Patent Application
20240000474
A variety of ultrasonic surgical instruments include an end effector having a blade element that vibrates at ultrasonic frequencies to cut and/or seal tissue (e.g., by denaturing proteins in tissue cells). These instruments include one or more piezoelectric elements that convert electrical power into ultrasonic vibrations, which are communicated along an acoustic waveguide to the blade element. Examples of ultrasonic surgical instruments and related concepts are disclosed in U.S. Pub. No. 2006/0079874, entitled “Tissue Pad for Use with an Ultrasonic Surgical Instrument,” published Apr. 13, 2006, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pub. No. 2007/0191713, entitled “Ultrasonic Device for Cutting and Coagulating,” published Aug. 16, 2007, now abandoned, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pub. No. 2008/0200940, entitled “Ultrasonic Device for Cutting and Coagulating,” published Aug. 21, 2008, the disclosure of which is incorporated by reference herein, in its entirety.
Some instruments are operable to seal tissue by applying radiofrequency (RF) electrosurgical energy to the tissue. Examples of such devices and related concepts are disclosed in U.S. Pat. No. 7,354,440, entitled “Electrosurgical Instrument and Method of Use,” issued Apr. 8, 2008, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 7,381,209, entitled “Electrosurgical Instrument,” issued Jun. 3, 2008, the disclosure of which is incorporated by reference herein, in its entirety.
Some instruments are capable of applying both ultrasonic energy and RF electrosurgical energy to tissue. Examples of such instruments are described in U.S. Pat. No. 9,949,785, entitled “Ultrasonic Surgical Instrument with Electrosurgical Feature,” issued Apr. 24, 2018, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 8,663,220, entitled “Ultrasonic Electrosurgical Instruments,” issued Mar. 4, 2014, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 10,835,307, entitled “Modular Battery Powered Handheld Surgical Instrument Containing Elongated Multi-Layered Shaft,” issued Nov. 17, 2020, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pat. No. 11,229,471, entitled “Modular Battery Powered Handheld Surgical Instrument with Selective Application of Energy Based on Tissue Characterization,” issued Jan. 25, 2022, the disclosure of which is incorporated by reference herein, in its entirety.
In some scenarios, it may be preferable to have surgical instruments grasped and manipulated directly by the hand or hands of one or more human operators. In addition, or as an alternative, it may be preferable to have surgical instruments controlled via a robotic surgical system. Examples of robotic surgical systems and associated instrumentation are disclosed in U.S. Pat. No. 10,624,709, entitled “Robotic Surgical Tool with Manual Release Lever,” published on May 2, 2019, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 9,314,308, entitled “Robotic Ultrasonic Surgical Device With Articulating End Effector,” issued on Apr. 19, 2016, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 9,125,662, entitled “Multi-Axis Articulating and Rotating Surgical Tools,” issued Sep. 8, 2015, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 8,820,605, entitled “Robotically-Controlled Surgical Instruments,” issued Sep. 2, 2014, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pub. No. 2019/0201077, entitled “Interruption of Energy Due to Inadvertent Capacitive Coupling,” published Jul. 4, 2019, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pub. No. 2012/0292367, entitled “Robotically-Controlled End Effector,” published on Nov. 11, 2012, now abandoned, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. patent application Ser. No. 16/556,661, entitled “Ultrasonic Surgical Instrument with a Multi-Planar Articulating Shaft Assembly,” filed on Aug. 30, 2019, the disclosure of which is incorporated by reference herein, in its entirety.
Such instruments and robotic surgical systems may be further be incorporated into a surgical system for performing procedures in a surgical environment, such as surgical operating theaters or rooms in a healthcare facility. A sterile field is typically created around the patient and may include properly attired, scrubbed healthcare professions as well as desired furniture and/or fixtures. Examples of such surgical systems and associated features are disclosed in U.S. Pat. Pub. No. 2019/0201046, entitled “Method for Controlling Smart Energy Devices,” published on Jul. 4, 2019, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. Pub. No. 2019/0201080, entitled “Ultrasonic Energy Device Which Varies Pressure Applied by Clamp Arm to Provide Threshold Control Pressure at a Cut Progression Location,” published on Jul. 4, 2019, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. Pub. No. 2019/0201091, entitled “Radio Frequency Energy Device for Delivering Combined Electrical Signals,” published Jul. 4, 2019, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. Pub. No. 2019/0274717, entitled “Methods for Controlling Temperature in Ultrasonic Device,” published Sep. 12, 2019, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pat. Pub. No. 2019/0207857, entitled “Surgical Network Determination of Prioritization of Communication, Interaction, or Processing Based on System or Device Needs,” published Jul. 4, 2019, the disclosure of which is incorporated by reference herein, in its entirety.
While several surgical instruments and systems have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.
While the specification concludes with claims which particularly point out and distinctly claim this technology, it is believed this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present technology, and together with the description explain the principles of the technology; it being understood, however, that this technology is not limited to the precise arrangements shown.
