the electrode 112g located on the second jaw 204 and one or more of the electrodes 112 , 1124, and 1126 located on the first jaw 202, and so on.
[0035] A person of ordinary skill in the pertinent art will readily understand that additional vectoring configurations of the electrode array 300 can similarly be produced by sequentially applying PFA pulses to different subsets of the electrodes 112. In various examples, such subsets of the electrodes 112 may be selected based on the overall objective of the corresponding medical procedure and on an estimated progress towards that objective.
[0036] FIGS. 7-14 are block diagrams illustrating electrode arrays implemented in the clamping device 210 according to various additional examples. The illustrated electrode arrays differ fromone another in one or more of: (i) a total number of electrodes 112 in the corresponding clamping device 210; (ii) numbers of electrodes 112 in the first jaw 202 and / or in the second jaw 204; (iii) inter-electrode distances; and (iv) relative alignment of the sets of electrodes 112 located in the first and second jaws 202, 204. Also shown in each of FIGS. 7-14 are example vectoring configurations that can be produced with the shown electrode arrays. Comparison of the shown vectoring configurations reveals that different clamping devices 210 having different respective electrode arrays can be used to achieve different PFA patterns in the target tissues, depending on the medical indications.
[0037] FIG. 7 is a block diagram illustrating an electrode array 700 implemented in the clamping device 210 according to one example. The electrode array 700 includes nine electrodes 112, which are labeled 1121-1129. The firstjaw 202 has the electrodes 1126-1129. The secondjaw 204 has the electrodes 1121-1125. The electrodes 112 are equidistant in each of the jaws 202, 204, with the inter-electrode distance being di. In one embodiment, the inter-electrode distance di is 1.5 cm. The relative alignment of the corresponding sets of electrodes 112 in the jaws 202, 204 is such that each of the electrodes 112e- 1129 in the first jaw 202 is aligned with a middle portion of the corresponding inter-electrode segment in the secondjaw 204. The electrodes 112i and 112e are the closest electrodes to the pivot axis 302 (not explicitly shown in FIG. 7; e.g., see FIG. 3). The electrodes 112s and 112g are the most distant electrodes from the pivot axis 302, with the electrode 112s being located at the distal end of the secondjaw 204. The vectoring configuration shown in FIG. 7 is produced by applying PFA pulses to adjacent electrodes 112 of the same jaw.
[0038] FIG. 8 is a block diagram illustrating an electrode array 800 implemented in the clamping device 210 according to another example. The electrode array 900 includes nine electrodes 112, which are labeled 1121-1129. The first jaw 202 has the electrodes 1126-1129. The secondjaw 204 has the electrodes 1121-1125. The electrodes 112 are equidistant in each of the jaws 202, 204. The relative alignment of the corresponding sets of electrodes 112 in the jaws 202, 204 is such that each of the electrodes 1126-1129 in the first jaw 202 is aligned to be next and parallel to the corresponding one of the electrodes 1121-1124 in the secondjaw 204 when the gap between the jaws 202, 204 is closed. The vectoring configuration shown in FIG. 8 is produced by applying PFA pulses to adjacent electrodes 112 of the same jaw.
[0039] FIG. 9 is a block diagram illustrating another vectoring configuration that can be produced with the electrode array 800. Unlike the vectoring configuration of FIG. 7, the vectoring configuration of FIG. 8 is produced by applying PFA pulses to electrodes 112 located in different jaws of the clamping device 210.
[0040] FIG. 10 is a block diagram illustrating an electrode array 1000 implemented in the clamping device 210 according to yet another example. The electrode array 1000 includes nine electrodes 112, which are labeled 112i- 1129. The first jaw 202 has the electrodes 112e- 1129. The second jaw 204 has the electrodes 1121-1125. The electrodes 112 are equidistant in each of the jaws 202, 204, with the inter-electrode distance being tfe, where di < d\. In one embodiment, the inter-electrode distance di is 1.2 cm. The relative alignment of the corresponding sets of electrodes 112 in the jaws 202, 204 is such that each of the electrodes 1126-1129 in the first jaw 202 is aligned with a middle portion of the corresponding inter-electrode segment in the second jaw 204. The electrodes 112i and 112e are the closest electrodes to the pivot axis 302 (not explicitly shown in FIG. 10; e.g., see FIG. 3). The electrodes 112s and 112e are the most distant electrodes from the pivot axis 302. Due to the smaller interelectrode distance d (< tZi), the electrode 112s is located at a nonzero distance di from the distal end of the second jaw 204. The vectoring configuration shown in FIG. 10 is produced by applying PFA pulses to adjacent electrodes 112 of the same jaw.
