ENERGY COUPLING MITIGATION DEVICE AND RELATED SYSTEMS AND METHODS

FIELD

The embodiments disclosed herein relate to various medical devices and related components that can make up a surgical system, including robotic and/or in vivo medical devices and related components. More specifically, the various devices and systems relate to robotic surgical devices for use in various surgical procedures, including laparoscopic surgery and the like.

BACKGROUND

Invasive surgical procedures are essential for addressing various medical conditions. When possible, minimally invasive procedures such as laparoscopy are preferred.

However, known minimally invasive technologies such as laparoscopy are limited in scope and complexity due in part to 1) mobility restrictions resulting from using rigid tools inserted through access ports, and 2) limited visual feedback. Known robotic systems such as the da Vinci® Surgical System (available from Intuitive Surgical, Inc., located in Sunnyvale, CA) are also restricted by the access ports, as well as having the additional disadvantages of being very large, very expensive, unavailable in most hospitals, and having limited sensory and mobility capabilities.

Further, various devices require multiple elongate electrical conductors coupled thereto that transmit several types of electrical signals and different types of electrical power. Often a single sheath or casing is used to contain all of those conductors, resulting in a single cable. The use of such a cable reduces the number of separate exposed conductors and thereby reduces the risks of entanglements, etc. Because all of the conductors are in close proximity within and along the extended length of the cable, energy coupling can result in the transfer of electrical energy from one conductor to another. This can lead to excessive/unintended current flowing through conductors intended to be unenergized, especially those used for electrocautery and/or advanced energy electrosurgical devices or systems, which can result in inadvertent actuation of the wrong tools and/or end effectors of those devices/systems.

There is a need in the art for improved surgical methods, systems, and devices.

BRIEF SUMMARY

Discussed herein are various electrical disconnection systems or devices, including such systems or devices incorporated into various robotic surgical devices for mitigation or prevention of electrical current leakage.

In Example 1, a surgical system comprises at least one end effector, at least one conductor coupled to the end effector, and a disconnection mechanism associated with the at least one conductor, wherein the mechanism is configured to electrically disconnect the end effector from an energy source when not in use so as to reduce energy leakage out the instrument.

Example 2 relates to the surgical system according to Example 1, wherein the disconnection mechanism is configured to electrically disconnect the at least one conductor from the energy source.

Example 3 relates to the surgical system according to Example 1, wherein the disconnection mechanism is an electrical relay.

Example 4 relates to the surgical system according to Example 1, wherein the end effector is a bi-polar end effector.

Example 5 relates to the surgical system according to Example 1, wherein the end effector is a monopolar end effector.

Example 6 relates to the surgical system according to Example 1, wherein the at least one end effector comprises two end effectors.

Example 7 relates to the surgical system according to Example 1, wherein the end effector is an electrosurgical end effector.

Example 8 relates to the surgical system according to Example 1, further comprising an electrical current sensor coupled to the at least one conductor, wherein the electrical current sensor is disposed between the disconnection mechanism and the end effector.

Example 9 relates to the surgical system according to Example 8, wherein the electrical current sensor comprises a transformer current sensor, a Hall Effect current sensor, or a shunt resistor.

Example 10 relates to the surgical system according to Example 8, wherein a controller of the surgical system is operably coupled to the electrical current sensor, wherein the controller is configured to receive information from the electrical current sensor and modulate energy delivery from the energy source to the end effector based on the information from the electrical current sensor.

Example 11 relates to the surgical system according to Example 10, wherein the controller is configured to shut down the energy source when a disconnection mechanism failure is detected at the electrical current sensor.

In Example 12, a robotic surgical device comprises an elongate device body, a first robotic arm operably coupled to the elongate device body, the first robotic arm comprising a first end effector operably coupled to the first robotic arm and a first conductor coupled to the first end effector. The first conductor comprises a proximal length disposed within the elongate device body and extending out of a proximal portion of the device body to an external energy source, and a distal length disposed within the elongate device body and extending out of a distal portion of the device body and through the first robotic arm to the first end effector. Further the robotic surgical device further comprises a disconnection mechanism disposed within the elongate device body and coupled with the proximal length and the distal length of the first conductor, wherein the disconnection mechanism comprises a switch comprising an open position and a closed position.

Example 13 relates to the robotic surgical device according to Example 12, wherein, when the switch is in the open position, the distal length is electrically disconnected from the proximal length of the first conductor.

Example 14 relates to the robotic surgical device according to Example 12, wherein the disconnection mechanism is an electrical relay.

Example 15 relates to the robotic surgical device according to Example 12, wherein the first end effector is a bi-polar end effector or a monopolar end effector.

Example 16 relates to the robotic surgical device according to Example 12, further comprising an electrical current sensor coupled to the distal length of the first conductor.

Example 17 relates to the robotic surgical device according to Example 16, wherein a controller of the surgical system is operably coupled to the electrical current sensor, wherein the controller is configured to receive information from the electrical current sensor and modulate energy delivery from the external energy source to the first end effector based on the information from the electrical current sensor.

Example 18 relates to the robotic surgical device according to Example 17, wherein the controller is configured to shut down the external energy source when a disconnection mechanism failure is detected at the electrical current sensor.

Example 19 relates to the robotic surgical device according to Example 12, further comprising a second robotic arm operably coupled to the elongate device body, the second robotic arm comprising a second end effector operably coupled to the second robotic arm.

In Example 20, a method of mitigating energy coupling during use of a robotic surgical device comprises positioning the robotic surgical device within a patient cavity, the robotic surgical device comprising an elongate device body, a first robotic arm operably coupled to the elongate device body, the first robotic arm comprising a first end effector operably coupled to the first robotic arm, a first conductor extending through the elongate device body and the first robotic arm and coupled to the first end effector, a disconnection mechanism disposed within the elongate device body and coupled with the first conductor, a second robotic arm operably coupled to the elongate device body, the second robotic arm comprising a second end effector operably coupled to the second robotic arm, and a second conductor extending through the elongate device body and the second robotic arm and coupled to the second end effector, whereby the elongate device body is disposed through an incision into the patient cavity and the first robotic arm is disposed within the patient cavity. The method further comprises actuating the disconnection mechanism to disconnect a proximal end of the first conductor from a distal end of the first conductor when the second end effector is actuated and actuating the disconnection mechanism to connect the proximal end of the first conductor to the distal end of the first conductor when the first end effector is actuated.

