Techniques for segmented electrodes for energy-based surgical instruments
By designing independently controllable distal and proximal electrodes and pressure variation mechanisms in the end effector of surgical instruments, the problem of difficulty in achieving both cutting and coagulation effects in existing technologies has been solved, enabling efficient and precise tissue processing.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- CILAG GMBH INTERNATIONAL
- Filing Date
- 2025-12-26
- Publication Date
- 2026-06-30
AI Technical Summary
Existing energy-based surgical instruments struggle to achieve efficient and precise control during tissue cutting and hemostasis, especially when switching between ultrasound and electrosurgical modes, making it difficult to balance cutting and coagulation effects.
An energy-based surgical instrument has been designed, whose end effector includes independently controllable distal and proximal electrodes capable of delivering radiofrequency energy separately or in concert, and providing different pressure controls through a pressure-changing mechanism to achieve flexible switching between cutting and coagulation functions.
It enables flexible switching between cutting and coagulation modes under different tissue conditions, improving the efficiency and precision of surgical procedures and reducing tissue damage.
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Figure CN122297074A_ABST
Abstract
Description
Cross-references to related applications
[0001] This application claims the benefit and priority of U.S. Patent Application No. 63 / 740,963, filed on December 31, 2024, entitled “TECHNOLOGIES FOR TISSUE PADSAND ELECTRODES FOR ENERGY-BASED SURGICAL INSTRUMENTS”, the entire contents of which are incorporated herein by reference. Technical Field
[0002] This disclosure relates generally to energy-based surgical instruments, and more specifically to harmonic and / or electrosurgical instruments. Background Technology
[0003] Energy-based surgical instruments are increasingly used in surgical procedures due to their unique performance characteristics. Depending on the specific device configuration and operating parameters, energy-based surgical instruments can provide both transverse incisions of tissue and tissue hemostasis through coagulation, which can reduce or otherwise minimize patient trauma. Depending on the specific application, energy-based surgical instruments can utilize various surgical techniques, including, for example, ultrasound and / or electrosurgery (e.g., radiofrequency (RF)).
[0004] Typical ultrasonic surgical instruments may include a handheld component comprising an ultrasonic transducer and a slender shaft assembly with a distally mounted end effector for cutting and sealing tissue. For example, the end effector may include a jaw assembly with an ultrasonic scalpel and a gripping arm, the gripping arm including a non-adhesive tissue pad or similar base to receive the ultrasonic scalpel. In some cases, the slender shaft assembly may be permanently attached to the handheld component. In other cases, such as in the presence of disposable shaft assemblies or shaft assemblies interchangeable between different handheld components, the slender shaft assembly may be detached from the handheld component. In use, the end effector transmits ultrasonic energy to the tissue in contact with the ultrasonic scalpel of the end effector to achieve cutting and sealing actions. Such ultrasonic surgical devices can be configured for open surgical purposes, laparoscopic and / or endoscopic surgical procedures, including robot-assisted procedures.
[0005] Ultrasonic energy uses temperatures lower than those used in electrosurgical procedures to cut and coagulate tissue. Through high-frequency vibrations (e.g., 55,500 times per second), the ultrasonic scalpel denatures proteins in the tissue to form a viscous coagulate. The pressure applied to the tissue by the surface of the ultrasonic scalpel causes blood vessels to collapse and the coagulate to form a hemostatic seal. The surgeon can control the cutting speed and coagulation by the force applied to the tissue by the end effector, the duration of that force application, and the selected offset level of the end effector.
[0006] In electrosurgical instruments, one or more electrodes are incorporated into an end effector and configured to apply a therapeutic current to the patient's tissue to form a hemostatic seal. In electrosurgical instruments that do not include harmonic modes (i.e., do not include a harmonic scalpel), the end effector may be embodied as two gripping arms or jaws. In such embodiments, the electrosurgical instrument may include a separate mechanical blade or scalpel for cutting tissue after the hemostatic seal has been formed, which may be incorporated into an elongated shaft attached to the end effector. In bipolar embodiments, an active electrode may be attached to one of the gripping arms of the end effector and configured to introduce current into the tissue, which is received by a return electrode attached to the other gripping arm of the end effector (or, in embodiments including harmonic modes, as the scalpel itself). Conversely, in unipolar embodiments, the return electrode (e.g., a "grounding pad") may be separate from the electrosurgical instrument and located on a different part of the patient's body. In some embodiments, the electrosurgical instrument may also be configured to apply a subtherapeutic current to the patient's tissue, which may be used for sensing purposes (e.g., measuring tissue impedance).
[0007] Electrosurgery creates a hemostatic seal by generating heat in the tissue via introduced electrical energy, which is embodied in radio frequency (“RF”) energy. The specific frequency used can vary from about 100 kHz to 1 MHz depending on the intended use of the electrosurgical instrument, but higher frequencies may be used in some implementations. Additionally, in some cases, sub-therapeutic frequencies may be used for purposes other than hemostatic sealing, such as performing various electrical measurements on the tissue.
[0008] It should be understood that some energy-based surgical instruments can employ dual-mode or multi-mode techniques to perform transverse incisions and / or hemostasis of patient tissue. For example, in some cases, energy-based surgical instruments may include both ultrasound and electrosurgical functions (e.g., by utilizing an ultrasonic scalpel as an electrode for the electrosurgical mode), which increases the surgical options offered to the surgeon by the surgical instrument. Summary of the Invention
[0009] According to one aspect of this disclosure, an energy-based surgical instrument includes an end effector comprising a first jaw clamp and a second jaw clamp, a first electrode coupled to the first jaw clamp, and a return electrode coupled to the second jaw clamp. The first electrode includes a distal portion and a proximal portion. The distal portion and the proximal portion are independently energized to deliver radio frequency (RF) energy through tissue between the first jaw clamp and the second jaw clamp to the return electrode.