The following description of certain examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the technology. As will be realized, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The following-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a human or robotic operator of the surgical instrument. The term “proximal” refers the position of an element closer to the human or robotic operator of the surgical instrument and further away from the surgical end effector of the surgical instrument. The term “distal” refers to the position of an element closer to the surgical end effector of the surgical instrument and further away from the human or robotic operator of the surgical instrument. In addition, the terms “upper,” “lower,” “top,” “bottom,” “above,” and “below,” are used with respect to the examples and associated figures and are not intended to unnecessarily limit the invention described herein.
With respect to
Other types of robotic systems can be readily adapted for use with surgical system (102). Various examples of robotic systems and surgical tools that are suitable for use with the present disclosure are described in U.S. Provisional patent application Ser. No. 62/611,339, entitled “Robot Assisted Surgical Platform,” filed Dec. 28, 2017, the disclosure of which is herein incorporated by reference in its entirety.
Various examples of cloud-based analytics that are performed by cloud (104, and are suitable for use with the present disclosure, are described in U.S. Provisional patent application Ser. No. 62/611,340, entitled Cloud-Based Medical Analytics,” filed Dec. 28, 2017, the disclosure of which is herein incorporated by reference in its entirety.
In various aspects, imaging device (124) includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors. In various aspects, imaging device (124) is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present disclosure include, but not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope. Some aspects of spectral and multi-spectral imaging are described in greater detail under the heading “Advanced Imaging Acquisition Module” in U.S. Provisional patent application Ser. No. 62/611,341, entitled “Interactive Surgical Platform,” filed Dec. 28, 2017, the disclosure of which is herein incorporated by reference in its entirety.
Strict sterilization of the operating room and surgical equipment is required during any surgery. The strict hygiene and sterilization conditions required in a “surgical theater,” i.e., an operating or treatment room, necessitate the highest possible sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes in contact with the patient or penetrates the sterile field. It will be appreciated that the sterile field may be considered a specified area, such as within a tray or on a sterile towel, which is considered free of microorganisms, or the sterile field may be considered an area, immediately around a patient, who has been prepared for a surgical procedure. The sterile field may include the scrubbed team members, who are properly attired, and all furniture and fixtures in the area.
In addition to the introduction of any features of surgical system (100), furniture, or fixtures into the sterile field requiring sterilization, additional complications may result from removal of these features from the sterile field, particularly when such features may have contacted, or presumed to have contacted, the patient, including any tissues and/or fluids associated with the surgical procedure. Such contamination of these features from the patient often requires special consideration during or after the surgical procedure, particularly when processing these features for disposal, reuse, or remanufacturing as desired. In one example, surgical system (100) and/or healthcare professionals associated with the surgical procedure may be specifically equipped to address such processing as discussed below in greater detail.
As illustrated in
In one aspect, hub (106) is also configured to route a diagnostic input or feedback entered by a non-sterile operator at visualization tower (111) to primary display (119) within the sterile field, where it can be viewed by a sterile operator at the operating table. In one example, the input can be in the form of a modification to the snapshot displayed on non-sterile display (107) or display (109), which can be routed to primary display (119) by hub (106).
Referring to
Referring now to
During a surgical procedure, energy application to tissue, for sealing and/or cutting, is generally associated with smoke evacuation, suction of excess fluid, and/or irrigation of the tissue. Fluid, power, and/or data lines from different sources are often entangled during the surgical procedure. Valuable time can be lost addressing this issue during a surgical procedure. Detangling the lines may necessitate disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular enclosure (136) offers a unified environment for managing the power, data, and fluid lines, which reduces the frequency of entanglement between such lines.
Referring to
Generator (150) of the present example is configured to drive multiple surgical instruments (152, 154, 156). One example of such surgical instrument is ultrasonic surgical instrument (152) and comprises a handpiece (160), an ultrasonic transducer 162, a shaft assembly (164), and an end effector (166). End effector (166) includes an ultrasonic blade (168) acoustically coupled to ultrasonic transducer (162) and a clamp arm (170). Handpiece (160) has a trigger (172) to operate clamp arm (170) and a combination of toggle buttons (173, 174, 175) to energize and drive ultrasonic blade (168) or other function. Toggle buttons (173, 174, 175) can be configured to energize ultrasonic transducer (162) with generator (150).
Generator (150) also is configured to drive another example of surgical instrument (154). RF electrosurgical instrument (154) includes a handpiece (176), a shaft assembly (178), and an end effector (180). End effector (180) includes electrodes in clamp arms (181, 182) and return through an electrical conductor portion of shaft assembly (178). Electrodes are coupled to and energized by a bipolar energy source within generator (150). Handpiece (176) includes a trigger (183) to operate clamp arms (181, 182) and an energy button (184) to actuate an energy switch to energize electrodes in end effector (180).
