WO2022248970A1 - Electrosurgical forceps with smart energy delivery system - Google Patents
Electrosurgical forceps with smart energy delivery system Download PDFInfo
- Publication number
- WO2022248970A1 WO2022248970A1 PCT/IB2022/054537 IB2022054537W WO2022248970A1 WO 2022248970 A1 WO2022248970 A1 WO 2022248970A1 IB 2022054537 W IB2022054537 W IB 2022054537W WO 2022248970 A1 WO2022248970 A1 WO 2022248970A1
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- WO
- WIPO (PCT)
- Prior art keywords
- jaw members
- housing
- energy
- end effector
- effector assembly
- Prior art date
Links
- 239000012636 effector Substances 0.000 claims abstract description 60
- 230000004913 activation Effects 0.000 claims abstract description 54
- 230000000007 visual effect Effects 0.000 claims description 12
- 230000000977 initiatory effect Effects 0.000 claims description 2
- 238000007789 sealing Methods 0.000 description 18
- 238000000926 separation method Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000002224 dissection Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000009429 electrical wiring Methods 0.000 description 2
- 238000012976 endoscopic surgical procedure Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000002355 open surgical procedure Methods 0.000 description 2
- 230000003213 activating effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 239000012212 insulator Substances 0.000 description 1
- 238000012830 laparoscopic surgical procedure Methods 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B18/1445—Probes 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00389—Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector
- A61B2017/00393—Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector with means for switching between functions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/0091—Handpieces of the surgical instrument or device
- A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
- A61B2018/00922—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device by switching or controlling the treatment energy directly within the hand-piece
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/0091—Handpieces of the surgical instrument or device
- A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
- A61B2018/0094—Types of switches or controllers
- A61B2018/00946—Types of switches or controllers slidable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B2018/1452—Probes having pivoting end effectors, e.g. forceps including means for cutting
- A61B2018/1455—Probes having pivoting end effectors, e.g. forceps including means for cutting having a moving blade for cutting tissue grasped by the jaws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
- A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
Definitions
- the present disclosure relates generally to the field of surgical instruments.
- the disclosure relates to electrosurgical forceps that enables selective engagement of a mode to automatically deliver electrosurgical energy upon reaching a threshold pressure between jaw members.
- Instruments such as electrosurgical forceps are commonly used in open and endoscopic surgical procedures to coagulate, cauterize and seal tissue.
- Such forceps typically include a pair of jaw members that can be controlled by a surgeon to grasp targeted tissue, such as, e.g., a blood vessel.
- the jaw members may be approximated to apply a mechanical clamping force to the tissue, and are associated with at least one electrode to permit the delivery of electrosurgical energy to the tissue.
- the combination of the mechanical clamping force and the electrosurgical energy has been demonstrated to join adjacent layers of tissue captured between the jaw members. When the adjacent layers of tissue include the walls of a blood vessel, sealing the tissue may result in hemostasis, which may facilitate the transection of the sealed tissue.
- a bipolar electrosurgical forceps typically includes opposed electrodes disposed on clamping faces of the jaw members.
- the electrodes are charged to opposite electrical potentials such that an electrosurgical current may be selectively transferred through tissue grasped between the electrodes.
- an electrosurgical current may be selectively transferred through tissue grasped between the electrodes.
- Both the pressure and gap distance influence the effectiveness of the resultant tissue seal. If an adequate gap distance is not maintained, there is a possibility that the opposed electrodes will contact one another, which may cause a short circuit and prevent energy from being transferred through the tissue. Also, if too low a force is applied the tissue may have a tendency to move before an adequate seal can be generated.
- the thickness of a typical effective tissue seal is optimally between about 0.001 and about 0.006 inches. Below this range, the seal may shred or tear and above this range the vessel walls may not be effectively joined. Closure pressures for sealing large tissue structures preferably fall within the range of about 3kg/cm 2 to about 16 kg/cm 2 .
- endoscopic surgical instruments utilize handle or levers to actuate the end effector assembly typically disposed at a distal end of the instrument. For example, actuation of the handle correspondingly actuates the jaw members in an endoscopic forceps typically with a one-to-one (1:1) ratio. Once closed about tissue electrical energy is delivered to treat tissue.
- endoscopic instruments with in-line activation surgeons prefer a clear distinction between full closure of the jaw members and in-line activation.
- Audible tones and various haptic interfaces are common feedback devices utilized for this purpose.
- the surgeon may need to simply grasp tissue between the jaw members under pressure, e.g., dissection or manipulation, without the desire to energize or otherwise treat the tissue therebetween. This may prove to be difficult with a forceps with in-line activation requiring the surgeon to pay careful attention to the various feedback devices.
- distal refers to the portion of the instrument or component thereof that is being described that is further from a user
- proximal refers to the portion of the instrument or component thereof that is being described that is closer to a user.
- tissue is meant to include variously-sized vessels.
- a surgical instrument that includes a housing having an elongated shaft extending distally therefrom and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members.
- a handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween.
- a smart energy delivery system is operably disposed on the housing and includes a selection knob moveable between: an energy delivery mode wherein upon reaching a threshold condition, energy is delivered to the jaw members; and a cold mode wherein energy activation is deactivated regardless of the threshold condition.
- the smart energy delivery system includes an activation switch disposed within the housing that is adapted to operably couple to a generator which, in turn, energizes jaw members upon activation thereof.
- the smart energy delivery system further includes: a pressure sensor disposed between the jaw members configured to electrically couple to an electrical control unit (ECU); and a solenoid valve disposed in the housing and electrically coupled to the ECU, the solenoid valve configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined between the jaw members.
- ECU electrical control unit
- solenoid valve disposed in the housing and electrically coupled to the ECU, the solenoid valve configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined between the jaw members.
- a DC power source is disposed in the housing and configured to power the ECU and/or the solenoid valve.
- the jaw members are energized upon reaching and maintaining a threshold pressure for a preset duration.
- an audible, tactile or visible indicator provides feedback to the user that the threshold pressure has been reached prior to the initiation of energy delivery.
- movement of the selection knob to the cold mode decouples the activation switch, pressure sensor, solenoid and/or the generator.
- one or more visual indicators is disposed on the housing and is configured to indicate the current mode of the smart energy delivery system.
- a surgical instrument that includes a housing having an elongated shaft extending distally therefrom and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members.
- a handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween.
- a smart energy delivery system having an activation switch disposed within the housing and adapted to operably couple to an electrosurgical generator, the activation switch configured to energize the jaw members upon activation thereof.
- a pressure sensor is disposed between the jaw members and is configured to electrically couple to an electrical control unit (ECU).
- ECU electrical control unit
- a solenoid valve is disposed in the housing and is electrically coupled to the ECU. The solenoid valve is configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined by the pressure sensor between the jaw members.
- a surgical instrument that includes a housing having an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof.
- the end effector assembly includes first and second jaw members adapted to couple to an electrosurgical generator configured to supply electrosurgical energy to the jaw members upon activation thereof.
- a handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween.
