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WO2025080737A1 - Dispositifs d'électrocautérisation à hydrodissection, irrigation et aspiration et procédés d'utilisation - Google Patents

Dispositifs d'électrocautérisation à hydrodissection, irrigation et aspiration et procédés d'utilisation Download PDF

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Publication number
WO2025080737A1
WO2025080737A1 PCT/US2024/050604 US2024050604W WO2025080737A1 WO 2025080737 A1 WO2025080737 A1 WO 2025080737A1 US 2024050604 W US2024050604 W US 2024050604W WO 2025080737 A1 WO2025080737 A1 WO 2025080737A1
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WIPO (PCT)
Prior art keywords
fluid
lumen
jaws
distal
sheath
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Inventor
Dinesh VYAS
Albert K. Chin
Jeffrey J. Christian
Devon Turgeon
Kayla Bucci
Ben Butler
Seth Heneveld
Thong Le
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Individual
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Individual
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Priority claimed from US18/378,354 external-priority patent/US20240180582A1/en
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Publication of WO2025080737A1 publication Critical patent/WO2025080737A1/fr
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B17/295Forceps for use in minimally invasive surgery combined with cutting implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/3203Fluid jet cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1482Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • A61B34/37Leader-follower robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00477Coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • A61B2017/00876Material properties magnetic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1475Electrodes retractable in or deployable from a housing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/007Auxiliary appliance with irrigation system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002Irrigation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007Aspiration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation

Definitions

  • BACKGROUND [0003] In laparoscopic, thoracic, gynecological, urological, and minimally invasive surgery, such as robotic surgical procedures, isolation of anatomic structures, such as blood vessels and ducts, are performed via blunt dissection maneuvers involving spreading and tearing of soft tissue adjacent to the vessels and ducts. If the organ involved in the surgery is ischemic or necrotic, the organ and surrounding soft tissue becomes swollen and edematous, making it impossible to discern the outlines and locations of underlying ducts and vessels.
  • Surgical maneuvers with existing laparoscopic graspers and dissectors carry significant potential of disrupting unrecognized organs, ducts, and vessels, which may lead to spillage of toxic infective contents into the abdominal cavity and hemorrhage.
  • Blunt dissection of soft tissue during laparoscopic surgery may be hazardous when the tissue is swollen and edematous, and the outline of blood vessels and ducts coursing through the soft tissue is not visible via endoscopic observation.
  • the gallbladder In gangrenous cholecystitis, the gallbladder is distended to such a degree that it becomes ischemic, with compromise to its blood supply.
  • the jaws of the forceps are electrically conductive, and electrocautery energy may be supplied to them by connecting the instrument to an electrosurgical generator.
  • the jaws may cauterize and/or cut tissue when they are fully exposed out of the retracted coaxial sheath.
  • the conductive path that supplies electrocautery energy is disengaged to prevent inadvertent activation of the forceps jaw tips in the irrigation and suction modes, which may otherwise potentially cause electrical arcing to tissue in the vicinity of the outer sheath tip that may injure both the tissue and the sheath tip.
  • the coaxial sheath extends nearly the entire length of the shaft of the forceps, and may translate axially along the forceps shaft, e.g., between a proximal position where jaws on the distal end of the shaft are fully exposed and distal position where the coaxial sheath covers or encloses the jaws.
  • axial translation of the coaxial sheath is performed via an actuator located on a handle on a proximal end of the instrument.
  • a bushing may be attached to the distal tip of the coaxial sheath, e.g., having a length of about twelve millimeters (12 mm) and including a lumen having an inner diameter of about four millimeters (4 mm).
  • the bushing may include an end cap, e.g., having a thickness of about one millimeter (1 mm) that includes a central lumen with an inner diameter that provides a sliding fit with the outer diameter of the shaft of the forceps and a tiny offset lumen, e.g., having an inner diameter of about 0.3 millimeters (0.3 mm).
  • an end cap e.g., having a thickness of about one millimeter (1 mm) that includes a central lumen with an inner diameter that provides a sliding fit with the outer diameter of the shaft of the forceps and a tiny offset lumen, e.g., having an inner diameter of about 0.3 millimeters (0.3 mm).
  • An actuator may be provided, e.g., a specialized spring loaded three-way control valve, may be included on the device handle.
  • a three-way valve may be provided that is movable between two positions by a control button or other actuator, e.g., a first position to couple the pump to the lumen of coaxial sheath to provide fluid flow or a second position to couple the vacuum to the lumen to provide aspiration.
  • the actuator is biased to a normal resting position, where the valve permits fluid flow to occur.
  • the valve shuttles to the second position, cutting off fluid flow while opening the vacuum line.
  • fluid flow is provided by a battery powered electric pump, e.g., activated by depression of an electrical button switch in the handle.
  • a battery powered electric pump e.g., activated by depression of an electrical button switch in the handle.
  • two nine volt batteries may supply power to the pump via an electronic control board that maintains a constant voltage delivery to ensure that a constant fluid jet velocity is achieved for reliable tissue hydro dissection.
  • a rotational switch or other actuator may be provided that controls a potentiometer may also be provided on the handle to allow a user to adjust the velocity of the hydro dissection jet.
  • the laparoscopic forceps may include electrocautery capability, and a connector on the handle of the device may interface with a power cable attached to an electrosurgical generator.
  • the electrosurgical generator may be configured to supply electricall energy, e.g., radiofrequency energy, to the forceps jaws, allowing the jaws to cauterize or cut tissue in the surgical field.
