# Patent

## Title
End effector with detectable configurations

## Abstract

A surgical end effector has a first jaw comprising a first electrode and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector between an open configuration, an approximated configuration, and a fully approximated configuration. The second jaw includes a second electrode and a spacer extending from the second electrode, wherein the spacer is configured to maintain a predetermined distance between the first electrode and the second electrode when the end effector is in the fully approximated configuration, wherein the spacer is in contact with the first electrode in the fully approximated configuration, wherein the spacer is spaced apart from the first electrode in the open configuration, and wherein the spacer is comprised of a semi-conductive material.

## Background
BACKGROUND
The present disclosure relates to surgical instruments and, in various circumstances, to surgical sealing and transecting instruments.
SUMMARY
In one embodiment, a surgical end effector includes a first jaw comprising a first electrode and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector between an open configuration, an approximated configuration, and a fully approximated configuration. The second jaw includes a second electrode and at least one spacer extending from the second electrode, wherein the at least one spacer is configured to maintain a minimum predetermined distance between the first electrode and the second electrode when the end effector is in the fully approximated configuration, wherein the at least one spacer is in contact with the first electrode in the fully approximated configuration, wherein the at least one spacer is spaced apart from the first electrode in the open configuration, and wherein the at least one spacer is comprised of a semi-conductive material.
In one embodiment, a surgical instrument includes an end effector that includes a first jaw comprising a first electrode and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector between an open configuration, an approximated configuration, and an fully approximated configuration. The second jaw includes a second electrode, wherein tissue is captured between the first electrode and the second electrode in the approximated configuration and at least one spacer extending from the second electrode, wherein the at least one spacer is configured to maintain a minimum predetermined distance between the first electrode and the second electrode when the end effector is in the fully approximated configuration, and wherein the at least one spacer is simultaneously in contact with the first electrode and the second electrode in the fully approximated configuration The surgical instrument further includes a switch configured to control energy transmission between the first electrode and the second electrode, wherein the switch is activatable to permit energy transmission between the first electrode and the second electrode and a circuit. The circuit is operable to: detect activation of the switch, detect an impedance between the first electrode and the second electrode in response to the activation of the switch, generate a first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to a predetermined threshold, generate a second response corresponding to the approximated configuration of the end effector when the impedance is in a first range of impedance, and generate a third response corresponding to the fully approximated configuration when the impedance is in a second range of impedance different from the first range of impedance.



BRIEF DESCRIPTION OF THE DRAWINGS
The features and advantages provided in this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of instances of the disclosure taken in conjunction with the accompanying drawings, wherein:
FIG. 1 illustrates a perspective view of a surgical instrument comprising a handle and an end effector;
FIG. 2 illustrates a perspective view of the surgical instrument of FIG. 1, according to one embodiment;
FIG. 3 illustrates a side-elevational view of the handle of the surgical instrument of FIG. 1, according to one embodiment;
FIG. 4 illustrates a perspective view of an end effector of the surgical instrument of FIG. 1, according to one embodiment;
FIG. 5 illustrates a side-elevational view of a jaw of the end effector of the surgical instrument of FIG. 1, according to one embodiment;
FIG. 6 illustrates a partial cross sectional view of the electrodes of the surgical instrument of FIG. 1 in an open configuration, according to one embodiment;
FIG. 7 illustrates a partial cross sectional view of the electrodes of the surgical instrument of FIG. 1 in an approximated configuration with tissue disposed between the electrodes, according to one embodiment;
FIG. 8 illustrates a partial cross sectional view of the electrodes of the surgical instrument of FIG. 1 in a fully approximated configuration with a plurality of spacers maintaining a minimum predetermined distance between the electrodes, according to one embodiment;
FIG. 9 illustrates a logic diagram, according to one embodiment;
FIG. 10 illustrates a circuit for implementing the logic diagram of FIG. 9, according to one embodiment;
FIG. 11 illustrates a controller for use with the circuit of FIG. 10, according to one embodiment;
FIG. 12 illustrates a combinational logic circuit for use with the circuit of FIG. 10, according to one embodiment; and
FIG. 13 illustrates a sequential logic circuit for use with the circuit of FIG. 10, according to one embodiment.



