Powered surgical stapling device

ES 2 646 491 T3

DESCRIPTION

Powered Surgical Stapling Device

Background

Technical field

The present disclosure relates to a surgical stapler for implanting mechanical surgical fasteners in the tissue of a patient, and in particular, to a surgical stapler that is powered by a motor for firing surgical fasteners into tissue and a feedback controller to control the stapler in response to one or more feedback signals felt.

Background of Related Art

Currently known devices may typically require 4.5-27.2 kg (10-60 pounds) of manual force to grasp tissue and unfold and form surgical fasteners in tissue which, with repetitive use, can cause the surgeon's hand to become fatigued. Gas-fired pneumatic staplers are known in the art that implant surgical fasteners in tissue. Some of these instruments use a pressurized gas supply that connects to a trigger mechanism. The trigger mechanism, when depressed, simply releases pressurized gas to implant a fastener in tissue.

Motor driven surgical staplers are also known in the art. These include powered surgical staplers that have motors that activate staple firing mechanisms. However, these motor driven devices only provide the user with limited control of the stapling process. The user can only toggle a single switch and / or button to operate the motor and apply the corresponding torque to the trigger mechanisms of the stapler. In certain other devices, a controller is used to control the stapler.

There is a continuing need for newer and better powered surgical staplers that include various sensors. The sensors provide pertinent feedback to feedback controllers that automatically adjust various parameters of the fed stapler in response to feedback signals felt representative of the operation of the stapler.

Document CA 2 451 558 describes an electro-mechanical surgical device with a data memory unit.

European patent EP 1 813 199 describes a surgical instrument having a feedback system.

US 2006/0278680 describes a surgical stapler with timer and feedback display.

US 5,954,259 describes a self-contained powered surgical apparatus for applying surgical fasteners.

The device of the latter document comprises a drive motor, a firing rod, an end effector, and a position and velocity calculator. Speed ​​and position are calculated by means of the output of an encoder that counts the revolutions of the push rod.

Compendium

The aspect and embodiments of the present invention are presented in the claims.

According to one aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is longitudinally translated and rotatable by the motor about the first longitudinal axis extending therethrough. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector is in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector. The stapler further includes a main drive switch that includes first and second switches formed together as a rocker switch. The first switch is adapted to activate the drive motor in a first direction to facilitate a first surgical end effector function and the second switch is adapted to activate the drive motor in a second direction to facilitate a second surgical end effector function.

According to another aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is moved 2

ES 2 646 491 T3 longitudinally by the engine. The stapler also includes a loading unit configured to removably connect to the endoscopic portion. The charging unit includes an end effector in mechanical cooperation with the firing rod so that the firing rod drives a surgical function of the end effector. The stapler also includes a load unit identification system that includes an identifier that identifies and disposes of the load unit and an interrogator configured to interface with the identifier to obtain an identification code uniquely associated with the unit. loading. The interrogator determines if the charge unit has been previously fired.

In one embodiment, the identifier and the interrogator are wireless transceivers configured to communicate with each other wirelessly. In another embodiment, the identifier is an electrical identifier having at least one of a rheostat, a capacitor, and an inductor, and the electrical identifier includes at least one electrical property uniquely associated with an identification code. The interrogator includes at least one contact adapted to interface with the electrical identifier and to determine the identification code based on the at least one electrical property.

In another embodiment, the identifier is a magnetic device having at least one of an identifier coded magnet and a ferrous node arranged in a predetermined magnetic pattern uniquely associated with an identification code. The interrogator is a magnetic sensor adapted to interface with the magnetic identifier and to determine the identification code based on predetermined magnetic patterns. The magnetic sensor can be a ferromagnetic sensor or a Hall effect sensor.

In a further embodiment, the identifier includes a plurality of protrusions configured to interface with a displacement sensor such that the displacement pattern corresponds to the identification code.

In another embodiment, the powered surgical stapler also includes a user interface that includes a plurality of visual outputs configured to convey an operating state of at least one of the loading unit and the powered surgical stapler based on a combination of al minus a part of the plurality of visual outputs that are activated. The user interface further includes a haptic feedback mechanism having an asynchronous motor disposed within the housing and configured to provide vibratory feedback that varies in intensity as a function of force exerted on the powered surgical stapler.

In one embodiment, the end effector includes a pair of opposing tissue engaging surfaces for deforming a plurality of surgical fasteners through tissue and holding the tissue, the tissue engaging surfaces are movable relative to one another between a position of opening and an approach position in which the tissue engaging surfaces are juxtaposed with each other. The end effector also includes a first tissue sensor and a second tissue sensor disposed on each of the tissue engaging surfaces respectively, the first and second tissue sensors configured to generate a field between them and to detect variations in the field indicative of foreign tissue. The first and second tissue sensors are calibrated to ignore at least one of air, body fluids, and tissue.

According to a further aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is longitudinally translated by the motor around the first longitudinal axis extending therethrough. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector is in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector. The stapler further includes a power source coupled to the drive motor. The power supply includes one or more power cells and one or more ultracapacitors encased within an insulating shield formed of an absorbent and flame retardant material.

The powered surgical stapler may also include a power adapter further configured to couple to an electrosurgical generator to provide power to charge the power source. In one embodiment, the powered surgical stapler may further include an inductive charging interface that includes an inductive coil disposed within the housing, wherein by positioning the housing and the inductive coil disposed therein within an electromagnetic field, the inductive coil converts the direct current electromagnetic field energy to charge the power supply.

In another embodiment, the powered surgical stapler may include a discharge circuit having a switch and a resistive load coupled to the power source, wherein upon activating the switch the power source is discharged to the resistive load.

The powered surgical stapler may also include a motor and a battery operating module coupled to at least one thermal sensor, the motor and battery operating module are configured to monitor the temperature of at least one of the drive motor and the source. feeding. The thermal sensor

ES 2 646 491 T3 can be a thermistor, a thermopile, a thermocouple or an Infrared thermal sensor.

In a further embodiment, the power supply further includes a temperature sensor for measuring the temperature therein and an embedded microcontroller for storing a unique identifier associated with the power supply. The powered surgical stapler may also include a microcontroller configured to interface with the embedded microcontroller to interrogate the microcontroller and to obtain the temperature and unique identifier of the power supply from it, wherein the microcontroller authenticates the power supply if it is required. temperature is within a predetermined operating range and the unique identifier is valid.

According to yet another aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is longitudinally translated by the motor. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector is in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector. The stapler further includes a position calculator to determine the current linear position of the firing rod. The position calculator is coupled to a linear displacement sensor disposed adjacent to the firing rod and configured to detect linear movement of the firing rod. The stapler further includes a speed calculator to determine at least one of the linear speed of the firing rod and rotational speed of the drive motor.

The firing rod may include a first indicator and a second indicator disposed thereon. The powered surgical stapler may include a stem home position sensor configured to signal to the position calculator when the first pointer interfaces with it, wherein the position of the first pointer denotes the start of firing rod movement and a clamping position sensor configured to signal the position calculator when the second indicator forms an interface with it, wherein the position of the second indicator denotes clamping of the end effector.

In one embodiment, at least a portion of the firing rod is magnetized or the firing rod may include a magnetic material disposed therein and the linear displacement sensor is configured to detect variations in the magnetic field corresponding to movement of the rod. shooting. The linear displacement sensor can be a ferromagnetic sensor or a Hall effect sensor.

In another embodiment, the linear displacement sensor can be a potentiometer or a rheostat and the trigger rod includes a contact in electromechanical contact with the linear displacement sensor, wherein the linear displacement sensor is configured to detect movement of the control rod. trigger based on a change of at least one electrical property thereof.

The speed calculator can be coupled to the linear displacement sensor, and the speed calculator can be configured to determine the linear speed of the trip rod based on the rate of change of the trip rod. The speed calculator is coupled to a rotational speed detecting apparatus having at least one encoder for transmitting pulses corresponding to the rotational speed of the drive motor.

In a further embodiment, a voltage sensor is connected to the drive motor that measures counter electromotive force thereof. The speed calculator can be coupled to the tension sensor and can be configured to determine at least one of the linear speed of the firing rod and rotational speed of the drive motor based on the measured electromotive force.

The powered surgical stapler may also include a current sensor coupled to a shunt rheostat that connects to the drive motor, the current sensor is configured to measure drive motor current draw, the speed calculator is coupled to the drive motor. current and is configured to determine at least one of the linear speed of the firing rod and rotational speed of the drive motor based on current consumption. The speed calculator is configured to compare the trip rod linear speed and the drive motor current draw to determine if the drive motor rotation is sufficiently translated to the trip rod. The speed calculator can also be configured to compare the linear speed of the firing rod and the rotational speed of the drive motor to determine if the rotation of the drive motor is sufficiently translated to the firing rod. In a further embodiment, the position calculator and the speed calculator are coupled to a control system that includes a microcontroller.

According to one aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is moved

ES 2 646 491 T3 longitudinally by the engine. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector defines a second longitudinal axis that is in mechanical cooperation with the firing rod so that the firing rod drives a surgical function of the end effector. The stapler further includes a hinge mechanism that includes a hinge motor configured to move the end effector between a first hinge position where the second longitudinal axis is substantially aligned with the first longitudinal axis toward a second hinge position where the second longitudinal axis is arranged at an angle to the first longitudinal axis. Additionally, the stapler includes an articulation sensor configured to determine during articulation when the end effector is in the first position, the articulation sensor is coupled to the articulation motor and is configured to signal the articulation motor to cease articulation when the articulation ceases. end effector is in the first position.

According to a further aspect of the present disclosure, a powered surgical stapler is disclosed. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is longitudinally translated by the motor about the first longitudinal axis extending therethrough. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector is in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector. The stapler further includes a control system having a plurality of sensors coupled to the drive motor, firing rod, loading unit, and end effector, the plurality of sensors configured to detect operating parameters thereof. The control system also includes a microcontroller coupled to the plurality of sensors and configured to determine the operating status of the powered surgical stapler as a function of detected operating parameters.

In one embodiment, the control system is adapted to couple to an external feedback controller configured to process the operating state of the powered surgical stapler to generate an output. The feedback controller is adapted to couple to a video processor, a video display, a heads-up-display (HUD) and a computing device. The feedback controller includes: an on-screen display module configured to overlap the output of the feedback controller on the video display and a HUD module configured to overlap the output of the feedback controller on the HUD display.

