Patent Description:
The present invention provides a surgical bipolar forceps instrument according to claim <NUM>. Embodiments of the invention are described in the dependent claims. An embodiment of the invention is shown in <FIG>.

Various features of the embodiments described herein, together with advantages thereof, may be understood in accordance with the following description taken in conjunction with the accompanying drawings as follows:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate various embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. Well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. The reader will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and illustrative. Variations and changes thereto may be made without departing from the scope of the 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" refers to the portion closest to the clinician and the term "distal" refers 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 exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader 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, the reader 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 elongate shaft of a surgical instrument can be advanced.

The embodiments disclosed herein are configured for use with surgical suturing instruments and systems such as those disclosed in <CIT>, now <CIT>, entitled CIRCULAR NEEDLE APPLIER WITH OFFSET NEEDLE AND CARRIER TRACKS; <CIT>, now <CIT>, entitled SURGICAL NEEDLE WITH RECESSED FEATURES; and <CIT>, now <CIT>, entitled SUTURING INSTRUMENT WITH MOTORIZED NEEDLE DRIVE. The embodiments discussed herein are also usable with the instruments, systems, and methods disclosed in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. The embodiments discussed herein are also usable with the instruments, systems, and methods disclosed in <CIT>, <CIT>, <CIT>, and <CIT>. Generally, these surgical suturing instruments comprise, among other things, a shaft, an end effector attached to the shaft, and drive systems positioned within the shaft to transfer motion from a source motion to the end effector. The motion source can comprise a manually driven actuator, an electric motor, and/or a robotic surgical system. The end effector comprises a body portion, a needle track defined within the body portion, and a needle driver configured to drive a needle through a rotational firing stroke. The needle is configured to be guided through its rotational firing stroke within the body portion by the needle track. In various instances, the needle driver is similar to that of a ratchet system. In at least one instance, the needle driver is configured to drive the needle through a first half of the rotational firing stroke which places the needle in a hand-off position - a position where a tissue-puncturing end of the needle has passed through the target tissue and reentered the body portion of the end effector. At such point, the needle driver can be returned to its original position to pick up the tissue-puncturing end of the needle and drive the needle through a second half of its rotational firing stroke. Once the needle driver pulls the needle through the second half of its rotational firing stroke, the needle driver is then returned to its original unfired position to grab the needle for another rotational firing stroke. The drive systems can be driven by one or more motors and/or manual drive actuation systems. The needle comprises suturing material, such as thread, for example, attached thereto. The suturing material is configured to be pulled through tissue as the needle is advanced through its rotational firing stroke to seal the tissue and/or attached the tissue to another structure, for example.

<FIG> depict a surgical suturing instrument <NUM> configured to suture the tissue of a patient. The surgical suturing instrument <NUM> comprises a handle <NUM>, a shaft <NUM> extending distally from the handle <NUM>, and an end effector <NUM> attached to the shaft <NUM> by way of an articulation joint <NUM>. The handle <NUM> comprises a firing trigger <NUM> configured to actuate a firing drive of the surgical suturing instrument <NUM>, a first rotational actuator <NUM> configured to articulate the end effector <NUM> about an articulation axis AA defined by the articulation joint <NUM>, and a second rotational actuator <NUM> configured to rotate the end effector <NUM> about a longitudinal axis LA defined by the end effector <NUM>. The surgical suturing instrument <NUM> further comprises a flush port <NUM>. Examples of surgical suturing devices, systems, and methods are disclosed in <CIT>, now <CIT>, entitled CIRCULAR NEEDLE APPLIER WITH OFFSET NEEDLE AND CARRIER TRACKS; <CIT>, now <CIT>, entitled SURGICAL NEEDLE WITH RECESSED FEATURES; and <CIT>, now <CIT>, entitled SUTURING INSTRUMENT WITH MOTORIZED NEEDLE DRIVE.

<FIG> depict a needle sensing system <NUM> configured to be used with a surgical suturing instrument system. The needle sensing system <NUM> comprises a resistive sensing circuit configured to allow a control program of a control interface to determine the position of a needle during its firing stroke by monitoring the resistance of the resistive sensing circuit. The needle sensing system <NUM> comprises a needle sensing circuit <NUM> and a needle <NUM>. The needle sensing circuit <NUM> comprises a supply portion, or leg, <NUM> terminating at a first terminal <NUM> and comprising a first resistance R1. The needle sensing circuit <NUM> further comprises a return portion <NUM> comprising a first return leg <NUM> terminating at a first return terminal <NUM> and a second return leg <NUM> terminating a second return terminal <NUM>. The first return leg <NUM> and the second return leg <NUM> are wired in parallel with respect to each other. The first return leg <NUM> comprises a second resistance R2 and the second return leg <NUM> comprises a third resistance R3. Discussed in greater detail below, the needle <NUM> is configured to act as a switch for the needle sensing circuit <NUM> by contacting the terminals <NUM>, <NUM>, and <NUM> during its firing stroke as the needle <NUM> moves in a rotational direction to suture tissue. The resistance of such a circuit can be monitored by a processor to determine the location of the needle <NUM> during its firing stroke.

The needle <NUM> comprises a tip <NUM>, a butt end <NUM>, and an arcuate shaft <NUM> extending between the tip <NUM> and the butt end <NUM>. The needle <NUM> further comprises suturing material <NUM> attached to the butt end <NUM> of the needle <NUM>. The tip <NUM> comprises a bevel, or point, <NUM> configured to pierce tissue during a firing stroke of the needle <NUM>. As the needle <NUM> moves through its firing stroke, it is configured to move into and out of contact with the terminals <NUM>, <NUM>, and <NUM>. In its starting, or home, position (<FIG>), the needle <NUM> is in contact with all three terminals <NUM>, <NUM>, and <NUM>. The total resistance of the circuit <NUM> in this configuration can be detected by the control system of the suturing instrument to identify that the needle <NUM> is in its starting position. The total resistance of the circuit <NUM> in this configuration is shown in the circuit diagram <NUM>' of <FIG> and can be referred to as the starting position resistance. Once the needle <NUM> is advanced out of its starting position and the butt end <NUM> of the needle <NUM> moves out of contact with the terminal <NUM>, the needle <NUM> has been partially fired and is now only in contact with two terminals <NUM>, <NUM> (<FIG>). The total resistance of the circuit <NUM> in this configuration can be detected by the control system to identify that the needle <NUM> is in a first partially-fired position. The total resistance of the circuit <NUM> in this configuration is shown in the circuit diagram <NUM>' of <FIG> and can be referred to as the first partially-fired position resistance. Once the needle <NUM> is advanced out of contact with the second terminal <NUM> and back into contact with the first terminal <NUM>, the circuit <NUM> now comprises a third total resistance that is different from the starting position resistance and the first-partially fired position resistance. This can be referred to as the second partially-fired position resistance (<FIG>). Because the second partially-fired position resistance is different than the starting position resistance and the first partially-fired position resistance, the second partially-fired position resistance can be detected to determine that the needle <NUM> has moved into the second partially-fired position.

The system <NUM> permits the needle location to be detected directly. Monitoring the needle location over a period of time can provide means for determining the rate of advancement of the needle and/or changes in rate of advancement of the needle during its firing stroke. In various instances, if the needle is sensed to be moving at a rate slower than preferred, for example, the instrument can automatically adjust a power control program of the motor which is advancing the needle through its firing stroke to speed up the needle. Similarly, if the needle is sensed to be moving at a rate faster than preferred, for example, the instrument can automatically adjust the power control program of the motor which is advancing the needle through its firing stroke to slow down the needle. This arrangement allows the control program to adapt the rate and/or sequence at which the needle is fired during a procedure and/or during each firing stroke of the needle to better accommodate variable conditions such as, for example, variable tissue thicknesses during suturing.

<FIG> illustrates a logic flow diagram of a process <NUM> depicting a control program for controlling a surgical suturing instrument. The process <NUM> comprises monitoring <NUM> a position sensing circuit output. For example, the output resistance of the system <NUM> can be monitored throughout the operation of a surgical suturing instrument. The process <NUM> further includes determining <NUM> if the control motions applied to the needle need to be adjusted based on the position sensing circuit output. A processor, for example, can monitor the position sensing circuit output over a period of time and calculate the speed of the needle during its firing stroke. If the speed is too fast or too slow for the present tissue thickness, for example, the control program can adjust <NUM> the control motions applied to the needle to change the speed of the needle firing stroke. If the speed of the needle is consistent with a predetermined speed profile for the present tissue thickness, the control program can continue <NUM> normal operation of the instrument. Other position sensing systems disclosed herein can be used with this process.

<FIG> depicts a needle sensing system <NUM> configured to allow a control system of a suturing instrument to monitor the motions of the needle within the end effector against the anticipated, or expected, motions of the needle. In various instances, backlash in a motor-driven needle drive system, for example, could cause the drive system to produce a shorter needle stroke than expected for a given amount of motor rotations. The needle sensing system <NUM> comprises an end effector <NUM>, a needle track <NUM> defined within the end effector <NUM>, and a needle <NUM>. Similar to the above, the needle <NUM> is configured to be actuated by a needle driver to move the needle <NUM> through a circular firing stroke. The needle <NUM> is guided by the needle track <NUM> as the needle <NUM> is actuated by the needle driver. The needle sensing system <NUM> comprises a plurality of sensors <NUM> designated as S1, S2, S3, and S4 which, as discussed below, are configured to track the motion of the needle <NUM>. The sensors <NUM> may be any suitable position-detecting sensor such that, as the needle <NUM> engages, or trips, a sensor <NUM>, that sensor sends a voltage signal to the control system that the sensor <NUM> has detected that the needle <NUM> indicating the position of the needle <NUM>. The needle <NUM> comprises a tip <NUM> that is configured to initially trip the sensors <NUM> as the tip <NUM> approaches and contacts, or otherwise trips, the sensors <NUM>. The end effector <NUM> further comprises a tissue opening <NUM> defined therein. In use, the end effector <NUM> is pressed against the patient tissue such that the tissue enters the opening <NUM>. At such point, the tip <NUM> can pierce tissue in the opening <NUM> and then re-enter the needle track <NUM> on the other side of the end effector <NUM>. The needle <NUM> is dimensioned to have a larger length than the distance of the opening <NUM> so that the needle <NUM> can be guided by the needle track <NUM> back into the needle track <NUM> before a butt end of the needle exits the end effector <NUM> into the opening <NUM>.

