Electro surgical device for total joint arthroplasty and other surgical applications
The integrated electrosurgical device addresses inefficiencies in current surgical tools by combining coagulation, cutting, and fluid removal functions, enhancing surgical efficiency and reducing complexity through a single tool system.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- RELIGN CORP
- Filing Date
- 2025-10-22
- Publication Date
- 2026-05-07
AI Technical Summary
Current surgical tools require multiple devices for various functions during procedures like total joint arthroplasty, leading to inefficiency, complexity, and increased surgical time, with challenges in managing mechanical and electrical connections while facilitating fluid exchange and RF delivery.
A single electrosurgical device with interchangeable probes that combine coagulation, cutting, fluid removal, and illumination capabilities, featuring multiple electrodes and fluid ports for irrigation, and a reusable handpiece that allows for vacuum aspiration without interfering with RF operation, reducing the need for multiple tools.
The device simplifies surgical procedures by integrating multiple functions into one tool, reducing complexity, cost, and surgical time, while maintaining effective tissue manipulation and fluid management.
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Figure US2025052057_07052026_PF_FP_ABST
Abstract
Description
ELECTRO SURGICAL DEVICE FOR TOTAL JOINT ARTHROPLASTY AND OTHERSURGICAL APPLICATIONSCLAIM OF PRIORITY
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 715,211, filed on November 1, 2024, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.FIELD OF THE INVENTION.
[0002] The present invention relates generally to an apparatus for surgical procedures such as a total joint arthroplasty and, more particularly, to apparatuses to surgically treat tissue such as bone and soft tissue.BACKGROUND
[0003] A variety of surgical apparatuses exist for endoscopic cutting and removal of bone including for subacromial decompression, anterior cruciate ligament reconstruction involving notchplasty, and arthroscopic resection of the acromioclavicular joint. Currently, surgeons use arthroscopic shavers and burrs having rotational cutting surfaces to remove hard tissue in such procedures.
[0004] To promote efficiency, endoscopic tool systems including a reusable handpiece and a selection of interchangeable tool probes having different working ends are available. Individual working ends may each have two or more functionalities, such as soft tissue removal and hard tissue resection, fluid removal and imaging, so such tools systems can provide dozens of specific functionalities, providing great flexibility. Typically multiple different tools must be utilized during surgery including different tools to perform coagulation and cutting. This is particularly the case with total joint arthroplasty procedures where multiple tools with different functionality are used.OVERVIEW
[0005] There is a need for a single tool system to accommodate various functions. However, design of such a single tool system is a challenge. Many endoscope probes in use include lumens within rotatable shafts for the vacuum aspiration of fluids including tissue debris from the working site. These tools also rely on the delivery of radiofrequency (RF) current from the handpiece to the working end of the probe for coagulation or ablation. Theinterface between the reusable handpiece and the replaceable (usually disposable) probe must be designed to allow mechanical and electrical connection while managing fluid exchange so that the tools may be operated without electrical shorting.
[0006] The present inventors have developed improved surgical apparatus and system, such as with the combined capability to perform coagulation, endoscopic tissue cutting using RF and fluid removal. The present inventors have also developed a surgical apparatus and system with further capabilities, including an apparatus and system that can illuminate the surgical site, can remove smoke in addition to other tissue debris generated from the coagulation, cutting or other processes, provide irrigation, etc. The present inventors have developed devices that utilize three or more electrodes including two electrodes used during a coagulation mode and at least a third electrode such as a blade electrode used as an active electrode during a radiofrequency resection (tissue ablation or cut) mode. The relative positioning and ability to retract and extend the third electrode relative to a tip of the device and the two electrodes can improve manipulation of device to cut tissue at various angles of approach. Furthermore, the present inventors have recognized the two electrodes can have at least two outflow ports each for an irrigating fluid. One of the at least two outflow ports the first electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a first lateral side thereof. One of the at least two outflow ports of the second electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a second lateral side thereof. Use of the irrigating fluid and injection toward the blade electrode is recognized by the present inventors to improve performance as locations were selected to ensure hydration of the tissue during both coagulation and cut modes.
[0007] The present inventors further have developed a system wherein a reusable or other handpiece may be removably connected to the replaceable, usually disposable, probe while permitting the various functions discussed above while allowing for vacuum aspiration of fluids including tissue debris through a probe shaft and outwardly through the handpiece without interfering with the electrical and / or mechanical operation of the surgical system to deliver radiofrequency (RF) current to the probe. The present inventors contemplate that the surgical apparatuses and systems can reduce costs by eliminating multiple surgical tools, reduce surgical complexity and reduce surgical time among other benefits. The probes and or electrosurgical devices disclosed herein can be configured to be reusable or can be configured to be disposable after the surgery.
[0008] Description of the Background Art: Relevant commonly owned patent publications include: WO 2023 / 183400 (now United States Application Serial No. 18 / 844,260); US2018-0303509; US 2019-0008541; US 2019-0059983; US 2019-0134279; US 2019-0021788; US 2018-0317957; US 2019-0008538; US 2019-0083121; US 2018-0263649; and US 2019- 0015151, the full disclosures of which are incorporated herein by reference.BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Various embodiments of the present invention will now be discussed with reference to the appended drawings. It should be appreciated that the drawings depict only typical embodiments of the invention and are therefore not to be considered limiting in scope.
[0010] FIG. 1 is an exploded view of an arthroscopic cutting system that includes an electrosurgical device having reusable handpiece with a detachable single-use probe, according to an example of the present disclosure.
[0011] FIG. 2 is a perspective view illustrating an electrosurgical device according to another example of the present disclosure.
[0012] FIG. 3 is a perspective view of the electrosurgical device of FIG. 2 in a resection mode, according to an example of the present disclosure.
[0013] FIG. 4 is a perspective view of the electrosurgical device of FIG. 2 in a coagulation mode, according to an example of the present disclosure.
[0014] FIG. 5 is an enlarged perspective view illustrating a distal end portion of a shaft of a probe of the electrosurgical device of FIGS. 2-4 with a cut electrode retracted during the coagulation mode of FIG. 4, according to an example of the present disclosure.
[0015] FIG. 6 is an enlarged perspective view illustrating a distal end portion of a shaft of a probe of the electrosurgical device of FIGS. 2-4 with the cut electrode extended during the resection mode of FIG. 3, according to an example of the present disclosure.
[0016] FIG. 7A is a perspective view of an example of the cut electrode, according to an example of the present disclosure.
[0017] FIG. 7B is a plan view of the cut electrode of FIG. 7A.
[0018] FIG. 7C shows an angle of approach of the cut electrode and a second electrode to tissue during a resection mode of operation, according to an example of the present application.
[0019] FIG. 8A is a first perspective view illustrating the distal end portion of the probe of FIGS. 2-7 with a plurality of fluid inflow ports on a first dome electrode, according to an example of the present disclosure.
[0020] FIG. 8B is a second perspective view illustrating the distal end portion of the probe with a plurality of fluid inflow ports from on a second dome electrode, according to an example of the present disclosure.
[0021] FIG. 9 is a schematic view illustrating the internal components of the shaft of the probe including a plurality of tubes (lumens) used for irrigation fluid inflow and outflow, according to an example of the present disclosure.
[0022] FIG. 10 is a chart illustrating a linear relationship between inflow rate and coagulation depth, according to an example of the present disclosure.
[0023] FIG. 11 is a schematic diagram illustrating directions of irrigating fluid inflow from a plurality of ports on a first dome electrode and a second dome electrode during the coagulation mode, according to an example of the present disclosure.
[0024] FIG. 12 is a schematic diagram illustrating directions of irrigating fluid inflow from the plurality of ports on the first dome electrode and the second dome electrode including toward the cut electrode during the resection mode, according to an example of the present disclosure.
[0025] FIG. 13 is a schematic diagram illustrating the movement of the device from a first position to a second position to cut tissue, according to an example of the present disclosure.
[0026] FIG. 14 is a cross-sectional view illustrating the internal components of the device, including a mechanism to drive an RF switching printed circuit board assembly and the cut electrode, according to an example of the present disclosure.
[0027] FIG. 15A is a detailed cross-sectional view illustrating aspects of the handpiece including an RF switching printed circuit board assembly, according to an example of the present disclosure.
[0028] FIG. 15B is a perspective partial cross-sectional view illustrating various aspects of the handpiece including a connection between the RF switching printed circuit board assembly and a main printed circuit board assembly, according to an example of the present disclosure.
[0029] FIG. 16A is a plan view illustrating an electrical connector used with the device, according to an example of the present disclosure.
[0030] FIG. 16B is a cross-sectional view illustrating the electrical connector of FIG. 16A and internal components thereof including a spring, according to an example of the present disclosure.