Corresponding reference characters indicate corresponding parts throughout the several views. The examples set out herein illustrate various embodiments of the disclosure, in one form, and such examples are not to be construed as limiting the scope of the disclosure in any manner.
DETAILED DESCRIPTION
Certain example embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting example embodiments and that the scope of the various embodiments of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one example embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a surgical system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of a system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.
The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Various example devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device that has a working channel through which the end effector and elongated shaft of a surgical instrument can be advanced.
FIG. 1 illustrates a perspective view of a surgical instrument 2 comprising a handle assembly 4 and an end effector 10 according to one embodiment. FIG. 2 illustrates a perspective view of the surgical instrument 2 of FIG. 1 according to one embodiment and FIG. 3 illustrates a side-elevational view of the handle assembly 4 of the surgical instrument of FIG. 1 according to one embodiment. Turning to FIGS. 1-3, one form of an electrosurgical instrument 2 is depicted. The electrosurgical instrument 2 comprises a handle assembly 4, a shaft assembly 12 coupled to a distal end of the handle assembly 4, and an end effector 10 coupled to the distal end of the shaft assembly 12. The handle assembly 4 is configured as a pistol grip and comprises a left handle housing shroud 6a, a right handle housing shroud 6b, a closure trigger 8, a pistol-grip handle 14, a firing trigger 16, an energy button 18, and a rotatable shaft knob 20. An electrical cable may enter the handle assembly 4 at a proximal end 15.
In some circumstances, the end effector 10 can be coupled to the distal end of the shaft assembly 12. The end effector 10 may include a first jaw 22a and a second jaw 22b. The first jaw 22a can be pivotably coupled to the second jaw 22b. The first jaw 22a is moveable with respect to the second jaw 22b to grasp tissue therebetween. In some circumstances, the second jaw 22b is fixed. In other circumstances, the first jaw 22a and the second jaw 22b are pivotably movable with respect to each other. The end effector 10 may include one or more electrodes such as, for example, electrode 92, 94. The electrodes 92, 94 can be configured to pass energy through tissue positioned between the electrodes 92, 94. Energy delivered by the electrodes 92, 94 may comprise, for example, radiofrequency (RF) energy, sub-therapeutic RF energy, therapeutic RF energy, ultrasonic energy, and/or other suitable forms of energy. In some circumstances, a cutting member (not shown) is receivable within a longitudinal slot 40 (FIG. 4) defined by the first jaw 22a and/or the second jaw 22b. The cutting member can be configured to cut tissue grasped between the first jaw 22a and the second jaw 22b. In some circumstances, the cutting member may include an electrode for delivering energy, such as, for example, RF and/or ultrasonic energy.
In certain instances, an energy button 18 is configured to deliver energy to the at least one electrode 92 from a power source. In certain instances, when the energy button 18 is depressed, a circuit is completed allowing delivery of energy to the electrode 92. In some embodiments, the power source is a generator. In certain instances, the generator is external to the surgical instrument 2 which is separably coupled to the generator. In other instances, the generator is integrated with the surgical instrument 2. In certain instances, the power source may be suitable for therapeutic tissue treatment, tissue cauterization/sealing, as well as sub-therapeutic treatment and measurement.
In certain instances, the surgical instrument 2 may include a closure drive assembly which may comprise an outer sheath 23, for example. In certain instances, the closure trigger 8 can be operatively coupled to at least one of the jaws 22a, 22b through the closure drive assembly such that actuation of the closure trigger 8 in a closure stroke may transition the jaws 22a, 22b between a plurality of configurations including an open configuration, an approximated configuration, and a fully approximated configuration, for example. In certain instances, the surgical instrument 2 may include a firing drive assembly. In certain instances, the firing trigger 16 may be operatively coupled to the cutting member of the end effector 10 through the firing drive assembly such that actuation of the firing trigger 16 in a firing stroke may cause the cutting member to be advanced relative to the end effector 10 to cut tissue captured between the jaws 22a, 22b, for example.
When electrical current is supplied to an electrode such as, for example, the electrodes 92 and/or 94, the electrical current can pass through the tissue in electrical communication with the surrounding electrodes 92 and/or 94, for example. In one instance, the electrical current can pass through the tissue positioned against and/or surrounding the electrode 92 and/or 94, for example. In various circumstances, the current flowing through the electrode can generate heat within the electrode and the surrounding tissue. In certain circumstances, the heat can denature proteins within the tissue and, in co-operation with clamping pressure provided by the jaws 22a, 22b of the end effector 10, the denatured proteins can form a seal within the tissue, for example.
FIG. 2 illustrates a side perspective view of the electrosurgical instrument 2 illustrated in FIG. 1. FIG. 2 illustrates the right handle housing shroud 6b. The energy button 18 may extend through the handle assembly 4 and is accessible on both sides of the handle assembly 4. The closure trigger 8, the firing trigger 16, and the energy button 18 may comprise an ergonomic design. In some circumstances, the handle assembly 4 is thinner near the energy button 18 to allow ease of access to the energy button 18 by a clinician. In some circumstances, the energy button 18 is disposed on either the left handle housing 6a or the right handle housing shroud 6b. FIG. 3 illustrates a side view of the electrosurgical instrument 2 and the right handle housing shroud 6b. Various electrosurgical instruments suitable for use with the present disclosure are described in U.S. patent application Ser. Nos. 14/075,839 and 14/075,863.
Referring to FIGS. 4-8, FIG. 4 illustrates an end effector 10 in an open configuration according to one embodiment. The end effector 10 includes one or more spacers 50 configured to maintain a minimum predetermined distance between the electrodes 92, 94. As described above, the closure trigger 8 can be operatively coupled to at least one of the jaws 22a, 22b through the closure drive assembly such that actuation of the closure trigger 8 in a closure stroke may transition the end effector 10 between a plurality of configurations.