- a smart energy delivery system is including having a pressure sensor disposed between the jaw members and configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the pressure sensor reaching a predetermined pressure threshold between jaw members.
- the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables the automatic delivery of electrosurgical energy to the jaw members when the predetermined pressure threshold is reached and a cold mode wherein energy activation is deactivated regardless of the pressure between jaw members.
- a surgical instrument that includes a housing having an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof.
- the end effector assembly includes first and second jaw members adapted to couple to an electrosurgical generator configured to supply electrosurgical energy to the jaw members upon activation thereof.
- a handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move at least one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween.
- a smart energy delivery system is included and is configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the handle reaching a predetermined position relative to the housing.
- the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables the automatic delivery of electrosurgical energy to the jaw members and when the handle reaches the predetermined position relative to the housing and a cold mode wherein energy activation is deactivated regardless of the position of the handle.
- FIGS. 1A-1C are views of a prior art endoscopic electrosurgical forceps including a housing, an elongated shaft, and an end effector at a distal end thereof;
- FIGS. 2A-2B are views of a prior art open electrosurgical forceps including opposing shafts and an end effector assembly at a distal end thereof;
- FIG. 3 is a side view of an endoscopic electrosurgical forceps according to the present disclosure including a smart energy delivery system
- FIG. 4 is a block diagram showing one embodiment of a smart energy delivery system.
- FIG. 5 is a side view of another embodiment of an endoscopic electrosurgical forceps according to the present disclosure including a smart energy delivery system.
- a prior art endoscopic electrosurgical forceps 100 generally includes a housing 112 that supports various actuators thereon for remotely controlling an end effector 114 through an elongated shaft 116.
- the housing 112 is constructed of a left housing half 112a and a right housing half 112b.
- the left and right designation of the housing halves 112a, 112b refer to the respective directions as perceived by an operator using the forceps 100.
- the housing halves 112a, 112b may be constructed of sturdy plastic, and may be joined to one another by adhesives, ultrasonic welding or other suitable assembly methods.
- the housing 112 supports a stationary handle 120, a movable handle 122, a trigger 126 and a rotation knob 128.
- the movable handle 122 is operable to move the end effector 114 between an open configuration wherein a pair of opposed jaw members 130, 132 are disposed in spaced relation relative to one another, and a closed or clamping configuration wherein the jaw members 130, 132 are closer together.
- Approximation of the movable handle 122 with the stationary handle 120 serves to move the end effector 114 to the closed configuration and separation of the movable handle 122 from the stationary handle 120 serves to move the end effector 114 to the open configuration.
- the trigger 126 is operable to extend and retract a knife blade 156 (FIG. IB) through the end effector 114 when the end effector 114 is in the closed configuration.
- the rotation knob 128 serves to rotate the elongated shaft 116 and the end effector 114 about a longitudinal axis A-A extending through the forceps 100.
- the stationary handle 120 supports a depressible button 137 thereon, which is operable by the user to initiate and terminate the delivery of electrosurgical energy to the end effector 114.
- the depressible button 137 is mechanically coupled to a switch (not shown) disposed within the stationary handle 120 which is in electrical communication with an electrosurgical generator 141 via suitable electrical wiring (not explicitly referenced) extending from the housing 112 through a cable 143 extending between the housing 112 and the electrosurgical generator 141.
- the generator 141 may include devices such as the LigaSure ® Vessel Sealing Generator and the ForceTriad ® Generator sold by Medtronic.
- the cable 143 may include a connector (not shown) thereon such that the forceps 100 may be selectively coupled electrically to the generator 141.
- the end effector 114 may be moved from the open configuration (FIG. IB) wherein tissue (not shown) is received between the jaw members 130, 132, and the closed configuration (FIG. 1C), wherein the tissue is clamped and treated.
- the jaw members 130, 132 pivot about a pivot pin 144 (FIG. IB) to move the end effector 114 to the closed configuration (FIG. 1C) of wherein sealing plates 148, 150 associated with respective jaw members 132, 130 provide a pressure to tissue grasped therebetween.
- a pressure within a range between about 3 kg/cm 2 to about 16 kg/cm 2 and, desirably, within a working range of about 7kg/cm 2 to about 13 kg/cm 2 may be applied to the tissue.
- a separation or gap distance is maintained between the sealing plates 148, 150 by an array of stop members 154 (FIG. IB) disposed on or adjacent the sealing plates 148, 150. The stop members 154 contact opposing surfaces on the opposing jaw member 130, 132 and prohibit further approximation of the sealing plates 148, 150.
- an appropriate gap distance of about 0.001 inches to about 0.010 inches and, desirably, between about 0.002 inches to about 0.005 inches may be provided.
- the stop members 154 are constructed of a heat-resistant ceramic deposited onto the jaw members 130, 132.
- the stop members 154 are constructed of an electrically non-conductive plastic molded onto the jaw members 130, 132, e.g., by a process such as overmolding or injection molding.
- the upper and lower jaw members 130, 132 are electrically coupled to cable 143, and thus to the generator 141 (e.g., via respective suitable electrical wiring extending through the elongated shaft 116) to provide an electrical pathway to a pair of electrically conductive, tissue- engaging sealing plates 148, 150 disposed on the lower and upper jaw members 132, 130, respectively.
- the sealing plate 148 of the lower jaw member 132 opposes the sealing plate 150 of the upper jaw member 130.
- the sealing plates 148 and 150 are electrically coupled to opposite terminals, e.g., positive or active (+) and negative or return (-) terminals associated with the generator 141.
- bipolar energy may be provided through the sealing plates 148 and 150 to tissue.
- the sealing plates 148 and 150 may be configured to deliver monopolar energy to tissue.
- one or both sealing plates 148 and 150 deliver electrosurgical energy from an active terminal, e.g., (+), while a return pad (not shown) is placed generally on a patient and provides a return path to the opposite terminal, e.g., (-), of the generator 141.
- Each jaw member 130, 132 includes a jaw insert (not shown) and an insulator (not shown) that serves to electrically insulate the sealing plates 150, 148 from the jaw insert of the jaw members 130, 132, respectively.
- Electrosurgical energy may be delivered to the tissue through the electrically conductive seal plates 148, 150 to effect a tissue seal.
- the knife blade 156 having a sharpened distal edge 157 may be advanced through a knife channel 158 defined in one or both jaw members 130, 132 to transect the sealed tissue.
- the knife blade 156 is depicted in FIG. IB as extending from the elongated shaft 116 when the end effector 114 is in an open configuration, in some embodiments, extension of the knife blade 156 into the knife channel 158 when the end effector 114 is in the open configuration may be prevented by one or more lockout features.
- FIGS. 2A-2B a prior art open forceps 10 contemplated for use in connection with traditional open surgical procedures is shown.
- an open instrument e.g., forceps 10
- an endoscopic instrument FIGS. 1A-1C
- FIGS. 1A-1C an endoscopic instrument
- forceps 10 includes two elongated shafts 12a and 12b, each having a proximal end 14a and 14b, and a distal end 16a and 16b, respectively.