While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. As will be realized, the various implementations are capable of modifications in various obvious aspects, all without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a robotic surgical system in an operating room, according to one embodiment.

FIG. 2 is perspective view of a robotic device, according to one embodiment.

FIG. 3A is an expanded side view of a device cable and the conductors contained therein, according to one embodiment.

FIG. 3B is an expanded side view of the device cable and conductors of FIG. 3A with energy coupling, according to one embodiment.

FIG. 4A is a perspective view of a robotic device showing inadvertent electrical current leakage into the left end effector, according to one embodiment.

FIG. 4B is a perspective view of a robotic device showing inadvertent electrical current leakage into the right end effector, according to one embodiment.

FIG. 5 is a cross-sectional front view of a robotic device with a disconnection system, according to one embodiment.

FIG. 6 is a perspective view of a robotic device with an exploded image of a disconnection mechanism that is disposed therein, according to one embodiment.

FIG. 7A is a front perspective view of the disconnection mechanism of FIG. 6, according to one embodiment.

FIG. 7B is a rear perspective view of the disconnection mechanism of FIG. 6, according to one embodiment.

FIG. 7C is an expanded view of the rear of the disconnection mechanism of FIG. 7B, according to one embodiment.

FIG. 8 is a schematic depiction of an exemplary relay housing, according to one embodiment.

FIG. 9A is a cross-sectional front view of a robotic device with a disconnection mechanism in which the relay switches are open, according to one embodiment.

FIG. 9B is a cross-sectional front view of the robotic device with the disconnection mechanism of FIG. 9A in which the relay switches are closed, according to one embodiment.

DETAILED DESCRIPTION

The various systems and devices disclosed herein relate to devices for use in medical procedures and systems. More specifically, various embodiments relate to various medical devices and related methods and systems having specific devices or systems for preventing or reducing the transfer of electrical energy between conductors within the devices, thereby reducing or eliminating excessive and/or unintentional electrical current flowing through conductors intended to be unenergized (have no electrical current flowing therethrough) during certain operational modes. For purposes of this application, a conductor intended to have no electrical current flowing therethrough in certain operational modes (typically because the end effector coupled thereto is not intended to be actuated in those specific modes) is also referred to herein as “quiescent conductor.”.

It is understood that the various embodiments of robotic devices and related methods and systems disclosed herein, including the devices or systems for prevention or reduction of unintentional electrical energy transfer, can be incorporated into or used with any other known medical devices, systems, and methods.

It is understood that the various embodiments of robotic devices and related methods and systems disclosed herein can be incorporated into or used with any other known medical devices, systems, and methods. For example, the various embodiments disclosed herein may be incorporated into or used with any of the medical devices and systems disclosed in U.S. Pat. No. 8,968,332 (issued on Mar. 3, 2015 and entitled “Magnetically Coupleable Robotic Devices and Related Methods”), U.S. Pat. No. 8,834,488 (issued on Sep. 16, 2014 and entitled “Magnetically Coupleable Surgical Robotic Devices and Related Methods”), U.S. Pat. No. 10,307,199 (issued on Jun. 4, 2019 and entitled “Robotic Surgical Devices and Related Methods”), U.S. Pat. No. 9,579,088 (issued on Feb. 28, 2017 and entitled “Methods, Systems, and Devices for Surgical Visualization and Device Manipulation”), U.S. Patent Application 61/030,588 (filed on Feb. 22, 2008), U.S. Pat. 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No. 7,772,796 (filed on Apr. 3, 2007 and entitled “Robot for Surgical applications”), U.S. Pat. No. 8,179,073 (issued on May 15, 2011, and entitled “Robotic Devices with Agent Delivery Components and Related Methods”), and U.S. patent application Ser. No. 16/736,329 (filed on Jan. 7, 2020 and entitled Robotically Assisted Surgical System and Related Devices and Methods), all of which are hereby incorporated herein by reference in their entireties.

Further, the various embodiments disclosed herein may be incorporated into or used with any other known electrosurgical medical devices and systems, including, for example, those disclosed in U.S. Pat. Nos. 9,427,282, 11,166,758, U.S. Published Application 2021/0169592, U.S. Published Application 2021/0290314, U.S. Published Application 2021/0290323, U.S. Published Application 2021/0068913, and U.S. Published Application 2011/0054462.

Certain device and system implementations disclosed in the applications listed above can be positioned within a body cavity of a patient, or a portion of the device can be placed within the body cavity, in combination with a support component similar to those disclosed herein. An “in vivo device” as used herein means any device that can be positioned, operated, or controlled at least in part by a user while being positioned within a body cavity of a patient, including any device that is coupled to a support component such as a rod or other such component that is disposed through an opening or orifice of the body cavity, also including any device positioned substantially against or adjacent to a wall of a body cavity of a patient, further including any such device that is internally actuated (having no external source of motive force), and additionally including any device that may be used laparoscopically or endoscopically during a surgical procedure. As used herein, the terms “robot,” and “robotic device” shall refer to any device that can perform a task either automatically or in response to a command.

Certain embodiments provide for insertion of the various devices herein into the cavity while maintaining sufficient insufflation of the cavity. Further embodiments minimize the physical contact of the surgeon or surgical users with the device during the insertion process. Other implementations enhance the safety of the insertion process for the patient and the various embodiments herein. For example, some embodiments provide visualization of the device as it is being inserted into the patient's cavity to ensure that no damaging contact occurs between the system/device and the patient. In addition, certain embodiments allow for minimization of the incision size/length. Other implementations include devices that can be inserted into the body via an incision or a natural orifice. Further implementations reduce the complexity of the access/insertion procedure and/or the steps required for the procedure. Other embodiments relate to devices that have minimal profiles, minimal size, or are generally minimal in function and appearance to enhance ease of handling and use.