[0010] In some embodiments, the proximal portion is configured to deliver coagulation energy, and the distal portion is configured to deliver coagulation energy or cutting energy individually or collaboratively. In some embodiments, the cutting energy is higher than the coagulation energy. In some embodiments, the distal portion is configured to deliver cutting energy individually when the tissue is located only within the distal portion of the first jaw clamp. In some embodiments, the distal portion is configured to deliver coagulation energy or cutting energy collaboratively when the tissue is located within both the distal and proximal portions of the first jaw clamp.
[0011] In some embodiments, the end effector further includes a pressure changing mechanism that selectively provides limited or concentrated pressure on the distal portion of the first electrode. In some embodiments, the end effector further includes a rotation mechanism that rotates a ridge below the first or second electrode, wherein as the ridge rotates, the pressure on the distal portion of the first electrode increases.
[0012] In some embodiments, the return electrode includes a distal portion. The distal portion includes a spring-deflectable portion that is spring-biased toward and capable of deflecting away from the first electrode. In some embodiments, the spring-deflectable portion includes a deflection stop that limits the deflection of the return electrode away from the first electrode. In some embodiments, when the first and second jaw clamps are closed and tissue is present between the distal and proximal portions of the first electrode and the return electrode, the spring-deflectable portion does not reach the deflection stop, and the pressure applied to the distal portion is limited. When the first and second jaw clamps are closed and tissue is present between the distal portion of the first electrode and the return electrode, and no tissue is present between the proximal portion of the first electrode and the return electrode, the spring-deflectable portion reaches the deflection stop, and increased pressure is applied to the distal portion. In some embodiments, the surgical instrument also includes a protrusion extending from the distal portion of the return electrode toward the distal portion of the first electrode. In some embodiments, the deflection stop limiter is movable between a first position and a second position, in which the deflection of the return electrode is suppressed and in the second position, the deflection of the return electrode is not suppressed.
[0013] According to another aspect, an energy-based surgical instrument includes an end effector comprising a jaw clamp, a tissue pad coupled to the jaw clamp, and an electrode. The jaw clamp extends from a proximal end to a distal end. The tissue pad extends from the proximal end to the distal end. The tissue pad includes a non-conductive top surface having a proximal pad geometry. The electrode is coupled to the top surface of the tissue pad and extends from the proximal end to the distal end. The electrode covers a first portion of the tissue pad but not a second portion. The electrode includes a distal feature extending to the distal end of the jaw clamp, and the distal feature has a retaining shape or geometry different from the proximal pad geometry.
[0014] In some embodiments, the electrode comprises a conformal or erosive RF electrode used with an ultrasonic scalpel. In some embodiments, a distal feature of the electrode electrically interacts with the tissue, followed by a proximal portion of the electrode. In some embodiments, the tissue pad comprises polytetrafluoroethylene (PTFE).
[0015] According to another aspect, a method for controlling an energy-based surgical instrument includes clamping tissue between a first jaw clamp and a second jaw clamp of an end effector of the energy-based surgical instrument, wherein the energy-based surgical instrument includes a first electrode coupled to the first jaw clamp, the first electrode including a distal portion and a proximal portion, and wherein the energy-based surgical instrument further includes a return electrode coupled to the second jaw clamp; when the tissue is only within the distal portion of the first jaw clamp, the distal portion is energized individually to deliver radio frequency (RF) energy through the tissue between the first jaw clamp and the second jaw clamp to the return electrode; and when the tissue is within both the distal and proximal portions of the first jaw clamp, the distal and proximal portions are cooperatively energized to deliver RF energy through the tissue between the first jaw clamp and the second jaw clamp to the return electrode.
[0016] In some embodiments, energizing the distal portion independently includes delivering cutting energy; and co-energizing the distal and proximal portions includes delivering solidification energy. In some embodiments, the cutting energy is higher than the solidification energy.
[0017] In some embodiments, the method further includes providing concentrated pressure on the distal portion of the first electrode using a pressure changing mechanism when the distal portion is energized independently. In some embodiments, the method further includes providing limited pressure on the distal portion of the first electrode using a pressure changing mechanism when the distal and proximal portions are energized collaboratively. Attached Figure Description
[0018] The specific implementation method refers to the following figures, in which:
[0019] Figure 1 This is a simplified diagram of the implementation scheme for a system used to perform energy-based surgical procedures;
[0020] Figure 2 yes Figure 1 A perspective view of an implementation scheme for an energy-based surgical instrument system;
[0021] Figure 3 It includes an ultrasonic scalpel and is in the open position. Figure 2 A side front view of the jaw assembly of the end effector of a surgical instrument;
[0022] Figure 4 It includes an ultrasonic scalpel and is in a closed state. Figure 2 A side front view of the jaw assembly of the end effector of a surgical instrument;
[0023] Figure 5A yes Figure 2 A perspective view of another embodiment of an end effector for a surgical instrument, the end effector including electrodes on the lower jaw gripper of a jaw assembly;
[0024] Figure 5B yes Figure 2 A perspective view of another embodiment of an end effector for a surgical instrument, the end effector comprising two jaw grippers, each jaw gripper having an electrode attached thereto;
[0025] Figure 6 yes Figure 2 Exploded view of surgical instruments;
[0026] Figure 7 yes Figure 2 A block diagram of the control circuit for a surgical instrument;
[0027] Figure 8 yes Figure 2 A perspective view of another embodiment of an end effector for a surgical instrument, the end effector including segmented cutting electrodes;
[0028] Figure 9 It is used for control Figure 8 A simplified flowchart of at least one method for using surgical instruments; and
[0029] Figure 10 yes Figure 2 A top view of another embodiment of a jaw clamping assembly for an end effector of a surgical instrument, the jaw clamping assembly including a compliant electrode. Detailed Implementation
[0030] While the concepts of this disclosure are readily available in various modifications and alternatives, specific exemplary embodiments thereof have been shown by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this disclosure is not intended to limit the concepts to the specific forms disclosed, but rather, the object of the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
[0031] Throughout this specification, when referring to the surgical instruments described herein and the natural anatomical structures of patients, terms indicating anatomical reference, such as anterior, posterior, medial, lateral, superior, inferior, distal, proximal, etc., may be used. These terms have well-known meanings in anatomical studies and surgery. Unless otherwise stated, these anatomical reference terms used in the written details and claims are intended to be consistent with their well-known meanings.