- Forceps 10 further includes an end effector assembly 200 attached to distal ends 16a and 16b of shafts 12a and 12b, respectively.
- End effector assembly 200 includes a pair of opposing jaw members 210, 220 that are pivotably connected about a pivot 203.
- Each shaft 12a and 12b includes a handle 17a and 17b disposed at the proximal end 14a and 14b thereof.
- Each handle 17a and 17b defines a finger hole 18a and 18b therethrough for receiving a finger of the user.
- Finger holes 18a and 18b facilitate movement of the shaft members 12a and 12b relative to one another between a spaced-apart position and an approximated position, which, in turn, pivot jaw members 210, 220 from an open position, wherein the jaw members 210, 220 are disposed in spaced-apart relation relative to one another, to a closed position, wherein the jaw members 210, 220 cooperate to grasp tissue therebetween.
- one of the shafts e.g., shaft 12b, includes a proximal shaft connector 19 that is designed to connect the forceps 10 to a source of electrosurgical energy such as an electrosurgical generator 141 (FIG. 1).
- Proximal shaft connector 19 secures an electrosurgical cable 310 to forceps 10 such that the user may selectively apply electrosurgical energy to electrically-conductive plates 212, 222 (see FIG 2B) of jaw members 210, 220, respectively.
- cable 310 includes a plurality of wires (not shown) extending therethrough that has sufficient length to extend through one of the shaft members, e.g., shaft member 12b, in order to provide electrical energy to the conductive plates 212, 222 of jaw members 210, 220, respectively, of end effector assembly 200, e.g., upon activation of activation switch 40b (See FIGS. 2A and 2B).
- Other types activation switches are also contemplated, e.g., finger switch, toggle switch, foot switch, etc. and may be configured for this purpose.
- Cable 310 operably connects to generator 141 via plug 300.
- Activation switch 40b is disposed at proximal end 14b of shaft member 12b and extends therefrom towards shaft member 12a.
- a corresponding surface 40a is defined along shaft member 12a toward proximal end 14a thereof and is configured to actuate activation switch 40b. More specifically, upon approximation of shaft members 12a, 12b, e.g., when jaw members 210, 220 are moved to the closed position, activation switch 40b is moved into contact with, or in close proximity of surface 40a. Upon further approximation of shaft members 12a, 12b, e.g., upon application of a pre- determined closure force to jaw members 210, 220, activation switch 40b is advanced further into surface 40a to depress activation switch 40b.
- Activation switch 40b controls the supply of electrosurgical energy to jaw members 210, 220 such that, upon depression of activation switch 40b, electrosurgical energy is supplied to conductive surface 212 and/or conductive surface 222 of jaw members 210, 220, respectively, to seal tissue grasped therebetween.
- the electrical energy may be energy supplied through a proprietary Ligasure ® sealing algorithm owned by Medtronic.
- the switch 40b may be disposed on either shaft 12a, 12b.
- forceps 400 an endoscopic electrosurgical forceps according to the present disclosure configured for use with a smart energy delivery system 410 is shown and is generally identified as forceps 400.
- Forceps 400 is similar to the above-identified forceps 100 and, as such, share many common components. For the purposes of brevity, similar components are generally identified and only those components that differ are discussed in detail below. Moreover, it is envisioned that an open forceps similar to forceps 10 may be configured in accordance with the various aspects describe below of the present disclosure.
- forceps 400 includes a housing 412 that supports a stationary handle 420, a movable handle 422, a trigger 426 and a rotation knob 428.
- the movable handle 422 is operable to move an end effector 500 between an open configuration and a closed or clamping configuration to treat tissue. Approximation of the movable handle 422 with the stationary handle 420 serves to move the end effector 500 to the closed configuration and separation of the movable handle 422 from the stationary handle 420 serves to move the end effector 500 to the open configuration.
- the trigger 426 is operable to extend and retract a knife blade, (e.g., see knife blade 156 of FIG. IB) through the end effector 500 when the end effector 500 is in the closed configuration.
- the rotation knob 428 serves to rotate the elongated shaft 416 and the end effector 500 about a longitudinal axis AA-AA extending through the forceps 400.
- a cable 443 connects the forceps to an electrosurgical generator, e.g., generator 141 of FIG. 1A.
- Smart energy delivery system (SEDS) 410 enables a surgeon to freely grasp and manipulate tissue when the forceps 400 is disposed in a first or “cold” mode and allows for the automatic delivery of electrosurgical energy when the forceps 400 is disposed in a second or “energy” mode. More particularly and unlike the in-line activation systems described above or typically switch-dependent systems of other known devices, a surgeon can opt to have the forceps 400 configured in the “cold” mode which allows the surgeon freely grasp and manipulate tissue without unintended activation of energy or an energy delivery algorithm. If and when the surgeon decides to electrically treat and cut tissue, the surgeon can opt to have the forceps 400 configured for automatic delivery of energy upon reaching a predetermined condition or threshold, e.g., pressure or gap distance between the jaw members.
- a predetermined condition or threshold e.g., pressure or gap distance between the jaw members.
- the SEDS 410 includes a selection knob 464 disposed within a slot 462 defined in the housing 412 that is selectively positionable within the slot 462 between the first or “cold” mode and the second or “energy” mode.
- One or more visual indicators are included to provide visual feedback to the user relating to the corresponding mode of the forceps 400, e.g., visual indicator 470 to signify the forceps 400 is disposed in a “cold” mode and visual indicator 475 to signify the forceps 400 is disposed in a “energy” mode.
- the SEDS 410 also may be used with two envisioned types of switching systems
- the switching systems 600, 700 for controlling the delivery of electrical energy to the end effector 500, e.g., electromechanical switching system and a mechanical switching system.
- the selection knob 464 and the visual indicators 470, 475 may be utilized in either instance while at the same time eliminating a manual energy activation switch.
- the switching systems 600, 700 are only utilized when the forceps is disposed in the “energy” delivery mode.
- FIG. 4 shows a block diagram of switching system 600 which utilizes a series of electrical and mechanical elements to automatically delivery energy once the forceps 400 reaches a threshold parameter. More particularly, generator 641 operable couples to an activation switch 630 which, in turn, energizes jaw members 610, 620. A pressure sensor 640 disposed between the jaw members 610, 620 couples to an electrical control unit (ECU) 650 that couples to a solenoid valve 660 which, in turn, is utilized to actuate the activation switch 630. A DC power source 670 may be utilized to power the ECU 650 and solenoid valve 660.
- ECU electrical control unit
- the surgeon grasps and manipulates tissue with the jaw members 610, 620 by actuating the movable handle 422 as needed. Once the desired tissue is disposed between the jaw members 610, 620, the surgeon fully actuates the movable handle 422 relative to handle 420 to apply further pressure to the tissue.
- the pressure sensor 640 sends a signal to the ECU 650 which then communicates with the solenoid valve 660 to activate the activation switch 630 to energize the tissue between the jaw members 610, 620.
- Activation may happen as soon as the threshold pressure is reached or after a predetermined threshold pressure between the jaw members 610, 620 is reached for a preset time limit.