Brief description of the drawings

Various embodiments of the subject instrument are described herein with reference to the drawings, where:

Figure 1 is a perspective view of a powered surgical instrument according to one embodiment of the present disclosure;

Figure 2 is an enlarged partial perspective view of the powered surgical instrument in accordance with the embodiment of the present disclosure of Figure 1;

Figure 3 is a partial enlarged plan view of the powered surgical instrument in accordance with the embodiment of the present disclosure of Figure 1;

Figure 4 is a partial perspective sectional view of internal components of the powered surgical instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 5 is a perspective view of an articulation mechanism with separate parts of the powered surgical instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 6 is a partial cross-sectional view showing internal components of the powered surgical instrument according to the embodiment of the present disclosure of Figure 1 arranged in a first position;

Figure 7 is a partial cross-sectional view showing internal components of the powered surgical instrument according to the embodiment of the present disclosure of Figure 1 arranged in a second position;

Figure 8 is a perspective view of the mounting assembly and proximal body portion of a loading unit with separate parts of the powered surgical instrument of Figure 1 in accordance with one embodiment of the present disclosure;

Figure 9 is a cross-sectional side view of an end effector of the powered surgical instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 10 is a partial enlarged side view showing internal components of the powered surgical instrument in accordance with the embodiment of the present disclosure of Figure 1;

ES 2 646 491 T3

Figure 11 is a perspective view of a one-way clutch plate of the powered Surgical Instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 12 is a partial enlarged side view showing internal components of the powered surgical instrument according to the embodiment of the present disclosure of Figure 1;

Figure 13 is a schematic diagram of a power source of the powered surgical instrument in accordance with the embodiment of the present disclosure of Figure 1;

Figure 14 is a flow chart illustrating a method for authenticating the power source of the powered surgical instrument of Figure 1;

Figures 15A-B are partial rear perspective views of a loading unit of the powered surgical instrument in accordance with the embodiment of the present description of Figure 1;

FIG. 16 is a flow chart illustrating a method for authenticating the loading unit of the powered surgical instrument in accordance with the embodiment of the present description of FIG. 1;

Figure 17 is a perspective view of the loading unit of the powered surgical instrument according to the embodiment of the present description of Figure 1;

Figure 18 is a cross-sectional side view of the end effector of the powered surgical instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 19 is a cross-sectional side view of the powered surgical instrument of Figure 1 according to one embodiment of the present disclosure;

Figure 20 is a schematic diagram of a powered surgical instrument control system in accordance with the embodiment of the present description of Figure 1;

Figure 21 is a schematic diagram of a feedback control system according to the present disclosure;

Figures 22A-B are front and rear perspective views of a feedback controller of the feedback control system according to the embodiment of the present disclosure;

Fig. 23 is a schematic diagram of the feedback controller in accordance with the embodiment of the present disclosure;

Figure 24 is a partial sectional view of internal components of a powered surgical instrument according to one embodiment of the present disclosure;

Figure 25 is a partial perspective sectional view of internal components of the powered surgical instrument according to one embodiment of the present disclosure;

Figure 26 is a partial perspective view of a nose assembly of the powered surgical instrument in accordance with one embodiment of the present disclosure;

Figure 27 is a partial perspective view of a retraction lever of the powered surgical instrument according to one embodiment of the present disclosure;

Figure 28 is a partial perspective view of the powered surgical instrument according to one embodiment of the present disclosure;

Figure 29 is a perspective view of the powered surgical instrument according to one embodiment of the present disclosure;

Figure 30 is a perspective view of a modular retraction assembly of the powered surgical instrument according to one embodiment of the present disclosure;

Figure 31 is an enlarged partial sectional view of internal components of a powered surgical instrument according to one embodiment of the present disclosure; Y

Figure 32 is an enlarged partial sectional view of internal components of a powered surgical instrument according to one embodiment of the present disclosure.

Detailed description

Embodiments of the currently described powered surgical instrument are now described in detail with reference to the drawings, in which like reference numerals designate identical elements or 6

ES 2 646 491 T3 corresponding in each of the several views. As used herein the term "dlstal" refers to the part of the powered surgical instrument, or component thereof, furthest from the user, while the term "proximal" refers to the part of the powered surgical instrument or component thereof, closest to the user. of the user.

A powered surgical instrument, e.g. For example, a surgical stapler, in accordance with the present disclosure, is referred to in the figures as reference numeral 10. Referring initially to Figure 1, the powered surgical instrument 10 includes a housing 110, an endoscopic portion 140 defining a first longitudinal axis AA extending therethrough, and an end effector 160, defining a second longitudinal axis BB extending therethrough. Endoscopic portion 140 extends distally from housing 110 and end effector 160 is disposed adjacent a distal portion of endoscopic portion 140. In one embodiment, housing components 110 are sealed against infiltration of particle and / or fluid contamination. and help prevent component damage from the sterilization process.

In accordance with one embodiment of the present disclosure, end effector 160 includes a first jaw member having one or more surgical fasteners (eg, cartridge assembly 164) and a second opposing jaw member that includes an anvil portion for unfolding and forming surgical fasteners (eg, anvil assembly 162). In certain embodiments, the staples are housed in a cartridge assembly 164 to apply linear rows of staples to body tissue either simultaneously or sequentially. Either one or both of the anvil assembly 162 and the cartridge assembly 164 are movable with respect to the other between an open position in which the anvil assembly 162 is spaced from the cartridge assembly 164 and a clamping or approaching position. wherein the anvil assembly 162 is in juxtaposed alignment with the cartridge assembly 164.

It is further envisioned that the end effector 160 is connected to a mounting portion 166, which is pivotally connected to a body portion 168. The body portion 168 may be integral with the endoscopic portion 140 of the powered surgical instrument 10, or can be removably connected to instrument 10 to provide a replaceable Disposable Loading Unit (DLU) or Single Use Loading Unit (SULU) (eg. e.g. load unit 169). In certain embodiments, the reusable portion can be configured for sterilization and reuse in a subsequent surgical procedure.

Charging unit 169 may be connectable to endoscopic portion 140 via a bayonet connection. The load unit 169 is envisioned to have an articulation link connected to the mounting portion 166 of the load unit 169 and the articulation link connects to a link rod so that the end effector 160 articulates when the rod The linkage translates distal-proximally along the first longitudinal axis AA. Other means may be used to connect end effector 160 to endoscopic portion 140 to allow articulation, such as a flexible tube or a tube comprising a plurality of pivotable members.

Loading unit 169 can be incorporated or configured to incorporate various end effectors, such as vessel sealing devices, linear stapling devices, circular stapling devices, cutters, and the like. Such end effectors may be coupled to the endoscopic portion 140 of the powered surgical instrument 10. The loading unit 169 may include a non-articulating linear stapling end effector. An intermediate flexible stem may be included between the handle portion 112 and the loading unit. It is conceived that the incorporation of a flexible stem can facilitate access to and / or within certain areas of the body.

Referring to FIG. 2, an enlarged view of housing 110 is illustrated in accordance with one embodiment of the present disclosure. In the illustrated embodiment, housing 110 includes a handle portion 112 having a main drive switch 114 disposed thereon. Switch 114 may include first and second switches 114a and 114b formed together as a rocker switch. The handle portion 112, which defines a handle axis HH, is configured to be grasped by the fingers of a user. The handle portion 112 is ergonomically shaped that provides abundant palm grip lever that helps prevent the handle portion 112 from slipping out of the user's hand during operation. Each switch 114a and 114b is shown arranged in a suitable location on the handle portion 112 to facilitate its being depressed by a finger or fingers of a user.

Additionally, and with reference to Figures 1 and 2, switches 114a, 114b can be used to start and / or stop movement of drive motor 200 (Figure 4). In one embodiment, switch 114a is configured to activate drive motor 200 in a first direction to advance firing rod 220 (FIG. 5) distally thereby gripping cartridge and anvil assemblies 162 and 164. Rather, switch 114b can be configured to retract firing rod 220 to open cartridge and anvil assemblies 162 and 164 by energizing drive motor 200 in reverse. The retract mode initiates a mechanical lock, preventing further stapling and cutting progression from the load unit 169. The rocker has a first position for activating switch 114a, a second position for activating switch 114b, and a neutral position between the first and second positions. Details of operation of the drive components of instrument 10 are discussed in more detail below.

Housing 110, particularly handle portion 112, includes switch guards 117a and 117b. The switch guards 117a and 117b may have a rib-like shape that surrounds the bottom of the switch.

ES 2 646 491 T3 switch 114a and the top of Switch 114b, respectively. Switch protector 117a and 117b Prevent accidental activation of switch 114. In addition, switches 114a and 114b have high tactile feedback that requires more pressure for activation.

In one embodiment, Switches 114a and 114b are configured as multi-speed Switches (eg, two or more), variable or incremental speed, that control the speed of drive motor 200 and trip rod 220 in a non-linear. For example, switches 114a, b can be pressure sensitive. This type of control interface allows a gradual increase in the speed rate of the drive components from a slower and more precise mode to a faster operation. To prevent accidental activation of the retract, switch 114b can be electronically tripped until a fail-safe switch is depressed. Additionally, a third switch 114c can also be used for this purpose. Additionally or alternatively, the backlash can be overcome by pressing and holding switch 114b for a predetermined period of time from about 100 ms to about 2 seconds. Trigger rod 220 then automatically retracts to its home position unless switch 114b is activated (eg, pressed and released) during the retract mode to stop retracting. Subsequent depressing of switch 114b upon release thereof resumes retraction. Alternatively, retraction of trip rod 220 can continue to full retraction even if switch 114b is released, in other embodiments.

Switches 114a and 114b are coupled to a non-linear speed control circuit 115 that can be implemented as a voltage regulating circuit, a variable resistance circuit, or a pulse width modulation microelectronic circuit. Switches 114a and 144b may interface with control circuit 115 by moving or actuating variable control devices, such as rheostatic devices, multiple position switch circuit, variable displacement linear and / or rotary transducers, linear potentiometers, and / or rotaries, optical encoders, ferromagnetic sensors and Hall effect sensors. This allows switches 114a and 114b to operate drive motor 200 in multiple speed modes, such as gradually increasing the speed of drive motor 200 either incrementally or gradually depending on the type of control circuit 115 that is used, over the base of the depressing of switches 114a and 114b.

In a particular embodiment, the switch 114c (Figures 1, 2 and 4) can also be included, where the depressing thereof can mechanically and / or electrically change the operating mode from clamping to firing. Switch 114c is recessed within housing 110 and has high tactile feedback to prevent false actuation. Providing a separate control switch to initiate firing mode allows the end effector jaws to be repeatedly opened and closed, so that instrument 10 is used as a gripper until switch 114c is pressed, thus activating stapling and / or cutting . Switch 114 may include one or more microelectronic membrane switches, for example. Such a microelectronic membrane switch includes a relatively low actuation force, small size, ergonomic size and shape, low profile, the ability to include switch cast letters, symbols, representations and / or indications, and low cost of material. Additionally, switches 114 (such as microelectronic membrane switches) can be sealed to help facilitate sterilization of instrument 10, as well as to help prevent contamination with particles and / or fluids.

As an alternative to or in addition to switches 114, other input devices may include voice input technology, which may include hardware and / or software incorporated into a control system 501 (FIG. 14), or a separate digital module connected thereto. Voice input technology can include voice recognition, voice activation, voice rectification, and / or embedded language. The user can control the operation of the instrument in whole or in part through voice commands, thus freeing one or both of the user's hands to operate other instruments. Voice or other audible output can also be used to provide feedback to the user.

Referring to FIG. 3, a proximal region 118 of housing 110 is shown having a user interface 120. User interface 120 includes a display 122 and a plurality of switches 124. User interface 120 can display various types of operating parameters of instrument 10 such as "mode" (eg, rotation, articulation, or actuation), that can be communicated to the user interface by means of a sensor, "status" (p. g., angle of articulation, speed of rotation or type of actuation) and "feedback", such as if staples have been fired based on the information reported by the sensors arranged in the instrument 10.

The screen 122 can be an LCD screen, a plasma screen, an electroluminescent screen, and the like. In one embodiment the screen 122 can be a touch screen, obviating the need for switches 124. The touch screen can incorporate resistive, surface wave, capacitive, infrared, strain gauge, optical, signal dispersive or pulse recognition touch screen technologies. acoustic. The touch screen can be used to allow the user to provide input while viewing operational feedback. This approach may allow for the provision of sealed screen components to help sterilize instrument 10, as well as prevent contamination with particles and / or fluid. In certain embodiments, the screen is pivotably or rotatably mounted on instrument 10 for flexibility in viewing the screen during use or setup (eg. g., by means of a hinge or ball joint).

ES 2 646 491 T3

Switches 124 can be used to start and / or stop movement of Instrument 10 as well as select pivot direction, speed, and / or torque. It is also envisioned that at least one switch 124 may be used to select an emergency mode that avoids various settings. Switches 124 can also be used to select various options on screen 122, such as responding to reminders while navigating user interface menus and selecting various settings, allowing a user to enter different types of fabric and various sizes and lengths. of staple cartridges.

Switches 124 can be formed of a tactile or non-tactile microelectronic membrane, a polyester, elastomeric membrane, plastic or metal keys of various shapes and sizes. Additionally, switches may be positioned at different heights from each other and / or may include raised prompts or other textured features (eg, concave or convex) to allow the user to depress an appropriate switch without looking at the user interface 120. .