[0041] FIG. 11 is a block diagram illustrating another vectoring configuration that can be produced with the electrode array 1000. Unlike the vectoring configuration of FIG. 10, the vectoring configuration of FIG. 11 is produced by applying some PFA pulses to electrodes 112 located in different jaws of the clamp 200 and further applying some additional PFA pulses to nonadjacent electrodes 112 located on the same jaw of the clamp 200.
[0042] FIG. 12 is a block diagram illustrating an electrode array 1200 implemented in the clamp 200 according to yet another example. The electrode array 1200 includes eighteen electrodes 112, which are labeled 1121-11218. The first jaw 202 has the electrodes 112io-l 12is. The second jaw 204 has the electrodes 112i- 112g. The electrodes 112 are equidistant in each of the jaws 202, 204. The relative alignment of the corresponding sets of electrodes 112 in the jaws 202, 204 is such that each of the electrodes 112io- 11218 in the first jaw 202 is aligned with thecorresponding one of the electrodes 1121-1129 in the second jaw 204. The electric field configuration shown in FIG. 12 is produced by individually biasing different ones of the electrodes 1121-11218.
[0043] FIG. 13 is a block diagram illustrating an electrode array 1300 implemented in the clamping device 210 according to yet another example. The electrode array 1300 includes seventeen electrodes 112, which are labeled 112i- 11217, and differs from the electrode array 1200 (FIG. 12) in the relative alignment of the corresponding sets of electrodes 112 in the jaws 202, 204. More specifically, in the electrode array 1300, the relative alignment is such that that each of the electrodes 112io-l 1217 in the first jaw 202 is aligned with a middle portion of the corresponding inter-electrode segment in the second jaw 204. The electric field configuration shown in FIG. 13 is produced by individually biasing different ones of the electrodes 112i- 11217.
[0044] FIG. 14 is a block diagram illustrating an electrode array 1400 implemented in the clamping device 210 according to yet another example. The electrode array 1400 includes nine electrodes 112, which are labeled 112i- 1129. All of the electrodes 112i-l 129 are located in the first jaw 202. The electric field configuration shown in FIG. 14 is produced by individually biasing different ones of the electrodes 112i- 1129. Comparison of the electric field configurations shown in FIGS. 12-14 qualitatively illustrates how the electric field configuration in the target tissue will depend on the geometric arrangement of the electrodes 112 in the clamping device 210.
[0045] FIG. 15 is a block diagram illustrating a transverse cross-sectional view of the clamping device 210 according to one example. In the example shown, the first jaw 202 of the clamping device 210 has a groove 1512 into which an electrode 112j is recessed. The second jaw 204 of the clamping device 210 has a similar groove 1514 into which an electrode 112i is recessed. When the jaws 202, 204 are pressed together to clamp a target tissue 1502, the target tissue 1502 bridges the open parts of the grooves 1512, 1514 as indicated in FIG. 15, thereby creating enclosed channels in the jaws 202, 204. The fluid delivery conduit 272 (see FIG. 2) has a respective output port in each of the grooves 1512, 1514, which enables the operator of the clamp 200 to fill the enclosed channels with fluid (e.g., an electrolyte solution) when desired.When injected, the electrolyte solution, together with the walls of the grooves 1512, 1514, helpsto confine the PFA fields to a relatively narrow region of the target tissue 1502 between the electrodes 112i and 112j, e.g., as indicated by the dashed lines in FIG. 15, thereby beneficially improving the effectiveness of PFA delivery.
