SURGICAL DEVICES AND METHODS FOR COLLECTING STERILIZATION DATA

A surgical device is provided including an energy harvesting device configured to harvest energy from a sterilization device to provide power to at least one of a sensor or a computing device. The sensor is configured to measure an energy output applied to the surgical device by a sterilization device. The computing device includes a processor or logic circuit and a memory and is configured to determine when a threshold energy output applied to the surgical device is met and to store in the memory an amount of times the threshold energy output applied to the surgical device is met.

BACKGROUND

Robotically-assisted surgery is increasingly being used in minimally invasive medical procedures. Some robotic surgical systems include a console supporting a surgical robotic arm and a robotic surgical instrument mounted to the robotic arm. The robotic surgical instrument may have an elongated shaft that supports at least one end effector (e.g., forceps or a grasping tool) on a distal end thereof.

After each use, the robotic surgical instrument is disposed of, reused, or partially disposed of and partially reused. Any part of a surgical instrument that is reused must be cleaned or sterilized to neutralize potentially infectious agents before being reused. Sterilization devices (e.g., pressure chambers, autoclaves, etc., or combinations thereof) are used to sterilize reusable surgical instruments. Typically, the surgical instrument is placed in the sterilization device for a period of time during which it is exposed to some form of energy (e.g., heat, light, kinetic, pressure, etc., or combinations thereof) in order to remove the infectious agents from the surgical instrument. However, repeated exposure of the surgical instrument to the sterilization device can degrade or deteriorate electrical and mechanical components within the housing of the surgical instrument. In many situations, it is difficult to determine how many times a particular surgical instrument has been sterilized.

Accordingly, a need exists for a surgical instrument capable of determining and recording sterilization data during a sterilization procedure.

SUMMARY

The present disclosure relates to surgical devices configured to be powered by and operate during a sterilization procedure to record sterilization data.

According to an aspect of the present disclosure, a surgical device is provided, including an energy harvesting device configured to harvest energy from a sterilization device to provide power to at least one of a sensor and a computing device. The sensor is configured to measure an energy output applied to the surgical device by a sterilization device. The computing device includes a processor and/or logic circuit and a non-volatile memory and may be configured to determine when a threshold energy output applied to the surgical device is met and to store in the memory an amount of times the threshold energy output applied to the surgical device is met.

In embodiments, when the threshold energy output applied to the surgical device is met, the computing device counts and the memory records a completed sterilization cycle.

In some embodiments, the computing device may be configured to determine when the surgical device requires servicing based on a number of completed sterilization cycles.

In certain embodiments, the energy harvesting device may be a thermoelectric generator configured to receive a concentration of thermal energy from a sterilization device. The thermoelectric generator may be configured to convert a concentration of thermal energy into electrical energy to power the surgical device.

In embodiments, the sensor may be a temperature sensor configured to measure a temperature of an outer surface or the differential temperature between the inner and outer surfaces of the surgical device.

In some embodiments, the temperature sensor may be operatively coupled to the computing device. The computing device may be configured to detect a threshold temperature necessary to sterilize the surgical device.

In certain embodiments, when the computing device detects a threshold temperature, the computing device counts and the memory records a completed sterilization cycle.

In embodiments, the surgical device may include a display configured for displaying at least one output of the computing device.

In some embodiments, the surgical device may include an energy storage device configured to store the harvested energy from the energy harvesting device.

In certain embodiments, the energy storage device may be a capacitor.

In embodiments, the surgical device may include an amplifier operatively connected to the energy harvesting device. The amplifier may be configured to condition the power (e.g., to increase the output voltage) of the harvested energy from the energy harvesting device.

In some embodiments, the energy harvesting device may include a photovoltaic cell configured to convert light energy from a sterilization device into electrical energy to power the surgical device.

In certain embodiments, the energy harvesting device may include a piezoelectric transducer configured to convert kinetic energy into electrical energy to power the surgical device.

In embodiments, the surgical device may include a data interface device configured to interface with an external device. The data interface device may be configured to upload data from the computing device onto the external device and to download data from the external device onto the computing device.

