end actuator calibration and control system

专利摘要:
The invention relates to methods and apparatus for end effector control and calibration which are described. The method may include detecting a signal in response to the movement of a first tube relative to a second tube, the first tube driving the movement of an end effector clamping arm. The method may further include determining an end effector clamping arm position relative to a signal-based ultrasonic end effector blade. The method may also include adjusting a power output for the end effector ultrasonic blade based on the position of the clamping arm.
公开号:BR112019010912A2
申请号:R112019010912
申请日:2017-11-22
公开日:2019-10-01
发明作者:Nott Cameron；J Ulrich Daniel；J Cagle David；F Cummings John；H Clauda Phillip
申请人:Ethicon Llc；
IPC主号:

专利说明:

Descriptive Report on the Invention Patent for the END ACTUATOR CALIBRATION AND CONTROL SYSTEM ”.
TECHNICAL FIELD [001] The technical field can refer generally to the control of surgical instruments and, in particular, to the control and calibration of the end actuators of surgical instruments. BACKGROUND OF THE INVENTION [002] Several aspects are addressed to surgical instruments, and to the control and calibration of the end actuators of surgical instruments.
[003] For example, ultrasonic surgical devices are finding increasingly widespread applications in surgical procedures due to their unique performance characteristics. Depending on specific device settings and operating parameters, ultrasonic surgical devices can offer, substantially simultaneously, tissue transection and coagulation homeostasis, desirably minimizing the patient's trauma. An ultrasonic surgical device may comprise a handle containing an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer that has a distally mounted end actuator (for example, an ultrasonic blade and a clamping arm, where the clamping arm may include a pad non-stick fabric) to cut and seal the fabric. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be separable from the handpiece, as in the case of a disposable instrument or an instrument that is interchangeable between different handpieces. The end actuator transmits ultrasonic energy to the tissues placed in
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2/114 contact with it, to perform the action of cutting and cauterization. Ultrasonic surgical devices of this nature can be configured for use in open, laparoscopic or endoscopic surgical procedures, including robotically assisted procedures.
[004] Ultrasonic energy cuts and coagulates tissues using lower temperatures than those used in electrosurgical procedures. Vibrating at high frequencies (for example, 55,500 times per second), the ultrasonic blade denatures the protein present in the tissues to form a sticky clot. The pressure exerted on the tissues by the ultrasonic blade surface flattens blood vessels and allows the clot to form a hemostatic seal. A surgeon can control the cutting and clotting speed through the force applied to the tissues by the end actuator, the time during which the force is applied and the selected excursion level for the end actuator.
SUMMARY OF THE INVENTION [005] In one aspect, a method of controlling an end actuator may include detecting a signal in response to the movement of a first tube in relation to a second tube, the first tube triggering the movement of an arm tightening of the end actuator. The method may also include determining a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal. The method may also include additionally adjusting an energy output to the ultrasonic blade of the end actuator based on the position of the clamping arm.
[006] One or more of the following resources may be included. The first tube can be an inner tube and the second tube can be an outer tube, the inner tube being movable in relation to
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3/114 to the outer tube, the outer tube being static in relation to the inner tube. The method can also include detecting the signal using a Hall effect sensor and a magnet positioned on the first tube. The method may also include moving a magnet positioned on the first tube in relation to a Hall effect sensor as the first tube triggers the movement of the end actuator clamping arm. The method may additionally include adjusting the energy output to the ultrasonic blade of the end actuator using an ultrasonic transducer based on a voltage change in a Hall effect sensor. In addition, the method may include dynamically adjusting the energy output to the ultrasonic blade of the end actuator, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade. In addition, the method may include adjusting the energy output to the ultrasonic blade of the end actuator dynamically, using an integral proportional controller, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
[007] In one or more implementations, the method may include determining a type of tissue between the clamping arm and the ultrasonic blade based on the signal. The method may additionally include adjusting an energy output to the ultrasonic blade of the end actuator based on the position of the clamping arm. The method may additionally include, in response to the determination that the type of tissue between the clamping arm and the ultrasonic blade is a small blood vessel, reducing the energy output to the ultrasonic blade of the end actuator by a smaller amount than for a larger blood vessel. In addition, the method may include, in response to the determination that the type of tissue between the clamping arm and the ultrasonic blade is a large blood vessel, reducing the output of
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4/114 energy for the ultrasonic blade of the end actuator in an amount greater than for a smaller blood vessel.
[008] In one aspect, an apparatus for controlling an end actuator may include a sensor configured to detect a signal in response to the movement of a first tube in relation to a second tube, the first tube triggering the movement of an arm of the end actuator. The apparatus may also include a processor configured to determine a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal. The apparatus may additionally include a transducer configured to adjust an energy output to the ultrasonic blade of the end actuator based on the clamping arm position.
[009] One or more of the following resources may be included. The first tube can be an inner tube and the second tube can be an outer tube, the inner tube is movable in relation to the outer tube, the outer tube being static in relation to the inner tube. The device can additionally include a magnet positioned on the first tube, the sensor being a Hall effect sensor used to detect the signal based on a position of the magnet. The magnet can be positioned on the first tube that moves in relation to a Hall effect sensor as the first tube triggers the movement of the end actuator clamping arm. The transducer can be an ultrasonic transducer configured to adjust the power output to the ultrasonic blade of the end actuator based on a voltage change in a Hall effect sensor. The apparatus may also include an integral proportional controller configured to dynamically adjust the energy output to the ultrasonic blade of the end actuator, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
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5/114 [0010] In one aspect, a method for calibrating an apparatus to control an end actuator may include detecting a first signal that corresponds to a fully open position of a clamping arm and an ultrasonic blade of the end actuator. The method may also include detecting a second signal that corresponds to an intermediate position of the clamping arm and the ultrasonic blade of the end actuator, the intermediate position resulting from the holding of a rigid body between the clamping arm and the ultrasonic blade . The method may additionally include detecting a third signal that corresponds to a completely closed position of the clamping arm and the ultrasonic blade of the end actuator. The method may additionally include determining a best fit curve to represent the signal strength as a function of the sensor shift based on at least one of the first, second and third signals, the completely open, intermediate and completely closed positions, and a rigid body dimension. In addition, the method may include creating a lookup table based on at least one of the first, second and third signals, and on completely open, intermediate and completely closed positions.
[0011] The details of one or more implementations are demonstrated in the attached drawings and in the description below. Other features and advantages will be evident from the description, drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS [0012] Figure 1 is an elevation view of an exemplary surgical instrument, according to an aspect of the present description;
[0013] Figure 2 is a perspective view of an exemplary surgical instrument, according to an aspect of the present
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6/114 description;
[0014] Figure 3 illustrates an end actuator exemplifying surgical instruments, according to an aspect of the present description;
[0015] Figure 4 illustrates an end actuator exemplifying a surgical instrument, according to an aspect of the present description;
[0016] Figure 5 is an exploded view of an aspect of a surgical instrument, in accordance with an aspect of the present description;
[0017] Figure 6 illustrates a logical diagram of a surgical instrument, in accordance with an aspect of the present description;
[0018] Figure 7 illustrates a structural view of a generator architecture, according to an aspect of the present description;
[0019] Figures 8A to 8C illustrate functional views of a generator architecture, in accordance with an aspect of the present description;
[0020] Figure 9 illustrates a controller for monitoring input devices and controlling output devices, in accordance with an aspect of the present description;
[0021] Figures 10A and 10B illustrate structural and functional aspects of an aspect of the generator, in accordance with an aspect of the present description;
[0022] Figure 11 illustrates an exemplary end actuator and drive shaft for a surgical instrument, in accordance with an aspect of the present description;
[0023] Figure 12 illustrates an exemplary magnet and Hall effect sensor configuration, according to an aspect of the present description, in which the Hall effect sensor is fixed and the magnet moves in a line perpendicular to the face of the Hall sensor ;
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7/114 [0024] Figure 13A illustrates an exemplary magnet and Hall effect sensor configuration, according to an aspect of the present description, in which the Hall effect sensor is fixed and the magnet moves in a line parallel to the face the Hall effect sensor;
[0025] Figure 13B illustrates an exemplary configuration of magnet and Hall effect sensor, according to an aspect of the present description, in which the Hall effect sensor is fixed and the magnet moves in a line parallel to the face of the sensor. Hall effect;
[0026] Figure 14A is an output voltage table of a Hall effect sensor as a function of distance as a clamping arm moves from a completely closed position to a completely open position, in accordance with an aspect of the present description;
[0027] Figure 14B is a graph of the output voltage of a Hall effect sensor as a function of the distance as a clamping arm moves from a completely closed position to a completely open position, according to an aspect of the present description;
[0028] Figure 15A is a top view of a Hall effect sensor and magnet configurations in a surgical instrument and a corresponding open claw end actuator position, in accordance with an aspect of the present description;
[0029] Figure 15B is a top view of a Hall effect sensor and magnet configurations in a surgical instrument and a corresponding closed claw end actuator position, in accordance with an aspect of the present description;
[0030] Figure 16 illustrates a plan view of a system comprising a Hall effect sensor and a magnet configuration in a surgical instrument, in accordance with an aspect of the present description;
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8/114 [0031] Figure 17A illustrates a view of a Hall effect sensor and magnet configurations in the context of a surgical instrument, in accordance with an aspect of the present description;
[0032] Figure 17B illustrates a view of a Hall effect sensor and magnet configurations in the context of a surgical instrument, in accordance with an aspect of the present description;
[0033] Figure 18 illustrates a Hall effect sensor and the magnet configuration in a surgical instrument, according to an aspect of the present description;
[0034] Figure 19A illustrates a Hall effect sensor and the magnet configuration, according to an aspect of the present description;
[0035] Figure 19B illustrates a Hall effect sensor and magnet configurations in a surgical instrument, in accordance with an aspect of the present description;
[0036] Figure 20 is a graph of a curve representing the displacement ratio (RD) along the y-axis, based on the output voltage of the Hall effect sensor, as a function of time (s) along the axis. geometric x, according to one aspect of the present description;
[0037] Figure 21 illustrates a graph of a first curve representing the displacement ratio (RD) along the left y-axis, based on the output voltage of the Hall effect sensor, as a function of time (s) over the geometric axis x, according to an aspect of the present description;
[0038] Figure 22 illustrates graphs showing the proportional integral control of energy output for an ultrasonic blade, according to an aspect of the present description;
[0039] Figure 23 illustrates several vessels that have been sealed using the techniques and resources described herein, in accordance with an aspect of the present description;
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9/114 [0040] Figure 24 illustrates a graph of a best fit curve for the output voltage of the Hall effect sensor as a function of the distance to various positions of the clamping arm as the clamping arm moves between fully closed positions a completely open position, in accordance with an aspect of the present description;
[0041] Figures 25 to 28 illustrate an end actuator being calibrated in four different configurations, according to several aspects of the present description, using gauge pins for two of the configurations in order to record a Hall effect sensor response corresponding to various positions of the clamping arm to record four data points (1 to 4) in order to create a better fit curve during production, where:
[0042] Figure 25 illustrates an end actuator in a completely open configuration for registering a first data point (1), in accordance with an aspect of the present description;
[0043] Figure 26 illustrates an end actuator in a second intermediate configuration that holds a first gauge pin of a known diameter to register a second data point (2), in accordance with an aspect of the present description;
[0044] Figure 27 illustrates an end actuator in a third intermediate configuration that holds a second gauge pin of a known diameter to register a third data point (3), in accordance with an aspect of the present description; and [0045] Figure 28 illustrates an end actuator in a completely closed configuration for recording a fourth data point (4), in accordance with an aspect of the present description;
[0046] Figures 29A to D illustrate an exemplary surgical instrument, according to an aspect of the present description, and graphs showing the exemplary output energy level in a
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10/114 hemostasis mode for small and large vessels, where:
[0047] Figure 29A is a schematic diagram of a surgical instrument configured to seal small and large vessels, in accordance with an aspect of the present description;
[0048] Figure 29B is a diagram of an example strip of a small vessel and a large vessel and the relative position of an end actuator clamping arm, in accordance with an aspect of the present description;
[0049] Figure 29C is a graph that represents a process for sealing small vessels by applying various levels of ultrasonic energy during different periods of time, according to an aspect of the present description; and [0050] Figure 29D is a graph representing a process for sealing large vessels by applying various levels of ultrasonic energy for different periods of time, in accordance with an aspect of the present description;
[0051] Figure 30 is a logic diagram illustrating an exemplary process for determining whether the hemostasis mode should be used, in accordance with an aspect of the present description;
[0052] Figure 31 is a logic diagram illustrating an exemplary process for controlling the end actuator, according to an aspect of the present description;
[0053] Figure 32 is a logic diagram illustrating an exemplary process for calibrating an apparatus for controlling an end actuator, in accordance with an aspect of the present description;
[0054] Figure 33 is a logical diagram of a process for tracking the wear of the tissue plaster portion of the clamping arm and compensating for the resulting deviation from the Hall effect sensor and determining the tissue friction coefficient, according to a aspect of the present description;
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11/114 [0055] Figure 34 illustrates a Hall effect sensor system that can be used with the process of Figure 33, according to an aspect of the present description; and [0056] Figure 35 illustrates an aspect of a ramp counter analog / digital converter (ADC, AD converter) that can be used with the Hall effect sensor system of Figure 34, in accordance with an aspect of the present description. .
DESCRIPTION [0057] Several aspects described here refer to surgical instruments comprising sets of articulating claws located in the distal position. Gripper assemblies can be used instead of or in addition to the drive shaft pivot. For example, claw sets can be used to attach tissues and move them towards an ultrasonic blade, radio frequency electrodes or other tissue treatment component.
[0058] In one aspect, a surgical instrument may comprise an end actuator with an ultrasonic blade extending distally from it. The set of claws can be articulated and can revolve around at least two geometric axes. A first geometry axis, or pulse pivot axis, can be substantially perpendicular to a longitudinal geometric axis of the instrument driving axis. The jaw assembly can rotate around the wrist pivot axis from a first position in which the jaw assembly is substantially parallel to the ultrasonic blade to a second position in which the jaw assembly is not substantially parallel to the ultrasonic blade. In addition, the jaw set may comprise a first and a second jaw member which are rotatable about a second jaw pivot axis or axis. The pivot axis of the grapple can be substantially perpendicular to the pivot axis of
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12/114 pulse. In some respects, the claw pivot axis itself can rotate as the claw set rotates around the wrist pivot axis. The first and second claw members can be pivoted to each other around the claw pivot axis so that the first and second claw members can open and close. Additionally, in some respects, the first and second claw members are also pivotable around the claw pivot axis, so that the direction of the first and second claw members can change.
[0059] Now, reference will be made, in detail, to several aspects, including aspects that show exemplary implementations of manual and robotic surgical instruments with end actuators that comprise ultrasonic and / or electrosurgical elements. Whenever possible, similar or similar reference numbers can be used in the figures, and may indicate similar or similar functionality. The Figures represent exemplifying aspects of the surgical instruments and / or methods of use presented, for illustrative purposes only. The person skilled in the art will readily recognize, from the description below, that alternative exemplifying aspects of the structures and methods illustrated here can be used without departing from the principles described here.
[0060] Figure 1 is a right side view of an aspect of an ultrasonic surgical instrument 10. In the illustrated aspect, the ultrasonic surgical instrument 10 can be used in various surgical procedures, including traditional endoscopic or open surgical procedures. In an exemplary aspect, the ultrasonic surgical instrument 10 comprises a cable assembly 12, an elongated drive shaft assembly 14 and an ultrasonic transducer 16. The handle assembly 12 comprises a set of
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13/114 trigger 24, a distal rotation assembly 13 and a key assembly 28. The elongated drive shaft assembly 14 comprises an end actuator assembly 26, which comprises elements for dissecting tissues or mutually grasping, cutting and coagulating blood vessels and / or tissues, and actuator elements to drive the end actuator assembly 26. The cable assembly 12 is adapted to receive the ultrasonic transducer 16 at the proximal end. The ultrasonic transducer 16 is mechanically engaged with the elongated drive shaft assembly 14 and with portions of the end actuator assembly 26. The ultrasonic transducer 16 is electrically coupled to a generator 20, via a cable 22. Although most designs represents a set with multiple end actuators 26, for use in conjunction with laparoscopic surgical procedures, the ultrasonic surgical instrument 10 can be used in more traditional open surgical procedures and in other aspects, can be configured for use in endoscopic procedures. For the purposes of the present invention, the ultrasonic surgical instrument 10 is described in terms of an endoscopic instrument; however, it is contemplated that an open and / or laparoscopic version of the ultrasonic surgical instrument 10 may also include the same or similar features and operational components, as described here.
[0061] In several aspects, generator 20 comprises several functional elements, such as modules and / or blocks. Different elements or functional modules can be configured to activate different types of surgical devices. For example, an ultrasonic generator module 21 can drive an ultrasonic device, such as the ultrasonic surgical instrument 10. In some exemplifying aspects, generator 20 also comprises an electrosurgery / RF generator module 23 to drive a device
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14/114 electrosurgical (or an electrosurgical aspect of the ultrasonic surgical instrument 10). In the exemplifying aspect illustrated in Figure 1, generator 20 includes a control system 25 integrated with generator 20, and a foot switch 29 connected to the generator by means of a cable 27. Generator 20 can also comprise a trigger mechanism to drive a surgical instrument, such as instrument 10. The trigger mechanism may include a power switch (not shown), as well as a foot switch 29. When activated by the foot switch 29, generator 20 can provide power to drive the acoustic set of the surgical instrument 10, and to drive the end actuator 18 at a predetermined stroke level. The generator 20 drives or excites the acoustic set at any suitable resonant frequency of the acoustic set, and / or derives electromagnetic energy or therapeutic / subtherapeutic RF. In one aspect, the electrosurgical / RF generator module 23 can be implemented as an electrosurgery unit (ESU) capable of providing sufficient energy to perform bipolar electrosurgery using radiofrequency (RF) energy. In one respect, the ESU may be a bipolar ERBE ICC 350 device, available from ERBE USA, Inc. of Marietta, GA, USA. In bipolar electrosurgery applications, as previously discussed, a surgical instrument with an active electrode and a return electrode can be used, in which the active electrode and the return electrode can be positioned against, or adjacent to, the tissue to be treated , so that current can flow from the active electrode to the return electrode through the tissue. Consequently, the generator of the electrosurgical / RF module 23 can be configured for therapeutic purposes by applying sufficient electrical energy to the T tissue to treat the tissue (for example, cauterization). For example, in some respects, the active and / or return electrode may be positioned over the set of jaws described here.
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15/114 [0062] In one aspect, the electrosurgical module / RF generator 23 can be configured to provide a subtherapeutic RF signal to implement a tissue impedance measurement module. In one aspect, the electrosurgical / RF generator module 23 comprises a bipolar radio frequency generator. In one aspect, the electrosurgical / RF generator module 23 can be configured to monitor the electrical impedance Z of the T tissue, and to control the time and energy level characteristics based on the T tissue, via a return electrode arranged on a clamp member of the end actuator assembly 26. Consequently, the electrosurgical / RF generator module 23 can be configured for subtherapeutic purposes, to measure impedance or other electrical characteristics of T tissue. Techniques and circuit configurations for measuring impedance or other electrical characteristics of T tissue are discussed in more detail in US patent publication No. 201 1/0015631, assigned to the same applicant, entitled Electrosurgical Generator for Ultrasonic Surgical Instrument, the description of which is incorporated herein by reference, in its entirety.
[0063] A suitable ultrasonic generator module 21 can be configured to functionally operate similarly to the GEN300 equipment, available from Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, USA, as presented in one or more of the following US patents , all of which are incorporated by reference: US Patent No. 6,480,796 (Meth od for Improving the Start Up of an Ultrasonic System Under Zero Load Conditions); US Patent No. 6,537,291 (Method for Detecting a Loose Blade in a Hand Piece Connected to an Ultrasonic Surgical System); US patent No. 6,662,127 (Method for Detecting Presence of a Blade in an Ultrasonic System), US patent No. 6,977,495 (Detection Circuitry for Sugical Handpiece System), US patent No. 7,077,853 (Method for Calcul reaches Transducer
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11/164
Capacitance to Determine Transducer Temperature); US patent No. 7,179,271 (Method for Driving an Ultrasonic System to Improve Acquisition of Blade Resonance Frequency at Startup); and US patent No. 7,273,483 (Apparatus and Method for Alerting Generator Function in an Ultrasonic Surgical System).
