A variety of 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. The precision of cutting and coagulation may be controlled by the operator's technique and adjusting the power level, blade edge angle, tissue traction, and blade pressure.
Examples of ultrasonic surgical instruments include the HARMONIC ACE® Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades, all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examples of such devices and related concepts are disclosed in U.S. Pat. No. 5,322,055, entitled “Clamp Coagulator/Cutting System for Ultrasonic Surgical Instruments,” issued Jun. 21, 1994, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,873,873, entitled “Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,” issued Feb. 23, 1999, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,980,510, entitled “Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Arm Pivot Mount,” filed Oct. 10, 1997, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,325,811, entitled “Blades with Functional Balance Asymmetries for use with Ultrasonic Surgical Instruments,” issued Dec. 4, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,773,444, entitled “Blades with Functional Balance Asymmetries for Use with Ultrasonic Surgical Instruments,” issued Aug. 10, 2004, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” issued Aug. 31, 2004, the disclosure of which is incorporated by reference herein.
Still further examples of ultrasonic surgical instruments are disclosed in U.S. Pub. No. 2006/0079874, entitled “Tissue Pad for Use with an Ultrasonic Surgical Instrument,” published Apr. 13, 2006, now abandoned, the disclosure of which is incorporated by reference herein; 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; U.S. Pub. No. 2007/0282333, entitled “Ultrasonic Waveguide and Blade,” published Dec. 6, 2007, now abandoned, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2008/0200940, entitled “Ultrasonic Device for Cutting and Coagulating,” published Aug. 21, 2008, now abandoned, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2009/0105750, entitled “Ergonomic Surgical Instruments,” published Apr. 23, 2009, issued as U.S. Pat. No. 8,623,027 on Jan. 7, 2014, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2010/0069940, entitled “Ultrasonic Device for Fingertip Control,” published Mar. 18, 2010, issued as U.S. Pat. No. 9,023,071 on May 5, 2015, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2011/0015660, entitled “Rotating Transducer Mount for Ultrasonic Surgical Instruments,” published Jan. 20, 2011, issued as U.S. Pat. No. 8,461,744 on Jul. 11, 2013, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2012/0029546, entitled “Ultrasonic Surgical Instrument Blades,” published Feb. 2, 2012, issued as U.S. Pat. No. 8,591,536 on Nov. 26, 2013, the disclosure of which is incorporated by reference herein.
Some ultrasonic surgical instruments may include a cordless transducer such as that disclosed in U.S. Pub. No. 2012/0112687, entitled “Recharge System for Medical Devices,” published May 10, 2012, issued as U.S. Pat. No. 9,381,058 on Jun. 5, 2016, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2012/0116265, entitled “Surgical Instrument with Charging Devices,” published May 10, 2012, now abandoned, the disclosure of which is incorporated by reference herein; and/or U.S. Pat. App. No. 61/410,603, filed Nov. 5, 2010, entitled “Energy-Based Surgical Instruments,” the disclosure of which is incorporated by reference herein.
Additionally, some ultrasonic surgical instruments may include an articulating shaft section. Examples of such ultrasonic surgical instruments are disclosed in U.S. patent application Ser. No. 13/538,588, filed Jun. 29, 2012, issued as U.S. Pat. No. 9,393,037 on Jul. 19, 2016, entitled “Surgical Instruments with Articulating Shafts,” the disclosure of which is incorporated by reference herein; and U.S. patent application Ser. No. 13/657,553, filed Oct. 22, 2012, issued as U.S. Pat. No. 9,095,367 on Aug. 4, 2015, entitled “Flexible Harmonic Waveguides/Blades for Surgical Instruments,” the disclosure of which is incorporated by reference herein.