[0046] FIG. 16 is a diagram illustrating a surgical ablation pen 1600 that can be used in the medical system 100 according to another example. The pen 1600 is another example of the ablation device 110 shown in FIG. 1. In some examples, the pen 1600 is used together with a catheter that includes a reference electrode for vectoring the electrodes 112 of the pen 1600. Several example catheters suitable for this purpose are illustrated in FIGS. 17-19. In some examples, the surgical ablation pen 1600 has means for securing or anchoring the pen to the cardiac wall. Some examples of such securing or anchoring means may include suction cups, pins abrasive member(s), and the like. The securing or anchoring means can beneficially be used, e.g., to facilitate the use the surgical ablation pen 1600 on the epicardial wall of a beating heart.
[0047] The pen 1600 has a plurality (illustratively nine) of electrodes 112, which area labeled 112i-l 129. In some examples, each of the electrodes 1121-1129 has a respective individual electrical wire connected thereto to make each of the electrodes individually operable. The individual electrical wires are connected to respective electrical conductors of an electrical cable 1640, which runs through a lumen of a cylindrical rod 1620 and a pen handle 1630 to a multi-pin connector. In some examples, the multi -pin connector connected to the cable 1640 is similar to the multi-pin connector 250 (see FIG. 2). In various additional embodiments, the pen 1600 may have more or fewer than nine electrodes 112. In such embodiments, the electrical cable 1640 and the multi-pin connector are designed accordingly to support an intended number of electrical connections to the electrodes 112 of the pen 1600.
[0048] In the example shown, the pen 1600 has a bent distal portion 1610 that is oriented at an angle of approximately 120 degrees with respect to the cylindrical rod 1620. In some examples, the distal portion 1610 is malleable and can be adjusted as needed, e.g., in terms of its shape and / or angle with respect to the rod 1620. The electrodes 1121-1129 are arranged in an equidistant linear array along the distal portion 1610. In other examples, the pen 1600 may have other suitable arrangements of the electrodes 112.
[0049] FIGS. 17-19 are block diagrams illustrating reference electrode configurations with which the surgical ablation pen 1600 can be used according to some examples. The distal portion 1610 of the pen 1600 has five electrodes 112, which are labeled 1121-112s. In the examples shown, the target tissue is a myocardium 1704. The distal portion 1610 is placed on an epicardial side 1706 of the myocardium 1704. One or more reference electrodes 1702, 1802, or 1902 for vectoring the electrodes 1121-1125 is / are placed on an endocardial side 1708 of the myocardium 1704 using a respective one of catheters 1700, 1800, and 1900. The catheter 1700, 1800, or 1900 can be navigated to a desired position inside the heart, e.g., using the tracking and navigation system 140 (also see FIG. 1). During the medical procedure, the position of the reference electrode(s) 1702, 1802, or 1902 can be kept stationary or be adjusted as needed for delivery of different PFA pulses of the corresponding pulse sequence. In some other examples, the reference electrode 1702, 1802, or 1902 is a part of a hand-held surgical ablation pen 1700, 1800, or 1900.
[0050] The reference electrode 1702 of the catheter 1700 (FIG. 17) is of approximately the same size as a single electrode 112i of the pen 1600. The reference electrode 1802 of the catheter 1800 (FIG. 18) has a larger longitudinal size (length) than a single electrode 112i of the pen 1600. In the example shown in FIG. 18, the electrode length difference is approximately by a factor of six. In one example, the reference electrode 1902 of the catheter 1900 (FIG. 1) is a coil electrode. In another example, the reference electrode 1902 includes a plurality of smaller electrodes each of which can be independently electrically biased. In the example shown, such reference electrode 1902 includes nineteen smaller electrodes. In other example, such reference electrode 1902 may include a different (from 19) number of smaller electrodes. In an example vectoring operation, the reference electrode 1702, 1802, or 1902 receives a negative potential (polarity), whereas the electrodes 1121-112s of the pen 1600 receive a positive potential (polarity). Different vectoring configurations produced in each of the shown examples are indicated by dashed lines in FIGS 17-19. Note that the configuration illustrated in FIG. 17 provides for a more focused delivery of the PFA energy whereas the configurations illustrated in FIGS. 18-19 provide for a wider spread of the PFA energy throughout the target tissue. In different cases, different vectoring configurations can be selected, e.g., based on medicalindications for the PFA treatment. In some examples, the catheter 1700, 1800, or 1900 may include two or more electrodes to provide more PFA vectoring options.