As in manual laparoscopic procedures, a known insufflation system can be used to pump sterile carbon dioxide (or other gas) into the patient's abdominal cavity. This lifts the abdominal wall from the organs and creates space for the robot. In certain implementations, the system has no direct interface with the insufflation system. Alternatively, the system can have a direct interface to the insufflation system.

In certain implementations in which the device is inserted through an insertion port, the insertion port is a known, commercially-available flexible membrane placed transabdominally to seal and protect the abdominal incision. This off-the-shelf component is the same device or substantially the same device that is used in substantially the same way for Hand-Assisted Laparoscopic Surgery (HALS). The only difference is that the arms of the robotic device according to the various embodiments herein are inserted into the abdominal cavity through the insertion port rather than the surgeon's hand. The robotic device body seals against the insertion port when it is positioned therethrough, thereby maintaining insufflation pressure. The port is single-use and disposable. Alternatively, any known port can be used. In further alternatives, the device can be inserted through an incision without a port or through a natural orifice.

Certain implementations disclosed herein relate to “combination” or “modular” medical devices that can be assembled in a variety of configurations. For purposes of this application, both “combination device” and “modular device” shall mean any medical device having modular or interchangeable components that can be arranged in a variety of different configurations.

Certain embodiments disclosed or contemplated herein can be used for colon resection, a surgical procedure performed to treat patients with lower gastrointestinal diseases such as diverticulitis, Crohn's disease, inflammatory bowel disease and colon cancer. Approximately two-thirds of known colon resection procedures are performed via a completely open surgical procedure involving an 8- to 12-inch incision and up to six weeks of recovery time. Because of the complicated nature of the procedure, existing robot-assisted surgical devices are rarely used for colon resection surgeries, and manual laparoscopic approaches are only used in one-third of cases. In contrast, the various implementations disclosed herein can be used in a minimally invasive approach to a variety of procedures that are typically performed ‘open’ by known technologies, with the potential to improve clinical outcomes and health care costs. Further, the various implementations disclosed herein can be used for any laparoscopic surgical procedure in place of the known mainframe-like laparoscopic surgical robots that reach into the body from outside the patient. That is, the less-invasive robotic systems, methods, and devices disclosed herein feature small, self-contained surgical devices that are inserted in their entireties through a single incision in the patient's abdomen. Designed to utilize existing tools and techniques familiar to surgeons, the devices disclosed herein will not require a dedicated operating room or specialized infrastructure, and, because of their much smaller size, are expected to be significantly less expensive than existing robotic alternatives for laparoscopic surgery. Due to these technological advances, the various embodiments herein could enable a minimally invasive approach to procedures performed in open surgery today.

FIG. 1 depicts one embodiment of a robotic surgical system 10 having several components that will be described in additional detail below. The components of the various system implementations disclosed or contemplated herein can include an external control console 16 and a robotic device 12 having a removable camera 14 as will also be described in additional detail below. In accordance with the implementation of FIG. 1, the robotic device 12 is shown mounted to the operating table 18 via a known, commercially available support arm 20. The system 10 can be, in certain implementations, operated by the surgeon 22 at the console 16 and one surgical assistant 25 positioned at the operating table 18. Alternatively, one surgeon 22 can operate the entire system 10. In a further alternative, three or more people can be involved in the operation of the system 10. It is further understood that the surgeon (or user) 22 can be located at a remote location in relation to the operating table 18 such that the surgeon 22 can be in a different city or country or on a different continent from the patient on the operating table 18.

In this specific implementation, the robotic device 12 with the camera 14 are both connected to the surgeon console 16 via cables: a device cable 24A and a camera cable 24B that will be described in additional detail below. For purposes of this application, the term “cable” is intended to mean any sheath or elongate casing that can contain two or more different elongate cables, wires, and/or cords (referred to herein as “conductors”). In the specific embodiment as shown in FIGS. 1-2, the device 12 and camera 14 are connected to the surgeon console 16 via the device cable 24A and the camera cable 24B, which are coupled to an interface pod and electrosurgical unit 26 (which can be mounted in certain embodiments on a companion cart 28), and the pod and surgical unit 26 are coupled to the console 16 via a separate cable 30. According to one implementation, the device cable 24A is fixedly attached to the device 12 and can extend several feet to the pod and surgical unit 26. The cable 24A can be bifurcated near its proximal end so that robot signal/power conductors (discussed below) can connect to the interface pod 26 and the electrosurgical conductors can attach to the electrosurgical unit 26. Alternatively, these could also be combined into one connector on a cable that does not bifurcate. Alternatively, any connection configuration can be used. In certain implementations, the system can also interact with other devices during use such as a electrosurgical generator, an insertion port, and auxiliary monitors.

FIG. 2 depicts one exemplary implementation of a robotic device 40 that can be incorporated into the exemplary system 10 discussed above or any other system disclosed or contemplated herein. The device 40 has a body (or “torso”) 42 having a distal end 42A and proximal end 42B, with the imaging device (or “camera”) 44 disposed therethrough, as mentioned above and as will be described in additional detail below. Briefly, the robotic device 40 has two robotic arms 46, 48 operably coupled thereto and the camera 44 is removably positionable through the body 42 such that the distal end of the camera 44 is disposed between the two arms 46, 48. That is, device 40 has a first (or “right”) arm 46 and a second (or “left”) arm 48, both of which are operably coupled to the device 40 as discussed in additional detail below. In this embodiment, the body 42 of the device 40 as shown has an enclosure (also referred to as a “cover” or “casing”) 52 such that the internal components and lumens of the body 42 are disposed within the enclosure 52. Each arm 46, 48 in this implementation also has an upper arm (also referred to herein as an “inner arm,” “inner arm assembly,” “inner link,” “inner link assembly,” “upper arm assembly,” “first link,” or “first link assembly”) 46A, 48A, and a forearm (also referred to herein as an “outer arm,” “outer arm assembly,” “outer link,” “outer link assembly,” “forearm assembly,” “second link,” or “second link assembly”) 46B, 48B. The right upper arm 46A is operably coupled to the body 42 at the right shoulder joint 46C and the left upper arm 48A is operably coupled to the body 42 at the left shoulder joint 48C. The shoulder joints 46C, 48C can be any known shoulder joints 46C, 48C of any configuration for rotatably attaching the arms 46, 48 to the body 42. Further, for each arm 46, 48, the forearm 46B, 48B is rotatably coupled to the upper arm 46A, 48A at the elbow joint 46D, 48D. In various embodiments, the forearms 46B, 48B are configured to receive various removeable, interchangeable end effectors 56A, 56B. Alternatively, each arm 46, 48 can be a single, unitary arm without an elbow joint, with the end effectors 56A, 56B disposed at the distal end of the unitary arms 46, 48. For purposes of this application, an “end effector” is any operational component, tool, instrument, or other device that is coupleable to a surgical device or system (including a robotic surgical device or system) and configured to interact with the environment, wherein such interaction can include performing a task or procedure.

