Nail forming detection mechanism

Abstract

The present invention discloses a medical device having an elongated channel configured to support a staple cartridge comprising a plurality of staples. The medical device also has an anvil mechanically coupled to the elongated channel, wherein the anvil comprises an outer surface extending between a proximal end and a distal end. In addition, the medical device comprises at least one electrical circuit at least partially positioned on the outer surface of the anvil, an indicator system comprising at least one indicator, and a logic circuit electrically connected to the at least one electrical circuit and the indicator system, wherein the logic circuit is configured to activate the at least one indicator when electrical continuity of the at least one electrical circuit is interrupted.

Description

[0001] This application is a divisional application of international application PCT / US2017 / 026328, entitled “Nail Forming Detection Agency”, which entered the Chinese national phase on December 7, 2018, with Chinese application number 2017800358102 and international application date of April 6, 2017. Technical Field

[0002] The present disclosure relates to surgical instruments and, in various cases, to surgical stapling and severing instruments and staple cartridges thereof designed for suturing and severing tissue. Background Art

[0003] In an electric surgical stapling and cutting instrument, it would be helpful to record that a cartridge has fired and possibly lock an empty cartridge via an electrical device. Additionally, it would be helpful to detect contact of a staple leg when the staple leg is positioned outside of the expected pit contact area on the anvil. Similarly, it would be helpful to detect the formation of a staple using anvil pit contact. Additionally, it would be helpful to detect the contact of a predetermined number of staple tips with the anvil pits and a predetermined sequence of staple contacts. Additionally, it would be helpful to sense the presence of a DLU, a removable channel, the loading status of the cartridge, the proper seating of the cartridge, and / or the closed status of the anvil. Additionally, most sensing systems rely on complex sensors or induction in order to detect and assess the status of the end effector system. It would be helpful to have a less intelligent but more powerful version to ensure reliability. Although several devices have been developed and used, it is believed that no one before the inventors have developed or used the device described in the appended claims. Summary of the Invention

[0004] In some aspects, a medical device is provided that includes an elongated channel configured to support a staple cartridge comprising a plurality of staples, an anvil mechanically coupled to the elongated channel, wherein the anvil defines a first staple-forming pocket and a second staple-forming pocket, a first conductive circuit element positioned within the first staple-forming pocket, a second conductive circuit element positioned within the second staple-forming pocket, and a control circuit electrically coupled to the first conductive circuit element and the second conductive circuit element, wherein the control circuit is configured to: determine a state of the first conductive element; determine a state of the second conductive element; and determine a forming characteristic of a staple in the plurality of staples based on the state of the first conductive element and the state of the second conductive element.

[0005] The above summary of the invention is only illustrative and is not intended to be limiting in any way. In addition to the above illustrative aspects and features, other aspects and features will become apparent with reference to the accompanying drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The novel features characteristic of the aspects described herein are set forth with particularity in the appended claims. However, aspects both as to organization and method of operation may be better understood with reference to the following description taken in conjunction with the accompanying drawings.

[0007] Figure 1 is a perspective view of a surgical instrument having an interchangeable shaft assembly operably coupled thereto in accordance with one or more aspects of the present disclosure.

[0008] Figure 2 According to one or more aspects of the present disclosure Figure 1 Exploded assembly view of the interchangeable shaft assembly and surgical instrument.

[0009] Figure 3 To illustrate one or more aspects of the present disclosure Figure 1 and Figure 2 Another exploded assembly view of the interchangeable shaft assembly and portions of the surgical instrument.

[0010] Figure 4 According to one or more aspects of the present disclosure Figures 1 to 3 An exploded assembly view of a portion of a surgical instrument.

[0011] Figure 5 According to one or more aspects of the present disclosure Figure 4 A cross-sectional side view of a portion of a surgical instrument with the firing trigger in a fully actuated position.

[0012] Figure 6 According to one or more aspects of the present disclosure Figure 5 Another cross-sectional view of a portion of a surgical instrument with the firing trigger in an actuated position.

[0013] Figure 7 According to one or more aspects of the present disclosure Figure 7 Another exploded assembly view of portions of the interchangeable shaft assembly.

[0014] Figure 8 According to one or more aspects of the present disclosure Figures 7 to 9 A cross-sectional view of a portion of an interchangeable shaft assembly.

[0015] Figure 9 Another perspective view of a portion of an interchangeable shaft assembly with a switch cartridge mounted thereon according to one or more aspects of the present disclosure.

[0016] Figure 10 According to one or more aspects of the present disclosure, the Figure 1 Part of a surgical instrument Figure 11A perspective view of a portion of the interchangeable shaft assembly is shown with the firing trigger of the surgical instrument in an unactuated position.

[0017] Figure 11 According to one or more aspects of the present disclosure Figure 10 Right side elevation view of the interchangeable shaft assembly and surgical instrument.

[0018] Figure 12 For operatively connecting to Figure 1 Part of a surgical instrument Figure 11 A perspective view of a portion of the interchangeable shaft assembly is shown with the closure trigger of the surgical instrument in an actuated position and its firing trigger in an unactuated position.

[0019] Figure 13 For operatively connecting to Figure 1 A right side elevational view of an interchangeable shaft assembly of a portion of a surgical instrument showing the closing trigger of the surgical instrument in an actuated position and the firing trigger thereof also in an actuated position.

[0020] Figure 14 According to one or more aspects of the present disclosure Figure 1 An exploded view of one aspect of an end effector of a surgical instrument.

[0021] Figure 15 Schematic diagram of a system for de-energizing an electrical connector of a surgical instrument handle when a shaft assembly is not coupled to the electrical connector according to one or more aspects of the present disclosure.

[0022] 16A to 16B is a diagram spanning two drawings according to one or more aspects of the present disclosure Figure 1 Circuit diagram of a surgical instrument.

[0023] 17A to 17B According to one or more aspects of the present disclosure Figure 1 Circuit diagram of a surgical instrument.

[0024] Figure 18 According to one or more aspects of the present disclosure Figure 1 Block diagram of a surgical instrument showing the interfaces between the handle assembly and the power assembly, and between the handle assembly and the interchangeable shaft assembly.

[0025] Figure 19 A logic diagram of a system for evaluating the sharpness of a cutting edge of a surgical instrument in accordance with one or more aspects of the present disclosure is shown.

[0026] Figure 20A logic diagram of a system for determining the force exerted by a sharpness testing member on a cutting edge of a surgical instrument at various sharpness levels is shown, in accordance with one or more aspects of the present disclosure.

[0027] Figure 21 One aspect of a process for adjusting the operation of a surgical instrument in accordance with one or more aspects of the present disclosure is shown.

[0028] Figure 22A Depicted are exemplary end effectors of medical devices that surround tissue according to one or more aspects of the present disclosure.

[0029] Figure 22B Depicted are exemplary end effectors of medical devices for compressing tissue according to one or more aspects of the present disclosure.

[0030] Figure 23A Depicted are exemplary forces applied by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure.

[0031] Figure 23B Also depicted are exemplary forces applied by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure.

[0032] Figure 24 Depicted are exemplary tissue compression sensor systems according to one or more aspects of the present disclosure.

[0033] Figure 25 Also depicted are exemplary tissue compression sensor systems according to one or more aspects of the present disclosure.

[0034] Figure 26 Also depicted are exemplary tissue compression sensor systems according to one or more aspects of the present disclosure.

[0035] Figure 27 Depicted are exemplary end effector channel frames according to one or more aspects of the present disclosure.

[0036] Figure 28 Depicted are exemplary end effectors according to one or more aspects of the present disclosure.

[0037] Figure 29 Also depicted are exemplary end effector channel frames according to one or more aspects of the present disclosure.

[0038] Figure 30 Also depicted are exemplary end effector channel frames according to one or more aspects of the present disclosure.

[0039] Figure 31 Also depicted are exemplary end effector channel frames according to one or more aspects of the present disclosure.

[0040] Figure 32 Depicted are exemplary electrodes according to one or more aspects of the present disclosure.

[0041] Figure 33 Depicted are exemplary electrode wiring systems according to one or more aspects of the present disclosure.

[0042] Figure 34 Also depicted are exemplary end effector channel frames according to one or more aspects of the present disclosure.

[0043] Figure 35 is an exemplary circuit diagram according to one or more aspects of the present disclosure.

[0044] Figure 36 Also provided is an exemplary circuit diagram according to one or more aspects of the present disclosure.

[0045] Figure 37 Also provided is an exemplary circuit diagram according to one or more aspects of the present disclosure.

[0046] Figure 38 is a perspective view of a surgical instrument having an articulatable, interchangeable shaft according to one or more aspects of the present disclosure.

[0047] Figure 39 According to one or more aspects of the present disclosure Figure 38 Side view of the tip of the surgical instrument shown in .

[0048] Figure 40 A cross-sectional view of an end effector of a surgical instrument according to one or more aspects of the present disclosure is shown.

[0049] Figure 41 A logic diagram of a feedback system according to one or more aspects of the present disclosure is shown.

[0050] Figure 42 A logic diagram of a feedback system according to one or more aspects of the present disclosure is shown.

[0051] Figure 43 is a diagram of a smart sensor component according to one aspect of the present disclosure.

[0052] Figure 44 One aspect of a circuit configured to convert signals from a first sensor and a plurality of second sensors into digital signals receivable by a processor is shown in accordance with one or more aspects of the present disclosure.

[0053] Figure 45 One aspect of an exploded view of a staple cartridge including a flexible cable connected to a magnetic field sensor and a processor is shown in accordance with one or more aspects of the present disclosure.

[0054] Figure 46 According to one or more aspects of the present disclosure Figure 46 The end effector shown in FIG has a flexible cable and no shaft assembly.

[0055] Figure 47 and Figure 48 An elongated channel portion of an end effector without an anvil or staple cartridge is shown according to one or more aspects of the present disclosure to illustrate Figure 46 How the flexible cable shown in FIG can be seated within the elongated channel.

[0056] Figure 49 According to one or more aspects of the present disclosure Figures 46 to 48 The flexible cable shown in .

[0057] Figure 50 According to one or more aspects of the present disclosure Figure 114 and Figure 115 A close up view of the elongated channel shown in , with a staple cartridge coupled thereto.

[0058] Figure 51 and Figure 52 One aspect of a distal sensor plug according to one or more aspects of the present disclosure is shown, wherein Figure 51 A cross-sectional view of the distal sensor plug is shown and Figure 52 Further shown are a magnetic field sensor and a processor operably coupled to the flex board to enable them to communicate.

[0059] Figure 53 Aspects of an end effector having a flexible cable operable to provide power to a sensor and electronics in a distal tip of an anvil portion are shown in accordance with one or more aspects of the present disclosure.

[0060] Figure 54 is a perspective view of an end effector of a surgical stapling instrument according to one or more aspects of the present disclosure, the surgical stapling instrument including a cartridge channel, a staple cartridge positioned in the cartridge channel, and an anvil.

[0061] Figure 55 According to one or more aspects of the present disclosure Figure 134 A cross-sectional front view of a surgical stapling instrument showing the slide and firing member in an unfired position.

[0062] Figure 56 To illustrate a partially advanced position according to one or more aspects of the present disclosure Figure 55 Detail of the slide and firing member in its unfired position.

[0063] Figure 57 An aspect of an end effector including a first sensor and a second sensor according to one or more aspects of the present disclosure is shown.

[0064] Figure 58 1 is a logic diagram illustrating one aspect of a process for determining the thickness of a tissue segment clamped between an anvil and a staple cartridge of an end effector in accordance with one or more aspects of the present disclosure.

[0065] Figure 59 1 is a logic diagram illustrating one aspect of a process for determining the thickness of a tissue segment clamped between an anvil and a staple cartridge of an end effector in accordance with one or more aspects of the present disclosure.

[0066] Figure 60 An aspect of an end effector including a first sensor and a second sensor according to one or more aspects of the present disclosure is shown.

[0067] Figure 61 An aspect of an end effector including a first sensor and a plurality of second sensors according to one or more aspects of the present disclosure is shown.

[0068] Figure 62 An aspect of an end effector including a plurality of sensors according to one or more aspects of the present disclosure is shown.

[0069] Figure 63 A logic diagram illustrating one aspect of a process for determining one or more tissue characteristics based on multiple sensors in accordance with one or more aspects of the present disclosure is shown.

[0070] Figure 64 One aspect of an end effector according to one or more aspects of the present disclosure is shown, the end effector including a plurality of sensors coupled to a jaw member.

[0071] Figure 65 An aspect of a staple cartridge including a plurality of sensors integrally formed therein is illustrated in accordance with one or more aspects of the present disclosure.

[0072] Figure 66 A logic diagram illustrating one aspect of a process for determining one or more parameters of a tissue segment clamped within an end effector in accordance with one or more aspects of the present disclosure is shown.

[0073] Figure 67 To illustrate one aspect of an end effector including a sensor according to one or more aspects of the present disclosure, the sensor has a particular sampling rate to limit or eliminate false signals.

[0074] Figure 68A logic diagram illustrating one aspect of a method for generating a thickness measurement of a tissue segment positioned between an anvil and a staple cartridge of an end effector in accordance with one or more aspects of the present disclosure.

[0075] Figures 69A to 69B An aspect of an end effector including a pressure sensor is shown in accordance with one or more aspects of the present disclosure.

[0076] Figure 70 An aspect of an end effector according to one or more aspects of the present disclosure is shown that includes a second sensor positioned between the staple cartridge and the jaw member.

[0077] Figure 71 To illustrate one or more aspects of the present disclosure Figures 69A to 69B or Figure 70 Logic diagram of one aspect of a process for determining the thickness of a tissue segment clamped in an end effector.

[0078] Figure 72 An aspect of an end effector according to one or more aspects of the present disclosure is shown, the end effector comprising a plurality of second sensors positioned between the staple cartridge and the elongated channel.

[0079] Figure 73A and Figure 73B The effects of full and partial occlusion of tissue according to one or more aspects of the present disclosure are further illustrated.

[0080] Figure 74 To illustrate aspects of an end effector according to one or more aspects of the present disclosure, the end effector is configured to determine the position of a cutting member or knife.

[0081] Figure 75 An example of an encoding strip operating with a red LED and an infrared LED is shown in accordance with one or more aspects of the present disclosure.

[0082] Figure 76 A partial perspective view of an end effector of a surgical instrument including a staple cartridge is shown in accordance with one or more aspects of the present disclosure.

[0083] Figure 77 According to one or more aspects of the present disclosure Figure 76 A front view of a portion of the end effector.

[0084] Figure 78 According to one or more aspects of the present disclosure Figure 76 Logical diagram of the surgical instrument module.

[0085] Figure 79 According to one or more aspects of the present disclosure Figure 76 A partial view of the cutting edge, optical sensor, and light source of a surgical instrument.

[0086] Figure 80 According to one or more aspects of the present disclosure Figure 76 A partial view of the cutting edge, optical sensor, and light source of a surgical instrument.

[0087] Figure 81 According to one or more aspects of the present disclosure Figure 76 A partial view of the cutting edge, optical sensor, and light source of a surgical instrument.

[0088] Figure 82 According to one or more aspects of the present disclosure Figure 76 A partial view of the cutting edge, optical sensor, and light source of a surgical instrument.

[0089] Figure 83 According to one or more aspects of the present disclosure Figure 76 A partial view of the cutting edge, optical sensor, and light source of a surgical instrument.

[0090] Figure 84 A perspective view of a staple cartridge including a sharpness testing member is shown in accordance with one or more aspects of the present disclosure.

[0091] Figure 85 A logical diagram of modules of a surgical instrument according to one or more aspects of the present disclosure is shown.

[0092] Figure 86 A logical diagram of modules of a surgical instrument according to one or more aspects of the present disclosure is shown.

[0093] Figure 87 A logic diagram outlining a method for evaluating the sharpness of a cutting edge of a surgical instrument according to one or more aspects of the present disclosure is shown.

[0094] Figure 88 A flow chart outlining a method for determining whether a cutting edge of a surgical instrument is sharp enough to transect tissue captured by the surgical instrument in accordance with one or more aspects of the present disclosure is shown.

[0095] Figure 89 A table showing predefined tissue thicknesses and corresponding predefined threshold forces is shown in accordance with one or more aspects of the present disclosure.

[0096] Figure 90 A logic diagram of a common controller for use with multiple motors of a surgical instrument is shown, in accordance with one or more aspects of the present disclosure.

[0097] Figure 91A partial front view of a handle of a surgical instrument with the outer housing removed is shown, in accordance with one or more aspects of the present disclosure.

[0098] Figure 92 A partial front view of a surgical instrument with an outer housing removed is shown in accordance with one or more aspects of the present disclosure.

[0099] Figure 93A A side angled view of an end effector with the anvil in a closed position is shown showing one LED on either side of the cartridge deck in accordance with one or more aspects of the present disclosure.

[0100] Figure 93B A quarter triangle view of an end effector is shown with the anvil in an open position, and one LED located on either side of the cartridge deck, in accordance with one or more aspects of the present disclosure.

[0101] Figure 94A Shown is a side angled view of an end effector with the anvil in a closed position, and a plurality of LEDs located on either side of the cartridge deck, in accordance with one or more aspects of the present disclosure.

[0102] Figure 94B A quarter triangle view of an end effector with an anvil in an open position is shown, along with a plurality of LEDs located on either side of the cartridge deck, in accordance with one or more aspects of the present disclosure.

[0103] Figure 95A Shown is a side angled view of an end effector with the anvil in a closed position and a plurality of LEDs located on either side of the cartridge deck from the proximal end to the distal end of the staple cartridge in accordance with one or more aspects of the present disclosure.

[0104] Figure 95B A quarter-angle view of an end effector with the anvil in an open position is shown showing a plurality of LEDs located on either side of the cartridge deck and from the proximal end to the distal end of the staple cartridge in accordance with one or more aspects of the present disclosure.

[0105] Figure 96 is a circuit diagram of an exemplary power assembly for a surgical instrument according to one or more aspects of the present disclosure.

[0106] Figure 97 is a circuit diagram of an exemplary power assembly for a surgical instrument according to one or more aspects of the present disclosure.

[0107] Figure 98 is a schematic block diagram of a control system for a surgical instrument according to one or more aspects of the present disclosure.

[0108] Figure 99 is a schematic block diagram of a control system for a surgical instrument according to one or more aspects of the present disclosure.

[0109] Figure 100 is a schematic diagram of an absolute positioning system including a controlled motor drive circuit configuration including a sensor configuration according to one or more aspects of the present disclosure.

[0110] Figure 101 Detailed perspective view of a sensor configuration for an absolute positioning system according to one or more aspects of the present disclosure.

[0111] Figure 102 An exploded perspective view of a sensor configuration of an absolute positioning system according to one or more aspects of the present disclosure illustrating the relative alignment of a control circuit board assembly and sensor configuration elements.

[0112] Figure 103 FIG. 1 is a schematic diagram of one aspect of a position sensor of an absolute positioning system including a magnetic rotation absolute positioning system according to one or more aspects of the present disclosure.

[0113] Figure 104 A schematic diagram illustrating a system for controlling the speed of a motor and / or the speed of a drivable member of a surgical instrument disclosed herein, according to one or more aspects of the present disclosure.

[0114] Figure 105 is a schematic diagram illustrating another system for controlling the speed of a motor and / or the speed of a drivable member of a surgical instrument disclosed herein, according to one or more aspects of the present disclosure.

[0115] Figure 106 A perspective view of a surgical stapling and severing instrument according to one or more aspects of the present disclosure is shown.

[0116] Figure 107 According to one or more aspects of the present disclosure Figure 106 An exploded view of the end effector of a surgical instrument, including an anvil and a staple cartridge.

[0117] Figure 108 A partial perspective view of an anvil including a plurality of electrical circuits and two rows of staples formed relative to the anvil is shown in accordance with one or more aspects of the present disclosure.

[0118] Figure 109 It shows that one or more aspects of the present disclosure can be positioned at Figure 108 Schematic top view of the indicator row on the outer surface of the anvil.

[0119] Figure 110A circuit comprising a conductive circuit element according to one or more aspects of the present disclosure is shown. Figure 108 A perspective view of the nail forming pocket of an anvil.

[0120] Figure 111 FIG. 1 shows a schematic diagram of a conductive circuit element after it has been severed by a staple leg during proper formation of the staple leg according to one or more aspects of the present disclosure. Figure 110 A perspective view of a nail forming recess.

[0121] Figure 112 A partial perspective view of an anvil including a plurality of electrical circuits and two rows of staples formed relative to the anvil is shown in accordance with one or more aspects of the present disclosure.

[0122] Figure 113A According to one or more aspects of the present disclosure Figure 112 A cross-sectional view of two adjacent nail forming pockets in a row of nail forming pockets of an anvil.

[0123] Figure 113B According to one or more aspects of the present disclosure Figure 113A A cross-sectional view of a staple forming recess engaged with a suitably formed staple including two staple legs of a conductive circuit element cutting into the staple forming recess.

[0124] Figure 113C According to one or more aspects of the present disclosure Figure 113A A cross-sectional view of a staple forming recess engaging an improperly formed staple including a staple leg of a conductive circuit element that fails to cut through or misses the staple forming recess.

[0125] Figure 114 A partial perspective view of an anvil according to one or more aspects of the present disclosure is shown, including a plurality of circuits and two rows of staples formed against the anvil according to at least one aspect of the present disclosure.

[0126] Figure 115 According to one or more aspects of the present disclosure Figure 114 A partial cross-sectional view of an anvil being pressed against the nails in the nail magazine.

[0127] Figure 116 A perspective view of an end effector including an anvil and a staple cartridge is shown in accordance with one or more aspects of the present disclosure.

[0128] Figure 117 is a circuit diagram illustrating conductive circuit elements disposed within staple forming pockets of an anvil in accordance with one or more aspects of the present disclosure.

[0129] Figure 118A logic circuit including a logic gate that receives input from an electrical circuit including conductive circuit elements is shown in accordance with one or more aspects of the present disclosure.

[0130] Figure 119 A cross-sectional view of an end effector including an anvil and a staple cartridge clamped to tissue is shown during a firing sequence in accordance with one or more aspects of the present disclosure.

[0131] Figure 120 According to one or more aspects of the present disclosure Figure 119 A perspective view of the end effector.

[0132] Figure 121 is a circuit diagram according to one or more aspects of the present disclosure.

[0133] Figure 122 is a circuit diagram according to one or more aspects of the present disclosure.

[0134] Figure 123 A wedge slide and E-beam assembly according to one or more aspects of the present disclosure is provided.

[0135] Figure 123A is a cross-sectional view illustrating staple formation according to one or more aspects of the present disclosure.

[0136] Figure 124 is a circuit diagram according to one or more aspects of the present disclosure.

[0137] Figure 124A is a circuit diagram according to one or more aspects of the present disclosure.

[0138] Figure 124B is a circuit diagram according to one or more aspects of the present disclosure.

[0139] Figure 125 A perspective view of an end effector including an anvil and a staple cartridge clamped to tissue is shown during a firing sequence in accordance with one or more aspects of the present disclosure.

[0140] Figure 126 A cross-sectional view of a staple being formed against a staple forming pocket by a staple driver in accordance with one or more aspects of the present disclosure is shown.

[0141] Figure 127 A wedge-shaped slide according to one or more aspects of the present disclosure.

[0142] Figure 128 An E-beam assembly according to one or more aspects of the present disclosure.

[0143] Figure 129A force sensor according to one or more aspects of the present disclosure.

[0144] Figure 130 is a circuit diagram according to one or more aspects of the present disclosure.

[0145] Figure 131 is a cross-sectional view illustrating a wedge sled engaged with a staple driver forming staples against staple forming pockets of an anvil in accordance with one or more aspects of the present disclosure.

[0146] Figure 132 is a circuit diagram according to one or more aspects of the present disclosure.

[0147] Figure 133 A perspective view of a surgical instrument including interchangeable units releasably attached to a housing is shown in accordance with one or more aspects of the present disclosure.

[0148] Figure 134 is a circuit diagram according to one or more aspects of the present disclosure. DETAILED DESCRIPTION

[0149] The applicant of the present application owns the following patent applications filed on April 15, 2016 and each of which is incorporated herein by reference in its entirety:

[0150] U.S. patent application serial number 15 / 130,582, entitled “SURGICAL INSTRUMENT WITH DETECTION SENSORS”;

[0151] U.S. patent application serial number 15 / 130,588, entitled “SURGICAL INSTRUMENT WITH IMPROVEDSTOP / START CONTROL DURING A FIRING MOTION”;

[0152] U.S. patent application serial number 15 / 130,595, entitled “SURGICAL INSTRUMENT WITH ADJUSTABLE STOP / START CONTROL DURING A FIRING MOTION”;

[0153] U.S. patent application serial number 15 / 130,566, entitled “SURGICAL INSTRUMENT WITH MULTIPLEPROGRAM RESPONSESDURING A FIRING MOTION”;

[0154] U.S. patent application serial number 15 / 130,571, entitled “SURGICAL INSTRUMENT WITH MULTIPLEPROGRAM RESPONSESDURING A FIRING MOTION”;

[0155] U.S. patent application serial number 15 / 130,581, entitled “MODULAR SURGICAL INSTRUMENT WITH CONFIGURABLE OPERATING MODE”;

[0156] U.S. Patent Application Serial No. 15 / 130,590, entitled “SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT”; and

[0157] U.S. Patent Application Serial No. 15 / 130,596, entitled “SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT.”

[0158] This disclosure provides a comprehensive understanding of the structures, functions, principles of manufacture, uses of the devices, and methods disclosed herein. One or more examples of these aspects are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting examples. Features illustrated or described in conjunction with one example may be combined with features of other examples. Such modifications and variations are intended to be included within the scope of this disclosure.

[0159] Various example devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, one of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in many surgical procedures and applications, including, for example, in conjunction with open surgical procedures. Continuing with this detailed description, one of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, and the like. The working portion or end effector portion of the instrument can be inserted directly into the patient's body or can be inserted through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument can be advanced.

[0160] In one aspect, the present disclosure provides an RFID tag positioned in a bin knife slot for indicating a bin status.

[0161] In another aspect, the present invention provides a system for detecting cartridge platform deflection. The system may include sensors to detect "unexpected" or "poor" staple formation by sensing when the tips of the outer rows of staples miss the anvil pits. A typical failure mode is when the outer rows of staples are pushed away by tissue flow and miss the outer anvil pits. This failure mode can be detected by having small electrical contacts on the edge of the anvil that, when "closed" by contact with the staple legs, complete the circuit. Tissue flow typically affects the outer staple legs the most—thus, monitoring the success of the outer staples is a good indicator of the success of all staples. The circuit is completed when the staple legs contact the anvil edge. Therefore, the edge of the anvil is provided with an electrically isolated wire or edge that serves as a common ground. The electrical conductivity of each outer staple is continuously checked via the reload's conductive path, where the staples and the anvil edge simultaneously contact the pit extension. The pit extension is connected to a wire or conductive element in the reload, which is connected to the endoscope cutter via an electrical connection between the reload and the channel. Alternatively, the circuit can be completed through a nail-driver-slide-knife-knife band, etc. to provide an electrical signal to the handle of the translation drive system through the articulation joint and axially.

[0162] On the other hand, the present invention provides a laminate in a multilayer knife for carrying electrical signals. The laminate of the knife band can be made by laminating a conductor or a printed flexible circuit between two insulators (e.g., a film circuit). The isolation circuit incorporated into the knife laminate can be used to pass the signal through the articulation joint and axially upward to a point where a brush or arc brush can pass the signal from the translation / rotation knife to the handle. Identifying poor nails on the outside row can be used to inform the surgeon that a problem may occur. This information can also be used to change the firing parameters in real time to obtain better nail formation with the rest of the nail line.

[0163] In another aspect, the present disclosure provides for detecting nail formation through contact with the anvil pit. This system can be used to detect "good" nail formation by sensing the scraping of the nail tip across the bottom of each anvil pit. This can be achieved by providing a small electrical circuit in each anvil pit, which would lose continuity if a nail leg passed through it. A layer of insulating / conductive / insulating ink can be applied to the anvil to form these circuits and isolate them from the conductive material of the anvil and tissue. When a nail passes through the anvil pit (a predictor of good nail formation), the circuit is broken, and the device interprets this as a good nail formation. Single-use anvils can have the electrical circuit printed directly on the anvil material. Reusable anvils would require repairing the circuit. This can be achieved by providing a film circuit that would act as a pressure-sensitive decal between firings. A special fixture with a pressure-sensitive adhesive circuit on it would allow alignment and transfer to the anvil. To minimize the amount of data to be collected, transmitted, and analyzed, the circuit can be confined to the outer anvils. Tissue flow typically affects the outer nail legs the most. Therefore, monitoring the success of the outer nails will be a good indicator of the success of all nails. In one aspect, the circuit can be printed with very small conductive traces because the current required for the conductivity check can be very small. To prevent false "success" readings when the circuit is severed outside the anvil pit, the circuit outside the anvil pit can be protected with a solid outer layer of armor and / or the circuit can be layered and run in a thin channel in the anvil (too thin to pass through the nail line) (sub-anvil platform).