Generator (150) also is configured to drive multifunction surgical instrument (156). Multifunction surgical instrument (156) includes a handpiece (185), a shaft assembly (186), and an end effector (188). End effector (188) has an ultrasonic blade (190) and a clamp arm (192). Ultrasonic blade (190) is acoustically coupled to ultrasonic transducer (162). Handpiece (185) has a trigger (194) to operate clamp arm (192) and a combination of toggle buttons (195, 196, 197) to energize and drive ultrasonic blade (190) or other function. Toggle buttons (195, 196, 197) can be configured to energize ultrasonic transducer (162) with generator (150) and energize ultrasonic blade (190) with a bipolar energy source also contained within generator (150). It will be appreciated that handpieces (160, 176, 185) may be replaced with a robotically controlled instrument for incorporating one or more aspects of surgical instruments (152, 154, 156). Accordingly, the term “handpiece” should not be limited to this context and to handheld use.
As used throughout this description, the term “wireless” and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they might not. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 family), WMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module may include a plurality of communication modules. For instance, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
As used herein a processor or processing unit is an electronic circuit which performs operations on some external data source, usually memory or some other data stream. The term is used herein to refer to the central processor (central processing unit) in a system or computer systems (especially systems on a chip (SoCs)) that combine a number of specialized “processors.”
As used herein, a system on a chip or system on chip (SoC or SOC) is an integrated circuit (also known as an “IC” or “chip”) that integrates all components of a computer or other electronic systems. It may contain digital, analog, mixed-signal, and often radio-frequency functions, all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals like graphics processing unit (GPU), Wi-Fi module, or coprocessor. A SoC may or may not contain built-in memory.
As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include a microcontroller as one of its components. A microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals. Program memory in the form of Ferroelectric RAM, NOR flash or OTP ROM is also often included on chip, as well as a small amount of RAM. Microcontrollers may be employed for embedded applications, in contrast to the microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips.
As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with a peripheral device. This may be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection with) that device. Modular devices include the modules (as described in connection with
In some instances, it may be desirable to provide a surgical instrument (1000) similar to any one or more of surgical instruments (112, 152, 154, 156) that includes components capable of delivering ultrasonic energy, RF energy, or both ultrasonic and RF energy that easily open to provide access to the internal components for separation into separate waste streams with minimal tools, such as no additional tools. Surgery customarily takes place within the sterile field, as described above. The sterile field, being free of microorganisms, enables the surgical team to decrease the chance of infection by ensuring that only sterilized equipment and tools are used within the sterile field. Surgical instruments are sterilized and packaged within sterile containers that are passed into the sterile field. Health care professionals may be required to disassemble the surgical instruments within the sterile field after a surgical procedure by hand or with tools provided within the sterile containers. For example, a torque wrench provided for assembling a surgical instrument, may have additional features to disassemble the surgical instrument. The surgical instruments include additional features that facilitate disassembly and removal of internal components. These additional features aid in selectively breaking the internal components so the components may be placed into separate waste streams. These separate waste streams are predetermined based on the material of the component or the use of the component. For example, the waste streams may include recycling, disposal, or refurbishing. Components placed in the disposal waste stream would be disposed of in a land fill. Components placed in the recycling waste stream may be further separated, shredded, and melted down into a base component. Components placed in the refurbishing waste stream would be cleaned, tested, repaired, and refitted within another surgical instrument. For example, the plastic and metal components of a shroud may be separated into one waste stream for disposal, heavy metals from an integrated circuit may be separated into a second waste stream for recycling, and ultrasonic transducers may be separated into a third waste stream for refurbishing.