The end effectors 56A, 56B on the distal end of the arms 46, 48 can be various tools 56A, 56B (scissors, graspers, needle drivers and the like), as will be described in additional detail below. In certain implementations, the tools 56A, 56B are designed to be removable, including in some instances by a small twist of the tool knob that couples the end effector 56A, 56B to the arm 46, 48. In certain implementations, at least two single-use, interchangeable, disposable surgical end effectors can be used with any of the robotic device embodiments herein (including device 40). Such end effectors can include, but are not limited to, a fenestrated grasper capable of bi-polar cautery, scissors that deliver mono-polar cautery, a hook that delivers mono-polar cautery, and a left/right needle driver set. The tools can be selected for the specific surgical task. Certain forearm and end effector configurations that allow for the removability and interchangeability of the end effectors are disclosed in detail in U.S. application Ser. No. 14/853,477, which is incorporated by reference above. Further, it is understood that any known forearm and end effector combinations can be used in any of the robotic device embodiments disclosed or contemplated herein.

In some embodiments, at least one of the two end effectors 56A, 56B is a cauterization device, such as a mono-polar cauterization device or a bi-polar cauterization device. In this exemplary implementation as shown in FIG. 2, the right end effector 56A is a scissors that is a monopolar cauterization device 56A and the left end effector 56B is a fenestrated grasper that is a bi-polar cauterization device 56B. Alternatively, many energy/cauterization device configurations are possible. It is also possible to deliver two or more types of energy through a single cauterization end effector.

In various implementations, the body 40 and each of the links of the arms 46, 48 can contain a variety of actuators or motors. In certain implementations, the body 40 has no motors disposed therein, while there is at least one motor in each of the arms 46, 48. In one embodiment, any of the motors discussed and depicted herein can be brush or brushless motors. Further, the motors can be, for example, 6 mm, 8 mm, or 10 mm diameter motors. Alternatively, any known size that can be integrated into a medical device can be used. In a further alternative, the actuators can be any known actuators, including any known motors, used in medical devices to actuate movement or action of a component. Examples of motors that could be used in the embodiments herein include the EC 10 BLDC+GP10A Planetary Gearhead, EC 8 BLDC+GP8A Planetary Gearhead, or EC 6 BLDC+GP6A Planetary Gearhead, all of which are commercially available from Maxon Motors, located in Fall River, MA. There are many ways to actuate these motions electrically, such as with DC motors, AC motors, permanent magnet DC motors, brushless motors, cables to remote motors, and the like. As such, the actuation source can be at least one motor or any other electrical actuation source disposed remotely from or proximally to the device 40 such that an appropriate coupling or transmission mechanism (such as at least one cable or any other electrical transmission mechanism) is disposed through the body 42.

In one embodiment, the various joints discussed above in accordance with any of the embodiments disclosed or contemplated herein can be driven by electrical motors disposed within the device and, in some implementations, near each joint. In additional alternative embodiments, the driving actuators are disposed outside the device and/or body cavity and electrical transmission mechanisms are provided to transmit the electrical energy from the external source to the various joints of any device herein. Such a transmission mechanism could, for example, take the form of cables or other known electrical mechanisms, or any combination thereof.

In accordance with one implementation, FIG. 2 also depicts the device cable 24A and the camera cable 24B discussed above, with the device cable 24A extending from the device body 42 and the camera cable 24B extending from the camera 44 as shown. According to various embodiments, the device cable 24A is a single cable 24A containing all the necessary separate elongate conductors for transmission of all electrical signals and power as discussed above. A single elongate device cable 24A can be desirable, because it can simplify set up and handling of the device 40 and system 10 without having to deal with numerous separate cables/conductors/etc. In this specific implementation, the cable 24A is permanently connected to the robot 40 and is removably coupleable to the interface pod 26 via an electrical connector (not shown). Alternatively, any connection is possible at either end of the cable 24A.

An exploded view of one exemplary device cable 24A is depicted in FIGS. 3A and 3B according to one embodiment, in which the cable 24A contains several conductors that transmit several types of electrical signals and different types of electrical power. For example, several of the conductors 80 transmit power and digital/analog signals that are used to power the motion of the robotic device 40 and to send signals (in one specific implementation, a version of RS-485 is used) to control the motion of the device 40. In addition, the device cable 24A also contains a pair of conductors 82A, 82B (which are typically twisted around each other along the length of the cable 24A) for transmission of bi-polar electrosurgical energy to any bi-polar cauterization end effector that may be coupled to either or both of the arms 46, 48. Further, the cable 24A has an elongate conductor 84 (in certain embodiments, a co-axial cable) that provides transmission of mono-polar energy to any mono-polar cauterization end effector that may be coupled to either or both arms 46, 48. Alternatively, the cable 24A can contain any combination of conductors necessary to provide appropriate electrical signals and power to a robotic surgical device such as device 40.

As discussed above, because all of the various elongate conductors within the single device cable 24A (including the conductors 82A, 82B and conductor 84) are in close proximity within and along the extended length of the cable 24A, some energy coupling exists between each pair of conductors within the cable 24A. For example, this energy coupling can be capacitance or inductance that can be envisioned as an impedance between each pair of conductors, shown schematically in FIG. 3B. Alternatively, any known form of energy coupling can result. In this schematic depiction, the coupling is shown as Zn between any pair of conductors. This energy coupling can result in the transfer of electrical energy from one conductor/cord to another.

