Laparoscopic devices for hydrodissection and aspiration and methods of use

Abstract

The laparoscopic instrument includes fluid delivery channels integrated into the sides of the instrument jaws and extending to outlets near the distal tips of the jaws, fluid delivery channels integrated into the instrument shaft, and flexible fluid delivery channels connecting the distal ends of the shaft channels to the proximal ends of each jaw channel. An actuator in the handle of the device controls either the delivery of a lateral jet of fluid to tissue grasped between the jaws of the instrument, or suction from the distal tips of the jaws to remove fluid adjacent the jaws. The fluid jet provides atraumatic tissue separation to the side of the structure grasped by the jaws, while the grasping jaws provide countertraction to hydrodissect the soft tissue by stationary tissue in a direction opposite to the force exerted by the hydrodissection fluid jet.

Description

[Technical field]

[0001] Related Application Data This application is a continuation-in-part of pending U.S. Application No. 18 / 089,368, filed December 27, 2022, and claims the benefit of pending U.S. Provisional Application No. 63 / 312,770, filed February 22, 2022, and U.S. Provisional Application No. 63 / 421,511, filed November 1, 2022, the entire disclosures of which are expressly incorporated herein by reference.

[0002] This application relates to surgical devices and systems, and more particularly to devices and methods for tissue dissection, for example, performed in laparoscopic surgery, which may provide blunt tissue separation performed via focused fluid jets instead of mechanical tissue dissection typically performed by laparoscopic dissectors and graspers. For example, the devices and systems herein may include a laparoscopic device that provides mechanical tissue separation, hydrodissection, aspiration, and irrigation modes in a single instrument. [Background technology]

[0003] In minimally invasive surgeries, such as laparoscopic, thoracoscopic, gynecological, urological, and robotic surgeries, separation of anatomical structures such as blood vessels and ducts is performed by blunt separation manipulations, which spread and peel away the soft tissue adjacent to the vessels and ducts. If the organ being operated on is ischemic or necrotic, the organ and surrounding soft tissues swell and become edematous, making it difficult to determine the outline and location of the underlying ducts and vessels. Surgical manipulations using existing laparoscopic grasping and cutting instruments are likely to destroy unrecognized organs, ducts, and vessels, which may result in the leakage of toxic and infectious contents into the abdominal cavity or bleeding.

[0004] Blunt separation of soft tissues during laparoscopic surgery is dangerous when the tissues are swollen and edematous, and the outline of blood vessels and ducts passing through the soft tissues cannot be seen with endoscopic observation. In gangrenous cholecystitis, the gallbladder becomes distended and ischemic, compromising the blood supply. When necrosis of the organ occurs, the result is inflammation and tissue swelling in the gallbladder area, obscuring the location of the cystic duct and cystic artery. For cholecystectomy, these structures must be surgically separated, ligated or clipped, and severed. Mechanical separation of a gangrenous gallbladder with conventional laparoscopic surgical instruments such as Maryland dissection forceps is prone to cutting or lacerating the unvisualized common bile duct, portal vein, colon, other intestinal tracts, cystic duct, and cystic artery, which may allow infected bile to leak into the abdominal cavity and cause bleeding.

[0005] Other endoscopic procedures requiring difficult and risky blunt surgical dissection include resection of intraperitoneal endometriotic lesions, adhesion lysis or dissection, and video-assisted thoracic surgery (VATS), which typically involves lung resection and empyema drainage.

[0006] Previously, laparoscopic forceps have provided irrigation and suction to the jaws of the instrument. One such instrument, described by Fischer in U.S. Patent No. 9,308,014, teaches the use of a fluid jet at or within the fixed jaws of the forceps to dissect tissue.

[0007] Therefore, improved devices and methods for performing tissue ablation within a patient's body would be useful. Summary of the Invention

[0008] This application relates generally to surgical devices and systems, and more particularly to devices for tissue separation, for example performed in laparoscopic and / or robotic surgery, and systems and methods for using such devices. The devices may include surgical instruments, such as laparoscopic graspers, forceps, scissors, clip appliers, vessel sealers, and the like, and may provide multiple modes of operation, such as hydrodissection, aspiration, and / or irrigation, in a single instrument, in addition to any other mechanical functions, including end effectors for mechanical tissue separation, cutting, and the like. The devices may be provided within a system that includes other components for operating the devices, such as fluid and / or vacuum sources, power sources, and the like. The devices may also be incorporated into a remotely operable robotic surgical system.

[0009] Optionally, the devices and systems may include one or more additional components or features. For example, the devices may include one or more sensors on or adjacent to the end effector, such as a Doppler or other sensor for identifying blood flow in contacted tissue, a microfluidic sensor for identifying tissue characteristics, etc., one or more electrodes or other ablation elements, a vessel sealing element, and / or one or more imaging elements. One or more processors or controllers may be coupled to these elements, for example, to analyze signals from the sensors and generate images on a display. If one or more imaging elements are provided on the device, a display may be provided, for example, at the proximal end of the device or remote from the device, to allow visual monitoring of the surgical field during use of the device.

[0010] According to one embodiment, an instrument, such as a laparoscopic grasper or forceps, is provided that has dual action jaws including a rigid nozzle on the side of each jaw. Fluid delivery channels extend along the side of the instrument shaft, and a length of flexible hose connects the distal end of each channel to the proximal end of each jaw nozzle channel. The short flexible hose section assumes a substantially straight position when the jaws are closed such that its profile does not exceed the profile of the instrument shaft, allowing the instrument to be inserted through a trocar, such as a five millimeter (5 mm) laparoscopic trocar.

[0011] In another embodiment, a laparoscopic forceps is provided with multiple modes of operation, e.g., two or more of mechanical tissue separation, hydrodissection, aspiration and irrigation, cauterization, vessel sealing, and microfluidics are provided in a single instrument. Alternatively, other surgical instruments with these modes of operation may be provided, e.g., intestinal graspers, clip appliers, scissors, vessel sealers, etc. Tissue manipulation and blunt tissue separation may be performed with the jaws of the forceps extended distally beyond the tip of the coaxial sheath. Tissue hydrodissection may also be performed in this configuration, with the forceps grasping the tissue and providing countertraction while a high velocity fluid jet provides atraumatic surgical separation without the mechanical tissue destruction typically performed with conventional laparoscopic dissectors and graspers. Hydrodissection may safely separate and / or cut ducts, vessels, and other anatomical structures during surgical procedures on gangrenous or edematous tissues and organs. The forceps may be fully retracted within the sheath, for example to provide suction and / or to perform pure hydrodissection without tissue countertraction. Suction allows for removal of hydrodissection fluid and / or blood from the surgical field, and fluid irrigation allows for removal of tissue debris and blood clots from the aspiration cannula. Optionally, the device may include an internal battery-powered fluid pump and a port for connection to a vacuum canister in the operating room.

[0012] In yet another embodiment, a hydrodissection and suction laparoscopic forceps device is provided, comprising two movable jaws connected to the distal end of a long, rigid shaft, e.g., five millimeter (5 mm) outer diameter, configured to be opened and closed by an actuator on a handle at the proximal end of the shaft, e.g., including an elongated fixed ring for accommodating fingers and a movable thumb ring for actuating the jaws. A tubular channel is provided on the side of the shaft and the jaws, e.g., a pair of shaft channels extending between the proximal and distal ends of the shaft, and a relatively short (e.g., 3 mm long) tubular jaw channel in each jaw, the tubular jaw channels being exposed circumferentially and adapted to receive two flexible tubes for fluid-tightly connecting each shaft channel to a corresponding jaw channel. The flexible tubes are adapted to maintain a desired maximum outer diameter or other profile (e.g., 5 mm outer diameter) over the length of the instrument, such that the instrument with closed jaws can be inserted, e.g., through a trocar or sheath of a corresponding inner diameter (e.g., five millimeter (5 mm)).