[0164] In yet another aspect, the present disclosure provides an electrical sensing of reload type and proper seating based on a non-integrated circuit. A series of continuity path electrical connections similar to ladder logic can be provided to allow the handle to determine what actions to allow or prevent based on the continuity of the components located in the end effector. For example, a track can penetrate a disposable loading unit attachment and bridge a removable channel on both sides and return through the loading unit attachment. In this way, the absence of a loading unit or channel will destroy the continuity of the circuit and the device will not fire. The same operation can also be accomplished by providing a main path in series or parallel with the circuit that penetrates the cartridge body and the slide in its fully retracted position, or provided through the cartridge and through the last three actuators on the right and left sides in their lowermost positions. Both of these systems will change the resistance and overall continuity of the entire circuit, allowing the device to sense whether the loaded cartridge is properly in place in addition to the attached channel and disposable reload.

[0165] In describing the combination Figures 106 to 134 Before describing the various aspects of the electric stapling and cutting instrument (surgical instrument), the present disclosure first turns to Figures 1 to 105 A general description of the electromechanical platform upon which the present powered surgical instrument may be implemented is provided, providing the background necessary to understand the basic operation and functionality of the powered surgical instrument. Figures 1 to 14An example is provided of a general description of a basic mechanical platform upon which the powered stapling and severing instrument of the present invention may be implemented. Figures 15 to 21 An example of a general basic microcontroller, motor driver, and electrical interconnect platform for a powered surgical instrument upon which the present invention may be implemented is described. Figures 22A to 34 An exemplary end effector channel frame and measured forces applied to tissue positioned between an anvil and a staple cartridge of an end effector are described. Figures 35 to 37 Exemplary circuitry for controlling the functions of the present powered surgical instrument is described. Figures 38 to 95B Exemplary sensor and feedback systems utilizing sensor outputs to implement the present powered surgical instrument are described. Figures 96 to 97 An exemplary power assembly for providing power to the present powered surgical instrument is described. Figures 98 to 105 An exemplary control system for controlling the motor speed and drivable members of the present surgical instrument, including sensors and feedback elements therefor, is described. After becoming familiar with the basic electromechanical platform upon which the present powered surgical instrument may be implemented, the reader turns to the following: Figures 106 to 134 Learn about the description of the electric surgical stapling and cutting instruments.

[0166] So now turning to the accompanying drawings, Figures 1 to 6A motor-driven surgical instrument 10 for cutting and fastening, which may or may not be reusable, is depicted. In the illustrated example, the surgical instrument 10 includes a housing 12 containing a handle assembly 14 configured to be grasped, manipulated, and actuated by a clinician. The housing 12 is configured to be operably attached to an interchangeable shaft assembly 200 having an end effector 300 operably coupled thereto, the end effector being configured to perform one or more surgical tasks or procedures. As will be appreciated from further reading of this detailed description, the various unique and novel arrangements of interchangeable shaft assemblies disclosed herein may also be effectively used in conjunction with robotically controlled surgical systems. Thus, the term "housing" may also encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control action that can be used to actuate the interchangeable shaft assemblies disclosed herein and their respective equivalents. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and / or a portion of a robotic system that can be used to operably control a surgical instrument. For example, the interchangeable shaft assemblies disclosed herein may be used in various robotic systems, instruments, components, and methods disclosed in U.S. Patent No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety.

[0167] Figures 1 to 2 The housing 12 shown in FIG is shown in conjunction with an interchangeable shaft assembly 200 including an end effector 300, the end effector including a surgical cutting and fastening device configured to operably support a surgical staple cartridge 304 therein. The housing 12 can be configured for use with an interchangeable shaft assembly including an end effector adapted to support staple cartridges of varying sizes and types, including those having varying shaft lengths, sizes, and types. Furthermore, the housing 12 can also be effectively used with a variety of other interchangeable shaft assemblies, including those configured to apply other motions and forms of energy (such as, for example, radiofrequency (RF) energy, ultrasonic energy, and / or motion) to an end effector arrangement suitable for use in conjunction with a variety of surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system can utilize any one or more suitable fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and / or attached to the end effector of the shaft assembly.

[0168] Figure 1 The surgical instrument 10 is shown having an interchangeable shaft assembly 200 operably coupled thereto. Figure 2 Attachment of the interchangeable shaft assembly 200 to the housing 12 or handle assembly 14 is shown. Figure 4 As shown, the handle assembly 14 can include a pair of interconnectable handle housing segments 16 and 18, which can be interconnected by screws, snap features, adhesives, etc. In the illustrated configuration, the handle housing segments 16, 18 cooperate to form a pistol grip portion 19 that can be grasped and manipulated by a clinician. As will be described in greater detail below, the handle assembly 14 operatively supports a plurality of drive systems therein that are configured to generate and apply various control motions to corresponding portions of the interchangeable shaft assembly operatively attached thereto.

[0169] Now see Figure 4 , the handle assembly 14 may also include a frame 20 that operably supports a plurality of drive systems. For example, the frame 20 may operably support a "first" or closure drive system, generally designated 30, that may be used to impart closing and opening motions to the interchangeable shaft assembly 200 operatively attached or coupled thereto. In at least one form, the closure drive system 30 may include an actuator in the form of a closure trigger 32 pivotally supported by the frame 20. More specifically, as Figure 4 As shown, the closing trigger 32 is pivotally coupled to the handle assembly 14 via a pivot pin 33. Such a construction enables the closing trigger 32 to be manipulated by the clinician so that when the clinician grasps the pistol grip portion 19 of the handle assembly 14, the closing trigger 32 can be easily pivoted from the activated or "unactuated" position to the "activated" position and more specifically to the fully compressed or fully actuated position. The closing trigger 32 can be biased into the unactuated position by a spring or other biasing arrangement (not shown). In various forms, the closing drive system 30 also includes a closing linkage assembly 34 pivotally coupled to the closing trigger 32. As shown Figure 4 As shown, the closure link assembly 34 may include a first closure link 36 and a second closure link 38 pivotally coupled to the closure trigger 32 by a pin 35. The second closure link 38 may also be referred to herein as an "attachment member" and includes a transverse attachment pin 37.

[0170] See also Figure 4, it can be observed that the first closure link 36 may have an end or locking wall 39 thereon that is configured to engage a closure release assembly 60 pivotally coupled to the frame 20. In at least one form, the closure release assembly 60 may include a closure release button assembly 62 having a distally projecting locking pawl 64 formed thereon. The closure release button assembly 62 can be pivoted counterclockwise by a release spring (not shown). When the clinician presses the closure trigger 32 from its unactuated position toward the pistol grip portion 19 of the handle assembly 14, the first closure link 36 pivots upward to a point where the locking pawl 64 falls into engagement with the locking wall 39 on the first closure link 36, thereby preventing the closure trigger 32 from returning to the unactuated position. Thus, the closure release assembly 60 serves to lock the closure trigger 32 in the fully actuated position. When the clinician desires to unlock the closure trigger 32 to allow it to be biased to the unactuated position, the clinician simply pivots the closure release button assembly 62, causing the locking pawl 64 to move out of engagement with the locking wall 39 on the first closure link 36. When the locking pawl 64 has moved out of engagement with the first closure link 36, the closure trigger 32 can be pivoted back to the unactuated position. Other closure trigger locking and release configurations may also be employed.

[0171] In addition to the above, Figures 10 and 11 The closure trigger 32 is shown in an unactuated position, which is associated with an open or unclamped configuration of the interchangeable shaft assembly 200 in which tissue may be positioned between the jaws of the interchangeable shaft assembly 200 . Figure 12 The closure trigger 32 is shown in an actuated position associated with the closed or clamped configuration of the interchangeable shaft assembly 200 in which tissue is clamped between the jaws of the interchangeable shaft assembly 200. Figure 11 and Figure 13 It will be seen from the comparison that when the closure trigger 32 is moved from its unactuated position ( Figure 11 ) to its actuated position ( Figure 13 ) movement, the closing release button assembly 62 is in the first position ( Figure 11 ) and the second position ( Figure 13 ) between the closed release button assembly 62. The rotation of the closed release button assembly 62 may be referred to as an upward rotation; however, at least a portion of the closed release button assembly 62 rotates toward the circuit board 100. Figure 4The closure release button assembly 62 may include an arm 61 extending therefrom and a magnetic element 63 (such as a permanent magnet) mounted to the arm 61. When the closure release button assembly 62 is rotated from its first position to its second position, the magnetic element 63 may move toward the circuit board 100. The circuit board 100 may include at least one sensor configured to detect the movement of the magnetic element 63. In at least one aspect, for example, a magnetic field sensor 65 may be mounted to the bottom surface of the circuit board 100. The magnetic field sensor 65 may be configured to detect changes in the magnetic field surrounding the magnetic field sensor 65 caused by the movement of the magnetic element 63. The magnetic field sensor 65 may, for example, be in signal communication with the controller 1500, which may determine whether the closure release button assembly 62 is in its first position, associated with the unactuated position of the closure trigger 32 and the open configuration of the end effector, or in any position therebetween. The first position is associated with the actuated position of the closure trigger 32 and the closed configuration of the end effector.

[0172] As used throughout this disclosure, the magnetic field sensor can be a Hall effect sensor, a detection coil, a flux gate, an optical pump, a nuclear spin, a superconducting quantum interference device (SQUID), a Hall effect, anisotropic magnetoresistance, giant magnetoresistance, a magnetic tunnel junction, giant magnetoimpedance, a magnetostrictive / piezoelectric composite material, a magnetosensitive diode, a magnetosensitive transistor, an optical fiber, magneto-optical, and a micro-electromechanical system-based magnetic sensor, etc.

[0173] In at least one form, the handle assembly 14 and frame 20 can operably support another drive system, referred to herein as a firing drive system 80, which is configured to apply a firing action to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 80 may also be referred to herein as a "second drive system." The firing drive system 80 may employ an electric motor 82 located in the pistol grip portion 19 of the handle assembly 14. In various forms, the electric motor 82 may be, for example, a DC brushed drive motor having a maximum rotation of approximately 25,000 RPM. In other constructions, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The electric motor 82 may be powered by a power source 90, which, in one form, may include a removable power pack 92. As Figure 4As shown, for example, the removable power pack 92 may include a proximal housing portion 94 that is configured to be attached to a distal housing portion 96. The proximal housing portion 94 and the distal housing portion 96 are configured to operably support a plurality of batteries 98 therein. The batteries 98 may each include, for example, a lithium ion ("LI") or other suitable battery. The distal housing portion 96 is configured to be removably operably attached to a control circuit board 100 that is also operably coupled to the electric motor 82. A plurality of batteries 98 that can be connected in series can be used as a power source for the surgical instrument 10. In addition, the power source 90 can be replaceable and / or rechargeable.

[0174] As outlined above with respect to the other various forms, the electric motor 82 may include a rotatable shaft (not shown) operably interfaced with a gear reducer assembly 84, which is mounted to mesh with a set or rack of drive teeth 122 on the longitudinally movable drive member 120. In use, the voltage polarity provided by the power source 90 can operate the electric motor 82 in a clockwise direction, wherein the voltage polarity applied to the electric motor by the battery can be reversed to operate the electric motor 82 in a counterclockwise direction. When the electric motor 82 rotates in one direction, the longitudinally movable drive member 120 will be driven axially in the distal direction "DD". When the electric motor 82 is driven in the opposite rotational direction, the longitudinally movable drive member 120 will be driven axially in the proximal direction "PD". The handle assembly 14 may include a switch that is configured to reverse the polarity applied to the electric motor 82 by the power source 90. As with other versions described herein, the handle assembly 14 may further include a sensor configured to detect the position of the longitudinally movable drive member 120 and / or the direction in which the longitudinally movable drive member 120 is moving.

[0175] Actuation of the electric motor 82 is controlled by a firing trigger 130 that is pivotally supported on the handle assembly 14. The firing trigger 130 is pivotable between an unactuated position and an actuated position. The firing trigger 130 may be biased into the unactuated position by a spring 132 or other biasing structure so that when the clinician releases the firing trigger 130, the firing trigger may be pivoted or otherwise returned to the unactuated position by the spring 132 or biasing structure. In at least one form, the firing trigger 130 may be positioned "outside" of the closing trigger 32 as described above. In at least one form, a firing trigger safety button 134 may be pivotally mounted to the closing trigger 32 by a pin 35. The firing trigger safety button 134 may be positioned between the firing trigger 130 and the closing trigger 32 and have a pivot arm 136 protruding therefrom. See Figure 4When the closure trigger 32 is in the unactuated position, the firing trigger safety button 134 is housed in the handle assembly 14 and may not be easily accessible to the clinician or movable between a safety position that prevents actuation of the firing trigger 130 and a fired position in which the firing trigger 130 can be fired. When the clinician depresses the closure trigger 32, the firing trigger safety button 134 and the firing trigger 130 pivot downward and can then be manipulated by the clinician.

[0176] As discussed above, the handle assembly 14 may include a closure trigger 32 and a firing trigger 130. Figures 11 to 13 , the firing trigger 130 can be pivotally mounted to the closure trigger 32. The closure trigger 32 may include an arm 31 extending therefrom, and the firing trigger 130 can be pivotally mounted to the arm 31 about a pivot pin 33. As outlined above, when the closure trigger 32 is moved from its unactuated position ( Figure 11 ) to its actuated position ( Figure 13 ) movement, the firing trigger 130 can drop downward. After the firing trigger safety button 134 has moved to its firing position, see mainly Figure 11 , the firing trigger 130 can be depressed to operate the motor of the surgical instrument firing system. In various cases, the handle assembly 14 can include a tracking system (such as system 800) that is configured to determine the position of the closure trigger 32 and / or the position of the firing trigger 130. Figure 11 and Figure 13 , the tracking system 800 may include a magnetic element, such as a magnet 802, mounted to an arm 801 extending from the firing trigger 130. The tracking system 800 may include one or more sensors, such as a first magnetic field sensor 803 and a second magnetic field sensor 804, which may be configured to track the position of the magnet 802.

[0177] Readers will Figure 11 and Figure 13 As will be appreciated by comparison, the magnet 802 may move between a first position adjacent to the first magnetic field sensor 803 and a second position adjacent to the second magnetic field sensor 804 as the closure trigger 32 moves from its unactuated position to its actuated position.

[0178] Readers will Figure 11 and Figure 13 After comparison, it will be further known that when the firing trigger 130 is in the unfired position ( Figure 11 ) to the firing position ( Figure 13) moves, the magnet 802 may move relative to the second magnetic field sensor 804. The first and second magnetic field sensors 803, 804 may track the movement of the magnet 802 and may communicate signals with a controller on the circuit board 100. The controller may use data from the first magnetic field sensor 803 and / or the second magnetic field sensor 804 to determine the position of the magnet 802 along a predefined path, and based on this position, the controller may determine whether the closing trigger 32 is in its unactuated position, its actuated position, or a position between its unactuated position and its actuated position. Similarly, the controller may use data from the first magnetic field sensor 803 and / or the second magnetic field sensor 804 to determine the position of the magnet 802 along a predefined path, and based on this position, the controller may determine whether the firing trigger 130 is in its unfired position, its fully fired position, or a position between its unfired position and its fully fired position.

[0179] As described above, in at least one form, the longitudinally movable drive member 120 has a rack of drive teeth 122 formed thereon for engaging with corresponding drive gears 86 of the gear reducer assembly 84. At least one form also includes a manually actuatable rescue assembly 140 configured to enable a clinician to manually retract the longitudinally movable drive member 120 in the event that the electric motor 82 becomes inoperative. The rescue assembly 140 may include a lever or handle assembly 14 configured to be manually pivoted into ratcheting engagement with teeth 124 also disposed in the longitudinally movable drive member 120. Thus, the clinician can manually retract the longitudinally movable drive member 120 by using the handle assembly 14 to engage the longitudinally movable drive member 120 in the proximal direction PD. No. 8,608,045, entitled "POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," discloses emergency configurations and other components, configurations, and systems that may also be used with the various apparatuses disclosed herein. US Patent No. 8,608,045 is hereby incorporated by reference in its entirety.

[0180] Now go to Figure 1 , the interchangeable shaft assembly 200 includes an end effector 300 including an elongated channel 302 configured to operably support a surgical staple cartridge 304 therein. The end effector 300 may further include an anvil 306 pivotally supported relative to the elongated channel 302. The interchangeable shaft assembly 200 may further include an articulation interface 270 and an articulation lock 350 ( Figure 7), the articulation lock can be configured to releasably maintain the end effector 300 in a desired position relative to the shaft axis SA-SA. Details regarding the construction and operation of the end effector 300, the articulation interface 270, and the articulation lock 350 are set forth in U.S. Patent Application Publication No. 2014 / 0263541, entitled “ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK,” which is incorporated herein by reference in its entirety. Figure 7 As shown, the interchangeable shaft assembly 200 may further include a proximal housing or nozzle 201 comprised of nozzle portions 202, 203. The interchangeable shaft assembly 200 may further include a closure tube 260 that may be used to close and / or open the anvil 306 of the end effector 300. Referring now primarily to Figure 7 , the interchangeable shaft assembly 200 may include a spine 210 that may be configured to fixably support a shaft frame 212 of an articulation lock 350. See Figure 7 . The spine 210 can be configured to: first, slidably support the firing member 220 therein; and second, slidably support the closure tube 260 extending around the spine 210. The spine 210 can also be configured to slidably support the articulation driver 230. The articulation driver 230 has a distal end 231 that is configured to operably engage the articulation lock 350. The articulation lock 350 interfaces with an articulation frame 352 that is configured to operably engage a drive pin (not shown) on an end effector frame (not shown). As described above, more details regarding the operation of the articulation lock 350 and the articulation frame can be found in U.S. Patent Application Publication 2014 / 0263541. In various embodiments, the spine 210 may include a proximal end 211 rotatably supported in the base 240. In one configuration, for example, the proximal end 211 of the spine 210 has threads 214 formed thereon for threaded attachment to a spine bearing 216 configured to be supported within a base 240. Such a configuration facilitates rotatable attachment of the spine 210 to the base 240 such that the spine 210 can be selectively rotated relative to the base 240 about the shaft axis SA-SA.

[0181] The interchangeable shaft assembly 200 includes a closure shuttle 250 slidably supported within the base 240 in an axially movable manner relative thereto. Figure 3As shown, the closure shuttle 250 includes a pair of proximally projecting hooks 252 configured to attach to a transverse attachment pin 37, which is attached to the second closure link 38, as will be discussed in further detail below. The proximal end 261 of the closure tube 260 is coupled to the closure shuttle 250 for rotation relative to the closure shuttle. For example, a U-shaped connector 263 is inserted into an annular slot 262 in the proximal end 261 of the closure tube 260 so that it is retained within the vertical slot 253 in the closure shuttle 250. This configuration is used to attach the closure tube 260 to the closure shuttle 250 for axial travel therewith while allowing the closure tube 260 to rotate relative to the closure shuttle 250 about the shaft axis SA-SA. A closure spring 268 is journaled on the closure tube 260 and serves to bias the closure tube 260 in the proximal direction “PD”, which can be used to pivot the closure trigger into the unactuated position when the shaft assembly is operatively coupled to the handle assembly 14 .

[0182] In at least one form, the interchangeable shaft assembly 200 may further include an articulation interface 270. However, other interchangeable shaft assemblies may not be able to articulate. According to various forms, the dual-pivot closure sleeve assembly 271 includes an end effector closure sleeve assembly 272 having an upper shank 273 and a lower shank 274 protruding distally. The end effector closure sleeve assembly 272 includes a horseshoe-shaped hole 275 and a plug 276 for engaging the open plug on the anvil 306 in various ways described in U.S. Patent Application Publication 2014 / 0263541. As further described in detail herein, when the anvil 306 is opened, the horseshoe-shaped hole 275 and the plug 276 engage the plug on the anvil. The upper dual pivot connection 277 includes upwardly projecting distal and proximal pivot pins that respectively engage an upper distal pin hole in the proximally projecting upper tang 273 and an upper proximal pin hole in the distally projecting upper tang 264 on the closure tube 260. The lower dual pivot connection 278 includes upwardly projecting distal and proximal pivot pins that respectively engage a lower distal pin hole in the proximally projecting lower tang 274 and a lower proximal pin hole in the distally projecting lower tang 265. See also Figure 7 .

[0183] In use, the closure tube 260 is translated distally (direction "DD") to close the anvil 306, for example, in response to actuation of the closure trigger 32. The anvil 306 is closed by translating the closure tube 260 and, therefore, the end effector closure sleeve assembly 272 distally, causing it to strike a proximal surface on the anvil 306 in a manner described in the above-referenced U.S. Patent Application Publication No. 2014 / 0263541. As also described in detail in that reference, the anvil 306 is opened by translating the closure tube 260 and the end effector closure sleeve assembly 272 proximally, causing the tab 276 and the horseshoe-shaped hole 275 to contact and push against the anvil tab to lift the anvil 306. In the anvil open position, the closure tube 260 moves to its proximal position.

[0184] As described above, the surgical instrument 10 may also include an articulation lock 350 of the type and configuration described in further detail in U.S. Patent Application Publication No. 2014 / 0263541, which may be configured to be operable to selectively lock the end effector 300 in position. When the articulation lock 350 is in its unlocked state, such configuration enables the end effector 300 to rotate or articulate relative to the closure tube 260. In this unlocked state, the end effector 300 may be positioned and urged against, for example, soft tissue and / or bone surrounding a surgical site within a patient's body to articulate the end effector 300 relative to the closure tube 260. The end effector 300 may also be articulated relative to the closure tube 260 by the articulation driver 230.

[0185] As also described above, the interchangeable shaft assembly 200 also includes a firing member 220 that is supported for axial travel within the spine 210. The firing member 220 includes an intermediate firing shaft 222 that is configured to be attached to the distal cutting portion or knife bar 280. The firing member 220 may also be referred to herein as a "second shaft" and / or a "second shaft assembly." Figure 7 As shown, the intermediate firing shaft 222 may include a longitudinal slot 223 in its distal end that may be configured to receive a tab 284 on the proximal end 282 of the knife bar 280. The longitudinal slot 223 and the proximal end 282 may be sized and configured to allow relative movement therebetween and may include a sliding joint 286. The sliding interface 286 may allow the intermediate firing shaft 222 of the firing drive member 220 to move so as to articulate the end effector 300 without moving, or at least substantially moving, the knife bar 280. Once the end effector 300 has been properly oriented, the intermediate firing shaft 222 may be advanced distally until the proximal sidewall of the longitudinal slot 223 contacts the tab 284 so as to advance the knife bar 280 and fire the staple cartridge positioned within the channel 302. As shown Figure 7As can be further seen, the spine 210 has an elongated opening or window 213 therein to facilitate assembly and insertion of the intermediate firing shaft 222 into the spine 210. Once the intermediate firing shaft 222 has been inserted into the shaft frame, the top frame segment 215 can be engaged with the shaft frame 212 to enclose the intermediate firing shaft 222 and the knife bar 280 therein. Further description of the operation of the firing member 220 can be found in U.S. Patent Application Publication No. 2014 / 0263541.

[0186] Further to the above, the interchangeable shaft assembly 200 can include a clutch assembly 400 that can be configured to selectively and releasably couple the articulation driver 230 to the firing member 220. In one form, the clutch assembly 400 includes a locking collar or locking sleeve 402 positioned about the firing member 220, wherein the locking sleeve 402 is rotatable between an engaged position, in which the locking sleeve 402 couples the articulation driver 360 to the firing member 220, and a disengaged position, in which the articulation driver 360 is not operably coupled to the firing member 220. When the locking sleeve 402 is in its engaged position, distal movement of the firing member 220 can move the articulation driver 360 distally, and correspondingly, proximal movement of the firing member 220 can move the articulation driver 230 proximally. When the locking sleeve 402 is in its disengaged position, movement of the firing member 220 is not transmitted to the articulation driver 230; and therefore, the firing member 220 can move independently of the articulation driver 230. In various circumstances, the articulation driver 230 can be held in place by the articulation lock 350 when the articulation driver 230 is not moved in either the proximal or distal direction by the firing member 220.

[0187] like Figures 7 to 9 As shown, the interchangeable shaft assembly 200 also includes a switch barrel 500 rotatably received on the closure tube 260. The switch barrel 500 includes a hollow shaft segment 502 having a shaft boss 504 formed thereon for receiving an outwardly projecting actuating pin 410 therein. In each case, the actuating pin 410 extends through the slot 267 into a longitudinal slot 408 provided in the locking sleeve 402 to facilitate axial movement of the locking sleeve 402 when it is engaged with the articulation driver 230. The rotating torsion spring 420 is configured to be capable of rotating as shown. Figure 8 The illustrated embodiment engages the shaft boss 504 on the switch cylinder 500 and a portion of the nozzle portion 203 to apply a biasing force to the switch cylinder 500. Figure 5 and Figure 6, the switching cylinder 500 may also include at least partially circumferential openings 506 defined therein, which may be configured to receive the peripheral mounting brackets 204, 205 extending from the nozzle portions 202, 203 and allow relative rotation, rather than relative translation, between the switching cylinder 500 and the nozzle 201. As shown in these figures, the peripheral mounting brackets 204, 205 also extend through the opening 266 in the closure tube 260 to be seated in a recessed portion located in the ridge 210. However, rotation of the nozzle 201 to a certain point (at which point the peripheral mounting brackets 204, 205 reach the end of their respective partially circumferential openings 506 in the switching cylinder 500) will cause the switching cylinder 500 to rotate about the shaft axis SA-SA. Rotation of the switching cylinder 500 will ultimately cause the actuating pin 410 and the locking sleeve 402 to rotate between their engaged and disengaged positions. Thus, in essence, the nozzle 201 can be used to operatively engage and disengage the articulation drive system with the firing drive system in a variety of manners as described in more detail in U.S. Patent Application Publication No. 2014 / 0263541.

[0188] Also like Figures 7 to 9As shown, the interchangeable shaft assembly 200 may include a slip ring assembly 600, which may be configured to conduct power to and / or from the end effector 300 and / or transmit signals to and / or receive signals from the end effector 300. The slip ring assembly 600 may include a proximal connector flange 604 mounted to a base mounting flange 242 extending from the base 240 and a distal connector flange 601 positioned within a slot defined in the nozzle portions 202, 203. The proximal connector flange 604 may include a first face, and the distal connector flange 601 may include a second face, wherein the second face is positioned adjacent to and movable relative to the first face. The distal connector flange 601 may be rotatable relative to the proximal connector flange 604 about a shaft axis SA-SA. The proximal connector flange 604 may include a plurality of concentric, or at least substantially concentric, conductors 602 defined within its first face. Connector 607 can be mounted on the proximal side of distal connector flange 601 and can have multiple contacts (not shown), each of which corresponds to and electrically contacts one of conductors 602. This configuration allows relative rotation between proximal connector flange 604 and distal connector flange 601 while maintaining electrical contact between the two flanges. For example, proximal connector flange 604 can include an electrical connector 606 that allows conductors 602 to communicate signals with shaft circuit board 610 mounted to base 240. In at least one embodiment, a wiring harness including multiple conductors can extend between electrical connector 606 and shaft circuit board 610. Electrical connector 606 can extend proximally through connector opening 243 defined in base mounting flange 242. U.S. Patent Application Publication No. 2014 / 0263551, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," is incorporated herein by reference in its entirety. The entirety of U.S. Patent Application Publication No. 2014 / 0263552, entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,” is incorporated herein by reference. More details regarding the slip ring assembly 600 can be found in U.S. Patent Application Publication No. 2014 / 0263541.

[0189] As discussed above, the interchangeable shaft assembly 200 may include a proximal portion that can be fixedly mounted to the handle assembly 14, and a distal portion that can rotate about a longitudinal axis. The rotatable distal shaft portion can rotate relative to the proximal portion about the slip ring assembly 600, as described above. The distal connector flange 601 of the slip ring assembly 600 can be positioned within the rotatable distal shaft portion. Furthermore, in addition to the above, the toggle barrel 500 can also be positioned within the rotatable distal shaft portion. When the rotatable distal shaft portion rotates, the distal connector flange 601 and the toggle barrel 500 can rotate synchronously with each other. In addition, the toggle barrel 500 can rotate relative to the distal connector flange 601 between a first position and a second position. When the toggle barrel 500 is in its first position, the articulation drive system can be operably disengaged from the firing drive system, thereby preventing operation of the firing drive system from causing the end effector 300 of the interchangeable shaft assembly 200 to articulate. When the switch drum 500 is in its second position, the articulation drive system can be operably engaged with the firing drive system so that operation of the firing drive system can cause the end effector 300 of the interchangeable shaft assembly 200 to articulate. When the switch drum 500 is moved between its first position and its second position, the switch drum 5500 moves relative to the distal connector flange 601. In various examples, the interchangeable shaft assembly 200 may include at least one sensor configured to detect the position of the switch drum 500. Now turning to Figure 9 The distal connector flange 601 may include, for example, a magnetic field sensor 605, and the switch barrel 500 may include, for example, a magnetic element, such as a permanent magnet 505. The magnetic field sensor 605 may be configured to detect the position of the permanent magnet 505. When the switch barrel 500 rotates between its first position and its second position, the permanent magnet 505 may move relative to the magnetic field sensor 605. In various embodiments, the magnetic field sensor 605 may detect changes in the magnetic field generated when the permanent magnet 505 moves. The magnetic field sensor 605 may, for example, communicate signals with the shaft circuit board 610 and / or the circuit board 100 located in the handle. Based on the signal from the magnetic field sensor 605, a controller on the shaft circuit board 610 and / or the circuit board 100 located in the handle may determine whether the articulation drive system is engaged or disengaged from the firing drive system.