Because of the possibility of electrical energy transferring to a quiescent conductor, the energy couplings Z1 and Z2 between the mono-polar conductor 84 and bi-polar conductors 82A, 82B as shown in FIG. 3B are of particular interest within the context of the various embodiments herein. That is, both the mono-polar conductor 84 and bi-polar conductors 82A, 82B carry relatively high voltage, high frequency electrical energy, which increases the possibility of transferring electrical energy therebetween. Further, because the mono-polar conductor 84 is connected to a mono-polar cauterization end effector (such as end effector 56A) and the bi-polar conductors 82A, 82B are connected to a bi-polar cauterization end effector (such as end effector 56B), any energy transferred from one conductor to the other (such as from the monopolar elongate conductor 84 to the bi-polar elongate conductors 82A, 82B) can be directly transmitted to the unintended end effector and thus to the target surgical tissue, thereby risking serious injury to the patient. (In contrast, transfer of energy to any of the other conductors is of little concern, because those conductors have no direct path to an end effector and/or the target surgical tissue.)

More specifically, as shown in FIG. 4A (with reference to FIGS. 3A and 3B), the mono-polar cauterization end effector 56A can be actuated (as represented by the lines A) to cauterize a target tissue of the patient, which means that the requisite electrical energy is intended to be transmitted to the end effector 56A along the monopolar elongate conductor 84 (as shown in FIGS. 3A and 3B above). This energy from the monopolar elongate conductor 84 can then inadvertently transfer to the bi-polar elongate conductors 82A, 82B as a result of the coupling Z1 and Z2 discussed above and shown in FIG. 3B. The energy transferred to the bi-polar elongate conductors 82A, 82B can travel along those conductors 82A, 82B to the bi-polar cauterization end effector 56B, thereby resulting in inadvertent actuation of the end effector 56B. That is, some electrical current “leaks” from the bi-polar cauterization end effector 56B as a result of the unintentional transfer of electrical energy from the monopolar conductor 84 to the bi-polar elongate conductors 82A, 82B.

The mono-polar electrical energy transmitted along the monopolar conductor 84 has a very high potential (up to 3,300V), so the coupling of the monopolar conductor 84 to the bipolar conductors 82A, 82B can result in the transfer of significant amounts of current to the bi-polar cauterization end effector (such as end effector 56B) that exceed the limits set by standard. For example, in some embodiments, more than 170 mA is transferred, which exceeds the 50 mA limit set by the standard set forth in the international standard IEC 60601-2-2 by the International Electrotechnical Commission (“IEC”). Alternatively, any known standard may be taken into account with respect to the amount of current transferred.

Similarly, as shown in FIG. 4B, the bi-polar cauterization end effector 56B can be actuated (as represented by lines B) to cauterize a target tissue of the patient, which means that the requisite electrical energy is intended to be transmitted to the end effector 56B along the bi-polar elongate conductors 82A, 82B (as shown in FIGS. 3A and 3B above). This energy from the bi-polar elongate conductors 82A, 82B can then inadvertently transfer to the monopolar elongate conductor 84 as a result of the coupling Z1 and Z2 discussed above and shown in FIG. 3B. The energy transferred to the monopolar elongate conductor 84 can travel along the conductor 84 to the mono-polar cauterization end effector 56A, thereby resulting in inadvertent actuation of the end effector 56A. That is, some electrical current “leaks” from the mono-polar cauterization end effector 56A as a result of the unintentional transfer of electrical energy from the bi-polar elongate conductors 82A, 82B to the monopolar conductor 84.

In one embodiment, a disconnection system 112 is provided to prevent or minimize the type of electrical energy leakage described above. For example, in one specific implementation, the disconnection system 112 is incorporated into a robotic device 100 as depicted in FIG. 5. The disconnection system 112 is positioned along the length of the bi-polar conductors 106A, 106B within the device 100, thereby providing for controllable disconnection of those conductors 106A, 106B from the bi-polar cauterization end effector 110B to prevent transmission of any energy transfer to the end effector 110B. That is, the disconnection system 112 does not prevent the energy transfer described above, because the transfer (represented by the symbol C in FIG. 5) can still occur anywhere along the length of the device cable 104 between the interface pod and electrosurgical unit (similar to the pod and unit 26 discussed above) and the device 100. Instead, the controllable disconnection provided by the system 112 prevents any such energy that has transferred to the bi-polar conductors 106A, 106B from reaching the end effector 110B.

According to one embodiment as shown, the disconnection system 112 is disposed within the body 102 of the device 100. Alternatively, the system 112 can be disposed anywhere within the device.

In this specific implementation as shown schematically in FIG. 5, the disconnection system 112 in this implementation is a set of two disconnection mechanisms 112A, 112B: a first relay 112A coupled to the first bi-polar conductor 106A and a second relay 112B coupled to the second bi-polar conductor 106B. For purposes of this application, the term “relay” is intended to broadly refer to any disconnection mechanism (including for example, any known relay, transistor, switch, etc.) that can be used to disconnect and reconnect any conductor, thereby controlling the ability of conductor to transmit electrical current therethrough.

In use, when the bi-polar electrocautery end effector 110B is actuated, the relays 112A, 112B can be positioned in the closed position to allow electricity to pass along the conductors 106A, 106B to the bi-polar cauterization end effector 110B. Further, when the monopolar electrocauterization end effector 110A is actuated, the relays 112A, 112B can be positioned in the open position (as shown in FIG. 5) such that electricity cannot pass along the conductors 106A, 106B to the end effector 110B, thereby preventing any “leakage” of energy from the monopolar conductor 108 to either or both of the quiescent bi-polar conductors 106A, 106B and thus to the bi-polar cauterization end effector 110B.