[0031] FIG. 17 is a schematic view illustrating components of the handpiece including a nut and lead screw with the cut electrode in a retracted position, according to an example of the present disclosure.
[0032] FIG. 17A is a plan view illustrating a distal end portion of the shaft of the device including the tip with the cut electrode in the retracted position, according to an example of the present disclosure.
[0033] FIG. 18 is a schematic view illustrating the components of the handpiece including the nut and the lead screw with the cut electrode in a first intermediate extended position, according to an example of the present disclosure.
[0034] FIG. 18A is a plan view illustrating the distal end portion of the shaft of the device including the tip with the cut electrode in the first intermediate extended position, according to an example of the present disclosure.
[0035] FIG. 19 is a schematic view illustrating the components of the handpiece including the nut and the lead screw with the cut electrode in a second fully extended position, according to an example of the present disclosure.
[0036] FIG. 19A is a plan view illustrating the distal end portion of the shaft of the device including the tip with the cut electrode in the second fully extended position, according to an example of the present disclosure.
[0037] FIG. 20 is a schematic diagram illustrating the electrical connections of the device during a coagulation mode, according to an example of the present disclosure.
[0038] FIG. 21 is a perspective view illustrating a movement of the RF switching printed circuit board assembly relative to the main printed circuit board that occurs prior to the coagulation mode, according to an example of the present disclosure.
[0039] FIG. 22 is a schematic diagram illustrating the RF pathways in the device including on the RF switching printed circuit board assembly during the coagulation mode, according to an example of the present disclosure.
[0040] FIG. 23 is a cross-sectional view of the handpiece illustrating the configuration of internal components during the coagulation mode of FIGS. 20-22, according to some example.
[0041] FIG. 24 is a perspective view of the distal end portion of the device during the coagulation mode of FIGS. 20-23, according to an example of the present disclosure.
[0042] FIG. 25 is a schematic diagram illustrating the electrical connections of the device during a resection mode, according to an example of the present disclosure.
[0043] FIG. 26 is a perspective view illustrating a movement of the RF switching printed circuit board assembly relative to the main printed circuit board that occurs prior to the resection mode, according to an example of the present disclosure.
[0044] FIG. 27 is a schematic diagram illustrating the RF pathways in the device including on the RF switching printed circuit board assembly during the resection mode, according to an example of the present disclosure.
[0045] FIG. 28 is a cross-sectional view of the handpiece illustrating the configuration of internal components during the resection mode of FIGS. 25-27, according to an example of the present disclosure.
[0046] FIG. 29 is a perspective view of the distal end of the device during the resection mode of FIGS. 25-28, according to an example of the present disclosure.
[0047] FIG. 30 is a cross-sectional view of a distal end portion of another example of an electrosurgical device and illustrating alternative irrigating fluid inflow to some of the electrodes.
[0048] FIG. 31 is a schematic diagram of a distal end portion of another example of an electrosurgical device illustrating an interaction of the electrosurgical device with tissue, according to an example of the present disclosure.
[0049] FIG. 32 is a cross-sectional view of internal components of the electrosurgical device of FIG. 31 including springs, according to an example of the present disclosure.
[0050] FIG. 33 is a plan view of another example of the RF switching printed circuit board assembly having magnets thereof for RF switching, according to an example of the present disclosure.
[0051] FIG. 34 is a perspective view illustrating the RF switching printed circuit board assembly of FIG. 33 positioned relative to the main printed circuit board during a coagulation mode, according to an example of the present disclosure.
[0052] FIG. 35 is a perspective view illustrating the RF switching printed circuit board assembly of FIG. 33 positioned relative to the main printed circuit board during a resection mode with a first intermediate extended position for the cut electrode, according to an example of the present disclosure.
[0053] FIG. 36 is a perspective view illustrating the RF switching printed circuit board assembly of FIG. 33 positioned relative to the main printed circuit board during a resection mode with a second fully extended position for the cut electrode, according to an example of the present disclosure.
[0054] FIG. 37 is a schematic view illustrating various angles of approach for electrosurgical device during resection that can determine a different depth of cut using the cut electrode, according to an example of the present application.
[0055] FIG. 38 is a cross-sectional view a handpiece of yet another example of an electrosurgical device with a mechanism positioned to facilitate the resection mode, according to an example of the present disclosure.
[0056] FIG. 38A is a perspective view of portions of the handpiece including the mechanism of FIG. 38 during the resection mode, according to an example of the present disclosure.
[0057] FIG. 39 is a cross-sectional view the handpiece of the electrosurgical device of FIGS. 38 and 38A with the mechanism positioned to facilitate the coagulation mode, according to an example of the present disclosure.
[0058] FIG. 39A is a perspective view of portions of the handpiece including the mechanism of FIG. 39 during the coagulation mode, according to an example of the present disclosure.
[0059] FIG. 40 a schematic diagram illustrating a solenoid actuated mechanism, according to an example of the present disclosure.DETAILED DESCRIPTION OF THE INVENTION
[0060] The present invention relates to electrosurgical devices that have various functions. Several embodiments of the devices will now be described to provide an overall understanding of the principles of the form, function and methods of use. In general, the present disclosure provides for electrosurgical devices that can be used as arthroscopic tools including for total joint arthroplasty. In most cases, the electrosurgical devices described herein can perform more than one surgical function. Thus, the electrosurgical devices can be configured for coagulation and / or cutting bone such as of soft tissue, meniscal tissue, etc. using RF energy. The arthroscopic tools can be disposable and are configured for detachable coupling to a nondisposable handpiece. This description of the general principles of this invention is not meant to limit the inventive concepts in the appended claims.
[0061] In one example shown in FIG. 1, an arthroscopic system 100 of the present invention provides an electrosurgical apparatus 102 having a handpiece 104 with motor drive 105 and a probe 110 with a proximal hub 120 that can be received by receiver or bore 122 in the handpiece 104. In one aspect, the probe 110 has a working or distal end 112 that carries RF electrodes configured for use in many arthroscopic surgical applications, including but not limited to treating bone in shoulders, knees, hips, wrists, ankles and the spine.
[0062] As can be seen in FIG. 1, the probe 110 is attachable to and detachable from the handpiece 104. In FIG. 1, the probe 110 has a shaft 125 extending along longitudinal axis 128.A distal portion of the shaft 125 including the distal end 112 can be angled (e.g., by 15 degrees, 30 degrees, or the like) relative to the longitudinal axis 128. The shaft 125 can be somewhat flexible or rigid as desired and can house various components that can extend from the hub 120 to the distal end 112 as further discussed. Thus, the shaft 125 can comprise tube or outer sleeve with components such as wires, flow channels, additional shafts, and the like passing therethrough. The shaft 125 extends from the hub 120 (located at a proximal end of the shaft 125) to the distal end 112. The shaft 125 can be coupled in a fixed manner to the hub 120 which can be an injection molded plastic, for example, with the shaft 125 insert molded therein. One or more components can pass through the shaft 125 including to provide RF energy to the electrodes, provide for fluid removal, provide for fluid application, provide for illumination or the like. The motor drive 105 need not be utilized for some of the functions of the electrosurgical device 102 with the probe 110.
[0063] In FIG. 1, it can be seen that the handpiece 104 is operatively coupled by electrical cable 160 to a controller 165 which can control the motor drive 105, communication with a pressure source 220, and communication with the RF source 225. Actuator buttons 166a, 166b, 166c, etc. on the handpiece 104 (sometimes called a handle herein) can be used to select operating modes, such as current strength for RF, motor speed, flow control, illumination control or the like. In one variation, a joystick 168 can be moved forward and backward to adjust the rotational speed of motor or other function such as to extend or retract an electrode (discussed subsequently). Motor speed can continuously adjustable, or can be adjusted in increments. An LCD screen 170 can provided in the handpiece 104 for displaying operating parameters, such as mode of operation, etc.
[0064] It can be understood from FIG. 1 that the system 100 and handpiece 104 can be configured for use with various disposable probes which can be designed for various different functions and procedures. Some of the probes can utilize the motor drive 105, for example, and some may not. These probes are various described in the various applications incorporated by reference with the U.S. Application Publications noted above.
[0065] FIG. 1 further shows that the system 100 also includes a pressure source 220 such as a negative pressure source coupled to aspiration tubing 222 which communicates with a flow channel 224 in handpiece 104 and can cooperate with one or more tubes of the probe 110. The system 100 includes the RF source 225 which can be connected to an electrode arrangement of the probe 110. The system 100 can include flow inducing device 226 such as a pump, positive pressure source or the like that passes in fluid communication to the handpiece 104 and to the distal end 112. The flow inducing device 226 (optionally controlled by the controller 165) canallow for flow to the distal tip of a fluid such as for application of an irrigating fluid (e.g., saline) utilized during operation of the electrosurgical apparatus 102. The controller 165 and microprocessor therein together with control algorithms are provided to operate and control all functionality, which includes controlling the motor drive 105, the RF source 225, the flow inducing device 226, illuminating device, and the negative pressure source 220 which can aspirate fluid including tissue debris to collection reservoir 230.