Surgical instrument (1000) of the present example is configured to deliver ultrasonic energy similar to surgical instrument (152). Body assembly (1010) surrounds a portion of an energy drive system (1040) and a portion of a circuit assembly (1050). Energy drive system (1040), in the present version, includes an ultrasonic transducer (1042), a waveguide (1044), and an ultrasonic blade (1046). Energy drive system (1040) may further include a battery (1048), or a generator (150) (see
Body assembly (1010) includes a plurality of selectively removeable shroud portions (1012, 1014, 1016, 1018). Shroud portions (1012, 1014, 1016, 1018) are configured to provide support for energy drive system (1040), shaft assembly (1020), and circuit assembly (1050). Shroud portions (1012, 1014, 1016, 1018) additionally inhibit access to a portion of energy drive system (1040) and a portion of circuit assembly (1050). As illustrated, shroud portions (1012, 1014, 1016, 1018) include a first shroud portion (1012), a second shroud portion (1014), a third shroud portion (1016), and a fourth shroud portion (1018), but may include any number of shroud portions (1012, 1014, 1016, 1018) that inhibit access to circuit assembly (1050) and energy drive system (1040). This configuration of shroud portions (1012, 1014, 1016, 1018) is merely one example and not intended to unnecessarily limit the invention. Each shroud portion (1012, 1014, 1016, 1018) is removably affixed to another shroud portion (1012, 1014, 1016, 1018) at a shroud edge (1002). Shroud portions (1012, 1014, 1016, 1018) are mated together at shroud edges (1002) with shroud couplings (1004). Shroud couplings (1004) connect two adjacent shroud edges (1002) during normal operation of surgical instrument (1000) in a connected state. Magnetic fastener in the form of a shroud coupling (1004) includes a first magnetic member (1006) and a second magnetic member (1008). One of first magnetic member (1006) or second magnetic member (1008) includes a rare earth magnet or an electromagnet. Other of first or second magnetic member (1006, 1008) includes rare earth magnet, electromagnet, or a ferromagnetic metal. Ferromagnetic metals include but are not limited to iron, cobalt, or nickel. First magnetic member (1006) is attracted to second magnetic member (1008) by a magnetic field (MF). Magnetic field (MF) includes sufficient force to retain adjacent shroud edges (1002) of shroud portions (1012, 1014, 1016, 1018) in a connected state during operation, but allows for a user to transition shroud portions (1012, 1014, 1016, 1018) to a disconnected state (see
Shroud portions (1012, 1014, 1016, 1018) further include a plurality of alignment features (1026) configured to align each shroud portion (1012, 1014, 1016, 1018) with an adjacent shroud portion (1012, 1014, 1016, 1018). Alignment features (1026) facilitate translating shroud portions (1012, 1014, 1016, 1018) from connected state to the disconnected state (see
Magnetic lock assembly (1134) further includes lock key (1136) that in the present example is separable from magnetic lock (1134) and the magnetic members (1106, 1108) are separate and apart from the magnetic lock (1134). In the present versions, lock key (1136) removes electricity from an electromagnet thereby removing magnetic field, which stops the magnetic attraction between first and second magnetic members (1106, 1108) when lock key (1136) is removed from the magnetic lock assembly (1134). In the alternative, lock key (1136) may be inserted into the magnetic lock assembly (1134) to transition magnetic locks (1135) from a locked state to an unlocked state. Lock key (1136) may remove the electricity by shorting an electrical circuit (not shown), breaking an electrical circuit (not shown), or by energizing a switch (not shown).
In some versions, lock key (1136) transitions magnetic lock (1135) from the locked state to the unlocked stated by physically moving one of first or second magnetic members (1106, 1108) away from other of first or second magnetic members (1106, 1108), thereby reducing the magnetic attraction between first and second magnetic members (1106, 1108). In such versions, magnetic lock (1135), first magnetic member (1106), and second magnetic member (1108) are proximate to one another. This reduced magnetic attraction or lack of magnetic attraction allows a user to manually separate shroud portions (1112, 1114, 1116, 1118).
Body assembly (1210) is configured to be disassembled to expose a portion of an energy drive system (1240) and a portion of a circuit assembly (1250). Body assembly (1210) includes a plurality of shroud portions (1212, 1214) having an upper shroud portion (1212) and a lower shroud portion (1214) configured to be coupled together with a shroud coupling in the form of push-pins (1204, 1260). Push-pins (1204, 1260) may be constructed of nylon or some other material known in the art to have resilient properties. More particularly, push-pin (1204) is a two-piece push-pin (1204), whereas push-pin (1260) is a single piece push-pin (1260). Two-piece push-pin (1204) of the present example includes a shank (1206), a shank head (1208) (see
Two-piece push-pin (1204) is installed by first inserting shank (1206) through upper and lower bores (1216, 1218) so that shank head (1208) rests on a surface adjacent to upper bore (1216). Before inserting, shank (1206) remains in an unexpanded state sized to be fitted within upper and lower bore (1216, 1218). Pin (1234) is pressed within a bore of shank (1206) until pin head (1236) is seated upon a top of shank head (1208). In the installed position, a distal portion of shank (1206) is expanded by pin (1234) to an expanded state and has a diameter that is larger than upper and lower bores (1216, 1218). The expanded shank (1206) axially pulls upper shroud portion (1212) towards lower shroud portion (12140). Installing pin (1234) distally into shank (1206) results in distal portion of shank (1206) having a larger outer diameter than distal portion of shank (1206) before pin (1234) was installed into shank (1206).
One-piece push-pin (1260) is installed by pressing on top of shank head (1266) while directing a distal end of shank (1262) into upper and lower bores (1216, 1218). One-piece push-pin (1260) is installed with shank head (1266) being positioned on a first side of upper bore (1216) and a proximal-most rib (1264) being positioned on a distal side of lower bore (1218) such that push-pin (1260) resists removal of upper shroud portion (1212) from lower shroud portion (1214).
Other versions of push-pins (not shown) may be configured for manual operation without additional tools. These other versions operate similar to a blind rivet but having an actuator (not shown), a spring (not shown), a pin (not shown) and a shank (not shown). Actuator is moved by a user translating pin within shank (not shown). An outside diameter of shank is reduced so that push-pin may be retracted through upper and lower bores (1216, 1218) and upper and lower shroud portions (1216, 1218) are transitioned from a connected state to a disconnected state.