- One or more algorithms may be utilized for this purpose. Once activated, the energy delivery may be controlled by an algorithm, e.g., the Ligasure ® sealing algorithm owned by Medtronic.
- the solenoid 660 e.g., solenoid 660 deactivates the position sensor, the pressure sensor 640, and/or simply decouples the electrical connection to the generator 141.
- forceps 700 may be used with a SEDS 710 having a mechanical switching system 760 as shown in FIG. 5.
- Forceps 700 is similar to the above-identified forceps 100, 400 and, as such, share many common components. For the purposes of brevity, similar components are generally identified and only those components that differ are discussed in detail below.
- forceps 700 includes a housing 712 that supports a stationary handle 720, a movable handle 722, a trigger 726 and a rotation knob 728.
- the movable handle 722 is operable to move an end effector 800 between an open configuration and a closed or clamping configuration to treat tissue. Approximation of the movable handle 722 with the stationary handle 720 serves to move the end effector 800 to the closed configuration and separation of the movable handle 722 from the stationary handle 720 serves to move the end effector 800 to the open configuration.
- the trigger 726 is operable to extend and retract a knife blade, (e.g., see knife blade 156 of FIG. IB) through the end effector 800 when the end effector 800 is in the closed configuration.
- the rotation knob 728 serves to rotate the elongated shaft 716 and the end effector 800 about a longitudinal axis AAA-AAA extending through the forceps 700.
- a cable 743 connects the forceps 700 to an electrosurgical generator, e.g., generator 141 of FIG. 1A or generator 641 of FIG. 4.
- the SEDS 710 of forceps 700 enables a surgeon to freely grasp and manipulate tissue when the forceps 700 is disposed in a first or “cold” mode and allows for the automatic delivery energy when the forceps 700 is disposed in a second or “energy” mode. If and when the surgeon decides to electrically treat and cut tissue, the surgeon can opt to have the forceps 700 configured for automatic delivery of energy upon the movable handle 722 reaching a predetermined position.
- the SEDS 710 includes a selection knob 764 disposed within a slot 762 defined in the housing 712 that is selectively positionable within the slot 762 between the first or “cold” mode and the second or “energy” mode.
- One or more visual indicators are included to provide visual feedback to the user relating to the corresponding mode of the forceps 700, e.g., visual indicator 770 to signify the forceps 700 is disposed in a “cold” mode and visual indicator 775 to signify the forceps 700 is disposed in a “energy” mode.
- Activation switch 780 may be disposed anywhere in the housing 712 and the threshold position may be sensed electrically or electro-mechanically (e.g., via a position sensor or the like) or, simply mechanically by movement or rotation of one or more mechanical components (not shown) to activate the activation switch 780, e.g., rotation of one or more components of the moveable handle 722.
- a tactile indicator, visual indicator and/or audible tone 655 may be used to signify that the movable handle 722 has reached the preset or threshold position and energy delivery is imminent or will be delivered after a predetermined time period, e.g., one second, two seconds, etc. Energy is then delivered according to the energy algorithm, e.g., Ligasure ® sealing algorithm. An end tone or tactile indication may be utilized to alert the surgeon upon tissue treatment completion.
- the surgeon When disposed in the “cold” mode, the surgeon is free to manipulate, grasp and dissect tissue as needed during surgery without unintentionally activating electrosurgical energy. Once energy delivery is desired, the surgeon simply moves the selection knob 764 to the “energy” mode position and grasps the tissue. In embodiments, the surgeon may manipulate and grasp tissue and then move the selection knob 764 to the “energy” mode while tissue continues to be grasped. If the movable handle 722 is disposed in the preset or threshold position, energy will be delivered (or delivered after a preset time limit). If the moveable handle 722 is not reached the preset or threshold position, the surgeon further grasps the tissue to activate energy.
- the forceps 700 may be used as a traditional grasper or dissection instrument or, if desired, as a cold cutting instrument, i.e., cutting tissue without energy activation.
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Abstract
A surgical instrument includes a housing (412) having an elongated shaft (416) extending distally therefrom and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members (500). A handle (422) is operably coupled to the housing and is moveable relative thereto to move the jaw members relative to each other to grasp tissue therebetween. A smart energy delivery system is disposed on the housing and includes a selection knob (464) moveable between: an energy delivery mode wherein movement of the handle to a preset position relative to the housing will automatically activate the delivery of electrosurgical energy; and a cold mode wherein energy activation is deactivated regardless of the position of the handle relative to the housing.
Description
ELECTROSTJRGICAL FORCEPS WITH SMART ENERGY DELIVERY SYSTEM
BACKGROUND
1. Technical Field
[0001] The present disclosure relates generally to the field of surgical instruments. In particular, the disclosure relates to electrosurgical forceps that enables selective engagement of a mode to automatically deliver electrosurgical energy upon reaching a threshold pressure between jaw members.
2. Background of Related Art
[0002] Instruments such as electrosurgical forceps are commonly used in open and endoscopic surgical procedures to coagulate, cauterize and seal tissue. Such forceps typically include a pair of jaw members that can be controlled by a surgeon to grasp targeted tissue, such as, e.g., a blood vessel. The jaw members may be approximated to apply a mechanical clamping force to the tissue, and are associated with at least one electrode to permit the delivery of electrosurgical energy to the tissue. The combination of the mechanical clamping force and the electrosurgical energy has been demonstrated to join adjacent layers of tissue captured between the jaw members. When the adjacent layers of tissue include the walls of a blood vessel, sealing the tissue may result in hemostasis, which may facilitate the transection of the sealed tissue. A detailed discussion of the use of an electrosurgical forceps may be found in U.S. Patent No
7,255,697 to Dycus et al.
[0003] A bipolar electrosurgical forceps typically includes opposed electrodes disposed on clamping faces of the jaw members. The electrodes are charged to opposite electrical potentials such that an electrosurgical current may be selectively transferred through tissue grasped between the electrodes. To effect a proper seal, particularly in relatively large vessels, two predominant mechanical parameters must be accurately controlled; the pressure applied to the vessel, and the gap distance established between the electrodes.
[0004] Both the pressure and gap distance influence the effectiveness of the resultant tissue seal. If an adequate gap distance is not maintained, there is a possibility that the opposed electrodes will contact one another, which may cause a short circuit and prevent energy from being transferred through the tissue. Also, if too low a force is applied the tissue may have a tendency to move before an adequate seal can be generated. The thickness of a typical effective tissue seal is optimally between about 0.001 and about 0.006 inches. Below this range, the seal may shred or tear and above this range the vessel walls may not be effectively joined. Closure pressures for sealing large tissue structures preferably fall within the range of about 3kg/cm2 to about 16 kg/cm2.
