Electrosurgical device with flexible shaft
The electrosurgical device with a flexible shaft and retractable sheath addresses the complexity and safety issues of existing plasma applicators by enabling precise plasma beam control and reducing mechanical complexity and stray currents, enhancing surgical efficiency and safety.
Patent Information
- Application Number
- JP2022550902
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-26
- Filing Date
- 2021-02-20
- Publication Date
- 2025-12-12
- Estimated Expiration
- 2041-02-20
AI Technical Summary
Existing electrosurgical devices with plasma applicators are mechanically complex, expensive, and difficult to operate effectively, especially in endoscopic procedures where redirecting the plasma beam is essential but limited by the small diameter of the endoscopic trocar, and bipolar devices pose risks due to stray currents.
An electrosurgical device with a flexible shaft and a retractable sheath over an electrode, allowing for both mechanical and electrosurgical cutting modes, and the ability to generate a plasma beam by supplying electrosurgical energy and inert gas to the electrode, with a mechanism for manipulating the distal tip using a grasper.
Enables precise control and redirection of the plasma beam, reducing mechanical complexity and operational difficulties while minimizing stray currents, facilitating safe and efficient surgical procedures.
Smart Images

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Abstract
Description
[Technical Field]
[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 981,558, entitled "ELECTROSURGICAL APPARATUS WITH FLEXIBLE SHAFT," filed February 26, 2020, the entire contents of which are incorporated herein by reference. Field
[0002] The present disclosure relates generally to electrosurgery and electrosurgical systems and devices, and more particularly to electrosurgical devices having a flexible shaft and a retractable sheath for exposing and covering electrodes, e.g., electrosurgical blades, needles, etc., for use in low-temperature plasma applications, electrosurgical cutting, and mechanical cutting. [Background technology]
[0003] Description of Related Technology
[0004] Radiofrequency electrical energy is widely used in surgery and is commonly referred to as electrosurgical energy, which is used to cut tissue and coagulate body fluids.
[0005] Electrosurgical instruments generally comprise either "monopolar" or "bipolar" devices. Monopolar devices have an active electrode on the electrosurgical instrument and a return electrode attached to the patient. In monopolar electrosurgery, electrosurgical energy flows through the active electrode on the instrument, through the patient's body, and to the return electrode. Such monopolar devices are useful in surgical procedures where cutting and coagulating tissue is required and stray currents do not pose a substantial risk to the patient.
[0006] A bipolar device includes an active electrode and a return electrode on a surgical instrument. In a bipolar electrosurgical device, electrosurgical energy flows through the active electrode into the patient's tissue, a short distance through the tissue, and then to the return electrode. The electrosurgical effect is substantially localized to a small area of tissue located between the two electrodes on the surgical instrument. While bipolar electrosurgical devices have proven useful in surgical procedures, stray currents can pose a risk to the patient, and proximity of the active and return electrodes is required in the context of other procedures. Surgeries involving bipolar electrosurgery often require methods and procedures that are substantially different from those involving monopolar electrosurgery.
[0007] Gas plasma is an ionized gas capable of transmitting electrical energy. Plasmas are used in surgical devices to transmit electrosurgical energy to a patient. The plasma transmits energy by providing a path of relatively low electrical resistance. Electrosurgical energy passes through the plasma to cut, coagulate, desiccate, or discharge the patient's blood or tissue. No physical contact is required between the electrode and the treated tissue.
[0008] Electrosurgical systems that do not incorporate a regulated gas source can ionize the ambient air between the active electrode and the patient, and the plasma thereby generated conducts electrosurgical energy to the patient, but the plasma arc generally appears to be more spatially dispersed compared to systems with a regulated ionized gas flow.
[0009] Atmospheric-pressure discharge cold plasma applicators have found use in a variety of applications, including surface sterilization, hemostasis, and tumor resection. Often, a simple scalpel is used to remove the tissue in question, followed by a cold plasma applicator for cauterization, sterilization, and hemostasis. Cold plasma beam applicators have been developed for both open and endoscopic procedures. In the latter case, it is often desirable to be able to redirect the cold plasma beam tip to a specific surgical site. The external incision and path for the endoscopic instrument may be selected to avoid major blood vessels and non-target organs, and may not coincide with optimal alignment of the target internal tissue site. In these situations, a means of redirecting the cold plasma beam is essential.
[0010] Sophisticated mechanisms have been developed to allow surgeons to redirect the plasma beam as needed. However, these mechanisms are mechanically complex, expensive to manufacture, and sometimes difficult to operate effectively. The small diameter of the endoscopic trocar through which surgical tools, such as plasma applicators, must be inserted imposes even more severe limitations on these issues. Summary of the Invention
[0011] In one aspect of the present disclosure, an electrosurgical device is provided. The electrosurgical device of the present disclosure includes a connector, a flexible shaft, and a distal tip. The connector is configured to be connected to an electrosurgical generator and a gas supply source. The distal tip of the electrosurgical device is configured to be grasped by a grasper, such as forceps, so that the orientation of the distal tip of the electrosurgical device can be manipulated in a number of ways about the flexible shaft. The electrosurgical device is configured to supply electrosurgical energy and an inert gas to an electrode within the distal tip of the electrosurgical device to generate a plasma beam.
[0012] In one aspect, the distal tip is configured as an extendable and retractable sheath over the electrode, exposing the electrode when the sheath is in a first position and concealing or covering the electrode when the sheath is in a second position. In one aspect, the electrode is configured as a conductive blade, and the electrosurgical device is configured for use in intraoperative mechanical and electrosurgical cutting when the sheath is in the first position, i.e., when the electrode is exposed, and for intraoperative low-temperature plasma applications when the sheath is in the second position, i.e., when the electrode is concealed or covered.
[0013] In accordance with one aspect of the present disclosure, an electrosurgical device includes a connector having a proximal end and a distal end, the proximal end of the connector configured to receive electrosurgical energy and a gas supply; a flexible insulating outer tube having a proximal end and a distal end, the proximal end of the flexible insulating outer tube being coupled to the distal end of the connector; and a distal tip having a proximal end and a distal end, the proximal end of the distal tip being coupled to the distal end of the flexible insulating outer tube, the distal tip including an electrode, the distal tip being extendable and retractable over the electrode. a distal tip configured as a flexible sheath that exposes the electrode when the sheath is in a first position and conceals or covers the electrode when the sheath is in a second position; and a flexible conductive member disposed through the flexible insulating outer tube and having a proximal end and a distal end, the distal end of the flexible conductive member being coupled to the electrode and configured to deliver electrosurgical energy to the distal end, wherein the flexible insulating outer tube and the flexible conductive member are configured to allow the distal tip to reach multiple positions relative to the flexible insulating outer tube.
[0014] In one aspect, the electrosurgical device further includes at least one memory disposed within the connector, the at least one memory storing information relating to use of the electrosurgical device.
[0015] In another aspect, the electrosurgical device further includes a coupler disposed within the connector and having a proximal end and a distal end, the proximal end configured to receive a gas supply and the distal end configured to be coupled to the proximal end of the flexible insulating outer tube, a fluid channel extending from the proximal end to the distal end of the coupler, the coupler further including an extension member extending perpendicularly away from the fluid channel, the extension member configured to receive a flexible conductive member and provide the flexible conductive member to the flexible insulating outer tube.
[0016] In yet another aspect, the electrosurgical device further includes a plug configured to be disposed within the extension member of the coupler, the plug including a channel for receiving the flexible conductive member such that when the flexible conductive member is disposed through the channel of the plug, the received gas is prevented from leaking into the connector.