<FIG> is a graph <NUM> depicting a portion of a needle firing stroke using the needle sensing system <NUM> of <FIG>. As can be seen in the graph <NUM> illustrated in <FIG>, there is an overlap of detection for each neighboring sensor. During a needle firing stroke, each sensor is configured to detect the tip <NUM> of the needle <NUM> before the previous sensor no longer detects the needle <NUM>. In another embodiment, more than two sensors are configured to sense the needle during the needle firing stroke.

The sensors <NUM> can be used in combination with a control program to ensure that a motor driving the needle <NUM> through its firing stroke is driving the needle <NUM> the expected amount. For example, a certain amount of rotation from the needle drive motor should produce a corresponding travel length of the needle <NUM>. Monitoring the position of the needle <NUM> in the end effector <NUM> along with rotational motion of the motor can provide a way to make sure that the motor is producing the anticipated drive motions of the needle. An example of a needle stroke where the rotational motion of the motor and the actual length of needle travel are monitored is depicted in the graph <NUM> illustrated in <FIG>. If the motion of the needle is not as anticipated, the control system can adjust the power delivered to the motor to account for these differences and assure that the needle is being driven all the way around its firing path during a firing stroke. For example, if the motor takes more rotations than expected to cause the needle to travel a certain distance, the control system can increase the number of rotations for the needle to complete the firing stroke. Such instances could be due to backlash in the drive system, for example.

If the actual motions sensed by a needle position sensing system are not as expected, the control program can place the system in a limp mode, for example, to prevent premature failure of components.

The needle sensing system <NUM> can also monitor the current drawn by the needle drive motor while monitoring the input from the sensors <NUM>. In such an embodiment, a control program can the reverse actuation of the needle <NUM> in the event that a substantial increase in current is detected in the motor and the subsequent sensor <NUM> has not been tripped - possibly indicating that the needle is jammed. In the same and/or another embodiment, an encoder can be used to measure the number of rotations being provided by the motor. A control program can compare the number of rotations being provided by the motor to the input from the sensors <NUM>. In an instance where the sensors <NUM> are not being tripped as expected by a given amount of rotation from the motor, the control program can interrogate the motor current to assess why the needle is not traveling the expected distance. If the motor current is substantially high, this could indicate a jam, as discussed above. If the motor current is substantially low, this could indicate that the needle and the needle driver are no longer coupled, for example, and that the needle driver is freely moving without driving the needle. In an alternative embodiment, motor torque can be sensed instead of motor current. An example of current monitoring can be seen in the graph <NUM> illustrated in <FIG>.

<FIG> depict a surgical suturing instrument <NUM> comprising a shaft <NUM>, an end effector <NUM>, and a needle drive system <NUM>. The surgical suturing instrument <NUM> is designed to provide a suturing bite width that is larger than the diameter of the shaft <NUM> by using an expandable/collapsible needle guide element. Various suturing devices are limited to a bite width that is constrained by the diameter of their shafts. The surgical suturing instrument <NUM> comprises a movable needle guide <NUM> rotatably mounted to a body <NUM> of the end effector <NUM> configured to permit the use of a needle <NUM>, which also comprises a length that exceeds the width of the shaft diameter. To actuate the movable needle guide <NUM>, a linear actuator <NUM> connected to a proximal end <NUM> of the movable needle guide <NUM> is configured to be pushed and pulled to pivot the movable needle guide <NUM> about its pivot point <NUM>. <FIG> illustrates the movable needle guide <NUM> in an expanded configuration where the surgical suturing instrument <NUM> is ready to be fired. To pivot the movable needle guide <NUM> into its closed configuration (<FIG>), the linear actuator <NUM> is pulled proximally. When the movable needle guide <NUM> is in its closed configuration, the surgical suturing instrument <NUM> is in a configuration sufficient to be passed through a trocar.

The needle drive system <NUM> comprises a linear actuator <NUM>, a proximal needle feed wheel <NUM> configured to be rotated about its pivot <NUM> by way of the linear actuator <NUM> and rotatably mounted within the body <NUM> of the end effector <NUM>, and a distal needle feed wheel <NUM> configured to be rotated about its pivot <NUM> by a connecting link <NUM> by way of the proximal needle feed wheel <NUM> and rotatably mounted within the body <NUM> of the end effector <NUM>. The feed wheels <NUM>, <NUM> are configured to be rotated together to move the flexible needle <NUM> through the body <NUM> of the end effector <NUM> and out of the body <NUM> of the end effector <NUM> against the movable needle guide <NUM>. The movable needle guide <NUM> comprises a curved tip <NUM> configured to guide the flexible needle <NUM> back into the body <NUM> of the end effector <NUM> so that the distal needle feed wheel <NUM> can begin guiding the flexible needle <NUM> back toward the proximal needle feed wheel <NUM>. The feed wheels <NUM>, <NUM> are connected by a coupler bar such that they rotate at the same time.

In various instances, the needle <NUM> may need to be repaired or replaced. To remove the needle <NUM> from the end effector <NUM>, the movable needle guide <NUM> may be pivoted outwardly to provide access to the needle <NUM> (<FIG>).

The needle <NUM> comprises an arc length A. The distance between the pivots <NUM>, <NUM> of the feed wheels <NUM>, <NUM> is labeled length B. The arc length A of the needle <NUM> must be greater than the length B in order to be able to guide the flexible needle <NUM> back into the end effector body <NUM> with the proximal needle feed wheel <NUM>. Such an arrangement allows a capture, or bite, width <NUM> of the surgical suturing instrument <NUM> to be larger than the diameter of the shaft <NUM>. In certain instances, a portion of the end effector containing the needle drive system <NUM> can be articulated relative to the end effector body <NUM> so that the capture width, or opening, <NUM> can hinge outwardly and face tissue distally with respect to the instrument <NUM>. This arrangement can prevent a user from having to preform the suturing procedure with respect to the side of the instrument <NUM>. Such a feature may utilize a hinge mechanism with snap features to rigidly hold the end effector body <NUM> in a firing position as opposed to a position suitable for insertion through a trocar.

As outlined above, a portion of the end effector <NUM> is movable to increase or decrease the width of the end effector <NUM>. Decreasing the width of the end effector <NUM> allows the end effector <NUM> to be inserted through a narrow trocar passageway. Increasing the width of the end effector <NUM> after it has been passed through the trocar allows the end effector <NUM> to make larger suture loops in the patient tissue, for example. In various instances, the end effector <NUM> and/or the needle <NUM> can be flexible so that they can be compressed as they are inserted through the trocar and then re-expand once they have passed through the trocar. Such an arrangement, as described above, allows a larger end effector to be used.

<FIG> depicts a collapsible suturing device <NUM> comprising a shaft <NUM> and an end effector <NUM> configured to be articulated relative to the shaft <NUM>. The device <NUM> comprises a tissue bite region having a larger width than its shaft diameter. The end effector <NUM> is hingedly coupled to the shaft <NUM>. The collapsible suturing device <NUM> comprises a separate actuation member to rotate the end effector <NUM> relative to the shaft <NUM>. In other embodiments, the end effector <NUM> can be spring biased into a straight configuration where a user may apply torque to a distal end of the end effector <NUM> by pressing the end effector <NUM> against tissue to rotate the end effector <NUM> relative to the shaft <NUM>. In either event, such an arrangement provides the device <NUM> with a distal-facing tissue bite region <NUM> which can permit a user to more accurately and/or easily target tissue to be sutured.

The tissue bite region <NUM> is larger than the diameter of the shaft <NUM>. During use, a user would insert the collapsible suturing device <NUM> into a trocar while the device <NUM> is in its straight configuration. After the device <NUM> is inserted through the trocar, the user may actively rotate the end effector <NUM> with an actuator to orient the end effector <NUM> properly to prepare to suture the tissue. Once the end effector <NUM> is oriented to face the tissue to be sutured, a movable needle guide may be actuated outwardly to prepare to advance the needle through a needle firing stroke. In this configuration, the end effector <NUM> can then be pressed against the tissue to be sutured and the needle can be advanced through a needle firing stroke. Once suturing is complete, the needle guide can be collapsed and the end effector <NUM> can be rotated back into its straight configuration to be removed from the patient through the trocar. The needle may be taken out of the end effector <NUM> before or after the end effector <NUM> has passed back out of the patient through the trocar.

<FIG> depicts a collapsible suturing device <NUM> comprising a shaft <NUM> and an end effector <NUM> attached to the distal end of the shaft <NUM>. The device <NUM> comprises a tissue bite region having a larger width than its shaft diameter. The end effector <NUM> further comprises a needle driving system <NUM> configured to drive a flexible needle through a needle firing stroke against a movable needle guide <NUM>. The needle driving system <NUM> comprises a proximal feed wheel <NUM>, a distal feed wheel <NUM>, and an intermediate feed wheel <NUM> configured to feed the flexible needle through the end effector <NUM>. The intermediate feed wheel <NUM> permits the use of a longer flexible needle than arrangements without an intermediate feed wheel. Embodiments are envisioned where the intermediate feed wheel is actively connected the needle driving system. In other instances, the intermediate feed wheel is an idler component and rotates freely. In at least one embodiment, the needle comprises a width that is larger than the width of the shaft with which is used.

<FIG> depict a surgical suturing end effector <NUM> configured to provide a suturing device with a variable needle stroke. In various instances, the needle stroke of the end effector <NUM> can be different every time the end effector <NUM> is fired. The end effector <NUM> also can provide a suturing bite width that is wider than the diameter of its shaft. The surgical suturing end effector <NUM> comprises a body portion <NUM> having a tissue-engaging opening <NUM>, a needle track <NUM> defined within the body portion <NUM>, and a needle <NUM> configured to be guided through a firing stroke by the needle track <NUM>. <FIG> illustrates the needle <NUM> in its parked position where the end effector <NUM> can be passed through a trocar. Once the end effector <NUM> is passed through a trocar, the needle <NUM> is advanced linearly from a park track portion <NUM> of the needle track <NUM> - by way of its proximal end <NUM> - to a ready-to-fire position (<FIG>). As can be seen in <FIG>, the needle <NUM> extends outwardly beyond the body <NUM> of the end effector <NUM> when the needle <NUM> is in its ready-to-fire position. Such an arrangement allows for an instrument to have a tissue bite width that is larger than the diameter of the instrument's shaft. The needle <NUM> comprises a canoe-like shape but can comprise any suitable shape to achieve this.

