Tissue monitoring electrosurgical instrument and method of using same
The electrosurgical instrument addresses thermal damage and staple inconsistency by using real-time tissue monitoring and a single-fire mechanism, ensuring precise energy control and improved surgical outcomes in minimally invasive procedures.
Patent Information
- Application Number
- JP2025514648
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-09-08
- Filing Date
- 2023-09-07
- Publication Date
- 2025-09-11
AI Technical Summary
Existing electrosurgical procedures face challenges with unwanted tissue damage due to thermal effects and inconsistent staple formation during tissue stapling and resection, particularly in minimally invasive surgeries.
An electrosurgical instrument with integrated tissue sensors and electrodes that monitor tissue temperature and impedance in real-time, adjusting energy delivery parameters to prevent overheating and ensure proper staple formation, using a single cartridge and single-fire mechanism for improved tissue handling.
Reduces tissue damage and ensures consistent staple formation by dynamically controlling energy delivery based on real-time tissue feedback, enhancing surgical precision and reducing procedural complexity.
Smart Images

Figure 2025530279000001_ABST
Abstract
Description
[Technical Field]
[0001] Embodiments of the disclosed technology relate generally to electrosurgical techniques, and more particularly to end effectors and stapling devices and methods of using these devices in surgical procedures that deliver energy to tissue and receive signals from tissue sensors based on the real-time status of the tissue. [Prior art documents] [Patent documents]
[0002] [Patent Document 1] U.S. Patent No. 9,936,953 Summary of the Invention [Means for solving the problem]
[0003] The following provides a summary of certain exemplary implementations of the disclosed technology. This summary is not an extensive overview, and is not intended to identify key or critical aspects or elements of the disclosed technology or to delineate the scope thereof. It should be understood, however, that the use of indefinite articles in the language used to describe and claim the disclosed technology is not intended to limit the described technology in any way. Instead, the use of "a" or "an" should be construed to mean "at least one" or "one or more."
[0004] One implementation of the disclosed technology provides an electrosurgical instrument including: an anvil including a first end, a second end, and an anvil face positionable on a first side of an anatomical structure; a cartridge operably configured to receive a plurality of staples, the cartridge including a first end, a second end, and a face positionable on the second side of the anatomical structure; a blade assembly including a blade including first and second sides joined by a cutting edge; an end effector including at least one electrode coupled to the blade, the at least one electrode in electrical communication with an electrosurgical generator generated from a controller; and at least one tissue sensor coupled to the blade; and a tissue monitoring system in electrical communication with the at least one tissue sensor, the at least one tissue sensor providing a feedback signal to the controller indicative of a tissue characteristic, the controller transmitting a signal to the electrosurgical generator to adjust operating parameters of the electrosurgical instrument based on the feedback signal.
[0005] When the blade is advanced from a first position at the distal end of the cartridge to a second position at the proximal end of the cartridge, an incision is formed in the anatomical structure, and the at least one electrode and the at least one tissue sensor contact and move along the anatomical structure. The controller may include analog or logic circuitry for processing a feedback signal received from the at least one tissue sensor to determine a signal to be sent to the electrosurgical generator. The circuitry may connect the at least one electrode to the electrosurgical generator and the at least one tissue sensor to a tissue monitoring system. The feedback signal may be related to a tissue temperature of the anatomical structure. The electrosurgical generator is terminated when the tissue temperature rises above a predetermined threshold. The predetermined tissue temperature threshold may be between 80-120°C. The firing rate of the electrosurgical instrument is reduced if the tissue temperature at a predetermined tissue location in the anatomical structure does not reach a target temperature. The target temperature at the predetermined tissue location may be between 60-100°C. The feedback signal may be related to a tissue impedance of the anatomical structure. The electrosurgical generator is terminated when tissue impedance at a predetermined tissue location in the anatomy fails to reach a target impedance, such as 200 ohms, and the firing rate of the electrosurgical instrument is reduced when tissue impedance rises above a predetermined threshold, such as 600 ohms.
[0006] Another implementation of the disclosed technology provides an electrosurgical instrument for stapling, resecting, and sealing a patient's anatomy. The surgical instrument includes an anvil including a first end, a second end, and an anvil face positionable on a first side of the anatomical structure; a cartridge operably configured to receive a plurality of staples, the cartridge including a first end, a second end, and a face positionable on the second side of the anatomical structure; a blade including a first side and a second side joined by a cutting edge, and a blade assembly including a beam; an end effector including at least one electrode coupled to the blade, the at least one electrode in electrical communication with an electrosurgical generator generated from a controller, and at least one tissue sensor coupled to the blade; and a tissue monitoring system in electrical communication with the at least one tissue sensor, the at least one tissue sensor providing a tissue impedance feedback signal to the controller when the blade is advanced from a first position at the distal end of the cartridge to a second position at the proximal end of the cartridge, the controller transmitting a signal to the electrosurgical generator to adjust the firing rate of the electrosurgical instrument based on the tissue impedance feedback signal.
[0007] When the blade is advanced from a first position at the distal end of the cartridge to a second position at the proximal end of the cartridge, an incision is formed in the anatomical structure, and the at least one electrode and the at least one tissue sensor contact and move along the anatomical structure. The controller may include analog or logic circuitry for processing feedback signals received from the at least one tissue sensor to determine a signal to be sent to the electrosurgical generator. The electrosurgical generator is terminated when tissue impedance at a predetermined tissue location in the anatomical structure fails to reach a target impedance, such as 200 ohms. The firing rate of the electrosurgical instrument is reduced when the tissue impedance rises above a predetermined threshold, such as 600 ohms. The at least one tissue sensor may further provide a tissue temperature feedback signal to the controller. The firing rate of the electrosurgical instrument is reduced when tissue temperature at a predetermined tissue location in the anatomical structure fails to reach the target temperature. The target temperature at the predetermined tissue location may be between 60-100°C. The electrosurgical generator is terminated when the tissue temperature rises above a predetermined threshold, such as between 80-120°C.
[0008] Certain embodiments of the disclosed technology include an end effector for use by a surgeon to staple a patient's anatomical structure, the end effector including: a first jaw having a first end, a second end, a longitudinal axis, and an anvil having an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a cartridge operably configured to receive a plurality of staples and having a cartridge face; a first coupling connecting the first end of the first jaw to the first end of the second jaw; and a second coupling movably connecting the second end of the first jaw to the second end of the second jaw. Certain embodiments include a blade having a cutting face and at least one transverse arm. Certain embodiments include a channel defined by the first jaw or the second jaw for retaining at least one transverse arm of the blade. In certain embodiments, the blade is translated from a first position at a distal end of the end effector to a second position at a proximal end of the end effector to resect the anatomical structure. Certain embodiments include multiple electrodes coupled to one side of the blade so that the multiple electrodes contact the anatomical structures during ablation and heat the tissue and blood vessels on that side of the blade to cauterize, coagulate / dehydrate, and / or seal the tissue, thereby achieving hemostasis. Certain embodiments further include at least one tissue sensor coupled to the blade proximate to the electrodes.
[0009] In certain embodiments, the first end of the first jaw is the distal end of the first jaw, and the second end of the first jaw is the proximal end of the first jaw. In certain embodiments, the first coupling includes a pin having a pin axis transverse to the longitudinal axis of the first jaw and the longitudinal axis of the second jaw, the pin pivotally coupling the first end of the first jaw to the first end of the second jaw. In certain embodiments, the second coupling includes a slot defined by the first jaw or the second jaw that holds a rigid link, such that the rigid link is slidable within the slot. In certain embodiments, the slot has a length of 3 to 8 millimeters. Certain embodiments include a plurality of staples at least partially held by a cartridge in the second jaw. In certain embodiments, the plurality of staples at least partially held by the cartridge are positioned between the first coupling and the second coupling. Certain embodiments include a blade having a cutting surface, at least one side arm, and first and second electrodes, and a tissue sensor coupled to one side of the blade. In certain embodiments, the first and second electrodes are in electrical communication with an electrosurgical power generation source, such as a bipolar energy source, and the tissue sensor is in electrical communication with a tissue monitoring system. Certain embodiments include a channel defined by the first jaw or the second jaw for holding at least one side arm of the blade. In certain embodiments, the blade is translated from a first position at the distal end of the end effector to a second position at the proximal end of the end effector so that the anatomical structure is resected. In certain embodiments, energy is delivered by the first and second electrodes to achieve hemostasis of the anatomical structure during resection, the first electrode being an active electrode and the second electrode being a return electrode. Operating parameters of the electrosurgical device, including the firing rate, can be varied based on real-time signaling received from the tissue sensor.
[0010] Certain embodiments of the disclosed technology provide a method for stapling a patient's anatomy, having a first side and a second side, during a minimally invasive procedure to achieve hemostasis, comprising the steps of providing an end effector including: a first jaw having a first end, a second end, a longitudinal axis, and an anvil having an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a cartridge holding a plurality of staples and having a cartridge face; a first coupling coupling the first end of the first jaw to the first end of the second jaw; a second coupling movably coupling the second end of the first jaw to the second end of the second jaw; a knife coupled to and slidable relative to the first jaw or the second jaw; active and return electrodes coupled to the knife; and at least one tissue sensor coupled to the knife; The method includes inserting an end effector through a trocar to access an anatomical structure, positioning a cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, actuating the end effector to move a rigid link such that a first jaw is pushed toward a second jaw to fasten the end effector onto the anatomical structure, actuating the end effector to eject a plurality of staples from the cartridge to staple the anatomical structure, actuating a knife to cut the anatomical structure, achieving hemostasis in the anatomical structure by applying energy to an active electrode and passing it through the anatomical structure to a return electrode, and monitoring the status of tissue at the hemostasis site using a tissue sensor.
[0011] Certain embodiments of the disclosed technology provide a surgical instrument for stapling, resecting, and sealing an anatomical structure of a patient, the surgical instrument including an end effector, the end effector including a first jaw having an anvil having a first end, a second end, a longitudinal axis, and an anvil face positionable on a first side of the anatomical structure, and a cartridge having a first end, a second end, a longitudinal axis, and a cartridge face positionable on a second side of the anatomical structure, the cartridge being operably configured to house a plurality of staples. The surgical instrument includes a second jaw having a ridge, a first coupling connecting a first end of the first jaw to a first end of the second jaw, a second coupling movably connecting a second end of the first jaw to a second end of the second jaw, the second coupling including a rigid link coupled to the first and second jaws, an elongated tube having a proximal end and a distal end coupled to the end effector, a handle having a proximal end and a distal end coupled to the proximal end of the elongated tube, and a drive assembly including a motor for actuating the end effector. In certain embodiments, the end effector includes first and second electrodes in communication with an electrosurgical power generation source, such as a bipolar energy source. The first and second electrodes collectively function to ablate, coagulate, cauterize, seal, or otherwise treat biological tissue during a surgical procedure. In certain embodiments, the end effector includes a tissue sensor in communication with a tissue monitoring system.
[0012] Certain embodiments of the disclosed technology provide a method of stapling, resecting, and sealing a patient anatomy having a first side and a second side during a minimally invasive procedure, the method comprising providing an end effector including: an anvil having a first end, a second end, an anvil face, a length, and a width, wherein the anvil length is at least 10 times the anvil width; a cartridge having a first end, a second end, a cartridge face, a length and a width that is at least 10 times the anvil width, the cartridge holding a plurality of staples, wherein the first end of the anvil is coupled to the first end of the cartridge and the second end of the anvil is movably coupled to the second end of the cartridge; and a rigid link having a distal portion and a proximal portion, the rigid link movably coupling the second end of the anvil to the second end of the cartridge. the anvil face against a second side of the anatomical structure; actuating the end effector to move the rigid link such that the anvil is pushed toward the cartridge to fasten the end effector onto the anatomical structure; actuating the end effector to eject a plurality of staples from the cartridge to staple the anatomical structure; actuating the knife to cut the anatomical structure; applying energy to the anatomical structure through electrodes positioned on one side of the knife during electrode actuation; and electronically monitoring at least one parameter of the anatomical structure as the anatomical structure is cut.
[0013] Certain embodiments of the disclosed technology provide a method for stapling, resecting, and sealing a patient's anatomical structure having a first side and a second side during a minimally invasive procedure, the method comprising: an anvil including a first end, a second end, and an anvil face; a cartridge holding a plurality of staples, the cartridge having a first end, a second end, a cartridge face including a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge pivotally coupled to the first end of the anvil; a blade having a cutting surface, first and second electrodes and a tissue sensor coupled to only one side of the blade; and a plurality of staples slidably engaged with the channel. and at least one elongated arm; inserting the end effector through a trocar to access the anatomical structure; positioning a cartridge face on a first side of the anatomical structure; positioning an anvil face on a second side of the anatomical structure; fastening the end effector onto the anatomical structure; actuating the end effector to expel a plurality of staples from the cartridge to staple the anatomical structure; actuating the blade to cut the anatomical structure; applying bipolar energy to the anatomical structure through a circuit including the first and second electrodes; and monitoring the temperature of the anatomical structure through a tissue sensor.
[0014] Certain embodiments of the disclosed technology provide a method for stapling, resecting, and sealing a patient anatomical structure having a first side and a second side during a minimally invasive procedure, the method comprising: an anvil including a first end, a second end, and an anvil face; a cartridge holding a plurality of staples, the cartridge having a first end, a second end, and a cartridge face including a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge being pivotally coupled to the first end of the anvil; a blade including a cutting face, first and second electrodes coupled to the first side of the blade, and third and fourth electrodes coupled to the second side of the blade; and at least one elongated arm slidably engaged with the channel. The method includes providing an end effector including at least one tissue sensor coupled to a blade; inserting the end effector through a trocar to access the anatomical structure; positioning a cartridge face on a first side of the anatomical structure; positioning an anvil face on a second side of the anatomical structure; fastening the end effector onto the anatomical structure; actuating the end effector to expel a plurality of staples from the cartridge to staple the anatomical structure; actuating the blade to cut the anatomical structure; applying bipolar energy to the anatomical structure through a circuit including first, second, third, and fourth electrodes; and monitoring a temperature of the anatomical structure through the at least one tissue sensor.