  • electricall energy e.g., radiofrequency energy
  • Activation of electrocautery energy is enabled only when the forceps jaws are fully exposed in their functional mode, with the coaxial sheath fully retracted, to avoid inadvertent electrical discharge to internal organs and tissue, with concomitant thermal destruction of the distal tip of the extended sheath.
  • any of the devices and systems herein may include one or more additional components or functionalities.
  • the devices may include one or more sensors on or adjacent their end effectors, e.g., Doppler or other sensors for identifying blood flow in contacted tissue, microfluidics sensors for identifying tissue characteristics and the like, one or more electrodes or other cautery elements, vessel sealing elements, and/or one or more imaging elements.
  • One or more processors or controllers may be coupled to these elements, e.g., to analyze signals from sensors, generate images on a display, and the like.
  • a display may be provided, e.g., mounted on a proximal end of the devices or remotely from the devices, which may allow visual monitoring of a surgical field during use of the devices.
  • an instrument e.g., a laparoscopic grasper or forceps
  • double action jaws that include rigid nozzles on lateral aspects of each jaw.
  • Fluid-carrying channels extend along lateral aspects of the instrument shaft, and a length of flexible hose connects the distal end of each channel to a proximal end of a respective jaw nozzle channel.
  • the short flexible hose sections may adopt a substantially straightened position when the jaws are closed, such that their outer profile does not exceed the outer profile of the instrument shaft, allowing the instrument to be inserted through a trocar, e.g., a five millimeter (5 mm) laparoscopic trocar.
  • a trocar e.g., a five millimeter (5 mm) laparoscopic trocar.
  • the flexible tubes may allow the closed jaw instrument to maintain a desired maximum outer diameter or other profile, e.g., a five millimeter (5 mm) outer diameter throughout the length of the device, e.g., for insertion through a corresponding, e.g., five millimeter (5 mm), inner diameter trocar or sheath.
  • a desired maximum outer diameter or other profile e.g., a five millimeter (5 mm) outer diameter throughout the length of the device, e.g., for insertion through a corresponding, e.g., five millimeter (5 mm), inner diameter trocar or sheath.
  • Such a method of lateral tissue hydro-dissection while applying centralized tissue counter traction may be less traumatic to tissue than conventional blunt dissection with conventional laparoscopic forceps, as the such conventional forceps typically involve tissue puncture and tissue tearing as components of mechanical blunt dissection.
  • hydro-dissection uses gentle fluid jet streams to separate tissue and isolate anatomic structures, eliminating the sharp force tissue interaction associated with mechanical blunt dissection.
  • Double action jaws may also enable the jaws to remain in axial orientation with the shaft of the instrument, with the jaws opening symmetrically on either side of the shaft.
  • Application of the laparoscopic forceps with double action jaws may be more intuitive, facilitating efficient surgical technique and saving operative time.
  • the instrument shaft needs to be displaced to the side of the stationary jaw to accurately grasp tissue as intended.
  • double action jaws on the device may be particularly useful, although, alternatively, single action jaws may also be provided, if desired.
  • a first trumpet valve may control both the electrical supply to the fluid pump and the fluid flow lateral to the forceps jaws, and a second trumpet valve may activate vacuum to clear fluid injected during hydro dissection.
  • the laparoscopic hydro dissection forceps and/or other devices described herein e.g., including fluid pump and battery, may be a single-use device that is disposed following the surgical procedure, to avoid the need for device cleaning, re- sterilization, and storage between successive procedures.
  • all or some components of the device may be reusable, e.g., after cleaning and/or sterilization.
  • Acute cholecystitis is inflammation of the gallbladder caused by occlusion of the cystic duct by gallstones.
  • the gallbladder becomes distended, and the pressure inside the organ may increase to such a level that it compromises the blood supply and causes ischemia, leading to gangrenous cholecystitis, which occurs in over 20% of acute cholecystitis cases.
  • the severe inflammation observed in gangrenous cholecystitis causes such a degree of swelling and edema in the gallbladder and surrounding tissues that the outlines of anatomic structures, such as the cystic duct and cystic artery are invisible under laparoscopic visualization, and normally observed outlines and landmarks are obscured.
  • a modified technique of tissue dissection is proposed herein, involving tissue dissection performed solely by simultaneous hydro-dissection lateral to both sides of double action movable laparoscopic grasper jaws.
  • the jaws of the devices described herein may not be applied in a typical fashion for mechanical tissue disruption and blunt dissection. Rather, the jaws may gently grasp and fixate exposed tissue prior to instillation of pressurized fluid jets lateral to the grasping jaws to perform hydro dissection of the soft tissue to achieve isolation of the desired anatomic structures.
  • the hydro dissection devices and methods herein may also be used in additional endoscopic procedures, e.g., to isolate delicate anatomic structures obscured by overlying amorphous tissue, such as resection of intra-abdominal endometriosis lesions, lysis of tissue and organ adhesions, and video assisted thoracic surgical procedures such as lung resection and lobectomy.
  • endoscopic procedures e.g., to isolate delicate anatomic structures obscured by overlying amorphous tissue, such as resection of intra-abdominal endometriosis lesions, lysis of tissue and organ adhesions, and video assisted thoracic surgical procedures such as lung resection and lobectomy.
  • dissection of connective tissue surrounding delicate organs, blood vessels and ducts may be performed less traumatically via hydro dissection versus standard mechanical blunt surgical dissection.