According to another aspect of the present disclosure, a method for operation of a surgical instrument during sterilization is provided, including placing a surgical instrument in a sterilization device. The surgical instrument includes an energy harvesting device configured to harvest energy from a sterilization device, a sensor configured to measure an energy output applied to the surgical device by a sterilization device, and a computing device including a processor and/or logic circuit, and a memory. The method also includes powering the sensor and the computing device using the harvested energy from the energy harvesting device, determining, with the computing device and the sensor, when a threshold energy output applied to the surgical device is met, and storing in the memory an amount of times that the threshold energy output applied to the surgical device is met.

In embodiments, the method may include counting, with the computing device, a completed sterilization cycle when a threshold energy output is applied to the surgical device.

In some embodiments, the method may include disabling the surgical device with the computing device when a threshold number of completed sterilization cycles is met.

In certain embodiments, the method may include storing the harvested energy from the energy harvesting device with an energy storage device.

In embodiments, the method may include displaying on a display device at least one output of the computing device.

In some embodiments, the method may include conditioning the harvested energy from the energy harvesting device with an amplifier.

DETAILED DESCRIPTION

Embodiments of the present surgical devices will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, nurse, or other care provider and may include support personnel. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. As used herein, the term “distal,” as is conventional, will refer to that portion of the instrument, apparatus, device or component thereof which is closer to farther the patient while, the term “proximal,” will refer to that portion of the instrument, apparatus, device or component thereof which is further from the patient.

The present disclosure relates to surgical instruments. Specifically, the present disclosure is directed to a surgical instrument configured to harvest energy from a sterilization device. The harvested energy from the sterilization device is used to power the surgical instrument while the surgical instrument is in the sterilization device to collect sterilization data. The surgical instrument then stores the sterilization data in memory. The stored sterilization data can be used to notify a user if the surgical instrument and/or parts thereof are fit for continued use, need replacement, and/or should be discarded or completely disable the instrument when all uses have expired.

Referring initially toFIG. 1, a robotic surgical system, such as, for example, medical work station1, generally includes a plurality of robot arms2and3, a control device4, and an operating console5coupled with control device4. Operating console5includes a display device6configured to display three-dimensional images, and manual input devices7and8, a clinician can use to telemanipulate (not shown) robot arms2and3in a first operating mode, as known in principle to a person skilled in the art.

Each of the robot arms2and3includes a plurality of members, which are connected through joints, and which may be releasably attached to a surgical assembly10. Robot arms2and3may be driven by electric drives (not shown) that are connected to control device4. Control device4(e.g., a computer) is set up to activate the drives (e.g., using a computer program) and execute a desired movement of robot arms2and3and/or surgical assembly10according to a movement defined by means of manual input devices7and8. Control device4may be configured to regulate the movement of robot arms2and3and/or of the drives (not shown). Control device4may control a plurality of motors, e.g., “Motor1. . . n,” with each motor configured to drive movement of robotic arms2and3in a plurality of directions.

Medical work station1is configured for use on a patient “P” lying on a patient table “ST” to be treated in a minimally invasive manner by or with surgical instrument100of surgical assembly10. Medical work station1may include more than two robot arms2and3, the additional robot arms likewise being connected to control device4and being telemanipulatable by means of operating console5. A surgical assembly10may be attached to the additional robot arm. Medical work station1may include a database9operatively (e.g., directly and/or indirectly) coupled with control device4. Database9may store, e.g., pre-operative data from patient “P” and/or anatomical atlases.

Turning now toFIG. 2, surgical assembly10is shown coupled with or to robotic arm2via a rail, track, or slide12. While surgical assembly10is discussed singularly, a person of ordinary skill in the art can readily appreciate that the medical work station1may also include a plurality of substantially identical surgical assemblies10coupled with or to each of the robotic arms2and3(FIG. 1). Surgical assembly10includes an instrument drive unit50coupled to an adapter or instrument drive connector70of surgical instrument100having a surgical loading unit80including an end effector90disposed at a distal end thereof.