[0015] Certain embodiments of the disclosed technology provide a method of stapling, resecting, and sealing a patient anatomy having a first side and a second side during a minimally invasive procedure, the method comprising: an anvil including a first end, a second end, and an anvil face; a cartridge holding a plurality of staples, the cartridge having a cartridge face including a first end, a second end, and a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge pivotally coupled to the first end of the anvil; a blade having a blade face, at least one resistive heating element coupled to the blade, and a blade slidably engaged with the channel. The method includes providing an end effector including at least one elongated arm, inserting the end effector through a trocar to access the anatomical structure, positioning a cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, fastening the end effector onto the anatomical structure, actuating the end effector to expel a plurality of staples from the cartridge to staple the anatomical structure, actuating the blade to cut the anatomical structure, and applying energy to the anatomical structure through a circuit including at least one resistive heating element to heat the anatomical structure.
[0016] Certain embodiments of the disclosed technology provide a method for stapling, resecting, and sealing a patient anatomical structure having a first side and a second side during a minimally invasive procedure, the method comprising: an anvil including a first end, a second end, and an anvil face; a cartridge holding a plurality of staples, the cartridge having a cartridge face including a first end, a second end, and a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge pivotally coupled to the first end of the anvil; a blade having a cutting surface, an electrode coupled to the blade, a tissue sensor coupled to the blade; and at least one elongated adapter slidably engaged with the channel. and a blade; providing an end effector including an anvil face; inserting the end effector through a trocar to access the anatomical structure; positioning a cartridge face on a first side of the anatomical structure; positioning an anvil face on a second side of the anatomical structure; fastening the end effector onto the anatomical structure; actuating the end effector to expel a plurality of staples from the cartridge to staple the anatomical structure; actuating the blade to cut the anatomical structure; applying monopolar energy to the anatomical structure through a circuit including the one electrode and a return electrode attached to the patient; and monitoring the temperature of the anatomical structure through a tissue sensor.
[0017] Certain embodiments of the disclosed technology provide a surgical instrument for stapling, resecting, and sealing an anatomical structure of a patient, the surgical instrument including an end effector, the end effector including an anvil including a first end, a second end, and an anvil face positionable on a first side of the anatomical structure; and a cartridge operably configured to house a plurality of staples, the cartridge including a first end, a second end, and a cartridge face positionable on the second side of the anatomical structure, the cartridge including a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge pivotally coupled to the first end of the anvil; The surgical instrument includes a blade having a cutting face and at least one elongated arm slidably engaged with the channel, an active electrode coupled to a first side of the blade and a return electrode coupled to the first side of the blade proximate the active electrode, a tissue sensor coupled to the blade, an elongated tube having a proximal end and a distal end coupled to the end effector, a handle having a proximal end and a distal end coupled to the proximal end of the elongated tube, a drive assembly having a motor for actuating the end effector, and circuitry extending through the elongated tube to the active and return electrodes and connecting the active and passive electrodes to an electrosurgical energy source, such as a bipolar energy source.
[0018] Certain embodiments of the disclosed technology provide a method of stapling a patient's anatomy having a first side and a second side during a minimally invasive procedure, the method including: a first jaw having a first end, a second end, an anvil having an anvil face, and a first channel; a second jaw having a first end, a second end, a cartridge face, and a second channel; a first coupling coupling the first end of the first jaw to the first end of the second jaw; a second coupling movably coupling the second end of the first jaw to the second end of the second jaw and including a rigid link; an I-shaped blade including a blade portion having a cutting edge, a first side, and a second side; at least one upper lateral arm slidably positioned within the first channel; a first electrode coupled to the first side of the blade and a second electrode coupled to the first side of the blade; The method includes providing an end effector including an coupled tissue sensor and at least one lower lateral arm slidably positioned within the second channel; inserting the end effector through a trocar to access the anatomical structure; positioning a cartridge face on a first side of the anatomical structure; positioning an anvil face on a second side of the anatomical structure; actuating the end effector to move the rigid link such that the anvil is pushed toward the cartridge to fasten the end effector onto the anatomical structure; actuating the end effector to push a plurality of staples from the cartridge to staple the anatomical structure; actuating the I-blade to cut the anatomical structure; and activating an electrosurgical circuit to seal the cut in the anatomical structure using the first and second electrodes.
[0019] Certain embodiments of the disclosed technology provide a surgical instrument for stapling, resecting, and sealing a patient's anatomy, the surgical instrument including: a first jaw having a first end, a second end, an anvil having an anvil face, and a first channel; a second jaw having a first end, a second end, a cartridge having a cartridge face, and a second channel; a first coupling connecting the first end of the first jaw to the first end of the second jaw; a second coupling movably connecting the second end of the first jaw to the second end of the second jaw and including a rigid link; an I-shaped blade including a blade portion having a cutting edge, a first side, and a second side; and at least one slidably positioned within the first channel. an end effector including an upper lateral arm, a first electrode coupled to the first side of the blade and a second electrode coupled to the first side of the blade, a tissue sensor coupled to the first side of the blade, and at least one lower lateral arm slidably positioned within the second channel; an elongated tube having a proximal end and a distal end coupled to the end effector; a handle having a proximal end and a distal end coupled to the proximal end of the elongated tube, the handle defining a cavity and having a spool positioned within the cavity; circuitry connecting the first and second electrodes to a source of electrosurgical energy; and a drive assembly having a motor that actuates the end effector, at least a portion of the circuitry being wound around the spool during actuation of the end effector.
[0020] Certain embodiments of the disclosed technology provide a surgical instrument for use by a surgeon to staple a patient's anatomical structure to achieve hemostasis during a minimally invasive procedure, the end effector including: an anvil including a first end, a second end, and an anvil face positionable on a first side of the anatomical structure; a cartridge operably configured to house a plurality of staples, the cartridge including a first end, a second end, and a cartridge face positionable on the second side of the anatomical structure and defining a channel extending from the first end of the cartridge to the second end of the cartridge, the first end of the cartridge pivotally coupled to the first end of the anvil; a blade assembly including a blade including first and second sides joined at a cutting edge, a beam, and a nut, at least a portion of the blade assembly slidably engaged with the channel; and first and second electrodes coupled to the first side of the blade. A tissue sensor is coupled to the first side of the blade. The surgical instrument includes an elongated tube having a proximal end and a distal end coupled to the end effector, a handle having a proximal end and a distal end coupled to the proximal end of the elongated tube, a drive assembly including a motor that actuates the end effector, and an electrosurgical power generation source in electrical communication with the first and second electrodes.
[0021] Certain embodiments of the disclosed technology provide an end effector for use by a surgeon to staple and resect a patient's anatomical structure during a minimally invasive procedure, the end effector including an anvil including a first end, a second end, and a surface positionable on the first side of the anatomical structure. The end effector further includes a cartridge configured to accommodate a plurality of staples and including the first end, the second end, and a surface positionable on the second side of the anatomical structure, and a blade assembly including the first side, the second side, and a cutting edge. The end effector further includes first and second electrodes and a tissue sensor coupled to the first side of the blade assembly, and a recess defined by the anvil to receive a first portion of the blade assembly. The end effector further includes a first slot defined by the anvil, the first slot opening against the anvil face and the recess to slidably receive a second portion of the blade assembly during cutting of the anatomical structure with the cutting edge, and a second slot defined by the cartridge, the second slot opening against the cartridge face to slidably receive a third portion of the blade assembly during cutting of the anatomical structure with the cutting edge. The second end of the anvil is movably coupled to the second end of the cartridge, each of the anvil and cartridge being insertable through a trocar, and the end effector being remotely actuable from outside the patient with at least a portion of one of the anvil and the cartridge being movable toward the other to fasten the end effector onto the anatomical structure.
[0022] Certain embodiments of the disclosed technology provide a method for stapling and sealing a patient's anatomical structure having a first side and a second side during a minimally invasive procedure, the method comprising the steps of providing a stapler with an end effector having a plurality of electrodes and a tissue sensor positioned proximate a cutting edge, a first jaw having an anvil having a first end, a second end, and an anvil face, a second jaw having the first end, the second end, a cartridge containing a plurality of staples and having a cartridge face, a first coupling connecting the first jaw to the second jaw, and a second coupling movably connecting the second end of the first jaw to the second end of the second jaw, the second coupling including a link movably coupled to the first and second jaws; The method may include inserting an end effector through a trocar to access the anatomical structure, positioning a cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, remotely actuating the stapler from outside the patient to move a link such that at least a portion of one of the anvil or the cartridge is moved toward the other to fasten the end effector onto the anatomical structure, firing the stapler and activating electrodes to simultaneously staple, cut, and seal the anatomical structure, and monitoring tissue temperature via a tissue sensor.
[0023] Certain embodiments of the disclosed technology provide a method for stapling a patient's anatomical structure having a first side and a second side during a minimally invasive procedure, the method including the steps of providing an anvil including a first end, a second end, and a face, positioning the anvil face on the first side of the anatomical structure, providing a cartridge containing a plurality of staples, the cartridge including a face including a first end, a second end, and a channel extending from the second end to the first end, the second end of the anvil being movably coupled to the second end of the cartridge, positioning the cartridge face on the second side of the anatomical structure, and providing a blade face and a blade positionable at least near the second end of the cartridge extending from the first end to the cartridge channel and slidably engaging the cartridge channel. providing a blade having an elongated arm connecting the anvil and the cartridge; providing active and passive electrodes positioned on one side of the blade; providing a tissue sensor on one side of the blade; providing a rigid link movably coupling a first end of the anvil to a first end of the cartridge; moving the rigid link to move at least a portion of one of the anvil and the cartridge toward the other to fasten the anatomical structure between the anvil face and the cartridge face; pulling the blade through the anatomical structure to activate the electrodes, simultaneously cutting, stapling, and sealing; and monitoring the temperature of the anatomical structure.
[0024] It should be appreciated that all combinations of the above concepts, and additional concepts discussed in more detail below (provided such concepts are not mutually inconsistent), are contemplated as part of the technology disclosed herein and can be implemented to achieve the benefits described herein. Additional features and aspects of the presently disclosed systems, devices, and methods will become apparent to those skilled in the art upon reading and understanding the following detailed description of exemplary implementations. As will be appreciated by those skilled in the art, still other implementations are possible without departing from the scope and spirit of the disclosure herein. Accordingly, the description provided herein should be considered as illustrative in nature and not limiting.
[0025] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate one or more exemplary implementations of the disclosed technology and, together with the general description given above and the detailed description given below, serve to explain the principles of the presently disclosed subject matter. [Brief explanation of the drawings]
[0026] [Figure 1] FIG. 1 depicts the anatomy of the stomach. [Figure 2] FIG. 1 is a perspective view of an electrosurgical stapling device having an end effector, an elongated tube, a handle portion, and a motor in an open position according to an exemplary embodiment; [Figure 3] FIG. 3 is a partially exploded perspective view of the end effector, elongated tube, and handle portion of the electrosurgical stapling device shown in FIG. 2; [Figure 4] FIG. 3 is a partial exploded perspective view of the motor of the electrosurgical stapling device shown in FIG. 2; [Figure 5A] FIG. 3 is a side view of the electrosurgical stapling device of FIG. 2 shown in the open position. [Figure 5B] FIG. 3 is a side view of the stapling device of FIG. 2 shown in a closed position; [Figure 6] 5B is a side cross-sectional view of the handle portion and motor shown in FIG. 5A taken along section line DD. [Figure 7] FIG. 5B is a side view of the end effector shown in FIG. 5A. [Figure 8] 5C is a side cross-sectional view of the handle portion and motor shown in FIG. 5B taken along section line EE. [Figure 9] FIG. 5C is a side view of the end effector shown in FIG. 5B. [Figure 10] FIG. 10 is a cross-sectional side view of a blade assembly and a drive assembly for an electrosurgical stapling device according to one embodiment; [Figure 11] FIG. 1 is a perspective view of a motor controller according to one embodiment. [Figure 12]FIG. 12 is an exploded perspective view of the motor controller shown in FIG. [Figure 13] FIG. 1 depicts an exemplary beam having first and second electrodes positioned at a distal end according to one embodiment. [Figure 14] 1A-1C depict an exemplary blade assembly according to various embodiments. [Figure 15] 1A-1C depict an exemplary blade assembly according to various embodiments. [Figure 16] 1A-1C depict an exemplary blade assembly according to various embodiments. [Figure 17A] 1A-1C are diagrams that schematically depict non-limiting exemplary embodiments of electrically connecting electrodes to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 17B] 1A-1C are diagrams that schematically depict non-limiting exemplary embodiments of electrically connecting electrodes to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 18A] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 18B] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 19] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 20] 10A-10C are diagrams that schematically depict yet another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 21] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 22] 10A-10C are diagrams that schematically depict yet another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 23A]1A-1C are diagrams that schematically depict non-limiting exemplary embodiments of electrically connecting electrodes to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 23B] 1A-1C are diagrams that schematically depict non-limiting exemplary embodiments of electrically connecting electrodes to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 24A] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 24B] 10A-10C are diagrams that schematically depict another non-limiting exemplary embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such coupling during surgery. [Figure 25] FIG. 1 depicts a nut with electrical contacts according to an exemplary embodiment. [Figure 26] FIG. 10 depicts another nut having electrical contacts according to another exemplary embodiment. [Figure 27] FIG. 10 is a cross-sectional side view of a handle assembly of an exemplary electrosurgical stapling device. [Figure 28] FIG. 28 is an enlarged view of the exemplary spool shown in FIG. 27. [Figure 29] FIG. 29 is an exploded view of the spool shown in FIG. 28. [Figure 30] FIG. 1 is a partial view of an exemplary end effector in accordance with an exemplary embodiment; [Figure 31] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 32] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 33] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 34] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 35] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 36] 1 illustrates an exemplary blade assembly according to an embodiment. [Figure 37]1 is a perspective view illustrating an exemplary electrosurgical circular stapler according to an exemplary embodiment; [Figure 38] FIG. 38 is an exploded perspective view of the stapling head assembly of FIG. 37; [Figure 39] 1A-1C depict an exemplary knife member of an electrosurgical circular stapler in accordance with an exemplary embodiment. [Figure 40] 1A-1C depict an exemplary bladed electrosurgical instrument. [Figure 41] 1A-1C depict an exemplary bladed electrosurgical instrument. [Figure 42] FIG. 1 is an elevated left side view of an electrosurgical stapling and severing instrument with an open end effector (staple applying assembly) with the shaft partially cut away to reveal the firing members of the proximal firing rod and distal firing bar guided by a frame ground and surrounded by a closure sleeve. [Figure 43] FIG. 43 is a left side view of a longitudinal vertical cross section taken along section line FF of the closed end effector (staple applying assembly) of the surgical stapling and severing instrument of FIG. 42 with the firing bar having a force-adjusted height according to the present invention retracted. [Figure 44] FIG. 44 is a left isometric view of the firing bar of FIG. 43. DETAILED DESCRIPTION OF THE INVENTION
[0027] Various non-limiting embodiments of the present disclosure will now be described below to provide a comprehensive understanding of the structure, function, and principles of use of the devices, systems, methods, and processes disclosed herein. These non-limiting embodiments, or one or more examples thereof, are illustrated in the accompanying drawings. Those skilled in the art will recognize that the systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. Features illustrated or described with respect to one non-limiting embodiment may be combined with features of other non-limiting embodiments. Such modifications and variations are intended to be included within the present disclosure. References throughout this specification to "various embodiments," "some embodiments," "in one embodiment," "some exemplary embodiments," "one exemplary embodiment," or "embodiments" mean that a particular feature, structure, or characteristic described with respect to any embodiment is included in at least one embodiment. Thus, the appearances of the phrases "various embodiments," "some embodiments," "in one embodiment," "some exemplary embodiments," "one exemplary embodiment," or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Described herein are exemplary embodiments of apparatus, systems, and methods relating to surgical instruments and tools, such as electrosurgical staplers. In one exemplary embodiment, an end effector and / or internal cutter stapling device (collectively referred to herein as "device") for forming resection lines during resection of organs, tissues, or other anatomical structures is disclosed. In some embodiments, these devices can be used during minimally invasive surgical procedures. This application is related to U.S. Patent No. 9,936,953, which is hereby incorporated by reference in its entirety.