[0017] In yet another aspect, the electrosurgical device further includes a cap configured to be placed over the extension member to prevent removal of the plug, the cap including at least one slot for securely fitting onto the coupler.
[0018] In yet another aspect, the electrosurgical device further includes an electrode coupler including a proximal end and a distal end, the proximal end of the electrode coupler coupled to the distal end of the flexible insulating outer tube, the distal end of the electrode coupler configured to support an electrode, and the sheath slidably positioned over the distal end of the electrode coupler.
[0019] In one aspect, the electrode coupler further includes at least one tab disposed on the outer wall, and the sheath includes at least one tab slot for receiving the at least one tab such that the sheath can be extended and retracted over the electrode coupler.
[0020] In another embodiment, the electrode coupler includes at least one hole through the sidewall proximate the distal end of the electrode coupler, and when gas is supplied to the electrode coupler through the flexible insulating outer tube, the gas exits the sheath through the at least one hole, flows over the electrode, and exits the distal end of the sheath.
[0021] In yet another aspect, the distal tip is configured to be grasped by a grasper to manipulate the position of the distal tip relative to the flexible insulating outer tube.
[0022] In one aspect, the distal tip includes a first gripping slot and a second gripping slot configured to allow grasping of the distal tip by a grasping tool.
[0023] In another aspect, the distal tip includes a gripping member extending away from an outer surface of the distal tip, the gripping member configured to allow grasping of the distal tip by a gripping tool.
[0024] In yet another aspect, the electrodes are configured as conductive needles.
[0025] In yet another aspect, the electrodes are configured as conductive blades.
[0026] According to yet another aspect of the present disclosure, in a first position of the distal tip, an electrode extends beyond the distal end of the distal tip for cutting, and in a second position of the distal tip, the electrode is retracted within the distal tip and an inert gas is supplied to the distal tip, whereby the electrode is energized via a flexible conductive member to generate plasma.
[0027] In one aspect, the electrosurgical device further includes an introducer including a rigid tube portion disposed on the flexible insulating outer tube and slidable along the flexible insulating outer tube between the connector and the distal end, the rigid tube portion maintaining in a straight position a portion of the flexible insulating outer tube over which the rigid tube portion is disposed.
[0028] In another aspect, the electrosurgical device further includes a conductive tubing coupler disposed within the connector and including a proximal end and a distal end, the proximal end of the conductive tubing coupler configured to receive a gas supply, the distal end of the conductive tubing coupler configured to be coupled to the proximal end of the flexible insulating outer tubing, a fluid channel extending from the proximal end of the conductive tubing coupler to the distal end of the conductive tubing coupler to supply an inert gas to the flexible insulating outer tubing, and the distal end of the conductive tubing coupler coupled to a flexible conductive member disposed within the flexible insulating outer tubing.
[0029] In yet another aspect, the electrosurgical device further includes a conductive clip configured to be positioned over a portion of the conductive tubing coupler, the clip coupled to a wire for receiving electrosurgical energy, the electrosurgical energy being provided to the electrode via the clip, the conductive tubing coupler, and the flexible conductive member.
[0030] In yet another embodiment, the electrode includes at least one tab located in a central portion of the electrode, the electrode coupler includes at least one recess, the at least one tab aligns with the at least one recess, and the at least one tab is bent into the at least one recess to secure the electrode.
[0031] In one aspect, the distal end of the electrode coupler further includes two diametrically opposed slots within the electrode coupler, the slots configured to receive at least one tab of the electrode to laterally secure the electrode.
[0032] In another aspect, the electrosurgical device further comprises a cylindrical ceramic tube coupled to the distal end of the sheath, wherein when the sheath is in the first position, the distal end of the electrode extends beyond the ceramic tube and when the sheath is in the second position, the distal end of the electrode is covered by the ceramic tube. [Brief explanation of the drawings]
[0033] The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description taken in conjunction with the accompanying drawings.
[0034] [Figure 1] 1 is a diagram of an exemplary monopolar electrosurgical system according to one embodiment of the present disclosure;
[0035] [Figure 2A] FIG. 1 is a side view of an electrosurgical device according to one embodiment of the present disclosure.
[0036] [Figure 2B] 2B is an exploded perspective view of a proximal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure;
[0037] [Figure 2C] FIG. 2B is a side view of a proximal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure.
[0038] [Figure 2D] 2D is a side cross-sectional view of a proximal portion of the electrosurgical device taken along line AA of FIG. 2C in accordance with the present disclosure.
[0039] [Figure 2E] 2B is an exploded perspective view of a connector subassembly of the electrosurgical device of FIG. 2A according to the present disclosure; FIG.
[0040] [Figure 2F] 2B is a perspective view of a coupler of the electrosurgical device of FIG. 2A according to the present disclosure;
[0041] [Figure 2G] FIG. 2F is a side view of the coupler of FIG. 2F according to the present disclosure.
[0042] [Figure 2H] FIG. 2F is a cross-sectional side view of the coupler of FIG. 2F according to the present disclosure.
[0043] [Figure 2I] 2B is a perspective view of a tapered plug of the electrosurgical device of FIG. 2A in accordance with the present disclosure;
[0044] [Figure 2J]2B is a perspective view of a cap of the electrosurgical device of FIG. 2A according to the present disclosure;
[0045] [Figure 2K] FIG. 2J is a cross-sectional side view of the cap of FIG. 2J according to the present disclosure.
[0046] [Figure 2L] FIG. 2B is a side view of a distal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure.
[0047] [Figure 2M] 2L is a side cross-sectional view of a distal portion of an electrosurgical device taken along line BB of FIG. 2L in accordance with the present disclosure.
[0048] [Figure 2N] 2B is an exploded perspective view of several components of a distal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure;
[0049] [Figure 2O] FIG. 2B is a side view of some components of a distal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure. [Figure 2P] FIG. 2B is a side view of some components of a distal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure.
[0050] [Figure 2Q] 2B is an exploded perspective view of a distal portion of the electrosurgical device of FIG. 2A in accordance with the present disclosure;
[0051] [Figure 3] 2B illustrates a forceps connected to the distal end of the electrosurgical device of FIG. 2A in accordance with the present disclosure.
[0052] [Figure 4A] FIG. 10 is a side view of an electrosurgical device according to another embodiment of the present disclosure.
[0053] [Figure 4B] 4B is a perspective view of a distal portion of the electrosurgical device of FIG. 4A according to the present disclosure;
[0054] [Figure 5A] 4B is an exploded perspective view of a proximal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure;
[0055] [Figure 5B] 4B is a side cross-sectional view of a proximal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0056] [Figure 6A] FIG. 4B is a side view of a distal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0057] [Figure 6B] 4B is a side cross-sectional view of a distal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0058] [Figure 6C] FIG. 4B is a side view of some components of a distal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure. [Figure 6D] FIG. 4B is a side view of some components of a distal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0059] [Figure 6E] 4B is a side cross-sectional view of an electrode and electrode coupler of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0060] [Figure 6F] 4B is a view of the distal end of the electrosurgical device of FIG. 4A in accordance with the present disclosure.