Some ultrasonic surgical instruments may include a clamp feature to press tissue against the ultrasonic blade of the end effector. Examples of such an arrangement (sometimes referred to as a clamp coagulator shears or an ultrasonic transector) is disclosed in U.S. Pat. No. 5,322,055, entitled “Clamp Coagulator/Cutting System for Ultrasonic Surgical Instruments,” issued Jun. 21, 1994, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,873,873, entitled “Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,” issued Feb. 23, 1999, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 6,325,811, entitled “Blades with Functional Balance Asymmetries for use with Ultrasonic Surgical Instruments,” issued Dec. 4, 2001, the disclosure of which is incorporated by reference herein. Some versions of clamp coagulator shears utilize handles that are either of a pistol or scissors grips design. The scissor grip designs may have one thumb or finger grip that is immovable and fixed to the housing; and one movable thumb or finger grip. Some designs have scissor arms that extend from the grips, with one of the arms rotating around a fixed pivot or rotation point that is perpendicular to the longitudinal axis of the working element. The operator may thus squeeze a handgrip or other feature to drive a clamp arm, to thereby press the clamp pad toward the blade.
Some ultrasonic devices may be used to provide acoustic cavitation. When acoustic cavitation is used to break down soft tissue, the process may be referred to as “histotripsy.” Examples of histotripsy techniques and associated technology are described in U.S. Pub. No. 2007/0083120, entitled “Pulsed Cavitational Ultrasound Therapy,” published Apr. 12, 2007, now abandoned, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2013/0190623, entitled “Histotripsy Therapy Transducer,” published Jul. 25, 2013, now abandoned, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 8,057,408, entitled “Pulsed Cavitational Ultrasound Therapy,” issued Nov. 15, 2011, the disclosure of which is incorporated by reference herein. A somewhat similar procedure is known as lithotripsy, where shock waves are used to break up kidney stones. Such shock waves may be generated by an ultrasonic transducer.
Some ultrasonic devices may be used to provide tissue emulsification and ultrasonic shearing. Examples of such devices are described in U.S. Pub. No. 2017/0105752, entitled “Surgical Instrument Providing Ultrasonic Tissue Emulsification and Ultrasonic Shearing,” published Apr. 20, 2017, the disclosure of which is incorporated by reference herein.
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 serve to 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 an operator or other operator grasping a surgical instrument having a distal surgical end effector. The term “proximal” refers the position of an element closer to the operator or other operator and 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 operator or other operator.
I. Overview of Exemplary Ultrasonic Surgical System
In some surgical procedures, it may be desirable to operate an ultrasonic debriding instrument to dissect tissue by applying ultrasonic vibrational energy to the tissue. In the same surgical procedure, it may be desirable to operate an ultrasonic shears instrument to transect tissue by compressing the tissue against an ultrasonically activated element. In conventional instrumentation, this may require the use of two separate instruments. This is because, even though both types of instruments rely on activation of an ultrasonically vibrating element, the debriding instrument may act on tissue that is positioned distal to the ultrasonically vibrating element (e.g., along the longitudinal axis of the ultrasonically vibrating element); while the clamping transection instrument may act on tissue that is positioned transverse to the ultrasonically vibrating element (e.g., perpendicular to the longitudinal axis of the ultrasonically vibrating element). It may therefore be desirable to provide a single instrument that is operable to both provide dissection of tissue that is distal to an ultrasonically vibrating element and provide clamping transection in tissue that is positioned transverse to the ultrasonically vibrating element. Several merely illustrative examples of such an instrument are described in greater detail below.
It should be understood that the instruments described below may be used in a variety of clinical contexts. By way of example only, the instruments described below may be used to remove portions of a liver. In some such uses, the ultrasonically vibrating element may be used like a scalpel to dissect the parenchyma of the liver. This process may ultimately reveal one or more blood vessels and/or biliary ducts. In some such instances (e.g., where a vessel or duct having a diameter greater than approximately 1 mm is encountered), the scalpel-like mode of operation may not be an ideal mode to use for transecting and sealing such vessels and/or ducts. The operator may thus use a scalpel-like mode of operation to separate parenchymal tissue from vessels and biliary ducts in the liver, then transition use of the instrument to a clamping transection mode of operation in order to transect and seal the one or more blood vessels and/or biliary ducts. Various ways in which this may be accomplished will be described in greater detail below. It should be understood that integrating both modes of operation may reduce the number of instruments used in a surgical procedure, thereby simplifying the surgical procedure; and enabling the operator to keep the surgical field within their view the entire time that they are transitioning between modes of operation (whereas using two instruments may require the operator to avert their eyes from the surgical field, which may cause the operator to have difficulty finding the vessels/ducts that are to be transected). It should also be understood that this clinical context and method of operation is merely one of many possible contexts and methods in which the below described instruments may be used. Various other suitable contexts and methods in which the below described instruments may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
By way of example only, generator (20) may comprise the GEN04, GEN11, or GEN 300 sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. In addition, or in the alternative, generator (20) may be constructed in accordance with at least some of the teachings of U.S. Pub. No. 2011/0087212, entitled “Surgical Generator for Ultrasonic and Electrosurgical Devices,” published Apr. 14, 2011, issued as U.S. Pat. No. 8,986,302 on Mar. 4, 2015, the disclosure of which is incorporated by reference herein. Alternatively, any other suitable generator (20) may be used. As will be described in greater detail below, generator (20) is operable to provide power to instrument (10) to perform ultrasonic surgical procedures.