[0051] In some examples, the surgical ablation clamp 200 can be used instead of the surgical ablation pen 1600 in one or more of the vectoring configurations illustrated in FIGS. 17-19.
[0052] FIG. 20 is a flowchart illustrating a method 2000 of delivering PFA treatment to a patient according to some examples. The method 2000 can be implemented, e.g., using the system 100 equipped with one or more ablation devices 110. The method 2000 includes positioning the one or more ablation devices 110 next to the target tissue (in a block 2002). Several examples of the positions into which the one or more ablation devices 110 can be placed via operations of the block 2002 are shown, e.g., in FIGS. 6, 15, and 17-19. In some examples of the block 2002, some of the positioning operations make use of the tracking and navigation system 140 (also see FIG. 1).
[0053] The method 2000 also includes selecting, with the electronic controller 123, one or more waveform profiles and vectoring configurations (in a block 2004). Example waveforms that can be selected in the block 2004 for the PFA delivery include monophasic (unipolar) pulses and biphasic (bipolar) pulses. A pulse is typically characterized by an amplitude and a width. A pulse sequence is characterized by the number of pulses therein and inter-pulse and interphase delays. All these parameters are controllable with the signal generator 122 via the electronic controller 123. Selecting the vectoring configurations in the block 2004 for the PFA delivery includes identifying pairs of electrodes of the one or more ablation devices 110 and possibly auxiliary devices (such as skin electrode patches) to which different segments of the pulse sequence are going to be applied. In some examples, the electronic controller 123 runs a suitable algorithm to automatically make decisions on vectoring configurations and waveform profiles given a specific tissue thickness.
[0054] The method 2000 also includes testing the readiness of the system for therapeutic PFA delivery using a test pulse sequence (in a block 2006). A test pulse sequence usually employs pulses of lower amplitudes for measuring impedances between various pairs of the PFA delivery electrodes of the vectoring configuration selected in the block 2004. A purpose of the test pulse sequence is to make sure that the various impedances are within their proper ranges and thatthere are no open (high impedance) or short (low impedance) circuits in the delivery paths. If it is determined that the impedances are not within their proper ranges (“No,” at the decision block 2008), then the processing of the method 2000 is directed to a block 2010. If it is determined that the impedances are within their proper ranges (“Yes,” at a decision block 2008), then the processing of the method 2000 is directed to a processing branch including blocks 2012-2016.
[0055] Operations of the block 2010 include making adjustments to the positions of the one or more ablation devices 110 and possibly making changes to the previously selected waveform profiles and / or vectoring configurations. Such adjustment can be performed, e.g., to accommodate thicker tissue. After such adjustments, the processing of the method 2000 is looped back to the operations of the block 2006 for further testing. In some examples, the block 2010 can be used in a feedback loop for both safety and optimization of energy delivery, e.g., based on tissue thickness and / or tissue characteristics, such as scar or fat.
[0056] Operations of the block 2012 include confirming that the patient’s EGM signals are being monitored and have acceptable characteristics. Operations of the block 2014 include confirming the proper placement of the one or more ablation devices 110 with respect to the target tissue. Operations of the block 2016 include delivering the PFA treatment to the patient.
[0057] According to an example embodiment disclosed above, e.g., in the summary section and / or in reference to any one or any combination of some or all of FIGS. 1-20, provided is a surgical ablation device comprising: a rod including a lumen between first and second ends of the rod; a handle attached to the first end of the rod, the handle including a body and a trigger movable with respect to the body; a clamping device attached to the second end of the rod and including a first jaw and a second jaw movable with respect to the first jaw, wherein the clamping device includes a plurality of electrodes, each of the electrodes being individually electrically connected via electrical wiring disposed along the lumen to an electrical cable connected to the handle; and wherein the trigger is mechanically coupled through the lumen to the clamping device and configured to cause movement of the second jaw with respect to the first jaw in response to movement of the trigger with respect to the body.