[0064] It will be recognized that, in several aspects, generator 20 can be configured to operate in various modes. In one mode, the generator 20 can be configured so that the ultrasonic generator module 21 and the electrosurgical / RF generator module 23 can be operated independently.
[0065] For example, the ultrasonic generator module 21 can be activated to apply ultrasonic energy to the end actuator set 26 and subsequently therapeutic or subtherapeutic RF energy can be applied to the end actuator set 26 by the electrosurgical generator module / RF 23. As previously discussed, the electrotherapeutic / RF energy sub-therapeutic can be applied to the tissue clamped between jaw elements of the end actuator assembly 26 to measure tissue impedance in order to control activation, or modify the activation, of the ultrasonic generator module 21. The feedback regarding the tissue impedance from the application of subtherapeutic energy can also be used to activate a therapeutic level of the electrosurgical / RF generator module 23 to cauterize the tissue (for example, blood vessel ) clamped between clamp elements of end actuator assembly 26.
[0066] In another aspect, the ultrasonic generator module 21 and the electrosurgical module / RF generator 23 can be activated simultaneously. In one example, the ultrasonic generator module 21 is simultaneously activated with a subtherapeutic RF energy level to measure tissue impedance while simultaneously
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17/114 ultrasonic blade of the end actuator set 26 cuts and coagulates the tissue (or blood vessel) clamped between the clamp elements of the end actuator set 26. This feedback can be used, for example, to modify the output of driving the ultrasonic generator module 21. In another example, the ultrasonic generator module 21 can be driven simultaneously with the electrosurgical / RF generator module 23 so that the ultrasonic blade portion of the end actuator assembly 26 is used to cut the tissue damaged, while electrosurgical / RF energy is applied to electrode portions of the end actuator clamp assembly 26 to cauterize the tissue (or blood vessel).
[0067] When generator 20 is activated by means of the triggering mechanism, electrical energy is continuously applied by generator 20 to a battery or set of transducers in the acoustic set. In another aspect, electrical energy is intermittently applied (for example, pulsed) by generator 20. A phase capture loop in the generator control system 20 can monitor feedback from the acoustic set. The phase capture mesh adjusts the frequency of the electrical energy sent by the generator 20 so that it corresponds to the resonance frequency of the longitudinal vibration mode selected from the acoustic set. In addition, a second feedback loop in the control system 25 maintains the electrical current supplied to the acoustic set at a constant level previously selected, in order to obtain a substantially constant stroke in the end actuator 18 of the acoustic set. In yet another aspect, a third feedback loop in the control system 25 monitors the impedance between the electrodes located in the end actuator assembly 26. Although Figures 1 to 5 show a manually operated ultrasonic surgical instrument, it will be recognized that the
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18/114 ultrasonic surgical instruments can also be used in robotic applications, for example, as described here, as well as in combinations of manual and robotic applications.
[0068] In the ultrasonic operation mode, the electrical signal supplied to the acoustic set can cause the distal end of the end actuator 18 to vibrate longitudinally in the range, for example, approximately 20 kHz to 250 kHz. According to various aspects, the ultrasonic blade 22 can vibrate in the range of about 54 kHz to 56 kHz, for example at about 55.5 kHz. In other respects, the ultrasonic blade 22 can vibrate at other frequencies including, for example, about 31 kHz or about 80 kHz. The excursion of vibrations in the ultrasonic blade can be controlled, for example, by controlling the amplitude of the electrical signal applied to the transducer assembly of the acoustic set by generator 20. As noted above, the activation mechanism of generator 20 allows a user to activate the generator 20 so that electrical energy can be supplied continuously or intermittently to the acoustic set. The generator 20 also has an electric power transmission line for insertion into an electrosurgical unit or into a conventional electrical outlet. It is contemplated that the generator 20 can, also, be fed by a source of direct current (CG), like a battery. The generator 20 can comprise any suitable generator, such as model No. GEN04 and / or model No. GEN11, available from Ethicon Endo-Surgery, Inc.
[0069] Figure 2 is a left perspective view of an exemplifying aspect of the ultrasonic surgical instrument 10, showing the cable assembly 12, the distal rotation assembly 13 and the elongated drive shaft assembly 14. Figure 3 shows the end actuator assembly 26. In the illustrated aspect, the elongated drive shaft assembly 14 comprises an end
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Distal 19/114 52 dimensioned to mechanically engage the end actuator assembly 26, and a proximal end 50 that mechanically engages the cable assembly 12 and the distal rotation assembly 13. The proximal end 50 of the shaft assembly elongated drive 14 is received inside the handle assembly 12 and the distal rotation assembly 13. Further details regarding the connections between the elongated endoscopic drive shaft assembly 14, the cable assembly 12 and the distal rotation assembly 13 are provided in the description of Figure 5. In the illustrated aspect, the trigger assembly 24 comprises a trigger 32 that works in conjunction with a fixed handle 34. The fixed handle 34 and the trigger 32 are ergonomically shaped and adapted to offer a comfortable user interface. The fixed cable 34 is integrally associated with the cable assembly 12. The trigger 32 is able to move articulated in relation to the fixed cable 34, as explained below in more detail regarding the operation of the ultrasonic surgical instrument 10. The trigger 32 is able to pivot in the direction 33a, towards the fixed cable 34, when the user applies a clamping force against the trigger 32. A spring element 98 (Figure 5) causes the trigger 32 to move articulated shape in direction 33b, when the user ceases the clamping force against the trigger 32.
[0070] In an exemplary aspect, the trigger 32 comprises an elongated trigger hook 36, which defines an opening 38 between the elongated trigger hook 36 and the trigger 32. The opening 38 is suitably sized to receive, through it, one or more user fingers. Trigger 32 may also comprise a resilient portion 32a molded onto the substrate of the trigger 32. The overmoulded resilient portion 32a is formed to provide a more comfortable contact surface for controlling the trigger 32 in the
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11/204 outward direction 33b. In an exemplary aspect, the overmoulded resilient portion 32a can be arranged over a portion of the elongated trigger hook 36. The proximal surface of the elongated trigger hook 32 remains uncoated or coated with a non-resilient substrate, to allow the user to slide easily your fingers in and out of the opening 38. In another aspect, the trigger geometry forms a totally closed loop, which defines an opening adequately sized to receive, through it, one or more fingers from the user. The fully closed loop trigger may also comprise a resilient portion molded on the trigger substrate.
[0071] In an exemplary aspect, the fixed cable 34 comprises a proximal contact surface 40 and a gripping anchor or concave surface 42. The concave surface 42 rests on the membrane of the hand where the thumb and the index finger join. The proximal contact surface 40 has a pistol grip contour that receives the palm of the hand in a normal pistol grip, with no rings or openings. The profile curve of the proximal contact surface 40 can be contoured to accommodate or receive the palm of the hand. A stabilization tail 44 is located towards a more proximal portion of the wrist assembly 12. The stabilization tail 44 may be in contact with the uppermost part of the membrane portion of the hand, located between the thumb and the index finger, to stabilize the handle assembly 12 and make it more controllable.
[0072] In an exemplary aspect, the key set 28 may comprise a bistable key 30. The bistable key 30 can be implemented in the form of a single component with a central pivot 304, located within the handle assembly 12, for eliminate the possibility of simultaneous activation. In an exemplifying aspect,
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21/114 the bistable switch 30 comprises a first protruding knob 30a and a second protruding knob 30b for selecting the power setting of the ultrasonic transducer 16 between a minimum energy level (eg MIN) and a maximum energy level (eg , MAX). In another aspect, the bistable key can be used to vote between a conventional setting and a special setting. The special configuration can enable one or more special programs, processes or algorithms, and described here, to be implemented by the device. The switch 30 rotates around the center pivot as the first protruding button 30a and the second protruding button 30b are operated. One or more protruding buttons 30a, 30b are coupled to one or more arms that move through a small arc and cause the electrical contacts to close or open an electrical circuit to energize or electrically de-energize the ultrasonic transducer 16 according to the activation of the first or the second projection button 30a, 30b. The bistable switch 30 is coupled to the generator 20 to control the activation of the ultrasonic transducer 16. The bistable switch 30 comprises one or more electrical power configuration switches to activate the ultrasonic transducer 16 in order to define one or more energy settings for the ultrasonic transducer 16. The forces required to activate the bistable switch 30 are directed substantially towards the concave point 42, thus preventing any tendency of the instrument to turn in the hand when the bistable switch 30 is activated. [0073] In an exemplary aspect, the first and second protruding button, 30a and 30b, are located on the distal end of the cable assembly 12, so that they can be easily accessed by the user to activate the energy with a repositioning minimal, or substantially null, of the grip, which is suitable for maintaining control and keeping attention focused on the surgical site (for example, a monitor in a laparoscopic procedure) during
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22/114 the activation of the bistable key 30. The protruding buttons, 30a and 30b, can be configured to go around the side of the handle assembly 12 to a certain point, to be more easily accessible at varying finger lengths, and to allow greater freedom of access for activation in uncomfortable positions or for shorter fingers. In the illustrated aspect, the first protruding button 30a comprises a plurality of tactile elements 30c, for example, protrusions or protrusions textured in the illustrated aspect, to enable the user to differentiate the first protruding button 30a from the second protruding button 30b. It will be understood by those skilled in the art that various ergonomic features can be incorporated into the handle assembly 12. Such ergonomic features are described in US patent application No. 2009/0105750, entitled gggonomic Surgical Instruments, hereby incorporated in its entirety, by way of reference. [0074] In an exemplary aspect, the bistable key 30 can be operated by the user's hand. The user can easily access the first and second protruding buttons, 30a and 30b, at any point, while also avoiding inadvertent or unintended activation at any time. The bistable switch 30 can be readily operated with a finger to control the power supply to the ultrasonic assembly 16 and / or the ultrasonic assembly 16. For example, the index finger can be used to activate the first contact portion 30a, to switch on the ultrasonic set 16 at a maximum power level (MAX). The index finger can be used to activate the second contact portion 30b, to connect the ultrasonic assembly 16 to one at the minimum power level (MIN). In another aspect, the bistable switch can switch instrument 10 between a conventional and a special setting. The special setting can allow one or more special programs to be implemented by instrument 10. The bistable switch 30 can be operated without the user having to look at the first
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23/114 or the second protruding button, 30a or 30b. For example, the first protruding button 30a or the second protruding button 30b may comprise a texture or protrusions to tactfully differentiate between the first and second protruding buttons, 30a and 30b, without looking.
[0075] In an exemplary aspect, the distal rotation set 13 rotates without limitation in any direction around a longitudinal geometric axis T. The distal rotation set 13 is mechanically coupled to the elongated drive shaft set
14. The distal rotation assembly 13 is located on a distal end of the handle assembly 12. The distal rotation assembly 13 comprises a cylindrical hub 46 and a rotary knob 48 formed on hub 46. Hub 46 mechanically engages the assembly elongated drive shaft 14. The rotary knob 48 may comprise ribbed polymeric features and can be manipulated by a finger (e.g., an index finger) to rotate the elongated drive shaft assembly 14. Hub 46 may comprise a molded material on the main structure to form the rotary knob 48. The rotary knob 48 can be overmoulded on hub 46. Hub 46 comprises a portion of plug 46a which is exposed at the distal end. The buffer portion 46a of cube 46 may come into contact with the surface of a trocar during laparoscopic procedures. The cube 46 can be formed of a durable rigid plastic, such as polycarbonate, to relieve any friction that may occur between the buffer portion 46a and the trocar. The rotary knob 48 may comprise ribs or ribs formed by raised ribs 48a and concave portions 48b located between the ribs 48a, to provide a more precise rotational grip. In an exemplary aspect, the rotary knob 48 may comprise a plurality of grooves (for example, three or more grooves). In other respects, any suitable number of stretch marks can be used. The button
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24/114 rotary 48 can be formed from a softer polymeric material, overmoulded into the rigid plastic material. For example, rotary knob 48 can be formed from malleable, resilient and flexible polymeric materials, including TPE Versaflex® alloys, available from GLS Corporation, for example. This softer overmoulded material can provide better grip and more precise control of the movement of the rotary knob 48. It should be understood that any materials that offer adequate resistance to sterilization, are biocompatible and provide adequate frictional resistance to surgical gloves, can be used to form the rotary knob 48.
[0076] In an exemplary aspect, the cable assembly 12 is formed from two (2) carcass portions, or shells, comprising a first portion 12a and a second portion 12b. From the perspective of a user looking at the wrist assembly 12 from the distal end and towards the proximal end, the first portion 12a is considered the right portion, and the second portion 12b is considered the left portion. Each of the first and second portions, 12a and 12b, includes a plurality of interfaces 69 (Figure 5) dimensioned to align and mechanically engage each other, so as to form the handle assembly 12 and contain the internal functional components of the same. The fixed handle 34, which is integrally associated with the handle assembly 12, takes shape by assembling the first and second portions 12a and 12b of the handle assembly 12. A plurality of additional interfaces (not shown) can be arranged at various points around the periphery of the first and second portions, 12a and 12b, of the handle assembly 12, for ultrasonic welding purposes, for example, energy direction / deflection points. The first and second portions, 12a and 12b (as well as the other components described below) can be
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25/114 mounted to each other in any manner known in the art. For example, alignment pins, snap-fit interfaces, tongue and groove interfaces, locking tabs and adhesive doors can all be used, either alone or in combination, for mounting purposes.
[0077] In an exemplary aspect, the elongated drive shaft assembly 14 comprises a proximal end 50 adapted to mechanically engage the cable assembly 12 and the distal rotation assembly 13; and a distal end 52 adapted to mechanically engage the end actuator assembly 26. The elongated drive shaft assembly 14 comprises an outer tubular sheath 56 and a reciprocating tubular actuator member 58 located within the outer tubular sheath 56. The proximal end of the reciprocating tubular actuating member 58 is mechanically engaged with the trigger 32 of the cable assembly 12 to move in the 60A or 60B direction in response to the triggering and / or releasing the trigger 32. The pivotally movable trigger 32 can generate reciprocating movement to the along the longitudinal geometric axis ^S T. Such movement can be used, for example, to drive the claws or the clamping mechanism of the end actuator assembly 26. A series of articulations converts the pivoting rotation of the trigger 32 into an axial movement of a rocker attached to a drive mechanism, which controls the opening and closing of the jaws of the clamp mechanism end actuator assembly 26. The distal end of the reciprocating tubular actuator member 58 is mechanically engaged with the end actuator assembly 26. In the illustrated aspect, the distal end of the alternative tubular actuator member 58 is mechanically engaged with an assembly clamping arm 64, which can rotate around a pivot point 70 (Figure 4) to open and close the clamping arm assembly 64 in
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26/114 response to actuation and / or release of trigger 32, For example, in the illustrated aspect, the clamping arm assembly 64 is able to move in the direction 62A, from an open position to a closed position, around a point pivot 70, when trigger 32 is pulled in direction 33a. The clamping arm assembly 64 is capable of moving in the direction 62B, from a closed position to an open position, around the pivot point 70, when the trigger 32 is released or pushed out in the direction 33b.
[0078] In an exemplary aspect, the end actuator assembly 26 is connected to the distal end 52 of the elongated drive shaft assembly 14 and includes a clamp arm assembly 64 and an ultrasonic blade 66. The claws of the clamping mechanism of the end actuator assembly 26 are formed by the clamping arm assembly 64 and the ultrasonic blade 66. The ultrasonic blade 66 is ultrasonically operable, and is acoustically coupled to the ultrasonic transducer 16. The trigger 32 on the handle assembly 12 is, finally, connected to a drive assembly, with which it cooperates mechanically to obtain the movement of the clamp arm assembly 64. Squeezing the trigger 32 in the direction 33a moves the clamping arm assembly 64 in the direction 62A from an open position, in which the clamping arm assembly 64 and the ultrasonic blade 66 are arranged in a spaced relation to each other, to a clamped or closed position hada, in which the clamping arm assembly 64 and the ultrasonic blade 66 cooperate to secure the fabric between them. The clamping arm assembly 64 may comprise a gripper block 69 for securing the tissue between the ultrasonic blade 66 and the clamping arm 64. Releasing the trigger 32 in the direction 33b moves the clamping arm assembly 64 in the direction 62B, from a closed relationship to an open position, in which the clamping arm assembly 64 and the ultrasonic blade 66 are arranged in a spaced relationship one
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27/114 in relation to the other.
[0079] The proximal portion of the handle assembly 12 comprises a proximal opening 68 for receiving a distal end of the ultrasonic assembly 16. The ultrasonic assembly 16 is inserted into the proximal opening 68, and is mechanically engaged with the elongated drive shaft assembly 14.
[0080] In an exemplary aspect, the elongated trigger hook portion 36 of trigger 32 offers a longer trigger lever, with a shorter extension stroke and rotation. The longer lever of the elongated trigger hook 36 allows the user to employ multiple fingers inside the aperture 38 to operate the elongated trigger hook 36 and cause the trigger 32 to revolve in direction 33b to open the claws of the actuator assembly. end 26. For example, the user can insert three fingers (for example, the middle, ring and little fingers) into opening 38. The use of multiple fingers allows the surgeon to exert greater input forces on the trigger 32 and the trigger hook elongated 326 to activate end actuator assembly 26. The shorter extension and rotation stroke creates a more comfortable grip when closing or pulling trigger 32 in direction 33a, or when opening trigger 32 in the opening movement outward, in direction 33b, lessening the need to extend your fingers further out. This substantially decreases fatigue and hand strain associated with opening the trigger 32 outward in direction 33b. The opening movement out of the trigger can be aided by springs, by the spring element 98 (Figure 5), to help relieve fatigue. The force of the opening spring is sufficient to aid ease of opening, but it is not strong enough to adversely affect the tactile retrain formation of tissue tension during the dissection propagation.
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28/114 [0081] For example, during a surgical procedure, the index finger can be used to control the rotation of the elongated drive shaft assembly 14 in order to position the jaws of the end actuator assembly 26 in a suitable orientation . The middle finger and / or the other smaller fingers can be used to squeeze the trigger 32 and secure the tissue between the jaws. Once the jaws are in the desired position and have clamped the tissue, the index finger can be used to activate the bistable key 30 in order to adjust the energy level of the ultrasonic transducer 16 to treat the tissue. Once the tissue has been treated, the user can release the trigger 32 by pushing out in the distal direction against the elongated trigger hook 36, with the middle finger and / or the smaller fingers, to open the jaws of the actuator assembly end cap 26. This basic procedure can be performed without the user having to adjust their grip on the handle assembly 12.
[0082] Figures 3 to 4 illustrate the connection of the elongated drive shaft assembly 14 with respect to the end actuator assembly 26. As previously described, in the illustrated aspect, the end actuator assembly 26 comprises an arm assembly clamp 64 and an ultrasonic blade 66 to form the claws of the clamping mechanism. The ultrasonic blade 66 can be an ultrasound-actuable ultrasonic blade, acoustically coupled to the ultrasonic transducer 16. Trigger 32 is mechanically connected to a drive assembly. Together, the trigger 32 and the drive assembly mechanically cooperate to move the clamping arm assembly 64 to an open position in the direction 62A, where the clamping arm assembly 64 and the ultrasonic blade 66 are spaced apart one by one. to the other, and to a clamped or closed position in the 62B direction, where the arm assembly
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Tightening 29/114 64 and the ultrasonic blade 66 cooperate to secure the fabric between them. The clamping arm assembly 64 may comprise a clamp block 69 for securing the tissue between the ultrasonic blade 66 and the clamping arm 64. The distal end of the reciprocating tubular actuator member 58 is mechanically engaged with the end actuator assembly 26. In the illustrated aspect, the distal end of the alternate tubular drive member 58 is mechanically engaged with the clamping arm assembly 64, which can rotate around pivot point 70 to open and close the clamping arm assembly 64 in response to actuation and / or release of the trigger 32. For example, in the illustrated aspect, the clamping arm assembly 64 is capable of moving from an open position to a closed position in the direction 62B, around a pivot point 70, when trigger 32 is pulled in direction 33a. The clamping arm assembly 64 is capable of moving from a closed position to an open position in the direction 62A, around the pivot point 70, when the trigger 32 is released or pushed out in the direction 33b.