[0013] Once the jaws are positioned within the patient's abdominal cavity, they can be opened and closed while a flexible tube provides fluid to the sides of the jaws to non-traumatically hydrodissect tissue lateral to an anatomical structure grasped by the jaws, for example, while applying countertraction to tissue held by the forceps. This method of hydrodissecting tissue lateral to an anatomical structure grasped by the jaws while applying focused countertraction to the tissue can be less traumatic to tissue than blunt separation with conventional laparoscopic forceps, since conventional laparoscopic forceps typically involve tissue puncture and tissue tearing as an element of blunt mechanical separation. In contrast, hydrodissection enabled by the devices and methods herein uses a gentle fluid jet stream to separate tissue and isolate anatomical structures, eliminating the sharp force tissue interaction associated with blunt mechanical separation.

[0014] In some laparoscopic procedures, it may be desirable to perform the procedure with forceps having double action jaws, rather than a single action jaw and a fixed jaw. Double action jaws provide a wider tissue grasp and prevent slippage during tissue manipulation. Double action jaws also allow the jaws to open symmetrically on either side of the shaft, allowing the jaws to maintain axial orientation with the instrument shaft. The use of laparoscopic forceps with double action jaws can facilitate a more intuitive and efficient surgical procedure and reduce surgical time. On the other hand, single action forceps require the instrument shaft to be offset toward the fixed jaw to accurately grasp the tissue as intended. Thus, double action jaws are particularly useful, although single action jaws may be provided if desired.

[0015] In one example, the hydrodissection laparoscopic forceps device provided herein can incorporate a built-in fluid pump and / or a battery or other power source for powering the pump, for example, in or on the handle device. Saline can be supplied to the pump, for example, via an IV line attached to a hanging IV bag. Optionally, a separate hose supplying wall suction from the operating room can be connected to the device's handle.

[0016] In one embodiment, the device may include two normally-closed valves coupled to respective actuators, e.g., arranged in series with drip lines attached to both tubular channels at the proximal end of the shaft, for example, a first trumpet valve may control both the electrical supply to the fluid pump and the fluid flow laterally to the forceps jaws, and a second trumpet valve may actuate a vacuum to remove fluid injected during hydrodissection.

[0017] Optionally, the laparoscopic hydrodissection forceps and / or other devices (e.g., including the fluid pump and battery) may be disposable devices that are discarded after surgery to avoid the need for cleaning, resterilization, and storage of the devices between successive surgeries. Alternatively, all or some components of the devices may be reusable, for example after cleaning and / or sterilization.

[0018] As an example, the fluid-carrying tubular channels in the gripping jaws may have a smaller inner diameter than the tubular channels disposed on the sides of the instrument shaft, allowing the velocity of the fluid jets emitted from the gripping jaw channels to be adjusted to a desired level based on, for example, the pressure and / or flow specifications generated by the fluid pump.

[0019] During endoscopic surgery, anatomical landmarks may become unclear, and pathological conditions may exist that make tissue dissection difficult and dangerous. For example, laparoscopic cholecystectomy requires surgical resection to separate, ligate, and cut the cystic artery and cystic duct before cholecystectomy. Acute cholecystitis is inflammation of the gallbladder caused by obstruction of the cystic duct by gallstones. The gallbladder distends, increasing intragallbladder pressure and impairing blood supply, causing ischemia, leading to gangrenous cholecystitis, which is seen in more than 20% of acute cholecystitis cases. Severe symptoms observed in gangrenous cholecystitis include significant swelling and edema of the gallbladder and surrounding tissues, which makes it difficult to see the contours of anatomical structures such as the cystic duct and cystic artery under laparoscopy, and the contours and landmarks that are normally observed become unclear.

[0020] Blunt tissue separation with traditional laparoscopic forceps requires the insertion of the closed tips of the jaws of the forceps into unmarked tissue and then spreading the tissue apart by opening the tips of the forceps. The tissue disruption associated with this blunt separation procedure can lacerate or sever unseen vessels and ducts. In contrast, hydrodissection is a less traumatic approach to separate anatomical structures buried in edematous tissue. Surgical separation of inflamed tissues increases operative time and physical stress on the patient from surgery and general anesthesia, resulting in increased patient morbidity and mortality.

[0021] Herein, we propose an improved technique for tissue separation in which tissue separation is achieved solely by hydrodissection on both sides of a dual-action movable laparoscopic grasping jaw simultaneously. The jaws of the instrument described herein are not applied in the typical manner for mechanical tissue disruption or blunt separation. Rather, the jaws softly grasp and immobilize the exposed tissue, after which a pressurized fluid jet can be injected to the side of the grasping jaws to perform soft tissue hydrodissection to achieve separation of the desired anatomical structures.

[0022] The hydrodissection devices and methods described herein may also be used in additional endoscopic procedures to separate delicate anatomical structures hidden by overlying amorphous tissue, such as, for example, resection of intraperitoneal endometriotic lesions, lysis of tissue and organ adhesions, and image-assisted thoracic surgical procedures such as lung resections and lobectomies, in which separation of connective tissue surrounding delicate organs, vessels, and ducts is less traumatic with hydrodissection than standard mechanical blunt surgical separation.

[0023] According to one embodiment, an apparatus for hydrodissection of tissue within a patient is provided, the apparatus comprising: an elongate shaft including a proximal end, a distal end sized for introduction into a patient's body, and one or more shaft channels extending between the proximal and distal ends; first and second jaws at the distal end coupled to an actuator at the proximal end for moving the jaws between closed and open positions, each jaw having a jaw channel including an outlet disposed near a distal tip of the respective jaw; and a flexible tube extending between each jaw and the distal end of the shaft, the flexible tube fluidly coupling the outlets of each jaw to the one or more shaft channels and supplying pressurized fluid from a fluid source through the one or more shaft channels, the flexible tube, the jaw channels, and the outlets to separate adjacent tissue grasped between the jaws.

[0024] According to another embodiment, there is provided an apparatus for hydrodissection of tissue within a patient, the apparatus comprising: an elongate shaft including a proximal end, a distal end sized for introduction into a patient's body, and first and second shaft channels extending between the proximal and distal ends; first and second jaws at the distal end, each jaw having an outlet disposed near a distal tip of a respective jaw; an actuator at the proximal end coupled to the jaws for manipulating the jaws between a closed position and an open position; first and second flexible tubes extending between the jaws and the distal end of the shaft, the first and second flexible tubes communicating between the outlets of each jaw and the first and second shaft channels, respectively; and a pressurized fluid source coupled to the first and second shaft channels for providing pressurized fluid through the shaft channels, the flexible tubes, the jaw channels and out the outlets to separate adjacent tissue grasped between the jaws.

[0025] According to yet another embodiment, a method for separating tissue within a patient's body is provided, the method including the steps of providing a dissection device having a distal end having a pair of jaws, each jaw including a nozzle near a distal tip of the jaws, introducing the distal end into the patient's body with the jaws in a closed position, opening the jaws, manipulating the device and jaws to grasp tissue between the jaws, and delivering pressurized fluid through the nozzles to separate tissue adjacent the jaws.

[0026] According to another embodiment, a combined hydrodissection, irrigation, and suction laparoscopic forceps is provided that includes a shaft having an outer diameter of, for example, about three millimeters (3.0 mm) or less that resides within the lumen of an outer sheath (e.g., a thin-walled sheath having an outer diameter of about 5 millimeters) and translates axially. The outer sheath includes a relatively large main or central lumen and a relatively small (e.g., about 0.0325 inch (0.81 mm) inner diameter) fluid channel (e.g., a fluid channel built into the wall throughout the length of the sheath) that can generate a high velocity hydrodissection jet that emanates from the distal tip of the sheath. The central lumen of the sheath can be configured to provide either vacuum suction or low velocity fluid irrigation when connected to an appropriate source, as desired.

[0027] Optionally, a control valve integrated with an electrical switch is provided to initiate fluid delivery from an attached fluid pump to select between a high velocity jet from a small bore hydrodissection nozzle or a low velocity fluid perfusion through the lumen of the outer sheath. Optionally, the control valve includes multiple settings to allow different flow rates and / or volumes to be delivered, for example, using a potentiometer and / or other control mechanism. A separate control valve generates suction through the outer sheath. In one embodiment, an elastomeric seal is provided at the proximal end of the outer sheath to form a fluid tight seal around the shaft of the forceps while allowing the forceps to be moved axially to expose the jaws of the forceps from the distal end of the sheath and to retract the jaws completely within the sheath.