[0058] In some embodiments of the above surgical ablation device, each of the electrodes is individually connected through the electrical cable and the electrical wiring to receive a respective electric potential from a signal generator.
[0059] In some embodiments of any of the above surgical ablation devices, the first jaw is fixedly attached to the rod; and wherein the second jaw is configured to move with respect to the rod in response to the movement of the trigger with respect to the body.
[0060] In some embodiments of any of the above surgical ablation devices, the plurality of electrodes includes: a first set of electrodes disposed along the first jaw; and a second set of electrodes disposed along the second jaw.
[0061] In some embodiments of any of the above surgical ablation devices, the first set of electrodes has a first number of electrodes; and wherein the second set of electrodes has a second number of electrodes that is different from the first number.
[0062] In some embodiments of any of the above surgical ablation devices, the first set of electrodes and a second set of electrodes are positioned such that, in a closed configuration of the clamping device, each of the electrodes of the first set of electrodes is aligned with a middle portion of a corresponding inter-electrode segment in the second set of electrodes.
[0063] In some embodiments of any of the above surgical ablation devices, the first set of electrodes and the second set of electrodes are positioned such that, in a closed configuration of the clamping device, at least one electrode of the first set of electrodes is aligned with a corresponding one of the electrodes of the second set of electrodes.
[0064] In some embodiments of any of the above surgical ablation devices, the first set of electrodes and the second set of electrodes are positioned such that, in a closed configuration of the clamping device, each electrode of the first set of electrodes is aligned with a corresponding one of the electrodes of the second set of electrodes.
[0065] In some embodiments of any of the above surgical ablation devices, the first set of electrodes or the second set of electrodes includes an electrode located at a distal end of a corresponding one of the first and second jaws.
[0066] In some embodiments of any of the above surgical ablation devices, the electrodes in the first set of electrodes or in the second set of electrodes are equidistantly distributed along a corresponding one of the first and second jaws.
[0067] In some embodiments of any of the above surgical ablation devices, only one of the first and second jaws has electrodes of the plurality of electrodes; and wherein another one of the first and second jaws has no electrodes.
[0068] In some embodiments of any of the above surgical ablation devices, the first jaw has a first groove in which one or more electrodes of the first set are located; and wherein the surgical ablation device further comprises tubing disposed along the lumen and configured to deliver fluid to the first groove.
[0069] In some embodiments of any of the above surgical ablation devices, the second jaw has a second groove in which one or more electrodes of the second set are located; and wherein the tubing is further configured to deliver the fluid to the second groove.
[0070] In some embodiments of any of the above surgical ablation devices, the first and second grooves are of a shape configured to encapsulate parts of the target tissue selected for ablation to control a spatial configuration of resulting ablated tissue.
[0071] In some embodiments of any of the above surgical ablation devices, when the clamping device is clamped onto a target tissue, the target tissue bridges the first and second grooves to create corresponding channels configured to surround the one or more electrodes of the first set and the one or more electrodes of the second set with the fluid.
[0072] In some embodiments of any of the above surgical ablation devices, the surgical ablation device further comprises a fluid-delivery device for delivering fluid, via tubing disposed in the handle and along the lumen, to at least one of the first and second jaws of the clamping device.
[0073] In some embodiments of any of the above surgical ablation devices, the fluid-delivery device comprises a syringe connected to the tubing.
[0074] In some embodiments of any of the above surgical ablation devices, the handle further includes a release button mechanically coupled to the clamping device and configured to loosen a grip of the clamping device on a target tissue when pressed.