In addition to display 124, user interface 120 may include one or more visual outputs 123 which may include one or more visible colored lights or light emitting diodes ("LEDs") to forward feedback to the user. The visual outputs 123 may include corresponding indicators of various shapes, sizes and colors that have numbers and / or text that identify the visual outputs 123. The visual outlets 123 are arranged in the upper part of the housing 110 so that the outlets 123 are raised and protrude with respect to the housing 110 allowing better visibility thereof.

The multiple lights are displayed in a certain combination to illustrate a user-specific mode of operation. In one embodiment, the visual outputs 123 include a first light (eg, yellow) 123a, a second light (eg, green) 123b, and a third light (eg, red) 123c. The lights operate in a particular combination associated with a particular mode of operation listed in Table 1 below.

ES 2 646 491 T3

Table 1

<td colspan="2">Combination of lights</td><td>Operating mode</td>

<td>Light</td><td>Condition</td><td rowspan="4">No load unit 169 or staple cartridge is loaded.</td>

<td>First light</td><td>Off</td>

<td>Second light</td><td>Off</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">The loading unit 169 and / or the staple cartridge is loaded and the feed is activated, allowing the end effector 160 to grip and hinge.</td>

<td>First light</td><td>Lit</td>

<td>Second light</td><td>Off</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">A used loading unit 169 or staple cartridge is loaded.</td>

<td>First light</td><td>Flash</td>

<td>Second light</td><td>Off</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">Instrument 10 disabled and cannot fire staples or cut.</td>

<td>First light</td><td>Not available</td>

<td>Second light</td><td>Off</td>

<td>Third light</td><td>Not available</td>

<td>Light</td><td>Condition</td><td rowspan="4">A new loading unit 169 has been loaded, end effector 160 is fully clamped, and instrument 10 is in the staple and cut firing modes.</td>

<td>First light</td><td>Lit</td>

<td>Second light</td><td>Lit</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">Due to the high stapling forces there is in effect a pulse mode, which allows a time delay during which tissue is compressed.</td>

<td>First light</td><td>Lit</td>

<td>Second light</td><td>Flash</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">No system errors have been detected.</td>

<td>First light</td><td>Not available</td>

<td>Second light</td><td>Not available</td>

<td>Third light</td><td>Off</td>

<td>Light</td><td>Condition</td><td rowspan="4">Fabric thickness and / or shot load are too high, this warning can be avoided.</td>

<td>First light</td><td>Lit</td>

<td>Second light</td><td>Lit</td>

<td>Third light</td><td>Lit</td>

<td>Light</td><td>Condition</td><td rowspan="4">System functional error detected, instrument must be replaced 10.</td>

<td>First light</td><td>Not available</td>

<td>Second light</td><td>Not available</td>

<td>Third light</td><td>Flash</td>

In another embodiment, the visual output 123 may include a single multi-color LED that displays a particular color associated with the modes of operation, as discussed above with respect to the first, second, and third lights in Table 1.

User interface 120 also includes audio outputs 125 (eg, tones, bells, buzzers, built-in speaker, etc.) to communicate various status changes to the user, such as low battery, empty cartridge, etc. Audible feedback can be used in conjunction with or instead of visual outputs 123. Audible feedback can be provided in the form of clicks, elastic jumps, beeps, rings, and buzzers in single- or multi-pulse sequences. In one embodiment, a simulated mechanical sound can be recorded in advance that replicates click and / or snap sounds generated by conventional mechanical locks and unpowered instrument mechanisms. This eliminates the need to generate such mechanical sounds through the actual components of instrument 10 and also avoids the use of beeps and other electronic sounds that are usually associated with other operating room equipment, thereby preventing confusion with extraneous audible feedback.

Instrument 10 may also provide haptic or vibratory feedback via a haptic mechanism (not explicitly shown) within housing 110. Haptic feedback can be used in conjunction with or in place of auditory and visual feedback to avoid confusion. with operating room teams that rely on audible and visual feedback. The haptic mechanism can be an asynchronous motor that vibrates in a pulsed manner. In one embodiment, the vibrations are at a frequency of about 30 Hz or higher providing a displacement having an amplitude of 1.5 mm or less to limit vibratory effects from reaching the load unit 169.

ES 2 646 491 T3

The User Interface 120 is also intended to include different colors and / or text intensities on screen and / or on switches for additional differentiation between displayed items. Visual, auditory, or haptic feedback can be increased or decreased in intensity. For example, the intensity of the feedback can be used to indicate that the forces on the instrument are becoming excessive.

Figures 2-4 illustrate a linkage mechanism 170, including a linkage housing 172, a linkage powered switch 174, a linkage motor 132, and a linkage hand control 176. Translation of linkage powered switch 174 or linkage hand control 176 pivot activates linkage motor 132 which then drives linkage gear 233 of linkage mechanism 170 as shown in FIG. C. Actuation of linkage mechanism 170 causes end effector 160 to move from its first position, where longitudinal axis BB is substantially aligned with longitudinal axis AA, to a position where longitudinal axis BB is disposed at an angle with the longitudinal axis AA. Preferably, a plurality of articulated positions are achieved. Link powered switch 174 may also incorporate similar non-linear speed controls as a clamping mechanism controlled by switches 114a and 114b.

In addition, housing 110 includes switch guards 169 that have a wing-like shape and extend from the top surface of housing 110 onto switch 174. Switch guards 169 prevent accidental activation of switch 174 and require the user to reach below guard 169 in order to activate linkage mechanism 170.

Additionally, link housing 172 and link powered switch 174 are mounted in a rotatable housing assembly 180. Rotation of a rotation knob 182 about the first longitudinal axis AA causes the housing assembly 180 as well as the link housing 172 and powered link switch 174 to rotate about the first longitudinal axis AA, and thus causes the corresponding rotation of distal portion 224 of firing rod 220 and end effector 160 about first longitudinal axis AA. Linkage mechanism 170 is electro-mechanically coupled to first and second lead rings 157 and 159 which are disposed on housing nose assembly 155 as shown in Figures 4 and 26. Lead rings 157 and 159 can be welded and / or crimp crimps on nose assembly 155 and are in electrical contact with power source 400 thereby providing electrical power to linkage mechanism 170. The nose assembly 155 may be modular and may be connected to the housing 110 during assembly to allow the rings to more easily weld and / or crimp crimp. Linkage mechanism 170 includes one or more brushes and / or spring-loaded contacts in contact with lead rings 157 and 159 such that when housing assembly 180 is rotated together with linkage housing 172 the linkage mechanism 170 it is in continuous contact with conductive rings 157 and 159 thereby receiving electrical energy from power source 400.

Additional details of the articulation housing 172, the articulation powered switch 174, the manual articulation control 176, and the articulation input to the end effector 160 are described in detail in co-owned U.S. Patent Application No. Serial No. 11 / 724,733 filed March 15, 2007.

It is envisioned that any combination of limit switches, proximity sensors (eg, optical and / or ferromagnetic), linear variable displacement transducers, and stem encoders, which may be arranged within housing 110, can be used to control and / or record an articulation angle of the end effector 160 and / or the position of the firing rod 220.

Figures 4-8 illustrate various internal components of instrument 10, including a drive motor 200, a drive tube 210, and a firing rod 220 having a proximal portion 222 and a distal portion 224. The drive tube 210 is rotatable. around the impulse tube axis CC extending therethrough. Drive motor 200 is arranged in mechanical cooperation with drive tube 210 and is configured to rotate drive tube 210 about drive gear axis CC. In one embodiment, the drive motor 200 can be an electric motor or a gear motor, which can include gears incorporated within its housing.

Housing 110 can be formed of two halves 110a and 110b as illustrated in Figure 3. The two housing half-parts 110a and 110b can be connected to each other using screws in lift locators 111 that align housing portions 110a and 110b. Additionally, housing 110 may be formed of plastic and may include rubber support members applied to the internal surface of housing 110 through a two-shot molding process. The rubber support members can isolate the vibration of the drive components (eg, drive motor 200) from the rest of the instrument 10.

Housing halves 110a and 110b can be connected to each other by means of a thin plastic section (eg, an active hinge) that interconnects halves 110a and 110b allowing housing 110 to be opened separating halves 110a and 110b.

In one embodiment, the drive components (eg, including a drive motor 200, a drive tube 210, and a trip rod 220, etc.) can be mounted on a support plate that allows removal of the drives.

ES 2 646 491 T3 drive components of housing 110 after Instrument 10 has been used. The backing plate mounting in conjunction with the hinged housing halves 110a and 110b allows the possibility of reuse and recycling of specific internal components while being limits contamination of it.

Referring to Figures 4-6, a firing rod coupling 190 is illustrated. The firing rod coupling 190 provides a link between the proximal portion 222 and the distal portion 224 of the firing rod 220. Specifically, the firing rod coupling 190 allows rotation of the distal portion 224 of the firing rod 220. relative to proximal portion 222 of firing rod 220. Thus, firing rod coupling 190 allows proximal portion 222 of firing rod 220 to remain non-rotatable, as discussed below with reference to an alignment plate 350, while allowing rotation of distal portion 224 of the trigger rod 220 (eg, with rotation of the rotation knob 182).

Referring to Figures 5 and 6, proximal portion 222 of firing rod 220 includes a threaded portion 226, which extends through an internally threaded portion 212 of push tube 210. This relationship between firing rod 220 and impulse tube 210 causes the firing rod 220 to move distally and / or proximally, in the directions of arrows D and E, along threaded portion 212 of impulse tube 210. with the rotation of the drive tube 210 in response to the rotation of the drive motor 200. As the drive tube 210 rotates in a first direction (p. g., clockwise), firing rod 220 moves proximally as illustrated in FIG. 5, firing rod 220 is disposed in its most proximal position. As push tube 210 rotates in a second direction (eg, counterclockwise), firing rod 220 moves distally as illustrated in Figure 6, firing rod 220 is disposed in its most distal position.

Firing rod 220 is distally and proximally translatable within particular limits. Specifically, a first end 222a of proximal portion 222 of firing rod 220 acts as a mechanical stop in combination with alignment plate 350. That is, with retraction when firing rod 220 is proximally translated, first end 222a contacts a distal surface 351 of alignment plate 350, thereby preventing proximal translation of firing rod 220 from continuing as shown in Figure 5. Additionally, threaded portion 226 of proximal portion 222 acts as a mechanical stop in combination with alignment plate 350. That is, when firing rod 220 is translated distally, threaded portion 226 contacts a proximal surface 353 of alignment plate 350, thus preventing further distal translation of firing rod 220 as shown in FIG. 6. The alignment plate 350 includes an opening therethrough, which has a non-round cross section. The non-round cross section of the opening prevents rotation of the proximal portion 222 of the firing rod 220, thus limiting the axial translation of the proximal portion 222 of the firing rod 220 therethrough. In addition, a proximal bearing 354 and a distal bearing 356 are disposed at least partially around the push tube 210 to facilitate rotation of the push tube 210, while helping to align the push tube 210 within the housing 110.

Rotation of drive tube 210 in a first direction (eg, counterclockwise) corresponds to distal translation of firing rod 220 which actuates jaw members 162, 164 of end effector 160 to grasp or clamp tissue held between the same. Further distal translation of firing rod 220 ejects surgical fasteners from end effector 160 to grasp tissue by actuation of cam bars and / or an actuation slide 74 (FIG. 9). Additionally, firing rod 220 can also be configured to actuate a blade (not explicitly shown) to sever tissue. Proximal translation of firing rod 220 corresponding with rotation of impulse tube 210 in a second direction (eg. g., clockwise) actuates the jaw members 162, 164 and / or the blade to retract or return to the corresponding pre-trigger positions. Additional details of the firing and otherwise actuation of end effector 160 are described in detail in co-owned US Patent No. 6,953,139 to Milliman et al. (the Milliman '139 patent).