[0032] References to "an embodiment," "an embodiment," "an exemplary embodiment," etc., in this specification mean that the embodiment may include a particular feature, structure, or characteristic, but each embodiment may or may not include that particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in connection with an embodiment, whether or not it is explicitly described, it should be assumed that implementing such a particular feature, structure, or characteristic in combination with other embodiments is within the knowledge of a person skilled in the art. Furthermore, it should be understood that items included in a list in the form of "at least one of A, B, and C" may mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C). Similarly, items listed in the form of "at least one of A, B, or C" may mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C).
[0033] In some cases, the disclosed embodiments may be implemented in hardware, firmware, software, or any combination thereof. The disclosed embodiments may also be implemented as instructions carried or stored on a transient or non-transitory machine-readable (e.g., computer-readable) storage medium, which may be read and executed by one or more processors. The machine-readable storage medium may be embodied in any storage device, mechanism, or other physical structure (e.g., volatile or non-volatile memory, media disk, or other media device) for storing or transmitting information in a machine-readable form.
[0034] In the accompanying drawings, some structural or methodological features may be shown in a specific arrangement and / or order. However, it should be understood that such a specific arrangement and / or order may not be necessary. Instead, in some embodiments, such features may be arranged in a different manner and / or order than those shown in the illustrative drawings. Furthermore, the inclusion of structural or methodological features in a particular drawing does not imply that such features are necessary in all embodiments, and in some embodiments, these features may be omitted or may be combined with other features.
[0035] See now Figure 1 and Figure 2 In an exemplary embodiment, system 100 for performing energy-based surgical procedures includes a surgical instrument 102, a transducer 104, and a generator 106. The surgical instrument 102 is exemplarily embodied as an ultrasound surgical instrument, but in other embodiments may be embodied as an electrosurgical surgical instrument or a multimodal ultrasound / electrosurgical surgical instrument. In use, the surgical instrument 102 can be used to perform various surgical procedures, including laparoscopic, endoscopic, or conventional open surgical procedures. In doing so, the surgeon may selectively activate an ultrasound mode (and / or an electrosurgical / RF mode) of the surgical instrument 102. In ultrasound mode, the generator 106 drives the transducer 104 to cause the ultrasonic scalpel 130 of the jaw assembly 122 of the end effector 120 of the surgical instrument 102 to vibrate at a reference frequency, which facilitates simultaneous cutting of patient tissue and hemostatic sealing. Additionally or alternatively, in some embodiments, the surgeon may selectively activate an electrosurgical mode of the surgical instrument 102 to deliver a therapeutic RF energy to the patient tissue to achieve hemostatic sealing. In such embodiments, the blade 130 may be embodied as an ultrasonic blade 130 or a mechanical blade designed to use mechanical force to cut tissue (e.g., in those embodiments that do not employ ultrasonic technology). Furthermore, in some embodiments, the surgical instrument 102 may be configured to have only an electrosurgical / RF mode, and in such embodiments, the jaw assembly 122 of the end effector 120 may not include the ultrasonic blade 130, as described below. Figure 5B To be discussed in more detail.
[0036] Surgical instrument 102 is illustratively embodied as ultrasonic surgical scissors, but in other embodiments may be embodied as other types of surgical instruments having an ultrasonic mode and / or an electrosurgical mode. In an illustrative embodiment, surgical instrument 102 includes a handle assembly 110 and an elongated shaft assembly 112 extending distally away from the handle assembly 110 and, in some embodiments, removably attached to the handle assembly 110. The elongated shaft assembly 112 includes an end effector 120 located at a distal end remote from the handle assembly 110. The end effector 120 includes a jaw assembly 122, which illustratively includes an ultrasonic scalpel 130 and a corresponding jaw clamp 132 (but in those embodiments having only an electrosurgical / RF mode, two jaw clamps may be included). Figure 3 and Figure 4 As shown, the jaw assembly 122 can be in the open state ( Figure 3 ) and closed state ( Figure 4 The jaw assembly 122 moves between the open and closed states. In the open state, the jaw clamp 132 is positioned away from the ultrasonic scalpel 130; in the closed state, the jaw clamp 132 is positioned near or otherwise contacts the ultrasonic scalpel 130. Actuation of the jaw assembly 122 from the open to the closed state allows for grasping, cutting, and coagulating blood vessels and / or tissues. It should be understood that the open state may correspond to a degree of opening less than the fully open position of the jaw assembly 122, and the closed state may correspond to a degree of closure less than the fully closed position. That is, the closed state may, for example, correspond to the minimum distance between the distal end of the jaw clamp 132 and the ultrasonic scalpel 130, and the open state may correspond to the maximum distance between the distal end of the jaw clamp 132 and the ultrasonic scalpel 130. However, in other embodiments, the open state may correspond to the fully open position of the jaw assembly 122, and the closed state may correspond to the fully closed position of the jaw assembly 122.