A disconnection system (similar to disconnection system 112 or any other disconnection system disclosed or contemplated herein) can also be incorporated into the mono-polar conductor 108 and used to disconnect the conductor 108 from the monopolar cauterization end effector 110A when the mono-polar conductor 108 is the quiescent conductor susceptible to leakage when the bi-polar cauterization end effector 110B is actuated in a fashion similar to the disconnection system 112 discussed above. While the description and the figures set forth herein are focused on the disconnection system 112 (and any other disconnection mechanism embodiments disclosed or contemplated herein) incorporated into the bi-polar conductors 106A, 106B, the various aspects, features, and functionalities of the system 112 (and any other such mechanism herein) can also apply to an equivalent mechanism coupled to the monopolar conductor 108 or any other quiescent conductor in any other robotic device or system with an electrosurgical end effector. Similarly, any disconnection mechanisms disclosed or contemplated herein can also be incorporated into any other elongate conductors in any robotic or medical devices to mitigate energy transfer in a similar fashion.

Additionally, in this exemplary implementation, the disconnect system 112 has current sensors 114A, 114B coupled to the conductors 106A, 106B, respectively. More specifically, the current sensor 114A is coupled to the conductor 106A such that the sensor 114A can detect the amount of electrical current passing through the conductor 106A, and the current sensor 114B is coupled to the conductor 106B such that the sensor 114B can detect the amount of current passing through the conductor 106B.

In certain embodiments, the sensors 114A, 114B are transformers 114A, 114B that supply a current through the secondary winding that is proportional to the current through the primary winding depending on the turns ratio of the transformer. In these embodiments, there is electrical isolation between the current being measured (e.g., the bipolar conductors 106A, 106B) and the system measuring the current (e.g., the system attached to the sensor—such as sensor 114A or sensor 114B). Alternatively, the current sensors 114A, 114B can be any known electrical current sensors, such as Hall effect current sensors, optocouplers, shunt resistors, or any other mechanism capable of measuring electrical current.

In use, the sensors 114A, 114B are coupled to a system controller (such as the electrosurgical unit 26 and console 16 as discussed above, for example) such that the system 10 can track electrical current passing through the conductors 106A, 106B. Thus, if one or both of the disconnection mechanisms 112A, 112B fail, the sensors 114A, 114B will detect the failure. More specifically, the sensors 114A, 114B can detect a failure in which either relay 112A, 112B remains open (such that no electricity can pass) or a failure in which either relay 112A, 112B remains closed (such that electricity continues to pass).

In the event that either or both disconnect circuits 112A, 112B fails in a “closed” position (e.g., either circuit 112A, 112B is unable to disconnect either bipolar conductor 106A, 106B from the bipolar instrument 110B when needed/desired), the current sensors 114A, 114B will detect a leakage current through either of these quiescent conductors 106A, 106B while the monopolar conductor 108 is actuated (such that electrical current is passing through the conductor 108). In some embodiments, this failure is transmitted to the system controller (such as the electrosurgical unit 26 and console 16) such that the controller can be used to take appropriate action. For example, in certain implementations, the controller will immediately disable the electrosurgical generator unit 26, thereby preventing further current from flowing through either of the quiescent conductors 106A, 106B and thus preventing any harm to the patient. In some embodiments, this condition can also trigger an error message to be displayed to the user at the console 16. In some embodiments, upon receiving the failure information, the controller prevents the user from further using the system.

In the event that either or both disconnect circuits 112A, 112B fails in an “open” position (e.g., either circuit 112A, 112B is unable to reconnect the respective bipolar conductor 106A, 106B to the bipolar end effector 110B when necessary/desired), the current sensors 114A, 114B will detect no current flowing, even when the bipolar generator is supplying energy. This failure renders the bipolar instrument 110B inoperable as a result of the inability to pass current through the conductors 106A, 106B to the end effector 110B. This failure, in accordance with certain implementations, is transmitted to the system controller (such as the electrosurgical unit 26 and console 16) such that the controller can be used to take appropriate action. For example, in certain implementations, the controller will transmit an error message to be displayed to the user at the console (such as console 16). Further, in some embodiments, upon receiving the failure information, the controller prevents the user from further using the system.

In certain embodiments, the current sensors 114A, 114B can also be used to enhance the operation of the system 10. More specifically, the system controller (such as the electrosurgical unit 26 and console 16) can use the sensors 114A, 114B as a feedback mechanism to modulate the output power transmitted to the end effector 110B. Thus, the controller can use the sensors 114A, 114B to enhance the consistency of the output power, to counteract any power loss in the either or both of the conductors 106A, 106B, or to provide power adjustments for any other reason based on the feedback from the sensors 114A, 114B.

In accordance with another implementation as best shown in FIGS. 6-8, a disconnection mechanism 132 can be coupled to, incorporated into, or otherwise associated with a local controller (also referred to herein as a “control board”) 130 (such as a printed circuit board 130) of a robotic device 120. In this exemplary embodiment as shown, the control board 130 is disposed within the elongate body 122 of the device as best shown in FIG. 6. More specifically, the board 130 is disposed on a structural support (or “sled”) 134 disposed within the body 122. Alternatively, the control board 130 can be disposed within the body 122 in any known fashion and/or coupled to any known structure associated therewith. In various embodiments, this control board 130 can be one of several printed control boards disposed within or otherwise associated with the device 120.

In this specific implementation, the control board 130 can perform many functions for controlling the actuation of the various motors of the device 120 (and thus movement of the arms and other components therein) and for managing the information regarding the device's functionalities and operation. As such, in this specific embodiment, the PCB 130 is coupled to and receives electrical power and signals via the device cable 126. More specifically, as best shown in FIGS. 7A and 7B (which depict the front and back sides of the control board 130, respectively), the device cable 126 ends within the device body 122 such that the various separate conductors therein extend out of the cable 126 inside the body 122. The low voltage signal and power conductors 140 connect directly to the PCB 130, while the mono-polar conductor 138 pass directly though the body 122 and extend into and through the right arm to the right (monopolar cauterization) end effector 124A. As such, in this embodiment, there is no disconnection mechanism coupled to the mono-polar cable 138. However, as mentioned above, in certain alternative implementations, a disconnection mechanism (not shown) could also be coupled to the mono-polar cable 138.