Figure X shows an exploded view of the charging unit 169. The end effector 160 may be actuated by an axial drive assembly 213 having a drive bar or drive member 266. The distal end of the drive bar 213 may include a knife blade. Additionally, the drive bar 213 includes a retaining lip 40 having a pair of cam members 40a that engage the anvil and cartridge assembly 162 and 164 during longitudinal advancement of the drive bar 213. The drive bar 213 longitudinally advances a drive sled 74 through staple cartridge 164. Slider 74 has cam wedges to engage pushers 68 disposed in slots of cartridge assembly 164, when slider 74 is advanced. Pushers 66 drive staples 66 disposed in the grooves through tissue and against anvil assembly 162.

Referring to FIG. 8, a drive motor stem 202 is shown extending from a planetary gear 204 that is connected to drive motor 200. Drive motor stem 202 is in mechanical cooperation with clutch 300. The drive motor stem 202 is rotated by drive motor 200, thus resulting in rotation of clutch 300. Clutch 300 includes a clutch plate 302 and a spring 304 and is shown to have wedged portions 306 disposed on clutch plate 302, which are configured to mate with an interface (eg, wedges 214) disposed on one face. proximal 216 of impulse tube 210.

Spring 304 is illustrated between planetary gear 204 and drive tube 210. Specifically, and in accordance with the embodiment illustrated in Figure 8, spring 304 is illustrated between clutch face 302 and a 12 gauge washer.

ES 2 646 491 T3 clutch 308. Additionally, drive motor 200 and planetary gear 204 are mounted on a motor bracket 310. As illustrated in FIG. 8, motor mount 310 is adjustable proximally and distally with respect to housing 110 by means of slots 312 provided on motor mount 310 and protrusions 314 provided on housing 110.

In one embodiment of the disclosure, clutch 300 is implemented as a one-way slip clutch to limit torque and high inertial loads on drive components. The wedged portions 306 of the clutch 300 are configured and arranged to slide relative to the wedges 214 of the proximal face 216 of the drive tube 210 unless a threshold force is applied to the clutch plate 302 by means of the clutch spring 304 . In addition, when spring 304 applies the threshold force necessary for wedged portions 306 and wedges 214 to engage without slipping, drive tube 210 will rotate with rotation of drive motor 200. It is envisioned that wedged portions 306 and / or or the wedges 214 are configured to slide in one and / or both directions (ie, clockwise and / or counter-clockwise) relative to each other until a threshold force is obtained.

As illustrated in Figures A and B, the clutch 300 is shown with a one-way clutch plate 700. The clutch plate 700 includes a plurality of wedged portions 702 having a sliding face 704 and a gripping face 706. The face Slide 704 has a curved edge that engages shims 214 of impulse tube 210 up to a predetermined load. Grip face 706 has a flat edge that fully engages delivery tube 210 and prevents slippage. When the clutch plate 700 is rotated in a first direction (eg, clockwise), the gripping face 706 of the wedged portions 702 engages the wedges 214 without slipping, providing full torque from the drive motor 200. When the clutch plate 700 is rotated in a reverse direction (p. g., counterclockwise), the sliding face 704 of the wedged parts 702 engages the wedges 214 and limits the torque transferred to the impulse tube 210. Thus, if the load applied to the sliding face 704 is over the limit , the clutch 300 slips and the drive tube 210 does not rotate. This prevents high load damage to the end effector 160 or tissue, which can occur due to momentum and dynamic friction of the drive components. More specifically, the drive mechanism of instrument 10 can drive the drive rod 220 in a forward direction with less torque than in reverse. Using a one-way clutch eliminates this problem. Additionally, an electronic clutch can also be used to increase motor potential during retract (eg, drive pushrod 220 in reverse) as discussed in more detail below.

It is further envisaged that the drive motor stem 202 includes a D-shaped cross section 708, including a substantially flat portion 710 and a rounded portion 712. Thus, while the drive motor stem 202 is translatable with respect to the clutch plate 302, drive motor stem 202 will not "slide" relative to clutch plate 302 with rotation of drive motor stem 202. That is, rotation of the drive motor stem 202 will result in non-slip rotation of the clutch plate 302.

The loading unit, in certain embodiments in accordance with the present disclosure, includes an axial drive assembly that cooperates with firing rod 220 to approximate anvil assembly 162 and cartridge assembly 164 to end effector 160, and firing staples from the firing cartridge. staples. The axial drive assembly may include a bar that travels distally through the staple cartridge and retracts after the staples have been fired, as discussed above and described in certain embodiments of the Milliman '139 patent.

Referring to Figure 4, instrument 10 includes a power source 400 which may be a rechargeable battery (eg, based on lead, nickel, lithium ion, etc.). It is also envisioned that the power supply 400 includes at least one disposable battery. The disposable battery can be between about 9 volts and about 30 volts.

Power supply 400 includes one or more battery cells 401, depending on the current charging needs of the instrument 10. In addition, power supply 400 includes one or more ultracapacitors 402 that act as supplemental energy storage due to their much higher energy density than conventional capacitors. Ultracapacitors 402 can be used in conjunction with cells 401 during high power consumption. Ultracapacitors 402 can be used for a burst of power when power is desired / required faster than just cells 401 can provide (e.g., when clamping thick tissue, rapid firing, clamping, etc.), and that cells 401 are typically slow discharge devices whose current cannot be drawn rapidly. This configuration can reduce the current load on the cells, thereby reducing the number of cells 401. It is envisioned that cells 401 can be connected to ultracapacitors 402 to charge the capacitors.

Power source 400 may be removable along with drive motor 200 to allow for recycling of these components and reuse of instrument 10. In another embodiment, power source 400 may be an external battery pack worn on a belt. and / or harness the user and wiring to the instrument 10 during use.

ES 2 646 491 T3

The power supply 400 is enclosed within an insulating shield 404 which can be formed of an absorbent, strong, and flame retardant material. Shield 404 prevents heat generated by power supply 400 from heating other components of instrument 10. Additionally, shield 404 can also be configured to absorb chemicals or fluids that may leak from cells 402 during heavy use and / or damage. .

Power supply 400 is coupled to a power adapter 406 that is configured to connect to an external power source (eg, DC transformer). The external power supply can be used to recharge the power supply 400 or allow for additional power requirements. Power adapter 406 can also be configured to interface with electrosurgical generators that can then supply power to instrument 10. In this configuration, instrument 10 also includes an AC to DC power source that converts RF energy from electrosurgical generators and powers instrument 10.

In another embodiment the power supply 400 is recharged using an inductive charging interface. Power supply 400 is coupled to an inductive coil (not explicitly shown) disposed within the proximal portion of housing 110. By being placed within an electromagnetic field, the inductive coil converts energy into electrical current which is then used to charge power supply 400. The electromagnetic field can be produced by a base station (not explicitly shown) that is configured to interface with the proximal portion of housing 110 such that the inductive coil is enveloped by the electromagnetic field. This configuration eliminates the need for external contacts and allows the proximal portion of the housing 110 to seal the power supply 400 and inductive coil within an airtight environment and prevents exposure to fluids and contamination.

Referring to Figure 5, instrument 10 also includes one or more safety circuits such as a discharge circuit 410 and a motor and a battery operating module 412. For clarity, no cables or other circuit elements interconnecting various electronic components of instrument 10 are shown, but such electromechanical connecting cables are contemplated by the present disclosure. Certain components of the instrument 10 communicate wirelessly.

Discharge circuit 410 is coupled to a switch 414 and a resistive load 417 which in turn are coupled to power source 400. Switch 414 may be a user-activated or automatic switch (eg, timer, counter ) that is activated when the power supply 400 needs to be fully discharged for safe, low temperature disposal (eg, at the end of the surgical procedure). Once switch 414 is activated, load 417 is electrically connected to power source 400 so that the potential of power source 400 is directed to load 417. The circuit breaker may be a timer or a counter that is automatically activates after a predetermined period of operation time or number of uses to discharge the power supply 400. Charge 417 has a predetermined strength sufficient to fully and safely discharge all cells 401.

The motor and battery operating module 412 are coupled to one or more thermal sensors 413 that determine the temperature within the drive motor 200 and power supply 400 to ensure safe operation of the instrument 10. The sensors may be an ammeter. for determining the current draw within the power source 400, a thermistor, a thermopile, a thermocouple, an infrared thermal sensor, and the like. Monitoring the temperature of these components allows the determination of the load applied to them. The increase in the current that flows through these components causes an increase in temperature in them. The temperature and / or current consumption data can then be used to control power consumption in an efficient manner or to ensure safe levels of operation.

In order to ensure safe and reliable operation of the instrument 10, it is desirable to ensure that the power supply 400 is authentic and / or valid (e.g., conforming to strict quality and safety standards) and that it operates within a default temperature range. Authentication that the power supply 400 is valid minimizes the risk of injury to the patient and / or the user due to poor quality.

Referring to FIG. 9, the power supply 400 is shown to have one or more battery cells 401, a temperature sensor 403, and an embedded microcontroller 405 coupled thereto. Microcontroller 405 couples via wired and / or wireless communication protocols to microcontroller 500 (FIG. 14) of instrument 10 to authenticate power supply 400. In one embodiment, the temperature sensor 403 can be coupled directly to the microcontroller 500 instead of being coupled to the embedded microcontroller 405. The temperature sensor 403 can be a thermistor, a thermopile, a thermocouple, an infrared thermal sensor, a resistance temperature, a linear active thermistor, temperature-responsive color change strips, bimetallic contact switches, and the like. Temperature sensor 403 reports the measured temperature to microcontroller 405 and / or microcontroller 500.

The embedded microcontroller 405 executes a so-called challenge-response authentication algorithm with the microcontroller 500 that is illustrated in Figure 10. In step 630, the power supply 400 is connected to the

ES 2 646 491 T3 instrument 10 and instrument 10 is turned on. Microcontroller 500 sends a challenge request to embedded microcontroller 405. At step 632, microcontroller 405 interprets the challenge request and generates a response in response to the request. The response may include an identifier, such as a unique serial number stored on a radio frequency identification tag or in the memory of microcontroller 405, a unique measurable electrical value from power supply 400 (eg, resistance, capacitance , inductance, etc.). Additionally, the response includes the temperature measured by temperature sensor 403.

In step 634, the microcontroller 500 decodes the response to obtain the identifier and the measured temperature. In step 636, microcontroller 500 determines whether power supply 400 is authentic based on the identifier by comparing the identifier against a previously approved list of authentic identifiers. If the identifier is invalid, the instrument 10 will not function and displays a "failed to authenticate battery" message via user interface 120. If the identifier is valid, the process proceeds to step 640 in which the measured temperature is analyzed to determine if the measurement is within a predetermined operating range. If the temperature is outside the limit, the instrument 10 also displays a fault message. Thus, if the temperature is within the predetermined limit and the identifier is valid, in step 642, the instrument begins to operate, which may include providing a "battery authenticated" message to the user.

Referring again to Figures 4 and 5, a plurality of sensors are illustrated to provide feedback information related to the function of instrument 10. Within instrument 10, any combination of sensors may be provided to determine its phase of operation, such as, detection of staple cartridge loading as well as its status, articulation, clamping, rotation, stapling, cutting and retraction, and the like. The sensors can be actuated by proximity, displacement, or contact of various internal components of instrument 10 (eg, trigger rod 220, drive motor 200, etc.).

In illustrated embodiments, the sensors can be rheostats (eg. variable resistance devices), current monitors, conductive sensors, capacitive sensors, inductive sensors, thermal sensors, limit actuated switches, multiple position switch circuits, pressure transducers, linear and / or rotary variable displacement transducers , linear and / or rotary potentiometers, optical encoders, ferromagnetic sensors, Hall effect sensors, and proximity switches. The sensors measure rotational speed, acceleration, deceleration, linear and / or angular displacement, detection of mechanical limits (eg stops), etc. This is achieved by implementing multiple indicators arranged in linear or rotational distributions in the mechanical drive components of the instrument 10. The sensors then transmit the measurements to the microcontroller 500 which determines the operational status of the instrument 10. Additionally, the microcontroller 500 also adjusts the speed or torque of the instrument 10 motor based on the measured feedback.