  • a device for performing hydro- dissection of tissue within a patient’s body that includes an elongate shaft comprising a proximal end, a distal end sized for introduction into the patient’s body, and one or more shaft channels extending between the proximal and distal ends; first and second jaws on the distal end coupled to an actuator on the proximal end for moving the jaws between closed and opened positions, each jaw comprising a jaw channel comprising an outlet disposed adjacent a distal tip of the respective jaw; and a flexible tube extending between each jaw and the distal end of the shaft to fluidly couple the outlet of the respective jaw to the one or more shaft channels to deliver pressurized fluid from a fluid source through the one or more shaft channels, the flexible tubes, the jaw channels, and out the outlets to dissect tissue adjacent grasped between the jaws.
  • a device for performing hydro-dissection of tissue within a patient’s body that includes an elongate shaft comprising a proximal end, a distal end sized for introduction into the patient’s body, and first and second shaft channels extending between the proximal and distal ends; first and second jaws on the distal end, each jaw comprising an outlet disposed adjacent a distal tip of the respective jaw; an actuator on the proximal end coupled to the jaws to manipulate the jaws between closed and opened positions; first and second flexible tubes extending between the jaws and the distal end of the shaft communicating between the outlet of the respective jaws and the first and second shaft channels, respectively; and a source of pressurized fluid coupled to the first and second shaft channels to deliver pressurized fluid through the shaft channels, the flexible tubes, the jaw channels, and out the outlets to dissect tissue adjacent grasped between the jaws.
  • a combination hydro-dissection, irrigation, and suction laparoscopic forceps may be provided that includes a shaft, e.g., having about a three millimeter (3.0 mm) or smaller outer diameter, that resides and translates axially within a lumen of an outer sheath, e.g., a thin-walled sheath having an outer diameter of about five millimeters.
  • a control valve integrated with an electrical switch may be provided that initiates fluid delivery by an attached fluid pump, with the capability to select either a high velocity jet emanating from the small diameter hydro dissection nozzle, or a low velocity fluid irrigation through the lumen of the outer sheath.
  • the control valve may include multiple settings, e.g., to allow different flow rates and/or volumes of fluid to be delivered, e.g., using a potentiometer and/or other control mechanism.
  • a separate control valve produces suction through the outer sheath.
  • an elastomeric seal maybe provided at a proximal end of the outer sheath, which may form a fluid-tight seal around the shaft of forceps while allowing the forceps to translate axially to expose the forceps jaws out of the distal end of the sheath or retract the jaws fully into the sheath.
  • Exemplary materials for the extrusion may include one or more of Nylon, polyimide, polyetheretherketone (PEEK), and the like.
  • a fluid pump and power source that powers the pump e.g., a nine-volt battery or cable connectable to an external power source, may be attached to the body of the forceps.
  • the outer sheath, fluid pump, battery, and control valves may be incorporated into a frame that accepts and rigidly attaches to a conventional laparoscopic forceps.
  • fluid flow is provided by a battery powered electric pump activated by depression of an electrical button switch in the device handle.
  • Two nine-volt batteries supply power to the pump via an electronic control board that maintains a constant voltage delivery to ensure that a constant fluid jet velocity is achieved for reliable tissue hydro dissection.
  • a rotational switch that controls a potentiometer may also be provided on the instrument handle to allow the surgeon to adjust the velocity of the hydro dissection jet.
  • FIG. 4 illustrates exemplary differences in width of jaw opening between a single action jaw instrument and a double action jaw instrument.
  • FIG. 5 depicts exemplary components of a hydro dissection laparoscopic forceps device.
  • FIGS. 6a-6c illustrate details of a distal portion of the device of FIG. 5.
  • FIGS. 7a and 7b depict an exemplary profile of the jaws of the device of FIG. 5 in closed and open configurations, respectively.
  • FIG. 8a shows another example of an apparatus that may provide hydro- dissection, irrigation and suction in a unitary format including a forceps movable relative to an outer sheath.
  • FIG. 8b is a cross-sectional view of the device of FIG.
  • FIG. 11a shows another example of an apparatus including a framework including an outer sheath for receiving a separate forceps instrument.
  • FIG. 11b shows the apparatus of FIG. 11a with the forceps advanced such that jaws extend from a distal end of the sheath.
  • FIG. 11c is a bottom view of the apparatus of FIGS. 11a and 11b.
  • FIG. 12 is a table showing results of exemplary water jet flow rate testing.
  • FIG. 13a shows another example of an apparatus that provide hydro- dissection, irrigation and suction in a unitary format including a forceps movable relative to an outer sheath connected to a robotic control system.
  • FIG. 13a shows another example of an apparatus that provide hydro- dissection, irrigation and suction in a unitary format including a forceps movable relative to an outer sheath connected to a robotic control system.
  • FIG. 1a illustrates an example of the surgical appearance of a gallbladder 10 attached to the underside of a liver 11, in a non-gangrenous situation.
  • the outline of the cystic duct 12 may typically be observed in a non-gangrenous laparoscopic cholecystectomy surgery.
  • FIG. 1b depicts an example of a gangrenous gallbladder 13, that is enlarged, swollen and edematous.
  • FIG. 2a depicts an example of mechanical blunt dissection of the gallbladder 10 using conventional laparoscopic forceps 14.