Instrument drive unit50of surgical assembly10may be supported on or connected to a slider11that is movably connected to a track12of robotic arm2. Slider11moves, slides, or translates along a longitudinal axis “Y” defined by track12of surgical robotic arm2upon a selective actuation by motors (not shown) disposed in track12of robotic arm2or motors (e.g., one or more of “Motor1. . . n”) of control device4. As such, slider11, with surgical assembly10connected thereto, can be moved to a selected position along track12of robotic arm2.

Instrument drive unit50includes a housing60having a proximal end62and a distal end64configured to be operably coupled to instrument drive connector70of surgical instrument100. Housing60of instrument drive unit50houses a plurality of motors (not shown) that are configured to power surgical instrument100, for example, to drive various operations of end effector90of surgical instrument100. Thus, in use, instrument drive unit50transfers power and actuation forces from the motors to instrument drive connector70of surgical instrument100to drive movement of end effector90of surgical instrument100.

Control device4(FIG. 1) may control the motors of instrument drive unit50. In some embodiments, one or more motors may receive signals wirelessly (e.g., from control device4). It is contemplated that control device4coordinates the activation of the various motors (“Motor1. . . n”), and the motors of instrument drive unit50, to coordinate an operation and/or movement of surgical instrument100.

Surgical loading unit80is selectively attachable to instrument drive connector70and includes an elongate portion82and an end effector90. Surgical loading unit80may be a single use loading unit that is disposable, or a multiple use loading unit that can be sterilized in a sterilization device for reuse. Elongate portion82of surgical loading unit80may have a proximal end82aconfigured to be coupled to a distal cap72of an elongated shaft74of instrument drive connector70. Elongate portion82of surgical loading unit80has a distal end82bhaving end effector90attached thereto. End effector90generally includes a pair of opposing jaw members92aand92b,and may include a staple cartridge, knife blade, among other fastening, cutting, clamping elements within the purview of those skilled in the art. It is contemplated that end effector90may be directly coupled to instrument drive connector70rather than be directly coupled to elongate portion82of surgical loading unit80.

Referring now toFIG. 3, instrument drive connector70of surgical instrument100includes a housing assembly70aand elongated shaft74extending distally therefrom and terminating at distal cap72. Housing assembly70aincludes a proximal housing75, a bottom or distal housing76, a tip housing77, and a circuit board150disposed within housing assembly70afor controlling various operations of surgical instrument100, as will be described in detail below.

For a detailed discussion of the construction and operation of a similar robotic surgical system having one or more of the same or similar components for use with one or more components of the presently described robotic surgical system, reference may be made to U.S. Pat. No. 8,828,023, the entire disclosure of which is incorporated by reference herein.

Reference may be made to commonly owned International Patent Application No. PCT/US14/61329, U.S. Pat. No. 8,636,192, or U.S. Pat. No. 8,925,786, the entire disclosures of each of which are incorporated by reference herein, for a detailed discussion of illustrative examples of the construction and operation of end effectors for use with, or connection to, the presently disclosed electromechanical surgical instruments.

As can be appreciated, surgical instruments are often reused from one procedure to the next. Any part of a surgical instrument that is reused must be sterilized to neutralize potentially infectious agents before being reused. Sterilization devices, e.g., pressure chambers, autoclaves, etc., or combinations thereof, are used in medical applications to sterilize surgical instruments. However, the repeated exposure to elevated temperatures, pressure, or other forms of energy emitted from the sterilization device may cause a surgical instrument or components thereof to malfunction or become inoperable. Thus, the usage of a surgical instrument may be limited by the number of times that the surgical instrument has been placed in a sterilization device for sterilization.

The surgical instrument100of the present disclosure is configured to provide a user with sterilization cycle data without a need for the user to independently keep track of sterilization data or to use external devices to keep track of sterilization data.

With reference toFIGS. 3 and 4, in an embodiment, for example, for energy harvesting, circuit board150of surgical instrument100generally includes a device configured to implement (or capable of implanting) a state machine such as a central processing unit (CPU) or logic circuit (hereinafter, “CPU”)152, a display153(optionally), an energy harvesting device154configured to provide power to CPU152, an amplifier156configured for conditioning the energy generated by the energy harvesting device154, an energy storage device158(optional) configured to store the harvested energy from the energy harvesting device154, and a sensor160for measuring the energy output of the sterilization device, as applied to the surgical instrument100.