In embodiments where clutch 300 is implemented as a slip clutch as shown in Figures A and B, linear displacement sensors (eg, linear displacement sensor 237) are positioned distally of clutch 300 to provide accurate measurements. . In this configuration, the slip of the clutch 300 does not affect the position, speed and acceleration measurements recorded by the sensors.

Referring to FIG. 4, a load switch 230 is provided within hinge housing 172. Switch 230 is connected in series with switch 114, preventing activation of instrument 10 unless load unit 169 is properly loaded. on instrument 10. If charging unit 169 does not charge on instrument 10, the main power switch (eg. switch 114) is open, thereby preventing the use of electronic or electrical components of the instrument 10. This also prevents any possible current draw from power source 400, allowing power source 400 to maintain maximum potential during its specified shelf life.

Thus, the switch 230 acts as a so-called "latched" switch that prevents false activation of the instrument 10 since the switch is inaccessible to external manipulation and can only be activated by the insertion of the load unit 169. The switch 230 is activated by displacement of a plunger or sensor tube as loading unit 169 is inserted into endoscopic portion 140. Once switch 230 is turned on, power from power source 400 is supplied to the electronic components (e.g., sensors, microcontroller 500, etc.) of instrument 10 providing the user with access to user interface 120 and other inputs / outputs. This also activates the visual outputs 123 to illuminate according to the light combination indicative of a properly charged load unit 169 where all lights are off as described in Table 1.

More specifically, as shown in Figures 18 and 19, the endoscopic portion 140 includes a sensor plate 360 ​​thereon that is in mechanical contact with a sensor tube also disposed within the endoscopic portion 140 and around the distal portion. 224 of trigger rod 220. Distal portion 224 of trigger rod 220 passes through an opening 368 in a distal end of a sensor cap 364. Sensor cap 364 includes a spring and abuts switch 230. This allows sensor cap 364 to bias against sensor tube 362 that rests on the distal end of sensor cap 364 without passing through aperture 368. biasing of the sensor tube 362 then pushes out the plate 360 ​​of 15

ES 2 646 491 T3 sensor.

When loading unit 169 is loaded onto endoscopic portion 140, proximal portion 171 abuts sensor plate 360 ​​and moves plate 360 ​​proximally. Sensor plate 360 ​​then pushes sensor tube 362 proximally which then applies pressure to sensor cap 364 thereby compressing spring 366 and activating switch 230 indicating that loading unit 169 has been properly inserted.

Once the charging unit 169 is inserted into the endoscopic portion, the switch 230 also determines whether the charging unit 169 is correctly charged based on the position thereof. If charging unit 169 charges improperly, switch 114 is not activated and an error code is issued to the user via user interface 120 (e.g., all lights off as described in Table 1). If the charging unit 169 has already tripped, any mechanical interlocks have previously been activated, or the staple cartridge has been used, the instrument 10 issues the error via user interface 120, e.g. eg, the first light 123a flashes.

In one embodiment, instrument 10 may implement a second latch switch 259 (FIG. 4) coupled to main switch 114 as a bioimpedance, capacitance, or pressure sensor disposed on the upper surface of handle portion 112 configured to activate when the user grasps instrument 10. Thus, unless instrument 10 is properly grasped, operation of switch 114 is disabled.

Referring to Figure 5, instrument 10 includes a position calculator 416 for determining and outputting the linear position at this time of trigger rod 220. Position calculator 416 is electrically connected to a linear displacement sensor 237 and a Rotational speed sensing apparatus 418 is coupled to drive motor 200. Apparatus 418 includes an encoder 420 coupled to the motor to produce two or more encoder pulse signals in response to the rotation of drive motor 200. Encoder 420 transmits the pulse signals to apparatus 418 which then determines the rotational speed of the motor. impulsion 200. The position calculator 416 thereafter determines the linear speed and the position of the firing rod based on the rotational speed of the drive motor 200 since the rotational speed is directly proportional to the linear speed of the firing rod. 220. Position calculator 416 and speed calculator 422 are coupled to microcontroller 500 that controls drive motor 200 in response to feedback from calculators 416 and 422. This configuration is discussed in more detail below with respect to FIG. 14.

Instrument 10 includes first and second gauges 320a, 320b disposed on firing rod 220, which determine the speed of firing rod 220 and the location of firing rod 220 relative to impulse tube 210 and / or housing. 110. For example, a limit switch can be activated (eg, stem home position sensor 231 and gripper position sensor 232) by first and second sensitive indicators 320a and / or 320b (eg. (e.g., lumps, grooves, recesses, etc.) that are passed to thereby determine the position of firing rod 220, the velocity of firing rod 220, and the mode of instrument 10 (e.g., clamping, grip, shot, seal, cut, retract). In addition, the feedback received from the first and second indicators 320a, 320b can be used to determine when the firing rod 220 should stop its axial movement (eg. eg, when the drive motor 200 should cease) depending on the size of the particular load unit connected to it.

More specifically, when firing rod 220 is moved distally from its home (eg, home) position, the first actuation of position sensor 231 is triggered by first indicator 320a indicating that operation has begun. instrument 10. As operation continues, firing rod 220 moves further distally to initiate clamping, which moves first pointer 320a to interface with clamp position sensor 232. Further advancement of trigger rod 220 moves second indicator 320b to interface with position sensor 232 indicating that instrument 10 has triggered.

As discussed above, position calculator 416 is coupled to a linear displacement sensor 237 disposed adjacent trigger rod 220. In one embodiment, linear displacement sensor 237 may be a magnetic sensor. Firing rod 220 can be magnetized or can include magnetic material therein. The magnetic sensor can be a ferromagnetic sensor or a Hall effect sensor that is configured to detect changes in a magnetic field. When the firing rod 220 is linearly translated due to the rotation of the drive motor 200, the change in magnetic field in response to the translational movement is recorded by the magnetic sensor. The magnetic sensor transmits data regarding changes in the magnetic field to the position calculator 416 which then determines the position of the firing rod 220 as a function of the magnetic field data.

In one embodiment, a select portion of firing rod 220 may be magnetized, such as the threads of internally threaded portion 212 or other indentations (eg, indicators 320a and / or 320b) provided on firing rod 220. they can include or be made of a magnetic material. This allows for the correlation of the cyclic variations in the magnetic field with each discrete translation of the threads as the magnetized portions of the firing rod 220 are linearly translated. The position calculator 416 thereafter determines the distance and position of the firing rod 220 by adding the number of cyclic changes in the magnetic field and

ES 2 646 491 T3 multiplies the sum by a predetermined distance between the threads and / or the grooves.

In one embodiment, the linear displacement sensor 237 can be a potentiometer or a rheostat. Trigger rod 220 includes a contact (eg, sweep terminal) disposed in electromechanical contact with linear displacement sensor 237. The contact slides along the surface of linear displacement sensor 237 when the rod Shot 220 is driven distally by drive motor 200. When the contact slides across the potentiometer and / or the rheostat, the potentiometer voltage and the rheostat resistance vary accordingly. Thus, the variation in tension and resistance is transmitted to the position calculator 416 which then extrapolates the distance traveled by the firing rod 220 and / or the firing rod coupling 190 and the position thereof.

In one embodiment, the position calculator 416 is coupled to one or more switches 421 that are actuated by the threads of the internally threaded portion 212 or indicators 320a and / or 320b when the trigger rod 220 and the trigger rod coupling 190 shot move distally. The position calculator 416 counts the number of threads that activate the switch 421 and then multiplies the number by a predetermined distance between the threads or indicators 320a and / or 320b.

The instrument 10 also includes a speed calculator 422 that determines the current speed of a linearly moving firing rod 220 and / or the torque that is provided by the drive motor 200. The speed calculator 422 is connected to the linear displacement sensor 237 that allows speed calculator 422 to determine the speed of firing rod 220 based on the rate of change of the displacement thereof.

Speed ​​calculator 422 is coupled to rotational speed detecting apparatus 424 which includes encoder 426. Encoder 426 transmits pulses correlative with the rotation of drive motor 200 which speed calculator 422 then uses to calculate linear speed trip rod 220. In another embodiment, the speed calculator 422 is coupled to a rotational sensor 239 that detects the rotation of the impulse tube 210, thus measuring the rate of rotation of the impulse tube 210 that allows the determination of the linear speed of the firing rod. 220.

Speed ​​calculator 422 is also coupled to a voltage sensor 428 that measures the counter electromotive force ("EMF") induced in drive motor 200. The counter EMF voltage of drive motor 200 is directly proportional to rotational speed. of drive motor 200 which, as discussed above, is used to determine the linear speed of firing rod 220.

Monitoring the speed of the drive motor 200 can also be accomplished by measuring the voltage across the terminals thereof under constant current conditions. An increase in a load of the drive motor 200 produces a decrease in the voltage applied at the motor terminals, which is directly related to the decrease in motor speed. Thus, measuring the voltage on the drive motor 200 enables the load placed on it to be determined. Additionally, by monitoring the change in voltage over time (dV / dt), the microprocessor 500 can detect a rapid voltage drop that correlates with a large change in load or an increase in temperature of the drive motor 200 and / or or power supply 400.

In a further embodiment, the speed calculator 422 is coupled to a current sensor 430 (eg, an ammeter). Current sensor 430 is in electrical communication with a bypass rheostat 432 that is coupled to drive motor 200. Current sensor 430 measures the current drawn by drive motor 200 by measuring the voltage drop across rheostat 432. Since the current used to power the drive motor 200 is proportional to the rotational speed of the drive motor 200 and thus the linear speed of the firing rod 220, the speed calculator 422 determines the speed of the firing rod. trip 220 based on current draw by drive motor 200.

The speed calculator 422 can also be coupled to a second voltage sensor (not explicitly shown) to determine the voltage within the power source 400 thereby calculating the power consumed directly from the source. Additionally, the change in current over time (dI / dt) can be monitored to detect rapid peaks in measurements that correspond to a large increase in torque applied by drive motor 200. Thus, the current sensor 430 is used to determine the speed and load of the drive motor 200.

Additionally, the speed of the firing rod 220 measured by the speed calculator 422 can then be compared to the current draw of the drive motor 200 to determine if the drive motor 200 is operating properly. That is, if the current draw is not commensurate (eg large) with the speed (eg low) of trip rod 220 then motor 200 is malfunctioning (eg stuck, stall , etc.). If a stall condition is detected, or the current draw exceeds predetermined limits, the position calculator 416 then determines whether the trip rod 220 is in a mechanical stop. If this is the case, then the microcontroller 500 may stop the drive motor 200 or enter a pulse and / or pause mode (eg, discontinuous supply of power to the drive motor 200), to unlock the instrument. 10 and retract the firing rod 220.

ES 2 646 491 T3

In one embodiment, the speed calculator 422 compares the rotational speed of the drive tube 210 detected by the rotation sensor 239 and that of the drive motor 200 based on the measurements of the rotational speed detecting apparatus 424. This Comparison allows speed calculator 422 to determine if there is a clutch engagement problem (eg, slip) if there is a discrepancy between the rotation of the clutch 300 and that of the drive tube 210. If slippage is detected, the position calculator 416 then determines whether the firing rod 220 is at a mechanical stop. If this is the case, then the microcontroller 500 may stop the instrument 10 or enter a pulse and / or pause mode (eg, discontinuous supply of power to the drive motor 200), or retract the firing rod. 220.

In addition to linear and / or rotational displacement of firing rod 220 and other drive components, instrument 10 also includes sensors adapted to detect articulation of end effector 160. Referring to Figure 4, instrument 10 includes a rotation sensor 241 adapted to indicate the initial position, direction of rotation, and angular displacement of the rotary housing assembly 180 at the start of the procedure as detected by the initial position sensor 231. stem. The rotation sensor 241 operates by counting the number of indicators disposed on the inner surface of the rotation knob 182 that the rotation knob 182 has been rotated. The count is then transmitted to the microcontroller 500 which then determines the rotational position of the endoscopic part 142. This can be communicated wirelessly or through an electrical connection in the endoscopic part and cables to the microcontroller 500.