[0005] Many endoscopic surgical instruments utilize handle or levers to actuate the end effector assembly typically disposed at a distal end of the instrument. For example, actuation of the handle correspondingly actuates the jaw members in an endoscopic forceps typically with a one-to-one (1:1) ratio. Once closed about tissue electrical energy is delivered to treat tissue. With endoscopic instruments with in-line activation surgeons’ prefer a clear distinction between full closure of the jaw members and in-line activation. Audible tones and various haptic interfaces are common feedback devices utilized for this purpose. However, in some instances the surgeon may need to simply grasp tissue between the jaw members under pressure, e.g.,
dissection or manipulation, without the desire to energize or otherwise treat the tissue therebetween. This may prove to be difficult with a forceps with in-line activation requiring the surgeon to pay careful attention to the various feedback devices.
SUMMARY
[0006] As used herein, the term “distal” refers to the portion of the instrument or component thereof that is being described that is further from a user, while the term “proximal” refers to the portion of the instrument or component thereof that is being described that is closer to a user. Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any of the other aspects described herein. As used herein the term “tissue” is meant to include variously-sized vessels.
[0007] Provided in accordance with aspects of the present disclosure is a surgical instrument that includes a housing having an elongated shaft extending distally therefrom and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members. A handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween. A smart energy delivery system is operably disposed on the housing and includes a selection knob moveable between: an energy delivery mode wherein upon reaching a threshold condition, energy is delivered to the jaw members; and a cold mode wherein energy activation is deactivated regardless of the threshold condition.
[0008] In aspects according to the present disclosure, the smart energy delivery system includes an activation switch disposed within the housing that is adapted to operably couple to a generator which, in turn, energizes jaw members upon activation thereof.
[0009] In aspects according to the present disclosure, the smart energy delivery system further includes: a pressure sensor disposed between the jaw members configured to electrically couple to an electrical control unit (ECU); and a solenoid valve disposed in the housing and electrically coupled to the ECU, the solenoid valve configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined between the jaw members. In other aspects according to the present disclosure, a DC power source is disposed in the housing and configured to power the ECU and/or the solenoid valve.
[0010] In aspects according to the present disclosure, the jaw members are energized upon reaching and maintaining a threshold pressure for a preset duration. In other aspects according to the present disclosure, an audible, tactile or visible indicator provides feedback to the user that the threshold pressure has been reached prior to the initiation of energy delivery. [0011] In aspects according to the present disclosure, movement of the selection knob to the cold mode decouples the activation switch, pressure sensor, solenoid and/or the generator. [0012] In aspects according to the present disclosure, one or more visual indicators is disposed on the housing and is configured to indicate the current mode of the smart energy delivery system.
[0013] Provided in accordance with aspects of the present disclosure is a surgical instrument that includes a housing having an elongated shaft extending distally therefrom and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members. A handle is operably coupled to the housing and is
moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween.
[0014] A smart energy delivery system is included having an activation switch disposed within the housing and adapted to operably couple to an electrosurgical generator, the activation switch configured to energize the jaw members upon activation thereof. A pressure sensor is disposed between the jaw members and is configured to electrically couple to an electrical control unit (ECU). A solenoid valve is disposed in the housing and is electrically coupled to the ECU. The solenoid valve is configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined by the pressure sensor between the jaw members.
[0015] Provided in accordance with aspects of the present disclosure is a surgical instrument that includes a housing having an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof. The end effector assembly includes first and second jaw members adapted to couple to an electrosurgical generator configured to supply electrosurgical energy to the jaw members upon activation thereof. A handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween. A smart energy delivery system is including having a pressure sensor disposed between the jaw members and configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the pressure sensor reaching a predetermined pressure threshold between jaw members.
[0016] In aspects according to the present disclosure, the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables
the automatic delivery of electrosurgical energy to the jaw members when the predetermined pressure threshold is reached and a cold mode wherein energy activation is deactivated regardless of the pressure between jaw members.
[0017] Provided in accordance with aspects of the present disclosure is a surgical instrument that includes a housing having an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof. The end effector assembly includes first and second jaw members adapted to couple to an electrosurgical generator configured to supply electrosurgical energy to the jaw members upon activation thereof. A handle is operably coupled to the housing and is moveable relative thereto to actuate the end effector assembly and move at least one or both of the first or second jaw members relative to the other jaw member to grasp tissue therebetween. A smart energy delivery system is included and is configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the handle reaching a predetermined position relative to the housing.
[0018] In aspects according to the present disclosure, the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables the automatic delivery of electrosurgical energy to the jaw members and when the handle reaches the predetermined position relative to the housing and a cold mode wherein energy activation is deactivated regardless of the position of the handle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure.
[0020] FIGS. 1A-1C are views of a prior art endoscopic electrosurgical forceps including a housing, an elongated shaft, and an end effector at a distal end thereof;
[0021] FIGS. 2A-2B are views of a prior art open electrosurgical forceps including opposing shafts and an end effector assembly at a distal end thereof;
[0022] FIG. 3 is a side view of an endoscopic electrosurgical forceps according to the present disclosure including a smart energy delivery system;
[0023] FIG. 4 is a block diagram showing one embodiment of a smart energy delivery system; and
[0024] FIG. 5 is a side view of another embodiment of an endoscopic electrosurgical forceps according to the present disclosure including a smart energy delivery system.
DETAILED DESCRIPTION
[0025] Referring initially to FIG. 1A, a prior art endoscopic electrosurgical forceps 100 generally includes a housing 112 that supports various actuators thereon for remotely controlling an end effector 114 through an elongated shaft 116. Although this configuration is typically associated with instruments for use in laparoscopic or endoscopic surgical procedures, various aspects of the present disclosure may be practiced with traditional open instruments and in connection with endoluminal procedures as well (See FIG. 2A). The housing 112 is constructed of a left housing half 112a and a right housing half 112b. The left and right designation of the housing halves 112a, 112b refer to the respective directions as perceived by an operator using the forceps 100. The housing halves 112a, 112b may be constructed of sturdy plastic, and may be joined to one another by adhesives, ultrasonic welding or other suitable assembly methods.
[0026] To mechanically control the end effector 114, the housing 112 supports a stationary handle 120, a movable handle 122, a trigger 126 and a rotation knob 128. The movable handle 122 is operable to move the end effector 114 between an open configuration wherein a pair of opposed jaw members 130, 132 are disposed in spaced relation relative to one another, and a closed or clamping configuration wherein the jaw members 130, 132 are closer together. Approximation of the movable handle 122 with the stationary handle 120 serves to move the end effector 114 to the closed configuration and separation of the movable handle 122 from the stationary handle 120 serves to move the end effector 114 to the open configuration. The trigger 126 is operable to extend and retract a knife blade 156 (FIG. IB) through the end effector 114 when the end effector 114 is in the closed configuration. The rotation knob 128 serves to rotate the elongated shaft 116 and the end effector 114 about a longitudinal axis A-A extending through the forceps 100.
[0027] To electrically control the end effector 114, the stationary handle 120 supports a depressible button 137 thereon, which is operable by the user to initiate and terminate the delivery of electrosurgical energy to the end effector 114. The depressible button 137 is mechanically coupled to a switch (not shown) disposed within the stationary handle 120 which is in electrical communication with an electrosurgical generator 141 via suitable electrical wiring (not explicitly referenced) extending from the housing 112 through a cable 143 extending between the housing 112 and the electrosurgical generator 141. The generator 141 may include devices such as the LigaSure® Vessel Sealing Generator and the ForceTriad® Generator sold by Medtronic. The cable 143 may include a connector (not shown) thereon such that the forceps 100 may be selectively coupled electrically to the generator 141.