In general, CPU152of circuit board150is configured to operate in conjunction with other components of surgical instrument100as described herein, to calculate and/or determine sterilization data, e.g., the number of times that that surgical instrument100has undergone sterilization in a sterilization device. Based on such sterilization data, CPU152is configured to determine whether surgical instrument100, and/or any parts/components thereof, need to be serviced, replaced, and/or discarded. CPU152may also be configured to perform a “self-destruct” operation to render surgical instrument100, and/or components thereof permanently inoperable, or unusable without voluntary user intervention. Specifically, if surgical instrument100has undergone a threshold limit or number of sterilization cycles, CPU152will automatically prohibit further use of surgical instrument100, or parts thereof, until certain components of surgical instrument100are replaced, serviced, disabled, or discarded. The threshold limit of the number of times that surgical instrument100or any part thereof can undergo a sterilization cycle may be pre-programmed into CPU152, or based on empirical or experimental data.

For example, after a threshold number of sterilization cycles have been performed on surgical instrument100, CPU152will indicate that a particular component of surgical instrument100requires servicing or replacement, or that surgical instrument100must be discarded. Specifically, CPU152may determine that surgical instrument100is no longer safely usable after undergoing a threshold number of sterilization cycles. CPU152will engage an auto lock to prevent surgical instrument100from being used. In embodiments, CPU152may be configured to determine a failure of surgical instrument100or any part thereof before the threshold limit of sterilization cycles is met.

In embodiments, CPU152of circuit board150may be any type of suitable processor or computer adapted to perform or execute techniques, operations, and/or instructions described herein. For example, the CPU152may be hardware processors programmed to perform the techniques described herein pursuant to the instructions in firmware, memory, or other storage, or a combination thereof. Similarly, CPU152may be one or more application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), Complex Programmable Logic Devices (CPLD) that are persistently programed to perform the techniques or operations described herein. CPU152may also be a digital signal process (DSP), a microprocessor, microcontroller, or any other device that incorporates hard wired logic or program logic or both to perform the operations or techniques described herein.

CPU152of circuit board150includes memory152awhich may be any type of hardware device used to store information from CPU152(e.g., sterilization data and service information), such as random access memory (RAM). The memory152amay be non-volatile memory, such as read-only memory (ROM) (e.g., programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), and/or non-volatile RAM (NVRAM), etc., or combinations thereof). The memory may also be magnetic, optical, or electrical media.

A digital display153of surgical instrument100may be operatively (e.g., directly and/or indirectly) connected to CPU152. Digital display153may be any device configured to display at least one output of CPU152, e.g., sterilization data, service information, or an indication of a condition, as calculated and/or determined by CPU152. For example, digital display153may provide a user with a numerical representation of successfully performed sterilization cycles on surgical instrument100. Digital display153may provide a user with service information, such as indicating an imminent need to replace, service, or dispose of one or more parts/components of surgical instrument100, e.g., “Replace Part X,” “Service Part Y,” “Discard Part Z,” Discard Instrument B,” or the like.

The display153may be a liquid crystal display, a plasma display, one or more light emitting diodes, a luminescent display, a multi-color display, an analog display, a passive display, an active display, a “twisted nematic” display, a “super twisted nematic” display, a “dual scan” display, a reflective display, a backlit display, an alpha numeric display, a monochrome display, a “Low Temperature Polysilicon Thin Film Transistor” or LPTS TFT display, Organic LED (OLED) Display, machine-encapsulated electrophoretic display such as an E-Ink (electronic ink) Di splay (a microencapsulated electrophoretic display), or any other display153that indicates a parameter, information, or graphics related to service or sterilization data of the surgical instrument100. In certain embodiments, display153may include a mechanical indicator that is configured to provide any suitable audible, tactile, and/or visual output.