The instrument 10 also includes an articulation sensor 235 that determines the articulation of the end effector 160. The articulation sensor 235 counts the number of features 263 disposed on the articulation gear 233 that the articulation knob 176 has been rotated from its home position. 0 °, that is the center position of the articulation knob 176 and therefore of the end effector 160 as shown in Figure C. The 0 ° position can be designated by a single central indicator 265 also disposed on the articulation gear 233 that corresponds to the first position of the end effector 160, where the longitudinal axis BB is substantially aligned with the longitudinal axis AA. The count is then transmitted to microcontroller 500 which then determines the hinge position of end effector 160 and reports the hinge angle via interface 120.

Additionally, the hinge angle can be used for a so-called "auto stop" mode. During this mode of operation, instrument 10 automatically stops articulation of end effector 160 when end effector 160 is in its first center position. That is, when the end effector 160 is articulated from a position in which the longitudinal axis BB is disposed at an angle with the longitudinal axis AA toward the first position, the articulation stops when the longitudinal axis BB is substantially aligned with the longitudinal axis. AA. This position is sensed by the articulation sensor 235 based on the central indicator. This mode allows endoscopic portion 140 to be removed without the user having to manually align end effector 160.

With reference to FIG. 1, the present disclosure provides a load unit identification system 440 that allows instrument 10 to identify the load unit 169 and determine the operating status thereof. The identification system 440 provides information to the instrument 10 on staple size, cartridge length, type of loading unit 169, cartridge status, proper coupling, and the like. This information allows the instrument to adjust clamping forces, clamping and firing speed, and limit switch for staple cartridges of various lengths.

The load unit identification system 440 can also be adapted to determine and communicate to instrument 10 (e.g., a control system 501 shown in Figure 14) various information, including speed, power, torque, clamping, travel length and force limitations for operation of the particular end effector 160. Control system 501 can also determine the mode of operation and adjust tension, clutch spring load, and stop points for component travel. More specifically, the identification system may include a component (eg, a microchip, emitter, or transmitter) disposed in the end effector 160 that communicates (eg, wirelessly, via infrared signals, etc.). ) with the 501 control system, or a receiver on it. It is also envisioned that a signal can be sent via firing rod 220, such that firing rod 220 functions as a conduit for communications between control system 501 and end effector 160. In another embodiment, the signals are they can send through an intermediate interface, such as a feedback controller 603 (Figures 15-17).

By way of example, the sensors discussed above can be used to determine if the staples have fired from the staple cartridge, if they have fired fully, if the bar has been retracted proximally and by how far through the staple cartridge and other information regarding the operation of the charging unit. In certain embodiments of the present disclosure, the loading unit incorporates components to identify the type of loading unit and / or staple cartridge loaded in instrument 10, including infrared, cellular, or radio frequency identification chips. The loading unit and / or staple cartridge type may be received by an associated receiver within the control system 501, or an external device in the operating room to provide feedback control and / or inventory analysis.

Information can be transmitted to instrument 10 via a variety of communication protocols (eg, wired or wireless) between charging unit 169 and instrument 10. Information can be stored within charging unit 169 in a microcontroller, microprocessor, non-volatile memory, identification labels 18

ES 2 646 491 T3 by radio frequency and identifiers of various types such as optical, color, displacement, magnetic, electrical, binary and Gray code (eg, conductance, resistance, capacitance, impedance).

In one embodiment, the charging unit 169 and instrument 10 include corresponding wireless transceivers, an identifier 442, and an interrogator 444 respectively. The identifier 442 includes memory or can be coupled to a microcontroller to store various identification and status information regarding the charging unit 169. Once the charging unit 169 is coupled to the instrument 10, the instrument 10 interrogates the identifier 442 via the interrogator 444 to obtain an identification code. In response to the interrogation, the identifier 442 responds with the identification code corresponding to the load unit 169. During operation, once identification has occurred, the identifier 442 is configured to provide the instrument with updates such as the status of the load unit 169 (eg, mechanical and / or electrical dysfunction, position, articulation, etc. .).

Identifier 442 and Interrogator 444 are configured to communicate with each other using one or more of the following communication protocols such as Bluetooth®, ANT3®, KNX®, ZWave®, X10® Wireless USB®, IrDA®, Nanonet®, Tiny OS®, ZigBee®, 802.11 IEEE, and other communications by radio, infrared, UHF, VHF and the like. In one embodiment, the transceiver 400 may be an active or passive radio frequency identification (RFID) tag, depending on the interrogator capabilities of the transceiver 402.

Figures 11A and B illustrate additional embodiments of the charging unit 169 having various types of identification devices. Referring to Figure 11A, a proximal end 171 of the charging unit 169 is shown having an electrical identifier 173. The identifier 173 may include one or more resistors, capacitors, inductors, and mates with a corresponding electrical contact 181 disposed in the distal end of endoscopic portion 140. The contact may include slip rings, brush, and / or fixed contacts disposed on the endoscopic portion. The identifier 173 can be arranged at any location on the charging unit 168 and can be formed in a flexible or fixed circuit or it can be traced directly on the surface of the charging unit 169.

When the charging unit 169 is coupled with the endoscopic portion 140, the contact applies a small current through the electrical identifier 173. The interrogating contact also includes a corresponding electrical sensor that measures the resistance, impedance, capacitance, and / or impedance of the identifier 173. Identifier 173 has a unique electrical property (eg. g., resistance, capacitance, inductance, etc.) that corresponds to the identification code of the load unit 169, thus, when the electrical property of the same is determined, the instrument 10 determines the identity of the load unit 169 on the basis of the measured property.

In one embodiment, the identifier 173 may be a magnetic identifier such as Gray-coded magnets and / or ferrous nodes that incorporate predetermined unique magnetic patterns that identify the charging unit 169 by the identification code. The magnetic identifier is read by means of a magnetic sensor (eg, ferromagnetic sensor, Hall effect sensor, etc.) disposed at the distal end of endoscopic portion 140. The magnetic sensor transmits the magnetic data to instrument 10 which then determines the identity of the charging unit 169.

Figure 11B illustrates the proximal end 171 of the loading unit 169 having one or more protrusions 175. The protrusions 175 can be of any shape, such as holes, bulges, strips, etc., of various dimensions. The bumps 175 interface with corresponding displacement sensors 183 disposed within the proximal segment of the endoscopic portion 140. The sensors move when the bumps 175 are inserted into the endoscopic portion. The amount of displacement is analyzed by the sensors and converted into identification data, allowing the instrument 10 to determine staple size, cartridge length, type of loading unit 169, proper coupling, and the like. Displacement sensors can be switches, contacts, magnetic sensors, optical sensors, variable rheostats, linear and rotary variable displacement transducers that can be spring loaded. The switches are configured to transmit binary code to instrument 10 based on its activation state. More specifically, some bumps 175 extend a sufficient distance to selectively activate some of the switches, thereby generating a unique code based on the combination of bumps 175.

In another embodiment, the protrusion 175 may be color-coded. Displacement sensors 183 include a color sensor configured to determine the color of bulge 175 to measure one or more properties of load unit 169 based on color and transmit the information to instrument 10.

Figure 12 shows a method of identifying the charging unit 169 and providing status information concerning the charging unit 169 to the instrument 10. At step 650 it is determined whether the charging unit 169 is properly charged in the instrument 10. This It can be determined by detecting whether the identifier 173 and / or the protrusions 175 have been contacted. If the charging unit 169 is properly charged, in step 652, the charging unit 169 communicates to the instrument 10 a ready state (eg, by turning on the first light of the visual outputs 123).

At 654, the instrument 10 verifies whether the load unit 169 has previously been triggered. The identifier 442 19

ES 2 646 491 T3 then stores a value indicative of the previously triggered state. If the load unit 169 has been triggered, in step 656, the instrument 10 provides an error response (eg, flashing of the first light of the visual outputs 123). If the charging unit 169 has not been triggered in step 658 the charging unit 169 provides identification and status information (eg. eg, the first light is turned on) to the instrument 10 by means of the identification system 440. The determination of whether the load unit 169 has been triggered is made on the basis of the stored "previously triggered" signal stored in memory. of identifier 442 as discussed in more detail below with respect to step 664. In step 660, instrument 10 adjusts its operating parameters in response to information received from load unit 169.

The user performs a surgical procedure via instrument 10 in step 662. After the procedure is complete and loading unit 169 has been fired, instrument 10 transmits a "pre-fired" signal to loading unit 169. At step 664, the loading unit 169 stores the "previously triggered" signal in the memory of the identifier 442 for future interrogations by the instrument 10 as discussed with respect to step 654.

Referring to FIG. 13, the loading unit 169 includes one or more tissue sensors disposed within the end effector 160 to detect the type of object grasped, thereby recognizing non-tissue objects and the tissue type of the object. The sensors are also configured to determine the amount of blood flow that passes between the jaw members of the end effector 160. More specifically, a first tissue sensor 177 is disposed on a distal portion of anvil assembly 162 and a second tissue sensor 179 is disposed on a distal portion of cartridge assembly 164. Sensors 177 and 179 mate with tag 442 allowing transmission of sensor data to microcontroller 500 of instrument 10.

Sensors 177 and 179 are adapted to generate a field and / or waves at one or more distributions or frequencies therebetween. Sensors 177 and 179 can be acoustic, ultrasonic, ferromagnetic, Hall effect sensors, laser, infrared, radio frequency, or piezoelectric devices. Sensors 177 and 179 are calibrated to ignore commonly occurring material, such as air, body fluids, and various types of human tissue, and to detect certain types of foreign matter. Foreign matter can be bone, tendons, cartilage, nerves, major arteries, and non-tissue matter, such as ceramic, metal, plastic, etc.

Sensors 177 and 179 detect foreign material passing between anvil and cartridge assemblies 162 and 164 based on absorption, reflection, and / or filtering of the field signals generated by the sensors. If the material reduces or reflects a signal, such that the material is outside the calibration range and therefore foreign, sensors 177 and 179 transmit the interference information to microcontroller 500 which then determines the type of material grabbed. by end effector 160. The determination can be made by comparing the interference signals to a lookup table that lists various types of materials and their associated interference ranges. The microcontroller 500 then alerts the user of the seized foreign material as well as its identity. This allows the user to prevent clamping, cutting or stapling through areas containing foreign matter.

Figure 14 illustrates a control system 501 including microcontroller 500 that couples to position and speed calculators 416 and 422, load unit identification system 440, user interface 120, drive motor 200 , and a data storage module 502. Additionally, the microcontroller 500 can be directly coupled to various sensors (eg. e.g., first and second tissue sensors 177 and 179, load switch 230, stem home position sensor 231, gripper position sensor 232, joint sensor 235, linear displacement sensor 237, rotational sensor 239, sensor trigger rod rotation 241, motor and battery operating module 412, rotation speed detection apparatus 418, switches 421, voltage sensor 428, current sensor 430, the interrogator 444, etc.).

The microcontroller 500 includes internal memory that stores one or more software applications (eg, firmware) to control the operation and functionality of the instrument 10. The microcontroller 500 processes input data from the user interface 120 and adjusts the operation. instrument 10 in response to the inputs. Adjustments to instrument 10 may include turning instrument 10 on or off, speed control via voltage regulation or voltage pulse width modulation, torque limiting reducing duty cycle, or pulsing voltage to limit average output of current for a predetermined period of time.

Microcontroller 500 is coupled to user interface 120 via user feedback module 504 that is configured to inform the user of operating parameters of instrument 10. User feedback module 504 instructs user interface 120 user to output operating data on screen 122. In particular, the outputs of the sensors are transmitted to the microcontroller 500 which then sends feedback to the user instructing the user to select a specific mode, speed or function for the instrument 10 in response thereto.