[0061] [Figure 6G] 4B is an exploded perspective view of a distal portion of the electrosurgical device of FIG. 4A in accordance with the present disclosure;
[0062] It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not necessarily the only possible configuration for illustrating the disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0063] Preferred embodiments of the present disclosure will now be described with reference to the accompanying drawings. In the following description, well-known functions or structures will not be described in detail to avoid unnecessarily obscuring the present disclosure. In the drawings and the following description, the term "proximal" conventionally refers to the end of a device, such as an instrument, device, applicator, handpiece, or forceps, that is closer to the user, and the term "distal" refers to the end that is farther from the user. As used herein, the term "coupled" is defined to mean directly connected or indirectly connected via one or more intermediate components. Such intermediate components may include both hardware-based and software-based components.
[0064] The present disclosure relates to an electrosurgical device. The electrosurgical device of the present disclosure includes a connector, a flexible shaft, and a distal tip. The connector is configured to connect to an electrosurgical generator and a gas supply source. The distal tip of the electrosurgical device is configured to be grasped by a grasper, such as forceps, so that the orientation of the distal tip of the electrosurgical device can be manipulated in multiple ways around the flexible shaft. The electrosurgical device is configured to deliver electrosurgical energy and an inert gas to an electrode within the distal tip of the electrosurgical device to generate a plasma beam. In one embodiment, the distal tip is configured as an extendable and retractable sheath over the electrode, exposing the electrode when the sheath is in a first position and concealing or covering the electrode when the sheath is in a second position. In one aspect, the electrode is configured as a conductive blade such that the electrosurgical device is configured for use in intraoperative mechanical and electrosurgical cutting when the sheath is in the first position, i.e., the electrode is exposed, and for use in intraoperative low-temperature plasma applications when the sheath is in the second position, i.e., the electrode is concealed or covered.
[0065] FIG. 1 illustrates an exemplary monopolar electrosurgical system, generally designated 10, including an electrosurgical generator (ESU), generally designated 12, for generating electrical power for the electrosurgical device 10 and a plasma generator, generally designated 14, for generating and irradiating a plasma stream 16 at a surgical site or target area 18 on a patient 20 resting on a conductive plate or support surface 22. The electrosurgical generator 12 includes a transformer, generally designated 24, including a primary and a secondary, coupled to a power source (not shown) to provide high-frequency electrical energy to the plasma generator 14. Typically, the electrosurgical generator 12 has an isolated floating potential, not referenced to any potential. Thus, current flows between the active and return electrodes. If the output is not isolated and referenced to "earth," current can flow to areas at ground potential. If the contact surface between these areas and the patient is relatively small, unwanted burns can occur.
[0066] The plasma generator 14 includes a handpiece or holder 26 having an electrode 28 disposed at least partially within a fluid flow housing 29 and coupled to a transformer 24 for receiving radio frequency electrical energy from the transformer 24 to at least partially ionize a noble gas supplied to the fluid flow housing 29 of the handpiece or holder 26 and generate or create the plasma stream 16. The radio frequency electrical energy is delivered from the secondary of the transformer 24 through an active conductor 30 to the electrode 28 (collectively, active electrodes) in the handpiece 26, creating the plasma stream 16 that is delivered to the surgical site 18 on the patient 20. Additionally, in some embodiments, a current-limiting capacitor 25 is provided in series with the electrode 28 to limit the amount of current flowing to the patient 20.
[0067] The return path to the electrosurgical generator 12 passes through the tissue and fluids of the patient 20, the conductive plate or support member 22, and the return conductor 32 (collectively the return electrode) to the secondary side of the transformer 24, completing the isolated floating potential circuit.
[0068] In another embodiment, the electrosurgical generator 12 comprises an isolated, non-floating potential that is not referenced to any potential. The plasma current returning to the electrosurgical generator 12 passes through the tissue and bodily fluids and the patient 20. From there, the return current circuit is completed via the combined external capacitance, the surgeon, and displacement current to the plasma generator handpiece 26. The capacitance depends, among other things, on the physical size of the patient 20. Such an electrosurgical device and generator is described in commonly owned U.S. Patent No. 7,316,682 to Konesky, the contents of which are incorporated herein by reference in their entirety.
[0069] It should be understood that the transformer 24 may be located within the plasma generator handpiece 26. In this configuration, other transformers, such as a step-down transformer, a step-up transformer, or any combination thereof, may be provided within the generator 12 to provide the appropriate voltage and current to the transformer within the handpiece 26.
[0070] In one embodiment of the present disclosure, a plasma generator handpiece or electrosurgical device is provided that includes a flexible shaft, and the direction of the distal tip of such an electrosurgical device can be manipulated in multiple ways about the flexible shaft to direct the generated plasma beam in various directions.
[0071] 2A, there is shown an electrosurgical device 100 according to one embodiment of the present disclosure, including a flexible insulated shaft 104. The device 100 includes a connector or plug 102, a flexible shaft or flow tube 104, an electrode coupler 110, a distal tip 106, and an electrode 108.
[0072] 2B-2E, a proximal portion of device 100 is shown in accordance with one embodiment of the present disclosure, with FIG. 2B showing an exploded perspective view of the proximal portion, FIG. 2C showing a side view of the proximal portion, and FIG. 2D showing a side cross-sectional view along line AA (shown in FIG. 2C). The proximal portion of device 100 includes connector 102, which includes distal end 101 and proximal end 103 (best shown in FIGS. 2C and 2D).
[0073] Connector 102 is configured to couple device 100 to an electrosurgical generator, such as ESU 12, to receive electrosurgical energy and fluid (e.g., an inert gas such as helium or argon) for use in a procedure performed using device 100, as described in more detail below. Connector 102 includes shells 112A, 112B that, when coupled together, form a housing for connector 102. Connector 102 includes an interior between shells 112A, 112B, within which a subassembly 116 of connector 102 is disposed. Subassembly 116 includes conductors 132A-132F, a base 130, a processor and / or memory 128, a tube coupler 148, a fluid tube 122, a tube coupler 124, a plug or seal 120, a cap 118, and a sleeve 126.
[0074] 2E, an exploded perspective view of base 130, coupler 148, and processor and / or memory 128 is shown in accordance with the present disclosure. As shown in FIG. 2E, conductors 132A-132F are disposed through and attached to base 130 such that conductors 132A-132F protrude distally and proximally from opposite sides of base 130. Conductors 132A, 132B are coupled to processor and / or memory 128 to form a circuit with which an electrosurgical generator (e.g., ESU 12) can communicate when connector 102 is coupled to a corresponding receptacle on the electrosurgical generator. In one embodiment, processor and / or memory 128 is an electrically erasable programmable read-only memory (EEPROM) that stores information that can be read by the electrosurgical generator for use with device 100 (e.g., settings, parameters, etc. associated with device 100). For example, memory 128 may store information regarding a recommended flow rate of inert gas supplied to device 100, characteristics of the electrosurgical energy supplied to device 100, time information used by ESU 12 to disable ESU 12 until a predetermined time (e.g., 12 hours) has elapsed since device 100 was used, etc. It should be understood that additional information and / or only a subset of the above information may be stored in memory 128.
[0075] Coupler 148 includes a proximal end 156 and a distal end 160. A fluid channel or lumen 162 extends from end 160 to end 156 within coupler 148. Distal end 160 is configured as a conical portion or male coupling member. As best shown in FIG. 2D , end 156 of coupler 148 includes an opening or channel 164 that is in fluid communication with channel 162 and is configured to receive inert gas from the electrosurgical generator when connector 102 is coupled to the electrosurgical generator. Distal end 160 is configured to be inserted into the proximal end of tube 122 so that inert gas is supplied from opening 164 and channel 162 into the lumen or channel of tube 122. Referring to FIGS. 2D and 2E , proximal end 156 of coupler 148 is disposed through a channel or mounting portion 157 of base 130 and is attached to base 130. Coupler 148 includes an annular slot 158 disposed around the exterior of coupler 148 and configured to receive a first O-ring 154. When coupler 148 is attached to base 130, first O-ring 154 is disposed within slot 158 and between coupler 148 and the inner wall of base 130, as shown in FIG. 2D . A second O-ring 152 is disposed against a proximal end 156 of coupler 148. O-rings 152, 154 are configured to seal coupler 148 and prevent gas leakage when inert gas is supplied to coupler 148.