Fluid source (30) may contain saline and/or any other suitable kind(s) of fluid(s). It should also be understood that the fluid may comprise a high surface tension fluid with or without bubbles. In some versions, fluid source (30) comprises a passive reservoir that is positioned to provide fluid to instrument (10) via gravity feed. In some other versions, fluid source (30) includes a fluid pump and/or some other feature(s) that is/are operable to pressurize fluid for deliver to and through instrument (10). Various suitable forms that fluid source (30) may take, as well as various kinds of fluids that may be used, will be apparent to those of ordinary skill in the art in view of the teachings herein.
Suction source (40) may comprise any suitable source of suction. For instance, suction source (40) may comprise a conventional vacuum wall outlet that leads to a centralized vacuum system. Of course, one or more fluid reservoirs, filters, and/or other components may be interposed between instrument (10) and a conventional vacuum wall outlet. As another merely illustrative example, suction source (40) may comprise a vacuum pump that is situated locally with instrument (10). As yet another merely illustrative example, suction source (40) may be integrated into a single piece of capital equipment along with generator (20) and/or fluid source (30). Various other suitable forms that suction source (40) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
Handle assembly (50) of the present example includes an integral finger ring (52) through which an operator's finger may be inserted to facilitate gripping of handle assembly (50). Handle assembly (50) further includes a ratchet feature (60) and a pair of triggers (90, 94). Each trigger (90, 94) is pivotably coupled with handle assembly (50) by a respective pin (92, 96). Ratchet feature (60) and triggers (90, 94) will be described in greater detail below. As shown ultrasonic blade (100) and irrigation flue (200) project distally from handle assembly (50).
Clamp arm assembly (70) comprises a shank (72), a thumb ring (74), and a clamp pad (76). Shank (72) is pivotably coupled with handle assembly (50) by a pin (80). Thumb ring (74) is configured to receive an operator's thumb to facilitate actuation of clamp arm assembly (70). It should therefore be understood that finger ring (52) and thumb ring (74) together enable an operator to grasp and manipulate instrument (10) using a scissor grip. Of course, such a configuration is merely optional. In some variations, instrument (10) is modified to provide a pistol grip with a pivoting trigger to control a clamp arm assembly. Various examples of such a configuration are shown and described in numerous references cited herein. As yet another merely illustrative example, some versions of instrument (10) may substitute handle assembly (50) and clamp arm assembly (70) with features that are coupled to a robotic surgical system that is configured to operate instrument (10) (e.g., via remote control, etc.).
Clamp arm assembly (70) is operable to pivot clamp pad (72) toward and away from ultrasonic blade (100). Clamp arm assembly (70) is thus operable to compress tissue between clamp pad (72) and ultrasonic blade (100). Those of ordinary skill in the art will recognize that, when ultrasonic blade (100) is activated to vibrate ultrasonically, the compression of tissue against ultrasonic blade (100) by clamp pad (72) may assist in further driving the ultrasonic vibrations of ultrasonic blade (100) through the tissue, thereby promoting transection and sealing of the tissue. By way of example only, clamp pad (72) may comprise polytetrafluoroethylene (PTFE) to reduce adhesion of tissue to clamp pad (72). Other suitable material(s) and/or configurations that may be incorporated into clamp pad (72) will be apparent to those of ordinary skill in the art in view of the teachings herein.