FIG. 6 illustrates a partial cross sectional view of the electrodes 92, 94 in an open configuration, according to one embodiment. FIG. 7 illustrates a partial cross section view of the electrodes 92, 94 in an approximated configuration, according to one embodiment. FIG. 8 illustrates a partial cross sectional view of the electrodes 92, 94 in a fully approximated configuration, according to one embodiment. In certain instances, the end effector 10 may include an open configuration wherein the electrodes 92, 94 are spaced apart and the spacers 50 are in contact with only one of the electrodes 92, 94, as illustrated in FIG. 6. In certain instances, the end effector 10 may comprise an approximated configuration, as illustrated in FIG. 7, wherein tissue is captured between the electrodes 92, 94, and wherein the spacers 50 are in contact with only one of the electrodes 92, 94.
Further to the above, the end effector 10 may also comprise a fully approximated configuration, wherein the spacers 50 are in electrical contact with the electrodes 92, 94. In one instance, the spacers 50 may be in direct electrical contact with the electrodes 92, 94. In the fully approximated configuration the spacers 50 may maintain a gap between the electrodes 92, 94, as illustrated in FIG. 8. The size of the gap between the electrodes 92, 94 in the fully approximated configuration may depend in part on the height, e.g., thickness, of the spacers 50. In one instance, the electrodes 92, 94 are allowed to fully close uninterrupted in the fully approximated configuration, which causes one or more of the spacers 50 to be in electrical contact with the electrode 92 and the electrode 94 simultaneously.
In certain instances, as illustrated in FIG. 8, a spacer 50 can prevent, or at least resist, electrical contact between the electrode 92 and the electrode 94 in the fully approximated configuration. In certain instances, depressing or activating the energy button 18 while the electrodes 92, 94 are in electrical contact with each other may yield a short circuit. In certain instances, one or more of the spacers 50 can create a barrier between the electrode 92 and the electrode 94 to avoid circuit shorting in the event the energy button 18 is depressed while the end effector 10 is in the fully approximated configuration.
FIG. 4 illustrates one embodiment of the end effector 10 in an open configuration. As illustrated in FIG. 4, the spacers 50 can be attached to the electrode 92, for example. In the fully approximated configuration, the electrode 94 may rest against one or more of the spacers 50, as illustrated in FIG. 8. In one example, the spacers 50 can be disposed onto the electrode 92 and may extend from an outer surface 43 of the electrode 92. A spacer 50 can be attached to the outer surface 43. For example, the spacer 50 can be glued onto the outer surface 92. Other techniques for attaching the pacer 50 to the outer surface 43 are contemplated by the present disclosure. For example, the electrode 92 may comprise a socket (not shown) configured to partially receive a spacer 50. In other words, the spacer 50 can be partially embedded in the socket of the electrode 92.
As illustrated in FIG. 4, the spacers 50 may be positioned at any suitable interval along the length of the electrode 92. In some examples, including the one shown in FIG. 4, the spacers 50 may be arranged in pairs, with each pair straddling the longitudinal slot 40. In various instances, the spacers 50 can be arranged in rows that extend in parallel, or at least substantially in parallel, with the elongate slot 40. For example, as illustrated in FIG. 4, a first row of the spacers 50 and a second row of the spacers 50 may be disposed on opposite lateral sides of the elongate slot 40. In certain instances, the spacers 50 can be in any array, offset, laterally across from one another, or staggered along a length of one or both of the jaws 22a, 22b. 
Referring to FIG. 8, a spacer 50 may protrude or extend a predetermined distance (d1) above or beyond the outer surface 43 of the electrode 92. As illustrated in FIG. 8, a minimum predetermined gap between the electrodes 92, 94 in the fully approximated configuration can be defined by the predetermined distance (d1). The predetermined distance (d1) may correspond to a height of the spacers 50, for example. In certain instances, the predetermined distance (d1) can be any distance selected from a range of about 0.001 inch to about 0.010 inch. In certain instances, the predetermined distance (d1) can be any distance selected from a range of about 0.003 inch to about 0.008 inch. In certain instances, the predetermined distance (d1) can be about 0.004 inch, for example. In certain instances, the predetermined distance (d1) can be about 0.005 inch, for example.
In various instances, one or more of the spacers 50 can be comprised of one or more semi-conductive materials. In various instances, one or more of the spacers 50 can be comprised of a plastic material that is considered a static dissipative material. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity in a range of about 106 to about 109 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity in a range of about 107 to about 108 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity of about 107 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity of about 108 ohm/square, for example.
In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity in a range of about 102 to about 106 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity in a range of about 103 to about 105 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity of about 103 ohm/square, for example. In certain instances, one or more of the spacers 50 can be comprised of one or more materials comprising a surface resistivity of about 104 ohm/square, for example. The reader will appreciate that a selection of the material composition of the spacer 50 depends, at least in part, on the size and shape of the spacers 50 and the method of determining impedance across the electrodes through the spacers. The reader will appreciate that a selection of the material composition of the spacer 50 takes into consideration that the resistance of the spacers 50 need to be sufficiently high to distinguish between a closed configuration and a short circuit, for example.
In certain instances, one or more of the spacers 50 can be comprised of one or more materials including ABS, Acetal, PEEK, Polycarbonate, Polypropylene, PDVF, UHMW-PE, and Polyamide filled with carbon powder, carbon fiber, or stainless steel. These fillers may in some instances be about 15% of the total weight. In certain instances, the fillers can be about 17% of the total weight. In certain instances, the fillers can be about 18% of the total weight. In certain instances, the fillers can be about 19% of the total weight. In certain instances, the fillers can be about 20% of the total weight. Other values of the material-to-filler ratio are contemplated by the present disclosure. Some of the suitable materials for the spacers 50 comprise the trade names HYDEL, TECAFORM, TECAPEEK, SINTIMID, SEMITRON, POMALUX, TIVAR, STATICON, KYDEX, and ABSYLUX, for example.
The following table provides a list of suitable materials for use with the present disclosure. The reader will appreciate, however, that the list of materials presented in the following table is not exhaustive and that the spacers 50 may be comprised of other materials, as described above.