[0028] The sheath may be constructed of a substantially rigid material, for example, a thin-walled stainless steel tube having a wall thickness of about 0.007 inches (0.18 mm) with a stainless steel tube having an outer diameter of about 0.042 inches (1.05 mm) by an inner diameter of about 0.0325 inches (0.81 mm) welded or otherwise axially secured along its inner surface to provide a fluid channel for the hydrodissection nozzle. Alternatively, the sheath may be a dual lumen polymer extrusion with a small diameter lumen, for example, 0.0325 inches (0.81 mm), incorporated into the wall of the extrusion. Exemplary materials for extrusion may include one or more of nylon, polyimide, polyetheretherketone (PEEK), and the like. A fluid pump and a power source (e.g., a 9 volt battery or a cable connectable to an external power source) for powering the pump may be attached to the forceps body. Alternatively, the outer sheath, fluid pump, battery, and control valve may be incorporated into a frame that receives and rigidly mounts a conventional laparoscopic forceps.

[0029] Tests of the hydrodissection jet, powered by a 12 volt 400 mA diaphragm pump powered by a 9 volt battery, have measured a waterjet velocity of 28 m / s, which is sufficient to separate connected tissue without cutting or lacerating blood vessels or ducts.

[0030] In robotic surgery, the constraint of the surgeon not working next to the patient creates a major problem with instrument exchange. Since instruments are inserted from the lower extremities, organs may block the inner opening of the port. During exchange, there is a risk that the assistant surgeon will perforate the organ, since the instrument always returns to its initial position when removing the previous instrument. Any of the devices and systems herein, including cameras, microfluidics, and / or other sensors, may alert the introducer to organs blocking the port and possible injury.

[0031] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0032] The invention is best understood by reading the following detailed description in conjunction with the accompanying drawings, in which it is emphasized that, according to common practice, the various features and design elements in the drawings are not drawn to scale. Conversely, the dimensions of the various features and design elements have been arbitrarily expanded or reduced for clarity. The drawings include the following figures: [Figure 1] 1a and 1b show the appearance of an exemplary non-gangrenous and gangrenous gallbladder, respectively. [Diagram 2] 2a and 2b show an exemplary procedure used for blunt mechanical separation of tissue. [Diagram 3] 3a-3c show an exemplary sequence of steps that may be used to hydrodissect tissue, for example, using the hydrodissection device described herein. [Figure 4] FIG. 4 illustrates exemplary width differences of the jaw openings between a single action jaw instrument and a dual action jaw instrument. [Diagram 5] FIG. 5 illustrates exemplary components of a hydrodissection laparoscopic clamp device. [Figure 6] 6a-6c show details of the distal portion of the device of FIG. [Figure 7] 7a and 7b show exemplary profiles of the jaws of the device of FIG. 5 in closed and open configurations, respectively. [Figure 8] Figure 8a shows another example of an instrument that can provide hydrodissection, irrigation, and suction in an integrated fashion including a forceps that is movable relative to an outer sheath. Figure 8b is a cross-sectional view taken along section 8b-8b of the device of Figure 8a. Figure 8c is a cross-sectional view of an alternative configuration of the device of Figure 8a. [Figure 9] Figure 9a shows the device of Figure 8a with the forceps advanced relative to the sheath to allow mechanical separation, irrigation, and / or hydrodissection, and Figure 9b shows the device of Figure 8a with the forceps retracted into the sheath to allow hydrodissection, irrigation, and / or aspiration. [Figure 10] FIG. 10 is a schematic diagram showing exemplary fluidic (solid lines) and electrical (dashed lines) paths that may be included in the device of FIG. 8a. [Figure 11] Figure 11a shows another example of an instrument that includes a framework that includes an outer sheath for receiving a separate forceps instrument. Figure 11b shows the device of Figure 11a with the forceps advanced and the jaws extended from the distal end of the sheath. Figure 11c is a bottom view of the device of Figures 11a and 11b. [Figure 12] FIG. 12 is a table showing exemplary water jet flow rate test results. [Figure 13] Figure 13a shows another example of a device that provides integrated hydrodissection, irrigation and suction including a forceps that is connected to a robotic control system and movable relative to an outer sheath, and Figure 13b shows an exemplary forceps instrument that can be connected to a robotic arm of a robotic surgical system. [Figure 14] 14a-14f show the device of FIG. 13 with the forceps deployed from a sheath (FIGS. 14a-14c) or retracted within the sheath (FIGS. 14d-14f) and selectively used to deliver hydrodissection jets or irrigation. [Figure 15] Figures 15a to 15f are cross-sectional detailed views of the distal end of the device shown in Figures 14a to 14f, respectively. [Figure 16]FIG. 16a shows another embodiment of a multi-function suction-irrigation dissector device, comprising a handle, a shaft extending from the handle, and an end effector having, for example, a pair of jaws at the distal end of the shaft, which may be used in laparoscopic, robotic, and / or machine learning surgery. FIG. 16b is a detailed view of the handle of the device of FIG. 16a, showing the configurations on the handle. FIG. 16c is a detailed view of the shaft of the device of FIG. 16a, including a pair of tubes extending to an outlet adjacent the distal end, a pair of control buttons connected to the motor chamber to enable aspiration and / or irrigation via the outlets of the tubes, and a microfluidic channel extending along the shaft to the distal end. FIG. 16d is a detailed view of the device of FIG. 16a, showing the aspiration / irrigation control buttons coupled to the tubes and the motor chamber, which may include an electronic multi-directional and multi-speed fan or pump. FIG. 16e is a detailed view of the distal end of the device of FIG. 16a. [Figure 17] FIG. 17 is a detailed view of an example pair of jaws that may be provided on the apparatus of FIG. 16a, shown with the jaws in an open position (shown in solid lines) and in a closed position (shown in dashed lines). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Before describing the embodiments, it is to be understood that the invention is not limited to the particular embodiments described. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the invention will be limited only by the appended claims.

[0034] Where a range of values ​​is presented, unless the context clearly indicates otherwise, each intervening value between the upper and lower limits of that range (to the tenth of the unit of the lower limit) is also understood to be specifically disclosed. Each smaller range between a stated value or intervening value in a stated range and any other stated or intervening value within that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may each be independently included or excluded within the range, and each range including either, neither, or both of the limits is also encompassed within the invention, subject to any specifically excluded limits in the stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the invention.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some possible exemplary methods and materials are described herein.

[0036] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, a reference to a "compound" includes a plurality of such compounds, a reference to a "polymer" includes a reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0037] Certain ranges are provided herein with the word "about" preceding the numerical values. In this specification, the word "about" is used to literally support the exact number that it precedes, as well as a number that is close to or approximately the number that it precedes. In determining whether a number is close to or approximately a specifically stated number, a number that is close to or approximately a number not specifically stated may be substantially equivalent to the specifically stated number in the context in which the number is provided.

[0038] Referring to the drawings, Figure 1a shows an example of the surgical appearance of a gallbladder 10 attached to the underside of the liver 11 in a non-gangrenous state. In a non-gangrenous laparoscopic cholecystectomy, the outline of the cystic duct 12 can usually be observed. Figure 1b shows an example of a gangrenous gallbladder 13 with enlargement, swelling and edema. The outline of the gangrenous gallbladder 13 and the normal surrounding anatomical landmarks are obscured by inflammation and edematous tissue.