It should also be understood that ultrasonic blade (100) may include various materials to prevent or reduce adhesion of tissue to blade (100). By way of example only, the distal external surface of ultrasonic blade (100) in the region of clamp pad (72) may be coated with a polymer such as Xylan to further reduce the potential for sticking. In addition, the inner surface defining lumen (122) of ultrasonic blade (100) may be coated with a polymer to help lessen the occurrence of clogging. Various other suitable materials that may be incorporated into ultrasonic blade (100) will be apparent to those of ordinary skill in the art in view of the teachings herein.
A. Exemplary Ultrasonic Communication Features
As best seen in
As best seen in
In the present example, ultrasonic blade (100) is integral with distal waveguide segment (102), such that blade (100) and segment (102) are formed together as a single unit. In some versions, ultrasonic blade (100) may be connected to distal waveguide segment (102) by a threaded connection, a welded joint, and/or some other coupling feature(s). It should be understood that ultrasonic transducer assembly (110), segments (102, 104), and ultrasonic blade (100) together form an acoustic drivetrain, such that ultrasonic vibrations generated by ultrasonic transducer assembly (110) will be communicated along segments (102, 104) to blade (100). In some instances, coupling feature (124) is located at a longitudinal position corresponding to a node associated with ultrasonic vibrations communicated along segments (102, 104). Handle assembly (50) and clamp arm assembly (70) are configured to substantially isolate the operator from the vibrations of the acoustic assembly formed by ultrasonic transducer assembly (110), segments (102, 104), and ultrasonic blade (100). In addition, as shown in
When ultrasonic transducer assembly (110) of the present example is activated, these mechanical oscillations are transmitted through waveguide segments (102, 104) to reach ultrasonic blade (100), thereby providing oscillation of ultrasonic blade (100) at the resonant ultrasonic frequency. In the present example, the distal end of ultrasonic blade (100) is located at a position corresponding to an anti-node associated with resonant ultrasonic vibrations communicated through waveguide segments (102, 104). When ultrasonic transducer assembly (110) is energized, the distal end of ultrasonic blade (100) is configured to move longitudinally in the range of, for example, approximately 10 to 500 microns peak-to-peak, and in some instances in the range of about 20 to about 200 microns at a predetermined vibratory frequency fo of, for example, 55.5 kHz. The distal tip of ultrasonic blade (100) may also vibrate in the y-axis at about 1 to about 10 percent of the motion in the x-axis. Of course, movement of the distal tip of ultrasonic blade (100) may alternatively have any other suitable characteristics. By way of example only, the distal tip of ultrasonic blade (100) may vibrate with more movement in the y-axis than in the x-axis. As another merely illustrative example, the distal tip of ultrasonic blade (100) may vibrate in the y-axis at up to about 50 percent of the motion in the x-axis. Other suitable vibrational characteristics will be apparent to those of ordinary skill in the art in view of the teachings herein. In the present example, the ultrasonic oscillation of ultrasonic blade (100) may simultaneously sever the tissue and denature the proteins in adjacent tissue cells, thereby providing a coagulative effect with relatively little thermal spread.
B. Exemplary Irrigation Flue
As shown in
Hub (220) is secured to the distal end of sheath (120), such that the position of irrigation flue (200) is longitudinally and pivotably fixed relative to the position of ultrasonic blade (100) (other than the vibrational movement of ultrasonic blade (100) relative to irrigation flue (200)).
As best seen in
C. Exemplary Valve Assembly
As shown in
Valve assembly (320) further includes a fluid valve actuator (340) and a suction valve actuator (360). Valve actuators (340, 360) are slidably disposed in corresponding bores (354, 356) formed in body (322). Fluid valve actuator (340) is configured to selectively couple fluid outlet port (334) with fluid inlet port (324), based on the position of fluid valve actuator (340) in body (322). Suction valve actuator (360) is configured to selectively couple suction outlet port (336) with suction inlet port (326), based on the position of suction valve actuator (360) in body (322). Valve assembly (320) may be further configured and operable in accordance with at least some of the teachings of U.S. Pub. No. 2017/0105752, entitled “Surgical Instrument Providing Ultrasonic Tissue Emulsification and Ultrasonic Shearing,” published Apr. 20, 2017, the disclosure of which is incorporated by reference herein.