[0083] As previously discussed, the clamping arm assembly 64 can comprise electrodes electrically coupled to the electrosurgical / RF generator module 23 to receive therapeutic and / or subtherapeutic energy, where electrosurgical / RF energy can be applied to the electrodes, either simultaneously or not simultaneously, with the ultrasonic energy being applied to the ultrasonic blade 66. These energy activations can be applied in any suitable combinations to obtain a desired effect on the tissue, in cooperation with an algorithm or other control logic.
[0084] Figure 5 is an exploded view of the ultrasonic surgical instrument 10 shown in Figure 2. In the illustrated aspect, the exploded view shows the internal elements of the cable assembly 12, the
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30/114 cable assembly 12, distal rotation assembly 13, key assembly 28, and elongated drive shaft assembly 14. In the illustrated aspect, the first and second portions, 12a and 12b, fit together to form the cable assembly 12. Each of the first and second portions, 12a and 12b, comprises a plurality of interfaces 69, dimensioned to align and mechanically engage with each other to form the handle assembly 12 and contain the internal functional components of the ultrasonic surgical instrument 10. The rotary knob 48 is mechanically engaged with the outer tubular sheath 56, so that it can be rotated in the circular direction 54 to 360 °. The outer tubular sheath 56 is located on the reciprocating tubular actuator member 58, which is mechanically engaged and retained within the cable assembly 12 by means of a plurality of coupling elements 72. The coupling elements 72 may comprise a sealing ring seal ring type 0 72a, a tube collar cap 72b, a distal washer 72c, a proximal washer 72d and a threaded tube collar 72e. The reciprocating tubular actuating member 58 is located within a reciprocating fork 84, which is retained between the first and second portions 12a, 12b of the cable assembly 12. Rocker 84 is part of a reciprocating rocker assembly 88. A series of articulations converts the pivoting rotation of the elongated trigger hook 32 into the axial movement of the reciprocating rocker 84, which controls the opening and closing of the jaws of the clamping mechanism of the end actuator assembly 26 at the distal end of the ultrasonic surgical instrument 10. For example, a four-link design offers mechanical advantage over a relatively short rotation span, for example.
[0085] In an exemplary aspect, an ultrasonic transmission waveguide 78 is disposed within the reciprocating tubular actuator member 58. The distal end 52 of the waveguide of
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31/114 ultrasonic transmission 78 is acoustically coupled (for example, directly or indirectly mechanically coupled) to the ultrasonic blade 66, and the proximal end 50 of the ultrasonic transmission waveguide 78 is received inside the cable assembly 12. The proximal end 50 of the ultrasonic transmission waveguide 78 is adapted to be acoustically coupled to the distal end of the ultrasonic transducer 16. The ultrasonic transmission waveguide 78 is isolated from the other elements of the elongated drive shaft assembly 14 by means of a sheath protection 80 and a plurality of insulating elements 82, such as silicone rings. The outer tubular sheath 56, the reciprocating tubular actuator member 58 and the ultrasonic transmission waveguide 78 are mechanically engaged by a pin 74. The switch set 28 comprises the bistable switch 30 and electrical elements 86a, b to electrically energize the transducer ultrasonic 16, according to the activation of the first or second protruding buttons, 30a or 30b.
[0086] In an exemplary aspect, the outer tubular sheath 56 isolates the user or patient from the ultrasonic vibrations of the ultrasonic transmission waveguide 78. The outer tubular sheath 56 usually includes a hub 76. The outer tubular sheath 56 is threaded on the distal end of the cuff assembly 12. The ultrasonic transmission waveguide 78 extends through the opening of the outer tubular sheath 56, and the insulating elements 82 isolate the ultrasonic transmission waveguide 24 from the outer tubular sheath 56. The sheath external tubular 56 can be fixed to the waveguide 78 with pin 74. The hole for receiving pin 74 in waveguide 78 can nominally occur in a displacement node. The waveguide 78 can be threaded or fitted within the handle assembly 12 of the handle by means of a captive screw. The flat portions in hub 76 can allow the assembly to be torqueed up to a
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32/114 level required. In an exemplary aspect, the hub portion 76 of the outer tubular sheath 56 is preferably constructed of plastic, and the elongated tubular portion of the outer tubular sheath 56 is made of stainless steel. Alternatively, the ultrasonic transmission waveguide 78 may comprise polymeric material surrounding it, for insulation against external contact.
[0087] In an exemplary aspect, the distal end of the ultrasonic transmission waveguide 78 can be coupled to the proximal end of the ultrasonic blade 66 by an internal threaded connection, preferably in or near a antinox. It is contemplated that the ultrasonic blade 66 can be attached to the ultrasonic transmission waveguide 78 by any suitable means, such as a welded joint or the like. Although the ultrasonic blade 66 can be removable from the ultrasonic transmission waveguide 78, it is also contemplated that the single element end actuator (for example, the ultrasonic blade 66) and the ultrasonic transmission waveguide 78 can be formed as a single unit piece.
[0088] In an exemplary aspect, trigger 32 is coupled to a connecting mechanism to translate the rotary movement of trigger 32 in directions 33a and 33b to the linear movement of the reciprocating tubular actuator member 58 in the corresponding directions 60a and 60b (Figure 2 ). Trigger 32 comprises a first set of flanges 98 with openings formed therein to receive a first rocker pin 94a. The first rocker pin 94a is also positioned through a set of openings formed at the distal end of rocker 84. Trigger 32 also comprises a second set of flanges 96 for receiving a first end of a link 92. A pin trigger 90 is received in the openings formed in link 92 and in the second set of flanges 96. The
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33/114 trigger pin 90 is received in the openings formed in link 92 and in the second set of flanges 96, and is adapted to be coupled to the first and second portions, 12a and 12b, of the handle set 12, to form a point of pivot for trigger 32. A second end of link 92 is received in a slot formed at a proximal end of rocker 84, and is held inside by a second rocker pin 94b. As the trigger 32 is rotated around a pivot point articulated by the formed trigger pin 90, the fork is horizontally moved along a longitudinal geometric axis T in a direction indicated by the arrows 60a, b.
[0089] Figure 6 illustrates a diagram of an aspect of a surgical force retraining device 100 that can include or implement many of the features described herein. For example, in one aspect, surgical device 100 may be similar to or representative of surgical instrument 10. Surgical device 100 may include a generator 102. Surgical device 100 may also include an ultrasonic end actuator 106, which can be activated when a doctor operates a trigger 110. When trigger 110 is actuated, a force sensor 112 can generate a signal that indicates the amount of force that is applied to trigger 110. In addition to, or instead of, a force sensor 112, the surgical device 100 may include a position sensor 113, which can generate a signal indicating the position of the trigger 110 (for example, how far the trigger has been pressed or otherwise acted on). In one aspect, the position sensor 113 may be a sensor positioned with the outer tubular sheath 56 described above or the reciprocating tubular actuator member 58 located within the outer tubular sheath 56 described above. In one aspect, the sensor can be a Hall effect sensor or any suitable transducer that varies its output voltage in response to a magnetic field. The Hall effect sensor can be used for switching applications
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34/114 proximity, positioning, speed detection and current detection. In one aspect, the Hall effect sensor works like an analog transducer, directly returning a voltage. With a known magnetic field, its distance from the Hall plate can be determined.
[0090] A control circuit 108 can receive signals from sensors 112 and / or 113.0 control circuit 108 can include any suitable analog or digital circuit components. Control circuit 108 can also communicate with generator 102 and / or transducer 104 to modulate the power supplied to end actuator 106 and / or the level of the generator or the amplitude of the ultrasonic blade of end actuator 106 based the force applied to the trigger 110 and / or the position of the trigger 110 and / or the position of the outer tubular sheath 56 described above in relation to the reciprocating tubular actuating member 58 located inside the outer tubular sheath 56 described above (for example, as measured by a combination of Hall effect sensor and magnet). For example, the more force is applied to trigger 110, the more energy and / or the greater ultrasonic blade amplitude can be supplied to end actuator 106. According to several aspects, the force sensor 112 can be replaced with a spanner. multiple positions.
[0091] According to various aspects, the end actuator 106 may include a clamping or locking mechanism, for example, as described above in connection with Figures 1 to
5. When trigger 110 is initially triggered, the locking mechanism can close, trap the fabric between a clamping arm and end actuator 106. As the force applied to the trigger increases (for example, as detected by the 112 force sensor) ), the control circuit 608 can increase the energy supplied to the end actuator 106 by transducer 104 and / or the generator level or the
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35/114 ultrasonic blade amplitude generated in end actuator 106. In one aspect, the position of the trigger as detected by the 113 position sensor or the claw or claw arm position as detected by the 113 position sensor (for example, example, with a Hall effect sensor), can be used by control circuit 108 to define the energy and / or amplitude of the end actuator 106. For example, as the trigger is further moved towards a fully actuated position, or the claw or claw arm moves further towards the ultrasonic blade (or end actuator 106), the energy and / or amplitude of end actuator 106 can be increased.
[0092] According to various aspects, surgical device 100 may also include one or more feedback devices to indicate the amount of energy supplied to end actuator 106. For example, a speaker 114 can emit a signal indicative of energy the end actuator. According to several aspects, the speaker 114 can emit a series of pulse sounds, where the frequency of the sounds indicates the energy. In addition to, or instead of, speaker 114, the device may include a visual screen 116. Visual screen 116 may indicate the end actuator according to any suitable method. For example, visual display 116 may include a series of light emitting diodes (LEDs), where the energy of the end actuator is indicated by the number of LEDs illuminated. Loudspeaker 114 and / or visual display 116 can be activated by control circuit 108. According to several aspects, device 100 may include a ratchet device (not shown) connected to trigger 110. The ratchet device can generate an audible signal the more force is applied to trigger 110, providing an indirect indication of energy from the end actuator. Device 100 may include other features that can increase security. For example, the
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36/114 control 108 can be configured to prevent power from being supplied to end actuator 106 beyond the predetermined threshold. In addition, control circuit 108 can implement a delay between the time when a change in power to the end actuator is indicated (for example, by speaker 114 or screen 116) and the time when the change in power to the end actuator is indicated. end actuator is provided. In this way, a physician may be well aware that the level of ultrasonic energy that must be supplied to the end actuator 106 is about to change.
[0093] Figure 7 is a simplified diagram of an aspect of generator 102 that can provide tuning without an inductor, among other benefits. Figures 8A to 8C illustrate an architecture of the generator 102 of Figure 7, in accordance with an aspect of the present description. Figure 9 illustrates a controller 196 for monitoring input devices and controlling output devices in accordance with an aspect of the present description. Referring now to Figures 7 to 9, generator 102 may comprise an isolated stage of patient 152 in communication with a non-isolated stage 154 by means of a power transformer 156. A secondary winding 158 of power transformer 156 is contained in the platform isolated 152 and can comprise a bypass configuration (for example, a central bypass or non-central bypass configuration) to define the trigger signal outputs 160a, 160b and 160c in order to provide trigger signals to different surgical devices, such as a surgical device 100, an ultrasonic surgical instrument 10 or an electrosurgical device 106. In particular, the trigger signal outputs 160a and 160c can provide a trigger signal (for example, a 420 V RMS trigger signal) to a ultrasonic instrument 10, and the trigger signal outputs 160b and 160c can provide a trigger signal (for example, example, a
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37/114 drive at 100 V RMS) to an electrosurgical device 106, with the output 160b corresponding to the central branch of the power transformer 156. The non-isolated stage 154 can comprise a power amplifier 162 that has an output connected to a primary winding 164 of the power transformer 156. In certain respects, the power amplifier 162 may comprise a push-pull type amplifier, for example. The non-isolated platform 154 may also contain a programmable logic device 166 to supply a digital output to a digital to analog converter (DAC) 168 which, in turn, provides an analog signal corresponding to an input of the power amplifier 162 In certain respects, programmable logic device 166 may comprise a field programmable port arrangement (FRGA), for example. The programmable logic device 166, by controlling the input of the power amplifier 162 through the DAC 168, can therefore control any of a number of parameters (for example, frequency, waveform, amplitude of the waveform) of drive signals appearing at the drive signal outputs 160a, 160b and 160c. In certain respects and as discussed below, programmable logic device 166, in conjunction with a processor (for example, processor 174 discussed below), can implement a number of control algorithms based on digital signal processing (DSP) and / or other control algorithms for control parameters of the drive signals provided by the generator 102.
[0094] Power may be supplied to a power amplifier feed rail 162 by a key mode regulator 170. In certain respects, the key mode regulator 170 may comprise an adjustable antagonist regulator, for example. The non-isolated platform 154 may also contain a processor 174
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38/114 which, in one aspect may comprise a DSP processor such as an ADSP-21469 SHARC DSP Analog Devices, available from Analog Devices, Norwood, Mass., USA, for example. In certain respects, processor 174 can control the operation of the key mode power converter 170 responsive to voltage feedback data received from power amplifier 162 by processor 174 via an analog-to-digital converter (ADC) 176 In one aspect, for example, processor 174 can receive the waveform envelope of a signal (for example, an RF signal) as input via the ADC 176 and is amplified by power amplifier 162. Processor 174 you can then control the key mode regulator 170 (for example, via a pulse-width modulated PWM output) so that the rail voltage provided to the power amplifier 162 follows the envelope amplified signal wave By dynamically modulating the rail voltage of the power amplifier 162 based on the waveform envelope, the efficiency of the power amplifier 162 can be significantly reduced. reduced in relation to amplifier schemes with fixed rail voltage.
[0095] In certain aspects and as discussed in further detail in connection with Figures 10A and 10B, programmable logic device 166, in conjunction with processor 174, can implement a direct digital synthesizer (DDS) control scheme to control the waveform, the frequency and / or the amplitude of the supply of trigger signals by the generator 102. In one aspect, for example, the programmable logic device 166 can implement a DDS 268 control algorithm by retrieving samples of wave stored in a dynamically updated lookup table (LUT), like a RAM LUT that can be integrated into an FPGA. This control algorithm
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39/114 is particularly useful for ultrasonic applications in which an ultrasonic transducer can be driven by a clean sinusoidal current at its resonant frequency. Since other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the branching current can correspondingly minimize or reduce the undesirable effects of the resonance. As the waveform of a drive signal output by generator 102 is impacted by various sources of distortion present in the output drive circuit (for example, power transformer 156, power amplifier 162), feedback data over voltage and current based on the trigger signal can be provided to an algorithm, such as an error control algorithm implemented by processor 174, which compensates for the distortion through adequate pre-distortion or modification of the waveform samples stored in the LUT dynamically and continuously (for example, in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between a current from the computerized motion branch and a desired current waveform, the error being determined on a basis of sample by sample. In this way, pre-distorted LUT samples, when processed through the drive circuit, can result in a motion branch trigger signal having the desired waveform (for example, sinusoidal) to optimally drive the ultrasonic transducer . In such respects, the LUT waveform samples will therefore not represent the desired waveform of the trigger signal, but rather the waveform that is needed to ultimately produce the desired waveform of the signal triggering of the motion branch, when distortion effects are taken into account.
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40/114 [0096] The non-isolated stage 154 may additionally comprise an ADC 178 and an ADC 180 coupled to the output of the power transformer 156 by means of the respective isolation transformers, 182 and 184, to respectively sample the voltage and current of trigger signals emitted by generator 102. In certain respects, ADCs 178 and 180 can be configured for sampling at high speeds (for example, 80 Msps) to enable over-sampling of the trigger signals. In one aspect, for example, the sampling speed of ADCs 178 and 180 can enable an oversampling of approximately 200x (depending on the trigger frequency) of the trigger signals. In certain aspects, the sampling operations of ADCs 178 and 180 can be performed by a single ADC receiving voltage and current input signals through a bidirectional multiplexer. The use of high-speed sampling in aspects of generator 102 can make it possible, among other things, to calculate the complex current flowing through the motion branch (which can be used in certain aspects to implement the DDS-based waveform control described above), accurate digital filtering of the sampled signals, and calculation of actual energy consumption with a high degree of accuracy. The output of voltage and current feedback data by ADCs 178 and 180 can be received and processed (for example, FIFO buffering, multiplexing) by programmable logic device 166 and stored in data memory for subsequent retrieval, for example, by processor 174. As noted above, feedback data about voltage and current can be used as an input for a pre-distortion or modification of waveform samples in the LUT, in a dynamic and continuous manner. In some respects, this may require that each voltage and current feedback data pair
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41/114 stored be indexed based on, or otherwise associated with, a corresponding LUT sample that was provided by the programmable logic device 166 when the voltage and current feedback data pair was captured, LUT sample synchronization with the feedback data about voltage and current this way contributes to the correct timing and stability of the pre-distortion algorithm.
[0097] In certain respects, feedback data about voltage and current can be used to control the frequency and / or amplitude (for example, current amplitude) of the trigger signals. In one aspect, for example, voltage and current feedback data can be used to determine the impedance phase. The frequency of the trigger signal can then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (for example, O '), thereby minimizing or reducing the effects of distortion ultrasonic and, correspondingly, enhancing the accuracy of the impedance phase measurement, the phase impedance determination and a frequency control signal can be implemented in processor 174, for example, with the frequency control signal being provided as input to a DDS control algorithm implemented by the programmable logic device 166. [0098] In another aspect, for example, the current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a setpoint of the current amplitude. The current amplitude set point can be specified directly or indirectly determined based on the specified set points for voltage and power amplitude. In certain aspects, the control of the current amplitude can be implemented by the control algorithm, such as, for example, a
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42/114 proportional-integral-derived control algorithm (PID) or proportional-integral control algorithm (Pl), in processor 174. Variables controlled by the control algorithm to adequately control the current amplitude of the drive signal may include, for example, the scaling of the LUT waveform samples stored in programmable logic device 166 and / or the full-scale output voltage of DAC 168 (which provides input to power amplifier 162) via a DAC 186.
[0099] The non-isolated platform 154 may also contain a processor 190 to provide, among other things, the functionality of the user interface (UI). In one aspect, processor 190 may comprise an Atmel SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, California, USA, for example. Examples of UI functionality supported by the 190 processor may include audible and visual feedback from the user, communication with peripheral devices (for example, via a universal serial bus (USB) interface, communication with the foot switch 120, communication with a data input device 145 (for example, a touch screen) and communication with an output device 146 (for example, a speaker). Processor 190 can communicate with processor 174 and the programmable logic device (for example, via serial peripheral interface (SPI) buses). Although processor 190 can primarily support UI functionality, it can also coordinate with processor 174 to implement risk mitigation in certain respects. For example, processor 190 can be programmed to monitor various aspects of inputs by the user and / or other inputs (for example, touchscreen inputs, foot switch inputs 120, temperature sensor inputs) and can disable the drive output
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43/114 of generator 102 when an error condition is detected.
[00100] In certain respects, both processor 174 and processor 190 can determine and monitor the operational state of generator 102. For processor 174, the operational state of generator 102 can determine, for example, which control processes and / or diagnostics are implemented by processor 174. For processor 190, the operational state of generator 102 can determine, for example, which elements of a user interface (for example, monitor screens, sounds) are presented to a user. Processors 174 and 190 can independently maintain the current operational state of generator 102, as well as recognize and evaluate possible transitions out of the current operational state. Processor 174 can act as the master in this relationship, and can determine when transitions between operational states should occur. Processor 190 can be aware of valid transitions between operational states, and can confirm that a particular transition is suitable. For example, when processor 174 instructs processor 190 to transition to a specific state, processor 190 may verify that the requested transition is valid. If a requested transition between states is determined to be invalid by processor 190, processor 190 may cause generator 102 to enter a fault mode.
[00101] The non-isolated platform 154 may also contain a controller 196 for monitoring input devices 145 (for example, a capacitive touch sensor used to turn generator 102 on and off, a capacitive touch screen). In certain aspects, controller 196 may comprise at least one processor and / or another controller device in communication with processor 190. In one aspect, for example, controller 196 may comprise a processor (e.g., a Mega168 controller
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44/114 8-bit available from Atmel) configured to monitor user inputs via one or more capacitive touch sensors. In one aspect, the 196 controller can comprise a touchscreen controller (for example, a QT5480 touchscreen controller available from Atmei) to control and manage the capture of touch data from a capacitive sensitive screen to the touch.