[0039] FIG. 2a is an example of blunt mechanical dissection of the gallbladder 10 using a conventional laparoscopic forceps 14. The tips of the jaws 15 of the laparoscopic forceps 14 are inserted into the tissue at the entry site 16 with the jaws 15 in a closed orientation. After tissue insertion, the jaws 15 are forced open as shown in FIG. 2b to dissect the tissue of the gallbladder 10, forming a cleavage surface or opening 17 in the bluntly separated tissue. Blunt mechanical dissection of tissue is generally safe when the gallbladder is non-gangrenous and anatomical structures such as blood vessels and ducts can be visually confirmed. However, when tissue edema or inflammation occurs due to gangrenous cholecystitis or other conditions that make it difficult to see the underlying blood vessels and ducts, blunt dissection operations using conventional laparoscopic forceps may result in laceration, perforation, or cutting of blood vessels and ducts. Application of a fluid jet to dissect gangrenous gallbladder tissue can be useful, especially in inflamed or edematous tissue that is more fragile than normal tissue, as a moderately pressurized fluid jet exerts less force during tissue separation than rigid forceps jaws.

[0040] 3a-3c show an exemplary procedure for atraumatic tissue separation using a hydrodissection laparoscopic forceps device 20. In FIG. 3a, the jaws 19 of the hydrodissection forceps 20 are gently closed so that the tip does not pierce the tissue of the gallbladder 10. After the jaws 19 are closed, the hydrodissection forceps device 20 remains in a fixed position, i.e., the device 20 is not moved to tear or displace the tissue. In FIG. 3b, after the jaws 19 are closed to fixate the tissue, a fluid jet 21 is jetted, for example, laterally of each jaw 19. The closed jaws 19 fixate the tissue and provide a counter traction force as the fluid jet 21 exerts a hydrodissection force on the tissue lateral to the site grasped by the jaws 19. The tissue separation is performed by hydrodissection alone, avoiding the conventional blunt dissection procedure involving tissue tearing or tissue puncture, allowing for atraumatically separating anatomical structures such as the duct 12 seen in FIG. 3c.

[0041] FIG. 4 illustrates the functional difference between a forceps 23 with a single action jaw 24 and a double action jaw 20 with two movable jaws 19. The jaws 19 of the double action forceps 20 open twice as wide as the forceps 23 with a single movable jaw 24, allowing the surgeon to grasp more tissue between the jaws 19, improving tissue control and preventing tissue from slipping out of the jaws 19's grasp. Proper tissue fixation is necessary to provide the necessary countertraction during the lateral hydrodissection procedure, especially in the moist tissue environment encountered in this procedure. Thus, the double action movable jaw 19 has an advantage over the single action jaw 24 during tissue separation.

[0042] Referring to FIG. 5, exemplary components that may be included in the hydrodissection laparoscopic grasping device 20 are shown. In general, the device 20 includes an elongated shaft 28 defining a longitudinal axis 22, e.g., a substantially rigid tubular or solid shaft including a proximal end 28a and a distal end 28b sized for introduction into a patient's body. The shaft 28 has a pair of shaft channels 27, e.g., including diametrically opposed rigid fluid supply tubes 27 attached to the sides of the shaft 28. Alternatively, the shaft channels 27 may be integrally formed in the wall of the shaft 28, e.g., by one or more of extrusion, molding, casting, machining, and the like. In a further alternative, the shaft 28 may include a single channel or infusion lumen extending from the proximal end 28a to the distal end 28b, with a fitting split or other branch (not shown) at the distal end to provide two openings that may be connected to respective flexible tubes and jaw channels 29.

[0043] The device 20 includes a pair of jaws 26 on the distal end 28b of the shaft 28 that can be manipulated between, for example, a closed position (e.g., shown in FIG. 7a) and an open position (e.g., shown in FIG. 7b) via manipulation of an actuator 43 on a handle 41 on the proximal end 28a of the shaft 28. In the illustrated example, the handle 41 includes a fixed ring extension 41 and a movable ring actuator 43 coupled to the jaws 26 for indicating between the closed and open positions. As best seen in FIG. 6a, the jaws 26 are coupled to the distal end 28b of the shaft 28, and manipulation of the actuator 43 moves both jaws 26 laterally away from the axis 22 when the jaws 26 are open, and generally aligns the jaws 26 along the axis 22 when the jaws 26 are closed, as shown, for example, in FIGS. 5 and 7a. Alternatively, the device may include only a single movable jaw and a fixed jaw attached to or extending from the distal end of the shaft (not shown), similar to, for example, the forceps 23 shown in FIG. 4. In this alternative, an actuator can move a single jaw between open and closed positions to grasp tissue between the jaws.

[0044] Optionally, the jaws 26 may have substantially blunt surfaces to prevent puncturing, cutting, and / or otherwise damaging tissue. For example, as shown, the inner contact surface 26a and / or distal tip 26b of the jaws 26 may have flat and / or rounded edges to allow tissue to be grasped between the jaws 26 with minimal risk of tearing or cutting. Alternatively, an end effector different from the blunt jaws 26 may be provided. For example, the jaws may have sharp inner edges and / or pointed tips to accommodate scissors or other cutting instruments (not shown). In another alternative, the end effector may be a stapler or clip applier, e.g., the end effector may include one or more staples or clips carried on one of the jaws and an anvil or other structure (not shown) on the opposing jaw to allow for the application of one or more staples or clips through tissue contacted between the jaws.

[0045] As best seen in FIG. 6a, a fluid supply tube 29 is attached to the jaw 26 and / or otherwise provided, which may extend, for example, along the sides of the jaw 26 on opposing outer longitudinal edges. For example, a separate substantially rigid tubular segment may be formed and permanently attached to the outer edge of the jaw 26 by one or more of adhesive bonding, welding, soldering, brazing, fusion, etc., or the jaw tube 29 may be integrally formed with the jaw 26. A flexible tube 30 extends from each shaft channel 27 to the respective jaw tube 29, for example, attaching the distal end of the shaft fluid supply tube 27 to the jaw fluid supply tube 29 in a fluid-tight manner. The flexible tube 30 is capable of supplying fluid when the jaw 26 is open, closed, or partially open.

[0046] In one embodiment, when jaws 26 are closed, the outer profile of the working portion of device 20, including jaws 26, fluid supply channels 29 and 27, and flexible tube 30, does not exceed approximately five millimeters (5 mm) or other maximum outer diameter or cross-section, e.g., to enable device 20 to be introduced into the body through a correspondingly sized access device, e.g., a five millimeter (5 mm) laparoscopic or thoracoscopic trocar, delivery sheath, etc. (not shown).

[0047] Optionally, the grasping instrument 20 may be connected to a radio frequency power source (not shown), for example via a connector 42 on the proximal end 28a of the handle 41, as shown in FIG. 5, to enable the jaws 26 to cauterize blood vessels, ducts, and / or other tissue, similar to a conventional laparoscopic grasping instrument. The connector 42 is coupled to the jaws 26 by one or more wires or other leads (not shown) extending between the proximal and distal ends 28a, 28b of the shaft 28, which leads may in turn be coupled to conductive electrodes or surfaces on the jaws 26. For example, the entire inner contact surface 26a of the jaws may be connected to a lead to provide electrical energy to tissue contacted between the jaws 26, if desired. Optionally, the jaws 26 may include one or more sensors, such as a Doppler sensor (not shown), in either jaw that can be used to identify blood flow in tissue captured between the jaws or in contact with the sensor. A processor (not shown) may be connected to the sensor and / or the ablation element to provide an output to a user when blood is flowing and / or when blood has stopped, for example, for use in conjunction with ablation of contacted tissue.

[0048] Pressurized fluid for hydrodissection is provided by a miniature fluid pump 36 included in the handle 41 or integrated into the top of a stationary portion of the handle 41. The fluid pump 36 may include a connector, e.g., a female Luer fitting 37, that accepts an IV fluid line connected to a saline bag or other fluid source (not shown) containing, e.g., 1-3 liters or other desired amount of sterile saline. In one embodiment, the fluid supply line 35 extends from the pump 36 to a normally closed fluid irrigation trumpet valve 32 provided in the handle 41.

[0049] Optionally, a connector 39, e.g., in communication with shaft channel 27, may be provided for connecting a vacuum or suction source (not shown) to device 20. For example, as shown in Fig. 5, stationary handle portion 41 may include a suction luer fitting 39 for connecting hydrodissection laparoscopic grasper 20 to wall suction in an operating or procedure room and allowing fluids to be evacuated via jaw channel 29. As shown, a suction connection tube 38 extends from luer fitting 39 to the inlet of suction trumpet valve 33, which is also in a normally closed position until depressed.