[0066] As can be understood from the above description of the system 100, the electrosurgical device 102 and handpiece 104, the controller 165 and controller algorithms can be configured to perform and automate many tasks to provide for system functionality. Although shown separate from the handpiece 104, the controller 165 can be integrated into the handpiece 104 according to some examples. In a first aspect, controller algorithms are needed for device identification so that when any of the different probes types are coupled to handpiece 104, the controller 165 will recognize the probe type and then select algorithms for operating the motor drive 105, RF source 225, flow inducing device 226, negative pressure source 220, etc. as is needed for the particular probe. In a second aspect, the controller can be configured with algorithms that identify whether the probe is coupled to the handpiece 104 in a particular orientation relative to the handpiece, wherein each orientation requires a different subset of the operating algorithms.
[0067] Referring to FIG. 1, the handpiece 104 can carry a first Hall effect sensor 240 in a distal region of the handpiece 104 adjacent the receiving passageway 122 that receives the hub 120 of probe 110. The handpiece 104 can carry a second Hall effect sensor 245 adjacent the rotatable drive coupling 150 of the probe 110. The probe 110 can carry a plurality of magnets that interact with the Hall effect sensors 240, 245 to provide multiple control functions in cooperation with controller algorithms, including (i) identification of the type of probe coupled to the handpiece, and (ii) the orientation of the probe hub 120 relative to the handpiece 104.
[0068] The Hall sensor 240 and controller algorithms can be adapted to read the magnetic field strength of the particular magnet(s) in the probe which can be compared to a library of field strengths that correspond to particular probe types. Then, a Hall identification signal can be generated or otherwise provided to the controller 165 to select the controller algorithms for operating the identified probe, which can include parameters for operating the motor drive 105, negative pressure source 220, the flow inducing device 226, power source (e.g., for illumination and other function) and / or RF source 225 as may be required for the probe type. The Hall sensor 240 and associated algorithms look for magnetic field strength regardless of polarity to identify the probe type.
[0069] As an example, the electrosurgical device 102 can be operated in different RF modes. As described below, in one mode can deliver RF current in a cutting waveform to thereby create a plasma that ablates tissue. Such mode can be utilized with the configurations of used in various of the FIGURES, for example. In another RF mode, the controller 165 can include an algorithm that utilizes a cut electrode in the extended position such as shown in various of the FIGURES. Then RF current in a coagulation waveform can be delivered to the electrodes. The operator can then move the stationary electrodes over a targeted site for coagulation of tissue.
[0070] FIG. 2 shows another example of an electrosurgical device 102'. This electrosurgical device 102' differs from the electrosurgical device 102 of FIG. 1 in that the probe 110' including a shaft 125' is integrated with the handpiece 104' as a single unit. Thus, the electrosurgical device 102' including the handpiece 104' can be disposable or reusable. Regarding the handpiece 104' this differs slightly in construction from the handpiece 104 of FIG. 1 in that various features (e.g., display, etc.) are not include. The handpiece 104' can include an activation button 166a' (e.g., power on, power off) and a mode switch button 166b' (e.g. for cut electrode extension during resection mode of FIG. 3 and cut electrode retraction during coagulation mode of FIG. 4). According to some examples, the activation button 166a' can be illuminated different colors based upon the mode selected.
[0071] FIG. 3 shows the electrosurgical device 102' having a first configuration for a plurality of electrodes during the resection (cut) mode. FIG. 4 illustrates the electrosurgical device 102' having a second configuration for the plurality of electrodes during the coagulation mode.
[0072] FIGS. 5 and 6 show an example of a distal end portion 112' of the shaft 125' of the probe 110' including a tip 112A'. The distal end portion 112' particularly at the tip 112A' can be made of or coated with an insulating material such as ceramic, for example. The tip 112 A' can be integrated (formed by) the shaft 125' or can be a separate component therefrom. FIG. 5 shows the coagulation mode, the second configuration for the plurality of electrodes. FIG. 6 shows the resection mode, the first configuration for the plurality of electrodes.
[0073] In FIG. 5, the a cut electrode 303 (also called a blade electrode herein) is substantially fully retracted into the tip 112A' and the distal end portion 112' such that only a first electrode 300 and a second electrode 302 remain exposed during the electrosurgical coagulation mode. In contrast, in FIG. 6, the cut electrode 303 is extended to have a distal end thereof distal of a distal end of the first electrode 300 and a distal end of the second electrode 302 during the electrosurgical resection mode.
[0074] As shown in FIGS. 5 and 6, the first electrode 300 can protrude from the tip 112A'. Similarly, the second electrode 302 can protrude from the tip 112A'. The second electrode 302 can be in a spaced apart relationship (e.g., from .25 mm to 25 mm, inclusive) from the first electrode 300. The first electrode 300 and second electrode 302 can have an elongate length along a longitudinal axis LA and can extend generally parallel with one another with respect to the longitudinal axis LA. In some examples, the first electrode 300 and / or the second electrode 302 can be partially formed from a flexible material allowing one or both of the electrodes 300, 302 to bend and move independently of one another such as laterally with respect to the longitudinal axis (FIG. 1). This configuration can offer a greater flexibility during operation in and around challenging tissue topography.
[0075] The first electrode 300 and the second electrode 302 can protrude substantially a same distance from the tip 112A' (e.g., between 2.5 mm and 20 mm, inclusive). However, it is contemplated that the first electrode 300 could protrude a greater distance than the second electrode 302 (or vice versa) according to further examples. The first electrode 300 and the second electrode 302 can be constructed of conductive metal or metal alloy such as tungsten, alloys including tungsten, or the like. The first electrode 300 and the second electrode 302 can be configured for bipolar operation with the first and second electrode 300, 302 alternating between active and return. Level of RF energy to the first and second electrodes 300, 302 can be controlled as desired for use in coagulation or RF ablation.
[0076] The first electrode 300 and the second electrode 302 can be similarly or identically shaped having a similar or substantially a same surface area. The first electrode 300 can include a distal tip 306 having a dome shape 304 according to the example of FIGS. 5 and 6. Similarly, the second electrode 302 can include a distal tip 306 having a dome shape 304 according to the example of FIGS. 5 and 6. However, other shapes for the distal tip are contemplated according to further examples. The first and second electrodes 300, 302 can extend internally within the shaft 125' a distance including all the way to a hub or other features within the handpiece in some cases. Alternatively, the electrodes 300, 302 can terminate such as at or just proximal of the distal end portion 112'.
[0077] The longitudinal length of the first electrode 300 and the second electrode 302 can be between 2.5 mm and 20 mm. The electrodes 300, 302 can be spaced apart a distance of 0.05 inches and 0.15 inches, inclusive. According to some examples, portions of the first electrode 300 and the second electrode 302 such as proximal portions 305 can be coated with electrically insulating material leaving only dome shape 304 of the distal tip 306 exposed with electrically conductive material. According to one example, the insulating material can be FluorinatedEthylene Propylene (FEP). Adding insulation on the electrodes 300, 302 reduces the conductive surface area, thereby lowering the current draw and preventing the electrosurgical device 102' from reaching the current limit set by the controller. Furthermore, The insulation length (e.g., about 2X the longitudinal length of the distal tip 306) and the corresponding, exposed surface area at the dome shape 304 of the distal tip 306 can be selected to ensure coagulation performance when the distal end portion 112' of the electrosurgical device 102' is submerged in blood, saline, or other conductive fluid (ringers lactate, etc.).
[0078] As further discussed subsequently, at least a third electrode referred to herein as the cut electrode 303 (shown in a retracted position received within the tip 112 A' in FIG. 5 and an extended position from the tip 112A' in FIG. 6) can be configured to move (e.g., retract and extend). This movement can be via direct engagement of the cut electrode 303 by an actuation mechanism or via other intermediate component(s) coupled to the actuation mechanism and the cut electrode 303. For simplicity, the present disclosure uses the term “actuator”, “wire”, “shaft” or “push rod” to describe not only any intermediate component(s) if utilized but the term also includes proximal portion(s) of the cut electrode 303 if directly engaged. Thus, the term “actuator”, “shaft”, “push rod”, “wire” or variations thereof can include proximal portions the cut electrode 303 itself or other component s) indirectly coupled to the cut electrode 303. In the extended position of FIG. 6, the distal end of the cut electrode 303 is positioned between 0.01 mm and 10 mm distal of the distal tip 306 of the first electrode 300 and the distal tip 306 of the second electrode 302. As also shown in FIG. 6, the cut electrode 303 is laterally offset a distance (e.g. between 0.005 mm and 5 mm) from between the first electrode 300 and the second electrode 302. According to further examples, this distance can be between 0.5 mm and 1.5 mm. This distance maintains a gap between the cut electrode 303, the first electrode 300 and the second electrode 302. The distance facilitates an angle of approach to tissue at the tip of between about 30 degrees and about 90 degrees as is further discussed and illustrated herein. The cut electrode 303 can be symmetrically arranged equidistant from the first electrode 300 and the second electrode 302. However, other relative arrangements of the cut electrode 303 relative to the first and second electrodes 300, 302 are contemplated.