[0028] Electrosurgical instruments described herein, including but not limited to electrosurgical staplers, can involve the application of electrical and / or electromagnetic energy to cut, dissect, ablate, coagulate, cauterize, seal, or otherwise treat biological tissue during a surgical procedure. Generally, electrosurgery is performed using an electrosurgical generator operable to output energy and a handpiece including an end effector adapted to transfer the energy to a tissue site during the electrosurgical procedure. Embodiments of these devices can be bipolar instruments having two electrodes of opposing polarity and positioned around each other to apply a current between them. The bipolar electrosurgical current flows from one electrode (sometimes referred to as the active electrode) through intervening tissue to the other electrode (sometimes referred to as the return electrode) to complete an electrical circuit.
[0029] One of the problems that can result from electrosurgical procedures is unwanted tissue damage due to thermal effects, in which otherwise healthy tissue surrounding the tissue to which electrosurgical energy is being applied is thermally damaged by an effect known in the art as "thermal diffusion." During thermal diffusion, excess heat from the surgical site may be transferred directly to adjacent tissue and / or vapor release from the tissue being treated at the surgical site may cause damage to the surrounding tissue. In accordance with the present disclosure, one or more sensors can be configured to provide a feedback signal indicative of a tissue characteristic, such as tissue temperature or impedance. Such feedback signals can be collected in real time while energy is being delivered to the tissue through one or more electrodes. The one or more sensors can be positioned in close proximity to the electrodes and can move through the tissue as it is being ablated, thereby providing a signal along the ablation site.
[0030] Electrosurgical staplers according to embodiments described herein can include a handle, an actuator, and an end effector including a fastening mechanism. The fastening mechanism can include a cartridge and an anvil. During surgery, a surgeon fastens two members (e.g., an anvil and a cartridge) to an organ, compressing the organ between them. Once the organ is compressed, the surgeon can use the stapler to drive or fire the staples through the organ. In one embodiment, multiple B-shaped staples can be formed with the desired compression and alignment of the fastening mechanism. In some embodiments, the stapling device can be fired multiple times using multiple cartridges, or in alternative embodiments, a single cartridge can be used to complete the resection of an organ with a single fire. Because the use of multiple cartridges and the lengthy procedure that can be associated with multiple stapler firings can increase the cost of a procedure, it would be advantageous to reduce the number of fires and cartridges required. Similarly, it would be advantageous to enable single-cartridge stapling and / or single organ resection, which can reduce the surgical time for patients, thereby improving clinical outcomes. For example, removing a portion of the stomach via a sleeve gastrectomy procedure using a single cartridge and one stapler firing can improve patient outcomes and reduce complications that may be associated with such procedures.
[0031] When a B-shaped staple configuration is desired, the integrity of the staple line can depend in part on the adequacy of such staple formation. Providing a single cartridge and single firing stapling device can improve the quality of staple formation over devices or systems that use multiple cartridges to complete the same procedure. For example, when an end effector is used multiple times to staple and resect tissue, previously deployed staples may be contacted by subsequently applied new staples and / or a cutting knife. Providing a single cartridge and single staple firing can help ensure consistent staple line and staple shape.
[0032] A single cartridge and single-fire stapling device can provide compression advantages compared to devices and systems requiring the use of multiple cartridges. It would be advantageous to provide a single-fire stapling device that allows for desirable compression along the length of the tissue being resected while simultaneously providing a single staple line with properly formed staples. B-shaped staples are standard practice in gastrointestinal, vascular, pulmonary, and hepatic applications of surgical tissue fastening devices. Self-alignment of the X-, Y-, and Z-axes of the fastening mechanism on each side of the organ (e.g., alignment of the anvil with the cartridge) can improve staple delivery and formation. It will be appreciated that any structure, staple configuration, staple shape, staple format, or other suitable mechanism for applying such alignment can be incorporated into the stapling devices described herein.
[0033] Embodiments of the electrosurgical stapling device can include an anvil and a cartridge, where the cartridge can include recesses that hold a plurality of staples. The staples can be held above one or more staple drivers that can drive each of the plurality of staples upwardly through tissue into the face of the anvil during surgery. The anvil, which can include pockets of any suitable size, number, and dimensions, can cooperate with the cartridge driver to form, for example, a B-shape in the tissue. In one embodiment, the pockets in the anvil can be sized to provide a desired closed staple height, which can be determined by the gap between the anvil and the cartridge, the pocket depth, and the staple height, and / or the staple driver and driver mechanism.
[0034] Embodiments of the electrosurgical stapling device can include an electrode and a tissue sensor positioned proximate the cutting edge of the blade assembly. In some embodiments, the tissue sensor and electrode are positioned on only a single side of the blade assembly. Such electrodes and tissue sensors can be configured and positioned to be in direct contact with the tissue cut by the cutting edge. One of the electrodes can be the active electrode and delivers energy through the tissue to the other electrode, which can be the return electrode. Such energy delivery can affect hemostasis by heating the tissue and blood vessels to cauterize, coagulate / dehydrate, and / or seal the tissue. The tissue sensor can move along the cutting site in the immediate vicinity of the electrode to provide feedback on the status of the tissue as it is cut.
[0035] Embodiments of the electrosurgical stapling devices described herein can include inserting a stapler end effector through a trocar to perform a surgical procedure according to a laparoscopic approach. As an example, a minimally invasive surgical procedure can include a laparoscopic vertical sleeve gastrectomy. Because the spatial environment for such procedures is limited, surgical stapling devices according to embodiments described herein can have a relatively small profile. Prior art minimally invasive devices are typically long (e.g., 35 mm to 60 mm) and slender (e.g., 5 mm to 15 mm in diameter). This slender configuration may be necessary to fit through a trocar and into a body cavity. Because forming a B-shaped staple typically requires a pressure of approximately 100 psi, this size limitation can present mechanical challenges. Under these pressures, a small, less rigid stapler may deform, thus preventing proper B-shaped staple formation.
[0036] Prior art devices used in minimally invasive surgical procedures often have a fixed hinge at the proximal end. This hinge allows the anvil and cartridge to separate into a V-shaped configuration. Once separated, a surgeon can position the open anvil and cartridge around an organ and then collapse the V over the organ. However, as the length of the anvil and cartridge increases, it can be difficult to maintain alignment between the anvil and cartridge across the length of tissue. Poor alignment due to such designs can be exacerbated at the distal ends of such devices, which can deflect due to the force required to compress the tissue. The length of current V-shaped staplers for minimally invasive procedures is limited due to this deflection. As a result of this limitation, the anvil and cartridge are correspondingly limited in length. This length limitation can require multiple reloading and firing of staples in larger organs, such as the stomach, to complete a procedure such as a sleeve gastrectomy. Each reload may require the surgeon to withdraw the stapler from the trocar, reload the cartridge, reinsert, and then reposition the stapler over the organ. Such systems may require longer surgical times, may be costly, may have a higher potential for adverse patient events, and may provide staple lines of less integrity.
[0037] The examples disclosed herein are merely examples and are provided to aid in the description of the apparatus, devices, systems, and methods described herein. None of the features or components shown in the drawings or discussed below should be construed as essential to any particular implementation of any of those apparatus, devices, systems, or methods, unless specifically indicated as essential. For ease of reading and clarity, certain components, modules, or methods may be described only with reference to particular figures. The failure to specifically describe a combination or subcombination of components should not be understood to imply that any combination or subcombination is impossible. Similarly, with respect to any described method, whether or not such method is described with reference to a flow diagram, unless otherwise specified or required, any explicit or suggested order of steps performed in the implementation of the method does not imply that the steps must be performed in the order presented, but instead could be performed in a different order or in parallel.
[0038] The exemplary embodiments described herein may be used, for example, for a sleeve gastrectomy procedure or resection of the stomach. However, it will be appreciated that the above-described devices may be used for other procedures intended for other anatomical structures. For example, the devices may be used for parenchymal resections, lung volume reduction procedures, or other procedures intended for the lungs. Furthermore, the embodiments described herein may be advantageous for anatomical resections, such as lobectomies, non-anatomical parenchymal resections, or other procedures intended for the liver, or for partial nephrectomies, total nephrectomies, or other procedures intended for the kidney.
[0039] Referring now to FIG. 1 , the anatomy of a stomach 10 and an exemplary resection line 12 for a vertical sleeve gastrectomy are shown. Generally, the stomach 10 includes a lower end 14, an upper end 16, an anterior surface 18, and a posterior surface 20. The gastroesophageal junction 22 opens into the stomach 10 and is a common landmark in bariatric surgery. The fundus 24 and the section of the stomach 10 defined by the greater curvature 26 are the portions of the stomach 10 typically removed during a vertical sleeve gastrectomy. The remaining pouch, or sleeve, is typically defined by the lesser curvature 28 and the resection line 12, providing a stomach with a significantly reduced volume. The desired location of the resection line 12 may be approximately 0.5 cm to approximately 2 cm away from the gastroesophageal junction 22 and approximately 2 cm to approximately 10 cm away from the pylorus 30. The embodiments described herein utilize an internal cutter stapling device to create a high-quality, consistent resection line during a vertical sleeve gastrectomy. These device embodiments are believed to be advantageous because they can be easily positioned using a laparoscope, can accommodate tissue of varying thickness along the length of the resection line, can have the ability to apply uniform compressive pressure to the tissue along the resection line, and can allow for light staple firing forces. These device embodiments can utilize electrical energy to cut, dissect, ablate, coagulate, cauterize, seal, or otherwise treat the resection line during a surgical procedure.
[0040] 2 is a perspective view of an exemplary electrosurgical stapling device 100 in accordance with one embodiment. Electrosurgical stapling device 100 can include an internal cutter 108 and a motor assembly 115. Electrosurgical stapling device 100 includes an end effector 121 including an anvil assembly 101, a cartridge assembly 103, a support tube 140, and a handle portion 123. Anvil assembly 101 can act as a first jaw of end effector 121, and cartridge assembly 103 can act as a second jaw of end effector 121. End effector 121 can be connected to handle portion 123 through support tube 140. Handle portion 123 can include a handle 111 and a trigger 104 for actuating electrosurgical stapling device 100.
[0041] Handle portion 123 may include a mode button 124 for switching among operating modes. For example, in a first mode, trigger 104 may be pressed upward to open the jaws (e.g., the anvil and cartridge) or downward to close the jaws. When the jaws are in the closed position, mode button 124 may be pressed to transition electrosurgical stapling device 100 to a firing mode. When in the firing mode, electrosurgical stapling device 100 may be fired by pressing trigger 104, which may simultaneously cut tissue and form a staple line comprised of one or more rows of staples. In one embodiment, pressing trigger 104 in the firing mode may deploy a staple line comprising six rows of staples, while a knife (not shown) simultaneously cuts the tissue between the third and fourth rows of staples. Electrical energy may be applied to the tissue immediately after it has been cut through an electrode 170 ( FIG. 3 ) positioned proximate to the knife, as described in more detail below.
[0042] 3 depicts an exploded perspective view of electrosurgical stapling device 100 (FIG. 2) according to at least one embodiment. Anvil assembly 101 can include an anvil frame 102 and an anvil plate 112. Anvil plate 112 can be welded to anvil frame 102 or attached elsewhere by gluing, brazing, sintering, machining, 3D printing, or the like. A cartridge 110 containing a plurality of staples can be attached to cartridge frame 116 by a first cartridge pin 143 at a first end and a second cartridge pin 118 at a second end, or alternatively, can be attached to cartridge frame 116 by snap-fit, glued, or other attachment methods.
[0043] In the embodiment shown in FIG. 3 , the cartridge frame 116 is insertable at its proximal end into the support tube 140, thereby aligning and connecting the end effector 121 of the internal cutter 108 to the handle portion 123. The blade assembly can include a knife or blade 107, which can be coupled to a rotating member 180 by a nut 109, bushing, or other suitable connection. An electrode 170, which can be positioned on only one side of the knife, can achieve hemostasis by, for example, heating tissue and blood vessels to cauterize, coagulate / dehydrate, and / or seal the tissue when the electrosurgical stapling device 100 is fired. The electrode 170 can be in electrical communication with an electrosurgical power generation source through a circuit (not shown). A tissue sensor 177 can be positioned about the knife 107. In some embodiments, the tissue sensor is coupled to the knife 107 and positioned distally from the electrode 170. 3 shows a single tissue sensor 177, any suitable number of tissue sensors 177 may be deployed within the end effector 121, and the present disclosure is not limited to a single tissue sensor 177. The tissue sensor 177 may be, for example, a resistance temperature device (RTD) used as a temperature sensor. The RTD may be a component of a temperature measurement circuit that includes a current source for passing a current through it and a voltage reading means for reading the voltage drop developed across the RTD. From these currents and voltages, a temperature resistance value may be derived that is indicative of the temperature being sensed.