In some instances, it may be desirable to provide a surgical instrument that includes components capable of delivering ultrasonic energy, RF energy, or both ultrasonic and RF energy that is easily opened so that the internal components may be separated into separate waste streams with minimal tools, such as no tools, within the sterile field. These surgical instruments are configured to stay intact during normal use but facilitate disassembly of internal components and/or selectively break the internal components. One such internal component is a circuit assembly that is configured to be separated by a hand or hands of the user into separate portions having different properties. The separate portions of the circuit assembly are placed in predetermined separate waste streams. These waste streams include but are not limited to recycling, disposal, or refurbishing.
In other versions, failure region (1866) includes a portion of pin connector (1868) that has a reduced diameter relative to a remaining portion of pin connector (1868). Failure region (1866) provides a location from which memory member (1856) may be broken away from main circuit board (1852) by a user's hand or hands with a reduced force (relative to the force to remove a memory member (1856) without a failure region (1866)) rendering the instrument inoperable and/or to provide for separate disposal in a separate waste stream than the other components of main circuit board (1852).
In some instances, it may be desirable to provide a surgical instrument that includes components capable of delivering ultrasonic energy, RF energy, or both ultrasonic and RF energy. It may be desirable that these surgical instruments be easily openable so that the internal components may be separated into separate waste streams with minimal tools, such as no tools, within the sterile field. These surgical instruments are configured to stay intact during normal use but facilitate disassembly of internal components and/or selectively break the internal components. One such internal component is an energy drive system that is configured to be removed, separated by a hand or hands of the user, and placed into separate waste streams. These waste streams include but are not limited to recycling, disposal, or refurbishing.
Waveguide (2344) includes a proximal end having an external waveguide thread (2360), and ultrasonic transducer (2343) including an internal transducer surface (2368). Screw thread insert (2352) of the present example is constructed of a helically wound wire, but may alternatively be a solid, machined piece. Screw thread insert (2352) includes an internal insert thread (2358) configured to engage an external waveguide thread (2360) and an external insert thread (2362) configured to engage internal bushing threads (2364). Bushing (2354) includes an internal bushing thread (2364) configured to be threaded around outer insert thread (2362). Bushing (2354) further includes an external bushing surface (2366) having a smooth bore sized for an interference fit relative to an internal transducer surface (2368). Bushing (2354) is press fit within ultrasonic transducer (2342). In some versions, external waveguide thread (2360) is mated with inner insert thread (2358), external insert thread (2362) is mated with internal bushing thread (2364), and external bushing surface (2366) is press fit within ultrasonic transducer (2342). Screw thread insert (2352) is separable from bushing (2354) so that, after use, ultrasonic transducer (2342) or waveguide (2344) may be removed for recycling or refurbishment and either screw thread insert (2352) and/or bushing (2350) may be disposed or recycled. Screw thread insert (2352) and bushing (2354) may be constructed of materials that conduct ultrasonic energy, but are less wear resistant than waveguide (2344) and/or ultrasonic transducer (2342) so screw thread insert (2352) and/or bushing (2354) may be replaced after a predetermined number of uses or after a predetermined amount of wear develops to prevent ultrasonic transducer (2342) and/or waveguide (2344) from developing wear.
Ultrasonic transducer (2442) may be removed and refurbished for reuse. More particularly, ultrasonic transducer (2442) includes a protective coating, such as a cover (2452), to inhibit damage to ultrasonic transducer (2442) when removed from body assembly (2410). Cover (2452) includes a non-conductive base such as rubber, plastic, or ceramic. Cover (2452) of the present example also includes a conductive base installed by electroplating or by being topically applied to the surface of ultrasonic transducer (2442). Such protective coating may be applied as a liquid and allowed to dry. In other versions, cover (2452) is in a solid state and is fastened over ultrasonic transducer (2442).
In some instances, it may be desirable to provide a surgical instrument that includes components capable of delivering ultrasonic energy, RF energy, or both ultrasonic and RF energy that is easily opened so that the internal components may be separated into separate waste streams with minimal tools, such as no tools, within the sterile field. These surgical instruments are configured to stay intact during normal use but facilitate disassembly of internal components and/or selectively break the internal components. One such internal component is an electrical cable that is configured to be removed by a hand or hands of the user after separating a housing for access to the electrical cable. The electrical cable is configured to be placed into a waste stream that may include, but are not limited to, recycling, disposal, or refurbishing. Other components may be placed in waste streams other than the waste stream desired for electrical cable.