[0028] As mentioned above, the end effector 114 may be moved from the open configuration (FIG. IB) wherein tissue (not shown) is received between the jaw members 130, 132, and the closed configuration (FIG. 1C), wherein the tissue is clamped and treated. The jaw members 130, 132 pivot about a pivot pin 144 (FIG. IB) to move the end effector 114 to the closed configuration (FIG. 1C) of wherein sealing plates 148, 150 associated with respective jaw members 132, 130 provide a pressure to tissue grasped therebetween. In some embodiments, to provide an effective tissue seal, a pressure within a range between about 3 kg/cm2 to about 16 kg/cm2 and, desirably, within a working range of about 7kg/cm2 to about 13 kg/cm2, may be applied to the tissue. Also, in the closed configuration, a separation or gap distance is maintained between the sealing plates 148, 150 by an array of stop members 154 (FIG. IB) disposed on or adjacent the sealing plates 148, 150. The stop members 154 contact opposing surfaces on the opposing jaw member 130, 132 and prohibit further approximation of the sealing plates 148, 150. In some embodiments, to provide an effective tissue seal, an appropriate gap distance of about 0.001 inches to about 0.010 inches and, desirably, between about 0.002 inches to about 0.005 inches, may be provided. In some embodiments, the stop members 154 are constructed of a heat-resistant ceramic deposited onto the jaw members 130, 132. In other embodiments, the stop members 154 are constructed of an electrically non-conductive plastic molded onto the jaw members 130, 132, e.g., by a process such as overmolding or injection molding.
[0029] The upper and lower jaw members 130, 132 are electrically coupled to cable 143, and thus to the generator 141 (e.g., via respective suitable electrical wiring extending through the elongated shaft 116) to provide an electrical pathway to a pair of electrically conductive, tissue- engaging sealing plates 148, 150 disposed on the lower and upper jaw members 132, 130,
respectively. The sealing plate 148 of the lower jaw member 132 opposes the sealing plate 150 of the upper jaw member 130. In some embodiments, the sealing plates 148 and 150 are electrically coupled to opposite terminals, e.g., positive or active (+) and negative or return (-) terminals associated with the generator 141. Thus, bipolar energy may be provided through the sealing plates 148 and 150 to tissue.
[0030] Alternatively, the sealing plates 148 and 150 may be configured to deliver monopolar energy to tissue. In a monopolar configuration, one or both sealing plates 148 and 150 deliver electrosurgical energy from an active terminal, e.g., (+), while a return pad (not shown) is placed generally on a patient and provides a return path to the opposite terminal, e.g., (-), of the generator 141. Each jaw member 130, 132 includes a jaw insert (not shown) and an insulator (not shown) that serves to electrically insulate the sealing plates 150, 148 from the jaw insert of the jaw members 130, 132, respectively.
[0031] Electrosurgical energy may be delivered to the tissue through the electrically conductive seal plates 148, 150 to effect a tissue seal. Once a tissue seal is established, the knife blade 156 having a sharpened distal edge 157 may be advanced through a knife channel 158 defined in one or both jaw members 130, 132 to transect the sealed tissue. Although the knife blade 156 is depicted in FIG. IB as extending from the elongated shaft 116 when the end effector 114 is in an open configuration, in some embodiments, extension of the knife blade 156 into the knife channel 158 when the end effector 114 is in the open configuration may be prevented by one or more lockout features.
[0032] Referring now to FIGS. 2A-2B, a prior art open forceps 10 contemplated for use in connection with traditional open surgical procedures is shown. For the purposes herein, either an open instrument, e.g., forceps 10, or an endoscopic instrument (FIGS. 1A-1C) may be utilized
in accordance with the present disclosure. Obviously, different electrical and mechanical connections and considerations apply to each particular type of instrument; however, the novel aspects with respect to the end effector assembly and its operating characteristics remain generally consistent with respect to both the open and endoscopic configurations.
[0033] With continued reference to FIGS. 2A-2B, forceps 10 includes two elongated shafts 12a and 12b, each having a proximal end 14a and 14b, and a distal end 16a and 16b, respectively. Forceps 10 further includes an end effector assembly 200 attached to distal ends 16a and 16b of shafts 12a and 12b, respectively. End effector assembly 200 includes a pair of opposing jaw members 210, 220 that are pivotably connected about a pivot 203. Each shaft 12a and 12b includes a handle 17a and 17b disposed at the proximal end 14a and 14b thereof. Each handle 17a and 17b defines a finger hole 18a and 18b therethrough for receiving a finger of the user. Finger holes 18a and 18b facilitate movement of the shaft members 12a and 12b relative to one another between a spaced-apart position and an approximated position, which, in turn, pivot jaw members 210, 220 from an open position, wherein the jaw members 210, 220 are disposed in spaced-apart relation relative to one another, to a closed position, wherein the jaw members 210, 220 cooperate to grasp tissue therebetween.
[0034] Continuing with reference to FIGS. 2A-2B, one of the shafts, e.g., shaft 12b, includes a proximal shaft connector 19 that is designed to connect the forceps 10 to a source of electrosurgical energy such as an electrosurgical generator 141 (FIG. 1). Proximal shaft connector 19 secures an electrosurgical cable 310 to forceps 10 such that the user may selectively apply electrosurgical energy to electrically-conductive plates 212, 222 (see FIG 2B) of jaw members 210, 220, respectively.
[0035] More specifically, cable 310 includes a plurality of wires (not shown) extending therethrough that has sufficient length to extend through one of the shaft members, e.g., shaft member 12b, in order to provide electrical energy to the conductive plates 212, 222 of jaw members 210, 220, respectively, of end effector assembly 200, e.g., upon activation of activation switch 40b (See FIGS. 2A and 2B). Other types activation switches are also contemplated, e.g., finger switch, toggle switch, foot switch, etc. and may be configured for this purpose. Cable 310 operably connects to generator 141 via plug 300.
[0036] Activation switch 40b is disposed at proximal end 14b of shaft member 12b and extends therefrom towards shaft member 12a. A corresponding surface 40a is defined along shaft member 12a toward proximal end 14a thereof and is configured to actuate activation switch 40b. More specifically, upon approximation of shaft members 12a, 12b, e.g., when jaw members 210, 220 are moved to the closed position, activation switch 40b is moved into contact with, or in close proximity of surface 40a. Upon further approximation of shaft members 12a, 12b, e.g., upon application of a pre- determined closure force to jaw members 210, 220, activation switch 40b is advanced further into surface 40a to depress activation switch 40b. Activation switch 40b controls the supply of electrosurgical energy to jaw members 210, 220 such that, upon depression of activation switch 40b, electrosurgical energy is supplied to conductive surface 212 and/or conductive surface 222 of jaw members 210, 220, respectively, to seal tissue grasped therebetween. The electrical energy may be energy supplied through a proprietary Ligasure® sealing algorithm owned by Medtronic. The switch 40b may be disposed on either shaft 12a, 12b.