[00102] In certain respects, when generator 102 is in an off state, controller 196 may continue to receive operational power (for example, through a line from a generator 102 power supply, such as power supply 211 discussed below). In this way, controller 196 can continue to monitor an input device 145 (for example, a capacitive touch sensor located on a front panel of generator 102) to turn generator 102 on and off. When generator 102 is in the off state, controller 196 can wake up the power supply (for example, enable the operation of one or more DC / DC voltage converters 213 of power supply 211) if the activation of the on / off input device 145 is detected by a user . Controller 196 can therefore initiate a sequence to transition the generator 102 to an on state. On the other hand, controller 196 can initiate a sequence to transition the generator 102 to the off state if activation of the on / off input device 145 is detected, when the generator 102 is in the on state. In certain respects, for example, controller 196 may report activation of the on / off input device 145 to processor 190 which, in turn, implements the process sequence required to transition generator 102 to the off state. In these respects, controller 196 may not have any independent capacity to cause the removal of power from generator 102, after
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45/114 its linked state has been established.
[00103] In certain respects, controller 196 may cause generator 102 to provide audible feedback or other sensory feedback to alert the user that an on or off sequence has been initiated. This type of alert can be provided at the beginning of an on or off sequence, and before other processes associated with the sequence begin.
[00104] In certain respects, the isolated platform 152 may comprise an instrument interface circuit 198 for, for example, offering a communication interface between a control circuit of a surgical device (e.g., a control circuit comprising switches cable) and non-isolated platform 154 components, such as programmable logic device 166, processor 174 and / or processor 190. Instrument interface circuit 198 can exchange information with non-isolated stage components 154 via a link communication that maintains an adequate degree of electrical isolation between stages 152 and 154 such as, for example, an infrared-based communication link (IR, infrared). Power can be supplied to the instrument interface circuit 198 using, for example, a low-drop voltage regulator powered by an isolation transformer driven from the non-isolated stage 154.
[00105] In one aspect, the instrument interface circuit 198 may comprise a programmable logic device 200 (e.g., a FRGA) in communication with a signal conditioning circuit 202. The signal conditioning circuit 202 can be configured to receive a periodic signal from programmable logic device 200 (e.g., a 2 kHz square wave) to generate an interrogation signal that has an identical frequency. The question mark can be generated, for example, using a bipolar current source powered by
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46/114 a differential amplifier. The question mark can be communicated to a control circuit of the surgical device (for example, using a conductive pair on a wire that connects generator 102 to the surgical device) and monitored to determine a state or configuration of the control circuit. . The control circuit may comprise numerous switches, resistors and / or diodes to modify one or more characteristics (for example, amplitude, rectification) of the question mark so that a state or configuration of the control circuit is unambiguously discernible, based on that one or more characteristics. In one aspect, for example, signal conditioning circuit 202 may comprise an ADO for generating samples of a voltage signal appearing between inputs of the control circuit, resulting from the passage of the interrogation signal through it. The programmable logic device 200 (or a non-isolated platform component 154) can then determine the status or configuration of the control circuit based on the ADO samples.
[00106] In one aspect, the instrument interface circuit 198 may comprise a first data circuit interface 204 to enable the exchange of information between programmable logic device 200 (or another element of the instrument interface circuit 198) and a first data circuit disposed in, or otherwise associated with, a surgical device. In certain respects, a first data circuit 206 may be arranged on a wire integrally attached to a handle of the surgical device, or on an adapter to interface between a specific type or model of surgical device and the generator 102. In certain respects , the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read-only memory device (EEPROM). In certain
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47/114 aspects and again with reference to Figure 7, the first data circuit interface 204 can be implemented separately from the programmable logic device 200 and comprises a suitable circuitry (for example, different logic devices, a processor) to enable the communication between programmable logic device 200 and the first data circuit. In other respects, the first data circuit interface 204 may be integral with the programmable logic device 200.
[00107] In certain aspects, the first data circuit 206 can store information related to the specific surgical device with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical device was used, and / or any other types of information. This information can be read by the instrument interface circuit 198 (for example, by the programmable logic device 200), transferred to a component of the non-isolated platform 154 (for example, to the programmable logic device 166, processor 174 and / or processor 190 ) for presentation to a user by means of an output device 146 and / or to control a function or operation of generator 102. In addition, any type of information can be communicated to the first data circuit 206 for storage in the same through the first data circuit interface 204 (for example, using programmable logic device 200). This information may include, for example, an updated number of operations in which the surgical device was used and / or the dates and / or times of its use.
[00108] A surgical instrument can be removable from a handle to promote interchangeability and / or disposability of the instrument. In such cases, known generators
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48/114 may be limited in their ability to recognize specific instrument configurations being used, as well as to optimize control and diagnostic processes as needed. The addition of readable data circuits to surgical device instruments to address this issue is problematic from a compatibility point of view, however. For example, designing a surgical device to remain compatible with previous versions of generators lacking the indispensable data reading functionality may be impractical, for example, due to different signaling schemes, design complexity and cost. Aspects of instruments can use data circuits that can be implemented in existing surgical instruments, economically and with minimal design changes to preserve the compatibility of surgical devices with current generator platforms.
[00109] Additionally, aspects of generator 102 may enable communication with instrument-based data circuits. For example, generator 102 can be configured to communicate with a second data circuit contained in an instrument of a surgical device. The instrument interface circuit 198 may comprise a second data circuit interface 210 to enable such communication. In one aspect, the second data circuit interface 210 may comprise a triplex digital interface, although other interfaces may also be used. In certain aspects, the second data circuit can generally be any circuit for transmitting and / or receiving data. In one aspect, for example, the second data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of
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49/114 information. In addition or alternatively, any type of information can be communicated to the second data circuit for storage there via the second data circuit interface 210 (for example, using programmable logic device 200). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use. In certain respects, the second data circuit can transmit data captured by one or more sensors (for example, an instrument-based temperature sensor). In certain respects, the second data circuit can receive data from generator 102 and provide an indication to the user (for example, an LED indication or other visible indication) based on the received data.
[00110] In certain respects, the second data circuit and the second data circuit interface 210 can be configured so that communication between programmable logic device 200 and the second data circuit can be achieved without the need to provide conductors for this purpose (for example, dedicated wire conductors connecting a cable to generator 102). In one aspect, for example, information can be communicated to and from the second data circuit using a 1-wire bus communication scheme, implemented in the existing wiring, as one of the conductors used transmitting interrogation signals from from signal conditioning circuit 202 to a control circuit on a cable. In this way, changes or modifications to the design of the surgical device that may otherwise be necessary are minimized or reduced. In addition, due to the fact that different types of communications can be implemented on a common physical channel (with or without frequency band separation), the presence of a second data circuit may be invisible to
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50/114 generators that do not have the indispensable data reading functionality, which, therefore, allows the backward compatibility of the surgical device instrument. In certain respects, the isolated platform 152 may comprise at least one blocking capacitor 296-1 connected to the output of the drive signal 160b, to prevent the passage of direct current to a patient. A single blocking capacitor may be required to comply with medical regulations and standards, for example. Although failures in single-capacitor designs are relatively uncommon, such failures can still have negative consequences. In one aspect, a second blocking capacitor 296-2 can be placed in series with the blocking capacitor 296-1, with current leakage from one point between blocking capacitors 296-1 and 296-2 being monitored, for example. example, by an ADC 298 for sampling a voltage induced by current leakage. Samples can be received by programmable logic device 200, for example. Based on changes in the dispersion current (as indicated by the voltage samples in the aspect of Figure 7), generator 102 can determine when at least one of the blocking capacitors 2961 and 296-2 has failed. Consequently, the appearance of Figure 7 can provide a benefit over designs with only one capacitor, having a single point of failure.
[00111] In certain respects, the non-insulated platform 154 may comprise a power supply 211 for DC power output with adequate voltage and current. The power supply may comprise, for example, a 400 W power supply to provide a system voltage of 48 VDC. The power supply 211 may additionally comprise one or more DC / DC voltage converters 213 to receive the output from the power supply to generate DC outputs at the voltages and currents required by the various
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51/114 generator components 102. As discussed above in relation to controller 196, one or more of the DC / DC voltage converters 213 can receive an input from controller 196 when activation of the Hga / off input device 145 by a user it is detected by controller 196, to enable the operation of the DC / DC voltage converters 213.
[00112] Figures 10A and 10B illustrate certain functional and structural aspects of an aspect of generator 102. The feedback indicating current and voltage output of secondary winding 158 of power transformer 156 is received by ADCs 178 and 180, respectively. As shown, ADCs 178 and 180 can be implemented in the form of a 2-channel ADC and can sample retraining signals at high speed (eg 80 Msps) to enable oversampling (eg approximately 200x of oversampling) of the trigger signals. Current and voltage retraining signals can be properly conditioned in the analog domain (for example, amplified, filtered) before processing by ADCs 178 and 180. Current and voltage feedback samples from ADCs 178 and 180 can be individually registered ( buffered) and subsequently multiplexed or merged into a single data stream within block 212 of programmable logic device 166. In the aspect of Figures 10A and 10B, programmable logic device 166 comprises an FRGA.
[00113] The multiplexed voltage and current feedback samples can be received by a parallel data capture port (PDAP) implemented inside block 214 of processor 174. The PDAP can comprise a packaging unit to implement any of the numerous methodologies for correlating multiplexed feedback information with a
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52/114 memory address. In one aspect, for example, the feedback data corresponding to a specific LUT sample output by the programmable logic device 166 can be stored in one or more memory addresses that are correlated or indexed to the LUT address in the LUT sample. In another aspect, the feedback samples corresponding to a specific LUT sample by the programmable logic device 166 can be stored, together with the LUT address of the LUT sample, in a common memory location. Either way, the feedback samples can be stored so that the address of a LUT sample from which a specific set of feedback information originated can be subsequently determined. As discussed above, the synchronization of the addresses of the LUT samples and the feedback data in this way contributes to the correct timing and stability of the pre-distortion algorithm. A direct memory access controller (DMA) implemented in block 216 of processor 174 can store the feedback samples (and any LUT sample address data, where applicable) in a designated memory location 218 of processor 174 (for example, Internal RAM).
[00114] Block 220 of processor 174 may implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in programmable logic device 166 dynamically and continuously. As discussed above, the pre-distortion of the LUT samples can compensate for various sources of distortion present in the generator output drive circuit 102. The pre-distorted LUT samples, when processed through the drive circuit, will therefore result in a trigger signal having the desired waveform (for example, sinusoidal)
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53/114 to optimally drive the ultrasonic transducer.
[00115] In block 222 of the pre-distortion algorithm, the current is determined through the movement branch of the ultrasonic transducer. The current of the motion branch can be determined using the Kirchoff Current Law based, for example, on the current and voltage feedback information stored in memory location 218, a value of the static capacitance of the ultrasonic transducer Co (measured or known a priori) and a known value of the trigger frequency. A sample of current from the motion branch can be determined for each set of stored current and voltage feedback information associated with a LUT sample.
[00116] In block 224 of the pre-distortion algorithm, each current sample of the motion branch determined in block 222 is compared to a sample of a desired current waveform to determine a difference, or error, of the sample amplitude, between the compared samples. For this determination, the sample with the desired current waveform can be provided, for example, from a LUT 226 waveform containing amplitude samples for a cycle of a desired current waveform. The specific LUT 226 current waveform sample used for the comparison can be determined by the LUT sample address associated with the current sample of the motion branch used in the comparison. As needed, the current input from the motion branch in block 224 can be synchronized with the entry of its associated LUT sample address in block 224. LUT samples stored in programmable logic device 166 and LUT samples stored in LUT waveforms 226 can therefore be equal in number. In some respects, the desired current waveform, represented by the
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54/114 LUT samples stored in the 226 waveform LUT can be a fundamental sine wave. Other waveforms may be desirable. For example, it is contemplated that a fundamental sine wave could be used to trigger the main longitudinal movement of an ultrasonic transducer, superimposed on one or more other trigger signals at other frequencies, such as a third-order ultrasonic to trigger at least two resonances mechanical in order to obtain beneficial vibrations in transverse or other modes.
[00117] Each value of the sample amplitude error determined in block 224 can be transmitted to the LUT of programmable logic device 166 (shown in block 228 in Figure 10A) together with an indication of its associated LUT address. Based on the amplitude error sample value and its associated address (and, optionally, the amplitude error sample values for the same LUT address previously received), LUT 228 (or another programmable logic device control block) 166) can pre-distort or modify the value of the LUT sample stored at the LUT address, so that the amplitude error sample is reduced or minimized. It should be understood that this pre-distortion or modification of each LUT sample in an iterative way over the LUT address range will cause the waveform of the generator output current to match or adapt to the waveform of the desired current, represented by the LUT 226 samples of waveforms.
[00118] Current and voltage amplitude measurements, power measurements and impedance measurements can be determined in block 230 of processor 174, based on current and voltage feedback samples stored in memory location 218. Before determination of these
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55/114 quantities, the feedback samples can be properly sized and, in certain aspects, processed through a suitable 232 filter to remove the noise resulting, for example, from the data capture process and the induced ultrasonic components. The filtered samples of voltage and current can therefore substantially represent the fundamental frequency of the output signal of the generator drive. In certain respects, filter 232 can be a finite impulse response filter (FIR) applied in the frequency domain. These aspects can use the fast Fourier transform (FFT) of the current and voltage output signals of the drive signal. In some respects, the resulting frequency spectrum can be used to provide additional functionality to the generator. In one aspect, for example, the ratio of the second and / or third order ultrasonic component to the fundamental frequency component can be used as a diagnostic indicator. In block 234, an average square value (RMS) calculation can be applied to a sample size of the current feedback samples representing an integral number of trigger signal cycles, to generate an Irms measurement representing the signal output current drive.
[00119] In block 236, an average square value (RMS) calculation can be applied to a sample size of the voltage feedback samples representing an integral number of trigger signal cycles, to determine a Vrms measurement representing the voltage output of the trigger signal. In block 238, the current and voltage feedback samples can be multiplied point by point, and an average calculation is applied to the samples representing an integral number of cycles of the trigger signal, to determine a Pr measurement of the actual output energy
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56/114 of the generator.
[00120] In block 240, the measurement Pa of the apparent output energy of the generator can be determined as the product Vrmsfrms.
[00121] In block 242, the measurement Zm of the magnitude of the load impedance can be determined as the quotient Vrms / lrms.
[00122] In certain aspects, the quantities! Rms, Vrms, Pr, Pa and Zm determined in blocks 234, 236, 238, 240 and 242, can be used by generator 102 to implement any of a number of control processes and / or diagnosis. In certain respects, any of these quantities can be communicated to a user through, for example, an output device 146 Integral to generator 102, or an output device 146 connected to generator 102 via a suitable communication interface (for example , a USB interface). The various diagnostic processes can include, without limitation, cable integrity, instrument integrity, instrument fixation integrity, instrument overload, proximity to instrument overload, frequency locking failure, over voltage, over current, over voltage power, voltage sensor failure, current sensor failure, audio indication failure, visual indication failure, short circuit, power supply failure and blocking capacitor failure, for example.
[00123] Block 244 of processor 174 can implement a phase control algorithm for determining and controlling the impedance phase of an electrical charge (eg, the ultrasonic transducer) conducted by generator 102. As discussed above, when controlling the frequency of the trigger signal to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (for example, O '), the effects of ultrasonic distortion can be minimized or reduced, and the measurement accuracy is increased phase.
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57/114 [00124] The phase control algorithm receives the current and voltage feedback information stored in memory location 218 as input. Before being used in the phase control algorithm, feedback feedback can be properly sized and , in certain aspects, processed through a suitable filter 246 (which can be identical to filter 232) to remove the noise resulting from the data capture process and the induced ultrasonic components, for example. The filtered samples of voltage and current can therefore substantially represent the fundamental frequency of the output signal of the generator drive.
[00125] In block 248 of the phase control algorithm, the current is determined through the movement branch of the ultrasonic transducer. This determination can be identical to that described above in connection with block 222 of the pre-distortion algorithm. Thus, the output of block 248 can be, for each set of stored current and voltage feedback information associated with a LUT sample, a sample of current from the movement branch.
[00126] In block 250 of the phase control algorithm, the impedance phase is determined based on the synchronized input of samples from the current of the motion branch determined in block 248 and corresponding to voltage feedback samples. In some respects, the impedance phase is determined as the average between the impedance phase measured at the rising edge of the waveforms and the impedance phase measured at the falling edge of the waveforms.
[00127] In block 252 of the phase control algorithm, the impedance phase value determined in block 222 is compared to the setpoint of phase 254 to determine a difference, or phase error, between the compared values.
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58/114 [00128] In block 256 of the phase control algorithm, based on a phase error value determined in block 252 and the impedance magnitude determined in block 242, a frequency output is determined to control the frequency of the trigger signal. The value of the frequency output can be continuously adjusted by block 256 and transferred to a DDS control block 268 (discussed below) in order to maintain the impedance phase determined in block 250 of the phase setpoint (for example, zero phase). In some respects, the impedance phase can be set to a phase setpoint of 0 ^o . In this way, any of this ultrasonic fraction will be centered around the crest of the voltage waveform, accentuating the accuracy of the phase impedance determination.
[00129] Block 258 of processor 174 can implement an algorithm for modulating the current amplitude of the drive signal, in order to control the current, voltage and power of the drive signal, according to user-specified set points , or according to requirements specified by other processes or algorithms implemented by the generator 102. The control of these quantities can be carried out, for example, by dimensioning the LUT samples in LUT 228, and / or by adjusting the output voltage in full scale of DAC 168 (which provides input to power amplifier 162) via DAC 186. Block 260 (which can be implemented as a PID controller in certain respects) can receive current feedback samples (which can be properly sized and filtered) from memory location 218. Current feedback samples can be compared to the demand value for Id current determined by the controlled variable (for example, current, voltage or power) to determine whether the trigger signal is supplying the required current. In aspects
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59/114 where the drive signal current is the control variable, the demand for current Id can be specified directly by a current setpoint 262A (Isp). For example, an RMS value of the current feedback data (determined as in block 234) can be compared to the RMS Isp current setpoint specified by the user to determine the appropriate action for the controller. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT dimensioning and / or full-scale output voltage of the DAC 168 can be adjusted by block 260, so that it is the current of the trigger signal is increased. On the other hand, block 260 can adjust a LUT dimensioning and / or the full-scale output voltage of DAC 168 to decrease the drive signal current when the current feedback data indicates a RMS value greater than the set point. current adjustment Isp.
[00130] In aspects where the drive signal voltage is the control variable, the current demand Id can be specified indirectly, for example, based on the current required to maintain a desired voltage reference value 262B (Vsp ) given the magnitude of the load impedance Zm measured in block 242 (for example, Id = Vsp / Zm). Likewise, in aspects where the inverter signal strength is the control variable, the current demand Id can be specified indirectly, for example, based on the current required to maintain a desired power setpoint 262C (Psp ) given the Vrms voltage measured in blocks 236 (for example, Id ~ Psp / Vrms).
[00131] Block 268 can implement a DDS control algorithm to control the trigger signal by retrieving LUT samples stored in LUT 228. In certain aspects, the DDS control algorithm is an oscillator algorithm numerically
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60/114 controlled (NCO, of numerically-controlled oscillator) to generate samples of a waveform at a fixed timing rate using a technique of skipping points (locations in memory). The NCO algorithm can implement a phase accumulator, or frequency to phase converter, which functions as an address pointer for retrieving LUT samples from the LUT 228. In one aspect, the phase accumulator can be a phase accumulator with size from step D, module N, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in LUT 228. A frequency control value D ~ 1, for example, can do cause the phase accumulator to point sequentially to each LUT 228 address, resulting in a waveform output that replicates the waveform stored in LUT 228. When D> 1, the phase accumulator can skip addresses in LUT 228, resulting in a waveform output that has a higher frequency. Consequently, the frequency of the waveform generated by the DDS control algorithm can therefore be controlled by varying the frequency control value accordingly. In certain aspects, the frequency control value can be determined based on the output of the phase control algorithm implemented in block 244. The output of block 268 can provide the input of (DAC) 168 which, in turn, provides a analog signal corresponding to a power amplifier input 162.