The charging unit identification system 440 informs the microcontroller 500 which end effector is on the charging unit. In one embodiment, the control system 501 may store information regarding the force applied to the firing rod 220 and / or the end effector 160, such that when the load unit 169 is identified, the microcontroller 500 automatically selects the trigger parameters. operation for instrument 10.

ES 2 646 491 T3

This allows control of the force applied to firing rod 220 so that firing rod 220 can drive the particular end effector 160 that is in the load unit in use at the time.

Microcontroller 500 also analyzes calculations from position and velocity calculators 416 and 422 and other sensors to determine the actual position and / or velocity of firing rod 220 and the operational status of instrument components 10. The analysis may include interpretation of the feedback signal felt from the calculators 416 and 422 to control the movement of the firing rod 220 and other components of the instrument 10 in response to the felt signal. Microcontroller 500 is configured to limit travel of firing rod 220 once firing rod 220 has moved beyond a predetermined point reported by position calculator 416. Additional parameters that can be used by microcontroller 500 to control instrument 10 include motor and / or battery temperature, number of cycles remaining and used, remaining battery life, tissue thickness, current state of end effector, transmission, and reception, external device connection status, etc.

In one embodiment, instrument 10 includes various sensors configured to measure current (eg, ammeter), voltage (eg, voltmeter), proximity (eg, optical sensors), temperature (eg. , thermocouples, thermistors, etc.), and force (eg, strain gauges, load cells, etc.) to determine load conditions in load unit 169. During operation of instrument 10 it is desirable to know the forces exerted by instrument 10 on the target tissue during the approach process and during the firing process. Detection of abnormal loads (eg, outside of a predetermined loading range) indicates a problem with the instrument 10 and / or subject tissue that is communicated to the user.

Monitoring of load conditions can be accomplished by one or more of the following methods: monitoring of drive motor 200 speed, monitoring of torque applied by the motor, proximity of jaw members 162 and 164, monitoring of component temperature of the instrument 10, measuring the load on the trigger rod 220 by means of an elongation sensor 185 (FIG. 4) and / or other load bearing components of the instrument 10. Speed ​​and torque monitoring has been discussed above with respect to Figure 5 and speed calculator 422.

Measuring the distance between jaw members 162 and 164 may also be indicative of loading conditions on end effector 160 and / or instrument 10. When large amounts of force are imparted on jaw members 162 and 164, the members jaw drift out. The jaw members 162 and 164 are parallel to each other during normal operation, however, during deformation the jaw members are at an angle relatively to each other. Thus, measuring the angle between the jaw members 162 and 164 allows the determination of the deformation of the jaw members due to the load exerted thereon. The jaw members may include strain gauges 187 and 189 as shown in Figure 13 to directly measure the load exerted thereon. Alternatively, one or more proximity sensors 191 and 193 may be provided at the distal ends of jaw members 162 and 164 to measure the angle between them. These measurements are then transmitted to microcontroller 500 which analyzes the angle and / or elongation measurements and alerts the user of the stress at the end effector 160.

In another embodiment, the trigger rod 220 or other load bearing components include one or more strain gauges and / or load sensors disposed therein. Under high elongation conditions, pressure exerted on instrument 10 and / or end effector 160 is transferred to firing rod 220 causing firing rod 220 to deflect, leading to increased elongation thereon. The strain gauges then report the stress measurements to the microcontroller 500. In another embodiment, a position, elongation, or force sensor may be provided on the clutch plate 302.

During the approach process, when end effector 160 clamps around tissue, sensors provided in instrument 10 and / or end effector 160 indicate to microprocessor 500 that end effector 160 is deployed around abnormal tissue (eg. , low or high load conditions). Low load conditions are indicative of a small amount of tissue being grasped by end effector 160 and high load conditions indicate that too much tissue and / or a foreign object is being grasped (e.g. tube, staple line, fasteners, etc.). The microprocessor 500 thereafter indicates to the user via the user interface 120 that a more appropriate charging unit 169 and / or instrument 10 should be chosen.

During the firing process, the sensors can alert the user to a variety of errors. The sensors can communicate to the microcontroller 500 that a staple cartridge or a part of the instrument 10 is defective. In addition, the sensors can detect sudden spikes in the force exerted on the blade, which is indicative that a foreign body is found. Peak force monitoring could also be used to detect the end of the firing stroke, such as when the firing rod 220 encounters the end of the staple cartridge and enters a hard stop. This hard stop creates a peak force that is relatively greater than those observed during normal operation of instrument 10 and could be used to signal to the microcontroller that firing rod 220 has reached the end of load unit 169. Peak force measurement can be combined with positional feedback measurements (e.g., from an encoder, linear variable displacement transducer, linear potentiometer, etc.) as discussed in connection with position and velocity calculators 416 and 422. This allows the use of various types of staple cartridges (eg, multiple lengths) with the instrument 10 without 21

ES 2 646 491 T3 modify end effector 160.

When force peaks are encountered, instrument 10 notifies the user of the situation and takes preventative action by entering a so-called "pulse" or electronic clutch mode, which is discussed in more detail below. During this mode, drive motor 200 is controlled to operate only in short bursts to allow equalization of pressure between grasped tissue and end effector 160. The electronic clutch limits the torque exerted by the drive motor 200 and prevents situations where large amounts of current are drawn from the power supply 400. This, in turn, prevents damage to electronic and mechanical components due to overheating that accompanies overload and high current draw situations.

The microcontroller 500 controls the drive motor 200 through a motor driver by means of a pulse width modulated control signal. The motor driver is configured to adjust the speed of the drive motor 200 either clockwise or counterclockwise. The motor drive is also configured to switch between a plurality of modes of operation including an electronic motor braking mode, a constant speed mode, an electronic clutch mode, and a controlled current drive mode. In electronic braking mode, two terminals of drive motor 200 are shorted and the counter EMF generated counteracts rotation of drive motor 200 allowing for faster stopping and greater positional accuracy by adjusting the linear position of trip rod 220.

In constant speed mode, the speed calculator 422 in conjunction with the microcontroller 500 and / or the motor driver adjusts the rotational speed of the drive motor 200 to ensure constant linear speed of the firing rod 220. The electronic clutch mode involves repeating engagement and / or disengagement of clutch 300 from drive motor 200 in response to feedback signals felt from position and speed calculators 416 and 422. In the controlled current drive mode, the current is increased or decreased to prevent damage from current and torque peaks during the transition from static to dynamic mode to provide so-called “soft start” and “soft stop”.

The data storage module 502 records the data from the sensors coupled to the microcontroller 500. Additionally, the data storage module 502 records the identification code of the charging unit 169, the status of the end effector 100, the number of cycles stapling during the procedure, etc. The data storage module 502 is also configured to connect to an external device such as a personal computer, PDA, smartphone, storage device (eg, Secure Digital® card, Compact Flash® card, MemoryStick ®, etc. through a wireless or wired data port 503. This allows the data storage module 502 to transmit performance data to the external device for subsequent analysis and / or storage. Data port 503 also allows microcontroller 500 firmware upgrades called "in the field."

A feedback control system 601 is shown in Figures 15-17. The system includes a feedback controller 603 shown in Figures 16A-B. Instrument 10 connects to feedback controller 603 via data port 502 which can be wired (eg, Firewire®, USB®, Serial RS232®, Serial RS485®, USART®, Ethernet®, etc.) or wireless (p. e.g. Bluetooth®, ANT3®, KNX®, ZWave®, X10® Wireless USB®, IrDA®, Nanonet®, Tiny OS®, ZigBee®, 802.11 IEEE, and other radio, infrared, UHF, VHF and similar communications ).

Referring to FIG. 15, the feedback controller 603 is configured to store the data transmitted thereto by the instrument 10 as well as to process and analyze the data. The feedback controller 603 also connects to other devices, such as a video display 604, a video processor 605, and a computing device 606 (eg, personal computer, PDA, smartphone, display device). storage, etc.). Video processor 605 is used to process output data generated by feedback controller 603 for output to video display 604. Computing device 606 is used for further processing of feedback data. In one embodiment, the results of sensor feedback analysis performed by microcontroller 600 can be stored internally for later retrieval by computing device 606.

Feedback controller 603 includes a data port 607 (FIG. 16B) coupled to microcontroller 600 that allows feedback controller 603 to connect to computing device 606. Data port 607 can allow wired and / or wireless communication with computing device 606 allowing an interface between computing device 606 and feedback controller 603 for retrieval of stored feedback data, configuration of feedback controller operating parameters 603 and firmware upgrade and / or other 603 feedback controller software.

Feedback controller 603 is further illustrated in Figures 16A-B. The feedback controller 603 includes a housing 610 and a plurality of input and output ports, such as a video input 614, a video output 616, a screen output "HUD" (head-up) 618. The feedback controller 603 also includes a display 620 for displaying status information concerning the feedback controller 603.

ES 2 646 491 T3

Components of the feedback controller 603 are shown in Figure 17. The feedback controller 603 includes a microcontroller 600 and a data storage module 602. The microcontroller 600 and data storage module 602 provide similar functionality as the microcontroller 500 and the data storage module 502 of instrument 10. Providing these components in a self-contained module, in the form of a feedback controller 603, alleviates the need to have these components within the instrument 10.

Data storage module 602 may include one or more internal and / or external storage devices, such as magnetic hard drives, flash memory (eg, Secure Digital® card, Compact Flash® card, MemoryStick®, etc. ) Data storage module 602 is used by feedback controller 603 to store feedback data from instrument 10 for later analysis of the data by computing device 606. The feedback data includes information supplied by sensors disposed within instrument 10 and the like.

Microcontroller 600 is configured to override and / or supplement control circuitry, if present, of instrument 10. Microcontroller 600 includes internal memory that stores one or more software applications (eg, firmware) to control operation and the functionality of the instrument 10. The microcontroller 600 processes input data from the user interface 120 and adjusts the operation of the instrument 10 in response to the inputs. The microcontroller 600 is coupled to the user interface 120 via a user feedback module 504 that is configured to inform the user of operating parameters of the instrument 10. More specifically, the instrument 10 is configured to connect to the feedback controller. 603 wirelessly or through a wired connection via data port 407 (Figure 5).

In a described embodiment, the microcontroller 600 is connected to the drive motor 200 and configured and arranged to monitor the impedance, voltage, temperature and / or current consumption of the battery and to control the operation of the instrument 10. The load (s) on the battery 400, transmission, drive motor 200, and drive components of instrument 10 are determined to control a motor speed if the load (s) indicate that a harmful limitation is reached or approaching. For example, one can determine the remaining power in the battery 400, the number of shots remaining, whether the battery 400 should be replaced or charged, and / or the approach to the potential charge limits of the instrument 10. Microcontroller 600 may also be connected to one or more of the instrument 10 sensors discussed above.

The microcontroller 600 is also configured to control the operation of the drive motor 200 in response to the monitored information. Pulse modulation control schemes, which may include an electronic clutch, can be used to control instrument 10. For example, the microcontroller 600 can regulate the voltage supply of the drive motor 200 or supply a pulse modulated signal thereto to adjust the power and / or torque output to prevent damage to the system or optimize energy use.

In one embodiment, an electric braking circuit can be used to control drive motor 200, which uses the existing counter electromotive force of rotary drive motor 200 to counteract and substantially reduce the moment of drive tube 210. The braking circuit Electrical can improve control of drive motor 200 and / or drive tube 210 for stopping precision and / or switching location of powered surgical instrument 10. Sensors for monitoring powered surgical instrument 10 components and helping to prevent overloading of powered surgical instrument 10 may include thermal type sensors, such as thermal sensors, thermistors, thermopiles, thermocouples, and / or infrared thermal imaging and provide feedback to microcontroller 600. Microcontroller 600 may control the components of powered surgical instrument 10 in the event that limits are reached or approached, and such control may include cutting power from power source 400, temporarily interrupting power, or going to a mode. pause and / or pulse modulation to limit the energy used. The microcontroller 600 can also monitor the temperature of components to determine when operation can resume. The above uses of the microcontroller 600 can be used independently or factored with current, voltage, temperature, and / or impedance measurements.