Supplier
Name









EMS
Grivory XE 4027



EMS
Grivory GV-5H



EMS
Grivory HTV-3H1



EMS
Grivory HT2V-3H



Solvay
Ixef 1524



Solvay
Ixef 1022



Solvay
Amodel HFFR-4133



Technical Polymers
Thermec N 5350R30F4H2 Bk-1



Technical Polymers
Thermec N 5357R30F4H2 Bk-1



PBI Products
Celazole TF-60V



Dupont
Zytel HTN FR52G30 NHF BK337










In certain instances, one or more of the spacers 50 can be comprised, or at least partially comprised, of a material with temperature dependent impedance. For example, a spacer 50 can be comprised, or at least partially comprised, of a positive temperature coefficient (PTC) thermistor, wherein impedance of the spacer 50 increases over a period of time in response to an increase in temperature of the spacer 50. As current flows through tissue captured between the electrodes 92, 94, the temperature of the tissue may increase which may increase the temperature of the spacer 50. As the temperature of the spacer 50 increases, the impedance of the spacer 50 may increase. In such instances, the current passing through the spacer 50 may decrease over time in response to the increase in the impedance of the spacer 50 resulting from the increased temperature of the spacer 50. Initially, the current passing through the spacer 50 may be sufficiently large to treat and/or seal tissue in contact, or at least partially in contact, with the spacer 50. As the temperature of the spacer 50 increases the current passing through the spacer 50 my decrease due to the increase in the impedance of the spacer 50, for example.
In another example, a spacer 50 can be comprised, or at least partially comprised, of a negative temperature coefficient (NTC) thermistor, wherein impedance of the spacer 50 decreases over a period of time in response to an increase in temperature of the spacer 50. As current flows through tissue captured between the electrodes 92, 94, the temperature of the tissue may increase which may increase the temperature of the spacer 50. As the temperature of the spacer 50 increases, the impedance of the spacer 50 may decrease. In such instances, the current passing through the spacer 50 may increase over time in response to the decrease in the impedance of the spacer 50 resulting from the decreased temperature of the spacer 50. Initially, limited or no current may pass through the spacer 50. As the temperature of the spacer 50 increases the current passing through the spacer 50 my increase due to the decrease in the impedance of the spacer 50, for example.
In certain instances, the semi-conductive spacers 50 can permit a limited current to flow between the electrodes 92, 94 through the semi-conductive spacers 50 when the semi-conductive spacers 50 are in electrical contact with the electrodes 92, 94 in the fully approximated configuration. In such instances, the limited current may flow through the semi-conductive spacers 50 when the energy button 18 is depressed while the electrode 92 and the electrode 94 are in contact with the semi-conductive spacers 50, for example. Said another way, the limited current may flow through the semi-conductive spacers 50 when the energy button 18 is depressed while the electrode 94 is rested against the semi-conductive spacers 50, for example.
In certain instances, a semi-conductive spacer 50 can act as a conduit for transmitting limited energy between the electrodes 92, 94 when the energy button 18 is depressed or activated while the electrodes 92, 94 are in contact with the semi-conductive spacer 50 in the fully approximated configuration, for example. In certain instances, as described above, a semi-conductive spacer 50 can be attached to the electrode 92, for example. In such instances, the limited energy may be transmitted between the electrodes 92, 94 when the energy button 18 is depressed or activated while the electrode 94 is rested against the semi-conductive spacer 50 that is attached to the electrode 92. In one example, the limited energy is in the form of current that flows between the electrodes 92, 94 through the semi-conductive spacer 50.
As described above, the end effector 10 can be transitioned between a plurality of configurations including, for example, an open configuration, as illustrated in FIG. 6, an approximated configuration, as illustrated in FIG. 7, and a fully approximated configuration, as illustrated in FIG. 8. Also as described above, the energy switch 18 can be activated while the end effector is in the approximated configuration to treat, seal, and/or cut tissue captured by the end effector 10 in the approximated configuration, for example. In certain instances, however, it may not be desirable to activate the energy switch 18 such as, for example, while the end effector 10 is in the open configuration or the fully approximated configuration. The present disclosure provides a method for detecting activation of the energy switch 18 and determining the configuration of the end effector 10 in response to the activation of the energy switch 18. The method further comprises generating a response suitable with the determined configuration of the end effector 10.
In certain instances, an activation circuit (not shown) can be employed to detect activation of the energy switch 18, as described in greater detail below. In certain instances, electrical energy transmission between the electrodes 92, 94, in response to activation of the energy switch 18, can be monitored to determine whether the end effector 10 is in the open configuration, the approximated configuration, or the fully approximated configuration. In one example, the energy transmission between the electrodes 92, 94 can be assessed by monitoring an impedance (Z) between the electrodes 92, 94. In one example, the energy transmission between the electrodes 92, 94 can be assessed by monitoring current flow between the electrodes 92, 94. Various sensing and/or monitoring devices can be employed to assess the energy transmission between the electrodes 92, 94.
In certain instances, when no electrical energy is transmitted between the electrodes 92, 94 in response to activation of the energy switch 18, it can be concluded that the end effector 10 is in the open configuration. In certain instances, when electrical energy is transmitted between the electrodes 92, 94 in response to activation of the energy switch 18 at an energy transmission rate that is in a first range of energy transmission rates, it can be concluded that the end effector 10 is in an approximated configuration. In certain instances, when electrical energy is transmitted between the electrodes 92, 94 in response to activation of the energy switch 18 at an energy transmission rate that is in a second range of energy transmission rates, different from the first range of energy transmission rates, it can be concluded that the end effector 10 is in a fully approximated configuration, for example.
FIG. 9 is a logic diagram for determining whether an end effector 10 is in the open configuration, the approximated configuration, or the fully approximated configuration and generating an appropriate response based on the outcome of the determination. As described above, whether electric energy is transmitted between the electrodes 92, 94 and its transmission rate can indicate the configuration of the end effector 10 following activation of the energy switch 18. In the example depicted in FIG. 9, the energy transmission between the electrodes 92, 94 is assessed by measuring an impedance (Z) between the electrodes 92, 94. Alternatively, current and/or voltage can be measured instead to assess the electric energy transmission between the electrodes 92, 94 or to assess the rate of change of electric energy transmission, e.g., power, between the electrodes 92, 94. In any event, the logic diagram depicted in FIG. 9 comprises detecting activation of the energy switch 18, measuring an impedance (Z) between the electrodes 92, 94, generating a first response when the measured impedance (Z) is greater than or equal to a predetermined threshold impedance (Zt), generating a second response when the measured impedance (Z) is in a first range of impedance, and generating a third response when the measured impedance (Z) is in a second range of impedance different from the first range of impedance.