  • the tips of the jaws 15 of the laparoscopic forceps 14 are inserted into tissue at an entry site 16, with the jaws 15 in a closed orientation. Following tissue insertion, the jaws 15 are forcibly opened, as shown in FIG. 2b, to dissect the tissue of gallbladder 10, creating a cleavage plane or opening 17 in the bluntly dissected tissue.
  • Blunt mechanical dissection of tissue is generally safe to perform when the gallbladder is non-gangrenous, and underlying anatomical structures such as blood vessels and ducts are visually perceived. If underlying blood vessels and ducts are obscured, however, e.g., due to tissue edema and inflammation in the event of gangrenous cholecystitis and the like, laceration, perforation, and/or transection of blood vessels and ducts may occur upon blunt dissection maneuvers using conventional laparoscopic forceps.
  • FIG. 3a-3c illustrate an exemplary technique of atraumatic tissue dissection using a hydro dissection laparoscopic forceps device 20.
  • the jaws 19 of the hydro dissection forceps 20 gently close on tissue of the gallbladder 10 without its tips puncturing into the tissue.
  • the hydro dissection forceps device 20 may remain in a fixed position, i.e., the device 20 is not moved to tear or otherwise displace tissue.
  • FIG. 3b following fixation of the tissue by closure of the jaws 19, fluid jets 21 are initiated, e.g., lateral to each jaw 19.
  • the closed jaws 19 fixate tissue and provide counter traction as the fluid jets 21 exert hydro dissection force against tissue lateral to the region grasped by the jaws 19.
  • Tissue separation is performed solely by hydro dissection, and avoidance of conventional blunt dissection maneuvers involving tissue tearing and tissue puncture leads to atraumatic isolation of anatomic structures, such as the duct 12 observed in FIG. 3c.
  • FIG. 4 illustrates functional differences that may be experienced between forceps 23 with a single action jaw 24 and double action forceps 20 with two moveable jaws 19.
  • Jaws 19 of double action forceps 20 open twice as wide as forceps 23 with a single moveable jaw 24, permitting a surgeon to grasp a larger amount of tissue between the jaws 19 for enhanced tissue control and avoidance of tissue slippage out of the grasp of jaws 19.
  • Proper tissue fixation is necessary to provide requisite counter traction during lateral hydro dissection procedures, particularly with the wet tissue environment encountered with the technique.
  • double action, movable jaws 19 may provide advantages over a single action jaw 24 during tissue dissection.
  • FIG. 5 exemplary components are shown that may be included in a hydro-dissection laparoscopic graspers device 20.
  • the shaft 28 may include a single channel or infusion lumen extending from the proximal end 28a to the distal end 28b and a fitting split, or other branch (not shown) may be provided on the distal end to provide two openings that may be connected to respective flexible tubes and jaw channels 29.
  • the device 20 includes a pair of jaws 26 on the distal end 28b of the shaft 28, e.g., that may be manipulated between a closed position (e.g., as shown in FIG. 7a) and an open position (e.g., as shown in FIG. 7b), via manipulation of an actuator 43 on a handle 41 on the proximal end 28a of the shaft 28.
  • the handle 41 includes a stationary ring extension 41 and a moveable ring actuator 43 coupled to the jaws 26 to direct them between the closed and open positions.
  • the jaws 26 are coupled to the distal end 28b of the shaft 28 such that, manipulation of the actuator 43 causes both jaws 26 to move laterally away from the axis 22 when the jaws 26 are opened and the jaws 26 are generally aligned along the axis 22 when the jaws are closed, e.g., as shown in FIGS. 5 and 7a.
  • the outer profile of the working portion of the device 20, including the jaws 26, fluid supply channels 29 and 27, and flexible tubes 30 do not exceed about five millimeters (5 mm) or other maximum outer diameter or cross-section, e.g., to allow the device 20 to be introduced into the body through a corresponding sized access device, e.g., a five millimeter (5 mm) laparoscopic or thoracoscopic trocar, delivery sheath, and the like (not shown).
  • the graspers 20 may be connected to a radiofrequency power source (not shown), e.g., via a connector 42 on the proximal end 28a, e.g., on handle 41 as shown in FIG.
  • the connector 42 may be coupled to the jaws 26 by one or wires or other leads (not shown) extending between the proximal and distal ends 28a, 28b of the shaft 28, which may, in turn, to electrically conductive electrodes or surfaces on the jaws 26.
  • the entire inner contact surface 26a of the jaws may be coupled to the leads to deliver electrical energy to tissue contacted between the jaws 26, if desired.
  • the jaws 26 may include one or more sensors, e.g., a Doppler sensor (not shown) on one of the jaws that may be used to identify blood flow in tissue captured between the jaws or otherwise contacted by the sensor(s).
  • a processor (not shown) may be coupled to the sensor(s) and/or cautery elements to provide an output to the user when blood is flowing and/or discontinued, e.g., for use in conjunction with cauterizing contacted tissue.
  • Pressurized fluid for hydro-dissection is supplied by a miniature fluid pump 36 included in or coupled to the handle 41, e.g., integrated into the superior aspect of the stationary portion of the handle 41.
  • the fluid pump 36 may include a connector, e.g., a female luer fitting 37, that accepts an intravenous fluid line connected to a saline bag or other source of fluid (not shown), e.g., containing one to three (1-3) liters or other desired volume of sterile saline.
  • a fluid supply line 35 extends from the pump 36 to a normally closed fluid irrigation trumpet valve 32 provided on the handle 41.