[0190] See again Figure 3 , the chassis 240 includes at least one and preferably two tapered attachment portions 244 formed thereon that are adapted to be received within corresponding dovetail slots 702 formed within the distal attachment flange 700 of the frame 20. Each dovetail slot 702 may be tapered, or in other words, may be slightly V-shaped, so as to receive the tapered attachment portion 244 therein in a seated manner. Figure 3As further seen in FIG, a shaft attachment ear 226 is formed on the proximal end of the intermediate firing shaft 222. As will be discussed in further detail below, when the interchangeable shaft assembly 200 is coupled to the handle assembly 14, the shaft attachment ear 226 is received in a firing shaft attachment bracket 126 formed in the distal end 125 of the longitudinally movable drive member 120, e.g., as shown in FIG. Figure 3 and Figure 6 shown.

[0191] The various shaft assemblies employ a latch system 710 to removably couple the interchangeable shaft assemblies 200 to the housing 12, and more specifically, to the frame 20. The proximally projecting locking ears 714 each have a pivot locking ear 716 formed thereon that is adapted to be received in a corresponding aperture 245 formed in the base 240. Such a configuration facilitates pivotal attachment of the locking yoke 712 to the base 240. The locking yoke 712 may include two proximally projecting locking ears 714 that are configured to releasably engage corresponding locking detents or recesses 704 in the distal attachment flange 700 of the frame 20. See FIG. Figure 3 . In various forms, the locking yoke 712 is biased in a proximal direction by a spring or biasing member (not shown). Actuation of the locking yoke 712 can be achieved by a latch button 722 slidably mounted on a latch actuator assembly 720, which is mounted to the chassis 240. The latch button 722 can be biased in a proximal direction relative to the locking yoke 712. As will be discussed in further detail below, the locking yoke 712 can be moved to an unlocked position by biasing the latch button in a distal direction, which also pivots the locking yoke 712 out of engagement with the distal attachment flange 700 of the frame 20. When the locking yoke 712 is "engaged" with the distal attachment flange 700 of the frame 20, the locking ears 716 remain seated within corresponding locking detents or recesses 704 in the distal attachment flange 700.

[0192] When adopting the interchangeable shaft assembly that comprises the end effector of the type described herein that is suitable for cutting and fastening tissue and other types of end effectors, it may be advantageous to prevent the interchangeable shaft assembly from being inadvertently disengaged from the housing during the actuation of the end effector. For example, in use, the clinician can actuate the closure trigger 32 to grasp the target tissue and manipulate it into the desired position. Once the target tissue is positioned in the end effector 300 with the desired orientation, the clinician can fully actuate the closure trigger 32 to close the anvil 306 and clamp the target tissue in the appropriate position for cutting and suturing. In this case, the first drive system 30 has been fully actuated. After the target tissue has been clamped in the end effector 300, it may be advantageous to prevent the interchangeable shaft assembly 200 from being inadvertently disengaged from the housing 12. A form of the latch system 710 is configured to prevent such inadvertent disengagement.

[0193] The locking yoke 712 includes at least one and preferably two locking hooks 718 that are adapted to contact locking ears 256 formed on the closing shuttle 250. Figure 10 and Figure 11 , when the closure shuttle 250 is in the unactuated position (i.e., the first closure drive system 30 is not actuated and the anvil 306 is open), the locking yoke 712 can be pivoted in the distal direction to unlock the interchangeable shaft assembly 200 from the housing 12. When in this position, the locking hook 718 does not contact the locking ear 256 on the closure shuttle 250. However, when the closure shuttle 250 is moved to the actuated position (i.e., the first closure drive system 30 is actuated and the anvil 306 is in the closed position), the locking yoke 712 is prevented from pivoting to the unlocked position. See Figure 12 and Figure 13 In other words, if the clinician attempts to pivot the locking yoke 712 to the unlocked position, or if, for example, the locking yoke 712 is inadvertently bumped or contacted in a manner that could otherwise cause it to pivot distally, the locking hooks 718 on the locking yoke 712 will contact the locking ears 256 on the closure shuttle 250 and prevent the locking yoke 712 from moving to the unlocked position.

[0194] Now refer to Figure 3 The operation of attaching the interchangeable shaft assembly 200 to the handle assembly 14 is described. To begin the coupling process, the clinician can position the base 240 of the interchangeable shaft assembly 200 above or near the distal attachment flange 700 of the frame 20 so that the tapered attachment portion 244 formed on the base 240 is aligned with the dovetail-shaped slot 702 in the frame 20. The clinician can then move the interchangeable shaft assembly 200 along the mounting axis IA, which is perpendicular to the shaft axis SA-SA, so that the tapered attachment portion 244 is seated into "operable engagement" with the corresponding dovetail-shaped receiving slot 702. In doing so, the shaft attachment ear 226 on the intermediate firing shaft 222 will also be seated in the firing shaft attachment bracket 126 in the longitudinally movable drive member 120, and a portion of the transverse attachment pin 37 on the second closure link 38 will be seated in a corresponding proximally protruding hook 252 in the closure shuttle 250. As used herein, the term "operably engaged" in the context of two components means that the two components are sufficiently engaged with each other such that upon application of an actuation motion thereto, the components can perform their intended action, function, and / or procedure.

[0195] As discussed above, at least five systems of the interchangeable shaft assembly 200 can be operably coupled to at least five corresponding systems of the handle assembly 14. A first system can include a frame system that couples and / or aligns the frame or spine of the interchangeable shaft assembly 200 with the frame 20 of the handle assembly 14. A second system can include a closure drive system 30 that operably couples the closure trigger 32 of the handle assembly 14 with the closure tube 260 and anvil 306 of the interchangeable shaft assembly 200. As outlined above, the closure shuttle 250 of the interchangeable shaft assembly 200 can engage the transverse attachment pin 37 on the second closure link 38. A third system can include a firing drive system 80 that operably couples the firing trigger 130 of the handle assembly 14 with the intermediate firing shaft 222 of the interchangeable shaft assembly 200.

[0196] As outlined above, the shaft attachment lug 226 can be operably connected to the firing shaft attachment bracket 126 of the longitudinally movable drive member 120. A fourth system can include an electrical system capable of: sending a signal to a controller (such as a controller) in the handle assembly 14 that the shaft assembly (such as the interchangeable shaft assembly 200) has been operably engaged with the handle assembly 14, and / or conducting power and / or communication signals between the interchangeable shaft assembly 200 and the handle assembly 14. For example, the interchangeable shaft assembly 200 can include an electrical connector 1410 operably mounted to the shaft circuit board 610. The electrical connector 1410 located on the shaft is configured to be matingly engaged with the electrical connector 1400 on the circuit board 100 located in the handle. Further details of the recapture circuit and control system can be found in U.S. Patent Application Publication 2014 / 0263541. A fifth system can consist of a latch system for releasably locking the interchangeable shaft assembly 200 to the handle assembly 14.

[0197] See also Figure 14 , shows a non-limiting form of an end effector 300. As described above, the end effector 300 may include an anvil 306 and a surgical staple cartridge 304. In this non-limiting example, the anvil 306 is coupled to the elongated channel 198. For example, a hole 199 may be defined in the elongated channel 198 that may receive the pin 152 extending from the anvil 306 and allow the anvil 306 to pivot from an open position to a closed position relative to the elongated channel 198 and the surgical staple cartridge 304. In addition, Figure 14Shown is a firing rod 172 configured to be able to translate longitudinally into the end effector 300. The firing rod 172 can be composed of a solid part, or in various examples, can include a laminated material comprising, for example, a stack of steel plates. The distal protruding end of the firing rod 172 can be attached to an E-beam 178, which can (among other things) help to space the anvil 306 from the surgical staple cartridge 304 positioned in the elongated channel 198 when the anvil 306 is in a closed position. The E-beam 178 can also include a sharp cutting edge 182, which can be used to cut off tissue when the E-beam 178 is advanced distally by the firing rod 172. In operation, the E-beam 178 can also actuate or fire the surgical staple cartridge 304. The surgical staple cartridge 304 can include a molded cartridge body 194 that holds a plurality of staples 191 seated on staple drivers 192 that are positioned within respective upwardly opening staple cavities 195. A wedge sled 190 is driven distally by the E-shaped crossbeam 178 to slide over a cartridge tray 196 that holds together the various components of the surgical staple cartridge 304. The wedge sled 190 cams the staple drivers 192 upward to extrude the staples 191 into deforming contact with the anvil 306 while the cutting edge 182 of the E-shaped crossbeam 178 severing the clamped tissue.

[0198] In addition to the above, the E-shaped beam 178 may include an upper pin 180 that engages the anvil 306 during firing. The E-shaped beam 178 may also include an intermediate pin 184 and a bottom foot 186 that may engage various portions of the cartridge body 194, the cartridge tray 196, and the elongated channel 198. When the surgical staple cartridge 304 is positioned within the elongated channel 198, the slots 193 defined in the cartridge body 194 may be aligned with the longitudinal slots 197 defined in the cartridge tray 196 and the slots 189 defined in the elongated channel 198. In use, the E-shaped beam 178 may slide through the aligned longitudinal slots 193, 197, and 189, as shown. Figure 14 198 , wherein the bottom foot 186 of the E-shaped crossbar 178 can engage a groove extending along the bottom surface of the elongated channel 198 along the length of the slot 189, the middle pin 184 can engage the top surface of the cartridge tray 196 along the length of the longitudinal slot 197, and the upper pin 180 can engage the anvil 306. In this case, when the firing rod 172 moves distally to fire staples from the surgical staple cartridge 304 and / or incise tissue trapped between the anvil 306 and the surgical staple cartridge 304, the E-shaped crossbar 178 can separate or limit relative movement between the anvil 306 and the surgical staple cartridge 304. Thereafter, the firing rod 172 and the E-shaped crossbar 178 can be retracted proximally, thereby allowing the anvil 306 to be opened to release the two stapled and incised tissue portions (not shown).

[0199] The surgical instrument 10 ( Figures 1 to 14), the various electrical / electronic components of the surgical instrument 10 will be described in detail below. Figure 2 and Figure 3 , the handle assembly 14 may include an electrical connector 1400 including a plurality of electrical contacts. Figure 15 , the electrical connector 1400 may include, for example, a first electrical contact 1401a, a second electrical contact 1401b, a third electrical contact 1401c, a fourth electrical contact 1401d, a fifth electrical contact 1401e, and a sixth electrical contact 1401f. Although the illustrated example utilizes six contacts, other examples are contemplated that may utilize more or fewer than six contacts.

[0200] like Figure 15 As shown, first electrical contact 1401a can be in electrical communication with transistor 1408, electrical contacts 1401b-1401e can be in electrical communication with controller 1500, and sixth electrical contact 1401f can be in electrical communication with ground. In some cases, one or more of electrical contacts 1401b-1401e can be in electrical communication with one or more output channels of controller 1500 and can be energized, or have a voltage potential applied thereto, when handle 1042 is in a powered state. In some cases, one or more of electrical contacts 1401b-1401e can be in electrical communication with one or more input channels of controller 1500, and controller 1500 can be configured to detect when a voltage potential is applied to such electrical contacts when handle assembly 14 is in a powered state. When a shaft assembly (such as interchangeable shaft assembly 200) is assembled to handle assembly 14, electrical contacts 1401a-1401f can be out of electrical communication with each other. However, when the shaft assembly is not assembled to the handle assembly 14, the electrical contacts 1401a-1401f of the electrical connector 1400 may be exposed, and in some cases, one or more of the electrical contacts 1401a-1401f may be accidentally placed in electrical communication with each other. For example, such a situation may occur when one or more of the electrical contacts 1401a-1401f come into contact with a conductive material. When this occurs, for example, the controller 1500 may receive erroneous inputs and / or the interchangeable shaft assembly 200 may receive erroneous outputs. To address this issue, in various situations, when the shaft assembly (such as the interchangeable shaft assembly 200) is not attached to the handle assembly 14, the handle assembly 14 may not be powered.

[0201] In other cases, the handle 1042 may be powered on when a shaft assembly, such as the interchangeable shaft assembly 200, is not attached to the handle. In such cases, for example, the controller 1500 may be configured to disregard input or voltage potentials applied to contacts in electrical communication with the controller 1500 (i.e., electrical contacts 1401b-1401e) until the shaft assembly is attached to the handle assembly 14. Even in such cases, the controller 1500 may provide power for operating other functions of the handle assembly 14, but the handle assembly 14 may be in a powered-off state. To some extent, the electrical connector 1400 may be in a powered-off state because the voltage potentials applied to the electrical contacts 1401b-1401e may not affect the operation of the handle assembly 14. The reader will appreciate that even though the electrical contacts 1401b-1401e may be in a powered-off state, the electrical contacts 1401a and 1401f, which are not in electrical communication with the controller 1500, may or may not be in a powered-off state. For example, the sixth electrical contact 1401f can remain in electrical communication with ground regardless of whether the handle assembly 14 is in a powered-on or powered-off state.

[0202] Furthermore, transistor 1408 and / or any other suitable arrangement of transistors (such as transistor 1412) and / or a switch can be configured to control the supply of power from a power source 1404 (such as a battery) within the handle assembly 14, for example, to the first electrical contact 1401a, regardless of whether the handle assembly 14 is in a powered-on or powered-off state. In various circumstances, for example, when the interchangeable shaft assembly 200 is engaged with the handle assembly 14, the interchangeable shaft assembly 200 can be configured to change the state of transistor 1408. In some cases, other than as described below, the magnetic field sensor 1402 can be configured to switch the state of transistor 1412, and therefore the state of transistor 1408, ultimately supplying power from the power source 1404 to the first electrical contact 1401a. In this way, both the power circuitry and the signal circuitry coupled to the electrical connector 1400 can be powered-off when the shaft assembly is not mounted to the handle assembly 14, and powered-on when the shaft assembly is mounted to the handle assembly 14.

[0203] In various cases, see again Figure 15 , the handle assembly 14 may include, for example, a magnetic field sensor 1402 that may be configured to detect a detectable element, such as a magnetic element 1407 ( ) located on the shaft assembly (such as the interchangeable shaft assembly 200 ) when the shaft assembly is coupled to the handle assembly 14 . Figure 3 ). The magnetic field sensor 1402 can be powered by a power source 1406 such as a battery, which can actually amplify the detection signal of the magnetic field sensor 1402 and transmit it to the Figure 15The illustrated circuit communicates with an input channel of the controller 1500. Once the controller 1500 receives an input indicating that the shaft assembly has been at least partially coupled to the handle assembly 14, and thus that the electrical contacts 1401a-1401f are no longer exposed, the controller 1500 may enter its normal, or powered, operating state. In such an operating state, the controller 1500 may evaluate signals transmitted from the shaft assembly to one or more electrical contacts 1401b-1401e and / or transmit signals to the shaft assembly via one or more electrical contacts 1401b-1401e in their normal operating state. In various embodiments, the interchangeable shaft assembly 200 may need to be fully seated before the magnetic field sensor 1402 can detect the magnetic element 1407. For example, while the magnetic field sensor 1402 may be utilized to detect the presence of the shaft assembly 200, any suitable system of sensors and / or switches may be utilized to detect whether the interchangeable shaft assembly has been assembled to the handle assembly 14. Thus, further to the above, both the power circuit and the signal circuit coupled to the electrical connector 1400 may be powered down when the shaft assembly is not mounted to the handle assembly 14 and may be powered up when the shaft assembly is mounted to the handle assembly 14 .

[0204] In various examples, as may be used throughout the present disclosure, for example, any suitable magnetic field sensor may be employed to detect whether the shaft assembly has been assembled to the handle assembly 14. For example, technologies for magnetic field sensing include Hall effect sensors, search coils, flux gates, optical pumping, nuclear spins, SQUIDs (superconducting quantum interference devices—a very sensitive magnetometer for measuring very small magnetic fields based on superconducting rings containing Josephson junctions), Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetosensitive diodes, magnetosensitive transistors, optical fibers, magneto-optics, and micro-electromechanical system-based magnetic sensors, among others.

[0205] See also Figure 15, the controller 1500 may generally include a processor ("microprocessor") and one or more memory units operably coupled to the processor. The processor may control various components of the surgical instrument, such as motors, various drive systems, and / or a user display, by executing instruction codes stored in the memory. The controller 1500 may be implemented using integrated and / or discrete hardware elements, software elements, and / or a combination thereof. Examples of integrated hardware elements may include a processor, a microprocessor, a microcontroller, a controller, an integrated circuit, an application specific integrated circuit (ASIC), a programmable logic device (PLD), a digital signal processor (DSP), a field programmable gate array (FPGA), logic gates, registers, semiconductor devices, chips, microchips, chipsets, controllers, systems on chips (SoCs), and / or systems in packages (SIPs). Examples of discrete hardware elements may include circuits and / or circuit elements, such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and / or relays. In some cases, for example, the controller 1500 may include a hybrid circuit comprising discrete and integrated circuit elements or components on one or more substrates.

[0206] See also Figure 15 , the controller 1500 may be, for example, the LM4F230H5QR available from Texas Instruments. In some cases, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory at up to 40MHz, a prefetch buffer for improved performance above 40MHz, 32KB of single-cycle serial random access memory (SRAM), a The controller includes built-in read-only memory (ROM) for software, 2KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features readily available from the product datasheet. Other controllers can be readily substituted for use in conjunction with the present disclosure. Therefore, the present disclosure should not be limited to this context.

[0207] As discussed above, when the interchangeable shaft assembly 200 is not assembled or not fully assembled to the handle assembly 14, the handle assembly 14 and / or the shaft assembly 200 may include the following systems and configurations to be configured to prevent or at least reduce the likelihood of shorting of the contacts of the electrical connector 1400 located on the handle and / or the contacts of the electrical connector 1410 located on the shaft. Figure 3, the electrical connector 1400 located on the handle can be at least partially recessed into a cavity 1409 defined in the frame 20. The six electrical contacts 1401a-1401f of the electrical connector 1400 can be completely recessed into the cavity 1409. Such a construction can reduce the likelihood of an object accidentally contacting one or more of the electrical contacts 1401a-1401f. Similarly, the electrical connector 1410 located on the shaft can be positioned within a recess defined in the base 240, which can reduce the likelihood of an object accidentally contacting one or more electrical contacts 1411a-1411f of the electrical connector 1410 located on the shaft. Figure 3 In the specific example depicted in FIG, the electrical contacts 1411a-1411f located on the shaft can include male contacts. In at least one example, each electrical contact 1411a-1411f located in the shaft can include a flexible protrusion extending therefrom that can be configured to engage, for example, an electrical contact 1401a-1401f located on the handle. The electrical contacts 1401a-1401f located on the handle can include female contacts. In at least one example, each electrical contact 1401a-1401f located on the handle can include a flat surface, for example, against which the male electrical contacts 1401a-1401f located in the shaft can rub or slide, thereby maintaining conductive engagement therebetween. In various circumstances, the direction of assembly of the interchangeable shaft assembly 200 to the handle assembly 14 can be parallel, or at least substantially parallel, to the electrical contacts 1401a-1401f located in the handle, such that the electrical contacts 1411a-1411f located in the shaft slide against the electrical contacts 1401a-1401f when the interchangeable shaft assembly 200 is assembled to the handle assembly 14. In various alternative examples, the electrical contacts 1401a-1401f located in the handle can include male contacts and the electrical contacts 1411a-1411f located in the shaft can include female contacts. In certain alternative examples, the electrical contacts 1401a-1401f located in the handle and the electrical contacts 1411a-1411f located in the shaft can have any suitable contact configuration.

[0208] In various embodiments, the handle assembly 14 may include a connector guard configured to at least partially cover an electrical connector 1400 located on the handle, and / or a connector guard configured to at least partially cover an electrical connector 1410 located on the shaft. When the shaft assembly is not attached to, or only partially attached to, the handle, the connector guard can prevent, or at least reduce the likelihood of an object accidentally contacting the contacts of the electrical connector. The connector guard can be movable. For example, the connector guard can be movable between a guarding position, in which the connector guard at least partially protects the connector, and an unguarding position, in which the connector guard does not protect the connector, or at least provides less protection, to the connector. In at least one example, the position of the connector guard can be displaced when the shaft assembly is attached to the handle. For example, if the handle includes a handle connector guard, the shaft assembly can contact and displace the handle connector guard when the shaft assembly is attached to the handle. Similarly, if the shaft assembly includes a shaft connector guard, the handle can contact and displace the shaft connector guard when the shaft assembly is attached to the handle. In various cases, for example, the connector guard may include a door. In at least one case, the door may include an inclined surface that facilitates displacement of the door in a predetermined direction when the door contacts the handle or shaft. In various cases, for example, the connector guard may be capable of translation and / or rotation. In some cases, the connector guard may include at least one membrane covering the electrical connector contacts. This membrane may be ruptured when the shaft assembly is assembled to the handle. In at least one case, the male contacts of the connector may penetrate the membrane before engaging corresponding contacts positioned beneath the membrane.

[0209] As described above, the surgical instrument may include a system capable of selectively energizing or activating contacts of an electrical connector (such as electrical connector 1400). In various circumstances, the contacts may be switched between an inactive state and an activated state. In some cases, the contacts may be switched between a monitoring state, a deactivated state, and an activated state. For example, when the shaft assembly has not yet been assembled to the handle assembly 14, the controller 1500 may monitor the electrical contacts 1401a-1401f to determine whether one or more of the electrical contacts 1401a-1401f may have shorted. The controller 1500 may be configured to apply a low voltage potential to each of the electrical contacts 1401a-1401f and assess whether there is only a minimum resistance at each of the electrical contacts. This operating state may include a monitoring state. If the resistance detected at a contact is high, or exceeds a threshold resistance, the controller 1500 may deactivate the contact, more than one contact, or all contacts. This operating state may include a deactivation state. As discussed above, if the shaft assembly is assembled to the handle assembly 14 and detected by the controller 1500, the controller 1500 may increase the voltage potential applied to the electrical contacts 1401a-1401f. This operating state may include a start condition.

[0210] The various shaft assemblies disclosed herein may employ sensors and various other components that require electrical communication with a controller within the housing. These shaft assemblies are typically configured to rotate relative to the housing, necessitating a connector between two or more components that are rotatable relative to one another to facilitate such electrical communication. When employing an end effector of the type disclosed herein, the connector arrangement must be relatively robust in nature while also being somewhat compact to fit within the connector portion of the shaft assembly.

[0211] Now go to Figure 16A and Figure 16B , which shows an example of a segmented circuit 2000 including a plurality of circuit segments 2002a-2002g. The segmented circuit 2000 includes a plurality of circuit segments 2002a to 2002g, which is configured to control a powered surgical instrument, such as but not limited to Figures 1 to 131. A plurality of circuit segments 2002a-2002g are configured to control one or more operations of the powered surgical instrument 10. Safety processor segment 2002a (segment 1) includes a safety processor 2004. Main processor segment 2002b (segment 2) includes a main processor 2006. Safety processor 2004 and / or main processor 2006 are configured to interact with one or more additional circuit segments 2002c-2002g to control the operation of the powered surgical instrument 10. Main processor 2006 includes a plurality of input devices coupled to, for example, one or more circuit segments 2002c-2002g, a battery 2008, and / or a plurality of switches 2058a-2070. Segment circuit 2000 may be implemented using any suitable circuitry, such as a printed circuit board assembly (PCBA) within powered surgical instrument 10. It should be understood that the term "processor" as used herein includes any microprocessor, processor, microcontroller, controller, or other basic computing device that combines the functionality of a computer's central processing unit (CPU) into one integrated circuit or at most several integrated circuits. A processor is a multi-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides a result as output. Because a processor has internal memory, it is an example of sequential digital logic. The objects of a processor's operation are numbers and symbols represented in the binary number system.

[0212] In one aspect, the main processor 2006 can be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one example, the safety processor 2004 can be a safety controller platform including two controller-based families (such as TMS570 and RM4x), also known under the trade name Hercules ARM Cortex R4 manufactured by Texas Instruments. However, other suitable alternatives to controllers and safety processors may be employed without limitation. In one example, the safety processor 2004 can be specifically configured for IEC 61508 and ISO 26262 safety-critical applications, etc., to provide advanced integrated safety features while delivering quantifiable performance, connectivity, and storage options. In some cases, the main processor 2006 can be, for example, a combination of Figures 14 to 17B The single-core or multi-core controller LM4F230H5QR.

[0213] In one aspect, the segmented circuit 2000 includes an acceleration segment 2002c (segment 3). The acceleration segment 2002c includes an accelerometer 2022. The accelerometer 2022 is configured to detect motion or acceleration of the powered surgical instrument 10. In some examples, input from the accelerometer 2022 is used, for example, to transition to and from a sleep mode, identify the orientation of the powered surgical instrument, and / or identify when the surgical instrument has been set down. In some examples, the acceleration segment 2002c is coupled to the safety processor 2004 and / or the main processor 2006.

[0214] In one aspect, segment circuit 2000 includes display segment 2002d (segment 4). Display segment 2002d includes a display connector 2024 coupled to host processor 2006. Display connector 2024 couples host processor 2006 to display 2028 via one or more integrated circuit drivers for display 2026. Display integrated circuit drivers 2026 may be integrated with display 2028 and / or may be located separately from display 2028. Display 2028 may include any suitable display, such as an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and / or any other suitable display. In some examples, display segment 2002d is coupled to security processor 2004.

[0215] In some aspects, the segmented circuit 2000 includes a shaft segment 2002e (segment 5). The shaft segment 2002e includes an interchangeable shaft assembly 200 ( Figure 1 ) and / or one or more controls for coupling to the interchangeable shaft assembly 200 ( Figure 1 ) for controlling one or more controls of the end effector 300 of the interchangeable shaft assembly 2000. The shaft segment 2002e includes a shaft connector 2030 configured to couple the main processor 2006 to a shaft PCBA 2031. The shaft PCBA 2031 includes a first articulation switch 2036, a second articulation switch 2032, and a shaft PCBA EEPROM 2034. In some examples, the shaft PCBA EEPROM 2034 includes one or more parameters, routines, and / or programs specific to the interchangeable shaft assembly 200 and / or the shaft PCBA 2031. The shaft PCBA 2031 can be coupled to the interchangeable shaft assembly 200 and / or integrally formed with the surgical instrument 10. In some examples, the shaft segment 2002e includes a second shaft EEPROM 2038. The second shaft EEPROM 2038 includes a plurality of algorithms, routines, parameters, and / or other data corresponding to one or more shaft assemblies 200 and / or end effectors 300 that may interface with the powered surgical instrument 10 .

[0216] In some aspects, the segmented circuit 2000 includes a position encoder segment 2002f (segment 6). The position encoder segment 2002f includes one or more magnetic angular rotation position encoders 2040a-2040b. The one or more magnetic angular rotation position encoders 2040a-2040b are configured to identify the motor 2048 of the surgical instrument 10, the interchangeable shaft assembly 200 ( Figure 1 ) and / or the rotational position of the end effector 300. In some examples, the magnetic angular rotational position encoders 2040a-2040b can be coupled to the security processor 2004 and / or the main processor 2006.

[0217] In some aspects, the segmented circuit 2000 includes a motor circuit segment 2002g (segment 7). The motor circuit segment 2002g includes a motor 2048 configured to control one or more motions of the powered surgical instrument 10. The motor 2048 is coupled to the main processor 2006 via an H-bridge driver 2042 and one or more H-bridge field effect transistors 2044 (FETs). The H-bridge FETs 2044 are coupled to the safety processor 2004. A motor current sensor 2046 is coupled in series with the motor 2048 for measuring the current draw of the motor 2048. The motor current sensor 2046 is in signal communication with the main processor 2006 and / or the safety processor 2004. In some examples, the motor 2048 is coupled to a motor electromagnetic interference (EMI) filter 2050.

[0218] In some embodiments, the segmented circuit 2000 includes a power segment 2002h (segment 8). A battery 2008 is coupled to the security processor 2004, the main processor 2006, and one or more of the additional circuit segments 2002c-2002g. The battery 2008 is coupled to the segmented circuit 2000 via a battery connector 2010 and a current sensor 2012. The current sensor 2012 is configured to measure the total current consumption of the segmented circuit 2000. In some examples, one or more voltage converters 2014a, 2014b, 2016 are configured to provide a predetermined voltage value to one or more circuit segments 2002a-2002g. For example, in some examples, the segmented circuit 2000 may include 3.3V voltage converters 2014a-2014b and / or a 5V voltage converter 2016. The boost converter 2018 is configured to provide a boosted voltage of up to a predetermined amount (e.g., up to 13V). Boost converter 2018 is configured to provide additional voltage and / or current during power-intensive operations and to prevent brownout conditions or low power conditions.

[0219] In some aspects, the safety processor segment 2002a includes a motor power switch 2020. The motor power switch 2020 is coupled between the power segment 2002h and the motor circuit segment 2002g. The safety processor segment 2002a is configured to interrupt power to the motor circuit segment 2002g when an error or fault condition is detected by the safety processor 2004 and / or the main processor 2006, as discussed in greater detail herein. Although the circuit segments 2002a-2002g are illustrated as having all components of the circuit segments 2002a-2002h physically proximate, those skilled in the art will recognize that the circuit segments 2002a-2002h may include other components that are physically and / or electrically separate from components of the same circuit segments 2002a-2002g. In some examples, one or more components may be shared by two or more circuit segments 2002a-2002g.