[0076] As best shown in FIGS. 2B and 2D, tube 122 is further coupled to a proximal end 125 of tube coupler 124. Referring to FIGS. 2F-2H, a coupler 124 according to the present disclosure is shown in more detail. Coupler 124 includes proximal end 125 and distal end 123, each of which is conically configured as a male coupling member for coupling to a fluid tube. End 125 (as shown in FIG. 2D) is configured to be inserted into and coupled to the distal end of tube 122, and end 123 is configured to be inserted into and coupled to the proximal end 105 of fluid tube or shaft 104. Fluid channel or lumen 127 extends from end 123 to end 125 and conveys inert gas delivered through tube 122 to fluid channel or lumen 109 (shown in FIG. 2D) of shaft 104.
[0077] Coupler 124 further includes an extension member 138 extending perpendicularly away from channel 127. Member 138 includes an open end 139 from which is visible a conical or frustoconical slot or channel 137 having a diameter that converges from open end 139 toward a central portion of channel 127. Channel or slot 137 is configured to receive tapered sealing plug 120, shown in FIGS. 2B, 2D, and 2I. As shown in FIG. 2I, tapered plug 120 includes ends 117, 119 and is shaped like a truncated cone. The shape of tapered plug 120 is configured to match the shape of slot 137 so that plug 120 prevents inert gas from leaking from channel 127 into slot 137. Plug 120 includes a channel 121 (shown in FIG. 2I) that extends from end 117 to end 119 and has a diameter on the order of the outer thickness of wire 140. 2D , channel 121 is configured to receive a portion of electrical conductor 140. Wire 140 includes a proximal end 142 that is coupled to conductor 132C of connector 102 for receiving electrosurgical energy supplied to electrode 108. An insulating cover or sheath 126 is disposed over the end of conductor 132C and the proximal end 142 of wire 140. Wire 140 is disposed through channel 121 (shown in FIG. 2I ) of plug 120, into channel 127 of coupler 124, and into channel 109 of shaft 104. It should be appreciated that the diameter of channel 121 is configured such that inert gas supplied through channel or lumen 127 does not leak into or out of channel 121 when wire 140 is disposed therethrough.
[0078] It should be further understood that wire 140 is a flexible conductive member, and that wire 140 moves and bends with the flexible outer tube or shaft 104 when disposed within shaft 104. Flexible conductive member 140 may take other forms and still be within the scope of the present disclosure. For example, flexible conductive member 140 may include, but is not limited to, a flexible conductive rod, a flexible conductive tube, a flexible conductive spring, etc.
[0079] As shown in Figures 2B and 2D, subassembly 116 includes cap 118, which is configured to be positioned over plug 120 and prevent plug 120 from being removed from slot 137 of coupler 124. Referring to Figures 2J-2K, cap 118 according to the present disclosure is shown in more detail. Cap 118 is substantially cylindrically configured and includes ends 113 and 114, with end 113 including a bore 170 providing access to an interior 172 of cap 118. Open end 114 is configured to receive extension member 138 of coupler 124 into interior 172. An outer wall of cap 118 includes two arcuate slots or bores 166 and 168 diametrically opposed about the outer wall of cap 118. Slots 166, 168 are configured to snap onto the exterior of coupler 124, i.e., fit snugly to coupler 124, to prevent cap 118 from disengaging from coupler 124 when coupled to coupler 124. Hole 170 is configured to align with channel 121 of plug 120 such that wire 140 passes through hole 170 and is disposed within channel 121.
[0080] 2A, 2B, and 2D, the proximal end 105 of the shaft 104 is disposed through the distal end 101 of the connector 102 and is coupled to the distal end 123 of the coupler 124. In one embodiment, a bushing 146 is disposed on the proximal portion of the shaft 104 and inserted into the distal end 101 of the connector 102, positioned between the exterior of the shaft 104 and the interior of the distal end 101.
[0081] Referring to Figures 2L and 2M, a distal portion of device 100 according to the present disclosure is shown, with Figure 2L showing a side view of the distal portion and Figure 2M showing a cross-sectional side view of the distal portion along line BB (shown in Figure 2L).
[0082] As shown in FIGS. 2L and 2M, the distal portion of the device 100 includes a distal end 107 of a shaft 104, an electrode coupler 110, a sheath 106, and a ceramic tube or tip 199. The distal end 107 of the shaft 104 is coupled to a proximal end 174 of the electrode coupler 110. Referring to FIG. 2N, the electrode coupler 110 includes a proximal end 174 and a distal end 176. A fluid channel or lumen 182 extends from end 174 to end 176. The coupler 110 is generally cylindrically configured, and the outer wall includes tabs or extension members 184, 185 (tab 185 is shown in FIG. 2O) and a slot 178. The proximal end 174 of the coupler 110 is conically configured as a male coupling member that is inserted into the distal end 107 of the shaft 104, connecting the coupler 110 to the distal end 107 of the shaft 104.
[0083] 2M, 2O, and 2P, the distal end 144 of the conductor 140 is disposed through the channel 182 and coupled to the proximal end 188 of the electrode 108, and the proximal end 188 of the electrode 180 is disposed through the end 176 of the coupler 110 and attached to the channel 182. As shown in FIGS. 2O and 2P, in one embodiment, the electrode 108 may be configured as a blade having a sharp edge from the central portion of the electrode 108 to the distal end 190. In one embodiment, the end 190 of the blade electrode 108 is blunt. It should be understood that in other embodiments, the electrode 108 may be configured in other shapes (e.g., other than as a blade), such as, for example, a needle shape, a ball shape, etc.
[0084] 2L, 2M, and 2Q, the distal tip 106 is disposed over the distal end 176 of the coupler 110 and configured as an extendable and retractable sheath over the distal end 176 of the coupler 110. The tip or sheath 106 includes an open proximal end 192 and an open distal end 194. The end 176 of the coupler 110 is disposed within the sheath 106 through end 192. In one embodiment, a ceramic tube 199 is disposed through and attached to the distal end 194 of the sheath 106. The sheath 106 includes a first tab slot 198 and a second tab slot (not shown) disposed on opposite sides of the sheath 106 and extending through the outer wall. Each tab slot extends along the length of the sheath 106 (e.g., from end 192 to end 194). The first slot 198 and the second slot are configured to receive the tabs 184, 185 of the coupler 110, allowing the sheath 106 to be extended and retracted over the coupler 110. When the sheath 106 is retracted over the coupler 110 toward the end 174 of the coupler 110, a distal portion of the electrode 108 (including the sharp blade edge) penetrates the ceramic tube 199 and extends distally beyond the end 194 of the sheath 106, exposing the blade electrode 108. When the sheath 106 is extended or advanced over the coupler 110 toward the end 176 of the coupler 110, the electrode 108 is covered by the sheath 106 and positioned within the interior 187 of the sheath 106.