  • a connector 39 may be provided to connect a source of vacuum or suction (not shown) to the device 20, e.g., communicating with the shaft channels 27. For example, as shown in FIG.
  • the stationary handle portion 41 may include a suction luer fitting 39 that allows the hydro-dissection laparoscopic graspers 20 to be connected to wall suction in the operating or procedure room, for evacuation of fluid via jaw channels 29.
  • a suction connecting tube 38 extends from luer fitting 39 to the inlet of a suction trumpet valve 33, which is also in a normally closed position until the trumpet valve 33 is depressed.
  • the outlets of both irrigation trumpet valve 32 and suction trumpet valve 33 are connected together to a common fitting 34 with a connecting line 39 extending to a connector 31 that is attached to both fluid supply tubes 27.
  • each shaft channel 27 is attached to or otherwise extends axially along either side of the shaft 28, except for desired offset, e.g., about a three millimeters (3 mm) long length of its distal portion, where circumferential clearance permits attachment of the proximal end of flexible tube 30.
  • An actuator may be coupled to the jaws 26 to manipulate the jaws between the open and closed positions.
  • FIG. 6b is a cross-section of the shaft 28, showing a central channel 46 that accommodates actuation rod 44 in a sliding fashion within its lumen.
  • two lateral grooves 47 may extend the length of shaft 28, to allow the attachment of fluid tubes 27, which may be elliptical rather than circular in cross-section, if desired, to increase its luminal area for maximal fluid delivery.
  • a relatively thin outer sheath 48 may cover the shaft 28 and attached fluid tubes 27, to provide a substantially smooth outer surface for insertion and sealing in a laparoscopic trocar port, and/or to electrically insulate the outside of shaft 28 as radiofrequency current is applied to cauterize tissue grasped by jaws 26.
  • FIG. 6c is an end view of an exemplary instrument jaw 26, illustrating the attachment of a fluid tube 29 to its lateral aspect.
  • the forceps 114 and outer sheath 115 may be manufactured and provided separately but, before or during a procedure, the forceps 114 may be inserted into the sheath 115 to allow the different modes of operation.
  • the sheath 115 may be made to accommodate inserting a conventional forceps instrument (or alternatively, another instrument, such as a bowel grasper, scissors, clip applier, vessel sealer, and the like not shown) to provide hydro-dissection and/or irrigation/suction during use of the conventional instrument.
  • the forceps 114 may be manufactured integrally with the sheath 115, yet may be movable axially to advance or retract the forceps 114 as desired during a procedure.
  • a conventional three millimeter (3 mm) or smaller laparoscopic forceps 114 may be provided that is inserted through a primary or central lumen 115a of the outer sheath 115 (e.g., shown in FIG. 8b), e.g., such that jaws 119 of the forceps 114 extend distal to a distal tip 115b of sheath 115, e.g., as shown in FIGS. 8a and 9a.
  • a fluid tight valve or other seal 116 may be provided on a proximal end 115c of sheath 115, e.g., such that the valve 116 slidably seals against the shaft of the forceps 114, and allows axial and/or rotational movement of the forceps 114 and sheath 115 relative to one another.
  • the valve 116 may allow advancement of the sheath 115 to retract the jaws 119 of the forceps 114 into the lumen 115a of the sheath 115, e.g., as shown in FIG. 9b, as well as rotation, while providing a fluid-tight seal to prevent fluid introduced into the lumen 115a from leaking.
  • the sheath 115 may include one or more ports communicating with the central lumen 115a, e.g., to allow fluid and/or suction to be applied.
  • a side port 117 is provided on the valve 116, which may be coupled to a source of fluid or vacuum to allow injection or removal of fluid in the surgical field via the sheath 115, i.e., through the distal opening of the primary lumen 115a at the tip 115b.
  • the sheath 115 may include one or more additional or secondary lumens or channels extending between the proximal and distal ends 115c, 115b.
  • hydro dissection fluid channel 18 may be attached to the sheath 115, e.g., extending along an inner surface of the sheath 115 adjacent the central lumen 115a, as shown in FIG. 8b.
  • the secondary fluid channel 118 may extend the length of the sheath 115 to provide an outlet at the distal tip 115b, which may be used to generate a high velocity jet for tissue dissection, as explained further elsewhere herein.
  • relatively low velocity fluid irrigation may be supplied via the central lumen 115a of the sheath 115, and/or high velocity jet may be supplied via the secondary channel 118, as selected at any given time by a surgeon or other use.
  • the fluid flow may be driven by a battery powered diaphragm pump or other fluid source 121 mounted or otherwise provided on the apparatus 120, e.g., rigidly attached to a superior aspect of a handle of the forceps 114.
  • an external pump or other fluid source may be provided that may be connected to the apparatus 120.
  • a luer fitting or other connector 121a may be provided on the pump 121 that may be connected to a source of fluid, e.g., a line from an intravenous saline bag (not shown). Pressurized fluid may exit the pump 121 via pump supply line 126, which connects to a fluid control valve 125.
  • the fluid control valve 125 may be a trumpet valve that includes an electrical switch 124, e.g., leading from a nine-volt battery or other power source 122 to the pump 20, e.g., as best seen in FIG. 10. Depression of the fluid control valve 125 opens the valve 125 to fluid flow and may power the pump 120 simultaneously.
  • the output from the fluid control valve a25 leads to a three-way stopcock a28 or other control, that allows the user to select either hydro-dissection flow line 129 to the channel 118, or low velocity irrigation via the central lumen 115a of the sheath 115.