[0037] In those embodiments where the surgical instrument 102 includes both ultrasound mode and electrosurgical / RF mode, the end effector 120 may include one or more RF electrodes 500 coupled to the jaw clamp 132, such as Figure 5A As shown. Although in Figure 5AIn some embodiments, the exemplary end effector 120 includes only a single electrode 500, but it should be understood that in other embodiments, the end effector 120 may include additional electrodes 500 (e.g., multiple electrode pads 500). Electrode 500 may be embodied as an active electrode configured to deliver RF energy or a return electrode configured to “absorb” the applied RF energy. In those embodiments utilizing bipolar RF, the ultrasonic scalpel 130 may embody an active electrode or a return electrode, wherein electrode 500 embodies another active electrode or return electrode. Alternatively, other active electrodes or return electrodes may be incorporated into the ultrasonic scalpel 130 or into another portion of the jaw assembly 122 of the end effector 120. In monopolar embodiments, the RF electrode 500 may be embodied as an active electrode, and the return electrode may be attached to a portion of the patient's body.
[0038] In those embodiments where the surgical instrument 102 includes only the electrosurgical / RF mode, the jaw assembly 122 of the end effector 120 includes a jaw clamping member 532, which replaces the ultrasonic scalpel 130, such as Figure 5B As shown. In such embodiments, electrode 500 may be attached to or otherwise incorporated into each jaw clamp 132, 532 and embodied as an active electrode or a return electrode to facilitate the application of RF energy to tissue captured between jaw clamps 132, 532. In such embodiments, surgical instrument 102 may include a blade incorporated into an elongated shaft assembly 112, the blade being configured to eject outward after the tissue has been sealed with RF energy to cut the patient's tissue.
[0039] See again Figure 1 and Figure 2 In embodiments that include ultrasound capability, the handle assembly 110 includes a receiver 140 configured to receive a transducer 104 to facilitate connection of the transducer 104 to the handle assembly 110 and the elongated shaft assembly 112. The handle assembly 110 also includes a trigger assembly 150 comprising a master trigger 152 and a switch assembly 154. The master trigger 152 is operable by a surgeon to move the jaw assembly 122 of the end effector 120 between an open and closed state. The switch assembly 154 includes one or more buttons operable by a surgeon to activate (and in some embodiments, configure) an ultrasound mode and / or an electrosurgical mode of the surgical instrument 102.
[0040] Transducer 104 is illustratively connected to generator 106 via cable assembly 108. As described above, generator 106 is configured to drive transducer 104 at a reference frequency or resonant frequency, thereby causing ultrasonic scalpel 130 to vibrate. For example, in one exemplary embodiment, generator 106 may supply an electrical signal to transducer 104 to cause ultrasonic scalpel 130 of jaw assembly 122 to vibrate longitudinally in, for example, a range of approximately 20 kHz to 250 kHz. In a specific embodiment, for example, ultrasonic scalpel 130 may vibrate in a range of approximately 54 kHz to 56 kHz (e.g., at approximately 55.5 kHz). In other embodiments, ultrasonic scalpel 130 may vibrate at other frequencies, including, for example, approximately 31 kHz or approximately 80 kHz. The vibration offset of ultrasonic scalpel 130 can be controlled, for example, by controlling the amplitude of the electrical signal applied to transducer 104 by generator 106. Generator 106 may be activated such that electrical energy can be supplied to transducer 104 continuously or intermittently. The generator 106 also has a power cord (not shown) for plugging into an electrosurgical unit or a conventional power outlet. Alternatively, the generator 106 can be powered by a direct current (DC) source such as a battery.
[0041] In some embodiments, generator 106 may be configured to operate in different modes. In such embodiments, generator 106 may include an ultrasound generator module 162 for controlling an ultrasound mode, an electrosurgical / radiofrequency (RF) generator module 164 for controlling an electrosurgical mode, and / or other generator modules (e.g., a thermal generator module) for controlling other operating modes. In some embodiments, the various modes of generator 106 may operate independently of each other. For example, generator 106 may activate the ultrasound mode of ultrasound generator module 162 to apply ultrasound energy to jaw assembly 122, and subsequently, therapeutic or subtherapeutic RF energy may be applied to jaw assembly 122 via electrosurgical generator module 164. Alternatively, the activation modes of generator 106 may operate simultaneously or concurrently with each other.
[0042] In electrosurgical mode, the electrosurgical generator module 164 is configured to generate RF energy at frequencies ranging from approximately 100 kHz (100 kHz) to approximately 1 MHz (1 MHz). The generated RF energy is supplied to the patient's tissue via electrodes 500 of the end effector 120, as described above with respect to Figure 5. In some embodiments, the electrosurgical generator module 164 may also be configured to selectively provide subtherapeutic levels of RF energy to perform various electrical measurements of the patient's tissue. For example, the electrosurgical generator module 164 may be configured to measure the impedance of the patient's tissue using electrodes 500 and an appropriate level of RF energy.