[0085] The coupler 110 includes at least one channel or hole 180 through a sidewall of the coupler 110 adjacent the distal end 176 and disposed proximally from an end 188 of the electrode 108 when the electrode 108 is attached to the coupler 110. When inert gas is supplied to a channel 182 of the coupler 110 via a channel 109 in the shaft 104, the inert gas passes through the channel 180 to an interior 187 of the sheath 106, where it flows over the electrode 108 and exits the device 100 through a distal end 194 of the sheath 106 (and through a ceramic tube 199). As shown in FIG. 2M, the slot 178 of the coupler 110 is configured to receive an O-ring or seal 186 disposed between and in contact with the exterior of the coupler 110 and the interior 187 of the shaft 106 to prevent the inert gas from escaping the sheath 106 through the proximal end 192. It should be understood that in addition to the sliding frictional force between the inner surface 187 and the outer surface that contacts the O-ring 186, the force that the O-ring 186 imparts or exerts on the inner surface 187 and the outer surface of the coupler 110 that contacts the O-ring 186 prevents the sheath 106 from sliding (e.g., extending or retracting) without the user's intent (e.g., without intentional extension or retraction by the user). In one embodiment, this force is in the range of 0.5 lbf to 1 lbf when applied along the longitudinal axis of the coupler 110 and the sheath 106.
[0086] When the electrode 108 is covered by the sheath 106, the device 100 is adapted to generate a plasma. In the covered position, RF energy is transmitted through the ESU 12, connector 102, and wires 140 and applied to the electrode 108. When an inert gas is supplied from the ESU 12 and delivered to the sheath 106 via the shaft 104 and coupler 110, the electrode 108 is maintained at a high voltage and frequency, generating a cold plasma beam that is emitted from the distal end of the tip 106.
[0087] Once the electrode 108 is exposed by retracting the sheath 106, the device 100 can be used in two cutting modes: mechanical cutting and electrosurgical cutting. In the mechanical cutting mode, no RF or electrosurgical energy is applied to the electrode 108, and therefore the electrode 108 is in a non-energized state. In this mode, the electrode 108 can be used to cut tissue by mechanical cutting, e.g., a blade electrode contacts the tissue and physically cuts it. In the electrosurgical cutting mode, the electrode 108 is used exposed while electrically energized and surrounded by a flow of inert gas.
[0088] 2A , connector 102 of device 100 can be coupled to an ESU, such as ESU 12, to receive electrosurgical energy and / or gas therefrom. Device 100 can include a footswitch interface 850 for controlling different operational modes of device 100, including the characteristics of the plasma beam emitted from tip 106. Footswitch interface 850 includes one or more footswitches 852, 854 and is coupled to ESU 12. In response to depression of one or more footswitches 852, 854, a communication signal is sent via footswitch interface 850 to ESU 12 to control the electrosurgical energy provided to device 100 via ESU 12. In this manner, footswitch interface 850 is configured to control the operational mode of device 100 during a procedure (e.g., cold plasma, coagulation, cauterization, etc.). While two footswitches 852, 854 are shown, it should be understood that in some embodiments, footswitch interface 850 includes at least one separate footswitch for each operational mode of device 100. In other embodiments, additional foot switches may be included in the foot switch interface 850 to control the power supplied to the device 100 by the ESU 12 and / or the gas supplied to the device 100 by a gas supply (e.g., included in the ESU 12).
[0089] It should be understood that in other embodiments, ESU 12 may include controls for controlling the electrosurgical energy and / or gas supplied to device 100, and interface 850 may be eliminated. For example, ESU 12 may include an input / output interface disposed on the housing of ESU 12 for inputting information into the ESU and displaying information to a user. The input / output interface may include, for example, buttons, push buttons, dials, etc. for inputting parameters into ESU 12. In one embodiment, ESU 12 may include a touch screen that allows for both inputting and displaying information.
[0090] The shaft 104 is constructed of a flexible, insulating material to allow the tip 106 to move and reach a wide range of positions. Exemplary materials for the flexible, insulating outer shaft 206 include, but are not limited to, PVC, Santoprene, and silicone materials.
[0091] 2L, tip 106 includes grasping slots 196, 197 configured to grasp and adjust the orientation of tip 106 using a grasping tool (e.g., forceps). For example, as shown in FIG. 3, device 100 is shown coupled to forceps 900 in accordance with the present disclosure. As shown in FIG. 3, forceps 900 includes a shaft 902 and a jaw or engagement member 906. Gripping slots 196 and 197 are configured to receive an engagement member of a grasping tool, such as jaws 906 of forceps 900. In this manner, grasping slots 196 and 197 allow the grasping tool to grasp tip 106. Referring to FIG. 3, jaws 906 of forceps 900 are shown grasping slots 196 and 197 in accordance with the present disclosure. Once the jaws 906 of the grasper or forceps 900 have a firm grip on the slots 196 and 197 of the tip 106, the forceps 900 can then be used to manipulate the position of the tip 106 as desired by the user.
[0092] In one embodiment, the jaws 906 of the first forceps 900 can be used to grasp the sheath 106 via the slots 196, 197, while a second forceps (e.g., configured similarly to the forceps 900) can be used to grasp the distal end 107 of the shaft 104. In this configuration, the first forceps 900 can manipulate the sheath 106 to slide (e.g., extend or retract) the sheath 106 over the coupler 110 to expose or cover the electrode 108 and direct the generated plasma beam in a desired direction.
[0093] It should be appreciated that the shaft 902 of the forceps 900 can be configured as a rigid linear shaft or as multiple links configured to be manipulated into different positions. In one embodiment, the shaft 902 can include one or more pivoting or rotating members 908 configured to rotate the tip 106 of the device 100 with the jaws 906 in multiple directions (e.g., rotational directions B, C, and D shown in FIG. 3 ) and to extend or retract the sheath 106 over the coupler 110, if a second forceps is provided. In one embodiment, the one or more forceps 900 are controlled via a control interface, which can be a manual control interface (e.g., including one or more controls for a human to manually control the forceps 900) or a computer or robotic control interface (e.g., the forceps 900 are computer-operated) for operating the device 100 during an electrosurgical procedure.
[0094] In an exemplary embodiment, the gripping tool used to manipulate the orientation of the tip 106 may be a robotic arm such as, but not limited to, the ProGrasp™ forceps of the da Vinci® surgical system manufactured by Intuitive Surgical®, although other robotic arm systems may be used with the device 100 to control the tip 106.
[0095] It should be understood that in one embodiment, device 100 and / or forceps 900 can be used with trocars. In this embodiment, a first trocar or cannula and a second trocar or cannula can each be placed through a portion of a patient's body (e.g., through the patient's abdomen) to access a desired tissue site within the patient. The distal tip 106 and at least a portion of the shaft 104 are placed through the first trocar, and a portion of the grasper or forceps 900 (including the jaws 906) is placed through the second trocar, thereby allowing both the distal tip 106 of device 100 and the jaws 906 of the forceps 900 to access the tissue site. It should be understood that if a second forceps is needed (e.g., to retract or retract the sheath 106 over the coupler 110), a portion of the second forceps is placed through the second trocar. Within the patient, slots 196, 197 in distal tip 106 receive jaws 906, and forceps 900 is used to control distal tip 106 to perform a surgical operation (e.g., mechanical dissection, electrosurgical dissection, cauterization, coagulation, radiofrequency coagulation, cold plasma beam irradiation, etc.) at a tissue site. In another embodiment, distal tip 106 and at least a portion of shaft 104 may be positioned within the same trocar or cannula as grasper or forceps 900 (and optionally a second forceps). In another embodiment, device 100 may be used in open surgery.