[0044] The handle portion 123 may include a right handle half 120 and a left handle half 122 that may be held together in a clamshell fashion. The right handle half 120 and the left handle half 122 may be joined by, for example, ultrasonic welding, glue, screws, grip or press-fit pins that fit into holes molded into the handles, or other assembly methods. To provide a pleasing aesthetic to the exterior of the handle portion 123, a left handle shell 150 and a right handle shell 152 may be used to cover the left handle half 122 and the right handle half 120.
[0045] A drive screw 154 can be used to drive the control arm 151 through a control arm nut 153. The drive screw 154 can be connected to a second drive gear coupling 145 that can engage with a motor assembly 115 (FIG. 4). The rotating member 180 can be coupled to the motor assembly 115 through a firing drive gear 166 and a second firing drive gear 169, where the second firing drive gear 169 can engage with the first drive gear coupling 156, which can be coupled to the motor assembly 115. In one embodiment, the second firing drive gear 169 and the first drive gear coupling 156 can be a single component or feature.
[0046] FIG. 4 is a perspective view of a motor assembly 115 according to one embodiment. A first electric motor 135 and a second electric motor 137 can be provided within a motor housing 113. In one embodiment, a first motor gear 163 can be coupled to a first drive gear coupling 156 (FIG. 3), and a second motor gear 165 can be coupled to a second drive gear coupling 145 (FIG. 3). The motor housing 113 can include a left motor housing half 127 and a right motor housing half 116. The motor housing 113 can include snaps 117 for coupling the motor assembly 115 with the handle portion 123 (FIG. 3). A strain relief 119 can be provided to assist in connecting wires to the motor assembly 115. A connector 125 can be provided between the motor assembly 115 and the electrosurgical stapling device 100 to electrically connect the trigger 104 (FIG. 3) and other electrical components.
[0047] 5A is a side view of an electrosurgical stapling device 100 according to one embodiment showing an end effector 121 in an open position. The end effector 121 can include a first jaw that includes an anvil assembly 101 and a second jaw that includes a cartridge assembly 103. The end effector 121 can include a master link 106 operably coupled to a motor assembly 115.
[0048] 5B is a side view of electrosurgical stapling device 100 showing end effector 121 in a closed position. In its closed position, end effector 121 can be ready for a firing phase, which can include deploying staples, cutting tissue, and / or applying electrosurgical energy to tissue.
[0049] FIG. 6 depicts a cross-sectional side view of the handle portion 123 of the electrosurgical stapling device 100 in an open position (e.g., the position shown in FIG. 5A ). A second drive gear coupling 145 for opening and closing the end effector 121 can be coupled to a second motor gear 165 ( FIG. 4 ) connected to a second electric motor 137. The second drive gear coupling 145 can rotate a drive screw 154 to transition the end effector 121 between an open position and a closed position, and vice versa, to open and close the end effector 121. FIG. 6 shows the control arm nut 153 in its distal-most position on the drive screw 154 such that the master link 106 is fully extended and the end effector 121 is in the open position. The control arm nut 153 in the illustrated position can contact a control arm distal limit switch 168 to cut off power to the second electric motor 137 when the end effector 121 is in the fully open position. First drive gear coupling 156 can be coupled to second motor gear 165 to deploy staples from electrosurgical stapling device 100 and simultaneously cut tissue and then hemostatically seal the same.
[0050] FIG. 6 also schematically depicts conductors 141 extending through support tube 140 and in electrical communication with electrode 170 (FIG. 3). In the illustrated embodiment, a spool 159 is positioned within a cavity defined by handle portion 123. Conductors 141 may include, for example, conductors 141A-141D, as shown in cross-sectional view AA. For example, conductors 141A and 141B may be components of a circuit with electrode 170, and conductors 141C and 141D may be components of a circuit with tissue sensor 177. Spool 159 may be configured to take up slack from conductor 141 as electrode 170 and tissue sensor 177 are drawn proximally toward handle portion 123 during a surgical procedure. In some embodiments, a constant force spring 161 may be coupled to spool 159 to assist in automatic rewinding of spool 159 during surgery.
[0051] 7 depicts a side view showing the end effector 121 of the electrosurgical stapling device 100 in the open position. The master link 106 can be attached to a first end of the anvil frame 102 by a first master link pin 120 such that the first master link pin 120 pivotally and slidably engages the master link slot 105. The master link slot 105 can be a channel parallel to the longitudinal axis of the anvil assembly 101 or can be angled upward or downward relative to the longitudinal axis. A second master link pin 138 can be used to pivotally couple the master link 106 to the control arm 151.
[0052] 8 depicts a cross-sectional side view showing handle portion 123 of electrosurgical stapling device 100 in a closed position. Control arm nut 153 is illustrated in a proximal-most position on drive screw 154 as anvil assembly 101 is closed relative to cartridge assembly 103. In one embodiment, as end effector 121 is closing, control arm nut 153 can advance proximally until it contacts proximal limit switch 155. When control arm nut 153 contacts proximal limit switch 155, it can cut off power to second electric motor 137. Electrosurgical stapling device 100 can be configured such that it cannot transition to a firing mode until control arm nut 153 engages proximal limit switch 155 to ensure it is in the closed position prior to firing.
[0053] 9 depicts a side view of end effector 121 of electrosurgical stapling device 100 in the closed position. Master link 106 is shown partially inserted into support tube 140 such that anvil assembly 101 and cartridge assembly 103 are in the closed position and ready to fire.
[0054] 10 is a side view of a drive assembly 260 for simultaneously stapling, cutting, and sealing tissue. The drive assembly 260 can include a blade assembly 208 including a blade 207 coupled to a beam 226. An electrode 270 and a tissue sensor 277 can be positioned on one side of the blade 207 so that they directly contact the tissue cut by the blade 207. The electrode 270 can be in electrical communication with a source of electrosurgical energy through a circuit 241. The beam 226 can include a nut 209 that can be threadably engaged with a rotating member 280. The rotating member 280 can be operably coupled to a first electric motor 212 such that rotation of the rotating member 280 urges the nut 209 proximally. During surgery, activation of the first electric motor 212 can urge the nut 209 proximally such that the beam 226 and the blade assembly 208 are moved proximally accordingly. As the blade assembly 208 is advanced proximally, the cutting edge 232 on the blade 207 can transect tissue. At the same time, energy can be passed through the transected tissue by the electrode 270 to heat the tissue and blood vessels, cauterizing, coagulating / dehydrating, and / or sealing the tissue along one side of the incision. At the same time, the tissue sensor 277 can provide real-time feedback regarding the status of the tissue surrounding the cut site. The blade 207 can include an upper portion 228 and a lower portion 230 that can press against the anvil and cartridge of an end effector when advanced proximally.
[0055] 10 , when the blade assembly 208 is pulled to its proximal-most position, the nut 209 can engage a fire-complete limit switch 268. When the nut 209 engages the fire-complete limit switch 268, power to the first electric motor 212 can be cut off. It is contemplated that the nut 209 can be attached to the blade assembly 208 or the beam 226 in any suitable manner, such as by pins, spot welding, or other attachment methods. Alternatively, the nut 209 can be monolithically formed as a unitary structure with the blade assembly 208 or the beam 226.
[0056] 11 is a perspective view of a motor controller 370 according to one embodiment. The motor controller 370 can include a controller housing 372 having an on / off switch 374, a display 375, and a device cable connector 376. The on / off switch 374 can provide the motor controller 370 with grid power, for example, 110 or 220 volt AC power from a wall outlet, or with battery power. The device cable connector 376 can connect multiple wires from the motor assembly of the stapling device to the motor controller 370. For example, the device cable connector 376 may provide positive and negative voltage wires to the first electric motor (e.g., first electric motor 135 shown in FIG. 4), positive and negative voltage wires to the second electric motor 137 (e.g., second electric motor 137 shown in FIG. 4), wires to the trigger (e.g., trigger 104 shown in FIG. 3), positive and negative sense wires to each of the fired limit switches 168 (FIG. 6), respective wires in electrical communication with the active and return electrodes (e.g., electrode 170 (FIG. 3), electrode 270 (FIG. 10)), wires in electrical communication with one or more tissue sensors (e.g., tissue sensor 177 (FIG. 3)), and any other wires advantageous to the internal cutter.
[0057] FIG. 12 is an exploded perspective view of the motor controller 370 in accordance with one embodiment. A lid 373, which may be part of the controller housing 372, may enclose the components inside the controller housing 372. In the embodiment shown in FIG. 11, grid power may be introduced into the controller housing 372 through an electrical plug 378. Additionally, a fan 380 may be included to cool the interior of the controller housing 372. A pair of speakers 382 may be provided to notify the user of the status of the stapling device, such as, for example, jaw open, jaw closed, firing complete, ready to fire, or other useful information. A display 375 may be used to provide visual indications, data, error conditions, instrument identification, or other useful data.
[0058] The motor controller board 328 can provide power to the first electric motor 135 (FIG. 4) or the second electric motor 137 (FIG. 4) accordingly. The motor controller board 328 can control the electrosurgical energy associated with various electrodes, such as electrode 170 or electrode 270 (FIG. 10). The motor controller board 328 can receive signals indicative of the status of the tissue provided by tissue sensor 177 or tissue sensor 277. The motor controller board 328 can receive instructions from the processor board 330 to activate or deactivate the first electric motor 135 or the second electric motor 137. The processor board 330 can include a processor, such as an ARM processor or other processor, advantageous for controlling the stapling device. For example, the processor board 330 can include software that can read the status of the limit switches 155, 168 (FIG. 6) and the trigger 104 (FIG. 6) and control the motor controller board 328 to, for example, open or close the jaws, fire the system, activate the electrosurgical energy source, or perform other advantageous functions.
[0059] In one exemplary embodiment, the ARM processor can be used to communicate with an internal cutter (e.g., stapling device 100 shown in FIG. 1 ). For example, electrosurgical stapling device 100 can include an EEPROM or other memory-holding device that can encode a serial number during manufacturing. The memory can be used to provide information to the motor controller. For example, the processor can be capable of measuring and recording opening and closing motor amperage during start-up on the manufacturing line, data regarding the condition of the tissue along the resection site, firing motor amperage during start-up on the manufacturing line, opening and closing motor amperage in clinical use, firing motor amperage during start-up in clinical use, or other data useful to the manufacturer or operator. This data can be communicated to and contained in motor controller 370. Such information can be displayed to the user during firing by connection of motor controller 370 to a screen or display that can be incorporated into electrosurgical stapling device 100 within motor controller 370, or the data can be transmitted to a monitor used by a laparoscopic camera in minimally invasive procedures.
[0060] In one embodiment, an electrosurgical stapling device system according to embodiments described herein can have a unique serial number or other identifier, allowing an operator to record the specific serial number of the instrument used in a patient's records. When the instrument is connected into a controller, such as motor controller 370, the controller can communicate with the memory to provide the serial number on the controller's display. The memory can be used to record information regarding the use of the instrument. For example, an event log can be recorded in the memory from the controller that records motor load, number of times the instrument has been opened and closed, number of times the instrument has been fired, error codes, or other useful information in the memory for later review.
[0061] 13 , an exemplary beam 426 is shown in accordance with one non-limiting embodiment of the present disclosure. A blade assembly 408 at the distal end of the beam 426 can include a top portion 428, a bottom portion 430, and a blade 407. As with prior embodiments, the top portion 428 and the bottom portion 430 can press against an anvil and cartridge of an end effector (not shown) when pushed proximally. The blade assembly 408 has a first side 409 on which first and second electrodes 471, 473 and a tissue sensor 477 can be coupled. As shown, the first and second electrodes 471, 473 and the tissue sensor 477 can be positioned around the blade 407 such that the tissue to be cut is positioned in near direct contact with the first and second electrodes 471, 473 and the tissue sensor 477. The first and second electrodes 471, 473 may be in electrical communication with a source of electrosurgical energy (not shown) through a circuit 411 that extends along the beam 426. In some embodiments, the circuit 411 may be coupled to the beam 426 using any suitable technique. For example, in some embodiments, the circuit 411 is positioned in a slot formed in the beam 426. In other embodiments, the circuit 411 may be molded with the beam 426. The tissue sensor 477 may also send a signal through the circuit 411 that extends along the beam 426.
[0062] The electrosurgical energy source can supply a bipolar electrosurgical current that flows from the first electrode 471, through the intervening tissue, to the second electrode 473 to complete the electrical circuit. More specifically, as the blade assembly 408 is advanced proximally, the blade 407 can transect the tissue along the resection line 12 (FIG. 1) and simultaneously deliver energy to the resected tissue. Such energy can thereby heat the tissue and blood vessels along the resection line 12 and cauterize, coagulate / dehydrate, and / or seal the tissue along the resection line 12. The tissue sensor 477 can provide a feedback signal indicative of one or more tissue parameters, such as, for example, tissue impedance, tissue temperature, output current, and / or output voltage.
[0063] The tissue will be divided along the resection line 12 so that the incision has a first side and a second side. Because the first and second electrodes 471, 473 are coupled to one side of the blade assembly 408, only one side of the incision (i.e., the first side) will be in contact with the first and second electrodes 471, 473 during the transection. In some embodiments, additional electrodes and one or more tissue sensors may be positioned on the other side of the blade assembly 408 so that both sides of the incision are in contact with a pair of electrodes and tissue sensor. For example, as shown, one pair of electrodes 471, 473 and tissue sensor 477 may be coupled to one side of the blade assembly 408, and another pair of electrodes (not shown) may be positioned on the opposite side of the blade assembly 408. The other pair of electrodes may also be in electrical communication with a source of electrosurgical energy (not shown) through a circuit 411 extending along the beam 426. In this arrangement, both sides of the incision can be in contact with a pair of electrodes during transection, and the condition of the tissue along both sides of the incision can be monitored as well. Thus, according to various embodiments, electrodes on both sides of the blade assembly 408 can be used to simultaneously cauterize, coagulate / dehydrate, and / or seal both sides of the incision made by the blade assembly 408.