[0043] See now Figure 6As described above, the exemplary surgical instrument 102 includes a handle assembly 110 and an elongated shaft assembly 112 extending distally away from the handle assembly 110. The handle assembly 110 includes a housing 600, which includes a right half-housing 602 and a left half-housing 604. The half-housings 602 and 604 are configured to mate with each other to form the housing 600. To facilitate such mating, each of the half-housings 602 and 604 may include various interfaces sized to be mechanically aligned and engaged with each other to form the housing 600 and enclose the internal working parts of the surgical instrument 102.
[0044] The main trigger 152 of the trigger assembly 150 is coupled to a linkage mechanism to convert the rotational motion of the main trigger 152 into axial motion of the bracket 610, which is then configured to move the jaw assembly 122 of the end effector 120 between an open and closed state via the elongated shaft assembly 112. The main trigger 152 includes a first set of flanges 620 having openings formed therein to receive a first bracket pin 630 extending through the bracket 610. The main trigger 152 also includes a second set of flanges 622 configured to receive a first end portion of the connector 624. A trigger pin 626 is received within the openings formed in the first end portion and the second set of flanges 622 of the connector 624. The trigger pin 626 forms a trigger pivot point for the main trigger 152. The second end portion of the connector 624, opposite the first end portion, is received within a slot formed in the proximal end portion of the bracket 610 and retained therein by the second bracket pin 632. As the master trigger 152 rotates about the pivot point formed by the trigger pin 626, the carriage 610 translates horizontally. The spring 634 is used to bias the carriage forward, such that the jaw assembly 122 of the end effector 120 is biased to the open (or fully open) state.
[0045] As described above, the trigger assembly 150 also includes a switch assembly 154. The switch assembly 154 illustratively includes a toggle switch 640 selectable to activate one or more switches 642. Activation of switch 642 energizes an electrical element 644, which energizes the ultrasonic transducer 104 to induce an ultrasonic mode of the surgical instrument 102.
[0046] The elongated shaft assembly 112 includes an outer tubular sheath 650 and a knob 652 coupled to the outer tubular sheath 650. The knob 652 is operable to rotate the outer tubular sheath 650 about an axis defined by the outer tubular sheath 650. A reciprocating tubular actuator 654 is located within the outer tubular sheath 650 and is mechanically engaged at its distal end with an end effector 120. The reciprocating tubular actuator 654 is also mechanically engaged at its proximal end with a bracket 610 within the shank assembly 110 via a coupling element 656. In an embodiment including an ultrasonic mode, an ultrasonic waveguide 670 is located within the reciprocating tubular actuator 654. The distal end of the ultrasonic waveguide 670 is acoustically coupled (e.g., directly or indirectly mechanically coupled) to an ultrasonic scalpel 130, and the proximal end is acoustically coupled to a transducer 104. The ultrasonic waveguide 670 is isolated from the other components of the elongated shaft assembly 112 by a protective sheath 672 and multiple isolation elements 674. The outer tubular sheath 650, the reciprocating tubular actuator 654, and the ultrasonic waveguide 670 are mechanically engaged together via pins 658.
[0047] See now Figure 7 In an exemplary embodiment, the surgical instrument 102 includes control circuitry 700. Control circuitry 700 includes a controller 702 and a trigger assembly 150, which cooperate to provide ultrasonic energy to the harmonic scalpel 130 of the jaw assembly 122 of the end effector 120 and / or to the RF electrode 500 of the jaw assembly 122, according to the operating modes of the surgical instrument 102 as described above. However, in other embodiments, control circuitry 700 may include additional or other electronic devices and / or circuitry.
[0048] Controller 702 may be embodied as any type of controller, function block, digital logic or other component, device, circuit or combination thereof capable of performing the functions described herein. In an exemplary embodiment, controller 702 includes processor 704, memory 706 and input / output (I / O) subsystem 708. Processor 704 may be embodied as any type of processor capable of performing the functions described herein. For example, processor 704 may be embodied as a single-core or multi-core processor, digital signal processor, microcontroller or other processor or processing / control circuitry. Similarly, memory 706 may be embodied as any type of volatile and / or non-volatile memory or data storage device capable of performing the functions described herein. In operation, memory 706 may store various data and software used during the operation of control circuitry 700, such as executable firmware or software, programs, libraries and drivers that may be executed by processor 704 or otherwise used.
[0049] Processor 704 and memory 706 are communicatively coupled to other components of control circuitry 700 via I / O subsystem 708, which may be embodied as circuitry and / or components to facilitate input / output operations between controller 702 (e.g., processor 704 and / or memory 706) and other components of control circuitry 700. For example, I / O subsystem 708 may be embodied as or otherwise include a memory controller hub, input / output control hub, firmware devices, communication links (i.e., point-to-point links, bus links, wires, cables, optical fibers, printed circuit board traces, etc.) and / or other components and subsystems facilitating input / output operations. In some embodiments, I / O subsystem 708 may form part of a system-on-a-chip (SoC) and be integrated onto a single integrated circuit chip along with processor 704, memory 706, and other components of surgical instrument 102. Additionally, in some embodiments, memory 706 or a portion thereof may be integrated into processor 704.