When a clinician wants to complete a suture stroke, discussed in greater detail below, the needle <NUM> is moved to the position shown in <FIG> referred to as the hand-off position. To get to this position, the proximal end <NUM> of the needle <NUM> is rotated and advanced linearly within a first track portion <NUM> of the track <NUM> until the proximal end <NUM> of the needle <NUM> reaches a distal end <NUM> of the first track portion <NUM> and a tip portion <NUM> of the needle <NUM> engages a distal end <NUM> of a second track portion <NUM> of the track <NUM>. This engagement allows a needle driver that rotates and linearly advances the needle <NUM> within the track <NUM> to move along the track <NUM> to the distal end <NUM> of the second track portion <NUM> to grab the tip portion <NUM> and pull the needle <NUM> through the end effector <NUM> by pulling the needle <NUM> proximally and rotating the needle <NUM> to prepare for a second firing stroke of the needle <NUM>. At a certain point after the needle <NUM> attains the hand-off position (<FIG>), the needle driver can re-connect, or re-engage, with the proximal end <NUM> of the needle <NUM> to begin a second firing stroke to return the needle <NUM> to its ready-to-fire position illustrated in <FIG>. The firing stroke of the needle <NUM>, having a canoe-like shape, can resemble a box-shaped, or diamond-shaped, path.

<FIG> is a stress-strain diagram <NUM> of the loads experienced by a needle during a firing stroke. A control system of a surgical suturing instrument can monitor input from a strain gauge and adjust the operation of the surgical suturing instrument based on the monitored strain and/or display the strain to a user during use. The surgical suturing instrument can alert a user when the needle has reached <NUM>% <NUM> of its yield strength during a suturing procedure. The surgical instrument can provide the clinician with an option to adjust the advancement speed of the needle to help prevent further spikes of the strain and/or stress within the needle. If the needle reaches <NUM>% <NUM> of its yield strength, overstress may be reported to the user and the control system will report the overstress to the system disclosed in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. If the needle reaches <NUM>% <NUM> of its yield strength, the user is alerted of this threshold and the control program automatically slows the speed and may disable the instrument from actuating the needle any further, and/or request action to be taken before any further use of the surgical suturing instrument.

<FIG> depict a method for detecting the proper and/or improper attachment of a modular shaft to a surgical instrument handle and/or surgical robot, for example. <FIG> depicts an attachment assembly <NUM> attachable to an attachment interface <NUM> - which can be a surgical instrument handle and/or robotic attachment, or control, interface. Monitoring the torque of a drive system coupled at the attachment interface <NUM> can provide a way to determine if the attachment interface <NUM> and the modular attachment <NUM> have been successfully attached or not.

Referring to the graph <NUM>, the solid plot line represents a scenario where an attempt at attaching the modular attachment <NUM> to the attachment interface <NUM> was made, and the modular attachment <NUM> and the attachment <NUM> slipped out of engagement thereby causing a reduction in torque of the actuation drive system below a minimum torque threshold representing an unsuccessful attachment and engagement of drive systems. The torque of a failed attempt is noticeably different than the torque of a successful attempt which is also illustrated in the graph <NUM>. In another embodiment, the current of the motor that drives the drive system can be directly monitored. Referring now to the graph <NUM>', the surgical instrument is equipped with a control system that shuts off the motor in this scenario (<NUM>) when the torque sensed drops below the minimum threshold torque. The control system can also alert a user that the motor has been stopped because attachment was not successful. Referring again to the graph <NUM>, a second scenario is illustrated by a dashed plot line where attachment is made, however, the torque sensed increases above a maximum torque threshold. This could indicate a jam between the attachment interface <NUM> and the modular attachment <NUM>. Referring again to the graph <NUM>', the surgical instrument is equipped with a control system that limits the torque delivered by the drive system when the torque sensed increases above the maximum threshold torque, as illustrated in the dashed plot line representing the second scenario (<NUM>). Such a limiting of torque delivery can prevent the breaking of components in the modular attachment <NUM> and/or the attachment interface <NUM>.

In various embodiments, strain gauges can be fitted to frame elements of the modular attachments to monitor force applied to tissue with the frame elements themselves. For example, a strain gauge can be fitted to an outer shaft element to monitor the force experienced by the shaft as the modular attachment is pushed against tissue and/or as the modular attachment pulls tissue. This information can be communicated to the user of the instrument so that the user is aware of the pressure being applied to the tissue by the grounded elements of the modular attachment due to manipulation and movement of the modular attachment within the surgical site.

<FIG> and <FIG> depict a surgical instrument system <NUM> that is configured to monitor unexpected electrical potential applied to a surgical instrument during an operation that involves using a mono-polar bridge instrument. <FIG> depicts a system <NUM> comprising a grasper <NUM> and a mono-polar bridge instrument <NUM> being used in the same surgical site. In one scenario, now referring to the graph <NUM> in <FIG>, the voltage potential of the grasper <NUM> can be monitored throughout the use of the system <NUM> during an operation. Stage (<NUM>) of the graph <NUM> represents the beginning of articulation of the grasper <NUM> using motorized articulation. Stage (<NUM>) represents a spike in detected voltage potential of the grasper <NUM>. Such a spike in voltage potential can be conducted to the grasper <NUM> by way of the mono-polar bridge instrument <NUM>. At this stage, the system <NUM> can automatically reverse the motor direction Stage (<NUM>) of articulation to move the grasper <NUM> away from the mono-polar bridge instrument <NUM> until the unexpected voltage spike subsides Stage (<NUM>). The control program of the system <NUM> can then instruct the articulation motor to automatically reverse the articulation a predetermined amount passed the point when the system <NUM> no longer detects the voltage spike to ensure that this voltage spike will not occur again due to minor inadvertent movement of either the grasper <NUM> and/or the mono-polar bridge instrument <NUM>.

The surgical instrument can also alert the user when an unexpected voltage potential is detected and await further action by a user of the instrument. If the user is using the instrument that experiences the voltage spike as a mono-polar bridge instrument then the user could inform the instrument of this to continue actuation of the instrument. The instrument can also include an electrical circuit, or ground path, to interrupt the flow of electricity beyond a dedicated position when the instrument experiences an unexpected voltage potential. In at least one instance, the ground path can extend within a flex circuit extending throughout the shaft.

<FIG> illustrates a logic diagram of a process <NUM> depicting a control program for controlling a surgical instrument. The process <NUM> comprises sensing <NUM> an electrical potential applied to the instrument. For example, the voltage of an electrical circuit which includes the instrument can be monitored. The process <NUM> further includes determining <NUM> if the sensed electrical potential is above a predetermined threshold based on the sensed electrical potential. A processor, for example, can monitor the voltage and, if a voltage spike occurs, the processor can change the operation of the surgical instrument. For instance, the process can adjust <NUM> the control motions of the instrument such as reversing a previous motion, for example. If the sensed electrical potential is below the predetermined threshold, the control program can continue <NUM> the normal operation of the instrument.

In various embodiments, surgical suturing instruments can include means for detecting the tension of the suture during the suturing procedure. This can be achieved by monitoring the force required to advance a needle through its firing stroke. Monitoring the force required to pull the suturing material through tissue can indicate stitch tightness and/or suture tension. Pulling the suturing material too tight during, for example, tying a knot can cause the suturing material to break. The instrument can use the detected forces to communicate stitch tightness to the user during a suturing procedure and let the user know that the stitch is approaching its failure tightness or, on the other hand, is not tight enough to create a sufficient stitch. The communicated stitch tightness can be shown to a user during a suturing procedure in an effort to improve the stitch tightness throughout the procedure.

In various embodiments, a surgical suturing instrument comprises a method for detecting load within the end effector, or head, of the instrument, and a control program to monitor this information and automatically modify, and/or adjust, the operation of the instrument. In one instance, a needle holder and/or a needle drive can comprise a strain gauge mounted thereon to monitor the force and stress being experienced by the needle during its firing stroke. A processor of the instrument can monitor the strain sensed by the strain gauge by monitoring the voltage reading that the strain gauge provides and, if the force detected is above a predetermined threshold, the processor can slow the needle and/or alert a user of the instrument that the needle is experiencing a force greater than a certain threshold. Other parameters, such as needle velocity and/or acceleration, for example, can be monitored and used to modify the operation of the surgical instrument.

Many different forces experienced by a surgical suturing instrument can be monitored throughout a suturing procedure to improve efficiency of the operation. <FIG> depicts a surgical suturing instrument <NUM> comprising a shaft <NUM>, an end effector <NUM>, and an articulation joint <NUM> attaching the end effector <NUM> to the shaft <NUM> and permitting articulation of the end effector <NUM> relative to the shaft <NUM>. The end effector <NUM> comprises a frame <NUM> and a suture cartridge <NUM>. The cartridge <NUM> comprises a needle <NUM> comprising suturing material <NUM> attached thereto configured to pass through tissue T.

Various parameters of the instrument <NUM> can be monitored during a surgical suturing procedure. The force, or load, experienced by the needle <NUM> can be monitored, the torque load that resists distal head rotation of the end effector <NUM> can be monitored, and/or the bending load of the shaft <NUM> that can cause drive systems within the shaft to bind up can be monitored. The monitoring of these parameters is illustrated in the graph <NUM> in <FIG>. The surgical instrument <NUM> is configured to limit corresponding motor current if certain thresholds of the parameters are exceeded. The force experienced by the needle <NUM> is represented by the solid plot line in the graph <NUM>. This force can directly correspond to the current drawn by the motor that fires the needle <NUM>. As the load on the needle <NUM> increases, the motor that is firing the needle slows down thereby reducing the load on the needle and reducing current through the motor. If this force, or current, exceeds a certain pre-determined threshold, the power applied to the needle firing motor can be limited to prevent possible failure of drive system components and/or driving a needle through an unintended target. This limiting event is labeled (<NUM>) in the reaction graph <NUM>. The torque load experienced by the end effector <NUM> is represented by the dashed plot in the graph <NUM>. This torque load can be a result of trying to rotate the end effector <NUM> while the suturing material <NUM> is still connected to tissue T and the needle <NUM>. This torque load can directly correspond to the current of the motor that rotates the end effector <NUM>. If this torque load, or current, exceeds a certain pre-determined threshold, power to the motor that rotates the end effector <NUM> can be limited. This limiting event is labeled (<NUM>) in the reaction graph <NUM>. The bending load experienced by the shaft <NUM> is represented by the dash-dot plot in the graph <NUM> and can be sensed by using a strain gauge placed on the shaft <NUM>, for example. If this bending load exceeds a certain pre-determined threshold, power to the motor that rotates the end effector <NUM> can be limited and reduced. This limiting event is labeled (<NUM>) in the reaction graph <NUM>.