  • the device may include a processor or controller (not shown) that may automatically open and close the appropriate flow line based on the actuator pressed by the operator to alternatively deliver hydro-dissection or irrigation flow. As shown, a low velocity irrigation line 130 exits the stopcock 128, and taps into an output suction line 117 exiting suction control valve 132.
  • the input line 134 to a suction control valve 132 leads to a vacuum fitting 133, e.g., on the inferior aspect of the handle of the forceps 114.
  • the fitting 133 may be connected to a source of vacuum, e.g., a line from the operating room vacuum source to provide suction capability via the central lumen 115a of the sheath 115, e.g., when the suction control valve 132 is depressed.
  • low velocity fluid irrigation may be delivered through the central lumen 115 of the sheath 115, e.g., to unclog the apparatus 120 when tissue debris and blood clots have reduced the suction capability.
  • FIG. 8b is an exemplary cross-sectional view of the sheath 115, illustrating a small diameter tubular body attached to a superior aspect of the central lumen 115a of the sheath 115 to provide the secondary channel 118.
  • the shaft of the forceps 114 occupies a portion of the central lumen 115a while providing area around the shaft to accommodate irrigation and/or suction.
  • FIG. 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 integral tubular body that includes a secondary lumen 118 integrally formed within the wall of the sheath 115 adjacent the primary lumen 115a. [000109] FIG.
  • the fluid diaphragm pump 121 receives fluid input via luer fitting 121a, and fluid exits via the output line 126.
  • the battery 122 supplies power to the pump 121 via conducting electrodes 123, with a power switch 124 integrated into the fluid control trumpet valve 125.
  • the fluid control trumpet valve 125 is normally in an off position, and power switch 124 normally in an open position. When the fluid control trumpet valve 125 is depressed, the valve 125 opens to fluid flow, and the power switch 124 is simultaneously closed to supply current to the pump 20.
  • the fluid output line 127 from the fluid control valve 125 forms the input into the three-way stopcock 128, which allows the surgeon to select one of two outputs – either hydro dissection output line 129 connecting to the small diameter fluid supply channel 118, or the low velocity irrigation output line 130.
  • the irrigation output line 130 connects to suction supply line 131, which leads from the output of suction control valve 132 to the side port 117 in communication with the central lumen 115a of the sheath 115. Suction is provided by connection of the operating room vacuum source to suction connector 133, with the suction line 134 forming the input to the suction control valve 132.
  • This configuration may be used to perform one or more of the following techniques: (1) pure hydro dissection without tissue counter-traction; (2) suction via the central lumen 115a of the sheath 115, e.g., to remove fluid and debris from the surgical field; and (3) low velocity fluid irrigation, e.g., to remove blood from the surgical field and/or to clear the sheath 115 of blood clots or tissue debris that clog its central lumen. [000111] Turning to FIGS.
  • FIG. 11a and 11b another example of an apparatus 220 is shown that may selectively provide hydro dissection, irrigation and/or suction using a laparoscopic forceps formed of two discrete devices – a frame 236 including an outer sheath 215, fluid pump 220, battery or power source 222, and control valves 225, 232 mounted on the frame 236; and a laparoscopic forceps 214 (or other instrument), generally similar to the previous examples.
  • the sheath 215 may be movable axially relative to the frame 236, e.g., to extend and retract with respect to frame 236 using a pin or other actuator 243, e.g., attached to the valve body 216 of the sheath 215, that translates within a slot 242 in the frame 236, as shown in FIG. 11c.
  • the forceps 214 may be movable axially relative to the sheath 215 between distal and proximal positions.
  • FIG. 11b shows the assembled configuration of the forceps 214 in the hydro dissection frame 236, with the forceps jaws 219 in the distal position, i.e., extended distal to the tip of the sheath 215.
  • FIG. 11b shows the assembled configuration of the forceps 214 in the hydro dissection frame 236, with the forceps jaws 219 in the distal position, i.e., extended distal to the tip of the sheath 215.
  • 11c shows the underside of the frame 236, with the sides of the channel 237 containing threaded holes 238 that accept setscrews for attachment to the handle of the forceps 214.
  • the slot 242 that forms part of the translation mechanism for sheath 215 is also visible.
  • 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.
  • the forceps 214 may be removable entirely from the sheath 215 while the distal end 215b of the sheath 215 is positioned within a surgical space, e.g., to allow one or more different instruments to be introduced through the sheath 215 to perform additional steps of the surgical procedure.
  • a surgical apparatus 320 that includes an outer sheath 315 and a forceps or other instrument 314 including an end effector, e.g., jaws 319, deployable from the sheath 315.
  • the sheath 315 and forceps 314 are mounted to a robotic control arm or system 330, which is coupled to an operator console or system 340, which may be operated remotely by a surgeon.
  • the sheath 315 may include a proximal mount or housing 316 on its proximal end that may include one or more connectors (not shown) for mounting to an end of the robotic arm system 330.
  • the housing 316 may include a pair of ports 321a, 321b that communicate with the primary and secondary lumens 315a, 318, respectively, that may be coupled to respective ports on the robotic arm system 330 when the housing 316 is connected to the robotic arm 330. These ports, e.g., including one or more seals and/or connectors (not shown) may then communicate with a source of fluid and/or vacuum, e.g., connected to a proximal end of the robotic arm 330.