In the present example, actuators (340, 360) travel upwardly simultaneously together and downwardly simultaneously together. Thus, whenever suction is being provided to ultrasonic blade (100), fluid is being provided to irrigation flue (200) and vice-versa. Similarly, whenever suction is not being provided to ultrasonic blade (100), fluid is not being provided to irrigation flue (200) and vice-versa. In some other versions, actuators (340, 360) may be actuated independently relative to each other. In some such versions, suction may be provided through blade (100) without fluid being provided through irrigation flue (200). In addition, or in the alternative, fluid may be provided through irrigation flue (200) without suction being provided through blade (100). Various suitable ways in which such functionality may be incorporated into instrument (10) will be apparent to those of ordinary skill in the art in view of the teachings herein.
II. Exemplary Features to Promote Removal of Debris from within Ultrasonic Surgical Instrument
When tissue is emulsified by ultrasonic blade (100), the process may create loose fragments of tissue. These fragments of tissue may be drawn into ultrasonic blade (100) by suction provided through lumen (122). During the course of use of instrument (10) in a given surgical procedure, such tissue fragments, perhaps in combination with coagulated blood and/or other debris, may eventually build up within lumen (122). Such a build-up within lumen (122) may restrict the flow through lumen (122). Such restriction may eventually result in clogging of lumen (122). It may therefore be desirable to provide features and/or operational techniques that reduce the likelihood of tissue, etc. building up in lumen (122). Examples of such features and techniques are described in greater detail below.
A. Exemplary Use of Reversible Fluid Flow to Prevent Clogging of Ultrasonic Blade Lumen
One exemplary technique that may be employed to prevent the buildup of debris in lumen (122) includes providing a combination of negative, proximally-oriented fluid pressure and positive, distally-oriented fluid pressure in lumen (122). For instance,
In this example, the duration of the negative, proximally-oriented fluid pressure exceeds the duration of the positive, distally-oriented fluid pressure in each cycle. In particular, where each cycle has a total duration of time (T), the duration of the negative, proximally-oriented fluid pressure is two thirds of that time (T) and the duration of the positive, distally-oriented fluid pressure is one third of that time (T). Alternatively, other suitable relationships may be used. In the present example, the relationship provides a net negative, proximally-oriented fluid pressure, as represented by arrow (402) in
In the event that a clog or other restriction occurs in lumen (122), the duty cycle may be changed to provide a net positive, distally-oriented fluid pressure, as represented by arrows (412, 414) in
Various kinds of components may be used to provide a duty cycle that alternates between a positive, distally-oriented pressure through lumen (122) and a negative, proximally-oriented pressure through lumen (122). By way of example only, such components may comprise a combination of a source of fluid (e.g., saline) at a positive pressure (e.g., fluid source (30)), a source of negative pressure (e.g., suction source (40)), and a valve coupled with lumen (122) to switch between these two sources. As another example, a reversible peristaltic pump or other kind of reversible pump may be used to alternate the direction of fluid flow through lumen (122). Other suitable components and techniques that may be used to provide a duty cycle that alternates between a positive, distally-oriented pressure through lumen (122) and a negative, proximally-oriented pressure through lumen (122) will be apparent to those of ordinary skill in the art in view of the teachings herein.
B. Exemplary Alternative Ultrasonic Blade with Lumen Having Varying Inner Diameter
Lumen (510) has a first inner diameter (d1) while lumen (512) has a second inner diameter (d2). The first inner diameter (d1) is constant along the length of lumen (510); while the second inner diameter (d2) is constant along the length of lumen (512). Second inner diameter (d2) is larger than first inner diameter (d1). The relatively larger size of second inner diameter (d2) may reduce the likelihood of debris building up within lumen (512). It may therefore be desirable to extend lumen (512) distally as far as possible without adversely impacting the ultrasonic emulsifying capabilities of ultrasonic blade (500). By providing a tapered transition from lumen (510) to lumen (512), tapered internal sidewall (514) may reduce the risk of debris building up at the transition from lumen (510) to lumen (512).
While ultrasonic blade (500) has two different inner diameters (d1, d2) in this example, some other versions may have more than two different inner diameters, with the inner diameters progressively increasing in size along the proximal direction.