<FIG> illustrates a logic diagram of a process <NUM> depicting a control program for controlling a surgical suturing instrument. The process <NUM> comprises monitoring <NUM> one or more detectable parameters of the surgical suturing instrument. For example, the force experienced by the suturing needle, the torque load experienced by the shaft of the instrument, and/or the torque load experienced by the end effector of the instrument can be monitored. In fact, any combination of detectable parameters can be monitored. The process <NUM> further includes determining <NUM> if the detected parameters warrant a change in the operation of the instrument. For example, if the shaft is experiencing a torque load that is greater than a predetermined threshold, the control program can adjust <NUM> the control motions applied to the end effector, such as stopping the actuation of the instrument, until the torque experienced by the shaft falls below the predetermined threshold. If all of the detected parameters are within operational conditions, the control program can continue <NUM> the normal operation of the instrument.

Another system for detecting and/or monitoring the location of the suturing needle during its firing stroke can include utilizing one or more magnets and Hall Effect sensors. In such an embodiment, a permanent magnet can be placed within and/or on the needle and a Hall Effect sensor can be placed within, or adjacent to, the needle track, for example. In such an instance, movement of the needle will cause the magnet to move into, within, and/or out of the field created by the Hall Effect sensor thereby providing a way to detect the location of the needle. In the same embodiment, and/or in another embodiment, a magnet can be placed on one side of the needle track and a corresponding Hall Effect sensor can be placed on the other side of the needle track. In such an embodiment, the needle itself can interrupt the magnetic field between the magnet and the Hall Effect sensor as the needle passes between the two magnets, thereby providing a way to detect the location of the needle.

<FIG> and <FIG> depict a surgical suturing end effector assembly <NUM> configured to suture the tissue of a patient during a surgical suturing procedure. The end effector assembly <NUM> comprises a shaft <NUM> and an end effector <NUM> extending distally from the shaft <NUM>. The end effector <NUM> comprises a first jaw <NUM> and a second jaw <NUM> configured to receive a replaceable suturing cartridge <NUM> therein. The suturing cartridge <NUM> comprises a needle <NUM> and suture material <NUM> attached thereto configured to be driven through a needle firing stroke and guided by a needle track <NUM> in the suturing cartridge <NUM>.

The surgical suturing end effector assembly <NUM> further comprises a needle sensing system comprising a magnet <NUM> and a Hall Effect sensor <NUM>. The magnet <NUM> and Hall Effect sensor <NUM> are positioned within the suturing cartridge <NUM> such that the needle <NUM> is configured to interrupt the magnetic field between the magnet <NUM> and the Hall Effect sensor <NUM>. Such an interruption can indicate to a control program the position of the needle <NUM> relative to the suturing cartridge <NUM> and/or within its firing stroke. The sensor and magnet may be embedded within the cartridge and/or placed adjacent the needle track such as, for example, on top of, on bottom of, and/or on the sides of the needle track.

<FIG> depicts a needle sensing system <NUM> positioned within a suturing cartridge <NUM>. The suturing cartridge <NUM> comprises a needle <NUM> and a needle track <NUM> configured to guide the needle <NUM> through a needle firing stroke. The needle sensing system <NUM> comprises a magnet <NUM> and a Hall Effect sensor <NUM> positioned above and below, respectively, the needle track <NUM>. The Hall Effect sensor <NUM> and the magnet <NUM> are configured to indicate the position of the needle to a control circuit as the needle interrupts the magnetic field between the Hall Effect sensor <NUM> and the magnet <NUM>. Such an arrangement can provide a more localized needle position detection system. In at least one embodiment, a suturing cartridge can contain more than one Hall Effect sensor and magnet arranged in this manner to provide multiple detection locations along the needle track. That said, any suitable sensor arrangement can be used. A control program can determine the position of the needle based on the sensor reading(s) of the Hall Effect sensor(s). A control program of the surgical instrument can adjust control motions applied to the surgical suturing instrument based on the readings from the Hall Effect sensor(s). For example, if the needle is detected to be moving slower than preferred during a firing stroke based on the time it takes for the needle to trip consecutive sensors, the control program can increase the speed of the motor driving the needle through its firing stroke. Also, for example, the control program can compensate for a lag in the position of the needle during its stroke. In at least one instance, the electrical motor of the needle firing drive can be left on for a few additional rotations to reposition the needle in its stroke.

Another system for detecting and/or monitoring the location of the suturing needle during its firing stroke can include utilizing one or more proximity sensors near the needle and/or the needle driver. As discussed above, the needle driver is configured to drive the needle out of its needle track and back into the other side of the needle track, release the needle, and return to its original position to grab the needle on the other side of the track to prepare for a second half of a firing stroke. The proximity sensor(s) can be used to monitor the location of the needle and/or the needle driver. In an instance where multiple proximity sensors are used, a first proximity sensor can be used near the entry point on the needle track and a second proximity sensor can be used near the exit point on the needle track, for example.

<FIG> depicts a needle sensing system <NUM> positioned within a suturing cartridge <NUM>. The suturing cartridge <NUM> comprises a needle <NUM> and a needle track <NUM> configured to guide the needle <NUM> through a needle firing stroke. The needle sensing system <NUM> comprises a plurality of proximity sensors <NUM> positioned within the needle track <NUM>. In at least one embodiment, the sensors <NUM> are molded into a sidewall <NUM> of the needle track <NUM>. In the same embodiment and/or another embodiment, the sensors <NUM> are molded into a top, or bottom, surface <NUM> of the needle track <NUM>. Any suitable location within the end effector assembly can be used. The sensor information can be used to determine the location of the needle <NUM> which can then be used to modify the operation of the surgical instrument if appropriate.

In at least one embodiment, a plurality of proximity sensors can be used within the end effector of a suturing device to determine if a needle of the suturing device has been de-tracked or fallen out of its track. To achieve this, an array of proximity sensors can be provided such that the needle contacts at least two sensors at all times during its firing stroke. If a control program determines that only one sensor is contacted based on the data from the proximity sensors, the control system can then determine that the needle has been de-tracked and modify the operation of the drive system accordingly.

<FIG> depicts a needle sensing system <NUM> positioned within a suturing cartridge <NUM>. The suturing cartridge <NUM> comprises a needle <NUM> and a needle track <NUM> configured to guide the needle <NUM> through a needle firing stroke. The needle sensing system <NUM> comprises a plurality of conductive sensors <NUM> positioned within the needle track <NUM>. In one embodiment, the sensors <NUM> are positioned adjacent a sidewall <NUM> of the needle track <NUM> such that the needle <NUM> may progressively contact the sensors <NUM> as the needle <NUM> progresses through a needle firing stroke. In the same embodiment and/or another embodiment, the sensors <NUM> are positioned adjacent a top, or bottom, surface <NUM> of the needle track <NUM>. Any suitable location within the end effector assembly can be used. The sensor information can be used to determine the location of the needle <NUM> which can then be used to modify the operation of the surgical instrument if appropriate.

Another system for detecting and/or monitoring the location of the suturing needle during its firing stroke can include placing a circuit in communication with the needle track. For example, a conductive supply leg can be wired in contact with one side of the needle track and a conductive return leg can be wired in contact with the other side of the needle track. Thus, as the needle passes by the circuit, the needle can act as a circuit switch and complete the circuit to lower the resistance within the circuit thereby providing a way to detect and/or monitor the location of the needle. Several of these circuits can be placed throughout the needle track. To aid the needle conductivity between the circuit contacts, brushes can be used to cradle the needle as the needle passes the circuit location. A flex circuit can also be used and can be adhered to inner walls of the needle track, for example. The flex circuit can contain multiple contacts, and/or terminals. In at least one instance, the contacts can be molded directly into the walls. In another instance, the contacts of the flex circuit can be folded over an inner wall of the needle track and stuck to the wall with an adhesive, for example, such that the contacts face the needle path. In yet another instance, both of these mounting options can be employed.

Another system for detecting and/or monitoring the location of the suturing needle during its firing stroke can include one or more inductive sensors. Such sensors can detect the needle and/or the needle grabber, or driver.

Another system for detecting and/or monitoring the location of the suturing needle during its firing stroke can include using a light source and a photodetector which are positioned such that movement of the needle interrupts the detection of the light source by the photodetector. A light source can be positioned within, and/or near, the needle track, for example, and faced toward the needle path. The photodetector can be positioned opposite the light source such that needle can pass between the light source and the photodetector thereby interrupting the detection of light by the photodetector as the needle passes between the light source and the photodetector. Interruption of the light provided by the light source can indicate the needle's presence or lack thereof. The light source may be an infrared LED emitter, for example. Infrared light may be preferred due to its ability to penetrate tissue and organic debris, especially within a suturing site, which otherwise could produce a false positive reading by the photodetector. That said, any suitable light emitter could be used.

<FIG> depicts a needle sensing system <NUM> positioned within a suturing cartridge <NUM>. The suturing cartridge <NUM> comprises a needle <NUM> and a needle track <NUM> configured to guide the needle <NUM> through a needle firing stroke. The needle sensing system <NUM> comprises a light source <NUM> positioned at an entry point <NUM> of the needle track <NUM> and a photodetector <NUM> positioned at an exit point <NUM> of the needle track <NUM>. When the needle <NUM> is in its home position as illustrated in <FIG>, the light source <NUM> is configured to emit light that spans across the capture opening of the suturing cartridge <NUM> to indicate that the needle <NUM> is in its home position. Once the needle <NUM> interrupts the path between the light source <NUM> and the photodetector <NUM>, a control program can determine that the needle is not in its home position. The location of the needle <NUM> can be determined by a control program based on the interruption of light between the light sources and photodetectors which can then be used to modify the operation of the surgical instrument if appropriate.