Surgical instrument100may include a data interface device152bconfigured to interface with CPU152and/or an external device, e.g., a tablet, smart device, computer, etc., or combinations thereof. Data interface device152bmay be configured to download data from CPU152and/or memory152aonto an external device. Additionally, data interface device152bmay be configured to upload data from an external device onto CPU152and/or memory152ato change and/or update the programming of CPU152(e.g., firmware updates). Data interface device152bmay be a Universal Serial Bus (USB) connector configured to interface with an external device using a USB cable. Additionally or alternatively, data interface device152bmay be configured to receive a USB flash media drive, an SD card, or other removable or non-removable storage medium to download/upload data from CPU152and/or memory152a.Data interface device152bmay also include, and is not limited to, Ethernet, Serial Peripheral Interface (SPI), Inter-Integrated Circuit (I2C), 1-Wire, or any other proprietary interface.

Energy harvesting device154may be any suitable device configured for deriving energy (e.g., light, thermal, kinetic, RF, pressure, etc., or combinations thereof) from a sterilization device (e.g., an autoclave) and using the energy from the sterilization device to activate or “power on” CPU152such that surgical instrument100can collect sterilization data during a sterilization procedure. Energy harvesting device154provides power to any or all components of circuit board150(e.g., CPU152, display153, storage device158, sensor160, etc., or combinations thereof).

For example, energy harvesting device154may be a thermoelectric or Seebeck generator154aconfigured to convert thermal energy into electrical energy. Thermoelectric generator154amay include P-Type and N-Type semiconductors disposed between two dissimilar materials, e.g., metals, ceramics, substrates, or the like. In use, as surgical instrument100receives a concentration of thermal energy from the sterilization device, a temperature differential is created between a hot side of thermoelectric generator154aon an outer surface of surgical instrument100that is exposed directly to the heat generated by the sterilization device, and a cool side of thermoelectric generator154ain/on an inner surface of the surgical instrument100. Thermoelectric generator154aconverts the thermal energy into electrical energy, or voltage, as a result of the temperature differential between each side of the thermoelectric generator154a,and/or between the respective inner and outer surfaces of the surgical instrument100.

In some embodiments, implementation may be effectuated via a piezo-electric device such as a Peltier. For instance, rather than being used as an output transducer, the piezo-electric device is configured to determine a difference in temperature on the sides of the device to generate an electric potential.

In certain embodiments, the voltage can be approximated using the following formula, V=(SB−SA)×(T2−T1), where V is the generated voltage, SAand SBare the respective Seebeck coefficients of the dissimilar materials used for thermoelectric generator154a,and T1and T2are the respective temperatures of the relatively hot and cold sides of the thermoelectric generator154aand/or the outer and inner surfaces of surgical instrument100. The voltage created by the thermoelectric generator154acan be used to power the circuit board150and surgical instrument100for performing certain functions during a sterilization procedure in a sterilization device, as will be described herein below.

Additionally or alternatively, energy harvesting device154may include a photovoltaic or solar cell154bconfigured to convert light energy into electrical energy. For example, when surgical instrument100is placed in a sterilization device that uses a light source to sterilize surgical instrument100, solar cell154bof harvesting device154may be used to convert the light energy from the sterilization device into electrical energy to provide power to surgical instrument100. In embodiments, solar cell154bmay be formed from crystalline silicon, thin film, multijunction cells, or the like.

An amplifier156of circuit board150may be configured to operate in conjunction or may be operatively (e.g., directly and/or indirectly) connected to energy harvesting device154to condition the voltage generated by energy harvesting device154. Amplifier156may be any type of amplifier, such as a transistor, vacuum-tube, magnetic, negative resistance, circuit, operational, differential, switched mode, etc., or combinations thereof.

In accordance with the present disclosure, the energy that is harvested is in Joules of energy, and the potential of this energy is measured in volts. The voltage is typically too low to power electronics. Accordingly, the voltage needs to be conditioned by an amplifier to amplify the voltage output. Specifically, for example, the energy harvester outputs the energy at1V and the electronics need 3V to operate. This would typically be done using a DC/DC converter, which could be considered a type of amplifier because it is boosting the voltage while the amount of energy stays the same. The output of this “amplifier” section is then at a higher potential (voltage) and powers the electronics. The amount of power used is determined by the voltage output of the “amplifier” multiplied by the current consumed by the electronics.