C. Exemplary Ultrasonic Surgical Instrument with Lumen Access Hatch
In addition to, or as an alternative to, providing varying fluid flow and/or a varying fluid flow path within instrument (10), it may be desirable to provide features that enable the operator to directly access and remove debris from lumen (122) of ultrasonic blade (100).
Instrument (600) of the present example differs from instrument (10) in that instrument (600) of the present example includes a hatch (610) that selectively opens and closes a lateral opening (620) of shaft (604). Hatch (610) is configured to transition between a closed position (
As shown in
During normal operation of instrument (600) in a surgical procedure, hatch (610) remains in the closed position. In the event that lumen (632) of ultrasonic blade (606) becomes clogged, the operator may open hatch (610) to access lateral notch (634). The operator may then insert a wire, brush, or other cleaning instrument through lateral notch (634) to clear debris from lumen (632). During this cleaning, suction may be provided through lumen (632). Alternatively, saline or some other fluid may be communicated through lumen (632) at a positive pressure as the operator cleans lumen (632) via lateral notch (634). Alternatively, a duty cycle such as the one shown in
D. Exemplary Alternative Cross-Sectional Profiles for Ultrasonic Blade
In addition to, or as an alternative to, the features and techniques described above, a variation of instrument (10) may include features that provide enhanced fragmentation of tissue. By providing enhanced fragmentation of tissue, the tissue particles may be finer and thereby less likely to clog lumen (122) of ultrasonic blade (100).
By way of example only, ultrasonic blade (100) may have an outer diameter of 0.100 inches with an inner diameter of 0.080 inches. Ultrasonic blade (700) may have flat faces (704) with widths of 0.100 inches and an inner diameter of 0.080 inches. Despite the similarities between the values of these size parameters, ultrasonic blade (700) of this example would have a cross-sectional area that is 76% larger than the cross-sectional area of ultrasonic blade (100) of this example. This larger cross-sectional area would provide a corresponding increase in mass.
Sharp corners (706) of ultrasonic blade (700) may provide additional functionality that enhances the ability of ultrasonic blade (700) to be used to perform back scoring and other scalpel-like operations. In the context of a liver procedure, back scoring may be used to cut the Glisson capsule. As an alternative, an ultrasonic blade (710) like the one shown in
In addition to providing faster tissue fragmentation during the emulsification process (e.g., using blade (700, 710, 720) to transect a liver parenchyma) due to the relatively large cross-sectional area and mass of blades (700, 710, 720), flat faces (704, 714, 724) may provide a better clamping surface to cooperate with clamp pad (76) during the process of transecting and sealing anatomical structures (e.g., when transecting and sealing vessels and biliary ducts of the liver after transection of the liver parenchyma). By providing a better clamping surface to cooperate with clamp pad (76), blade (700, 710, 720) may provide a better seal of transected tissue.
E. Exemplary Ultrasonic Surgical Instrument with Pinching Valve Assembly
Fluid communication lines (830, 832) are further in communication with a fluid source (860). By way of example only, fluid source (860) may comprise a source of saline. In some versions, the saline is pressurized. In some other versions, the saline is simply gravity-fed. Suction line (834) is in communication with a suction source (862), such as a conventional vacuum pump. Each line (830, 832, 834) comprises a flexible tube in the present example.
As best seen in
Actuator (854) is configured to translate vertically relative to housing (840) to selectively pinch lines (830, 832, 834) against corresponding pinch walls (842, 844) of housing (840). As shown in
In the present example, actuator (854) is manually operated. Actuator (854) and housing (840) may include complementary detenting features that selectively retain actuator in the position shown in
III. Exemplary Combinations
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.
An instrument, comprising: (a) an ultrasonic blade, wherein the ultrasonic blade defines a distal opening, wherein the ultrasonic blade is operable in a first mode to emulsify tissue that is distally positioned relative to the ultrasonic blade, wherein the ultrasonic blade is further operable in a second mode to transect and seal tissue that is transversely positioned relative to the ultrasonic blade; (b) a first fluid port in communication with the distal opening of the ultrasonic blade; (c) an irrigation member positioned adjacent to the distal end of the ultrasonic blade; (d) a second fluid port in communication with the irrigation member; and (e) a fluid communication assembly, wherein the fluid communication assembly is configured to: (i) couple the first fluid port with a fluid source, (ii) couple the first fluid port with a suction source, and (iii) couple the second fluid port with the fluid source.