[0075] According to another example embodiment disclosed above, e.g., in the summary section and / or in reference to any one or any combination of some or all of FIGS. 1-20, provided is a medical system comprising: a surgical ablation device including an array of electrodes configured to be placed on an epicardial side of a heart; a catheter including a reference electrode configured to be placed on an endocardial side of the heart; and a signal generator configured to apply voltage pulses between the reference electrode and a selectable set of the electrodes of the array to produce pulsed electric fields in a tissue of the heart between the reference electrode and the selectable set of the electrodes of the array.
[0076] In some embodiments of the above system, the surgical ablation device comprises: a rod including a lumen between a first end of the rod and a second end of the rod; a handle attached to the first end of the rod, the handle including a body and a trigger movable with respect to the body; and a clamping device attached to the second end of the rod and including a first jaw and a second jaw movable with respect to the first jaw, wherein the clamping device includes the array of electrodes, each of the electrodes being individually electrically connected via electrical wiring disposed along the lumen to an electrical cable connected to the handle; and wherein the trigger is mechanically coupled through the lumen to the clamping device and configured to cause movement of the second jaw with respect to the first jaw in response to movement of the trigger with respect to the body.
[0077] In some embodiments of any of the above systems, the surgical ablation device comprises a surgical ablation pen having the array of electrodes along a distal portion thereof.
[0078] In some embodiments of any of the above systems, the medical system further comprises an electronic controller configured to cause the signal generator to change an energy of the voltage pulses based on measurements of tissue impedance or tissue thickness.
[0079] In some embodiments of any of the above systems, the electronic controller is further configured to cause the signal generator to generate a test waveform for evaluating system integrity prior to the application of the voltage pulses.
[0080] In some embodiments of any of the above systems, the medical system further comprises a mapping or navigation module configured to track a position of at least one of the surgical ablation device and the catheter with respect to patient anatomy.
[0081] In some embodiments of any of the above systems, the surgical ablation device has a groove in which one or more electrodes of the array are located; and wherein the surgical ablation device comprises tubing configured to deliver fluid to the groove.
[0082] In some embodiments of any of the above systems, when the surgical ablation device is positioned next to a target tissue, the target tissue bridges the groove to create a channel configured to surround the one or more electrodes with the fluid.
[0083] In some embodiments of any of the above systems, the groove is of a shape configured to encapsulate parts of the target tissue selected for ablation to control a spatial configuration of resulting ablated tissue.
[0084] In some embodiments of any of the above systems, the medical system further comprises a fluid-delivery device for delivering the fluid to the surgical ablation device.
[0085] In some embodiments of any of the above systems, the fluid-delivery device is configured to deliver the fluid which includes one or more of: a drug; DNA; RNA; a biologically active agent; and an electrolyte.
[0086] In some embodiments of any of the above systems, the medical system further comprises an electronic controller configured to cause the fluid-delivery device to select the fluid from a plurality of fluids having different respective electrical conductivities.
[0087] In some embodiments of any of the above systems, each electrode of the array is individually connectable to receive a respective electric potential from the signal generator.
[0088] With regard to the processes, systems, methods, heuristics, etc. described herein, it should be understood that, although the steps of such processes, etc. have been described as occurring according to a certain ordered sequence, such processes could be practiced with the described steps performed in an order other than the order described herein. It further should be understood that certain steps could be performed simultaneously, that other steps could be added, or that certain steps described herein could be omitted. In other words, the descriptions of processes herein are provided for the purpose of illustrating certain implementations and should in no way be construed to limit the claims.
[0089] Accordingly, it is to be understood that the above description is intended to be illustrative and not restrictive. Many embodiments and applications other than the examples provided would be apparent upon reading the above description. The scope should be determined, not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. It is anticipated and intended that future developments will occur in the technologies discussed herein, and that the disclosed systems and methods will be incorporated into such future embodiments. In sum, it should be understood that the application is capable of modification and variation.
[0090] All terms used in the claims are intended to be given their broadest reasonable constructions and their ordinary meanings as understood by those knowledgeable in the technologies described herein unless an explicit indication to the contrary in made herein. In particular, use of the singular articles such as “a,” “the,” “said,” etc. should be read to recite one or more of the indicated elements unless a claim recites an explicit limitation to the contrary.