[0050] During operation, as described above, the controller 702 is configured to control the activation of the ultrasound mode and / or electrosurgical / RF mode of the surgical instrument 102. For this purpose, the controller 702 can monitor the activation of the main trigger 152 and / or one or more activation switches 154 of the trigger assembly 150. In response to the activation of the appropriate trigger 152 or switch 154, the controller 702 controls the transducer 104 to generate ultrasound energy, which is propagated to the harmonic scalpel 130 via the ultrasonic waveguide 670. Additionally or alternatively, in response to the activation of the corresponding switch 154 of the trigger assembly 150, the controller 702 can be configured to supply a certain amount of RF energy to the RF electrode 500 via the interconnect 710 through the electrosurgical generator module 164. It should be understood that although the transducer 104 and generator 106 are in... Figure 1 and Figure 7 The transducer 104 is shown as a separate component from the energy-based surgical instrument 102, but in other embodiments, the transducer 104 and / or generator 106 may be incorporated into the surgical instrument 102.
[0051] See now Figure 8 In another embodiment, the jaw assembly 122 of the end effector 120 includes a pair of jaw clamps 132, 832, similar to those described above. Figure 5B Those shown. In Figure 8In the illustrated exemplary end effector, jaw clamp 132 includes an electrode 800, and jaw clamp 832 includes another electrode 802. In one embodiment, electrode 800 may be embodied as an active electrode, and electrode 802 may be embodied as a return electrode to facilitate the application of RF energy to tissue trapped between jaw clamps 132, 832. As shown, electrode 800 includes a distal segment 804 and a proximal segment 806. In some embodiments, each of segments 804, 806 may be energized independently. In some embodiments, segments 804, 806 may be electrically insulated from each other. For example, in one embodiment, segments 804, 806 may be separated by a pair of insulating strips 812, such as... Figure 8 As shown.
[0052] Alternatively, in some embodiments, segments 804 and 806 may be energized together. When connected together, when the jaw assembly 122 is clamped closed and there is no tissue between the jaw clamps 132 and 832, the insulating stop in the jaw assembly 122 prevents RF energy conduction between the proximal segment 806 and the return electrode 802. Therefore, in those embodiments, RF energy can be transferred through the distal segment 804, for example, when at least a portion of the distal segment 804 is exposed through the jaw assembly 122 and the distal end of the end effector 120 is end-pressed against the bleeding source, causing energy to flow from the distal segment 804 through the tissue to the return electrode 802.
[0053] Therefore, a distal-proximal segmented RF cutting electrode 800 (including a distal segment 804 and a proximal segment 806) capable of independent energization can be used to perform distal-end energized "bite-off" cutting and coagulation. In one embodiment, the bipolar electrosurgical (RF) instrument 102 may have a U-shaped coagulation electrode 800 on a jaw 132 and at least one return path electrode 802 on an opposing jaw 832. The distal end of the electrode 800 may have a segmented distal portion 804 that is capable of being energized separately or cooperatively with the main coagulation portion 806 of the electrode 800.
[0054] In some embodiments, the distal end portion 804 may have a pressure-changing mechanism that can provide limited pressure (e.g., for conventional coagulation only) or concentrated pressure (e.g., end biting / cutting) depending on the jaw closure state. In one embodiment, the trigger for individual or collaborative activation of electrode portions 804, 806 may be user-initiated or user-selected only in the distal end 804.
[0055] In some embodiments, the shape and conformability of the distal end RF electrode can combine pressure with RF energy to induce localized distal end tissue welding and bladeless cutting (i.e., "biting off"). In some embodiments, the end effector 120 may include a rotating mechanism that creates a ridge in either of the electrodes 800, 802. For example, when activated, the torsional blade mechanism rotates about its main axis to use the ridge to increase the pressure on the distal end 804. This increase in pressure on the end 804 allows for lower displacement upon firing RF energy.
[0056] In some embodiments, jaws 132, 832 may close to different final states based on whether the jaws have closed tissue and are operating in coagulation mode, or whether only the ends have closed tissue and are undergoing bite-cutting. In one embodiment, return electrode 802 may have a distal portion 808 and a proximal portion 810. In one embodiment, the distal bipolar electrode return path may have a spring-deflectable portion, for example, at the distal portion 808 of electrode 802. The spring-deflectable portion has a deflection stop limiting element. When jaws 132, 832 are fully filled with tissue, such as in coagulation mode, return path 808 may deflect away, thereby limiting the pressure applied at the distal end. If tissue is only located in the distal end, the electrically operated jaws 132, 832 may overclose, thereby compressing the spring-deflected end 808 into its stop and beyond, thereby increasing the cutting-biting force or pressure.
[0057] In some embodiments, the distal deflectable end may have tissue-facing protrusions (i.e., "tooth-like protrusions") such that the pressure density is very high at the center of the bite when it reaches the stop and decreases as it moves away from the tooth-like protrusion. This will manifest as a very high energy density when the stop is struck and the jaws 132, 832 are highly energized (meaning the power level may differ when only the distal end is used compared to when only solidification occurs during operation). In some embodiments, the stop may be immovable or distally movable. When the stop is distally movable, the proximal deflectable stop can be pulled to inhibit deflection when a bite is required.
[0058] See now Figure 9 This illustrates a method 900 for controlling an energy-based surgical instrument 102. Method 900 can be performed by a controller 702, a generator 106, and / or one or more other microcontrollers or other control elements of the system 100. Method 900 begins at block 902, where tissue is clamped in the jaws of the end effector 120 of the surgical instrument 102 (e.g., [missing information]). Figure 8The jaws 132, 832 of the end effector 120 are shown. For example, tissue can be gripped when a user activates the trigger mechanism 152. In some embodiments, the jaw assembly 122 may be electrically powered, and the jaws may grip tissue in response to activation of a button or other input included in the switch assembly 154.