[0220] In some examples, a plurality of switches 2056-2070 are coupled to the safety processor 2004 and / or the main processor 2006. The plurality of switches 2056-2070 can be configured to control one or more operations of the surgical instrument 10, to control one or more operations of the segment circuit 2000, and / or to indicate the status of the surgical instrument 10. For example, the emergency door switch 2056 is configured to indicate the status of the emergency door. A plurality of articulation switches (such as a left-to-left articulation switch 2058a, a left-to-right articulation switch 2060a, a left-to-center articulation switch 2062a, a right-to-left articulation switch 2058b, a right-to-right articulation switch 2060b, and a right-to-center articulation switch 2062b) are configured to control the articulation of the shaft assembly 200 and / or the end effector 300. The left reversing switch 2064a and the right reversing switch 2064b are coupled to the main processor 2006. In some examples, the left side switches (including the left-hand articulation switch 2058a, the left-hand articulation switch 2060a, the left-hand center articulation switch 2062a, and the left reversing switch 2064a) are coupled to the main processor 2006 via a left flexible connector 2072a. The right side switches (including the right-hand left articulation switch 2058b, the right-hand right articulation switch 2060b, the right-hand center articulation switch 2062b, and the right reversing switch 2064b) are coupled to the main processor 2006 via a right flexible connector 2072b. In some examples, the fire switch 2066, the clamp release switch 2068, and the shaft engagement switch 2070 are coupled to the main processor 2006.

[0221] In some aspects, the plurality of switches 2056-2070 can include, for example, a plurality of handle controls mounted to the handle of the surgical instrument 10, a plurality of indicator switches, and / or any combination thereof. In various examples, the plurality of switches 2056-2070 allow the surgeon to manipulate the surgical instrument, provide feedback to the segment circuit 2000 regarding the position and / or operation of the surgical instrument, and / or indicate unsafe operation of the surgical instrument 10. In some examples, additional or fewer switches can be coupled to the segment circuit 2000, one or more of the switches 2056-2070 can be combined into a single switch, and / or expanded into multiple switches. For example, in one example, one or more of the left articulation switch and / or the right articulation switches 2058a-2064b can be combined into a single multi-position switch.

[0222] In one aspect, the safety processor 2004 is configured to implement a watchdog function in addition to other safety operations. The safety processor 2004 of the segmented circuit 2000 communicates signals with the main processor 2006. The processor heartbeat signal is provided at the output 2097. The acceleration segment 2002c includes an accelerometer 2022 that is configured to monitor the movement of the surgical instrument 10. In various examples, the accelerometer 2022 can be a single-axis, dual-axis, or tri-axis accelerometer. The accelerometer 2022 can be used to measure appropriate accelerations that are not necessarily coordinate accelerations (rates of change of velocity). Alternatively, the accelerometer observes the acceleration associated with the weight phenomenon experienced by the test mass when the reference frame of the accelerometer 2022 is stationary. For example, an accelerometer 2022 at rest on the surface of the earth will measure a vertically upward (gravitational) acceleration of g=9.8 m / s due to its weight. 2 Another type of acceleration that can be measured by the accelerometer 2022 is the acceleration due to gravity. In various other examples, the accelerometer 2022 may include a single-axis, dual-axis, or tri-axis accelerometer. In addition, the acceleration segment 2002c may include one or more inertial sensors to detect and measure acceleration, tilt, shock, vibration, rotation, and multiple degrees of freedom (DoF). Suitable inertial sensors may include an accelerometer (single-axis, dual-axis, or tri-axis), a magnetometer for measuring a magnetic field in space (such as the Earth's magnetic field), and / or a gyroscope for measuring angular velocity.

[0223] In one aspect, the safety processor 2004 is configured to implement a watchdog function for one or more circuit segments 2002c-2002h (such as the motor circuit segment 2002g). In this regard, the safety processor 2004 employs the watchdog function to detect and recover from failures of the main processor 2006. During normal operation, the safety processor 2004 monitors the main processor 2006 for hardware failures or program errors and initiates one or more corrective actions. The corrective action may include placing the main processor 2006 in a safe state and restoring normal system operation. In one example, the safety processor 2004 is coupled to at least a first sensor. The first sensor measures the state of the surgical instrument 10 ( Figures 1 to 4 ). In some examples, the safety processor 2004 is configured to compare the measured property of the surgical instrument 10 with a predetermined value. For example, in one example, a magnetic angular rotational position encoder 2040a is coupled to the safety processor 2004. The magnetic angular rotational position encoder 2040a provides motor speed and position information to the safety processor 2004. The safety processor 2004 monitors the magnetic angular rotational position encoder 2040a and compares the value to a maximum speed and / or position value and, if the value is above a predetermined value, blocks operation of the motor 2048. In some examples, the predetermined value is calculated based on a real-time speed and / or position calculation of the motor 2048, a value provided by a second magnetic angular rotational position encoder 2040b in communication with the main processor 2006, and / or is provided to the safety processor 2004 from, for example, a memory module coupled to the safety processor 2004.

[0224] In some aspects, a second sensor is coupled to the main processor 2006. The second sensor is configured to measure a first physical property. The safety processor 2004 and the main processor 2006 are configured to provide signals representing a value of the first sensor and a value of the second sensor, respectively. When the safety processor 2004 or the main processor 2006 indicates that a value is outside an acceptable range, the segmented circuit 2000 prevents operation of at least one of the circuit segments 2002c-2002h (such as the motor circuit segment 2002g). For example, in Figure 16A and Figure 16B In the example shown, the safety processor 2004 is coupled to a first magnetic angular rotary position encoder 2040a, and the main processor 2006 is coupled to a second magnetic angular rotary position encoder 2040b. The magnetic angular rotary position encoders 2040a, 2040b may comprise any suitable motor position sensor, such as a magnetic angular rotary input device having sine and cosine outputs. The magnetic angular rotary position encoders 2040a, 2040b provide respective signals indicating the position of the motor 2048 to the safety processor 2004 and the main processor 2006.

[0225] When the values of the first magnetic angular rotary position encoder 2040a and the second magnetic angular rotary position encoder 2040b are within a predetermined range, the safety processor 2004 and the main processor 2006 generate an activation signal. When the main processor 2006 or the safety processor 2004 detects that the values are outside the predetermined range, the activation signal is terminated, thereby interrupting and / or preventing the operation of at least one of the circuit segments 2002c-2002h (such as the motor circuit segment 2002g). For example, in some examples, the activation signal from the main processor 2006 and the activation signal from the safety processor 2004 are coupled to an AND gate. The AND gate is coupled to the motor power switch 2020. When the activation signals from both the safety processor 2004 and the main processor 2006 are high (indicating that the values of the magnetic angular rotary position encoders 2040a, 2040b are within the predetermined range), the AND gate maintains the motor power switch 2020 in the closed or open position. When either magnetic angular rotary position encoder 2040a, 2040b detects a value outside a predetermined range, the activation signal from the magnetic angular rotary position encoder 2040a, 2040b is set low, and the output of the AND gate is also set low, thereby opening the motor power switch 2020. In some examples, the value of the first magnetic angular rotary position encoder 2040a is compared to the value of the second magnetic angular rotary position encoder 2040b, for example, by the safety processor 2004 and / or the main processor 2006. When the value of the first sensor differs from the value of the second sensor, the safety processor 2004 and / or the main processor 2006 can prevent operation of the motor circuit segment 2002g.

[0226] In some aspects, the safety processor 2004 receives a signal indicating the value of the second magnetic angular rotational position encoder 2040b and compares the value of the second sensor to the value of the first sensor. For example, in one aspect, the safety processor 2004 is directly coupled to the first magnetic angular rotational position encoder 2040a. The second magnetic angular rotational position encoder 2040b is coupled to the host processor 2006 (which provides the value of the second magnetic angular rotational position encoder 2040b to the safety processor 2004) and / or is directly coupled to the safety processor 2004. The safety processor 2004 compares the value of the first magnetic angular rotational position encoder 2040b to the value of the second magnetic angular rotational position encoder 2040b. When the safety processor 2004 detects a mismatch between the first magnetic angular rotational position encoder 2040a and the second magnetic angular rotational position encoder 2040b, the safety processor 2004 can interrupt operation of the motor circuit segment 2002g, for example by cutting power to the motor circuit segment 2002g.

[0227] In some aspects, the safety processor 2004 and / or the main processor 2006 are coupled to a first magnetic angular rotational position encoder 2040a configured to measure a first property of the surgical instrument and a second magnetic angular rotational position encoder 2040b configured to measure a second property of the surgical instrument. The first property and the second property comprise a predetermined relationship during normal operation of the surgical instrument. The safety processor 2004 monitors the first property and the second property. When a mismatch between the value of the first property and / or the value of the second property and the predetermined relationship is detected, a fault is generated. Upon a mismatch, the safety processor 2004 takes at least one action, such as preventing operation of at least one of the circuit segments, performing a predetermined action, and / or resetting the main processor 2006. For example, upon detecting a mismatch, the safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g.

[0228] In one aspect, the safety processor 2004 is configured to execute independent control algorithms. In operation, the safety processor 2004 monitors the segmented circuit 2000 and is configured to independently control and / or override signals from other circuit components, such as the main processor 2006. The safety processor 2004 can execute pre-programmed algorithms and / or can be updated or programmed online during operation based on one or more movements and / or positions of the surgical instrument 10. For example, in one example, the safety processor 2004 is reprogrammed with new parameters and / or safety algorithms each time a new shaft and / or end effector is coupled to the surgical instrument 10. In some examples, one or more safety values stored by the safety processor 2004 are copied by the main processor 2006. Bidirectional error checking is performed to ensure that the values and / or parameters stored by the safety processor 2004 or the main processor 2006 are correct.

[0229] In some aspects, the safety processor 2004 and the main processor 2006 implement redundant safety checks. The safety processor 2004 and the main processor 2006 provide periodic signals to indicate normal operation. For example, during operation, the safety processor 2004 may indicate to the main processor 2006 that the safety processor 2004 is executing code and operating normally. The main processor 2006 may similarly indicate to the safety processor 2004 that the main processor 2006 is executing code and operating normally. In some examples, the safety processor 2004 and the main processor 2006 communicate at predetermined intervals. The predetermined interval may be constant or may vary depending on the circuit state and / or the operation of the surgical instrument 10.

[0230] Figure 17A and Figure 17B shows a device configured to control Figures 1 to 14Another aspect of the segmented circuit 3000 of the electric surgical instrument 10 is shown. Figure 14 、 Figure 17B As shown, the handle assembly 14 may include an electric motor 3014 that can be controlled by a motor driver 3015 and used by the firing system of the surgical instrument 10. In various forms, the electric motor 3014 can be, for example, a DC brush drive motor having a maximum rotation of about 25,000 RPM. In other constructions, the electric motor 3014 can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. In some cases, the motor driver 3015 can include, for example, H-Bridge FETs 3019, such as Figure 17A and Figure 17B As shown. The electric motor 3014 can be powered by a power assembly 3006, which can be releasably mounted to the handle assembly 14. The power assembly 3006 is configured to supply control power to the surgical instrument 10. The power assembly 3006 may include a battery, which may include a plurality of battery cells connected in series and which can be used as a power source to power the surgical instrument 10. In this configuration, the power assembly 3006 may be referred to as a battery pack. In some cases, the battery cells of the power assembly 3006 may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium-ion batteries that can be detachably coupled to the power assembly 3006.

[0231] Examples of drive systems and closure systems suitable for use with the surgical instrument 10 are disclosed in U.S. Patent Application Publication No. 2014 / 0263539, entitled "CONTROL SYSTEM OF A SURGICAL INSTRUMENT," the disclosure of which is incorporated herein by reference in its entirety. For example, the electric motor 3014 can include a rotatable shaft (not shown) operably connected to a gear reducer assembly, which can be mounted on a longitudinally movable drive member in meshing engagement with a set or rack of drive teeth. In use, the voltage polarity provided by the battery can operate the electric motor 3014 to drive the longitudinally movable drive member to activate the end effector 300. For example, the electric motor 3014 can be configured to drive the longitudinally movable drive member to advance a firing mechanism to fire staples from a staple cartridge assembled with the end effector 300 into tissue captured by the end effector 300, and / or to advance a cutting member to, for example, cut tissue captured by the end effector 300.

[0232] like Figure 17A and Figure 17BAs shown, and as described in more detail below, for example, the power assembly 3006 can include a power management controller that can be configured to regulate the power output of the power assembly 3006 so that when the interchangeable shaft assembly 200 is coupled to the handle assembly 14 ( Figure 1 ), a first power output is delivered to the electric motor 3014 to power the cutting member when the interchangeable shaft assembly 200 is coupled to the handle assembly 14, and a second power output is delivered to the electric motor 3014 to power the cutting member when the interchangeable shaft assembly 200 is coupled to the handle assembly 14. This regulation can be advantageous in avoiding transmitting excessive power to the electric motor 3014 beyond the requirements of the interchangeable shaft assembly coupled to the handle assembly 14.

[0233] In some cases, for example, by routing one or more communication signals through a Figure 1 ) in the main controller 3017, the interface 3024 can facilitate the transmission of such communication signals between the power management controller 3016 and the axis assembly controller 3022. In other cases, when the interchangeable axis assembly 200 ( Figure 1 ) and the power assembly 3006 are coupled to the handle assembly 14, the interface 3024 can facilitate a direct communication line between the power management controller 3016 of the handle assembly 14 and the shaft assembly controller 3022.

[0234] In one embodiment, the main controller 3017 can be any single-core or multi-core processor, such as those processors known under the trade name ARM Cortex provided by Texas Instruments. In one embodiment, the surgical instrument 10 ( Figures 1 to 4 ) may include a power management controller 3016, such as a security controller platform (also known as the Hercules ARM Cortex R4, also manufactured by Texas Instruments) based on two controller families (such as TMS570 and RM4x). However, other suitable alternatives for controllers and security processors may be employed without limitation. In one embodiment, the security processor 2004 ( Figure 16A ) can be specifically architected for IEC 61508 and ISO 26262 safety-critical applications, among others, to provide advanced integrated safety features while delivering quantifiable performance, connectivity, and storage options.

[0235] In some cases, the main controller 3017 may be such as in combination with Figures 15 to 17B The single-core or multi-core controller LM4F230H5QR.

[0236] Figure 18 for Figure 1 1 is a block diagram of a surgical instrument, wherein the handle assembly 14 ( Figure 1 ) and the power assembly, and between the handle assembly 14 and the interchangeable shaft assembly. Figure 18 As shown, the power assembly 3006 may include a power management circuit 3034, which may include a power management controller 3016, a power modulator 3038, and a current sensing circuit 3036. The power management circuit 3034 may be configured to provide a current sense circuit 3036 based on the interchangeable shaft assembly 200 ( Figure 1 ) power requirements to regulate the power output of the battery 3007. For example, the power management controller 3016 can be programmed to control the power modulator 3038 to regulate the power output of the power component 3006, and the current sensing circuit 3036 can be used to monitor the power output of the power component 3006 to provide the power management controller 3016 with feedback related to the power output of the battery 3007, so that the power management controller 3016 can regulate the power output of the power component 3006 to maintain the desired output.

[0237] It is worth noting that the power management controller 3016 and / or the shaft assembly controller 3022 may each include one or more processors and / or memory units that may store a plurality of software modules. Figure 1 ) may be described by way of example, but it should be understood that a greater or fewer number of modules and / or blocks may be used. Furthermore, while various aspects may be described in terms of modules and / or blocks for ease of description, these modules and / or blocks may be implemented by one or more hardware components (e.g., processors, digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers) and / or software components (e.g., programs, subroutines, logic), and / or a combination of hardware and software components.

[0238] In some cases, the surgical instrument 10 ( Figures 1 to 4 ) may include an output device 3042, which may include one or more devices for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (e.g., an LCD display, an LED indicator), an auditory feedback device (e.g., a speaker, a buzzer), or a tactile feedback device (e.g., a tactile actuator). In some cases, the output device 3042 may include a display 3043, which may be included in the handle assembly 14 ( Figure 1). The shaft assembly controller 3022 and / or the power management controller 3016 can provide feedback to the user of the surgical instrument 10 via the output device 3042. The interface 3024 can be configured to connect the shaft assembly controller 3022 and / or the power management controller 3016 to the output device 3042. The reader will appreciate that, as an alternative, the output device 3042 can be integrated with the power assembly 3006. In such cases, when the interchangeable shaft assembly 200 is coupled to the handle assembly 14, communication between the output device 3042 and the shaft assembly controller 3022 can be achieved via the interface 3024.

[0239] A surgical instrument 10 ( Figures 1 to 4 ) and one or more segmented circuits 2000, 3000, the present disclosure now turns to various specific configurations of the surgical instrument 10 and the segmented circuit 2000 (or 3000).

[0240] In various aspects, the present disclosure provides techniques for data storage and use. In one aspect, the data storage and use is based on multi-level action thresholds. Such thresholds include upper and lower limit limits, where the limit limits for closing the motor or starting the return are current, pressure, firing load, or exceeding torque. Alternatively, when operating within the limits, the device automatically compensates for the motor load.

[0241] In one aspect, the surgical instrument 10 (combined Figures 1 to 18 The surgical instrument 10 may be configured to monitor upper and lower limit thresholds to keep the minimum and maximum closed clamp loads within acceptable limits. If the minimum is not reached, the surgical instrument 10 cannot be started or if it drops below the minimum, user action is required. If the clamp load is at an appropriate level but drops to a minimum during firing, the surgical instrument 10 may adjust the speed of the motor or warn the user. If the minimum limit is violated during operation, the unit may issue a warning, which may not be entirely as expected. The surgical instrument 10 may also be configured to monitor when the battery voltage drops below the lower limit, with the remaining battery power only directly enabling the device to return to the I-beam park state. Blockages in the end effector may be sensed by the opening force on the anvil. Alternatively, the surgical instrument 10 may be configured to monitor when the motor current rises or the associated speed drops, with the motor control then increasing the pulse width or frequency modulation to keep the speed constant.

[0242] In another aspect, the surgical instrument 10 may ( Figure 1) is configured to detect limiting thresholds of current consumption, pressure, firing load, torque, so that when any of these thresholds is exceeded, the surgical instrument 10 closes the motor or causes the motor to return the knife to a pre-firing position. A second threshold value less than the limiting threshold value can be used to change the motor control program to adapt to changes in conditions by changing the motor control parameters. The marginal threshold value can be constructed as a step function or a ramp function based on a proportional response to another counter or input. For example, in the case of sterilization, there is no change between 0-200 sterilization cycles, a 1% slower motor is used each time from 201-400 sterilization cycles, and use of more than 400 sterilization cycles is prevented. The speed of the motor can also be varied based on tissue clearance and current consumption.

[0243] There are many parameters that can affect the ideal function of an electric reusable suturing device. Most of these parameters have extreme maximum and / or minimum thresholds, beyond which the device should not be operated. However, there are also marginal limitations that may affect the functional operation of the device. These multiple limitations of multiple parameters can have an overlying and cumulative effect on the operating procedures of the device.

[0244] Accordingly, the present invention relates to surgical instruments and, in various instances, to surgical stapling and severing instruments and staple cartridges thereof designed for suturing and severing tissue.

[0245] The efficient performance of an electromechanical device depends on various factors. One is the operating envelope—the range of parameters, conditions, and events within which the device performs its intended function. For example, for a motor power supply device driven by electric current, there may be an operating region above a certain current threshold where the device operates less efficiently than desired. In other words, there may be an upper "speed limit" above which efficiency decreases. This upper threshold can have a value that prevents substantial inefficiency or even device degradation.

[0246] However, there may be thresholds within the operating envelope that can shape the available region to improve efficiency within the operating state. In other words, there may be regions where the device can adjust and perform within a defined operating envelope (or sub-envelope). This region can be the area between marginal and extreme thresholds. Additionally, these regions can include "sweet spots" or predetermined, optional ranges or points. These regions can also include large ranges within which performance is deemed adequate.

[0247] A limiting threshold may be defined above or below which one or more actions, such as stopping the device, may be taken (or avoided). Additionally, a marginal threshold or threshold may be defined above or below which one or more actions may be taken (or avoided). As a non-limiting example, a marginal threshold may be set to define the point at which the current draw of the motor exceeds 75% of the limiting threshold. For example, exceeding the marginal threshold may cause the device to begin slowing the motor at an increasing rate as it continues to climb toward the limiting threshold.

[0248] Various mechanisms can be employed to perform adjustments due to exceeding a threshold. For example, the adjustment can reflect a step function. It can also reflect a ramp function. Other functions can be utilized.

[0249] In various aspects, in order to enhance performance through additional mechanisms, overlapping thresholds can be defined. Overlapping thresholds can include one or more thresholds defined by multiple parameters. Overlapping thresholds can result in one or more thresholds being inputs to another threshold or the generation of thresholds. Overlapping thresholds can be predetermined or dynamically generated, such as at runtime. Overlapping thresholds may take effect when thresholds are defined by multiple inputs. For example, when the number of disinfection cycles exceeds 300 (marginal threshold) but does not exceed 500 (extreme threshold), the device causes the motor to run slower. Then when the current draw exceeds 75% of its marginal threshold, it causes the deceleration factor to be even slower.

[0250] Figure 19 A method for evaluating a surgical instrument 10 ( Figures 1 to 4 ) of the cutting edge 182 ( Figure 14 ) is a logic diagram of a system 4311 for evaluating the sharpness of a cutting edge 182. In some cases, the system 4311 can evaluate the sharpness of the cutting edge 182 by testing the ability of the cutting edge 182 to advance through the sharpness testing member 4302. For example, the system 4311 can be configured to observe the time period required for the cutting edge 182 to completely transect and / or completely pass through at least a predetermined portion of the sharpness testing member 4302. If the observed time period exceeds a predefined threshold, the circuit 4310 can conclude that the sharpness of the cutting edge 182 has fallen below an acceptable level, for example.

[0251] In one aspect, the sharpness testing member 4302 can be used to test the sharpness of the cutting edge 182 ( Figure 14 In some cases, the sharpness test member 4302 may be attached to the surgical staple cartridge 304, for example. Figure 1 、 Figure 2 and Figure 15 ) of the warehouse 194 ( Figure 14) and / or integral therewith. In some cases, the sharpness testing member 4302 can be disposed, for example, in a proximal portion of the surgical staple cartridge 304. In some cases, the sharpness testing member 4302 can be disposed, for example, on the cartridge deck or cartridge body 194 of the surgical staple cartridge 304.

[0252] In some cases, the load cell 4335 can be configured to monitor, for example, when the cutting edge 182 ( Figure 14 ) engages and / or contacts the sharpness testing member 4302. The reader will appreciate that the force (Fx) applied to the cutting edge 182 by the sharpness testing member 4302 when the cutting edge 182 engages and / or contacts the sharpness testing member 4302 depends at least in part on the sharpness of the cutting edge 182. In some cases, a decrease in the sharpness of the cutting edge 182 may result in an increase in the force (Fx) required for the cutting edge 182 to cut or pass through the sharpness testing member 4302. The force (Fx) applied to the cutting edge 182 while the cutting edge 182 travels a predetermined distance (D) through the sharpness testing member 4302 can be measured using the load cell 4335 of the sharpness testing member 4302, which can be used to determine the sharpness of the cutting edge 182.

[0253] In some cases, the system 4311 may include a controller 4313 ("microcontroller"), which may include a processor 4315 ("microprocessor") and one or more computer-readable media or storage units 4317 ("memory"). In some cases, the memory 4317 may store various program instructions that, when executed, may cause the processor 4315 to perform the various functions and / or calculations described herein. In some cases, the memory 4317 may be coupled to the processor 4315, for example. A power source 4319 may be configured to supply power to the controller 4313, for example. In some cases, the power source 4319 may include a battery (or "battery pack" or "power pack"), for example, a lithium-ion battery. In some cases, the battery pack may be configured to be releasably mounted to the handle assembly 14. A plurality of battery cells connected in series may be used as the power source 4319. In some cases, the power source 4319 may be, for example, replaceable and / or rechargeable.

[0254] In some cases, the controller 4313 may be operably coupled to, for example, a feedback system and / or a latching mechanism 4123 .

[0255] The system 4311 may include one or more position sensors. Example position sensors and positioning systems suitable for use with the present disclosure are described in U.S. Patent Application Serial No. 2014 / 0263538, entitled “SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS,” the disclosure of which is incorporated herein by reference in its entirety. In some cases, the system 4311 may include a first position sensor 4321 and a second position sensor 4323. In some cases, the first position sensor 4321 may be used to detect, for example, the cutting edge 182 ( Figure 14 ) in a first position; and a second position sensor 4323 can be used to detect, for example, a second position of the cutting edge 182 at the distal end of the sharpness test member 4302.

[0256] In some cases, the first and second position sensors 4321, 4323 can be used to provide a first position signal and a second position signal, respectively, to the controller 4313. It should be understood that the position signals can be analog signals or digital values, depending on the interface between the controller 4313 and the first and second position sensors 4321 and 4323. In one example, the interface between the controller 4313 and the first and second position sensors 4321 and 4323 can be a standard serial peripheral interface (SPI), and the position signals can be digital values representing the first position and the second position of the cutting edge 182, as described above.

[0257] In addition to the above, the processor 4315 may determine a time period between receiving the first position signal and receiving the second position signal. The determined time period may correspond to the cutting edge 182 ( Figure 14 ) The time required to advance through the sharpness test member 4302 from a first position, for example, at the proximal end of the sharpness test member 4302, to a second position, for example, at the distal end of the sharpness test member 4302. In at least one example, the controller 4313 may include a timing element that can be activated by the processor 4315 upon receiving the first position signal and can be deactivated upon receiving the second position signal. The time period between activation and deactivation of the timing element can correspond to, for example, the time required for the cutting edge 182 to advance from the first position to the second position. The timing element can include a real-time clock, a processor configured to perform a timing function, or any other suitable timing circuit.

[0258] In various cases, the controller 4313 may, for example, set the cutting edge 182 ( Figure 14) The time period required to advance from the first position to the second position is compared to a predefined threshold to evaluate whether the sharpness of the cutting edge 182 has dropped below an acceptable level. In some cases, if the measured time period exceeds a predefined threshold, such as 1%, 5%, 10%, 25%, 50%, 100%, and / or more than 100%, the controller 4313 may conclude that the sharpness of the cutting edge 182 has dropped below an acceptable level.

[0259] Figure 20 A method for determining the sharpness of a surgical instrument 10 ( FIG. 1 ) at various sharpness levels by using a sharpness testing member 4302 is shown according to various aspects. Figures 1 to 4 ) of the cutting edge of the force system 4340. See Figure 20 In various cases, the electric motor 4331 can drive the firing rod 172 ( Figure 20 ) to advance the cutting edge 182 ( Figure 14 ) and / or retract the cutting edge 182 during the return stroke. The motor driver 4333 can control the electric motor 4331; and a controller (such as, controller 4313) can communicate signals with the motor driver 4333. When the electric motor 4331 advances the cutting edge 182, the controller 4313 can, for example, determine the current consumed by the electric motor 4331. In such cases, the force required to advance the cutting edge 182 can correspond to, for example, the current consumed by the electric motor 4331. See also Figure 20 , the controller 4313 of the surgical instrument 10 can determine whether the current consumed by the electric motor 4331 during advancement of the cutting edge 182 increases, and if so, can calculate the percentage of the increase in current.

[0260] In some cases, when the cutting edge 182 ( Figure 14 ) is in contact with the sharpness testing member 4302, the current drawn by the electric motor 4331 can increase significantly due to the resistance offered by the sharpness testing member 4302 to the cutting edge 182. For example, as the cutting edge 182 engages, passes through, and / or cuts through the sharpness testing member 4302, the current drawn by the electric motor 4331 can increase significantly. The reader will appreciate that the resistance offered by the sharpness testing member 4302 to the cutting edge 182 depends in part on the sharpness of the cutting edge 182; and as the sharpness of the cutting edge 182 decreases due to repeated use, the resistance offered by the sharpness testing member 4302 to the cutting edge 182 will increase. Thus, the value of the incremental percentage of current drawn by the electric motor 4331 when the cutting edge is in contact with the sharpness testing member 4302 can increase, for example, as the sharpness of the cutting edge 182 decreases due to repeated use.

[0261] In some cases, the value of the determined percentage increase in current drawn by electric motor 4331 may be a maximum detected percentage increase in current drawn by electric motor 4331. In various cases, controller 4313 may compare the value of the determined percentage increase in current drawn by electric motor 4331 to a predefined threshold value for the percentage increase in current drawn by electric motor 4331. If the determined value exceeds the predefined threshold value, controller 4313 may conclude, for example, that the sharpness of cutting edge 182 has fallen below an acceptable level.

[0262] In some cases, such as Figure 20 As shown, the processor 4315 may communicate with a feedback system and / or a locking mechanism, for example. In some cases, if the value of the incremental percentage of the current consumed by the electric motor 4331 exceeds a predefined threshold, the processor 4315 may, for example, employ a feedback system to alert the user. In some cases, if the value of the incremental percentage of the current consumed by the electric motor 4331 exceeds a predefined threshold, the processor 4315 may, for example, employ a locking mechanism to prevent the cutting edge 182 ( Figure 14 ) is advanced. In some cases, the system 4311 may include first and second position sensors 4321, 4323. The surgical instrument 10 ( Figures 1 to 4 ) may include a load unit 4335.