[0091] Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value or range.
[0092] The use of figure numbers and / or figure reference labels (if any) in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
[0093] Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.
[0094] Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”
[0095] Unless otherwise specified herein, the use of the ordinal adjectives “first,” “second,” “third,” etc., to refer to an object of a plurality of like objects merely indicates that different instances of such like objects are being referred to, and is not intended to imply that the like objects so referred-to have to be in a corresponding order or sequence, either temporally, spatially, in ranking, or in any other manner.
[0096] Unless otherwise specified herein, in addition to its plain meaning, the conjunction “if’ may also or alternatively be construed to mean “when” or “upon” or “in response to determining” or “in response to detecting,” which construal may depend on the corresponding specific context. For example, the phrase “if it is determined” or “if [a stated condition] is detected” may be construed to mean “upon determining” or “in response to determining” or “upon detecting [the stated condition or event]” or “in response to detecting [the stated condition or event].”
[0097] Throughout the detailed description, the drawings, which are not to scale, are illustrative only and are used in order to explain, rather than limit the disclosure. The use of terms such as height, length, width, top, bottom, is strictly to facilitate the description of the embodiments and is not intended to limit the embodiments to a specific orientation. For example, height does not imply only a vertical rise limitation, but is used to identify one of the three dimensions of a three-dimensional structure as shown in the figures. Such "height" would be vertical where the electrodes are horizontal but would be horizontal where the electrodes arevertical, and so on. Similarly, while all figures show the different layers as horizontal layers such orientation is for descriptive purpose only and not to be construed as a limitation.
[0098] Also, for purposes of this description, the terms “couple,” “coupling,” “coupled,” “connect,” “connecting,” or “connected” refer to any manner known in the art or later developed in which energy is allowed to be transferred between two or more elements, and the interposition of one or more additional elements is contemplated, although not required. Conversely, the terms “directly coupled,” “directly connected,” etc., imply the absence of such additional elements. The same type of distinction applies to the use of terms “attached” and “directly attached,” as applied to a description of a physical structure. For example, a relatively thin layer of adhesive or other suitable binder can be used to implement such “direct attachment” of the two corresponding components in such physical structure.
[0099] The described embodiments are to be considered in all respects as only illustrative and not restrictive. In particular, the scope of the disclosure is indicated by the appended claims rather than by the description and figures herein. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
[0100] The functions of the various elements shown in the figures, including any functional blocks labeled as “processors” and / or “controllers,” may be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and may implicitly include, without limitation, digital signal processor (DSP) hardware, network processor, application specific integrated circuit (ASIC), field programmable gate array (FPGA), read only memory (ROM) for storing software, random access memory (RAM), and nonvolatile storage. Other hardware, conventional and / or custom, may also be included. Similarly, any switches shown in the figures are conceptual only. Their function may be carried out through the operation of program logic, through dedicated logic, through the interaction of program controland dedicated logic, or even manually, the particular technique being selectable by the implementer as more specifically understood from the context.
[0101] As used in this application, the term “circuitry” may refer to one or more or all of the following: (a) hardware-only circuit implementations (such as implementations in only analog and / or digital circuitry); (b) combinations of hardware circuits and software, such as (as applicable): (i) a combination of analog and / or digital hardware circuit(s) with software / firmware and (ii) any portions of hardware processor(s) with software (including digital signal processor(s)), software, and memory(ies) that work together to cause an apparatus, such as a mobile phone or server, to perform various functions); and (c) hardware circuit(s) and or processor(s), such as a microprocessor(s) or a portion of a microprocessor(s), that requires software (e.g., firmware) for operation, but the software may not be present when it is not needed for operation.” This definition of circuitry applies to all uses of this term in this application, including in any claims. As a further example, as used in this application, the term circuitry also covers an implementation of merely a hardware circuit or processor (or multiple processors) or portion of a hardware circuit or processor and its (or their) accompanying software and / or firmware. The term circuitry also covers, for example and if applicable to the particular claim element, a baseband integrated circuit or processor integrated circuit for a mobile device or a similar integrated circuit in server, a cellular network device, or other computing or network device.