[0059] In block 904, the control element determines whether tissue is present in the proximal portion of the jaw assembly 122, for example, at a location corresponding to the proximal segment 806 of electrode 800 between jaws 132 and 832. The presence of tissue in the proximal portion of the jaw assembly 122 can be determined by the final closed state of the jaw assembly 122 (e.g., the final distance between jaws 132 and 832), by sensing the presence of tissue (e.g., by sensing impedance), or by any other technique. If tissue is present in the proximal portion of the jaw assembly, method 900 branches to block 906, where the control element determines whether tissue is present in the distal portion of the jaw assembly 122, for example, at a location between jaws 132 and 832 corresponding to the distal segment 804 of electrode 800. The presence of tissue in the distal portion of the jaw assembly 122 can be determined using any suitable technique as described above. If no tissue is present, method 900 loops back to block 902 to continue performing control operations. If the tissue is present in the distal portion of the jaw assembly 122 (and therefore also in the proximal portion of the jaw assembly 122), then method 900 proceeds to box 908.
[0060] In block 908, the control element uses solidification energy to cooperatively energize the proximal section 806 and the distal section 804 to perform a solidification operation. In some embodiments, in block 910, a pressure-changing mechanism may be used to provide limited pressure on the distal portion of the jaw assembly, as described above. After delivering solidification energy, method 900 cycles back to block 902 to continue performing the control operation.
[0061] Referring again to box 904, if the tissue is not present in the proximal portion of the jaw assembly 122, method 900 branches to box 912. In box 912, the control element determines whether the tissue is present in the distal portion of the jaw assembly 122. The presence of tissue in the distal portion of the jaw assembly 122 can be determined using any suitable technique as described above. If no tissue is present, method 900 loops back to box 902 to continue performing control operations. If the tissue is present in the distal portion of the jaw assembly 122 (and therefore also not in the proximal portion of the jaw assembly 122), method 900 proceeds to box 914.
[0062] In block 914, the control element, independent of the proximal segment 806, energizes the distal segment 804 with cutting energy to perform a bite / cutting operation. As described above, the cutting energy is higher than the coagulation energy. In some embodiments, in block 916, a pressure variation mechanism may be used to provide concentrated pressure on the distal portion of the jaw assembly, as described above. After the cutting energy is delivered, method 900 cycles back to block 902 to continue performing the control operation.
[0063] See now Figure 10 The jaw assembly 1000 includes similar components. Figures 1 to 8 The jaws 132 of the clamping elements are coupled to the tissue pad 1002. The tissue pad 1002 includes non-conductive portions that may be formed of polytetrafluoroethylene (PTFE). The tissue pad 1002 is configured to receive the ultrasonic scalpel 130 when used in the combined ultrasonic / RF surgical instrument 102.
[0064] The jaw assembly 1000 also includes a compliant RF electrode 1004 positioned on the upper surface of the tissue pad 1002. The electrode 1004 extends from a proximal end 1006 to a distal end 1008 and includes a distal end feature 1010. The electrode 1004 is formed of a conductive material, such as a metallic material, conductive ink, or another material. As shown, the electrode 1004 does not cover the entire surface of the non-conductive tissue pad 1002. Therefore, the jaw assembly 1000 includes both non-conductive and conductive portions.
[0065] As shown in the figure, the jaw assembly 1000 may include a conductive portion of the RF compliant electrode 1004 extending to an extension 1010 on the distal surface of the jaw 132 of the clamping arm, while retaining the electrode 1004 distally within the structural electrode support. The distal conductive RF electrode 1010 has a shape / geometry that allows the distal distal RF to be bitten / welded differently from the arcuate clamping arm, which causes the distal distal end to make proximal migration compression contact.
[0066] In some embodiments, electrode 1004 may be a conformal or erosive RF electrode 1004 used with ultrasonic scalpel 130. The distal end 1010 of electrode 1004 has a retaining shape or geometry that differs from the geometry of proximal pad 1002, which minimizes unintended release of the distal portion of electrode 1010 during high-temperature use.
[0067] In some implementations, in addition to the limiting portion 1002, the distal electrode geometry may have different tracks or patterns on the conductive portion 1004, which allows the distal end to electrically interact at the bipolar tissue treatment site before the proximal portion of the electrode has conductivity or interaction.
[0068] For example, a surgical instrument 102 having a jaw assembly 1000 may include a distal geometry 1010 for applying an energy tip to a bleeding source. A non-conductive portion of the tissue pad 1002 may include a geometry that holds the distal geometry 1010 in place. This geometry may be used with an ultrasonic scalpel 130 and may have a geometry that minimizes unintended release of the distal distal geometry 1010 during high-temperature use. Furthermore, when used with a deflectable electrode having a deflection stop to prevent deflection from the ultrasonic scalpel 130, the jaw assembly may include additional stops or other features to hold the distal geometry 1010 and prevent short circuits with the blade 130.
[0069] Although the present disclosure has been illustrated and described in detail in the accompanying drawings and the foregoing description, such illustrations and descriptions should be regarded as exemplary rather than restrictive in nature, and it should be understood that only exemplary embodiments are shown and described, and all changes and modifications made within the substance of the present disclosure should be protected.