[0079] The cut electrode 303 can have a different shape than the first electrode 300 and the second electrode 302 (and hence the surface area of the cut electrode 303 can differ from the surface area of the first electrode 300 and the second electrode 302). The first electrode 300 and the second electrode 302 can have a cylindrically shaped body with the dome shape 304 (a semi-spherical distal tip 306). A diameter of the first electrode 300 can be between .02 inchesto .75 inches (about .5 mm to about 19 mm), inclusive. The distal tip 306 can have another shape such as be flat, concave, convex, etc. according to further examples.
[0080] The cut electrode 303 is best shown in FIGS. 6, 7A and 7B and further subsequent FIGURES can have a shape of a blade or paddle, for example. Thus, the cut electrode 303 can have one or more surfaces that are substantially flat or only slightly curved. Other surfaces of the cut electrode 303 can be chamfered to create a ridge or blade type edge(s). Referring to FIGS. 7A and 7B, the cut electrode 303 can include major surfaces 308 substantially coated in suitable electrically insulating material(s) 308' (e.g., silicone). The major surfaces 308 can include surfaces that have the electrically insulating material 308' interface with the first electrode 300 and the second electrode 302 when the cut electrode 303 is extended as shown in FIG. 6. Referring again to FIGS. 7A and 7B, other areas such as along part or all of a minor surface 310 can be uncoated with insulating material so as to have electrically conductive material 310' (e.g., metal alloy) exposed. These one or more minor surfaces 310 can be much smaller dimensionally and in surface area than the major surfaces 308. As an example, the surface area of the minor surfaces 310 to the major surfaces 308 can be between 1 :5 to 1 :20 times smaller. Thus, at least a majority of the cut electrode 303 and up to 95% of the cut electrode 303 can be covered with the insulating material 308' leaving the electrically conducting material 310' exposed only along a distal tip portion 312. Collectively, the minor surfaces 310 can have a very small surface area, for example 0.024 in2(about 0.155 cm2), for example. This can focus RF energy into a small but precise area. The cut electrode 303 can have the distal tip portion 312. The distal tip portion 312 can be curved, flat, chamfered, or otherwise shaped as desired. The shape of the distal tip portion 312 can differ from that of the dome shape 304 as the geometry of the first electrode 300 and the second electrode 302 differs from the geometry of the cut electrode 303. It should be noted that the RF conducting portion 310' formed by the minor surfaces 310 can vary slightly along a first longitudinal extending side v. a second longitudinally extending side along the distal tip portion 312. This variation can be due to an angle of approach of the cut electrode 303 to tissue as further discussed herein and illustrated in FIG. 7C. The concentration of energy provided by the relatively small conducting portion 310', paired with a surface area ratio of between 2:25 and 4:25 between the exposed metals of the active and return electrodes, increases the energy density at the remaining exposed conductive surface 310' of the distal tip portion 312 (the cutting edge), leading to more effective and efficient tissue dissection. The arrangement and configurations of the electrodes shown in FIGS. 5-7C can provide for effective ablation and tissue resection even when the tip112A' is submerged in fluid. The insulating material 308' prevents electrical leakage and maintains a focused current path, preventing the dispersion of energy in the water.
[0081] FIG. 7C shows the cut electrode 303 in an extended position for a resection mode of operation with an angle of approach to tissue. FIG. 7C shows the orientation of the conducting portion 310' and minor surfaces 310 and the insulating material(s) 308' of the major surfaces 308 relative to the second electrode 302 and the tissue.
[0082] Referring again to FIGS. 5 and 6, the first electrode 300 can have a plurality of ports including a port 314 therein. A diameter of the port 314 can be between 0.025 inches and 0.055 inches, inclusive. The port 314 can be an outlet from a first flow tube (shown subsequently such as in FIG. 9) that defines a flow channel. Thus, the port 314 can be an oulet port for irrigating fluid to pass to tissue. The first flow tube can be partially defined by the first electrode 300, can be in fluid communication with a flow channel through the first electrode 300 or can be an entirely separate component from the first electrode 300 that can have an outlet adjacent the first electrode 300. The first flow tube(s) can extend along the shaft 125' and can be in fluid communication with the flow inducing device 226 (FIG. 1). Via the port 314 (and other ports not shown in FIGS. 5 and 6) irrigating fluid can be delivered to the surgical space adjacent the first electrode 300.
[0083] FIGS. 5 and 6 show a port 315 that can act as a suction port during operation of the device. This suction port 315 can communicate with a flow channel (e.g., formed by a flow tube) and is in further in communication with the aspiration tubing 222 which communicates with the negative pressure source 220 (FIG. 1). Via the port 315, the debris (e.g., irrigating fluid, blood, tissue, smoke, etc.) can be aspirated and pass away from the surgical site. The location of the port 315 in FIGS. 5 and 6 (lateral of the longitudinal axis and between and below the first electrode 300 and the second electrode 302) is purely exemplary and can be in other locations such as at one of the electrodes. The use of additional ports are also contemplated. A minimum suction flow rate through the port 315 can be substantially equal to the outflow rate collectively through the ports 314 and 316. However, the suction flow rate through the port 315 can be anywhere from 1.1 : 1 to 6: 1 times greater as compared to the inflow rate collectively through the ports 314 and 316. Inflow and suction flow rates are paired to create a stable fluid equilibrium at the surgical site. The flow rate through the port 315 can be about 3: 1 times greater than the inflow rate collectively through the ports 314 and 316 according to some examples.
[0084] The second electrode 302 can have a plurality of ports including a second port 316 therein. A diameter of the port 316 can be between 0.025 inches and 0.055 inches, inclusive.It should be noted as shown in FIG. 6 that the port 314 and the port 316 can be arranged to point directly at the cut electrode 303 when the cut electrode 303 is in the extended position. Put another way, the port 314 can be positioned and angulated to allow the irrigating fluid to be injected directly at the cut electrode 303 from a first lateral side thereof. The second port 316 is positioned and angulated to allow the irrigating fluid to be injected directly at the blade electrode from a second lateral side thereof. However, other locations or additional ports or alternative port locations are contemplated. The port 316 can be an outlet for irrigating fluid to pass to the surgical area (also called the surgical site herein) allowing the irrigating fluid to pass from the electrosurgical device to the surgical area. The port 316 can be in fluid communication with a second flow tube (shown subsequently such as in FIG. 9) that defines a flow channel. The second flow tube can be partially defined by the second electrode 302 or can be in fluid communication with a flow channel through the second electrode 302. The first flow tube(s) can extend along the shaft 125' and can be in fluid communication with the flow inducing device 226 (FIG. 1).
[0085] An illumination element 318 can be positioned at or adjacent the distal end portion 112' such as along a distal face of the tip 112A'. This location can be generally between the first electrode 300 and the second electrode 302 but slightly laterally offset from the longitudinal axis, the first electrode 300 and the second electrode 302, for example. The illumination element 318 can be a light emitting diode (LED) or plurality of LEDs for example. The illumination element 318 can be actuated and controlled by the buttons on the handpiece, foot pedal, etc. The illumination element 318 can increase or decrease in luminance, change illumination color, etc. under control such as actuated by the buttons on the handpiece as contemplated herein. Although a single illumination element 318 is shown it is contemplated a plurality of such illumination elements can be utilized at or adjacent the distal end portion 112'. Other locations for the single illumination element 318 such as proximal of the distal end portion 112' and the tip 112A' are also contemplated.
[0086] FIGS. 8A and 8B show the distal end portion 112' including the tip 112A' of the shaft 125' from two different perspectives. FIG. 8A illustrates the first electrode 300 can include a plurality of ports including the port 314 and a second port 314A. Further ports are also contemplated. The port 314 and the second port 314A can be angled from one another, for example between about 15 degrees and about 60 degrees, inclusive. Similarly, FIG. 8B illustrates the second electrode 302 can include a plurality of ports including the port 316 and a second port 316A. Further ports are also contemplated. The port 316 and the second port 316A can be angled from one another, for example between about 15 degrees and about 60degrees, inclusive. Although the ports 314, 314A, 316 and 316A of FIGS. 8 A and 8B are shown mirror symmetrically arranged, further examples contemplate the ports can be staggered in a non-mirror symmetry.