The instrument of Example 1, further comprising a clamp arm, wherein the clamp arm is pivotable toward and away from the ultrasonic blade to cooperate with the ultrasonic blade in the second mode.
The instrument of any one or more of Examples 1 through 2, wherein the fluid communication assembly further comprises a controller, wherein the controller is configured to execute a control algorithm that includes alternating between coupling the first fluid port with the fluid source for a first duration and coupling the first fluid port with the suction source for a second duration.
The instrument of Example 3, wherein the first duration is longer than the second duration.
The instrument of Example 3, wherein the first duration is shorter than the second duration.
The instrument of any one or more of Examples 3 through 5, wherein the fluid communication assembly further comprises a sensor, wherein the sensor is operable to detect a clog or other restriction in the ultrasonic blade, wherein the sensor is in communication with the controller.
The instrument of Example 6, wherein the controller is configured to provide a first duty cycle in response to the sensor failing to detect a clog or other restriction in the ultrasonic blade, wherein the first duration is shorter than the second duration during the first duty cycle.
The instrument of Example 7, wherein the controller is configured to provide a second duty cycle in response to the sensor detecting a clog or other restriction in the ultrasonic blade, wherein the first duration is longer than the second duration during the second duty cycle.
The instrument of any one or more of Examples 1 through 8, wherein the ultrasonic blade further defines a distal lumen portion and a proximal lumen portion, wherein the lumen portions are in fluid communication with the distal opening, wherein the lumen portions are coaxially aligned with each other, wherein the proximal lumen portion has a larger diameter than the distal lumen portion.
The instrument of Example 9, wherein the ultrasonic blade further defines a tapered inner sidewall, wherein the tapered inner sidewall provides a tapered transition from the distal lumen portion to the proximal lumen portion.
The instrument of any one or more of Examples 1 through 10, further comprising a shaft surrounding a portion of the ultrasonic blade, wherein the shaft includes a movable hatch, wherein the hatch is movable to selectively uncover a portion of the ultrasonic blade.
The instrument of Example 11, wherein the ultrasonic blade defines a lumen and a lateral opening, wherein the lumen is in fluid communication with the distal opening, wherein the lateral opening is in fluid communication with the lumen, wherein the lateral opening is spaced proximally from the distal opening.
The instrument of Example 12, wherein the hatch is positioned to selectively cover and uncover the lateral opening.
The instrument of Example 13, wherein the hatch comprises a gasket, wherein the gasket is configured to seal the lateral opening when the hatch is in a closed position, wherein the gasket is configured to open the lateral opening when the hatch is in an open position.
The instrument of any one or more of Examples 1 through 14, wherein the ultrasonic blade has a generally square shaped cross-sectional profile.
The instrument of Example 15, wherein the generally square shaped cross-sectional profile includes at least one rounded corner.
The instrument of Example 16, wherein the generally square shaped cross-sectional profile includes at least one sharp corner.
The instrument of any one or more of Examples 1 through 17, wherein the fluid communication assembly further comprises: (i) a set of flexible conduits, (ii) a set of pinching members, and (iii) a set of pinching surfaces, wherein the pinging members are operable to selectively pinch the flexible conduits against the pinching surfaces to thereby selectively control fluid flow between: (A) the first fluid port and the fluid source, (B) the first fluid port and the suction source, and (C) the second fluid port and the fluid source.
An instrument, comprising: (a) an ultrasonic blade, wherein the ultrasonic blade comprises: (i) an elongate shaft, (ii) a lumen extending through the elongate shaft, (iii) distal opening located at a distal end of the shaft, wherein the distal opening is in fluid communication with the lumen, (iv) a lateral opening spaced proximally apart from the distal end, wherein the lateral opening is in fluid communication with the lumen; (b) a body including an elongate outer shaft, wherein the elongate outer shaft defines a lateral opening corresponding with the lateral opening of the ultrasonic blade; and (c) a hatch movably coupled with the elongate outer shaft at the lateral opening of the elongate outer shaft, wherein the hatch includes an inner gasket, wherein the gasket is configured to selectively seal the lateral opening of the ultrasonic blade.