[0064] While FIG. 13 illustrates one exemplary arrangement of electrodes and tissue sensors, the present disclosure is not limited to such an arrangement. Indeed, a variety of different electrode layouts, as well as various shapes, configurations, and locations of electrodes and tissue sensors, as well as the total number of electrodes and sensors, can be used without departing from the scope of the present disclosure. Each of FIGS. 14-15 depicts an exemplary layout of electrodes and sensors according to various embodiments. Furthermore, while FIGS. 14-15 illustrate electrodes and one or more tissue sensors positioned on a first side of the blade assembly for illustrative purposes, it should be appreciated that the electrodes and / or one or more tissue sensors can additionally or alternatively be positioned on a second side of the blade assembly without departing from the scope of the present disclosure.
[0065] 14 , there is shown a blade assembly 508 coupled to a beam 526. First and second electrodes 571, 573 are coupled to one side of the blade assembly 508 and are in electrical communication with a source of electrosurgical energy (not shown) through circuitry 511. A tissue sensor 577 is also coupled to one side of the blade assembly 508 through circuitry 511, providing feedback to a tissue monitoring system (not shown). In this embodiment, the first and second electrodes 571, 573 are positioned along the longitudinal axis of the beam 526. In one embodiment, the first electrode 571 is the active electrode and the second electrode 573 is the return electrode. In another embodiment, the first electrode 571 is the return electrode and the second electrode 573 is the active electrode. Each of the first and second electrodes 571, 573 can have a curved outer surface that can assist in placing the first and second electrodes 571, 573 in contact with tissue during ablation. In some embodiments, each of the first and second electrodes 571, 573 can be a truncated cylinder (as shown). In other embodiments, each of the first and second electrodes 571, 573 can be a hemispherical block, a rectangular block, or any of a variety of other suitable shapes. The tissue sensor 577 can have a similar form factor to the electrodes 571, 573, as shown in FIG. 14, or can have a different form factor without departing from the scope of this disclosure.
[0066] Implementations of the disclosed technology including tissue monitoring systems (see, e.g., FIGS. 17A-23B) can include a closed-loop control mechanism including a feedback control loop in which one or more tissue sensors (e.g., tissue sensors 477 and 577) provide feedback to a motor controller (e.g., motor controller 370). The tissue sensors can provide information obtained from one or more sensing mechanisms to transmit various tissue parameters, such as, for example, tissue impedance, tissue temperature, output current, and / or output voltage. The motor controller can then transmit signals through a motor controller board (e.g., motor controller board 328) to an electrosurgical power generation source, which can then adjust various operating parameters, such as the firing rate of the electrosurgical stapling device. The motor controller can include analog and / or logic circuitry for processing sensed values from the tissue sensors and determining control signals to be sent to the electrosurgical power generation source. The tissue sensors can be provided with leads (or wireless) for transmitting information to the controller, and the tissue sensors are moved along the tissue during the resection procedure.
[0067] In one non-limiting example, one or more tissue sensors provide measured tissue temperature feedback to the motor controller to adjust the firing rate of the electrosurgical stapling device. Once the tissue temperature rises above a predetermined threshold, energy from the electrosurgical power generation source is terminated and not used, thereby stopping the firing of the electrosurgical stapling device. In one embodiment, the predetermined threshold is between 80-120°C. Furthermore, the firing rate of the electrosurgical stapling device is reduced if the tissue temperature at a predetermined location along the resection line 12 (shown in FIG. 1) does not reach a predetermined target temperature. In one embodiment, the predetermined target tissue temperature is between 60-100°C.
[0068] In another non-limiting example, one or more tissue sensors provide measured tissue impedance feedback to the motor controller to adjust the firing rate of the electrosurgical stapling device. As tissue is cauterized along the resection line 12, impedance in the tissue increases. Therefore, if the tissue impedance at a predetermined location along the resection line 12 does not reach a predetermined target impedance, energy from the electrosurgical generating source is terminated and not used. Furthermore, if the tissue impedance rises above a predetermined threshold, the firing rate of the electrosurgical stapling device is reduced, thereby stopping the firing of the electrosurgical stapling device. In one embodiment, the target impedance required to maintain a temperature between 90-100°C is between 200-600 ohms (Ω). If the tissue impedance is greater than 600 Ω, the firing rate of the electrosurgical stapling device is reduced, and if the tissue impedance is less than 200 Ω, energy from the electrosurgical generating source is disabled.
[0069] 15 , there is shown a blade assembly 608 coupled to a beam 626. First and second electrodes 671, 673 are coupled to one side of the blade assembly 608 and are in electrical communication with a source of electrosurgical energy (not shown) through circuitry 611. A tissue sensor 677 is also coupled to one side of the blade assembly 608 through circuitry 611, providing feedback to a tissue monitoring system. In this embodiment, the first and second electrodes 671, 673 are positioned along an axis perpendicular to the longitudinal axis of the beam 626. In one embodiment, the first electrode 671 is the active electrode and the second electrode 673 is the return electrode. In another embodiment, the first electrode 671 is the return electrode and the second electrode 673 is the active electrode. Although the first and second electrodes 671, 673 are shown as being generally rectangular, each of the electrodes may have any of a variety of other suitable shapes.
[0070] 16 , there is shown a blade assembly 708 coupled to a beam 726. First and second electrodes 771, 773 are coupled to one side of the blade assembly 708 and are in electrical communication with a source of electrosurgical energy (not shown) through circuitry 711. Also coupled to one side of the blade assembly 708 is a tissue sensor 777 that provides feedback to a tissue monitoring system through circuitry 711. In this embodiment, the blade assembly includes a distal extension 709 that assists in providing desired electrode placement. Such a distal extension 709 can be used, for example, to accommodate larger sized electrodes and / or to accommodate additional lateral separation between the electrodes.
[0071] 17A-17B schematically depict one exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system, and maintaining such coupling during surgery. Referring initially to FIG. 17A , a blade assembly 808 is shown coupled to a beam 826 extending through a support tube 840, shown in cross section. As shown, first and second electrodes 871, 873, and a tissue sensor 877 may be coupled to the blade assembly 808. Similar to the arrangement shown in FIG. 10 , a nut 809 may be threadedly engaged with a rotatable member 880 such that rotation of the rotatable member 880 provides longitudinal movement of the nut 809 along the length of the rotatable member 880. The proximal end of the beam 826 may be coupled or otherwise engaged to the nut 809 such that proximal movement of the nut 809 along the rotatable member 880 provides movement of the beam 826 in the same direction.
[0072] The proximal end of the beam may include a first contact 845 and a second contact 847. The first contact 845 may be in electrical contact with a first electrode 871 through a conductor 849 routed along the beam 826. The second contact 847 may be in electrical contact with a second electrode 873 through a conductor 851 routed along the beam 826. Additionally, the proximal end of the beam may include a third contact 846 and a fourth contact 848. The third contact 846 may be in electrical contact with a tissue sensor 877 through a conductor 850 routed along the beam 826. The fourth contact 848 may be in electrical contact with the tissue sensor 877 through a conductor 852 routed along the beam 826.
[0073] A first conductive strip 841 can be positioned on the inner surface of the support tube 840. The first conductive strip 841 can be in electrical communication with an electrosurgical energy source, such as a bipolar energy source 860, through a conductor 861. Additionally, a second conductive strip 843 can be positioned on the inner surface of the support tube 840. The second conductive strip 841 can be in electrical communication with an electrosurgical energy source, such as a bipolar energy source 860, through a conductor 863. A first contact 845 can physically touch the first conductive strip 841 and maintain such contact while the first contact 845 moves relative to the first conductive strip 841. A second contact 847 can physically touch the second conductive strip 843 and maintain such contact while the second contact 847 moves relative to the second conductive strip 843.
[0074] A third conductive strip 842 can be positioned on the inner surface of the support tube 840. The third conductive strip 842 can be in electrical communication with a tissue monitoring system 862. Additionally, a fourth conductive strip 844 can be positioned on the inner surface of the support tube 840. The fourth conductive strip 844 can be in electrical communication with the tissue monitoring system 862. A third contact 846 can physically touch the third conductive strip 842 and maintain such contact while the third contact 846 moves relative to the third conductive strip 842. A fourth contact 848 can physically touch the fourth conductive strip 844 and maintain such contact while the fourth contact 848 moves relative to the fourth conductive strip 844.
[0075] Each of contacts 845, 846, 847, and 848 may include a brush, a leaf spring, or any other suitable connection that allows for the transmission of electrical current between the contact and the respective conductive strip when beam 826 moves relative to support tube 840.
[0076] FIG. 17B schematically illustrates the delivery of energy to tissue (not shown) during surgery. During surgery, nut 809 is moved in the direction indicated by arrow A by rotation of rotating member 880. A continuous energy supply path can be provided to the tissue being ablated by blade assembly 808. More specifically, a path including conductor 861, first conductive strip 841, first contact 845, and conductor 849 forms an energy supply path from bipolar energy source 860 to first electrode 871. A path including conductor 851, second contact 847, second conductive strip 843, and conductor 863 can provide a continuous energy return path from second electrode 873 to bipolar energy source 860. Additionally, tissue monitoring system 862 can receive continuous signals from the tissue being ablated by blade assembly 808. More specifically, the circuit from tissue monitor system 862 to tissue sensor 877 includes a third conductive strip 842, a third contact 846, and a conductor 850 on one leg, and a fourth conductive strip 844, a fourth contact 848, and a conductor 852 on the other leg.
[0077] 18A-18B schematically depict another exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system, and maintaining such coupling during surgery. Referring initially to FIG. 18A , a blade assembly 908 is shown coupled to a beam 926 extending through a support tube 940, shown in cross section. As shown, first and second electrodes 971, 973, and a tissue sensor 977 may be coupled to the blade assembly 908. A nut 909 may be threadedly engaged with a rotatable member 980 such that rotation of the rotatable member 980 provides longitudinal movement of the nut 909 along the length of the rotatable member 980. The proximal end of the beam 926 may be coupled or otherwise engaged to the nut 909 such that proximal movement of the nut 909 along the rotatable member 980 provides movement of the beam 926 in the same direction.
[0078] The nut 909 may include a first contact 945 and a second contact 947. The first contact 945 may be in electrical contact with a first electrode 971 through a conductor 949 routed from the nut 909 along the beam 926. The second contact 947 may be in electrical contact with a second electrode 973 through a conductor 951 routed from the nut 909 along the beam 926. Additionally, the nut 909 may include a third contact 946 and a fourth contact 948. The third contact 946 may be in electrical contact with a tissue sensor 977 through a conductor 950 routed along the beam 926. The fourth contact 948 may be in electrical contact with the tissue sensor 977 through a conductor 952 routed along the beam 926.
[0079] Similar to FIGS. 17A-17B , a first conductive strip 941 can be positioned on the inner surface of the support tube 940. The first conductive strip 941 can be in electrical communication with an electrosurgical energy source, such as a bipolar energy source 960, through a conductor 961. Additionally, a second conductive strip 943 can be positioned on the inner surface of the support tube 940. The second conductive strip 941 can be in electrical communication with an electrosurgical energy source, such as a bipolar energy source 960, through a conductor 963. A first contact 945 can physically touch the first conductive strip 941 and maintain such contact while the first contact 945 moves relative to the first conductive strip 941. A second contact 947 can physically touch the second conductive strip 943 and maintain such contact while the second contact 947 moves relative to the second conductive strip 943. A third conductive strip 942 can be positioned on the inner surface of the support tube 940. The third conductive strip 942 can be in electrical communication with the tissue monitoring system 962. Additionally, a fourth conductive strip 944 can be positioned on the inner surface of the support tube 940. The fourth conductive strip 944 can be in electrical communication with the tissue monitoring system 962. The third contact 946 can physically touch the third conductive strip 942 and maintain such contact while the third contact 946 moves relative to the third conductive strip 942. The fourth contact 948 can physically touch the fourth conductive strip 944 and maintain such contact while the fourth contact 948 moves relative to the fourth conductive strip 944.
[0080] Each of the contacts 945, 946, 947, and 948 may include a brush, a leaf spring, or any other suitable connection that allows for the transmission of electrical current between the contact and the respective conductive strip when the nut 909 moves relative to the support tube 940.
[0081] FIG. 18B schematically illustrates the delivery of energy to tissue (not shown) during surgery. During surgery, nut 909 is moved in the direction indicated by arrow A by rotation of rotating member 980. A continuous energy supply path can be provided to the tissue being ablated by blade assembly 908. More specifically, a path including conductor 961, first conductive strip 941, first contact 945, and conductor 949 forms an energy supply path from bipolar energy source 960 to first electrode 971. A path including conductor 951, second contact 947, second conductive strip 943, and conductor 963 can provide a continuous energy return path from second electrode 973 to bipolar energy source 960. Additionally, tissue monitoring system 962 can receive a continuous signal from the tissue being ablated by blade assembly 908. More specifically, the circuit from tissue monitor system 962 to tissue sensor 977 includes a third conductive strip 942, a third contact 946, and a conductor 950 on one leg, and a fourth conductive strip 944, a fourth contact 948, and a conductor 952 on the other leg.
[0082] 19 schematically depicts another exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system and maintaining such coupling during surgery. A blade assembly 1008 is shown coupled to a beam 1026 extending through a support tube 1040, shown in cross section. As shown, first and second electrodes 1071, 1073, and a tissue sensor 1077 can be coupled to the blade assembly 1008. A nut 1009 can be threadedly engaged with a rotatable member 1080 such that rotation of the rotatable member 1080 provides longitudinal movement of the nut 1009 along the length of the rotatable member 1080. The proximal end of the beam 1026 can be coupled or otherwise engaged to the nut 1009 such that proximal movement of the nut 1009 along the rotatable member 1080 provides movement of the beam 1026 in the same direction.
[0083] The proximal end of the beam 1026 may include a first contact 1045 and a second contact 1047. The first contact 1045 may be in electrical contact with a first electrode 1071 through a conductor 1049 routed along the beam 1026. The second contact 1047 may be in electrical contact with a second electrode 1073 through a conductor 1051 routed along the beam 1026. Additionally, the proximal end of the beam 1026 may include a third contact 1046 and a fourth contact 1048. The third contact 1046 may be in electrical contact with a tissue sensor 1077 through a conductor 1050 routed along the beam 1026. The fourth contact 1048 may be in electrical contact with the tissue sensor 1077 through a conductor 1052 routed along the beam 1026.