<FIG> depicts a needle sensing system <NUM> positioned within a suturing cartridge <NUM>. The suturing cartridge <NUM> comprises a needle <NUM> and a needle track <NUM> configured to guide the needle <NUM> through a needle firing stroke. The needle sensing system <NUM> comprises a light source <NUM> and a photodetector <NUM> positioned at an exit point <NUM> of the needle track <NUM>. The light source <NUM> is configured to emit light that spans across the needle track cavity of the suturing cartridge <NUM> to indicate the position of the needle <NUM>. In another embodiment, another photodetector and light source are positioned at an exit point <NUM> of the needle track <NUM>. In yet another embodiment, an array of photodetectors and light sources are placed along the length of the needle track <NUM>. The location of the needle <NUM> can be determined by a control program based on the interruption of light between the light source <NUM> and the photodetector <NUM>.

In at least one embodiment, a surgical suturing needle can comprise a helical profile to provide helical suturing strokes. Such a needle comprises a length spanning <NUM> degrees where a butt end of the needle and a tip of the needle do not reside in the same plane and define a vertical distance therebetween. This needle can be actuated through a helical, or coil shaped, stroke to over-sew a staple line, for example, providing a three dimensional needle stroke. A needle having the helical shape discussed above provides a three dimensional suturing path.

<FIG> and <FIG> depict a helical suturing needle assembly <NUM> for use with a surgical suturing instrument. The suturing needle assembly <NUM> comprises a tip <NUM>, a proximal end <NUM>, and a helical body portion <NUM> extending therebetween. The helical body portion <NUM> comprises a catch feature <NUM> that a needle driver of a surgical suturing instrument is configured to catch on a return stroke of the driver. The tip <NUM> and the proximal end <NUM> reside in different horizontal planes and comprise a vertical distance therebetween; however, the tip <NUM> and the proximal end <NUM> terminate along a common axis A (<FIG>). The needle assembly <NUM> can be actuated through a helical, or coil shaped, stroke to over-sew a staple line, for example, providing a three dimensional needle stroke.

In various instances, the needle comprises a circular configuration that is less than <NUM> degrees in circumference. In at least one instance, the needle can be stored in the end effector in an orientation which stores the needle within the profile of the end effector. Once the end effector is positioned within the patient, the needle can be rotated out of its stored position to then perform a firing stroke.

In various embodiments, a surgical suturing instrument can accommodate different needle and suture sizes for different suturing procedures. Such an instrument can comprise a means for detecting the size of the needle and/or suture loaded into the instrument. This information can be communicated to the instrument so that the instrument can adjust the control program accordingly. Larger diameter needles may be rotated angularly at a slower rate than smaller diameter needles. Needles with different lengths may also be used with a single instrument. In such instances, a surgical instrument can comprise means for detecting the length of the needle. This information can be communicated to a surgical instrument to modify the needle driver's path, for example. A longer needle may require a smaller stroke path from the needle driver to sufficiently advance the longer needle through its firing stroke as opposed to a smaller needle which may require a longer stroke path from the needle driver to sufficiently advance the shorter needle through its firing stroke in the same needle track.

<FIG> depicts a logic diagram of a process <NUM> depicting a control program for controlling a surgical instrument. The process <NUM> comprises detecting <NUM> the type of suturing cartridge installed within the surgical suturing instrument. In various instances, different suture cartridges may have different suture lengths, needle lengths, needle diameters, and/or suture materials, for example. The type of suture cartridge and/or its characteristics can be communicated to a control circuit by an identification chip positioned within the cartridge such that, when a suture cartridge is installed within a surgical instrument, the control circuit can identify what type of cartridge has been installed and assess the characteristics of the suture cartridge. In order to accommodate different cartridge types, a control circuit may adjust the control motions that will be applied to the suture cartridge. For example, firing speeds may differ for different sized needles. Another example may include adjusting the range of angular needle rotation based on different needle lengths, or sizes. To accommodate such differences, the process <NUM> implemented by a process, for example, comprises adjusting <NUM> a motor control program of the instrument based on what type of suture cartridge is installed.

In at least one embodiment, a suture needle is stored in a suturing instrument in a folded manner. In at least one such instance, the suture needle comprises two portions which are hingedly connected to one another at a hinge. After the end effector has been passed through the trocar, the suture needle can be unfolded and locked into its unfolded configuration. In at least one instance, a one-way snap feature can be used to rigidly hold the suture needle in its unfolded configuration.

In at least one embodiment, a surgical instrument is configured to apply a suture to the tissue of a patient which comprises a lockout system. The lockout system comprises a locked configuration and an unlocked configuration. The surgical instrument further comprises a control circuit and is configured to identify if a cartridge is installed or not installed within an end effector of the surgical instrument. The control circuit is configured to place the lockout system in the locked condition when a cartridge is not installed in the end effector and place the lockout system in the unlocked condition when a cartridge is installed in the end effector. Such a lockout system can include an electrical sensing circuit of which a cartridge can complete upon installation indicating that a cartridge has been installed. In at least one instance, the actuator comprises an electric motor and the lockout system can prevent power from being supplied to the electric motor. In at least one instance, the actuator comprises a mechanical trigger, and the lockout system blocks the mechanical trigger from being pulled to actuate the suture needle. When the lockout system is in the locked configuration, the lockout system prevents an actuator from being actuated. When the lockout system is in the unlocked configuration, the lockout system permits the actuator to deploy the suture positioned within the cartridge. In one embodiment, the control circuit provides haptic feedback to a user of the surgical instrument when the electrical sensing circuit places the surgical instrument in the locked configuration. In one embodiment, the control circuit prevents the actuation of an electric motor configured to actuate the actuator when the electrical sensing circuit determines that the lockout system is in the locked configuration. In one embodiment, the lockout system is in the unlocked configuration when a cartridge is positioned in the end effector and the cartridge has not been completely expended.

<FIG> and <FIG> depict a handle assembly <NUM> that is operable for use a surgical suturing instrument. The handle assembly <NUM> is connected to a proximal end of a shaft. The handle assembly <NUM> includes a motor <NUM> and a transmission assembly <NUM>. The motor <NUM> is configured to actuate a needle of a surgical suturing end effector by way of a needle driver, articulate the end effector, and rotate the end effector by way of the transmission assembly <NUM>. The transmission assembly <NUM> is shifted between three states by a double acting solenoid, for example, so as to allow the motor <NUM> to be used to actuate a needle of a surgical suturing end effector, articulate the end effector, and/or rotate the end effector. In at least one embodiment, the handle assembly <NUM> could take the form of a robotic interface or a housing comprising gears, pulleys, and/or servomechanisms, for example. Such an arrangement could be used with a robotic surgical system.

<FIG> depicts a suturing cartridge <NUM> comprising a lower body <NUM>, an upper body <NUM>, and a needle cover <NUM>. The cartridge <NUM> further comprises a drive system comprising a needle driver <NUM>, a rotary input <NUM>, and a link <NUM> connecting the needle driver <NUM> and the rotary input <NUM>. The needle driver <NUM>, rotary input <NUM>, and link <NUM> are captured between the lower body <NUM> and the upper body <NUM>. The needle driver <NUM>, the link <NUM>, and the rotary input <NUM> are configured to be actuated to drive a needle <NUM> through a needle firing stroke by way of a motor-driven system, a manually-driven handheld system, and/or a robotic system, for example. The lower and upper bodies <NUM>, <NUM> are attached to one another using any suitable technique, such as, for example, welds, pins, adhesives, and/or the like to form the cartridge body. The needle <NUM> comprises a leading end <NUM> configured to puncture tissue, a trailing end <NUM>, and a length of suture <NUM> extending from and attached to the trailing end <NUM>. The needle <NUM> is configured to rotate in a circular path defined by a needle track <NUM>. The needle track <NUM> is defined in the cartridge body. The needle <NUM> is configured to exit one of a first arm 95393A and a second arm 95393B of the cartridge body and enter the other of the first arm 95393A and the second arm 95393B during a needle firing stroke. Recessed features <NUM> are provided to so that the needle driver <NUM> can engage and drive the needle <NUM> through the needle firing stroke in a ratchet-like motion. The needle <NUM> is positioned between the needle track <NUM> and the needle cover <NUM>. The suturing cartridge <NUM> further comprises a cage <NUM> that is configured to slide over the cartridge body to attach the needle cover <NUM> to the lower body <NUM>.

A surgical system <NUM> is illustrated in <FIG>. The surgical system <NUM> comprises a handle, a shaft <NUM> extending from the handle, and an end effector <NUM> extending from the shaft <NUM>. In alternative embodiments, the surgical system <NUM> comprises a housing configured to be mounted to a robotic surgical system. In at least one such embodiment, the shaft <NUM> extends from the robotic housing mount instead of the handle. In either event, the end effector <NUM> comprises jaws <NUM> and <NUM> which are closeable to grasp a target, such as the tissue T of a patient and/or a suture needle, for example, as discussed in greater detail below. The jaws <NUM> and <NUM> are also openable to dissect the tissue of a patient, for example. In at least one instance, the jaws <NUM> and <NUM> are insertable into the patient tissue to create an otomy therein and then spread to open the otomy, as discussed in greater detail below.

Referring again to <FIG>, the jaws <NUM> and <NUM> are pivotably coupled to the shaft <NUM> about a pivot joint <NUM>. The pivot joint <NUM> defines a fixed axis of rotation, although any suitable arrangement could be used. The jaw <NUM> comprises a distal end, or tip, <NUM> and an elongate profile which narrows from its proximal end to its distal end <NUM>. Similarly, the jaw <NUM> comprises a distal end, or tip, <NUM> and an elongate profile which narrows from its proximal end to its distal end <NUM>. The distance between the tips <NUM> and <NUM> define the mouth width, or opening, <NUM> of the end effector <NUM>. When the tips <NUM> and <NUM> are close to one another, or in contact with one another, the mouth <NUM> is small, or closed, and the mouth angle e is small, or zero. When the tips <NUM> and <NUM> are far apart, the mouth <NUM> is large and the mouth angle e is large.