A method of operating an instrument, the method comprising: (a) expelling fluid at a surgical site through an irrigation member, wherein the irrigation member is positioned adjacent to an ultrasonic blade; (b) applying ultrasonic energy at the surgical site via the ultrasonic blade; and (c) alternating between: (i) applying suction through a lumen of the ultrasonic blade at the surgical site, and (ii) expelling fluid through the lumen of the ultrasonic blade at the surgical site.
IV. Miscellaneous
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.
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, that 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 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. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif. Similarly, those of ordinary skill in the art will recognize that various teachings herein may be readily combined with various teachings of U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004, the disclosure of which is incorporated by reference herein.
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.
This application is a continuation of U.S. patent application Ser. No. 15/643,585 filed on Jul. 7, 2017, published as U.S. Pat. App. No. 2019/0008545 on Jan. 10, 2019, issued as U.S. Pat. No. 10,478,211 on Nov. 19, 2019.
Number | Name | Date | Kind |
---|---|---|---|
3805787 | Banko | Apr 1974 | A |
3812855 | Banko | May 1974 | A |
4368734 | Banko | Jan 1983 | A |
4770654 | Rogers et al. | Sep 1988 | A |
4935005 | Haines | Jun 1990 | A |
5322055 | Davison | Jun 1994 | A |
5725495 | Strukel | Mar 1998 | A |
5873873 | Smith et al. | Feb 1999 | A |
5935096 | Barrett | Aug 1999 | A |
5980510 | Tsonton et al. | Nov 1999 | A |
6325811 | Messerly | Dec 2001 | B1 |
6652547 | Rabiner et al. | Nov 2003 | B2 |
6773444 | Messerly | Aug 2004 | B2 |
6783524 | Anderson et al. | Aug 2004 | B2 |
8057408 | Cain et al. | Nov 2011 | B2 |
8152825 | Madan et al. | Apr 2012 | B2 |
8461744 | Wiener et al. | Jun 2013 | B2 |
8531064 | Robertson et al. | Sep 2013 | B2 |
8591536 | Robertson | Nov 2013 | B2 |
8623027 | Price et al. | Jan 2014 | B2 |
8986302 | Aldridge et al. | Mar 2015 | B2 |
9023071 | Miller et al. | Apr 2015 | B2 |
9095367 | Olson et al. | Jul 2015 | B2 |
9381058 | Houser et al. | Jul 2016 | B2 |
9393037 | Olson et al. | Jul 2016 | B2 |
10178999 | Komiya et al. | Jan 2019 | B2 |
10478211 | Stulen | Nov 2019 | B2 |
20060079874 | Faller et al. | Apr 2006 | A1 |
20070083120 | Cain et al. | Apr 2007 | A1 |
20070191713 | Eichmann et al. | Aug 2007 | A1 |
20070282333 | Fortson et al. | Dec 2007 | A1 |
20080200940 | Eichmann et al. | Aug 2008 | A1 |
20110237880 | Hamel | Sep 2011 | A1 |
20120116265 | Houser et al. | May 2012 | A1 |
20130190623 | Bertolina et al. | Jul 2013 | A1 |
20170007451 | Depenbusch | Jan 2017 | A1 |
20170105752 | Boudreaux | Apr 2017 | A1 |
20170172699 | Otrembiak et al. | Jun 2017 | A1 |
Number | Date | Country |
---|---|---|
2581053 | Apr 2013 | EP |
2581053 | Sep 2016 | EP |
WO 2004110524 | Dec 2004 | WO |
Entry |
---|
U.S. Pat. No. 10,478,211. |
International Search Report and Written Opinion dated Jan. 7, 2019 for International Application No. PCT/US2018/040873, 20 pages. |
U.S. Appl. No. 61/410,603, filed Nov. 5, 2010. |
Indian Office Action dated Mar. 3, 2022, for Application No. 201917048609, 7 pages. |
Number | Date | Country | |
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20200069325 A1 | Mar 2020 | US |
Number | Date | Country | |
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Parent | 15643585 | Jul 2017 | US |
Child | 16549809 | US |