[0102] It should be appreciated by those of ordinary skill in the art that any block diagrams herein represent conceptual views of illustrative circuitry embodying the principles of the disclosure. Similarly, it will be appreciated that any flow charts, flow diagrams, state transition diagrams, pseudo code, and the like represent various processes which may be substantially represented in computer readable medium and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.
Claims
CLAIMSWhat is claimed is:
1. A surgical ablation device, comprising: a rod including a lumen between first and second ends of the rod; a handle attached to the first end of the rod, the handle including a body and a trigger movable with respect to the body; and a clamping device attached to the second end of the rod and including a first jaw and a second jaw movable with respect to the first jaw, wherein the clamping device includes a plurality of electrodes, each of the electrodes being individually electrically connected via electrical wiring disposed along the lumen to an electrical cable connected to the handle; and wherein the trigger is mechanically coupled through the lumen to the clamping device and configured to cause movement of the second jaw with respect to the first jaw in response to movement of the trigger with respect to the body.
2. The surgical ablation device of claim 1, wherein each of the electrodes is individually connected through the electrical cable and the electrical wiring to receive a respective electric potential from a signal generator.
3. The surgical ablation device of claim 1, wherein the first jaw is fixedly attached to the rod; and wherein the second jaw is configured to move with respect to the rod in response to the movement of the trigger with respect to the body.
4. The surgical ablation device of claim 1, wherein the plurality of electrodes includes: a first set of electrodes disposed along the first jaw; and a second set of electrodes disposed along the second jaw.
5. The surgical ablation device of claim 4, wherein the first set of electrodes has a first number of electrodes; andwherein the second set of electrodes has a second number of electrodes that is different from the first number.
6. The surgical ablation device of claim 4, wherein the first set of electrodes and the second set of electrodes are positioned such that, in a closed configuration of the clamping device, each of the electrodes of the first set of electrodes is aligned with a middle portion of a corresponding inter-electrode segment in the second set of electrodes.
7. The surgical ablation device of claim 4, wherein the first set of electrodes and the second set of electrodes are positioned such that, in a closed configuration of the clamping device, at least one electrode of the first set of electrodes is aligned with a corresponding one of the electrodes of the second set of electrodes.
8. The surgical ablation device of claim 4, wherein the first set of electrodes and the second set of electrodes are positioned such that, in a closed configuration of the clamping device, each electrode of the first set of electrodes is aligned with a corresponding one of the electrodes of the second set of electrodes.
9. The surgical ablation device of claim 4, wherein the first set of electrodes or the second set of electrodes includes an electrode located at a distal end of a corresponding one of the first and second jaws.
10. The surgical ablation device of claim 4, wherein the electrodes in the first set of electrodes or in the second set of electrodes are equidistantly distributed along a corresponding one of the first and second jaws.
11. The surgical ablation device of claim 4, wherein only one of the first and second jaws has electrodes of the plurality of electrodes; and wherein another one of the first and second jaws has no electrodes.
12. The surgical ablation device of claim 4, wherein the first jaw has a first groove in which one or more electrodes of the first set are located; wherein the surgical ablation device further comprises tubing disposed along the lumen and configured to deliver fluid to the first groove; wherein the second jaw has a second groove in which one or more electrodes of the second set are located; and wherein the tubing is further configured to deliver the fluid to the second groove.
13. The surgical ablation device of claim 12, wherein, when the clamping device is clamped onto a target tissue, the target tissue bridges the first and second grooves to create corresponding channels configured to surround the one or more electrodes of the first set and the one or more electrodes of the second set with the fluid.
14. The surgical ablation device of claim 11, wherein the first and second grooves are of a shape configured to encapsulate parts of the target tissue selected for ablation to control a spatial configuration of resulting ablated tissue.
15. The surgical ablation device of claim 1, further comprising a fluid-delivery device for delivering fluid, via tubing disposed in the handle and along the lumen, to at least one of the first and second jaws of the clamping device.
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