In certain instances, when the value of the measured impedance (Z) is greater than or equal to a predetermined threshold impedance (Zt), an electric/electronic conduit (circuit) can be configured to determine that the end effector 10 is in an open configuration. In other words, when the value of the measured impedance (Z) is greater than or equal to the predetermined threshold impedance (Zt), the circuit can be configured to determine that the electrodes 92, 94 are spaced apart from each other with no tissue disposed therebetween. In such instances, a first response may be generated by the surgical instrument 2. The first response may comprise an alert response and/or an action response. In at least one example, the first response may comprise an error signal. In at least one example, the first response may comprise deactivating the energy switch 18. In at least one example, the first response may comprise alerting a user to deactivate or release the energy switch 18. In at least one example, the first response may comprise deactivating an energy source connected to the energy switch 18. In at least one example, the first response may comprise alerting the user that the end effector 10 is in the open configuration. In certain instances, the first response may comprise providing the user with instructions to capture tissue with the end effector 10 before reactivating the energy switch 18, for example.
In certain instances, the threshold impedance (Zt) can be greater than or equal to about 2100 ohms. In certain instances, the threshold impedance (Zt) can be greater than or equal to about 3000 ohms, for example. In certain instances, the threshold impedance (Zt) can be greater than or equal to about 4000 ohms, for example.
In certain instances, when the value of the measured impedance (Z) is in a first range of impedance, it can be concluded that the end effector 10 is in an approximated configuration. In other words, when the value of the measured impedance (Z) is in the first range of impedance, it can be concluded that tissue is captured between the electrodes 92, 94. In such instances, a second response can be generated by the surgical instrument 2. The second response can be an alert response and/or an action response. In at least one example, the second response comprises alerting a user that current is flowing through the captured tissue. In at least one example, the second response may comprise allowing current to continue to flow through the captured tissue until the energy switch 18 is released, for example. In at least one example, the second response comprises not deactivating the energy switch 18.
In certain instances, the first range of impedance may correspond to the impedance of tissue captured between the electrodes 92, 94 as current flows through the captured tissue. Typically, tissue impedance is in a range of about 3 ohms to about 400 ohms, for example. In at least on example, the first range of impedance can be selected from a range of about 1 ohm to about 499 ohms. In at least on example, the first range of impedance can be about 3 ohms to about 400 ohms. In at least on example, the first range of impedance can be about 100 ohms to about 300 ohms. In at least on example, the first range of impedance can be about 200 ohms to about 400 ohms. Other values for the first range of impedance are contemplated by the present disclosure. Various types of tissue may comprise various ranges of tissue impedance. Accordingly, the first range of impedance can be selected based on the type of tissue to be treated, for example.
In certain instances, when the value of the measured impedance (Z) is in a second range of impedance, the circuit can be configured to determine that the end effector 10 is in a fully approximated configuration. In other words, when the value of the measured impedance (Z) is in the second range of impedance, the circuit can be configured of determine that the electrodes 92, 94 are simultaneously in contact with a spacer 50. In such instances, a third response may be generated by the surgical instrument 2. The third response may comprise an alert response and/or an action response. In at least one example, the third response may comprise an error signal. In at least one example, the third response may comprise deactivating the energy switch 18. In at least one example, the third response may comprise alerting a user to deactivate or release the energy switch 18. In at least one example, the third response may comprise deactivating an energy source connected to the energy switch 18. In at least one example, the third response may comprise alerting the user that the end effector 10 is in the fully approximated configuration, deactivating the energy switch 18, and/or instructing the user to open the jaws 22a, 22b and capture tissue with the end effector 10 before reactivating the energy switch 18, for example.
In certain instances, the second range of impedance may be defined by the impedance of a spacer 50 as current flows between the electrodes 92, 94 through the spacer 50 in the fully approximated configuration. In at least one example, as described above, the spacer 50 may be comprised, or at least partially comprised, of a semi-conductive material. A semi-conductive spacer 50 may comprise an impedance in a range of about 500 ohms to about 2000 ohms, for example. In such instances, the second range of impedance can be selected from a range of about 500 ohms to about 2000 ohms. In at least on example, the second range of impedance can be about 500 ohms to about 1000 ohms. In at least on example, the second range of impedance can be about 1000 ohms to about 2000 ohms. In at least on example, the second range of impedance can be about 500 ohms to about 1500 ohms. Other values for the second range of impedance are contemplated by the present disclosure.
In certain instances, the semi-conductive spacer 50 may comprise an impedance (Z1). In such instances, in at least one example, the second range of impedance can be the impedance (Z1) ±1% of the impedance (Z1). In another example, the second range of impedance can be the impedance (Z1) ±5% of the impedance (Z1). In yet another example, the second range of impedance can be the impedance (Z1) ±10% of the impedance (Z1). In yet another example, the second range of impedance can be the impedance (Z1) ±50% of the impedance (Z1).