[0096] 4A-6G, another embodiment of an electrosurgical device 200 is provided. Unless otherwise indicated, components of electrosurgical device 200 that are numbered similarly to corresponding components of electrosurgical device 100 shown in FIGS. 2A-3 are configured in the manner and features described above and may not be repeated below for the sake of brevity.
[0097] 4A and 4B, an electrosurgical device 200 is provided that includes a connector or plug 202, a flexible insulating outer shaft or flow tube 204, an electrode coupler 210, a distal tip 206, and an electrode 208. The device 200 further includes an introducer 251 that includes a handle portion 253 and a rigid tube portion 255. The introducer 251 is disposed on the flexible tube 204 and is slidable along the tube 204 between the connector 202 and the distal end 206. The rigid tube portion 255 maintains the portion of the flexible tube 204 on which it is disposed in a straight position. For example, during use, when the distal tip 206 is being introduced into a trocar or cannula, the introducer 251 can be slid toward the distal tip 206 to ensure that the distal tip 206 is straight along the longitudinal axis of the tube 204. The introducer 251 stabilizes the tip 206, which may be grasped by a grasping device, such as forceps 900. When the distal tip 206 is in a suitable position near the desired surgical site or grasped by a suitable grasping device 900, the introducer 251 can be slid toward the proximal end 205 of the tube 204 by grasping the handle 253 and sliding the introducer 251 toward the connector 202. Once the distal end 259 of the rigid tube 255 is a predetermined distance from the distal tip 206 and the introducer 251 does not cover at least a portion of the distal end 207 of the flexible shaft 204, the distal tip 206 can be manipulated as described above. Additionally, the introducer 251 may be slid toward the proximal end 205 of the tube until it exits the surgical port, such as a trocar or cannula, and held outside the surgical port until the introducer 251 is reintroduced into the surgical port if necessary, such as to mechanically support the distal tip 206 when grasped by a grasper.
[0098] 5A-5B, a proximal portion of device 200 is shown in accordance with one embodiment of the present disclosure, with FIG. 5A showing an exploded perspective view of the proximal portion and FIG. 5B showing a cross-sectional side view of the proximal portion. The proximal portion of device 200 includes connector 202 including distal end 201 and proximal end 203 (best seen in FIGS. 4A and 5B).
[0099] Connector 202 is configured to couple device 200 to an electrosurgical generator, such as ESU 12, for receiving electrosurgical energy and fluid (e.g., an inert gas such as helium or argon) for use in a procedure performed using device 200, as described above. Connector 202 includes shells 212A, 212B that, when coupled together, form a housing for connector 202. Connector 202 includes an interior between shells 212A, 212B within which a subassembly 216 of connector 202 is disposed. Subassembly 216 includes conductors 232A-232F, a base 230, a processor and / or memory 228, a tube coupler 248, a fluid conduit 222, a tube coupler 224, and a sleeve 226.
[0100] Coupler 248 includes a proximal end 256 and a distal end 260. A fluid channel or lumen 262 extends from end 260 to end 256 within coupler 248. Distal end 260 is configured as a conical portion or male coupling member. As best shown in FIG. 5B , end 256 of coupler 248 includes an opening or channel 264 that is in fluid communication with channel 262 and is configured to receive inert gas from an electrosurgical generator (or other gas source) when connector 202 is coupled to the electrosurgical generator (or other gas source). Distal end 260 is configured to be inserted into the proximal end of tube 222, and inert gas is supplied from opening 264 and channel 262 into the lumen or channel of tube 222. 5B , a proximal end 256 of the coupler 248 is disposed through a channel or mounting portion 257 of the base 230 and is attached to the base 230. The coupler 248 includes an annular slot 258 disposed around the exterior of the coupler 248 and configured to receive a first O-ring 254. As shown in FIG. 5B , when the coupler 248 is attached to the base 230, the first O-ring 254 is disposed within the slot 258 and between the coupler 248 and the inner wall of the base 230. A second O-ring 252 is disposed in contact with the proximal end 256 of the coupler 248. The O-rings 252, 254 are configured to seal the coupler 248 and prevent gas leakage when an inert gas is supplied to the coupler 248.
[0101] As best shown in FIG. 5B, tube 222 is further coupled to a proximal end 225 of tube coupler 224. Coupler 224 includes a proximal end 225 and a distal end 223, with end 225 configured as a conical male coupling member for coupling to a fluid tube. End 225 is configured to be inserted into and coupled to the distal end of tube 222 (as shown in FIG. 5B), and end 223 is configured to be inserted into and coupled to the proximal end 205 of fluid tube or shaft 204. Fluid channel or lumen 227 extends from end 223 to end 225 and conveys inert gas delivered through tube 222 to fluid channel or lumen 209 (shown in FIG. 5B) of shaft 204. Coupler 224 is made of a conductive material, such as stainless steel.
[0102] Wire 240 includes a proximal end 242 that is coupled to conductor 232D of connector 202 for receiving electrosurgical energy delivered to electrode 208. An insulating cover or sheath 226, e.g., heat shrink, is placed over the end of conductor 232D and proximal end 242 of wire 240. This sheath 226 provides electrical insulation for the assembly when thermally assembled. A conductive clip 229 slides over a portion of coupler 224 to make the electrical connection. Wire 240 is coupled (e.g., by soldering) to clip 229 at its distal end and to pin 232D at its proximal end 242, thereby completing the electrical connection from pin 232D to coupler 224 via wire 240 and conductive clip 229. In one embodiment, clip 229 is coupled to coupler 224 by an interference fit, which provides a tight fit between clip 229 and coupler 224 and ensures a proper electrical connection. A distal end 223 of coupler 224 is coupled to a wire 241 disposed within outer tube 204. A sheath 233 is disposed over the coupling between distal end 223 of coupler 224 and the proximal end of wire 241.
[0103] It should be understood that wire 241 is a flexible conductive member, and wire 241 moves and bends with flexible outer tube or shaft 204 when disposed within shaft 204. Flexible conductive member 241 may take other forms and still be within the scope of the present disclosure. For example, flexible conductive member 241 may include, but is not limited to, a flexible conductive rod, a flexible conductive tube, a flexible conductive spring, etc.
[0104] The proximal end 205 of the shaft 204 is disposed through the distal end 201 of the connector 202 and coupled to the distal end 223 of the coupler 224. In one embodiment, a bushing 246 is disposed over the proximal portion of the shaft 204 and inserted into the distal end 201 of the connector 202 between the exterior of the shaft 204 and the interior of the distal end 201. In another embodiment, a shrink wrap 231 may be disposed over the bushing 246 and over the distal end 201 of the connector 202. The shrink wrap 231 may serve, among other functions, to provide strain relief for the shaft 204 at the distal end 201 of the connector 202 and to hide the assembly of the connector halves and bushing 246 at the distal end 201 of the connector 202 for better aesthetics.
[0105] 6A-6G, the distal portion of device 200 according to the present disclosure is shown in greater detail.
[0106] As shown in Figures 6A and 6B, the distal portion of the device 200 includes a distal end 207 of a shaft 204, an electrode coupler 210, a sheath 206, and a ceramic tube or tip 299. The distal end 207 of the shaft 204 is coupled to a proximal end 274 of the electrode coupler 210. Referring to Figure 6C, the electrode coupler 210 includes a proximal end 274 and a distal end 276. A fluid channel or lumen extends from end 274 to end 276. The coupler 210 is generally cylindrically configured and includes tabs or extension members 284, 285 and a slot 278 on its outer wall. The proximal end 274 of the coupler 210 is conically configured as a male coupling member that is inserted into the distal end 207 of the shaft 204 to couple the coupler 210 to the distal end 207 of the shaft 204.