[0050] In one example, the outlets of both the irrigation trumpet valve 32 and the suction trumpet valve 33 are connected together to a common fitting 34 having a connection line 39 extending to a connector 31 attached to both fluid supply tubes 27. Thus, in this example, when the irrigation trumpet valve 32 is depressed, a fluid separation jet is ejected from both fluid supply tubes 27, and when the suction trumpet valve 33 is depressed, fluid is aspirated through the shaft and jaw channels 27, 29. If the jaw and / or shaft channels 29, 27 become clogged while operating in the suction mode, the irrigation mode can be activated to clear debris that has clogged the channels 29, 27.

[0051] 6a is an enlarged view of jaws 26 and distal end 28b of shaft 28 of device 20. Each jaw channel 29 is attached to or extends from a side of jaw 26, e.g., along an outer edge of each jaw 29. The proximal end of each jaw channel 29 is offset distally from the hinge connecting jaws 29, e.g., about three millimeters (3 mm) from the proximal end of each jaw 26 to allow for attachment of flexible tube 30 and / or to provide circumferential clearance to allow rotational movement of jaw 26. Similarly, each shaft channel 27 is attached to or otherwise extends axially along either side of shaft 28, except for a desired offset, e.g., about three millimeters (3 mm) in the length of the distal portion, which allows for attachment of the proximal end of flexible tube 30.

[0052] An actuator may be coupled to the jaws 26 to operate the jaws between open and closed positions. For example, as shown, the jaws 26 are opened and closed by advancing and retracting an elongated member, such as a stainless steel rod 44, that extends through the length of the shaft 28 and is connected to a jaw actuation linkage 45. FIG. 6b is a cross-sectional view of the shaft 28, showing a central channel 46 that slidably receives the actuation rod 44 within its lumen. In the illustrated example, two transverse grooves 47 extend the length of the shaft 28 and allow attachment of the fluid tube 27. The fluid tube 27 may be elliptical rather than circular in cross-section, if desired, to increase its luminal area and maximize fluid delivery. Optionally, the shaft 28 and attached fluid tube 27 may be covered with a relatively thin outer sheath 48, for example of a polymeric heat shrink or other material, to provide a substantially smooth outer surface for insertion and sealing into a laparoscopic trocar port and / or to electrically insulate the exterior of the shaft 28 when high frequency current is applied to cauterize tissue grasped by the jaws 26.

[0053] FIG. 6c is an end view of an exemplary instrument jaw 26 showing the attachment of a fluid tube 29 to a side thereof. If desired, the jaw 26 may be thinned or grooved along its length to allow for the attachment of the fluid tube 29 while maintaining a desired outer profile when the jaws 26 are closed, e.g., not more than about five millimeters (5 mm). The fluid tube 29 may be attached to the side of the jaw 26 using one or more of adhesives, soldering, brazing, welding, and the like. The attachment material may form a contour fillet 49 along the length of the attached tube 29 to smooth the contour of the side of the jaw 26 to prevent contact trauma to tissue during surgery.

[0054] FIG. 7a shows the hydrodissection laparoscopic forceps 20 with the jaws 26 in a closed position. In the illustrated example, when the jaws 26 are closed, the flexible fluid supply connection tube 30 remains substantially flush against the forceps 20 and can be inserted unimpeded through a desired access device, such as a 5 mm endoscopic trocar (not shown). FIG. 7b shows the forceps 20 with the jaws 26 in an open position. The flexible connection tube 30 spreads laterally when the jaws 26 are opened. Insertion and removal of the forceps 20 should only be performed with the jaws 26 of the instrument in a closed position.

[0055] 8a, another example of an apparatus 120 is shown, which includes an outer sheath 115 and a forceps instrument 114 that can be used, for example, to selectively perform hydrodissection, irrigation, and / or aspiration as needed during a surgical procedure. In the example shown, the forceps 114 and the outer sheath 115 can be manufactured and provided separately, but the forceps 114 can be inserted into the sheath 115 before or during the procedure to allow for different modes of operation. For example, the sheath 115 can be made to allow for the insertion of a conventional forceps instrument (or another instrument, such as a bowel grasper, scissors, clip applier, vessel sealer, etc., not shown) to provide hydrodissection and / or irrigation / aspiration during use of the conventional instrument. Alternatively, the forceps 114 can be manufactured integrally with the sheath 115 and axially movable to advance or retract the forceps 114 as needed during the procedure.

[0056] For example, as shown, a conventional three millimeter (3 mm) or smaller laparoscopic forceps 114 may be provided and inserted through a primary or central lumen 115a of an outer sheath 115 (e.g., as shown in FIG. 8b) such that jaws 119 of the forceps 114 extend distally of a distal tip 115b of the sheath 115, as shown in, for example, FIGS. 8a and 9a. A fluid-tight valve or other seal 116 may be provided at the proximal end 115c of the sheath 115, for example, such that the valve 116 slidably seals against the shaft of the forceps 114 and allows the forceps 114 and sheath 115 to move axially and / or rotationally relative to one another. For example, the valve 116 may provide a fluid-tight seal to prevent leakage of fluid introduced into the lumen 115a while allowing the sheath 115 to be advanced and rotated to retract the jaws 119 of the forceps 114 into the lumen 115a of the sheath 115, as shown in FIG. 9b.

[0057] The sheath 115 may include one or more ports in communication with the central lumen 115a, for example, to allow for the application of fluids and / or suction. For example, as shown, the valve 116 may be provided with a side port 117 that may be connected to a source of fluid or vacuum to allow fluids to be infused or removed from the surgical field through the sheath 115 (i.e., through a distal opening of the primary lumen 115a in the tip 115b).

[0058] Additionally, the sheath 115 may include one or more additional or secondary lumens or channels extending between the proximal end 115c and the distal end 115b. For example, as shown, a relatively small (e.g., about 0.0325 inch (0.81 mm) inner diameter) hydrodissection fluid channel 18 may be attached to the sheath 115 to extend along the inner surface of the sheath 115 adjacent the central lumen 115a, for example as shown in FIG. 8b. This secondary fluid channel 118 extends the length of the sheath 115 and provides an outlet at the distal tip 115b that may be used to generate a high velocity jet for tissue separation, as further described elsewhere herein. Thus, a relatively slow fluid irrigation may be provided through the central lumen 115a of the sheath 115 and / or a high velocity jet may be provided through the secondary channel 118, as selected at any time by the surgeon or other application.

[0059] In the illustrated example, the fluid flow may be driven by a battery-powered diaphragm pump or other fluid source 121 attached or otherwise provided to the instrument 120, for example, rigidly attached to the upper side of the handle of the forceps 114. Alternatively, an external pump or other fluid source (not shown) may be provided that is connected to the device 120. The pump 121 may be provided with a luer fitting or other connector 121a that may be connected to a source of fluid, for example, a line from an IV saline bag (not shown). Pressurized fluid leaves the pump 121 via a pump supply line 126 that connects to a fluid control valve 125. In one embodiment, the fluid control valve 125 may be a trumpet valve that includes an electrical switch 124 that connects from a 9 volt battery or other power source 122 to the pump 20, as best seen in FIG. 10, for example. When the fluid control valve 125 is depressed, the valve 125 opens to allow fluid to flow and simultaneously powers the pump 120.

[0060] In the exemplary schematic diagram shown in FIG. 10, the output from the fluid control valve 125 connects to a three-way stopcock 128 or other control that allows the user to select either a hydrodissection flow path 129 to the channel 118 or a slow irrigation flow through the central lumen 115a of the sheath 115. Alternatively, a processor or controller (not shown) may be included that automatically opens or closes the appropriate flow path based on which actuator the operator presses to provide alternating hydrodissection or irrigation flow. As shown, a slow irrigation line 130 exits the stopcock 128 and connects to an output suction line 117 exiting the suction control valve 132. An input line 134 to the suction control valve 132 leads to a vacuum fitting 133, for example, on the underside of the handle of the forceps 114. This fitting 133 may be connected to a vacuum source, such as a line from a vacuum source in an operating room, to provide suction capability through the central lumen 115a of the sheath 115, for example, when the suction control valve 132 is depressed. Alternatively, a slow rate of fluid irrigation may be delivered through the central lumen 115 of the sheath 115 to unclog the device 120 if, for example, tissue debris or blood clots reduce suction capabilities.