Further to the above, the jaws of the end effector <NUM> are driven by a jaw drive system including an electric motor. In use, a voltage potential is applied to the electric motor to rotate the drive shaft of the electric motor and drive the jaw drive system. The surgical system <NUM> comprises a motor control system configured to apply the voltage potential to the electric motor. In at least one instance, the motor control system is configured to apply a constant DC voltage potential to the electric motor. In such instances, the electric motor will run at a constant speed, or an at least substantially constant speed. In various instances, the motor control system comprises a pulse width modulation (PWM) circuit and/or a frequency modulation (FM) circuit which can apply voltage pulses to the electric motor. The PWM and/or FM circuits can control the speed of the electric motor by controlling the frequency of the voltage pulses supplied to the electric motor, the duration of the voltage pulses supplied to the electric motor, and/or the duration between the voltage pulses supplied to the electric motor.

The motor control system is also configured to monitor the current drawn by the electric motor as a means for monitoring the force being applied by the jaws of the end effector <NUM>. When the current being drawn by the electric motor is low, the loading force on the jaws is low. Correspondingly, the loading force on the jaws is high when the current being drawn by the electric motor is high. In various instances, the voltage being applied to the electric motor is fixed, or held constant, and the motor current is permitted to fluctuate as a function of the force loading at the jaws. In certain instances, the motor control system is configured to limit the current drawn by the electric motor to limit the force that can be applied by the jaws. In at least one embodiment, the motor control system can include a current regulation circuit that holds constant, or at least substantially constant, the current drawn by the electric motor to maintain a constant loading force at the jaws.

The force generated between the jaws of the end effector <NUM>, and/or on the jaws of the end effector <NUM>, may be different depending on the task that the jaws are being used to perform. For instance, the force needed to hold a suture needle may be high as suture needles are typically small and it is possible that a suture needle may slip during use. As such, the jaws of the end effector <NUM> are often used to generate large forces when the jaws are close together. On the other hand, the jaws of the end effector <NUM> are often used to apply smaller forces when the jaws are positioned further apart to perform larger, or gross, tissue manipulation, for example.

Referring to the upper portion <NUM> of the graph <NUM> illustrated in <FIG>, the loading force, f, experienced by the jaws of the end effector <NUM> can be limited by a force profile stored in the motor control system. The force limit profile 128110o for opening the jaws <NUM> and <NUM> is different than the force limit profile 128110c for closing the jaws <NUM> and <NUM>. This is because the procedures performed when forcing the jaws <NUM> and <NUM> open are typically different than the procedures performed when forcing the jaws <NUM> and <NUM> closed. That said, the opening and closing force limit profiles could be the same. While it is likely that the jaws <NUM> and <NUM> will experience some force loading regardless of whether the jaws <NUM> are being opened or closed, the force limit profiles typically come into play when the jaws <NUM> and <NUM> are being used to perform a particular procedure within the patient. For instance, the jaws <NUM> and <NUM> are forced open to create and expand an otomy in the tissue of a patient, as represented by graph sections <NUM> and <NUM>, respectively, of graph <NUM>, while the jaws <NUM> and <NUM> are forced closed to grasp a needle and/or the patient tissue, as represented by graph sections <NUM> and <NUM>, respectively, of graph <NUM>.

Referring again to <FIG>, the opening and closing jaw force limit profiles 128110o and 128110c, respectively, are depicted on the opposite sides of a zero force line depicted in the graph <NUM>. As can be seen in the upper section <NUM> of graph <NUM>, the jaw force limit threshold is higher - for both force limit profiles 128110o and 128110c - when the jaws <NUM> and <NUM> are just being opened from their fully-closed position. As can also be seen in the upper section <NUM> of graph <NUM>, the jaw force limit threshold is lower - for both force limit profiles 128110o and 128110c - when the jaws <NUM> and <NUM> are reaching their fully-opened position. Such an arrangement can reduce the possibility of the jaws <NUM> and <NUM> damaging adjacent tissue when the being fully opened, for example. In any event, the force that the jaws <NUM> and <NUM> are allowed to apply is a function of the mouth opening size between the jaws and/or the direction in which the jaws are being moved. For instance, when the jaws <NUM> and <NUM> are opened widely, or at their maximum, to grasp large objects, referring to graph section <NUM> of upper graph section <NUM>, the jaw force f limit is very low as compared to when the jaws <NUM> and <NUM> are more closed to perform gross tissue manipulation, referring to graph section <NUM> of upper graph section <NUM>. Moreover, different jaw force limit profiles can be used for different jaw configurations. For instance, Maryland dissectors, which have narrow and pointy jaws, may have a different jaw force limit profile than a grasper having blunt jaws, for example.

In addition to or in lieu of the above, the speed of the jaws <NUM> and <NUM> can be controlled and/or limited by the motor control system as a function of the mouth opening size between the jaws <NUM> and <NUM> and/or the direction the jaws are being moved. Referring to the middle portion <NUM> and lower portion <NUM> of the graph <NUM> in <FIG>, the rate limit profile for moving the jaws <NUM> and <NUM> permits the jaws to be moved slowly when the jaws are near their closed position and moved quickly when the jaws are near their open position. In such instances, the jaws <NUM> and <NUM> are accelerated as the jaws are opened. Such an arrangement can provide fine control over the jaws <NUM> and <NUM> when they are close together to facilitate the fine dissection of tissue, for example. Notably, the rate limit profile for opening and closing the jaws <NUM> and <NUM> is the same, but they could be different in other embodiments. In alternative embodiments, the rate limit profile for moving the jaws <NUM> and <NUM> permits the jaws to be moved quickly when the jaws are near their closed position and slowly when the jaws are near their open position. In such instances, the jaws <NUM> and <NUM> are decelerated as the jaws are opened. Such an arrangement can provide fine control over the jaws <NUM> and <NUM> when the jaws are being used to stretch an otomy, for example. The above being said, the speed of the jaws <NUM> and <NUM> can be adjusted once the jaws experience loading resistance from the patient tissue, for example. In at least one such instance, the jaw opening rate and/or the jaw closing rate can be reduced once the jaws <NUM> and <NUM> begin to experience force resistance above a threshold, for example.

In various instances, further to the above, the handle of the surgical system <NUM> comprises an actuator, the motion of which tracks, or is supposed to track, the motion of the jaws <NUM> and <NUM> of the end effector <NUM>. For instance, the actuator can comprise a scissors-grip configuration which is openable and closable to mimic the opening and closing of the end effector jaws <NUM> and <NUM>. The control system of the surgical system <NUM> can comprise one or more sensor systems configured to monitor the state of the end effector jaws <NUM> and <NUM> and the state of the handle actuator and, if there is a discrepancy between the two states, the control system can take a corrective action once the discrepancy exceeds a threshold and/or threshold range. In at least one instance, the control system can provide feedback, such as audio, tactile, and/or haptic feedback, for example, to the clinician that the discrepancy exists and/or provide the degree of discrepancy to the clinician. In such instances, the clinician can make mental compensations for this discrepancy. In addition to or in lieu of the above, the control system can adapt its control program of the jaws <NUM> and <NUM> to match the motion of the actuator. In at least one instance, the control system can monitor the loading force being applied to the jaws and align the closed position of the actuator with the position of the jaws when the jaws experience the peak force loading condition when grasping tissue. Similarly, the control system can align the open position of the actuator with the position of the jaws when the jaws experience the minimum force loading condition when grasping tissue. In various instances, the control system is configured to provide the clinician with a control to override these adjustments and allow the clinician to use their own discretion in using the surgical system <NUM> in an appropriate manner.

A surgical system <NUM> is illustrated in <FIG>. The surgical system <NUM> comprises a handle, a shaft assembly <NUM> extending from the handle, and an end effector <NUM> extending from the shaft assembly <NUM>. In alternative embodiments, the surgical system <NUM> comprises a housing configured to be mounted to a robotic surgical system. In at least one such embodiment, the shaft <NUM> extends from the robotic housing mount instead of the handle. In either event, the end effector <NUM> comprises shears configured to transect the tissue of a patient. The shears comprise two jaws <NUM> and <NUM> configured to transect the patient tissue positioned between the jaws <NUM> and <NUM> as the jaws <NUM> and <NUM> are being closed. Each of the jaws <NUM> and <NUM> comprises a sharp edge configured to cut the tissue and are pivotably mounted to the shaft <NUM> about a pivot joint <NUM>. Such an arrangement can comprise bypassing scissors shears. Other embodiments are envisioned in which one of the jaws <NUM> and <NUM> comprises a knife edge and the other comprises a mandrel against the tissue is supported and transected. Such an arrangement can comprise a knife wedge in which the knife wedge is moved toward the mandrel. In at least one embodiment, the jaw comprising the knife edge is movable and the jaw comprising the mandrel is stationary. The above being said, embodiments are envisioned in which the tissue-engaging edges of one or both of the jaws <NUM> and <NUM> are not necessarily sharp.

As discussed above, the end effector <NUM> comprises two scissor jaws <NUM> and <NUM> movable between an open position and a closed position to cut the tissue of a patient. The jaw <NUM> comprises a sharp distal end <NUM> and the jaw <NUM> comprises a sharp distal end <NUM> which are configured to snip the tissue of the patient at the mouth <NUM> of the end effector <NUM>, for example. That said, other embodiments are envisioned in which the distal ends <NUM> and <NUM> are blunt and can be used to dissect tissue, for example. In any event, the jaws are driven by a jaw drive system including an electric drive motor, the speed of which is adjustable to adjust the closure rate and/or opening rate of the jaws. Referring to the graph <NUM> of <FIG>, the control system of the surgical system is configured to monitor the loading, or shear, force on the jaws <NUM> and <NUM> as the jaws <NUM> and <NUM> are being closed and adaptively slow down the drive motor when large forces, or forces above a threshold Fc, are experienced by the jaws <NUM> and <NUM>. Such large forces often occur when the tissue T being cut by the jaws <NUM> and <NUM> is thick, for example. Similar to the above, the control system can monitor the current drawn by the drive motor as a proxy for the loading force being experienced by the jaws <NUM> and <NUM>. In addition to or in lieu of this approach, the control system can be configured to measure the jaw loading force directly by one or more load cells and/or strain gauges, for example. Once the loading force experienced by the jaws <NUM> and <NUM> drops below the force threshold Fc, the control system can adaptively speed up the jaw closure rate. Alternatively, the control system can maintain the lower closure rate of the jaws <NUM> and <NUM> even though the force threshold is no longer being exceeded.