Continuing with FIGS. 7A and 7B, along with exploded view of the back of the control board 130 in FIG. 7C, the disconnection mechanism 132 is comprised of two relay housings (or bodies) 132A, 132B disposed on the control board 130. The conductor 136A is coupled to the relay housing 132A and the conductor 136B is coupled to the relay housing 132B as depicted. More specifically, the two bi-polar conductors 136A, 136B extend through the cable 126 and are coupled at their distal ends to the relay housings 132A, 132B (respectively) of the disconnection mechanism 132. Distally of the relay housings 132A, 132B, the two bi-polar conductors are identified as conductors 137A, 137B and extend from the housings 132A, 132B distally to the end effector as discussed in detail below.

As shown in FIG. 7C, according to one embodiment, the disconnection mechanism 132 can also have a safety mechanism in the form of electrical current sensors 142A, 142B associated with the distal lengths of the bi-polar conductors 137A, 137B. These sensors 142A, 142B can be similar to and operate in a fashion similar to the sensors 114A, 114B discussed above. More specifically, in this exemplary implementation, the sensors 142A, 142B are electrical current sensors 142A, 142B that are disposed around the conductors 137A, 137B on the end effector side of the mechanisms 132. As such, the sensors 142A, 142B can be used to sense whether any current is passing through the disconnection mechanism 132 via the conductors 137A, 137B to the bi-polar cauterization end effector 124B. Any current in the conductors 137A, 137B extending from the mechanism 132 creates a signal that is detected by the sensors 142A, 142B, which are operably coupled to the PCB 130 such that the information about such signals is processed by the device system. Thus, if the disconnection mechanism 132 has been actuated to disconnect the conductors 137A, 137B from the conductors 136A, 136B such that no electricity should be transmitted to the end effector 124B, and yet electrical current is detected by the sensors 142A, 142B, the information is transmitted to the appropriate processor in the system and the transmission of energy along the conductor 138 is stopped. As such, the sensors 142A, 142B are part of a safety mechanism to shut down the actuation of the monopolar cauterization end effector 124A if the disconnection mechanism 132 fails.

Alternatively, any known electrical current sensors can be used in the safety mechanism. In a further alternative, the safety mechanism can be any known safety mechanism for use in such electrical medical devices.

According to one embodiment, one exemplary relay housing 132A (of the two housings 132A, 132B discussed above) is depicted schematically in further detail in FIG. 8. In this specific implementation, the relay housing 132A has isolation barriers (more specifically, a combination of insulation sheaths 154A, 154B and insulation beads 156A, 156B, as discussed in further detail below) that electrically isolate the exemplary housing 132A from the control board 130. It is understood that while the relay housing 132A will be discussed in detail herein with respect to FIG. 8, the second relay housing 132B can have substantially similar components and features (such as the isolation barriers) and operate in substantially the same fashion. The incoming bi-polar conductor 136A is coupled to the housing 132A at a first insulated coupling 150A, and the outgoing bi-polar conductor 137A is coupled to the housing 132A at a second insulated coupling 150B. Both insulated couplings 150A, 150B have a coupling pin 152A, 152B to which the conductors 136A, 137A are physically and electrically coupled. Further, as mentioned above, both insulated couplings 150A, 150B have isolation barriers that consist of an insulation sheath 154A, 154B coupled to and extending along the coupling of the pin 152A, 152B and a length of the end of the conductors 136A, 137A and an insulation bead (or “fillet” or “bonding structure”) 156A, 156B. These sheaths 154A, 154B and beads 156A, 156B create the isolation barriers between the base of the pins 152A, 152B and the control board 130. In certain embodiments, the conductors 136A, 137A are soldered to the pins 152A, 152B. Alternatively, the conductors 136A, 137A can be coupled to the pins 152A, 152B using any known coupling mechanism or process.

Each of the insulation sheaths 154A, 154B, in accordance with certain embodiments, has a length sufficient to help create an insulative barrier that prevents current from creeping or otherwise jumping from the pins 152A, 152B along the insulation of either of the conductors 154A, 154B to any other conductive part of the device or system (such as, for example, the control board 130 or the control pins 166A, 166B, which are discussed in further detail below). In one specific example, the sheaths 154A, 154 extend along at least 13.5 mm of the bi-polar conductors 136A, 137A to provide a 4.5 kV isolation barrier per the IEC60601 specification for creepage and clearance distances. Alternatively, the length can be any length that decreases the risk of current creepage, satisfies the desired regulatory standards for the design's isolation voltage rating, or both. According to some implementations, the insulation sheaths 154A, 154B are heat shrink insulation sheaths that can be made of polyolefin, fluoropolymer (such as, for example, FEP, PTFE, or Kynar), PVC, neoprene, silicone elastomer, or Viton. Alternatively, the insulation sheaths 154A, 154B can be made of any known insulation material.

In accordance with various implementations, the bonding structures 156A, 156B are made of an electrically insulating and bonding epoxy, glue, or coating that is applied at an appropriate, known thickness to achieve the desired and/or required dialectric strength and resulting in an insulation barrier between each pin 152A, 152B and other conductive elements of the device or system. In certain embodiments, the insulation barrier is a standards-compliant barrier. For example, according to one exemplary, non-limiting embodiment, each of the structures 156A, 156B are made of Loctite 4090 epoxy, which has a dielectric strength of approximately 500 V/mil. Alternatively, any known epoxy, glue, or coating having an appropriate dialectric strength can be used. In certain embodiments, each structure 156A, 156B has a thickness of at least 9 mil, resulting in a minimum dialectric strength of 4,500V. Alternatively, the structures 156A, 156B each have any thickness that results in sufficient dialectric strength as desired for the design or for standards compliance.

Alternatively, any known insulated couplings having any known configuration can be used.

Continuing with FIG. 8, the exemplary relay housing 132A (also referred to as a “relay”) contains an elongate electrical conductor 160 that extends from the first coupling pin 152A to the second coupling pin 152B and includes a actuable switch 162 disposed along the length of the elongate conductor 160. In use, the switch 162 can be positioned in the closed position to allow electricity to pass along the conductor 160 from the incoming bi-polar conductor 136A coupled to the pin 152A to the outgoing bi-polar conductor 137A coupled to the pin 152B. Further, the switch 162 can be positioned in the open position (as shown in FIG. 8) such that electricity cannot pass to the outgoing conductor 137A and thus cannot be transmitted to the end effector 124B, thereby preventing any “leakage” of energy from the end effector 124B.