The result of the analysis and processing of the data by the microcontroller 600 is output on the video screen 604 and / or the HUD screen 622. The video screen 604 can be any type of screen such as an LCD screen, a plasma screen, electroluminescent screen and the like. In one embodiment, video display 604 may include a touch screen and may incorporate resistive, surface wave, capacitive, infrared, strain gauge, optical, signal dispersive, or acoustic pulse recognition touch screen technologies. The touch screen can be used to allow the user to provide input while viewing operational feedback. The HUD 622 can be projected onto any surface visible to the user during surgical procedures, such as lenses from a pair of glasses and / or binoculars, a face shield, and the like. This allows the user to view vital feedback information from the feedback controller 603 without losing focus on the procedure.

Feedback controller 603 includes an on-screen display module 624 and a HUD module 626. Modules 626 process the output of microcontroller 600 for display on respective displays 604 and 622. 23

ES 2 646 491 T3

More specifically, the OSD module 624 overlays text and / or graphical information from the feedback controller 603 on other video images received from the surgical site via cameras disposed therein. The modified video signal, which has superimposed text, is transmitted to video display 604, allowing the user to view useful feedback information from instrument 10 and / or feedback controller 603 while still viewing the surgical site.

Figures 24-25 illustrate another embodiment of instrument 10 '. Instrument 10 'includes a power supply 400' having a plurality of cells 401 arranged in a straight configuration. The power supply 400 'is vertically inserted into a vertical battery chamber 800 within the handle portion 112. The battery chamber 800 includes a spring 802 within the top thereof to bias the power supply 400 downward. '. In one embodiment, spring 802 may include contacts to electrically couple with power source 400 '. Power supply 400 'is held within battery chamber 800 by a battery cap 804 that is configured to slide distally to lock in place. Cap 804 and handle 112 may include tongue and groove attachments to prevent cap 804 from sliding off. Power supply 400 'biases against cap 804 due to the downward force of spring 802. As cap 804 slides proximally, power supply 400' is ejected from battery chamber 800 by spring 802 .

Figure 25 shows another embodiment of the rotational sensor 239 that detects the rotation of the impulse tube 210, thus measuring the rate of rotation of the impulse tube 210 that allows the determination of the linear speed of the firing rod 220. The rotational sensor 239 includes an encoder wheel 810 mounted on push tube 210 and an optical reader 812 (eg, photo switch). Optical reader 812 is configured to determine the number of interruptions in a beam of light that is continuously provided between two opposite edges 814 and 816 thereof. Roulette 810 rotates with drive tube 210 and includes a plurality of slits 811 therethrough.

The outer edge of the roulette 810 is arranged between the opposite edges of the optical reader 812 so that the light that is transmitted between the edges 814 and 816 shines through the slits 811. In other words, the light beam between the edges 814 and 816 is interrupted by wheel 810 when impulse tube 210 is rotated. Optical reader 812 measures the number of interruptions in the light beam and the rate of occurrences thereof and transmits these measurements to speed calculator 422 which then determines the speed of pushrod 220 as discussed above.

Figures 27-32 show instrument 10 'having a retraction assembly 820 for retracting firing rod 220 from its firing position. Retraction assembly 820 provides a manually actuated mechanical interface with push tube 210 that allows manual retraction of firing rod 210 by means of the ratcheting action of retraction assembly 820 in emergency situations (eg, electrical malfunction). , end effector 160 stuck, etc.). The retraction assembly 820 can be configured as a modular assembly that can be inserted into the instrument 10 '.

Referring to FIG. 30, retraction assembly 820 includes a retraction chassis 822 having an upper portion 823 and a lower portion 825. Retraction assembly 820 is mechanically interfaced with drive tube 210 by means of a coupling gear. drive 826 and a retract gear 824. Drive gear 826 connects to drive tube 210 and translates in response to rotation of drive tube 210. In contrast, rotation of drive gear 826 imparts rotation in drive tube 210. Drive gear 826 and retraction gear 824 can be bevel gears that allow gears 824 and 826 to interface in a perpendicular manner.

The retraction gear 824 engages a first shaft 828 which is arranged in a substantially perpendicular manner between the upper and lower portions 823 and 825 of the retraction chassis 822 and is rotatable about a longitudinal axis defined thereby. First shaft 828 further includes a first spur gear 830 connected thereto and retraction gear 824. The first spur gear 830 interfaces with a second spur gear 832 disposed on a second shaft 834 that is also disposed in a substantially perpendicular manner between the upper and lower portions 823 and 825 of the retraction chassis 822 and is rotatable about an axis. longitudinal defined by it.

The second spur gear 832 has a mechanical interface with a third spur gear 836 that is disposed on the first shaft 828. The third spur gear 836 connects to a first clutch portion 838 of a one-way clutch assembly 840. The clutch assembly 840 further includes a second clutch part 840 rotatably disposed on the first shaft 828 above the first clutch part 838 with a spring 843 disposed between the first and second clutch parts 838 and 840, thereby maintaining the First and second clutch parts 838 and 840 in a raised configuration without interlocking (eg, first configuration) as shown in Figure 31.

Rotation of drive tube 210 and / or drive gear 826 imparts rotation to retraction gear 824 and first, second, and third spur gears 830, 832, and 836 along with first part 838 and respective shafts 828 and 834 Since the second clutch part 842 can rotate around the shaft 828 and

ES 2 646 491 T3 is separated from the first clutch part 838 by the spring 843, the rotation of the first part 838 does not translate thereto.

The first and second clutch parts 838 and 842 include a plurality of interlocking teeth 844 having a flat interlocking surface 846 and an inclined sliding surface 848. In a second configuration as shown in Figure 32, the second Clutch portion 842 is pushed down by a retract lever 845 thereby interfacing with teeth 844. The sliding surfaces 848 allow the interlocking surfaces 846 to contact each other thereby allowing the rotation of the second clutch part 842 to rotate the first clutch part 838 and all interface gears.

The retraction lever 845 includes a cam portion 847 and a handle 849 connected thereto. Cam portion 847 includes an aperture 853 that houses a one-way roller clutch 855 that is in mechanical cooperation with a coupling 856 connected to first shaft 828 thereby allowing retract lever 845 to rotate around first shaft 828. With reference Referring to FIG. 29, lever 845 includes one or more cam members 850 having a cam surface 852. In the first configuration, lever 845 is disposed along a lever pocket 860 of housing 110 as shown in FIG. 27. Lever 845 is pushed up by spring 843 against top 823 and the members of the housing. Cam 850 are disposed within corresponding cam pockets 858. Lever 845 is held in the first configuration by a return extension spring 862 mounted between upper portion 823 and cam portion 847. The cam members 850 and the lever pocket 860 prevent further rotation of the lever 845.

When the lever 845 is removed from the lever pocket 860, the cam members 850 interface with the corresponding cam pockets 823 and push down on the cam portion 847 of the lever 845. The downward movement compresses the spring 843 and pushes the first and second clutch parts 838 and 842 bringing them together to mutually lock the teeth 844 thereby engaging the parts 838 and 842. Counterclockwise rotation of cam portion 847 drives roller clutch 855 which interfaces with coupling 856 and first shaft 828. Continued rotation of lever 845 rotates clutch assembly 840 which in turn makes rotating spur gears 836, 832, and 830 and drive and retract gears 824 and 826. This in turn rotates drive tube 210 and retracts drive rod 220.

Lever 845 can be rotated a predetermined amount until handle 849 abuts housing 110 as shown in Figure 28. After that, lever 845 is brought back to its first configuration by return extension spring 862. This raises the cam portion 847 allowing the second clutch portion 842 to also move upward and disengage the first clutch portion 838. Roller clutch 855 releases coupling 856 allowing lever 845 to return to the first setting without affecting the movement of drive tube 210. Once lever 845 is returned to the first setting, lever 845 can be retracted once again to continue ratcheting pushrod 220.

It will be understood that various modifications can be made to the embodiments shown herein. Therefore, the above description should not be construed as limiting, but merely as examples of preferred embodiments. Those skilled in the art will envision other modifications within the scope of the appended claims.

A powered surgical stapler is described. The stapler includes a housing, an endoscopic portion extending distally from the housing and defining a first longitudinal axis, a drive motor disposed at least partially within a housing, and a firing rod arranged in mechanical cooperation with the drive motor. . The firing rod is rotatable by the motor about the first longitudinal axis extending through it. The stapler also includes an end effector disposed adjacent a distal portion of the endoscopic portion. The end effector is in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector. The stapler further includes a control system having a plurality of sensors coupled to the drive motor, firing rod, loading unit, and end effector, the plurality of sensors configured to detect operating parameters thereof. The control system also includes a microcontroller coupled to the plurality of sensors and configured to determine the operating status of the powered surgical stapler as a function of detected operating parameters.

The disclosure can be described by reference to the following numbered paragraphs:

1. A powered surgical stapler comprising: a housing; an endoscopic portion extending distally from the housing and defining a first longitudinal axis; a drive motor disposed at least partially within a housing; a firing rod arranged in mechanical cooperation with the drive motor; an end effector disposed adjacent a distal portion of the endoscopic portion, the end effector in mechanical cooperation with the firing rod such that the firing rod drives a surgical function of the end effector; and a main drive switch including first and second switches formed together as a rocker switch, wherein the first switch is adapted to activate the drive motor in a first direction to facilitate a first surgical end effector function and the second switch is adapted

ES 2 646 491 T3 to activate the drive motor in a second direction to facilitate a second surgical function of the end effector.

two. A surgical stapler powered according to paragraph 1, wherein the first and second switches are coupled to a non-linear speed control circuit adapted to control the rate of rotation of the drive motor as a function of the depressing of the first and second switches.

3. A surgical stapler powered according to paragraph 2, wherein the non-linear speed control circuit is selected from the group consisting of a voltage regulating circuit, a variable resistance circuit, and a pulse width modulation microelectronic circuit.

Four. A surgical stapler powered according to paragraph 2, wherein the first and second switches and the non-linear speed control circuit are coupled to a variable control device.

5. A surgical stapler powered according to paragraph 4, wherein the variable control device is selected from the group consisting of a rheostat, a multi-position switch, a variable displacement linear transducer, a variable displacement rotary transducer, a linear potentiometer, a rotary potentiometer, an optical encoder, a ferromagnetic sensor, and a Hall effect sensor.

6. A surgical stapler fed according to paragraph 1, wherein the end effector includes a pair of opposing tissue-engaging surfaces for deforming a plurality of surgical fasteners through and holding tissue, the tissue-engaging surfaces are movable one at a time. relative to another between an open position and an approach position in which the tissue engaging surfaces are juxtaposed with each other.

7. A surgical stapler powered according to paragraph 6, wherein the first surgical function of the end effector includes advancing the firing rod distally to move the pair of opposing tissue-engaging surfaces to the approach position and the second surgical function of the End effector includes retracting the firing rod proximally to move the pair of opposing tissue engaging surfaces to an approximation position.

8. A powered surgical stapler according to paragraph 6, further comprising: a third switch adapted to activate the drive motor to drive the firing rod to deploy and deform the surgical fasteners.

9. A powered surgical stapler according to paragraph 1, further comprising: a loading unit configured to removably connect to the endoscopic portion, the loading unit includes an end effector in mechanical cooperation with the firing rod so that the firing rod firing drives a surgical end effector function; and a load switch arranged within the endoscopic part and coupled to the main push switch, wherein the main push switch is disabled until actuation of the load switch by connecting the load unit to the endoscopic part.

10. A powered surgical stapler according to paragraph 1, further comprising: a latch switch disposed on the upper surface of a handle portion of the housing and coupled to the main drive switch, wherein the main drive switch is disabled until actuation of the Lock switch when gripping the handle part.

eleven. A surgical stapler powered according to paragraph 10, wherein the lock switch is selected from the group consisting of a bioimpedance sensor, a capacitance sensor, and a pressure sensor.