  • the housing 316 includes a first shaft connector 322 that is coupled to a shaft of the forceps 314, which is connected to a corresponding shaft in the robotic arm system 330.
  • 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.
  • the housing 316 may include a connector 323, e.g., an electrical connector, that may be connected to a corresponding connector on the robotic arm system 330 to allow activation of the cautery element(s) during use of the apparatus 320.
  • the robotic arm 330 may be coupled to a generator and/or controller (not shown) for providing electrical or other energy to the cautery element(s).
  • one or more additional connectors may be provided on the housing 316 to provide power to the imaging element(s) and/or to receive signals from the imaging element(s), e.g., to provide signals to a processor of the control console 340 to generate images on a display (not shown) included in the control console 340.
  • the surgeon may operate the apparatus 320 to manipulate the sheath 315 remotely as desired, e.g., to introduce the sheath 315 into a surgical space, e.g., through a trocar or other access port (not shown), whereupon the forceps 314 may be deployed and manipulated and/or fluid may be delivered into the surgical space to perform hydro-dissection, irrigation, and/or suction, as needed during the procedure.
  • the robotic arm system 330 may be connected to one or more sources of fluid and/or vacuum, e.g., one or more pumps, one or more power sources, one or more processors and/or controllers, and the like (not shown), which may be activated using the control console 340, similar to conventional robotic surgical procedure systems.
  • any of the devices and apparatus described herein may include one or more additional features.
  • one or more micro-fluidic channels may be provided on the instrument, e.g., extending to the distal end and/or jaws of the forceps, that may include one or more sensors coupled to a processor (not shown) of the apparatus.
  • Signals from the sensor(s) may be analyzed by the processor, e.g., to identify tissues and/or analyze body fluids to identify the presence of one or more diseases or other conditions.
  • the devices or apparatus may include a Doppler or other sensor, e.g., carried on one or both jaws of the forceps or other end effector, that may be coupled to a processor to identify blood flow in tissues captured between the jaws.
  • the devices or apparatus may include one or more electrodes or other cautery elements, vessel sealing elements, and the like, e.g., on one or both jaws or other location on the end effector, which may be coupled to an energy source (not shown), which may be selectively activated to cauterize tissues that are captured or severed by the forceps or other instrument.
  • One or more actuators may be provided on the handle of the forceps or other location of the apparatus or system, which may be used to activate such sensors and/or cautery elements.
  • a display may be mounted on or otherwise carried on the proximal end of the device, e.g., on the handle 41 of the devices 20, 120 shown in FIGS. 5 or 8a, on the proximal end of the sheath 115 shown in FIG. 8a, on the frame 236 shown in FIG. 11a, or separate from the devices or systems, e.g., included in the control console 340 shown in FIG. 13a.
  • FIG. 16 another example of a laparoscopic forceps device 410 is shown that may selectively be operated to perform hydro dissection, irrigation, and suction.
  • the lumen 412 has an inner diameter larger than the outer diameter of the shaft 411a to provide a fluid flow path through the sheath 412 around the shaft 411a.
  • the shaft 411 of a three-millimeter (3 mm) diameter laparoscopic forceps is provided within the length of a five millimeter (5 mm) diameter outer sheath 412, and the jaws 413 of the laparoscopic forceps extend distally beyond a distal tip of the outer sheath 412.
  • the handle 450 and sheath 412 may be mounted to a standard forceps instrument to provide the device 410 provided to a surgeon or other user.
  • the handle 450 may include an actuator 415 for manipulating the sheath 412 relative to the forceps 411, e.g., to advance and retract the sheath 412 relative to the jaws 413 of the forceps 411.
  • the sheath 412 may be advanced distally to a distal or advanced position that completely covers the forceps jaws 413, e.g., as shown in FIGS. 17b and 20a, and proximally to a proximal or retracted position where the jaws 413 are exposed, by axial displacement of the sheath actuator 415.
  • the handle 450 may include one or more actuators coupled to the jaws 413 to direct the jaws 413 between open and closed positions.
  • the forceps jaws 413 may be opened and closed via thumb manipulation of a movable ring or other actuator 416, while the stationary loop 417 accommodates the user’s third and fourth fingers.
  • the inner components of the device 410 may be observed in the opened view of the handle housing 450 shown in FIG. 16, i.e., with a cover of the handle removed to facilitate observation of the components.
  • the device 410 may include a source of pressurized fluid and a power source and/or controller that may be actuated to deliver the pressurized fluid from the device 410, e.g., from the distal tip of the sheath 412, as described further elsewhere herein.
  • Button switch 425 is depressed to activate electrical fluid pump 418, causing fluid to flow into the pump 418 via fluid input connector 422, as illustrated by the dashed arrows. Fluid output from the pump 418, as illustrated by the solid arrows, enters valve 424, proceeds through flexible fluid line 427, and continues through the lumen of the sheath 414.
  • FIG. 18b illustrates activation of suction in the device 410. Depression of suction button 426 exerts traction on the inelastic cable 439 that actuates valve 424, simultaneously cutting off antegrade fluid flow while enabling retrograde suction to occur.
  • the solid arrows illustrate the path of suction flow in a retrograde manner from the lumen of outer sheath 414 through valve 424 to the suction connector 423.