The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
A surgical instrument, comprising: (a) a shaft assembly extending along a longitudinal axis; (b) an end effector distally extending from the shaft assembly; (c) an energy drive system operatively connected to the end effector and configured to apply a radio frequency (RF) energy or an ultrasonic energy to a tissue of a patient via the end effector; (d) a circuit assembly operatively connected to the energy drive system; and (e) a body assembly proximally extending from the shaft assembly and including: (i) a first shroud portion, (ii) a second shroud portion, and (iii) a shroud coupling configured to removably affix the first shroud portion to the second shroud portion in a connected state, wherein the shroud coupling is further configured to detach the first shroud portion from the second shroud portion in a disconnected state, wherein the shroud coupling is selected from the group consisting of: a push-pin and a magnetic fastener, wherein the first and second shroud portions in the connected state enclose and inhibit access to at least a portion of at least one of the circuit assembly or the energy drive system for containment therein, and wherein the first and second shroud portions in the disconnected state allow access to the at least the portion of at least one of the circuit assembly or the energy drive system for removal of the at least the portion of at least one of the circuit assembly or the energy drive system from the body assembly.
The surgical instrument of Example 1, wherein the push-pin includes a plurality of resilient ribs configured to be inserted through a first bore defined by the first shroud portion and a second bore defined by the second shroud portion, wherein the plurality of resilient ribs expand after being inserted through the first and second bores to retain the first and second shroud portions in a connected state.
The surgical instrument of any one or more of Examples 1 through 2, wherein the push-pin includes a shank configured to include a first outer diameter in an unexpanded state, wherein the first outer diameter of the shank is sized to fit within a pair of bores that extends through the first and second shroud portions, and a pin configured to be fitted within the shank to transition the shank to an expanded state thereby connecting the first shroud portion to the second shroud portion.
The surgical instrument of any one or more of Examples 1 through 3, wherein the energy drive system, includes: (i) a transducer, (ii) a waveguide, and (iii) an energy coupling configured to removably connect the transducer to the waveguide, wherein the energy coupling is selected from the group consisting of: a frangible division, a press fit bushing, and a threaded bushing.
The surgical instrument of any one or more of Examples 1 through 4, wherein the magnetic fastener includes a magnetic coupling having a first magnetic member operatively secured to the first shroud portion and a second magnetic member operatively secured to the second shroud portion, wherein the magnetic members are selected from the group consisting of: a rare earth magnet, a ferromagnetic metal, and a electromagnet, wherein the first magnetic member is operatively secured to the second magnetic member by magnetic attraction, wherein the first and second shroud portions are configured to transition from the connected state to the disconnected state by separating the first magnetic member from the second magnetic member by a user.
The surgical instrument of any one or more of Examples 1 through 5, wherein the shroud includes an alignment feature configured to align the first shroud portion with the second shroud portions while being transitioned from the connected state to the disconnected state thereby aligning the first magnetic member with the second magnetic member.
The surgical instrument of any one or more of Examples 1 through 6, wherein the magnetic fastener includes a magnetic lock assembly configured to connect the first shroud portion to the second shroud portion in a connected state, wherein the magnetic lock assembly includes at least one magnetic member selected from the group consisting of: a rare earth magnet, a ferromagnetic metal, and a electromagnet, wherein the magnetic lock assembly uses magnetic attraction to render the first and second shroud portions in a locked state that disallows inadvertent movement of the first and second shroud portions from the connected state to the disconnected state.
The surgical instrument of Example 7, wherein the magnetic lock assembly includes a key configured to transition the magnetic lock assembly from the locked state to an unlocked state.
The surgical instrument of any one or more of Examples 7 through 8, wherein the at least one magnetic member includes a first magnetic member operatively connected to the first shroud portion and a second magnetic member operatively connected to a second magnetic member, wherein one of the first magnetic member or the second magnetic member is magnetically attracted to the other of the first magnetic member or the second magnetic member, wherein the first and second magnetic members have high magnetic attraction between each other in the locked state and the first and second magnetic members have low magnetic attraction between each other in the unlocked state.
The surgical instrument of any one or more of Examples 1 through 9, wherein the circuit assembly includes a memory and a main circuit board, wherein the memory is connected to the main circuit board by a circuit coupling, and wherein the memory is configured to be permanently separated from the main circuit board at the circuit coupling, and wherein the circuit coupling is selected from the group consisting of: a failure region, a reduced diameter of a pin connector, or a frangible notch.
The surgical instrument of any one or more of Examples 1 through 9, wherein the circuit assembly includes a main circuit board and a sub-board, wherein the sub-board is connected to the main circuit board by a pluggable coupling, and wherein the sub-board is configured to be separated from the main circuit board at the pluggable coupling.
The surgical instrument of any one or more of Examples 1 through 11, wherein the circuit assembly includes a memory, wherein the shroud coupling includes a latch configured to selectively move from a secured position to an unsecured position upon respectively transitioning from the connected state to the disconnected state, and wherein the latch is configured to erase the memory while selectively moving from the secured position to the unsecured position.