[0263] In various cases, the controller 4313 may utilize an algorithm to determine changes in the current consumed by the electric motor 4331. For example, a current sensor may detect the current consumed by the electric motor 4331 during the firing stroke. The current sensor may continuously detect the current consumed by the electric motor and / or may intermittently detect the current consumed by the electric motor. In various cases, the algorithm may compare the most recent current reading with, for example, the immediately preceding current reading. Additionally or alternatively, the algorithm may compare a sample reading X within time period X with a previous current reading. For example, the algorithm may compare the sample reading with, for example, a sample reading within a previous time period X (such as, for example, the immediately preceding time period X). In other cases, the algorithm may calculate a trend average of the current consumed by the motor. The algorithm may calculate the average current consumed during time period X (including, for example, the most recent current reading) and may compare the average current consumed with, for example, the average current consumed during the immediately preceding time period X.

[0264] In some cases, load cell 4335 ( Figure 19 、 Figure 20 ) can be configured to be able to, for example, when the cutting edge 182 ( Figure 14 ) engages and / or contacts the sharpness testing member 4302 ( Figure 19 、 Figure 20) monitors the force (Fx) applied to the cutting edge 182 when the controller 4313 ( ) is in operation. The reader will appreciate that the force (Fx) applied to the cutting edge 182 by the sharpness testing member 4302 when the cutting edge 182 engages and / or contacts the sharpness testing member 4302 depends at least in part on the sharpness of the cutting edge 182. In some cases, a decrease in the sharpness of the cutting edge 182 may result in an increase in the force (Fx) required for the cutting edge 182 to cut or pass through the sharpness testing member 4302. In some cases, the controller 4313 ( Figure 19 、 Figure 20 ) can be applied to the cutting edge 182 ( Figure 14 ) is compared with one or more predefined thresholds.

[0265] In some cases, for example, the cutting edge 182 ( Figure 14 ) may be sharp enough to transect captured tissue having a first thickness, but may not be sharp enough to transect captured tissue having a second thickness greater than the first thickness. In some cases, for example, if the captured tissue has a tissue thickness within a particular tissue thickness range, the sharpness level of cutting edge 182, as defined by the force required by cutting edge 182 to transect the captured tissue, may be sufficient to transect the captured tissue. In some cases, memory 4317 ( Figure 19 、 Figure 20 ) can store one or more predetermined ranges of tissue thicknesses of tissue captured by the end effector 300; and predefined threshold forces are associated with the predetermined ranges of tissue thicknesses. In some cases, each predefined threshold force may represent a minimum level of sharpness of the cutting edge 182 suitable for transecting captured tissue having a tissue thickness (Tx) encompassed by the range of tissue thicknesses associated with the predefined threshold force. In some cases, when the force (Fx) required for the cutting edge 182 to transect captured tissue having a tissue thickness (Tx) exceeds, for example, a predefined threshold force associated with the predefined range of tissue thicknesses encompassing the tissue thickness (Tx), the cutting edge 182 may not be sharp enough to transect the captured tissue.

[0266] In various aspects, the present disclosure provides techniques for determining tissue compression and for controlling a surgical instrument 10 (in combination with a Figures 1 to 18 In one example, the cartridge can be configured to define a variable compression algorithm that drives the surgical instrument 10 to close differently based on the expected tissue type and thickness. In another example, the surgical instrument 10 learns from the surgeon's use and the original tissue compression profile to adapt closure based on the load experienced during firing. When the surgical instrument 10 experiences a tissue compression load that is significantly different from that experienced by the cartridge type, the instrument highlights this to the user.

[0267] Actively adjusting the motor control algorithm over time as the device adapts to hospital use can improve the life expectancy of the rechargeable battery and can adjust to tissue / procedural requirements to minimize tissue flow, thereby improving staple formation in tissue sealing.

[0268] Thus, the present invention relates to surgical instruments and, in various instances, to surgical stapling and cutting instruments designed for suturing and cutting tissue and their staple cartridges. For example, in various aspects, the present disclosure provides an endoscopic instrument configured to sense cartridge type or tissue clearance, enabling the handle to adjust the closing and firing algorithms to accommodate anticipated tissue characteristics. This adaptive algorithm adjustment can "learn" from the user's actions, allowing the device to react to and benefit from two different systems. A first benefit provided by the disclosed adaptive algorithm involves tissue flow and staple formation. As the device learns the user's baseline habits and step timing, it can adjust the closing and firing speeds to provide a more consistent and reliable output. A second benefit provided by the disclosed adaptive algorithm relates to the battery pack. As the device learns the number of firings and conditions under which the instrument is used, it can adjust the motor current demand / speed in a predefined manner to extend battery life. It is highly unlikely that a device used in a hospital primarily performing bariatric procedures would operate in a manner similar to a device used in a hospital primarily performing colorectal or thoracic procedures. Thus, as the device is used to perform substantially similar procedures, over time, the device is configured to learn and adjust its operating algorithms to maintain within the "ideal" drainage and tissue flow envelope.

[0269] Safe and effective surgery requires proper understanding and respect for the tissues involved. Clinicians note that adjustments made during surgery may be beneficial. These adjustments include mechanisms to detect and promote desired nail formation.

[0270] Endoscopic instruments can generate, monitor, and process large amounts of data during their use in connection with a surgical procedure. Such data can be obtained from the surgical instrument itself, including battery usage. Additionally, data can be obtained from properties of the tissue with which the surgical instrument interacts, including properties such as tissue compression. Furthermore, data can be obtained from the clinician's interaction with the surgical instrument itself. The repository of data so obtained can be processed, and, if necessary, the surgical instrument can be designed to adapt to the environment to promote safe and effective outcomes for the current surgical procedure and to lay the foundation for broader productive use by multiple clinicians. Such adaptability—both during the surgical procedure, and where the instrument "learns" based on usage patterns acquired from multiple surgical procedures—can provide a variety of mechanisms to enhance the overall patient care environment.

[0271] Figure 21One aspect of a process for adapting the operation of a surgical instrument is shown. Figure 21 As depicted, the module may be attached or otherwise loaded into the surgical instrument 10 (step 5160) ( Figures 1 to 4 ). The module may contain a program that was selected or uploaded (step 5162). Controls may be activated (step 5164) so that they may be ready to operate the surgical instrument 10. During or after use of the surgical instrument 10, control measures may be included to adapt to the program (step 5166). For example, this may include adjusting the data rate within the surgical instrument 10 or remote operation relative to the surgical instrument 10. This may include adjusting the speed, such as the anvil 306 ( Figure 1 ) and surgical staple cartridge 304 ( Figure 1 ) speed of engagement in the closing motion. This may also include pulses from the transmitter and sensor, or application of current pulses to the tissue, and the timing of such pulses. This may include adjusting the program to accommodate accelerations, such as accelerating the surgical instrument 10 if dropped, or transitioning from sleep mode. The program may be adapted to handle actual and / or anticipated loads based on the clamping force.

[0272] Surgical instrument 10( Figures 1 to 4 ) can be used to complete an action (step 5168), for example, to perform a suturing procedure. The data can be recorded (step 5170) in an appropriate storage location of the surgical instrument 10. Sensor behavior can be evaluated (step 5172), such as the degree to which the sensor accurately measures and / or measures parameters. Expected data can be evaluated (step 5174), including but not limited to tissue properties, latency, and firing speed. The aforementioned mechanisms disclosed herein can provide input to further adapt the procedure (step 5166). In addition, tissue recognition (step 5178) can be performed based on historical, actual, or expected tissue properties, and this can provide input to further adjust the procedure (step 5166). In addition, tissue recognition properties can be updated (step 5178). Moreover, sensor inputs measured during the procedure (step 5176) can be used as additional input to further adapt the procedure (step 5166); such sensor measurements can include those of the gap between the anvil 306 and the surgical staple cartridge 304, thereby obtaining derivative measurements including derivatives of a function, current, or torque.

[0273] The end effector 6006 can be used to compress, cut or staple tissue. Figure 23A Before compressing, cutting or stapling, the physician can position the end effector 6030 around the tissue 6032. Figure 23A As shown, no compression should be applied to the tissue when preparing to use the end effector. Figure 23BBy engaging the handle of the endoscopic cutter (e.g., handle 6002), the physician can use the end effector 6030 to compress tissue 6032. In one aspect, the tissue 6032 can be compressed to its maximum threshold, such as Figure 23B shown.

[0274] See also Figure 23A , various forces can be applied to the tissue 6032 by the end effector 6030. For example, when the tissue 6032 is compressed between the anvil 6034 and the channel frame 6036 of the end effector 6030, vertical forces F1 and F2 can be applied by the anvil and the channel frame. Figure 23B When tissue is compressed by the end effector 6030, various diagonal and / or lateral forces may also be applied to the tissue 6032. For example, force F3 may be applied. To operate a medical device such as an endocutter 6000, it is desirable to sense or calculate various forms of compression applied to tissue by the end effector. For example, knowing vertical or lateral compression may allow the end effector to perform a more precise or accurate stapling operation or may inform the operator of the endocutter, thereby enabling more correct or safe use of the endocutter.

[0275] Compression across the tissue 6032 can be determined from the impedance of the tissue 6032. At various compression levels, the impedance Z of the tissue 6032 can increase or decrease. By applying a voltage V and a current I to the tissue 6032, the impedance Z of the tissue 6032 can be determined at various compression levels. For example, the impedance Z can be calculated by dividing the applied voltage V by the current I.

[0276] Now see Figure 24 In one aspect, the RF electrode 6038 can be positioned on the end effector 6030 (e.g., on the staple cartridge, blade, or channel frame of the end effector 6030). Additionally, the electrical contact 6040 can be positioned on the anvil 6034 of the end effector 6030. In one aspect, the electrical contact can be positioned on the channel frame of the end effector. When the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. The vertical tissue compression 6042 caused by the end effector 6030 can be measured as a function of the impedance Z of the tissue 6032.

[0277] Now see Figure 25In one aspect, when the RF electrode 6038 is positioned, the electrical contacts 6044 can be positioned on opposite ends of the anvil 6034 of the end effector 6030. When the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. The lateral tissue compression 6046 caused by the end effector 6030 can be measured as a function of the impedance Z of the tissue 6032.

[0278] Now see Figure 26 In one aspect, an electrical contact 6050 can be positioned on the anvil 6034, and an electrical contact 6052 can be positioned on the opposite end of the end effector 6030 at the channel frame 6036. The RF electrode 6048 can be positioned lateral to the center of the end effector 6030. When the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. Lateral or angular compressions 6054 and 6056 on either side of the RF electrode 6048 can be caused by the end effector 6030 and can be measured as a function of the different impedances Z of the tissue 6032 based on the relative positioning of the RF electrode 6048 and the electrical contacts 6050 and 6052.

[0279] According to one or more techniques and features described in this disclosure, and as described above, the RF electrode can be used as an RF sensor. Figure 27 In one aspect, the RF sensor 6062 can be positioned on the staple cartridge 6060 that is inserted into the channel frame 6066 of the end effector. The RF electrode can extend from a power cord 6064 that can be powered by a power source in the handle of the endoscope cutter (e.g., handle 6002).

[0280] Now see Figure 28 In one aspect, RF electrodes 6074 and 6076 can be positioned on a staple cartridge 6072 inserted into a channel frame 6078 of an end effector 6070. As shown, the RF electrode 6074 can be positioned at a proximal end of the end effector relative to the endoscope cutter handle. Additionally, the RF electrode 6076 can be positioned distally of the end effector relative to the endoscope cutter handle. The RF electrodes 6074 and 6076 can be used to measure vertical, lateral, proximal, or distal compression at different points in the tissue based on the position of one or more electrical contacts on the end effector.

[0281] Now see Figure 29 In one aspect, the RF electrodes 6084-6116 can be positioned on the staple cartridge 6082 inserted into the channel frame 6080 (or other component of the end effector) at various points based on the desired compression information. Figure 30In one aspect, the RF electrodes 6122-6140 can be positioned on the staple cartridge 6120 at discrete points where compression information is desired. Figure 31 , RF electrodes 6152-6172 can be positioned at different points in multiple areas of the staple cartridge based on the accuracy or precision of the compression measurements. For example, RF electrodes 6152-6156 can be positioned in area 6158 of the staple cartridge 6150, depending on the accuracy or precision of the compression measurements in area 6158. Additionally, RF electrodes 6160-6164 can be positioned in area 6166 of the staple cartridge 6150, depending on the accuracy or precision of the compression measurements in area 6166. Furthermore, RF electrodes 6168-6172 can be positioned in area 6174 of the staple cartridge 6150, depending on the accuracy or precision of the compression measurements in area 6174.

[0282] The RF electrodes discussed herein can be routed through a cartridge inserted into a channel frame. Figure 32 , in one aspect, the RF electrode can have a stamped "mushroom head" 6180 having a diameter of approximately 1.0 mm. While the RF electrode can have a stamped "mushroom head" having a diameter of approximately 1.0 mm, this is intended to be a non-limiting example, and the RF electrode can have different shapes and sizes depending on each specific application or design. The RF electrode can be connected to, fastened to, or can shape the conductive wire 6182. The conductive wire 6182 can have a diameter of approximately 0.5 mm, or can have a larger or smaller diameter based on the specific application or design. Additionally, the conductive wire can have an insulating coating 6184. In one example, the RF electrode can protrude through the staple cartridge, channel frame, knife, or other component of the end effector.

[0283] Now see Figure 33 , the RF electrodes can pass through a single wall or through multiple walls of the staple cartridge or channel frame of the end effector. For example, the RF electrodes 6190-6194 can pass through the wall 6196 of the staple cartridge or the channel frame of the end effector. One or more of the wires 6198 can be connected to, fastened to, or be part of the RF electrodes 6190-6194 and can pass through the wall 6196 from, for example, a power source in the handle of an endoscopic cutter.

[0284] Now see Figure 34, the power source can be in communication with the RF electrodes, or power can be provided to the RF electrodes via a wire or cable. The wire or cable can join each individual wire and lead to the power source. For example, the RF electrodes 6204-6212 can receive power from the power source via a wire or cable 6202, which can extend through the channel frame of the staple cartridge 6200 or end effector. In one example, each of the RF electrodes 6204-6212 can have its own wire that extends to or through the wire or cable 6202. The staple cartridge 6200 or channel frame can also include a controller 6214, such as in conjunction with Figure 16A and Figure 16B The main processor 2006 shown, or for example in combination with Figure 17A 、 Figure 17B and Figure 18 The main controller 3017 is shown. It should be understood that the controller 6214 should be sized to fit within the staple cartridge 6200 or channel frame form factor.

[0285] Also, the controller

[0286] In various aspects, the tissue compression sensor system for a medical device described herein may include a frequency generator. The frequency generator may be located on a circuit board of a medical device, such as an endoscopic cutter. For example, the frequency generator may be located on a circuit board in a shaft or handle of an endoscopic cutter. Figure 35 , which shows an example circuit diagram 6220 according to an example of the present disclosure. As shown, a frequency generator 6222 can receive power or current from a power source 6221 and can supply one or more RF signals to one or more RF electrodes 6224. As described above, one or more RF electrodes can be positioned at various locations or components on an end effector or endoscopic cutter, such as a staple cartridge or channel frame. One or more electrical contacts, such as electrical contacts 6226 or 6228 can be positioned on the channel frame or anvil of the end effector. In addition, one or more filters, such as filters 6230 or 6232 can be communicatively coupled to electrical contacts 6226 or 6228, such as Figure 35 Filters 6230 and 6232 can filter the one or more RF signals provided by the frequency generator 6222 before joining a single return path 6234. The voltage V and current I associated with the one or more RF signals can be used to calculate the impedance Z associated with tissue that can be compressed and / or communicatively coupled between the one or more RF electrodes 6224 and the electrical contacts 6226 or 6228.

[0287] Now see Figure 36Various components of the tissue compression sensor system described herein may be located within the handle 6236 of an endoscopic cutter. For example, as shown in circuit diagram 6220a, a frequency generator 6222 may be located within the handle 6236 and receive power from a power source 6221. Furthermore, currents I1 and I2 may be measured on the return paths corresponding to electrical contacts 6228 and 6226. Impedances Z1 and Z2 may be calculated using the voltage V applied between the supply and return paths. Z1 may correspond to the impedance of tissue compressing and / or communicating between the RF electrode 6224 and one or more of the electrical contacts 6228. Furthermore, Z2 may correspond to the impedance of tissue compressing and / or communicating between the RF electrode 6224 and one or more of the electrical contacts 6226. Impedances Z1 and Z2 corresponding to different levels of tissue compression by the end effector may be calculated using the equations Z1 = V / I1 and Z2 = V / I2.

[0288] Now see Figure 37 , one or more aspects of the present disclosure are described in circuit diagram 6250. In one embodiment, a power source at the handle 6252 of the endoscope cutter can provide power to a frequency generator 6254. The frequency generator 6254 can generate one or more RF signals. The one or more RF signals can be multiplexed or overlaid at a multiplexer 6256, which can be within the shaft 6258 of the endoscope cutter. In this way, two or more RF signals can be overlaid (or, for example, nested or modulated together) and transmitted to the end effector. The one or more RF signals can power one or more RF electrodes 6260 of an end effector 6262 of the endoscope cutter (e.g., positioned in a staple cartridge). Tissue (not shown) can be compressed and / or communicatively coupled between one or more of the RF electrodes 6260 and one or more electrical contacts. For example, tissue can be compressed and / or communicatively coupled between one or more RF electrodes 6260 and electrical contacts 6264 positioned in the channel frame of the end effector 6262 or electrical contacts 6266 located in the anvil of the end effector 6262. A filter 6268 can be communicatively coupled to the electrical contacts 6264, and a filter 6270 can be communicatively coupled to the electrical contacts 6266.

[0289] The voltage V and current I associated with one or more RF signals can be used to calculate the impedance Z associated with tissue that can be compressed between the nail magazine (and communicatively connected to one or more RF electrodes 6260) and the channel frame or anvil (and communicatively connected to one or more of the electrical contacts 6264 or 6266).

[0290] In one aspect, various components of the tissue compression sensor system described herein can be located in the shaft 6258 of the endoscopic cutter. For example, as shown in the circuit diagram 6250 (and in addition to the frequency generator 6254), the impedance calculator 6272, the controller 6274, the non-volatile memory 6276, and the communication channel 6278 can be located in the shaft 6258. In one example, the frequency generator 6254, the impedance calculator 6272, the controller 6274, the non-volatile memory 6276, and the communication channel 6278 can be located on a circuit board in the shaft 6258.

[0291] Two or more RF signals can return on a common path via electrical contacts. Furthermore, the two or more RF signals can be filtered before being combined on the common path to distinguish the individual tissue impedances represented by the two or more RF signals. Current I1 and current I2 can be measured on the return paths corresponding to electrical contacts 6264 and 6266. Impedances Z1 and Z2 can be calculated using the voltage V applied between the supply and return paths. Z1 can correspond to the impedance of the tissue compressed and / or communicated between the RF electrode 6260 and one or more of the electrical contacts 6264. Furthermore, Z2 can correspond to the impedance of the tissue compressed and / or communicated between the RF electrode 6260 and one or more of the electrical contacts 6266. Impedances Z1 and Z2 corresponding to different levels of tissue compression by the end effector 6262 can be calculated using the formulas Z1=V / I1 and Z2=V / I2. In an example, impedances Z1 and Z2 can be calculated by an impedance calculator 6272. Impedances Z1 and Z2 can be used to calculate various levels of tissue compression.

[0292] In one aspect, filters 6268 and 6270 can be high-Q filters so that the filter range can be narrow (e.g., Q=10). Q can be defined by center frequency (Wo) / bandwidth (BW), where Q=Wo / BW. In one example, frequency 1 can be 150 kHz and frequency 2 can be 300 kHz. The feasible impedance measurement range can be 100 kHz-20 MHz. In various examples, other complex techniques such as correlation, quadrature detection, etc. can be used to separate the RF signals.

[0293] Using one or more techniques and features described herein, a single powered electrode on a staple cartridge or an isolated blade of an end effector can be used to take multiple tissue compression measurements simultaneously. If two or more RF signals are overlapped or multiplexed (or nested or modulated), they can be transmitted down a single power side of the end effector and can return on the channel frame or anvil of the end effector. If filters are built into the anvil and channel contacts before they engage a common return path, the tissue impedance represented by the two paths can be distinguished. This can provide a measure of vertical tissue versus lateral tissue compression. The method can also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metal return path. The frequency generator and signal processor can be located on one or more chips on a circuit board or daughter board (which may already be present in the internal cutter).

[0294] In various aspects, the present disclosure provides techniques for monitoring the speed and precision increments of a drive motor in a surgical instrument 10 (in combination with Figures 1 to 18 Description). In one example, a magnet can be placed on the planetary frame of one of the gear reduction stages, with an inductive sensor on the gear housing. In another example, placing the magnet and magnetic field sensor on the last stage will provide the most accurate incremental motion monitoring.

[0295] Conventional motor control systems use encoders to detect the position and speed of motors in handheld, battery-powered endoscopic surgical instruments, such as electric endoscopic cutters / staplers. Precise operation of endoscopic cutters / staplers relies in part on the ability to verify motor operation under load. Verifying motor operation under load can be accomplished using simple sensor implementations.

[0296] Thus, the present disclosure encompasses either a magnetic body on one of the planetary gear carriers in a gear reduction system or the use of brushless motor technology. Both approaches involve placing an inductive sensor on the external housing of the motor or planetary gear system. In the case of a brushless motor, there are electromagnetic field coils (windings, inductors, etc.) radially arranged around the motor's central magnetic axis. These coils are sequentially activated and deactivated to drive the central motor shaft. One or more inductive sensors can be placed outside the motor, adjacent to at least some of the coils, to sense the activation / deactivation cycles of the motor windings and determine the number of shaft rotations. Alternatively, a permanent magnet can be placed on one of the planetary gear carriers, and an inductive sensor can be placed near the planetary carrier's radial path to measure the number of rotations of a stage in the gear train. This embodiment can be applied to any rotating component in the system, with increasing resolution in areas with relatively high rotations during operation, or as the rotating component becomes closer (in terms of number of connections) to the end effector depending on the design. The gear train sensing approach may be preferred because it actually measures the rotation of one of the stages, while the motor sensing approach senses the number of times the motor is commanded to power, rather than actual shaft rotations. For example, if the motor stalls under high load, the motor sensing method will not be able to detect the lack of rotation because it only senses the power cycle and not the shaft rotation. However, both techniques can be used to sense motor rotation in a cost-effective manner.

[0297] During suturing, for example, before driving the nail into the clamped tissue, the tissue is firmly clamped between the relative jaws. Tissue compression during clamping can cause fluid to be displaced from the compressed tissue, and the rate or amount of displacement varies according to tissue type, tissue thickness, surgical procedure (e.g., clamping pressure and clamping time). In various cases, the fluid discharge between the relative jaws of the end effector can cause the nail between the relative jaws to deform (e.g., bend). Therefore, in various cases, it may be advantageous to control the firing stroke, such as controlling the firing speed, based on detecting that there is fluid flow or no fluid flow in the middle of the relative jaws of the surgical end effector.

[0298] Thus, methods are also provided herein for monitoring the speed and incremental motion of a surgical instrument drive train, which in turn provides information regarding the speed of operation of the device (e.g., jaw closing, suturing). According to this example, the surgical instrument 10 ( Figures 1 to 4) does not include a motor encoder. Instead, according to an illustrative example, the surgical instrument 10 may be equipped with a motor that includes a speed sensor assembly for the motor's power train. The speed sensor assembly may include a motor having an output shaft that is directly or indirectly coupled to a drive shaft. In some examples, the output shaft is connected to a gear reduction assembly, such as a planetary gear train, which includes a sensor for detecting the rotational speed of any suitable component of the system. For example, the sensor may be a proximity sensor, such as an inductive sensor, that detects the movement of one or more detectable elements attached to any rotating part of the gear reduction assembly. The detectable elements are attached to the final stage ring gear, and the sensors are positioned near the radial path of the detectable elements to detect their movement. The rotating components may vary depending on the design, and the sensors may be attached to any rotating component of the gear reduction assembly. For example, in another example, the detectable element is associated with the load gear or even the drive gear of the final stage. In some examples, the detectable element is located external to the gear reduction assembly, such as on the drive shaft between the gear reduction assembly and the end effector. In some examples, the detectable element is located on a rotating component in the final gear reduction at the end effector.

[0299] Various functions can be realized by using the circuit described previously. For example, a motor can be used similarly to a motor in combination with Figure 16A 、 Figure 16B 、 Figure 17A 、 Figure 17B 、 Figure 18 The motor controller is controlled by the motor controller, wherein the encoder is replaced to monitor speed control and precision increments for the motor system of the powered surgical instrument described herein.

[0300] In one aspect, the present disclosure provides a surgical instrument 10 (combined with various sensing systems) configured Figures 1 to 18 Description). Therefore, for convenience and clarity, the details of operation and construction will not be repeated here. In one aspect, the sensing system includes a viscoelastic / rate of change sensing system to monitor blade acceleration, impedance rate of change, and tissue contact rate of change. In one example, the rate of change of blade acceleration can be used as a measure of tissue type. In another example, the rate of change of impedance can be measured with a pulse sensor and can be used as a measure of compressibility. Finally, the rate of change of tissue contact can be measured using a sensor based on the blade firing rate to measure tissue flow.

[0301] The rate of change of a sensed parameter, or otherwise stated, how long it takes for a tissue parameter to reach an asymptotic steady-state value, is itself a separate measurement and may be more valuable than the sensed parameter from which it is derived. To enhance measurements of tissue parameters, such as waiting a predetermined amount of time before taking a measurement, the present disclosure provides a novel technique for employing a derivative of that measurement, such as the rate of change of a tissue parameter.

[0302] Derivative techniques or rate of change measurements become most useful, and it should be understood that there is no single measurement that can be used alone to significantly improve nail formation. A combination of multiple measurements makes the measurement effective. In the case of tissue gaps, it is helpful to know how much of the jaws are covered by tissue to correlate the gap measurement. The rate of change measurement of impedance can be combined with the strain measurement in the anvil to correlate the force and pressure applied to the tissue between the jaw members (such as the anvil and the nail magazine) grasped by the end effector. Endoscopic surgical devices can use rate of change measurements to determine tissue type rather than just tissue compression. Although stomach and lung tissue sometimes have similar thicknesses, and even have similar compression characteristics when lung tissue is calcified, the instrument can distinguish these tissue types by using a combination of measurements such as gap, compression, applied force, tissue contact area, compression rate of change, or gap rate of change. If any one of these measurements is used alone, it may be difficult for the endoscopic surgical device to distinguish one tissue type from another. The compression rate of change may also help the device determine whether the tissue is "normal" or whether there are some abnormalities. Measuring not only how much time has passed, but also measuring the change in the sensor signal and determining the derivative of the signal will provide another measurement to enable the endoscopic surgical device to measure the signal. The rate of change information can also be used to determine when a steady state is reached to signal the next step in the process. For example, after grasping tissue between the jaw members of an end effector (such as an anvil and a staple cartridge), when the tissue compression reaches a steady state (e.g., approximately 15 seconds), an indicator or trigger to start firing the device can be activated.

[0303] Also provided herein are methods, apparatus, and systems for performing time-dependent evaluation of sensor data to determine stability, creep, and viscoelastic characteristics of tissue during surgical instrument operation. Figure 1 The stapler shown in FIG may include various sensors for measuring operating parameters such as jaw gap size or distance, firing current, tissue compression, the amount of jaws covered by tissue, anvil strain, and trigger force, etc. These sensed measurements are important for automatic control of the surgical instrument and for providing feedback to the clinician.

[0304] Can be combined Figures 22A to 37 The example shown is used to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. A current sensor 2312 connected in series with a battery 2308 as described herein can be used to monitor motor current. A current sensor 2412 connected in series with a battery 2308 as described herein can be used to monitor motor current. Figure 18 The battery 2408 or the current sensor 3027 is connected in series.

[0305] Figure 38A motor driven surgical instrument 8010 for cutting and fastening is shown, which may or may not be reusable. The surgical instrument 8010 is similarly constructed and equipped to incorporate Figures 1 to 18 A surgical instrument 10 for cutting and fastening is described. Figure 38 In the illustrated example, surgical instrument 8010 includes a housing 8012 that includes a handle assembly 8014 configured to be grasped, manipulated, and actuated by a clinician. Housing 8012 is configured to be operably attached to an interchangeable shaft assembly 8200 having an end effector 8300 operably coupled thereto that is configured to perform one or more surgical tasks or procedures. Figures 1 to 18 The surgical instrument 10 for cutting and fastening has been described, and for the sake of convenience and clarity, the details of its operation and construction will not be repeated here.

[0306] Figure 38 The illustrated housing 8012 is shown in conjunction with an interchangeable shaft assembly 8200, which includes an end effector 8300 including a surgical cutting and fastening device configured to operably support a surgical staple cartridge 8304 therein. The housing 8012 can be configured for use with interchangeable shaft assemblies including end effectors adapted to support staple cartridges of varying sizes and types, including those having varying shaft lengths, sizes, and types, etc. Additionally, the housing 8012 can also be effectively used with a variety of other interchangeable shaft assemblies, including those configured to impart other motions and forms of energy (such as, for example, radio frequency (RF) energy, ultrasonic energy, and / or motion) to end effector arrangements suitable for use in conjunction with various surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system can utilize any one or more suitable fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and / or attached to an end effector of a shaft assembly.