[0061] FIGURE 8b is an exemplary cross-sectional view of a sheath 115, showing a small diameter tubular body attached above the central lumen 115a of the sheath 115 to provide a secondary channel 118. As shown, the shaft of the forceps 114 occupies a portion of the central lumen 115a, but provides areas for irrigation and / or aspiration around the shaft. FIGURE 8c is a cross-sectional view of an alternative construction of the sheath 115, in which the sheath 115 is a polymer extrusion or other unitary tubular body that includes a secondary lumen 118 integrally formed within the wall of the sheath 115 adjacent the primary lumen 115a.

[0062] FIG. 10 is an exemplary schematic diagram showing the fluid and electrical systems of the device 120. In the illustrated example, a fluidic diaphragm pump 121 receives fluid input via a luer fitting 121a and exits via an output line 126. A battery 122 powers the pump 121 via a conductive electrode 123, and a power switch 124 is integrated into a fluid control trumpet valve 125. The fluid control trumpet valve 125 is normally in the off position, and the power switch 124 is normally in the open position. When the fluid control trumpet valve 125 is pressed, the valve 125 opens to allow fluid flow while the power switch 124 closes to provide electrical current to the pump 20. A fluid output line 127 from the fluid control valve 125 forms the input to a three-way stopcock 128, allowing the surgeon to select one of two outputs: a hydrodissection output line 129 that connects to the small diameter fluid supply channel 118, or a slow irrigation output line 130. Irrigation output line 130 is connected to aspiration supply line 131 which leads from the output of aspiration control valve 132 to a side port 117 which communicates with the central lumen 115a of sheath 115. Aspiration is provided by connecting a source of vacuum in the operating room to aspiration connector 133, with aspiration line 134 forming the input to aspiration control valve 132. When slow irrigation is selected by depressing fluid control valve 125 with three-way stopcock 128 set on irrigation output line 130, aspiration control valve 132 closes and fluid flows through aspiration supply line 131 to the central lumen 115a of sheath 115.

[0063] FIG. 9a shows the instrument 120 in a configuration with the sheath 115 retracted (or the forceps 114 advanced) to expose the jaws 119 of the forceps. In this configuration, the jaws 119 can be used to perform one or both of the following: (1) surgical tissue manipulation and blunt mechanical separation; and (2) hydrodissection with tissue countertraction, i.e., grasping tissue between the jaws 119 and then activating the jet. As described elsewhere herein, hydrodissection with tissue countertraction can be performed by holding the tissue with the forceps jaws 119 while a high velocity fluid jet 135 is ejected from the distal tip 115b of the sheath 115 to gently separate the tissue, avoiding the destruction of tissue, vessels, and ducts associated with blunt mechanical separation. FIG. 9b shows the instrument 120 after the forceps 114 have been retracted so that the jaws 119 are fully retracted within the sheath 115. This configuration can be used to perform one or more of the following procedures: (1) pure hydrodissection without tissue countertraction; (2) suction through the central lumen 115a of the sheath 115, e.g., to remove fluids and debris from the surgical field; and (3) low-rate fluid irrigation, e.g., to remove blood from the surgical field and / or remove blood clots or tissue debris clogging the central lumen of the sheath 115.

[0064] 11a and 11b, there is shown another embodiment of a device 220 capable of selectively performing hydrodissection, irrigation and / or aspiration using a laparoscopic forceps formed of two separate devices: a frame 236 including an outer sheath 215, a fluid pump 220, a battery or power source 222, and control valves 225, 232 attached to the frame 236, and a laparoscopic forceps 214 (or other instrument) generally similar to the embodiments described above. The laparoscopic forceps 214 is inserted into the sheath 215 and may be rigidly secured to the frame 236 (e.g., in a channel 237 in the frame 236) using one or more connectors (e.g., a set screw 239 that secures the frame 236 to a handle of the forceps 214). Additionally or alternatively, a fixed handle portion of the forceps 214 may be secured to the frame (eg, fitted into a groove 240 in the frame 236 having one or more detents 241 in its walls) to further secure the laparoscopic forceps 214.

[0065] The sheath 215 may be axially movable relative to the frame 236, for example by means of a pin or other actuator 243 attached to the valve body 216 of the sheath 215, which translates within a slot 242 in the frame 236, as shown in FIG. 11c. Alternatively, the forceps 214 may be axially movable relative to the sheath 215 between a distal position and a proximal position. FIG. 11b shows the assembled configuration of the forceps 214 on the hydrodissection frame 236, with the forceps jaws 219 in a distal position, i.e., extending distally beyond the tip of the sheath 215. FIG. 11c shows the underside of the frame 236, with the side of the channel 237 including a threaded hole 238 that receives a set screw for attachment to the handle of the forceps 214. Also visible is the slot 242 that forms part of the translation mechanism of the sheath 215.

[0066] Thus, during use, tissue may be grasped by the jaws 219 and a hydrodissection fluid jet may be generated to separate the tissue. If desired, the jaws 219 may be retracted into the sheath 215 to provide a hydrodissection fluid jet and / or generate irrigation / suction without traction. Optionally, the forceps 214 may be rotatable relative to the sheath 215, e.g., to adjust the orientation of the jaws 218 when extended to facilitate grasping tissue. Optionally, the forceps 214 may be fully removable from the sheath 215 while the distal end 215b of the sheath 215 is positioned within the surgical space, e.g., to allow one or more different instruments to be introduced through the sheath 215 to perform additional steps of a surgical procedure.

[0067] 13-15, another example of a surgical device 320 is shown that includes an outer sheath 315 and a forceps or other instrument 314 having an end effector (e.g., jaws 319) deployable from the sheath 315. Unlike the devices described above, the sheath 315 and forceps 314 are attached to a robotic control arm or system 330, which is connected to an operating console or system 340 that can be remotely operated by a surgeon. For example, as best seen in FIG. 13b, the sheath 315 includes a proximal mount or housing 316 at its proximal end, which may include one or more connectors (not shown) for attachment to the end of a robotic arm system 330. For example, the housing 316 and robotic arm may include one or more mating screws, detents, latches, etc. (not shown) that secure the sheath 315 relative to the robotic arm system 330, and once attached, the sheath 315 can be manipulated by actuating the robotic arm system 330. As shown, the housing 316 may include one or more ports, knobs, nipples, or other connectors 321-323 for connecting elements of the device 320 to corresponding elements 331 on the robotic arm system 330, as further described elsewhere herein.

[0068] As best seen in Figures 15a-15f, sheath 315 includes a primary lumen 315a sized to slidably receive the shaft of forceps 314 and a secondary lumen or jet channel 318 adjacent primary lumen 315a, generally similar to the previous devices. Forceps 314 are axially and / or rotationally movable relative to sheath 314 such that jaws 319 of forceps 314 can be advanced out of distal end 315b of sheath 315, as shown, for example, in Figures 14a-14c and 15a-15c, and jaws 319 can be retracted within sheath 315, as shown, for example, in Figures 14d-14f and 15d-15f. Additionally, similar to the previous devices, fluid can be supplied either through the primary lumen 315a (e.g., a low pressure fluid flow I / S for perfusion, as shown in Figures 14c, 14f, 15c, 15f) or through the jet channel 318 (e.g., a high pressure fluid jet K for hydrodissection, as shown in Figures 14b, 14e, 15b, 15e).