[0037] Referring to FIG. 3, an endoscopic electrosurgical forceps according to the present disclosure configured for use with a smart energy delivery system 410 is shown and is
generally identified as forceps 400. Forceps 400 is similar to the above-identified forceps 100 and, as such, share many common components. For the purposes of brevity, similar components are generally identified and only those components that differ are discussed in detail below. Moreover, it is envisioned that an open forceps similar to forceps 10 may be configured in accordance with the various aspects describe below of the present disclosure. In general, forceps 400 includes a housing 412 that supports a stationary handle 420, a movable handle 422, a trigger 426 and a rotation knob 428. The movable handle 422 is operable to move an end effector 500 between an open configuration and a closed or clamping configuration to treat tissue. Approximation of the movable handle 422 with the stationary handle 420 serves to move the end effector 500 to the closed configuration and separation of the movable handle 422 from the stationary handle 420 serves to move the end effector 500 to the open configuration.
[0038] The trigger 426 is operable to extend and retract a knife blade, (e.g., see knife blade 156 of FIG. IB) through the end effector 500 when the end effector 500 is in the closed configuration. The rotation knob 428 serves to rotate the elongated shaft 416 and the end effector 500 about a longitudinal axis AA-AA extending through the forceps 400. A cable 443 connects the forceps to an electrosurgical generator, e.g., generator 141 of FIG. 1A.
[0039] Smart energy delivery system (SEDS) 410 enables a surgeon to freely grasp and manipulate tissue when the forceps 400 is disposed in a first or “cold” mode and allows for the automatic delivery of electrosurgical energy when the forceps 400 is disposed in a second or “energy” mode. More particularly and unlike the in-line activation systems described above or typically switch-dependent systems of other known devices, a surgeon can opt to have the forceps 400 configured in the “cold” mode which allows the surgeon freely grasp and manipulate tissue without unintended activation of energy or an energy delivery algorithm. If and when the
surgeon decides to electrically treat and cut tissue, the surgeon can opt to have the forceps 400 configured for automatic delivery of energy upon reaching a predetermined condition or threshold, e.g., pressure or gap distance between the jaw members.
[0040] More particularly and as shown in FIG. 3 above, the SEDS 410 includes a selection knob 464 disposed within a slot 462 defined in the housing 412 that is selectively positionable within the slot 462 between the first or “cold” mode and the second or “energy” mode. One or more visual indicators (and/or audible) are included to provide visual feedback to the user relating to the corresponding mode of the forceps 400, e.g., visual indicator 470 to signify the forceps 400 is disposed in a “cold” mode and visual indicator 475 to signify the forceps 400 is disposed in a “energy” mode.
[0041] The SEDS 410 also may be used with two envisioned types of switching systems
600, 700 for controlling the delivery of electrical energy to the end effector 500, e.g., electromechanical switching system and a mechanical switching system. The selection knob 464 and the visual indicators 470, 475 may be utilized in either instance while at the same time eliminating a manual energy activation switch. The switching systems 600, 700 are only utilized when the forceps is disposed in the “energy” delivery mode.
[0042] FIG. 4 shows a block diagram of switching system 600 which utilizes a series of electrical and mechanical elements to automatically delivery energy once the forceps 400 reaches a threshold parameter. More particularly, generator 641 operable couples to an activation switch 630 which, in turn, energizes jaw members 610, 620. A pressure sensor 640 disposed between the jaw members 610, 620 couples to an electrical control unit (ECU) 650 that couples to a solenoid valve 660 which, in turn, is utilized to actuate the activation switch 630. A DC power source 670 may be utilized to power the ECU 650 and solenoid valve 660. When the “energy”
mode is selected by the surgeon, the surgeon grasps and manipulates tissue with the jaw members 610, 620 by actuating the movable handle 422 as needed. Once the desired tissue is disposed between the jaw members 610, 620, the surgeon fully actuates the movable handle 422 relative to handle 420 to apply further pressure to the tissue.
[0043] When the pressure between the jaw members 610, 620 reaches a predetermined threshold, the pressure sensor 640 sends a signal to the ECU 650 which then communicates with the solenoid valve 660 to activate the activation switch 630 to energize the tissue between the jaw members 610, 620. Activation may happen as soon as the threshold pressure is reached or after a predetermined threshold pressure between the jaw members 610, 620 is reached for a preset time limit. One or more algorithms may be utilized for this purpose. Once activated, the energy delivery may be controlled by an algorithm, e.g., the Ligasure® sealing algorithm owned by Medtronic.
[0044] Moving the selection knob 664 to the “cold” mode deactivates the activation switch 630, the solenoid 660, e.g., solenoid 660 deactivates the position sensor, the pressure sensor 640, and/or simply decouples the electrical connection to the generator 141.
[0045] In embodiments, forceps 700 may be used with a SEDS 710 having a mechanical switching system 760 as shown in FIG. 5. Forceps 700 is similar to the above-identified forceps 100, 400 and, as such, share many common components. For the purposes of brevity, similar components are generally identified and only those components that differ are discussed in detail below. In general, forceps 700 includes a housing 712 that supports a stationary handle 720, a movable handle 722, a trigger 726 and a rotation knob 728. The movable handle 722 is operable to move an end effector 800 between an open configuration and a closed or clamping configuration to treat tissue. Approximation of the movable handle 722 with the stationary
handle 720 serves to move the end effector 800 to the closed configuration and separation of the movable handle 722 from the stationary handle 720 serves to move the end effector 800 to the open configuration.
[0046] The trigger 726 is operable to extend and retract a knife blade, (e.g., see knife blade 156 of FIG. IB) through the end effector 800 when the end effector 800 is in the closed configuration. The rotation knob 728 serves to rotate the elongated shaft 716 and the end effector 800 about a longitudinal axis AAA-AAA extending through the forceps 700. A cable 743 connects the forceps 700 to an electrosurgical generator, e.g., generator 141 of FIG. 1A or generator 641 of FIG. 4.
[0047] The SEDS 710 of forceps 700 enables a surgeon to freely grasp and manipulate tissue when the forceps 700 is disposed in a first or “cold” mode and allows for the automatic delivery energy when the forceps 700 is disposed in a second or “energy” mode. If and when the surgeon decides to electrically treat and cut tissue, the surgeon can opt to have the forceps 700 configured for automatic delivery of energy upon the movable handle 722 reaching a predetermined position. As mentioned above in FIG. 3, the SEDS 710 includes a selection knob 764 disposed within a slot 762 defined in the housing 712 that is selectively positionable within the slot 762 between the first or “cold” mode and the second or “energy” mode. One or more visual indicators (and/or audible) are included to provide visual feedback to the user relating to the corresponding mode of the forceps 700, e.g., visual indicator 770 to signify the forceps 700 is disposed in a “cold” mode and visual indicator 775 to signify the forceps 700 is disposed in a “energy” mode.