[00132] Block 270 of processor 174 can implement a key mode converter control algorithm to dynamically modulate the Power Amplifier Rail Voltage 162 based on the signal waveform envelope being amplified, thereby improving efficiency power amplifier 162. In certain respects, the characteristics of the waveform envelope can be determined by monitoring one or more
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61/114 signals contained in power amplifier 162. In one aspect, for example, the characteristics of the waveform envelope can be determined by monitoring the minimum of a drain voltage (for example, a MOSFETj drain voltage that is modulated according to the amplified signal envelope. A minimum voltage signal can be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal can be sampled by ADC 176, with the samples of minimum output voltage being received in block 272 of the switching mode converter control algorithm.Based on the values of the minimum voltage samples, block 274 can control a PWM signal output by a PWM generator 276 which, for example, in turn, controls the rail voltage supplied to the power amplifier 162 by switching mode regulator 170. In certain respects, as long as the values of the minimum voltage samples are smaller than a target input for the 278 low in block 262, the voltage on the rail can be modulated according to the waveform envelope, as characterized by the low voltage samples. When voltage samples from the minimum indicate low levels of envelope power, for example, block 274 can cause low voltage on the rail to be supplied to the power amplifier 162, with the total rail voltage being supplied only when the voltage samples are minimum voltage indicates maximum envelope power levels. When the voltage samples from the minimum drop below the target to the minimum 278, block 274 can cause the rail voltage to be maintained at an adequate minimum value to ensure the proper operation of the power amplifier 162.
[00133] In one aspect, a method and / or apparatus can provide functionality to detect a clamping arm position in relation to an ultrasonic blade of an end actuator, and a
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62/114 generator like generator 102 and a controller like control circuit 108 and / or controller 196 can be used to adjust a power output to the ultrasonic blade based on the clamping arm position. Now with reference to Figure 32, a 3200 process for controlling an end actuator is shown. Process 3200 may be performed at least in part by a processor that may be in communication with or may be part of one or more of generator 102, control circuit 108 and / or controller 196. Now with reference to Figure 32 , a 3300 process for calibrating a controller for an end actuator is shown. Process 3200 may be performed at least in part by a processor that may be in communication with or may be part of one or more of generator 102, control circuit 108 and / or controller 196. [00134] Now with reference Figure 11 shows an example end actuator 300 and drive shaft 302 are shown. The clamping arm 304 may have a position (for example, represented by the angle, arrow or offset) in relation to the ultrasonic blade 306, which can be measured using one or more sensors as a Hall effect sensor. Detecting the position of the clamping arm in relation to the ultrasonic blade can provide relevant information about the device, allowing for new features, such as the ability to detect the thickness, quantity or types of tissues trapped within the claws. In one aspect, the 3200 process of Figure 32 can determine 3220 a type of tissue between the clamping arm and the ultrasonic blade based on a signal (from, for example, a Hall effect sensor). Additionally, with the use of a processor and / or memory, one or more algorithms (for example, to seal a vessel without transection) can be chosen based on the thickness, quantity or type of fabric determined to be trapped within the claws.
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63/114 [00135] The ultrasonic blade 306 can provide a tissue effect through mechanical vibration to tissues and / or blood vessels. The clamping arm 304 can rotate around point 314, which can represent a connection between the clamping arm and an outer tube 310. An inner tube 308 can move back and forth and can trigger the closing of the clamping arm 304 on the ultrasonic blade 306. In many respects, it may be desirable to measure the angle between the clamping arm 304 and the ultrasonic blade 306.
[00136] In one aspect, the position of the clamping arm 304 in relation to the ultrasonic blade 306 (for example, during activation) can be approximated through a coupling with the inner tube 308. The inner tube 308 can be connected to the arm clamp 304 and may be similar to the reciprocating tubular actuator member 58 located inside the outer tubular sheath 56. The outer tube 310, which may be similar to the outer tubular sheath 56, and / or ultrasonic blade 306, can be used to determine a position and / or angle of the clamping arm 304 in relation to the ultrasonic blade 306. The outer tube 310 can be static and, in one aspect, can be connected to the clamping arm 304. As a result, using the techniques and resources here described, the movement (for example, represented with the bidirectional arrow 312) of the inner tube 308 in relation to the outer tube 310 can be measured and used to approximate the position of the clamping arm.
[00137] With brief reference to Figure 32, the 3200 process can detect 3202 a signal (for example, in a Hall effect sensor) in response to the movement of a first tube in relation to a second tube, the first tube being triggered the movement of an end actuator clamping arm. The first tube can be, for example, similar to the reciprocating tubular actuating member 58 and the second tube can be, for example, similar to the outer tubular sheath 56. In other words, as described in Figure 32, the first tube
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64/114 can be an inner tube and the second tube is an outer tube. The inner tube can be movable 3208 in relation to the outer tube. The outer tube can be static in relation to the inner tube. The 3200 process can detect the 3210 signal using a Hall effect sensor and a magnet positioned on the first tube.
[00138] The use of Hall effect sensors will be described here in relation to several aspects of the present description, however, other types of sensors can be used to measure 312 motion. For example, linear variation differential transformers (LVDT), rotary differential differential transformer, piezoelectric transducers, potentiometers, photoelectric sensors can be used to measure motion 312. In addition, appropriate Hall effect sensors and equivalents can be used to measure the position of two bodies relative to each other through the use of a small electronic board and magnets.
[00139] Now with reference to Figure 12, a representation of an exemplary Hall effect sensor is shown. A 402 magnet can have north and south poles that move in a line perpendicular to the face of the Hall 404 effect sensor, which can be in a fixed position. Now with reference to Figure 13A, another representation of an exemplary Hall effect sensor is shown. A 408 magnet can have north and south poles moving in a line parallel to the face of the Hall 410 effect sensor, which can be in a fixed position. Now with reference to Figure 13B, another representation of an exemplary Hall effect sensor is shown. A magnet 414 can have north and south poles moving in a line (418) parallel to the face of the Hall 416 effect sensor, which can be in a fixed position. The magnet can have diameter D and the magnet and Hall 416 effect sensor can have a total effective air gap (TEAG) 420. This configuration can enable very sensitive measurement of movement over short distances with the combination of
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65/114 suitable magnet.
[00140] The Hall effect sensor can include a small electronic integrated circuit that can detect magnetic fields and change its electrical output based on the relative proximity of the magnet or the resistance of the magnetic fields to the Hall effect sensor. As the magnet moves along the face of the Hall effect sensor (for example, marked X) and approaches being directly in front of the face, an output signal from the Hall effect sensor can change and be used to determine a position of the magnet in relation to the Hall effect sensor. In one aspect, the magnet may not cause much change in the output signal from the Hall effect sensor. For example, with the use of a magnet and a Hall effect sensor that has particular characteristics, the magnet being more than 1.5 inches or other distances from the Hall effect sensor can produce very little in terms of the output signal. , but as the magnet moves closer and closer to the Hall effect sensor, the electrical output changes more quickly, so that a very noticeable signal change occurs in response to small movements of the magnet as it moves closer to a critical position. The electrical response of the Hall effect sensor in various positions of the magnet can be used to create a better fit curve. For example, the voltage output of the Hall effect sensor as a function of the displacement of the magnet can be determined.
[00141] Figure 14A is a table 1400 of the output voltage of a Hall effect sensor as a function of the distance as a clamping arm moves from a completely closed position to a completely open position, according to the present description. The relative distance (mm) is mentioned in the first column 1402. The absolute distance (mm) is listed in the second column 1404 and the absolute distance in cm (inches) is listed in the third column 1406. The output voltage of the Hall effect sensor is mentioned in the fourth column
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1410 and the position of the clamping arm is mentioned in the fifth column, where the highest cell indicates the clamping arm in the fully closed position and the lowest cell indicates the clamping arm in the fully open position.
[00142] Now with reference to Figures 14A and 14B, a table 1400 and a graph 1450 of the output voltage of a Hall effect sensor (geometric axis y) as a function of the displacement (geometric axis x) and related data are shown. In this example, the sensitivity of a Hall effect sensor / prototype magnet combination is shown as a relatively small linear motion (for example, 0.100%) that can result in a 1.5 volt signal change. This signal change can be read by a generator (for example, generator 102) and used to make determinations about the displacement of the ultrasonic blade, or provide auditory, tactile and / or other feedback to a user (for example, through high speaker 114 and / or visual screen 116). A best-fit curve 1452 can be determined from plotted data points 145a-h (for example, one or more among relative displacement, absolute displacement, voltage output and position) and a polynomial equation for output voltage of the Hall effect sensor (geometric axis y) as a function of the displacement (geometric axis x) of the magnet. The best fit curve can be 2 ^a , 3 ^a , 4 ^a ... nth order. Data points 1454a-h and / or the best-fit curve 1452 can be used to create a lookup table stored in memory and / or the resulting equation can be run on a processor to determine, for example, an offset to the magnet (and a corresponding clamping arm position) given a specific output voltage of the Hall effect sensor. Thus, returning briefly to Figure 32, process 3200 can determine 3204 a clamping arm position of the end actuator in
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67/114 relative to an ultrasonic blade of the end actuator based on the signal (from, for example, voltage output of the Hall effect sensor).
[00143] Turning now to Figure 15A, a top view of a Hall effect sensor 510 and magnet configurations 508 is shown on a surgical instrument and a corresponding open claw end actuator position 500, according to an aspect of the present description, and Figure 15B is a top view of the Hall effect sensor 510 and magnet 508 configurations on a surgical instrument and the position of the corresponding closed claw end actuator 500, according to an aspect of this description. In one aspect, as shown in Figures 15A and 15B, the voltage output of the Hall 50 effect sensor is 1.6 VDC when the claws of the end actuator 500 are open and 3.1 VDC when the claws of the end actuator 500 are closed.
[00144] Now with reference to Figures 15A and 15B, an aspect of a combination of Hall effect sensor 510 and magnet 508 is shown as implemented in a surgical device as one or more of those discussed in the present invention. Figures 15A and 15B show two top-down images of the example. An internal threaded collar 502 can be attached to a magnet 508. As a surgical device driver is closed, a clamping arm 504 of the end actuator 500 comes in close contact with an ultrasonic blade 504, the magnet 508 moves more proximally as shown in top-down views. As magnet 508 moves (in a direction indicated by arrow 506), the voltage potential of the Hall 510 sensor changes. The magnet 508 positioned on the first tube in relation to the Hall 510 effect sensor can move as the first tube triggers the movement of the clamping arm 503 of the end actuator 500.
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68/114 [00145] It should be noted that although several aspects discussed in the present invention are described to include an outer tube that is static and an inner tube that triggers the movement of the clamping arm, other configurations are possible and are within the scope of this description. For example, in many ways, an outer tube can trigger the movement of the clamping arm and the inner tube can be static. In addition, although several aspects discussed in the present invention are described to include a Hall effect sensor 510 and / or integrated circuit (for example, chip) that is static and a magnet 508 that moves as the clamping arm 500 moves, others configurations are possible and are within the scope of this description. For example, in many ways, the Hall 510 effect sensor can move as clamping arm 503 moves and the magnet can be static. Many combinations are possible, including a fixed outer tube and a moving interior, a 508 movable magnet and a stationary Hall effect sensor 510 or other detection circuit, a Hall effect sensor 510 or other detection circuit and a 508 stationary magnet , a movable outer tube and a fixed inner tube, a magnet fixed in one of the inner and outer tubes and / or a movable magnet in one of the inner and outer tubes. The Hall 510 effect sensor or other circuit can be mounted on the moving part (for example, inner or outer tube) or mounted on the stationary part (for example, inner or outer tube), as long as flexible electrical connections are considered and achieved.
[00146] As shown in Figure 15A, the internal threaded collar 502 with the fixed magnet 508 is positioned farther to the left than in Figure 15B, and the corresponding end actuator 500 has an open claw, for example, open clamping arm 503. When the user pulls the trigger and closes the end actuator 500, multiple springs and the internal threaded collar 502 move (in the direction
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69/114 indicated by arrow 506), the clamping arm 503 is activated closed or is carried to the graft of tissue captured between the clamping arm 503 and the ultrasonic blade 504. A Hall effect sensor 510 and a magnet 508 are shown, which can be cylindrical, moving over the Hall 510 effect sensor, as the clamping arm 503 closes towards the ultrasonic blade 504.
[00147] Now with reference to Figure 16, a plan view of a system 600 is shown which comprises a Hall effect sensor 602 and a magnet arrangement 606. The Hall effect sensor 602 includes a circuit board 604 and a circuit integrated 606. Magnet 608 moves back and forth along line 610 as the clamping arm is closed and opened. As magnet 608 moves towards the center of the Hall 606 integrated circuit, the sensitivity of the Hall 602 effect sensor changes and the output signal increases. A support 612 for magnet 608 can be attached to the inner tube that drives the clamping arm. In one aspect, as the inner tube is pulled towards the handle of the surgical instrument (for example, by the trigger), the claw closes (for example, the clamping arm closes). The 608 magnet is connected to an extended leg of the threaded inner collar of the outer tube.
[00148] Figures 17A and 17B illustrate different views of the system 600 comprising a Hall effect sensor 602 and magnet configurations 608 in the context of a surgical instrument, in accordance with an aspect of the present description. With reference to Figures 17A and 17B, the Hall 602 effect sensor is shown positioned inside a surgical instrument. The Hall 602 effect sensor is positioned on the threaded inner collar 620 of outer tube 622. A slot 624 is defined in a rotating knob on outer tube 622 to enable magnet 608 to move. The magnet 608 is positioned inside the support 612, which is slidably movable inside the slot 624. For example,
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70/114 the Hall 602 effect sensor as described in the present invention can be static and is attached to a rotation button, so that it can rotate around the center line of the ultrasonic blade. A pin 626 can be positioned inside an opening 628 through the rotation button and the Hall effect sensor 602 and through a portion of the central ultrasonic blade. As a result, the ultrasonic blade does not move axially, but the inner tube is able to move axially to the right and left of pin 626. A 630 threaded connection is made of nylon or any other suitable material with minimal magnetic flux.
[00149] Figure 18 illustrates a Hall effect sensor 602 and the configuration of magnet 608 in the context of a surgical instrument according to the present description. Now with reference to Figure 18, a drive shaft of a surgical instrument is shown and the magnet 608 is positioned inside the support 612. A movement of the magnet 632 is coupled to the inner tube 634. The magnet 608 can be coupled with pressure fittings to a threaded collar 638 of the inner tube 634. The Hall 602 effect sensor as described in the present invention is static and is attached to a rotation button so that it can rotate around the center line of the ultrasonic blade.
[00150] Figure 19A illustrates a Hall effect sensor 602 and a magnet configuration 608, in accordance with an aspect of the present description. Figure 19B is a detailed view of the Hall 602 effect sensor and the magnet 608 configuration in the context of a surgical instrument, according to the present description. Now with reference to Figures 19A AND 19B, in one aspect, the Hall effect sensor 602 and the magnet configuration 608 are located on a drive axis of a surgical instrument. In one aspect, the pole faces of the magnet 608 and the Hall effect sensor 602 move in line with each other. In Figures 17A, 17B, 19A and 19B, the
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71/114 Hall effect 602 is stationary, while magnet 608 moves in connection with the clamping arm. In one aspect, the inner threaded collar is configured to carry the 608 magnet and can be directly connected to the inner tube. In this way, the Hall effect sensor 602 can be positioned in a different way on the rotation button, so that the faces of the magnet 608 and the Hall effect sensor 602 come together perpendicularly as shown by the moving arrow 640.
[00151] In one aspect, an ultrasonic algorithm or process can be used to enable a surgical device to seal tissue without transection. The implementation of this algorithm or process may require measuring the position of the clamping arm in relation to the ultrasonic blade of an end actuator. One method can be used to detect the position of the clamping arm in relation to the ultrasonic sheet, as described here, and that the positioning can be consistently calibrated during fabrication, as will be described below, so that fabric thickness estimates can be made. For example, an algorithm or process that is fed information about the amount of tissue can react as the amount changes. This can enable the surgical device to treat the tissue without completely transecting a vessel.
[00152] Now returning briefly to Figure 32, once the clamping arm position in relation to the ultrasonic blade is known, the way the ultrasonic blade vibrates can be adjusted to obtain different tissue effects. In this mode, the 3200 process can adjust 3206 an energy output to the ultrasonic blade of the end actuator based on the clamping arm position. For example, the 3200 process can adjust the 3214 power output to the ultrasonic blade of the end actuator using a
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72/114 ultrasonic transducer based on a voltage change in a Hall effect sensor.
[00153] Typically, end actuators can be used to coagulate and cut vessels at the same time. However, using the techniques and features described here, an end actuator can be used to seal a carotid or vessel without effectively transiting it, as may be desired by a surgeon. With information on the position of the clamping arm, a displacement ratio (RD) can be calculated, whereby if the clamping arm is in the completely closed position with nothing captured in the end actuator, the sensor (for example, Hall effect) can indicate an RD of 1. For example, for illustrative purposes only, let the XT represent a relative clamping arm position at any given time on activation, X1 being a clamping arm position when the surgical device is fully stuck without fabric, and X2 being a clamping arm position at the start of activation, with the fabric held in the end actuator, where:
[00154] Continuing with the example above, X1 can be a value programmed in the surgical device for the clamping arm position when the jaws are completely closed and nothing is captured in the end actuator. X2 can be the clamping arm position at the start of an activation, so that if a vessel is attached to the end actuator and the clamping arm is closed all the way, the clamping arm can compress the vessel downwards, but with some distance to travel before the vessel is cut across and the clamping arm is directly opposite the ultrasonic blade with full contact. XT can change dynamically, since it is the position of the clamping arm at any given time.
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73/114 [00155] For example, at the start of activation, RD can be zero, since X1 can be adjusted to represent the position of the clamping arm being completely closed with nothing captured. X2, at the start of activation, when the clamping arm is touching a vessel, can provide a relative thickness before the ultrasonic blade is fired. XT can be the value in the equation that is continuously updating over time as the clamping arm moves further and compresses and begins to cut the fabric. In one respect, it may be desirable to disable (for example, stop firing) the ultrasonic blade when the clamping arm has traveled 70% or 0.7. This way, it can be determined empirically in advance that an RD is desired 0.7 of the way between the clamping arm being closed with a total bite of tissue and being completely closed with nothing between the clamping arm and the ultrasonic blade.
[00156] The RD of 0.7 has been described for illustrative purposes only and may depend on many parameters. For example, the desired DR for the point at which the ultrasonic blade will be closed can be based on the size of the vessel. The RD can be any value observed to work to treat a given tissue or vessel without transection. Once the desired position is known, the vibration of the ultrasonic blade can be adjusted based on the desired position. Figure 20 is a 2000 graph of a 2002 curve representing the displacement ratio (RD) along the y-axis, based on the output voltage of the Hall effect sensor, as a function of time (s) along the geometry axis. x. As shown in Figure 20, the desired RD is 0.7, which means that the ultrasonic blade is disabled (for example, stop firing) when the clamping arm has traveled 70% or 0.7. This is related to a clamping arm in a vessel with an ultrasonic blade shot in
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74/114 that the RD of the desired end was 0.7. In the specific example in Figure 20, the ultrasonic blade was activated (for example, firing) in a carotid and turned off in the DR of 0.7 after about 16 seconds.
[00157] In one aspect, it may be desirable to use a proportional integral controller. Figure 21 is a graph 2100 of a first curve 2102 representing the displacement ratio (RD) along the y-axis, based on the output voltage of the Hall effect sensor, as a function of time (s) along the axis. geometric x. A second curve 2104 represents power (Watts) along the right y axis as a function of time (s) along the x axis. Graph 2100 provides an example of what can be done with an integral proportional controller (PI). The displacement ratio (RD) curve 2102 is represented in graph 2100 by the line marked DISPLACEMENT RATIO. The target or desired value for the displacement ratio can be 0.7, as shown by the line marked desired value, although several other values can be used. The 2104 energy output curve represents the power through the ultrasonic blade and is shown and marked POWER (Watts).