[0069] 13b, the housing 316 includes a pair of ports 321a, 321b in communication with the primary and secondary lumens 315a, 318, respectively, which may each be coupled to a respective port on the robotic arm system 330 when the housing 316 is connected to the robotic arm 330. These ports may include, for example, one or more seals and / or connectors (not shown) and may be in communication, for example, with a fluid and / or vacuum source connected to a proximal end of the robotic arm 330. Additionally, as shown, the housing 316 includes a first shaft connector 322 that couples to a shaft of the forceps 314, which in turn couples to a corresponding shaft of the robotic arm system 330. Thus, when connected, the robotic arm shaft may be advanced axially and / or rotated about a longitudinal axis, thereby causing corresponding axial and / or rotational movement of the jaws 319 of the forceps 314.

[0070] Optionally, if one or more electrodes or other cauterizing elements are provided on jaws 319 (or elsewhere at the distal end of the forceps), housing 316 may include a connector 323 (e.g., an electrical connector) that may be connected to a corresponding connector on robotic arm system 330 to enable actuation of the cauterizing elements during use of device 320. For example, robotic arm 330 may be coupled to a generator and / or controller (not shown) for providing electrical or other energy to the cauterizing elements. Further optionally, if sheath 315 and / or forceps 314 include other operable features, additional connectors may be provided on housing 316 and robotic arm system 330. For example, if forceps 314 includes microfluidic channels and / or sensors, connectors may be provided to enable actuation of the sensors during use.

[0071] In another option, as shown in FIG. 15a, the sheath 315 may include a camera and / or other imaging element 324 on the distal end 315b, for example, to image the jaw 319 and / or to view beyond the distal end 315b of the sheath 315. For example, a CCD, CMOS, or other camera 324 may be provided at the distal end 315b with a field of view FOV sufficient to view the jaw 319 and / or tissue structures within the surgical space into which the device 320 is introduced. Additionally, the imaging element 324 may include, for example, one or more LEDs or other light sources (not shown) necessary to illuminate the field of view FOV. One or more leads 325 may be provided, for example, embedded within the wall of the sheath 315 or within a separate lumen (not shown) that extends to the proximal end of the sheath 315. In this option, one or more additional connectors (not shown) may be provided on the housing 316 to provide power to and / or receive signals from the imaging elements, e.g., to provide signals to a processor in the control console 340 for generating an image on a display (not shown) included in the control console 340.

[0072] Unlike the previous devices, the surgeon can operate device 320 to remotely manipulate sheath 315 as desired, for example, through a trocar or other access port (not shown) to introduce sheath 315 into a surgical space where it can be deployed and manipulated, and / or fluids can be delivered to the surgical space for hydrodissection, irrigation, and / or aspiration as needed during surgery. Similar to conventional robotic surgical systems, robotic arm system 330 can be connected to one or more fluid and / or vacuum sources (e.g., one or more pumps, one or more power sources, one or more processors and / or controllers, etc. (not shown)) that can be activated using a control console 340.

[0073] Optionally, any of the devices and instruments described herein may include one or more additional features. For example, the instrument may be provided with one or more microfluidic channels containing one or more sensors extending to the distal end and / or jaws of the forceps connected to a processor (not shown) of the instrument, as appropriate. Signals from the sensors may be analyzed by the processor to, for example, identify tissue and / or analyze bodily fluids to identify the presence of one or more diseases or other conditions.

[0074] Additionally or alternatively, the device or instrument may include a Doppler or other sensor mounted, for example, on one or both jaws of the forceps or other end effector and coupled to the processor to identify blood flow in tissue captured between the jaws. Optionally, the device or instrument may include one or more electrodes or other cauterizing elements, vessel sealing elements, etc., on one or both jaws or elsewhere on the end effector, which may be coupled to an energy source (not shown) that may be selectively activated, for example, to cauterize tissue captured or cut by the forceps or other instrument. One or more actuators (also not shown) may be provided on the handles of the forceps or elsewhere in the device or system, which may be used to actuate such sensors and / or cauterizing elements.

[0075] Optionally, any of the devices and systems herein may include one or more imaging elements (e.g., CCD, CMOS, or other cameras) and / or one or more LEDs or light sources (not shown), for example at the distal end of the sheath or instrument, which may be used to image the end effector of the device deployed from the sheath and / or to image the surgical field during a procedure. One or more processors may be connected to the imaging elements to operate the imaging elements, acquire images or other signals, and / or provide output signals to a display that may be viewed by the surgeon during use. For example, the display may be attached or otherwise carried at the proximal end of the device (e.g., on the handle 41 of the device 20, 120 shown in FIG. 5 or 8a, on the proximal end of the sheath 115 shown in FIG. 8a, on the frame 236 shown in FIG. 11a), or may be included separately from the device or system, for example, in the control console 340 shown in FIG. 13a.

[0076] For example, referring to Figures 16a-16e, another embodiment of a multi-function suction-irrigation surgical device 420 is shown, comprising a handle 422, a shaft 424 extending from the handle, and an end effector 426, including, for example, a pair of jaws, at a distal end 424b of the shaft 424, which can be opened and closed using an actuator 428 on the handle 424, or can be used for robotic and / or machine learning surgery, for example, similar to device 320. Optionally, as shown in Figures 16b-16e, device 420 can include microfluidic components, a Doppler sensor, and / or a microprocessor and display 430 on top of the handle 422. For example, as best shown in Figure 16c, a pair of tubes 432 can extend along the shaft 424 to an outlet adjacent the distal end 424b, and a pair of control buttons 434 can be connected to a motor chamber 436 to provide suction and / or irrigation via the outlets of the tubes 432. Additionally or alternatively, a microfluidic channel 440 may extend along the shaft to the distal end and be coupled to one or more sensors and / or processors (not shown) for analyzing tissue samples.

[0077] As best seen in FIG. 16d, an aspiration / irrigation control button 434 is coupled to the tubing 432 and to a motor chamber 436, which may include an electronic multi-directional and multi-speed motor 436a. The aspiration and irrigation chambers may be selectively activated by depressing or otherwise activating the button 434. When the button 434 is actuated, an electrical circuit for operating the motors may be activated substantially simultaneously. As shown, a tubing 438 may extend from the aspiration and irrigation control 434 to the motor chamber 436. In the illustrated embodiment, the chamber 436 includes a fan or pump wheel 436b that operates, for example, in a clockwise or counterclockwise direction to generate aspiration or irrigation, respectively, thereby aspirating or pushing fluid or other material adjacent the distal end 424b of the shaft 424.

[0078] As shown in Fig. 16e, the shaft 424 of the instrument 420 may include tubing (e.g., tubing connecting an outlet at the distal end to a fan chamber, microfluidic tubing) and / or one or more sensors (e.g., a Doppler sensor on the exterior surface of the jaw to detect blood flow and / or perform other diagnostics). Optionally, as shown in Fig. 17, the distal tip 442 of the jaw or other end effector may have hollow cavities for various channels 440 and / or multiple outlets within the jaw to the outside, for example, to provide one or more of suction, irrigation, sensors, heating, microfluidics, and digital technology.

[0079] While the invention is susceptible to various modifications and alternative forms, certain embodiments thereof have been shown in the drawings and are herein described in detail, it being understood, however, that the invention is not limited to the particular forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. 1. An apparatus for performing a surgical procedure inside a patient, comprising: an elongate sheath having a proximal end, a distal end, a primary lumen extending between the proximal and distal ends, and a secondary lumen extending between the proximal and distal ends adjacent the primary lumen; an instrument having a shaft, an end effector at a distal end of the shaft, and a handle at a proximal end of the shaft, the instrument shaft being slidably received within the primary lumen such that the end effector can be deployed beyond the distal end of the sheath and retracted into the primary lumen; a fluid source coupled to the secondary lumen for delivering pressurized fluid through the secondary lumen and out an outlet at the distal end of the sheath to separate tissue.

2. The device of claim 1 , wherein the instrument is completely removable from the primary lumen of the sheath to allow a second instrument to be introduced into the primary lumen.

3. 10. The device of claim 1, wherein the instrument is axially movable relative to the sheath between a proximal position in which the end effector is fully retracted within the primary lumen and a distal position in which the end effector extends beyond the sheath distal end.