[0307] Now go to Figure 38 , which depicts a surgical instrument 8010 that may or may not be reused. The surgical instrument 8010 is similarly constructed and equipped as the surgical instrument 10 described herein for cutting and fastening. Figure 38In the illustrated example, surgical instrument 8010 includes a housing 8012 that includes a handle assembly 8014 configured to be grasped, manipulated, and actuated by a clinician. Housing 8012 is configured to be operably attached to an interchangeable shaft assembly 8200 having an end effector 8300 operably coupled thereto that is configured to perform one or more surgical tasks or procedures. Since surgical instrument 8010 is similarly configured and equipped to be used in conjunction with the present invention, Figures 1 to 18 The surgical instrument 10 for cutting and fastening has been described, and for the sake of convenience and clarity, the details of its operation and construction will not be repeated here.

[0308] Figure 38 The illustrated housing 8012 is shown in conjunction with an interchangeable shaft assembly 8200, which includes an end effector 8300 including a surgical cutting and fastening device configured to operably support a surgical staple cartridge 8304 therein. The housing 8012 can be configured for use with interchangeable shaft assemblies including end effectors adapted to support staple cartridges of varying sizes and types, including those having varying shaft lengths, sizes, and types, etc. Additionally, the housing 8012 can also be effectively used with a variety of other interchangeable shaft assemblies, including those configured to impart other motions and forms of energy (such as, for example, radio frequency (RF) energy, ultrasonic energy, and / or motion) to end effector arrangements suitable for use in conjunction with various surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system can utilize any one or more suitable fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and / or attached to an end effector of a shaft assembly.

[0309] Figure 38 A surgical instrument 8010 is shown having an interchangeable shaft assembly 8200 operably coupled thereto. In the illustrated configuration, the handle housing forms a pistol grip portion 8019 that can be grasped and manipulated by a clinician. The handle assembly 8014 operatively supports a plurality of drive systems therein that are configured to generate and apply various control motions to corresponding portions of the interchangeable shaft assembly operatively attached thereto. A trigger 8032 is operably associated with the pistol grip portion for controlling various of these control motions.

[0310] Continue to see Figure 38, the interchangeable shaft assembly 8200 includes a surgical end effector 8300 comprising an elongated channel 8302 configured to operably support a staple cartridge 8304 therein. The end effector 8300 may further comprise an anvil 8306 pivotally supported relative to the elongated channel 8302.

[0311] The present inventors have discovered that for controlling surgical instruments such as Figure 38 ), derived parameters may be even more useful than the sensed parameters on which they are based. Non-limiting examples of derived parameters include the rate of change of a sensed parameter (e.g., jaw gap distance) and the length of time that elapses before a tissue parameter reaches an asymptotic steady-state value (e.g., 15 seconds). Derived parameters, such as rate of change, are particularly useful because they significantly improve measurement accuracy and also provide information directly from the sensed parameters. For example, the rate of change of impedance (i.e., tissue compression) can be combined with the strain in the anvil to correlate compression and force, which enables the controller to determine tissue type rather than just the amount of tissue compression. This example is exemplary only, and any derived parameter can be combined with one or more sensed parameters to provide more accurate information about tissue type (e.g., stomach vs. lung), tissue health (calcified vs. normal), and the operating state of the surgical device (e.g., clamping complete). Different tissues have unique viscoelastic properties and unique rates of change, making these and other parameters discussed herein useful markers for monitoring and automatically adjusting surgical procedures.

[0312] Specifically, see Figure 38 and Figure 39 , the gap 8040 is the distance between the anvil 8306 and the elongated channel 8302 of the end effector 8300. In the open jaw position, at time zero, the gap 8040 between the anvil 8306 and the elongated member is at its maximum distance. The width of the gap 8040 decreases as the anvil 8306 closes, such as during tissue clamping. The rate of change of the gap distance can vary because tissue has non-uniform elasticity. For example, certain tissue types may initially show rapid compression, resulting in a faster rate of change. However, as the tissue is continuously compressed, the viscoelastic nature of the tissue may cause the rate of change to decrease until the tissue cannot be compressed further, at which point the gap distance will remain substantially constant. As the tissue is squeezed between the anvil 8306 of the end effector 8300 and the surgical staple cartridge 8304, the gap decreases over time. Combined Figures 22A to 37 and Figure 40The one or more sensors described can be adapted and configured to measure the gap distance "d" between the anvil 8306 and the surgical staple cartridge 8304 as a function of time t, and the rate of change of the gap distance "d" as a function of time t is the slope of the curve, where slope = Δd / Δt. Additionally, the rate of change of the firing current can be used as an indication of the transition of tissue from one state to another. Thus, the firing current, and in particular the rate of change of the firing current, can be used to monitor device operation. As the knife cuts through tissue, the firing current decreases over time. If the cut tissue is damaged by the knife 8305 ( Figure 39 ) provides more or less resistance due to the tissue characteristics or sharpness, the rate of change of the firing current can be varied. For example, a current sensor 2312 in series with the battery 2308 as described herein, a current sensor 2412 in series with the battery 2408 shown herein, or Figure 18 The motor current is monitored by the current sensor 3027 shown in FIG. The current sensors 2312, 2314, 3027 can be adapted and configured to measure the motor firing current "i" over time t, and the rate of change of the firing current "i" over time t is the slope of the curve, where slope = Δi / Δt. Figures 22A to 37 and Figure 40 The described sensor can be adapted and configured to measure the compression / impedance of tissue. The sensor can be adapted and configured to measure the tissue impedance "Z" over time t, and the rate of change of the tissue impedance "Z" over time t is the slope, where slope = ΔZ / Δt. The rate of change of the strain of the anvil 8306 can be determined by positioning the anvil 8306 and the surgical staple cartridge 8304 ( Figure 38 、 Figure 39 ) to measure the pressure or strain applied to the tissue gripped between the anvil 8306 and the surgical staple cartridge 8304. Thus, at time zero, the trigger 8020 ( Figure 38 ) pressure can be at its lowest value and the trigger pressure can be increased until the operation is completed (e.g., clamping, cutting, or suturing). Figure 38 ) of the pistol grip portion 8019 of the handle to measure the rate of change of the trigger force to drive the knife 8305 ( Figure 39 ) The force required to penetrate the tissue clamped between the anvil 8306 and the surgical staple cartridge 8304.

[0313] Temporary turn Figure 40 , the end effector 9012 is the end effector 8300 ( Figure 38 ) which may be adapted for use with surgical instrument 8010 ( Figure 38) operate together to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. Figure 40 The end effector 9012 shown in FIG may include one or more sensors configured to measure one or more parameters or characteristics associated with the end effector 9012 and / or the tissue segment captured by the end effector 9012. Figure 40 In the illustrated example, the end effector 9012 includes a first sensor 9020 and a second sensor 9026. In various examples, the first sensor 9020 and / or the second sensor 9026 can include, for example, a magnetic sensor (such as a magnetic field sensor), a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 9012.

[0314] In some cases, the first sensor 9020 and / or the second sensor 9026 may include, for example, a magnetic field sensor embedded in the anvil 9014 and configured to detect a magnetic field generated by a magnet 9024 embedded in the jaw member 9016 and / or the staple cartridge 9018. The anvil 9014 can pivotally rotate between an open and a closed position. The strength of the detected magnetic field may correspond to, for example, the thickness of tissue positioned between the anvil 9014 and the jaw member 9016 and / or the completeness of the bite. In some cases, the first sensor 9020 and / or the second sensor 9026 may include a strain gauge, such as a micro strain gauge, which is configured to measure the amount of strain in the anvil 9014 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the amount of strain.

[0315] In some aspects, one or more sensors of the end effector 9012 (such as the first sensor 9020 and / or the second sensor 9026) can include a pressure sensor that is configured to detect pressure generated by the presence of compressed tissue between the anvil 9014 and the jaw member 9016. In some examples, one or more sensors of the end effector 9012 (such as the first sensor 9020 and / or the second sensor 9026) can be configured to detect the impedance of the tissue segment located between the anvil 9014 and the jaw member 9016. The detected impedance can be indicative of the thickness and / or completeness of the tissue positioned between the anvil 9014 and the jaw member 9016.

[0316] In one aspect, one or more sensors (such as, first sensor 9020) of end effector 9012 are configured to measure a gap 9022 between anvil 9014 and jaw member 9016. In some cases, gap 9022 can represent the thickness and / or compressibility of the tissue segment clamped between anvil 9014 and jaw member 9016. In at least one example, gap 9022 can be equal to or substantially equal to the thickness of the tissue segment clamped between anvil 9014 and jaw member 9016. In one example, one or more sensors (such as, first sensor 9020) of end effector 9012 are configured to measure one or more forces applied to anvil 9014 by jaw member 9016 and / or tissue clamped between anvil 9014 and jaw member 9016. The force applied to anvil 9014 can represent the tissue compression experienced by the tissue segment captured between anvil 9014 and jaw member 9016. In one aspect, the gap 9022 between the anvil 9014 and the jaw member 9016 can be measured by positioning a magnetic field sensor on the anvil 9014 and positioning a magnet on the jaw member 9016 such that the gap 9022 is proportional to the signal detected by the magnetic field sensor, and the signal is proportional to the distance between the magnet and the magnetic field sensor. It should be understood that the positions of the magnetic field sensor and the magnet can be interchanged such that the magnetic field sensor is positioned on the jaw member 9016 and the magnet is placed on the anvil 9014.

[0317] One or more sensors, such as the first sensor 9020 and / or the second sensor 9026, can be measured in real time during the clamping operation. The real-time measurements allow the time-based information to be analyzed, for example, by a processor and used to select one or more algorithms and / or lookup tables to evaluate in real time the operator's manual input to the surgical instrument 9010. In addition, real-time feedback can be provided to the operator to help the operator calibrate the manual input to produce the desired output.

[0318] Figure 41 is a logic diagram illustrating one aspect of a real-time feedback system 9060 for evaluating manual input 9064 of an operator of a surgical instrument 9010 in real time and providing real-time feedback to the operator regarding the adequacy of the manual input 9064. Figure 40 and Figure 41 ,exist Figure 41In the illustrated example, the real-time feedback system 9060 includes circuitry. The circuitry includes a controller 9061, which includes a processor 9062. The processor 9062 uses a sensor, such as the first sensor 9020, to measure a parameter of the end effector 9012. Furthermore, the processor 9062 can be configured to determine or receive a value representing a manual input 9064 from an operator of the surgical instrument 9010. Manual input 9064 can be continuously evaluated by the processor 9062 as long as the operator provides it. The processor 9062 can be configured to monitor the value representing the manual input 9064. Furthermore, the processor 9062 can assign, select, or determine a position, level, and / or state of the determined value relative to a desired region or range. The processor 9062 can use the measured and determined values of the parameter of the end effector 9012 to select or determine a position, level, and / or state associated with the determined value, as described in more detail below. A change in the manual input 9064 produces a change in the determined value, which in turn produces a change in the position, level and / or status assigned to the determined value relative to the desired area or range.

[0319] like Figure 41 As shown, the real-time feedback system 9060 may also include a feedback indicator 9066 that can adjust between multiple positions, levels, and / or states within and outside a desired area or range. In one example, the processor 9062 may select a first position (P1), level, and / or state representing the manual input 9064 based on a measured value (M1) of a parameter of the end effector 9012 and a first determined value (V1) representing the first manual input (I1). In some cases, the first position (P1), level, and / or state may fall outside the desired area or range. In such a case, the operator may change the manual input 9064 from the first manual input (I1) to a second manual input (I2) by, for example, increasing or decreasing the manual input 9064. In response, the processor 9062 may adjust the feedback indicator 9066 from the first position (P1), level, and / or state to a second position (P2), level, and / or state representing the change to the manual input 9064. The processor 9062 can select a second position (I2), level, and / or state based on the measured value (M1) of the parameter of the end effector 9012 and the second determined value (V2) representing the second manual input (I2). In some cases, the second position (P2), level, and / or state may fall within a desired area or range. In such cases, for example, the operator can maintain the second manual input (I2) for the remainder of the treatment cycle or procedure.

[0320] exist Figure 41In the illustrated aspect, the controller 9061 includes a storage medium, such as a memory 9068. The memory 9068 can be configured to store correlations between one or more parameters of the end effector 9012, values representing manual inputs, and measured values representing the corresponding position, level, and / or state of the manual input 9064 relative to a desired region or range. In one example, the memory 9068 can store correlations between a measured value (M1), a first determined value (V1), and a first manual input (I1), as well as correlations between a measured value (M1), a second determined value (V2), and a second manual input (I2). In one example, the memory 9068 can store an algorithm, equation, or lookup table for determining correlations between measured values of one or more parameters of the end effector 9012, values representing manual inputs, and the corresponding position, level, or state relative to a desired region or range. The processor 9062 can employ such algorithms, equations, and / or lookup tables to characterize the manual input 9064 provided by the operator of the surgical instrument 9010 and provide feedback to the operator regarding the adequacy of the manual input 9064.

[0321] Figure 42 is a logical diagram of one aspect of real-time feedback system 9070. Real-time feedback system 9070 is similar in many respects to real-time feedback system 9060. For example, like real-time feedback system 9060, real-time feedback system 9070 is configured to evaluate manual inputs of an operator of surgical instrument 9010 in real time and provide real-time feedback to the operator regarding the adequacy of the manual inputs. Furthermore, similar to real-time feedback system 9060, real-time feedback system 9070 includes circuitry that may include controller 9061.

[0322] exist Figure 42 In the illustrated aspect, a sensor 9072 (such as a strain gauge or microstrain gauge) is configured to measure one or more parameters of the end effector 9012, such as the magnitude of the strain applied to the anvil 9014 during the clamping operation, which can indicate tissue compression. The measured strain is converted into a digital signal and provided to the processor 9062. A sensor 9074 (such as a load cell) can measure the force used to advance the cutting member 9040 to cut the tissue captured between the anvil 9014 and the staple cartridge 9018. Alternatively, a current sensor (not shown) can be used to measure the current consumed by the motor 9082. The force required to advance the firing rod 9036 can correspond to, for example, the current consumed by the motor 9082. The measured force is converted into a digital signal and provided to the processor 9062. As described above, a sensor 9076 (such as a magnetic field sensor) can be used to measure the thickness of the captured tissue. The measurement of the magnetic field sensor 9076 can also be converted into a digital signal and provided to the processor 9062.

[0323] exist Figure 42 In the aspect shown, real-time feedback system 9070 also includes tracking system 9080, which can be configured to determine the position of the firing trigger. As described above, the firing trigger 9094 can be pressed or actuated by moving the firing trigger 9094 between a plurality of positions, each position corresponding to one of a plurality of values of the motion characteristics of firing rod 9036 and / or cutting member 9040 during the firing stroke. As described above, the motion characteristics can be the propulsion speed of firing rod 9036 and / or cutting member 9040 during the firing stroke. In some cases, motor driver 9092 can communicate with controller 9061 and can be configured to drive motor 9082 according to the manual input of the operator detected by tracking system 9080.

[0324] In addition to the above, the real-time feedback system 9070 may include a feedback indicator 9066. In one aspect, the feedback indicator 9066 may be provided in the handle 9030. Alternatively, for example, the feedback indicator may be provided in the shaft assembly 9032. In any case, the controller 9061 may employ the feedback indicator 9066 to provide feedback to the operator of the surgical instrument 9010 regarding the adequacy of manual inputs, such as, for example, the selected position of the firing trigger 9094. To this end, the controller 9061 may evaluate the corresponding values of the selected position of the firing trigger 9094 and / or the velocity of the firing rod 9036 and / or the cutting member 9040. The measured values of tissue compression, tissue thickness, and / or the force required to advance the firing rod 9036, respectively, measured by sensors 9072, 9074, and 9076, may be used by the controller 9061 to characterize the corresponding values of the selected position of the firing trigger 9094 and / or the velocity of the firing rod 9036 and / or the cutting member 9040. In one embodiment, the memory 9068 can store algorithms, formulas, and / or lookup tables that can be used by the controller 9061 in the evaluation. In one example, the measurements of the sensors 9072, 9074, and / or 9076 can be used to select or determine a position, level, and / or state that represents a selected position of the firing trigger 9094 and / or a corresponding value of the velocity of the firing rod 9036 and / or the cutting member 9040. The determined position, level, and / or state can be communicated to the operator via the feedback indicator 9066.

[0325] The reader will appreciate that the optimal velocity of the firing rod 9036 and / or cutting member 9040 during the firing stroke may depend on several parameters of the end effector 9012, such as the thickness of the tissue captured by the end effector 9012, tissue compression, and / or the force required to advance the firing rod 9036 and, in turn, the cutting member 9040. As such, the controller 9061 may utilize measurements of these parameters to assess whether the current velocity of advancement of the cutting member 9040 through the captured tissue is within an optimal region or range.

[0326] In one aspect, a plurality of smart sensors can be positioned on the power cord of the end effector and can be communicatively coupled to the handle of the endoscope cutter. The smart sensors can be positioned in series or in parallel with respect to the power cord. Figure 43 , smart sensors 12060 and 12062 can communicate with a signal processing component or processor 12064, which can be a local processor of the smart sensor. Smart sensors 12060 and 12062 and processor 12064 can all be located in the end effector (represented by the dashed box 12066). For example, smart sensor 12060 can output a signal or data to an operational amplifier 12068 and an ADC converter 12070, which can condition the signal or data for input to processor 12064. Similarly, smart sensor 12062 can output a signal or data to an operational amplifier 12072 and an ADC converter 12074, which can condition the signal or data for input to processor 12064.

[0327] Smart sensors 12060 and / or 12062 can be different types of sensors or the same type of sensor, which can be, for example, magnetic field sensors, magnetic sensors, inductive sensors, capacitive sensors, or other types of sensors used in medical devices or endoscopes. Component 12064, previously referred to as a processor, can also be a computing core, an FPGA (field programmable gate array), a logic unit (e.g., a logic processor or logic controller), a signal processing unit, or other type of processor. Processor 12064 can communicate with a memory, such as non-volatile memory 12076, which can store computational data, device information such as the type of cartridge inserted into end effector 12066, tabular data, or other reference data that enables processor 12064 to process signals or data received from one or more of smart sensors 12060 or 12062 for operating end effector 12066 or endoscopes.

[0328] In addition, the shaft 12078 can include a return path through which at least one of the plurality of smart sensors (e.g., smart sensor 12060 or 12062) and the handle 12080 are communicatively coupled. The shaft can include one or more wires that can transmit information from the processor 12064 to the handle 12080 to operate the end effector 12066 or endoscopic cutter. In one example, information from the processor 12064 can be transmitted to the handle 12080 (through the shaft 12078 or directly without the shaft 12078) via one or more of the following: a wired line, a single-wire line, a multi-wire line, a wireless communication protocol (such as Bluetooth), an optical line, or an acoustic line.

[0329] In one aspect, at least one of the plurality of smart sensors positioned at the end effector can include a signal processing assembly. For example, the signal processing assembly can be built into the smart sensor or can be locally coupled to the smart sensor as a separate module. The signal processing assembly can be configured to process data received from a sensor assembly (e.g., sensor assembly 12020) of at least one of the plurality of smart sensors. A controller 12024 (e.g., a controller) at the handle can be communicatively coupled to at least one of the plurality of smart sensors.

[0330] In one aspect, the smart sensor can be configured to be used for local signal processing in a medical device. The smart sensor may include at least one sensor component (e.g., sensor component 12020) and at least one processing component (e.g., processing component 12022). The processing component can be configured to receive data from at least one sensor component and process the data into information for use by the medical device. The medical device can be, for example, an endoscopic cutter, but this is not intended to limit the present disclosure. It should be understood that the techniques and features discussed herein for smart sensors with local signal processing can be used in any medical device where processing of sensor signals or data is used for the operation of the medical device.

[0331] In addition, the controller (e.g., controller 12024, controller) in the medical device can be configured to receive information (i.e., processed signals or data) from at least one processing component (e.g., processing component 12022). As described above, the medical device can be a surgical instrument such as an endoscopic cutter, and the smart sensor can be configured to be used for local signal processing in the surgical instrument. Local signal processing can refer to, for example, processing signals or data of a sensor component at a processing component connected to the sensor, where the resulting processed information can be used by a separate component. For example, the controller 12024 can be positioned in the handle 12012 of the surgical instrument (i.e., the endoscopic cutter 12010), and the smart sensor can be configured to be positioned in a separate component (i.e., the end effector 12016) of the surgical instrument (i.e., the endoscopic cutter 12010), separate from the handle 12012. Thus, the controller 12024 can be positioned at the handle 12012 of the surgical instrument, and the signal processing assembly 12022 and the sensor 12020 can be located in a component separate from the handle 12012 (e.g., the end effector 12016).

[0332] In this way, the handle or controller 12024 does not need to have information about the smart sensors, knowledge of what the smart sensors are doing, or the ability to interpret the data fed back from the smart sensors. This is because the processing component 12022 can convert or condition the data from the smart sensors and generate information from the data that can be used directly by the handle or controller 12024. The information generated by the processing component can be used directly without the need to process the data from the smart sensors in another part of the medical device (e.g., near the handle 12012 or controller 12024). Therefore, the surgical instrument can be controlled based on (processed) information from the signal processing component local to the sensor.

[0333] In one aspect, the current draw on a power cord communicatively coupled to the signal processing assembly 12022 (i.e., local to the sensor 12020) can be monitored. The current draw can be monitored by a processor, controller, or other monitoring device at the shaft 12014 or handle 12012, or at another processor, controller, or other monitoring device separate from the signal processing assembly 12022. For example, the monitoring can be a standard Morse code type monitoring of the current draw on the power cord. Problems with the surgical instrument based on the current draw and specific sensors can be determined by, for example, a separate processor at the handle 12012. In this way, the monitoring can allow the handle (or a processor or controller therein) to be informed of various problems with signals or data received by one or more sensors, and which specific sensor identified the problem, without further communication requirements (e.g., pairing or other coupled communications).

[0334] Figure 44 One aspect of a circuit 13190 is shown that is configured to convert signals from a first sensor 13158 and a plurality of second sensors 13160a, 13160b into digital signals (eg, signals received by a processor (eg, main processor 2006)). 16A to 16B ). Circuit 13190 includes an analog-to-digital converter 13194. In some examples, analog-to-digital converter 13194 includes a 4-channel, 18-bit analog-to-digital converter. Those skilled in the art will recognize that analog-to-digital converter 13194 may include any suitable number of channels and / or number of bits to convert one or more inputs from an analog signal to a digital signal. Circuit 13190 includes one or more level shifting resistors 13196 that are configured to receive an input from a first sensor 13158 (e.g., a magnetic field sensor). Level shifting resistor 13196 adjusts the input from the first sensor, thereby converting the value to a higher or lower voltage, depending on the input. Level shifting resistor 13196 provides the level shifted input from first sensor 13158 to the analog-to-digital converter.

[0335] In some aspects, multiple second sensors 13160a, 13160b are coupled to multiple bridges 13192a, 13192b within circuit 13190. Bridges 13192a, 13192b can provide filtering for inputs from the multiple second sensors 13160a, 13160b. After filtering the input signals, bridges 13192a, 13192b provide the inputs from the multiple second sensors 13160a, 13160b to an analog-to-digital converter 13194. In some examples, a switch 13198 coupled to one or more level-shifting resistors can be coupled to analog-to-digital converter 13194. Switch 13198 is configured to correct one or more of the input signals, such as inputs from a magnetic field sensor. Switch 13198 can be used to provide one or more level-shifted signals to adjust the inputs of one or more of the sensors, for example, to correct the inputs of the magnetic field sensors. In some examples, adjustment is not required and the switch 13198 is kept in the open position to disconnect the level shifting resistor. The switch 13198 is coupled to the analog-to-digital converter 13194. The analog-to-digital converter 13194 provides an output to one or more processors, such as the main processor 2006 ( 16A to 16B ). The main processor 2006 calculates one or more parameters of the end effector 13150 based on the input from the analog-to-digital converter 13194. For example, in one example, the main processor 2006 calculates the thickness of the tissue located between the anvil 13152 and the staple cartridge 13156 based on the input from the first sensor 13158 and the plurality of second sensors 13160a, 13160b.

[0336] Figure 45 One aspect of a staple cartridge 13606 is shown including a flexible cable 13630 connected to a magnetic field sensor 13610 and a processor 13612. The staple cartridge 13606 is similar to the staple cartridge 13606 described above in connection with the surgical instrument 10 ( Figures 1 to 6 ) described surgical staple cartridge 304 ( Figure 1 ). Figure 11213606. FIG1 is an exploded view of a staple cartridge 13606. The staple cartridge 13606 includes a cartridge body 13620, a wedge-shaped sled 13618, a cartridge tray 13622, and a flexible cable 13630. The flexible cable 13630 also includes electrical contacts 13632 located at the proximal end of the staple cartridge 13606, which are arranged to establish an electrical connection when the staple cartridge 13606 is operably coupled to an end effector (e.g., end effector 13800 described below). The electrical contacts 13632 are integral with a cable trace 13634 that extends along a portion of the length of the staple cartridge 13606. The cable trace 13634 connects to a connection 13636 near the distal end of the staple cartridge 13606, and this connection 13636 engages with the conductive coupling 13614. The magnetic field sensor 13610 and the processor 13612 are operably coupled to the conductive coupling 13614 such that the magnetic field sensor 13610 and the processor 13612 can communicate.

[0337] Figure 46 One aspect of an end effector 13800 is shown having a flexible cable 13830 operable to provide power to a staple cartridge 13806 including a distal sensor plug 13816. The end effector 13800 is similar to that described above in connection with the surgical instrument 10 ( Figures 1 to 6 ) described end effector 300 ( Figure 1 ). The end effector 13800 includes an anvil 13802, a jaw member or elongated channel 13804, and a staple cartridge 13806 operably coupled to the elongated channel 13804. The end effector 13800 is operably coupled to a shaft assembly. The shaft assembly is similar to that described above in conjunction with surgical instrument 10 ( Figures 1 to 6 ) describes the interchangeable shaft assembly 200 ( Figure 1 ). The shaft assembly also includes a closure tube that encloses the exterior of the shaft assembly. In some examples, the shaft assembly also includes an articulation interface 13904 that includes a dual-pivot closure sleeve assembly. The dual-pivot closure sleeve assembly includes an end effector closure sleeve assembly operable to couple with the end effector 13800.

[0338] Figure 47 and Figure 48 The portion of the elongated channel 13804 of the end effector 13800 is shown without the anvil 13802 or staple cartridge to illustrate how the flexible cable 13830 may be positioned within the elongated channel 13804. In some examples, the elongated channel 13804 also includes a third aperture 13824 for receiving the flexible cable 13830. Within the body of the elongated channel 13804, the flexible cable splits 13834 to form extensions 13836 on either side of the elongated channel 13804. Figure 48 Connector 13838 is also shown operably coupled to flexible cable extension 13836 .

[0339] Figure 49 Only the flexible cable 13830 is shown. As shown, the flexible cable 13830 includes a cable that is operable to wrap around the joint motion interface 13904 ( Figure 46 ) and a split portion 13834 attached to an extension 13836. The extension can be coupled to a connector 13838 having pins 13840 located on a distal facing surface thereof for coupling to a staple cartridge 13806, as described below.

[0340] Figure 50 Shown Figure 47 and 48 , which has a staple cartridge 13804 coupled thereto. The staple cartridge 13804 includes a cartridge body 13822 and a cartridge tray 13820. In some examples, the staple cartridge 13806 further includes electrical traces 13828 coupled to proximal contacts 13856 at the proximal end of the staple cartridge 13806. The proximal contacts 13856 can be positioned to form an electrically conductive connection with pins 13840 of a connector 13838 coupled to the flexible cable extension 13836. Thus, when the staple cartridge 13806 is operably coupled to the elongated channel 13804, the flexible cable 13830 can provide electrical power to the staple cartridge 13806 via the connector 13838 and the connector pins 13840.

[0341] Figure 51 and Figure 52 One aspect of distal sensor plug 13816 is shown. Figure 51 13816. As shown, the distal sensor plug 13816 includes a magnetic field sensor 13810 and a processor 13812. The distal sensor plug 13816 also includes a flexible board 13814. Figure 52 As further shown, the magnetic field sensor 13810 and the processor 13812 are operably coupled to the flexible board 13814 so that they can communicate.

[0342] Figure 53One aspect of an end effector 13950 is shown having a flexible cable 13980 operable to provide power to sensors and electronics in a distal end 13952 of an anvil 13961 portion. The end effector 13950 includes an anvil 13961, a jaw member or elongated channel 13954, and a staple cartridge 13956 operably coupled to the elongated channel. The end effector 13950 is operably coupled to a shaft assembly 13960. The shaft assembly 13960 also includes a closure tube 13962 enclosing the shaft assembly 13960. In some examples, the shaft assembly 13960 also includes an articulation interface 13964 comprising a dual-pivot closure sleeve assembly 13966.

[0343] In various aspects, the end effector 13950 further includes a flexible cable 13980 that is configured to not interfere with the function of the articulation interface 13964. In some examples, the closure tube 13962 includes a first hole 13968 through which the flexible cable 13980 can extend. In some examples, the flexible cable 13980 further includes a loop or coil 13982 that is wrapped around the articulation interface 13964 so that the flexible cable 13980 does not interfere with the operation of the articulation interface 13964, as described further below. In some examples, the flexible cable 13980 extends along the length of the anvil 13961 to a second hole 13970 in the distal end of the anvil 13961.