[0070] The methods, apparatus, and systems described herein possess numerous advantages due to their various features. It should be noted that alternative embodiments of the methods, apparatus, and systems of this disclosure may exclude all described features, but may still benefit from at least some of the advantages of such features. Those skilled in the art will readily conceive of their own implementations of the methods, apparatus, and systems described above, which may incorporate one or more features of the invention and fall within the spirit and scope of this disclosure as defined by the appended claims.
Claims
1. An energy-based surgical instrument, the surgical instrument comprising: An end effector, the end effector comprising a first jaw clamping member and a second jaw clamping member; A first electrode is connected to the first jaw clamping member, and the first electrode includes a distal portion and a proximal portion; as well as Return electrode, the return electrode being connected to the second jaw clamping member; The distal portion and the proximal portion are independently energized to deliver radio frequency (RF) energy through the tissue between the first jaw clamp and the second jaw clamp to the return electrode.
2. The surgical instrument according to claim 1, wherein: The proximal portion is configured to deliver solidification energy; and The distal portion is configured to deliver the solidification energy or cutting energy individually or collaboratively.
3. The surgical instrument according to claim 2, wherein, The cutting energy is higher than the solidification energy.
4. The surgical instrument according to claim 2, wherein, The distal portion is configured to deliver the cutting energy individually when the tissue is located only within the distal portion of the first jaw gripper.
5. The surgical instrument according to claim 2, wherein, The distal portion is configured to cooperatively deliver the coagulation energy or the cutting energy when tissue is located within the distal and proximal portions of the first jaw gripper.
6. The surgical instrument according to claim 1, wherein, The end effector further includes a pressure changing mechanism that selectively provides limited or concentrated pressure on the distal portion of the first electrode.
7. The surgical instrument according to claim 1, wherein, The end effector further includes a rotation mechanism that rotates a raised portion below the first electrode or the second electrode, wherein, when the raised portion rotates, the pressure on the distal portion of the first electrode increases.
8. The surgical instrument according to claim 1, wherein, The return electrode includes a distal portion, wherein the distal portion includes a spring-deflectable portion that is spring-biased toward the first electrode and capable of deflecting away from the first electrode.
9. The surgical instrument according to claim 8, wherein, The deflectable portion of the spring includes a deflection stop limiting member that limits the deflection of the return electrode away from the first electrode.
10. The surgical instrument according to claim 9, wherein: When the first and second jaw clamps are closed and there is tissue between the distal and proximal portions of the first electrode and the return electrode, the deflectable portion of the spring does not reach the deflection stop limit, and the pressure applied at the distal portion is limited; and When the first jaw clamp and the second jaw clamp are closed and there is tissue between the distal portion of the first electrode and the return electrode and no tissue between the proximal portion of the first electrode and the return electrode, the deflectable portion of the spring reaches the deflection stop limiter and applies increased pressure at the distal portion.
11. The surgical instrument of claim 9, further comprising a protrusion extending from the distal portion of the return electrode toward the distal portion of the first electrode.
12. The surgical instrument according to claim 9, wherein, The deflection stop limiter is movable between a first position and a second position, in which the deflection of the return electrode is suppressed, and in the second position, the deflection of the return electrode is not suppressed.
13. An energy-based surgical instrument, the surgical instrument comprising: An end effector, the end effector including a jaw clamping member, wherein the jaw clamping member extends from a proximal end to a distal end; A tissue pad, the tissue pad being coupled to the jaw clamp and extending from the proximal end to the distal end, wherein the tissue pad includes a non-conductive top surface having a proximal pad geometry; and An electrode is coupled to the top surface of the tissue pad and extends from the proximal end to the distal end, wherein the electrode covers a first portion of the tissue pad and does not cover a second portion of the tissue pad, wherein the electrode includes a distal feature extending to the distal end of the jaw clamp, and wherein the distal feature has a retaining shape or geometry different from the geometry of the proximal pad.
14. The surgical instrument according to claim 13, wherein, The electrodes include conformal or erosive RF electrodes used with ultrasonic scalpels.
15. The surgical instrument according to claim 13, wherein, The distal feature of the electrode interacts electrically with the tissue, and subsequently the proximal portion of the electrode interacts electrically with the tissue.
16. The surgical instrument according to claim 13, wherein, The tissue pad contains polytetrafluoroethylene (PTFE).
17. A method for controlling an energy-based surgical instrument, the method comprising: Tissue is held between a first jaw clamp and a second jaw clamp of an end effector of an energy-based surgical instrument, wherein the energy-based surgical instrument includes a first electrode coupled to the first jaw clamp, the first electrode including a distal portion and a proximal portion, and wherein the energy-based surgical instrument further includes a return electrode coupled to the second jaw clamp. When the tissue is only within the distal portion of the first jaw clamp, the distal portion is energized individually to deliver radio frequency (RF) energy through the tissue between the first and second jaw clamps to the return electrode; and When the tissue is within the distal and proximal portions of the first jaw clamp, the distal and proximal portions are energized in a cooperative manner to deliver RF energy through the tissue between the first and second jaw clamps to the return electrode.
18. The method of claim 17, wherein: Independently energizing the distal portion includes delivering cutting energy; and Cooperative energization of the distal and proximal portions includes the delivery of solidification energy.
19. The method according to claim 18, wherein, The cutting energy is higher than the solidification energy.
20. The method of claim 17, further comprising: When the distal portion is energized independently, a concentrated pressure is provided on the distal portion of the first electrode using a pressure changing mechanism; as well as When the distal portion and the proximal portion are energized in cooperation, the pressure changing mechanism provides limited pressure on the distal portion of the first electrode.