[0087] FIG. 9 schematically illustrates the shaft 125' having flow tubes 319, 320 for irrigating fluid. Tube 319 can communicate with the first electrode 300 and the tube 320 can communicate with the second electrode 302. Alternatively a common tube communicating with both the first electrode 300 and the second electrode 302 is contemplated according to some examples. FIG. 9 shows an aspiration tube 322 communicating with the port 315 (FIGS. 5 and 6). Inflow rate of irrigating fluid (e.g., saline) can be between 5 mL / min to 30 mL / minute. However, higher rates of inflow such as up to 100 mL / min are possible if desired.
[0088] FIG. 10 graphically shows an average coagulation depth v. inflow (mL / min) over plotted over various time durations (5 seconds and 10 seconds). FIG. 10 illustrates that saline inflow and coagulation depth are proportional. As the amount of saline increases the coagulation depth into the tissue increases. The saline rehydrates the tissue, preventing tissue desiccation, allowing the RF energy to continue to conduct through the tissue causing coagulation.
[0089] FIGS. 11 and 12 show the arrangement of the ports 314, 314A, 316 and 316A of the first electrode 300 and second electrode 302. As discussed, the port 314 can be angled between about 15 degrees and about 60 degrees, inclusive relative to the port 314A. The port 316 can be angled between about 15 degrees and about 60 degrees, inclusive relative to the port 316A. As shown in FIG. 12, the port 314 can be positioned and angulated to allow the irrigating fluid (indicated with arrows) to be injected directly at the cut electrode 303 from a first lateral side thereof. This lateral side can be one of the major surfaces discussed previously in regard to FIGS. 7A and 7B. The second port 316 is positioned and angulated to allow the irrigating fluid (indicated with arrows) to be injected directly at the blade electrode from a second lateral side thereof. This lateral side can be one of the major surfaces discussed previously in regard to FIGS. 7 A and 7B.
[0090] FIG. 13 schematically illustrates the device with the first electrode 300, the second electrode 302 and the cut electrode 303 moving along tissue from a first position to a second position. An area 324 of irrigating fluid 326 from the 314, 314A, 316 and 316A into the surgical area is illustrated. Each electrode dome has at least two irrigating fluid outflow ports for the infusion of saline into the surgical site. The inflow port locations were selected to ensure hydration of the tissue during both coagulation and cut modes. The angle of the outflow ports directs fluid in at least two directions, forward towards the cut electrode 303 and backward towhere the cut electrode 303 will move as the blade cuts. This ensures that the blade remains wetted by saline throughout the cutting process.
[0091] FIG. 14 shows the electrosurgical device 102', in particular the handpiece 104' in cross-section. The handpiece 104' includes a housing 328, the buttons 166a' and 166b', a main printed circuit board assembly 330, an RF switching printed circuit board assembly 332 and a mechanism 334.
[0092] The housing 328 can contain the buttons 166a' and 166b', the main printed circuit board assembly 330, the RF switching printed circuit board assembly 332 and the mechanism 334 at least partially therein. The mechanism 334 can comprise an actuator for the cut electrode (not shown) and additionally for the RF switching printed circuit board assembly 332. The mechanism 334 can include a motor 336, a drive screw 338 and a nut 340. The mechanism 334 can be coupled to the RF switching printed circuit board assembly 332 by a drive rod 342 (sometimes called a push rod or simply a shaft herein).
[0093] The mechanism 334 can be used for extending and retracting the cut electrode as further described and illustrated. The nut 340 can be arranged on the drive screw 338 (also called a lead screw herein). The nut 340 can travel along the drive screw 338 with rotation of the drive screw 338 by the motor 336. The nut 340 can be coupled to the drive rod 342 such that the drive rod 342 can move linearly with linear movement of the nut 340 along the drive screw 338. The motor-driven nut 340 travels along the drive screw 338 and drives the blade electrode distally or proximally depending on a rotation direction of the motor 336.
[0094] As shown in FIG. 14 and further illustrated in greater detail in FIGS. 15A and 15B, the RF switching printed circuit board assembly 332 can be arranged generally parallel but spaced from the main printed circuit board assembly 330. The RF switching printed circuit board assembly 332 can be selectively electrically connected to the main printed circuit board assembly 330 as further described herein. Additionally, the RF switching printed circuit board assembly 332 can be moveable (e.g., can translate) relative to the main printed circuit board assembly 330 as actuated by the mechanism 334.
[0095] FIGS. 15A and 15B show the handpiece 104' with the housing 328, the buttons 166a' and 166b', the main printed circuit board assembly 330, the RF switching printed circuit board assembly 332, the drive rod 342 and a second drive rod 344. FIGS. 15A and 15B illustrate the arrangement of the RF switching printed circuit board assembly 332 relative to the main printed circuit board assembly 330 in further detail.
[0096] Recall the mode switching button 166b' can be used to switch between the coagulation mode and the resection mode. As such, the mode switch button 166b' can be usedby the surgeon to extend and retract the cut electrode as further discussed and illustrated. The main printed circuit board assembly 330 can include features of the buttons 166a' and 166b' and other components (e.g., electronics) not specifically shown. The RF switching printed circuit board assembly 332 can be moveably supported by the housing 328. The RF switching printed circuit board assembly 332 can be coupled to the drive rod 342 at a first end and is coupled to the second drive rod 344 at a second opposing end. The second drive rod 344 can be coupled to the cut electrode.
[0097] The main printed circuit board assembly 330 and the RF switching printed circuit board assembly 332 can be responsible for data communication for the button control, LED control, motor control, motor current measuring / monitoring, and radiofrequency delivery. The radiofrequency energy is transferred from the main printed circuit board assembly 330 into the RF switching printed circuit board assembly 332. This transfer controls which components on the distal tip of the electrosurgical device 102' are energized.
[0098] FIGS. 15A, 15B, 16A and 16B additionally show electrical connectors 346A, 346B (shown only in FIG. 15B) and 346C (shown only in FIG. 15C). These electrical connectors 346A, 346B and 346C (sometimes called pogos herein) can be biased by a spring 348 as shown in FIG. 16B. These electrical connectors 346A, 346B and 346C can be leaf springs or ball spring plungers and can selectively contact electrical pads on the RF switching printed circuit board assembly 332 as further discussed.
[0099] FIGS. 17-19A illustrate operation of the electrosurgical device 102' in various operation modes. Such modes are facilitated by the mechanism 334. The mechanism 334 drives movement of the RF switching printed circuit board assembly 332 (FIGS. 14-15B) relative to the main printed circuit board assembly 330 (FIGS. 14-15B) between a first position and a second position (and indeed to a third position) as further discussed and illustrated. FIGS. 17 and 17A show a configuration of the electrosurgical device 102' during the coagulation mode. As shown in FIG. 17, components of the handpiece 104' including the nut 340 and drive screw 338 are in a first position with the cut electrode in a retracted position within the tip 112 A' as shown in FIG. 17 A.
[0100] FIG. 18 and 18A show a first resection mode configuration for the electrosurgical device 104'. As shown in FIG. 18, travel of the nut 340 along the lead screw 338 as driven by the motor 336 is to a second position. As shown in FIG. 18A this movement extends the cut electrode 303 to an intermediate extended position with a distal tip of the cut electrode 303 distal of the tip of the second electrode 302 and the first electrode (not shown).
[0101] If a deeper resection cut is desired by the surgeon, the electrosurgical device 102' has the capability of achieving such deeper resection. FIGS. 19 and 19A show a second resection mode for deeper cutting of tissue. In particular, FIG. 19 shows travel of the nut 340 along the lead screw 338 as driven by the motor 336 is to a third (distal most) position. As shown in FIG. 19A this movement extends the cut electrode 303 to a fully extended position with the distal tip of the cut electrode 303 even further distal of the tip of the second electrode 302 and the first electrode (not shown) than was the case in the intermediate extended position of FIG. 18 A.