[00158] Turning now briefly to Figure 32, it is shown that the 3200 process can adjust 3216 the output energy for the ultrasonic blade of the end actuator dynamically, based on the displacement ratio that changes as the clamping arm moves approaches the ultrasonic sheet. For example, as the clamping arm moves towards the ultrasonic sheet and the desired value is approximate, the amount of energy output for the ultrasonic sheet and into the tissue can be reduced. This is because the ultrasonic blade will cut through the tissue with sufficient energy. However, if the power being produced is reduced over time as the desired value is approximated (where a transection
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75/114 total can be represented by a displacement ratio of 1), the chance of the tissue being transected can be drastically reduced. In this way, effective sealing can be achieved without cutting the tissue as may be desired by the surgeon.
[00159] Returning to Figure 21, it is shown that the output energy curve 2104 shown in Figure 21 can represent the power applied with a trigger signal to a transducer cell to activate (for example, trigger) the ultrasonic blade. The power value can be proportional to the movement of the clamping arm portion of the end actuator and applied to the fabric and the power curve can represent the voltage and current applied to the ultrasonic transducer. In one aspect, the ultrasonic generator (eg, generator 102) can read the voltage output data from the Hall effect sensor and, in response, send commands for how much voltage and current to supply the transducer to drive the ultrasonic blade, as desired . As the end actuator clamping arm portion is moved and the desired value is approached, the ultrasonic blade can be forced to release less energy to the tissue and reduce the likelihood of cutting the tissue.
[00160] As the ultrasonic sheet is energized, the ultrasonic sheet will produce the tissue or the vessel, so that friction at the interface of the ultrasonic sheet and the tissue causes heat to drive moisture in and dry the tissue. During this process, the clamping arm portion is able to compress the fabric more and more as the seal develops. As the RD increases over time, the fabric by applying more pressure flattens with the clamping arm as the fabric dries. In this way, a PI controller can be used to cook the fabric from a starting point (where RD-0) to a certain second position by controlling the energy outlet to effectively seal large vessels. With the PI controller, as the RD approaches the desired value, the ultrasonic device
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76/114 drops the application of energy (to the ultrasonic sheet) to gently control the compression and coagulation of the tissue. This process proved to be able to effectively seal vessels without transection. In this mode, the 3200 process can adjust the energy output to the ultrasonic blade of the end actuator 3218 dynamically, using an integral proportional controller (Pl), based on a displacement ratio that changes as the clamping arm approaches of the ultrasonic blade. It will be understood that the control of Pl is not the only logical system through which energy can be controlled. There are many mathematical mappings to properly reduce power as a function of the Hall effect sensor. Examples of other logic systems include PID controllers, proportional controllers, fuzzy logic, neural networks, polynomials, Bayesian networks, among others.
[00161] Figure 22 is a 2200 graph showing how the Pl controller works. The proportional term can be an indication of the absolute difference between RD and the desired value for RD. The RD approaches the desired value, the effect of the proportional term can shrink and as a result the ultrasonic power (for example, delivered by the ultrasonic blade) can be reduced. The integral term, shown as the area 2202 under the curve, can be an accumulation of errors over a given section of time. For example, as shown above, the full term may not start to accumulate until after 5 seconds. After 5 seconds, the integral term can begin to take effect and the energy for the ultrasonic blade can be increased. After about 9 seconds, the reduction of the effect in the proportional term can compensate for the effect of the increase in the integral term causing the application of energy to the ultrasonic blade to be reduced. In this example, a target value of 0.7 for DR was used, however, as discussed above, the DR value can be
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77/114 optimized for a specific device together with the proportional and integral terms of the controller.
[00162] In effect, the PI controller can indicate that the energy output must be based on the distance at any given time between the displacement ratio and the desired value. From that distance, the PI controller can generate a certain value (for example, 0.4). In the example in Figure 22, at a point in time (for example, 1 second) the distance is based on the values assigned to Pe I. This distance can be multiplied by a constant that represents P and results in 0.78. The generator can instruct the system to send 0.78 or send, for example, 7.8 watts of power when the distance between these two is a certain amount. As a result, the RD curve approaches the desired value, and the distance is reduced. Over time, the amount of energy from the generator tells the system to send less, which may be the desired result. However, this could also mean that if only P and not I is used, when the time approaches 15 seconds, there may not be enough output energy for the tissue to complete the objective. This is where portion I (integral portion) is calculated over a defined period of time, which can be about five seconds. By calculating the area under curve 2202 (shown in Figure 22 by subjected to hatched lines, captured between the desired value and displacement ratio over time) and additionally at 0.78, shown between 0 and 5 seconds, portion I starts adding its own amount of power to help progress the displacement ratio to the desired value and make sure it gets there in a short time. For example, in five seconds, portion I is not active, but as time progresses, portion I starts calculating the area captured between the two curves and adds that value (for example, four additional Watts) which is the area under the curve, in addition to the power from the value
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Proportional 78/114. Using these two calculations together can provide the curved power (that is, the energy output) as shown in Figure 22. The PI controller is configured to drive towards the sealing effect in a somewhat timely manner.
[00163] In one aspect, the techniques described here can be used to seal different vessel sizes (for example, 5 mm, 6 mm and 7 mm round vessels). The strength of the seals can be tested until the seal breaks and records the burst pressure. Higher burst pressure indicates a stronger seal. In the case of real surgery, if a surgical instrument or device as described in the present invention is used to seal a vessel, the seal will not leak if it has an associated high burst pressure. In one aspect, burst pressures can be measured in different vessel sizes, for example, round vessels of 5 mm, 6 mm and 7 mm, respectively. Typically, smaller vessels have greater burst pressure with larger vessels, the burst pressure is decreased.
[00164] Now with reference to Figure 23, several 2400 vessels are shown that were sealed using the techniques and resources described here (for example, with the use of an ultrasonic blade and a Hall effect sensor). Using the PI controller as described above, 60 vessels were sealed. 58 vessels were sealed without transection.
[00165] In one aspect, it has been observed that the activation of an ultrasonic sheet with the clamping arm open can help to release tissue that may have adhered to the ultrasonic sheet when being clotted. Detecting a change in the signal from a Hall effect sensor can indicate when the user is opening the clamping arm after activating the device. This information can trigger the system to send a low level ultrasonic signal over a short period of time, so
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79/114 to release any tissue attached to the ultrasonic sheet. This short subtherapeutic signal can reduce the level of adherence experienced by the user. This feature can be useful if an ultrasonic shear device has been designed for multiple uses and the coated ultrasonic blade starts to wear out. Thus, the techniques and resources described here can be used to reduce the amount of tissue attached to the ultrasonic sheet.
[00166] A method for calibrating an end actuator and Hall effect sensor may include calibrating the end actuator and Hall effect sensor during manufacturing thereafter. As discussed above, the 3300 process shown in Figure 32, can be used to calibrate a controller for the end actuator. For example, a position of the clamping arm of an ultrasonic device can be calibrated during assembly. As discussed here, detecting the position of the clamping arm in relation to the ultrasonic blade can provide information relevant to the surgical device that may enable new capabilities, including, but not limited to, the ability to detect a quantity or type of tissues that can be fixed within. claws. In addition, determinations to be performed on various algorithms (for example, this sealing of a vessel without transection) can be made based on the detection of the position of the clamping arm. However, in several respects, for this information to be useful and reliable, the surgical device needs to be calibrated against a baseline such as when the clamping arm is fully open or when the clamping arm is completely closed with zero material in the end actuator.
[00167] As described above, the determination of a displacement ratio (RD) can help in several processes to control an end actuator. In determining RD, X1 is the position of the
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80/114 clamping arm when the device is completely closed without fabric. Determining the value (for example, Hall effect signal) corresponding to X1 can be done during manufacture and can be part of the calibration process.
[00168] Now returning to Figure 24, a 2500 graph of a best fit curve 2502 of the output voltage of the Hall effect sensor along the y axis is shown as a function of absolute distance (inch) along the x axis for various positions of the clamping arm. The best fit curve 2502 is plotted based on the absolute distance (inch) of the clamping arm of the ultrasonic blade, as listed in the third column 1406 of table 1400 shown in Figure 14A and the output voltage of the corresponding Hall effect sensor, listed in fourth column 1408 of table 1400 shown in Figure 14A, when the clamping arm moves from a fully open position to a fully closed position in accordance with the present disclosure.
[00169] Still with reference to Figure 24, an exemplary electrical output of a Hall effect sensor configured to detect the position of the shown clamping arm is shown. The signal strength of the Hall effect sensor plotted against sensor displacement (for example, a magnet) can follow a parabolic shape as shown by the best fit curve 2502. To calibrate the Hall effect sensor, several sensor readings are taken at known baseline locations. During calibration, the best fit curve 2502 as shown in Figure 24 can be analyzed to confirm that the Hall effect sensor is actually reading based on readings taken in a production configuration. In this way, a Hall effect sensor response corresponding to various positions of the clamping arm (for example, completely open, completely closed and distinct between them) can be recorded to create
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81/114 a better fit curve during production. Multiple data points can be recorded (for example, four data points 1--4, as shown in Figure 24 or more, as needed) to create the best fit curve 2502. For example, in a first position, a response of the Hall effect sensor can be measured when the clamping arm is fully open. Thus, returning briefly to Figure 32, the 3300 process shown in Figure 32 can detect 3302 a first measurement signal (for example, a Hall effect sensor response) corresponding to a fully open position of a clamping arm and a ultrasonic blade of the end actuator.
[00170] Now returning to Figure 24 together with Figure 25, the four data points 1-4 represent the voltage measured with a Hall effect sensor as a function of the gap between the clamping arm 2606 and the ultrasonic blade 2608, as shown in Figure 24. These data points 1-4 can be registered as described in connection with Figures 25 to 28. The first data point (1) is registered when the end actuator 2600 is in the configuration shown in Figure 25. The first data point (1) corresponds to the output voltage of the Hall effect sensor registered when the clamping arm 2606 is in the fully open position in relation to the 2608 ultrasonic blade.
[00171] The second data point (2) is registered when the end actuator 2600 is in the configuration shown in Figure 26. In order to obtain a precise gap between the clamping arm 2606 and the ultrasonic blade 2808, a first pin caliber 2602 of known diameter is placed at a predetermined location within the claws of the end actuator 2600, for example, between the clamping arm 2606 and the ultrasonic blade 2608. As shown in Figure 26, the first caliber pin 2602 is positioned between the distal end
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82/114 and the proximal end of the ultrasonic blade 2608 and is held between the clamping arm 2606 and the ultrasonic sheet 2608 to define a precise gap between the clamping arm 2606 and the ultrasonic sheet 2808. Once the clamping arm 2606 is closed to hold the first pin of caliber 2602, the output voltage of the Hall effect sensor is measured and recorded. The second data point (2) is correlated to the gap defined between the clamping arm 2606 and the ultrasonic blade 2608 by the first pin of caliber 2602. In this way, the output horn of the Hall effect sensor is matched to the gap between the clamping arm 2606 and the ultrasonic blade 2608. The second data point (2) is one of several data points to develop the polynomial to generate the best fit curve 2502 shown in Figure 24. The 3300 process described in Figure 32 senses 3304 a real Hall sensor sensor voltage 3304 and determines the span between the clamping arm 2606 and the ultrasonic blade 2608 based on the best first curve 2502 (for example, computing the polynomial).
[00172] The third data point (3) is registered when the end actuator 2600 is in the configuration shown in Figure 27. To obtain another precise gap between the clamping arm 2606 and the ultrasonic blade 2808, the first pin of caliber 2602 is removed and a second pin of caliber 2604 of known diameter is placed at a predetermined location within the claws of the end actuator 2600, for example, between the clamping arm 2606 and the ultrasonic blade 2608, which is different from the location of the first pin caliber 2602. As shown in Figure 27, the second caliber pin 2604 is positioned between the distal end and the proximal end of the ultrasonic blade 2608 and is held between the clamping arm 2606 and the ultrasonic blade 2608 to define a precise gap between the clamping arm 2606 and the ultrasonic blade 2808. Once the clamping arm 2606 is closed to hold the second caliber pin 2602, the
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83/114 Hall effect sensor output voltage is measured and recorded. The third data point (3) is correlated to the gap defined between the clamping arm 2606 and the ultrasonic blade 2608 by the second pin of caliber 2604. In this way, the output horn of the Hall effect sensor is matched to the gap between the clamping arm 2606 and the ultrasonic blade 2608. The third data point (3) is one of several data points to develop the polynomial to generate the best fit curve 2502 shown in Figure 24. The 3300 process described in Figure 32 senses 3304 a real Hall sensor sensor voltage 3304 and determines the span between the clamping arm 2606 and the ultrasonic blade 2608 based on the best first curve 2502 (for example, computing the polynomial).
[00173] The fourth data point (4) is registered when the end actuator 2600 is in the configuration shown in Figure 28. To obtain the fourth data point (4), there are no 2602, 2604 caliber pins placed between the clamping arm 2606 and ultrasonic blade 2608, but rather, clamping arm 2606 is placed in the fully closed position in relation to the ultrasonic blade 2608. Once the clamping arm 2606 is placed in the fully closed position, the output voltage of the Hall effect sensor is measured and recorded. The fourth data point (4) correlates with the position of the clamping arm 2606 completely closed. In this way, the output voltage of the Hall effect sensor is equivalent to the clamping arm 2606 completely closed position in relation to the ultrasonic blade 2608. The fourth data point (4) is one of several data points to develop the polynomial to generate the best fit curve 2502 shown in Figure 24. The 3300 process described in Figure 32 detects 3304 a real Hall effect sensor voltage 3304 and determines the span between the clamping arm 2606 and the ultrasonic blade 2608 based on the best first curve 2502 (for example, compute
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84/114 the polynomial).
[00174] Various gauge pin configurations can create known displacements and / or angles between the clamping arm 2606 and the ultrasonic blade 2608 of the end actuator 2600. Using the kinematics of a given clamping arm / ultrasonic blade / shaft design drive and calibration pins of known diameter, a theoretical displacement of the set of drive axes can be known in each of, for example, four or more positions. This information can be entered, along with the voltage readings of the Hall effect sensor, to fit a parabolic curve (for example, best fit curve 2502 as shown in Figure 24), which can be made a characteristic of each individual surgical device. . This information can be loaded onto the surgical device via an EEPROM or other programmable electronic device configured to communicate with the generator (for example, generator 102 shown in Figure 6) while using the surgical device.
[00175] The signal response of the Hall effect sensor in, for example, the four positions of the clamp arm described above can be plotted and the responses can be adjusted and inserted into a lookup table or developed into a polynomial that can be used to define / calibrate the Hall effect sensor, such that, when used by a surgeon, the final effector provides the desired tissue effect. In this way, the 3300 process can determine a best-fit curve to represent the signal strength (for example, the Hall effect sensor) as a function of the sensor shift (for example, magnet shift) based on at least the first, the second and third signs, the fully open, intermediate and fully closed positions, and a rigid body dimension. The 3300 process can also create a 3310 lookup table with
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85/114 base on at least the first, the second and the third signal and the fully open, intermediate and fully closed positions.
[00176] The positioning of the Hall effect magnet / sensor arrangement in the configurations described above can be used to calibrate the surgical device, in such a way that the most sensitive movements of the fixing arm 2606 exist when the fixing arm 2606 is closest of the 2608 ultrasonic blade. Four positions, corresponding to four data points (1-4), were chosen in the example described above, but any number of positions could be used at the discretion of design and development teams to ensure proper calibration.
[00177] In one aspect, the techniques and resources described here can be used to provide feedback to a surgeon to indicate when the surgeon should use the hemostasis mode for the vessel sealing procedure before engaging the cutting procedure. For example, the hemostasis mode algorithm can be changed dynamically based on the size of a vessel attached by the 2600 end actuator to save time. This may require feedback based on the position of the 2606 clamping arm.
[00178] Figure 29A is a schematic diagram 3000 of a surgical instrument 3002 configured to seal small and large vessels, in accordance with an aspect of the present description. The surgical instrument 3002 comprises an end actuator 3004, where the end actuator comprises a clamping arm 3006 and an ultrasonic blade 3008 for treating tissue including vessels of various sizes. The surgical instrument 3002 comprises a Hall effect sensor 3010 to measure the position of the end actuator 3004. A lock switch 3012 is provided to provide a feedback signal that indicates whether the trigger cable 3013 of the surgical instrument is in a fully position
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86/114 closed.
[00179] Turning now to Figure 29B, there is shown a diagram of an example strip of a small vessel 3014 and a large vessel 3016 and the relative position of an end actuator clamping arm according to an aspect of the present description. With reference to Figures 29A to B, the surgical instrument 3002 shown in Figure 29A is configured to seal small vessels 3014 with a diameter <4 mm and large containers 3016 with a diameter> 4 mm and the relative position of the clamp arm 3006 when grasping small and large vessels 3014, 3016 and the different voltage readings provided by the final effector 3010 depending on the vessel size.
[00180] Figures 29C and 29D are two graphs 3020, 3030 that describe two processes for sealing small and large vessels by applying various levels of ultrasonic energy for different periods of time in accordance with an aspect of the present description. The ultrasonic energy level is shown along the y-axis and the time (s) is shown along the x-axis. With reference now to Figures 29A to C, the first 3020 graph shown in Figure 29C shows a process for adjusting the ultrasonic energy trigger level of an ultrasonic line to seal a small 3014 vessel. According to the process illustrated by the first 3020 graph to seal and transect a small vessel 3014, a high ultrasonic energy (5) is applied during a first period 3022. The energy level is then decreased to (3.5) during a second period 3024. Finally, the energy level is raised back to (5) for a third period 3026 to complete the sealing of the small vessel 3014 and achieve the transection and then the energy level is turned off. The entire cycle lasted about 5 seconds.
[00181] With reference now to Figures 29A to D, the second graphic 3030 shown in Figure 29D shows a process for adjusting the level
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87/114 for driving ultrasonic energy from an ultrasonic line to seal a large 3016 vessel. According to the process illustrated by the second graphic 3030 for sealing and transitioning a large 3016 vessel, a high ultrasonic energy (5) is applied during a first period 3032. The energy level is then decreased to (1) during a second period 3034. Finally, the energy level is raised back to (5) during a third period 3036 to complete the sealing of the large vessel 3016 and achieve the transection and then the energy level is turned off. The entire cycle lasted about 10 seconds.
[00182] Smaller vessels 3014 may be easier to seal at high burst pressure levels. Thus, it may be desirable to detect and determine whether a smaller vessel 3014 (eg 4 mm less) is attached by the clamping arm 3006, and if so, the ultrasonic energy level may not need to be decreased to 1. In instead, the energy level could decrease less, to about 3.5, for example, as shown by the first graph 3020 shown in Figure 29C. This can enable the surgeon to pass through the vessel, clot and cut the vessel more quickly, knowing that the process can go faster because vessel 3014 is slightly smaller. If vessel 3016 is larger (for example, 4 mm or greater), a process that heats the vessel more slowly and over a longer period of time may be more desirable, as shown by the second graphic 3030 in Figure 29D.
[00183] Figure 30 is a logic diagram illustrating an example 3100 process for determining whether the hemostasis mode should be used, in accordance with an aspect of the present description. In the beginning, process 3100 indicates 3102 that the signal from a Hall effect sensor determines 3102 the position of a final actuator. Process 3100 then determines 3104 whether a full surgical device closing key is pressed, or whether the surgical device handle is fully closed. If the full lock switch
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88/114 of the surgical device is not pressed and / or if the cable of the surgical device is not fully closed, process 3100 can continue to read the Hall effect sensor 3102 to determine the position of the end actuator. If the full closure switch on the surgical device is pressed, or if the surgical device cable is completely closed, process 3100 will determine 3106 if the position of the end actuator indicates a vessel greater than 5 mm. If the position of the end actuator does not indicate a vessel greater than 5 mm, and no system indicator is found 3108, process 3100 can continue to read 3102 the Hall effect sensor and determine the position of the end actuator.