[0084] A first conductor 1041A in electrical communication with an electrosurgical energy source, such as a bipolar energy source 1060, can be routed through the support tube 1040 and connected to the first contact 1045. Additionally, a second conductor 1041B in electrical communication with an electrosurgical energy source, such as a bipolar energy source 1060, can be routed through the support tube 1040 and connected to the first contact 1047. A third conductor 1043A in electrical communication with a tissue monitoring system 1062 can be routed through the support tube 1040 and connected to the third contact 1046. Additionally, a fourth conductor 1043B in electrical communication with a tissue monitoring system 1062 can be routed through the support tube 1040 and connected to the fourth contact 1048. The first and second conductors 1041A, 1041B can be wound around a spool 1059, which can be similar to the spool 159 of FIG. 8, for example. The third and fourth conductors 1043A, 1043B may be wound around a spool 1061, for example.
[0085] During surgery, the nut 1009 is moved in the direction indicated by arrow A by rotation of the rotating member 1080. A continuous energy supply path can be provided to the tissue being ablated by the blade assembly 1008. More specifically, a path including conductor 1041A, first contact 1045, and conductor 1049 forms an energy supply path from the bipolar energy source 1060 to the first electrode 1071. A path including conductor 1051, second contact 1047, and second conductor 1041B provides a continuous energy return path from the second electrode 1073 to the bipolar energy source 1060. As the nut 1009 is moved in the direction indicated by arrow A, rotation of the spool 1059 can take up excess slack in the first and second conductors 1041A, 1041B. Additionally, the tissue monitoring system 1062 can receive a continuous signal from the tissue being ablated by the blade assembly 1008. More specifically, the circuit from tissue monitoring system 1062 to tissue sensor 1077 includes third conductor 1043A, third contact 1046, and conductor 1050 on one leg, and fourth conductor 1043B, fourth contact 1048, and conductor 1052 on the other leg. When nut 1009 is moved in the direction indicated by arrow A, rotation of spool 1061 can take up excess slack in third and fourth conductors 1043A, 1043B.
[0086] 20 schematically depicts another exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system, and maintaining such coupling during surgery. A blade assembly 1108 is shown coupled to a beam 1126 extending through a support tube 1140, shown in cross section. As shown, first and second electrodes 1171, 1173, and a tissue sensor 1177 can be coupled to the blade assembly 1108. A nut 1109 can be threadedly engaged with a rotatable member 1180 such that rotation of the rotatable member 1180 provides longitudinal movement of the nut 1109 along the length of the rotatable member 1180. The proximal end of the beam 1126 can be coupled or otherwise engaged to the nut 1109 such that proximal movement of the nut 1109 along the rotatable member 1180 provides movement of the beam 1126 in the same direction.
[0087] The proximal end of the beam can include a flexible circuit connection 1145. The flexible circuit connection 1145 can be in electrical contact with a first electrode 1171 through conductors 1149 routed along the beam 1126. Similarly, the flexible circuit connection 1145 can be in electrical contact with a second electrode 1173 through conductors 1151 routed along the beam 1126. Additionally, the flexible circuit connection 1145 can be in electrical contact with a tissue sensor 1177 through conductors 1150, 1152 routed along the beam 1126.
[0088] A flexible circuit 1141 (sometimes referred to as a flexible printed circuit or flex circuit) in electrical communication with an electrosurgical energy source, such as a bipolar energy source 1160, can be routed through the support tube 1140 and connected to a flexible circuit connection 1145. The flexible circuit 1141 can be in electrical communication with a slip ring 1159, which can be coupled to a spool, for example. The flexible circuit 1141 can contain multiple conductors (i.e., traces) adhered to a substrate. For example, the flexible circuit 1141 can include first and second traces, each in electrical communication with the bipolar energy source 1160, and a trace in electrical communication with the tissue monitoring system 1162.
[0089] During surgery, the nut 1109 is moved in the direction indicated by arrow A by rotation of the rotating member 1180. A continuous energy delivery path can be provided to the tissue being ablated by the blade assembly 1108. More specifically, the path including the flexible circuit 1141, the flexible circuit connection 1145, and the conductor 1149 forms an energy delivery path from the bipolar energy source 1160 to the first electrode 1171. The path including the conductor 1151, the flexible circuit connection 1145, and the flexible circuit 1141 provides a continuous energy return path from the second electrode 1173 to the bipolar energy source 1160. Additionally, the tissue monitoring system 1062 can receive a continuous signal from the tissue being ablated by the blade assembly 1108.
[0090] 21 schematically depicts another exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system, and maintaining such coupling during surgery. A blade assembly 1208 is shown coupled to a beam 1226 extending through a support tube 1240, shown in cross section. As shown, first and second electrodes 1271, 1273, and a tissue sensor 1277 may be coupled to the blade assembly 1208. A nut 1209 may be threadedly engaged with a rotatable member 1280 such that rotation of the rotatable member 1280 provides longitudinal movement of the nut 1209 along the length of the rotatable member 1280. The proximal end of the beam 1226 may be coupled or otherwise engaged to the nut 1209 such that proximal movement of the nut 1209 along the rotatable member 1280 provides movement of the beam 1226 in the same direction.
[0091] The nut 1209 may include a first contact 1245 and a second contact 1247. The first contact 1245 may be in electrical contact with a first electrode 1271 through a conductor 1249 routed from the nut 1209 along the beam 1226. The second contact 1247 may be in electrical contact with a second electrode 1273 through a conductor 1251 routed from the nut 1209 along the beam 1226. Additionally, the nut 1209 may include a third contact 1246 and a fourth contact 1248. The third contact 1246 may be in electrical contact with a tissue sensor 1277 through a conductor 1250 routed along the beam 1226. The fourth contact 1248 may be in electrical contact with the tissue sensor 1277 through a conductor 1252 routed along the beam 1226.
[0092] A first conductor 1241A in electrical communication with an electrosurgical energy source, such as bipolar energy source 1260, can be routed through support tube 1240 and connected to first contact 1245. Additionally, a second conductor 1241B in electrical communication with an electrosurgical energy source, such as bipolar energy source 1260, can be routed through support tube 1240 and connected to second contact 1247. A third conductor 1243A in electrical communication with tissue monitoring system 1262 can be routed through support tube 1240 and connected to third contact 1246. Additionally, a fourth conductor 1243B in electrical communication with tissue monitoring system 1262 can be routed through support tube 1240 and connected to fourth contact 1248. The first and second conductors 1241A, 1241B can be wound around a spool 1259, which can be similar to spool 159 of FIG. 8, for example. The third and fourth conductors 1243A, 1243B may be wound around a spool 1261, for example.
[0093] During surgery, the nut 1209 is moved in the direction indicated by arrow A by rotation of the rotating member 1280. A continuous energy supply path can be provided to the tissue being ablated by the blade assembly 1208. More specifically, the path including the conductor 1241A, the first contact 1245, and the conductor 1249 forms an energy supply path from the bipolar energy source 1260 to the first electrode 1271. The path including the conductor 1251, the second contact 1247, and the second conductor 1241B provides a continuous energy return path from the second electrode 1273 to the bipolar energy source 1260. As the nut 1209 is moved in the direction indicated by arrow A, rotation of the spool 1259 can take up excess slack in the first and second conductors 1241A, 1241B. Additionally, the tissue monitoring system 1262 can receive a continuous signal from the tissue being ablated by the blade assembly 1208. More specifically, the circuit from tissue monitoring system 1262 to tissue sensor 1277 includes third conductor 1243A, third contact 1246, and conductor 1250 on one leg, and fourth conductor 1243B, fourth contact 1248, and conductor 1252 on the other leg. When nut 1209 is moved in the direction indicated by arrow A, rotation of spool 1261 can take up excess slack in third and fourth conductors 1243A, 1243B.
[0094] 22 schematically depicts another exemplary, non-limiting embodiment for electrically connecting electrodes to a source of electrosurgical energy and coupling a tissue sensor to a tissue monitoring system, and maintaining such coupling during surgery. A blade assembly 1308 is shown coupled to a beam 1326 extending through a support tube 1340, shown in cross section. As shown, first and second electrodes 1371, 1373, and a tissue sensor 1177 can be coupled to the blade assembly 1308. A nut 1309 can be threadedly engaged with a rotatable member 1380 such that rotation of the rotatable member 1380 provides longitudinal movement of the nut 1309 along the length of the rotatable member 1380. The proximal end of the beam 1326 can be coupled or otherwise engaged to the nut 1309 such that proximal movement of the nut 1309 along the rotatable member 1380 provides movement of the beam 1326 in the same direction.
[0095] The nut 1309 can include a flexible circuit connection 1345. The flexible circuit connection 1345 can be in electrical contact with a first electrode 1371 through conductors 1349 routed from the nut 1309 along the beam 1326. Further, the flexible circuit connection 1345 can be in electrical contact with a second electrode 1373 through conductors 1351 routed from the nut 1309 along the beam 1326. Similarly, the flexible circuit connection 1345 can be in electrical contact with a tissue sensor 1377 through conductors 1350, 1352 routed along the beam 1326.
[0096] A flexible circuit 1341 (sometimes referred to as a flexible printed circuit or flex circuit) in electrical communication with an electrosurgical energy source, such as a bipolar energy source 1360, can be routed through the support tube 1340 and connected to a flexible circuit connection 1345. The flexible circuit 1341 can be in electrical communication with a slip ring 1359, which can be coupled to a spool, for example. The flexible circuit 1341 can contain multiple conductors (i.e., traces) adhered to a substrate. For example, the flexible circuit 1341 can include first and second traces, each in electrical communication with the bipolar energy source 1360, and a trace in electrical communication with a tissue monitoring system 1362.
[0097] During surgery, the nut 1309 is moved in the direction indicated by arrow A by rotation of the rotating member 1380. A continuous energy delivery path can be provided to the tissue being ablated by the blade assembly 1308. More specifically, the path including the flexible circuit 1341, the flexible circuit connection 1345, and the conductor 1349 forms an energy delivery path from the bipolar energy source 1360 to the first electrode 1371. The path including the conductor 1351, the flexible circuit connection 1345, and the flexible circuit 1341 provides a continuous energy return path from the second electrode 1373 to the bipolar energy source 1360. Additionally, the tissue monitoring system 1362 can receive a continuous signal from the tissue being ablated by the blade assembly 1308.
[0098] 23A-23B schematically depict another exemplary, non-limiting embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such connection during surgery. A blade assembly 1408 is shown coupled to a beam 1426 extending through a support tube 1440, shown in cross section. As shown, first and second electrodes 1471, 1473 can be coupled to the blade assembly 1408. A nut 1409 can be threadedly engaged with a rotatable member 1480 such that rotation of the rotatable member 1480 provides longitudinal movement of the nut 1409 along the length of the rotatable member 1480. The proximal end of the beam 1426 can be coupled or otherwise engaged to the nut 1409 such that proximal movement of the nut 1409 along the rotatable member 1480 provides movement of the beam 1426 in the same direction.
[0099] A tracking nut 1411 can be positioned distally from nut 1409. The tracking nut 1411 can be threaded onto the rotating member 1480 as shown, or can be threaded onto a different rotating member. The tracking nut 1411 can be configured to move proximally at a slower rate than the proximal movement of nut 1409. To accommodate this speed differential when the tracking nut 1411 is threaded onto the rotating member 1480, the tracking nut 1411 can have a different thread pattern than nut 1409. The tracking nut 1411 can include one or more pins, shown as pin 1413 and pin 1415.
[0100] The proximal end of the beam can include a first contact 1445 and a second contact 1447. The first contact 1445 can be in electrical contact with a first electrode 1471 through a conductor 1449 routed along the beam 1426. The second contact 1447 can be in electrical contact with a second electrode 1473 through a conductor 1451 routed along the beam 1426.
[0101] A first conductor 1441 in electrical communication with an electrosurgical energy source, such as bipolar energy source 1460, can be routed within support tube 1440, looped around pin 1413, and then connected to first contact 1445. Additionally, a second conductor 1443 in electrical communication with an electrosurgical energy source, such as bipolar energy source 1460, can be routed within support tube 1440, looped around pin 1415, and then connected to second contact 1447.
[0102] During surgery, a continuous energy delivery path can be provided to the tissue being ablated by the blade assembly 1408. More specifically, a path including conductor 1441, first contact 1445, and conductor 1449 forms an energy delivery path from the bipolar energy source 1460 to the first electrode 1471. A path including conductor 1451, second contact 1447, and second conductor 1443 can provide a continuous energy return path from the second electrode 1473 to the bipolar energy source 1460.
[0103] The nut 1409 can initially be longitudinally separated from the trailing nut 1411 by a distance D1 ( FIG. 23A ). Both nuts can be moved in the direction indicated by arrow A by rotation of the rotating member 1480. The nut 1409 can travel a greater distance, thereby increasing the distance between the nut 1409 and the trailing nut 1411 to a distance D2 ( FIG. 23B ). Because the conductors 1441 and 1443 are looped around the pins 1413 and 1415, respectively, this increased separation during surgery can help manage slack created in the conductors 1441 and 1443 as the nut 1409 is moved in the direction indicated by arrow A. Additionally, in some embodiments, a tissue sensor can be coupled to the blade assembly. The conductors associated with the tissue sensor can be routed similarly to the conductors 1441 and 1443 to help manage their slack during surgery.
[0104] 24A-24B schematically depict another exemplary, non-limiting embodiment for electrically connecting an electrode to a source of electrosurgical energy and maintaining such connection during surgery. A blade assembly 1508 is shown coupled to a beam 1526 extending through a support tube 1540, shown in cross section. As shown, first and second electrodes 1571, 1573 can be coupled to the blade assembly 1508. A nut 1509 can be threadedly engaged with a rotatable member 1580 such that rotation of the rotatable member 1580 provides longitudinal movement of the nut 1509 along the length of the rotatable member 1580. The proximal end of the beam 1526 can be coupled or otherwise engaged to the nut 1509 such that proximal movement of the nut 1509 along the rotatable member 1580 provides movement of the beam 1526 in the same direction.
[0105] A tracking nut 1511 can be positioned distally from nut 1509. The tracking nut 1511 can be threaded onto the rotating member 1580 as shown, or can be threaded onto a different rotating member. The tracking nut 1511 can be configured to move proximally at a slower rate than the proximal movement of nut 1509. To accommodate this speed differential when the tracking nut 1511 is threaded onto the rotating member 1580, the tracking nut 1511 can have a different thread pattern than nut 1509. The tracking nut 1511 can include one or more pins, shown as pin 1513 and pin 1515.