[0102] Thus, with the electrosurgical device 102' allows the surgeon to switch between the different modes of operation by pressing the mode switch button 166b' (shown in FIGS. 14- 15B). For example, when pressing the button 166b', the cut electrode extends to its default cut length position (e.g., the intermediate extended position). When holding the button 166b', the cut electrode extends to its maximum extension length (e.g., the fully extended position). When pressing the button 166b' again, the cut electrode retracts and the electrosurgical device 102' switches to coagulation mode. The mechanism drives movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
[0103] FIGS. 20-24 show aspects of the electrical configuration during the coagulation mode. FIG. 20 illustrates the electrical connections of the device during the coagulation mode with the first electrode 300 serving as the active electrode and the second electrode 302 serving as the return electrode. FIG. 21 illustrates movement of the RF switching printed circuit board assembly 332 relative to the main printed circuit board assembly 330 between a first position and a second position. FIG. 21 shows a switch between operation modes where the RF switching printed circuit board assembly 332 holding contact pads (see FIG. 22) moves to complete a desired first electrical circuit. FIG. 22 illustrates the first electrical circuit configuration. This circuit is completed by the RF switching printed circuit board assembly 332 moved to a first position and having a plurality of electrical pads (contacts) 348A and 348B facilitating electrical connection between the first electrode and the second electrode and the RF source (e.g., active output and return output from controller) via the main printed circuit board (not shown) and the electrical connectors (see FIGS. 15A-16B).
[0104] FIG. 23 illustrates the relative positioning of internal components of the handpiece 104' of the electrosurgical device 102' in the coagulation mode including the main printed circuit board assembly 330, the RF switching printed circuit board assembly 332 and the nut 340. FIG. 24 shows the distal end portion 112' of the electrosurgical device 102' during thecoagulation mode with EF field lines shown passing from the first electrode 300 (active) to the second electrode 302 (return). EF current can pass between the first electrode 300 and the second electrode 302 within the surgical site for coagulation. Although the first electrode 300 is shown as the active electrode in FIGS. 20-24, according to other examples the active electrode can be the second electrode 302.
[0105] FIGS. 25-29 show aspects of the electrical configuration during the resection mode. FIG. 25 illustrates the electrical connections of the device during the resection mode with the first electrode 300 serving as one return electrode, the second electrode 302 serving as a second return electrode and the cut electrode 303 serving as the active electrode. FIG. 26 illustrates movement of the RF switching printed circuit board assembly 332 relative to the main printed circuit board assembly 330 between the second position and the first position. FIG. 26 shows a switch between operation modes where the RF switching printed circuit board assembly 332 holding contact pads (see FIG. 27) moves to complete a desired second electrical circuit used for resection cutting of tissue. FIG. 27 illustrates the second electrical circuit configuration. This circuit is completed by the RF switching printed circuit board assembly 332 moved to the second position and having a contact bar 350 and contact pad 352 facilitating electrical connection between the cut electrode, the first electrode and the second electrode and the RF source (e.g., active output and return output from controller) via the main printed circuit board (not shown) and the electrical connectors (see FIGS. 15A-16B).
[0106] FIG. 28 illustrates the relative positioning of internal components of the handpiece 104' of the electrosurgical device 102' in the resection mode including the main printed circuit board assembly 330, the RF switching printed circuit board assembly 332 and the nut 340. FIG. 29 shows the distal end portion 112' of the electrosurgical device 102' during the coagulation mode with EF field lines shown passing from the exposed distal tip of the cut electrode 303 (active) to the first electrode 300 (return) and the second electrode 302 (return). EF current can pass between the cut electrode 303 to the first electrode 300 and the second electrode 302 within the surgical site for resection of tissue. Although the cut electrode 303 is shown as the active electrode in FIGS. 25-29, according to other examples the active electrode can be one or the combination of the first electrode 300 and the second electrode 302.
[0107] As illustrated in various of FIGS. 20-29, in the first position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a first circuit for a first operation mode, and in the second position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connectedthereto to complete a second circuit for a second operation mode. Furthermore, the first electrode is a return electrode for both the first operation mode and the second operation mode, the cut electrode is an active electrode in the first operation mode, and the second electrode is the active electrode in the second operation mode. The first operation mode occurs with the cut electrode in one or both of an intermediate extended position and a fully extended position relative to the tip, the first electrode and the second electrode. The second operation mode occurs with the cut electrode positioned in a fully retracted position relative to the tip, the first electrode and the second electrode. Movement of the cut electrode from the fully extended position to the fully retracted position occurs during movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
[0108] FIG. 30 shows a distal end portion 412 of another example of an electrosurgical device 400. This device 400 differs from those previously discussed in that the first electrode 300 can include a compression spring 402 and the second electrode 302 can include a compression spring 404. This design includes a plunger housing where irrigating fluid inflow fills a cavity, forcing the fluid flow to exit the tip 412A through a gap between the tip 412A and the first and second electrodes 300 and 302. This method of entry for the irrigating fluid allows the fluid to uniformly coat the entire circumference of the first and second electrodes 300 and 302.
[0109] FIGS. 31 and 32 show a distal end portion 512 of yet another example of an electrosurgical device 500 with the device 500. Each FIG. 31 and 32 is shown in two different configurations for the first electrode 300 and the second electrode 302. This device 500 differs from those previously discussed in that the first electrode 300 and the second electrode 302 are retractable via respective springs 502 and 504 (FIG 32). Incorporating retractable first electrode 300 and second electrode 302 into the design allows the "extra cut depth" currently provided by the electrosurgical device 102' (FIGS. 2-29) motor extension to be achieved manually. This is done by compressing the springs 502 and 504 and retracting the first electrode 300 and the second electrode 302. By fully retracting the first electrode 300 and the second electrode 302, a 2X cut electrode 303 extension can be accomplished.
[0110] FIGS. 33-36 show an RF switching printed circuit board assembly 632 with a different configuration than the RF switching printed circuit board assembly described previously. The RF switching printed circuit board assembly 632 can include a plurality of magnets 600, 602 and 604 therein or thereon as shown in FIG. 33.[OHl] As shown in FIGS. 34-36, a hall effect sensor 606 can interact with the magnets 600, 602 and 604 respectively, to achieve the various coagulation mode, the resection mode with the intermediate cut electrode position and the fully extended cut electrode position previously described in regards to FIGS. 17-19A. Hall sensor 606 is shown located on the main printed circuit board assembly in FIGS. 34-36. However, other locations are contemplated for the hall sensor 606 such as on the housing. As shown in FIGS. 33-36, to transition from coagulation mode to cut mode, the linear, bipolar hall sensor 606 combined with strategically placed magnets is used. Magnets 600, 602 and 604 are positioned on the RF switching printed circuit board assembly 632 in a way that, in the coagulation position of FIG. 34, a north facing magnet 600 is directly beneath the Hall sensor 606, resulting in sensor readings. In FIG. 35, as the RF switching printed circuit board assembly 632 moves to the first extension position for the cut electrode (the intermediate position), the smaller south facing magnet 602 aligns with the Hall sensor 606. As shown in FIG. 36, at the second extension position for the cut electrode (the fully extended position, the larger south facing magnet 604 is positioned under the Hall sensor 606. The use of two differently sized south facing magnets ensures a significant difference in sensor readings between the two extensions, allowing the system to reliably distinguish between them and switch modes accordingly. If the second extension is not required, an omnipolar Hall sensor can be used with only one magnet. The software can be configured to switch modes whenever the sensor detects a magnetic field, regardless of its polarity. This simplifies the design by reducing the number of magnets needed and allows for more straightforward mode switching based on the presence of any magnetic field. Additionally, the same functionality can be achieved using detection switches (e.g., optical detectors). These switches can be configured to detect the position of the moving board and switch modes accordingly.
[0112] FIG. 37 shows different angles of approach that can be achieved with the electrosurgical device 102' (or any of the other devices disclosed herein) during resection of tissue. The angle of approach can determine a depth of the resection of the cut electrode 303 as demonstrated in FIG. 37. If a deeper resection is desired a steeper angle of approach for the distal end portion 112' should be utilized.
[0113] FIGS. 38-39A show an alternative actuation mechanism 702 for an electrosurgical device 700. The mechanism 702 can include a slider 704. As shown in FIGS. 38 and 39, the design, slider 704 is attached to a pushrod coupled to the cut electrode. The slider 704 is configured to move distally and proximally, to extend and retract the cut electrode. Optionally, a magnet 706A and 706B can be located on either end of the slider's travel path. Each magnet706A and 706B interacts with a magnet 708 of opposite polarity affixed at the middle of the slider 704. This configuration can be used to lock the respective position of the slider 704 (and hence the cut electrode) in place. The slider 704 can additionally move the RF switching printed circuit board assembly (not shown) which switches the electrical connections required for our devices' RF mode switch.
[0114] FIG. 40 schematically illustrates a solenoid actuation mechanism 800 that can be used as mechanism to extend and retract the cut electrode and change operation modes as previously discussed herein. When the electric current is on, the magnetic field generated by the solenoid actuation mechanism 800 pushes a plunger 802. When the current is off, the magnetic force disappears, allowing the plunger 802 to move freely and return to its original position. The plunger 802 can be connected directly or indirectly to the cut electrode such as via a push rod.