[00184] If the position of the end actuator indicates a vessel greater than 5 mm, process 3100 will determine 3110 if the position of the final actuator indicates a vessel greater than 7 mm. If the position of the end actuator does not indicate a vessel larger than 7 mm, process 3100 indicates 3112 that the hemostasis mode should be used. This condition can be indicated using a variety of auditory, vibratory or visual retraining techniques including, for example, a green LED located on the surgical device (for example, at the top of the cable) can be activated. If the position of the end actuator indicates a vessel larger than 7 mm, process 3100 indicates 3114 that the tissue should not be taken (that is, hemostasis mode should not be used), due to the fact that a lot of tissue has been captured by the end actuator. This condition can be indicated using a variety of auditory, vibratory or visual feedback techniques including, for example, a red LED on the surgical device (for example, at the top of the cable) can be activated.
[00185] Figure 31 is a logic diagram illustrating an example 3200 process for controlling the end actuator, according to an aspect of the present description; In one respect,
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89/114 referring to Figure 31, process 3200 detects 3202 a signal (for example, in a Hall effect sensor) in response to the movement of a first tube in relation to a second tube, the first tube activating the movement of an end actuator clamping arm. The first tube can be, for example, similar to the reciprocating tubular actuating member 58 (Figures 3 and 4) and the second tube can be, for example, similar to the external tubular sheath 56 (Figures 3 and 4). In other words, as described in Figure 31, the first tube can be an inner tube and the second tube is an outer tube. The inner tube can be movable 3208 in relation to the outer tube. The outer tube can be static in relation to the inner tube. The 3200 process detects the 3210 signal using a Hall effect sensor and a magnet positioned on the first tube.
[00186] Process 3200 continues and determines 3204 a clamping arm position of the end actuator in relation to an ultrasonic blade of the end actuator based on the signal (from, for example, voltage output of the Hall effect sensor). Once the position of the clamping arm in relation to the ultrasonic blade is known, the vibrational mode of the ultrasonic blade can be adjusted to obtain different tissue effects. In this mode, the 3200 process adjusts 3206 a power output to the ultrasonic blade of the end actuator based on the clamping arm position. For example, the 3200 process can adjust the 3214 power output to the ultrasonic blade of the end actuator using an ultrasonic transducer based on a voltage change in a Hall effect sensor. Alternatively, the process can effectively seal vessels without transection. In this mode, the 3200 process can adjust the energy output to the ultrasonic blade of the end actuator 3218 dynamically, using an integral proportional controller, based on a displacement ratio that changes as the
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90/114 tightening approaches the ultrasonic blade.
[00187] In another aspect, the 3200 process can adjust the 3216 energy output to the ultrasonic blade of the end actuator dynamically based on the displacement ratio that changes as the clamping arm approaches the ultrasonic blade. For example, as the clamping arm moves towards the ultrasonic sheet and a desired value (Figures 21 and 22) is approximated, the amount of energy output for the ultrasonic sheet and into the tissue can be reduced. This is because the ultrasonic blade will cut through the tissue with sufficient energy. However, if the power being produced is reduced over time as the desired value is approximated (where a total transection can be represented by a displacement ratio of 1), the chance of the tissue being transected can be drastically reduced. In this way, effective sealing can be achieved without cutting the tissue as may be desired by the surgeon.
[00188] In one aspect, the 3200 process of Figure 31 moves a 3212 magnet positioned on the first tube in relation to a Hall effect sensor as the first tube triggers the movement of the end actuator clamping arm. The 3200 process then determines a type of tissue 3220 between the clamping arm and the ultrasonic blade based on a signal (from, for example, a Hall effect sensor). Additionally, with the use of a processor and / or memory, one or more algorithms (for example, to seal a vessel without transection) can be chosen based on the thickness, quantity or type of fabric determined to be trapped within the claws. In response to determining that the type of tissue between the clamp and the ultrasonic blade is a large vessel, the 3200 process can reduce 3226 the output energy to the ultrasonic blade of the end actuator by an amount greater than that of a small vessel. In addition, in response to
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91/114 Determining that the type of tissue between the clamp and the ultrasonic blade is a small vessel, the 3200 process can reduce 3224 the output energy to the ultrasonic blade of the end actuator by a smaller amount than for a large vessel. In one aspect, instead of changing algorithms for small vessels, as described above, an indicator can be provided to the surgeon to indicate the thickness of the tissue captured in the end actuator. In one aspect, the 3200 process adjusts 3222 output energy to the ultrasonic blade of the end actuator based on the type of fabric.
[00189] Figure 32 is a logic diagram illustrating an exemplary 3300 process for calibrating an apparatus for controlling an end actuator, in accordance with an aspect of the present description. In one aspect, process 3300 detects 3302 a first signal that corresponds to a completely open position of a clamping arm and an ultrasonic blade of the end actuator. The 3300 process then detects 3304 a second signal that corresponds to an intermediate position of the clamping arm and the blade of the end actuator, the intermediate position resulting from the holding of a rigid body between the clamping arm and the blade . The 3306 process detects a third signal that corresponds to a completely closed position of the clamping arm and the blade of the end actuator. Once the three signals are detected, the 3300 process determines 3308 a best fit curve to represent the signal strength as a function of the sensor shift based on at least the first, second and third signal corresponding to the fully open positions, intermediate and fully closed, respectively, and a rigid body dimension. An example of a best fit curve in this context is shown in Figures 14B and 24. Finally, process 3300 creates a 3310 lookup table based on at least the first, second and
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92/114 third signal corresponding to the fully open, intermediate and fully closed positions, respectively.
[00190] As described above, the position of the end actuator clamping arm part can be measured with a Hall effect magnet / sensor arrangement. A fabric plaster, usually made of TEFLON, can be positioned on the clamping arm to prevent the fabric from adhering to the clamping arm. As the end actuator is used and the tissue patch is used, it will be necessary to track the deviation of the output signal from the Hall effect sensor and establish change limits to maintain the integrity of the selection of the tissue treatment algorithm and the end of the return of the cut trigger points to the tissue treatment algorithms.
[00191] Consequently, a control system is provided. The output of the Hall effect sensor in the form of counts can be used to track the opening of the end actuator clamping arm. The reader can refer to Figures 34 and 35 for ADC 3500, 3600 systems that can employ the counter output of an ADC. The position of the clamping arm, with or without a tissue patch, can be calibrated using the techniques described here. Once the position of the clamping arm is calibrated, the position of the clamping arm and the wear of the tissue patch can be monitored. In one aspect, the control system determines that the clamping arm is in a closed position for monitoring by an increase in the acoustic impedance that occurs when the ultrasonic blade comes into contact with the tissue or tissue plaster. In this way, a specific number of ADC counters will accumulate a specific number of counts from the moment the clamping arm goes from a completely open position to a completely closed position. In an implementation, based on the configuration of the Hall effect sensor, the ADC counts of the Hall effect sensor increase
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93/114 as the clamping arm closes towards the ultrasonic blade. As the tissue patch wears out, the counter will accumulate an additional incremental number of counts due to the additional rotational displacement experienced by the clamping arm due to the wear of the tissue patch. By tracking the new count value to a closed clamping arm position, the control system can adjust the trigger limit for a cutting edge and better predict the total clamping arm opening range that has occurred.
[00192] In addition, the ADC counts of the Hall effect sensor can be used to determine the tissue friction coefficient (μ) of the tissue under treatment based on the opening of the clamping arm using predetermined μ values stored in a table consultation. For example, the specific tissue treatment algorithm can be dynamically adjusted or modified during an ultrasonic treatment cycle (for example, trigger sequence or ultrasonic energy activation) to optimize tissue cutting based on the type of tissue (for example , adipose tissue, mesentery, vessel) or the amount or thickness of the tissue.
[00193] Figure 33 is a logical diagram of a 3400 process for tracking wear of the tissue plaster portion of the clamping arm and compensating for the resulting deviation from the Hall effect sensor and determining the tissue friction coefficient, according to an aspect of the present description. The 3400 process can be implemented in software, hardware, firmware or a combination thereof, using the generator circuit environment illustrated in connection with Figures 6 to 10.
[00194] In one aspect, the 3400 process can be implemented by a circuit that can comprise a controller comprising one or more processors (for example, microprocessor,
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94/114 microcontroller) coupled to at least one memory circuit. At least one memory circuit stores executable instructions per machine that, when executed by the processor, cause the processor to execute the 3400 process.
[00195] The processor can be any one of a number of single-core or multi-core (multi-core) processors known in the art. The memory circuit may comprise volatile and non-volatile storage media. In one aspect, the processor may include an instruction processing unit and an arithmetic unit. The instruction processing unit can be configured to receive instructions from the memory circuit.
[00196] In one aspect, a circuit may comprise a finite state machine comprising a combinational logic circuit configured to implement the 3400 process described herein. In one aspect, a circuit can comprise a finite state machine comprising a sequential logic circuit comprising a combinational logic circuit and at least a memory circuit, for example. The at least one memory circuit can store a finite state machine's current state. The sequential logic circuit or the combinatorial logic circuit can be configured to implement the 3400 process described here. In certain cases, the sequential logic circuit can be synchronous or asynchronous.
[00197] In other aspects, the circuit may comprise a combination of the processor and the finite state machine to implement the compression and decompression techniques described here. In other embodiments, the finite state machine may comprise a combination of the combinational logic circuit and the sequential logic circuit.
[00198] As described here, the position of the clamping arm is
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95/114 detected by a Hall effect sensor in relation to a magnet located in a closing tube of a surgical instrument. Turning now to process 3400, the initial position of the clamping arm, for example, the position of the Hall effect sensor located in the closing tube, is stored 3402 in memory. As the closing tube is moved in a distal direction, the clamping arm is closed in the direction of the ultrasonic blade and the instantaneous position of the clamping arm is stored 3404 in memory. The difference, delta (x), between the instantaneous position and the initial position of the clamping arm is calculated 3406. The difference, delta (x), can be used to determine a change in pipe displacement, which can be used to calculate the angle and force applied by the clamping arm to the tissue located between the clamping arm and the ultrasonic blade. The instantaneous position of the clamping arm is compared to the closed position of the clamping arm 3408 to determine whether the clamping arm is in a closed position. While the clamping arm is not yet in a closed position, process 3400 proceeds along the no (N) path and compares the instantaneous position of the clamping arm with the initial position of the clamping arm until the clamp reaches a closed position.
[00199] When the clamping arm reaches a closed position, process 3400 continues along the yes (Y) path and the closed clamping arm position is applied to an input of a 3410 logic AND function. The AND function of logic 3410 is a high-level representation of a logical operation, which can comprise Boolean AND, OR, XOR and AND operations implemented in software, hardware or a combination of them. When a condition of abuse or wear of the tissue patch is determined based on acoustic impedance measurements, the closing position of the current fixation arm is adjusted 3414 as the new initial position of the fixation arm to compensate for the abuse or wear condition . If
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96/114 no abuse or wear of the tissue patch is determined, the initial position of the fixation arm remains the same. The abuse or wear of the tissue plaster of the clamping arm is determined by monitoring 3420 of the 3422 impedance of the ultrasonic blade. The interface impedance of the ultrasonic blade / tissue patch ID determined 3422 and compared 3412 with a condition of abuse or wear of the tissue patch. When the impedance corresponds to a condition of abuse or wear of the tissue patch, process 3400 proceeds along the path yes (Y) and the current closed position of the clamping arm is defined as the new initial position of the clamping arm to compensate the condition of abuse or wear of the tissue patch. When the impedance does not correspond to a condition of abuse or wear of the tissue patch, process 3400 continues along the no (N) path and the initial position of the clamping arm remains the same.
[00200] The instantaneous position 3404 of the clamping arm is also provided at the input of another logical function AND 3416 to determine the quantity and thickness of the tissue trapped between the clamping arm and the ultrasonic blade. The impedance of the tissue / ultrasonic blade interface is determined 3422 and is compared to 3424, 34267, 3428 for multiple tissue friction coefficients μ = x, μ = y or μ = Z. Thus, when the impedance of the ultrasonic blade / tissue interface corresponds to one of the friction coefficients μ - x, μ - y or μ - z based on the amount or thickness of the tissue, for example, the opening of the clamping arm, the current tissue algorithm is maintained 3430 and the current algorithm is used to monitor 3420 the 3422 impedance of the ultrasonic blade. If the tissue friction coefficient μ = x, μ = y or μ = Z based on the amount or thickness of the tissue, for example, the opening of the clamping arm, is changed 3418 based on the new tissue friction coefficient μ and the amount or thickness of the fabric,
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97/114 for example, the opening of the clamping arm, the current tissue algorithm is used to monitor 3420 the 3422 impedance of the ultrasonic blade.
[00201] Consequently, the current opening of the fixation arm is used to determine the current tissue friction coefficient μ based on the amount and thickness of the fabric, as measured by the opening of the clamping arm. In this way, an initial algorithm can be based on an initial opening of the clamping arm. The impedance of the ultrasonic blade is compared 3424, 3426, 3428 to various tissue friction coefficients μ = x, μ = y ου μ = z, which are stored in a look-up table, and correspond to adipose tissue, mesentery tissue or tissue the vessel, for example. If there is no coincidence between the impedance of the ultrasonic blade and the tissue friction coefficient, the 3400 process proceeds along the non (N) paths of any of the tissue impedance comparisons 3424, 3426, 3428 and the current tissue algorithm is held. If any of the outputs of the comparison functions 3424, 3426, 3428 are true, the processor switches to a different tissue treatment algorithm based on the new tissue impedance and the clamping arm opening. Consequently, a new tissue treatment algorithm is loaded into the ultrasonic instrument. The 3400 process continues by monitoring 3420 the impedance of the ultrasonic blade, the opening of the clamping arm and the abuse or wear of the tissue patch.
[00202] Figure 34 illustrates a Hall 3500 effect sensor system that can be used with the 3400 process of Figure 33, according to an aspect of the present description. In connection with the 3400 process described in Figure 33, the Hall 3500 effect sensor system in Figure 34 includes a Hall effect sensor 3502 powered by a voltage regulator 3504. The output of the Hall effect sensor 3502 is a voltage
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98/114 analog proportional to the position of the clamping arm, which is applied to a 3506 analog-to-digital converter (ADC). The ADO 3506 n-bit digital output is applied to a 3508 microprocessor coupled to a 3510 memory. The 3508 microprocessor is configured to process and determine the clamping arm position based on the ADC 3505 n-bit digital input. that the digital output of the ADC 3506 can be called a count.
[00203] As described in the present invention, the analog output of the Hall effect sensor is provided to an internal or external analog-to-digital converter like the ADC 3506 shown in Figure 34 or any of the analog to digital converter circuits located in the generator. The transducer 104 shown in Figure 6 can comprise a Hall effect sensor comprising an analog to digital converter circuit whose output is applied to control circuit 108. In one aspect, generator 102 shown in Figure 7 comprises several analog / digital converter circuits such as ADCs 176,178,180, which can be adapted and configured to receive the analog voltage output from the Hall effect sensor and convert it into digital forms to obtain counts and to interface the Hall effect sensor with a DSP 174 processor, microprocessor 190, a device logic 166 and / or a controller 196.
[00204] Figure 35 illustrates an aspect of an analog to digital converter (ADC) with ramp counter type 3600 that can be used with the Hall 3500 effect sensor system of Figure 34, according to an aspect of the present description. The digital ramp ADC 3600 receives an analog input voltage from a Hall effect sensor at the positive input terminal Vin of a comparator 3602 and Dn to D0 (Dn to D0) are the digital outputs (n bits). The control line found on a 3606 counter turns on the 3606 counter when it is low and to the 3606 counter when it is high. In operation, the
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99/114 counter 3606 is increased until the value found on counter 3606 corresponds to the value of the analog input signal in Vin. The digital output Dn ~ D0 is applied to a 3604 digital-to-analog converter (DAC) and the analog output is applied to the negative terminal of comparator 3602 and is compared to the analog input voltage in Vin. When this condition is met, the value in counter 3606 is the digital equivalent of the analog input signal in Vin.
[00205] A START pulse is provided for each Vin analog input voltage to be converted into a digital signal. The END signal represents the end of the conversion for each individual analog input voltage found in Vin (each sample), and not for the entire analog input signal. Each clock pulse increases the 3606 counter. Assuming an 8-bit ADC, to convert the analog value of 128 into digital, for example, 128 cycles per instruction would be required. The ADC 3600 counts from 0 to the maximum possible value (2n-1) until the correct digital output Dn-DO value is identified for the analog input voltage present in Vin. When this is true, the END signal is given and the digital value for Vin is for Dn ~ D0.
[00206] Although several aspects have been described, it must be evident, however, that various modifications, alterations and adaptations to these modalities can occur to individuals skilled in the art with the attainment of some or all of the advantages of the invention. The disclosed aspects are, therefore, intended to include all these modifications, alterations and adaptations without departing from the scope and spirit of the invention. Therefore, other aspects and implementations are within the scope of the following claims. For example, the actions mentioned in the claims can be carried out in a different order and still obtain desirable results. [00207] Although several details have been presented in the description above, it will be recognized that the various aspects of the techniques
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100/114 to operate a generator to digitally generate electrical signal waveforms and surgical instruments can be practiced without these specific details. Those skilled in the art will recognize that the components (for example, operations), devices and objectives described in the present invention, and the accompanying discussion, are used as examples with a view to conceptual clarity, and that various configuration changes are contemplated. Consequently, as used in the present invention, the specific examples presented and the accompanying discussion are intended to be representative of their more general classes. In general, the use of any specific specimen is intended to be representative of its class, and the non-inclusion of components (for example, operations), specific devices and objects should not be considered limiting. [00208] Furthermore, although several forms have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the attached claims to such detail. Numerous modifications, variations, alterations, substitutions, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of the present description. In addition, the structure of each element associated with the shape can alternatively be described as a means of providing the function performed by the element. In addition, where materials are revealed for certain components, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to cover all such modifications, combinations and variations that fall within the scope of the modalities presented. The attached claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.
[00209] For brevity and clarity of the description, aspects
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101/114 selected from the description above were presented as a block diagram and not in detail. Some portions of the detailed descriptions provided here can be presented in terms of instructions that operate on data that is stored in one or more computer memories or one or more data storage devices (for example, floppy disk, hard disk drive, compact disk (CD), Digital Video Disc (DVD) or digital tape). These descriptions and representations are used by those skilled in the art to describe and convey the substance of their work to others skilled in the art. In general, an algorithm refers to the self-consistent sequence in steps that lead to the desired result, where a step ”refers to the manipulation of physical quantities and / or logical states that may, although not necessarily need to, take the form of electrical signals or magnetic devices that can be stored, transferred, combined, compared and manipulated in any other way. It is common use to call these signs bits, values, elements, symbols, characters, terms, numbers or the like. These terms and similar terms may be associated with the appropriate physical quantities and are merely convenient identifications applied to these quantities and / or states.
[00210] Unless otherwise stated, as is evident from the preceding description, it is understood that, throughout the preceding description, discussions that use terms such as processing, or computation, or calculation, or determination, or display, or the like , refer to the action and processes of a computer, or similar electronic computing device, that manipulates and transforms the data represented in the form of physical (electronic) quantities in the computer's records and memories into other data represented in a similar way under the form of physical quantities in the memories or records of the
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102/114 computer, or other similar information storage, transmission or display devices.
[00211] In a general sense, those skilled in the art will recognize that the various aspects described here, which can be implemented, individually and / or collectively, through a wide range of hardware, software, firmware, or any combination thereof, can be seen as being composed of various types of '' electrical circuits. Consequently, as used in the present invention, electrical circuits include, but are not limited to, electrical circuits that have at least one discrete electrical circuit, electrical circuits that have at least one integrated circuit, electrical circuits that have at least one integrated circuit for application electrical circuits that form a general-purpose computing device configured by a computer program (for example, a general-purpose computer configured by a computer program that at least partially performs processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially performs the processes and / or devices described here), electrical circuits that form a memory device (for example, forms of random access memory), and / or electrical circuits that form a device communications (for example, a modem, routers or optical-electrical equipment). Those skilled in the art will recognize that the subject described here can be implemented in an analog or digital way, or in some combination of these.