In one embodiment, the present disclosure provides a circuit 1000 configured to implement the logic diagram of FIG. 9 and/or variations thereof. In certain instances, the circuit 1000 can be configured to determine whether an end effector 10 is in the open configuration, the approximated configuration, or the fully approximated configuration. In addition, the circuit 1000 can be configured to generate an appropriate response based on the outcome of the determination. As described above, whether energy is transmitted between the electrodes 92, 94, in response to activation of the energy switch 18, can indicate the configuration of the end effector 10. In one example, an energy transmission between the electrodes 92, 94 is assessed by measuring an impedance (Z) between the electrodes 92, 94. Alternatively, current and/or voltage can be measured instead to assess the energy transmission between the electrodes 92, 94. In any event, the circuit 1000 may be configured to detect activation of the energy switch 18, measure an impedance (Z) between the electrodes 92, 94, and generate the first response when the measured impedance (Z) is greater than or equal to the threshold impedance (Zt), generate the second response when the measured impedance (Z) is in the first range of impedance, or generate the third response when the measured impedance (Z) is in the second range of impedance different from the first range of impedance.
In certain instances, the logic diagram of the present disclosure such as, for example, the logic diagram of FIG. 9 may be implemented by one or more hardware components, one or more software components, or combinations of hardware and software components. In certain instances, the hardware components may include electrical and/or electronic circuits. Such circuits may comprise processors, microprocessors, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth. In certain instances, the software component may include machine executable instructions commonly referred to as programs, applications, computer programs, application programs, system programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, application program interfaces (API), instruction sets, computing code, computer code, code segments, computer code segments, words, values, symbols, or any combination thereof. Determining whether to employ hardware components and/or software components to implement the logic diagram of the present disclosure may vary in accordance with any number of factors, such as desired computational rate, power levels, heat tolerances, processing cycle budget, input data rates, output data rates, memory resources, data bus speeds and other design or performance constraints.
In certain instances, the logic diagram of the present disclosure such as, for example, the logic diagram of FIG. 9 may be implemented, for example, by logic (e.g., instructions, data, and/or code) to be executed by a logic device (e.g., processor). Such logic may be stored internally or externally to a logic device on one or more types of computer-readable storage media and/or memory (e.g., flash memory).
In one embodiment, as illustrated in FIG. 10, the circuit 1000 may comprise a controller 1002. The controller 1002 may comprise one or more processors 1004 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 1006. The at least one memory circuit 1006 stores machine executable instructions that when executed by the processor 1004, cause the processor 1004 to detect activation of the energy switch 18, measure an impedance (Z) between the electrodes 92, 94, and generate the first response when the measured impedance (Z) is greater than or equal to the threshold impedance (Zt), generate the second response when the measured impedance (Z) is in the first range of impedance, or generate the third response when the measured impedance (Z) is in the second range of impedance different from the first range of impedance.
The processor 1004 may be any one of a number of single or multi-core processors known in the art. The memory circuit 1006 may comprise volatile and non-volatile storage media. In one embodiment, as illustrated in FIG. 11, the processor 1004 may include an instruction processing unit 1007 and an arithmetic unit 1009. The instruction processing unit may be configured to receive instructions from the one memory circuit 1006.
In certain instances, as illustrated in FIG. 10, a current sense circuit 1014 can be employed to sense current flowing between the electrodes 92, 94. Furthermore, a voltage sense circuit 1016 can be employed to sense an output voltage applied to the electrodes 92, 94 by an energy source such as, for example a generator 102. The sensed values of current and voltage may be applied to an analog-to-digital converter (ADC) 1018 via an analog multiplexer 1020 circuit or switching circuit arrangement. The analog multiplexer 1020 may transmit the appropriate samples of the analog signal to the ADC 1018 for conversion. The processor 1004 may be configured to receive the digital output of the ADC 1018 and calculate the impedance (Z) based on the measured values of current and voltage, for example. Other techniques for determining the impedance (Z) are contemplated by the present disclosure.
In certain instances, one or more of the switches described by the present disclosure such as, for example, the energy switch 18 may comprise mechanical switches, electro-mechanical switches, and/or solid state switches. In certain instances, one or more of the switches of the present disclosure such as, for example, the energy switch 18 may comprise open, inactive, and/or non-conductive positions, states, and/or configurations. In certain instances, one or more of the switches of the present disclosure such as, for example, the energy switch 18 may comprise closed, active, and/or conductive positions, states and/or configurations. In certain instances, one or more of the switches of the present disclosure such as, for example, the energy switch 18 can be transitioned from the open, inactive, and/or non-conductive positions, states, and/or configurations to the closed, active, and/or conductive positions, states and/or configurations to close and/or activate one or more circuits associated with such switches, for example.
In one embodiment, the energy switch 18 can be associated with an activation circuit (not shown) which can be operably coupled to the controller 1002. The activation circuit of the energy switch 18 may be transitioned from an open configuration to a closed configuration in response to activation of the energy switch 18. The processor 1004 can be configured to detect the transition of the activation circuit to the closed configuration. The transition of the activation circuit to the closed configuration may indicate to the processor 1004 that the energy switch 18 is activated. The processor 1004 can be configured to measure the impedance (Z), as described above, in response to the transition of the activation circuit to the closed configuration.
In certain instances, the selected values of the threshold impedance (Zt), the first range of impedance, and/or the second range of impedance can be stored in at least one memory circuit such as, for example, the at least one memory circuit 1006. The processor 1004 may be configured to compare the measured value of the impedance (z) to the stored values of the threshold impedance (Zt), the first range of impedance, and/or the second range of impedance stored in the at least one memory circuit 1006. When the measured impedance (Z) is greater than or equal to the threshold impedance (Zt), the processor 1004 may generate the first response; when the measured impedance (Z) is in the first range of impedance, the processor 1004 may generate the second response; and when the measured impedance (Z) is in the second range of impedance, the processor 1004 may generate the third response.