[0115] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
[0116] In some aspects, the techniques described herein relate to a probe for an electrosurgical device for treating tissue, the probe including: an elongated shaft having a proximal end portion, a distal end portion with a tip, and a longitudinal axis; a first dome electrode positioned at the tip; a second dome electrode positioned at the tip and spaced laterally from the first dome electrode; and a blade electrode positioned at the tip, wherein the blade electrode is retractable and extendible relative to the tip, the first dome electrode and the second dome electrode.
[0117] In some aspects, the techniques described herein relate to a probe, wherein the blade electrode is substantially fully retracted into the tip and the distal end portion such that only the first dome electrode and the second dome electrode remain exposed during an electrosurgical coagulation mode.
[0118] In some aspects, the techniques described herein relate to a probe, wherein the blade electrode is extended to have a distal end thereof distal of a distal end of the first dome electrode and a distal end of the second dome electrode during an electrosurgical resection mode.
[0119] In some aspects, the techniques described herein relate to a probe, wherein the distal end of the blade electrode is positioned between 0.01 mm and 10 mm distal of the distal end of the first dome electrode and the distal end of the second dome electrode.
[0120] In some aspects, the techniques described herein relate to a probe, wherein the blade electrode is laterally offset a distance from between the first dome electrode and the second dome electrode.
[0121] In some aspects, the techniques described herein relate to a probe, wherein the distance is between 0.5 mm and 1.5 mm, wherein the distance maintains a gap between the blade electrode, the first dome electrode and the second dome electrode, and wherein the distance facilitates an angle of approach to tissue at the tip of between about 30 degrees and about 90 degrees.
[0122] In some aspects, the techniques described herein relate to a probe, wherein at least a majority of the blade electrode and up to 95% of the blade electrode is covered with an insulating material leaving an electrically conducting material exposed only along a distal end portion thereof.
[0123] In some aspects, the techniques described herein relate to a probe, wherein the first dome electrode has at least two outflow ports for an irrigating fluid, wherein one of the at least two outflow ports of the first dome electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a first lateral side thereof, wherein the second dome electrode has at least two outflow ports for the irrigating fluid, and wherein one of the at least two outflow ports of the second dome electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a second lateral side thereof.
[0124] In some aspects, the techniques described herein relate to a probe, further including a mechanism for extending and retracting the blade electrode.
[0125] In some aspects, the techniques described herein relate to a probe, wherein the mechanism is one of a motor-driven nut that travels along a lead screw with the motor-driven nut coupled to a shaft that is coupled to the blade electrode, a hand actuated slider component, a spring and locking mechanism, a mechanical slider, a mechanism with magnets and hall sensor, a push-pull mechanism or a solenoid actuated mechanism.
[0126] In some aspects, the techniques described herein relate to a probe, wherein the mechanism drives movement of a radiofrequency switching printed circuit board assembly relative to a main printed circuit board assembly between a first position and a second position.
[0127] In some aspects, the techniques described herein relate to a probe, wherein, in the first position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a first circuit for a first operation mode, and in the second position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a second circuit for a second operation mode.
[0128] In some aspects, the techniques described herein relate to a probe, wherein the radiofrequency switching printed circuit board assembly is electrically connected to the main printed circuit board assembly using a plurality of spring-loaded connectors.
[0129] In some aspects, the techniques described herein relate to a probe, wherein the first dome electrode is a return electrode for both the first operation mode and the second operation mode, wherein the blade electrode is an active electrode in the first operation mode, and wherein the second dome electrode is the active electrode in the second operation mode.
[0130] In some aspects, the techniques described herein relate to a probe, wherein the first operation mode occurs with the blade electrode in one or both of an intermediate extended position and a fully extended position relative to the tip, the first dome electrode and the second dome electrode, wherein the second operation mode occurs with the blade electrode positioned in a fully retracted position relative to the tip, the first dome electrode and the second dome electrode, and wherein movement of the blade electrode from the fully extended position to the fully retracted position occurs during movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
[0131] In some aspects, the techniques described herein relate to a probe, wherein the motor-driven nut travels along the lead screw and drives the blade electrode distally or proximally depending on a rotation direction of a motor.
[0132] In some aspects, the techniques described herein relate to a probe, further including an illumination device positioned at the tip.
[0133] In some aspects, the techniques described herein relate to a probe, further including a handpiece, wherein the probe is configured to couple with the handpiece.
[0134] In some aspects, the techniques described herein relate to an electrosurgical device for treating tissue, the device including: a handpiece including: a housing, a main printed circuit board assembly within the housing, a radiofrequency switching printed circuit board assembly within the housing, and a mechanism at least partially positioned within the housing, a probe coupled to the handpiece, the probe including: an elongated shaft having a proximal end portion, a distal end portion with a tip, and a longitudinal axis; a first electrode positioned at the tip; a second electrode positioned at the tip and spaced laterally from the first electrode; and a cut electrode positioned at the tip, wherein the cut electrode is retractable and extendible relative to the tip, the first electrode and the second electrode by the mechanism, wherein the mechanism drives movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between a first position and a secondposition, and wherein in the first position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a first circuit for a first operation mode, and in the second position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a second circuit for a second operation mode.
[0135] In some aspects, the techniques described herein relate to a device, wherein the cut electrode is substantially fully retracted into the tip and the distal end portion such that only the first electrode and the second electrode remain exposed in the second operation mode which is an electrosurgical coagulation mode, and wherein the cut electrode is extended to have a distal end thereof distal of a distal end of the first electrode and a distal end of the second electrode during the first operation mode which is an electrosurgical resection mode.
[0136] In some aspects, the techniques described herein relate to a device, wherein the distal end of the cut electrode is positioned between 0.01 mm and 10 mm distal of the distal end of the first electrode and the distal end of the second electrode.
[0137] In some aspects, the techniques described herein relate to a device, wherein the first electrode is a return electrode for both the first operation mode and the second operation mode, wherein the cut electrode is an active electrode in the first operation mode, and wherein the second electrode is the active electrode in the second operation mode.
[0138] In some aspects, the techniques described herein relate to a device, wherein the first operation mode occurs with the cut electrode in one or both of an intermediate extended position and a fully extended position relative to the tip, the first electrode and the second electrode, wherein the second operation mode occurs with the cut electrode positioned in a fully retracted position relative to the tip, the first electrode and the second electrode, and wherein movement of the cut electrode from the fully extended position to the fully retracted position occurs during movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
[0139] In some aspects, the techniques described herein relate to a device, wherein the cut electrode is laterally offset a distance from between the first electrode and the second electrode.
[0140] In some aspects, the techniques described herein relate to a device, wherein the distance is between 0.5 mm and 1.5 mm, wherein the distance maintains a gap between the cut electrode, the first electrode and the second electrode, and wherein the distance facilitates an angle of approach to tissue at the tip of between about 30 degrees and about 90 degrees.
[0141] In some aspects, the techniques described herein relate to a device, wherein at least a majority of the cut electrode and up to 95% of the cut electrode is covered with an insulating material leaving an electrically conducting material exposed only along a distal end portion thereof.
[0142] In some aspects, the techniques described herein relate to a device, further including a plurality of tubes extending along the elongated shaft to the distal end portion, wherein the first electrode is connected to at least a first of the plurality of tubes and has a channel therein extending to at least two outflow ports for an irrigating fluid, wherein one of the at least two outflow ports of the first electrode is positioned to allow the irrigating fluid to be injected directly at the cut electrode from a first lateral side thereof, wherein the second electrode is connected to at least a second of the plurality of tubes and has a channel therein extending to at least two outflow ports for the irrigating fluid, and wherein one of the at least two outflow ports of the second electrode is positioned to allow the irrigating fluid to be injected directly at the cut electrode from a second lateral side thereof.
[0143] In some aspects, the techniques described herein relate to a device, wherein the at least two outflow ports for the irrigating fluid of the first electrode include two ports that are angled between 30 degrees and 60 degrees with respect to one another, and wherein the at least two outflow ports for the irrigating fluid of the second electrode include two ports that are angled between 30 degrees and 60 degrees with respect to one another.
[0144] In some aspects, the techniques described herein relate to a device, wherein the cut electrode has a first configuration relative to the first electrode and the second electrode in an electrosurgical coagulation mode and has a second configuration relative to the first electrode and the second electrode in an electrosurgical resection mode.
[0145] In some aspects, the techniques described herein relate to a device, wherein the first electrode has a dome shaped tip and the second electrode has a dome shaped tip, and wherein the cut electrode is shaped as a blade along one or more portions thereof.