[0344] A portion of the surgical stapling instrument 16000 is shown in FIG. Figures 54 to 56 For example, the stapling instrument 16000 can be used with a manually operated system and / or a robotically controlled system. The stapling instrument 16000 includes a shaft 16010 and an end effector 16020 extending from the shaft 16010. The end effector 16020 includes a cartridge channel 16030 and a staple cartridge 16050 positioned in the cartridge channel 16030. The staple cartridge 16050 includes a cartridge body 16051 and a retainer 16057 attached to the cartridge body 16051. The cartridge body 16051 is constructed, for example, of a plastic material, and the retainer 16057 is constructed, for example, of a metal. However, the cartridge body 16051 and the retainer 16057 can be constructed of any suitable material. The cartridge body 16051 includes a platform 16052 configured to support tissue, a longitudinal slot 16056, and a plurality of staple cavities 16053 defined in the platform 16052.

[0345] Main references Figure 55 and Figure 56, staples 16055 are removably positioned in staple cavities 16053 and supported by staple drivers 16054, which are also movably positioned in staple cavities 16053. Retainers 16057 extend around the bottom of cartridge body 16051 to retain staple drivers 16054 and / or staples 16055 from falling out of the bottom of staple cavities 16053. Staple drivers 16054 and staples 16055 can be positioned in the unfired position ( Figure 55 ) and the firing position. The slide 16060 can move between the proximal unfired position ( Figure 55 ) moves toward the distal firing position to eject the nail 16055 from the nail magazine 16050, such as Figure 56 As shown. The sled 16060 includes one or more inclined surfaces 16064 that are configured to slide under the staple drivers 16054. The end effector 16020 also includes an anvil 16040 that is configured to deform the staples 16055 as they are ejected from the staple cartridge 16050. In various circumstances, the anvil 16040 can include forming pockets 16045 defined therein that are configured to deform the staples 16055.

[0346] The shaft 16010 includes a frame 16012 and an outer sleeve 16014 that is movable relative to the frame 16012. The cartridge channel 16030 is mounted to the shaft frame 16012 and extends therefrom. The outer sleeve 16014 is operably engaged with the anvil 16040 and is configured to enable the anvil 16040 to be in an open position ( Figure 54 ) and closed position ( Figure 55) between the anvil 16040 and the staple cartridge 16050. In use, the anvil 16040 can move toward the staple cartridge 16050 positioned in the cartridge channel 16030 to clamp the tissue on the platform 16052 of the staple cartridge 16050. In various alternative aspects, the cartridge channel 16030 and the staple cartridge 16050 can be movable relative to the anvil 16040 to clamp the tissue therebetween. In either case, the shaft 16010 further includes a firing member 16070 configured to push the slider 16060 distally. The firing member 16070 includes a blade 16076 that is movable within the longitudinal slot 16056 and is configured to cut the tissue located between the anvil 16040 and the staple cartridge 16050 when the firing member 16070 is advanced distally to eject the staples 16055 from the staple cartridge 16050. The firing member 16070 also includes a first cam 16071 that is configured to engage the staple cartridge channel 16030 and a second cam 16079 that is configured to engage the anvil 16040 and hold the anvil 16040 in position relative to the staple cartridge 16050. The first cam 16071 is configured to slide beneath the cartridge channel 16030, and the second cam 16079 is configured to slide within the elongated slot 16049 defined in the anvil 16040.

[0347] Figure 57 One aspect of an end effector 3011 is shown that includes a first sensor 3008a and a second sensor 3008b. The end effector 3011 is similar to the end effector 300 described above. The end effector 3011 includes an anvil 3013 that can be pivotally coupled to a jaw member 3004. The jaw member 3004 is configured to receive a staple cartridge 3021 therein. The staple cartridge 3021 includes a plurality of staples (not shown). The plurality of staples can be deployed from the staple cartridge 3021 during a surgical procedure. The end effector 3011 includes a first sensor 3008a that is configured to measure one or more parameters of the end effector 3011. For example, in one aspect, the first sensor 3008a is configured to measure a gap 3023 between the anvil 3013 and the jaw member 3004. The first sensor 3008a can comprise, for example, a Hall effect sensor configured to detect a magnetic field generated by a magnet 3012 embedded in the second jaw member 3004 and / or the staple cartridge 3021. As another example, in one aspect, the first sensor 3008a can be configured to measure one or more forces applied to the anvil 3013 by the second jaw member 3004 and / or tissue clamped therebetween.

[0348] The end effector 3011 includes a second sensor 3008b. The second sensor 3008b is configured to measure one or more parameters of the end effector 3011. For example, in various aspects, the second sensor 3008b may include a strain gauge configured to measure the amount of strain in the anvil 3013 during a clamped state. The strain gauge provides an electrical signal whose amplitude varies with the amount of strain. In various aspects, the first sensor 3008a and / or the second sensor 3008b may include, for example, a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 3011. The first sensor 3008a and the second sensor 3008b may be arranged in a series configuration and / or in a parallel configuration. In a series configuration, the second sensor 3008b may be configured to directly affect the output of the first sensor 3008a. In a parallel configuration, the second sensor 3008b can be configured to indirectly affect the output of the first sensor 3008a.

[0349] In one aspect, one or more parameters measured by the first sensor 3008a are correlated with one or more parameters measured by the second sensor 3008b. For example, in one aspect, the first sensor 3008a is configured to measure a gap 3023 between the anvil 3013 and the jaw member 3004. The gap 3023 represents the thickness and / or compressibility of the tissue segment clamped between the anvil 3013 and the staple cartridge 3021 of the jaw member 3004. The first sensor 3008a may comprise, for example, a Hall effect sensor configured to detect a magnetic field generated by a magnet 3012 coupled to the second jaw member 3004 and / or the staple cartridge 3021. An accurate measurement at a single location may describe the compressed tissue thickness of the corrected tissue when fully engaged, but may provide inaccurate results when a partial engagement of the tissue is provided between the anvil 3013 and the second jaw member 3004. Partial engagement of the tissue (either proximal or distal) changes the clamping geometry of the anvil 3013.

[0350] In some aspects, the second sensor 3008b is configured to detect one or more parameters indicative of the type of tissue engagement (e.g., full engagement, partial proximal engagement, and / or partial distal engagement). Measurements from the second sensor 3008b can be used to adjust measurements from the first sensor 3008a to accurately represent the true compressive tissue thickness of a proximally or distally positioned partial engagement. For example, in one aspect, the second sensor 3008b comprises a strain gauge, such as a microstrain gauge, configured to monitor the strain amplitude in the anvil during the clamping state. The strain amplitude of the anvil 3013 is used to modify the output of the first sensor 3008a, such as a Hall effect sensor, to accurately represent the true compressive tissue thickness of a proximally or distally positioned partial engagement. The first and second sensors 3008a, 3008b, can be measured in real time during the clamping operation. Real-time measurements allow time-based information to be analyzed, for example, by the main processor 2006 and used to select one or more algorithms and / or lookup tables to dynamically adjust tissue thickness measurements based on tissue characteristics and clamping positioning.

[0351] In some aspects, the tissue measurements of the first sensor 3008a can be provided to an output device of the surgical instrument 10 coupled to the end effector 3011. For example, in one aspect, the end effector 3011 is coupled to a surgical instrument 10 that includes a display 2028. The measurements of the first sensor 3008a are provided to a processor, such as the main processor 2006. The main processor 2006 adjusts the measurements of the first sensor 3008a based on the measurements of the second sensor 3008b to reflect the actual tissue thickness of the tissue segment clamped between the anvil 3013 and the staple cartridge 3021. The main processor 2006 outputs the adjusted tissue thickness measurements and an indication of full or partial engagement to the display 2028. The operator can determine whether to deploy the staples in the staple cartridge 3021 based on the displayed values.

[0352] In some aspects, the first sensor 3008a and the second sensor 3008b can be positioned in different environments, for example, the first sensor 3008a is positioned at the treatment site within the patient's body and the second sensor 3008b is positioned external to the patient. The second sensor 3008b can be configured to correct and / or modify the output of the first sensor 3008a. The first sensor 3008a and / or the second sensor 3008b can include, for example, an environmental sensor. The environmental sensor can include, for example, a temperature sensor, a humidity sensor, a pressure sensor, and / or any other suitable environmental sensor.

[0353] Figure 5830 is a logic diagram illustrating one aspect of a method 3050 for determining and displaying the thickness of a tissue segment clamped between the anvil 3013 and the staple cartridge 3021 of an end effector 3011. The method 3050 includes obtaining a Hall effect voltage 3052, for example, from a Hall effect sensor positioned at the distal end of the anvil 3013. The Hall effect voltage 3052 is provided to an analog-to-digital converter 3054 and converted into a digital signal. The digital signal is provided to a processor, for example, the main processor 2006. The main processor 2006 corrects the curve input of the Hall effect voltage 3052 signal (step 3056). A strain gauge 3058 (e.g., a microstrain gauge) is configured to measure one or more parameters of the end effector 3011, for example, the magnitude of the strain applied to the anvil 3013 during the clamping operation. The measured strain is converted 3060 into a digital signal and provided to a processor, for example, the main processor 2006. The main processor 2006 adjusts the Hall effect voltage 3052 using one or more algorithms and / or lookup tables in response to the strain measured by the strain gauge 3058 to reflect the true thickness and completeness of the bite of the tissue clamped by the anvil 3013 and the staple cartridge 3021. The adjusted thickness is displayed to the operator via, for example, a display 2026 embedded in the surgical instrument 10 (step 3026).

[0354] In some aspects, the surgical instrument can further include a load sensor 3082 or load cell. The load sensor 3082 can be located, for example, in the interchangeable shaft assembly 200 (described above) or in the housing 12 (also described above).

[0355] Figure 5930 is a logic diagram illustrating one aspect of a method 3070 for determining and displaying the thickness of a tissue segment clamped between the anvil 3013 and the staple cartridge 3021 of an end effector 3011. The method includes obtaining a Hall effect voltage 3072, for example, via a Hall effect sensor positioned at the distal end of the anvil 3013. The Hall effect voltage 3072 is provided to an analog-to-digital converter 3074 and converted into a digital signal. The digital signal is provided to a processor, for example, the main processor 2006. The main processor 2006 applies a correction to the curve input of the Hall effect voltage 3072 signal (step 3076). A strain gauge 3078 (e.g., a microstrain gauge) is configured to measure one or more parameters of the end effector 3011, for example, the magnitude of the strain applied to the anvil 3013 during the clamping operation. The measured strain is converted into a digital signal (step 3080) and provided to a processor, for example, the main processor 2006. The load sensor 3082 measures the clamping force of the anvil 3013 relative to the staple cartridge 3021. The measured clamping force is converted into a digital signal (step 3084) and provided to a processor, such as the main processor 2006. The main processor 2006 uses one or more algorithms and / or lookup tables to adjust the Hall effect voltage 3072 in response to the strain measured by the strain gauge 3078 and the clamping force measured by the load sensor 3082 to reflect the true thickness and bite integrity of the tissue clamped by the anvil 3013 and staple cartridge 3021. The adjusted thickness is displayed to the operator via, for example, a display 2026 embedded in the surgical instrument 10 (step 3026).

[0356] Figure 60 One aspect of an end effector 3100 is shown that includes a first sensor 3108a and a second sensor 3108b. The end effector 3100 is similar to the end effector 3011. The end effector 3100 includes an anvil, anvil 3102, pivotally coupled to a jaw member 3104. The jaw member 3104 is configured to receive a staple cartridge 3106 therein. The end effector 3100 includes a first sensor 3108a coupled to the anvil 3102. The first sensor 3108a is configured to measure one or more parameters of the end effector 3100, such as, for example, a gap 3110 between the anvil 3102 and the staple cartridge 3106. The gap 3110 may correspond to, for example, the thickness of tissue clamped between the anvil 3102 and the staple cartridge 3106. The first sensor 3108a may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various aspects, the first sensor 3108a may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0357] In some aspects, the end effector 3100 includes a second sensor 3108b. The second sensor 3108b is coupled to the jaw member 3104 and / or the staple cartridge 3106. The second sensor 3108b is configured to detect one or more parameters of the end effector 3100. For example, in some aspects, the second sensor 3108b is configured to detect one or more instrument states, such as the color of the staple cartridge 3106 coupled to the jaw member 3104, the length of the staple cartridge 3106, the clamping state of the end effector 3100, the number of uses / remaining uses of the end effector 3100 and / or the staple cartridge 3106, and / or any other suitable instrument state. The second sensor 3108b may include any suitable sensor for detecting one or more instrument states, such as a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0358] In one aspect, input from the second sensor 3108b can be used to correct the input from the first sensor 3108a. The second sensor 3108b can be configured to detect one or more parameters of the staple cartridge 3106, such as the color and / or length of the staple cartridge 3106. The detected parameters (e.g., the color and / or length of the staple cartridge 3106) can correspond to one or more characteristics of the cartridge, such as the height of the cartridge platform, the usable / optimal tissue thickness for the staple cartridge, and / or the pattern of staples in the staple cartridge 3106. The known parameters of the staple cartridge 3106 can be used to adjust the thickness measurement provided by the first sensor 3108a. For example, if the staple cartridge 3106 has a higher platform height, the thickness measurement provided by the first sensor 3108a can be reduced to compensate for the increased platform height. The adjusted thickness can be displayed to the operator, for example, via a display 2026 coupled to the surgical instrument 10.

[0359] Figure 61One aspect of an end effector 3150 is shown including a first sensor 3158 and a plurality of second sensors 3160a, 3160b. The end effector 3150 includes an anvil, or anvil 3152, and a jaw member 3154. The jaw member 3154 is configured to receive a staple cartridge 3156. The anvil 3152 is pivotally movable relative to the jaw member 3154 to clamp tissue between the anvil 3152 and the staple cartridge 3156. The anvil includes a first sensor 3158. The first sensor 3158 is configured to detect one or more parameters of the end effector 3150, such as, for example, a gap 3110 between the anvil 3152 and the staple cartridge 3156. The gap 3110 may correspond to, for example, the thickness of tissue clamped between the anvil 3152 and the staple cartridge 3156. The first sensor 3158 may include any suitable sensor for detecting one or more parameters of the end effector. For example, in various aspects, the first sensor 3158 may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0360] In some aspects, the end effector 3150 includes a plurality of second sensors 3160a, 3160b. The second sensors 3160a, 3160b are configured to detect one or more parameters of the end effector 3150. For example, in some aspects, the second sensors 3160a, 3160b are configured to measure the magnitude of the strain applied to the anvil 3152 during clamping. In various aspects, the second sensors 3160a, 3160b may include magnetic sensors (such as Hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors. The second sensors 3160a, 3160b may be configured to measure one or more of the same parameters at different locations on the anvil 3152, different parameters at the same location on the anvil 3152, and / or different parameters at different locations on the anvil 3152.

[0361] Figure 62One aspect of an end effector 3200 including a plurality of sensors 3208a-3208d is shown. The end effector 3200 includes an anvil 3202 that is pivotally coupled to a jaw member 3204. The jaw member 3204 is configured to receive a staple cartridge 3206 therein. The anvil 3202 includes a plurality of sensors 3208a-3208d thereon. The plurality of sensors 3208a-3208d are configured to detect one or more parameters of the end effector 3200 (such as the anvil 3202). The plurality of sensors 3208a-3208d may include one or more identical sensors and / or different sensors. The plurality of sensors 3208a-3208d may include, for example, magnetic sensors (such as Hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors or combinations thereof. For example, in one aspect, the plurality of sensors 3208a-3208d may include a plurality of strain gauges.

[0362] In one aspect, multiple sensors 3208a-3208d allow for robust tissue thickness sensing methods. By detecting various parameters along the length of the anvil 3202, multiple sensors 3208a-3208d allow surgical instruments (e.g., surgical instrument 10) to calculate the tissue thickness in the jaws, regardless of the occlusion, e.g., partial or complete. In some aspects, multiple sensors 3208a-3208d include multiple strain gauges configured to measure the strain at various points on the anvil 3202. The amplitude and / or slope of the strain at each of the various points on the anvil 3202 can be used to determine the thickness of the tissue between the anvil 3202 and the staple cartridge 3206. Multiple strain gauges can be configured to optimize the maximum amplitude and / or slope difference based on clamping dynamics to determine thickness, tissue placement, and / or material properties of the tissue. Time-based detection of multiple sensors 3208a-3208d during clamping allows a processor (e.g., the main processor 2006) to utilize algorithms and lookup tables to identify tissue characteristics and clamping positions and dynamically adjust the end effector 3200 and / or the tissue clamped between the anvil 3202 and the staple cartridge 3206.

[0363] Figure 633 is a logic diagram illustrating one aspect of a method 3220 for determining one or more tissue characteristics based on a plurality of sensors 3208a-3208d. In one aspect, the plurality of sensors 3208a-3208d generates a plurality of signals representing one or more parameters of the end effector 3200 (steps 3222a-3222d). The plurality of generated signals are converted into digital signals (steps 3224a-3224d) and provided to a processor. For example, in one aspect including a plurality of strain gauges, a plurality of electronic μStrain (microstrain) conversion circuits convert the strain gauge signals into digital signals (steps 3224a-3224d). The digital signals are provided to a processor, such as the main processor 2006. The main processor 2006 determines one or more tissue characteristics based on the plurality of signals (step 3226). The main processor 2006 may determine the one or more tissue characteristics by applying an algorithm and / or a lookup table. The one or more tissue characteristics are displayed to an operator via, for example, a display 2026 embedded in the surgical instrument 10 (step 3026).

[0364] Figure 64 One aspect of an end effector 3250 is shown that includes a plurality of second sensors 3260a-3260d coupled to a jaw member 3254. The end effector 3250 includes an anvil 3252 pivotally coupled to the jaw member 3254. The anvil 3252 is movable relative to the jaw member 3254 to clamp one or more materials, such as a tissue segment 3264, therebetween. The jaw member 3254 is configured to receive a staple cartridge 3256. A first sensor 3258 is coupled to the anvil 3252. The first sensor is configured to detect one or more parameters of the end effector 3150, such as a gap 3110 between the anvil 3252 and the staple cartridge 3256. The gap 3110 may correspond to, for example, a thickness of tissue clamped between the anvil 3252 and the staple cartridge 3256. The first sensor 3258 may include any suitable sensor for detecting one or more parameters of the end effector. For example, in various aspects, the first sensor 3258 may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0365] A plurality of second sensors 3260a-3260d are coupled to the jaw member 3254. The plurality of second sensors 3260a-3260d can be integrally formed with the jaw member 3254 and / or the staple cartridge 3256. For example, in one aspect, the plurality of second sensors 3260a-3260d are disposed on an outer row of the staple cartridge 3256 (see FIG. Figure 63). The plurality of second sensors 3260a-3260d are configured to detect one or more parameters of the end effector 3250 and / or the tissue segment 3264 clamped between the anvil 3252 and the staple cartridge 3256. The plurality of second sensors 3260a-3260d may comprise any suitable sensor for detecting one or more parameters of the end effector 3250 and / or the tissue segment 3264, for example, a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor or a combination thereof. The plurality of second sensors 3260a-3260d may comprise the same sensor and / or different sensors.

[0366] In some aspects, the plurality of second sensors 3260a-3260d comprise dual-purpose sensors and tissue stabilizing elements. The plurality of second sensors 3260a-3260d comprise electrodes and / or sensing geometries configured to produce a stable tissue state when the plurality of second sensors 3260a-3260d engage the tissue segment 3264, for example, during a clamping operation. In some aspects, one or more of the plurality of second sensors 3260a-3260d can be replaced by a non-sensing tissue stabilizing element. The second sensors 3260a-3260d produce a stable tissue state by controlling tissue flow, staple deformation, and / or other tissue states during clamping, suturing, and / or other processing procedures.

[0367] Figure 65One aspect of a staple cartridge 3270 is shown, comprising a plurality of sensors 3272a-3272h integrally formed therein. The staple cartridge 3270 includes a plurality of rows that accommodate a plurality of apertures for storing staples therein. One or more apertures in an outer row 3278 are replaced by one of the plurality of sensors 3272a-3272h. A cross-sectional portion 3274 is shown to illustrate a sensor 3272f coupled to a sensor wire 3276b. The sensor wires 3276a, 3276b may comprise a plurality of wires for coupling the plurality of sensors 3272a-3272h to one or more circuits of a surgical instrument (e.g., surgical instrument 10). In some aspects, one or more of the plurality of sensors 3272a-3272h comprise a dual-purpose sensor and a tissue stabilizing element having electrodes and / or sensing geometries configured to provide tissue stabilization. In some aspects, the plurality of sensors 3272a-3272h may be replaced and / or replaced by a plurality of tissue stabilizing elements. Tissue stabilization may be provided by, for example, tissue flow and / or staple formation during clamping and / or suturing.A plurality of sensors 3272a-3272h provide signals to one or more circuits of the surgical instrument 10 to enhance feedback for suturing performance and / or tissue thickness sensing.

[0368] Figure 66 is a logic diagram illustrating a method for determining a clamp on an end effector (e.g., Figure 64 3250) within a tissue segment 3264 positioned between an anvil 3252 and a staple cartridge 3256. In one aspect, a first sensor 3258 is configured to detect one or more parameters of the end effector 3250 and / or the tissue segment 3264 positioned between the anvil 3252 and the staple cartridge 3256. A first signal is generated by the first sensor 3258 (step 3282). The first signal represents the one or more parameters detected by the first sensor 3258. One or more second sensors 3260 are configured to detect one or more parameters of the end effector 3250 and / or the tissue segment 3264. Like the first sensor 3258, the second sensor 3260 may be configured to detect the same parameters, additional parameters, or different parameters. A second signal 3284 is generated by the second sensor 3260. The second signal 3284 represents the one or more parameters detected by the second sensor 3260. The first signal and the second signal are provided to a processor, e.g., the main processor 2006. The main processor 2006 adjusts the first signal generated by the first sensor 3258 based on the input generated by the second sensor 3260 (step 3286). The adjusted signal can represent, for example, the true thickness and completeness of occlusion of the tissue segment 3264. The adjusted signal is displayed to the operator via, for example, a display 2026 embedded in the surgical instrument 10 (step 3026).

[0369] Figure 67 An aspect of an end effector 3350 comprising a magnetic sensor 3358 is shown having a specific sampling rate to limit or eliminate false signals. The end effector 3350 includes an anvil, anvil 3352, which can be pivotally coupled to a jaw member 3354. The jaw member 3354 is configured to receive a staple cartridge 3356 therein. The staple cartridge 3356 includes a plurality of staples that can be delivered to a tissue segment positioned between the anvil 3352 and the staple cartridge 3356. The magnetic sensor 3358 is coupled to the anvil 3352. The magnetic sensor 3358 is configured to detect one or more parameters of the end effector 3350, such as a gap 3364 between the anvil 3352 and the staple cartridge 3356. The gap 3364 can correspond to the thickness of a material (e.g., a tissue segment) and / or the completeness of the bite of the material positioned between the anvil 3352 and the staple cartridge 3356. The magnetic sensor 3358 may include any suitable sensor for detecting one or more parameters of the end actuator 3350, such as, a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0370] In one aspect, the magnetic sensor 3358 comprises a magnetic sensor configured to detect a magnetic field generated by an electromagnetic source 3360 coupled to the jaw member 3354 and / or the staple cartridge 3356. The electromagnetic source 3360 generates a magnetic field that is detected by the magnetic sensor 3358. The strength of the detected magnetic field can correspond to, for example, the thickness of tissue positioned between the anvil 3352 and the staple cartridge 3356 and / or the completeness of the bite. In some aspects, the electromagnetic source 3360 generates a signal of a known frequency (e.g., 1 MHz). In other aspects, the magnetic field generated by the electromagnetic source 3360 can be adjusted based on, for example, the type of staple cartridge 3356 mounted in the jaw member 3354, one or more additional sensors, an algorithm, and / or one or more parameters.

[0371] In one aspect, a signal processor 3362 is coupled to the end effector 3350, such as the anvil 3352. The signal processor 3362 is configured to process the signal generated by the magnetic sensor 3358 to eliminate false signals and enhance the input from the magnetic sensor 3358. In some aspects, the signal processor 3362 can be located independently of the end effector 3350, such as within the handle assembly 14 of the surgical instrument 10. In some aspects, the signal processor 3362 is integrally formed with and / or includes an algorithm executed by a general processor (such as the main processor 2006). The signal processor 3362 is configured to process a signal from the magnetic sensor 3358 at a specific frequency that is substantially equal to the frequency of the signal generated by the electromagnetic source 3360. For example, in one aspect, the electromagnetic source 3360 generates a signal at a frequency of 1 MHz. The signal is detected by the magnetic sensor 3358. The magnetic sensor 3358 generates a signal representing the detected magnetic field that is provided to the signal processor 3362. The signal is processed by the signal processor 3362 at a frequency of 1 MHz to eliminate aliasing. The processed signal is provided to a processor, for example, the main processor 2006. The main processor 2006 correlates the received signal with one or more parameters of the end effector 3350, such as the gap 3364 between the anvil 3352 and the staple cartridge 3356.

[0372] Figure 68 is a logic diagram illustrating a method for generating a positioning signal for an end effector such as, Figure 45 One aspect of method 3370 for measuring the thickness of a tissue segment between an anvil and a staple cartridge of an end effector 3350 (shown in FIG. 33 ) is provided. In one aspect of method 3370 , a signal is generated by a modulated electromagnetic source 3360 (step 3372 ). The generated signal may include, for example, a 1 MHz signal. A magnetic sensor 3358 is configured to detect 3374 the signal generated by the electromagnetic source 3360 . The magnetic sensor 3358 generates a signal indicative of the detected magnetic field and provides the signal to a signal processor 3362 . The signal processor 3362 processes the signal (step 3376 ) to remove noise, artifacts, and / or enhance the signal. The processed signal is provided to an analog-to-digital converter for conversion to a digital signal (step 3378 ). Calibration 3380 of the digital signal may be performed, for example, by applying a calibration curve input algorithm and / or a lookup table. The processing (step 3376 ), conversion (step 3378 ), and correction (step 3380 ) may be performed by one or more circuits. The corrected signal is displayed to the user via a display 2026 , for example, formed integrally with the surgical instrument 10 (step 3026 ).

[0373] Figures 69A to 69BOne aspect of an end effector 3800 including a pressure sensor is shown. The end effector 3800 includes an anvil, anvil 3802, pivotally coupled to a jaw member 3804. The jaw member 3804 is configured to receive a staple cartridge 3806 therein. The staple cartridge 3806 includes a plurality of staples. A first sensor 3808 is coupled to the anvil 3802 at a distal end. The first sensor 3808 is configured to detect one or more parameters of the end effector, such as a distance or gap 3814 between the anvil 3802 and the staple cartridge 3806. The first sensor 3808 may include any suitable sensor, such as a magnetic sensor. A magnet 3810 may be coupled to the jaw member 3804 and / or the staple cartridge 3806 to provide a magnetic signal to the magnetic sensor.

[0374] In some aspects, the end effector 3800 includes a second sensor 3812. The second sensor 3812 is configured to detect one or more parameters of the end effector 3800 and / or the tissue segment positioned therebetween. The second sensor 3812 may include any suitable sensor, for example, one or more pressure sensors. The second sensor 3812 may be coupled to the anvil 3802, the jaw member 3804, and / or the staple cartridge 3806. The signal obtained from the second sensor 3812 may be used to adjust the measurement results of the first sensor 3808 to adjust the reading of the first sensor to accurately represent the true compressed tissue thickness of the proximally and / or distally positioned partial bite. In some aspects, the second sensor 3812 may be a substitute for the first sensor 3808.

[0375] In some aspects, the second sensor 3812 can comprise, for example, a single continuous pressure sensing membrane and / or a series of pressure sensing membranes. The second sensor 3812 is coupled to the platform of the staple cartridge 3806 along a central axis, thereby covering a slot 3816 configured to receive a cutting and / or staple deployment member. The second sensor 3812 provides a signal indicative of the magnitude of the pressure applied by the tissue during the clamping operation. During the firing of the cutting and / or deployment member, the signal from the second sensor 3812 can be disconnected, for example, by disconnecting the electrical connection between the second sensor 3812 and one or more circuits. In some aspects, the disconnect current of the second sensor 3812 can indicate a spent staple cartridge 3806. In other aspects, the second sensor 3812 can be positioned such that deployment of the cutting and / or deployment member does not disconnect the second sensor 3812.

[0376] Figure 70One aspect of an end effector 3850 is shown, which includes a second sensor 3862 positioned between a staple cartridge 3806 and a jaw member 3804. The end effector 3850 includes an anvil, anvil 3852, pivotally coupled to a jaw member 3854. The jaw member 3854 is configured to receive a staple cartridge 3856 therein. A first sensor 3858 is coupled to a distal end of the anvil 3852. The first sensor 3858 is configured to detect one or more parameters of the end effector 3850, such as, for example, a distance or gap 3864 between the anvil 3852 and the staple cartridge 3856. The first sensor 3858 may include any suitable sensor, such as a magnetic sensor. A magnet 3860 may be coupled to the jaw member 3854 and / or the staple cartridge 3856 to provide a magnetic signal to the magnetic sensor. In some aspects, the end effector 3850 includes a second sensor 3862 that is similar in all respects to the second sensor except that it is positioned between the staple cartridge 3856 and the jaw member 3854. Figures 69A to 69B The second sensor 3812.