In certain instances, the parameters of the first response, the second response, and/or the third response are stored in at least one memory circuit such as, for example, the at least one memory circuit 1006. The processor 1004 may employ a user interface 1022 to generate the first response, the second response, and/or the third response, for example. In certain instances, the user interface 1022 may comprise visual feedback devices (e.g., an LCD display screen, LED indicators), audio feedback devices (e.g., a speaker, a buzzer) and/or tactile feedback devices (e.g., haptic actuators), for example.
In one embodiment, the circuit 1000 may comprise a finite state machine comprising a combinational logic circuit 1030, as illustrated in FIG. 12. In one embodiment, the circuit 1000 may comprise a finite state machine comprising a sequential logic circuit 1040, as illustrated in FIG. 13. The sequential logic circuit 1040 may comprise the combinational logic circuit 1030 and at least one memory circuit 1036, for example. The at least one memory circuit 1036 can store a current state of the finite state machine, as illustrated in FIG. 13. The sequential logic circuit 1040 or the combinational logic circuit 1030 can be configured to cause the finite state machine to detect activation of the energy switch 18, measure an impedance (Z) between the electrodes 92, 94, and generate the first response when the measured impedance (Z) is greater than or equal to the threshold impedance (Zt), generate the second response when the measured impedance (Z) is in the first range of impedance, or generate the third response when the measured impedance (Z) is in the second range of impedance different from the first range of impedance. In certain instances, the sequential logic circuit 1040 may be synchronous or asynchronous.
In other embodiments, the circuit 1000 may comprise a combination of the processor 1004 and the finite state machine to detect activation of the energy switch 18, measure an impedance (Z) between the electrodes 92, 94, and generate the first response when the measured impedance (Z) is greater than or equal to the threshold impedance (Zt), generate the second response when the measured impedance (Z) is in the first range of impedance, or generate the third response when the measured impedance (Z) is in the second range of impedance different from the first range of impedance. In other embodiments, the finite state machine may comprise a combination of the combinational logic circuit 1030 and the sequential logic circuit 1040.
In some cases, various embodiments may be implemented as an article of manufacture. The article of manufacture may include a computer readable storage medium arranged to store logic, instructions and/or data for performing various operations of one or more embodiments. In various embodiments, for example, the article of manufacture may comprise a magnetic disk, optical disk, flash memory or firmware containing computer program instructions suitable for execution by a general purpose processor or application specific processor. The embodiments, however, are not limited in this context.
The functions of the various functional elements, logical blocks, modules, and circuits elements described in connection with the embodiments disclosed herein may be implemented in the general context of computer executable instructions, such as software, control modules, logic, and/or logic modules executed by the processing unit. Generally, software, control modules, logic, and/or logic modules comprise any software element arranged to perform particular operations. Software, control modules, logic, and/or logic modules can comprise routines, programs, objects, components, data structures and the like that perform particular tasks or implement particular abstract data types. An implementation of the software, control modules, logic, and/or logic modules and techniques may be stored on and/or transmitted across some form of computer-readable media. In this regard, computer-readable media can be any available medium or media useable to store information and accessible by a computing device. Some embodiments also may be practiced in distributed computing environments where operations are performed by one or more remote processing devices that are linked through a communications network. In a distributed computing environment, software, control modules, logic, and/or logic modules may be located in both local and remote computer storage media including memory storage devices.
Additionally, it is to be appreciated that the embodiments described herein illustrate example implementations, and that the functional elements, logical blocks, modules, and circuits elements may be implemented in various other ways which are consistent with the described embodiments. Furthermore, the operations performed by such functional elements, logical blocks, modules, and circuits elements may be combined and/or separated for a given implementation and may be performed by a greater number or fewer number of components or modules. As will be apparent to those of skill in the art upon reading the present disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several aspects without departing from the scope of the present disclosure. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.
Unless specifically stated otherwise, it may be appreciated that terms such as “processing,” “computing,” “calculating,” “determining,” or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, such as a general purpose processor, a DSP, ASIC, FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein that manipulates and/or transforms data represented as physical quantities (e.g., electronic) within registers and/or memories into other data similarly represented as physical quantities within the memories, registers or other such information storage, transmission or display devices.
It is worthy to note that some embodiments may be described using the expression “coupled” and “connected” along with their derivatives. These terms are not intended as synonyms for each other. For example, some embodiments may be described using the terms “connected” and/or “coupled” to indicate that two or more elements are in direct physical or electrical contact with each other. The term “coupled,” however, also may mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. With respect to software elements, for example, the term “coupled” may refer to interfaces, message interfaces, and application program interface (API), exchanging messages, and so forth.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the embodiments described herein will be processed before surgery. First, a new or used instrument is obtained and when necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Any patent, publication, or other disclosure material, in whole or in part, that is the to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is the to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
While the present disclosure provides example designs, the claimed subject matter may be further modified within the scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
The entire disclosures of:
U.S. patent application Ser. No. 14/563,091, entitled ELECTRODE CONFIGURATIONS FOR SURGICAL INSTRUMENTS, filed Dec. 8, 2014;
U.S. patent application Ser. No. 12/576,789, entitled SURGICAL INSTRUMENT FOR TRANSMITTING ENERGY TO TISSUE COMPRISING NON-CONDUCTIVE GRASPING PORTIONS, filed Oct. 9, 2009, now U.S. Pat. No. 8,747,404;
U.S. patent application Ser. No. 14/075,839, entitled ELECTROSURGICAL DEVICES, filed Nov. 8, 2013;
U.S. patent application Ser. No. 14/075,863, entitled ELECTROSURGICAL DEVICES, filed Nov. 8, 2013; and
U.S. patent application Ser. No. 14/229,033, entitled DISTAL SEALING END EFFECTOR WITH SPACERS, filed Mar. 28, 2014, are hereby incorporated by reference herein.