[0107] 6B, 6C, 6D, and 6E, distal end 244 of conductor 241 is disposed through channel 282 and coupled to proximal end 288 of electrode 208, and proximal end 288 of electrode 280 is disposed through end 276 of coupler 210 and attached to end 276, within channel 282. As shown in FIGS. 6D and 6E, in one embodiment, electrode 208 may be configured as a blade having a sharp edge from a central portion of electrode 208 to distal end 290. In one embodiment, end 290 of blade electrode 208 is blunt. It should be understood that in other embodiments, electrode 208 may be configured in other shapes (e.g., other than as a blade), such as, for example, a needle shape, a ball shape, etc.
[0108] 6A, 6B, and 6G, the distal tip 206 is configured as an extendable and retractable sheath that is positioned over the distal end 276 of the coupler 210. The tip or sheath 206 includes an open proximal end 292 and an open distal end 294. The end 276 of the coupler 210 is positioned inside the sheath 206 through end 292. In one embodiment, a ceramic tube 299 is positioned through the distal end 294 of the sheath 206 and attached to the sheath. The sheath 206 includes a first tab slot 298 and a second tab slot (not shown) that are positioned on opposite sides of the sheath 206 and extend through the outer wall, respectively. Each tab slot extends along a portion of the length of the sheath 206 (e.g., a portion along the length from end 292 to end 294). The first slot 298 and the second slot are configured to receive the tabs 284, 285 of the coupler 210 so that the sheath 206 can be extended and retracted over the coupler 210. When the sheath 206 is retracted over the coupler 210 toward the end 274 of the coupler 210, a distal portion of the electrode 208 (including the sharp blade edge) penetrates the ceramic tube 299 and extends distally beyond the end 294 of the sheath 206, exposing the blade electrode 208. When the sheath 206 is extended or advanced over the coupler 210 toward the end 276 of the coupler 110, the electrode 208 is covered by the sheath 110 and is positioned within the interior 287 of the sheath 206.
[0109] Referring to FIG. 6E, an electrode 208 and an electrode coupler 210 are shown. The electrode 208 is generally flat and includes a plurality of tabs 291. The plurality of tabs 291 are located in a central portion of the electrode 208 between the proximal end 288 and the distal end 290. The outer tabs 293 are substantially rigid, while the inner tabs 295 are bendable or adjustable. The proximal end 288 of the electrode 208 is inserted into the distal end 276 of the coupler 210 until the tabs 295 align with recesses 281 formed in the distal end 276 of the coupler 210. The tabs 295 are then folded into the recesses 281, securing the electrode 208 within the coupler 210. Referring to FIG. 6F, the distal end 276 of the coupler 210 further includes two diametrically opposed slots 283 within the coupler 210. The slots 283 are configured to receive at least one of the tabs 293 of the electrode 208. In this manner, the electrode 208 is fixed longitudinally within the recess 281 via the tab 295 (i.e., the electrode 208 does not move longitudinally relative to the electrode coupler 210) and laterally within the slot 283 via the tab 293 (i.e., the electrode 208 does not move side to side).
[0110] When inert gas is supplied to channel 282 of coupler 210 via channel 209 in shaft 204, the inert gas passes through passageway 289 to interior 287 of sheath 206, where it flows over electrode 208 and exits device 200 through distal end 294 of sheath 206 (and through ceramic tube 299). As shown in Figures 6C and 6E, slot 278 of coupler 210 is configured to receive O-ring or seal 286, which is disposed between and in contact with the exterior of coupler 210 and interior 287 of shaft 206 to prevent the inert gas from escaping sheath 206 through proximal end 292. It should be understood that in addition to the sliding friction force between the inner surface 287 and the outer surface of coupler 210 that are in contact with O-ring 286, the force that O-ring 286 imparts or exerts on the inner surface 287 and the outer surface of coupler 210 that are in contact with O-ring 286 prevents sliding (e.g., extension and retraction) of sheath 206 without the user's intent (e.g., absent intentional extension or retraction by the user). In one embodiment, this force ranges from about 0.3 lbf to about 0.8 lbf when applied along the longitudinal axis of coupler 110 and sheath 106.
[0111] When the electrode 208 is covered by the sheath 206, the device 200 is adapted to generate a plasma. In the covered position, RF energy is transmitted through the ESU 12, the connector 202, and the wires 240, 241 and applied to the electrode 208. When an inert gas is supplied from the ESU 12 and delivered to the sheath 206 via the shaft 204 and the coupler 210, the electrode 208 is maintained at a high voltage and frequency, generating a low-temperature plasma beam that is emitted from the distal end of the tip 206.
[0112] Once the electrode 208 is exposed by retracting the sheath 206, the device 200 can be used in two cutting modes: mechanical cutting and electrosurgical cutting. In the mechanical cutting mode, no RF or electrosurgical energy is applied to the electrode 208, and therefore the electrode 208 is in a de-energized state. In this mode, the electrode 208 can be used to cut tissue by mechanical cutting, e.g., a blade electrode contacts the tissue and physically cuts it. In the electrosurgical cutting mode, the electrode 208 is used exposed while electrically energized and surrounded by a flow of inert gas.
[0113] Referring to FIG. 4A , connector 202 of device 200 can be coupled to an ESU, such as ESU 12, to receive electrosurgical energy and / or gas therefrom. Device 200 can include a footswitch interface 850, as shown and described in connection with FIG. 2A . It should be understood that in other embodiments, ESU 12 includes controls for controlling the electrosurgical energy and / or gas supplied to device 200, and interface 850 can be eliminated. For example, ESU 12 can include an input / output interface disposed on the housing of ESU 12 for inputting information into the ESU and displaying information to a user. The input / output interface can include, for example, buttons, push buttons, dials, etc. for inputting parameters into ESU 12. In one embodiment, ESU 12 can include a touch screen that allows for both inputting and displaying information.
[0114] The shaft 204 is constructed of a flexible insulating material to allow the tip 206 to move and reach a wide range of positions. Exemplary materials for the flexible insulating outer shaft 206 include, but are not limited to, PVC, Santoprene, and silicone materials.
[0115] 6A , tip 206 includes a gripping member 296 configured to grasp tip 206 using a gripping tool (e.g., forceps) to adjust the orientation of tip 206. Grip member 296 extends away from the outer surface of distal tip 206 and is configured to receive an engagement member of a gripping tool, such as jaws 906 of forceps 900, as described above in connection with FIG. 3 . In this manner, gripping member 296 enables the gripping tool to grasp tip 206. Once the jaws 906 of the gripping tool or forceps 900 firmly grasp gripping member 296 of tip 206, the forceps 900 can then be used to manipulate the position of tip 206 as desired by a user.
[0116] As described above, the jaws 906 of the first forceps 900 can be used to grasp the sheath 206 via the member 296, while a second forceps (e.g., configured similarly to the forceps 900) can be used to grasp the distal end 207 of the shaft 204. In this configuration, the first forceps 900 slides (e.g., extends or retracts) the sheath 206 over the coupler 210 to expose or cover the electrode 208. Alternatively, the introducer 251 can be advanced toward the distal end 207 of the shaft 204 to keep the shaft 204 substantially straight as the jaws 906 of the first forceps 900 grasp the sheath 206 via the member 296 to extend or retract and / or manipulate the sheath 206 to guide the generated plasma beam.