[0106] The nut 1509 may include a first contact 1545 and a second contact 1547. The first contact 1545 may be in electrical contact with a first electrode 1571 through a conductor 1549 routed from the nut 1509 along the beam 1526. The second contact 1547 may be in electrical contact with a second electrode 1573 through a conductor 1551 routed from the nut 1509 along the beam 1526.
[0107] A first conductor 1541 in electrical communication with an electrosurgical energy source, such as bipolar energy source 1560, can be routed within support tube 1540, looped around pin 1513, and then connected to first contact 1545. Additionally, a second conductor 1543 in electrical communication with an electrosurgical energy source, such as bipolar energy source 1560, can be routed within support tube 1540, looped around pin 1515, and then connected to second contact 1547.
[0108] During surgery, a continuous energy delivery path can be provided to the tissue being ablated by the blade assembly 1508. More specifically, a path including conductor 1541, first contact 1545, and conductor 1549 forms an energy delivery path from the bipolar energy source 1560 to the first electrode 1571. A path including conductor 1551, second contact 1547, and second conductor 1543 can provide a continuous energy return path from the second electrode 1573 to the bipolar energy source 1560.
[0109] The nut 1509 can initially be longitudinally separated from the trailing nut 1511 by a distance D1 ( FIG. 24A ). Both nuts can be moved in the direction indicated by arrow A by rotation of the rotating member 1580. The nut 1509 can travel a greater distance, thereby increasing the distance between the nut 1509 and the trailing nut 1511 to a distance D2 ( FIG. 24B ). Because the conductors 1541 and 1543 are looped around the pins 1513 and 1515, respectively, this increased separation during surgery can help manage slack created in the conductors 1541 and 1543 as the nut 1509 is moved in the direction indicated by arrow A. Additionally, in some embodiments, a tissue sensor can be coupled to the blade assembly. The conductors associated with the tissue sensor can be routed similarly to the conductors 1541 and 1543 to help manage their slack during surgery.
[0110] Referring now to FIG. 25 , an exemplary nut 1609 is shown according to one non-limiting embodiment. The nut 1609 can be similar to, for example, nut 909 ( FIGS. 18A-18B ). The nut 1609 can include threads 1611 configured to engage a rotating member. Additionally, the nut 1609 can further include a first contact 1645, a second contact 1646, a third contact 1647, and a fourth contact 1648. In FIG. 25 , the contacts 1645, 1646, 1647, and 1648 are illustrated as leaf springs configured to contact conductive strips, such as conductive strips 941, 942, 943, and 944 ( FIGS. 18A-18B ). The nut 1609 can further include conductors 1649, 1650, 1651, and 1652 that are coupled to a circuit on a beam (not shown).
[0111] Referring now to FIG. 26 , another exemplary nut 1709 is shown according to one non-limiting embodiment. The nut 1709 can be similar to, for example, nut 909 ( FIGS. 18A-18B ). The nut 1709 can include threads 1711 configured to engage a rotating member. Additionally, the nut 1709 can further include a first contact 1745, a second contact 1746, a third contact 1747, and a fourth contact 1748. In FIG. 26 , the contacts 1745, 1746, 1747, and 1748 are illustrated as brushes configured to contact conductive strips, such as conductive strips 941, 942, 943, and 944 ( FIGS. 18A-18B ). The nut 1709 can further include conductors 1649, 1650, 1651, and 1652 that are coupled to a circuit on a beam (not shown).
[0112] 27, there is shown a cutaway view of an exemplary electrosurgical stapling device 1900. Electrosurgical stapling device 1900 can be similar to electrosurgical stapling device 100 (FIGS. 1-2). In this regard, electrosurgical stapling device 1900 can include a nut 1909 that moves along rotatable member 1980 during rotation of rotatable member 1980. In the illustrated embodiment, nut 1909 has a flexible circuit 1941 connected thereto, for example, similar to the arrangement in FIG. 22. Spool assembly 1959 can be configured to receive flexible circuit 1941 when nut 1909 moves in the direction indicated by arrow A during surgery.
[0113] 28 provides a close-up view of the spool assembly 1959, and FIG. 29 provides an exploded view of the spool assembly 1959. The spool assembly 1959 can include a shell 1912 that defines a slot 1914 through which the flexible circuit 1941 passes and wraps around the bobbin 1910. The bobbin 1910 can be rotated about the axis of rotation 1920 as the nut 1909 moves toward the spool assembly 1959 to retrieve the flexible circuit 1941. Thus, during operation, the bobbin 1910 can be rotated relative to the shell 1912 to retract the flexible circuit 1941 into the spool assembly 1959.
[0114] The spool assembly 1959 may further include a slip ring assembly 1957 for delivering energy to the flexible circuit 1941. The slip ring assembly 1957 may include first and second contacts 1902, 1906 positioned on an outer surface of the bobbin 1910. The contacts 1902, 1906, 1922, and 1926 may be in electrical communication with the flexible circuit 1941 through any suitable connection. The first contact 1902 may be configured to remain in constant contact with the first circular electrode 1904 during rotation of the bobbin 1910. The second contact 1906 may be configured to remain in constant contact with the second circular electrode 1908 during rotation of the bobbin 1910. Each of the first and second electrodes 1904, 1908 may be in electrical communication with a bipolar energy source 1960 ( FIG. 29 ). The third contact 1922 can be configured to remain in constant contact with the third circular electrode 1928 during rotation of the bobbin 1910. The fourth contact 1926 can be configured to remain in constant contact with the fourth circular electrode 1924 during rotation of the bobbin 1910. The third and fourth electrodes 1928, 1924 can be in electrical communication with a tissue monitoring system 1962.
[0115] While certain embodiments described herein illustrate the use of a circuit along the beam to deliver electrosurgical energy to electrodes positioned on the blade assembly, the present disclosure is not limited to such use. For example, with reference to FIGS. 30-31 , an exemplary embodiment is shown in which a first conductive strip 2041 is positioned within the anvil assembly 2001 and a second conductive strip 2043 is positioned within the cartridge assembly 2003. Each of the conductive strips 2041, 2043 can be in electrical communication with a suitable source of electrosurgical energy (not shown). FIG. 31 depicts an exemplary blade assembly 2008 having first and second electrodes 2071, 2073, which can be substantially similar to conventional embodiments. The exemplary blade assembly 2008 further includes a first pickup electrode 2045 in electrical communication with the first electrode 2071. The first pickup electrode 2045 is configured to contact the first conductive strip 2041 positioned within the anvil assembly 2001. The exemplary blade assembly 2008 further includes a second pickup electrode 2047 in electrical communication with the second electrode 2073. The second pickup electrode 2047 is configured to contact a second conductive strip 2043 positioned within the cartridge assembly 2003. That is, the pickup electrodes 2045, 2047 can remain in contact with the conductive strips 2041, 2043 as the blade assembly 2008 passes through the anvil assembly 2001 and cartridge assembly 2003 during actuation impact.
[0116] FIG. 32 depicts another exemplary blade assembly 3008 having first and second electrodes 3071, 3073, which may be generally similar to prior embodiments. The exemplary blade assembly 3008 further includes a first pickup electrode 3045 in electrical communication with the first electrode 3071. The first pickup electrode 3045 is configured to contact a first conductive strip positioned in the anvil assembly. The exemplary blade assembly 3008 further includes a second pickup electrode 3047 in electrical communication with the second electrode 3073. The second pickup electrode 3047 is configured to contact a second conductive strip positioned in the anvil assembly. The configuration of FIG. 32 may allow the configuration strip to be embedded deeper within the anvil assembly and, therefore, farther from the patient's tissue during surgery. As will be appreciated, an approach similar to that depicted in FIGS. 30-32 can be used to implement a tissue sensor on the blade assembly utilizing conductive strips positioned on the anvil assembly 2001 and cartridge assembly 2003.
[0117] While many of the embodiments of the present invention depict the use of electrodes, it should be appreciated that any technique that can be used to cauterize, coagulate / dehydrate, and / or seal tissue can be used. For example, in some implementations, one or more resistive heating elements can be coupled to the blade assembly. When energized, the one or more resistive heating elements can deliver heat directly to the tissue along the incision. In some implementations, the one or more resistive heating elements can be positioned on only one side of the blade assembly so that heat is directed to one side of the incision. Alternatively, one or more resistive heating elements can be positioned on both sides of the blade assembly. Additionally, in some embodiments, the blade assembly can include a heating assembly including a resistive heating element and, for example, a heating pad or other suitable heat dissipation structure. Such a structure can be positioned proximate to the resistive heating element and configured to directly contact the tissue. The heat dissipation structure can help dissipate heat from the resistive heating element into the tissue, for example, during a transection.
[0118] FIG. 33 depicts an exemplary blade assembly 3108 including an exemplary resistive heating element 3171. The exemplary blade assembly 3108 also includes a heating pad 3172 configured to cover the resistive heating element 3171 and assist in dissipating heat generated by the resistive heating element 3171 during surgery. The resistive heating element 3171 may be energized through a circuit 3111 extending along the beam 3126. While FIG. 33 shows the resistive heating element 3171 positioned only on a first side of the blade assembly 3108, it should be appreciated that other embodiments may have a similar resistive heating element positioned on the other side. Additionally, one or more tissue sensors may be incorporated into the blade assembly 3108 in accordance with the present disclosure.
[0119] FIG. 34 depicts an exemplary blade assembly 3208 including another exemplary resistive heating element 3271. The resistive heating element 3271 can be energized through a circuit 3211 extending along the beam 3226. While FIG. 34 shows the resistive heating element 3271 positioned only on a first side of the blade assembly 3208, it should be appreciated that other embodiments can have a similar resistive heating element positioned on the other side. As shown, the resistive heating element 3271 can include a curved outer surface that can assist in bringing it into contact with tissue during ablation. Additionally, one or more tissue sensors can be incorporated into the blade assembly 3208 in accordance with the present disclosure.
[0120] FIG. 35 depicts an exemplary blade assembly 3308 including multiple resistive heating elements 3371. The resistive heating elements 3371 can be energized through a circuit 3311 extending along the beam 3326. While FIG. 35 shows the resistive heating elements 3371 positioned only on a first side of the blade assembly 3308, it is appreciated that other embodiments can have similar resistive heating elements positioned on the other side. As shown, the resistive heating elements 3371 include curved outer surfaces, but the present disclosure is not limited to including curved outer surfaces. In the illustrated embodiment, the resistive heating elements 3371 are positioned linearly in the direction of travel of the beam 3326 with gaps positioned therebetween. The particular spacing between adjacent resistive heating elements 3371, as well as the size of the resistive heating elements 3371, can be selected based on various operating parameters. As an example, the spacing between adjacent resistive heating elements 3371 can help reduce the likelihood of tissue burns during surgery. Additionally, in some embodiments, each resistive heating element 3371 can be configured to heat to substantially the same temperature when energized. In other embodiments, the respective operating temperatures of the various resistive heating elements 3371 can be varied to achieve a desired temperature profile, for example. Finally, while three resistive heating elements 3371 are shown in FIG. 35 , it is to be appreciated that the present disclosure is not limited to three resistive heating elements 3371, as some embodiments can utilize fewer than three resistive heating elements 3371, while other embodiments can utilize more than three resistive heating elements 3371. Additionally, the present disclosure allows for the incorporation of one or more tissue sensors into the blade assembly 3308.
[0121] In other embodiments, instead of utilizing bipolar electrosurgical techniques or resistive heating elements to cauterize and seal tissue, some surgical devices may utilize monopolar electrosurgical techniques to deliver energy to tissue. FIG. 36, for example, depicts an exemplary blade assembly 3408 including an exemplary active electrode 3471. The active electrode 3471 may be energized through a circuit 3411 extending along the beam 3426. During surgery, a return electrode (not shown) may be attached to the patient such that current flows from the generator to the active electrode 3471, through the target tissue, to the return electrode, and back to the generator. That is, the active electrode 3471 may be used to deliver energy into the tissue to cauterize tissue along the incision. In accordance with the present disclosure, one or more tissue sensors may additionally be incorporated into the blade assembly 3408.
[0122] While various embodiments are described herein in the context of internal cutters, it should be appreciated that the present disclosure is not limited to the context of internal cutters. Instead, bipolar electrode arrangements according to the present disclosure can be incorporated into a wide variety of surgical tools and systems having cutting edges. More specifically, electrodes according to the present disclosure can be incorporated into tools and systems that can be configured to cauterize, coagulate / dehydrate, and / or seal tissue cut by such cutting edges in proximity to the cutting edges.
[0123] 37-39, an exemplary electrosurgical circular stapler 4000 in accordance with the present disclosure is shown. The exemplary electrosurgical circular stapler 4000 can be used to provide an end-to-end anastomosis, a side-to-side anastomosis, or an end-to-side anastomosis between two sections of an anatomical lumen, such as a portion of a patient's digestive tract. The electrosurgical circular stapler 4000 can include a handle assembly 4100, a shaft assembly 4200, a stapling head assembly 4300, and an anvil 4400.
[0124] The electrosurgical circular stapler 4000 can further include a bipolar energy source 4060 and a connection 4120 to a tissue monitoring system 4062. The bipolar energy source 4060 can be configured to deliver electrosurgical energy to electrodes positioned on the stapling head assembly 4300. The stapling head assembly 4300 is positioned at the distal end of the shaft assembly 4200. The anvil 4400 is configured to removably couple to the shaft assembly 4200 at a location adjacent the stapling head assembly 4300. The anvil 4400 and the stapling head assembly 4300 can cooperate to fasten, cut, staple, and seal tissue. A knob 4130 at the proximal end of the handle assembly 4100 can be rotatable relative to the casing 4110 to enable precise fastening of tissue between the anvil 4400 and the stapling head assembly 4300. When the safety trigger 4140 of the handle assembly 4100 is pivoted away from the firing trigger 4150 of the handle assembly 4100, the firing trigger 4150 can be actuated, thereby providing tissue cutting, stapling, and sealing.
[0125] 38 provides an exploded view of the stapling head assembly 4300. The stapling head assembly 4300 can include a body member 4310 and a slidable staple driver member 4350. The body member 4310 includes a distally extending cylindrical inner core member 4312. The body member 4310 is fixedly secured to the outer sheath 4210 of the shaft assembly 4200 (FIG. 37).