The above-provided discussion with respect to the surgical system <NUM> can provide mechanical energy or a mechanical cutting force to the tissue of a patient. That said, the surgical system <NUM> is also configured to provide electrosurgical energy or an electrosurgical cutting force to the tissue of a patient. In various instances, the electrosurgical energy comprises RF energy, for example; however, electrosurgical energy could be supplied to the patient tissue at any suitable frequency. In addition to or in lieu of AC power, the surgical system <NUM> can be configured to supply DC power to the patient tissue. The surgical system <NUM> comprises a generator in electrical communication with one or more electrical pathways defined in the instrument shaft <NUM> which can supply electrical power to the jaws <NUM> and <NUM> and also provide a return path for the current. In at least one instance, the jaw <NUM> comprises an electrode <NUM> in electrical communication with a first electrical pathway in the shaft <NUM> and the jaw <NUM> comprises an electrode <NUM> in electrical communication with a second electrical pathway in the shaft <NUM>. The first and second electrical pathways are electrically insulated, or at least substantially insulated, from one another and the surrounding shaft structure such that the first and second electrical pathways, the electrodes <NUM> and <NUM>, and the tissue positioned between the electrodes <NUM> and <NUM> forms a circuit. Such an arrangement provides a bipolar arrangement between the electrodes <NUM> and <NUM>. That said, embodiments are envisioned in which a monopolar arrangement could be used. In such an arrangement, the return path for the current goes through the patient and into a return electrode positioned on or under the patient, for example.

As discussed above, the tissue of a patient can be cut by using a mechanical force and/or an electrical force. Such mechanical and electrical forces can be applied simultaneously and/or sequentially. For instance, both forces can be applied at the beginning of a tissue cutting actuation and then the mechanical force can be discontinued in favor of the electrosurgical force finishing the tissue cutting actuation. Such an approach can apply an energy-created hemostatic seal to the tissue after the mechanical cutting has been completed. In such arrangements, the electrosurgical force is applied throughout the duration of the tissue cutting actuation. In other instances, the mechanical cutting force, without the electrosurgical cutting force, can be used to start a tissue cutting actuation which is then followed by the electrosurgical cutting force after the mechanical cutting force has been stopped. In such arrangements, the mechanical and electrosurgical forces are not overlapping or co-extensive. In various instances, both the mechanical and electrosurgical forces are overlapping and co-extensive throughout the entire tissue cutting actuation. In at least one instance, both forces are overlapping and co-extensive throughout the entire tissue cutting actuation but in magnitudes or intensities that change during the tissue cutting actuation. The above being said, any suitable combination, pattern, and/or sequence of mechanical and electrosurgical cutting forces and energies could be used.

Further to the above, the surgical system <NUM> comprises a control system configured to co-ordinate the application of the mechanical force and electrosurgical energy to the patient tissue. In various instances, the control system is in communication with the motor controller which drives the jaws <NUM> and <NUM> and, also, the electrical generator and comprises one or more sensing systems for monitoring the mechanical force and electrosurgical energy being applied to the tissue. Systems for monitoring the forces within a mechanical drive system are disclosed elsewhere herein. Systems for monitoring the electrosurgical energy being applied to the patient tissue include monitoring the impedance, or changes in the impedance, of the patient tissue via the electrical pathways of the electrosurgical circuit. In at least one instance, referring to the graph <NUM> in <FIG>, the RF current/voltage ratio of the electrosurgical power being applied to the patient tissue by the generator is evaluated by monitoring the current and voltage of the power being supplied by the generator. The impedance of the tissue and the RF current/voltage ratio of the electrosurgical power are a function of many variables such as the temperature of the tissue, the density of the tissue, the thickness of the tissue, the type of tissue between the jaws <NUM> and <NUM>, the duration in which the power is applied to the tissue, among others, which change throughout the application of the electrosurgical energy.

Further to the above, the control system and/or generator of the surgical system <NUM> comprises one or more ammeter circuits and/or voltmeter circuits configured to monitor the electrosurgical current and/or voltage, respectively, being applied to the patient tissue. Referring again to <FIG>, a minimum amplitude limit and/or a maximum amplitude limit on the current being applied to the patient tissue can be preset in the control system and/or can be controllable by the user of the surgical instrument system through one or more input controls. The minimum and maximum amplitude limits can define a current envelope within which the electrosurgical portion of the surgical system <NUM> is operated.

In various instances, the control system of the surgical system <NUM> is configured to adaptively increase the electrosurgical energy applied to the patient tissue when the drive motor slows. The motor slowing can be a reaction to an increase in the tissue cutting load and/or an adaptation of the control system. Similarly, the control system of the surgical system <NUM> is configured to adaptively increase the electrosurgical energy applied to the patient tissue when the drive motor stops. Again, the motor stopping can be a reaction to an increase in the tissue cutting load and/or an adaptation of the control system. Increasing the electrosurgical energy when the electric motor slows and/or stops can compensate for a reduction in mechanical cutting energy. In alternative embodiments, the electrosurgical energy can be reduced and/or stopped when the electric motor slows and/or stops. Such embodiments can afford the clinician to evaluate the situation in a low-energy environment.

In various instances, the control system of the surgical system <NUM> is configured to adaptively decrease the electrosurgical energy applied to the patient tissue when the drive motor speeds up. The motor speeding up can be a reaction to a decrease in the cutting load and/or an adaptation of the control system. Decreasing the electrosurgical energy when the electric motor slows and/or stops can compensate for, or balance out, an increase in mechanical cutting energy. In alternative embodiments, the electrosurgical energy can be increased when the electric motor speeds up. Such embodiments can accelerate the closure of the jaws and provide a clean, quick cutting motion.

In various instances, the control system of the surgical system <NUM> is configured to adaptively increase the speed of the drive motor when the electrosurgical energy applied to the patient tissue decreases. The electrosurgical energy decreasing can be a reaction to a change in tissue properties and/or an adaptation of the control system. Similarly, the control system of the surgical system <NUM> is configured to adaptively increase the speed of the drive motor when electrosurgical energy applied to the patient tissue stops in response to an adaptation of the control system. Increasing the speed of the drive motor when the electrosurgical energy decreases or is stopped can compensate for a reduction in electrosurgical cutting energy. In alternative embodiments, the speed of the drive motor can be reduced and/or stopped when the electrosurgical energy decreases and/or is stopped. Such embodiments can afford the clinician to evaluate the situation in a low-energy and/or static environment.

In various instances, the control system of the surgical system <NUM> is configured to adaptively decrease the speed of the electric motor when the electrosurgical energy applied to the patient tissue increases. The electrosurgical energy increasing can be a reaction to a change in tissue properties and/or an adaptation of the control system. Decreasing the drive motor speed when the electrosurgical energy increases can compensate for, or balance out, an increase in electrosurgical cutting energy. In alternative embodiments, the drive motor speed can be increased when the electrosurgical energy increases. Such embodiments can accelerate the closure of the jaws and provide a clean, quick cutting motion.

In various instances, the surgical system <NUM> comprises controls, such as on the handle of the surgical system <NUM>, for example, that a clinician can use to control when the mechanical and/or electrosurgical forces are applied. In addition to or in lieu of manual controls, the control system of the surgical system <NUM> is configured to monitor the mechanical force and electrical energy being applied to the tissue and adjust one or the other, if needed, to cut the tissue in a desirable manner according to one or more predetermined force-energy curves and/or matrices. In at least one instance, the control system can increase the electrical energy being delivered to the tissue once the mechanical force being applied reaches a threshold limit. Moreover, the control system is configured to consider other parameters, such as the impedance of the tissue being cut, when making adjustments to the mechanical force and/or electrical energy being applied to the tissue.

<FIG> is a logic diagram of a control system <NUM> for use with any of the various suturing instruments described herein. The control system <NUM> comprises a control circuit. The control circuit includes a microcontroller <NUM> comprising a processor <NUM> and a memory <NUM>. One or more sensors, such as sensor <NUM>, sensor <NUM>, sensor <NUM>, and sensor array <NUM>, for example, provide real time feedback to the processor <NUM>. The control system <NUM> further comprises a motor driver <NUM> configured to control an electric motor <NUM> and a tracking system <NUM> configured to determine the position of one or more movable components in the suturing instruments, such as a needle, needle drive system, suture, and/or suture spool, for example. The tracking system <NUM> provides position information to the processor <NUM>, which can be programmed or configured to, among other things, determine the position of the suture needle, for example. The motor driver <NUM> may be an A3941 available from Allegro Microsystems, Inc. , for example; however, other motor drivers may be readily substituted for use in the tracking system <NUM>. A detailed description of an absolute positioning system is described in <CIT>, entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT.

The microcontroller <NUM> may be any single core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments, for example. In at least one instance, the microcontroller <NUM> is a LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas Instruments, for example, comprising on-chip memory of <NUM> KB single-cycle flash memory, or other non-volatile memory, up to <NUM>, a prefetch buffer to improve performance above <NUM>, a <NUM> KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, <NUM> KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules and/or frequency modulation (FM) modules, one or more quadrature encoder inputs (QEI) analog, one or more <NUM>-bit Analog-to-Digital Converters (ADC) with <NUM> analog input channels, for example, details of which are available from the product datasheet.

In various instances, the microcontroller <NUM> comprises a safety controller comprising two controller-based families such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller may be configured specifically for IEC <NUM> and ISO <NUM> safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

The microcontroller <NUM> is programmed to perform various functions such as precisely controlling the speed and/or position of the suture needle, for example. The microcontroller <NUM> is also programmed to precisely control the rotational speed and position of the end effector of the suturing instrument and the articulation speed and position of the end effector of the suturing instrument. In various instances, the microcontroller <NUM> computes a response in the software of the microcontroller <NUM>. The computed response is compared to a measured response of the actual system to obtain an "observed" response, which is used for actual feedback decisions. The observed response is a favorable, tuned, value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect outside influences on the system.