[0117] It should be understood that the device 200 and / or forceps 900 may be used in conjunction with at least one trocar or cannula, as described above with respect to the device 100.
[0118] It should be understood that the various features shown and described are interchangeable, that is, features shown in one embodiment may be incorporated into another embodiment.
[0119] While the present disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims.
[0120] Furthermore, while the above text sets forth detailed descriptions of numerous embodiments, it should be understood that the legal scope of the present invention is defined by the language of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment, as describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and still fall within the scope of the claims.
[0121] It is also understood that unless a term is expressly defined in this patent using the phrase "As used herein, the term '______' is hereby defined to mean..." or similar phrase, no intention is made to limit the meaning of the term, expressly or impliedly, beyond its plain or ordinary meaning, and that such term should not be construed as limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent any term recited in the claims at the end of this patent is referred to in a manner consistent with a single meaning in this patent, this is done solely for clarity to avoid confusing the reader, and such claim term is not intended to be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by the word "means" and a recitation of a function without any recitation of structure, it is not intended to construe the scope of any claim element based on application of 35 U.S.C. § 112, paragraph 6.
Claims
1. a connector including a proximal end and a distal end and configured to connect to an electrosurgical generator, the proximal end of the connector configured to receive electrosurgical energy and a gas supply from the electrosurgical generator; a flexible insulating outer tube having a proximal end and a distal end, the proximal end of the flexible insulating outer tube being directly connected to the distal end of the connector; a distal tip including a proximal end and a distal end, the distal tip configured to be grasped using a grasper, the proximal end of the distal tip being directly connected to the distal end of the flexible insulating outer tube, the distal tip including an electrode, the distal tip including an extendable and retractable sheath over the electrode, the distal tip exposing the electrode when the sheath is in a first position and hiding or covering the electrode when the sheath is in a second position; a flexible conductive member disposed through the flexible insulating outer tube and including a proximal end and a distal end, the proximal end of the flexible conductive member coupled to the connector and the distal end of the flexible conductive member extending into the distal tip and coupled to the electrode for delivering the electrosurgical energy to the electrode; the flexible insulating outer tube and the flexible conductive member are configured such that the distal tip can be positioned in multiple positions relative to the flexible insulating outer tube. Electrosurgical equipment.
2. The electrosurgical device of claim 1 , further comprising at least one memory disposed within the connector, the at least one memory storing information relating to use of the electrosurgical device.
3. 2. The electrosurgical device of claim 1, further comprising a coupler disposed within the connector and including a proximal end and a distal end, the proximal end configured to receive the gas supply and the distal end configured to be coupled to the proximal end of the flexible insulating outer tubing, a fluid channel extending from the proximal end of the coupler to the distal end of the coupler to provide the received gas supply to the flexible insulating outer tubing, the coupler further including an extension member extending perpendicularly from the fluid channel, the extension member including a second channel fluidly coupled to the fluid channel, the extension member configured to receive the flexible conductive member and provide the flexible conductive member to the electrode via the flexible insulating outer tubing.
4. 4. The electrosurgical device of claim 3, further comprising a plug configured to be disposed within the second channel of the extension member of the coupler, the plug including a third channel that receives the flexible conductive member, and wherein when the flexible conductive member is disposed through the third channel of the plug, the received gas is prevented from leaking from the coupler into the connector.
5. The electrosurgical device of claim 4, further comprising a cap configured to be positioned over the extension member to prevent the plug from becoming dislodged from the extension member, the cap including at least one slot for securely fitting onto the coupler.
6. 2. The electrosurgical device of claim 1, wherein the distal tip further comprises an electrode coupler including a proximal end and a distal end, the proximal end of the electrode coupler coupled to the distal end of the flexible insulating outer tube, the distal end of the electrode coupler configured to support the electrode, and the sheath slidably positioned over the distal end of the electrode coupler.
7. 7. The electrosurgical device of claim 6, wherein the electrode coupler further includes at least one tab disposed on an outer wall, the sheath includes at least one tab slot for receiving the at least one tab, and the sheath is extendable and retractable over the electrode coupler to extend and retract a length of the tab slot.
8. 7. The electrosurgical device of claim 6, wherein the electrode coupler includes at least one hole through a sidewall proximate the distal end of the electrode coupler, and wherein when gas is supplied to the electrode coupler through the flexible insulating outer tube, the gas enters the interior of the sheath through the at least one hole, flows over the electrode, and exits the distal end of the sheath.
9. The electrosurgical device of claim 1 , wherein the distal tip is configured to be grasped by a grasper to manipulate the position of the distal tip relative to the flexible insulating outer tube.
10. The electrosurgical device of claim 9, wherein the distal tip includes first and second gripping slots configured to enable grasping of the distal tip by the grasper.
11. The electrosurgical device of claim 9, wherein the distal tip includes a gripping member extending away from an outer surface of the distal tip, the gripping member configured to enable grasping of the distal tip by the grasper.
12. The electrosurgical device of claim 1 , wherein the electrode is configured as a conductive needle.
13. The electrosurgical device of claim 1 , wherein the electrode is configured as a conductive blade.
14. 2. The electrosurgical device of claim 1, wherein in a first position of the distal tip, the electrode extends beyond the distal end of the distal tip for cutting, and in a second position of the distal tip, the electrode is retracted within the distal tip and an inert gas is supplied to the distal tip such that the electrode is energized via the flexible conductive member to generate a plasma.
15. 2. The electrosurgical device of claim 1, further comprising an introducer including a rigid tube disposed on and slidable along the flexible insulating outer tube between the connector and the distal end of the flexible insulating outer tube, the rigid tube maintaining in a straight position the portion of the flexible insulating outer tube over which the rigid tube is disposed.
16. 2. The electrosurgical device of claim 1, further comprising a conductive tubing coupler disposed within the connector and including a proximal end and a distal end, the proximal end of the conductive tubing coupler configured to receive the gas supply, the distal end of the conductive tubing coupler configured to be coupled to the proximal end of the flexible insulating outer tubing, a fluid channel extending from the proximal end of the conductive tubing coupler to the distal end of the conductive tubing coupler, the fluid channel supplying an inert gas to the flexible insulating outer tubing, and the distal end of the conductive tubing coupler coupled to the flexible conductive member disposed within the flexible insulating outer tubing.
17. 17. The electrosurgical device of claim 16, further comprising a clip configured to be positioned over a portion of the conductive tubing coupler, the clip coupled to a wire for receiving the electrosurgical energy, the electrosurgical energy being provided to the electrode via the clip, the conductive tubing coupler, and the flexible conductive member.
18. 7. The electrosurgical device of claim 6, wherein the electrode includes at least one tab extending from a central portion of the electrode, the electrode coupler includes at least one recess, the at least one tab aligns with the at least one recess, and the at least one tab is bent into the at least one recess to secure the electrode.
19. 20. The electrosurgical device of claim 18, wherein the distal end of the electrode coupler further includes two diametrically opposed slots therein, the slots configured to receive the at least one tab of the electrode to laterally secure the electrode.
20. 2. The electrosurgical device of claim 1, further comprising a cylindrical ceramic tube coupled to the distal end of the sheath, wherein the distal end of the electrode extends beyond the ceramic tube when the sheath is in the first position and the distal end of the electrode is covered by the ceramic tube when the sheath is in the second position.
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