[0146] In the above aspects, the devices or systems of any one or any combination of aspects can optionally be configured such that all elements or options recited are available to use or select from.
[0147] Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations andalternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
[0148] Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
[0149] The term “substantially”, “generally” or “about” mean within 15% of the value provided. The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[0150] Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than asspecifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
[0151] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
Claims
What is claimed is:
1. A probe for an electrosurgical device for treating tissue, the probe comprising: an elongated shaft having a proximal end portion, a distal end portion with a tip, and a longitudinal axis; a first dome electrode positioned at the tip; a second dome electrode positioned at the tip and spaced laterally from the first dome electrode; and a blade electrode positioned at the tip, wherein the blade electrode is retractable and extendible relative to the tip, the first dome electrode and the second dome electrode.
2. The probe of claim 1, wherein the blade electrode is substantially fully retracted into the tip and the distal end portion such that only the first dome electrode and the second dome electrode remain exposed during an electrosurgical coagulation mode.
3. The probe of any one of claims 1-2, wherein the blade electrode is extended to have a distal end thereof distal of a distal end of the first dome electrode and a distal end of the second dome electrode during an electrosurgical resection mode.
4. The probe of claim 3, wherein the distal end of the blade electrode is positioned between 0.01 mm and 10 mm distal of the distal end of the first dome electrode and the distal end of the second dome electrode.
5. The probe of any one of claims 1-4, wherein the blade electrode is laterally offset a distance from between the first dome electrode and the second dome electrode.
6. The probe of claim 5, wherein the distance is between 0.5 mm and 1.5 mm, wherein the distance maintains a gap between the blade electrode, the first dome electrode and the second dome electrode, and wherein the distance facilitates an angle of approach to tissue at the tip of between about 30 degrees and about 90 degrees.
7. The probe of any one of claims 1-6, wherein at least a majority of the blade electrode and up to 95% of the blade electrode is covered with an insulating material leaving an electrically conducting material exposed only along a distal end portion thereof.
8. The probe of any one of claims 1-7, wherein the first dome electrode has at least two outflow ports for an irrigating fluid, wherein one of the at least two outflow ports of the first dome electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a first lateral side thereof, wherein the second dome electrode has at least two outflow ports for the irrigating fluid, and wherein one of the at least two outflow ports of the second dome electrode is positioned to allow the irrigating fluid to be injected directly at the blade electrode from a second lateral side thereof.
9. The probe of any one of claims 1-8, further comprising a mechanism for extending and retracting the blade electrode.
10. The probe of claim 9, wherein the mechanism is one of: a motor-driven nut that travels along a lead screw with the motor-driven nut coupled to a shaft that is coupled to the blade electrode, a hand actuated slider component, a spring and locking mechanism, a mechanical slider, a mechanism with magnets and hall sensor, a push-pull mechanism or a solenoid actuated mechanism.
11. The probe of any one of claims 9 or 10, wherein the mechanism drives movement of a radiofrequency switching printed circuit board assembly relative to a main printed circuit board assembly between a first position and a second position.
12. The probe of claim 11, wherein, in the first position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a first circuit for a first operation mode, and in the second position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a second circuit for a second operation mode.
13. The probe of claim 12, wherein the radiofrequency switching printed circuit board assembly is electrically connected to the main printed circuit board assembly using a plurality of spring-loaded connectors.
14. The probe of any one of claims 12 or 13, wherein the first dome electrode is a return electrode for both the first operation mode and the second operation mode, wherein the bladeelectrode is an active electrode in the first operation mode, and wherein the second dome electrode is the active electrode in the second operation mode.
15. The probe of any one of claims 12-14, wherein the first operation mode occurs with the blade electrode in one or both of an intermediate extended position and a fully extended position relative to the tip, the first dome electrode and the second dome electrode, wherein the second operation mode occurs with the blade electrode positioned in a fully retracted position relative to the tip, the first dome electrode and the second dome electrode, and wherein movement of the blade electrode from the fully extended position to the fully retracted position occurs during movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
16. The probe of any one of claims 10-15, wherein the motor-driven nut travels along the lead screw and drives the blade electrode distally or proximally depending on a rotation direction of a motor.
17. The probe of any one of claims 1-16, further comprising an illumination device positioned at the tip.
18. The probe of any one of claims 1-17, further comprising a handpiece, wherein the probe is configured to couple with the handpiece.
19. An electrosurgical device for treating tissue, the device comprising: a handpiece comprising: a housing, a main printed circuit board assembly within the housing, a radiofrequency switching printed circuit board assembly within the housing, and a mechanism at least partially positioned within the housing, a probe coupled to the handpiece, the probe comprising: an elongated shaft having a proximal end portion, a distal end portion with a tip, and a longitudinal axis; a first electrode positioned at the tip;a second electrode positioned at the tip and spaced laterally from the first electrode; and a cut electrode positioned at the tip, wherein the cut electrode is retractable and extendible relative to the tip, the first electrode and the second electrode by the mechanism, wherein the mechanism drives movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between a first position and a second position, and wherein in the first position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a first circuit for a first operation mode, and in the second position, the radiofrequency switching printed circuit board assembly is positioned relative to the main printed circuit board assembly to be electrically connected thereto to complete a second circuit for a second operation mode.
20. The device of claim 19, wherein the cut electrode is substantially fully retracted into the tip and the distal end portion such that only the first electrode and the second electrode remain exposed in the second operation mode which is an electrosurgical coagulation mode, and wherein the cut electrode is extended to have a distal end thereof distal of a distal end of the first electrode and a distal end of the second electrode during the first operation mode which is an electrosurgical resection mode.
21. The device of claim 20, wherein the distal end of the cut electrode is positioned between 0.01 mm and 10 mm distal of the distal end of the first electrode and the distal end of the second electrode.
22. The device of any one of claims 19-21, wherein the first electrode is a return electrode for both the first operation mode and the second operation mode, wherein the cut electrode is an active electrode in the first operation mode, and wherein the second electrode is the active electrode in the second operation mode.
23. The device of any one of claims 19-22, wherein the first operation mode occurs with the cut electrode in one or both of an intermediate extended position and a fully extended position relative to the tip, the first electrode and the second electrode, wherein the second operation mode occurs with the cut electrode positioned in a fully retracted position relative tothe tip, the first electrode and the second electrode, and wherein movement of the cut electrode from the fully extended position to the fully retracted position occurs during movement of the radiofrequency switching printed circuit board assembly relative to the main printed circuit board assembly between the first position and the second position.
24. The device of any one of claims 19-23, wherein the cut electrode is laterally offset a distance from between the first electrode and the second electrode.
25. The device of claim 24, wherein the distance is between 0.5 mm and 1.5 mm, wherein the distance maintains a gap between the cut electrode, the first electrode and the second electrode, and wherein the distance facilitates an angle of approach to tissue at the tip of between about 30 degrees and about 90 degrees.
26. The device of any one of claims 19-25, wherein at least a majority of the cut electrode and up to 95% of the cut electrode is covered with an insulating material leaving an electrically conducting material exposed only along a distal end portion thereof.
27. The device of any one of claims 19-26, further comprising a plurality of tubes extending along the elongated shaft to the distal end portion, wherein the first electrode is connected to at least a first of the plurality of tubes and has a channel therein extending to at least two outflow ports for an irrigating fluid, wherein one of the at least two outflow ports of the first electrode is positioned to allow the irrigating fluid to be injected directly at the cut electrode from a first lateral side thereof, wherein the second electrode is connected to at least a second of the plurality of tubes and has a channel therein extending to at least two outflow ports for the irrigating fluid, and wherein one of the at least two outflow ports of the second electrode is positioned to allow the irrigating fluid to be injected directly at the cut electrode from a second lateral side thereof.
28. The device of claim 27, wherein the at least two outflow ports for the irrigating fluid of the first electrode comprise two ports that are angled between 30 degrees and 60 degrees with respect to one another, and wherein the at least two outflow ports for the irrigating fluid of the second electrode comprise two ports that are angled between 30 degrees and 60 degrees with respect to one another.
29. The device of claim 19, wherein the cut electrode has a first configuration relative to the first electrode and the second electrode in an electrosurgical coagulation mode and has a second configuration relative to the first electrode and the second electrode in an electrosurgical resection mode.
30. The device of any one of claims 19-29, wherein the first electrode has a dome shaped tip and the second electrode has a dome shaped tip, and wherein the cut electrode is shaped as a blade along one or more portions thereof.
Citation Information
Patent Citations
Arthroscopic devices and methods
US20180263649A1
Arthroscopic devices and methods
US20180303509A1
Arthroscopic devices and methods
US20180317957A1
Arthroscopic devices and methods
US20190008538A1
Artroscopic devices and methods
US20190008541A1