The motor <NUM> is controlled by the motor driver <NUM>. In various forms, the motor <NUM> is a DC brushed driving motor having a maximum rotational speed of approximately <NUM>,<NUM> RPM, for example. In other arrangements, the motor <NUM> includes a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver <NUM> may comprise an H-bridge driver comprising field-effect transistors (FETs), for example. The motor driver <NUM> may be an A3941 available from Allegro Microsystems, Inc. , for example. The A3941 motor driver <NUM> is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads, such as brush DC motors. In various instances, the motor driver <NUM> comprises a unique charge pump regulator provides full (><NUM> V) gate drive for battery voltages down to <NUM> V and allows the A3941 motor driver <NUM> to operate with a reduced gate drive, down to <NUM> V. A bootstrap capacitor may be employed to provide the above-battery supply voltage required for N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (<NUM>% duty cycle) operation. The full bridge can be driven in fast or slow decay modes using diode or synchronous rectification. In the slow decay mode, current recirculation can be through the high-side or the lowside FETs. The power FETs are protected from shoot-through by resistor adjustable dead time. Integrated diagnostics provide indication of undervoltage, overtemperature, and power bridge faults, and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers may be readily substituted.

The tracking system <NUM> comprises a controlled motor drive circuit arrangement comprising one or more position sensors, such as the sensor <NUM>, sensor <NUM>, sensor <NUM>, and sensory array <NUM>, for example. The position sensors for an absolute positioning system provide a unique position signal corresponding to the location of a displacement member. As used herein, the term displacement member is used generically to refer to any movable member of any of the surgical instruments disclosed herein. In various instances, the displacement member may be coupled to any position sensor suitable for measuring linear displacement or rotational displacement. Linear displacement sensors may include contact or non-contact displacement sensors. The displacement sensors may comprise linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall Effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall Effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photo diodes or photo detectors, or an optical sensing system comprising a fixed light source and a series of movable linearly arranged photo diodes or photo detectors, or any combination thereof.

The position sensors <NUM>, <NUM>, <NUM>, and <NUM> for example, may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field. The techniques used to produce both types of magnetic sensors encompass many aspects of physics and electronics. The technologies used for magnetic field sensing include search coil, fluxgate, optically pumped, nuclear precession, SQUID, Hall-Effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive/piezoelectric composites, magnetodiode, magnetotransistor, fiber optic, magnetooptic, and microelectromechanical systems-based magnetic sensors, among others.

In various instances, one or more of the position sensors of the tracking system <NUM> comprise a magnetic rotary absolute positioning system. Such position sensors may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG and can be interfaced with the controller <NUM> to provide an absolute positioning system. In certain instances, a position sensor comprises a low-voltage and low-power component and includes four Hall-Effect elements in an area of the position sensor that is located adjacent a magnet. A high resolution ADC and a smart power management controller are also provided on the chip. A CORDIC processor (for Coordinate Rotation Digital Computer), also known as the digit-by-digit method and Volder's algorithm, is provided to implement a simple and efficient algorithm to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations. The angle position, alarm bits, and magnetic field information are transmitted over a standard serial communication interface such as an SPI interface to the controller <NUM>. The position sensors can provide <NUM> or <NUM> bits of resolution, for example. The position sensors can be an AS5055 chip provided in a small QFN <NUM>-pin 4x4x0. <NUM> package, for example.

The tracking system <NUM> may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power source converts the signal from the feedback controller into a physical input to the system, in this case voltage. Other examples include pulse width modulation (PWM) and/or frequency modulation (FM) of the voltage, current, and force. Other sensor(s) may be provided to measure physical parameters of the physical system in addition to position. In various instances, the other sensor(s) can include sensor arrangements such as those described in <CIT>, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM; <CIT>, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM; and <CIT>, entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT. In a digital signal processing system, absolute positioning system is coupled to a digital data acquisition system where the output of the absolute positioning system will have finite resolution and sampling frequency. The absolute positioning system may comprise a compare and combine circuit to combine a computed response with a measured response using algorithms such as weighted average and theoretical control loop that drives the computed response towards the measured response. The computed response of the physical system takes into account properties like mass, inertial, viscous friction, inductance resistance, etc., to predict what the states and outputs of the physical system will be by knowing the input.

The absolute positioning system provides an absolute position of the displacement member upon power up of the instrument without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor <NUM> has taken to infer the position of a device actuator, the needle driver, and the like.

A sensor <NUM> and/or <NUM> comprising a strain gauge or a micro-strain gauge, for example, is configured to measure one or more parameters of the end effector of the suturing instrument, such as, for example, the strain experienced by the needle during a suturing operation. The measured strain is converted to a digital signal and provided to the processor <NUM>. A sensor <NUM> comprising a load sensor, for example, can measure another force applied by the suturing instrument. In various instances, a current sensor <NUM> can be employed to measure the current drawn by the motor <NUM>. The force required to throw, or rotate, the suturing needle can correspond to the current drawn by the motor <NUM>, for example. The measured force is converted to a digital signal and provided to the processor <NUM>. A magnetic field sensor can be employed to measure the thickness of the captured tissue. The measurement of the magnetic field sensor can also be converted to a digital signal and provided to the processor <NUM>.

The measurements of the tissue thickness and/or the force required to rotate the needle through tissue as measured by the sensors can be used by the controller <NUM> to characterize the position and/or speed of the movable member being tracked. In at least one instance, the memory <NUM> may store a technique, an equation, and/or a look-up table which can be employed by the controller <NUM> in the assessment. In various instances, the controller <NUM> can provide the user of the suturing instrument with a choice as to the manner in which the suturing instrument should be operated. To this end, a display <NUM> can display a variety of operating conditions of the suturing instrument and can include touch screen functionality for data input. Moreover, information displayed on the display <NUM> may be overlaid with images acquired via the imaging modules of one or more endoscopes and/or one or more additional surgical instruments used during the surgical procedure.

As discussed above, the suturing instruments disclosed herein may comprise control systems. Each of the control systems can comprise a circuit board having one or more processors and/or memory devices. Among other things, the control systems are configured to store sensor data, for example. They are also configured to store data which identifies the type of suturing instrument attached to a handle or housing. More specifically, the type of suturing instrument can be identified when attached to the handle or housing by the sensors and the sensor data can be stored in the control system. Moreover, they are also configured to store data including whether or not the suturing instrument has been previously used and/or how many times the suture needle has been cycled. This information can be obtained by the control system to assess whether or not the suturing instrument is suitable for use and/or has been used less than a predetermined number of times, for example.

The surgical instrument systems described herein are motivated by an electric motor; however, the surgical instrument systems described herein can be motivated in any suitable manner. In certain instances, the motors disclosed herein may comprise a portion or portions of a robotically controlled system. <CIT>, entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now <CIT>, for example, discloses several examples of a robotic surgical instrument system in greater detail.

The devices, systems, and methods disclosed in the Subject Application can be used with the devices, systems, and methods disclosed in <CIT>, now <CIT>, entitled CIRCULAR NEEDLE APPLIER WITH OFFSET NEEDLE AND CARRIER TRACKS; <CIT>, now <CIT>, entitled SURGICAL NEEDLE WITH RECESSED FEATURES; and <CIT>, now <CIT>, entitled SUTURING INSTRUMENT WITH MOTORIZED NEEDLE DRIVE.

The devices, systems, and methods disclosed in the Subject Application can also be used with the devices, systems, and methods disclosed in <CIT>, <CIT>, <CIT>, and <CIT>.

The devices, systems, and methods disclosed in the Subject Application can also be used with the devices, systems, and methods disclosed in <CIT>, <CIT>, <CIT>, entitled SURGICAL INSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE END EFFECTOR FUNCTIONS, filed on February <NUM>, <NUM>, <CIT>, entitled SURGICAL INSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE END EFFECTOR FUNCTIONS, filed on February <NUM>, <NUM>, <CIT>, and <CIT>.

The surgical instrument systems described herein can be used in connection with the deployment of suture material to seal tissue. Moreover, various embodiments are envisioned which utilize any suitable means for sealing tissue. For instance, an end effector in accordance with various embodiments can comprise electrodes configured to heat and seal the tissue. Also, for instance, an end effector in accordance with certain embodiments can apply vibrational energy to seal the tissue. In addition, various embodiments are envisioned which utilize a suitable cutting means to cut the tissue.

Although various devices have been described herein in connection with certain embodiments, modifications and variations to those embodiments may be implemented. Particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined in whole or in part, with the features, structures or characteristics of one or more other embodiments without limitation. Also, where materials are disclosed for certain components, other materials may be used. Furthermore, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. The foregoing description and following claims are intended to cover all such modification and variations.

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, a device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps including, but not limited to, the disassembly of the device, followed by cleaning or replacement of particular pieces of the device, and subsequent reassembly of the device. In particular, a reconditioning facility and/or surgical team can disassemble a device and, after cleaning and/or replacing particular parts of the device, the device can be reassembled for subsequent use. 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 disclosure.

The devices disclosed herein may be processed before surgery. First, a new or used instrument may be obtained and, when necessary, cleaned. The instrument may 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 may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, and/or high-energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container may keep the instrument sterile until it is opened in a medical facility. A device may also be sterilized using any other technique known in the art, including but not limited to beta radiation, gamma radiation, ethylene oxide, plasma peroxide, and/or steam.

Claim 1:
A surgical bipolar forceps instrument, comprising:
a shaft (<NUM>) comprising a first electrical pathway and a second electrical pathway;
a closable jaw assembly, comprising:
a first jaw (<NUM>), comprising a first electrically-conductive portion (<NUM>) in electrical communication with said first electrical pathway; and
a second jaw (<NUM>), comprising a second electrically-conductive portion (<NUM>) in electrical communication with said second electrical pathway;
a pivot (<NUM>), wherein at least one of said first jaw and said second jaw are rotatable about said pivot;
a drive system comprising an electric motor operably engaged with at least one of said first jaw (<NUM>) and said second jaw (<NUM>);
a power supply system in electrical communication with said first electrical pathway and said second electrical pathway configured to apply electrosurgical energy to the tissue through at least one of said first electrically-conductive portion (<NUM>) and said second electrically-conductive portion (<NUM>); and
a control system configured to control when the mechanical cutting force and the electrosurgical energy are applied to the tissue;
characterized in that:
the first jaw comprises a first tissue cutting blade;
the second jaw comprises a second tissue cutting blade;
the drive system is configured to apply a mechanical cutting force to the tissue through the rotation of at least one of the first jaw and the second jaw; and
the control system is configured to co-ordinate the application of both the mechanical cutting force and the electrosurgical energy such that the mechanical cutting force and electrosurgical energy are applied simultaneously.