## Claims

1. A surgical instrument, comprising:
an end effector, comprising:
a first jaw comprising a first electrode;
a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector between an open configuration, an approximated configuration, and a fully approximated configuration, and wherein the second jaw comprises:
a second electrode, wherein tissue is captured between the first electrode and the second electrode in the approximated configuration; and
at least one spacer extending from the second electrode, wherein the at least one spacer is configured to maintain a minimum predetermined distance between the first electrode and the second electrode when the end effector is in the fully approximated configuration, and wherein the at least one spacer is simultaneously in contact with the first electrode and the second electrode in the fully approximated configuration;


a switch configured to control energy transmission between the first electrode and the second electrode, wherein the switch is activatable to permit energy transmission between the first electrode and the second electrode; and
a circuit configured to:
detect activation of the switch;
detect an impedance between the first electrode and the second electrode in response to the activation of the switch;
generate a first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to a predetermined threshold;
generate a second response corresponding to the approximated configuration of the end effector when the impedance is in a first range of impedance; and
generate a third response corresponding to the fully approximated configuration when the impedance is in a second range of impedance different from the first range of impedance.

2. The surgical instrument of claim 1, wherein the second range of impedance is defined by an impedance of the at least one spacer.

3. The surgical instrument of claim 1, wherein the at least one spacer comprises a semi-conductive material.

4. The surgical instrument of claim 1, wherein the second range of impedance is selected from a range of about 500 ohms to about 2000 ohms.

5. The surgical instrument of claim 1, wherein the first range of impedance is defined by an impedance of the tissue.

6. The surgical instrument of claim 1, wherein the first range of impedance is selected from a range of about 3 ohms to about 400 ohms.

7. The surgical instrument of claim 1, wherein the circuit comprises a finite state machine configured to:
detect the activation of the switch;
detect the impedance between the first electrode and the second electrode in response to the activation of the switch;
generate the first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to the predetermined threshold;
generate the second response corresponding to the approximated configuration of the end effector when the impedance is in the first range of impedance; and
generate the third response corresponding to the fully approximated configuration when the impedance is in the second range of impedance.

8. The surgical instrument of claim 1, wherein the circuit comprises:
a processor; and
a memory that stores program instructions, which when executed from the memory cause the processor to:
detect the activation of the switch;
detect the impedance between the first electrode and the second electrode in response to the activation of the switch;
generate the first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to the predetermined threshold;
generate the second response corresponding to the approximated configuration of the end effector when the impedance is in the first range of impedance; and
generate the third response corresponding to the fully approximated configuration when the impedance is in the second range of impedance.

9. The surgical instrument of claim 8, wherein the circuit comprises a finite state machine, wherein the finite state machine comprises at least one combinational logic circuit configured to cause the finite state machine to:
detect the activation of the switch;
detect the impedance between the first electrode and the second electrode in response to the activation of the switch;
generate the first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to the predetermined threshold;
generate the second response corresponding to the approximated configuration of the end effector when the impedance is in the first range of impedance; and
generate the third response corresponding to the fully approximated configuration when the impedance is in the second range of impedance.

10. The surgical instrument of claim 8, wherein the circuit comprises a finite state machine, wherein the finite state machine comprises at least one sequential logic circuit coupled to at least one memory circuit, the at least one memory circuit configured to store a current state of the finite state machine, wherein the sequential logic circuit is configured to cause the finite state machine to:
detect the activation of the switch;
detect the impedance between the first electrode and the second electrode in response to the activation of the switch;
generate the first response corresponding to the open configuration of the end effector when the impedance is greater than or equal to the predetermined threshold;
generate the second response corresponding to the approximated configuration of the end effector when the impedance is in the first range of impedance; and
generate the third response corresponding to the fully approximated configuration when the impedance is in the second range of impedance.

11. The surgical instrument of claim 10, wherein the sequential logic circuit is either synchronous or asynchronous.