[0126] As shown in FIG. 38 , the stapling head assembly 4300 can further include a trocar 4330 and a circular knife member 4340 coaxially positioned within the staple driver member 4350. The knife member 4340 includes a sharp, circular cutting edge 4342 directed distally. The knife member 4340 is sized such that it defines an outer diameter that is smaller than the diameter defined by the inner annular array of staple drivers 4352. The knife member 4340 has a cylindrical wall 4360 having first and second electrodes 4071, 4073 positioned thereon. One or more tissue sensors 4077 can further be positioned on the cylindrical wall 4360. Other suitable structural relationships between the knife member 4340 and the staple driver member 4350 will be apparent to those skilled in the art in light of the teachings herein.
[0127] As shown in the close-up view of the knife member 4340 in FIG. 38 , the first and second electrodes 4071, 4073 can be in electrical communication with the first and second contacts 4045, 4047, respectively. The flexible circuit 4041 can be in electrical communication with the first and second contacts 4045, 4047 and the bipolar energy source 4059, for example. While FIG. 38 depicts the first and second electrodes 4071, 4073 as substantially rings surrounding the knife member 4340, the present disclosure is not limited to that configuration. For example, FIG. 39 depicts a knife member 5340 having multiple laterally spaced electrodes 5071, 5073 positioned in an alternating manner about the outer surface 5075. The electrodes 5071, 5073 can be in communication with the bipolar energy source 5059, for example, through the flexible circuit 5041. In this embodiment, electrode 5071 is shown as the "active" electrode and is in communication with the bipolar energy source 5059 through contact 5045. Electrode 5073 is shown as the "passive" electrode and is in communication with the bipolar energy source 5059 through contact 5047. One or more tissue sensors 5077 in communication with the tissue monitoring system 5062 may also be positioned on the knife member 4340.
[0128] Additionally, the systems and methods described herein can be used with a variety of different types of bladed medical tools and instruments, some non-limiting examples of which are depicted generally in FIGS. 40-41 . Referring initially to FIG. 40 , an electrosurgical scalpel 6000 is shown in electrical communication with a bipolar energy source 6059. The electrosurgical scalpel 6000 can include two electrodes 6071, 6073 positioned at its distal end proximate a cutting edge 6007. The electrodes 6071, 6073 can be in electrical communication with the bipolar energy source 6059 through a flexible circuit 6041, among various suitable connection techniques. Referring now to FIG. 41 , electrosurgical scissors 7000 are shown in electrical communication with the bipolar energy source 6059. The electrosurgical scissors 7000 can include two electrodes 7071, 7073 positioned proximate a cutting edge 7007 of the electrosurgical scissors. The electrodes 7071, 7073 may be in electrical communication with the bipolar energy source 7059 through a flexible circuit 7041, among other suitable connection techniques. Additionally, in accordance with the present disclosure, one or more tissue sensors may be incorporated into the electrosurgical scalpel 6000 and / or electrosurgical scissors 7000.
[0129] Figures 42-44 illustrate an electrosurgical stapling and severing instrument according to various non-limiting embodiments, with Figure 43 illustrating a cross-sectional view of the end effector and Figure 44 illustrating a firing bar. Referring to Figure 42, the electrosurgical stapling and severing instrument 8010 includes a handle portion 8012 that is manipulated to position an implement portion 8014 that includes a fastener end effector, shown as a staple applying assembly 8016, attached distally to an elongated shaft 8018. The implement portion 8014 is sized for insertion through a cannula of a trocar (not shown) in an endoscopic or laparoscopic surgical procedure by depressing a closure trigger 8024 toward a pistol grip 8026 of the handle portion 8012, thereby advancing an outer closure sleeve 8028 of the elongated shaft 8018 and pivoting the anvil 8020 closed to close the upper and lower jaws 8020, 8022 of the staple applying assembly 8016.
[0130] Once inserted into an insufflated body cavity or lumen, the surgeon can rotate the implement portion 8014 about its longitudinal axis by twisting the shaft rotation knob 8030 that engages across the distal end of the handle 8012 and the proximal end of the elongate shaft 8018. Once so positioned, the closure trigger 8024 can be released, opening the anvil 8020 so that tissue can be grasped and positioned. With tissue sufficiently held within the staple applying assembly 8016, the surgeon depresses the closure trigger 8024 until it locks against the pistol grip 8026, fastening the tissue within the staple applying assembly 8016.
[0131] The firing trigger 8032 is then depressed and drawn toward the closure trigger 8024 and pistol grip 8026, thereby applying a firing force or motion to the firing trigger 8032 that advances the firing member distally from an unfired position. The firing member is supported in a frame ground 8038 that connects the handle portion 8012 to the staple applying assembly 8016 and is shown as including a proximal firing rod 8034 attached to a distal firing bar 8036. During the staple firing motion, the firing bar 8036 engages the elongated staple channel 8040 and actuates the staple cartridge 8042 trapped therein, both of which form the lower jaw 8022. The firing bar 8036 also engages the anvil 8020. After releasing the firing trigger 8032 and applying a retraction force or movement to the firing bar 8036, the closure trigger 8024 can be released by depressing the closure release button 8044, thereby retracting the closure sleeve 8028 and pivoting open the anvil 8020, releasing the severed and stapled tissue from the staple applying assembly 8016.
[0132] In FIG. 43 , the staple applying assembly 8016 is closed on compressed tissue 8046. In FIGS. 43 and 44 , the firing bar 8036 has a proximal portion 8048 attached to a distal E-beam 8060 that travels within the staple applying assembly 8016. As shown with the firing bar 8036 in the retracted position, as after a new staple cartridge 8042 has been inserted into the elongated staple channel 8040, the vertical portion 8052 of the E-beam 8060 resides substantially rearward of the staple cartridge 8042. An upper pin 8054 extending laterally from an upper portion of the vertical portion 8052 of the E-beam 8060 initially resides in an invaginated anvil pocket 8056 near the proximal pivot end of the anvil 8020. As the E-beam 8060 advances distally during the staple firing movement, the vertical portion 8052 passes through a narrow longitudinal anvil slot 8058 formed in the staple-forming lower surface 8050 of the anvil 8020, a proximally opening vertical slot 8062 formed in the cartridge 8042, and an underlying longitudinal channel slot 8064 formed in the elongated staple channel 8040.
[0133] The narrow longitudinal anvil slot 8058 communicates upwardly with a laterally wide longitudinal anvil channel 8066 sized to slidably receive the upper pin 8054. The longitudinal channel slot 8064 communicates downwardly with a laterally wide longitudinal channel track 8068 that receives a lower foot 8070 sized to slide within the laterally wide longitudinal channel track 8068 and attached to the bottom of the vertical portion 8052 of the E-beam 8060. A laterally wide middle pin 8072 extending from the vertical portion 8052 of the E-beam 8060 is positioned to slide along an upper surface of a bottom tray 8074 of the staple cartridge 8042 that abuts on the elongated staple channel 8040. A longitudinal firing recess 8075 formed within the staple cartridge 8042 above the bottom tray 8074 is sized to allow the middle pin 8072 to travel through the staple cartridge 8042 .
[0134] A distal drive surface 8076 of the vertical portion 8052 of the E-beam 8060 is positioned to travel through the proximally-opening vertical slot 8062 of the staple cartridge 8042 to distally drive a wedge sled 8078 positioned proximally within the staple cartridge 8042. The vertical portion 8052 of the E-beam 8060 includes a cutting surface 8080 along its distal edge above the distal drive surface 8076 and below the upper pin 8054 that simultaneously staples and severs the fastened tissue 8046.
[0135] First and second electrodes 8071, 8073 can be positioned on the E-beam 8060. The first and second electrodes 8071, 8073 can be in electrical communication with the bipolar energy source 8059 through circuitry 8041 and can be activated during distal advancement of the E-beam 8060 through the tissue 8046. While the first and second electrodes 8071, 8073 are shown positioned only on a first side of the E-beam 8060, the present disclosure is not limited to this positioning. Instead, one or more electrodes can be positioned on either side of the E-beam 8060 to achieve hemostasis by heating the tissue 8046 and blood vessels to cauterize, coagulate / dehydrate, and / or seal the tissue 8046. Additionally, one or more tissue sensors 8077 can be positioned on the E-beam 8060 in communication with a tissue monitoring system 8062.
[0136] In various embodiments disclosed herein, multiple components may be substituted for single components and multiple components may be substituted for single components to perform a given function or functions. Unless such substitution is deemed impractical, such substitution is within the intended scope of these embodiments. For example, staple leg height, staple material of manufacture, anvil pocket depth, anvil pocket shape, and anvil pocket asymmetry may all be varied in any combination.
[0137] The foregoing description of embodiments and examples has been provided for purposes of illustration and description. This description is not intended to be exhaustive or to be limited to the form described. Many modifications are possible in light of the above teachings. Some of these modifications have been discussed, while others will be apparent to those skilled in the art. The above-described embodiments were chosen and described in order to best illustrate the principles of various embodiments suitable for the particular use contemplated. The scope is, of course, not limited to the examples set forth herein, but can be employed by those skilled in the art in any number of applications and equivalent devices. Rather, the scope of the present invention is hereby intended to be defined by the claims appended hereto. [Explanation of symbols]
[0138] 100 Electrosurgical stapling device 101 Anvil Assembly 103 Cartridge Assembly 106 Master Link 108 Internal Cutter 121 End Effector
Claims
1. (a)(i) an anvil including a first end, a second end, and an anvil face positionable on a first side of the anatomical structure; (ii) a cartridge operably configured to house a plurality of staples, the cartridge including a first end, a second end, and a surface positionable on a second side of the anatomical structure; (iii) a blade assembly including a blade, the blade including a first side and a second side joined at a cutting edge; (iv) at least one electrode coupled to the blade and in electrical communication with an electrosurgical power source generated from a controller; and (v) at least one tissue sensor coupled to the blade; an end effector including: (b) a tissue monitoring system in electrical communication with the at least one tissue sensor, comprising: the at least one tissue sensor providing a feedback signal indicative of a tissue characteristic to the controller; the controller transmitting a signal to the electrosurgical generator to adjust an operating parameter of the electrosurgical instrument based on the feedback signal. the tissue monitoring system; 1. An electrosurgical instrument comprising:
2. When the blade is advanced from a first position at the distal end of the cartridge to a second position at the proximal end of the cartridge, (a) an incision is made in the anatomical structure; (b) the at least one electrode and the at least one tissue sensor contact and move along the anatomical structure; 10. The electrosurgical instrument of claim 1.
3. The controller (a) processing the feedback signal received from the at least one tissue sensor; and (b) determining the signal sent to the electrosurgical generator; including analog or logic circuits for 10. The electrosurgical instrument of claim 1.
4. The electrosurgical instrument of claim 1, wherein a circuit connects the at least one electrode to the electrosurgical generator and the at least one tissue sensor to the tissue monitoring system.
5. The electrosurgical instrument of claim 1 , wherein the feedback signal is related to tissue temperature of the anatomical structure.
6. The electrosurgical instrument of claim 5, wherein the electrosurgical generator is terminated when the tissue temperature rises above a predetermined threshold.
7. The electrosurgical instrument of claim 6, wherein the predetermined threshold of the tissue temperature is between 80-120°C.
8. The electrosurgical instrument of claim 5, wherein the firing rate of the electrosurgical instrument is reduced if the tissue temperature at a predetermined tissue location of the anatomical structure does not reach a target temperature.
9. The electrosurgical instrument of claim 8, wherein the target temperature at the predetermined tissue location is between 60-100°C.
10. The electrosurgical instrument of claim 1 , wherein the feedback signal is related to tissue impedance of the anatomical structure.
11. The electrosurgical instrument of claim 10, wherein the electrosurgical generator is terminated if the tissue impedance at a predetermined tissue location in the anatomical structure fails to reach a target impedance of 200 ohms.
12. 11. The electrosurgical instrument of claim 10, wherein the firing rate of the electrosurgical instrument is slowed down when the tissue impedance rises above a predetermined threshold of 600 ohms.
13. 1. An electrosurgical instrument for stapling, resecting, and sealing an anatomical structure of a patient, comprising: (a)(i) an anvil including a first end, a second end, and an anvil face positionable on a first side of the anatomical structure; (ii) a cartridge operably configured to house a plurality of staples, the cartridge including a first end, a second end, and a surface positionable on a second side of the anatomical structure; (iii) a blade assembly including a blade and a beam, the blade including a first side and a second side joined at a cutting edge; (iv) at least one electrode coupled to the blade and in electrical communication with an electrosurgical power source generated from a controller; and (v) at least one tissue sensor coupled to the blade; an end effector including: (b) a tissue monitoring system in electrical communication with the at least one tissue sensor, comprising: the at least one tissue sensor provides a tissue impedance feedback signal to the controller when the blade is advanced from a first position at the distal end of the cartridge to a second position at the proximal end of the cartridge; the controller transmitting a signal to the electrosurgical generator to adjust the firing rate of the electrosurgical instrument based on the tissue impedance feedback signal. the tissue monitoring system; 1. An electrosurgical instrument comprising:
14. when the blade is advanced from the first position at the distal end of the cartridge to the second position at the proximal end of the cartridge; (a) an incision is made in the anatomical structure; (b) the at least one electrode and the at least one tissue sensor contact and move along the anatomical structure; 14. The electrosurgical instrument of claim 13.
15. The controller (a) processing the feedback signal received from the at least one tissue sensor; and (b) determining the signal sent to the electrosurgical generator; including analog or logic circuits for 14. The electrosurgical instrument of claim 13.
16. The electrosurgical instrument of claim 13, wherein the electrosurgical generator is terminated if the tissue impedance at a predetermined tissue location in the anatomical structure fails to reach a target impedance of 200 ohms.
17. The electrosurgical instrument of claim 13, wherein the firing rate of the electrosurgical instrument is slowed down when the tissue impedance rises above a predetermined threshold of 600 ohms.
18. The electrosurgical instrument of claim 13, wherein the at least one tissue sensor further provides a tissue temperature feedback signal to the controller.
19. 20. The electrosurgical instrument of claim 18, wherein the firing rate of the electrosurgical instrument is reduced if the tissue temperature at the predetermined tissue location of the anatomical structure does not reach a target temperature between 60-100°C.
20. The electrosurgical instrument of claim 18, wherein the electrosurgical generator is terminated when the tissue temperature rises above a predetermined threshold between 80-120°C.
Citation Information
Patent Citations
End effectors, surgical stapling devices, and methods of using same
US9936953B2