An energy storage device158of circuit board150may be configured to store the energy generated from energy harvesting device154to provide power to surgical instrument100, or components thereof. The energy storage device158may allow CPU152to operate for an extended period of time, e.g., to record data during an entire sterilization cycle in a sterilization device. Energy storage device158may also be configured to provide a burst of power when energy is desired or required more quickly such as if this were to be used to permanently disable the device (e.g., self-destruction). The energy storage device158may be any suitable device configured to store energy, such as, e.g., a capacitor, a battery, or the like.

Sensor160of surgical instrument100is operatively (e.g., directly and/or indirectly) connected to CPU152and may be configured to measure the energy output of a sterilization device, as applied to surgical instrument100. The threshold energy output required to sufficiently sterilize surgical instrument100(e.g., remove harmful bacteria or other infectious agents from surgical instrument100) may be based on empirical or experimental data, which may be programmed or pre-programmed into CPU152of circuit board150. Once the threshold energy output is met or measured by sensor160, CPU152will count a full sterilization cycle and record the sterilization data into memory152aof CPU152.

For example, sensor160may be a temperature sensor configured to measure temperature of surfaces of the surgical instrument100. If an outer surface of surgical instrument100reaches a threshold temperature, e.g., a temperature sufficient for sterilization of surgical instrument100, and maintains the threshold temperature for a predetermined period of time, then CPU152will record a full sterilization cycle and record the data in memory152a.

Sensor160can be configured to determine and calculate other forms of energy output applied to surgical instrument100sufficient to sterilization surgical instrument100, such as a light energy, kinetic energy, or the like. As described above, once a threshold energy output is measured by sensor160, CPU152records a full sterilization cycle, which is recorded into memory152a.

With reference toFIG. 5, a flowchart depicting operation of surgical instrument100during a sterilization procedure is provided. In step200, surgical instrument100is placed in a sterilization device (e.g., an autoclave, pressure chamber, or the like, not explicitly shown) to undergo sterilization. In step202, the sterilization device is activated such that energy (e.g., thermal, light, pressure, kinetic, etc., or combinations thereof) is applied to surgical instrument100to sterilize surgical instrument100. In step204, the energy harvesting device154harvests the energy from the sterilization device. The energy harvested from energy harvesting device154may be conditioned (e.g., voltage boosted) by amplifier156.

In step206, energy storage device158may selectively store the absorbed energy from energy harvesting device154. In some aspects, if the power requirements of circuit board150are minimal, energy storage device158may be powered without step206(e.g., directly from the energy harvesting element). In certain aspects, this may also apply to the amplifier/boost/condition circuit. In step208, energy harvesting device154and/or the energy storage device158provide power to CPU152such that CPU152, sensor160, or combinations thereof are “powered on” and can begin performing functions. In step210, sensor160measures the energy output of the sterilization device, as applied to the surgical instrument100. CPU152then determines if a threshold energy output (e.g., a maximum temperature, light, kinetic, pressure, or energy value) sufficient for sterilization of surgical instrument100has been met. In step210, if the threshold energy output is met, CPU152counts and memory152arecords a full or completed sterilization cycle. In accordance with the present disclosure, the usage count is only changed once per sterilization cycle (e.g., the measured applied energy must fall below a certain predetermined threshold before the usage count is changed again). Once the sterilization cycle is complete, in step214, CPU152determines if surgical instrument100, or any parts thereof, has undergone a threshold limit of sterilization cycles. CPU152then determines and optionally display153displays a service recommendation. Additionally or alternatively, a user can download the data onto an external device (e.g., tablet, smartphone, computer, etc., or combinations thereof) using data interface device153a.If the threshold limit of sterilization cycles is not met, then the surgical instrument100is ready for use. It is contemplated that the data (e.g., usage count) may also be read by the instrument drive unit50through a data interface, or, alternatively, surgical instrument100may be disabled.

Although surgical instrument100is configured for use with robotic surgical systems, it should be appreciated that the disclosed systems and methods are applicable to any type of surgical instrument, device, tool, or assembly, such as for example, the powered handheld surgical instruments described in commonly owned U.S. Pat. Nos. 8,968,276 and 9,055,943, and commonly owned U.S. Patent Application No. 2016/0310134, the entire contents of each of which is hereby incorporated by reference.

Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown or described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variations are also included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.