4. The device of claim 1 , wherein the secondary lumen has a smaller cross-section than the primary lumen.

5. The apparatus of any one of claims 1 to 4, further comprising an actuator in the handle of the instrument for actuating the end effector.

6. The device of claim 5 , wherein the end effector comprises a pair of jaws coupled to the actuator, the jaws being movable between an open position and a closed position.

7. The device of claim 6 , wherein the jaws include substantially blunt contact surfaces configured to grasp tissue between the jaws in the closed position.

8. 8. The device of claim 7, further comprising an actuator on the handle configured to activate the fluid source after the jaws have grasped tissue to supply pressurized fluid through the outlet to perform hydrodissection.

9. The device of any one of claims 1 to 4, wherein the source of fluid comprises a pump carried on one of the proximal end of the shaft or the handle.

10. The apparatus of claim 9 , wherein the fluid source further comprises a fluid reservoir coupled to the pump.

11. 5. The device of claim 1, wherein the fluid source is coupled to the primary lumen, and the device further comprises an actuator that selectively opens and closes a first pathway between the source and the primary lumen and a second pathway between the source and the secondary lumen to supply fluid through one of the primary and secondary lumens.

12. 12. The device of claim 11, wherein the actuator includes a first valve manually actuable between first and second positions to selectively connect the fluid source to one of the first and second pathways, and a second valve actuable to open a selected flow path to supply fluid through a selected lumen, optionally the second valve including multiple settings, for example using a potentiometer or other mechanism.

13. 12. The device of claim 11, wherein the actuator comprises an electrically operated valve that automatically opens and closes the first and second fluid paths when the actuator is oriented between the first and second positions, and a manually operated valve that is operable to open the selected fluid path to deliver fluid through the selected lumen.

14. 12. The apparatus of claim 11, wherein the source of fluid includes a pump, and the actuator further comprises a switch that activates the pump when the actuator is activated to dispense fluid.

15. a connector at the proximal end of the shaft configured to be coupled to a suction source; a valve in a third flow path between the connector and the primary lumen; and an actuator for selectively operating the valve to selectively open and close the third flow path to provide suction through the first lumen.

16. 5. The apparatus of claim 1, wherein the sheath comprises a housing at a proximal end thereof configured to connect the sheath to an arm of a robotic surgical system, the housing comprising one or more connectors for coupling the instrument and components of the sheath to components of a robotic control system.

17. 17. The device of claim 16, wherein the housing and the arm include one or more mechanical connectors for releasably securing the housing and the arm together.

18. 17. The device of claim 16, wherein the one or more connectors of the housing include a connector for coupling a proximal end of the instrument shaft to an actuator shaft of the arm to enable manipulation of the instrument relative to the sheath by the robotic control system.

19. 17. The device of claim 16, wherein the fluid source is coupled to the robotic control system, and wherein one or more connectors on the housing include ports for connecting the primary and secondary lumens to lumens of the arms to enable delivery of fluid from the fluid source to the primary and secondary lumens.

20. further comprising a cauterizing element on the end effector, and the one or more connectors of the housing include a connector for coupling the cauterizing element to an energy source for supplying energy to the cauterizing element to cauterize tissue contacted by the cauterizing element; or further comprising a Doppler sensor on the end effector, wherein one or more connectors on the housing include a connector for coupling the sensor to a processor of the robotic control system for identifying blood flow in tissue contacting the sensor; or 17. The device of claim 16, further comprising an imaging element at a distal end of the sheath, wherein the one or more connectors of the housing include a connector for coupling the imaging element to a processor of the robotic control system to acquire images beyond the distal end of the sheath.

21. further comprising a cauterizing or vessel sealing element on the end effector; a connector on the handle connectable to a power source; one or more leads extending along the shaft and connecting the connector to a cauterizing or vessel-sealing element; and an actuator for activating a power source to supply energy to the ablation element to ablate tissue contacted by the ablation element.

22. The device of claim 21 , wherein the cauterizing element comprises one or more electrodes on the end effector.

23. 22. The device of claim 21, wherein the end effector comprises a pair of jaws, and the cauterizing element includes one of a conductive surface and an electrode disposed on one of the jaws.

24. 22. The device of claim 21, wherein the power source includes a generator configured to be coupled to the connector to supply electrical energy to the ablation element via the one or more leads to ablate tissue contacted by the ablation element.

25. The device of any one of claims 1 to 4, further comprising a Doppler sensor in the end effector and a processor that analyzes signals from the sensor to detect blood flow in tissue contacting the sensor.

26. 26. The apparatus of claim 25, wherein the end effector comprises a pair of jaws, and the sensor is located on a contact surface of one of the jaws.

27. an imaging element provided at the distal end of the sheath and configured to acquire an image of a surgical field beyond the distal end of the sheath; a display mounted on one of the proximal end of the sheath and the handle; An apparatus according to any preceding claim, comprising a processor coupled to the imager and to a display for processing signals from the imager and displaying an image on the display.

28. An apparatus for hydrodissecting tissue within a patient, comprising: an elongate shaft including a proximal end, a distal end sized for introduction into a patient's body, and one or more shaft channels extending between the proximal and distal ends; first and second jaws at the distal end coupled to an actuator at the proximal end for moving the jaws between closed and open positions, each jaw having a jaw channel including an outlet located near a distal tip of the respective jaw; a flexible tube extending between each jaw and the distal end of the shaft, the flexible tube fluidly coupling the outlet of each jaw to the one or more shaft channels and supplying pressurized fluid from a fluid source through the one or more shaft channels, the flexible tube, the jaw channels, and the outlet to separate adjacent tissue grasped between the jaws.

29. 1. An apparatus for performing a surgical procedure inside a patient, comprising: an instrument shaft including a proximal end and a distal end; an end effector at a distal end of the shaft; a handle at the proximal end of the shaft including a first actuator for manipulating the end effector; a hydrodissection lumen extending between the proximal and distal ends, the lumen connectable to a fluid source for delivering pressurized fluid through the lumen and out an outlet beyond the sheath distal end to separate tissue; a second actuator on the handle configured to open a flow path for pressurized fluid through the lumen and out an outlet.

30. 30. The apparatus of claim 29, further comprising an elongate sheath including a proximal end, a distal end, and a primary lumen extending between the proximal and distal ends, the instrument shaft being slidably received within the primary lumen such that the end effector can be deployed beyond the sheath distal end and retracted within the primary lumen.

31. 31. The device of claim 30, wherein the hydrodissection lumen extends along the wall of the sheath between the sheath proximal end and the sheath distal end.

32. 32. The device of any one of claims 29 to 31, further comprising a vacuum source connectable to the handle for generating suction through a channel in the shaft.

33. further comprising: a cauterizing element of the end effector; a Doppler sensor of the end effector; an imaging element for acquiring an image beyond the distal tip; a microfluidic sensor; a vacuum source connectable to the handle to generate suction through a channel in the shaft.

34. The device of claim 29, wherein the second actuator comprises a pair of control buttons connected to a motor chamber to enable suction and / or irrigation through the outlet.

35. The device described in claim 34, wherein the handle includes one or more chambers for suction and irrigation that can be selectively activated by depressing or otherwise activating the control button.

36. The device described in claim 35, wherein the handle has a tube extending from the control button to a motor chamber 436, the motor chamber including a fan or pump wheel for generating suction or irrigation, respectively, thereby drawing or pushing fluid or other material through the outlet.

37. An apparatus for performing a surgical procedure inside a patient, comprising: an elongate sheath having a proximal end, a distal end, a primary lumen extending between the proximal and distal ends, and a secondary lumen extending between the proximal and distal ends adjacent the primary lumen; an instrument having a shaft, an end effector at a distal end of the shaft, and a handle at a proximal end of the shaft, the instrument shaft being slidably received within the primary lumen such that the end effector can be deployed beyond the distal end of the sheath and retracted into the primary lumen; a fluid source coupled to the secondary lumen for delivering pressurized fluid through the secondary lumen and out an outlet at the distal end of the sheath to separate tissue and effect one or more lateral separations relative to the end effector.

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