[0377] Figure 71 is a logic diagram that shows the method for determining and displaying the clamped Figures 69A to 69B or Figure 70 One aspect of a method 3870 for measuring the thickness of a tissue segment in an end effector 3800 or 3850 of an anvil 3800 or 3850 is disclosed. The method includes obtaining a Hall effect voltage 3872 via a Hall effect sensor, for example, positioned at the distal end of anvil 3802. The Hall effect voltage 3872 is provided to an analog-to-digital converter 3876 and converted into a digital signal. The digital signal is provided to a processor, such as the main processor 2006. The main processor 2006 calibrates the curve input of the Hall effect voltage 3872 signal (step 3874). A pressure sensor (e.g., the second sensor 3812) is configured to measure, for example, one or more parameters of the end effector 3800 (step 3880), such as the amount of pressure applied by the anvil 3802 to tissue clamped in the end effector 3800. In some aspects, the pressure sensor may include a single continuous pressure sensing diaphragm and / or a series of pressure sensing diaphragms. The pressure sensor may thus be operable to determine changes in measured pressure at different locations between the proximal and distal ends of the end effector 3800. The measured pressure is provided to a processor, such as the main processor 2006. The main processor 2006 adjusts the Hall effect voltage 3872 using one or more algorithms and / or lookup tables in response to the pressure measured by the pressure sensor 3880 (step 3882) to more accurately reflect the thickness of the tissue clamped, for example, between the anvil 3802 and the staple cartridge 3806. The adjusted thickness is displayed to the operator via, for example, the display 2026 embedded in the surgical instrument 10 (step 3878).

[0378] Figure 72 One aspect of an end effector 3900 is shown, which includes a plurality of second sensors 3192a-3192b positioned between a staple cartridge 3906 and an elongated channel 3904. The end effector 3900 includes an anvil 3902 pivotally coupled to a jaw member or elongated channel 3904. The elongated channel 3904 is configured to receive a staple cartridge 3906 therein. The anvil 3902 also includes a first sensor 3908 located in a distal end. The first sensor 3908 is configured to detect one or more parameters of the end effector 3900, such as, for example, a distance or gap between the anvil 3902 and the staple cartridge 3906. The first sensor 3908 may include any suitable sensor, such as a magnetic sensor. A magnet 3910 may be coupled to the elongated channel 3904 and / or the staple cartridge 3906 to provide a magnetic signal to the first sensor 3908. In some aspects, the end effector 3900 includes a plurality of second sensors 3912a-3912c located between the staple cartridge 3906 and the elongated channel 3904. The second sensors 3912a-3912c can include any suitable sensors, such as, for example, piezoresistive pressure membrane strips. In some aspects, the second sensors 3912a-3912c can be evenly distributed between the distal and proximal ends of the end effector 3900.

[0379] In some aspects, the signals obtained from the second sensors 3912a-3912c can be used to adjust the measurements of the first sensor 3908. For example, the signals obtained from the second sensors 3912a-3912c can be used to adjust the readings of the first sensor 3908 to accurately represent the gap between the anvil 3902 and the staple cartridge 3906, which gap can vary between the distal end and the proximal end of the end effector 3900 depending on the position and / or density of the tissue 3920 between the anvil 3902 and the staple cartridge 3906. Figure 11 An example of partial engagement of tissue 3920 is shown. As shown for purposes of this example, tissue is positioned only in the proximal region of the end effector 3900, thereby creating a high pressure region 3918 near the proximal region of the end effector 3900 and a corresponding low pressure region 3916 near the distal end of the end effector.

[0380] Figure 73A and Figure 73B The effect of complete occlusion of tissue 3920 relative to partial occlusion is further illustrated. Figure 73AThe end effector 3900 is shown with full engagement of tissue 3920, wherein the tissue 3920 has a uniform density. With full engagement of tissue 3920 having a uniform density, a first gap 3914a measured at the distal tip of the end effector 3900 may be substantially equal to a second gap 3922a measured in the middle or proximal end of the end effector 3900. For example, the first gap 3914a may measure 2.4 mm, and the second gap may measure 2.3 mm. Figure 73B The end effector 3900 is shown with partial engagement of tissue 3920 or alternatively full engagement of tissue 3920 having uneven density. In this case, the first gap 3914b will measure smaller than the second gap 3922b measured at the thickest or densest portion of the tissue 3920. For example, the first gap may measure 1.0 mm, while the second gap may measure 1.9 mm. Figures 73A to 73B In the case shown, signals from the second sensors 3912a-3912c (such as measured pressure at different points along the length of the end effector 3900) can be used by the instrument to determine the arrangement of the tissue 3920 and / or the material properties of the tissue 3920. The instrument is also operable to utilize the measured pressure over time to identify tissue properties and tissue location and dynamically adjust tissue thickness measurements.

[0381] Figure 74Aspects of an end effector 4050 are shown that are configured to determine the position of a cutting member or knife 4062. The end effector 4050 includes an anvil 4052 pivotally coupled to a jaw member or elongated channel 4054. The elongated channel 4054 is configured to receive a staple cartridge 4056 therein. The staple cartridge 4056 also includes a slot (not shown) and a cutting member or knife 4062 positioned therein. The knife 4062 is operably coupled to a knife bar 4064. The knife bar 4064 is operable to move the knife 4062 from a proximal end of the slot to a distal end. The end effector 4050 may also include an optical sensor 4060 positioned near the proximal end of the slot. The optical sensor may be coupled to a processor, such as the main processor 2006. The optical sensor 4060 may be operable to emit an optical signal toward the knife bar 4064. The knife bar 4064 may also include an encoding strip 4066 along its length. The encoding strip 4066 can include a notch, a notch, a reflective member, or any other optically readable configuration. The encoding strip 4066 is arranged so that the light signal from the optical sensor 4060 is reflected from or passes through the encoding strip 4066. When the knife 4062 moves and the knife bar 4064 moves 4068 along the narrow slot 4058, the optical sensor 4060 will detect the reflection of the emitted light signal coupled to the encoding strip 4066. The optical sensor 4060 is operable to send the detected signal to the main processor 2006. The main processor 2006 can be configured to determine the position of the knife 4062 using the detected signal. The position of the knife 4062 can be more accurately sensed by designing the encoding strip 4066 so that the detected light signal has a gradual increase and decrease.

[0382] Figure 75 An example of an encoder strip 4066 operating in conjunction with a red LED 4070 and an infrared LED 4072 is shown. For purposes of this example only, the encoder strip 4066 includes a notch. As the encoder strip 4066 is moved 4068, the light emitted by the red LED 4070 is interrupted as the notch passes in front of it. The infrared LED 4072 will thus detect the movement of the encoder strip 4066, and by extension, the movement of the knife 4062.

[0383] Figure 76 A partial view of the end effector 300 of the surgical instrument 10 is shown. Figure 76 In the illustrated example form, the end effector 300 includes a staple cartridge 1100 that is similar in many respects to the surgical staple cartridge 304 ( Figure 15 ). Several portions of the end effector 300 are omitted to allow for a clearer understanding of the present disclosure. In some cases, the end effector 300 may include a first jaw (e.g., anvil 306 ( Figure 20 )) and a second jaw (such as, elongated channel 198 ( Figure 14 )). In some cases, as described above, the elongated channel 198 can accommodate a staple cartridge, such as the surgical staple cartridge 304 or the staple cartridge 1100. At least one of the elongated channel 198 and the anvil 306 can be moved relative to the other of the elongated channel 198 and the anvil 306 to capture tissue between the staple cartridge 1100 and the anvil 306. Various actuation assemblies are described herein to facilitate the elongated channel 198 and / or the anvil 306 to be moved, for example, in an open configuration ( Figure 1 ) and closed configuration ( Figure 77 ) between the movements.

[0384] In some cases, as described above, the E-shaped beam 178 can be advanced distally to deploy the staples 191 into the captured tissue and / or the cutting edge 182 can be advanced between multiple locations to engage and cut the captured tissue. Figure 76 As shown, cutting edge 182 can be advanced distally, for example, along a path defined by slot 193. In some cases, cutting edge 182 can be advanced from proximal portion 1103 of staple cartridge 1100 to distal portion 1105 of staple cartridge 1100 to cut captured tissue. In some cases, cutting edge 182 can be retracted proximally from distal portion 1105 to proximal portion 1103, for example, by retracting E-shaped cross-beam 178 proximally.

[0385] In some cases, the cutting edge 182 may be employed to cut tissue captured by the end effector 300 during multiple procedures. The reader will appreciate that repeated use of the cutting edge 182 may affect the sharpness of the cutting edge 182. The reader will also appreciate that as the sharpness of the cutting edge 182 decreases, the force required to cut the captured tissue using the cutting edge 182 may increase. Figures 78 to 83 In some cases, the surgical instrument 10 may include circuit 1106 ( Figure 78 ) for monitoring the sharpness of cutting edge 182, e.g., during, before, and / or after operation of surgical instrument 10 during a surgical procedure. In some cases, circuit 1106 may be employed to test the sharpness of cutting edge 182 before cutting captured tissue with cutting edge 182. In some cases, circuit 1106 may be employed to test the sharpness of cutting edge 182 after cutting edge 182 has been used to cut captured tissue. In some cases, circuit 1106 may be employed to test the sharpness of cutting edge 182 both before and after cutting edge 182 is used to cut captured tissue. In some cases, circuit 1106 may be employed to test the sharpness of cutting edge 182 at proximal portion 1103 and / or distal portion 1105.

[0386] See also Figures 78 to 83, the circuit 1106 may include one or more sensors, such as an optical sensor 1108; for example, the optical sensor 1108 of the circuit 1106 may be used to test the reflective ability of the cutting edge 182. In some cases, the ability of the cutting edge 182 to reflect light may be associated with the sharpness of the cutting edge 182. In other words, a reduction in the sharpness of the cutting edge 182 may result in a reduction in the ability of the cutting edge 182 to reflect light. Therefore, in some cases, the dullness of the cutting edge 182 may be assessed, for example, by detecting the intensity of light reflected from the cutting edge 182. In some cases, the optical sensor 1108 may define a light sensing area. The optical sensor 1108 may, for example, be oriented so that the light sensing area is disposed in the path of the cutting edge 182. When the cutting edge 182 is, for example, located in the light sensing area, the optical sensor 1108 may be used to sense the light reflected from the cutting edge 182. A reduction in the intensity of the reflected light below a threshold value may indicate that the sharpness of the cutting edge 182 has been reduced to below an acceptable level.

[0387] See again Figures 78-83 , the circuit 1106 may include one or more light sources, such as light source 1110. In some cases, the circuit 1106 may include a controller 1112 ("microcontroller") that is operably coupled to the optical sensor 1108, such as Figures 78 to 83 As shown. In some cases, the controller 1112 may include a processor 1114 ("microprocessor") and one or more computer-readable media or memories 1116 ("storage units"). In some cases, the memory 1116 may store various program instructions that, when executed, may cause the processor 1114 to perform the various functions and / or calculations described herein. In some cases, the memory 1116 may be coupled to the processor 1114, for example. The power source 1118 may be configured to provide power to the controller 1112, the optical sensor 1108, and / or the light source 1110, for example. In some cases, the power source 1118 may include a battery (or "battery pack" or "power pack"), for example, a lithium-ion battery. In some cases, the battery pack may be configured to be releasably mounted to the handle assembly 14 for supplying power to the surgical instrument 10. A plurality of battery cells connected in series may be used as the power source 4428. In some cases, the power source 1118 may be, for example, replaceable and / or rechargeable.

[0388] Controller 1112 and / or other controllers of the present disclosure may be implemented using integrated and / or discrete hardware elements, software elements, and / or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, controllers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, controllers, SoCs, and / or SIPs. Examples of discrete hardware elements may include circuits and / or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and / or relays. In some cases, for example, controller 1112 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates. In some cases, such as in combination with Figures 14 to 17B As described, the controller 1112 and / or other controllers of the present disclosure may be a single-core or multi-core controller LM4F230H5QR.

[0389] In some cases, the light source 1110 can be used to emit light that can be directed, for example, to the cutting edge 182 in the light sensing region. The optical sensor 1108 can be used to measure the intensity of light reflected from the cutting edge 182 in the light sensing region in response to exposure to the light emitted by the light source 1110. In some cases, the processor 1114 can receive one or more values of the measured intensity of the reflected light and can store the one or more values of the measured intensity of the reflected light on, for example, a memory 1116. The stored values can be detected and / or recorded, for example, before, after, and / or during a surgical procedure performed by the surgical instrument 10.

[0390] In some cases, the processor 1114 may compare the measured intensity of the reflected light to a predefined threshold value, which may be stored, for example, in the memory 1116. In some cases, if the measured light intensity exceeds a predefined threshold value, such as 1%, 5%, 10%, 25%, 50%, 100%, and / or more than 100%, the controller 1112 may conclude that the sharpness of the cutting edge 182 has fallen below an acceptable level. In some cases, the processor 1114 may be configured to detect a downward trend in the stored value of the measured intensity of light reflected from the cutting edge 182 in the light sensing region.

[0391] In some cases, the surgical instrument 10 may include one or more feedback systems, such as a feedback system 1120. In some cases, if the measured light intensity of the light reflected from the cutting edge 182 in the light sensing area exceeds a stored threshold, for example, the processor 1114 may employ the feedback system 1120 to alert the user. In some cases, the feedback system 1120 may include, for example, one or more visual feedback systems, such as a display screen, a backlight, and / or an LED. In some cases, the feedback system 1120 may include, for example, one or more auditory feedback devices, such as a speaker and / or a buzzer. In some cases, the feedback system 1120 may include, for example, one or more tactile feedback systems. In some cases, the feedback system 1120 may include, for example, a combination of a visual feedback system, an auditory feedback system, and / or a tactile feedback system.

[0392] In some cases, the surgical instrument 10 may include a firing lockout mechanism 1122 that can be used to prevent advancement of the cutting edge 182. Various suitable firing lockout mechanisms are described in more detail in U.S. Patent Publication No. 2014 / 0001231, entitled "FIRING SYSTEM LOCKOUT ARRANGEMENTS FOR SURGICALINSTRUMENTS," the disclosure of which is incorporated herein by reference in its entirety. Figure 78 As shown, the processor 1114 can be operably coupled to a firing lockout mechanism 1122; if it is determined that the measured intensity of light reflected from the cutting edge 182 exceeds, for example, a stored threshold, the processor 1114 can employ the firing lockout mechanism 1122 to prevent advancement of the cutting edge 182. In other words, if the cutting edge is not sharp enough to cut tissue captured by the end effector 300, the processor 1114 can activate the firing lockout mechanism 1122.

[0393] In some cases, the optical sensor 1108 and the light source 1110 may be housed at the distal portion of the interchangeable shaft assembly 200. In some cases, as described above, the sharpness of the cutting edge 182 may be assessed by the optical sensor 1108 before the cutting edge 182 transitions into the end effector 300. When, for example, the cutting edge 182 is in the interchangeable shaft assembly 182 and before entering the end effector 300, the firing rod 172 ( Figure 14 ) can advance the cutting edge 200 through the light sensing area defined by the optical sensor 1108. In some cases, the sharpness of the cutting edge 182 can be evaluated by the optical sensor 1108 after the cutting edge 182 is retracted proximally from the end effector 300. When, for example, the cutting edge 182 is retracted from the end effector 300 into the interchangeable shaft assembly 200, the firing rod 172 ( Figure 14) The retractable cutting edge 182 passes through the light sensing area defined by the optical sensor 1108.

[0394] In some cases, the optical sensor 1108 and the light source 1110 can be housed, for example, at a proximal portion of the end effector 300, which can be located proximal to the staple cartridge 1100. The sharpness of the cutting edge 182 can be assessed by the optical sensor 1108, for example, after the cutting edge 182 transitions into the end effector 300 but before engaging the staple cartridge 1100. In some cases, the firing rod 172 ( Figure 14 ) can advance the cutting edge 182 through the light sensing area defined by the optical sensor 1108.

[0395] In various circumstances, the sharpness of the cutting edge 182 can be assessed by the optical sensor 1108 as the cutting edge 182 is advanced through the slot 193 by the firing rod 172. Figures 78 to 83 As shown, the optical sensor 1108 and the light source 1110 can be housed in, for example, the proximal portion 1103 of the staple cartridge 1100; the sharpness of the cutting edge 182 can be assessed by, for example, the optical sensor 1108 at the proximal portion 1103. Figure 14 ) can, for example, advance cutting edge 182 through a light sensing region defined by optical sensor 1108 at proximal portion 1103 before cutting edge 182 engages tissue captured between staple cartridge 1100 and anvil 306. In some cases, such as Figures 78 to 83 As shown, the optical sensor 1108 and the light source 1110 can be housed at, for example, the distal portion 1105 of the staple cartridge 1100. The sharpness of the cutting edge 182 can be assessed by the optical sensor 1108 at the distal portion 1105. In some cases, the firing rod 172 ( Figure 14 ) can advance the cutting edge 182 through the light sensing area defined by the optical sensor 1108 at the distal portion 1105, for example, after the cutting edge 182 has passed through tissue captured between the staple cartridge 1100 and the anvil 306.

[0396] See again Figure 76 , the staple cartridge 1100 may include, for example, a plurality of optical sensors 1108 and a plurality of corresponding light sources 1110. In some cases, a pair of optical sensors 1108 and light sources 1110 may be housed, for example, at the distal portion 1103 of the staple cartridge 1100; and a pair of optical sensors 1108 and light sources 1110 may be housed, for example, at the proximal portion 1105 of the staple cartridge 1100. In such cases, the sharpness of the cutting edge 182 may be first assessed at the proximal portion 1103, for example, prior to engaging tissue, and a second assessed at the distal portion 1105, for example, after passing through the captured tissue.

[0397] The reader will appreciate that the optical sensor 1108 can assess the sharpness of the cutting edge 182 multiple times during a surgical procedure. For example, the sharpness of the cutting edge can be assessed a first time, such as during the firing stroke, while the cutting edge 182 is advanced through the slot 193, and a second time, such as during the return stroke, while the cutting edge 182 is retracted through the slot 193. In other words, light reflected from the cutting edge 182 can be measured by the optical sensor 1108 once, such as when the cutting edge is advanced through the light sensing region, and once when the cutting edge 182 is retracted through the light sensing region.

[0398] The reader will appreciate that the processor 1114 may receive multiple readings of the intensity of light reflected from the cutting edge 182 from one or more of the optical sensors 1108. In some cases, the processor 1114 may be configured to, for example, ignore outliers and calculate an average reading from the multiple readings. In some cases, the average reading may be compared to, for example, a threshold stored in the memory 1116. In some cases, the processor 1114 may be configured to, for example, alert a user via the feedback system 1120 and / or activate the lockout mechanism 1122 if it is determined that the calculated average reading exceeds a threshold stored in the memory 1116.

[0399] In some cases, such as Figure 77 、 Figure 79 ,and Figure 80 As shown, a pair of optical sensors 1108 and light sources 1110 can be positioned on opposite sides of the staple cartridge 1100. In other words, the optical sensor 1108 can be positioned, for example, on a first side 1124 of the slot 193, and the light source 1110 can be positioned, for example, on a second side 1126 of the slot 193 (opposite the first side 1124). In some cases, the pair of optical sensors 1108 and light sources 1110 can be disposed substantially in a plane that intersects the staple cartridge 1100, such as Figure 77 As shown. The pair of optical sensors 1108 and light sources 1110 can be oriented to define a light sensing area that is, for example, positioned on or at least substantially positioned on a plane that traverses the staple cartridge 1100. Alternatively, the pair of optical sensors 1108 and light sources 1110 can be oriented to define a light sensing area that is, for example, positioned proximal to a plane that traverses the staple cartridge 1100, as shown. Figure 80 shown.

[0400] In some cases, a pair of optical sensors 1108 and light sources 1110 may be positioned on the same side of the staple cartridge 1100. In other words, Figure 81As shown, the pair of optical sensors 1108 and light sources 1110 can be positioned on a first side of the cutting edge 182, e.g., side 1128, as the cutting edge 182 is advanced through the slot 193. In this case, the light source 1110 can be oriented to direct light at the side 1128 of the cutting edge 182; and the intensity of the light reflected from the side 1128 measured by the optical sensor 1108 can indicate the sharpness of the side 1128.

[0401] In some cases, such as Figure 82 As shown, a second pair of optical sensors 1108 and light sources 1110 can be positioned, for example, on a second side of the cutting edge 182, such as side 1130. This second pair can be used to assess the sharpness of side 1130. For example, the second pair of light sources 1110 can be oriented to direct light at side 1130 of the cutting edge 182; and the intensity of light reflected from side 1130 measured by the second pair of optical sensors 1108 can be indicative of the sharpness of side 1130. In some cases, the processor can be configured to assess the sharpness of the cutting edge 182 based on, for example, the measured intensity of light reflected from sides 1128 and 1130 of the cutting edge 182.

[0402] In some cases, such as Figure 77 As shown, a pair of optical sensors 1108 and a light source 1110 can be housed at the distal portion 1105 of the staple cartridge 1100. Figure 81 As shown, the optical sensor 1108 can be positioned, for example, or at least substantially positioned, on an axis LL that extends longitudinally along the path of the cutting edge 182 through the slot 193. Additionally, the light source 1110 can be positioned, for example, distal to the cutting edge 182 and oriented to direct light toward the cutting edge 182 as the cutting edge advances toward the light source 1110. Additionally, the optical sensor 1108 can be positioned, or at least substantially positioned, on an axis AA that intersects the axis LL, as shown. Figure 81 In some cases, axis AA may be, for example, perpendicular to axis LL. In any case, optical sensor 1108 may be oriented to define a light sensing region at, for example, the intersection of axis LL and axis AA.

[0403] The reader will appreciate that the positions, orientations, and / or numbers of optical sensors and corresponding light sources associated with surgical instrument 10 described herein are exemplary aspects intended for illustrative purposes. Various other arrangements of optical sensors and light sources may be employed to assess the sharpness of cutting edge 182.

[0404] The reader will appreciate that during each firing of the surgical instrument 10, the advancement of the cutting edge 182 through tissue captured by the end effector 300 may cause the cutting edge to collect tissue debris and / or bodily fluids. Such debris may interfere with the ability of the circuit 1106 to accurately assess the sharpness of the cutting edge 182. In some cases, the surgical instrument 10 may be equipped with one or more cleaning mechanisms that can be used to clean the cutting edge 182, for example, before assessing the sharpness of the cutting edge 182.

[0405] See also Figure 76 In some cases, the staple cartridge 1100 can include, for example, a first pair of optical sensors 1108 and a light source 1110 that can be housed in the proximal portion 1103 of the staple cartridge 1100. Figure 76 As shown, staple cartridge 1100 can include a first pair of cleaning members 1132 that can be received on opposite sides of slot 193 in proximal portion 1103. First pair of cleaning members 1132 can be positioned distal to first pair of optical sensors 1108 and light sources 1110, for example. Figure 76 As shown, the staple cartridge 1100 can include a second pair of optical sensors 1108 and a light source 1110, for example, which can be housed in the distal portion 1105 of the staple cartridge 1100. Figure 76 As shown, staple cartridge 1100 can include a second pair of cleaning members 1132 receivable on opposing sides of slot 193 in distal portion 1105. Second pair of cleaning members 1132 can be positioned proximal to second pair of optical sensors 1108 and light sources 1110.

[0406] In addition to the above, if Figure 76 As shown, cutting edge 182 can be advanced distally during the firing stroke to cut tissue captured by end effector 300. As cutting edge 182 is advanced, a first assessment of the sharpness of cutting edge 182 can be performed, for example, by first pair of optical sensors 1108 and light source 1110, before cutting edge 182 engages tissue. A second assessment of the sharpness of cutting edge 182 can be performed, for example, after cutting edge 182 has transected the captured tissue, by second pair of optical sensors 1108 and light source 1110. Cutting edge 182 can be advanced through second pair of cleaning members 1132 prior to the second assessment of the sharpness of cutting edge 182 to remove any debris collected by cutting edge 182 during transecting of the captured tissue.

[0407] In addition to the above, if Figure 76As shown, cutting edge 182 can be retracted proximally during the return stroke. As cutting edge 182 is retracted, a third assessment of the sharpness of cutting edge 182 can be performed during the return stroke by first pair of optical sensors 1108 and light source 1110. Cutting edge 182 can be advanced through first pair of cleaning members 1132, for example, prior to the third assessment of the sharpness of cutting edge 182, to remove any debris collected by cutting edge 182 during transection of captured tissue.

[0408] In some cases, one or more of the light sources 1110 can include one or more fiber optic cables. In some cases, one or more flex circuits 1134 can be used to transmit energy from the power source 1118 to the optical sensor 1108 and / or the light sources 1110. In some cases, the flex circuits 1134 can be configured to transmit one or more of the readings from the optical sensor 1108 to the controller 1112, for example.

[0409] Now see Figure 84 , showing a staple cartridge 4300. The staple cartridge 4300 is similar in many respects to the surgical staple cartridge 304 ( Figure 14 ). For example, the staple cartridge 4300 can be used with the end effector 300. In some cases, such as Figure 84 As shown, the staple cartridge 4300 may include a sharpness testing member 4302 that can be used to test the sharpness of the cutting edge 182. In some cases, the sharpness testing member 4302 can be attached to and / or integral with the cartridge body 194 of the staple cartridge 4300, for example. In some cases, the sharpness testing member 4302 can be disposed in the proximal portion 1103 of the staple cartridge 4300, for example. In some cases, as shown, the sharpness testing member 4302 can be attached to and / or integral with the cartridge body 194 of the staple cartridge 4300, for example. Figure 84 As shown, the sharpness testing member 4302 can be disposed on a cartridge deck 4304 of a staple cartridge 4300 , for example.

[0410] In some cases, such as Figure 84As shown, the sharpness testing member 4302 can, for example, extend across the slot 193 of the staple cartridge 4300 to bridge or at least partially bridge the gap defined by the slot 193. In some cases, the sharpness testing member 4302 can interrupt or at least partially interrupt the path of the cutting edge 182. When the cutting edge 182 is advanced, for example, during a firing stroke, the cutting edge 182 can engage, cut, and / or pass through the sharpness testing member 4302. In some cases, the cutting edge 182 can be configured to engage, cut, and / or pass through the sharpness testing member 4302, for example, during a firing stroke, before engaging tissue captured by the end effector 300. In some cases, the cutting edge 182 can be configured to engage the sharpness testing member 4302, for example, at its proximal end 4306, and to exit and / or disengage from the sharpness testing member 4302 at its distal end 4308. In certain circumstances, as the cutting edge 182 is advanced during the firing stroke, the cutting edge 182 may travel and / or cut a distance (D) between the proximal end 4306 and the distal end 4308, for example, through the sharpness test member 4302.

[0411] Main references Figure 84 and Figure 85 , the surgical instrument 10 may include, for example, a circuit 4310 for testing the sharpness of the cutting edge 182. In some cases, the circuit 4310 may assess the sharpness of the cutting edge 182 by testing the ability of the cutting edge 182 to advance through the sharpness testing member 4302. For example, the circuit 4310 may be configured to observe the time period required for the cutting edge 182 to completely transect and / or completely pass through at least a predetermined portion of the sharpness testing member 4302. If the observed time period exceeds a predefined threshold, the circuit 4310 may conclude that the sharpness of the cutting edge 182 has fallen below an acceptable level, for example. ...

Claims

1. A medical device, comprising: an elongated channel configured to support a staple cartridge comprising a plurality of staples; an anvil mechanically coupled to the elongated channel, wherein the anvil includes an outer surface extending between a proximal end and a distal end; at least one electrical circuit positioned at least partially on the outer surface of the anvil and comprising: a first conductive circuit element positioned within the first staple-forming pocket; a second conductive circuit element positioned within the second staple-forming pocket; and; an indicator system comprising at least one indicator; and a logic circuit in electrical communication with the at least one electrical circuit and the indicator system, wherein the logic circuit is configured to activate the at least one indicator when electrical continuity of the at least one electrical circuit is interrupted; and wherein portions of the at least one electrical circuit other than the first conductive circuit element and the second conductive circuit element are capable of: Armored with a protective outer layer; layered and / or running beneath the tissue contacting surface of the anvil; or Running in thin channels that are too thin for the staple legs to penetrate; and The first conductive circuit element and the second conductive circuit element are not any of the following: Armored with a protective outer layer; layered and / or running beneath the tissue contacting surface of the anvil; or Runs in thin channels that are too thin for the staple legs to penetrate.

2. The medical device of claim 1 , wherein the outer surface of the anvil comprises at least one staple forming recess, and wherein the at least one electrical circuit comprises at least one portion positioned on the outer surface adjacent the at least one staple forming recess.

3. The medical device of claim 2, wherein the at least one indicator is activated when the at least one portion is destroyed.

4. The medical device of claim 1, wherein the outer surface of the anvil comprises an outer edge, and wherein the at least one electrical circuit comprises at least one portion positioned on the outer edge.

5. The medical device of claim 4, wherein the at least one indicator is activated when the at least one portion is destroyed.

6. The medical device of Claim 1, wherein the outer surface of the anvil comprises at least one staple forming pocket, and wherein the at least one electrical circuit comprises at least one portion on the outer surface positioned within the at least one staple forming pocket.

7. The medical device of claim 6, wherein the at least one indicator is activated when the at least one portion is destroyed.

8. The medical device of claim 1, wherein the at least one indicator is positioned on the outer surface of the anvil.

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