[00212] The previous detailed description presented various forms of the devices and / or processes through the use of block diagrams, flowcharts and / or examples. Although these block diagrams, flowcharts and / or examples contain one or more functions and / or operations, it will be understood by those skilled in the art that each
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103/114 function and / or operation within these block diagrams, flowcharts and / or examples can be implemented, individually and / or collectively, through a wide range of hardware, software, firmware or virtually any combination of these. In one embodiment, several portions of the subject described here can be implemented through application-specific integrated circuits (ASICs), field programmable port arrangements (FPGAs), digital signal processors (PSDs) or other integrated formats. However, those skilled in the art will recognize that some aspects of the modalities disclosed herein, in whole or in part, can be implemented in an equivalent manner in integrated circuits, such as one or more computer programs running on one or more computers (for example, as a or more programs running on one or more computer systems), as one or more programs running on one or more processors (for example, as one or more programs running on one or more microprocessors), as firmware, or virtually as any combination of and that designing the circuitry and / or writing the code for the software and firmware would be within the scope of practice of an element versed in the technique in the light of this description. In addition, those skilled in the art will understand that the mechanisms of the subject described herein can be distributed as one or more program products in a variety of ways and that an illustrative form of the subject described here is applicable regardless of the specific type of transmission medium. signals used to effectively carry out the distribution. Examples of a signal transmission medium include, but are not limited to, the following: a recordable media such as a floppy disk, a hard disk drive, a compact disc (CD), a digital video disc (DVD), a tape digital, computer memory, etc .; and transmission-type media, such as digital and / or analog communication media (for example, a fiber cable
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104/114 optical, a waveguide, a wired communication link, a wireless communication link (for example, transmitter, receiver, transmission logic, reception logic, etc.), etc.).
[00213] In some cases, one or more elements can be described using the expression coupled and connected together with their derivatives. It must be understood that these terms are not meant to be synonymous with each other. For example, some aspects can be described using the term connected to indicate that two or more elements are in direct physical contact or in electrical contact with each other. In another example, some aspects can be described using the coupled term to indicate that two or more elements are in direct physical contact or in electrical contact. The coupled term, however, can also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other. It must be understood that the architectures represented by different components contained within, or connected to other different components are merely examples, and that, in fact, many other architectures that achieve the same functionality can be implemented. In the conceptual sense, any arrangement of components to achieve the same functionality is effectively associated if the desired functionality is achieved. Thus, any two components mentioned in the present invention that are combined to achieve a specific functionality can be seen as associated with each other if the desired functionality is achieved, regardless of the architectures or intermediate components. Similarly, any of these two components so associated can also be seen as being operationally connected or operationally coupled to each other to achieve the desired functionality, and
Petition 870190062513, of 07/04/2019, p. 107/162
105/114 any of these two components capable of being associated in this way can be seen as' Operationally coupled to each other to achieve the desired functionality. Specific examples of operationally dockable components include, but are not limited to, physically interlocking and / or physically interacting components and / or those that can interact wirelessly and / or components that interact wirelessly and / or that interact logically and / or components that can interact by logic and / or components that interact electrically and / or components that can interact electrically and / or components that interact optically and / or components that can interact optically.
[00214] In other cases, one or more components in the present invention may be called configured for, configurable for, operable / operational for, adapted / adaptable for, capable of, conformable / conformed for, etc. Those skilled in the art will recognize that configured to can, in general, cover components in an active state and / or components in an inactive state and / or components in a standby state, except when the context determines otherwise.
[00215] Although specific aspects of the present description have been shown and described, it will be evident to those skilled in the art that, based on the teachings of the present invention, changes and modifications can be made without departing from the subject described here and its broader aspects and, therefore, the appended claims cover in their scope all these changes and modifications in the same way that they are within the true scope of the subject described here. It will be understood by those skilled in the art that, in general, the terms used here, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as open terms (for example, the term including
Petition 870190062513, of 07/04/2019, p. 108/162
106/114 should be interpreted as including, but not limited to, the term having must be interpreted as having, at least, the term includes must be interpreted as including, but not limited to, etc.). It will also be understood by those skilled in the art that, when a specific number of a claim statement entered is intended, that intention will be expressly mentioned in the claim and, in the absence of such mention, no intention will be present. For example, as an aid to understanding, the following appended claims may contain the use of introductory phrases at least one and one or more to introduce claim statements. However, the use of such phrases should not be interpreted as implying that the introduction of a claim statement by the indefinite articles one, one or one, ones limits any specific claim containing the mention of the claim entered to claims that contain only such a mention, even when the same claim includes introductory phrases one or more or at least one and indefinite articles, such as one, ones or one, ones (for example, one, ones and / or one, ones should typically be interpreted as meaning at least one or one or more); the same goes for the use of defined articles used to introduce claims.
[00216] Furthermore, even if a specific number of an introduced claim statement is explicitly mentioned, those skilled in the art will recognize that that statement must typically be interpreted as meaning at least the number mentioned (for example, the mere mention of two mentions , without other modifiers, typically means at least two mentions, or two or more mentions). In addition, in cases where a convention analogous to at least one of A, B and C, etc. is used, in general this construction is intended to have the meaning in which the convention would be
Petition 870190062513, of 07/04/2019, p. 109/162
107/114 understood by (for example, a system that has at least one of A, B and C would include, but would not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B and C together, etc.). In cases where a convention analogous to at least one of A, B or C, etc. is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, a system that has at least one of A, B and C would include, but would not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B and C together, etc.). It will be further understood by those skilled in the art that typically a disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, in the claims or in the drawings, must be understood as contemplating the possibility of including one of the terms, any of the terms or both terms, except where the context dictates something different. For example, the phrase A or B will typically be understood to include the possibilities of A or B or A and B.
[00217] With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be performed in any order. In addition, although several operational flows are presented in one or more sequences, it must be understood that the various operations can be performed in orders other than those shown, or can be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse or other variant orders, except when the context determines otherwise. In addition, terms such as responsive to, related to or other adjectival participles are not intended to generally exclude these variants, except when the
Petition 870190062513, of 07/04/2019, p. 110/162
108/114 context determine otherwise.
[00218] It is worth noting that any reference to an (1) aspect, an aspect, a (1) shape or a shape means that a particular feature, structure or characteristic described in connection with the aspect is included in at least one aspect. Thus, the use of expressions as in one (1) aspect, in one aspect, in one (1) modality, in one modality, in several places throughout this specification does not necessarily refer to the same aspect. In addition, specific features, structures or characteristics can be combined in any appropriate way in one or more aspects.
[00219] With respect to the use of substantially any plural and / or singular terms in the present invention, those skilled in the art may change from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. The various singular / plural permutations are not expressly presented here for the sake of clarity.
[00220] In certain cases, the use of a system or method can occur even if the components in a territory are located outside the territory. For example, in a distributed computing context, the use of a distributed computing system can occur in a region even though parts of the system can be located outside the territory (for example, relay, server, processor, signal containing medium, transmission of computer, computer, etc., located outside the territory).
[00221] A sale of a system or method may likewise occur in a territory even if the components of the system and / or method are located and / or are used outside the territory. Additionally, the implementation of at least part of a system to execute a method in a territory does not prevent the use of the system
Petition 870190062513, of 07/04/2019, p. 111/162
109/114 in another territory.
[00222] All US patents, US patent application publications, US patent applications, foreign patents, foreign patent applications and non-patent publications mentioned in this specification and / or listed on any Order Data Sheet (ADS, Application Data Sheet), or any other description material are hereby incorporated by reference, insofar as they are not inconsistent with the content of this description. Accordingly, and to the extent necessary, the description as explicitly presented herein replaces any conflicting material incorporated by reference to the present invention. Any material, or portion thereof, which is incorporated herein by reference, but which conflicts with the definitions, statements, or other description materials contained herein, will be incorporated here only insofar as there is no conflict between the material and the existing description material.
[00223] In summary, numerous benefits have been described that result from the use of the concepts described in this document. The previously mentioned description of one or more modalities has been presented for purposes of illustration and description. This description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. One or more modalities were chosen and described in order to illustrate the principles and practical application to, thus, allow those skilled in the art to use the various modalities and with various modifications, as they are convenient to the specific use contemplated. The claims presented in the annex are intended to define the global scope.
[00224] Several aspects of the subject described here are defined in the following numbered clauses:
Petition 870190062513, of 07/04/2019, p. 112/162
110/114 [00225] 1. Method for controlling an end actuator, the method being characterized by the fact that it comprises: detecting a signal in response to the movement of a first tube in relation to a second tube, the first being tube activates the movement of a clamping arm of the end actuator; determining a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal; and adjusting a power output to the ultrasonic blade of the end actuator based on the position of the clamping arm.
[00226] 2. Method, according to claim 1, characterized by the fact that the adjustment of the energy output to the ultrasonic blade is achieved by manipulating the electric current sent to the handle.
[00227] 3. Method, according to claim 1 or 2, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the inner tube being movable in relation to the outer tube, the outer tube is static in relation to the inner tube.
[00228] 4. Method according to either claim 2 or 2, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the outer tube being movable in relation to the inner tube , the inner tube being static in relation to the inner tube.
[00229] 5. Method according to any one of claims 4, characterized by the fact that it additionally comprises detecting the signal with the use of a Hall effect sensor and a magnet positioned on the first tube.
[00230] 6. Method according to any one of claims to 5, characterized by the fact that it further comprises moving a magnet positioned in the first tube in relation to an effect sensor
Petition 870190062513, of 07/04/2019, p. 113/162
111/114
Hall as the first tube triggers the movement of the end actuator clamping arm.
[00231] 7. Method according to any one of claims to 6, characterized by the fact that it further comprises adjusting the energy output to the ultrasonic blade of the end actuator with the use of an ultrasonic transducer based on a voltage change in a Hall effect sensor.
[00232] 8. Method according to any one of claims to 7, characterized by the fact that it further comprises adjusting the energy output to the ultrasonic blade of the end actuator dynamically, based on a displacement ratio that changes as that the clamping arm approaches the ultrasonic blade.
[00233] 9. Method according to any one of claims to 8, characterized by the fact that it further comprises adjusting the energy output to the ultrasonic blade of the end actuator dynamically, using an integral proportional controller, based on a ratio of displacement that changes as the clamping arm approaches the ultrasonic blade.
[00234] 10. Method according to any one of claims 1 to 9, characterized by the fact that it additionally comprises completely shutting off the energy output to the ultrasonic blade of the end actuator once a displacement ratio limit has been reached .
[00235] 11. Method according to any one of claims 1 to 10, characterized in that it further comprises: determining a quantity or thickness of the tissue between the clamping arm and the ultrasonic blade based on the signal; and adjusting the energy output to the ultrasonic blade of the end actuator based on the amount or thickness of the tissue.
Petition 870190062513, of 07/04/2019, p. 114/162
112/114 [00236] 12. Method according to claim 11, characterized in that it additionally comprises in response to the determination that the amount or thickness of tissue between the clamping arm and the ultrasonic blade is less than one predetermined limit, reduce the energy output for the ultrasonic blade of the end actuator by a smaller amount than for a greater amount or thickness of tissue.
[00237] 13. Method according to claim 11 or 12, characterized in that it further comprises in response to the determination that the amount or thickness of tissue between the clamping arm and the ultrasonic blade is above a predetermined limit , reduce the energy output for the ultrasonic blade of the end actuator by a greater amount than for a smaller amount or thickness of tissue.
[00238] 14. Apparatus for controlling an end actuator, the apparatus being characterized by the fact that it comprises: a sensor configured to detect a signal in response to the movement of a first tube in relation to a second tube, the first tube activates the movement of a clamping arm of the end actuator; a processor configured to determine a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal; and a transducer configured to adjust an energy output to the ultrasonic blade of the end actuator based on the position of the clamping arm.
[00239] 15. Apparatus, according to claim 14, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the outer tube being movable in relation to the inner tube, the inner tube is static in relation to the outer tube.
Petition 870190062513, of 07/04/2019, p. 115/162
113/114 [00240] 16. Apparatus according to claim 14, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the inner tube being movable in relation to the outer tube , the outer tube being static in relation to the inner tube.
[00241] 17. Apparatus according to any one of claims 14 to 16, characterized by the fact that it further comprises: a magnet positioned on the first tube; and the sensor is a Hall effect sensor used to detect the signal based on a position of the magnet.
[00242] 18. Apparatus according to any of claims 14 to 17, characterized by the fact that the magnet positioned on the first tube moves in relation to a Hall effect sensor as the first tube triggers the movement of the arm of the end actuator.
[00243] 19. Apparatus according to any of claims 14 to 18, characterized by the fact that the transducer is an ultrasonic transducer configured to adjust the energy output to the ultrasonic blade of the end actuator based on a voltage change in a Hall effect sensor.
[00244] 20. Apparatus according to any of claims 14 to 19, characterized by the fact that the transducer is configured to dynamically adjust the energy output to the ultrasonic blade of the end actuator, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
[00245] 21. Apparatus according to any of claims 14 to 20, characterized by the fact that it comprises: a proportional integral controller configured to adjust the energy output to the ultrasonic blade of the end actuator
Petition 870190062513, of 07/04/2019, p. 116/162
114/114 dynamically, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
[00246] 22. Method for calibrating an apparatus to control an end actuator, the method being characterized by the fact that it comprises: detecting a first signal that corresponds to a completely open position of a clamping arm and an ultrasonic blade of the end actuator; detecting a second signal that corresponds to an intermediate position of the clamping arm and the ultrasonic blade of the end actuator, the intermediate position resulting from the holding of a rigid body between the clamping arm and the ultrasonic blade; and detecting a third signal that corresponds to a completely closed position of the clamping arm and the ultrasonic blade of the end actuator.
[00247] 23. Method, according to claim 22, characterized by the fact that it additionally comprises: determining a best fit curve to represent the signal strength as a function of the sensor displacement based on at least one of the first, the second and third signs, the positions completely open, intermediate and completely closed, and a dimension of the rigid body.
[00248] 24. Method, according to claim 22 or 23, characterized by the fact that it comprises: creating a lookup table based on at least one of the first, second and third signs, and in the completely open, intermediate positions and completely closed.

权利要求:
Claims (24)
[1]
1. Method for controlling an instrument an end actuator, characterized by the fact that it comprises:
detecting a signal in response to the movement of a first tube in relation to a second tube, the first tube activating the movement of a clamping arm of the end actuator;
determining a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal; and adjusting a power output to the ultrasonic blade of the end actuator based on the clamping arm position.
[2]
2. Method, according to claim 1, characterized by the fact that the adjustment of the power output to the ultrasonic blade is achieved by manipulating the electric current sent to the handle.
[3]
3. Method, according to claim 1, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the inner tube being movable in relation to the outer tube, the outer tube being it is static in relation to the inner tube.
[4]
4. Method, according to claim 1, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the outer tube being movable in relation to the inner tube, the inner tube being it is static in relation to the inner tube.
[5]
5. Method, according to claim 1, characterized by the fact that it additionally comprises detecting the signal with the use of a Hall effect sensor and a magnet positioned on the first tube.
[6]
6. Method according to claim 1, characterized by the fact that it additionally comprises moving a magnet positioned on the first tube in relation to a Hall effect sensor as the first tube activates the movement of the clamping arm of the
Petition 870190062513, of 07/04/2019, p. 118/162
2/5 end actuator.
[7]
7. Method, according to claim 1, characterized by the fact that it additionally comprises adjusting the power output to the ultrasonic blade of the end actuator with the use of an ultrasonic transducer based on a voltage change in a Hall effect sensor .
[8]
8. Method according to claim 1, characterized by the fact that it additionally comprises adjusting the power output to the ultrasonic blade of the end actuator dynamically, based on a displacement ratio that changes as the clamping arm approaches of the ultrasonic blade.
[9]
9. Method according to claim 1, characterized by the fact that it additionally comprises adjusting the power output to the ultrasonic blade of the end actuator dynamically, using an integral proportional controller, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
[10]
10. Method according to claim 1, characterized by the fact that it additionally comprises completely disconnecting the power output to the ultrasonic blade of the end actuator once a displacement ratio limit has been reached.
[11]
11. Method according to claim 1, characterized by the fact that it additionally comprises:
determining a quantity or thickness of the tissue between the clamping arm and the ultrasonic blade based on the signal; and adjusting the power output to the ultrasonic blade of the end actuator based on the amount or thickness of the tissue.
[12]
12. Method according to claim 11, characterized by the fact that it additionally comprises in response to the determination that the amount or thickness of tissue between the arm
Petition 870190062513, of 07/04/2019, p. 119/162
3/5 of tightening and the ultrasonic blade is less than a predetermined limit, reduce the power output to the ultrasonic blade of the end actuator by a smaller amount than for a greater amount or thickness of tissue.
[13]
13. Method according to claim 11, characterized in that it further comprises in response to the determination that the amount or thickness of tissue between the clamping arm and the ultrasonic blade is above a predetermined limit, reducing the output of power for the ultrasonic blade of the end actuator in an amount greater than for a lesser amount or thickness of tissue.
[14]
14. Apparatus for controlling an end actuator, characterized by the fact that it comprises:
a sensor configured to detect a signal in response to the movement of a first tube in relation to a second tube, the first tube triggering the movement of a clamping arm of the end actuator;
a processor configured to determine a position of the end actuator clamping arm in relation to an ultrasonic blade of the end actuator based on the signal; and a transducer configured to adjust a power output to the ultrasonic blade of the end actuator based on the clamping arm position.
[15]
15. Apparatus according to claim 14, characterized by the fact that the first tube is an inner tube and the second tube is an outer tube, the outer tube being movable in relation to the inner tube, the inner tube being it is static in relation to the outer tube.
[16]
16. Apparatus according to claim 14, characterized by the fact that the first tube is an inner tube and the
Petition 870190062513, of 07/04/2019, p. 120/162
4/5 second tube is an outer tube, the inner tube being movable in relation to the outer tube, the outer tube being static in relation to the inner tube.
[17]
17. Apparatus according to claim 14, characterized by the fact that it additionally comprises:
a magnet positioned on the first tube; and the sensor is a Hall effect sensor used to detect the signal based on a position of the magnet.
[18]
18. Apparatus according to claim 14, characterized by the fact that the magnet positioned in the first tube moves in relation to a Hall effect sensor as the first tube activates the movement of the clamping arm of the end actuator.
[19]
19. Apparatus according to claim 14, characterized by the fact that the transducer is an ultrasonic transducer configured to adjust the power output to the ultrasonic blade of the end actuator based on a voltage change in a Hall effect sensor.
[20]
20. Apparatus according to claim 14, characterized by the fact that the transducer is configured to dynamically adjust the power output to the ultrasonic blade of the end actuator, based on a displacement ratio that changes as the tightness approaches the ultrasonic blade.
[21]
21. Apparatus according to claim 14, characterized by the fact that it additionally comprises:
an integral proportional controller configured to dynamically adjust the power output to the ultrasonic blade of the end actuator, based on a displacement ratio that changes as the clamping arm approaches the ultrasonic blade.
[22]
22. Method for calibrating an apparatus to control an end actuator, characterized by the fact that it comprises:
Petition 870190062513, of 07/04/2019, p. 121/162
5/5 detect a first signal that corresponds to a completely open position of a clamping arm and an ultrasonic blade of the end actuator;
detecting a second signal that corresponds to an intermediate position of the clamping arm and the ultrasonic blade of the end actuator, the intermediate position resulting from the holding of a rigid body between the clamping arm and the ultrasonic blade; and detecting a third signal that corresponds to a completely closed position of the clamping arm and the ultrasonic blade of the end actuator.
[23]
23. Method, according to claim 22, characterized by the fact that it additionally comprises:
determine a best fit curve to represent the signal strength as a function of the sensor shift based on at least one of the first, second and third signals, completely open, intermediate and completely closed positions, and a dimension of the rigid body.
[24]
24. Method, according to claim 22, characterized by the fact that it additionally comprises:
create a lookup table based on at least one of the first, second and third signals, and in the completely open, intermediate and completely closed positions.

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法律状态:
2021-10-05| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2022-02-22| B06W| Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US15/363,244|US11266430B2|2016-11-29|2016-11-29|End effector control and calibration|

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PCT/US2017/062959|WO2018102210A1|2016-11-29|2017-11-22|End effector control and calibration system|

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