  • FIG. 20d is a sectional view of the instrument shaft at B-B, with the cross-hatched region 444 depicting the suction flow path area between the instrument shaft 411 and the contours of the jet flow tube 442 and the outer tube 443, for an instrument with the previous configuration. Calculations show that the cross-sectional suction flow area 444 of the previous device is 22.2% less than the effective flow area 441 of the proposed device. This suction capability will be significant during clinical use, when blood clots and debris are encountered during suction use. [000138] Turning to FIG.
  • the handle 550 may include a fluid control button 521 that is depressed to deliver fluid delivery out of the distal end of coaxial sheath 512, and suction control button 522 that is depressed to provide vacuum suction to the device tip.
  • FIG. 22a depicts the elements associated with supplying and controlling electrocautery energy to the forceps jaws 512.
  • Current from the electrosurgical generator is delivered to the jaws 513 of the forceps 511 via the electrical connector 523F and one or more insulated conducting cables 516.
  • the sliding actuator 515 controls extension and retraction of the coaxial sheath 51 to retract or expose the jaws 513 of the forceps 511, while simultaneously operating an electrical switch to interrupt or supply electrocautery energy to the jaws 513.
  • the electrical switch includes a conductive plate electrode 522b attached to the sliding actuator 515, and one or more stationary post electrodes 522a fixed to the inside handle surface of device 510.
  • FIG. 22e is a magnified two-dimensional view of the electrical switch mechanism, with the plate electrode 522b attached to the sliding actuator 515.
  • the sliding actuator 515 is advanced distally in this illustration, such that plate electrode 522b does not contact the (in this case two) post electrodes 522a.
  • the conducting cable 516 connects to the left-sided post electrode 522a, while insulated cable 524 connects the right-sided post electrode 522a to the shaft of laparoscopic forceps 511.
  • the device 510 may include one or more features to stabilize the sheath 512 during manipulation and/or to provide feedback to the operator confirming the position of the sheath 512.
  • actuator attached magnets 526 are attached to the sliding actuator 515 that interact with two handle attached magnets 527, attached to the inner surface of the handle 550.
  • FIG. 22f The magnified two-dimensional view in FIG. 22f shows that electrocautery current may now be conducted to the jaws 513 of the forceps 511 via the electrical cables 516, 524.
  • the actuator attached magnets 526 are in attractive coupling with the proximal handle attached magnet 527, stabilizing the coaxial sheath 512 in the retracted or proximal position.

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Abstract

Un instrument laparoscopique intègre une pince d'électrocautérisation avec une capacité d'hydrodissection à grande vitesse, d'irrigation à faible vitesse et d'aspiration. Lorsqu'une gaine contenant une douille interne distale est complètement rétractée sur l'arbre de pince, exposant ses mâchoires, la lumière interne de la douille scelle contre la surface externe de l'arbre de pince. Le fluide à l'intérieur de la gaine est dirigé vers une minuscule buse, formant ainsi un jet de fluide à grande vitesse pour l'hydro-dissection tissulaire. Une électrode fixée à l'actionneur de rétraction de gaine établit un contact électrique avec une électrode correspondante dans le boîtier de poignée de dispositif pour administrer une électrocautérisation uniquement lorsque la pince est déployée. Le couplage magnétique assure un contact électrique stable et fournit une rétroaction haptique d'utilisateur concernant une rétraction de gaine complète. Une extension de gaine distale agrandit le trajet d'écoulement entre les mâchoires de pince effilées et la lumière interne de la douille, fournissant une irrigation de fluide à faible vitesse ou permettant à une aspiration de fluide de se produire.
PCT/US2024/050604 2023-10-10 2024-10-09 Dispositifs d'électrocautérisation à hydrodissection, irrigation et aspiration et procédés d'utilisation Pending WO2025080737A1 (fr)

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US18/378,354 US20240180582A1 (en) 2022-02-22 2023-10-10 Hydro dissection and suction laparoscopic instruments and methods of use

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170209165A1 (en) * 2014-07-21 2017-07-27 Ab Medica Holding S.P.A. Dissector device
US20190343582A1 (en) * 2012-07-17 2019-11-14 Covidien Lp Surgical instrument for energy-based tissue treatment
JP2020519405A (ja) * 2017-05-23 2020-07-02 朝日インテック株式会社 補助ジェット吸引血栓摘出カテーテルおよびその使用方法
EP3909520A1 (fr) * 2020-05-11 2021-11-17 Covidien LP Ensemble poignée motorisé pour dispositifs chirurgicaux
US20230133233A1 (en) * 2021-10-29 2023-05-04 Olympus Medical Systems Corp. Endoscope treatment tool
US20240180582A1 (en) * 2022-02-22 2024-06-06 Dinesh Vyas Hydro dissection and suction laparoscopic instruments and methods of use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190343582A1 (en) * 2012-07-17 2019-11-14 Covidien Lp Surgical instrument for energy-based tissue treatment
US20170209165A1 (en) * 2014-07-21 2017-07-27 Ab Medica Holding S.P.A. Dissector device
JP2020519405A (ja) * 2017-05-23 2020-07-02 朝日インテック株式会社 補助ジェット吸引血栓摘出カテーテルおよびその使用方法
EP3909520A1 (fr) * 2020-05-11 2021-11-17 Covidien LP Ensemble poignée motorisé pour dispositifs chirurgicaux
US20230133233A1 (en) * 2021-10-29 2023-05-04 Olympus Medical Systems Corp. Endoscope treatment tool
US20240180582A1 (en) * 2022-02-22 2024-06-06 Dinesh Vyas Hydro dissection and suction laparoscopic instruments and methods of use

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