The surgical instrument of any one or more of Examples 1 through 11, wherein the circuit assembly includes a memory and a latch, wherein the latch is configured to render the memory inoperable, and wherein the latch renders the memory inoperable with a reset element selected from the group consisting of: an integrated circuit, an integrated capacitor, a current reverser, and a hall effect sensor.
The surgical instrument of any one or more of Examples 1 through 13, wherein the circuit assembly includes a first circuit portion, a second circuit portion, and a frangible separator, wherein the frangible separator connects the first circuit portion to the second circuit portion in an operable state, and wherein the frangible separator is configured to permanently separate the first circuit portion from the second circuit portion in an inoperable state.
The surgical instrument of any one or more of Examples 1 through 14, further comprising a cable, wherein the cable is captured by the first and second shroud portions in the connected state, and wherein the cable is released from the first and second shroud portions in the disconnected state.
A surgical instrument, comprising: (a) a shaft assembly extending along a longitudinal axis including a shaft and a waveguide positioned within the shaft; (b) an end effector distally extending from the shaft assembly; and (c) a body assembly proximally extending from the shaft assembly and including: (i) a transducer removably connected to the waveguide, (ii) a circuit assembly operatively connected to the transducer, and (iii) a plurality of shrouds covering the transducer and the circuit assembly, wherein the plurality of shrouds includes a first shroud portion, a second shroud portion, and a shroud coupling, wherein the first shroud portion is removably affixed to the second shroud portion by the shroud coupling in a connected state, wherein the shroud coupling is further configured to detach the first shroud portion from the second shroud portion in a disconnected state, wherein the first and second shroud portions in the connected state enclose and inhibit access to at least a portion of at least one of the circuit assembly or the transducer for containment therein, wherein the first and second shroud portions in the disconnected state allow access to the at least the portion of at least one of the circuit assembly or the transducer from the body assembly, and wherein the transducer is configured to be disconnected from the waveguide to enable removal of the transducer from the body assembly.
The surgical instrument of Example 16, further comprising a bushing removably coupling the transducer to the waveguide, wherein the bushing is configured to be constructed of a less wear resistant material than each of the waveguide and the transducer.
The surgical instrument of Example 16, wherein the transducer is removably coupled to the waveguide with a frangible coupling.
The surgical instrument of any one or more of Examples 16 through 18, wherein the transducer includes a protective covering, wherein the protective covering is configured to prevent the transducer from being damaged during removal.
A surgical instrument, comprising: (a) a shaft assembly extending along a longitudinal axis; (b) an end effector distally extending from the shaft assembly; (c) an energy drive system operatively connected to the end effector and configured to apply a radio frequency (RF) energy or ultrasonic energy to a tissue of a patient; (d) a circuit assembly operatively connected to the energy drive system; (e) a cable operatively connected to and in electrical communication with at least one of the circuit assembly or the energy drive system; and (f) a body assembly proximally extending from the shaft assembly and including a cover removably affixed over a portion of the energy drive system and the circuit assembly, wherein the cover includes a first cover portion and a second cover portion removably affixed to one another in a connected state, wherein the first cover portion and second cover portion in a connected state capture the cable in a connected state, and wherein the first cover portion and the second cover portion release the cable in a disconnected state.
The surgical instrument of any one of Examples 1 through 15, wherein the body assembly includes a handle configured to be gripped by a user.
The surgical instrument of any one of Examples 1 through 15, wherein the housing assembly is configured to couple with a complementary component of a robotic arm.
A method of disassembling a surgical instrument, the surgical instrument including (a) a shaft assembly extending along a longitudinal axis; (b) an end effector distally extending from the shaft assembly; (c) an energy drive system operatively connected to the end effector and configured to apply a radio frequency (RF) energy or an ultrasonic energy to a tissue of a patient via the end effector; (d) a circuit assembly operatively connected to the energy drive system; and (e) a body assembly proximally extending from the shaft assembly and including: (i) a first shroud portion, (ii) a second shroud portion, and (iii) a shroud coupling configured to removably affix the first shroud portion to the second shroud portion in a connected state, wherein the shroud coupling is further configured to detach the first shroud portion from the second shroud portion in a disconnected state, wherein the shroud coupling is selected from the group consisting of: a push-pin and a magnetic fastener, wherein the first and second shroud portions in the connected state enclose and inhibit access to at least a portion of at least one of the circuit assembly or the energy drive system for containment therein, and wherein the first and second shroud portions in the disconnected state allow access to the at least the portion of at least one of the circuit assembly or the energy drive system for removal of the at least the portion of at least one of the circuit assembly or the energy drive system from the body assembly, the method comprising (a) removing a first shroud portion with a hand or hands of the user; and (b) removing a portion of the circuit assembly.
The method of Example 23, further comprising (c) removing the portion of the circuit assembly by breaking the circuit assembly with a hand or the hands of a user.
The method of any one of Examples 23 through 24, further comprising (d) placing the portion of the circuit assembly in a first waste stream selected from the group consisting of: disposing, recycling, and refurbishing.