In one specific implementation, the relay 132A is a Standex-Meder SHV05-1A85-78D4K relay having a contact-to-contact dielectric rating of 4 kV, which is commercially available from Standex Electronics, Inc. in Fairfield, OH. It should be noted that the second relay 132B can also be the same device. Alternatively, the relays 132A, 132B can be any known relays or other types of electrical disconnection mechanisms with an appropriate dialectric rating.

In one embodiment, the housing 132A also has a switch controller 164 that is configured to actuate/urge the switch 162 to move between its open and closed positions as described above. The controller 164 has first and second control pins 166A, 166B that are coupled to the magnetic coil 168 of the relay 132A such that an electrical current can be passed through the pins 166A, 166B and thus through the coil 168 to magnetically urge the switch 162 open or closed. As such, the control board 130 can be used to control the actuable switch 162 by actuating the magnetic coil 168 to urge the switch 162 into either the open or closed position as necessary. According to one implementation, the relay 132A has a contact-to-coil dielectric rating that provides sufficient electrical isolation between the control board 130 and the high voltage bipolar current passing through the relay 132A.

According to certain embodiments, the electrosurgical unit 26 is prevented from operating when the switch 162 is moving between its open and closed position to prevent electrical arcing between the contacts of the switch 162. In various implementations, this failsafe can satisfy the make-or-break voltage rating of the relay, which may be less than the monopolar cautery voltage. Thus, according to some exemplary embodiments, the timing of the closing of the switch 162 is set such that the switch 162 will always be closed when electrical energy is applied across the bi-polar conductor 136A, 137A to actuate the bi-polar end effector.

According to certain implementations, the control board 130 is configured to control the switch 162 to move into the open position and thereby electrically disconnect the proximal bi-polar conductor 136A from the distal bi-polar conductor 137A (and thus the end effector 124B) when the mono-polar end effector 124A is being actuated. More specifically, this disconnection can be automatic—it can be automatically actuated when the mono-polar end effector 124A is actuated. It is understood that the second housing 132B with the second bi-polar conductor 136B, 137B can have a similar configuration. As such, the disconnection housings 132A, 132B provide for disconnection of the proximal lengths of the bi-polar conductors 136A, 136B from the distal lengths of the conductors 137A, 137B in a similar fashion. Alternatively, any known disconnection mechanism (such as mechanical disconnection mechanisms, for example) can be incorporated into each housing 132A, 132B and the actuator can be any known actuator for urging such mechanisms to connect and disconnect the proximal lengths of the conductors 136A, 136B from the distal lengths of the conductors 137A, 137B.

In use, regardless of the specific configuration, a disconnection mechanism (such as the mechanism 182 in a device 180 as depicted schematically in FIGS. 9A and 9B) is a safety feature that eliminates the problem of the energy from the mono-polar conductor 186 coupling with the bi-polar conductors 184A, 184B such that electrical energy is unintentionally delivered to the surgical target via the bi-polar cauterization end effector 186B. As discussed above, this disconnection mechanism does not stop the energy coupling from occurring along the device cable (such as cable 24A, 104 or 126 as discussed above), but instead prevents any such coupled electrical energy from being transmitted along the bi-polar conductors 184A, 184B to the bi-polar cauterization end effector 186B by eliminating the electrical path to that end effector 186B. Thus, according to certain embodiments, when it is desired to use the bi-polar cauterization end effector 186B, the disconnection mechanism 182 is actuated to close the switches 188A, 188B as shown in FIG. 9B, thereby allowing electrical energy to be transmitted to the end effector 186B. On the other hand, when it is desired to use the monopolar cauterization end effector 186A, the disconnection mechanism can be manually or automatically actuated to open the switches 188A, 188B as shown in FIG. 9A, thereby preventing any electrical energy that may have been transferred to the bi-polar conductors 184A, 184B from the monopolar conductor 186 as a result of energy coupling from actually being transmitted along the bi-polar conductors 184A, 184B to the bi-polar cauterization end effector 186B. Alternatively, as discussed above, the actual mechanisms within the disconnection mechanism 182 can be any known mechanisms for connecting and disconnecting conductive components.

Alternatively, the mitigation devices, features, and methods disclosed or contemplated herein need not be limited to use in a specific robotic surgical device as described herein. Instead, such devices, features, and methods can also be used to mitigate or prevent energy transfer via any type of coupling of any conductors used in any known electrical devices.

While the various systems described above are separate implementations, any of the individual components, mechanisms, or devices, and related features and functionality, within the various system embodiments described in detail above can be incorporated into any of the other system embodiments herein.

The terms “about” and “substantially,” as used herein, refers to variation that can occur (including in numerical quantity or structure), for example, through typical measuring techniques and equipment, with respect to any quantifiable variable, including, but not limited to, mass, volume, time, distance, wave length, frequency, voltage, current, and electromagnetic field. Further, there is certain inadvertent error and variation in the real world that is likely through differences in the manufacture, source, or precision of the components used to make the various components or carry out the methods and the like. The terms “about” and “substantially” also encompass these variations. The term “about” and “substantially” can include any variation of 5% or 10%, or any amount—including any integer—between 0% and 10%. Further, whether or not modified by the term “about” or “substantially,” the claims include equivalents to the quantities or amounts.

Numeric ranges recited within the specification are inclusive of the numbers defining the range and include each integer within the defined range. Throughout this disclosure, various aspects of this disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges, fractions, and individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6, and decimals and fractions, for example, 1.2, 3.8, 1½, and 4¾. This applies regardless of the breadth of the range. Although the various embodiments have been described with reference to preferred implementations, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.

Although the various embodiments have been described with reference to preferred implementations, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.

ENERGY COUPLING MITIGATION DEVICE AND RELATED SYSTEMS AND METHODS

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