[0048] When the forceps is disposed in the “energy” mode, rotation of the moveable handle 722 to a preset or threshold position relative to handle 720 activates the activation switch
780 disposed in the housing 712. Activation switch 780 may be disposed anywhere in the housing 712 and the threshold position may be sensed electrically or electro-mechanically (e.g., via a position sensor or the like) or, simply mechanically by movement or rotation of one or more mechanical components (not shown) to activate the activation switch 780, e.g., rotation of one or more components of the moveable handle 722. In embodiments, a tactile indicator, visual indicator and/or audible tone 655 (shown in phantom) may be used to signify that the movable handle 722 has reached the preset or threshold position and energy delivery is imminent or will be delivered after a predetermined time period, e.g., one second, two seconds, etc. Energy is then delivered according to the energy algorithm, e.g., Ligasure® sealing algorithm. An end tone or tactile indication may be utilized to alert the surgeon upon tissue treatment completion.
[0049] Once the surgeon releases the movable handle 722 (e.g., when the moveable handle 722 is no longer at the preset or threshold position), energy is ceased enabling the surgeon to cut the tissue or reposition the jaw members (e.g., jaw members 610, 620) about tissue. At this point the algorithm resets for another tissue treatment.
[0050] When the forceps is disposed in the “cold” mode, rotation of the moveable handle
722 to any position including the preset or threshold position relative to handle 720 will not cause energy activation. Moving the selection knob 764 to the “cold” mode deactivates the activation switch 780, deactivates the position sensor, or simply decouples the electrical connection to the generator 141.
[0051] When disposed in the “cold” mode, the surgeon is free to manipulate, grasp and dissect tissue as needed during surgery without unintentionally activating electrosurgical energy. Once energy delivery is desired, the surgeon simply moves the selection knob 764 to the “energy” mode position and grasps the tissue. In embodiments, the surgeon may manipulate and
grasp tissue and then move the selection knob 764 to the “energy” mode while tissue continues to be grasped. If the movable handle 722 is disposed in the preset or threshold position, energy will be delivered (or delivered after a preset time limit). If the moveable handle 722 is not reached the preset or threshold position, the surgeon further grasps the tissue to activate energy.
[0052] Although not explicitly shown, either of the above-described SEDS may be utilized with the forceps 10 described above. In this instance, certain features or components may have to rearranged to accomplish this purpose.
[0053] Once the selection knob 764 is moved to the “cold” mode, the forceps 700 (or forceps 400) may be used as a traditional grasper or dissection instrument or, if desired, as a cold cutting instrument, i.e., cutting tissue without energy activation.
[0054] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as examples of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
[0055] Although the foregoing disclosure has been described in some detail by way of illustration and example, for purposes of clarity or understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.
Claims
1. A surgical instrument, comprising: a housing; an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members; a handle operably coupled to the housing and moveable relative thereto to actuate the end effector assembly and move at least one of the first or second jaw members relative to the other jaw member to grasp tissue therebetween; and a smart energy delivery system operably disposed on the housing and including a selection knob moveable between: an energy delivery mode wherein upon reaching a threshold condition, energy is delivered to the jaw members; and a cold mode wherein energy activation is deactivated regardless of the threshold condition.
2. The surgical instrument according to claim 1, wherein the smart energy delivery system includes an activation switch disposed within the housing that is adapted to operably couple to a generator which, in turn, energizes jaw members upon activation thereof.
3. The surgical instrument according to claim 2, wherein the smart energy delivery system further includes: a pressure sensor disposed between the jaw members configured to electrically couple to an electrical control unit (ECU); and
a solenoid valve disposed in the housing and electrically coupled to the ECU, the solenoid valve configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined between the jaw members.
4. The surgical instrument according to claim 3, further comprising a DC power source disposed in the housing and configured to power at least one of the ECU or the solenoid valve.
5. The surgical instrument according to claim 3, wherein the jaw members are energized upon reaching and maintaining a threshold pressure for a preset duration.
6. The surgical instrument according to claim 5, wherein an audible, tactile or visible indicator provides feedback to the user that the threshold pressure has been reached prior to the initiation of energy delivery.
7. The surgical instrument according to claim 3, wherein movement of the selection knob to the cold mode decouples at least one of the activation switch, pressure sensor, solenoid or generator.
8. The surgical instrument according to claim 1, further comprising at least one visual indicator disposed on the housing configured to indicate the current mode of the smart energy delivery system.
9. A surgical instrument, comprising: a housing; an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members; a handle operably coupled to the housing and moveable relative thereto to actuate the end effector assembly and move at least one of the first or second jaw members relative to the other jaw member to grasp tissue therebetween; a smart energy delivery system including: an activation switch disposed within the housing and adapted to operably couple to an electrosurgical generator, the activation switch configured to energize the jaw members upon activation thereof; a pressure sensor disposed between the jaw members configured to electrically couple to an electrical control unit (ECU); and a solenoid valve disposed in the housing and electrically coupled to the ECU, the solenoid valve configured to actuate the activation switch to energize the jaw members when a threshold pressure is determined by the pressure sensor between the jaw members.
10. A surgical instrument, comprising: a housing; an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw
members adapted to couple to an electrosurgical generator configured to supply electrosurgical energy to the jaw members upon activation thereof; a handle operably coupled to the housing and moveable relative thereto to actuate the end effector assembly and move at least one of the first or second jaw members relative to the other jaw member to grasp tissue therebetween; and a smart energy delivery system including a pressure sensor disposed between the jaw members and configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the pressure sensor reaching a predetermined pressure threshold between jaw members.
11. The surgical instrument according to claim 10 wherein the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables the automatic delivery of electrosurgical energy to the jaw members when the predetermined pressure threshold is reached and a cold mode wherein energy activation is deactivated regardless of the pressure between jaw members.
12. A surgical instrument, comprising: a housing; an elongated shaft extending distally from the housing and configured to support an end effector assembly at a distal end thereof, the end effector assembly including first and second jaw members adapted to couple to a generator configured to supply electrosurgical energy to the jaw members upon activation thereof;
a handle operably coupled to the housing and moveable relative thereto to actuate the end effector assembly and move at least one of the first or second jaw members relative to the other jaw member to grasp tissue therebetween; and a smart energy delivery system configured to automatically initiate delivery of electrosurgical energy to the jaw members upon the handle reaching a predetermined position relative to the housing.
13. The surgical instrument according to claim 12 wherein the smart energy delivery system includes a selection knob that is selectively positionable between an energy mode that enables the automatic delivery of electrosurgical energy to the jaw members when the handle reaches the predetermined position relative to the housing and a cold mode wherein energy activation is deactivated regardless of the position of the handle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US202163194249P | 2021-05-28 | 2021-05-28 | |
US63/194,249 | 2021-05-28 |
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WO2022248970A1 true WO2022248970A1 (en) | 2022-12-01 |
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PCT/IB2022/054537 WO2022248970A1 (en) | 2021-05-28 | 2022-05-16 | Electrosurgical forceps with smart energy delivery system |
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