The method of any one of Examples 23 through Example 25, wherein the portion of the circuit assembly is a first portion of the circuit assembly, further comprising (e) removing a second portion of the circuit assembly and the placing the second portion of the circuit assembly in a second waste stream selected from the group consisting of: disposing, recycling, and refurbishing, wherein the second waste stream is different than the first waste stream.
A method of disassembling a surgical instrument, the surgical instrument including (a) a shaft assembly extending along a longitudinal axis; (b) an end effector distally extending from the shaft assembly; (c) an energy drive system operatively connected to the end effector and configured to apply a radio frequency (RF) energy or an ultrasonic energy to a tissue of a patient via the end effector; (d) a circuit assembly operatively connected to the energy drive system; and (e) a body assembly proximally extending from the shaft assembly and including: (i) a first shroud portion, (ii) a second shroud portion, and (iii) a shroud coupling configured to removably affix the first shroud portion to the second shroud portion in a connected state, wherein the shroud coupling is further configured to detach the first shroud portion from the second shroud portion in a disconnected state, wherein the shroud coupling is selected from the group consisting of: a push-pin and a magnetic fastener, wherein the first and second shroud portions in the connected state enclose and inhibit access to at least a portion of at least one of the circuit assembly or the energy drive system for containment therein, and wherein the first and second shroud portions in the disconnected state allow access to the at least the portion of at least one of the circuit assembly or the energy drive system for removal of the at least the portion of at least one of the circuit assembly or the energy drive system from the body assembly, the method comprising: (a) removing a first shroud portion with a hand or hands of the user; and (b) removing a portion of the energy drive assembly.
The method of Example 27, further comprising (c) removing the portion of the energy drive assembly by breaking with a hand or the hands of a user.
The method of any one of Examples 27 through 28, further comprising (d) placing the portion of the energy drive assembly in a first waste stream selected from the group consisting of: disposing, recycling, and refurbishing.
The method of any one of Examples 27 through 29, wherein the portion of the circuit assembly includes a first portion of the circuit assembly, further comprising (e) removing a second portion of the energy drive assembly and the placing the second portion of the energy drive assembly in a second waste stream selected from the group consisting of: disposing, recycling, and refurbishing, wherein the second waste stream is different than the first waste stream.
A method of disassembling a surgical instrument, the surgical instrument including (a) a shaft assembly extending along a longitudinal axis; (b) an end effector distally extending from the shaft assembly; (c) a body assembly proximally extending from the shaft assembly and including: (i) a first shroud portion, (ii) a second shroud portion, and (iii) a shroud coupling configured to removably affix the first shroud portion to the second shroud portion in a connected state, wherein the shroud coupling is further configured to detach the first shroud portion from the second shroud portion in a disconnected state; (d) an internal assembly housed within the body assembly including a first internal component operably connected to a second internal component, wherein the first and second shroud portions in the connected state enclose and inhibit access to an internal component for containment therein, the method comprising (a) removing a first shroud portion; (b) breaking the first internal component from the second internal component; and (c) removal of the first internal component from the body assembly.
The method of Example 31, further comprising removal of the second internal component from the body assembly.
The method of Examples 31 through 32, further comprising placing the first internal component in a first waste stream and placing the second internal component in a second waste stream.
Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures.
It should be understood that any of the versions of instruments described herein may include various other features in addition to or in lieu of those described above. By way of example only, any of the instruments described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein. It should also be understood that the teachings herein may be readily applied to any of the instruments described in any of the other references cited herein, such that the teachings herein may be readily combined with the teachings of any of the references cited herein in numerous ways. Other types of instruments into which the teachings herein may be incorporated will be apparent to those of ordinary skill in the art.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Method of Reclaiming Portions of Surgical Instruments for Remanufacturing and Sustainability,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Surgical Instrument with Removeable Cable and Associated Couplings,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Surgical System and Methods of Assembly and Disassembly of Surgical Instrument,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Robotic Surgical System with Removable Portion and Method of Disassembling Same,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “System for Determining Disposal of Surgical Instrument and Related methods,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Reclamation Packaging for Surgical Instrument and Related Methods,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Surgical Instrument with Various Alignment Features and Methods for Improved Disassembly and Assembly,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. Pat. App. No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
In addition to the foregoing, the teachings herein may be readily combined with the teachings of U.S. patent application No., entitled “Surgical System and Methods for Instrument Assessment and Cleaning,” filed on even date herewith, the disclosure of which is incorporated by reference herein. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application No. will be apparent to those of ordinary skill in the art in view of the teachings herein.
It should also be understood that any ranges of values referred to herein should be read to include the upper and lower boundaries of such ranges. For instance, a range expressed as ranging “between approximately 1.0 inches and approximately 1.5 inches” should be read to include approximately 1.0 inches and approximately 1.5 inches, in addition to including the values between those upper and lower boundaries.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, which is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Versions described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by an operator immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
